Federal Register Vol. 81, No.21,

Federal Register Volume 81, Issue 21 (February 2, 2016)

Page Range5365-5571
FR Document

81_FR_21
Current View
Page and SubjectPDF
81 FR 5569 - Delegation of Certain Authority and Assignment of Certain Functions Under Section 103(a)(1)(A) and Section 103(b)(1) of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015PDF
81 FR 5489 - Sunshine Act Meetings; National Science BoardPDF
81 FR 5418 - Initiation of Five-Year (“Sunset”) ReviewPDF
81 FR 5440 - Revised Filing Window Dates for FCC Form 175 Application To Participate in the Forward Auction (Auction 1002)PDF
81 FR 5419 - Availability of Seats for National Marine Sanctuary Advisory CouncilsPDF
81 FR 5506 - Sunshine Act MeetingPDF
81 FR 5520 - West Los Angeles VA Medical Center; Draft Master PlanPDF
81 FR 5447 - Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment PeriodPDF
81 FR 5507 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
81 FR 5507 - Connecticut Disaster #CT-00037PDF
81 FR 5506 - Military Reservist Economic Injury Disaster Loans Interest Rate for Second Quarter FY 2016PDF
81 FR 5508 - Small Business Investment Companies-Early Stage SBICsPDF
81 FR 5507 - Region III-Charleston, WV; Regulatory Fairness HearingPDF
81 FR 5514 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel HAWK; Invitation for Public CommentsPDF
81 FR 5511 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NN59; Invitation for Public CommentsPDF
81 FR 5515 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PAU HANA; Invitation for Public CommentsPDF
81 FR 5512 - Inventory of U.S.-Flag Launch BargesPDF
81 FR 5484 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on CHEDE-VIIPDF
81 FR 5515 - Request for Comments of a Previously Approved Information CollectionPDF
81 FR 5514 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel Altitude Adjustment (Traveller); Invitation for Public CommentsPDF
81 FR 5475 - Agency Information Collection Activities: Application to Replace Permanent Resident Card, Form I-90; Revision of a Currently Approved CollectionPDF
81 FR 5477 - Agency Information Collection Activities: Request for the Return of Original Documents (Form G-884); Revision of an Existing Information Collection; Comment RequestPDF
81 FR 5505 - Submission for OMB Review; Comments RequestPDF
81 FR 5424 - DoD Board of Actuaries; Notice of Federal Advisory Committee MeetingPDF
81 FR 5423 - DoD Medicare-Eligible Retiree Health Care Board of Actuaries; Notice of Federal Advisory Committee MeetingPDF
81 FR 5488 - Notice of Information CollectionPDF
81 FR 5442 - LabMD, Inc. Oral Argument Before the CommissionPDF
81 FR 5381 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Pot Catcher/Processors in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 5486 - Comment Request for Information Collection for the Trade Activity Participant Report (TAPR), Extension Without RevisionsPDF
81 FR 5485 - Change of Address for the National Prevailing Wage Center: Prevailing Wage Determination Requests for Use in the E-3, H-1B, H-1B1, H-2B, and Permanent/“Green Card” Visa ProgramsPDF
81 FR 5487 - Assessing the Goals in the Strategic Plan 2012-2016; Request for Comments; CorrectionPDF
81 FR 5431 - Agency Information Collection Activities; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data CollectionPDF
81 FR 5420 - Pacific Fishery Management Council; Public MeetingPDF
81 FR 5421 - New England Fishery Management Council; Public MeetingPDF
81 FR 5478 - Endangered and Threatened Wildlife and Plants; Permit ApplicationsPDF
81 FR 5480 - Notice of Meeting of the Northwest Oregon Resource Advisory CouncilPDF
81 FR 5516 - Office of the Assistant Secretary for Research and Technology; University Transportation Centers Program CompetitionPDF
81 FR 5448 - Medicaid Program; Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital LimitsPDF
81 FR 5444 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extended Temporary Moratoria on Enrollment of Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsPDF
81 FR 5479 - Endangered and Threatened Wildlife and Plants; Recovery Permit ApplicationsPDF
81 FR 5442 - Statement of Organization, Functions, and Delegations of AuthorityPDF
81 FR 5425 - Applications for New Awards; Educational Opportunity Centers ProgramPDF
81 FR 5463 - Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral ProhibitionPDF
81 FR 5527 - Commission on CarePDF
81 FR 5520 - Sanctions Actions Pursuant to Executive Orders 13224PDF
81 FR 5420 - Marine Mammals; File No. 15510PDF
81 FR 5518 - Proposed Collection; Comment Request; Bank Secrecy Act Currency Transaction Report (BCTR) Revised Layout and Proposed Additional Data FieldsPDF
81 FR 5439 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 5441 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 5439 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 5440 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 5473 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal AgenciesPDF
81 FR 5472 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 5473 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingsPDF
81 FR 5473 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 5481 - Native American Graves Protection and Repatriation Review Committee; MeetingsPDF
81 FR 5481 - Wekiva River System Advisory Management Committee 2016 Meeting SchedulePDF
81 FR 5378 - Transferring Certain Dispute Resolution Service Matters to the Commission's Landowner HelplinePDF
81 FR 5435 - Green Mountain Power Corporation; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 5432 - Brookfield White Pine Hydro LLC; Notice of Intent To File License Application, Filing of Pre-Application Document (PAD), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the Pad and Scoping Document, and Identification of Issues and Associated Study Requests; and Scoping MeetingPDF
81 FR 5432 - Notice of Commission Staff AttendancePDF
81 FR 5434 - Bethel Wind Farm LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 5432 - Notice of Commission Half-Day ClosingPDF
81 FR 5438 - Notice Concerning Submissions Made During Federal Government ClosuresPDF
81 FR 5438 - NRG Wholesale Generation LP; Seward Generation, LLC: Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 5436 - Cheniere Corpus Christi Pipeline, L.P.; Notice of Request Under Blanket AuthorizationPDF
81 FR 5438 - Iroquois Gas Transmission System, L.P.; Notice of ApplicationPDF
81 FR 5436 - Combined Notice of Filings #1PDF
81 FR 5433 - Combined Notice of Filings #2PDF
81 FR 5437 - Combined Notice Of Filings #1PDF
81 FR 5434 - Columbia Gulf Transmission, LLC; Notice of Initiation of Section 5 ProceedingPDF
81 FR 5432 - Iroquois Gas Transmission System, L.P.; Notice of Initiation of Section 5 ProceedingPDF
81 FR 5436 - Empire Pipeline, Inc.; Notice of Initiation of Section 5 ProceedingPDF
81 FR 5436 - Tuscarora Gas Transmission Company; Notice of Initiation of Section 5 ProceedingPDF
81 FR 5474 - Agency Information Collection Activities: Application for Citizenship and Issuance of Certificate Under Section 322, Form N-600K; Revision of a Currently Approved CollectionPDF
81 FR 5476 - Agency Information Collection Activities: Application of Certificate of Citizenship, Form N-600, Form N-600; Revision of a Currently Approved CollectionPDF
81 FR 5484 - Certain Magnesia Carbon Bricks From China and MexicoPDF
81 FR 5478 - 30-Day Notice of Proposed Information Collection: Disaster ManagementPDF
81 FR 5397 - Medicare Program: Expanding Uses of Medicare Data by Qualified EntitiesPDF
81 FR 5467 - The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials WorkshopPDF
81 FR 5470 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco ProductsPDF
81 FR 5470 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered PlantsPDF
81 FR 5468 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local CapacitiesPDF
81 FR 5469 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and NotificationPDF
81 FR 5467 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar ApplicationsPDF
81 FR 5465 - Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be InfringedPDF
81 FR 5469 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring CommitteesPDF
81 FR 5468 - Regulatory Site Visit Training ProgramPDF
81 FR 5423 - Agency Information Collection Activities; Submission for OMB Review; Comment Request-Baby Bouncers and Walker-JumpersPDF
81 FR 5369 - Commission Participation and Commission Employee Involvement in Voluntary Standards ActivitiesPDF
81 FR 5488 - Request for Comment Regarding National Credit Union Administration Draft 2017-2021 Strategic PlanPDF
81 FR 5421 - Agency Information Collection Activities Under OMB ReviewPDF
81 FR 5422 - Agency Information Collection Activities Under OMB ReviewPDF
81 FR 5484 - Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Campus Program Grantee Needs and Progress Assessment ToolPDF
81 FR 5495 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
81 FR 5395 - Airworthiness Directives; Turbomeca S.A. Turboshaft EnginesPDF
81 FR 5367 - Airworthiness Directives; Bell Helicopter Textron Canada LimitedPDF
81 FR 5365 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 5480 - Notice of Public Meetings, Northwest Resource Advisory Council MeetingPDF
81 FR 5383 - Coordination of Federal Authorizations for Electric Transmission FacilitiesPDF
81 FR 5487 - Discount Rates for Cost-Effectiveness Analysis of Federal ProgramsPDF
81 FR 5529 - Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home HealthPDF
81 FR 5505 - Nanotechnology Commercialization Success StoriesPDF
81 FR 5489 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards InformationPDF
81 FR 5380 - Revitalization of the AM Radio ServicePDF

Issue

81 21 Tuesday, February 2, 2016 Contents Antitrust Division Antitrust Division NOTICES Membership Changes under the National Cooperative Research and Production Act: Cooperative Research Group on CHEDE-VII, 5484 2016-01870 Centers Disease Centers for Disease Control and Prevention NOTICES Statements of Organization, Functions, and Delegations of Authority, 5442-5444 2016-01833 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicaid Program: Face-to-Face Requirements for Home Health Services, 5530-5567 2016-01585 PROPOSED RULES Medicare Program: Expanding Uses of Medicare Data by Qualified Entities, 5397-5417 2016-01790 NOTICES Medicaid Program: Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital Limits, 5448-5463 2016-01836 Medicare Programs: Request for an Exception to the Prohibition on Expansion of Facility Capacity under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition, 5463-5465 2016-01830 Medicare, Medicaid, and Children's Health Insurance Programs: Extended Temporary Moratoria on Enrollment of Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations, 5444-5447 2016-01835 Requests for Information: Certification Frequency and Requirements for the Reporting of Quality Measures under CMS Programs; Extension of Comment Period, 5447-5448 2016-01937 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5421-5423 2016-01774 2016-01773 Consumer Product Consumer Product Safety Commission RULES Commission Participation and Commission Employee Involvement in Voluntary Standards Activities, 5369-5378 2016-01778 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Baby Bouncers and Walker-Jumpers, 5423 2016-01779 Defense Department Defense Department NOTICES Meetings: DoD Board of Actuaries, 5424-5425 2016-01855 DoD Medicare-Eligible Retiree Health Care Board of Actuaries, 5423-5424 2016-01854 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection, 5431-5432 2016-01844 Applications for New Awards: Educational Opportunity Centers Program, 5425-5431 2016-01832 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Trade Activity Participant Report, 5486-5487 2016-01849 Change of Address: National Prevailing Wage Center, 5485-5486 2016-01848 Energy Department Energy Department See

Federal Energy Regulatory Commission

PROPOSED RULES Coordination of Federal Authorizations for Electric Transmission Facilities, 5383-5395 2016-01641
Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bell Helicopter Textron Canada Limited, 5367-5369 2016-01747 Bombardier, Inc. Airplanes, 5365-5367 2016-01741 PROPOSED RULES Airworthiness Directives: Turbomeca S.A. Turboshaft Engines, 5395-5397 2016-01770 Federal Communications Federal Communications Commission RULES Revitalization of the AM Radio Service, 5380-5381 2016-01321 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5439-5442 2016-01821 2016-01822 2016-01823 2016-01824 Revised Filing Window Dates, 5440 2016-01980 Federal Energy Federal Energy Regulatory Commission RULES Transferring Certain Dispute Resolution Service Matters to the Commission's Landowner Helpline, 5378-5380 2016-01812 NOTICES Applications: Brookfield White Pine Hydro, LLC, 5432-5433 2016-01810 Green Mountain Power Corp., 5435 2016-01811 Iroquois Gas Transmission System, LP, 5438 2016-01802 Combined Filings, 5433-5434, 5436-5438 2016-01799 2016-01800 2016-01801 Commission Half-Day Closing, 5432 2016-01806 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Bethel Wind Farm, LLC, 5434-5435 2016-01808 Initiation of Section 5 Proceedings: Columbia Gulf Transmission, LLC, 5434 2016-01798 Empire Pipeline, Inc., 5436 2016-01796 Iroquois Gas Transmission System, LP, 5432 2016-01797 Tuscarora Gas Transmission Co., 5436 2016-01795 Refund Effective Dates: NRG Wholesale Generation LP; Seward Generation, LLC, 5438 2016-01804 Requests under Blanket Authorization: Cheniere Corpus Christi Pipeline, LP, 5436-5437 2016-01803 Staff Attendances, 5432 2016-01809 Submissions Made During Federal Government Closures, 5438-5439 2016-01805 Federal Trade Federal Trade Commission NOTICES Meetings: LabMD, Inc.; Oral Argument Before the Commission, 5442 2016-01852 Financial Crimes Financial Crimes Enforcement Network NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Bank Secrecy Act Currency Transaction Report Revised Layout and Proposed Additional Data Fields, 5518-5519 2016-01825 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Recovery Permit Applications, 5479-5480 2016-01834 Endangered and Threatened Wildlife and Plants; Permit Applications, 5478-5479 2016-01840 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applications for Approval to Market a New Drug—Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications, etc., 5465-5467 2016-01782 Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products, 5470-5472 2016-01788 Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committees, 5469 2016-01781 Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, 5469 2016-01784 Improving Food Safety and Defense Capacity of the State and Local Level; Review of State and Local Capacities, 5468 2016-01785 Section 351(k) Biosimilar Applications, 5467 2016-01783 Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants, 5470 2016-01786 Meetings: Arthritis Foundation—Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop, 5467-5468 2016-01789 Regulatory Site Visit Training Program, 5468-5469 2016-01780 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 5520 2016-01828 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

U.S. Citizenship and Immigration Services

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Disaster Management, 5478 2016-01791 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews, 5418-5419 2016-01999 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Certain Magnesia Carbon Bricks from China and Mexico, 5484 2016-01792 Justice Department Justice Department See

Antitrust Division

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Campus Program Grantee Needs and Progress Assessment Tool, 5484-5485 2016-01772
Labor Department Labor Department See

Employment and Training Administration

Land Land Management Bureau NOTICES Meetings: Northwest Oregon Resource Advisory Council, 5480-5481 2016-01839 Northwest Resource Advisory Council, 5480 2016-01740 Legal Legal Services Corporation NOTICES Assessing the Goals in the Strategic Plan 2012-2016; Correction, 5487 2016-01845 Management Management and Budget Office NOTICES Discount Rates for Cost-Effectiveness Analysis of Federal Programs, 5487-5488 2016-01604 Maritime Maritime Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5515 2016-01863 Inventory of U.S.-Flag Launch Barges, 5512-5514 2016-01871 Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ALTITUDE ADJUSTMENT (TRAVELLER), 5514-5515 2016-01862 Vessel HAWK, 5514 2016-01876 Vessel NN59, 5511-5512 2016-01874 Vessel PAU HANA, 5515-5516 2016-01873 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5488 2016-01853 National Credit National Credit Union Administration NOTICES Draft 2017-2021 Strategic Plan; Correction, 5488-5489 2016-01777 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 5472 2016-01818 National Heart, Lung, and Blood Institute, 5473 2016-01816 2016-01817 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod by Pot Catcher/Processors in the Bering Sea and Aleutian Islands Management Area, 5381-5382 2016-01851 NOTICES Availability of Seats for National Marine Sanctuary Advisory Councils, 5419-5420 2016-01976 Meetings: New England Fishery Management Council, 5421 2016-01842 Pacific Fishery Management Council, 5420 2016-01843 Permits: Marine Mammals; File No. 15510, 5420-5421 2016-01826 National Park National Park Service NOTICES Meetings: Native American Graves Protection and Repatriation Review Committee, 5481-5484 2016-01815 Wekiva River System Advisory Management Committee, 5481 2016-01814 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 5489 2016-02015 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 5489-5505 2016-01373 2016-01771 Overseas Overseas Private Investment Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5505 2016-01859 Presidential Documents Presidential Documents ADMINISTRATIVE ORDERS Bipartisan Congressional Trade Priorities and Accountability Act of 2015; Delegation of Authority and Assignment of Functions (Memorandum of January 29, 2016), 5569-5571 2016-02084 Science Technology Science and Technology Policy Office NOTICES Requests for Information: Nanotechnology Commercialization Success Stories, 5505-5506 2016-01521 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 5506 2016-01942 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5507 2016-01886 Disaster Declarations: Connecticut, 5507 2016-01881 Early Stage Small Business Investment Companies, 5508-5511 2016-01879 Meetings: Regulatory Fairness, 5507-5508 2016-01878 Military Reservist Economic Injury Disaster Loans Interest Rate for Second Quarter FY 2016, 5506-5507 2016-01880 Substance Substance Abuse and Mental Health Services Administration NOTICES HHS-Certified Laboratories and Instrumented Initial Testing Facilities Meeting Minimum Standards to Engage in Urine Drug Testing for Federal Agencies, 5473-5474 2016-01819 Transportation Department Transportation Department See

Federal Aviation Administration

See

Maritime Administration

NOTICES Grant Applications: University Transportation Centers Program Competition; Office of the Assistant Secretary for Research and Technology, 5516-5518 2016-01838
Treasury Treasury Department See

Financial Crimes Enforcement Network

See

Foreign Assets Control Office

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 5477-5478 2016-01860 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Citizenship and Issuance of Certificate under Section 322, 5474-5475 2016-01794 Application of Certificate of Citizenship, 5476-5477 2016-01793 Application to Replace Permanent Resident Card, 5475-5476 2016-01861 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Commission on Care, 5527 2016-01829 West Los Angeles VA Medical Center; Draft Master Plan, 5520-5527 2016-01940 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 5530-5567 2016-01585 Part III Presidential Documents, 5569-5571 2016-02084 Reader Aids

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

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

81 21 Tuesday, February 2, 2016 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3140; Directorate Identifier 2015-NM-063-AD; Amendment 39-18385; AD 2016-02-05] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. This AD was prompted by multiple reports of a short circuit between the heater element and the metal sheath of the pitot-static probe heater. This AD requires replacement of the left and right pitot-static probes with newly redesigned left and right pitot-static probes. We are issuing this AD to prevent degradation of the heating ability of the pitot-static probe heater, resulting in erroneous airspeed indication during flight in icing conditions and consequent reduced controllability of the airplane.

DATES:

This AD becomes effective March 8, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 8, 2016.

ADDRESSES:

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-3140; or in person at the Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email: [email protected]; Internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3140.

FOR FURTHER INFORMATION CONTACT:

Assata Dessaline, Aerospace Engineer, Avionics and Services Branch, ANE-172, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7301; fax: 516-794-5531.

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. The NPRM published in the Federal Register on July 31, 2015 (80 FR 45617).

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2015-04, dated March 17, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes. The MCAI states:

There have been several reports where the pitot-static probe heater came on and remained on regardless of the heater control selected position. Investigation determined that the root cause is a short circuit between the heater element and the metal sheath. If not corrected, this condition may degrade the heating, resulting in erroneous Airspeed Indication when flying in icing condition [and consequent reduced controllability of the airplane].

This [Canadian] AD mandates the replacement of the pitot-static probes with a redesigned probe which will prevent this failure mode.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3140-0002.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 45617, July 31, 2015) or on the determination of the cost to the public.

Conclusion

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 45617, July 31, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 45617, July 31, 2015).

Related Service Information Under 1 CFR Part 51

Bombardier issued Service Bulletin 100-34-38, dated January 9, 2014. The service information describes procedures for replacement of the left and right pitot-static probes with newly redesigned left and right pitot-static probes, part numbers 0856WC3 and 0856WC4 respectively. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 126 airplanes of U.S. registry.

We also estimate that it will take about 12 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $13,468 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,825,488, or $14,488 per product.

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

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-3140; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-02-05 Bombardier, Inc.: Amendment 39-18385. Docket No. FAA-2015-3140; Directorate Identifier 2015-NM-063-AD. (a) Effective Date

This AD becomes effective March 8, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes, certificated in any category, serial numbers 20003 through 20500 inclusive.

(d) Subject

Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

This AD was prompted by multiple reports of a short circuit between the heater element and the metal sheath of the pitot-static probe heater. We are issuing this AD to prevent degradation of the heating ability of the pitot-static probe heater, resulting in erroneous airspeed indication during flight in icing conditions and consequent reduced controllability of the airplane.

(f) Compliance

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

(g) Replacement of Left and Right Pitot-Static Probes

Within 24 months after the effective date of this AD, replace the left and right pitot-static probes with newly designed pitot-static probes, part numbers (P/N) 0856WC3 and 0856WC4 respectively, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 100-34-38, dated January 9, 2014.

(h) Parts Installation Prohibition

As of the effective date of this AD, no person may install a pitot-static probe, P/N 0856WC1 or 0856WC2, on any airplane.

(i) Other FAA AD Provisions

The following provisions also apply to this AD:

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

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

(j) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2015-04, dated March 17, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3140-0002.

(k) Material Incorporated by Reference

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

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

(i) Bombardier Service Bulletin 100-34-38, dated January 9, 2014.

(ii) Reserved.

(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email: [email protected]; Internet http://www.bombardier.com.

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

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

Issued in Renton, Washington, on January 20, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-01741 Filed 2-1-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-2068; Directorate Identifier 2016-SW-002-AD; Amendment 39-18387; AD 2016-02-06] RIN 2120-AA64 Airworthiness Directives; Bell Helicopter Textron Canada Limited AGENCY:

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

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. This AD requires inspecting each tail rotor (T/R) pitch link (link) bearing bore for corrosion and pitting and either replacing the T/R link or applying sealant. This AD also requires a recurring inspection of the sealant and repeating the inspections for corrosion and pitting if any sealant is missing. This AD is prompted by an incident in which a helicopter experienced an in-flight failure of a T/R link. These actions are intended to detect corrosion or pitting and to prevent failure of a T/R link and subsequent loss of control of the helicopter.

DATES:

This AD becomes effective February 2, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain document listed in this AD as of February 2, 2016.

We must receive comments on this AD by April 4, 2016.

ADDRESSES:

You may send comments by any of the following methods:

Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your comments electronically.

Fax: 202-493-2251.

Mail: Send comments to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.

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

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-2068; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the Transport Canada AD, the incorporated by reference service information, the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT:

Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

SUPPLEMENTARY INFORMATION: Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

Discussion

We are adopting a new AD for Bell Model 429 helicopters with a T/R link part number (P/N) 429-012-112-101, -101FM, -103, or -103FM installed. This AD requires inspecting each T/R link bearing bore for any aluminum oxide corrosion and then cleaning the affected area of the T/R link and inspecting for any pitting. If there is any corrosion or any pitting, this AD requires replacing the T/R link. If there is no corrosion or pitting, this AD requires applying corrosion preventative sealant. This AD also requires a recurring inspection of the sealant, and repeating the inspection for corrosion and pitting if any sealant is missing.

This AD was prompted by AD No. CF-2016-01, dated January 5, 2016, issued by Transport Canada, which is the aviation authority for Canada, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advises of an incident in which a T/R link on a Model 429 helicopter failed, causing vibration and difficulty controlling the helicopter. According to Transport Canada, the failure was caused by a crack that had initiated at a corrosion pit between the roll staked lip of the bearing and the beveled edge of the link. Transport Canada further states deficiencies in the application of corrosion resistant finishes to the link during manufacturing caused the corrosion.

This condition, if not detected, could result in failure of a link and loss of control of the helicopter. For these reasons, Transport Canada AD No. CF-2016-01 requires inspection of the T/R link and replacement of any link with corrosion. The Transport Canada AD also requires application of corrosion preventative sealant and re-identification of the T/R link.

FAA's Determination

This helicopter has been approved by the aviation authority of Canada and is approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in the Canadian AD. We are issuing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other helicopters of the same type design.

Related Service Information Under 1 CFR Part 51

Bell Helicopter issued Alert Service Bulletin 429-15-26, dated December 7, 2015 (ASB), which advises of receiving reports of corrosion on T/R links between the roll staked lip of bearing P/N 429-312-107-103 and the beveled edge of T/R link P/N 429-012-112-101/-103. The ASB specifies, within 10 flight hours or before March 7, 2016, an inspection with 10X magnification of all 8 T/R link bearing bores between the roll staked lip of the bearing outer race and the link bearing bore for corrosion. If there is corrosion, the ASB specifies replacing the link. If there is no corrosion, the ASB specifies cleaning the area and performing a second inspection with 10X magnification. If there is corrosion, the ASB specifies replacing the link. If there is no corrosion, the ASB specifies removing the torque stripe, cleaning the area, and applying corrosion preventative sealant. The ASB also specifies re-identifying the P/Ns as 429-012-112-101FM and 429-012-112-103FM. Further, the ASB specifies, at intervals of 50 flight hours after the initial actions, an inspection of the sealant and reapplication if the sealant is damaged.

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

AD Requirements

This AD requires, within 10 hours time-in-service (TIS), without first cleaning the T/R link bearing bores, using 10X or higher magnification to inspect each T/R link bearing bore for any aluminum oxide corrosion extruding from between the roll staked lip of the bearing outer race and the link bearing bore. If there is any aluminum oxide corrosion, this AD requires replacing the T/R link before further flight. If there is no corrosion, this AD requires cleaning the T/R link bearing bores and inspecting for any pitting. If there is any pitting, this AD requires replacing the T/R link before further flight. If there is no pitting, this AD requires applying corrosion preventative sealant. Within 50 hours TIS and thereafter at intervals not to exceed 50 hours TIS, this AD requires inspecting the corrosion preventative sealant of each T/R link by using 10X or higher magnification. If the corrosion preventative sealant is missing, this AD requires performing the inspections for any aluminum oxide corrosion and pitting.

Differences Between This AD and the Transport Canada AD

This AD only applies to helicopters with certain link P/Ns installed. The Transport Canada AD does not specify link P/Ns. This AD requires inspecting the bearing bores for any pitting after cleaning the T/R link, while the Transport Canada AD requires inspecting for corrosion after cleaning the T/R link. This AD requires inspecting the sealant with 10X or higher magnification, while the Transport Canada AD does not specify any magnification. This AD does not require re-identifying the P/N of the link, whereas the Transport Canada AD does. As part of the recurring inspection of the corrosion preventative sealant, if the sealant is missing, this AD requires repeating the inspections for aluminum oxide corrosion and pitting to ensure part integrity before reapplying sealant. The Transport Canada AD only specifies reapplying sealant if the sealant is damaged.

Costs of Compliance

We estimate that this AD affects 73 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. We estimate the cost of labor at $85 per work-hour.

Inspecting the set of T/R links (eight bearings) for corrosion will take about one work-hour for an estimated cost of $85 per helicopter and $6,205 for the U.S. fleet. Cleaning and inspecting the set of T/R links for pitting will take about one work-hour for an estimated cost of $85 per helicopter. Replacing a T/R link will require no additional work-hours after inspection and required parts cost $2,739 for an estimated replacement cost of $2,739 per T/R link. Removing the torque stripe, cleaning, and applying sealant to the set of T/R links will take about one work-hour with a negligible parts cost for an estimated cost of $85 per helicopter. Inspecting the sealant on a set of T/R links will take about one work-hour for an estimated cost of $85 per helicopter and $6,205 for the U.S. fleet per inspection cycle.

According to Bell Helicopter's service information some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Bell Helicopter. Accordingly, we have included all costs in our cost estimate.

FAA's Justification and Determination of the Effective Date

Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we find that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the unsafe condition can adversely affect control of the helicopter, and certain required corrective actions must be accomplished within 10 hours TIS.

Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and contrary to the public interest and that good cause exists for making this amendment effective in less than 30 days.

Authority for This Rulemaking

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

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

Regulatory Findings

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

For the reasons discussed, I certify that this AD:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-02-06 Bell Helicopter Textron Canada Limited: Amendment 39-18387; Docket No. FAA-2016-2068; Directorate Identifier 2016-SW-002-AD. (a) Applicability

This AD applies to Bell Helicopter Textron Canada Limited Model 429 helicopters with a tail rotor (T/R) pitch link (link) part number (P/N) 429-012-112-101, -101FM, -103, or -103FM installed, certificated in any category.

(b) Unsafe Condition

This AD defines the unsafe condition as failure of a T/R link. This condition could result in loss of T/R flight control and subsequent loss of control of the helicopter.

(c) Effective Date

This AD becomes effective February 2, 2016.

(d) Compliance

You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.

(e) Required Actions

(1) For T/R link P/N 429-012-112-101 and 429-012-112-103, within 10 hours time-in-service (TIS):

(i) Remove each T/R link assembly. Prior to cleaning the T/R link bearing bores, using 10X or higher power magnification, inspect each T/R link bearing bore for aluminum oxide corrosion extruding from between the roll staked lip of the bearing outer race and the link bearing bore. Aluminum oxide corrosion appears as a white crystalline material in contrast with the black finish and any accumulated soot. An example of this corrosion is shown in Figure 1 of Bell Helicopter Alert Service Bulletin 429-15-26, dated December 7, 2015 (ASB 429-15-26).

(ii) If there is any aluminum oxide corrosion, replace the T/R link before further flight.

(iii) If there is no aluminum oxide corrosion, clean each T/R link bearing bore with isopropyl alcohol and inspect for pitting.

(A) If there is any pitting, replace the T/R link before further flight.

(B) If there is no pitting, apply corrosion preventative sealant by following the Accomplishment Instructions, paragraph 5. of Part I, of ASB 429-15-26.

(2) For all T/R links listed in paragraph (a) of this AD, within 50 hours TIS and thereafter at intervals not to exceed 50 hours TIS, using 10X or higher power magnification, inspect each T/R link bearing bore for missing corrosion preventative sealant. If any corrosion preventative sealant is missing, perform the actions in paragraph (e)(1)(i) through (e)(1)(iii) of this AD before further flight.

(3) Do not install T/R link P/N 429-012-112-101 or -103 on any helicopter before complying with the actions in paragraph (e)(1) of this AD.

(f) Alternative Methods of Compliance (AMOCs)

(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email [email protected]

(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.

(g) Additional Information

The subject of this AD is addressed in Transport Canada AD CF-2016-01, dated January 5, 2016. You may view the Transport Canada AD on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2016-2068.

(h) Subject

Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor System.

(i) Material Incorporated by Reference

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

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

(i) Bell Helicopter Alert Service Bulletin 429-15-26, dated December 7, 2015.

(ii) Reserved.

(3) For Bell Helicopter service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at http://www.bellcustomer.com/files/.

(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.

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

Issued in Fort Worth, Texas, on January 22, 2016. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2016-01747 Filed 2-1-16; 8:45 am] BILLING CODE 4910-13-P
CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1031 [CPSC Docket No. CPSC-2013-0034] Commission Participation and Commission Employee Involvement in Voluntary Standards Activities AGENCY:

Consumer Product Safety Commission.

ACTION:

Final rule.

SUMMARY:

The United States Consumer Product Safety Commission (“Commission” or “CPSC”) is issuing this final rule to amend the existing regulation on Commission participation and employee involvement in voluntary standards activities. Currently, Commission rules allow employees to participate in voluntary standard development groups on a non-voting basis and do not allow Commission employees to accept leadership positions in voluntary standard development groups. This final rule removes these restrictions and allows Commission employees to participate as voting members and to accept leadership positions in voluntary standard development groups, subject to prior approval by CPSC's Office of the Executive Director (“OEX”).

DATES:

The final rule will become effective on March 3, 2016.

FOR FURTHER INFORMATION CONTACT:

Patricia K. Adair, Supervisory Program Analyst, Office of Hazard Identification and Reduction, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-7335; [email protected].

SUPPLEMENTARY INFORMATION: I. Introduction

Many consumer products under the Commission's jurisdiction are covered by voluntary standards. Voluntary standards provide safety provisions addressing potential hazards associated with consumer products found in locations such as homes, schools, and recreational areas. Developing voluntary standards may involve multiple revisions to a standard within 1 year, or over multiple years. Voluntary standards development activities for consumer products within the Commission's jurisdiction are handled primarily by three standards development/coordinating organizations: ASTM International (previously called the American Society for Testing and Materials), the American National Standards Institute (“ANSI”), and Underwriters Laboratories Inc. (“UL”). Along with industry, consumer groups, and product safety experts, CPSC staff works with these and other organizations to coordinate the development of voluntary standards.

Currently, CPSC staff provides technical support to organizations that coordinate the development of voluntary standards. According to the CPSC's Voluntary Standards Activities FY 2014 Annual Report, CPSC staff provided technical support or monitored voluntary standards activities for 83 products in FY 2014. Staff participates in the voluntary standards development process by providing expert advice, technical assistance, and information, based on analyses of the numbers and causes of deaths, injuries, or incidents associated with a product. Staff may also conduct CPSC research, perform laboratory tests, and provide draft language for a voluntary standard.

The Commission's involvement and staff's participation in voluntary standards activities are governed by the Commission's rule at 16 CFR part 1031, Commission Participation and Commission Employee Involvement in Voluntary Standards Activities (“part 1031”). Part 1031 prohibits CPSC staff from voting and precludes staff from holding leadership positions in voluntary standards development groups. This final rule amends part 1031 to eliminate these prohibitions and allows CPSC staff to vote and hold leadership positions on an optional basis, provided that such activities have the prior approval of the CPSC's OEX.

A. Statutory and Regulatory Background

The Consumer Product Safety Act (“CPSA”) gives the Commission authority to promulgate mandatory safety standards for consumer products. 15 U.S.C. 2056(a)(1)(A). The Commission issued regulations in 1978, describing the extent and form of Commission involvement in the development of voluntary standards (43 FR 19216 (May 4, 1978)). Acknowledging the contribution that voluntary standards had made to reducing hazards associated with consumer products, the Commission stated its support for an effective voluntary standards program, finding that a proper combination of voluntary and mandatory standards can increase product safety better than either mandatory or voluntary activities alone.

In 1981, Congress amended the CPSA, the Federal Hazardous Substances Act (“FHSA”), and the Flammable Fabrics Act (“FFA”), to, among other things, mandate that the Commission give preference to voluntary standards, as opposed to promulgating mandatory standards, if the Commission determines that a voluntary standard would eliminate or adequately reduce an unreasonable risk of injury and there will likely be substantial compliance with the voluntary standard. 15 U.S.C. 2056(b), 15 U.S.C. 1262(g)(2), 15 U.S.C. 1193(h)(2). In 1989, the Commission adopted regulations to reflect the policies set forth by the 1981 amendments, making several changes in the agency's policies on employee participation in voluntary standards development activities. The 1989 amendments also combined parts 1031 (on employee membership and participation) and 1032 (on Commission involvement) into a revised part 1031, titled, Commission Participation and Commission Employee Involvement in Voluntary Standards Activities. 54 FR 6646 (Feb. 14, 1989).

In 2006, the Commission amended several provisions of part 1031. 71 FR 38754 (July 10, 2006). Among other things, the 2006 amendments provided that Commission employees only participate in voluntary standards efforts consistent with the Commission's priorities identified in the Commission's operating plan, performance budget, mid-year review, or other official Commission document. In addition, the Commission added a requirement that employees with ongoing participation in voluntary standards activities report regularly to the Voluntary Standards Coordinator, to help ensure ongoing oversight and coordination. Lastly, the 2006 amendments added a requirement that the CPSC provide notice and the opportunity for the public to comment on staff's positions on voluntary standards activities.

B. Recent Statutory Changes Involving Voluntary Standards

In the past, CPSC staff typically served on voluntary standards committees based on the Commission's priorities. Staff participated without any expectation that such voluntary standards would necessarily form the basis of a mandatory standard. The Consumer Product Safety Improvement Act of 2008 (“CPSIA”), however, gave rise to the expectation that, for certain children's products, voluntary standards would form the basis for mandatory standards development. For example, section 104(b) of the CPSIA requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard, if the Commission determines that more stringent requirements would further reduce the risk of injury associated with the product.

Congress also has addressed participation by federal agencies in voluntary standards development. Public Law 104-113 directed federal agencies to “use technical standards that are developed or adopted by voluntary consensus standards bodies” and to “participate with such bodies in the development of technical standards.” Public Law 104-113, 12(d)(1) & (2), 110 Stat. 775, 783 (1996), 15 U.S.C. 272 note. Congress anticipated that federal agencies would “work closely” with voluntary standards organizations, that these organizations would “include active government participation,” and that agencies would “work with these voluntary consensus bodies, whenever and wherever appropriate.” H.R. Rep. 104-390 at 15, 25 (1995). See also 141 Cong. Rec. H14334 (daily ed. December 12, 1995) (Statement of Rep. Morella).

C. GAO Report

On May 16, 2012, the U.S. Government Accountability Office (“GAO”) issued a report titled, “Consumer Product Safety Commission: A More Active Role in Voluntary Standards Development Should Be Considered” (“GAO Report”) (available at: http://www.gao.gov/assets/600/590990.pdf). The GAO Report recommended that the Commission review its policy for staff participation in voluntary standards development activities and determine the feasibility of agency staff assuming a more active, engaged role in developing voluntary standards. Specifically, the GAO Report recommended that CPSC staff be allowed to vote on balloted provisions of voluntary standards and to hold leadership positions at various levels of standards development organizations, including task groups, subcommittees, or committees. GAO concluded that changing the CPSC's regulations to allow staff to participate more actively in voluntary standards activities, especially when working with technical committees for which CPSC staff can provide expertise, and permitting CPSC staff to vote on voluntary standards, could result in stronger voluntary standards, without compromising the CPSC's independence.

D. Notice of Proposed Rulemaking

In response to the GAO Report recommendations, the Commission issued a proposed rule (“NPR”) to remove the prohibitions on CPSC staff participating as voting members and accepting leadership positions in voluntary standard development groups. 78 FR 57818 (Sept. 20, 2013). The NPR proposed that CPSC staff participation in such activities would receive prior approval by OEX. The preamble to the NPR stated that when approving staff's participation in such activities, OEX should consider the policy concerns set forth in 16 CFR 1031.9 (appearance of preferential treatment, loss of impartiality, compromise of the agency's independence, and a real or apparent conflict of interest) and balance these concerns against Commission priorities, available resources, the need for greater staff involvement, and the efficiency of the voluntary standards process. 78 FR at 57820. The NPR stated that OEX would evaluate each request for staff to participate as a voting member or to accept a leadership position on a case-by-case basis. Additionally, the preamble to the NPR stated that OEX would authorize staff to vote on actions for a specified voluntary standard but would not be approving each individual vote. Id.

E. Rationale for the Rule

The Commission is finalizing the proposed rule without any changes. As discussed in the preamble to the NPR, the Commission believes that permitting CPSC staff the option to vote on a voluntary standard and/or accept a leadership position in a voluntary standard development group may result in a more effective voluntary standards process and accelerate standards development and implementation, without compromising the CPSC's independence. Such participation could gain CPSC staff additional access to and familiarity with the latest technologies, and will provide an opportunity for staff to help establish standards that will advance CPSC's safety goals. In addition, “full” federal government participation in standards development increases the likelihood that the standards can meet both public and private sector needs. 141 Cong. Rec. H14334 (daily ed. December 12, 1995) (Statement of Rep. Morella).

Additionally, optional staff participation in voluntary standard development groups by voting and taking leadership roles is consistent with the guidance in OMB Circular A-119 Revised, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities” (February 10, 1998). Among other things, OMB Circular A-119 encourages agency representatives serving as members of voluntary consensus standards bodies to “participate actively and on an equal basis with other members,” and to “vote . . . at each stage of the standards development process unless prohibited from doing so by law of their agencies.”

When participating as a voting member of, or in a leadership position on, a voluntary standard development group, the Commission directs CPSC staff to indicate clearly that any views expressed in connection with such participation represent CPSC staff's position and may not necessarily represent the Commission's position. Making such a disclaimer is consistent with current staff practice regarding representations in oral and written presentations and staff documents intended for public release. In these contexts, CPSC staff's views cannot serve as a proxy for the Commission's or the agency's views on any particular issue, as stated in the final rule at § 1031.11(c). Similarly, CPSC staff serving in leadership positions on a voluntary standard development group will act in their capacity as CPSC staff members, and their views will not necessarily represent the views of the Commission. In particular, the Commission warns that CPSC staff participation in a voluntary standard development group, even in a leadership position, does not provide any assurance that the Commission will support the resulting voluntary standard.

Removing prohibitions on employees voting and serving in leadership positions should not result in the Commission compromising the policy concerns set forth in § 1031.9. Generally, before any substantive issue is balloted on a voluntary standards committee, the committee is given the opportunity to discuss the proposals in detail. Currently, Commission staff engages in these discussions, such that the technical opinions of staff are known before a proposed change in a voluntary standard is balloted. Accordingly, CPSC staff's ability to vote on such ballots should not fundamentally alter current procedures in a manner that impinges on the Commission's independence. Rather, staff's ability to vote on a voluntary standard may improve the credibility and efficiency of the standard. Additionally, not only can OEX consider policy concerns when deciding whether to authorize staff participation in voluntary standards activities as voting members or in leadership roles, but OEX's approval also can impose constraints or limitations tailored to specific circumstances, such as measures to avoid undue influence or any appearance of impropriety.

Finally, to serve in a leadership position on a voluntary standards development group, CPSC staff must agree to follow the procedures set forth by the voluntary standards development group for leadership positions. Staff's leadership role may involve helping the development group to run more smoothly and assisting the committee in achieving timely deliberations.

II. Response to Comments

CPSC received 14 comments regarding the NPR that address 29 separate issues. Comments submitted in response to the NPR are available at: www.regulations.gov, by searching under the docket number of the rulemaking, CPSC-2013-0034. We summarize the comments received on the NPR and CPSC's responses below. To make identification of the comments and our responses easier, we numbered the comments and responses, and placed the word “Comment” before each comment summary, and the word “Response” before the Commission's response.

A. Support for Greater Staff Participation in a Voting Capacity or in a Leadership Role in Voluntary Standards

Comment 1: A commenter noted that, “involvement of CPSC personnel in voluntary standards activities ensures that the agency and other affected stakeholders (standards developers, industry, consumers, etc.) can address safety needs in an open forum, thereby reducing the likelihood that mandatory rulemaking will be necessary. Such rulemaking is often time-consuming, can preclude more robust stakeholder input and participation, and may not be able to react and adapt to changing market dynamics on a rolling basis.” Other commenters echoed the conclusion that staff engagement produces “better, more protective and timelier voluntary standards” and those members with voting privileges are often more engaged in the process.

Response 1: The Commission agrees that there are benefits to staff participation in voluntary standards organizations. Staff participation in a voluntary standards body facilitates more open, efficient interactions with stakeholders and such communication with stakeholders yields effective injury-prevention strategies for consumers. Sometimes, staff's participation in the voluntary standards process may be more efficient and timely in reducing safety hazards than mandatory rulemaking. For example, the ability to update standards quickly is an important benefit of voluntary standards. However, the ability to create mandatory rules is an important part of product safety. The Commission, not CPSC staff, generally determines when to follow a voluntary standard and when to initiate rulemaking, often based on staff's recommendations. Together, staff's participation in voluntary standards development and the Commission's rulemaking ability help fulfill the Commission's mission to prevent serious injury and death to consumers from unreasonable risks associated with consumer products. The Commission previously observed that an effective voluntary standards program, along with mandatory standards, can increase product safety better than either mandatory or voluntary standards alone (43 FR 19216 (May 4, 1978)).

Comment 2: A commenter expressed concern that staff's inability to “officially” represent CPSC in voluntary standards development activities might be perceived negatively by other standards development group participants who expect that individuals in the group represent the views of their organizations.

Response 2: CPSC staff currently provides input to voluntary standards development groups; this input represents the views and expertise of Commission staff, not the Commission. The fact that staff cannot represent the views of the Commission will not change if staff participates in voting. Leadership responsibilities in a voluntary standards organization are determined by each organization and generally require impartiality. A CPSC staff leader will be subject to all the rules and regulations of the voluntary standards, as any other member in the same role.

Comment 3: A commenter noted that staff from the U.S. Environmental Protection Agency (“EPA”) participates and votes in voluntary standards development groups and has held leadership positions.

Response 3: As GAO's report noted, CPSC's existing policy on voting and holding leadership positions in voluntary standards organizations is more restrictive than OMB's guidance on voluntary standard's participation in OMB Circular A-119 Revised, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities” (February 10, 1998). Each agency independently decides on an appropriate policy for voluntary standards activities.

B. Concerns With Greater Staff Participation in a Voting Capacity or in a Leadership Role in Voluntary Standards

Comment 4: Some commenters stated that allowing staff to vote in voluntary standards development activities would “compromise the CPSC's objectivity and have a `chilling effect' on candid discussions needed to develop the most effective standards.” The commenters do not see the benefit of allowing staff to vote when an “abstention with comment” serves to provide substantive staff input.

Response 4: Staff currently expresses its opinions of ballot items in voluntary standards development activities through an abstention with comment, participation in meetings, email communications, conference calls, and formal letters submitted to the standards development groups. At this time, the Commission is not aware of any instances in which expressions of opinion adversely affected discussions. Allowing staff to express staff's views through a vote may increase the speed and efficiency of staff communicating during standards development meetings. In addition to ballot votes, dozens of proposals can be made and voted on during any given standards development meeting. Allowing staff to cast a vote like other members can provide instant feedback about staff opinions.

Comment 5: A commenter expressed concern that CPSC staff's negative vote could effectively negate the legitimacy and effectiveness of an entire standard, even when a standard has the full support of an entire committee. The commenter expressed concern that allowing CPSC staff to vote could cause manufacturers to decline altogether from participating in voluntary standards development.

Response 5: The Commission disagrees. Staff regularly expresses its approval or disapproval of proposals in presentations and letters during standards development activities, usually verbally, but often in the form of a written “abstention with comment.” Even when staff provides negative feedback, voluntary standards development groups continue their work.

Comment 6: Several commenters suggested that any CPSC staff position on a subject could be seen as an official Commission position, implying that staff's usual disclaimer cannot be effective. One commenter stated that the Commission should vote on every position taken by a staffer and expressed concern that a CPSC staff member stating a view that was “materially different from one or more Commissioners, could create a conflict with an ultimate Commission determination.”

Response 6: The Commission is comprised of five individual Commissioners. Accordingly, every Commissioner may not always agree with the recommendations or opinions of staff. The Commission's official position is determined by a majority vote of the five Commissioners. CPSC staff routinely expresses its opinions about proposals in voluntary standards activities with the disclaimer that staff cannot represent the Commission's opinions. The disclaimer that staff cannot “represent the views of the Commission” is generally understood within voluntary standards organizations and will be included as part of the comments attached to a staff vote if there is any indication that staff opinion could be misinterpreted as representing the views of the Commission.

Comment 7: A commenter noted that CPSC's current policy preventing staff from voting in and leading voluntary standards activities ensures that the CPSC “maintain[s] its independence as an impartial participant . . .”

Response 7: The Commission's decision to permit the option for staff representatives to vote or hold leadership positions should not prevent the Commission from maintaining its independence. CPSC's regulation at 16 CFR 1031.13(e) states: “Involvement by Commission officials and employees in voluntary standards bodies or standards-development groups does not, of itself, connote Commission agreement with, or endorsement of, decisions reached, approved or published by such bodies or groups.” The final rule requires OEX to approve staff participation, and to consider whether “loss of impartiality” would be an issue in each case.

Comment 8: A commenter asserted that having staff in leadership positions of voluntary standards development groups would have “a chilling effect” on participation because, “it is difficult to believe that any manufacturer representative would ever risk the ire of CPSC (a potential enforcement action?) against its company by voicing disagreement with a CPSC committee or subcommittee chair or voting against a CPSC position.”

Response 8: According to CPSC staff, staff's experience participating in voluntary standards development groups does not support the commenter's claim. CPSC staff regularly engages in full and vigorous debates about staff's views in standards development meetings where a subcommittee disregards or votes against CPSC staff's position. Organizations, such as ASTM, have stated that leaders are subject to rules that maintain the development of consensus standards in accordance with rigorous democratic procedures that ensure open and balanced participation, due process, and consensus. Members may monitor, critique, and correct any actions of a subcommittee or task group chairman according to the rules and by-laws of the standards development organization. Additionally, although each organization may differ, leaders are nominated and appointed according to the standards development organization's rules and procedures. For example, UL employs UL staff to lead UL's standards technical panels. ASTM members elect a chairman who appoints subcommittee chairmen from the general membership, subject to the approval of ASTM's Executive Subcommittee (Section 6.3.1, ASTM, 2013).1 Task group leaders are appointed during subcommittee meetings.

1http://www.astm.org/COMMIT/Regs.pdf—ASTM International, Regulations Governing ASTM Technical Committees, 100 Barr Harbor Drive, West Conshohocken, PA, October, 2013.

Under the final rule, CPSC staff could be nominated and appointed to leadership roles only after the approval of the standards development organization that makes the invitation. OEX will subsequently need to approve staff participation. The final rule gives standards development organizations the option to offer a leadership role to CPSC staff and for OEX to review and approve each offer on a case-by-case basis. Furthermore, execution of a leadership role is subject to the bylaws of the pertinent standards development organization, many of which require impartiality of people in leadership positions.

Comment 9: Commenters argued that having CPSC staff in a leadership role in a voluntary standards development group could create the practice or appearance of undue influence if staff is allowed, for example, to schedule meetings, set agendas, and decide the direction of the conversation on the voluntary standard.

Response 9: Standards development organizations have rules and bylaws that govern and protect the validity of their respective consensus-building procedures. Although the leader of a committee can have influence over the scheduling of meetings and discussions, the agenda and direction of the conversation are governed and selected by the committee members. Every proposal made by a member of the group must be voted on and approved by the members, and any irregularities in procedures are open to challenge by any member, as specified in the standards organization's rules of conduct or bylaws. Chairmen or other leaders cannot dictate the content or wording of a voluntary standard, nor can they move proposals forward without group consensus. Removing the prohibition will not alter or affect these rules and principles.

Comment 10: A commenter asserted that the Commission has not shown “a reason why prohibiting staff from accepting leadership positions is no longer necessary.” Another commenter termed the reasons for the proposed rule, “a mystery.”

Response 10: As noted above, a GAO report recommended that the Commission review its policy for participating in voluntary standards development activities and determine the feasibility of agency staff assuming a more active, engaged role in developing voluntary standards. The GAO concluded that CPSC had interpreted its level of participation more strictly than OMB guidance specified for activities such as voting on standards and taking leadership positions. Other participants in voluntary standards development activities familiar with CPSC contributions agreed with OMB that “earlier and more active participation could increase CPSC's efficiency and effectiveness in developing standards” (p. 10, GAO-12-582). After reviewing the GAO report, the Commission agreed with CPSC staff, that in certain limited circumstances, if CPSC staff is allowed to vote or serve in leadership positions, CPSC staff's participation may advance efficient development of safety standards. Importantly, removing the prohibition against these activities from part 1031 does not require CPSC staff to vote or to serve as leaders; however, removing the prohibition does provide a framework for CPSC to consider, on a case-by-case basis, whether staff should undertake such activities.

C. Potential Legal Issues With Greater Staff Participation Identified by Commenters

Comment 11: Several commenters argued that allowing staff members to vote would “usurp the regulatory process, effectively allowing the CPSC to develop a de facto `mandatory standard' outside of the notice and comment rulemaking process in violation of the Administrative Procedures Act, as such vote would likely be given significant weight.” The commenters further asserted that, if staff assumes a leadership role in a voluntary standards development group, such a role would equate to an “end run” around the normal rulemaking safeguards that are needed to give small businesses a voice in the creation of a mandatory rule.

Response 11: The Commission disagrees. Voluntary standards are not mandatory standards. Allowing staff to serve in leadership positions in a voluntary standards development group will not alter or circumvent any procedures for mandatory rulemaking. If the Commission engages in mandatory rulemaking, the Commission will continue to follow the appropriate notice and comment rulemaking procedures.

Comment 12: A commenter noted that the CPSIA requires the Commission to make some voluntary standards into mandatory rules and expresses concern that a “blurring” is occurring between the needed distinction between voluntary standards versus CPSC-mandated regulations. The commenter is concerned that this perceived “blurring” of the distinction between voluntary and mandatory standards is a “slippery slope that could undermine the legitimacy, independence, and effectiveness of the entire voluntary standards framework.”

Response 12: Several provisions of the CPSIA mandated or provided for the Commission to adopt as mandatory regulations, certain voluntary standards, such as those for toys, durable infant and toddler products, and all-terrain vehicles. In these circumstances, there is a closer link between voluntary standards and mandatory CPSC standards than in other situations. However, the Commission follows appropriate rulemaking procedures when issuing a mandatory rule and clearly distinguishes between the staff's activities with a voluntary standards development group and the Commission's promulgation of a mandatory rule. Allowing staff to hold leadership positions or vote will not conflict with the rulemaking process.

Most of CPSC staff's work with voluntary standards groups is outside of the unique circumstances of these provisions of the CPSIA and does not involve any rulemaking activity. Staff is engaged in the voluntary standards process for a range of other consumer products. Rather than “undermining the legitimacy” of the voluntary standards framework, CPSC staff, in addition to stakeholder engagement in the voluntary standards process, has added to the legitimacy and credibility of the voluntary standards process. Participation by all concerned stakeholders collectively to develop safety standards is the most effective way to mitigate the risk of injury through the sharing of information, such as testing and data.

Comment 13: A commenter suggested that the language of the NPR sounds like the Commission believes that voluntary standards development is “some kind of precursor to mandatory rulemaking or a substitute for an Advanced Notice of Proposed Rulemaking (“ANPR”).”

Response 13: In the case of section 104 of the CPSIA, voluntary standards are the basis for the Commission's rulemaking for a durable infant or toddler product. Congress required the Commission to issue mandatory rules for certain durable infant and toddler products that are substantially the same as, or more stringent than, the voluntary standard for such products. Congress directed the Commission to issue such rules under section 553 of the Administrative Procedure Act (“APA”), rather than the Commission's rulemaking authority under sections 7 and 9 of the CPSA. In effect, Congress directed certain juvenile product voluntary standards to become precursors of mandatory rules, but still required the Commission to use notice and comment rulemaking to make such standards mandatory rules. Congress also made voluntary standards for both toys and ATVs mandatory CPSC rules.

Voluntary standards are important to CPSC, as demonstrated by the large number of voluntary standards committees staff participates in annually. However, staff involvement in a voluntary standard committee is not a precursor to a mandatory rule. When the Commission engages in rulemaking under the CPSA, the Commission must consider the efficacy of any existing voluntary standards to address the risk of injury or death identified, and whether products substantially comply with the voluntary standard.

Comment 14: A commenter stated that the proposed rule would have a “chilling effect” on participating in the development of standards because “. . . . the plaintiffs' bar will likely attempt to argue in product liability cases that a negative CPSC vote suggests that a voluntary standard (that was properly adopted through, for example, the ANSI or ASTM process) is still `unsafe.' ”

Response 14: If lawyers wanted to make an argument based on an individual CPSC staffer's opinion, lawyers could do that today, based on staff's communications with a voluntary standards development group. Staff regularly and openly expresses opinions about voluntary standards in documents easily obtained and during open meetings. Expressing the same opinion in a vote will not change this dynamic.

Comment 15: A commenter stated that one of the provisions of the Regulations Governing ASTM Technical Committees (Section 19.2.5) is that “. . . no subcommittee or task group shall make any effort to bring about the standardization of any product or service for the purpose or with the effect of (a) preventing the manufacture or sale of any product or service not conforming to a specified standard. . . .” The commenter argued that agency staff would violate this ASTM requirement if the proposed rule were approved.

Response 15: The Commission disagrees with the commenter. CPSC staff's voting or holding leadership positions will have no effect on ASTM's requirements or procedures used for standards development. All members, including CPSC staff participating in the ASTM subcommittees are required to follow the rules of standard development set out by ASTM.

Under the CPSA, the Commission must rely on a voluntary consumer product safety standard rather than promulgate a mandatory standard when compliance with the voluntary standard would eliminate or adequately reduce the risk of injury and it is likely there will be substantial compliance with the voluntary standard. Under section 104 of the CPSIA, the Commission is required to issue a mandatory regulation for certain durable infant or toddler products that is the same as, or more stringent than, the voluntary standard if the Commission determines that more stringent standards would further reduce the risk of injury associated with such products. Contrary to the commenter's assertion, voluntary standards do not “immediately become a mandatory standard.” The Commission can only issue a final mandatory rule if the Commission follows the notice and comment rulemaking procedures under the APA or is otherwise instructed by Congress. Rulemaking can occur in parallel to the voluntary standards development process, but cannot be replaced by the voluntary standards development process.

Comment 16: One commenter recommended that, if staff is given the opportunity to vote on a ballot item, and staff casts a negative vote that is later deemed nonpersuasive by the subcommittee, then staff's recommendation or suggestion should not be included in any final mandatory standard that incorporates the standard by reference.

Response 16: This comment refers to the ASTM practice of allowing a subcommittee to find a negative vote nonpersuasive, thereby overriding the negative vote and allowing a ballot to pass, even though the ballot does not have the consensus of all voters. The commenter is confusing the roles of CPSC staff and the Commission. CPSC staff's opinions and suggestions are just that, they are the staff's opinions and suggestions, not the opinions and suggestions of the Commission. The creation of a mandatory standard, even one with origins in a voluntary standard, is separate from voluntary standards development and requires action by the Commission. Neither opinions of CPSC staff, nor the opinions of the standards organization members, can bind the Commission to any decision about a mandatory standard. CPSC rulemaking must be conducted following the appropriate statutory rulemaking procedure. Furthermore, the commenter's suggestion goes against separation of the voluntary and mandatory standards processes discussed previously.

Comment 17: Commenters suggested that staff leadership and voting in voluntary standards development activities might activate certain requirements of the APA. These requirements “could hinder or cripple the process” of developing a standard.

Response 17: CPSC staff voting and/or accepting a leadership position in a standards development organization does not implicate the APA. Procedural requirements of the APA do not apply to voluntary standard proceedings but only to rulemaking undertaken by the Commission through its statutory procedures.

Comment 18: A commenter suggested that staff leadership in standards development activities might trigger the need to follow the Federal Advisory Committee Act (“FACA”).

Response 18: FACA is not implicated by CPSC staff serving in a leadership position in a voluntary standards development group. FACA defines an “advisory committee,” in relevant part, as one that is “established or utilized by one or more agencies, in the interest of obtaining advice or recommendations for the President or one or more agencies or officers of the Federal Government . . .” 5 U.S.C. 3 App. 2. Voluntary standards organizations, committees, and subcommittees are not “established or utilized” by the Commission or CPSC staff. Voluntary standards committees exist to create and revise voluntary standards, irrespective of whether CPSC staff serves in a leadership function. Additionally, neither the Commission, nor staff, is establishing or utilizing a voluntary standards development group to advise the agency on any matter.

Comment 19: A commenter suggested that staff leadership roles might trigger certain requirements of the Sunshine Act (“SA”), such as calendar notices and the accommodation of additional public participation beyond members who regularly contribute to standards development activities. The commenter was concerned that SA obligations would suppress participation and raise the costs of holding meetings for standards development organizations.

Response 19: The SA, 5 U.S.C. 552b, does not apply to staff serving in leadership positions in a voluntary standards development group. As provided in the Commission's regulations implementing the SA, 16 CFR 1013.1, SA requirements only apply to Commissioners, not to staff. The CPSC does have a meetings policy for the agency that applies to CPSC staff, as well as Commissioners. 16 CFR part 1012. The meetings policy fosters transparency and openness. Under the meetings policy, certain meetings involving CPSC staff (such as meetings concerning the development of voluntary standards) must be open to the public and must be noticed in CPSC's public calendar. The Commission's voluntary standards regulations at 16 CFR part 1031 explicitly reference and incorporate the meetings policy requiring CPSC employees to comply with applicable provisions. 16 CFR 1031.11(f) and 1031.13(c). CPSC staff has followed this meetings policy since its 1981 implementation when participating in the voluntary standards development process, including routinely posting voluntary standards organization meeting notices on the CPSC's public calendar and creating meeting logs to record participation.

Comment 20: A commenter wrote that staff participation on technical committees “could impede the ability of these committees to function effectively by precluding industry participants from discussing or disclosing privileged information.” The commenter recommended allowing technical committee meetings to be closed to the public to facilitate “the open, honest dialogue and self-critical analysis that are the cornerstones of voluntary standard development.”

Response 20: The final rule allows CPSC staff to vote on ballot items and to hold leadership positions. These revisions do not alter standards organizations' procedural rules or the CPSC's meetings policy (discussed in the previous response).

D. Other Procedural and Burden Considerations

Comment 21: A commenter recommended that CPSC staff engagement be consistent with the Office of Science and Technology Policy (“OSTP”) guidance,2 namely:

2 Principles for Federal Engagement in Standards Activities to Address National Priorities (Jan. 17, 2012), available at http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08.pdf (last accessed March 25, 2014).

1. Produce timely, effective standards and efficient conformity assessment schemes that are essential to addressing an identified need;

2. Achieve cost-efficient, timely, and effective solutions to legitimate regulatory procurement and policy objectives;

3. Promote standards and standardization schemes that promote and sustain innovation and foster competition;

4. Enhance U.S. growth and competitiveness and ensure non-discrimination, consistent with international obligations; and

5. Facilitate international trade and avoid the creation of unnecessary obstacles to trade.

The commenter also recommended that CPSC staff only accept leadership positions when the standard is a national priority and consistent with CPSC's current operating plan. Even then, the commenter recommended that leadership roles should be the exception, not the rule.

Response 21: The Commission believes that the final rule will contribute to the objectives outlined in the OSTP guidance. OEX will approve staff participation on a case-by-case basis, based on the considerations outlined in the rule. The Commission expects that standards organizations will only extend an invitation for staff to take leadership positions during exceptional circumstances because many willing standard organization members are often available for taking leadership roles in standards organizations.

Comment 22: Another commenter suggested that the Commission should be involved in the decision to approve staff participation because it is a policy decision, not just a budgetary concern.

Response 22: The Chairman, not the Commission, is responsible for allocating staff resources. 15 U.S.C. 2053(f)(1). The Executive Director, as chief operating officer, manages staff's work. 16 CFR 1000.18. Staff's work includes participation in voluntary standards activities, whether on a voting or non-voting basis and whether in a leadership or non-leadership capacity.

Comment 23: A commenter questioned the criteria OEX would apply to determine when it was advisable for staff to participate actively in a standards initiative. What rules for gaining approval would be set and what criteria would OEX apply in the decision?

Response 23: OEX will approve staff participation on a case-by-case basis, based on the considerations outlined in the rule, namely the policy concerns set forth in 16 CFR 1031.9:

• An appearance of preferential treatment,

• loss of impartiality,

• compromise of the agency's independence, and

• a real or apparent conflict of interest.

Policy concerns in 16 CFR 1031.9 should be balanced against Commission priorities, available resources, and the need for greater staff involvement, among other things. Nominations for leadership roles will be subject to the rules set by the standards development organization, and an OEX decision will be rendered in a timely manner.

Comment 24: Commenters strongly encouraged the Commission to ensure that the personnel assigned to participate in voluntary standards development groups have the technical qualifications to address the entire subject of the standard, as opposed to a political appointee without relevant background training. Another commenter echoed this concern and also recommended that staff participation should involve regular attendance at meetings so that any votes cast by staff would be fully informed.

Response 24: Staff members approved by OEX to hold leadership positions will be qualified to fulfill the responsibilities of their positions. CPSC's regulation at 16 CFR 1031.12 prohibits certain Commission personnel who have final decision-making responsibilities, such as political appointees, from becoming members of a voluntary standards development group.

Comment 25: A commenter suggested that the procedures governing the chairman of a voluntary standards committee only allow that person to vote when there is a tie on a proposal. The commenter claimed that this would undermine one of the objectives of the rule.

Response 25: The chairman's role in a voluntary standard committee is defined by each organization's by-laws, policies, and procedures. Anyone from CPSC staff taking a leadership role in a standards organization is required to adhere to those bylaws and policies. If this role is defined in standards organization bylaws and policies as one of a facilitator, then, staff will work to facilitate open discussion and debate, in accordance with the defined role of a chairman, and will avoid casting a vote when in that role.

Comment 26: Some commenters expressed concern that the proposed rule could affect the ability of staff to monitor and informally participate in the greatest number of voluntary standards. Leadership roles demand significant resources and administrative responsibilities that may not be of significant interest to the Commission.

Response 26: The Commission understands and agrees that leadership roles can be demanding and that the Commission's resources are limited. Some leadership roles, such as leading a small task group, may take less time and fewer resources and be an appropriate use of staff's time. For a staff member already committed to participating in a task group, serving as chairman may not involve a significant amount of extra time and preparation. However, as noted previously, resource demands and availability will be factors considered by the OEX when deciding on a request for staff to hold a leadership position.

Comment 27: A commenter noted that the policy of limited staff participation in voluntary standards development activities was, in part, to reduce the financial burden on the government. The commenter did not see how lifting the prohibitions on staff participation in voluntary standards development activities would reduce the financial burdens on the government.

Response 27: The final rule allows staff participation in a leadership role on a voluntary standards development group with OEX approval after taking into consideration a variety of factors, which may include resource availability. The level of participation in the voluntary standards process and the necessary commitment of time and resources can vary from situation to situation, and will be taken into account by OEX in considering approval. Implementing or revising mandatory standards can be costly in terms of the time and resources required to achieve a product safety objective. Participation in the voluntary standards development process is often a cost-efficient means to achieve the Commission's product safety objectives when the result is an effective standard with industry compliance. Implementing or revising an effective voluntary standard is in the interest of the Commission, consumers, and the industry.

Comment 28: A commenter expressed concern that using staff in leadership roles could slow down the development of voluntary standards because those staffers would need to maintain their daily duties at the Commission.

Response 28: Before approving staff to serve in a leadership position, the OEX will consider many factors, including the employee's then current duties and activities. Leaders in voluntary standards development groups typically have other duties at their place of employment, and if a leader is unable to fulfill his/her duties, the standards organization has procedures for replacing the leader to get the work completed on a timely basis. These procedures will apply to staff in leadership roles as well. For standards organizations that use volunteers in leadership roles (rather than voluntary standards development groups led by paid employees like UL), having another committee member who is allowed to volunteer for leadership duties will be beneficial during times of increased activity.

Comment 29: Several commenters noted that if staff took leadership positions in voluntary standards activities and the government was shut down, then the standards development process would be slowed down.

Response 29: Government shut downs are not common; however, the inability of staff to participate in voluntary standards activities based on this situation are similar to other circumstances, such as health-related issues, which can prohibit any person from fulfilling their duties on a committee. In the event of a leadership lapse, voluntary standards organizations have standing procedures for replacing leaders who cannot complete their duties.

III. Description of the Final Rule

Following is a section-by-section description of the changes to part 1031. These changes are the same as those set out in the proposed rule.

Section 1031.10(b)—Existing § 1031.10(b), regarding definitions, lists the types of activities that may comprise “employee involvement” in voluntary standards development activities. Section 1031.10(b) of the final rule expands the list of activities to include: “participating as a voting member of, or in a leadership position on, a voluntary standard development group, when authorized,” to recognize that such activities are part of the term “employee involvement.”

Section 1031.11(c)—Existing § 1031.11(c), regarding procedural safeguards, states that involvement in voluntary standards activities by Commission officials and employees is predicated on an understanding by the voluntary standards group that such involvement is on a non-voting basis. The final rule deletes this provision as inconsistent with the goal of allowing employees the option, with prior approval, to participate as voting members of a voluntary standards committee.

Section 1031.11(d)—Existing § 1031.11(d), regarding procedural safeguards, states: “[i]n no case shall Commission employees or officials vote or otherwise formally indicate approval or disapproval of a voluntary standard during the course of a voluntary standard development process.” The final rule renumbers this section to § 1031.11(c), and revises the content to remove the existing language, which is inconsistent with allowing Commission employees the option, with prior approval, to vote. The final rule provides that employees authorized to participate as voting members of a voluntary standard development group represent the position of CPSC staff. Such votes do not necessarily represent the opinions or views of the Commission, and would not be binding on the Commission.

Section 1031.11(e)—Existing § 1031.11(e), on procedural safeguards, states that Commission officials and employees cannot accept voluntary standards committee leadership positions, except that the Voluntary Standards Coordinator may accept leadership positions with the governing bodies of standards-making entities with the approval of the Executive Director. The final rule renumbers this provision to § 1031.11(d), and revises the language to state that Commission officials or employees may accept leadership positions in voluntary standards development groups or leadership positions with the governing bodies of standards-making entities, when authorized with prior approval by the Office of the Executive Director.

Section 1031.11(f)—The final rule renumbers existing § 1031.11(f) to § 1031.11(e).

Section 1031.12(b)—Existing § 1031.12(b), on membership criteria, states that all officials and employees not discussed in § 1031.12(a) [which lists Commissioners and employees who may not become members of voluntary standards groups because they either make or advise on final agency decisions] may be advisory, non-voting members of voluntary standards development and advisory groups with the prior approval of the Executive Director, including the Voluntary Standards Coordinator. Section 1031.12(b) of the final rule revises the language to provide that all other officials and employees not covered under § 1031.12(a) may participate as voting members or accept leadership positions in voluntary standard development groups, when authorized with the prior approval of the Office of the Executive Director. Section 1031.12(b) of the final rule removes the reference to the Voluntary Standards Coordinator because such person is not prohibited from becoming a member of a voluntary standards group in § 1031.12(a). Thus, the Voluntary Standards Coordinator would fall within the class of persons discussed in final § 1031.12(b) who may serve as a voting member and hold leadership positions, as authorized.

Section 1031.12(c)—Existing § 1031.12(c) references the Executive Director as the management official with the authority to approve staff serving as members of a voluntary standards organization or group. Section 1031.12(c) of the final rule removes the reference to the “Executive Director” and replaces it with “Office of the Executive Director” to reflect that prior approval for membership in voluntary standards activities must be approved by the Office of the Executive Director.

IV. Environmental Impact

Generally, the Commission's regulations are considered to have little or no potential for affecting the human environment, and environmental assessments and impact statements are not usually required. See 16 CFR 1021.5(a). This final rule solely involves Commission procedure, and therefore, is not expected to have an adverse impact on the environment. The final rule generally falls within the categorical exclusion in 16 CFR 1021.5(c), eliminating the need for an environmental assessment or environmental impact statement.

V. Regulatory Flexibility Act

The Regulatory Flexibility Act (“RFA”) requires agencies conduct regulatory impact analyses to assess the potential economic impact on small entities, including small businesses, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The Commission provided such a certification in the NPR because the rule would not impose any new requirements on businesses, including small businesses nor require any greater governmental participation in voluntary standards. The Commission did not receive any comments related to the certification, and the final rule does not differ from the proposed rule. Accordingly, the Commission finds that the final rule will not have a significant impact on a substantial number of small entities.

VI. Paperwork Reduction Act

The final rule does not require any stakeholder to create, maintain, or disclose information. Thus, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not implicated in this rulemaking.

VII. Effective Date

The APA generally requires that the effective date of a rule be at least 30 days after publication of a final rule. 5 U.S.C. 553(d). Because the final rule solely affects Commission procedure and does not require stakeholders to take any action, the final rule is effective 30 days after publication in the Federal Register.

List of Subjects in 16 CFR Part 1031

Business and industry, Consumer protection, Voluntary standards.

For the reasons stated in the preamble, the Commission amends 16 CFR part 1031 as follows:

PART 1031—COMMISSION PARTICIPATION AND COMMISSION EMPLOYEE INVOLVEMENT IN VOLUNTARY STANDARDS ACTIVITIES 1. The authority citation for part 1031 is revised to read as follows: Authority:

15 U.S.C. 2051-2083; 15 U.S.C. 1261-1276; 15 U.S.C. 1191-1204; Sec. 3, 104, 106, 223 Pub. L. 110-314, 122 Stat. 3016, 3017 (2008), Sec. 3, 4 Pub. L. 112-28 (2011).

2. In § 1031.10 paragraph (b), revise the third sentence to read as follows:
§ 1031.10 Definitions.

(b) * * * Employee involvement may include regularly attending meetings of a standards development committee or group, taking an active part in discussions and technical debates, expressing opinions, expending other resources in support of a voluntary standard development activity, and participating as a voting member of, or in a leadership position on, a voluntary standard development group, when authorized. * * *

3. In § 1031.11, remove paragraph (f) and revise paragraphs (c), (d), and (e) to read as follows:
§ 1031.11 Procedural safeguards.

(c) Commission officials or employees who are authorized to participate as a voting member of a voluntary standard development group represent the position of CPSC staff. Such votes or opinions do not bind the Commission in any way or necessarily represent the opinions or views of the Commission, but rather, solely represent the views of the CPSC staff.

(d) Commission employees and officials who are involved in the development of voluntary standards may accept leadership positions in voluntary standard development groups (e.g., committee chairman or secretary) or leadership positions with the governing bodies of standard-making entities, when authorized with the prior approval of the Office of the Executive Director.

(e) Attendance of Commission personnel at voluntary standards meetings shall be noted in the public calendar, and meeting summaries shall be submitted to the Office of the Secretary, as required by the Commission's meetings policy, 16 CFR part 1012.

4. In § 1031.12: a. Revise paragraph (b). b. In paragraph (c), remove the phrase: “Executive Director,” and add in its place “Office of the Executive Director”.

The revision reads as follows:

§ 1031.12 Membership criteria.

(b) All other officials and employees not covered under § 1031.12(a) may participate as voting members or accept leadership positions in voluntary standard development groups, when authorized with the prior approval of the Office of the Executive Director.

Dated: January 27, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
[FR Doc. 2016-01778 Filed 2-1-16; 8:45 am] BILLING CODE 6355-01-P
DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Parts 1b, 2, 157, and 380 [Docket No. RM15-26-000; Order No. 821] Transferring Certain Dispute Resolution Service Matters to the Commission's Landowner Helpline AGENCY:

Federal Energy Regulatory Commission, Department of Energy (DOE).

ACTION:

Final rule.

SUMMARY:

The Commission is revising its regulations to reflect an internal reorganization. On June 14, 2013, the Dispute Resolution Service moved from the Commission's Office of Administrative Litigation (OAL) to the Commission's Office of Administrative Law Judges (OALJ), and the resulting new office was named the Office of Administrative Law Judges and Dispute Resolution (OALJDR). On January 11, 2015, the Commission designated a Landowner Helpline function in the OALJDR. The revised regulations substitute the Commission's recently established Landowner Helpline in place of the Commission's Dispute Resolution Service (DRS) as the contact for handling dispute-related calls, emails, and letters, pertaining to the construction and operation of jurisdictional infrastructure projects. This revision does not preclude disputants from utilizing other means to address disputes at the Commission. The transfer of responsibility for dispute-related calls, emails, and letters pertaining to infrastructure projects to the Landowner Helpline reflects an allocation of dedicated resources to serve the public interest.

DATES:

This rule will become effective March 3, 2016.

FOR FURTHER INFORMATION CONTACT:

Thomas Sharp, Office of the General Counsel, 888 First Street NE., Washington, DC 20426, 202-502-6461, [email protected]

SUPPLEMENTARY INFORMATION: Order No. 821 Final Rule (Issued January 21, 2016)

1. 1. By this instant Final Rule, the Commission is revising its regulations 1 to substitute the Commission's recently established Landowner Helpline in place of the Commission's Dispute Resolution Service (DRS) as the point of contact for dispute-related calls, emails, and letters, pertaining to the construction or operation of jurisdictional natural gas and hydroelectric projects. The Commission is implementing this Final Rule as a result of a recent internal reorganization, which designated a Landowner Helpline function in the Commission's Office of Administrative Law Judges and Dispute Resolution (OALJDR).

1 18 CFR 1b.21(g-h), 2.55(c)(1)(ii)(C), 157.203(d)(1)(iii)(D), and 380.15(c)(1)(ii)(C) (2015).

I. Background

2. The Commission's Enforcement Hotline has been in existence since June 1987. In April 1999, the Enforcement Hotline was codified under section 1b.21 of the Commission's regulations.2 In addition to providing information to the public, and informal, non-binding staff opinions, any person may seek the Enforcement Hotline's assistance in the informal resolution of a dispute, provided that the dispute is not before the Commission in a docketed proceeding.3 The Enforcement Hotline is staffed by personnel from the Division of Investigations in the Office of Enforcement.

2 18 CFR 1b.21 (2015).

3Id.

3. On April 15, 2010, the Commission substituted the DRS, with its expertise in conflict resolution, for the Enforcement Hotline as the contact for landowners that have unresolved disputes with natural gas companies following use of the companies' environmental complaint resolution procedure.4 The Commission also transferred the responsibility of dispute-related calls pertaining to the construction and operation of hydroelectric projects to DRS.5

4Instant Final Rule Transferring Certain Enforcement Hotline Matters to the Dispute Resolution Service, 75 FR 21503, at 21504 (April 26, 2010); FERC Stat. & Regs. ¶ 31,308 (2010) (cross-referenced at 131 FERC ¶ 61,018 (2010)).

5Id. These include calls to OEP's Division of Hydropower Administration and Compliance (DHAC) regarding compliance with hydroelectric project licensing conditions which DHAC elects to refer to DRS.

4. The Commission's regulations require that natural gas companies seeking automatic authorization for replacement facilities or blanket certificate authorization for a project under the Natural Gas Act (NGA) must provide all affected landowners with a description of the company's environmental complaint resolution procedures, including company contact telephone numbers which landowners can use to identify and resolve environmental mitigation problems and concerns during construction of the project and restoration of the right-of-way.6 Companies must also provide affected landowners with the current telephone number and email address of the DRS and instruct them that if they are not satisfied with the company's response to their complaints, they may contact the DRS.7

6 18 CFR 157.203(d)(1)(iii) (2015).

7 18 CFR 157.203(d)(1)(iii)(D) (2015).

5. Going forward, the above-described DRS responsibilities will be handled by the new OALJDR Landowner Helpline.

II. Discussion

6. This Final Rule amends 18 CFR 157.203(d)(1)(iii)(D) to substitute the Commission's recently established Landowner Helpline for the DRS Helpline as the contact for members of the public that have unresolved disputes with pipeline companies following use of the pipeline companies' environmental complaint resolution procedure.8 This Final Rule also removes and renumbers 18 CFR 1b.21 (g) and (h) to create 18 CFR 1b.22 (a) and (b), which substitutes the Commission's recently established Landowner Helpline for the DRS Helpline as the contact for any person affected by either the construction or operation of natural gas facilities under the NGA or by the construction or operation of a project under the Federal Power Act (FPA), who may wish to seek the informal resolution of a dispute. This final rule makes this same substitution in 18 CFR 2.55(c)(1)(ii)(C) and 18 CFR 380.15(c)(1)(ii)(C). These changes reflect the allocation of a dedicated Commission resource to serve the public interest.

8 Notwithstanding the name of the helpline, in accordance with section 1b.21(g), any person affected by a jurisdictional project—whether a landowner or not—may make use of the Landowner Helpline.

III. Information Collection Statement

7. Office of Management and Budget (OMB) regulations require OMB to approve certain information collection requirements imposed by agency rule.9 However, this instant Final Rule does not contain or modify any information collection requirements.

9 5 CFR 1320.12 (2015).

IV. Environmental Analysis

8. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.10 Part 380 of the Commission's regulations lists exemptions to the requirement to draft an Environmental Assessment or Environmental Impact Statement, and this rulemaking qualifies under the exemption for procedural, ministerial or internal administrative actions.11

10 Order No. 486, Regulations Implementing the National Environmental Policy Act of 1969, 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs. Preambles 1986-1990 ¶ 30,783 (1987).

11 18 CFR 380.4(a)(1) (2015).

V. Regulatory Flexibility Act

9. The Regulatory Flexibility Act of 1980 (RFA) 12 generally requires a description and analysis of final rules that will have significant economic impact on a substantial number of small entities. This instant Final Rule concerns agency procedures. The Commission certifies that it will not have a significant economic impact upon participants in Commission proceedings. Therefore, an analysis under the RFA is thus not required.

12 5 U.S.C. 601-612 (2012).

VI. Document Availability

10. In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through the Commission's Home Page (http://www.ferc.gov) and in the Commission's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC 20426.

11. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

12. User assistance is available for eLibrary and the Commission's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at [email protected], or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659. Email the Public Reference Room at [email protected]

VII. Effective Date and Congressional Notification

13. These regulations are effective as an instant Final Rule without a period for public comment. Under 5 U.S.C. 533(b), notice and comment procedures are unnecessary where a rulemaking concerns only agency procedure or practice, or where the agency finds that notice and comment is unnecessary. This rule concerns only matters of agency procedure, and will not significantly affect regulated entities or the general public. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996.

14. These regulations are effective March 3, 2016.

List of Subjects 18 CFR Part 1b

Investigations.

18 CFR Part 2

Administrative practice and procedure, Electric utilities, Natural gas, Pipelines, Reporting and recordkeeping requirements.

18 CFR Part 157

Administrative practice and procedure, Natural gas, Reporting and recordkeeping requirements.

18 CFR Part 380

Environmental impact statements, Reporting and recordkeeping requirements.

By the Commission.

Issued: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.

In consideration of the foregoing, the Commission amends Parts 1b, 2, 157, and 380, Chapter I, Title 18, Code of Federal Regulations, as follows.

PART 1b—RULES RELATING TO INVESTIGATIONS 1. The authority citation for Part 1 continues to read as follows: Authority:

15 U.S.C. 717-717z, 3301-3432; 16 U.S.C. 792-828c, 2601-2645; 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C. 1-85 (1988); E.O. 12009, 3 CFR 1978 Comp., p. 142.

§ 1b.21 [Amended]
2. Section 1b.21 is amended by removing paragraphs (g) and (h).
3. Section 1b.22 is added to read as follows:
§ 1b.22 Landowner Helpline.

(a) Any person affected by either the construction or operation of a certificated or authorized natural gas project under the Natural Gas Act or by the construction or operation of a project under the Federal Power Act may seek the informal resolution of a dispute by contacting the Commission's Landowner Helpline. The Commission's Landowner Helpline may be reached by calling toll-free at 1-877-337-2237, or by email at [email protected], or writing to: Commission's Landowner Helpline, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

(b) Any person who contacts the Landowner Helpline is not precluded from filing a formal action with the Commission if discussions assisted by the Landowner Helpline staff are unsuccessful at resolving the matter. A caller may terminate the use of alternative dispute resolution procedures at any time.

PART 2—GENERAL POLICY AND INTERPRETATIONS 4. The authority citation for Part 2 continues to read as follows: Authority:

5 U.S.C. 601; 15 U.S.C. 717-717z, 3301-3432; 16 U.S.C. 792-828c, 2601-2645; 42 U.S.C. 4321-4370h, 7101-7352.

5. Section 2.55(c)(1)(ii)(C) is revised to read as follows:
§ 2.55 Auxiliary installations and replacement facilities.

(c) * * *

(1) * * *

(ii) * * *

(C) A description of the Commission's Landowner Helpline, which an affected person may contact to seek an informal resolution of a dispute as explained in § 1b.22(a) of this chapter and the Landowner Helpline number.

PART 157—APPLICATIONS FOR CERTIFICATES OF PUBLIC CONVENIENCE AND NECESSITY AND FOR ORDERS PERMITTING AND APPROVING ABANDONMENT UNDER SECTION 7 OF THE NATURAL GAS ACT 6. The authority citation for Part 157 continues to read as follows: Authority:

15 U.S.C. 717-717z.

7. Section 157.203(d)(1)(iii)(D) is revised to read as follows:
§ 157.203 Blanket certification.

(d) * * *

(1) * * *

(iii) * * *

(D) Instruct landowners that, if they are still not satisfied with the response, they may contact the Commission's Landowner Helpline at the current telephone number and email address, which is to be provided in the notification.

PART 380—REGULATIONS IMPLEMENTING THE NATIONAL ENVIRONMENTAL POLICY ACT 8. The authority citation for Part 380 continues to read as follows: Authority:

42 U.S.C. 4321-4370h, 7101-7352; E.O. 12009, 3 CFR 1978 Comp., p. 142.

9. Section 380.15(c)(1)(ii)(C) is amended to read as follows:
§ 380.15 Siting and maintenance requirements.

(c) * * *

(1) * * *

(ii) * * *

(C) A description of the Commission's Landowner Helpline, which an affected person may contact to seek an informal resolution of a dispute as explained in § 1b.22(a) of this chapter and the Landowner Helpline number.

[FR Doc. 2016-01812 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 13-249; FCC 15-142] Revitalization of the AM Radio Service AGENCY:

Federal Communications Commission.

ACTION:

Final rule; announcement of effective date.

SUMMARY:

In this document, the Commission announces that the Office of Management and Budget (OMB) approved on January 19, 2016, for a period for three years, an information collection for FCC Form 338, AM Station Modulation Dependent Carrier Level (MDCL) Notification Form and 47 CFR 73.1560 contained in the Report and Order, FCC 15-142. This document is consistent with the Report and Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of the requirements.

DATES:

The amendment to 47 CFR 73.1560 in the final rule published at 81 FR 2751, January 19, 2016, is effective on March 3, 2016.

FOR FURTHER INFORMATION CONTACT:

For additional information contact Cathy Williams, [email protected], (202) 418-2918.

SUPPLEMENTARY INFORMATION:

This document announces that, on January 19, 2016, OMB approved the information collection requirements for FCC Form 338, AM Station Modulation Dependent Carrier Level (MDCL) Notification Form and 47 CFR 73.1560, published at 81 FR2751 on January 19, 2016. The OMB Control Number is 3060-1194. The Commission publishes this document as an announcement of the effective date of the requirements. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1194, in your correspondence. The Commission will also accept your comments via the Internet if you send them to [email protected].

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

Synopsis

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on January 19, 2016, for the information collection requirements contained in the information collection 3060-1194.

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1194. The foregoing document is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1194.

OMB Approval Date: January 19, 2016.

OMB Expiration Date: January 31, 2019.

Title: AM Station Modulation Dependent Carrier Level (MDCL) Notification Form; FCC Form 338.

Form Number: FCC Form 338.

Type of Review: New information collection.

Respondents: Business or other for-profit entities; Not-for-profit institutions.

Number of Respondents and Responses: 100 respondents and 100 responses.

Estimated Hours per Response: 1 hour.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 100 hours.

Total Annual Costs: None.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in Sections 154(i), 303, 310 and 533 of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: There is no need for confidentiality required with this collection of information.

Privacy Impact Assessment: No impact(s).

Needs and Uses: On October 31, 2013, the Commission released the Notice of Proposed Rule Making, Revitalization of the AM Radio Service (NPRM), FCC 13-139, MB Docket No. 13-249. In the NPRM, the Commission recognized that in September 2011, the Media Bureau (Bureau) had released an MDCL Public Notice, in which it stated that it would permit AM stations, by rule waiver or experimental authorization, to use transmitter control techniques that vary either the carrier power level or both the carrier and sideband power levels as a function of the modulation level. This allows AM licensees to reduce power consumption while maintaining audio quality and their licensed station coverage areas. These techniques are known as Modulation Dependent Carrier Level (MDCL) control technologies.

There are two basic types of MDCL control technologies. In one type, the carrier power is reduced at low modulation levels and increased at higher modulation levels. In the other type, there is full carrier power at low modulation levels and reduced carrier power and sideband powers at higher modulation levels. Use of any of these MDCL control technologies reduces the station's antenna input power to levels not permitted by 47 CFR 73.1560(a).

The MDCL Public Notice permitted AM station licensees wanting to use MDCL control technologies to seek either a permanent waiver of 47 CFR 73.1560(a) for those licensees already certain of the particular MDCL control technology to be used, or an experimental authorization pursuant to 47 CFR 73.1510 for those licensees wishing to determine which of the MDCL control technologies would result in maximum cost savings and minimum effects on the station's coverage area and audio quality. Since release of the MDCL Public Notice, 33 permanent waiver requests and 20 experimental requests authorizing use of MDCL control technologies have been granted by the Bureau.

AM station licensees using MDCL control technologies have reported significant savings on electrical power costs and few, if any, perceptible effects on station coverage area and audio quality. Accordingly, the NPRM tentatively concluded that use of MDCL control technologies reduces AM broadcasters' operating costs while maintaining a station's current level of service to the public, without interference to other stations. The Commission therefore, proposed wider implementation of MDCL control technologies by amending 47 CFR 73.1560(a), to provide that an AM station may commence operation using MDCL control technology without prior Commission authority, provided that the AM station licensee notifies the Commission of the station's MDCL control operation within 10 days after commencement of such operation using the Bureau's Consolidated Database System (CDBS). The NPRM solicited comments on the proposed rule change, as well as on the potential adverse effects of allowing AM stations to commence MDCL control technology operation without prior Commission authority. The NPRM also sought comment as to the potential adverse effects, if any, of MDCL control technology implementation on other AM stations.

AM broadcasters are allowed to implement MDCL technologies without prior authorization, by electronic notification within 10 days of commencing MDCL operations, the Commission created FCC Form 338, AM Station Modulation Dependent Carrier Level (MDCL) Notification. In addition to the standard general contact information, FCC Form 338 solicits minimal technical data, as well as the date that MDCL control operation commenced.

The following rule section is also covered by this information collection:

47 CFR 73.1560(a)(1) specifies the limits on antenna input power for AM stations. AM stations using MDCL control technologies are not required to adhere to these operating power parameters. AM stations may, without prior Commission authority, commence MDCL control technology use, provided that within ten days after commencing such operation, the licensee submits an electronic notification of commencement of MDCL operation using FCC Form 338. OMB preapproved the information collection requirements contained in FCC 13-139 on January 28, 2014. The final information collection requirements were adopted as proposed in FCC 15-142. OMB approved the final information collection requirements on January 19, 2016.

Federal Communications Commission.

Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
[FR Doc. 2016-01321 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 141021887-5172-02] RIN 0648-XE418 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Pot Catcher/Processors in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the A season apportionment of the 2016 Pacific cod total allowable catch allocated to catcher/processors using pot gear in the BSAI.

DATES:

Effective 1200 hours, Alaska local time (A.l.t.), January 29, 2016, through 1200 hours, A.l.t., September 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Josh Keaton, 907-586-7228.

SUPPLEMENTARY INFORMATION:

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

The A season apportionment of the 2016 Pacific cod total allowable catch (TAC) allocated to catcher/processors using pot gear in the BSAI is 1,712 metric tons (mt) as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and inseason adjustment (81 FR 184, January 5, 2016).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the A season apportionment of the 2016 Pacific cod TAC allocated as a directed fishing allowance to catcher/processors using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by pot catcher/processors in the BSAI.

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

Classification

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by pot catcher/processors in the BSAI. NMFS was unable to publish a document providing time for public comment because the most recent, relevant data only became available as of January 27, 2016.

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

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

Authority:

16 U.S.C. 1801 et seq.

Dated: January 28, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
[FR Doc. 2016-01851 Filed 1-28-16; 4:15 pm] BILLING CODE 3510-22-P
81 21 Tuesday, February 2, 2016 Proposed Rules DEPARTMENT OF ENERGY 10 CFR Part 900 RIN 1901-AB36 Coordination of Federal Authorizations for Electric Transmission Facilities AGENCY:

Office of Electricity Delivery and Energy Reliability, Department of Energy.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Department of Energy (DOE) proposes to amend its regulations for the timely coordination of Federal Authorizations for proposed interstate electric transmission facilities pursuant to section 216(h) of the Federal Power Act (FPA). The proposed amendments are intended to improve the pre-application procedures and result in more efficient processing of applications.

DATES:

Public comment on this proposed rule will be accepted until April 4, 2016. DOE will hold a public workshop and will announce the date, time and location in a subsequent notice.

ADDRESSES:

You may submit comments, identified by RIN 1901-AB36, by any of the following methods:

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

2. Send email to [email protected]. Include RIN 1901-AB36 in the subject line of the email. Please include the full body of your comments in the text of the message or as an attachment.

3. Address postal mail to U.S. Department of Energy, Office of Electricity Delivery and Energy Reliability, Mailstop OE-20, Room 8G-017, 1000 Independence Avenue SW., Washington, DC 20585.

Due to potential delays in the delivery of postal mail, we encourage respondents to submit comments electronically to ensure timely receipt.

This notice of proposed rulemaking and any comments that DOE receives will be made available on the DOE Web site at http://energy.gov/oe/services/electricity-policy-coordination-and-implementation/transmission-planning/improving. You may request a hardcopy of the workshop transcript or comments be sent to you via postal mail by contacting the DOE's Office of Electricity Delivery and Energy Reliability.

FOR FURTHER INFORMATION CONTACT:

Julie A. Smith, Ph.D. with the U.S. Department of Energy, Office of Electricity Delivery and Energy Reliability, Mailstop OE-20, Room 8G-017, 1000 Independence Avenue SW., Washington, DC 20585; or [email protected].

SUPPLEMENTARY INFORMATION:

Acronyms and Abbreviations. A number of acronyms and abbreviations are used in this preamble. While this may not be an exhaustive list, to ease the reading of this preamble and for reference purposes, the following terms, acronyms, and abbreviations are defined as follows:

CEQ Council on Environmental Quality CFR Code of Federal Regulations DOE Department of Energy EIS Environmental Impact Statement E.O. Executive Order EPAct Energy Policy Act of 2005 FERC Federal Energy Regulatory Commission FPA Federal Power Act FR Federal Register IIP Integrated Interagency Pre-Application MOU Memorandum of Understanding NEPA National Environmental Policy Act OMB Office of Management and Budget PM Presidential Memorandum PMA Federal Power Marketing Administration RFI Request for Information RRTT Rapid Response Team for Transmission RTO Regional Transmission Operators I. Background II. Discussion of Proposed Rule A. General B. Applicability C. Definitions D. Integrated Interagency Pre-Application (IIP) Process E. Selection of NEPA Lead Agency F. IIP Process Administrative File III. Regulatory Review A. Executive Orders 12866 and 13563 B. National Environmental Policy Act C. Regulatory Flexibility Act D. Paperwork Reduction Act E. Unfunded Mandates Reform Act of 1995 F. Treasury and General Government Appropriations Act, 1999 G. Executive Order 13132 H. Executive Order 12988 I. Treasury and General Government Appropriations Act, 2001 J. Executive Order 13211 IV. Approval of the Office of the Secretary I. Background

The Energy Policy Act of 2005 (Pub. L. 109-58) (EPAct) established a national policy to enhance and, to the extent possible, increase the coordination and communication among Federal agencies with authority to site electric transmission facilities. The policies set forth by Congress in EPAct reinforced policies announced in E.O. 13212, Actions to Expedite Energy-Related Projects (66 FR 28357, May 22, 2001) by mandating each agency with the authority to issue Federal authorizations to ensure the timely and coordinated review and permitting of electric transmission facilities. Section 1221(a) of EPAct added a new section 216(h) to the Federal Power Act (16 U.S.C. 791-828c) (FPA), which sets forth provisions relevant to the siting of interstate electric transmission facilities. Section 216(h) of the FPA (16 U.S.C. 824p(h)), “Coordination of Federal Authorizations for Transmission Facilities,” provides for DOE to coordinate all Federal authorizations and related environmental reviews needed for siting interstate electric transmission projects, including National Environmental Policy Act of 1969 (NEPA) reviews.

Section 216(h) of the FPA provides for the coordination of Federal transmission siting determinations for project proponents seeking permits, special use authorizations, certifications, opinions, or other approvals required under Federal law to site an electric transmission facility. Section 216(h)(3) requires the Secretary, to the maximum extent practicable under Federal law, to coordinate the Federal authorization and review process with any Indian tribes, multi-state entities, and state agencies that have their own separate permitting and environmental reviews. Section 216(h)(4)(C) further requires that DOE establish an expeditious pre-application mechanism to allow project proponents to confer with Federal agencies involved, and for each such agency to communicate to the proponent any information needs relevant to a prospective application and key issues of concern to the agencies and public. The DOE proposes to amend its existing regulations to implement the Integrated Interagency Pre-application (IIP) process described in section II.

On September 19, 2008, DOE published an interim final rule establishing procedures under which prospective applicants may request that DOE coordinate interstate electric transmission facilities and related environmental reviews pursuant to FPA section 216(h) (73 FR 54456). The interim final rule became effective on October 20, 2008, and the regulations can be found at 10 CFR 900.1 through 900.6. Also on September 19, 2008, DOE published a notice of proposed rulemaking (NOPR), which proposed amendments to the interim final rule (73 FR 54461) that was intended to amend the interim final rule. Comments were filed in response to the 2008 interim final rule and 2008 NOPR. DOE addressed the comments submitted in response to both the interim final rule and the 2008 NOPR in another NOPR issued on December 13, 2011 (76 FR 77432).1

1 With the publication of this proposed rule, DOE withdraws a previously proposed rulemaking for the Coordination of Federal Authorizations for Electric Transmission Facilities in December 2011 (76 FR 77432; Dec. 13, 2011). In that action, DOE proposed requirements for permitting entities to inform DOE of requests for authorizations, established a process by which prospective Project Proponents may request DOE's coordination under section 216(h) for Federal authorizations for interstate electric transmission facilities, provided for the selection of a Federal lead agency for the purposes of compiling a single environmental review document and consolidated administrative record for Qualifying Projects, as well as provided for the establishment of intermediate and final deadlines for the review of Federal authorization decisions, as well as established a date certain after which all permit decisions and related environmental reviews under all applicable Federal laws shall be completed in one year or as soon thereafter as permissible by law.

On October 23, 2009, DOE and eight other Federal agencies with permitting or other Federal authorization responsibility for the siting of electric transmission facilities entered into a “Memorandum of Understanding Regarding Coordination in Federal Agency Review of Electric Transmission Facilities on Federal Land” (2009 MOU). The signatories to the 2009 MOU were DOE, the Departments of Defense, Agriculture (USDA), the Interior (DOI), and Commerce, the Federal Regulatory Energy Commission (FERC), the Environmental Protection Agency (USEPA), the Council on Environmental Quality (CEQ), and the Advisory Council on Historic Preservation.

The purpose of the 2009 MOU is to establish a framework to improve coordination among project proponents, Federal agencies, states, and tribes involved in the siting and permitting process for electric transmission facilities on Federal lands. The MOU is intended to improve uniformity, consistency, and transparency by describing each entity's role and responsibilities when project proponents wish to build electric transmission facilities. Additionally, the MOU designates a “Lead Agency” serving as the single point-of-contact for coordinating all Federal environmental reviews necessary to site electric transmission facilities on Federal lands. In most instances, the Departments of Agriculture or Interior will be the Lead Agency, since they have jurisdiction over most of the Federal lands and right-of-ways for proposed electric transmission facilities. Nothing in this proposed rule modifies this aspect of the MOU. The proposed 10 CFR 900.5 would maintain the agreements reached in the MOU in the context of identifying and selecting a potential NEPA lead for environmental reviews once applications for Federal authorizations are received by Federal agencies.

In October 2011, in an effort to improve the performance of Federal siting, permitting, and review processes for infrastructure development, the President created a Rapid Response Team for Transmission (RRTT), a collaborative effort involving nine executive departments and agencies that are signatories to the 2009 MOU. The RRTT is an interagency group working to improve the efficiency, effectiveness and predictability of transmission siting, permitting, and review processes, in part through increasing interagency coordination and transparency. Lessons learned through the RRTT have informed the Integrated Interagency Pre-application (IIP) process proposed in this proposed rule.

On March 22, 2012, the President issued Executive Order 13604, “Improving Performance of Federal Permitting and Review of Infrastructure Projects” that directed all Federal executive departments and agencies to take all authorized steps, consistent with available resources, to execute Federal permitting and review processes with maximum efficiency and effectiveness, ensuring the health, safety, and security of communities and the environment while supporting economic growth. The E.O. emphasized early and active consultation with tribal, state, and local governments to avoid conflicts or duplication of effort, resolve concerns, and allow for concurrent rather than sequential reviews. The E.O. also noted that these elements must be integrated into project planning processes so that projects are designed to avoid, minimize or mitigate, to the extent practicable, adverse impacts on public health, security, historic properties and cultural resources, and the environment.

On May 17, 2013, the President issued a memorandum on Modernizing Federal Infrastructure Review and Permitting Regulations, Policies, and Procedures to the heads of Executive Departments and Agencies, that discussed agency best practices identified as a result of E.O. 13604. These best practices include, but are not limited to: Early coordination among Federal agencies, as well as with tribal, state, and local governments; strategic outreach to stakeholders; project-planning processes and individual project designs that consider local and regional ecological planning goals; landscape- and watershed-level mitigation practices; sharing of scientific and environmental data in open-data formats to minimize redundancy, facilitate informed project planning, and identify data gaps early in the review and permitting process; and the application of best environmental and cultural practices as set forth in the governing statutes.

On June 7, 2013, the President issued a memorandum on Transforming our Nation's Electric Grid Through Improved Siting, Permitting, and Review to the heads of Executive Departments and Agencies. Building on the work of the RRTT, that memorandum strongly affirms that robust collaboration among Federal, tribal, state, and local governments must be a critical component of the Administration's effort to improve the Federal siting, permitting, and review processes for transmission projects because a single project may cross multiple governmental jurisdictions over hundreds of miles. Section 4(a) of the memorandum directs that Member Agencies of the Steering Committee created under E.O. 13604 to develop an integrated, interagency pre-application process for significant onshore electric transmission projects requiring Federal approval. The process must be designed to: Promote predictability in Federal siting, permitting, and review processes; encourage early engagement, coordination, and collaboration of Federal, tribal, state, and local governments, non-governmental organizations, and the public; increase the use of integrated project planning early in the siting, permitting, and review processes; facilitate early identification of issues that could diminish the likelihood that projects will ultimately be permitted; promote early planning for integrated and strategic mitigation plans; expedite siting, permitting, and review processes through a mutual understanding of the needs of all affected Federal agencies and tribal, state, and local governments; and improve environmental and cultural resource outcomes.

On August 29, 2013, DOE published a Request for Information (RFI) seeking information on a new draft IIP Process for significant onshore electric transmission projects requiring Federal authorizations developed by the RRTT. The proposed IIP Process presented in the RFI consisted of a series of four (4) iterative meetings, with direct federal involvement throughout the entire development of a transmission line project—from the identification of two substation endpoints (study area), to the selection of study corridors within a study area, and through identification of route alternative(s) within those study corridors. In response to comments received from the public, Federal agencies, state agencies, environmental groups, and industry representatives,2 DOE proposes a revised simplified IIP Process that consists of two (2) meetings that focus on projects in which study corridors and route alternatives are already under development. The IIP Process is discussed in section II of this proposed rule.

2 Comments received in response to the 2013 RFI may be accessed at: http://energy.gov/oe/downloads/comments-request-information-improving-performance-Federal-permitting-and-review.

II. Discussion of Proposed Rule A. General

10 CFR 900.1 states the purpose of the regulations, which is to provide a process for the timely coordination of Federal authorizations for proposed transmission facilities pursuant to section 216(h) of the FPA (16 U.S.C. 824p(h)), including the development of an early pre-application process in support of this coordination and the selection of a NEPA lead agency. These proposed regulations provide a framework for DOE to coordinate early cooperation and exchange of environmental information. These proposed regulations provide a framework for DOE to facilitate early cooperation and exchange of environmental information required to site qualified electric transmission facilities. These activities would occur prior to an applicant filing a request for authorization with Federal permitting agencies. The proposed regulations also provide an opportunity for non-Federal agencies (tribal, state, or local governments) to coordinate separate non-Federal permitting and environmental reviews with that of the Federal permitting agencies.

B. Applicability

Section 900.2 of the proposed rule explains when the provisions of part 900 would apply to the coordination of Federal authorizations. The provisions of part 900, which are consistent with DOE's existing regulations and the 2009 MOU, would apply to Qualifying Projects, and would also apply to Other Projects at the discretion of the Assistant Secretary of DOE's Office of Electricity Delivery and Energy Reliability (OE-1). Both types of projects must be for transmission facilities that are used for the transmission of electric energy in interstate commerce, but Qualifying Projects are generally 230 kV or above and cross jurisdictions administered by more than one Federal Entity or MOU Signatory Agency.

Further, there would be no coordination role for DOE for Federal authorizations for electric transmission facilities located within the Electric Reliability Council of Texas (ERCOT) interconnection because section 216(k) of the FPA states that section 216 of the FPA shall not apply within the ERCOT area (16 U.S.C. 824p(k)). Section 900.2 also provides that section 216(h) does not apply when an application has been submitted to FERC for issuance of a permit for construction or modification of a transmission facility, or a pre-filing procedure has been initiated, under section 216(b) of the FPA (16 U.S.C. 824p(b)) (transmission lines within a DOE-designated National Interest Electric Transmission Corridor). In those circumstances, DOE has delegated its section 216(h) coordination authority to FERC and, in Order No. 689,3 FERC adopted regulations setting forth the procedures it will follow in such circumstances.

3 Department of Energy Delegation Order No. 00-004-00A, sec. 1.22, issued May 16. 2006.

Section 900.2 also provides that this part does not apply to transmission lines that cross the U.S. international border, Federal submerged lands, national marine sanctuaries, marine national monuments, or facilities constructed by Federal Power Marketing Administrations (PMAs).4 Section 216(h) does not affect any requirements of U.S. environmental laws, and in the above mentioned cases, does not waive any requirements to obtain necessary Federal authorizations for electric transmission facilities.

4 DOE does not consider applications to the PMAs for transmission interconnections to be Federal authorization requests within the meaning of 216(h).

C. Definitions

Section 900.3 defines terms for this part.

D. Integrated Interagency Pre-Application (IIP) Process

Section 900.4 provides the procedures and information requirements of the proposed IIP Process. This section sets forth a proposed framework for implementing the proposed IIP Process, provisions for how DOE would fulfill its section 216(h) Lead Coordinating Agency role as defined in § 900.2 of this part, provisions describing expected outcomes of each IIP Initial Meeting and IIP Close-Out Meeting, and provisions describing the nature and purpose of products generated during the IIP Process (e.g., Final IIP Environmental Report).

For proponents of Qualifying Projects, participation in the IIP Process is voluntary. A Project Proponent initiates the IIP Process by submitting an Initiation Request as described in proposed § 900.4. A Project Proponent may elect to request initiation of the IIP Process for a Qualifying Project or Other Project as defined in § 900.2. The timing of the Initiation Request is determined by the Project Proponent.

When a Project Proponent elects to utilize the IIP Process, DOE will require the active participation of the Project Proponent to ensure effective coordination covered in this part. Active participation includes providing project-related and environmental information required as part of the Initiation Request to DOE. DOE must determine that adequate information has been provided by the Project Proponent consistent with § 900.4 before DOE will initiate its coordination function under this part.

Information requested as part of the Initiation Request in this proposed rule retains many of the existing requirements contained in § 900.5 “Request for coordination' of the existing section 216(h) regulation (January 2011), and expands on some of those elements based on RRTT agency experience and information received in response to the August 2013 RFI (78 FR 53436). DOE will provide electronic access to a checklist, as well as other helpful information and publicly-available resources in a central electronic repository, as currently provided for in § 900.6(b) of the existing regulations at 10 CFR part 900.5

5 Electronic tools currently exist that may serve as a resource for the information required as a part of the IIP Process. For example, the Regulatory and Permitting Information Desktop (RAPID) Toolkit, an online tool that streamlines the challenge of siting and permitting transmission lines in the West. The RAPID Toolkit offers a single location for agencies, developers, and industry stakeholders to work together on electric energy transmission regulatory processes by using a wiki environment to collaborate on regulatory processes, permit guidance, regulations, contacts, and other relevant information. The RAPID Toolkit can be accessed at http://en.openei.org/wiki/RAPID.

DOE will notify and request participation by all Federal Entities in the IIP Process that have a potential authorization or consultation for a Qualifying Project after DOE has reviewed and determined that an Initiation Request meets the informational requirements of § 900.4(a) through (d). All Federal Entities notified by DOE as having a potential authorization or consultation required for the siting of a Qualifying Project will be expected to participate in the Initial Meeting and the Final Meeting, unless the notified agency clarifies in writing to DOE within seven (7) calendar days of notification that they do not have any involvement or have minimal involvement, along with the supporting rationale used by the notified agency for their non- or minimal involvement. 6

6 Provided, however, that a Federal Entity whose permitting authority for the construction or modification of electric transmission facilities is limited to those facilities for which an application is filed under section 216(b) of the Federal Power Act may participate at its sole discretion.

DOE will schedule IIP meetings no less than thirty (30) calendar days from each other and only after Federal Entities are given notice of the need for their participation in the IIP Process. The notification described applies to both initiation and close-out of the IIP Process, in response to the Project Proponent's request for such meetings.

The list of Federal Entities notified by DOE following its review of the Initiation Request as having a potential authorization or consultation required for the siting of a Qualified Project may be revised as necessary during the IIP Process based on information provided by the Project Proponent, the Federal Entity, and otherwise publicly-available information. DOE will oversee the IIP Process and coordinate the involvement of the Federal Entities as described below in § 900.4 even though DOE is not responsible for issuing a Federal Authorization. DOE will provide Federal Entities and Non-Federal Entities access to all information received from the Project Proponent as a part of an Initiation Request determined by DOE to meet the information requirements of this part in § 900.4, which will be coordinated through the use of the Office of Management and Budget's (OMB's) MAX electronic system (https://max.omb.gov/maxportal) throughout an IIP Process for a Qualifying Project.

In-person attendance at IIP Process meetings by each Federal Entity will depend on the availability of resources or the authority to recover costs from Project Proponents. Currently, certain Federal Entities may recover costs only after an application has been submitted, and some Federal entities lack cost recovery authority altogether. Even in instances where cost recovery may be available, each Federal agency will make its own determination regarding its participation and use of resources. Each Federal agency will provide its rationale to DOE in writing when or if a determination is made that it may not be expeditious to use of staff time and funds to attend all or some meetings. To the extent allowed by law Federal Entities may seek cost recovery from the Project Proponents during the IIP Process. DOE will provide an opportunity for Federal and Non-Federal Entities to participate in IIP meetings by using teleconferencing and webinars.

Coordinating the preparation of the Final IIP Resources Report document prepared by DOE and related administrative file will facilitate more efficient preparation of a single environmental review document that all agencies can strive to utilize to inform their relevant decision making. The Final IIP Resources Report is designed in terms of format and substance to be similar to an “early corporate environmental assessment” or typical applicant-generated environmental study in accordance with: (1) Council on Environmental Quality (CEQ) regulations implementing NEPA (40 CFR parts 1500 through 1508); (2) CEQ guidance related to early consultation or engagement of Federal agencies with prospective applicants; and (3) NEPA's Forty Most Asked Questions related to the ability of agencies to authorize preparation of environmental assessments by applicants (46 FR 18026; March 23, 1981, as amended). 7 Such actions continue to be encouraged by CEQ as “they call for private, Federal and non-Federal entities to build environmental considerations into their own planning processes in a way that facilitates the application of NEPA and avoids delay.” 8

7 CEQ, NEPA's Forty Most Asked Questions (46 FR 18026; March 23, 1981, as amended), Question 8 discusses “early corporate environmental assessments”

8Id.

The Final IIP Resources Report will be included by DOE, along with all other support information, datasets, maps, figures, etc. collected as part of the IIP Process in an IIP Process Administrative File that would be provided to the NEPA Lead Agency to inform their environmental reviews once an application is filed. This information can, and should, also be used by other agencies on related decision making. DOE will maintain the IIP Process Administrative File for the duration of the IIP Process and until no later than thirty (30) calendar days after the IIP Close out Meeting has been convened.

E. Selection of NEPA Lead Agency

Section 900.5 provides a mechanism for the identification and selection of a NEPA Lead Agency responsible for meeting Federal environmental review requirements 9 for permitting interstate transmission lines across multiple Federal jurisdictions once applications are filed with permitting agencies. This section incorporates the terms and mechanisms provided for identification and determination of NEPA Lead Agency for transmission facilities proposed for siting on majority Federal lands as set forth in the 2009 MOU and in accordance with CEQ's NEPA regulations.

9 Each participating Federal Entity is responsible for meeting its own agency-specific requirements.

F. IIP Process Administrative File

Section 900.6 defines the contents of a consolidated IIP Process Administrative File intended to document IIP Process-related products and information. This new section replaces the existing § 900.6. This section also describes the intent and process by which this file will be maintained by DOE as Lead 216(h) Agency in coordination with the Federal Entities for the duration of the IIP Process.

III. Regulatory Review A. Executive Orders 12866 and 13563

This regulatory action has been determined to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993). Accordingly, this action was subject to review under that Executive Order by the Office of Information and Regulatory Affairs of the Office of Management and Budget.

DOE has also reviewed this regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281, Jan. 21, 2011). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.

DOE concludes that this proposed rule is consistent with these principles. Specifically, this proposed rule sets forth voluntary procedures for DOE coordination of Federal Authorizations for the siting of interstate electric transmission facilities. As described in section III.C., therefore, the costs of the rule will impact Federal agencies. Among the benefits expected from this proposed rule, actions taken to coordinate information and agency communication before applications for Federal Authorizations are submitted to Federal agencies for review and consideration would help reduce application review and decision-making timelines. Because use of the proposed IIP Process is voluntary, DOE further expects that the Project Proponent requesting assistance has made the calculation that the request was in the best interests of the Project Proponent. The request would also help transmission developers determine the likelihood that they would successfully obtain permits, which is necessary to make their proposed project successful in the competitive, regional transmission planning processes.

B. National Environmental Policy Act

DOE has determined that promulgation of these regulations fall into a class of actions that does not individually or cumulatively have a significant impact on the human environment as set forth under DOE's regulations implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq). Specifically, this rulemaking is covered under the Categorical Exclusion found in the DOE's National Environmental Policy Act regulations at paragraph A6 of Appendix A to Subpart D, 10 CFR part 1021, which applies to Rulemakings that are strictly procedural. Accordingly, neither an environmental assessment nor an environmental impact statement is required.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (August 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process (68 FR 7990). DOE has made its procedures and policies available on the Office of General Counsel's Web site: http://www.gc.doe.gov.

DOE has reviewed this proposed rule under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. This proposed rule sets forth simplified or revised procedures for DOE coordination of Federal Authorizations for the siting of interstate electric transmission facilities. As a result, the rule directly impacts Federal agencies and not small entities. In those cases where a Project Proponent requests DOE assistance for a project that is not a Qualifying Project, DOE expects that the provisions of this proposed rule, if adopted, would not affect the substantive interests of such Project Proponents, including any Project Proponents that are small entities. DOE expects actions taken under the proposed provisions to coordinate information and agency communication before applications for Federal Authorizations are submitted to Federal agencies for review and consideration would help reduce application review and decision-making timelines. Because use of the IIP Process set forth in the proposed rule is voluntary, DOE further expects that the Project Proponent requesting assistance has made the calculation that the request was in the best interests of the Project Proponent. The request would also help facilitate transmission developers with determining the likelihood that they would successfully obtain permits, which is necessary to make their proposed project successful in the competitive, regional transmission planning processes. On the basis of the foregoing, DOE certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel for Advocacy of the Small Business Administration pursuant to 5 U.S.C. 605(b).

D. Paperwork Reduction Act

The proposed rule contains information collection requirements subject to review and approval by OMB pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and the procedures implementing that Act, 5 CFR 1320.1 et seq. This requirement has been submitted to OMB for approval. Public reporting burden for requesting information during the pre-application process is estimated to average 30 minutes per response. Public reporting burden for requesting DOE assistance in the Federal authorization process is estimated to average one hour per response. Both of these burden estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

DOE invites public comment on: (1) Whether the proposed information collection requirements are necessary for the performance of DOE's functions, including whether the information will have practical utility; (2) the accuracy of DOE's estimates of the burden of the proposed information collection requirements; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the information collection requirements on respondents. Comments should be addressed to the DOE Desk Officer, Office of Information and Regulatory Affairs, OMB, 725 17th Street NW., Washington, DC 20503. Persons submitting comments to OMB also are requested to send a copy to the contact person at the address given in the ADDRESSES section of this notice of proposed rulemaking. Interested persons may obtain a copy of the DOE's Paperwork Reduction Act Submission to OMB from the contact person named in this notice of proposed rulemaking.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

E. Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires Federal agencies to examine closely the impacts of regulatory actions on tribal, state, and local governments. Subsection 101(5) of title I of that law defines a Federal intergovernmental mandate to include any regulation that would impose upon tribal, state, or local governments an enforceable duty, except a condition of Federal assistance or a duty arising from participating in a voluntary Federal program. Title II of that law requires each Federal agency to assess the effects of Federal regulatory actions on tribal, state, and local governments, in the aggregate, or to the private sector, other than to the extent such actions merely incorporate requirements specifically set forth in a statute. Section 202 of that title requires a Federal agency to perform a detailed assessment of the anticipated costs and benefits of any rule that includes a Federal mandate which may result in costs to tribal, state, or local governments, or to the private sector, of $100 million or more in any one year (adjusted annually for inflation). 2 U.S.C. 1532(a) and (b). Section 204 of that title requires each agency that proposes a rule containing a significant Federal intergovernmental mandate to develop an effective process for obtaining meaningful and timely input from elected officers of tribal, state, and local governments. 2 U.S.C. 1534.

This proposed rule would revise procedures for an Integrated Interagency Pre-application process by which transmission developers, Federal, state, local agencies and tribes may coordinate early either in person or via teleconference/web conference and share information through the existing Office of Management and Budget MAX Web site collaborative tool. DOE has determined that the proposed rule would not result in the expenditure by tribal, state, and local governments in the aggregate, or by the private sector, of $100 million or more in any one year. Accordingly, no assessment or analysis is required under the Unfunded Mandates Reform Act of 1995.

F. Treasury and General Government Appropriations Act, 1999

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family well being. The proposed rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

G. Executive Order 13132

Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt state law or that have Federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the states and carefully assess the necessity for such actions. DOE has examined this proposed rule and has determined that it would not preempt state law and would not have a substantial direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. No further action is required by Executive Order 13132.

H. Executive Order 12988

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.

I. Treasury and General Government Appropriations Act, 2001

The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB.

OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

J. Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires Federal agencies to prepare and submit to the OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action, which is intended to improve the pre-application procedures for certain transmission projects and therefore result in the more efficient processing of applications, would not have a significant adverse effect on the supply, distribution, or use of energy and is therefore not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.

IV. Approval of the Office of the Secretary

The Secretary of Energy has approved the publication of this proposed rule.

List of Subjects in 10 CFR Part 900

Electric power, Electric utilities, Energy, Reporting and record keeping requirements.

Issued in Washington, DC, on January 20, 2016. Patricia A. Hoffman, Assistant Secretary, Office of Electricity Delivery and Energy Reliability.

For the reasons stated in the preamble, DOE proposes to revise part 900 of chapter II of title 10, Code of Federal Regulations as set forth below:

PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES Sec. 900.1 Purpose. 900.2 Applicability. 900.3 Definitions. 900.4 Integrated interagency pre-application (IIP) process. 900.5 Selection of NEPA lead agency. 900.6 IIP Process administrative file. Authority:

16 U.S.C. 824p(h).

§ 900.1 Purpose.

This part provides a process for the timely coordination of information needed for Federal authorizations for proposed electric transmission facilities pursuant to section 216(h) of the Federal Power Act (FPA) (16 U.S.C. 824p(h)). This part seeks to ensure electric transmission projects are consistent with the nation's environmental laws, including laws that protect endangered and threatened species, critical habitats and historic properties. This part provides a framework called the Integrated Interagency Pre-Application (IIP) process by which DOE cooperates with applicable Federal and non-Federal entities for the purpose of early coordination of information for permitting and environmental reviews required under Federal law to site qualified electric transmission facilities prior to submission of required Federal request(s). The IIP process provides for timely and focused pre-application meetings with key Federal and non-Federal entities, as well as for early identification of potential siting constraints or opportunities, and seeks to promote thorough and consistent stakeholder outreach by a project proponent during transmission line planning efforts. The IIP process occurs before any application or request for authorization is submitted to Federal entities. This part improves the siting process by facilitating the early submission, compilation, and documentation of information needed for subsequent coordinated, transparent environmental review of a Qualifying Project or approved Other Project by Federal entities under the National Environmental Policy Act (NEPA) following the submission of an application or request for authorization. This part also provides an opportunity for non-Federal entities to coordinate their non-Federal permitting and environmental reviews with that of the Federal entities.

§ 900.2 Applicability.

(a) The regulations under this part apply to Qualifying Projects. At the discretion of the Assistant Secretary (OE-1) the provisions of part 900 may also apply to Other Projects.

(b) Other Projects. (1) Persons seeking DOE assistance in the Federal Authorization process for Other Projects must file a request for coordination with the OE-1. The request must contain:

(i) The legal name of the requester; its principal place of business; whether the requester is an individual, partnership, corporation, or other entity; citations to the state laws under which the requester is organized or authorized; and the name, title, and mailing address of the person or persons to whom communications concerning the request for coordination are to be addressed;

(ii) A concise general description of the proposed Other Project sufficient to explain its scope and purpose;

(iii) A list of all potential Federal entities; and

(iv) A list of anticipated non-Federal entities, including any agency serial or docket numbers for pending applications.

(2) Within thirty (30) calendar days of receiving this request, the OE-1, in consultation with the affected Federal Entities with jurisdiction, will determine if the Other Project should be treated as a Qualifying Project under this part and will notify the Project Proponent of one of the following:

(i) If accepted for processing under this rule, the project will be treated as a Qualifying Project and the Project Proponent must submit an Initiation Request as set forth under § 900.5; or

(ii) If not accepted for processing under this rule, the Project Proponent must follow the standard procedures for Federal Entities that will have jurisdiction over the project.

(c) This part does not apply to Federal Authorizations for electric transmission facilities wholly located within the Electric Reliability Council of Texas interconnection.

(d) This part does not apply to electric transmission facilities in a DOE-designated National Interest Electric Transmission Corridor where a Project Proponent seeks a construction or modification permit from the Federal Energy Regulatory Commission (FERC) under section 216(b) of the Federal Power Act (16 U.S.C. 824p(b)).

(e) This part does not affect any requirements of Federal law. Participation or non-participation in the IIP process does not waive any requirements to obtain necessary Federal authorizations for electric transmission facilities. This part shall not alter or diminish any responsibilities of the Federal entities to consult under applicable law.

(f) This part does not supplant but rather complements the Federal entities' pre-application procedures for a Federal authorization. Participation in the IIP Process does not guarantee issuance of any required Federal authorization for a proposed Qualifying Project or selection of the project proponent's proposed study corridors and proposed routes as a range of reasonable alternatives or the preferred alternative for NEPA purposes.

(g) DOE, in exercising its responsibilities under this part, will communicate regularly with the FERC, electric reliability organizations and electric transmission organizations approved by FERC, other Federal entities, and Project Proponents. DOE will use information technologies to provide opportunities for Federal entities to participate remotely.

(h) DOE, in exercising its responsibilities under this part, will to the maximum extent practicable and consistent with Federal law, coordinate the IIP Process with any non-Federal entities. DOE will use information technologies to provide opportunities for non-Federal entities to participate remotely.

§ 900.3 Definitions.

As used in this part:

Affected landowner means an owner of real property interests who is usually referenced in the most recent county or city tax records, and whose real property:

(1) Is located within either 0.25 miles of a proposed centerline of a Qualifying Project or at a minimum distance specified by state law, whichever is greater; or

(2) Contains a residence within 3000 feet of a proposed construction work area for a Qualifying Project.

DOE means the United States Department of Energy.

Early identification of project issues refers to an early and open stakeholder participation process carried out by a project proponent to identify potential environmental issues Federal and non-Federal entities' may consider for further study, issues of concern to the affected public and stakeholders, and potential project alternatives.

Federal authorization means any authorization required under Federal law to site an electric transmission facility, including permits, rights-of-way, special use authorizations, certifications, opinions, or other approvals. This term includes those authorizations that may involve determinations under Federal law by either Federal or non-Federal entities.

Federal entity means any Federal agency with jurisdictional interests that may have an effect on a proposed Qualifying Project, that is responsible for issuing a Federal authorization for the proposed Qualifying Project or attendant facilities, has relevant expertise with respect to environmental and other issues pertinent to or that are potentially affected by the proposed Qualifying Project or its attendant facilities, or provides funding for the proposed Qualifying Project or its attendant facilities. Federal entities include those with either permitting or non-permitting authority; for example, those entities with which consultation or review must be completed before a project may commence, such as the Department of Defense for an examination of military test, training or operational impacts.

FPA means the Federal Power Act (16 U.S.C. 791 through 828c).

IIP Process Administrative File means the information assembled and maintained by DOE as the Lead 216(h) Agency and the NEPA Lead Agency for all Federal authorization decisions. The IIP Process Administrative File will include, without limitation, the IIP Initiation Request, which includes a summary of Qualifying Project, Affected Environmental Resources and Impacts summary, associated maps, geospatial information, and data (provided in electronic format), and a summary of Early Identification of Project Issues, IIP meeting summaries, and other documents, including but not limited to maps, publicly-available data, and other supporting documentation submitted by the project proponent as part of the IIP Process, and that inform the Federal entities.

IIP Resource Report means the resource summary information provided by the Project Proponent as a part of the IIP process that meets the content requirements pursuant to § 900.4. The IIP Resource Report contains the environmental information used by a Project Proponent to plan a Qualifying Project.

Indian tribe has the same meaning as provided for in 25 U.S.C. 450b(e).

Lead 216(h) Agency means the Department of Energy, which section 216(h) of the FPA (16 U.S.C. 824p(h)) makes responsible for timely coordination of Federal authorization requests for proposed electric transmission facilities.

MOU signatory agency means a signatory of the interagency MOU executed on October 23, 2009, entitled, “Memorandum of Understanding among the United States (U.S.) Department of Agriculture (USDA), the Department of Commerce, Department of Defense (DoD), Department of Energy (DOE), Environmental Protection Agency (EPA), the Council on Environmental Quality (CEQ), the Federal Energy Regulatory Commission (FERC), the Advisory Council on Historic Preservation (ACHP), and Department of the Interior (DOI), regarding Coordination in Federal Agency Review of Electric Transmission Facilities on Federal Lands.”

MOU principals means the heads of each of the MOU signatory agencies.

NEPA means the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.)

NEPA Lead Agency means the Federal agency or agencies preparing or having primary responsibility for preparing an environmental impact statement or environmental assessment as defined in 40 CFR 1508.16 and in accordance with 40 CFR 1501.5(c).

Non-Federal entity means an Indian tribe, multistate governmental entity, or state and local government agency with relevant expertise and/or jurisdiction within the project area, that is responsible for conducting permitting and environmental reviews of the proposed Qualifying Project or its attendant facilities, that has special expertise with respect to environmental and other issues pertinent to or that are potentially affected by the proposed Qualifying Project or its attendant facilities, or provides funding for the proposed Qualifying Project or its attendant facilities. Non-Federal entities may include those with either permitting or non-permitting authority, e.g., entities such as State Historic Preservation Offices, with whom consultation must be completed in accordance with section 106 of the National Historic Preservation Act, 54 U.S.C. 306108, before a project can commence.

OE-1 means the Assistant Secretary for DOE's Office of Electricity Delivery and Energy Reliability.

Other Projects mean electric transmission facilities that are not Qualifying Projects. Other Projects include facilities for the transmission of electric energy in interstate commerce for the sale of electric energy at wholesale, but do not need to meet the 230 kV or above qualification, or be otherwise identified as regionally or nationally significant with attendant facilities, in which all or part of a proposed transmission line crosses jurisdictions administered by more than one Federal entity.

Project area means the geographic area considered when the project proponent develops study corridors and then potential routes for environmental review and potential project siting as a part of the project proponent's planning process for a Qualifying Project. It is an area located between the two end points of the project (e.g., substations), including their immediate surroundings within at least one-mile of that area, and over any proposed intermediate substations. The size of the project area should be sufficient to allow for the evaluation of various potential alternative routes with differing environmental, engineering, and regulatory constraints. Note that the project area does not necessarily coincide with “permit area,” “area of potential effect,” “action area,” or other defined terms of art that are specific to types of regulatory review.

Project Proponent means a person or entity who initiates the IIP Process in anticipation of seeking Federal authorizations for a Qualifying Project or Other Project.

Qualifying Project means—

(1) A non-marine high voltage electric transmission line (230 kV or above) and its attendant facilities or other regionally or nationally significant non-marine electric transmission line and its attendant facilities, in which:

(i) All or part of the proposed electric transmission line is used for the transmission of electric energy in interstate commerce for sale at wholesale; and

(ii) All or part of the proposed electric transmission line crosses jurisdictions administered by more than one Federal entity or crosses jurisdictions administered by a Federal entity and is considered for Federal financial assistance from a Federal entity.

(2) Qualifying Projects do not include those for which a project proponent seeks a construction or modification permit from the FERC for electric transmission facilities in a DOE-designated National Interest Electric Transmission Corridor under section 216(b) of the FPA (16 U.S.C.824p(b)).

Regional mitigation approach means an approach that applies the mitigation hierarchy (first seeking to avoid, then minimize impacts, then, when necessary, compensate for residual impacts) when developing mitigation measures for impacts to resources from Qualifying Projects at scales relevant to the resource, however narrow or broad, necessary to sustain, or otherwise achieve established goals for those resources. The approach identifies the needs and baseline conditions of targeted resources, potential impacts from the Qualifying Projects, cumulative impacts of past and likely projected disturbance to those resources, and future disturbance trends. The approach then uses such information to identify priorities for avoidance, minimization, and compensatory mitigation measures across that relevant area to provide the maximum benefit to the impacted resources.

Regional mitigation strategies or plans mean documents developed through or external to, the NEPA process that apply a regional mitigation approach to identify appropriate mitigation measures in advance of potential impacts to resources from Qualifying Projects.

Route means a linear area within which a Qualifying Project could be sited. It should be wide enough to allow minor adjustments in the alignment of the Qualifying Project so as to avoid sensitive features or accommodate potential engineering constraints but narrow enough to allow detailed study.

Stakeholder means any non-Federal entity, any non-governmental organization, affected landowner, or other person potentially affected by a proposed Qualifying Project.

Stakeholder outreach plan means a concise description and plan for how a project proponent coordinates stakeholder interface, communications, and involvement so as to provide information to and receive feedback from stakeholders as defined in this part as part of the development of a Qualifying Project and during the IIP Process. It directly informs and supports the development of the summary of early identification of project issues required as part of the initiation request pursuant to § 900.5. The purpose of the stakeholder outreach plan is to ensure that a Project Proponent actively engages and receives feedback from stakeholders when the Project Proponent is evaluating potential study corridors or potential routes before and during the IIP Process.

Study corridor means a contiguous area (but not to exceed one-mile) in width within the project area where alternative routes may be considered for further study.

§ 900.4 Integrated interagency pre-application (IIP) process.

(a) The IIP Process is intended for a Project Proponent who has identified potential study corridors and/or potential routes within an established project area and the proposed locations of any intermediate substations for a Qualifying Project. The IIP Process is also intended to accommodate proposed Qualifying Projects that have been selected in a regional electric transmission plan for purposes of cost allocation or a similar process where an electric transmission plan has been identified and the permitting and siting phase must commence. While the IIP Process is optional, the early coordination provided by DOE between Federal entities, non-Federal entities, and the Project Proponent ensures that the Project Proponent fully understands application and permitting requirements, including data potentially necessary to satisfy application requirements for all permitting entities. The two-meeting structure also allows for early interaction between the Project Proponents, Federal entities, and non-Federal entities in order to enhance early understanding by those having an authorization or consultation related to the Qualifying Project with a clear description of a Qualifying Project, the Project Proponent's siting process, and the environmental and community setting being considered by the Project Proponent for siting the transmission line, including early identification of project issues.

(b) A Project Proponent electing to utilize the IIP Process must submit an initiation request to DOE to start the IIP Process. The timing of the submission of the initiation request for IIP Process is determined by the Project Proponent. The initiation request must include, based on best available information, a Summary of Qualifying Project, Affected Environmental Resources and Impacts Summary, associated maps, geospatial information, and studies (provided in electronic format), a summary of early identification of project issues, and must adhere to the page limits established by this part.

(c) Summary of the Qualifying Project. The Summary of the Qualifying Project is limited to a maximum length of ten (10) pages, single-spaced and must include:

(1) A statement that the Project Proponent requests to use the IIP Process;

(2) Primary contact information for the Project Proponent, including a primary email address;

(3) The legal information for the Project Proponent: legal name; principal place of business; whether the requester is an individual, partnership, corporation, or other entity; the state laws under which the requester is organized or authorized; and if the Project Proponent resides or has its principal office outside the United States, documentation related to designation by irrevocable power of attorney of an agent residing within the United States;

(4) A description of the Project Proponent's financial and technical capability to construct, operate, maintain, and decommission the Qualifying Project;

(5) A statement of the Project Proponent's interests and objectives;

(6) To the extent available, regional electric transmission planning documents, including status of regional reliability studies, regional congestion or other related studies where applicable, and interconnection requests;

(7) A brief description of the evaluation criteria and methods that are being used by the Project Proponent to identify and develop the potential study corridors or potential routes for the proposed Qualifying Project;

(8) A brief description of the proposed Qualifying Project, including endpoints, voltage, ownership, justification for the line, intermediate substations if applicable, and, to the extent known, any information about constraints or flexibility with respect to the Qualifying Project;

(9) Project Proponent's proposed schedule, including timeframe for filing necessary Federal and State applications, construction start date, and planned in-service date if the Qualifying Project receives needed Federal authorizations and approvals by non-Federal entities; and

(10) A list of potentially affected Federal and non-Federal entities.

(d) Affected Environmental Resources and Impacts Summary. The Affected Environmental Resources and Impacts Summary is limited to a maximum length of twenty (20), single-spaced pages, not including associated maps, and must include concise descriptions, based on existing, relevant, and reasonably-available information, of the known existing environment, and major site conditions in project area, including:

(1) An overview of topographical and resource features that are relevant to the siting of electric transmission lines present;

(2) Summary of known land uses, including Federal and state public lands of various types (e.g., parks and monuments), associated land ownership, and any land use restrictions;

(3) Summary of known or potential adverse effects to cultural and historic resources;

(4) Summary of known or potential conflicts with or adverse impacts on military activities;

(5) Summary of known or potential impacts on the U.S. aviation system, including FAA restricted airspace;

(6) Summary of known or potential impacts on the U.S. marine transportation system, including impacts on waterways under jurisdiction of the U.S. Coast Guard;

(7) Summary of known information about Federal- and State-protected avian, aquatic, and terrestrial species, and Critical Habitat or otherwise protected habitat, that may be present, as well as other biological resources information that is necessary for an environmental review;

(8) Summary of the aquatic habitats (to include estuarine environments, and water bodies, including wetlands, as well as any known river crossings and potential constraints caused by impacts to navigable waters of the United States considered for the Qualifying Project);

(9) Summary of known information about the presence of low-income communities and minority populations that could be affected by the Qualifying Project;

(10) Identification of existing or proposed Qualifying Project facilities or operations in the project area;

(11) Summary of the proposed use of previously-disturbed lands, existing, agency-designated corridors, including but not limited to corridors designated under section 503 of the Federal Land Policy and Management Act and section 368 of the Energy Policy Act of 2005,transportation rights-of-way, and the feasibility for co-location of the Qualifying Project with existing facilities or location in existing corridors and transportation rights-of-way; and

(12) Summary of potential avoidance, minimization, and conservation measures, such as compensatory mitigation (onsite and offsite), developed through the use of regional mitigation approach or, where available, regional mitigation strategies or plans, and considered by the Project Proponent to reduce the potential impacts of the proposed Qualifying Project to resources requiring mitigation.

(e) Maps, geospatial information, and studies. Maps, geospatial information, and studies in support of the information provided in the summary descriptions for the known existing environmental, cultural, and historic resources in the project area under paragraph (d) of this section must be included, and do not contribute to the overall page length of the IIP Initiation Request. Project proponents must provide maps as electronic data files that may be readily accessed by Federal entities and non-Federal entities, including:

(1) A map of the project area showing the locations of potential study corridors or potential routes;

(2) Detailed maps that accurately show information supporting summaries of the known existing environmental resources within the potential study corridors or potential routes;

(3) Electronic access to existing data or studies that are relevant to the summary information provided as part of paragraphs (c) and (d) of this section; and

(4) Citations identifying sources, data, and analyses used to develop the IIP Process Initiation Request materials.

(f) Summary of Early Identification of Project Issues. The Summary of Early Identification of Project Issues must not exceed ten (10), single-spaced pages in length and is intended to provide a summary of stakeholder outreach or interactions conducted for the Qualifying Project prior to submission of the initiation request and inform the development of issues and project alternatives for study in an environmental review document. The Summary of Early Identification of Project Issues will:

(1) Discuss the specific tools and actions used by the project proponent to facilitate stakeholder communications and public information, including an existing, current project proponent Web site for the proposed Qualifying Project, where available, and a readily-accessible, easily-identifiable, single point of contact for the project proponent;

(2) Identify how and when meetings on the location of potential study corridors or potential routes have been and would be publicized prior to the submission of applications for Federal authorization, as well as where and when those meetings were held and how many more meetings may be planned during the IIP Process;

(3) Identify known stakeholders and how stakeholders are identified;

(4) Briefly explain how the project proponent responds to requests for information from stakeholders, as well as records stakeholder requests, information received, and project proponent responses to stakeholders;

(5) Provide the type of location (for example, libraries, community reading rooms, or city halls) in each county potentially affected by the proposed Qualifying Project, and specify those where the Project Proponent has provided publicly-available copies of documents and materials related to the proposed Qualifying Project;

(6) Describe the evaluation criteria being used by the Project Proponent to identify and develop the potential study corridors or potential routes and that are presented by the Project Proponent to stakeholders during its project planning outreach efforts prior to submission of applications for Federal authorizations or non-Federal permits or authorizations;

(7) Provide information collected as result of the Project Proponent's stakeholder outreach efforts; and

(8) Include a summary of issues identified, differing project alternative corridors or routes, and revisions to routes developed as a result of issues identified by stakeholders during the project proponent's stakeholder outreach efforts the Qualifying Project.

(g) Within fifteen (15) calendar days of receiving the initiation request, DOE shall notify by electronic mail all Federal entities and non-Federal entities with an authorization potentially necessary to site the Qualifying Project that:

(1) Based on its initial review of information submitted by the Project Proponent in response to requirements in paragraphs (c) through (f) of this section, DOE has identified the contacted Federal entities or non-Federal entities as having an authorization or consultation responsibility related to the Qualifying Project; and

(2) Federal and non-Federal entities notified by DOE should participate in the IIP Process for the Qualifying Project with DOE's rationale for that determination provided; and

(3) Federal and non-Federal entities notified by DOE will provide DOE with a name and information for a point of contact, and any initial questions or concerns about their level of participation in the IIP Process based on DOE's justification within seven (7) calendar days of receiving DOE's notification.

(h) Within thirty (30) calendar days of receiving the initiation request, DOE shall notify the Project Proponent that:

(1) The initiation request meets the requirements in paragraphs (c) through (f) of this section, including whether the project constitutes a Qualifying Project; or

(2) The initiation request does not meet the requirements in paragraphs (c) through (f) of this section and provide the reasons for that finding and a description of how the Project Proponent may, if applicable, address any deficiencies through supplementation of the information contained in the initiation request and DOE will consider its determination.

(i) DOE shall provide Federal and non-Federal entities with access to an electronic copy of the initiation request and associated maps, geospatial data, and studies that meet the requirements in paragraphs (c) through (f) of this section, at the same time that DOE provides notice to the Project Proponent.

(j) IIP initial meeting. DOE, in consultation with the identified Federal entities, shall convene the IIP initial meeting with the Project Proponent and all Federal entities and non-Federal entities notified by DOE as having an authorization or consultation related to the Qualifying Project as soon as practicable and no later than forty-five (45) calendar days after notifying the Project Proponent and Federal and non-Federal entities that the initiation request meets the requirements in paragraphs (c) through (f) of this section. The initial meeting shall be convened in the area or region where the proposed Qualifying Project is located. Federal and non-Federal entities shall have at least thirty (30) calendar days to review the information provided by the Project Proponent as part of the initiation request prior to the meeting. Federal entities identified by DOE as having a Federal authorization related to the Qualifying Project are expected to participate in the initial meeting. DOE also shall invite non-Federal entities identified by DOE as having an authorization or consultation related to the Qualifying Project to participate in the initial meeting. During the initial meeting:

(1) DOE shall discuss the IIP process with the Project Proponent and any cost recovery requirements, where applicable.

(2) The Project Proponent shall describe the proposed Qualifying Project and the contents of its initiation request.

(3) The Federal entities shall, to the extent possible and based on agency expertise and experience, review the information provided by the Project Proponent, and publicly-available information, preliminarily identify the following and other reasonable criteria for adding, deleting, or modifying preliminary routes from further consideration within the identified study corridors:

(i) Potential environmental visual, historic, cultural, economic, social, or health effects or harm based on potential project or proposed siting, and anticipated constraints;

(ii) Potential cultural resources and historic properties of concern;

(iii) Areas under special protection by Federal statute or other Federal entity or non-entity decision that could potentially increase the time needed for project evaluation and potentially foreclose approval of siting a transmission line route through such areas, and may include but are not limited to properties or sites which may be of traditional or cultural importance to Indian tribe(s), National Scenic and Historic Trails, National Landscape Conservation system units managed by BLM, National Wildlife Refuges, units of the National Park System, national marine sanctuaries, or marine national monuments;

(iv) Opportunities to site routes through designated corridors, previously disturbed lands, and lands with existing infrastructure as a means of potentially reducing impacts and known conflicts as well as the time needed for affected Federal land managers to evaluate an application for a Federal authorization if the route is sited through such areas (e.g., co-location with existing infrastructure or location on previously disturbed lands or in energy corridors designated by the DOI or USDA under section 503 of the Federal Land Policy and Management Act or section 368 of the Energy Policy Act of 2005, an existing right-of-way, or a utility corridor identified in a land management plan);

(v) Potential constraints caused by impacts on military test, training, and operational missions, including impacts on installations, ranges, and airspace;

(vi) Potential constraints caused by impacts on the United States' aviation system;

(vii) Potential constraints caused by impacts to navigable waters of the United States;

(viii) Potential avoidance, minimization, and conservation measures, such as compensatory mitigation (onsite and offsite), developed through the use of a regional mitigation approach or, where available, regional mitigation strategies or plans to reduce the potential impact of the proposed Qualifying Project to resources requiring mitigation; and

(ix) Based on available information provided by the project proponent, biological (including threatened, endangered, or otherwise protected avian, aquatic, and terrestrial species and aquatic habitats), visual, cultural, historic, and other surveys and studies that may be required for preliminary proposed routes.

(4) Information and feedback provided in paragraphs (j)(1) through (3) of this section to the Project Proponent does not constitute a commitment by Federal entities to approve or deny any Federal authorization request. Moreover, no agency would or could determine that the Project Proponent's proposed preliminary routes presented or discussed during the IIP Process would constitute a range of reasonable alternatives for NEPA purposes. The IIP Process does not limit agency discretion regarding NEPA review. Participating non-Federal entities are encouraged to identify risks and benefits of siting the proposed Qualifying Project within the preliminary proposed routes.

(5) The DOE shall record key issues, information gaps, and data needs identified by Federal and non-Federal entities during the initial meeting, and shall convey a summary of the meeting discussions, key issues, and information gaps and requests to the project proponent, all Federal entities, and any non-Federal entities that participated in the IIP Process in a draft initial meeting summary within fifteen (15) calendar days after the meeting. Participating Federal entities and non-Federal entities, and the Project Proponent will then have fifteen (15) calendar days following its receipt of the IIP Process meeting summary to review the IIP Process meeting summary and provide corrections to DOE for resolution in a final initial meeting summary, as appropriate. Thirty (30) calendar days following the close of the 15-day review period, DOE will incorporate the final initial meeting summary into the IIP Process administrative file for the Qualifying Project, and at the same time, provide all Federal and non-Federal entities and the Project Proponent an electronic copy of a final IIP initial meeting summary.

(k) IIP close-out meeting request. A Project Proponent electing to utilize the IIP Process pursuant to this section must submit a close-out meeting request to DOE to complete the IIP Process. The timing of the submission of the close-out meeting request for the IIP Process is determined by the Project Proponent but must be submitted no less than forty-five (45) calendar days following the initial meeting. The close-out meeting request shall include:

(1) A statement that the Project Proponent is requesting the close-out meeting for the IIP Process;

(2) A summary table of changes made to the Qualifying Project during the IIP Process, including potential environmental and community benefits from improved siting or design;

(3) Maps of updates to potential proposed routes within study corridors, including the line, substations and other infrastructure, which include at least as much detail as required for the initial meeting described above and as modified in response to early stakeholder input and outreach and agency feedback documented as a part of the IIP initial meeting summary;

(4) An updated summary of all project-specific biological (including threatened, endangered or otherwise protected avian, aquatic, and terrestrial species, and aquatic habitats), visual, cultural, historic or other surveys sponsored by the Project Proponent;

(5) If known, a schedule for completing upcoming field resource surveys;

(6) An updated summary of all known or potential adverse impacts to natural resources;

(7) An updated summary of any known or potential adverse effects to cultural and historic resources;

(8) A conceptual plan for potential implementation and monitoring of mitigation measures, including avoidance, minimization, and conservation measures, such as compensatory mitigation (offsite and onsite), developed through the use of a regional mitigation approach or, where available, regional mitigation strategies or plans to reduce the potential impact of the proposed Qualifying Project to resources requiring mitigation;

(9) An estimated time of filing its requests for Federal authorizations for the proposed Qualifying Project; and

(10) An estimated time of filing its requests for all other authorizations and consultations with non-Federal entities.

(l) Close-out meeting. The IIP process close-out meeting shall result in a description by Federal entities of the remaining issues of concern, identified information gaps or data needs, and potential issues or conflicts that could impact the time it will take affected Federal entities to process applications for Federal authorizations for the proposed Qualifying Project. The non-Federal entities shall also be encouraged to provide a description of remaining issues of concern, information needs, and potential issues or conflicts. The IIP Process close-out meeting will also result in the identification of a potential NEPA lead agency pursuant to § 900.6.

(1) Within fifteen (15) calendar days of receiving the close-out meeting request, DOE shall notify by electronic mail the appropriate POCs of all Federal entities and non-Federal entities with a known or potential authorization necessary to site the Qualifying Project.

(2) Within thirty (30) calendar days of receiving a close-out meeting request, DOE shall determine whether the close-out meeting request meets the requirements in paragraph (k) of this section and inform the Project Proponent of its acceptance, and provide Federal entities and non-Federal entities with close-out meeting request materials, including map, geospatial data, and surveys in electronic format, preferably via the OMB MAX collaboration Web site at https://max.omb.gov/maxportal/.

(3) Within (sixty) 60 calendar days of making a determination that the close-out meeting request meets the requirements of this section, DOE shall convene the close-out meeting in the same region or location at the initial meeting with the project proponent and all Federal entities. All non-Federal entities participating in the IIP Process shall also be invited to attend. During the close-out meeting:

(i) The Project Proponent's updates to the siting process to date shall be discussed, including stakeholder outreach activities, resultant stakeholder input, and Project Proponent response to stakeholder input;

(ii) Based on information provided by the Project Proponent to date, the Federal entities shall discuss key issues of concern and potential mitigation measures identified for the proposed Qualifying Project;

(iii) Led by DOE, all Federal entities shall discuss statutory and regulatory standards that must be met to make decisions for Federal authorizations required for the proposed Qualifying Project;

(iv) Led by DOE, all Federal entities shall describe the estimated time to make decisions for required Federal authorizations and the anticipated cost (e.g., processing and monitoring fees and land use fees);

(v) Led by DOE, all affected Federal entities shall describe their expectations for a complete application for a Federal authorization for the proposed Qualifying Project;

(vi) DOE shall prepare and include a final IIP Resources Report in the IIP Process Administrative File, which provides an accurate description of the proposed Qualifying Project, including stakeholder outreach activities and feedback, summary information on environmental resources, and potential impacts (with electronic access to associated maps, geospatial data and/or survey data), potential issues, and identification of constraints by Federal entities and non-Federal entities for the proposed Qualifying Project;

(vii) When it is included in the IIP Process Administrative File, DOE shall recommend that participating Federal entities use the final IIP Resources Report to inform the NEPA process for the proposed Qualifying Project, for example, during scoping for an EIS and identifying potential routes, explaining why certain alternatives were eliminated from further consideration, and preliminarily identifying impacts, potential avoidance, minimization, and conservation measures, such as compensatory mitigation (onsite and offsite), developed through the use of a regional mitigation approach or, where available, regional mitigation strategies or plans and considered by the project proponent to reduce the potential impacts of the proposed Qualifying Project to resources requiring mitigation; and

(viii) All participating Federal and non-Federal entities shall identify a preliminary schedule for authorizations for the proposed Qualifying Project contingent upon timely filing of applications and related materials by the Project Proponent.

§ 900.5 Selection of the NEPA lead agency.

DOE, in consultation with the Federal entities, shall coordinate the selection of a potential NEPA Lead Agency responsible for preparing an environmental review document under NEPA for proposed Qualifying Projects. Determination and responsibilities of the NEPA Lead Agency for preparing the EIS shall be in compliance with applicable law, including the National Environmental Policy Act of 1969 and CEQ implementing regulations at 40 CFR part 1500, and each agency's respective NEPA implementing regulations and procedures. However:

(a) For proposed Qualifying Projects that cross lands administered by both DOI and USDA, DOI and USDA shall consult and jointly determine within thirty (30) calendar days of receiving the initiation request information from DOE to determine which Department has a greater land management interest in the proposed Qualifying Project and which Department should therefore assume the role of NEPA Lead Agency.

(b) DOI and USDA shall notify DOE of their determination regarding the NEPA Lead Agency in writing within ten (10) calendar days of making the determination.

(c) Unless DOE notifies DOI and USDA in writing of its objection to that determination within ten (10) calendar days of the DOI/USDA notification, the determination shall be deemed accepted and final. In deciding whether to object to the determination, DOE shall consider the CEQ regulations pertaining to selection of the lead agency, including 40 CFR 1501.5(c).

(d) When the NEPA Lead Agency is not established pursuant to paragraphs (a) through (c) of this section, the Federal entities that will likely constitute the cooperating agencies for an environmental review document under NEPA shall consult and jointly recommend a NEPA Lead Agency within 45 calendar days of receiving an IIP Process close-out meeting request to the Council on Environmental Quality for a fine determination. No determination of a Federal entity as the NEPA Lead Agency under this part shall be made absent that Federal entity's consent.

§ 900.6 IIP Process administrative file.

(a) When communicating with the Project Proponent during the IIP Process, Federal entities are expected to include DOE involved in the IIP Process for the Project Proponent's proposed Qualifying Project.

(b) DOE shall maintain all information, including documents and communications, it disseminates or receives from the Project Proponent, Federal entities, and non-Federal entities during the IIP Process for future use in reviewing any applications for required Federal authorizations for the proposed Qualifying Project. Before disseminating information specific to a Federal entity's or non-Federal entity's review, DOE must receive approval from that agency in accordance with that Federal entity's Freedom of Information Act requirements.

(c) DOE shall document the list of issues identified during the IIP process for a proposed Qualifying Project and updates to information provided as part of the close-out meeting discussion in a final IIP Resources Report, if any, for the IIP Process Administrative File.

(d) Each Federal entity is encouraged to maintain the documents and communications developed in the IIP Process subject to each Federal entity's administrative record policies and, as appropriate and applicable, those documents and communications could become part of that Federal entity's administrative record for granting or denying a Federal authorization for each Qualifying Project.

[FR Doc. 2016-01641 Filed 2-1-16; 8:45 am] BILLING CODE 6450-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-7490; Directorate Identifier 2015-NE-40-AD] RIN 2120-AA64 Airworthiness Directives; Turbomeca S.A. Turboshaft Engines AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Notice of proposed rulemaking (NPRM).

SUMMARY:

We propose to adopt a new airworthiness directive (AD) for certain Turbomeca S.A. Astazou XIV B and H turboshaft engines. This proposed AD was prompted by a report of a crack on the 3rd stage turbine wheel. This proposed AD would require a one-time inspection of the front surface of the 3rd stage turbine for a groove. We are proposing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.

DATES:

We must receive comments on this proposed AD by April 4, 2016.

ADDRESSES:

You may send comments by any of the following methods:

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

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

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

Fax: 202-493-2251.

For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7490; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the mandatory continuing airworthiness information (MCAI), the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email: [email protected]

SUPPLEMENTARY INFORMATION:

Comments Invited

We invite you to send any written relevant data, views, or arguments about this NPRM. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-7490; Directorate Identifier 2015-NE-40-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2015-0223, dated November 16, 2015 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

During the overhaul of an ASTAZOU XIV engine, a crack was detected on the front face of the third stage turbine wheel between two balancing lugs. The cause of the crack is probably linked to a geometric singularity, likely caused by the transformation operation aimed at introducing expansion slots between the blades during embodiment of Turbomeca mod AB 173. Although there is only one known case of this type of crack, and although it was detected, the possibility exists that additional parts have the same geometric singularity.

This condition, if not detected and corrected, may lead to failure of a turbine blade and its associated piece of rim, possibly resulting in an uncommanded in-flight shut-down and/or release of high energy debris.

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7490.

Related Service Information Under 1 CFR Part 51

Turbomeca S.A. has issued Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015. The SB describes procedures for inspection of the 3rd stage turbine wheel. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

FAA's Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of France, and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this NPRM because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This NPRM would require inspecting the front surface of the 3rd stage turbine for a groove.

Costs of Compliance

We estimate that this proposed AD affects 9 engines installed on helicopters of U.S. registry. We also estimate that it would take about 5 hours per engine to comply with this proposed AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $3,825.

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Turbomeca S.A.: Docket No. FAA-2015-7490; Directorate Identifier 2015-NE-40-AD. (a) Comments Due Date

We must receive comments by April 4, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all Astazou XIV B and XIV H turboshaft engines with 3rd stage turbine wheel, part number (P/N) 0 265 25 700 0 or P/N 0 265 25 706 0, installed, if the engine incorporates Turbomeca modification AB-173 or AB-208.

(d) Reason

This AD was prompted by a report of a crack on the 3rd stage turbine wheel. We are issuing this AD to prevent cracks in the 3rd stage turbine wheel, failure of the engine, in-flight shutdown, and loss of control of the helicopter.

(e) Actions and Compliance

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

(1) At the next piece part exposure of the 3rd stage turbine wheel or within 1,000 engine hours after the effective date of this AD whichever comes first, perform a one-time inspection for a groove on the front surface of the 3rd stage turbine wheel. Use Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015 to perform the inspection.

(2) If the 3rd stage turbine wheel passes inspection required by paragraph (e)(1) of this AD, no further action is required.

(3) If the 3rd stage turbine wheel fails inspection required by paragraph (e)(1) of this AD, remove the part and replace with a part eligible for installation.

(f) Installation Prohibition

After the effective date of this AD, do not install any 3rd stage turbine wheel, P/N 0 265 25 700 0 or P/N 0 265 25 706 0, unless it was inspected per the Accomplishment Instructions, paragraph 4.4.2, of Turbomeca S.A. SB No. 283 72 0811, Version A, dated August 25, 2015.

(g) Alternative Methods of Compliance (AMOCs)

The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to: [email protected]

(h) Related Information

(1) For more information about this AD, contact Wego Wang, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7134; fax: 781-238-7199; email: [email protected]

(2) Refer to MCAI European Aviation Safety Agency AD 2015-0223, dated November 16, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2015-7490.

(3) Turbomeca S.A. SB No. 283 72 0811, Version A, dated August 25, 2015, can be obtained from Turbomeca S.A., using the contact information in paragraph (h)(4) of this proposed AD.

(4) For service information identified in this proposed AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15.

(5) You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.

Issued in Burlington, Massachusetts, on January 27, 2016. Colleen M. D'Alessandro, Manager, Engine & Propeller Directorate, Aircraft Certification Service.
[FR Doc. 2016-01770 Filed 2-1-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 401 [CMS-5061-P] RIN 0938-AS66 Medicare Program: Expanding Uses of Medicare Data by Qualified Entities AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would implement new statutory requirements that would expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. In doing so, this proposed rule would explain how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This proposed rule would also implement certain privacy and security requirements, and impose assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement (DUA) required by the qualified entity program.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 29, 2016.

ADDRESSES:

In commenting, please refer to file code CMS-5061-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5061-P, P.O. Box 8010, Baltimore, MD 21244-1850.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5061-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses prior to the close of the comment period:

a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Allison Oelschlaeger, (202) 690-8257. Kari Gaare, (410) 786-8612.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

I. Background

On April 16, 2015, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted. The law included a provision, Section 105, Expanding the Availability of Medicare Data, which takes effect on July 1, 2016. This section expands how qualified entities will be allowed to use and disclose data under the qualified entity program, including data subject to section 1874(e) of the Social Security Act (the Act), to the extent consistent with other applicable laws, including information, privacy, security and disclosure laws.

The Qualified Entity program was established by Section 10332 of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148). The implementing regulations, which became effective January 6, 2012, are found in subpart G of 42 CFR part 401 (76 FR 76542). Under those provisions, CMS provides standardized extracts of Medicare Part A and B claims data and Part D drug event data (hereinafter collectively referred to as Medicare claims data) covering one or more geographic regions to qualified entities at a fee equal to the cost of producing the data. Under the original statutory provisions, such Medicare claims data must be combined with other non-Medicare claims data and may only be used to evaluate the performance of providers and suppliers. The measures, methodologies and results that comprise such evaluations are subject to review and correction by the subject providers and suppliers, after which the results are to be disseminated in public reports.

Those wishing to become qualified entities are required to apply to the program. Currently, thirteen organizations have applied and received approval to be a qualified entity. Of these organizations, two have completed public reporting while the other eleven are in various stages of preparing for public reporting. While we have been pleased with the participation in the program so far, we expect that the changes required by MACRA will increase interest in the program.

Under section 105 of MACRA, effective July 1, 2016, qualified entities will be allowed to use the combined data and information derived from the evaluations described in 1874(e)(4)(D) of the Act to conduct non-public analyses and provide or sell these analyses to authorized users for non-public use in accordance with the program requirements and other applicable laws. In highlighting the need to comply with other applicable laws, we particularly note that any qualified entity that is a covered entity or business associate as defined in the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) regulations at 45 CFR 160.103 will need to ensure compliance with any applicable HIPAA requirements, including the bar on the sale of Protected Health Information.

In addition, qualified entities will be permitted to provide or sell the combined data, or provide the Medicare claims data alone at no cost, again, in accordance with the program requirements and other applicable laws, to providers, suppliers, hospital associations, and medical societies. Qualified entities that elect to provide or sell analyses and/or data under these new provisions will be subject to an assessment if they or the authorized users to whom they disclose beneficiary identifiable data in the form of analyses or raw data act in a manner that violates the terms of a program-required Qualified EntityData Use Agreement (QE DUA). Furthermore, qualified entities that make analyses or data available under these new provisions will be subject to new annual reporting requirements to aid CMS in monitoring compliance with the program requirements. These new annual reporting requirements will only apply to qualified entities that choose to provide or sell non-public analyses and/or provide or sell combined data, or provide Medicare claims data alone at no cost.

We believe these changes to the qualified entity program will be important in driving higher quality, lower cost care in Medicare and the health system in general. We also believe that these changes will drive renewed interest in the qualified entity program, leading to more transparency regarding provider and supplier performance and innovative uses of data that will result in improvements to the healthcare delivery system while still ensuring appropriate privacy and security protections for beneficiary-identifiable data.

II. Provisions of the Proposed Regulations

To implement the new statutory provisions of section 105 of MACRA, we propose to amend and make conforming changes to Part 401 Subpart G, “Availability of Medicare Data for Performance Measurement.” Throughout the preamble, we identify options and alternatives to the provisions we propose. We strongly encourage comments on our proposed approach, as well as any alternatives.

A. Non-Public Analyses

Section 105(a)(1) of MACRA expands how qualified entities will be allowed to use and disclose the combined data and any information derived from the evaluations described in section 1874(e)(4)(D) of the Act. The section provides for such data's use and/or disclosure in additional non-public analyses that may be given or, in certain circumstances, sold to authorized users in accordance with program requirements and other applicable laws, including information, privacy, security, and disclosure laws. An authorized user is defined at § 401.703(j) and the definition is discussed below in section II.C. The new proposals regarding the disclosure and/or sale of combined data or the disclosure of Medicare data at no cost are discussed below in section II.B.

To implement the non-public analyses provisions, we propose to add a new § 401.716. Under § 401.716, paragraph (a) would provide for the qualified entity's use of the combined data or information derived from the evaluations described in section 1874(e)(4)(D) of the Act to create non-public analyses. Paragraph (b) would provide for the provision or sale of these analyses to authorized users in accordance with the program requirements discussed later in this section, as well as other applicable laws.

1. Additional Analyses

We propose at § 401.703(q) to define combined data as a set of CMS claims data provided under subpart G combined with a subset of claims data from at least one of the other claims data sources described in § 401.707(d). § 401.707(d) requires qualified entities to submit to CMS information on the claims data it possesses from other sources, that is, any other provider-identifiable or supplier-identifiable data for which the qualified entity has full data usage rights. In defining the term in this manner, we are not proposing to establish a minimum amount of data that must be included in the combined data set from other sources, but, as we noted in our December 7, 2011 final rule (76 FR 76542), we believe that the requirement to use combined data is likely to lead to increased validity and reliability of the performance findings through the use of larger and more diverse samples. As such, we expect qualified entities will choose to use sufficient claims data from other sources to ensure such validity and reliability. That said, we recognize that there may be instances in which other sources of claims data (for example, Medicaid or private payer data) may be of limited value. For instance, depending on the other claims data a given qualified entity may hold, Medicare data may provide the best opportunity to conduct analyses on chronically ill or other resource-intensive populations that may not be commonly represented in other sources of claims data. Thus, while the statute requires the use of combined data for the analyses, it does not specify the minimum amount of data from other sources to qualify as combined data, and, as we believe it would be difficult to establish a threshold given the variability in the analyses that the qualified entities may conduct, we propose not to adopt any minimum standard for the amount of other sources of claims data that must be included in a combined data set. We are requesting comments on this proposal as well as suggestions for other possible alternatives or options.

2. Limitations on the Qualified Entities With Respect to the Sale and Provision of Non-Public Analyses

MACRA imposes a number of limitations on qualified entities with respect to the sale and provision of non-public analyses. It mandates that a qualified entity may not provide or sell non-public analyses to a health insurance issuer unless the issuer is providing the qualified entity with claims data under section 1874(e)(4)(B)(iii) of the Act. In doing so, the statute does not specify the minimum amount of data that the issuer must be providing to the qualified entity. We considered not imposing a threshold on the amount of data being provided by the issuer, but decided that specifying a threshold would encourage issuers to submit data to the qualified entity to be included in the public performance reports, increasing the reports' reliability and sample size. As a result, we propose at § 401.716(b)(1) to limit qualified entities to only providing or selling non-public analyses to issuers after they provide the qualified entity with claims data that represents a majority of the issuers' covered lives in the geographic region and during the time frame of the non-public analyses requested by the issuer. For example, if an issuer requested non-public analyses using the combined data for the first 6 months of 2015 in Minnesota, it would need to provide the qualified entity with data that represents over 50 percent of the issuer's covered lives during those 6 months in Minnesota. We believe this threshold will ensure that issuers submit a large portion of their data to the qualified entity without requiring them to share data for their entire population in order to be eligible to receive non-public analyses. We seek comment on whether the threshold of a majority of the issuer's covered lives in the desired geographic area during the time frame covered by the non-public analyses requested by the issuer is too high or low, as well as other alternatives to specify the amount of data the issuer must provide to a qualified entity to be eligible to receive or purchase non-public analyses.

Section 105(a)(3) of MACRA imposes additional requirements on the dissemination of non-public analyses or data that contain information that individually identify a patient. Because we define the term “patient” later in this section and in a manner that does not relate to de-identification of individually identifiable information, we will use the word beneficiary in relation to de-identification rather than patient. In light of these MACRA provisions, as well as our belief that protecting the privacy and security of beneficiaries' information is of the utmost importance and our belief that identifiable information on individual beneficiaries would generally not be needed by authorized users, we propose to impose limits on the content of the non-public analyses. In doing so, we recognize that when non-public analyses are provided or sold to a provider or supplier, individually identifying information such as name, age, gender, or date of birth may be essential for the provider or supplier to proactively use the information gleaned from the analyses. For example, a provider may not know who a patient is based on the unique identifier assigned by the payer and as a result would not be able to use the analyses to improve care or better coordinate care with other providers for that patient. In addition, there is a high likelihood that providers may have patients with the same or similar names, so age or date of birth may be necessary to identify the patient in the analyses. We therefore propose at § 401.716(b)(2) to limit the provision or sale of non-public analyses that individually identify a beneficiary to providers or suppliers with whom the subject individual(s) have established a patient relationship.

While the term “patient” is commonly used in the provision of healthcare, reasonable minds may differ on the periodicity with which an individual must have contact with a provider or supplier to maintain a “patient” relationship. Depending on individual practice or applicable laws, a person may still be considered a patient of a provider or supplier even though a number of years have passed since they were seen or provided services by the provider or supplier. However, when the individual has not visited a provider or supplier in a number of years, analyses that contain individually identifiable information about that patient may not be very useful, as any care coordination or quality improvement efforts would, presumably, require continued contact with that patient. Therefore, for the purposes of this program, we propose to define patient as an individual who has visited the provider or supplier for a face-to-face or telehealth appointment at least once in the past 12 months. This definition is similar to that used in the Medicare Shared Savings Program which assigns beneficiaries to Accountable Care Organizations based on services delivered in the past 12 months. We also believe this definition will ensure that providers and suppliers are able to receive information about patients they are actively treating. We seek comments on this proposal, particularly any beneficiary concerns if we were to implement this proposal, and any reasonable alternatives to this proposal that might address those concerns.

Except when patient-identifiable non-public analyses are shared with the patient's provider or supplier as described above, we propose at § 401.716(b)(3) to require that all non-public analyses must be beneficiary de-identified using the de-identification standards in the HIPAA Privacy Rule at 45 CFR 164.514(b). De-identification under this standard requires the removal of specified data elements or reliance on a statistical analysis that concludes that the information is unlikely to be able to be used alone or in combination with other available information to identify/re-identify the patient subjects of the data. The statistical de-identification approach may be more difficult because an entity may not have access to an expert capable of performing the analysis in accordance with HIPAA Rules, but we believe that the protections afforded by HIPAA-like standards of de-identification are appropriate, as HIPAA has, in many ways, established a reasoned and appropriate privacy and security floor for the health care industry. That said, the framework for de-identification that is laid out in the HIPAA Privacy Rule represents a widely accepted industry standard for de-identification, so we think its concepts are appropriate for adoption into this program. Additional information on the HIPAA de-identification standards can be found on the HHS Office for Civil Rights Web site at http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/De-identification/guidance.html.

We seek comment on this proposal and whether another set of de-identification standards would be more appropriate to ensure that non-public analyses do not contain information that individually identifies a beneficiary, except as provided for above where the individual is a patient of the provider or supplier who is receiving the analyses, and how qualified entities that are HIPAA-covered entities could comply with such alternate qualified entity program standards while still meeting any applicable HIPAA obligations.

In addition, section 105(a)(6) of MACRA preserves providers' and suppliers' opportunity to review analyses (now including non-public analyses) that individually identify the provider or supplier. As such, we propose at § 401.716(b)(4) to bar qualified entities' disclosure of non-public analyses that individually identify a provider or supplier unless: (a) The analysis only individually identifies the singular recipient of the analysis or (b) each provider or supplier who is individually identified in a non-public analysis that identifies multiple providers/suppliers has been afforded an opportunity to review the aspects of the analysis about them, and, if applicable, request error correction. We describe the proposed appeal and error correction process in more detail in section II.A.4 below.

3. Limitations on the Authorized User

While CMS has been granted statutory authority to impose requirements and limitations on the qualified entity, it has limited authority to oversee authorized users. As such, this proposed regulatory scheme is generally structured to require the qualified entity to ensure authorized users' compliance with the concepts laid out in MACRA through contractual means. In keeping with this, we propose at § 401.716(b)(2) and § 401.716(c) to require the qualified entity's use of legally binding agreements with any authorized users to whom it provides or sells the non-public analyses.

Types of Legally Binding Agreements

For non-public analyses that include patient identifiable data, we propose at § 401.716(b)(2) to require the qualified entity to enter into a QE DUA with any authorized users as a pre-condition to providing or selling such non-public analyses. As we are also proposing to require use of the QE DUA in the context of the provision or sale of combined data, or the provision of Medicare data at no cost, we discuss the QE DUA in the data disclosure discussion in section II.B below. For non-public analyses that include beneficiary de-identified data, we propose at § 401.716(c) to require the qualified entity to enter into a contractually binding non-public analyses agreement with any authorized users as a pre-condition to providing or selling such non-public analyses. A discussion of the proposed requirements for the non-public analyses agreements follows in this section.

We believe that the use of the non-public analyses agreement when authorized users receive non-public analyses containing de-identified data and the QE DUA when authorized users receive non-public analyses that contain patient identifiable information are the best mechanisms for ensuring that both qualified entities and authorized users are aware of and compliant with the data use and disclosure limitations established by MACRA. We seek comment on whether the non-public analyses agreement and the QE DUA are the best mechanisms to ensure compliance with these restrictions given the authorities established by MACRA.

Requirements in the Non-Public Analyses Agreement

The statute generally allows qualified entities to provide or sell their non-public analyses to authorized users for non-public use, but it bars use or disclosure of such analyses for marketing (see section 105(a)(3)(c) of MACRA). Such analyses therefore may include, but would not be limited to analyses intended to assist providers' and suppliers' development of, and participation in, quality and patient care improvement activities, including development of new models of care. But, while many types of non-public analyses could lead to improvements in the health care delivery system, certain types of analyses could cause harm to patients or lead to additional fraud and/or abuse concerns for the delivery system. Therefore, despite the breadth of the statutory authority, we believe it is important to establish additional limits on the non-public analyses, given the expansive types of non-public analyses that could be conducted by the qualified entities if no limits are placed on such analyses, and the potential deleterious consequences of some such analyses.

With this in mind, we propose at § 401.716(c)(1) that the non-public analyses agreement require that non-public analyses conducted using combined data or the information derived from the evaluations described in section 1874(e)(4)(D) of the Act may not be used or disclosed for the following purposes: marketing, harming or seeking to harm patients and other individuals both within and outside the healthcare system regardless of whether their data are included in the analyses (for example, an employer using the analyses to attempt to identify and fire employees with high healthcare costs), or effectuating or seeking opportunities to effectuate fraud and/or abuse in the healthcare system (for example, a provider using the analyses to identify ways to submit fraudulent claims that might not be caught by auditing software).

Rather than developing a new definition for marketing under this program, we propose at § 401.703(s) to generally define marketing using the definition at 45 CFR 164.501 in the HIPAA Privacy Rule. Under this definition, marketing means making a communication about a product or service that encourages recipients of the communication to purchase or use the product or service. In doing so, we note that the HIPAA Privacy Rule also includes a general restriction on use of an individual's Protected Health Information (PHI) for marketing. Given the similarities between the use and disclosure of PHI under HIPAA and the data sharing limitations under this program, we believe the definition of marketing in HIPAA should also generally be used for this program, but, given the categorical statutory bar on marketing in this program, we are not proposing a consent exception to the bar like that seen in the HIPAA Privacy Rule. We also believe that use of this HIPAA definition as modified will simplify compliance with the qualified entity program requirements, especially decisions regarding what is and is not considered marketing. We seek comment on the proposal to use this definition as modified from HIPAA for the purposes of this program.

The proposed restrictions on using analyses and/or derivative data, meaning data gleaned from the analyses, that would or could be used to exploit patients or other individuals or to effectuate fraud and/or abuse in the healthcare system are intended to ensure that the analyses are unlikely to result in physical or financial harm to patients or other individuals within or outside the health care delivery system. We seek comments on these proposals as well as whether there are other restrictions that should be imposed to limit potential physical or financial harm to patients or other individuals within or outside the healthcare system.

Section 105(a)(1)(B)(i) of MACRA requires that any non-public analyses provided or sold to an employer may only be used by the employer for the purposes of providing health insurance to employees and retirees of the employer. We believe this limit should also apply to “dependents” of either category whenever the employer offers coverage for family members who are neither employees nor retirees. As such, we further propose that if the qualified entity is providing or selling non-public analyses to an employer that this requirement be included in the non-public analyses agreement. We seek comment on whether the resulting non-public analyses agreement between the qualified entity and the employer is the best mechanism to ensure compliance with this restriction given the authorities established by MACRA.

The statute also contains limitations on the re-disclosure of non-public analyses provided or sold to authorized users at section 105(a)(5) of MACRA. Under that provision, re-disclosure is limited to authorized users who are a provider or supplier. Furthermore, these providers and suppliers are to limit any re-disclosures to instances in which the recipient would use the non-public analyses for provider/supplier “performance improvement.” As many if not most providers and suppliers that receive non-public analyses from the qualified entity will be HIPAA-covered entities, we propose to limit performance improvement re-disclosures to those that would support quality assessment and improvement, and care coordination activities by or on behalf of the eligible downstream provider or supplier. For example, providers may need to share the non-public analyses or derivative data with someone working on their behalf to carry out such quality assessment and improvement or care coordination activities. That is, if they are a HIPAA-covered entity, they may wish to share the non-public analyses or derivative data with their business associate. Such a scenario could arise when a consultant is hired to assist the provider/supplier in interpreting the non-public analyses, or in determining what changes in the delivery of care are needed to assess or improve the quality of care, or to better coordinate care. Another example is if the provider or supplier wants to share the non-public analyses with other treating providers/suppliers for quality assessment and improvement or care coordination purposes.

In addition, especially under circumstances in which patient identifiable data is included in the non-public analysis, we recognize that there are instances in which a provider or supplier may be required to produce information to a regulatory authority as required by a statute or regulation. For example, a HIPAA-covered entity may be required to produce PHI to the Secretary for purposes of an investigation of a potential HIPAA violation. Therefore, for purposes of this qualified entity program, we propose to adopt the HIPAA definition of “required by law” at 45 CFR 164.103 so as to allow for such mandatory disclosures. As defined at 45 CFR 164.103, “required by law” means any mandate in law that compels an entity to make a use or disclosure of PHI that is enforceable in a court of law (including disclosures compelled by court order, statute, or regulation). An example would be a court order to turn over medical records as part of litigation. Another common example would be disclosures required by the regulations governing the submission of a claim for payment for Medicare fee-for-service covered services.

As a result, we propose at § 401.716(c)(3)(i) to require qualified entities to include in the non-public analysis agreement a requirement to limit re-disclosure of non-public analyses or derivative data to instances in which the authorized user is a provider or supplier, and the re-disclosure is as a covered entity would be permitted under 45 CFR 164.506(c)(4)(i) or 164.502(e)(1). Accordingly, a qualified entity may only re-disclose individually identifiable health information to a covered entity for the purposes of the covered entity's quality assessment and improvement or for the purposes of care coordination activities, where that entity has a patient relationship with the individual who is the subject of the information, or to a business associate of such a covered entity under a written contract as defined at 45 CFR 164.502(e)(1). Furthermore, as section 105(a)(5)(A) of MACRA states that the analyses generally may not be re-disclosed or released to the public, we generally propose at § 401.716(c)(3)(ii) to require qualified entities to use non-public analyses agreements to explicitly bar authorized users from any other re-disclosure of the non-public analyses or any derivative data except to the extent a disclosure qualifies as a “required by law” disclosure. We seek comment on our proposal to require qualified entities to contractually limit re-disclosures of beneficiary de-identified non-public analyses or any derivative data other than as described above.

As discussed above, the non-public analyses agreement can only be used in the disclosure of analyses that include beneficiary de-identified data. However, even though the analyses subject to a non-public analyses agreement are beneficiary de-identified, we believe that additional restrictions on the authorized user are necessary to ensure appropriate privacy and security protections for our beneficiaries. We therefore propose at § 401.716(c)(5) to require qualified entities to impose a legally enforceable bar on the authorized user's use or disclosure of any non-public analyses (or data or analyses derived from such non-public analyses) to re-identify or attempt to re-identify any individual whose data is included in the analyses or any derivative data. We believe this additional level of privacy and security protection is necessary to protect beneficiaries. We seek comment on this proposal.

Finally, we propose at § 401.716(d)(6) to require qualified entities to use their non-public analyses agreements to bind their non-public analyses recipients to reporting any violation of the terms of that non-public analyses agreement to the qualified entity. As explained below in Section D, qualified entities will be expected to report on these violations as part of their annual reporting to CMS. Even though the analyses covered by the non-public analyses agreement will be de-identified, due to the risk of re-identification of beneficiary information, we still believe that this requirement is essential to our ability to monitor and ensure the privacy and security of beneficiary information. We seek comment on these proposals.

4. Confidential Opportunity To Review, Appeal, and Correct Analyses

As noted briefly above, section 105(a)(6) of MACRA directs us to ensure that qualified entities provide providers and suppliers who are individually identified in a non-public analysis with an opportunity to review and request corrections before the qualified entity provides or sells the non-public analyses to an authorized user. But, as noted above, we have proposed one exception to this general rule in cases where the analysis only individually identifies the (singular) provider or supplier who is being provided or sold the analysis. In all other cases, we propose that the qualified entity must follow the confidential review, appeal, and error correction requirements in section 1874(e)(4)(C)(ii) of the Act.

Specifically, we propose at § 401.717(f) that a qualified entity generally must comply with the same error corrections process and timelines as are required for public performance reporting before disclosing non-public analyses. This process includes confidentially sharing the measures, measure methodologies and measure results that comprise such evaluations with providers and suppliers at least 60 calendar days before providing or selling the analyses to one or more authorized users. During these 60 calendar days, the provider or supplier may make a request for the Medicare claims data and beneficiary names that may be needed to confirm statements about the care that they delivered to their patients. If the provider or supplier requests such data, the qualified entity must release the Medicare claims and beneficiary names relevant to what is said about the requesting provider/supplier in the draft non-public analyses. We believe that for many providers and suppliers, a beneficiary's name will be of more practical use in determining the accuracy of analyses than the underlying claims used in the analyses. The sharing of such data must be done via a secure mechanism that is suitable for transmitting or providing access to individually identifiable health information. The qualified entity also must ensure that the provider or supplier has been notified of the date on which the analyses will be shared with the authorized user. If any requests for error correction are not resolved by the date on which the analyses are to be shared, the qualified entity may release the analyses, but must inform the authorized user that the analyses are still under appeal, and the reason for the appeal.

We believe that the process we established for review and error correction for public performance reporting finds the right balance between allowing providers and suppliers the opportunity to review the non-public analyses while also ensuring that the information is disseminated in a timely manner. However, we have had limited public reporting thus far to confirm this. Furthermore, using the same process for review and error correction for non-public analyses and the public reports creates continuity and a balance between the needs and interests of providers and suppliers and those of the qualified entities, authorized users and the public. We also believe that using the same timeframes and requirements will simplify the review process for providers and suppliers. We seek comment on our proposal generally to require qualified entities to comply with the same error corrections process and timelines as are required for public performance reporting when sharing analyses that individually identify a provider or supplier.

Although we do not believe that we have statutory authority to require it given that section 1874(e) of the Act only covers the disclosure of Medicare claims data, to the extent permitted by applicable law, we strongly encourage qualified entities to also share the claims data from other sources with providers and suppliers if they ask for the underlying data used for the analyses.

B. Dissemination of Data and the Use of QE DUAs for Data Dissemination and Patient-Identifiable Non-Public Analyses

Subject to other applicable law, section 105(a)(2) of MACRA expands the permissible uses and disclosures of data by a qualified entity to include providing or selling combined data for non-public use to certain authorized users, including providers of services, suppliers, medical societies, and hospital associations. Subject to the same limits, it also permits a qualified entity to provide Medicare claims data for non-public use to these authorized users; however, a qualified entity may not charge a fee for providing such Medicare claims data. But, in order to provide or sell combined data or Medicare data, section 501(a)(4) of MACRA instructs the qualified entity to enter into a DUA with their intended data recipient(s).

1. General Requirements for Data Dissemination

To implement these provisions in MACRA, we propose at § 401.718(a) to provide that, subject to other applicable laws (including applicable information, privacy, security and disclosure laws) and certain defined program requirements, including that the data be used only for non-public purposes, a qualified entity may provide or sell combined data or provide Medicare claims data at no cost to certain authorized users, including providers of services, suppliers, medical societies, and hospital associations. Where a qualified entity is a HIPAA-covered entity or is acting as a business associate, compliance with other applicable laws will include the need to ensure that it fulfills the requirements under the HIPAA Privacy Rule, including the bar on the sale of PHI.

We note that we propose definitions for authorized user, medical societies, and hospital associations in section II.C below, and have already proposed a definition for combined data in section II.A above.

2. Limitations on the Qualified Entity Regarding Data Disclosure

The statute places a number of limitations on the sale or provision of combined data and the provision of Medicare claims data by qualified entities, including generally barring the disclosure of beneficiary identifiable data obtained through the qualified entity program. Therefore, in keeping with our other proposals at § 401.716(b)(3), we propose at § 401.718(b)(1) to generally require that any combined data or Medicare claims data that is provided to an authorized user by a qualified entity under subpart G be beneficiary de-identified in accordance with the de-identification standards in the HIPAA Privacy Rule at 45 CFR 164.514(b). As noted above, we believe that the HIPAA Privacy Rule de-identification standard represents a widely accepted industry standard for de-identification, so we think its concepts are appropriate for adoption under the qualified entity program.

We do recognize, however, that providers or suppliers with current treatment relationships with the patient subjects of such data may desire and benefit from receiving data that contains individually identifiable information about those patients. Therefore, we also propose an exception at § 401.718(b)(2) that would allow a qualified entity to provide or sell patient identifiable combined data/and or provide patient identifiable Medicare claims data at no cost to an individual or entity that is a provider or supplier if the provider or supplier has a patient relationship with every patient about whom individually identifiable information is provided and the disclosure is consistent with applicable law.

MACRA also requires qualified entities to bind the recipients of their data to a DUA that will govern the use and, where applicable, re-disclosure of any data received through this program prior to the provision or sale of such data to an authorized user. Therefore, we further propose at § 401.718(c), to require that a qualified entity impose certain contractually binding use/re-disclosure requirements as a condition of providing and/or selling combined data and/or providing Medicare claims data to an authorized user. The following section provides the proposed requirements for such DUAs between qualified entities and authorized users.

3. Data Use Agreement

Section 501(a)(4) of MACRA requires execution of a DUA as a precondition to a qualified entity's provision or sale of data to an authorized user. The DUA must address the use and, if applicable, re-disclosure of the data, and the applicable privacy and security requirements that must be established and maintained by or for the authorized user. The statute also imposes a number of other limitations on the authorized user. But, while CMS has authority to impose requirements on the qualified entity, we must rely upon the qualified entity to impose legally enforceable obligations on the authorized users.

Therefore, in § 401.713(a), we propose certain clarifying changes that will recognize that there are now two distinct DUAs in the qualified entity program—the CMS DUA, which is the agreement between CMS and a qualified entity, and what we will refer to as the QE DUA, which will be the legally binding agreement between a qualified entity and an authorized user. We are not proposing any changes to the requirements for the CMS DUA, but rather are clarifying that there are now two DUAs—the CMS DUA and the QE DUA.

Furthermore, in § 401.713(d), we propose a number of provisions that address the privacy and security of the combined data and/or the Medicare claims data and/or non-public analyses that contain patient identifiable data. These provisions require the qualified entity to condition the disclosure of data on the imposition of contractually binding limits on the permissible uses and re-disclosures that can be made of the combined data and/or the Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data. Such contractually binding provisions would be included in the QE DUA.

First, we propose to require that the QE DUA contain certain limitations on the authorized user's use of the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data. In § 401.713(d)(1), we propose that the QE DUA limit authorized users use of the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data to the purposes described in the first or second paragraph of the definition of “health care operations” under 45 CFR 164.501, or that which qualifies as “fraud and abuse detection or compliance activities” under 45 CFR 164.506(c)(4). If finalized, this means that authorized users would only be permitted to use the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data provided by the qualified entity for quality assessment and improvement activities, care coordination activities, including the review of provider or supplier performance, and/or for fraud, waste, and abuse detection and compliance purposes. We believe these uses need to be permitted to support quality improvement and care coordination activities, as well as efforts to ensure fraud, waste, and abuse detection and compliance, and that these uses should encompass the full range of activities for which the authorized users will legitimately need the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data. We also propose to require that all other uses and disclosures of combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data be forbidden except to the extent a disclosure qualifies as a “required by law” disclosure.

The statute also prohibits the authorized user from using the combined data and/or Medicare claims data for marketing purposes. We therefore propose at § 401.713(d)(2) to require qualified entities to use the QE DUA to contractually prohibit the authorized users from using the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data for marketing purposes. As noted above, we propose to define “marketing” as it is defined in the HIPAA Privacy Rule, but, given the statutory bar, we do not propose to adopt an exception to the bar for “consent”-based marketing. As noted above, HIPAA provides well-recognized standards for the appropriate use and disclosure of certain individually identifiable health information, and we believe that the HIPAA definition for “marketing” is appropriate for the qualified entity program as well. For additional information and guidance on the HIPAA Privacy Rule, including guidance on what constitutes marketing, please visit the HHS Office for Civil Rights Web site at http://www.hhs.gov/ocr/privacy/.

Furthermore, we propose to require qualified entities' use of the QE DUA to address minimum privacy and security standards. CMS is committed to protecting the privacy and security of beneficiary-identifiable data when it is disseminated, including when it is in the hands of authorized users. This is especially important as there are no guarantees that authorized users will be subject to the HIPAA Privacy and Security Rules. Therefore, we propose at § 401.713(d)(3) to require qualified entities to contractually bind authorized users using the QE DUA to protect patient identifiable combined data and/or Medicare data, any patient identifiable derivative data, and/or non-public analyses that contain patient identifiable data, with at least the privacy and security protections that would be required of covered entities and their business associates under HIPAA Privacy and Security Rules. Additional guidance on the Security rule can be found on the Office for Civil Rights Web site at http://www.hhs.gov/ocr/privacy/hipaa/. Such protections would apply when using, disclosing, or maintaining patient identifiable data, regardless of whether the authorized user is a HIPAA Covered Entity or business associate. In addition, we propose to require that the QE DUA contain provisions that require that the authorized user maintain written privacy and security policies and procedures that ensure compliance with these HIPAA-based privacy and security standards and the other standards required under this subpart for the duration of the QE DUA, or for so long as they hold combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data that was subject to the QE DUA, should return/destruction of the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data not be feasible as of the expiration of the QE DUA.

Furthermore, we propose to require QE DUA provisions detailing such policies and procedures must survive termination of the QE DUA, whether for cause or not. We believe that requiring compliance with these HIPAA Privacy and Security Rule concepts outside of the HIPAA context will provide the needed protection for the combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data provided or sold to authorized users under the qualified entity program.

We also propose at § 401.713(d)(7) to require that the qualified entity use the QE DUA to contractually bind an authorized user as a condition of receiving combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data under the qualified entity program to notify the qualified entity of any violations of the QE DUA. Violations might include reportable breaches of data, such as those defined in the HIPAA Breach Rule, or other violations of QE DUA provisions. The QE DUA also will require the authorized user to fully cooperate in the qualified entity's effort to mitigate any harm that may result from such violations, as well as any assistance the qualified entity may request to fulfill the qualified entity's obligations under this subpart.

We request comment on whether the proposed privacy and security requirements are appropriate and adequate, or whether there are more appropriate standards or additional protections that are advisable.

MACRA section 105(a)(5) directs that any combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data provided or sold under this program to authorized users is to be non-public, and it requires the imposition of re-disclosure limitations on authorized users. Under those provisions, qualified entities may only permit providers and suppliers to re-disclose combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data for the purposes of performance improvement and care coordination. We propose to require qualified entities to include provisions in their QE DUA that contractually limit the re-disclosure and/or linking of combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data provided or sold under this program.

We therefore propose at § 401.713(d)(4) to require that the qualified entity include a provision in its QE DUAs that prohibits the authorized user from re-disclosing or making public any combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data subject to QE DUA except as provided under the QE DUA. Furthermore, we propose at § 401.713(d)(5) to require that the qualified entity use the QE DUA to limit provider's and supplier's re-disclosures to a covered entity pursuant to 45 CFR 164.506(c)(4)(i) or 164.502(e)(1). Therefore, a provider or supplier would only be permitted to re-disclose combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data, subject to the QE DUA, to a covered entity for activities focused on quality assessment and improvement, including the review of provider or supplier performance or a business associate of the provider or supplier. We also propose to require re-disclosure when required by law. We propose these limitations in an effort to ensure that the combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data will be protected in the hands of the downstream entity despite these regulations not reaching such individuals/entities directly. We believe that limiting downstream re-disclosures to entities that are subject to the HIPAA Privacy and Security rules will ensure that the combined data and/or Medicare claims data and/or non-public analyses that contain patient identifiable data and/or any derivative data is appropriately maintained, used, and disclosed. We seek comment on whether the proposed re-disclosure requirements should be more restrictive or should be broadened to allow for additional re-disclosure.

We also propose to require qualified entities to impose a contractual bar using their QE DUA on the downstream recipients' linking of the re-disclosed combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data to any other identifiable source of information. The only exception to this general policy would be if a provider or supplier were to receive identifiable information limited to their/its own patients. We request comment on whether an authorized user should be permitted to link combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data with other data sources, and whether the proposed provisions are adequate to protect the privacy and security of the combined data, Medicare claims data, and/or non-public analyses that contain patient identifiable data and/or any derivative data given to downstream users.

C. Authorized Users 1. Definition of Authorized User

As discussed above, section 105(a)(1) of MACRA permits qualified entities to provide or sell non-public analyses to authorized users. In addition, section 105(a)(2) of MACRA permits qualified entities to provide or sell combined data, or to provide Medicare data at no cost, only to certain authorized users. These include providers, suppliers, medical societies, and hospital associations.

Section 105(a)(9)(A) of MACRA defines authorized users as:

• A provider of services.

• A supplier.

• An employer (as defined in section 3(5) of the Employee Retirement Insurance Security Act of 1974).

• A health insurance issuer (as defined in section 2791 of the Public Health Service Act).

• A medical society or hospital association.

• Any entity not yet described in clauses (i) through (v) that is approved by the Secretary (other than an employer or health insurance issuer not described in clauses (iii) and (iv), respectively, as determined by the Secretary).

We propose a definition for authorized user at § 401.703(k) that is consistent with these statutory provisions. Specifically, we define an authorized user as: (1) A provider; (2) a supplier; (3) an employer; (4) a health insurance issuer; (5) a medical society; (6) a hospital association; (7) a health care professional association; or (8) a state agency.

We also propose definitions for entities that are authorized users, but are not yet defined within this subpart. Therefore, we propose definitions for employer, health insurance issuer, medical society, hospital association, a healthcare professional association, and a state agency.

2. Definition of Employer

We have proposed a definition for employer at § 401.703(k) that is consistent with existing statutory provisions. Specifically, we propose to define an employer as having the same meaning as the term “employer” defined in section 3(5) of the Employee Retirement Insurance Security Act of 1974. Under that provision, an employer means any person acting directly as an employer, or indirectly in the interest of an employer, in relation to an employee benefit plan; and includes a group or association of employers acting for an employer in such capacity.

3. Definition of Health Insurance Issuer

We have also proposed a definition for health insurance issuer at § 401.703(l) that is consistent with existing statutory provisions. Specifically, we propose to define a health insurance issuer as having the same meaning as the term “health insurance issuer” defined in section 2791(b)(2) of the Public Health Service Act. Under that provision, health insurance issuer means an insurance company, insurance service, or insurance organization (including an HMO) that is licensed to engage in the business of insurance in a State and is subject to State law that regulates insurance. Such term does not include a group health plan.

4. Definition of “Medical Society”

We propose to define “medical society” at § 401.703(m) as a nonprofit organization or association that provides unified representation for a large number of physicians at the national or state level and whose membership is comprised of a majority of physicians.

We conducted extensive research to develop this definition, including reviewing mission statements of national and state healthcare professional associations and medical societies, as well as state laws. While we were unable to identify a commonly recognized definition of “medical society,” our research did reveal a number of common themes that shaped our proposed definition of medical society.

We propose to define medical society as comprised of a majority of physicians, based on state law definitions around the practice of medicine. Although medical societies may also include non-physician members, due to the strong emphasis on physicians as practitioners of medicine, we propose that a medical society's membership must be comprised of a majority of physicians. Medical societies often serve as the consensus voice of their members in matters related to their profession, the patient-physician relationship, and other issues pertaining to the practice of medicine. Therefore, we propose that medical societies be at the national or state level as we believe these larger groups will have the capacity to act on the data and analyses available through this program, and to do so in accordance with the statute and the implementing regulations.

While we recognize that there are many local medical societies (for example, regional and county) performing similar functions to their national and state counterparts, we propose to maintain the definition of a medical society at the national or state level to reduce redundancy in the dissemination of data. State societies often serve as federations of local medical societies, and therefore, any use of the data by state societies could benefit their constituent local organizations.

We also propose that these organizations be nonprofit as many of the existing medical societies are nonprofit organizations. In addition, because medical societies will be eligible to receive non-public analyses and data, we believe it is important that these entities be nonprofit to ensure that data provided under this program are used to support quality improvement and assessment activities with their members rather than for profit driven purposes.

5. Definition of “Hospital Association”

We propose to define a “hospital association” at § 401.703(n) as a nonprofit organization or association that provides unified representation for a large number of hospitals or health systems at a national or state level and whose membership is comprised of a majority of hospitals and health systems.

For purposes of this definition, we propose to give hospitals the same meaning as SSA § 1861(e), 42 U.S.C. 1395x(e). We propose to include health systems in this definition as our review of national and state hospital associations member lists revealed that these larger organizations (that are generally comprised of healthcare facilities, such as surgical centers and long terms care facilities, as well as hospitals) were members. Due to their membership status in existing hospital associations, we find it appropriate to propose their inclusion into this definition. Hospital associations often serve as the consensus voice of their members in matters related to their facilities, quality and affordability of services, and other issues regarding the provision of health care. Therefore, we propose that hospital associations at the national or state level be included in this definition as we believe that these larger groups will have the capacity to act on the data, and to do so in accordance with the statute and implementing regulations.

While we recognize that there are many local hospital associations (for example, regional and county) performing similar functions to their national and state counterparts, we proposed to maintain the definition at the national or state level to reduce redundancy. State-level hospital associations are often affiliated with those local associations, and therefore, any use of the data by state hospital associations could benefit those affiliated associations.

We also propose that these organizations be nonprofit as many of the existing hospital associations are nonprofit organizations. In addition, because hospital associations will be eligible to receive non-public analyses and data, we believe it is important that these entities be nonprofit to ensure that data provided under this program are used to support quality improvement and assessment activities with their members rather than for profit driven purposes.

6. Definition of “Healthcare Provider and/or Supplier Association”

We recognize that within the field of health care, there are many other suppliers and providers beyond physicians, hospitals, and health systems. These entities also form organizations for the betterment of their professions and to improve the quality of patient care. We believe these types of entities would also benefit from the opportunity to purchase or receive non-public analyses and data from qualified entities.

While the term “healthcare professional association” is not specifically included in the definition of authorized user, the Secretary, in the exercise of her discretion pursuant to 105(a)(9)(A)(vi) of MACRA, proposes to include these organizations as authorized users. Therefore, we propose to define “healthcare provider and/or supplier association” at § 401.703(o) as a nonprofit organization or association that represents suppliers and providers at the national or state level and whose membership is comprised of a majority of suppliers or providers. Similar to the themes that emerge for medical societies and hospital associations, we believe these organizations and associations often serve as the consensus voice of their members in matters related to their respective professions, and that representation at the national or state level is most appropriate as we believe that these larger groups will have the capacity to act on the data and analyses available through this program, and to do so in accordance with the statute and the implementing regulations.

7. Definition of “State Agency”

While state agencies were not specifically included in the definition of authorized user at section 105(a)(9) of MACRA, we believe that state agencies would benefit from the ability to purchase or receive non-public analyses from qualified entities. States are important partners with CMS in transforming the health care delivery system, and these analyses would have the potential to help states improve the quality of care and reduce costs. Therefore, the Secretary, in the exercise of her discretion pursuant to 105(a)(9)(A)(vi) of MACRA, proposes to include state agencies within the definition of authorized user and to define it at § 401.703(p) as any office, department, division, bureau, board, commission, agency, institution, or committee within the executive branch of a state government.

Because there is currently no federal definition of a state agency, we looked to state laws for definitions. While states differ in the definition of state agency, we propose to exclude the judiciary and legislative branches from our proposed definition of state agency under this subpart. We believe that entities within the executive branch of a state government, for example state Medicaid agencies or state public health departments, will have the greatest interest in and need to receive these analyses. We solicit comment on whether we should expand the definition to include other branches of state government or should further limit the definition of state agency to only certain agencies, such as those working to regulate the health and/or insurance industry.

We invite comments on the proposed definitions for authorized user, medical society, hospital association, healthcare professional association, and state agency.

D. Annual Report Requirements 1. Reporting Requirements for Analyses

Section 105(a)(8) of MACRA expands the information that a qualified entity must report annually to the Secretary if a qualified entity provides or sells non-public analyses. Specifically, it requires the qualified entity to provide a summary of the analyses provided or sold, including information on the number of such analyses, the number of purchasers of such analyses, and the total amount of fees received for such analyses. It also requires the qualified entity to provide a description of the topics and purposes of such analyses. Furthermore, the Secretary may impose other reporting requirements, as appropriate.

In § 401.719(b)(3), we propose the annual reporting requirements that a qualified entity must perform if it provides or sells non-public analyses under this subpart. Consistent with the statutory requirements, we propose to require that the qualified entity provide a summary of the non-public analyses provided or sold under this subpart, including specific information about the number of analyses, the number of purchasers of such analyses, the types of authorized users that purchased analyses, the total amount of fees received for such analyses. We also propose to require the qualified entity to provide a description of the topics and purposes of such analyses. In addition, we propose to require a qualified entity to provide information on QE DUA and non-public analyses agreement violations.

2. Reporting Requirements for Data

Section 105(a)(8) of MACRA also requires a qualified entity to submit a report annually if it provides or sells data. It specifically requires information on the entities who received data under section 105(a)(2) of MACRA, the uses of the data, and the total amount of fees received for providing, selling, or sharing the data. In addition, the Secretary may require additional information as determined appropriate.

Therefore, in § 401.719(b)(4), we also propose to require qualified entities that provide or sell data under this subpart to provide the following information as part of its annual report: Information on the entities who received data, the uses of the data, the total amount of fees received for providing, selling, or sharing the data, and any QE DUA violations.

We do not propose to require any additional information at this time; however, we seek comment on whether any additional information should be collected in the future.

E. Assessment for a Breach 1. Violation of a DUA

Section 105(a)(7) of MACRA requires the Secretary to impose an assessment on a qualified entity in the case of a “breach” of a CMS DUA between the Secretary and a qualified entity or a breach of a QE DUA between a qualified entity and an authorized user. Because the term “breach” is defined in HIPAA, and this definition is not consistent with the use of the term for this program, we propose instead to adopt the term “violation” when referring to a “breach” of a DUA for purposes of this program. We anticipate this will reduce the potential for confusion. Therefore in § 401.703(t), we propose to define the term “violation” to mean a failure to comply with a requirement in a CMS DUA or QE DUA. We request comments on the proposed definition of violation.

We also propose at § 401.719(d)(5) to impose an assessment on any qualified entity that violates a CMS DUA or fails to ensure that their authorized users do not violate a QE DUA.

MACRA provides guidance only on the assessment amount and what triggers an assessment, but it does not dictate the procedures for imposing such assessments. We therefore propose to adopt certain relevant provisions of section 1128A of the Social Security Act (the Act) (Civil Money Penalties) and part 402 (Civil Money Penalties, Assessments, and Exclusions) to specify the process and procedures for calculating the assessment, notifying a qualified entity of a violation, collecting the assessment, and providing qualified entities an appeals process.

2. Amount of Assessment

Section 105(a)(7)(B) of MACRA specifies that when a violation occurs, the assessment is to be calculated based on the number of affected individuals who are entitled to, or enrolled in, benefits under part A of title XVIII of the Act, or enrolled in part B of such title. Affected individuals are those whose information, either identifiable or de-identified, was provided to a qualified entity or an authorized user under a DUA. Assessments can be up to $100 per affected individual, but, given the broad discretion in establishing some lesser amount, we looked to part 402 as a model for proposing aggravating and mitigating circumstances that would be considered when calculating the assessment amount per impacted individual. However, violations under section 105(a)(7)(B) of MACRA are considered point-in-time violations, not continuing violations.

Number of Individuals

We propose at § 401.719(d)(5)(i) that CMS will calculate the amount of the assessment of up to $100 per individual entitled to, or enrolled in part A of title XVIII of the Act and/or enrolled in part B of such title whose data was implicated in the violation.

We generally propose to determine the number of potentially affected individuals by looking at the number of beneficiaries whose Medicare claims information was provided either by CMS to the qualified entity or by the qualified entity to the authorized user in the form of individually identifiable or de-identified data sets that were potentially affected by the violation.

We recognize that, depending on the number and types of datasets requested, a single beneficiary may appear multiple times within a dataset or non-public analysis. We propose that a single beneficiary, regardless of the number of times their information appears in a singular non-public report or dataset, would only count towards the calculation of an assessment for a violation once. We propose to use the unique beneficiary identification number in the Chronic Conditions Warehouse (CCW) to establish the number of beneficiaries that were included in a given dataset that was transferred to the qualified entity, and subsequently re-disclosed in accordance with this subpart. For qualified entities that provide or sell subsets of the dataset that CMS provided to them, combined information, or non-public analyses, we propose to require that the qualified entity provide the Secretary with an accurate number of beneficiaries whose data was sold or provided to the authorized user and, thereby, potentially affected by the violation. In those instances in which the qualified entity is unable to establish a reliable number of potentially affected beneficiaries, we propose to impose the assessment based on the total number of beneficiaries that were included in the data set(s) that was/were transferred to the qualified entity under that DUA.

Assessment Amount per Impacted Individual

MACRA allows an assessment in the amount of up to $100 per potentially affected individual. We therefore propose to draw on factors established in 42 CFR part 402 to specify the factors and circumstances that will be considered in determining the assessment amount per potentially affected individual.

We propose at § 401.719(d)(5)(i)(A) that the following basic factors be considered in establishing the assessment amount per potentially affected individual: (1) The nature and extent of the violation; (2) the nature and extent of the harm or potential harm resulting from the violation; and (3) the degree of culpability and history of prior violations.

In addition, in considering these basic factors and determining the amount of the assessment per potentially affected individual, we propose to take into account certain aggravating and mitigating circumstances.

We propose at § 401.719(d)(5)(i)(B)(1) that CMS consider certain aggravating circumstances in determining the amount per potentially affected individual, including the following: Whether there were several types of violations, occurring over a lengthy period of time; whether there were many violations or the nature and circumstances indicate a pattern of violations; and whether the nature of the violation had the potential or actually resulted in harm to beneficiaries.

In addition, we propose at § 401.719(d)(5)(i)(B)(2) that CMS take into account certain mitigating circumstances in determining the amount per potentially affected individual, including the following: Whether all of the violations subject to the imposition of an assessment were few in number, of the same type, and occurring within a short period of time, and/or whether the violation was the result of an unintentional and unrecognized error and the qualified entity took corrective steps immediately after discovering the error.

We request comment on the proposed method for calculating the number of individuals. In addition, we request comments on whether the proposed factors for determining the amount of the assessment per potentially affected individual are sufficient, or whether additional factors should be considered. We also request comment on the proposed basic, aggravating, and mitigating factors.

3. Notice of Determination

We looked to the relevant provisions in 42 CFR part 402 and Section 1128A of the Act to frame proposals regarding the specific elements that would be included in the notice of determination. To that end, we propose at § 401.719(d)(5)(ii) that the Secretary would provide notice of a determination to a qualified entity by certified mail with return receipt requested. The notice of determination would include information on (1) the assessment amount, (2) the statutory and regulatory bases for the assessment, (3) a description of the violations upon which the assessment was proposed, (4) information concerning response to the notice, and (5) the means by which the qualified entity must pay the assessment if they do not intend to request a hearing in accordance with procedures established at Section 1128A of the Act and implemented in 42 CFR part 1005.

We believe this information will provide a qualified entity with sufficient information to understand why an assessment was imposed and how the amount of the assessment was calculated. We seek comment regarding these proposals, including whether any additional information should be provided in the notice of determination.

4. Failure To Request a Hearing

We also looked to the relevant provisions in 42 CFR part 402 and section 1128A of the Act to inform our proposals regarding what happens when a hearing is not requested.

We propose at § 401.719(d)(5)(iii) that an assessment will become final if a qualified entity does not request a hearing within 60 days of receipt of the notice of the proposed determination. At this point, CMS would impose the proposed assessment. CMS would notify the qualified entity, by certified mail with return receipt, of the assessment and the means by which the qualified entity may pay the assessment. Under these proposals a qualified entity would not have the right to appeal an assessment unless it has requested a hearing within 60 days of receipt of the notice of the proposed determination.

5. When an Assessment Is Collectible

We again looked to the relevant provisions in 42 CFR part 402 and section 1128A of the Act to inform our proposed policies regarding when an assessment becomes collectible.

We propose at § 401.719(d)(5)(iv) that an assessment becomes collectible after the earliest of the following situations: (1) On the 61st day after the qualified entity receives CMS's notice of proposed determination under § 401.719(d)(5)(ii), if the entity does not request a hearing; (2) immediately after the qualified entity abandons or waives its appeal right at any administrative level; (3) 30 days after the qualified entity receives the Administrative Law Judge's (ALJ) decision imposing an assessment under § 1005.20(d), if the qualified entity has not requested a review before the Department Appeal Board (DAB); or (4) 60 days after the qualified entity receives the DAB's decision imposing an assessment if the qualified entity has not requested a stay of the decision under § 1005.22(b).

6. Collection of an Assessment

We also looked to the relevant provisions in 42 CFR part 402 and section 1128A of the Act in framing our proposals regarding the collection of an Assessment.

We propose at § 401.719(d)(5)(v) that CMS be responsible for collecting any assessment once a determination is made final by HHS. In addition, we propose that the General Counsel may compromise an assessment imposed under this part, after consulting with CMS or Office of Inspector General (OIG), and the Federal government may recover the assessment in a civil action brought in the United States district court for the district where the claim was presented or where the qualified entity resides. We also propose that the United States may deduct the amount of an assessment when finally determined, or the amount agreed upon in compromise, from any sum then or later owing the qualified entity. Finally, we propose that matters that were raised or that could have been raised in a hearing before an ALJ or in an appeal under section 1128A(e) of the Act may not be raised as a defense in a civil action by the United States to collect an assessment.

We seek comments on these proposals.

F. Termination of Qualified Entity Agreement

We propose at § 401.721(a)(7) that CMS may unilaterally terminate the qualified entity's agreement and trigger the data destruction requirements in the CMS DUA if CMS determines that a qualified entity or its contractor fails to monitor authorized users' compliance with the terms of their QE DUAs or non-public analysis use agreements. We believe this proposed provision is consistent with the intent of MACRA to ensure the protection of data and analyses provided by qualified entities to authorized users under this subpart. We request comments on this proposed provision.

G. Additional Data

Section 105(c) of MACRA expands, at the discretion of the Secretary, the data that the Secretary may make available to qualified entities, including standardized extracts of claims data under titles XIX (Medicaid) and XXI (the Children's Health Insurance Program, CHIP) for one or more specified geographic areas and time periods as may be requested by the qualified entity. Currently, CMS is only required to provide qualified entities with standardized extracts of claims data from Medicare Parts A, B, and D. While CMS has data for Medicare and Medicaid/CHIP, the timeliness and quality of data differs significantly between the programs.

Medicare is a national program that is administered by CMS and, as a result, the claims data are available on a relatively timely basis, and guidelines about claims submission and data cleaning are consistent across the entire program. Medicaid and CHIP, however, are state-run programs where the states submit data to CMS. Each state's Medicaid agency collects enrollment and claims data for persons enrolled in Medicaid and CHIP. These data are collected in the state's Medicaid Management Information System (MMIS). Each state's MMIS is tailored to the needs of that state's Medicaid program. In partnership with the states, the federal government does manage aspects of the Medicaid program, and works with the various Medicaid State Agencies to monitor health care delivery and payment on a national level. To aid in that work the data in the MMIS are converted into a national standard and submitted to CMS via the Medicaid and CHIP Statistical Information System (MSIS). But the MSIS data (enrollment and claims data) are only reported to CMS on a quarterly basis, and the MSIS data can be challenging to use due to the data representing a mixture of time periods.

Given the difficulties in using the MSIS data, the timeliness issues with our Medicaid data, and the variation of time periods reflected in our data, we believe that qualified entities would be better off seeking Medicaid and/or CHIP data through the State Medicaid Agencies. As a result, we propose not to expand the data available to qualified entities from CMS.

H. Qualified Clinical Data Registries

Section 105(b) of MACRA allows qualified clinical data registries to request access to Medicare data for the purposes of linking the data with clinical outcomes data and performing risk-adjusted, scientifically valid analyses, and research to support quality improvement or patient safety. The CMS research data disclosure policies already allow qualified clinical data registries to request Medicare data for these purposes, as well as other types of research. More information on accessing CMS data for research can be found on the Research Data Assistance Center (ResDAC) Web site at www.resdac.org. Given these existing processes and procedures, we propose not to adopt any new policies or procedures regarding qualified clinical data registries' access to Medicare claims data for quality improvement or patient safety research.

III. Collection of Information Requirements

Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

We are soliciting public comment on each of these issues for the following sections of this proposed rule that contain information collection requirements (ICRs).

Proposed § 401.718(c) and § 401.716(b)(2)(ii) require a qualified entity to enter into a QE DUA with an authorized user prior to providing or selling data or selling a non-public analyses that contains individually identifiable beneficiary information. Proposed § 401.713(d) requires specific provisions in the QE DUA. Proposed § 401.716(c) requires a qualified entity to enter into a non-public analyses agreement with the authorized user as a pre-condition to providing or selling de-identified analyses. We estimate that it will take each qualified entity a total of 40 hours to develop the QE DUA and non-public analyses agreement. Of the 40 hours, we estimate it will take a professional/technical services employee with an hourly labor cost of $75.08 a total of 20 hours to develop both the QE DUA and non-public analyses agreement and estimate that it will require a total of 20 hours of legal review at an hourly labor cost of $77.16 for both the QE DUA and non-public analyses agreement. We also estimate that it will take each qualified entity 2 hours to process and maintain each QE DUA or non-public analyses agreement with an authorized user by a professional/technical service employee with an hourly labor cost of $75.08. While there may be two different staff positions that perform these duties (one that is responsible for processing the QE DUAs and/or non-public analyses agreement and one that is responsible for maintaining the QE DUA and/or non-public analyses agreement), we believe that both positions would fall under the professional/technical services employee labor category with an hourly labor cost of $75.08. This would mean that to develop each QE DUA and non-public analysis agreement, the burden cost per qualified entity would be $3,045 with a total estimated burden for all 15 qualified entities of $45,675. This does not include the two hours to process and maintain each QE DUA.

As discussed in the regulatory impact analysis below, we estimate that each qualified entity would need to process and maintain 70 QE DUAs or non-public analyses agreements as some authorized users may receive both datasets and a non-public analyses and would only need to execute one QE DUA. We estimate that it will take each qualified entity 2 hours to process and maintain each QE DUA or non-public analyses agreement. This would mean the burden cost per qualified entity to process and maintain 70 QE DUAs or non-public analyses agreements would be $10,511 with a total estimated burden for all 15 qualified entities of $157,668. While we anticipate that the requirement to create a QE DUA and/or non-public analyses agreement will only be incurred once by a qualified entity, we believe that the requirement to process and maintain the QE DUAs and/or non-public analyses will be an ongoing cost. We request comment on the number of hours that will be needed to create and process the QE DUA and non-public analyses agreement.

If finalized, these regulations would also require a qualified entity to submit additional information as part of its annual report to CMS. A qualified entity is currently required to submit an annual report to CMS under § 401.719(b). Proposed § 401.719(b)(3) and (4) provide for additional reporting requirements if a qualified entity chooses to provide or sell analyses and/or data to authorized users. The burden associated with this requirement is the time and effort necessary to gather, process, and submit the required information to CMS. There are currently 13 qualified entities; however we estimate that number will increase to 20 if these proposals are finalized. Some qualified entities may not want to bear the risk of the potential assessments and have been able to accomplish their program goals under other CMS data sharing programs, therefore some qualified entities may not elect to provide or sell analyses and/or data to authorized users. As a result, we estimate that 15 qualified entities will choose to provide or sell analyses and/or data to authorized users, and therefore, would be required to comply with these additional reporting requirements within the first three years of the program. We further estimate that it would take each qualified entity 50 hours to gather, process, and submit the required information. We estimate that it will take each qualified entity 34 hours to gather the required information, 15 hours to process the information, and 1 hour to submit the information to CMS. We believe a professional or technical services employee of the qualified entity with an hourly labor cost of $75.08 will fulfill these additional annual report requirements. We estimate that 15 qualified entities will need to comply with this requirement and that the total estimated burden associated with this requirement is $56,310. We request comment on the type of employee and the number of hours that will be needed to fulfill these additional annual reporting requirements.

As a reminder, the final rule for the qualified entity program, published December 7, 2011, included information about the burden associated with the provisions in that rule. Specifically, Sections 401.705-401.709 provide the application and reapplication requirements for qualified entities. The burden associated with these requirements is currently approved under OMB control number 0938-1144 with an expiration date of May 31, 2018. This package accounts for 35 responses. Section 401.713(a) states that as part of the application review and approval process, a qualified entity would be required to execute a DUA with CMS, that among other things, reaffirms the statutory bar on the use of Medicare data for purposes other than those referenced above. The burden associated with executing this DUA is currently approved under OMB control number 0938-0734 with an expiration date of December 31, 2017. This package accounts for 9,240 responses (this package covers all CMS DUAs, not only DUAs under the qualified entity program). We currently have 13 qualified entities and estimate it will increase to 20 so we have not surpassed the previously approved numbers.

We based the hourly labor costs on those reported by the Bureau of Labor Statistics (BLS) at http://data.bls.gov/pdq/querytool.jsp?survey=ce for this labor category. We used the annual rate for 2014 and added 100 percent for overhead and fringe benefit costs.

Table 1—Collection of Information Regulation section(s) OMB control No. Number of
  • respondents
  • Number of responses per
  • respondent
  • Burden per response
  • (hours)
  • Total
  • annual
  • burden
  • (hours)
  • Hourly labor cost of
  • reporting
  • ($) *
  • Total
  • labor
  • cost of
  • reporting
  • ($)
  • Total
  • cost
  • ($)
  • § 401.718, § 401.716, and § 401.713 (DUA and non-public analyses agreement Development) 0938—New 15 1 20 300 75.08 22,524 22,524 § 401.718 and § 401.716 (Legal Review) 0938—New 15 1 20 300 77.16 23,148 23,148 § 401.718 and § 401.716 (Processing and Maintenance) 0938—New 15 70 2 2,100 75.08 157,668 157,668 § 401.719(b) 0938—New 15 1 50 750 75.08 56,310 56,310 Total 15 73 3,450 259,650 * The values listed are based on 100 percent overhead and fringe benefit calculations. Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 1.

    If you comment on these information collection and recordkeeping requirements, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule.

    Comments must be received on/by April 4, 2016.

    IV. Response to Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    V. Regulatory Impact Statement

    In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

    A. Overall Impact

    We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, 96), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). For the reasons discussed below, we estimate that the total impact of this proposed rule would be less than $58 million and therefore, it would not reach the threshold for economically significant effects and is not considered a major rule.

    The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that most hospitals and most other providers are small entities as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). However, since the total estimated impact of this rule is less than $100 million, and the total estimated impact would be spread over 82,500 providers and suppliers (who are the subject of reports), no one entity would face significant impact. Of the 82,500 providers, we estimate that 78,605 would be physician offices that have average annual receipts of $11 million and 4,125 would be hospitals that have average annual receipts of $38.5 million. As discussed below, the estimated cost per provider is $8,426 (see table 5 below) and the estimated cost per hospital is $6,523 (see table 5 below). For both types of entities, these costs would be a very small percentage of overall receipts. Thus, we are not preparing an analysis of options for regulatory relief of small businesses because we have determined that this rule would not have a significant economic impact on a substantial number of small entities.

    For section 105(a) of MACRA, we estimate that two types of entities may be affected by the additional program opportunities: Qualified entities that choose to provide or sell non-public analyses or data to authorized users; and providers and suppliers who are identified in the non-public analyses create by qualified entities and provided or sold to authorized users.

    We anticipate that most providers and suppliers that may be identified in qualified entities' non-public analyses would be hospitals and physicians. Many hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration definition of a small business (having revenues of less than $38.5 million in any 1 year) (for details see the Small Business Administration's Web site at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf (refer to the 620000 series). For purposes of the RFA, physicians are considered small businesses if they generate revenues of $11 million or less based on Small Business Administration size standards. Approximately 95 percent of physicians are considered to be small entities.

    The analysis and discussion provided in this section and elsewhere in this proposed rule complies with the RFA requirements. Because we acknowledge that many of the affected entities are small entities, the analysis discussed throughout the preamble of this proposed rule constitutes our regulatory flexibility analysis for the remaining provisions and addresses comments received on these issues.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis, if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Any such regulatory impact analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe this proposed rule has impact on significant operations of a substantial number of small rural hospitals because we anticipate that most qualified entities would focus their performance evaluation efforts on metropolitan areas where the majority of health services are provided. As a result, this rule would not have a significant impact on small rural hospitals. Therefore, the Secretary has determined that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that 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 2015, that threshold is approximately $144 million. This proposed rule will not impose spending costs on state, local, or tribal governments in the aggregate, or by the private sector, of $144 million or more. Specifically, as explained below we anticipate the total impact of this rule on all parties to be approximately $58 million.

    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. We have examined this proposed rule in accordance with Executive Order 13132 and have determined that this regulation would not have any substantial direct effect on State or local governments, preempt States, or otherwise have a Federalism implication.

    B. Anticipated Effects 1. Impact on Qualified Entities

    Because section 105(a) of MACRA allows qualified entities to use the data in new ways to provide or sell non-public analyses or data to authorized users, there is little quantitative information to inform our estimates on the number of analyses and datasets that the qualified entity costs may provide or sell or on the costs associated with the creation of the non-public analyses or datasets. Therefore, we look to the estimates from the original qualified entity rules to estimate the number of hours that it may take to create non-public analyses and to process provider appeals and revisions. We also looked to the Centers for Medicare and Medicaid's cost of providing data to qualified entities since qualified entities' data fees are equal to the government's cost to make the data available.

    There are currently 13 qualified entities and these qualified entities all are in different stages of the qualified entity program. For example, some qualified entities have released public reports and some qualified entities are still completing the security requirements in order to receive CMS data. Given the requirements in the different phases and the current status of the qualified entities, we estimate that 11 qualified entities will be able to provide or sell analyses and/or data to authorized users within the first year of the program, and therefore, would be incurring extra costs. As discussed above, we believe the total number of qualified entities will ultimately grow to 20 in subsequent years, with 15 entities providing or selling analyses and/or data to authorized users. In estimating qualified entity impacts, we used hourly labor costs in several labor categories reported by the Bureau of Labor Statistics (BLS) at http://data.bls.gov/pdq/querytool.jsp?survey=ce. We used the annual rates for 2014 and added 100 percent for overhead and fringe benefit costs. These rates are displayed in Table 2.

    Table 2—Labor Rates for Qualified Entity Impact Estimates 2014 hourly wage rate
  • (BLS)
  • OH and fringe
  • (100%)
  • Total hourly costs
    Professional and technical services $37.54 $37.54 $75.08 Legal review 38.58 38.58 77.16 Custom computer programming 43.05 43.05 86.10 Data processing and hosting 34.02 34.02 68.04 Other information services 39.72 39.72 79.44

    We estimate that within the first year that 11 qualified entities will provide or sell on average 55 non-public analyses or provide or sell 35 datasets. We do not believe the number of datasets and non-public analyses per qualified entity will change in future years of the program. We seek comment on the number of non-public analyses or datasets that a qualified entity will create and provide or sell within the first year and future years.

    In the original proposed rule for the qualified entity program (76 FR 33566), we estimated that each qualified entities' activities to analyze the Medicare claims data, calculate performance measures and produce public provider performance reports would require 5,500 hours of effort per qualified entity. We anticipate under this proposed rule that implements section 105(a) of MACRA that qualified entities will base the non-public analyses on their public performance reports. Therefore, the creation of the non-public analyses will require much less effort and only require a fraction of the time it takes to produce the public reports. We estimate that a qualified entity's activities for each non-public analysis to analyze the Medicare claims data, calculate performance measures, and produce the report would require 320 hours, between five and six percent of the time to produce the public reports. We anticipate that half of this time will be spent on data analysis, measure calculation, and report creation and the other half on data processing. We request comment on the level of effort to create the non-public analyses.

    We anticipate that within the first year of the program a qualified entity will, on average, provide one-year datasets containing all data types for a cohort of 750,000 to 1.75 million beneficiaries to 35 authorized users. We estimate that it will require 226 hours to create each dataset that will be provided to an authorized user. We looked to the Centers for Medicare and Medicaid Centers' data costs and time to estimate a qualified entity's costs and time to create datasets. While the majority of the time will be devoted to computer processing, we anticipate about 100 hours will be spent on computer programming, particularly if the qualified entity is de-identiying the data. We seek comment of the level of effort required to create each dataset and the number of authorized users that will obtain or purchases data from a qualified entity.

    We further estimate that, on average, each qualified entity would expend 7,500 hours of effort processing providers' and suppliers' appeals of their performance reports and producing revised reports, including legal review of the appeals and revised reports. These estimates assume that, as discussed below in the section on provider and supplier impacts, on average 25 percent of providers and suppliers would appeal their results from a qualified entity. Responding to these appeals in an appropriate manner would require a significant investment of time on the part of qualified entities. This equates to an average of four hours per appeal for each qualified entity. These estimates are similar to those in the Qualified Entities final rule. We assume that the complexity of appeals would vary greatly, and as such, the time required to address them would also vary greatly. Many appeals may be able to be dealt with in an hour or less while some appeals may require multiple meetings between the qualified entity and the affected provider or supplier. On average, however, we believe that this is a reasonable estimate of the burden of the appeals process on qualified entities. We discuss the burden of the appeals process on providers and suppliers below.

    We estimate that each qualified entity would spend 40 hours creating a non-public analyses agreement template and a QE DUA. We also estimate that it would take a qualified entity 2 hours to process a QE DUA or non-public analyses agreement.

    Finally, we estimate that each qualified entity would spend 50 hours on the additional annual reporting requirements.

    Qualified entities would be required to notify CMS of inappropriate disclosures or use of beneficiary identifiable data pursuant to the requirements in the CMS DUA. We believe that the report generated in response to an inappropriate disclosure or use of beneficiary identifiable data would be generated as a matter of course by the qualified entities and therefore, would not require significant additional effort. Based on the assumptions we have described, we estimate the total impact on qualified entities for the first year of the program to be a cost of $27,925,198.

    Table 3—Impact on Qualified Entities for the First Year of the Program Impact on qualified entities Activity Hours Professional
  • and
  • technical
  • Legal Computer programming Data
  • processing and hosting
  • Labor hourly cost Cost per
  • authorized user
  • Number of authorized users Number of qualified
  • entities
  • Total cost impact
    Dissemination of Data: Data processing & hosting 126 $68.04 $8,573 35 11 $3,300,620 Computer programming 100 86.10 8,610 35 11 3,314,850 Total: Dissemination of Data 6,615,470 Non-Public Analyses: Data analysis/measure calculation/report preparation 160 86.10 13,776 55 11 8,334,480 Data Processing and hosting 160 68.04 10,886 55 11 6,586,272 Total Non-public Analyses 14,920,752 Qualified entity processing of provider appeals and report revision 5,500 75.08 412,940 11 4,542,340 Qualified entity legal analysis of provider appeals and report revisions 2,000 77.16 154,320 11 1,697,520 Total qualified entity processing of provider appeals and report revision 6,239,860 QE DUA and Non-public analyses: Development of the QE DUA and non-public analyses agreement 20 75.08 1,502 11 16,518 Legal review of the QE DUA and non-public analyses agreement 20 77.16 1,543 11 16,975 Processing QE DUA and non-public analyses agreement 2 75.08 150 70 11 115,623 Total QE DUA and non-public analyses agreements 149,116 Additional Annual Report Requirements 50 75.08 3,754 11 41,294 Total qualified entity Impacts 27,966,492
    2. Impact on Health Care Providers and Suppliers

    We note that numerous health care payers, community quality collaboratives, States, and other organizations are producing performance measures for health care providers and suppliers using data from other sources, and that providers and suppliers are already receiving performance reports from these sources. We anticipate that the review of non-public analyses would merely be added to those existing efforts to improve the statistical validity of the measure findings. However, we invite comments on the impact of this new voluntary program.

    Table 4 reflects the hourly labor rates used in our estimate of the impacts of the first year of section 105(a) of MACRA on health care providers and suppliers.

    Table 4—Labor Rates for Provider and Supplier Impact Estimates 2014 hourly
  • wage rate
  • (BLS)
  • Overhead and
  • fringe
  • benefits
  • (100%)
  • Total hourly
  • costs
  • Physicians' offices $38.27 $38.27 $76.54 Hospitals 29.65 29.65 59.30

    We anticipate that the impacts on providers and suppliers consist of costs to review the performance reports generated by qualified entities and, if they choose, appeal the performance calculations. We believe, on average, each qualified entity would produce non-public analyses that in total include information on 7,500 health providers and suppliers. This is based on estimates in the qualified entity final rule, but also include an increase of 50 percent because we believe that more providers and suppliers will be included in the non-public analyses. We anticipate that the largest proportion of providers and suppliers would be physicians because they comprise the largest group of providers and suppliers, and are a primary focus of many recent performance evaluation efforts. We also believe that many providers and suppliers will be the recipients of the non-public analyses in order to support their own performance improvement activities, and therefore, there would be no requirement for a correction or appeals process. As discussed above, there is no requirement for a corrections or appeals process where the analysis only individually identifies the (singular) provider or supplier who is being provided or sold the analysis. Based on our review of information from existing programs, we assume that 95 percent of the recipients of performance reports (that is, an average of 7,125 per qualified entity) would be physicians, and 5 percent (that is, an average of 375 per qualified entity) would be hospitals and other suppliers. Providers and suppliers receive these reports with no obligation to review them, but we assume that most would do so to verify that their calculated performance measures reflect their actual patients and health events. Because these non-public analyses will be based on the same underlying data as the public performance reports, we estimate that it would take less time for providers or suppliers to review theses analyses and generate an appeal. We estimate that, on average, each provider or supplier would devote three hours to reviewing these analyses. We also estimate that 25 percent of the providers and suppliers would decide to appeal their performance calculations, and that preparing the appeal would involve an average of seven hours of effort on the part of a provider or supplier. As with our assumptions regarding the level of effort required by qualified entities in operating the appeals process, we believe that this average covers a range of provider efforts from providers who would need just one or two hours to clarify any questions or concerns regarding their performance reports to providers who would devote significant time and resources to the appeals process.

    Using the hourly costs displayed in Table 4, the impacts on providers and suppliers are calculated below in Table 5. Based on the assumptions we have described, we estimate the total impact on providers for the first year of the program to be a cost of $29,690,386.

    As stated above in Table 3, we estimate the total impact on qualified entities to be a cost of $27,966,492. Therefore, the total impact on qualified entities and on providers and suppliers for the first year of the program is estimated to be $57,656,878.

    Table 5—Impact on Providers and Suppliers for the First Year of the Program Impact on Providers and Suppliers Activity Hours per provider Physician
  • offices
  • Hospitals Labor hourly cost Cost per
  • provider
  • Number of providers per qualified entity Number of qualified
  • entities
  • Total cost
  • impact
  • Physician office review of performance reports 3 76.54 $230 7,125 11 $18,026,250 Hospital review of performance reports 3 59.30 178 375 11 734,250 Physician office preparing and submitting appeal requests to qualified entities 7 76.54 536 1,781 11 10,500,776 Hospital preparing and submitting appeal requests to qualified entities 7 59.30 415 94 11 429,110 Total Impact on Providers and Suppliers 29,690,386
    C. Alternatives Considered

    The statutory provisions added by section 105(a) of MACRA are detailed and prescriptive about the permissible uses of the data under the Qualified Entity Program. We believe there are limited approaches that would ensure statutory compliance. We considered proposing less prescriptive requirements on the provisions that would need to be included in the agreements between qualified entities and authorized users that received or purchased analyses or data. For example, we could have required less strenuous data privacy and security protections such as not setting a minimum standard for protection of beneficiary identifiable data or non-public analyses. In addition, we could have reduced additional restrictions on re-disclosure or permitted data or analyses to be re-disclosed to additional downstream users. While these approaches might reduce costs for qualified entities, we did not adopt such an approach because of the importance of protecting beneficiary data. We believe if we do not require qualified entities to provide sufficient evidence of data privacy and security protection capabilities, there would be increased risks related to the protection of beneficiary identifiable data.

    D. Conclusion

    As explained above, we estimate the total impact for the first year of the program on qualified entities and providers to be a cost of $57,656,878. While we anticipate the number of qualified entities to increase slightly, we do not anticipate significant growth in the qualified entity program given the qualified entity program requirements, as well as other existing programs that allow entities to obtain Medicare data. Based on these estimates, we conclude this proposed rule does not reach the threshold for economically significant effects and thus is not considered a major rule.

    In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

    List of Subjects in 42 CFR Part 401

    Claims, Freedom of information, Health facilities, Medicare, Privacy.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 401 as set forth below:

    PART 401—GENERAL ADMINISTRATIVE REQUIREMENTS 1. The authority citation for part 401 is revised to read as follows: Authority:

    Secs. 1102, 1871, and 1874(e) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395w-5) and section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10).

    2. Section 401.703 is amended by adding paragraphs (j) through (u) to read as follows:
    § 401.703 Definitions.

    (j) Authorized user is a third party (meaning not the qualified entity or its contractors) to whom/which the qualified entity provides or sells data as permitted under this subpart. Authorized users are limited to the following entities:

    (1) A provider.

    (2) A supplier.

    (3) A medical society.

    (4) A hospital association.

    (5) An employer.

    (6) A health insurance issuer.

    (7) A healthcare provider and/or supplier association.

    (8) A state agency.

    (k) Employer has the same meaning as the term “employer” as defined in section 3(5) of the Employee Retirement Insurance Security Act of 1974.

    (l) Health insurance issuer has the same meaning as the term “health insurance issuer” as defined in section 2791 of the Public Health Service Act.

    (m) Medical society means a nonprofit organization or association that provides unified representation and advocacy for physicians at the national or state level and whose membership is comprised of a majority of physicians.

    (n) Hospital association means a nonprofit organization or association that provides unified representation and advocacy for hospitals or health systems at a national or state level and whose membership is comprised of a majority of hospitals and health systems.

    (o) Healthcare Provider and/or Supplier Association means a nonprofit organization or association that provides unified representation and advocacy for providers and suppliers at the national or state level and whose membership is comprised of a majority of suppliers or providers.

    (p) State Agency means any office, department, division, bureau, board, commission, agency, institution, or committee within the executive branch of a state government.

    (q) Combined data means a set of CMS claims data provided under subpart G combined with claims data, or a subset of claims data from at least one of the other claims data sources described in § 401.707(d).

    (r) Patient means an individual who has visited the provider or supplier for a face-to-face or telehealth appointment at least once in the past 12 months.

    (s) Marketing means the same as the term “marketing” at 45 CFR 164.501 without the exception to the bar for “consent” based marketing.

    (t) Violation means a failure to comply with a requirement of a CMS DUA or QE DUA.

    (u) Required by law means the same as the phrase “required by law” at 45 CFR 164.103.

    3. Section 401.713 is amended by revising paragraph (a) and adding paragraph (d) to read as follows:
    § 401.713 Ensuring the privacy and security of data.

    (a) Data Use Agreement between CMS and a qualified entity. A qualified entity must comply with the data requirements in its data use agreement with CMS (hereinafter the CMS DUA). Contractors of qualified entities that are anticipated to have access to the Medicare claims data or beneficiary identifiable data in the context of this program are also required to execute and comply with the CMS DUA. The CMS DUA will require the qualified entity to maintain privacy and security protocols throughout the duration of the agreement with CMS, and will ban the use or disclosure of CMS data or any derivative data for purposes other than those set out in this subpart. The CMS DUA will also prohibit the use of unsecured telecommunications to transmit such data, and will specify the circumstances under which such data must be stored and may be transmitted.

    (d) Data Use Agreement between a qualified entity and an authorized user. In addition to meeting the other requirements of this subpart, and as a pre-condition of selling or disclosing any combined data or any Medicare claims data (or any beneficiary-identifiable derivative data of either kind) and as a pre-condition of selling or disclosing non-public analyses that include individually identifiable beneficiary data, the qualified entity must enter a DUA (hereinafter the QE DUA) with the authorized user. Among other things laid out in this subpart, such QE DUA must contractually bind the authorized user to the following:

    (1)(i) The authorized user may be permitted to use such data and non-public analyses in a manner that a HIPAA Covered Entity could do under the following provisions:

    (A) Activities falling under the first paragraph of the definition of “health care operations” under 45 CFR 164.501: Quality improvement activities, including care coordination activities and efforts to track and manage medical costs.

    (B) Activities falling under the second paragraph of the definition of “health care operations” under 45 CFR 164.501: Population-based activities such as those aimed at improving patient safety, quality of care, or population health, including the development of new models of care, the development of means to expand coverage and improve access to healthcare, the development of means of reducing health care disparities, and the development or improvement of methods of payment or coverage policies.

    (C) Activities that qualify as “fraud and abuse detection or compliance activities” under 45 CFR 164.506(c)(4)(ii).

    (ii) All other uses and disclosures of such data and/or such non-public analyses must be forbidden except to the extent a disclosure qualifies as a “required by law” disclosure.

    (2) The authorized user is prohibited from using or disclosing the data or non-public analyses for marketing purposes as defined at § 401.703(s).

    (3) The authorized user is required to ensure adequate privacy and security protection for such data and non-public analyses. At a minimum, regardless of whether the authorized user is a HIPAA covered entity, such protections of beneficiary identifiable data must be at least as protective as what is required of covered entities regarding protected health information (PHI) under the HIPAA Privacy and Security Rules. In all cases, these requirements must be imposed for the life of such beneficiary identifiable data or non-public analyses and/or any derivative data, that is until all copies of such data or non-public analyses are returned or destroyed. Such duties must be written in such a manner as to survive termination of the QE DUA, whether for cause or not.

    (4) Except as provided for in paragraph (d)(5) of this section, the authorized user must be prohibited from re-disclosing or making public any such data or non-public analyses.

    (5)(i) At the qualified entity's discretion, it may permit an authorized user that is a provider as defined in § 401.703(b) or a supplier as defined in § 401.703(c), to re-disclose such data and non-public analyses as a covered entity would be permitted to disclose PHI under 45 CFR 164.506(c)(4)(i)), or under 45 CFR 164.502(e)(1).

    (ii) All other uses and disclosures of such data and/or such non-public analyses is forbidden except to the extent a disclosure qualifies as a “required by law” disclosure.

    (6) Authorized users who/that receive the beneficiary de-identified combined data or Medicare data as contemplated under § 401.718 are contractually prohibited from linking the beneficiary de-identified data to any other identifiable source of information, and must be contractually barred from attempting any other means of re-identifying any individual whose data is included in such data.

    (7) The QE DUA must bind authorized user(s) to notifying the qualified entity of any violations of the QE DUA, and it must require the full cooperation of the authorized user in the qualified entity's efforts to mitigate any harm that may result from such violations, or to comply with the breach provisions governing qualified entities under this subpart.

    4. Section 401.716 is added to read as follows:
    § 401.716 Non-public analyses.

    (a) General. So long as it meets the other requirements of this subpart, and subject to the limits in paragraphs (b) and (c) of this section, the qualified entity may use the combined data to create non-public analyses in addition to performance measures.

    (b) Limitations on a qualified entity. In addition to meeting the other requirements of this subpart, a qualified entity must comply with the following limitations as a pre-condition of dissemination or selling non-public analyses to an authorized user:

    (1) A qualified entity may only provide or sell a non-public analysis to a health insurance issuer as defined in § 401.703(l), after the health insurance issuer has provided the qualified entity with claims data that represents a majority of the health insurance issuer's covered lives for the time period and geographic region covered by the issuer-requested non-public analyses.

    (2) Analyses that contain information that individually identifies one or more beneficiaries may only be disclosed to a provider or supplier (as defined at § 401.703(b) and (c)) when the following conditions are met:

    (i) The analyses only contain identifiable information on beneficiaries with whom the provider or supplier have a patient relationship as defined at § 401.703(r), and

    (ii) a QE DUA as defined at § 401.713(d) is executed between the qualified entity and the provider or supplier prior to making any individually identifiable beneficiary information available to the provider or supplier.

    (3) Except as specified under paragraph (c)(2) of this section, all analyses must be limited to beneficiary de-identified data. Regardless of the HIPAA covered entity or business associate status of the qualified entity and/or the authorized user, de-identification must be determined based on the standards for HIPAA covered entities found at 45 CFR 164.514(b).

    (4) Analyses that contain information that individually identifies a provider or supplier may not be disclosed unless:

    (i) The analysis only individually identifies the provider or supplier that is being supplied the analysis, or

    (ii) Every provider or supplier individually identified in the analysis has been afforded the opportunity to appeal or correct errors using the process at § 401.717(f).

    (c) Non-public analyses agreement between a qualified entity and an authorized user for beneficiary de-identified non-public analyses disclosures. In addition to the other requirements of this subpart, a qualified entity must enter a contractually binding non-public analyses agreement with the authorized user as a pre-condition to providing or selling de-identified analyses. Such non-public analyses agreement must contain the following provisions:

    (1) The authorized user may not use the analyses or derivative data for the following purposes:

    (i) Marketing, as defined at § 401.703(s).

    (ii) Harming or seeking to harm patients or other individuals both within and outside the healthcare system regardless of whether their data are included in the analyses.

    (iii) Effectuating or seeking opportunities to effectuate fraud and/or abuse in the health care system.

    (2) If the authorized user is an employer as defined in § 401.703(k), the authorized user may only use the analyses or derivative data for purposes of providing health insurance to employees, retirees, or dependents of employees or retirees of that employer.

    (3)(i) At the qualified entity's discretion, it may permit an authorized user that is a provider as defined in § 401.703(b) or a supplier as defined in § 401.703(c), to re-disclose the de-identified analyses or derivative data, as a covered entity would be permitted under 45 CFR 164.506(c)(4)(i), or under 45 CFR 164.502(e)(1).

    (ii) All other uses and disclosures of such data and/or such non-public analyses is forbidden except to the extent a disclosure qualifies as a “required by law” disclosure.

    (4) If the authorized user is not a provider or supplier, the authorized user may not re-disclose or make public any non-public analyses or derivative data except as required by law.

    (5) The authorized user may not link the de-identified analyses to any other identifiable source of information and may not in any other way attempt to identify any individual whose de-identified data is included in the analyses.

    (6) The authorized user must notify the qualified entity of any DUA violations, and it must fully cooperate with the qualified entity's efforts to mitigate any harm that may result from such violations.

    5. Section 401.717 is amended by adding paragraph (f) to read as follows:
    § 401.717 Provider and supplier requests for error correction.

    (f) A qualified entity also must comply with paragraphs (a) through (e) of this section before disclosing non-public analyses, as defined at § 401.716, that contain information that individually identifies a provider or supplier.

    6. Section 401.718 is added to read as follows:
    § 401.718 Dissemination of data.

    (a) General. Subject to the other requirements in this subpart, the requirements in paragraphs (b) and (c) of this section and any other applicable laws or contractual agreements, a qualified entity may provide or sell combined data, or provide Medicare data at no cost to authorized users defined at § 401.703(b), (c), (m), and (n).

    (b) Data—(1) De-identification. Except as specified in paragraph (b)(2) of this section, any data provided or sold by a qualified entity to an authorized user must be limited to beneficiary de-identified data. De-identification must be determined based on the de-identification standards for HIPAA covered entities found at § 164.514(b).

    (2) Exception. If such disclosure would be consistent with all applicable laws, data that individually identifies a beneficiary may only be disclosed to a provider or supplier (as defined at § 401.703(b) and (c)) with whom the identifiable individuals in such data have a current patient relationship as defined at § 401.703(r).

    (c) Data Use Agreement between a qualified entity and an authorized user. A qualified entity must contractually require an authorized user to comply with the requirements in § 401.713(d) prior to providing or selling data to an authorized user under § 401.718.

    7. Section 401.719 is amended by adding paragraphs (b)(3) and (4) and (d)(5) to read as follows:
    § 401.719 Monitoring and sanctioning of qualified entities.

    (b) * * *

    (3) Non-public analyses provided or sold to authorized users under this subpart, including the following information:

    (i) A summary of the analyses provided or sold, including—

    (A) The number of analyses.

    (B) The number of purchasers of such analyses.

    (C) The types of authorized users that purchased analyses.

    (D) The total amount of fees received for such analyses.

    (E) QE DUA or non-public analyses agreement violations.

    (ii) A description of the topics and purposes of such analyses.

    (4) Data provided or sold to authorized users under this subpart, including the following information:

    (i) The entities who received data.

    (ii) The basis under which each entity received such data.

    (iii) The total amount of fees received for providing, selling, or sharing the data.

    (iv) QE DUA violations.

    (d) * * *

    (5) In the case of a violation, as defined at § 401.703(t) of the CMS DUA or the QE DUA, CMS will impose an assessment on a qualified entity in accordance with the following:

    (i) Amount of Assessment. CMS will calculate the amount of the assessment of up to $100 per individual entitled to, or enrolled for, benefits under part A of title XVIII of the Social Security Act or enrolled for benefits under part B of such title whose data was implicated in the violation based on the following:

    (A) Basic Factors. In determining the amount per impacted individual, CMS takes into account the following:

    (1) The nature and the extent of the violation.

    (2) The nature and the extent of the harm or potential harm resulting from the violation.

    (3) The degree of culpability and the history of prior violations.

    (B) Criteria to be considered. In establishing the basic factors, CMS considers the following circumstances, including:

    (1) Aggravating Circumstances. Aggravating circumstances include the following:

    (i) There were several types of violations occurring over a lengthy period of time.

    (ii) There were many of these violations or the nature and circumstances indicate a pattern of violations.

    (iii) The nature of the violation had the potential or actually resulted in harm to beneficiaries.

    (2) Mitigating circumstances. Mitigating circumstances include the following:

    (i) All of the violations subject to the imposition of an assessment were few in number, of the same type, and occurring within a short period of time.

    (ii) The violation was the result of an unintentional and unrecognized error and the qualified entity took corrective steps immediately after discovering the error.

    (C) Effects of aggravating or mitigating circumstances. In determining the amount of the assessment to be imposed under (d)(5)(i)(A) of this section.

    (1) If there are substantial or several mitigating circumstance, the aggregate amount of the assessment is set at an amount sufficiently below the maximum permitted by (d)(5)(A) of this section to reflect the mitigating circumstances.

    (2) If there are substantial or several aggravating circumstances, the aggregate amount of the assessment is set at an amount at or sufficiently close to the maximum permitted by (d)(5)(i)(A) of this section to reflect the aggravating circumstances.

    (D) The standards set for the qualified entity in this paragraph are binding, except to the extent that—

    (1) The amount imposed is not less than the approximate amount required to fully compensate the United States, or any State, for its damages and costs, tangible and intangible, including but not limited to the costs attributable to the investigation, prosecution, and administrative review of the case.

    (2) Nothing in this section limits the authority of CMS to settle any issue or case as provided by part 1005 of this title or to compromise any assessment as provided by (d)(5)(E) of this section.

    (ii) Notice of Determination. CMS must propose an assessment in accordance with this paragraph, by notifying the qualified entity by certified mail, return receipt requested. Such notice must include the following information:

    (A) The assessment amount.

    (B) The statutory and regulatory bases for the assessment.

    (C) A description of the violations upon which the assessment was proposed.

    (D) Any mitigating or aggravating circumstances that CMS considered when it calculated the amount of the proposed assessment.

    (E) Information concerning response to the notice, including:

    (1) A specific statement of the respondent's right to a hearing in accordance with procedures established at Section 1128A of the Act and implemented in 42 CFR part 1005.

    (2) A statement that failure to respond within 60 days renders the proposed determination final and permits the imposition of the proposed assessment.

    (3) A statement that the debt may be collected through an administrative offset.

    (4) In the case of a respondent that has an agreement under section 1866 of the Act, notice that imposition of an exclusion may result in termination of the provider's agreement in accordance with section 1866(b)(2)(C) of the Act.

    (F) The means by which the qualified entity may pay the amount if they do not intend to request a hearing.

    (iii) Failure to request a hearing. If the qualified entity does not request a hearing within 60 days of receipt of the notice of proposed determination specified in the preceding paragraph, any assessment becomes final and CMS may impose the proposed assessment.

    (A) CMS notifies the qualified entity, by certified mail with return receipt requested, of any assessment that has been imposed and of the means by which the qualified entity may satisfy the judgment.

    (B) The qualified entity has no right to appeal an assessment for which the qualified entity has not requested a hearing.

    (iv) When an assessment is collectible. An assessment becomes collectible after the earliest of the following:

    (A) 60 days after the qualified entity receives CMS's notice of proposed determination under (d)(5)(ii) of this section, if the qualified entity has not requested a hearing.

    (B) Immediately after the qualified entity abandons or waives its appeal right at any administrative level.

    (C) 30 days after the qualified entity receives the ALJ's decision imposing an assessment under § 1005.20(d) of this title, if the qualified entity has not requested a review before the DAB.

    (D) 60 days after the qualified entity receives the DAB's decision imposing an assessment if the qualified entity has not requested a stay of the decision under § 1005.22(b) of this title.

    (v) Collection of an assessment. Once a determination by HHS has become final, CMS is responsible for the collection of any assessment.

    (A) The General Counsel may compromise an assessment imposed under this part, after consulting with CMS or OIG, and the Federal government may recover the assessment in a civil action brought in the United States district court for the district where the claim was presented or where the qualified entity resides.

    (B) The United States or a state agency may deduct the amount of an assessment when finally determined, or the amount agreed upon in compromise, from any sum then or later owing the qualified entity.

    (C) Matters that were raised or that could have been raised in a hearing before an ALJ or in an appeal under section 1128A(e) of the Act may not be raised as a defense in a civil action by the United States to collect an assessment.

    8. Section 401.721 is amended by adding paragraph (a)(7) to read as follows:
    § 401.721 Terminating an agreement with a qualified entity.

    (a) * * *

    (7) Fails to ensure authorized users comply with their QE DUAs or analysis use agreements.

    Dated: October 15, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: January 27, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.
    [FR Doc. 2016-01790 Filed 1-29-16; 11:15 am] BILLING CODE 4120-01-P
    81 21 Tuesday, February 2, 2016 Notices DEPARTMENT OF COMMERCE International Trade Administration Initiation of Five-Year (“Sunset”) Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    In accordance with section 751(c) of the Tariff Act of 1930, as amended (“the Act”), the Department of Commerce (“the Department”) is automatically initiating the five-year review (“Sunset Review”) of the antidumping and countervailing duty (“AD/CVD”) orders listed below. The International Trade Commission (“the Commission”) is publishing concurrently with this notice its notice of Institution of Five-Year Review which covers the same orders.

    DATES:

    Effective Date: February 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    The Department official identified in the Initiation of Review section below at AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230. For information from the Commission contact Mary Messer, Office of Investigations, U.S. International Trade Commission at (202) 205-3193.

    SUPPLEMENTARY INFORMATION:

    Background

    The Department's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to the Department's conduct of Sunset Reviews is set forth in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012).

    Initiation of Review

    In accordance with 19 CFR 351.218(c), we are initiating Sunset Reviews of the following antidumping and countervailing duty orders: 1

    1 In addition, we note that in the sunset initiation notice that published on November 3, 2015 (80 FR 67705) the Department inadvertently listed an incorrect effective date. The effective date is November 2, 2015.

    DOC Case No. ITC Case No. Country Product Department contact A-570-896 731-TA-1071 PRC Magnesium Metal (2nd Review) David Goldberger.
  • (202) 482-4136.
  • A-570-506 731-TA-282 PRC Porcelain-On-Steel Cooking Ware (4th Review) Matthew Renkey.
  • (202) 482-2312.
  • Filing Information

    As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Department's regulations, the Department's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on the Department's Web site at the following address: http://enforcement.trade.gov/sunset/. All submissions in these Sunset Reviews must be filed in accordance with the Department's regulations regarding format, translation, and service of documents. These rules, including electronic filing requirements via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”), can be found at 19 CFR 351.303.2

    2See also Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    This notice serves as a reminder that any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information.3 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives in these segments.4 The formats for the revised certifications are provided at the end of the Final Rule. The Department intends to reject factual submissions if the submitting party does not comply with the revised certification requirements.

    3See section 782(b) of the Act.

    4See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (“Final Rule”) (amending 19 CFR 351.303(g)).

    On April 10, 2013, the Department modified two regulations related to AD/CVD proceedings: the definition of factual information (19 CFR 351.102(b)(21)), and the time limits for the submission of factual information (19 CFR 351.301).5 Parties are advised to review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in these segments. To the extent that other regulations govern the submission of factual information in a segment (such as 19 CFR 351.218), these time limits will continue to be applied. Parties are also advised to review the final rule concerning the extension of time limits for submissions in AD/CVD proceedings, available at http://enforcement.trade.gov/frn/2013/1309frn/2013-22853.txt, prior to submitting factual information in these segments.6

    5See Definition of Factual Information and Time Limits for Submission of Factual Information: Final Rule, 78 FR 21246 (April 10, 2013).

    6See Extension of Time Limits, 78 FR 57790 (September 20, 2013).

    Letters of Appearance and Administrative Protective Orders

    Pursuant to 19 CFR 351.103(d), the Department will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d)). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation.

    Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (“APO”) to file an APO application immediately following publication in the Federal Register of this notice of initiation. The Department's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306.

    Information Required From Interested Parties

    Domestic interested parties, as defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the Federal Register of this notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with the Department's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, the Department will automatically revoke the order without further review.7

    7See 19 CFR 351.218(d)(1)(iii).

    If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that all parties wishing to participate in a Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of this notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that the Department's information requirements are distinct from the Commission's information requirements. Consult the Department's regulations for information regarding the Department's conduct of Sunset Reviews. Consult the Department's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at the Department.

    This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

    Dated: January 28, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-01999 Filed 2-1-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Availability of Seats for National Marine Sanctuary Advisory Councils AGENCY:

    Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION:

    Notice and request for applications.

    SUMMARY:

    ONMS is seeking applications for vacant seats for five of its 13 national marine sanctuary advisory councils (advisory councils). Vacant seats, including positions (i.e., primary member and alternate), for each of the advisory councils are listed in this notice under SUPPLEMENTARY INFORMATION. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; views regarding the protection and management of marine or Great Lake resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members or alternates should expect to serve two or three year terms, pursuant to the charter of the specific national marine sanctuary advisory council.

    DATES:

    Applications are due by February 29, 2016.

    ADDRESSES:

    Application kits are specific to each advisory council. As such, application kits must be obtained from and returned to the council-specific addresses noted below.

    • Flower Garden Banks National Marine Sanctuary Advisory Council: Kelly Drinnen, Flower Garden Banks National Marine Sanctuary, 4700 Avenue U, Building 216, Galveston, TX 77551; (409) 621-5151 extension 105; email [email protected]; or download application from http://flowergarden.noaa.gov.

    • Hawaiian Islands Humpback Whale National Marine Sanctuary Advisory Council: Inouye Regional Center, ATTN: NOS/ONMS/Shannon Lyday, 1845 Wasp Boulevard, Building 176, Honolulu, HI 96818; (808) 725-5905; email [email protected]; or download application from http://hawaiihumpbackwhale.noaa.gov/council/council_app_accepting.html.

    • Monterey Bay National Marine Sanctuary Advisory Council: Nichole Rodriguez, Monterey Bay National Marine Sanctuary, 99 Pacific Street, Building 455A, Monterey, CA 93940; (831) 647-4206; email [email protected]; or download application from http://montereybay.noaa.gov/welcome.html.

    • National Marine Sanctuary of American Samoa Advisory Council: Joseph Paulin, National Marine Sanctuary of American Samoa, Tauese P.F. Sunia Ocean Center, P.O. Box 4318, Pago Pago, AS 96799 (Utelei, American Samoa); (684) 633-6500; email [email protected]; or download application from http://americansamoa.noaa.gov/about/samoa.html.

    • Stellwagen Bank National Marine Sanctuary Advisory Council: Elizabeth Stokes, Stellwagen Bank National Marine Sanctuary, 175 Edward Foster Road, Scituate, MA 02066; (781) 545-8026 extension 201; email [email protected]; or download application from http://stellwagen.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    For further information on a particular national marine sanctuary advisory council, please contact the individual identified in the Addresses section of this notice.

    SUPPLEMENTARY INFORMATION:

    ONMS serves as the trustee for a network of underwater parks encompassing more than 170,000 square miles of marine and Great Lakes waters from Washington state to the Florida Keys, and from Lake Huron to American Samoa. The network includes a system of 13 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. National marine sanctuaries protect our nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustain healthy environments that are the foundation for thriving communities and stable economies. One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. National marine sanctuary advisory councils are community-based advisory groups established to provide advice and recommendations to the superintendents of the national marine sanctuaries on issues including management, science, service, and stewardship; and to serve as liaisons between their constituents in the community and the sanctuary. Additional information on ONMS and its advisory councils can be found at http://sanctuaries.noaa.gov. Information related to the purpose, policies, and operational requirements for advisory councils can be found in the charter for a particular advisory council (http://sanctuaries.noaa.gov/management/ac/council_charters.html) and the National Marine Sanctuary Advisory Council Implementation Handbook (http://sanctuaries.noaa.gov/management/pdfs/2010-ac-handbook-appendices-07162015.pdf).

    The following is a list of the vacant seats, including positions (i.e., primary member or alternate), for each of the advisory councils currently seeking applications for members and alternates:

    Flower Garden Banks National Marine Sanctuary Advisory Council: Conservation (primary); Education (primary); Recreational Fishing (primary); and Research (primary).

    Hawaiian Islands Humpback Whale National Marine Sanctuary Advisory Council: Lāna`i Island (alternate); and Moloka`i Island (alternate).

    Monterey Bay National Marine Sanctuary Advisory Council: Agriculture (primary); Agriculture (alternate); At-Large (two primaries); At-Large (alternate); Business/Industry (primary); Business/Industry (alternate); College (primary); College (alternate); Commercial Fishing (primary); Commercial Fishing (alternate); Conservation (primary); Recreation (primary); Recreation (alternate); Recreational Fishing (primary); Recreational Fishing (alternate); Research (primary); and Research (alternate).

    National Marine Sanctuary of American Samoa Advisory Council: West Side of Tutuila (primary).

    Stellwagen Bank National Marine Sanctuary Advisory Council: At-Large (alternate); Business/Industry (alternate); Mobile Gear Commercial Fishing (alternate); Whale Watch (alternate); and Youth (alternate).

    Authority:

    16 U.S.C. 1431, et seq.

    (Federal Domestic Assistance Catalog Number 11.429 Marine Sanctuary Program) Dated: December 23, 2015. John Armor, Acting Director, Office of National Marine Sanctuaries, National Ocean Service, National Oceanic and Atmospheric Administration.
    [FR Doc. 2016-01976 Filed 2-1-16; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Pacific Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The Pacific Fishery Management Council (Pacific Council) will convene a meeting of its Coastal Pelagic Species (CPS) Subcommittee of the Scientific and Statistical Committee (SSC). The meeting is open to the public.

    DATES:

    The meeting will be held Thursday, March 10, 2016, from 8 a.m. to 5 p.m. Pacific Standard Time.

    ADDRESSES:

    The meeting will be held at the Doubletree by Hilton Sacramento, Yuba River Room, 2001 Point West Way, Sacramento, CA 95815.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220.

    FOR FURTHER INFORMATION CONTACT:

    Kerry Griffin, Staff Officer; telephone: (503) 820-2409.

    SUPPLEMENTARY INFORMATION:

    The primary purpose of the meeting is to review a stock assessment update of the Pacific sardine resource. The SSC CPS subcommittee will conduct the review, and one member each from the CPS Management Team and CPS Advisory Subpanel will serve as advisers. The Council will set harvest specifications and management measures at its April 9-14, 2016 meeting in Vancouver, WA.

    Special Accommodations

    Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (503) 820-2280 at least 5 days prior to the meeting date.

    Dated: January 28, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-01843 Filed 2-1-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XA165 Marine Mammals; File No. 15510 AGENCY:

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

    ACTION:

    Notice; issuance of permit amendment.

    SUMMARY:

    Notice is hereby given that a major amendment to Permit No. 15510 has been issued to Jennifer Burns, Ph.D., University of Alaska Anchorage, CPISB 202C, 3101 Science Circle, Anchorage, AK 99508.

    ADDRESSES:

    The permit amendment and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Rosa L. González or Amy Sloan, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On December 8, 2015, notice was published in the Federal Register (80 FR 76276) that a request for an amendment Permit No. 15510 to collect, receive, import, and export specimens from marine mammals for scientific research had been submitted by the above-named applicant. The requested permit amendment has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq.).

    The original permit (No. 15510), issued on April 25, 2011 (76 FR 25308) authorized Dr. Burns to obtain samples from up to 50 animals of each of the following species: Harp (Pagophilus groenlandica), hooded (Cystophora cristata), gray (Halichoerus grypus), bearded (Erignathus barbatus), ringed (Phoca hispida), harbor (Phoca vitulina), spotted (Phoca largha), and ribbon (Histriophoca fasciata) seals; and to obtain samples annually from up to 6 captive Northern fur seals, Callorhinus ursinus; and 6 captive Steller Sea lions, Eumetopias jubatus, through April 30, 2016.

    Permit 15510-01 authorizes the Permit Holder to increase the number of harbor seals from which samples may be collected, received, imported, and exported from 50 to 100 annually; and, extends the duration of the permit through April 30, 2017.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, issuance of this permit was based on a finding that such permit: (1) Was applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: January 27, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-01826 Filed 2-1-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council), Sea Scallop Committee, Advisory Panel and PDT are scheduling an inshore Atlantic Sea Scallop Fishing Industry workshop to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

    DATES:

    This meeting will be held on Monday, February 22 and Tuesday, February 23, 2016, beginning at 8:30 a.m. both days.

    ADDRESSES:

    The workshop will be held at the Crowne Plaza, 801 Greenwich Ave., Warwick, RI 02886; telephone: (401) 732-6000.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION: Workshop Agenda

    The Council is hosting a workshop to provide an opportunity for participants in the scallop fishery to discuss concerns raised by some about the consequences of inshore scallop fishing practices. The workshop will support constructive and open dialogue between all users of the resource, scientific experts, fishery managers, and interested members of the public. In accordance with section 302(g)(2) of the Magnuson-Stevens Act, this workshop is considered to be an ad hoc advisory panel. Any recommendations made by this panel will be forwarded to the Council's Scallop Advisory Panel and Oversight Committee for full consideration.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 28, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-01842 Filed 2-1-16; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before March 3, 2016.

    ADDRESSES:

    Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs in OMB, within 30 days of publication of the notice, by email at [email protected] Please identify the comments by OMB Control No. 3038-0061. Please provide the Commission with a copy of all submitted comments at the address listed below. Please refer to OMB Reference No. 3038-0061, found on http://reginfo.gov. Comments may also be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW., Washington, DC 20503, and to the Commission through its Web site at http://comments.cftc.gov. Follow the instructions for submitting comments through the Web site.

    Comments may also be mailed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581, or by Hand Delivery/Courier at the same address.

    A copy of the supporting statements for the collection of information discussed above may be obtained by visiting http://reginfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Tom Guerin, Division of Market Oversight, Commodity Futures Trading Commission, (202) 734-4194, email: [email protected], and refer to OMB Control No. 3038-0061.

    SUPPLEMENTARY INFORMATION:

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The Federal Register notice with a 60-day comment period soliciting comments on this collection of information was published on December 3, 2015 (80 FR 75663).

    Title: Daily Trade and Supporting Data Reports (OMB Control No. 3038-0061). This is a request for extension of a currently approved information collection.

    Abstract: Commission Regulation 16.02 requires Reporting Markets, including Designated Contract Markets, to provide the Commission with trade and supporting data reports on a daily basis. The Commission analyzes the daily trade and supporting data reports to discharge its regulatory responsibilities, including the responsibilities to prevent market manipulations and commodity price distortions and ensure the financial integrity of its jurisdictional markets.

    This ICR concerns the collections of information required by 17 CFR 16.02. Commission staff estimates that up to 30 reporting markets could provide this data to the Commission in the future. The Commission did not receive any comments regarding the burden estimate or any other aspect of this ICR.

    Burden Statement: Commission staff estimate that the total annual time burden for this ICR is 15,000 hours. Commission staff estimates that the total annual cost for this ICR is $1,139,700. The time burden estimate represents the annual burden that Reporting Markets incur to operate and maintain automated reporting systems and processes that facilitate the reporting of trade and supporting data reports to the Commission on a daily basis. The electronic reporting required by Commission Rule 16.02 is generally accomplished in an automated manner by respondents' computer systems. Reporting entities have already incurred significant one-time costs to establish the capability to electronically report trade and supporting data to the Commission on a daily basis. The burden hours currently incurred by respondents to comply with Commission Rule 16.02 are primarily related to the hours necessary to oversee, maintain, and utilize respondents' existing automated reporting functionality.

    Commission staff estimates that Reporting Markets expend an average of two hours per trading day to oversee, maintain, and utilize their systems and procesess to comply with Commission Rule 16.02. Commission staff calculated the estimated cost burden by multiplying the estimated time burden by an estimated appropriate hourly wage rate of $75.98. Commission staff derived the estimated appropriate hourly wage rate by averaging the salaries and bonuses of relevant professions reported in the SIFMA Report on Management & Professional Earnings in the Securities Industry 2013.

    Respondents/Affected Entities: Reporting Markets.

    Estimated Number of Respondents: 30.

    Estimated Total Annual Burden on Respondents: 15,000 hours.

    Estimated Total Annual Cost: $1,139,700.

    Frequency of Collection: Ongoing.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: January 27, 2016. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2016-01774 Filed 2-1-16; 8:45 am] BILLING CODE 6351-01-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Under OMB Review AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 (“PRA”), this notice announces that the Information Collection Request (“ICR”) abstracted below has been forwarded to the Office of Management and Budget (“OMB”) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.

    DATES:

    Comments must be submitted on or before March 3, 2016.

    ADDRESSES:

    Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs in OMB, within 30 days of the notice's publication, by email at [email protected] Please identify the comments by OMB Control No. 3038-0084. Please provide the Commodity Futures Trading Commission (“CFTC” or “Commission”) with a copy of all submitted comments at the address listed below. Please refer to OMB Reference No. 3038-0084, found on http://reginfo.gov. Comments may also be mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Commodity Futures Trading Commission, 725 17th Street NW., Washington, DC 20503, and to the Commission through its Web site at http://comments.cftc.gov. Follow the instructions for submitting comments through the Web site.

    Comments may also be mailed to: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581 or by Hand Delivery/Courier at the same address.

    A copy of the supporting statements for the collection of information discussed above may be obtained by visiting http://RegInfo.gov. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Adam Kezsbom, Special Counsel, Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, (202) 418-5372, email: [email protected], and refer to OMB Control No. 3038-0084.

    SUPPLEMENTARY INFORMATION:

    Title: Regulations Establishing and Governing the Duties of Swap Dealers and Major Swap Participants (OMB Control No. 3038-0084). This is a request for an extension of a currently approved information collection.

    Abstract: On April 3, 2012, the Commission adopted Commission regulations 23.600 (Risk Management Program), 23.601 (Monitoring of Position Limits), 23.602 (Diligent Supervision), 23.603 (Business Continuity and Disaster Recovery), 23.606 (General Information: Availability for Disclosure and Inspection), and 23.607 (Antitrust Considerations) 1 pursuant to section 4s(j) 2 of the Commodity Exchange Act (“CEA”). The above regulations adopted by the Commission require, among other things, swap dealers (“SD”) 3 and major swap participants (“MSP”) 4 to develop a risk management program (including a plan for business continuity and disaster recovery and policies and procedures designed to ensure compliance with applicable position limits). The Commission believes that the information collection obligations imposed by the above regulations are essential to ensuring that swap dealers and major swap participants maintain adequate and effective risk management programs and policies and procedures to ensure compliance with position limits. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The Commission did not receive any comments on the 60-day Federal Register notice, 80 FR 74766, dated November 30, 2015.

    1 17 CFR 23.600, 23.601, 23.602, 23.603, 23.606, 23.607.

    2 7 U.S.C. 6s(j).

    3 For the definition of SD, see section 1a(49) of the CEA and Commission regulation 1.3(ggg). 7 U.S.C. 1a(49) and 17 CFR 1.3(ggg).

    4 For the definitions of MSP, see section 1a(33) of the CEA and Commission regulation 1.3(hhh). 7 U.S.C. a(33) and 17 CFR 1.3(hhh).

    Burden Statement: The Commission is revising its estimate of the burden for this collection to reflect the current number of registered SDs and MSPs. Accordingly, the respondent burden for this collection is estimated to be as follows:

    Number of Registrants: 105.5

    5 The 60-day notice indicated that there were 106 Swap Dealers and Major Swap Participants. The estimates have been adjusted to reflect the current number of 105 Swap Dealers and Major Swap Participants registered with the Commission.

    Estimated Average Burden Hours per Registrant: 1,148.5.

    Estimated Aggregate Burden Hours: 120,592.5.6

    6 The estimated aggregate burden hour is adjusted to reflect the correct total burden hours based on the new number of Swap Dealers and Major Swap Participants registered with the Commission.

    Frequency of Recordkeeping/Third-party Disclosure: As applicable.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: January 27, 2016. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2016-01773 Filed 2-1-16; 8:45 am] BILLING CODE 6351-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0034] Agency Information Collection Activities; Submission for OMB Review; Comment Request—Baby Bouncers and Walker-Jumpers AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. chapter 35), the Consumer Product Safety Commission (“Commission” or “CPSC”) announces that the Commission has submitted to the Office of Management and Budget (“OMB”) a request for extension of approval of a collection of information relating to certain children's articles known as baby-bouncers and walker-jumpers, approved previously under OMB Control No. 3041-0019. In the Federal Register of October 26, 2015 (80 FR 65218), the CPSC published a notice to announce the agency's intention to seek extension of approval of the collection of information. The Commission received no comments. Therefore, by publication of this notice, the Commission announces that CPSC has submitted to the OMB a request for extension of approval of that collection of information, without change.

    DATES:

    Written comments on this request for extension of approval of information collection requirements should be submitted by March 3, 2016.

    ADDRESSES:

    Submit comments about this request by email: [email protected] or fax: 202-395-6881. Comments by mail should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the CPSC, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503. In addition, written comments that are sent to OMB also should be submitted electronically at: http://www.regulations.gov, under Docket No. CPSC-2012-0034.

    FOR FURTHER INFORMATION CONTACT:

    For further information contact: Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    CPSC has submitted the following currently approved collection of information to OMB for extension:

    Title: Ban of Certain Articles Known as Baby-Bouncers or Walker-Jumpers.

    OMB Number: 3041-0019.

    Type of Review: Renewal of collection.

    Frequency of Response: On occasion.

    Affected Public: Manufacturers and importers of baby-bouncers or walker-jumpers.

    Estimated Number of Respondents: 33 firms that supply baby-bouncers or walker-jumpers to the United States market have been identified; there are approximately 4 new models per firm annually.

    Estimated Time per Response: 30 minutes/model associated with labeling requirements and 1 hour/model associated with recordkeeping requirements.

    Total Estimated Annual Burden: 132 hours on recordkeeping (33 firms × 1 hour × 4 models) and 66 hours for labeling (33 firms × 1/2 hour × 4 models) for a total annual burden of 198 hours per year.

    General Description of Collection: Under 16 CFR 1500.18(a)(6), certain articles known as “baby-bouncers” and “walker-jumpers” that are intended to support very young children while sitting, bouncing, jumping, and/or reclining, are banned if they are designed in such a way that exposed parts present hazards, such as amputation, crushing, laceration, fracture, hematoma, bruise, or other injury to fingers, toes, or other parts of the anatomy of young children. An exemption from the ban is provided at 16 CFR 1500.86(a)(4) if the products are designed to guard against or prevent those same injuries. Among other requirements, the regulations require manufacturers, including importers, to meet the collection of information requirements for labeling and recordkeeping requirements.

    Products that are the subject of this information collection are distinguishable from the infant bouncer seats that are the subject of the Commission's recent proposed safety standard on infant bouncer seats at 80 FR 63168 (Oct. 19, 2015). Infant bouncer seats described in the Commission's proposed standard are intended to hold young infants that cannot sit up unassisted in a reclined position (approximately 0 to 6 months of age). The products subject to this information collection are typically described as doorway jumpers, and allow the child to jump in place. Such products are intended for use with children that are beginning to develop leg strength to aid in learning to walk.

    Dated: January 27, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-01779 Filed 2-1-16; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary DoD Medicare-Eligible Retiree Health Care Board of Actuaries; Notice of Federal Advisory Committee Meeting AGENCY:

    DoD.

    ACTION:

    Meeting notice.

    SUMMARY:

    The Department of Defense announces that the following Federal Advisory Committee meeting of the DoD Medicare-Eligible Retiree Health Care Board of Actuaries will take place. This meeting will be open to the public.

    DATES:

    Friday, July 29, 2016, from 10:00 a.m. to 12:00 p.m.

    ADDRESSES:

    4800 Mark Center Drive, Conference Room 19, Level B1, Alexandria, VA 22350.

    FOR FURTHER INFORMATION CONTACT:

    Mrs. Kathleen Ludwig at the Defense Human Resource Activity, DoD Office of the Actuary, 4800 Mark Center Drive, STE 05E22, Alexandria, VA 22350-7000. Phone: 571-372-1993. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: The purpose of the meeting is to execute the provisions of chapter 56, title 10, United States Code (10 U.S.C. 1114 et. seq.). The Board shall review DoD actuarial methods and assumptions to be used in the valuation of benefits under DoD retiree health care programs for Medicare-eligible beneficiaries.

    Agenda:

    1. Meeting Objective

    Approve actuarial assumptions and methods needed for calculating:

    i. FY 2018 per capita full-time and part-time normal cost amounts ii. September 30, 2015, unfunded liability (UFL) iii. October 1, 2016, Treasury UFL amortization and normal cost payments 2. Trust Fund Update 3. Medicare-Eligible Retiree Health Care Fund Update 4. September 30, 2014, Actuarial Valuation Results 5. September 30, 2015, Actuarial Valuation Proposals 6. Decisions

    Actuarial assumptions and methods needed for calculating:

    a. FY 2018 per capita full-time and part-time normal cost amounts b. September 30, 2015, unfunded liability (UFL) c. October 1, 2016, Treasury UFL amortization and normal cost payments

    Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165 and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The Mark Center is an annex of the Pentagon. Those without a valid DoD Common Access Card must contact Kathleen Ludwig at 571-372-1993 no later than June 30, 2016. Failure to make the necessary arrangements will result in building access being denied. It is strongly recommended that attendees plan to arrive at the Mark Center at least 30 minutes prior to the start of the meeting.

    Committee's Designated Federal Officer or Point of Contact: The Designated Federal Officer is Ms. Inger M. Pettygrove. Phone: 571-372-1998. Email: [email protected] Persons desiring to attend the DoD Medicare-Eligible Retiree Health Care Board of Actuaries meeting or make an oral presentation or submit a written statement for consideration at the meeting, must notify Kathleen Ludwig at 571-372-1993, or [email protected], by June 30, 2016.

    Dated: January 28, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-01854 Filed 2-1-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary DoD Board of Actuaries; Notice of Federal Advisory Committee Meeting AGENCY:

    DoD.

    ACTION:

    Meeting notice.

    SUMMARY:

    The Department of Defense announces that the following Federal Advisory Committee meeting of the DoD Board of Actuaries will take place. This meeting is open to the public.

    DATES:

    Thursday, July 14, 2016, from 1:00 p.m. to 4:00 p.m. and Friday, July 15, 2016, from 10:00 a.m. to 1:00 p.m.

    ADDRESSES:

    4800 Mark Center Drive, Conference Room 18, Level B1, Alexandria, VA 22350.

    FOR FURTHER INFORMATION CONTACT:

    Mrs. Kathleen Ludwig at the Defense Human Resources Activity, DoD Office of the Actuary, 4800 Mark Center Drive, STE 05E22, Alexandria, VA 22350-7000. Phone: 571-372-1993. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provision of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the meeting: The purpose of the meeting is for the Board to review DoD actuarial methods and assumptions to be used in the valuations of the Education Benefits Fund, the Military Retirement Fund, and the Voluntary Separation Incentive Fund, in accordance with the provisions of Section 183, Section 2006, Chapter 74 (10 U.S.C. 1464 et. seq.), and 10 U.S.C. 1175.

    Agenda:

    Education Benefits Fund (July 14, 1:00 p.m.-4:00 p.m.) 1. Briefing on Investment Experience 2. September 30, 2015, Valuation Proposed Economic Assumptions * 3. September 30, 2015, Valuation Proposed Methods and Assumptions—Reserve Programs * 4. September 30, 2015, Valuation Proposed Methods and Assumptions—Active Duty Programs * 5. Developments in Education Benefits Military Retirement Fund (July 15, 10:00 a.m.-1:00 p.m.) 1. Briefing on Investment Experience 2. September 30, 2015, Valuation of the Military Retirement Fund * 3. Proposed Methods and Assumptions for September 30, 2016, Valuation of the Military Retirement Fund *

    4. Proposed Methods and Assumptions for September 30, 2015, Voluntary Separation Incentive (VSI) Fund Valuation *

    5. Recent and Proposed Legislation

    * Board approval required

    Public's accessibility to the meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis. The Mark Center is an annex of the Pentagon. Those without a valid DoD Common Access Card must contact Kathleen Ludwig at 571-372-1993 no later than June 16, 2016. Failure to make the necessary arrangements will result in building access being denied. It is strongly recommended that attendees plan to arrive at the Mark Center at least 30 minutes prior to the start of the meeting.

    Committee's Designated Federal Officer or Point of Contact: The Designated Federal Officer is Ms. Inger M. Pettygrove. Phone: 571-372-1998. Email: [email protected] Persons desiring to attend the DoD Board of Actuaries meeting or make an oral presentation or submit a written statement for consideration at the meeting must notify Kathleen Ludwig at 571-372-1993, or [email protected], by June 16, 2016.

    Dated: January 28, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-01855 Filed 2-1-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Educational Opportunity Centers Program AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    Overview Information: Educational Opportunity Centers Program (EOC Program) Notice Inviting Applications for New Awards for Fiscal Year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.066A.

    Dates:

    Applications Available: February 2, 2016.

    Deadline for Transmittal of Applications: April 4, 2016.

    Deadline for Intergovernmental Review: June 1, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The purposes of the EOC Program are to: provide information regarding financial and academic assistance available for qualified adults who want to enter or continue to pursue a program of postsecondary education; provide assistance to those individuals in applying for admission to institutions at which a program of postsecondary education is offered, including preparing necessary applications for use by admissions and financial aid officers; and assist in improving the financial and economic literacy of program participants.

    An Educational Opportunity Centers project may provide the following services:

    (1) Public information campaigns designed to inform the community regarding opportunities for postsecondary education and training;

    (2) Academic advice and assistance in course selection;

    (3) Assistance in completing college admission and financial aid applications;

    (4) Assistance in preparing for college entrance examinations;

    (5) Education or counseling services designed to improve the financial literacy and economic literacy of students;

    (6) Guidance on secondary school reentry or entry to a general educational development (GED) program or other alternative education program for secondary school dropouts;

    (7) Individualized personal, career, and academic counseling;

    (8) Tutorial services;

    (9) Career workshops and counseling;

    (10) Mentoring programs involving elementary or secondary school teachers, faculty members at institutions of higher education (IHEs), students, or any combination of these persons; and

    (11) Programs and activities as described in items (1) through (10) that are specially designed for students who are limited English proficient, students from groups that are traditionally underrepresented in postsecondary education, students with disabilities, students who are homeless children and youths, students who are in foster care or are aging out of the foster care system, or other disconnected students.

    (12) Other activities designed to meet the purposes of the EOC Program.

    Note:

    Consistent with 34 CFR 75.209, the Secretary will use the selection criteria outlined in 34 CFR 644.21 to evaluate the applications submitted for new grants under this program. In addition, consistent with the Department's increasing emphasis on promoting evidence-based practices through our grant competitions, the Secretary will also evaluate applications on the extent to which the components of the proposed project are supported by a logic model that meets the evidence standard of “strong theory” (as defined in this notice). We encourage applicants to read carefully the Selection Criteria section of this notice. Resources to assist applicants in creating a logic model can be found here: http://ies.ed.gov/ncee/edlabs/regions/pacific/pdf/REL_2014007.pdf.

    Priorities: This notice contains two competitive preference priorities. The competitive preference priorities are from the notice of final supplemental priorities and definitions for discretionary grant programs, published in the Federal Register on December 10, 2014 (79 FR 73425) (Supplemental Priorities).

    Competitive Preference Priorities: For FY 2016 and any subsequent year in which we make awards from the list of unfunded applicants from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award an application up to two additional points for each priority, for a total of up to four additional points, depending on how well the application meets each of these priorities.

    The competitive preference priorities are:

    Competitive Preference Priority 1: Improving Parent, Family, and Community Engagement (up to 2 additional points).

    The Secretary gives priority to projects that are designed to improve student outcomes through implementing initiatives that improve community engagement (as defined in this notice), the relationships between parents or families and school or program staff by cultivating sustained partnerships (as defined in this notice).

    Competitive Preference Priority 2: Supporting Military Families and Veterans (up to 2 additional points).

    The Secretary gives priority to projects that are designed to address the needs of military- or veteran-connected students (as defined in this notice).

    Note:

    Applicants must include, in the one-page abstract submitted with the application, a statement indicating which, if any, of the competitive preference priorities are addressed. If the applicant has addressed the competitive preference priorities, this information must also be listed in the application package on the EOC Program Profile Form.

    Definitions: These definitions are from the Supplemental Priorities and 34 CFR 77.1.

    Community engagement means the systematic inclusion of community organizations as partners with State educational agencies (SEAs), local educational agencies (LEAs), or other educational institutions, or their school or program staff to accomplish activities that may include developing a shared community vision, establishing a shared accountability agreement, participating in shared data collection and analysis, or establishing community networks that are focused on shared community-level outcomes. These organizations may include faith- and community-based organizations, IHEs (including minority-serving institutions eligible to receive aid under title III or title V of the Higher Education Act of 1965 (HEA)), businesses and industries, labor organizations, State and local government entities, or Federal entities other than the Department.

    Logic model (also referred to as theory of action) means a well-specified conceptual framework that identifies key components of the proposed process, product, strategy, or practice (i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the relationships among the key components and outcomes, theoretically and operationally.

    Military- or veteran-connected student means (a) A child participating in an early learning and development program, a student enrolled in preschool through grade 12, or a student enrolled in postsecondary education or career and technical training who has a parent or guardian who is a member of the uniformed services (as defined by 37 U.S.C. 101, in the Army, Navy, Air Force, Marine Corps, Coast Guard, National Guard, National Oceanic and Atmospheric Administration, or Public Health Service); (b) A student who is a member of the uniformed services, a veteran of the uniformed services, or the spouse of a service member or veteran; or (c) A child participating in an early learning and development program or a student enrolled in preschool through grade 12 who has a parent or guardian who is a veteran of the uniformed services (as defined by 37 U.S.C. 101).

    Note:

    For the purpose of this competition, only subpart (b) of this definition is applicable, and the term “students” in this definition includes prospective students.

    Parent and family engagement means the systematic inclusion of parents and families, working in partnership with SEAs, State lead agencies (under Part C of the Individuals with Disabilities Education Act or the State's race to the Top-Early Learning Challenge grant), LEAs, or other educational institutions, or their staff, in their child's education, which may include strengthening the ability of (a) parents and families to support their child's education; and (b) school or program staff to work with parents and families.

    Strong theory means a rationale for the proposed process, product, strategy, or practice that includes a logic model.

    Sustained partnership means a relationship that has demonstrably adequate resources and other support to continue beyond the funding period and that consists of community organizations as partners with an LEA and one or more of its schools. These organizations may include faith- and community-based organizations, IHEs (including minority-serving institutions eligible to receive aid under title III or title V of the HEA), businesses and industries, labor organizations, State and local government entities, or Federal entities other than the Department.

    Program Authority: 20 U.S.C. 1070a-11 and 20 U.S.C. 1070a-16.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75 (except for 75.215 through 75.221), 77, 79, 82, 84, 86, 97, 98, and 99. (b) The Education Department debarment and suspension regulations as adopted in 2 CFR part 3485 and the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards as adopted in 2 CFR part 3474. (c) The regulations for this program in 34 CFR part 644. (d) The Supplemental Priorities.

    Note:

    The regulations in 34 CFR part 79 apply to all applicants except Federally recognized Indian tribes.

    Note:

    The regulations in 34 CFR part 86 apply to IHEs only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $54,296,053.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applications from this competition.

    Estimated Range of Awards: $236,000-$1,207,694.

    Estimated Average Size of Awards: $377,661.

    Maximum Award:

    • For an applicant that is not currently receiving an EOC Program grant, the maximum award amount is $236,000, based upon a per-participant cost of no more than $236 and a minimum of 1,000 participants.

    • For an applicant that is currently receiving an EOC Program grant, the maximum award amount is an amount equal to 103 percent of the applicant's base award amount for FY 2015. The minimum number of participants an applicant proposes to serve must be at least the number of participants approved to serve in FY 2015.

    We will reject any application that proposes a budget exceeding the applicable maximum amount listed above for a single budget period of 12 months. We will also reject any application that proposes a budget to serve fewer than 1,000 participants, or any application that proposes a budget that exceeds the maximum per-participant cost of $309.

    Estimated Number of Awards: 151.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Up to 60 months.

    III. Eligibility Information

    1. Eligible Applicants: IHEs, public and private agencies and organizations including community-based organizations with experience in serving disadvantaged youth; combinations of such institutions, agencies, and organizations; and secondary schools.

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    3. Other: An applicant may submit more than one application for an EOC Program grant so long as each application describes a project that serves a different target area (34 CFR 644.10(a)). The term “target area” is defined as a geographic area served by a project (34 CFR 644.7(b)).

    IV. Application and Submission Information

    1. Address to Request Application Package: Rachael Couch, Ed.D., U.S. Department of Education, 400 Maryland Avenue SW., Room 7E311, Washington, DC 20202. Telephone: (202) 502-7655 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.

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

    2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative, which includes the budget narrative, to no more than 60 pages using the following standards. However, any application addressing the competitive preference priorities may include up to 4 additional pages for each of the priorities that is addressed. Those additional pages must be used to discuss how the application meets the competitive preference priorities.

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. Page numbers and an identifier may be within the 1″ margin.

    • Each page on which there is text or graphics will be counted as one full page.

    • Double space (no more than three lines per vertical inch) all text in the application narrative.

    • Titles, headings, footnotes, quotations, references, and captions, as well as all text in figures, charts, and graphs, may be single-spaced.

    • Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).

    • Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman and Arial Narrow) will not be accepted.

    The page limit does not apply to Part I—the Application for Federal Assistance Face Sheet (SF 424); Part II—the Budget Information Summary form (ED Form 524); Part III—the EOC Program Profile form; Part III—the one-page Project Abstract form; and Part IV—the Assurances and Certifications. The page limit also does not apply to a table of contents, which you should include in the application narrative. If you include any attachments or appendices, these items will be counted as part of Part III—the application narrative for purpose of the page-limit requirement. You must include your complete response to the selection criteria in Part III—the application narrative.

    We will reject your application if you exceed the page limit.

    3. Submission Dates and Times:

    Applications Available: February 2, 2016.

    Deadline for Transmittal of Applications: April 4, 2016.

    Applications for grants under this program must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the program contact person listed under For Further Information Contact in section VII in this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: June 1, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    5. Funding Restrictions: We specify unallowable costs in 34 CFR 644.31. We reference additional regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note:

    Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: http://www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements: Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications.

    Applications for grants under the EOC Program, CFDA number 84.066A, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the EOC Program at www.Grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.066, not 84.066A).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (e.g., Word, Excel, WordPerfect, etc.) or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department then will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the program contact person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note:

    The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through Grants.gov because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system; and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: Gaby Watts, U.S. Department of Education, 400 Maryland Avenue SW., Room 7E311, Washington, DC 20202. Fax: (202) 205-0063.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail.

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.066A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note:

    The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the deadline date.

    c. Submission of Paper Applications by Hand Delivery.

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application, by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.066A), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications:

    If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this grant notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Selection Criteria: The following selection criteria for this competition total 105 points and are from 34 CFR 644.21 and 34 CFR 75.210:

    (a) Need for the project (24 points). The Secretary evaluates the need for an EOC project in the proposed target area on the basis of the extent to which the application contains clear evidence of—

    (1) A high number or percentage, or both, of low-income families residing in the target area;

    (2) A high number or percentage, or both, of individuals residing in the target area with education completion levels below the baccalaureate level;

    (3) A high need on the part of residents of the target area for further education and training from programs of postsecondary education in order to meet changing employment trends; and

    (4) Other indicators of need for an EOC project, including the presence of unaddressed educational or socio-economic problems of adult residents in the target area.

    (b) Objectives (8 points). The Secretary evaluates the quality of the applicant's objectives and proposed targets (percentages) in the following areas on the basis of the extent to which they are both ambitious, as related to the need data provided under paragraph (a) of this section, and attainable, given the project's plan of operation, budget, and other resources—

    (1) Secondary school diploma or equivalent (2 points).

    (2) Postsecondary enrollment (3 points).

    (3) Financial aid applications (1.5 points).

    (4) College admission applications (1.5 points).

    (c) Plan of operation (30 points). The Secretary evaluates the quality of the applicant's plan of operation on the basis of the following—

    (1) The plan to inform the residents, schools, and community organizations in the target area of the goals, objectives, and services of the project and the eligibility requirements for participation in the project (4 points);

    (2) The plan to identify and select eligible participants and ensure their participation without regard to race, color, national origin, gender, or disability (4 points);

    (3) The plan to assess each participant's need for services provided by the project (2 points);

    (4) The plan to provide services that meet the participants' needs and achieve the objectives of the project (12 points); and

    (5) The management plan to ensure the proper and efficient administration of the project including, but not limited to, the project's organizational structure, the time committed to the project by the project director and other personnel, and, where appropriate, its coordination with other projects for disadvantaged students (8 points).

    (d) Applicant and community support (16 points). The Secretary evaluates the applicant and community support for the proposed project on the basis of the extent to which the applicant has made provision for resources to supplement the grant and enhance the project's services, including—

    (1) Facilities, equipment, supplies, personnel, and other resources committed by the applicant (8 points); and

    (2) Resources secured through written commitments from schools, community organizations, and others (8 points).

    (e) Quality of personnel (9 points). (1) The Secretary evaluates the quality of the personnel the applicant plans to use in the project on the basis of the following—

    (i) The qualifications required of the project director.

    (ii) The qualifications required of each of the other personnel to be used in the project.

    (iii) The plan to employ personnel who have succeeded in overcoming disadvantages or circumstances like those of the population of the target area.

    (2) In evaluating the qualifications of a person, the Secretary considers his or her experience and training in fields related to the objectives of the project.

    (f) Budget (5 points). The Secretary evaluates the extent to which the project budget is reasonable, cost-effective, and adequate to support the project.

    (g) Evaluation plan (8 points). The Secretary evaluates the quality of the evaluation plan for the project on the basis of the extent to which the applicant's methods of evaluation—

    (1) Are appropriate to the project's objectives;

    (2) Provide for the applicant to determine, using specific and quantifiable measures, the success of the project in—

    (i) Making progress toward achieving its objectives (a formative evaluation); and

    (ii) Achieving its objectives at the end of the project period (a summative evaluation); and

    (3) Provide for the disclosure of unanticipated project outcomes, using quantifiable measures if appropriate.

    (h) Quality of the project design (5 points). The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the extent to which the proposed project is supported by strong theory (as defined in this notice).

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal assistance from the Department of Education (34 CFR 100.4,104.5,106.4,108.8, and 110.23).

    For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 644.21 and 34 CFR 75.210. The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process. Additionally, in accordance with 34 CFR 644.22, the Secretary will award prior experience points to applicants that conducted an EOC Program project during budget periods 2012-13, 2013-14, and 2014-15, based on their documented experience. Prior experience points, if any, will be added to the application's averaged reader score to determine the total score for each application.

    If there are insufficient funds for all applications with the same total scores, the Secretary will choose among the tied applications so as to serve geographic areas and eligible populations that have been underserved by the EOC Program.

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Measures: The success of the EOC Program will be measured by the EOC Program participants' success in completing a secondary school diploma or its equivalent, completion of applications for student financial aid, submission of applications for postsecondary admission, and postsecondary enrollment. All EOC Program grantees will be required to submit annual performance reports.

    5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance management requirements, the performance targets in the grantee's approved application.

    In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    VII. Agency Contacts FOR FURTHER INFORMATION CONTACT:

    Rachael Couch, Ed.D., U.S. Department of Education, 400 Maryland Avenue SW., room 7E311, Washington, DC 20202. Telephone: (202) 502-7655 or by email: [email protected]

    If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or computer disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice.

    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 this 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 feature at this site, you can limit your search to documents published by the Department.

    Dated: January 27, 2016. Lynn Mahaffie, Deputy Assistant Secretary for Policy, Planning and Innovation Delegated the Duties of Assistant Secretary for Postsecondary Education.
    [FR Doc. 2016-01832 Filed 2-1-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0012] Agency Information Collection Activities; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection AGENCY:

    Office of Elementary and Secondary Education (OESE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before April 4, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0012. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-115, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact John Cheek, 202-401-0274.

    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: Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection.

    OMB Control Number: 1810-0698.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local and Tribal Governments.

    Total Estimated Number of Annual Responses: 5,412.

    Total Estimated Number of Annual Burden Hours: 2,728.

    Abstract: “Indian Education—Individual Reporting on Regulatory Compliance Related to the Indian Education Professional Development Program's Service Obligation and the Government Performance and Results Act of 1993 (GPRA).”

    The Indian Education Professional Development program, authorized under title VII, part A of the Elementary and Secondary Education Act of 1965, as amended (ESEA), is designed to increase the number of, provide training to, and improve the skills of American Indian or Alaska Natives serving as teachers and school administrators in schools serving American Indian or Alaska Native students.

    Section 7122(h) of the ESEA (20 U.S.C. 7442(h)) requires that individuals who receive financial assistance through the Indian Education Professional Development program subsequently complete a service obligation equivalent to the amount of time for which the participant received financial assistance. Participants who do not satisfy the requirements of the regulations must repay all or a pro-rated part of the cost of assistance, in accordance with 20 U.S.C. 7442(h) and 34 CFR 263.8(a)(3). The regulations in part 263 implement requirements governing, among other things, the service obligation and reporting requirements of the participants in the Indian Education Professional Development program, and repayment of financial assistance by these participants. In order for the Federal Government to ensure that the goals of the program are achieved, certain data collection, recordkeeping, and documentation are necessary.

    In addition, GPRA requires Federal agencies to establish performance measures for all programs, and the Department has established performance measures for the Indian Education Professional Development program. Data collection from participants who have received financial assistance under the Indian Education Professional Development program is a necessary element of the Department's effort to evaluate progress on these measures.

    The Department tracks participants who are receiving or have previously received support through the Indian Education Professional Development program. Participants must sign a payback agreement that includes contact information. Additionally, the Department receives information about participants from institutions of higher education (IHEs) and other eligible grantees when participants are no longer receiving assistance through the Indian Education Professional Development program. When the performance period is complete, the participant data are collected from the grantee and also from the participants.

    Dated: January 28, 2016. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-01844 Filed 2-1-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP16-301-000] Iroquois Gas Transmission System, L.P.; Notice of Initiation of Section 5 Proceeding

    On January 21, 2016, the Commission issued an order in Docket No. RP16-301-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d (2012), instituting an investigation into the justness and reasonableness of Iroquois Gas Transmission System, LP's (Iroquois) currently effective tariff rates. The Commission's order directs Iroquois to file a full cost and revenue study within 75 days of the issuance of the order. Iroquois Gas Transmission System, L.P., 154 FERC ¶61,028 (2016).

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01797 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Half-Day Closing

    Pursuant to the Office of Personnel Management announcement on January 22, 2016, all Federal Government offices in the District of Columbia metropolitan area will be closed at 12 noon.

    In accordance with section 385.2007 of the Commission's Rules, 18 CFR 385.2007, filings and documents due to be filed on Friday, January 22, 2016 will be accepted as timely on the next official business day.

    Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01806 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meeting related to the transmission planning activities of the New York Independent System Operator, Inc.

    The New York Independent System Operator, Inc. Electric System Planning Working Group Meeting January 28, 2016, 10:00 a.m.-3:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

    The New York Independent System Operator, Inc. Joint Electric System Planning Working Group and Transmission Planning Advisory Meeting February 5, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

    The New York Independent System Operator, Inc. Electric System Planning Working Group Meeting February 25, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

    The discussions at the meeting described above may address matters at issue in the following proceedings:

    New York Independent System Operator, Inc., Docket No. ER13-102.

    New York Independent System Operator, Inc., Docket No. ER15-2059.

    New York Independent System Operator, Inc., Docket No. ER16-120.

    New York Transco, LLC, Docket No. ER15-572.

    For more information, contact James Eason, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-8622 or [email protected]

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01809 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2322-060] Brookfield White Pine Hydro LLC; Notice of Intent To File License Application, Filing of Pre-Application Document (PAD), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the Pad and Scoping Document, and Identification of Issues and Associated Study Requests; and Scoping Meeting

    a. Type of Filing: Notice of Intent to File License Application for a New License and Pre-Application Document (PAD) (including a proposed process plan and schedule), pursuant to 18 CFR 5.6 of the Commission's regulations.

    b. Project No.: 2322-060.

    c. Date Filed: September 21, 2015.

    d. Submitted By: Brookfield White Pine Hydro LLC (White Pine Hydro).

    e. Name of Project: Shawmut Hydroelectric Project.

    f. Location: On the Kennebec River in the towns of Skowhegan, Fairfield, Clinton, and Benton, within Kennebec and Somerset Counties, Maine. The project does not occupy United States lands.

    g. Filed Pursuant to: 18 CFR part 5 of the Commission's Regulations.

    h. Potential Applicant Contact: Frank Dunlap, Licensing Specialist, Brookfield White Pine Hydro LLC, 150 Main St., Lewiston, ME 04240; (207) 755-5603; [email protected].

    i. FERC Contact: Dustin Wilson at (202) 502-6528, or email at [email protected].

    j. Cooperating agencies: Federal, state, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues that wish to cooperate in the preparation of the environmental document should follow the instructions for filing such requests described in paragraph o. below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation of the environmental document cannot also intervene. See 94 FERC ¶ 61,076 (2001).

    k. With this notice, we are initiating informal consultation with: (1) The U.S. Fish and Wildlife Service and/or the National Marine Fisheries Service under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and (2) the State Historic Preservation Officer, as required by section 106, National Historical Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.

    l. With this notice, we are designating White Pine Hydro as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 106 of the National Historic Preservation Act.

    m. Commission staff issued a Scoping Document 1 (SD1) on November 20, 2015, which also asked for study requests.

    n. A copy of the PAD and SD1 are available for review at the Commission in the Public Reference Room, or may be viewed on the Commission's Web site (http://www.ferc.gov) using the “eLibrary” link. Enter P-2322 in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected], or toll free at 1-866-208-3676, or for TTY, (202) 502-8659. A copy is also available for inspection and reproduction at the address in paragraph h.

    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.

    o. With this notice, we are soliciting public comments on the PAD and the SD1, as well as on issues and associated study requests. All comments and study requests should be sent to the address above in paragraph h. In addition, all comments on the PAD and SD1, study requests, requests for cooperating agency status, and all communications to and from Commission staff related to the merits of the potential application must be filed with the Commission. Documents 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. 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.

    All filings with the Commission must include on the first page, the project name (Shawmut Hydroelectric Project) and number (P-2322-060), and bear the appropriate heading: “Comments on Pre-Application Document,” “Study Requests,” “Comments on Scoping Document 1,” “Request for Cooperating Agency Status,” or “Communications to and from Commission Staff.” Any individual or entity interested in submitting study requests, commenting on the PAD or SD1, and any agency requesting cooperating status must do so by March 21, 2016.

    Study requests and comments on the PAD or SD1 that have been filed previously are part of the relicensing record and do not need to be refiled.

    p. Although our current intent is to prepare an environmental assessment (EA), there is the possibility that an Environmental Impact Statement (EIS) will be required. Nevertheless, the scoping meetings held December 16, 2015, and the scoping meeting to be held February 9, 2016, will satisfy the NEPA scoping requirements, irrespective of whether an EA or EIS is issued by the Commission.

    Scoping Meeting

    Commission staff held scoping meetings December 16, 2015. The transcripts for the meetings are in the public record for this project, and are available for review through the Commission's Web site, using the “eLibrary” link.

    Commission staff will hold a third scoping meeting in the vicinity of the project at the time and place noted below. All interested individuals and entities, particularly those who were unable to attend the December 16 scoping meetings, are invited to attend the meeting, and to assist staff in identifying particular study needs, as well as the scope of environmental issues to be addressed in the environmental document. The time and location of the meeting is as follows:

    Evening Scoping Meeting

    Date: Tuesday, February 9, 2016.

    Time: 6:00 p.m.

    Location: Skowhegan Community Center, 39 Poulin Dr., Skowhegan, Maine 04976.

    Phone: (207) 474-6901.

    As noted in item m. of this notice, SD1 was mailed to the individuals and entities on the Commission's mailing list. Copies of SD1 will be available at the scoping meeting, or may be viewed on the web at http://www.ferc.gov, using the “eLibrary” link. Follow the directions for accessing information in paragraph n. Based on all oral and written comments, a Scoping Document 2 (SD2) may be issued. SD2 may include a revised process plan and schedule, as well as a list of issues.

    Meeting Objectives

    At the scoping meeting, Commission staff will: (1) Initiate scoping of the issues; (2) review and discuss existing conditions and resource management objectives; (3) review and discuss existing information and identify preliminary information and study needs; and (4) review and discuss the process plan and schedule for pre-filing activities.

    Meeting participants should come prepared to discuss their issues and/or concerns. Please review the PAD in preparation for the scoping meeting. Directions on how to obtain a copy of the PAD and SD1 are included in item n. of this notice.

    Meeting Procedures

    The meeting will be recorded by a stenographer. The transcript will be placed in the public record for the project.

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01810 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-59-000.

    Applicants: RE Astoria LLC.

    Description: Clarification to January 11, 2016 Application for Authorization Under Section 203 of the Federal Power Act and Request for Expedited Consideration, Confidential Treatment and Waivers of RE Astoria LLC.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5161.

    Comments Due: 5 p.m. ET 2/1/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2331-054; ER14-630-029; ER10-2319-045; ER10-2317-045; ER13-1351-027; ER10-2330-052.

    Applicants: J.P. Morgan Ventures Energy Corporation, AlphaGen Power LLC, BE Alabama LLC, BE CA LLC, Florida Power Development LLC, Utility Contract Funding, L.L.C.

    Description: Non-Material Change in Status of the J.P. Morgan Sellers.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5189.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER12-2448-012.

    Applicants: Chisholm View Wind Project, LLC.

    Description: Notice of Change in Status of Chisholm View Wind Project, LLC.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5155.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-277-001.

    Applicants: Talen Energy Marketing, LLC.

    Description: Tariff Amendment: Response to FERC Request for Additional Information to be effective 12/31/9998.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5137.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-620-001.

    Applicants: Safe Harbor Water Power Corporation.

    Description: Tariff Amendment: Amendment to Pending Safe Harbor PPA eTariff Filing to be effective 12/31/2015.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5180.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-743-000.

    Applicants: ITC Great Plains, LLC.

    Description: § 205(d) Rate Filing: Settlement Agreement to be effective 1/1/2016.

    Filed Date: 1/19/16.

    Accession Number: 20160119-5235.

    Comments Due: 5 p.m. ET 2/9/16.

    Docket Numbers: ER16-752-000.

    Applicants: Carousel Wind Farm, LLC.

    Description: Amendment to January 20, 2016 Carousel Wind Farm, LLC submits tariff filing.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5167.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-757-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to OATT re: Merchant Network Upgrades to be effective 5/1/2016.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5211.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-758-000.

    Applicants: New England Power Company.

    Description: § 205(d) Rate Filing: NEP Sched III-B Integrated Facilities Provisions Amdts & Notice Waiver Request to be effective 1/1/2014.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5215.

    Comments Due: 5 p.m. ET 2/11/16.

    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: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01800 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP16-302-000] Columbia Gulf Transmission, LLC; Notice of Initiation of Section 5 Proceeding

    On January 21, 2016, the Commission issued an order in Docket No. RP16-302-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d (2012), instituting an investigation into the justness and reasonableness of Columbia Gulf Transmission, LLC's (Columbia Gulf) currently effective tariff rates. The Commission's order directs Columbia Gulf to file a full cost and revenue study within 75 days of the issuance of the order. Columbia Gulf Transmission, LLC, 154 FERC ¶ 61,027 (2016).

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01798 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-750-000] Bethel Wind Farm 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 Bethel Wind Farm 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 February 10, 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: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01808 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2558-043] Green Mountain Power Corporation; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Type of Application: Application to amend license.

    b. Project No.: 2558-043.

    c. Date Filed: December 15, 2015.

    d. Applicant: Green Mountain Power Corporation.

    e. Name of Project: Otter Creek Hydroelectric Project.

    f. Location: The project is located on Otter Creek in Addison and Rutland counties, Vermont.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: Mr. Josh Castonguay, Director, Generation and Renewable Innovation, Green Mountain Power Corporation, 163 Acorn Ln., Colchester, VT 05446, (802) 655-8754.

    i. FERC Contact: Mr. Steven Sachs, (202) 502-8666, or [email protected]

    j. Deadline for filing comments, motions to intervene, protests, and recommendations is 30 days from the date of issuance of this notice. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. Please include the project number (P-2558-043) on any comments, motions to intervene, protests, or recommendations filed.

    k. Description of Request: The applicant requests a temporary amendment to release an interim bypass conservation flow of 48 cubic feet per second (cfs) into the bypassed reach of the Huntington Falls development at the project. The license, issued October 23, 2014, requires the applicant to release a bypass conservation flow of 66 cfs at the development; however, the applicant states it currently lacks the equipment to efficiently release the required flow and is requesting the temporary amendment while it builds a new gate to comply with the requirement. The applicant expects to construct the gate and release the required 66 cfs by the end of 2016.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits in the docket number field to access the document. 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, call 1-866-208- 3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions To Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Responsive Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading, the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). All comments, motions to intervene, or protests should relate to project works which are the subject of the license amendment. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. If an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: January 21, 2016. Nathanial J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01811 Filed 2-1-16; 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: EC15-206-000.

    Applicants: South Central MCN, LLC.

    Description: Response to Request for Further Information of South Central MCN LLC.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5142.

    Comments Due: 5 p.m. ET 2/3/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER12-2542-008.

    Applicants: Prairie Rose Wind, LLC.

    Description: Compliance filing: Prairie Rose Wind, LLC MBR Tariff to be effective 10/1/2012.

    Filed Date: 1/22/16.

    Accession Number: 20160122-5002.

    Comments Due: 5 p.m. ET 2/12/16.

    Docket Numbers: ER14-2752-004.

    Applicants: Xcel Energy Transmission Development Company, LLC.

    Description: Second Formula Rate Compliance Filing of Xcel Energy Transmission Development Company, LLC.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5265.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER15-1405-002.

    Applicants: The Empire District Electric Company.

    Description: Compliance filing: Supplement to Compliance Filing re Reactive to be effective 6/1/2015.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5225.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-759-000.

    Applicants: Innovative Solar 43, LLC.

    Description: Innovative Solar 43, LLC submits tariff filing per 35.12: Innovative Solar 43, LLC MBR Tariff to be effective 2/20/2016.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5261.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-760-000.

    Applicants: New England Power Company.

    Description: § 205(d) Rate Filing: New England Power Filing of LGIA with Wheelabrator Saugus, Inc. to be effective 1/1/2016.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5238.

    Comments Due: 5 p.m. ET 2/11/16.

    Docket Numbers: ER16-761-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2016-01-22_SA 2763 Termination of ATCLLC-Escanaba FCA to be effective 1/23/2016.

    Filed Date: 1/22/16.

    Accession Number: 20160122-5033.

    Comments Due: 5 p.m. ET 2/12/16.

    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: January 22, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01801 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP16-300-000] Empire Pipeline, Inc.; Notice of Initiation of Section 5 Proceeding

    On January 21, 2016, the Commission issued an order in Docket No. RP16-300-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d (2012), instituting an investigation into the justness and reasonableness of Empire Pipeline, Inc.'s (Empire) currently effective tariff rates. The Commission's order directs Empire to file a full cost and revenue study within 75 days of the issuance of the order. Empire Pipeline, Inc., 154 FERC ¶61,029 (2016).

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01796 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP16-299-000] Tuscarora Gas Transmission Company; Notice of Initiation of Section 5 Proceeding

    On January 21, 2016, the Commission issued an order in Docket No. RP16-299-000, pursuant to section 5 of the Natural Gas Act, 15 U.S.C. 717d (2012), instituting an investigation into the justness and reasonableness of Tuscarora Gas Transmission Company (Tuscarora) currently effective tariff rates. The Commission's order directs Tuscarora to file a full cost and revenue study within 75 days of the issuance of the order. Tuscarora Gas Transmission Company, 154 FERC ¶61,030 (2016).

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01795 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-59-000] Cheniere Corpus Christi Pipeline, L.P.; Notice of Request Under Blanket Authorization

    Take notice that on January 15, 2016, Cheniere Corpus Christi Pipeline, L.P. (Cheniere Corpus Christi), 700 Milam Street, Suite 1900, Houston, Texas 77002, filed in Docket No. CP16-59-000 a prior notice request pursuant to sections 157.205, 157.208 and 157.210 of the Commission's regulations under the Natural Gas Act (NGA) as amended, requesting authorization to install two electric motor drive (EMD) compressors and associated facilities at the previously authorized Sinton Compressor Station site at San Patricio County, Texas (Sinton Compressor Station EMD Project).

    Cheniere Corpus Christi was granted authorization in Docket No. CP12-508-000 1 to construct its Corpus Christi Pipeline Project which included two compressor stations. Cheniere Corpus Christi states that the Taft Compressor Station is no longer needed and proposes to install approximately 29,600 horsepower (HP) of additional compression via two Solar EMD compressor units (14,800 HP each) at the Sinton Compressor Station. Cheniere Corpus Christi states that, as a result of the relocation of compression, neither the capacity nor the maximum allowable operating pressure of the Corpus Christi Pipeline will differ from what was authorized by the Commission in the Certificate.

    1 149 FERC ¶61,283 (2014).

    Cheniere Corpus Christi estimates the cost of the Sinton Compressor Station EMD Project to be approximately $30 million, 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 Patricia Outtrim, Cheniere Energy Inc., 700 Milam Street, Suite 1900, Houston, Texas 77002, by telephone at (713) 375-5000, by facsimile at (713) 375-6485, or by email at [email protected]

    Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.

    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 for Environmental Review 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.

    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 seven copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01803 Filed 2-1-16; 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: ER10-2331-053; ER14-630-028; ER10-2319-044; ER10-2317-044; ER13-1351-026; ER10-2330-051.

    Applicants: J.P. Morgan Ventures Energy Corporation, AlphaGen Power LLC, BE Alabama LLC, BE CA LLC, Florida Power Development LLC, Utility Contract Funding, L.L.C.

    Description: Non-Material Change in Status of the J.P. Morgan Sellers.

    Filed Date: 1/19/16.

    Accession Number: 20160119-5455.

    Comments Due: 5 p.m. ET 2/9/16.

    Docket Numbers: ER11-4073-003.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Complaince Filing for Service Agreement No. 2962 to be effective 6/17/2011.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5122.

    Comments Due: 5 p.m. ET 2/10/16.

    Docket Numbers: ER14-325-007; ER13-2409-007; ER11-4498-011; ER11-4499-011; ER11-4500-010; ER11-4507-009; ER12-128-008; ER11-4501-012; ER12-979-011; ER14-2858-006; ER11-4363-007; ER12-2448-011; ER12-2542-007.

    Applicants: Enel Cove Fort, LLC, Buffalo Dunes Wind Project, LLC, Smoky Hills Wind Farm, LLC, Smoky Hills Wind Project II, LLC, Enel Stillwater, LLC, Canastota Windpower, LLC, EGP Stillwater Solar, LLC, Caney River Wind Project, LLC, Rocky Ridge Wind Project, LLC, Origin Wind Energy, LLC, Osage Wind, LLC, Chisholm View Wind Project, LLC, Prairie Rose Wind, LLC.

    Description: Notice of Change in Status of Enel Cove Fort, LLC, et. al. under ER14-325, et. al.

    Filed Date: 1/19/16.

    Accession Number: 20160119-5448.

    Comments Due: 5 p.m. ET 2/9/16.

    Docket Numbers: ER16-457-001.

    Applicants: California Independent System Operator Corporation.

    Description: Tariff Amendment: 20160120-Errata_Pearblossom Certificate of Concurrence-SvcAgmt3480 to be effective 12/2/2015.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5139.

    Comments Due: 5 p.m. ET 2/1/16.

    Docket Numbers: ER16-754-000.

    Applicants: PacifiCorp.

    Description: § 205(d) Rate Filing: Tri-State NITSA Rev 7 to be effective 1/1/2016.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5141.

    Comments Due: 5 p.m. ET 2/10/16.

    Docket Numbers: ER16-755-000.

    Applicants: Frontier El Dorado Refining LLC.

    Description: § 205(d) Rate Filing: HollyFrontier El Dorado Refining LLC Notice of Succession Filing to be effective 1/21/2016.

    Filed Date: 1/20/16.

    Accession Number: 20160120-5148.

    Comments Due: 5 p.m. ET 2/10/16.

    Docket Numbers: ER16-756-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA No. 3320, Queue No. X3-043 to be effective 3/7/2016.

    Filed Date: 1/21/16.

    Accession Number: 20160121-5070.

    Comments Due: 5 p.m. ET 2/11/16.

    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: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01799 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-58-000] Iroquois Gas Transmission System, L.P.; Notice of Application

    Take notice that on January 15, 2016, Iroquois Gas Transmission System, L.P. (Iroquois), One Corporate Drive, Shelton, Connecticut 06484, filed an application pursuant to section 7 of the Natural Gas Act and Part 157 of the Commission's regulations for authorization to enter into a payment-in-lieu-of-taxes (PILOT) transaction, including a lease and leaseback arrangement, with the Schoharie County Industrial Development Agency (Agency) in the State of New York. Specifically, Iroquois requests that the Commission (i) grant Iroquois authority to abandon passive leasehold interests in certain jurisdictional facilities located in Schoharie County, New York, by transferring such passive leasehold interests to the Agency; (ii) issue a certificate of public convenience and necessity to Iroquois to simultaneously lease back the leasehold interests from the Agency; and (3) grant Iroquois' request for pre-granted authorization to reacquire the leasehold interests from the Agency at the time the lease/leaseback agreements terminate.

    The filing may 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, contact FERC at [email protected] or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

    Any questions regarding this application should be directed to Helen M. Gallagher, Director of Legal Services and Secretary, Iroquois Pipeline Operating Company, One Corporate Drive, Suite 600, Shelton, CT 06484, phone: (203) 925-7201, or email: [email protected]

    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.

    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.

    Comment Date: 5:00 p.m. Eastern Time on February 1, 2016.

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01802 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-28-000] NRG Wholesale Generation LP; Seward Generation, LLC: Notice of Institution of Section 206 Proceeding and Refund Effective Date

    On January 14, 2016, the Commission issued an order in Docket No. EL16-28-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of NRG Wholesale Generation LP's reactive power rates for the Seward Generation Facility. NRG Wholesale Generation LP, 154 FERC ¶ 61,017 (2016).

    The refund effective date in Docket No. EL16-28-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Dated: January 21, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01804 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice Concerning Submissions Made During Federal Government Closures

    Take notice that the Commission is adopting the following practice with respect to submittals to the Commission during Federal government office closures.

    Effective January 22, 2016, the Commission will not accept submittals—either in electronic format submitted through “FERC Online” (including through eFiling and eTariff) or in hardcopy format—when the Commission is closed at the direction of the Office of Personnel Management (OPM) or Presidential Executive Order closing Federal government offices in Washington, DC.1

    1 On January 22, 2016, OPM announced that all Federal Government offices in the District of Columbia metropolitan area will be closed at 12 noon. The above-described practice will be in effect that day.

    At such time as the Commission reopens, it will again accept submittals both in electronic format through “FERC Online” (including through eFiling and eTariff) and in hardcopy format.

    Dated: January 22, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-01805 Filed 2-1-16; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0265] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before April 4, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0265.

    Title: Section 80.868, Card of Instructions.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions and state, local or tribal government.

    Number of Respondents: 4,506 respondents; 4,506 responses.

    Estimated Time per Response: 10 minutes (0.167 hours).

    Frequency of Response: Third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 303, 307(e), 309 and 332.

    Total Annual Burden: 753 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: The third party disclosure requirement contained in 47 CFR 80.868 of the Commission's rules is necessary to ensure that radiotelephone distress procedures must be securely mounted and displayed in full view of the principal operating position on board certain vessels (300 gross tons) required by the Communications Act or the International Convention for Safety of Life at Sea to be equipped with a radiotelephone station.

    The information is used by a vessel radio operator during an emergency situation, and is designed to assist the radio operator to utilize proper distress procedures during a time when he or she may be subject to considerable stress or confusion.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-01822 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0678] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before April 4, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control No.: 3060-0678.

    Title: Part 25 of the Federal Communications Commission's Rules: Governing the Licensing of, and Spectrum Usage by, Commercial Earth Stations and Space Stations.

    Form Nos.: FCC Form 312; Schedule A; Schedule B; Schedule S; FCC Form 312-EZ; FCC Form 312-R.

    Type of Review: Revision of a currently approved information collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents: 4,924 respondents; 4,972 responses.

    Estimated Time per Response: 0.5-80 hours per response.

    Frequency of Response: On occasion, one time, and annual reporting requirements; third-party disclosure requirement; recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 154, 301, 302, 303, 307, 309, 310, 319, 332, 605, and 721.

    Total Annual Burden: 34,099 hours.

    Annual Cost Burden: $10,617,860.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: In general, there is no need for confidentiality with this collection of information. Certain information collected regarding international coordination of satellite systems is not routinely available for public inspection pursuant to 5 U.S.C. 552(b) and 47 CFR 0.457(d)(vii).

    Needs and Uses: On December 17, 2015, the Commission released a Second Report and Order, FCC 15-167, titled, “In the Comprehensive Review of Licensing and Operating Rules for Satellite Services.” In this Report and Order, the Commission adopted comprehensive changes to 47 CFR part 25, which governs licensing and operation of space stations and earth stations for the provision of satellite communication services. Many of the amendments are substantive changes intended to give licensees greater operational flexibility.

    The information collection requirements in this collection are needed to determine the technical, legal, and other qualifications of applicants and licensees to operate a radio station and to determine whether grant of an authorization serves the public interest, convenience and necessity. Without such information, the Commission could not determine whether to permit respondents to provide communications services in the United States. Therefore, the Commission would not be able to fulfill its statutory responsibilities in accordance with the Communications Act of 1934, as amended, and the obligations imposed on parties to the World Trade Organization Basic Telecom Agreement.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-01824 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [AU Docket No. 14-252; GN Docket No. 12-268; WT Docket No. 12-269; DA 16-89] Revised Filing Window Dates for FCC Form 175 Application To Participate in the Forward Auction (Auction 1002) AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice.

    SUMMARY:

    This document announces revised filing window dates for FCC Form 175, the application for parties seeking to participate in the forward auction phase (Auction 1002) of the broadcast incentive auction (Auction 1000).

    DATES:

    The forward auction FCC Form 175 filing window opened at 12:00 p.m. Eastern Time (ET) on January 27, 2016, and will close at 6:00 p.m. ET on February 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Wireless Telecommunications Bureau, Auctions and Spectrum Access Division: for general forward auction questions Leslie Barnes or Valerie Barrish at (202) 418-0660.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Forward Auction Application Filing Window Opens Today at Noon After One-Day Weather Delay; FCC Form 175 Deadline Extended to February 10, 2016 (Forward Auction 1002 FCC Form 175 Revised Filing Window Dates Public Notice), AU Docket No. 14-252, GN Docket No. 12-268, WT Docket No. 12-269, DA 16-89, released on January 27, 2016. The complete text of the Forward Auction 1002 FCC Form 175 Revised Filing Window Dates Public Notice is available for public inspection and copying from 8:00 a.m. to 4:30 p.m. ET Monday through Thursday or from 8:00 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's Web site at http://wireless.fcc.gov, the Auction 1002 Web site at http://www.fcc.gov/auctions/1002, or by using the search function on the ECFS Web page at http://www.fcc.gov/cgb/ecfs/. Alternative formats are available to persons with disabilities by sending an email to [email protected] or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

    General Information

    The Forward Auction 1002 FCC Form 175 Revised Filing Window Dates Public Notice announced that the filing window for the FCC Form 175, the application to participate in the forward auction phase of the broadcast incentive auction, opened on January 27, 2016, after a one-day delay due to severe weather in the Washington, DC area. In addition, the closing of the filing window will be extended for one day from its originally scheduled date. Specifically, the FCC Form 175 filing window opened at 12:00 p.m. ET on January 27, 2016, and will close at 6:00 p.m. ET on February 10, 2016. Applications must be filed prior to the closing of the filing window. All other procedures, terms and requirements as set out in the Auction 1000 Application Procedures Public Notice, 80 FR 66429, October 29, 2015, remain unchanged. Additional information for potential broadcast incentive auction participants is available on the Auction 1000 Web site at www.fcc.gov/auctions/1000.

    Federal Communications Commission. Gary D. Michaels, Deputy Chief, Auctions and Spectrum Access Division, WTB.
    [FR Doc. 2016-01980 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0937] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before April 4, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0937.

    Title: Establishment of a Class A Television Service, MM Docket No. 00-10.

    Form Number: Not applicable.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Frequency of Response: Recordkeeping requirement; Third party disclosure requirement; On occasion and quarterly reporting requirements.

    Number of Respondents and Responses: 430 respondents; 10,850 responses.

    Estimated Time per Response: 0.017 hours-52 hours.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i), 307, 308, 309 and 319 of the Communications Act of 1934, as amended.

    Total Annual Burden: 202,133 hours.

    Total Annual Cost: $1,911,000.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: On November 29, 1999, the Community Broadcasters Protection Act of 1999 (CBPA), Public Law 106-113, 113 Stat. Appendix I at pp. 1501A-594-1501A-598 (1999), codified at 47 U.S.C. 336(f), was enacted. That legislation provided that a low power television (LPTV) licensee should be permitted to convert the secondary status of its station to the new Class A status, provided it can satisfy certain statutorily-established criteria. The CBPA directs that Class A licensees be subject to the same license terms and renewal standards as full-power television licenses and that Class A licensees be accorded primary status as television broadcasters as long as they continue to meet the requirements set forth in the statute for a qualifying low power station.

    The CBPA sets out certain certification and application procedures for LPTV licensees seeking Class A designation, prescribes the criteria LPTV licensees must meet to be eligible for Class A licenses, and outlines the interference protection Class A applicants must provide to analog, digital, LPTV and TV translator stations.

    The CBPA directs that Class A stations must comply with the operating requirements for full-service television broadcast stations. Therefore, beginning on the date of its application for a Class A license and thereafter, a station must be “in compliance” with the Commission's operating rules for full-service television stations, contained in 47 CFR part 73.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-01821 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0998] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before April 4, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control No.: 3060-0998.

    Title: Section 87.109, Station logs.

    Form No.: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 5 respondents and 5 responses.

    Estimated Time per Response: 100 hours.

    Frequency of Response: Recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in 47 U.S.C. 154, 303 and 307(e) unless otherwise noted.

    Total Annual Burden: 500 hours.

    Annual Cost Burden: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Needs and Uses: Section 87.109 of the Commission's rules require that a station at a fixed location in the international aeronautical mobile service (IAMS) must maintain a log (written or automatic log) in accordance with the Annex 10 provisions of the International Civil Aviation Organization (ICAO) Convention. This log is necessary to document the quality of service provided by fixed stations, including the harmful interference, equipment failure, and logging of distress and safety calls where applicable. This information is used by the Commission to ensure that particular stations are licensed and operated in compliance with applicable rules, statutes, and treaties.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-01823 Filed 2-1-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL TRADE COMMISSION [Docket No. 9357] LabMD, Inc. Oral Argument Before the Commission AGENCY:

    Federal Trade Commission.

    ACTION:

    Oral argument; open meeting.

    SUMMARY:

    The Federal Trade Commission (“FTC” or “Commission”) will meet on Tuesday, March 8, 2016, in Room 532 of the FTC Building for an Oral Argument In the Matter of LabMD, Inc. The public is invited to attend and observe the open portion of the meeting, which is scheduled to begin at 1:00 p.m. The remainder of the meeting will be closed to the public.

    DATES:

    Oral argument is scheduled for March 8, 2016 at 1:00 p.m.

    ADDRESSES:

    Federal Trade Commission Building, 600 Pennsylvania Avenue NW., Washington, DC 20580.

    FOR FURTHER INFORMATION CONTACT:

    Donald S. Clark, Secretary, Office of the Secretary, 600 Pennsylvania Avenue NW., Washington, DC 20580, 202-326-2515.

    SUPPLEMENTARY INFORMATION:

    Open Meeting

    (1) Oral Argument In the Matter of LabMD, Inc., Docket No. 9357.

    Closed Meeting

    (2) Executive Session to follow Oral Argument In the Matter of LabMD, Inc., Docket No. 9357.

    Record of Commission's Vote

    On January 20, 2016, Commissioners Ramirez, Ohlhausen, and McSweeny were recorded as voting in the affirmative to close Matter Number (2), and to withhold from this meeting notice such information as is exempt from disclosure under 5 U.S.C. 552b(c)(10). Commissioner Brill was recorded as not participating.

    Commission's Explanation of Closing

    The Commission has determined that Matter Number (2) may be closed under 5 U.S.C. 552b(c)(10), and that the public interest does not require the matter to be open.

    General Counsel Certification

    The General Counsel has certified that Matter Number (2) may properly be closed, citing the following relevant provision: 5 U.S.C. 552b(c)(10).

    Expected Attendees

    Expected to attend the closed meeting are the Commissioners themselves, an advisor to one of the Commissioners, and such other Commission staff as may be appropriate.

    By direction of the Commission, Commissioner Brill not participating.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-01852 Filed 2-1-16; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority

    Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 81 FR 4912-4913, dated January 28, 2016) is amended to reflect the reorganization of the National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention.

    Section C-B, Organization and Functions, is hereby amended as follows:

    Delete in its entirety the title and function statements for the Division of Birth Defects and Developmental Disabilities (CUBB) and insert the following:

    Division of Congenital and Developmental Disorders (CUBB). (1) Conducts research to determine the causes and prevention of birth defects and developmental disabilities; (2) maintains and expands support for state-based surveillance; (3) evaluates the effectiveness of efforts to prevent birth defects and developmental disabilities; (4) conducts and disseminates findings of epidemiologic research, investigations, demonstrations, and programs directed toward the prevention of selected adverse reproductive outcomes that are environmentally related; (5) provides assistance to State and local health departments on community exposures to terotogenic, mutagenic, embryotoxic, other environmental agents, and genetic influences adversely interfering with normal growth and development; (6) conducts research and develops programs to identify women at high risk of an alcohol-exposed pregnancy and to fund epidemiologic and clinical research studies aimed at early identification and intervention of children affected by prenatal alcohol exposure; (7) works closely with international organizations and entities in developing strategies and programs for reducing the number of birth defects and developmental disabilities; (8) develops and evaluates prevention strategies and provides training, technical consultation, and assistance to States and localities in developing their capacity for planning, establishing, and maintaining surveillance and prevention programs; (9) maintains and oversees funding and technical assistance to state-based institutions (e.g., the Centers for Birth Defects Research and Prevention that seek causes and promotes prevention of birth defects); (10) plans, develops, establishes, and maintains systems of surveillance including registries for monitoring, evaluating and disseminating information; (11) assists in increasing the capacity of States to prevent and control birth defects and developmental disabilities through training, technology transfer, grants, cooperative agreements, contracts, and other means; (12) provides information and education to the public; (13) provides services, consultation, technical assistance, and information to States, localities, other Federal agencies, international organizations, and other public and private organizations; (14) provides training in the epidemiology to professionals throughout the U.S. and abroad; and (15) collaborates and coordinates activities with other CIOs and HHS agencies.

    Office of the Director (CUBB1). (1) Manages, directs, and coordinates the research agenda and activities of the division; (2) provides leadership and guidance on strategic planning, policy, program and project priority planning and setting, program management, and operations; (3) establishes division goals, objectives, and priorities; (4) monitors progress in implementation of projects and achievement of objectives; (5) plans, allocates, and monitors resources; (6) provides management, administrative, and support services, and coordinates with appropriate NCBDDD offices on program and administrative matters; (7) provides liaison with other CDC organizations, other governmental agencies, international organizations, and other outside groups; (8) provides support for internal scientific advisory groups; (9) provides scientific leadership and guidance to the division to assure highest scientific quality and professional standards; and (10) provides coordinative support for CDC's efforts to reduce adverse consequences from birth defects, developmental disabilities, and pediatric genetic conditions.

    Birth Defects Branch (CUBBB). (1) Designs and conducts epidemiologic and genetic research to identify causes and risk factors of birth defects; (2) conducts and evaluates interventions to improve infant and child health by preventing or reducing the adverse consequences of birth defects; (3) designs and conducts surveillance of selected birth defects to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs; (4) disseminates findings of studies to the scientific and public health communities, and to the general public; (5) provides technical assistance to state and local agencies on surveillance of birth defects, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research; (6) funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of birth defects through surveillance, epidemiologic research, and applies research of preventive interventions; (7) coordinates activities with other CDC functional units, HHS, other federal agencies, and appropriate private organizations regarding research and prevention programs for birth defects; (8) works with international organizations in developing strategies for the prevention of birth defects; and (9) disseminates findings of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means.

    Prevention Research and Translation Branch (CUBBC). (1) Modifies the impact of prenatal exposures leading to adverse physical and developmental impairments in infants, children, and adults including integrating successful prevention programs into social and medical environments, and evaluating innovative, effective, and strategic health promotion programs; (2) develops, implements, evaluates, and disseminates education and communication interventions that lead to the prevention of birth defects and developmental disabilities; (3) designs and conducts surveillance of preventable birth defects and developmental disabilities to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs; (4) disseminates findings of epidemiologic studies to the scientific and public health communities, and to the general public; (5) conducts prevention effectiveness research to evaluate interventions strategies for the prevention of birth defects and developmental disabilities; (6) identifies and monitors major preconception, prenatal and perinatal risks, and protective factors for fetal alcohol spectrum disorders (FASD) and other prenatal alcohol attributable conditions; (7) provides technical assistance to state and local agencies on surveillance, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research; (8) funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of birth defects and developmental disabilities through surveillance, epidemiologic research, and applies research of preventive interventions; (9) coordinates activities with other CDC functional units, HHS, other federal agencies and appropriate private organizations regarding research and prevention programs for birth defects and developmental disabilities; (10) works with international organizations in developing strategies for the prevention of birth defects and developmental disabilities; and (11) disseminates finding of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means.

    Developmental Disabilities Branch (CUBBD). (1) Designs and conducts surveillance of developmental disabilities to identify rates, trends, and patterns of occurrence, and to evaluate the effectiveness of prevention programs; (2) conducts epidemiologic studies of developmental disabilities to identify causes and risk factors for these conditions; (3) disseminates findings of epidemiologic studies to the scientific and public health communities and to the general public; (4) conducts prevention effectiveness research to evaluate interventions strategies for the prevention of developmental disabilities; (5) conducts epidemiologic studies to identify and describe specific conditions and long-term outcomes of developmental disabilities; (6) provides technical assistance to state and local agencies on surveillance of developmental disabilities, epidemiologic research, prevention program design and evaluation, and prevention effectiveness research; (7) funds and coordinates grant and cooperative agreement programs and other extramural activities to improve the knowledge base for the prevention of developmental disabilities through surveillance, epidemiologic research, and applies research of preventive interventions; (8) coordinates activities with other CDC functional units, HHS, other federal agencies and appropriate private organizations regarding research and prevention programs for developmental disabilities; (9) collaborates with international organizations in developing strategies for the prevention of developmental disabilities; (10) disseminates findings of research through direct contact with health authorities, publication and distribution of special reports, publication in scientific and technical journals, conference presentations, and other appropriate means; and (11) provides training in the epidemiology of developmental disabilities to professionals throughout the United States and abroad.

    Delete in its entirety the title and function statement for the Epidemiology and Surveillance Branch (CUBDB) and insert the following:

    Epidemiology and Surveillance Branch (CUBDB). (1) Provides scientific leadership in the design and implementation of monitoring systems as well as designs and conducts epidemiologic and genetic research to identify causes, risk factors and complications of blood disorders in affected populations; (2) designs and manages surveillance systems to evaluate the incidence, morbidity, and mortality associated with blood diseases and disorders; (3) plans, develops and coordinates special surveys and populations studies to monitor and assess the complications of blood disorders; (4) designs and implements studies using surveillance data to identify risk factors for the complications of blood disorders, and evaluating the effectiveness of the prevention activities; (5) provides epidemiologic and medical consultation and technical assistance, including epidemic aids to state and local health departments, other governmental agencies, and other public and private institutions in the investigation of blood disorders and related complications; (6) designing and implements studies to evaluate the effectiveness of implemented prevention strategies in the treatment centers, (7) works closely with internal and external organizations in applying prevalence and incidence data to target and evaluate programs to prevent the complications of blood diseases and chronic hereditary disorders, (8) publishes findings and advances arising out of surveillance and epidemiologic research to the scientific and public health communities; (9) provides training services to states, localities, and other countries in investigation, diagnosis, prevention, and control of blood diseases and chronic hereditary disorders; (10) assists in designing, implementing, and evaluating prevention and counseling programs for persons and their families with chronic blood diseases and selected chronic hereditary disorders; (11) designs, implements and coordinates the prevention and surveillance activities of specialized federally funded prevention centers organized to prevent the complications of blood diseases and chronic hereditary disorders; (12) conducts and supports both qualitative and quantitative research to expand the knowledge base related to blood disorders across the lifespan; (13) collaborates with hemostasis laboratory branch and incorporates the findings of these branches' activities which leads to prevention of complications of blood disorders; (14) supports public health analysis to include facilitating data collection, data management, data manipulation, analysis, project reporting and presentation; and (15) conducts applied research to develop, evaluate, improve and standardize public information systems and educational modules which support the prevention of complications from blood disorders.

    Delete in its entirety the title and function statement for the Laboratory Research Branch (CUBDC) and insert the following:

    Hemostasis Laboratory Branch (CUBDC). (1) Identifies new genetic markers of risk factors and clotting defects for affected groups; (2) provides reference laboratory diagnosis for multi-site epidemiologic and surveillance studies; (3) develops techniques and interpretation methods to improve molecular and coagulation diagnosis; (4) provides diagnostic support for epidemiologic studies and epidemic aids on emerging blood disorders and chronic hereditary disorders; (5) determines the mechanisms of pathogenesis and complications of blood disorders and chronic hereditary disorders;

    (6) conducts research and providing reference services on diagnostic techniques for blood disorders and chronic hereditary disorders; (7) conducts research to improve laboratory methodologies and materials; (8) where appropriate, maintains the national reference laboratory for blood disorders and chronic hereditary disorders; (9) works closely with entities and organizations within the agency and organizations external to the agency to provide laboratory services in support of projects whose primary aim is to prevent and reduce complications associated with blood disorders and chronic hereditary disorders; and (10) publishes findings and advances arising out of surveillance and epidemiologic research to the scientific and public health communities.

    Delete in its entirety the title and function statement for the Prevention Research and Informatics Branch (CUBDD).

    Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2016-01833 Filed 2-1-16; 8:45 am] BILLING CODE 4160-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-6059-N4] Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extended Temporary Moratoria on Enrollment of Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations AGENCY:

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

    ACTION:

    Extension of temporary moratoria.

    SUMMARY:

    This document announces the extension of temporary moratoria on the enrollment of new Medicare Part B ground ambulance suppliers and Medicare home health agencies, subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. These moratoria also apply to the enrollment of home health agencies and ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.

    DATES:

    Effective Date: January 29, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Belinda Gravel, (410) 786-8934. News media representatives must contact CMS' Public Affairs Office at (202) 690-6145 or email them at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background A. CMS' Imposition of Temporary Enrollment Moratoria

    Section 6401(a) of the Affordable Care Act added a new section 1866(j)(7) to the Social Security Act (the Act) to provide the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid, or Children's Health Insurance Program (CHIP) providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. For a more detailed explanation of these authorities, please see the July 31, 2013 notice (78 FR 46339) that first established temporary moratoria in certain geographic locations, or the February 4, 2014 (79 FR 6475) document that extended and expanded such moratoria (hereinafter referred to as the February 4, 2014 moratoria document).

    Based on this authority and our regulations at § 424.570, we initially imposed moratoria to prevent enrollment of new home health agencies, subunits, and branch locations 1 (hereafter referred to as HHAs) in Miami-Dade County, Florida and Cook County, Illinois, as well as surrounding counties, and Medicare Part B ground ambulance suppliers in Harris County, Texas and surrounding counties, in a notice issued on July 31, 2013 (78 FR 46339). We exercised this authority again in a document published on February 4, 2014 (79 FR 6475) when we extended the existing moratoria for an additional 6 months and expanded it to include enrollment of HHAs in Broward County, Florida; Dallas County, Texas; Harris County, Texas; and Wayne County, Michigan and surrounding counties, and enrollment of ground ambulance suppliers in Philadelphia, Pennsylvania and surrounding counties. Then, we further extended these moratoria in documents issued on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), and July 28, 2015 (80 FR 44967).

    1 As noted in the preamble to the final rule with comment period implementing the moratorium authority (February 2, 2011, CMS-6028-FC (76 FR 5870), home health agency subunits and branch locations are subject to the moratoria to the same extent as any other newly enrolling home health agency.

    B. Determination of the Need for Moratoria

    In imposing these enrollment moratoria, CMS considered both qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse. CMS relied on law enforcement's longstanding experience with ongoing and emerging fraud trends and activities through civil, criminal, and administrative investigations and prosecutions. CMS' determination of a high risk of fraud, waste, or abuse in these provider and supplier types within these geographic locations was then confirmed by CMS' data analysis, which relied on factors the agency identified as strong indicators of risk. (For a more detailed explanation of this determination process and of these authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475)).

    1. Consultation With Law Enforcement

    In consultation with the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ), CMS identified two provider and supplier types in nine geographic locations that warrant a temporary enrollment moratorium. For a more detailed discussion of this consultation process, see the July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria document (79 FR 6475).

    2. Beneficiary Access to Care

    Beneficiary access to care in Medicare, Medicaid, and CHIP is of critical importance to CMS and its state partners, and CMS carefully evaluated access for the target moratorium locations. Prior to imposing these moratoria, CMS reviewed Medicare data for these areas and found no concerns with beneficiary access to HHAs or ground ambulance suppliers. CMS also consulted with the appropriate State Medicaid Agencies and with the appropriate State Departments of Emergency Medical Services to determine if the moratoria would create access to care concerns for Medicaid and CHIP beneficiaries in the targeted locations and surrounding counties. All of CMS' state partners were supportive of CMS' analysis and proposals, and together with CMS, determined that these moratoria would not create access to care issues for Medicaid or CHIP beneficiaries.

    3. Lifting a Temporary Moratorium

    In accordance with § 424.570(b), a temporary enrollment moratorium imposed by CMS will remain in effect for 6 months. If CMS deems it necessary, the moratorium may be extended in 6-month increments. CMS will evaluate whether to extend or lift the moratorium before any subsequent moratorium periods. If one or more of the moratoria announced in this document are extended or lifted, CMS will publish a document to that effect in the Federal Register.

    Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to CMS' high screening level under § 424.518(c)(3)(iii) and § 455.450(e)(2) for 6 months from the date the moratorium is lifted.

    II. Extension of Home Health and Ambulance Moratoria—Geographic Locations

    As noted earlier, we previously imposed moratoria on the enrollment of new HHAs in the Florida counties of Broward, Miami-Dade, and Monroe; the Illinois counties of Cook, DuPage, Kane, Lake, McHenry, and Will; the Michigan counties of Macomb, Monroe, Oakland, Washtenaw, and Wayne; and the Texas counties of Brazoria, Chambers, Collin, Fort Bend, Galveston, Dallas, Harris, Liberty, Denton, Ellis, Kaufman, Montgomery, Rockwall, Tarrant, and Waller. Further, we previously imposed moratoria on the enrollment of new ground ambulance suppliers in the Texas counties of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller; the Pennsylvania counties of Bucks, Delaware, Montgomery, and Philadelphia; and the New Jersey counties of Burlington, Camden, and Gloucester. These moratoria became effective upon publication of the notice in the Federal Register on July 31, 2013 (78 FR 46339) and the moratoria document on February 4, 2014 (79 FR 6475), and were subsequently extended by documents published in the Federal Register on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), and July 28, 2015 (80 FR 44967).

    As provided in § 424.570(b), CMS may deem it necessary to extend previously-imposed moratoria in 6-month increments. Under this authority, CMS is extending the temporary moratoria on the Medicare enrollment of HHAs and ground ambulance suppliers in the geographic locations discussed herein. Under regulations at §§ 455.470 and 457.990, these moratoria also apply to the enrollment of HHAs and ground ambulance suppliers in Medicaid and CHIP. Under § 424.570(b), CMS is required to publish a document in the Federal Register announcing any extension of a moratorium, and this extension of moratoria document fulfills that requirement.

    CMS consulted with the HHS OIG regarding the extension of the moratoria on new HHAs and ground ambulance suppliers in all of the moratoria counties, and the HHS OIG agrees that a significant potential for fraud, waste, and abuse continues to exist in these geographic areas. The circumstances warranting the imposition of the moratoria have not yet abated, and CMS has determined that the moratoria are still needed as we monitor the indicators and continue with administrative actions, such as payment suspensions and revocations of provider/supplier numbers. (For more information regarding the monitored indicators, see the February 4, 2014 moratoria document (79 FR 6475)).

    Based upon CMS' consultation with the relevant State Medicaid Agencies, CMS has concluded that extending these moratoria will not create an access to care issue for Medicaid or CHIP beneficiaries in the affected counties at this time. CMS also reviewed Medicare data for these areas and found there are no current problems with access to HHAs or ground ambulance suppliers. Nevertheless, the agency will continue to monitor these locations to make sure that no access to care issues arise in the future.

    Based upon our consultation with law enforcement and consideration of the factors and activities described previously, CMS has determined that the temporary enrollment moratoria should be extended for an additional 6 months.

    III. Summary of the Moratoria Locations

    CMS is executing its authority under sections 1866(j)(7), 1902(kk)(4), and 2107(e)(1)(D) of the Act to extend the enrollment moratoria in the following counties for HHAs and ground ambulance suppliers:

    Table 1—HHA Moratoria State City/metropolitan area Counties FL Fort Lauderdale Broward. FL Miami Monroe
  • Miami-Dade.
  • IL Chicago Cook. DuPage. Kane. Lake. McHenry. Will. MI Detroit Macomb. Monroe. Oakland. Washtenaw. Wayne. TX Dallas Collin. Dallas. Denton. Ellis. Kaufman. Rockwall. Tarrant. TX Houston Brazoria. Chambers. Fort Bend. Galveston. Harris. Liberty. Montgomery. Waller.
    Table 2—Ground Ambulance Moratoria State City/metropolitan area Counties PA/NJ Philadelphia Bucks. Burlington (NJ). Camden (NJ). Delaware. Gloucester (NJ). Montgomery. Philadelphia. TX Houston Brazoria. Chambers. Fort Bend. Galveston. Harris. Liberty. Montgomery. Waller. IV. Clarification of Right to Judicial Review

    Section 1866(j)(7)(B) of the Act states that there shall be no judicial review under section 1869, section 1878, or otherwise, of a temporary moratorium imposed on the enrollment of new providers of services and suppliers if the Secretary determines that the moratorium is necessary to prevent or combat fraud, waste, or abuse. Accordingly, our regulations at 42 CFR 498.5(l)(4) state that for appeals of denials based on a temporary moratorium, the scope of review will be limited to whether the temporary moratorium applies to the provider or supplier appealing the denial. The agency's basis for imposing a temporary moratorium is not subject to review. Our regulations do not limit the right to seek judicial review of a final agency decision that the temporary moratorium applies to a particular provider or supplier. In the preamble to the February 2, 2011 (76 FR 5918) final rule with comment period establishing this regulation, we explained that “a provider or supplier may administratively appeal an adverse determination based on the imposition of a temporary moratorium up to and including the Department Appeal Board (DAB) level of review.” We are clarifying that providers and suppliers that have received unfavorable decisions in accordance with the limited scope of review described in § 498.5(l)(4) may seek judicial review of those decisions after they exhaust their administrative appeals. We reiterate, however, that section 1866(j)(7)(B) of the Act precludes judicial review of the agency's basis for imposing a temporary moratorium.

    V. Collection of Information Requirements

    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    VI. Regulatory Impact Statement

    CMS has examined the impact of this document as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major regulatory actions with economically significant effects ($100 million or more in any one year). This document will prevent the enrollment of new home health providers and ground ambulance suppliers in Medicare and new home health providers and ground ambulance suppliers in Medicaid and CHIP. Though savings may accrue by denying enrollments, the monetary amount cannot be quantified. After the imposition of the initial moratoria on July 31, 2013, 848 HHAs and 14 ambulance companies in all geographic areas affected by the moratoria had their applications denied. We have found the number of applications that are denied after 60 days declines dramatically, as most providers and suppliers will not submit applications during the moratoria period. Therefore, this document does not reach the economic threshold, and thus is not considered a major action.

    The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $35.5 million in any one year. Individuals and states are not included in the definition of a small entity. CMS is not preparing an analysis for the RFA because it has determined, and the Secretary certifies, that this document will not have a significant economic impact on a substantial number of small entities.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if an action may have a significant 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. For purposes of section 1102(b) of the Act, CMS defines a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment purposes and has fewer than 100 beds. CMS is not preparing an analysis for section 1102(b) of the Act because it has determined, and the Secretary certifies, that this document will not have a significant impact on the operations of a substantial number of small rural hospitals.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that threshold is approximately $144 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed regulatory action (and subsequent final action) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Because this document does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

    In accordance with the provisions of Executive Order 12866, the Office of Management and Budget reviewed this document.

    Authority:

    Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.

    Dated: December 7, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2016-01835 Filed 1-29-16; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3323-N] Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment Period AGENCY:

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

    ACTION:

    Request for information; extension of comment period.

    SUMMARY:

    This document extends the comment period for the December 31, 2015 request for information entitled “Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs” (80 FR 81824) (referred to in this document as December 31 RFI). The comment period for the December 31 RFI, which would have ended on February 1, 2016, is extended for 15 days.

    DATES:

    The comment period is extended to February 16, 2016. To be assured consideration, written or electronic comments on the December 31 RFI must be received at one of the addresses provided below no later than February 16, 2016.

    ADDRESSES:

    In commenting on the December 31 RFI, please refer either to file code CMS-3323-NC and comment as indicated in that document (80 FR 81824) or file code CMS-3323-N and comment as provided in this document. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3323-N, P.O. Box 8013, Baltimore, MD 21244-8013.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3323-N, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses:

    a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

    Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Marie Gomez, (410) 786-1175.

    SUPPLEMENTARY INFORMATION:

    On December 31, 2015, we published a request for information in the Federal Register (80 FR 81824) entitled, “Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs” (referred to in this document as “the December 31 RFI”). That request for information seek public comment regarding several items related to the certification of health information technology (IT), including electronic health records (EHR) products used for reporting to certain CMS quality reporting programs such as, but not limited to, the Hospital Inpatient Quality Reporting (IQR) Program and the Physician Quality Reporting System (PQRS). In addition, it requested feedback on how often to require recertification, the number of clinical quality measures (CQMs) a certified Health IT Module should be required to certify to, and testing of certified Health IT Module(s).

    We have received inquiries from stakeholders regarding the 30-day comment period to submit comments regarding the December 31 RFI. The stakeholders stated that they need additional time to respond to the questions posed in the December 31 RFI. Since we requested the public's comments on several options, we believe that it is important to allow ample time for the public to prepare their comments. Therefore, we have decided to extend the comment period for an additional 15 days. This document announces the extension of the public comment period to February 16, 2016.

    Dated: January 28, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2016-01937 Filed 2-1-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2398-N] RIN 0983-ZB24 Medicaid Program; Final FY 2013 and Preliminary FY 2015 Disproportionate Share Hospital Allotments, and Final FY 2013 and Preliminary FY 2015 Institutions for Mental Diseases Disproportionate Share Hospital Limits AGENCY:

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

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2013 and the preliminary federal share DSH allotments for FY 2015. This notice also announces the final FY 2013 and the preliminary FY 2015 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.

    DATES:

    This notice is effective March 3, 2016. The final allotments and limitations set forth in this notice are effective for the fiscal years specified.

    FOR FURTHER INFORMATION CONTACT:

    Stuart Goldstein, (410) 786-0694 and Richard Cuno, (410) 786-1111.

    SUPPLEMENTARY INFORMATION: I. Background A. Fiscal Year DSH Allotments

    A state's federal fiscal year (FY) disproportionate share hospital (DSH) allotment represents the aggregate limit on the federal share amount of the state's payments to DSH hospitals in the state for the FY. The amount of such allotment is determined in accordance with the provisions of section 1923(f)(3) of the Social Security Act (the Act). Under such provisions, in general a state's FY DSH allotment is calculated by increasing the amount of its DSH allotment for the preceding FY by the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) for the previous FY.

    The Affordable Care Act amended Medicaid DSH provisions, adding section 1923(f)(7) of the Act which would have required reductions to states' FY DSH allotments beginning with FY 2014, the calculation of which was described in the Disproportionate Share Hospital Payment Reduction final rule published in the September 18, 2013 Federal Register (78 FR 57293). Under the DSH reduction methodology, first, each state's unreduced FY DSH allotment would have been calculated in accordance with the provisions of section 1923(f) of the Act, excluding section 1923(f)(7) of the Act; then, the reduction amount for each state would have been determined under the provisions of section 1923(f)(7) of the Act and implementing regulations at 42 CFR 447.294; and, finally, the net FY DSH allotment for each state would have been determined by subtracting the DSH reduction amount for the state from its unreduced FY 2014 DSH allotment.

    The reductions under section 1923(f)(7) of the Act were most recently delayed and modified by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), enacted on April 16, 2015. The reductions of states' fiscal year DSH allotments under section 1923(f)(7) of the Act that were applicable to FY 2017 were repealed, and are instead scheduled to begin in FY 2018 at modified levels. MACRA also extended DSH allotment reductions through 2025.

    Because there is no reduction to DSH allotments for FY 2015 under section 1923(f)(7) of the Act, this notice contains only the state-specific preliminary FY 2015 DSH allotments, as calculated under the statute without application of the reductions that would have otherwise been imposed. This notice also provides information on the calculation of such FY DSH allotments, the calculation of the states' IMD DSH limits, and the amounts of states' preliminary FY 2015 IMD DSH limits.

    B. Determination of Fiscal Year DSH Allotments

    Generally, in accordance with the methodology specified under section 1923(f)(3) of the Act, a state's FY DSH allotment is calculated by increasing the amount of its DSH allotment for the preceding FY by the percentage change in the CPI-U for the previous FY. Also in accordance with section 1923(f)(3) of the Act, a state's DSH allotment for a FY is subject to the limitation that an increase to a state's DSH allotment for a FY cannot result in the DSH allotment exceeding the greater of the state's DSH allotment for the previous FY or 12 percent of the state's total medical assistance expenditures for the allotment year (this is referred to as the 12 percent limit).

    Furthermore, under section 1923(h) of the Act, federal financial participation (FFP) for DSH payments to institutions for mental diseases (IMDs) and other mental health facilities is limited to state-specific aggregate amounts. Under this provision, the aggregate limit for DSH payments to IMDs and other mental health facilities is the lesser of a state's FY 1995 total computable (state and federal share) IMD and other mental health facility DSH expenditures applicable to the state's FY 1995 DSH allotment (as reported on the Form CMS-64 as of January 1, 1997), or the amount equal to the product of the state's current year total computable DSH allotment and the applicable percentage specified in section 1902(h) of the Act (the applicable percentage is the IMD share of DSH total computable expenditures as of FY 1995).

    In general, we determine states' DSH allotments for a FY and the IMD DSH limits for the same FY using the most recent available estimates of or actual medical assistance expenditures, including DSH expenditures in their Medicaid programs and the most recent available change in the CPI-U used for the FY in accordance with the methodology prescribed in the statute. The indicated estimated or actual expenditures are obtained from states for each relevant FY from the most recent available quarterly Medicaid budget reports (Form CMS-37) or quarterly Medicaid expenditure reports (Form CMS-64), respectively, submitted by the states. For example, as part of the initial determination of a state's FY DSH allotment (referred to as the preliminary DSH allotments) that is determined before the beginning of the FY for which the DSH allotments and IMD DSH limits are being determined, we use estimated expenditures for the FY obtained from the August submission of the CMS-37 submitted by states prior to the beginning of the FY; such estimated expenditures are subject to update and revision during the FY before such actual expenditure data become available. We also use the most recent available estimated CPI-U percentage change that is available before the beginning of the FY for determining the states' preliminary FY DSH allotments; such estimated CPI-U percentage change is subject to update and revision during the FY before the actual CPI-U percentage change becomes available. In determining the final DSH allotments and IMD DSH limits for a FY we use the actual expenditures for the FY and actual CPI-U percentage change for the previous FY.

    II. Provisions of the Notice A. Calculation of the Final FY 2013 Federal Share State DSH Allotments and the Preliminary FY 2015 Federal Share State DSH Allotments 1. Final FY 2013 Federal Share State DSH Allotments

    Addendum 1 to this notice provides the states' final FY 2013 DSH allotments determined in accordance with section 1923(f)(3) of the Act. As described in the background section of this notice, in general, the DSH allotment for a FY is calculated by increasing the FY DSH allotment for the preceding FY by the CPI-U increase for the previous fiscal year. For purposes of calculating the states' final FY 2013 DSH allotments, the preceding final fiscal year DSH allotments (for FY 2012) were published in the July 26, 2013 Federal Register (78 FR 45217). For purposes of calculating the states' final FY 2013 DSH allotments we are using the actual Medicaid expenditures for FY 2013. Finally, for purposes of calculating the states' final FY 2013 DSH allotments, the applicable historical percentage change in the CPI-U for the previous FY (FY 2012) was 2.4 percent; we note that this is the same as the estimated 2.4 percentage change in the CPI-U for FY 2012 that was available and used in the calculation of the preliminary FY 2013 DSH allotments which were published in the July 26, 2013 Federal Register (78 FR 45217).

    2. Calculation of the Preliminary FY 2015 Federal Share State DSH Allotments

    Addendum 2 to this notice provides the preliminary FY 2015 DSH allotments determined in accordance with section 1923(f)(3) of the Act. The preliminary FY 2015 DSH allotments contained in this notice were determined based on the most recent available estimates from states of their FY 2015 total computable Medicaid expenditures. Also, the preliminary FY 2015 allotments contained in this notice were determined by increasing the preliminary FY 2014 DSH allotments as contained in the notice published in the February 28, 2014 Federal Register (79 FR 11436) by 1.6 percent, representing the most recent available estimate of the percentage increase in the CPI-U for FY 2014 (the previous FY to FY 2015).

    We will publish states' final FY 2015 DSH allotments in future notices based on the states' four quarterly Medicaid expenditure reports (Form CMS-64) for FY 2015 available following the end of FY 2015 and the actual change in the CPI-U for FY 2014.

    B. Calculation of the Final FY 2013 and Preliminary FY 2015 IMD DSH Limits

    Section 1923(h) of the Act specifies the methodology to be used to establish the limits on the amount of DSH payments that a state can make to IMDs and other mental health facilities. FFP is not available for IMD or DSH payments that exceed the IMD limits. In this notice, we are publishing the final FY 2013 and the preliminary FY 2015 IMD DSH Limits determined in accordance with the provisions discussed above.

    Addendums 3 and 4 to this notice detail each state's final FY 2013 and preliminary FY 2015 IMD DSH Limit, respectively, determined in accordance with section 1923(h) of the Act.

    III. Collection of Information Requirements

    This notice does not impose any new or revised information collection or recordkeeping requirements. The requirements and burden associated with form CMS-37 (OMB control number 0938-1265) and form CMS-64 (OMB control number 0938-1265) are unaffected by this notice. As it pertains to the content of this notice, CMS-37 and CMS-64 are not subject to formal Office of Management and Budget review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    IV. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

    Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This notice reaches the $100 million economic threshold and thus is considered a major rule under the Congressional Review Act.

    The final FY 2013 DSH allotments being published in this notice are equal to the preliminary FY 2013 DSH allotments published in the July 26, 2013 Federal Register (78 FR 45217). This is due to the actual percentage change in the CPI-U for FY 2012 used in the calculation of the final FY 2013 allotments (2.4 percent) being equal to the estimated percentage change in the CPI-U for FY 2012 used in the calculation of the preliminary FY 2013 allotments (2.4 percent). The final FY 2013 IMD DSH limits being published in this notice are also equal to the preliminary FY 2013 IMD DSH limits published in the July 26, 2013 Federal Register (78 FR 45217). Since the final FY 2013 DSH allotments were equal to the preliminary FY 2013 DSH allotments, the associated FY 2013 IMD DSH limits also remained the same.

    The preliminary FY 2015 DSH allotments being published in this notice are about $240 million more than the preliminary FY 2014 DSH allotments published in the February 28, 2014 Federal Register (79 FR 11436). The increase in the DSH allotments is due to the application of the statutory formula for calculating DSH allotments under which the prior fiscal year allotments are increased by the percentage increase in the CPI-U for the prior fiscal year. The preliminary FY 2015 IMD DSH limits being published in this notice are about $14 million more than the preliminary FY 2014 IMD DSH limits published in the February 28, 2014 Federal Register (79 FR 11436). The increase in the IMD DSH limits is because the DSH allotment for a FY is a factor in the determination of the IMD DSH limit for the FY. Since the preliminary FY 2015 DSH allotments are greater than the preliminary FY 2014 DSH allotments, the associated preliminary FY 2015 IMD DSH limits for some states also increased.

    The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because the Secretary has determined that this notice will not have significant economic impact on a substantial number of small entities. Specifically, any impact on providers is due to the effect of the various controlling statutes; providers are not impacted as a result of the independent regulatory action in publishing this notice. The purpose of the notice is to announce the latest distributions as required by the statute.

    In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant 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. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area for Medicaid payment regulations and has fewer than 100 beds. We are not preparing analysis for section 1102(b) of the Act because the Secretary has determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

    The Medicaid statute specifies the methodology for determining the amounts of states' DSH allotments and IMD DSH limits; and as described previously, the application of the methodology specified in statute results in the decreases or increases in states' DSH allotments and IMD DSH limits for the applicable FYs. The statute applicable to these allotments and limits does not apply to the determination of the amounts of DSH payments made to specific DSH hospitals; rather, these allotments and limits represent an overall limit on the total of such DSH payments. In this regard, we do not believe that this notice will have a significant economic impact on a substantial number of small entities.

    Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that 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 2015, that is approximately $144 million. This notice will have no consequential effect on state, local, or tribal governments, in the aggregate, or on the private sector.

    Executive Order 13132 establishes certain requirements that an agency must meet when it issues 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. Since this notice does not impose any costs on state or local governments, the requirements of E.O. 13132 are not applicable.

    A. Alternatives Considered

    The methodologies for determining the states' fiscal year DSH allotments and IMD DSH Limits, as reflected in this notice, were established in accordance with the methodologies and formula for determining states' allotments as specified in the statute. This notice does not put forward any further discretionary administrative policies for determining such allotments.

    B. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in the Table 1, we have prepared an accounting statement showing the classification of the estimated expenditures associated with the provisions of this notice. Table 1 provides our best estimate of the change (decrease) in the federal share of states' Medicaid DSH payments resulting from the application of the provisions of the Medicaid statute relating to the calculation of states' FY DSH allotments and the increase in the FY DSH allotments from FY 2014 to FY 2015.

    Table 1—Accounting Statement: Classification of Estimated Expenditures, From the FY 2014 to FY 2015 [In millions] Category Transfers Annualized Monetized Transfers $240. From Whom To Whom? Federal Government to States. Congressional Review Act

    This proposed regulation is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress and the Comptroller General for review.

    In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.

    Dated: December 3, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: January 20, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. Key to Addendum 1—Final DSH Allotments for FY 2013 [The Final FY 2013 DSH Allotments for the NON-Low DSH States are presented in the top section of this addendum, and the Final FY 2013 DSH Allotments for the Low-DSH States are presented in the bottom section of this addendum] Column Description Column A State. Column B FY 2013 FMAPs.
  • This column contains the States' FY 2013 Federal Medical Assistance Percentages.
  • Column C Prior FY (2012) DSH Allotments
  • This column contains the States' prior FY 2012 DSH Allotments.
  • Column D Prior FY (2012) DSH Allotments (Col C) × (100 percent + Percentage Increase in CPIU): 102.4 percent.
  • This column contains the amount in Column C increased by 1 plus the percentage increase in the CPI-U for the prior FY (102.4 percent).
  • Column E FY 2013 TC MAP Exp. Including DSH.
  • This column contains the amount of the States' FY 2013 total computable (TC) medical assistance expenditures including DSH expenditures.
  • Column F FY 2013 TC DSH Expenditures.
  • This column contains the amount of the States' FY 2013 total computable DSH expenditures.
  • Column G FY 2013 TC MAP Exp. Net of DSH.
  • This column contains the amount of the States' FY 2013 total computable medical assistance expenditures net of DSH expenditures, calculated as the amount in Column E minus the amount in Column F.
  • Column H 12 percent Amount.
  • This column contains the amount of the “12 percent limit” in Federal share, determined in accordance with the provisions of section 1923(f)(3) of the Act.
  • Column I Greater of FY 2012 Allotment or 12 percent Limit.
  • This column contains the greater of the State's prior FY (FY 2012) DSH allotment or the amount of the 12 percent Limit, determined as the maximum of the amount in Column C or Column H
  • Column J FY 2013 DSH Allotment.
  • This column contains the States' final FY 2013 DSH allotments, determined as the minimum of the amount in Column I or Column D.
  • For states with “na” in Columns I or D, refer to the footnotes in the addendum.
    Addendum 1—Final DSH Allotments for FY 2013 State FY 2013 FMAPs
  • (percent)
  • Prior FY (2012) DSH allotments Prior FY (2012) DSH allotment (Col C) × 100% + Pct increase in CPIU: 102.4% FY 2013 TC MAP Exp. including DSH FY 2013 TC DSH expenditures FY 2013 TC MAP EXP. net of DSH Col E-F “12% Amount” = Col G × .12/(1-.12/Col B)*
  • (in FS)
  • Greater of Col H or Col C (12% limit, FY 2012
  • Allotment)
  • FY 2013 DSH
  • allotment
  • MIN Col I, Col D
  • A B C D E F G H I J ALABAMA 68.53 $315,520,769 $323,093,267 $4,999,646,843 $470,923,104 $4,528,723,739 $658,807,935 $658,807,935 $323,093,267 ARIZONA 65.68 103,890,985 106,384,369 8,437,380,837 173,082,813 8,264,298,024 1,213,410,792 1,213,410,792 106,384,369 CALIFORNIA 50.00 1,124,844,365 1,151,840,630 61,425,894,719 2,119,710,409 59,306,184,310 9,364,134,365 9,364,134,365 1,151,840,630 COLORADO 50.00 94,912,751 97,190,657 5,048,193,724 194,191,858 4,854,001,866 766,421,347 766,421,347 97,190,657 CONNECTICUT 50.00 205,216,760 210,141,962 6,415,388,481 272,860,246 6,142,528,235 969,872,879 969,872,879 210,141,962 DISTRICT OF COLUMBIA 70.00 62,847,632 64,355,975 2,275,681,171 56,387,767 2,219,293,404 321,414,907 321,414,907 64,355,975 FLORIDA 58.08 205,216,760 210,141,962 18,411,438,180 335,009,637 18,076,428,543 2,734,059,817 2,734,059,817 210,141,962 GEORGIA 65.56 275,760,021 282,378,262 8,887,641,041 429,964,548 8,457,676,493 1,242,312,033 1,242,312,033 282,378,262 ILLINOIS 50.00 220,608,017 225,902,609 15,493,580,784 447,072,185 15,046,508,599 2,375,764,516 2,375,764,516 225,902,609 INDIANA 67.16 219,325,413 224,589,223 7,930,553,510 337,536,579 7,593,016,931 1,109,384,374 1,109,384,374 224,589,223 KANSAS 56.51 42,325,957 43,341,780 2,544,769,057 76,622,785 2,468,146,272 376,027,713 376,027,713 43,341,780 KENTUCKY 70.55 148,782,151 152,352,923 5,726,056,802 216,263,666 5,509,793,136 796,685,033 796,685,033 152,352,923 LOUISIANA/1 na na na na na na na na 731,960,000 MAINE 62.57 107,738,799 110,324,530 2,826,874,563 37,489,437 2,789,385,126 414,155,018 414,155,018 110,324,530 MARYLAND 50.00 78,238,890 80,116,623 7,688,146,740 134,340,816 7,553,805,924 1,192,706,199 1,192,706,199 80,116,623 MASSACHUSETTS 50.00 312,955,559 320,466,492 12,999,170,453 0 12,999,170,453 2,052,500,598 2,052,500,598 320,466,492 MICHIGAN 66.39 271,912,207 278,438,100 12,308,409,960 387,951,247 11,920,458,713 1,746,054,614 1,746,054,614 278,438,100 MISSISSIPPI 73.43 156,477,779 160,233,246 4,708,563,005 217,999,554 4,490,563,451 644,132,328 644,132,328 160,233,246 MISSOURI 61.37 486,107,200 497,773,773 8,863,322,084 703,393,659 8,159,928,425 1,217,196,210 1,217,196,210 497,773,773 NEVADA 59.74 47,456,375 48,595,328 1,797,228,664 81,373,600 1,715,855,064 257,658,605 257,658,605 48,595,328 NEW HAMPSHIRE 50.00 164,274,500 168,217,088 1,188,634,372 40,923,914 1,147,710,458 181,217,441 181,217,441 168,217,088 NEW JERSEY 50.00 660,541,446 676,394,441 10,480,866,440 1,298,115,161 9,182,751,279 1,449,908,097 1,449,908,097 676,394,441 NEW YORK 50.00 1,648,147,103 1,687,702,633 52,489,778,879 3,423,365,423 49,066,413,456 7,747,328,440 7,747,328,440 1,687,702,633 NORTH CAROLINA 65.51 302,694,721 309,959,394 11,721,921,735 617,376,633 11,104,545,102 1,631,378,246 1,631,378,246 309,959,394 OHIO 63.58 416,846,544 426,850,861 16,628,494,101 649,120,744 15,979,373,357 2,363,633,714 2,363,633,714 426,850,861 PENNSYLVANIA 54.28 575,889,532 589,710,881 20,922,389,122 847,055,684 20,075,333,438 3,092,778,900 3,092,778,900 589,710,881 RHODE ISLAND 51.26 66,695,447 68,296,138 1,909,141,351 129,846,057 1,779,295,294 278,777,412 278,777,412 68,296,138 SOUTH CAROLINA 70.43 336,042,444 344,107,463 4,690,094,944 457,173,209 4,232,921,735 612,270,432 612,270,432 344,107,463 TENNESSEE/2 na na na na na na na na 53,100,000 TEXAS 59.30 981,192,634 1,004,741,257 27,752,018,303 226,747,941 27,525,270,362 4,141,011,076 4,141,011,076 1,004,741,257 VERMONT 56.04 23,086,886 23,640,971 1,452,095,084 37,448,781 1,414,646,303 216,013,021 216,013,021 23,640,971 VIRGINIA 50.00 89,892,713 92,050,138 7,218,485,856 186,468,433 7,032,017,423 1,110,318,540 1,110,318,540 92,050,138 WASHINGTON 50.00 189,825,503 194,381,315 7,805,501,929 366,733,930 7,438,767,999 1,174,542,316 1,174,542,316 194,381,315 WEST VIRGINIA 72.04 69,260,656 70,922,912 3,007,417,198 75,434,137 2,931,983,061 422,158,680 422,158,680 70,922,912 Total 0.00 10,004,528,519 10,244,637,203 366,054,779,932 15,047,983,957 351,006,795,975 53,874,035,598 53,874,035,598 11,029,697,203 LOW DSH STATES ALASKA 50.00 20,901,012 21,402,636 1,340,719,400 21,706,474 1,319,012,926 208,265,198.84 208,265,199 21,402,636 ARKANSAS 70.17 44,262,980 45,325,292 4,156,350,929 61,000,000 4,095,350,929 592,822,640 592,822,640 45,325,292 DELAWARE 55.67 9,289,338 9,512,282 1,557,544,100 10,874,669 1,546,669,431 236,601,110 236,601,110 9,512,282 HAWAII 51.86 10,000,000 10,240,000 1,586,220,307 24,971,280 1,561,249,027 243,752,256.52 243,752,257 10,240,000 IDAHO 71.00 16,866,254 17,271,044 1,641,925,393 23,708,980 1,618,216,413 233,681,421.00 233,681,421 17,271,044 IOWA 59.59 40,408,349 41,378,149 3,622,873,642 54,606,370 3,568,267,272 536,162,337 536,162,337 41,378,149 MINNESOTA 50.00 76,637,045 78,476,334 8,781,239,289 46,287,099 8,734,952,190 1,379,202,977 1,379,202,977 78,476,334 MONTANA 66.00 11,646,847 11,926,371 996,801,715 17,703,206 979,098,509 143,601,115 143,601,115 11,926,371 NEBRASKA 55.76 29,036,347 29,733,219 1,790,372,947 45,313,162 1,745,059,785 266,831,445 266,831,445 29,733,219 NEW MEXICO 69.07 20,901,012 21,402,636 3,280,561,202 25,164,146 3,255,397,056 472,788,382 472,788,382 21,402,636 NORTH DAKOTA 52.27 9,801,133 10,036,360 775,035,726 1,265,931 773,769,795 120,521,323 120,521,323 10,036,360 OKLAHOMA 64.00 37,157,353 38,049,129 4,481,944,280 41,759,650 4,440,184,630 655,781,115 655,781,115 38,049,129 OREGON 62.44 46,446,693 47,561,414 5,070,815,864 76,536,235 4,994,279,629 741,894,100 741,894,100 47,561,414 SOUTH DAKOTA 56.19 11,332,733 11,604,719 758,090,042 1,441,151 756,648,891 115,454,450 115,454,450 11,604,719 UTAH 69.61 20,129,695 20,612,808 2,087,187,059 28,794,708 2,058,392,351 298,457,958 298,457,958 20,612,808 WISCONSIN 59.74 96,998,597 99,326,563 7,034,898,860 581,325 7,034,317,535 1,056,296,932 1,056,296,932 99,326,563 WYOMING 50.00 232,233 237,807 546,576,901 463,560 546,113,341 86,228,422 86,228,422 237,807 Total Low DSH States 0.00 502,047,621 514,096,764 49,509,157,656 482,177,946 49,026,979,710 7,388,343,182 7,388,343,182 514,096,763 Total 0.00 10,506,576,140 10,758,733,967 415,563,937,588 15,530,161,903 400,033,775,685 61,262,378,780 61,262,378,780 11,543,793,966 1 FY 2013 DSH allotment for Louisiana determined under the provisions of section 1903(f)(3)(C) and (D) of the Act. 2 Tennessee's DSH allotments are determined under section 1923(f)(6)(A)(v)(II) of the Act. Under this provision, Tennessee's DSH payments for FY 2013 are limited to $53,100,000. 3 Beginning FY 2013, under section 1923(f)(6)(B)(II) of the Act, Hawaii's DSH allotments are determined as for low-DSH states. This means its allotments are determined as for all States, by increasing the previous fiscal year allotment by the CPIU for the previous fiscal year.
    Key to Addendum 2—Preliminary DSH Allotments for FY 2015 [The Preliminary FY 2015 DSH Allotments for the NON-Low DSH States are presented in the top section of this addendum, and the Preliminary FY 2015 DSH Allotments for the Low-DSH States are presented in the bottom section of this addendum] Column Description Column A State. Column B FY 2015 FMAPs.
  • This column contains the States' FY 2015 Federal Medical Assistance Percentages.
  • Column C Prior FY (2014) DSH Allotments.
  • This column contains the States' prior FY 2014 DSH Allotments
  • Column D Prior FY (2014) DSH Allotments (Col C) × (100 percent + Percentage Increase in CPIU): 101.6 percent.
  • This column contains the amount in Column C increased by 1 plus the estimated percentage increase in the CPI-U for the prior FY (101.6 percent).
  • Column E FY 2015 TC MAP Exp. Including DSH.
  • This column contains the amount of the States' projected FY 2015 total computable (TC) medical assistance expenditures including DSH expenditures.
  • Column F FY 2015 TC DSH Expenditures.
  • This column contains the amount of the States' projected FY 2015 total computable DSH expenditures.
  • Column G FY 2015 TC MAP Exp. Net of DSH.
  • This column contains the amount of the States' projected FY 2015 total computable medical assistance expenditures net of DSH expenditures, calculated as the amount in Column E minus the amount in Column F.
  • Column H 12 percent Amount.
  • This column contains the amount of the “12 percent limit” in Federal share, determined in accordance with the provisions of section 1923(f)(3) of the Act.
  • Column I Greater of FY 2014 Allotment or 12 percent Limit.
  • This column contains the greater of the State's prior FY (FY 2014) DSH allotment or the amount of the 12 percent Limit, determined as the maximum of the amount in Column C or Column H.
  • Column J FY 2015 DSH Allotment.
  • This column contains the States' preliminary FY 2015 DSH allotments, determined as the minimum of the amount in Column I or Column D.
  • For states with “na” in Columns I or D, refer to the footnotes in the addendum.
  • Addendum 2—Preliminary DSH Allotments for FY 2015 State FY 2015 FMAPs
  • (percent)
  • Prior FY (2014) DSH allotments Prior FY (2014) DSH Allotment (Col C) × 100% + Pct increase in CPIU: 101.6% FY 2015 TC MAP Exp. Including DSH 4 FY 2015 TC DSH Expenditures 4 FY 2015 TC MAP EXP. Net Of DSH Col E-F “12% Amount” = Col G × .12/(1-.12/Col B)* (in FS) Greater of Col H or Col C (12% Limit, FY 2014
  • allotment)
  • FY 2015 DSH
  • Allotment Min Col I, Col D
  • A B C D E F G H I J ALABAMA 68.99 $327,939,666 $333,186,701 $5,727,646,000 $507,528,000 $5,220,118,000 $758,313,966 $758,313,966 $333,186,701 ARIZONA 68.46 107,980,135 109,707,817 11,262,757,000 167,012,000 11,095,745,000 1,614,483,959 1,614,483,959 109,707,817 CALIFORNIA 50.00 1,169,118,239 1,187,824,131 96,031,140,000 597,609,000 95,433,531,000 15,068,452,263 15,068,452,263 1,187,824,131 COLORADO 51.01 98,648,517 100,226,893 6,927,502,000 204,899,000 6,722,603,000 1,054,867,918 1,054,867,918 100,226,893 CONNECTICUT 50.00 213,294,091 216,706,796 7,094,230,000 125,646,000 6,968,584,000 1,100,302,737 1,100,302,737 216,706,796 DISTRICT OF COLUMBIA 70.00 65,321,315 66,366,456 2,630,681,000 37,174,000 2,593,507,000 375,611,359 375,611,359 66,366,456 FLORIDA 59.72 213,294,091 216,706,796 22,430,097,000 362,102,000 22,067,995,000 3,314,083,809 3,314,083,809 216,706,796 GEORGIA 66.94 286,613,936 291,199,759 9,915,707,000 434,725,000 9,480,982,000 1,386,218,278 1,386,218,278 291,199,759 ILLINOIS 50.76 229,291,148 232,959,806 19,753,482,000 456,614,000 19,296,868,000 3,032,535,665 3,032,535,665 232,959,806 INDIANA 66.52 227,958,061 231,605,390 10,719,730,000 474,987,000 10,244,743,000 1,499,956,649 1,499,956,649 231,605,390 KANSAS 56.63 43,991,907 44,695,778 3,161,490,000 74,228,000 3,087,262,000 470,082,851 470,082,851 44,695,778 KENTUCKY 69.94 154,638,217 157,112,428 8,903,447,000 241,000,000 8,662,447,000 1,254,784,004 1,254,784,004 157,112,428 LOUISIANA 1 62.05 731,960,000 743,671,360 7,995,712,000 551,048,000 7,444,664,000 1,107,551,811 1,107,551,811 743,671,360 MAINE 61.88 111,979,398 113,771,068 2,565,931,000 38,566,000 2,527,365,000 376,247,024 376,247,024 113,771,068 MARYLAND 50.00 81,318,372 82,619,466 11,133,665,000 92,859,000 11,040,806,000 1,743,285,158 1,743,285,158 82,619,466 MASSACHUSETTS 50.00 325,273,489 330,477,865 16,287,567,000 0 16,287,567,000 2,571,721,105 2,571,721,105 330,477,865 MICHIGAN 65.54 282,614,672 287,136,507 16,050,268,000 322,351,000 15,727,917,000 2,310,364,618 2,310,364,618 287,136,507 MISSISSIPPI 73.58 162,636,745 165,238,933 5,362,441,000 228,204,000 5,134,237,000 736,168,545 736,168,545 165,238,933 MISSOURI 63.45 505,240,380 513,324,226 9,641,725,000 713,722,000 8,928,003,000 1,321,240,327 1,321,240,327 513,324,226 NEVADA 64.36 49,324,258 50,113,446 2,848,030,000 78,128,000 2,769,902,000 408,565,835 408,565,835 50,113,446 NEW HAMPSHIRE 50.00 170,740,344 173,472,190 1,816,048,000 76,097,000 1,739,951,000 274,729,105 274,729,105 173,472,190 NEW JERSEY 50.00 686,540,358 697,525,004 14,214,233,000 1,213,776,000 13,000,457,000 2,052,703,737 2,052,703,737 697,525,004 NEW YORK 50.00 1,713,018,172 1,740,426,463 68,512,267,000 5,326,800,000 63,185,467,000 9,976,652,684 9,976,652,684 1,740,426,463 NORTH CAROLINA 65.88 314,608,785 319,642,526 12,482,232,000 411,389,000 12,070,843,000 1,771,107,209 1,771,107,209 319,642,526 OHIO 62.64 433,253,624 440,185,682 21,305,059,000 0 21,305,059,000 3,162,438,142 3,162,438,142 440,185,682 PENNSYLVANIA 51.82 598,556,544 608,133,449 24,679,963,000 787,072,000 23,892,891,000 3,731,179,141 3,731,179,141 608,133,449 RHODE ISLAND 50.00 69,320,580 70,429,709 3,117,756,000 142,487,000 2,975,269,000 469,779,316 469,779,316 70,429,709 SOUTH CAROLINA 70.64 349,269,075 354,857,380 5,636,583,000 494,437,000 5,142,146,000 743,331,228 743,331,228 354,857,380 TENNESSEE 2 na na na na na na na na 53,100,000 TEXAS 58.05 1,019,812,376 1,036,129,374 35,894,535,000 2,630,047,000 33,264,488,000 5,031,931,019 5,031,931,019 1,036,129,374 VERMONT 5 56.21 23,995,586 24,379,515 1,577,599,000 37,449,000 1,540,150,000 234,983,483 234,983,483 24,379,515 VIRGINIA 50.00 93,430,890 94,925,784 8,689,637,000 193,862,000 8,495,775,000 1,341,438,158 1,341,438,158 94,925,784 WASHINGTON 50.03 197,297,035 200,453,788 12,536,442,000 405,243,000 12,131,199,000 1,915,089,832 1,915,089,832 200,453,788 WEST VIRGINIA 71.35 71,986,756 73,138,544 3,631,855,000 71,987,000 3,559,868,000 513,556,694 513,556,694 73,138,544 Total 11,130,266,762 11,308,351,030 490,537,457,000 17,499,048,000 473,038,409,000 72,723,757,629 72,723,757,629 11,361,451,030 LOW DSH STATES ALASKA 50.00 21,723,676 22,071,255 1,661,590,000 21,894,000 1,639,696,000 258,899,368.42 258,899,368 22,071,255 ARKANSAS 70.88 46,005,171 46,741,254 6,070,657,000 65,820,000 6,004,837,000 867,437,867 867,437,867 46,741,254 DELAWARE 53.63 9,654,966 9,809,445 1,549,168,000 24,248,000 1,524,920,000 235,738,053 235,738,053 9,809,445 HAWAII 3 52.23 10,393,600 10,559,898 1,951,834,000 0 1,951,834,000 304,084,384.25 304,084,384 10,559,898 IDAHO 71.75 17,530,110 17,810,592 2,009,716,000 24,470,000 1,985,246,000 286,074,779.25 286,074,779 17,810,592 IOWA 55.54 41,998,821 42,670,802 4,714,183,000 34,688,000 4,679,495,000 716,304,508 716,304,508 42,670,802 MINNESOTA 50.00 79,653,479 80,927,935 11,849,443,000 154,792,000 11,694,651,000 1,846,523,842 1,846,523,842 80,927,935 MONTANA 65.90 12,105,267 12,298,951 1,030,146,000 1,896,000 1,028,250,000 150,860,872 150,860,872 12,298,951 NEBRASKA 53.27 30,179,217 30,662,084 2,053,612,000 42,720,000 2,010,892,000 311,471,433 311,471,433 30,662,084 NEW MEXICO 69.65 21,723,676 22,071,255 4,758,998,000 31,196,000 4,727,802,000 685,428,779 685,428,779 22,071,255 NORTH DAKOTA 50.00 10,186,905 10,349,895 1,155,141,000 1,735,000 1,153,406,000 182,116,737 182,116,737 10,349,895 OKLAHOMA 62.30 38,619,866 39,237,784 5,404,554,000 58,140,000 5,346,414,000 794,628,053 794,628,053 39,237,784 OREGON 64.06 48,274,835 49,047,232 8,294,293,000 81,136,000 8,213,157,000 1,212,757,981 1,212,757,981 49,047,232 SOUTH DAKOTA 51.64 11,778,790 11,967,251 857,827,000 1,613,000 856,214,000 133,849,317 133,849,317 11,967,251 UTAH 70.56 20,922,000 21,256,752 2,276,646,000 31,390,000 2,245,256,000 324,641,933 324,641,933 21,256,752 WISCONSIN 58.27 100,816,461 102,429,524 8,016,231,000 166,265,000 7,849,966,000 1,186,300,027 1,186,300,027 102,429,524 WYOMING 50.00 241,374 245,236 596,915,000 476,000 596,439,000 94,174,579 94,174,579 245,236 Total Low DSH States 521,808,214 530,157,145 64,250,954,000 742,479,000 63,508,475,000 9,591,292,512 9,591,292,512 530,157,145 Total 11,652,074,976 11,838,508,176 554,788,411,000 18,241,527,000 536,546,884,000 82,315,050,141 82,315,050,141 11,891,608,175 1 Louisiana's FY 2015 DSH allotment is determined under the provisions of section 1923(f)(3)(C) and (D) of the Act. 2 Tennessee's DSH allotment for FY 2015 determined under section 1923(f)(6)(A)(vi) of the Act 3 Beginning FY 2013, under section 1923(f)(6)(B)(II) of the Act, Hawaii's DSH allotment for a fiscal year is determined as for low-DSH states. This means Hawaii's DSH allotment for a fiscal year is determined as for all States, by increasing the previous fiscal year allotment by the percentage increase in the CPIU for the previous fiscal year. 4 Expenditures based on the amounts reported by States on the Form CMS-37. 5 FMAP for Vermont for FY 2015 determined in accordance with section 1905(z)(1)(A) of the Act.
    Key to Addendum 3—Final IMD DSH Limits for FY 2013 [The final FY 2013 IMD DSH Limits for the Non-Low DSH States are presented in the top section of this addendum and the preliminary FY 2013 IMD DSH Limits for the Low-DSH States are presented in the bottom section of the addendum] Column Description Column A State. Column B Inpatient Hospital Services FY 95 DSH Total Computable
  • This column contains the States' total computable FY 1995 inpatient hospital DSH expenditures as reported on the Form CMS-64.
  • Column C IMD and Mental Health Services FY 95 DSH Total
  • Computable. This column contains the total computable FY 1995 mental health facility DSH expenditures as reported on the Form CMS-64 as of January 1, 1997.
  • Column D Total Inpatient Hospital & IMD & Mental Health FY 95 DSH Total
  • Computable, Col. B + C. This column contains the total computation of all inpatient hospital DSH expenditures and mental health facility DSH expenditures for FY 1995 as reported on the Form CMS-64 as of January 1, 1997 (representing the sum of Column B and Column C).
  • Column E Applicable Percentage, Col. C/D.
  • This column contains the “applicable percentage” representing the total Computable FY 1995 mental health facility DSH expenditures divided by total computable all inpatient hospital and mental health facility DSH expenditures for FY 1995 (the amount in Column C divided by the amount in Column D) Per section 1923(h)(2)(A)(ii)(III) of the Act, for FYs after FY 2002, the applicable percentage can be no greater than 33 percent.
  • Column F FY 2013 Federal Share DSH Allotment
  • This column contains the states' FY 2013 DSH allotments from Column J Addendum 1.
  • Column G FY 2013 FMAP. Column H FY 2013 DSH Allotments in Total Computable, Col. F/G.
  • This column contains states' FY 2013 total computable DSH allotment (determined as Column F/Column G).
  • Column I Applicable Percentage Applied to FY 2013 Allotments in TC, Col E × Col H.
  • This column contains the applicable percentage of FY 2012 total computable DSH allotment (calculated as the percentage in Column E multiplied by the amount in Column H).
  • Column J FY 2013 TC IMD DSH Limit. Lesser of Col.
  • I or C. This column contains the total computable FY 2013 TC IMD DSH Limit equal to the lesser of the amount in Column I or Column C.
  • Column K FY 2013 IMD DSH Limit in Federal Share, Col. G × J.
  • This column contains the FY 2013 Federal Share IMD DSH limit determined by converting the total computable FY 2013 IMD DSH Limit from Column J into a federal share amount by multiplying it by the FY 2013 FMAP in Column G.
  • Addendum 3—Final IMD DSH Limits for FY 2013 State Inpatient
  • Hospital
  • services FY
  • 95 DSH
  • Total
  • computable
  • IMD And
  • mental
  • health
  • services FY
  • 95 DSH
  • Total
  • computable
  • Total inpatient
  • & IMD &
  • mental health
  • FY 95 DSH
  • total
  • computable
  • Col B + C
  • Applicable
  • percent
  • Col C/D
  • (percent)
  • FY 2013
  • Allotment
  • In FS
  • FY 2013
  • FMAPs
  • (percent)
  • FY 2013
  • Allotments
  • in TC
  • Col F/G
  • Applicable
  • percentage
  • applied to
  • FY 2013
  • allotments
  • in TC
  • Col E × Col H
  • FY 2013
  • TC IMD Limit
  • (Lesser Of
  • Col I or Col C)
  • FY 2013
  • IMD Limit
  • In FS
  • Col G × J
  • MMA
  • LOW DSH
  • Status
  • A B C D E F G H I J K L ALABAMA $413,006,229 $4,451,770 $417,457,999 1.07 $323,093,267 68.53 471,462,523 $5,027,674 $4,451,770 $3,050,798 N/A ARIZONA 93,916,100 28,474,900 122,391,000 23.27 106,384,369 65.68 161,973,765 37,684,035 28,474,900 18,702,314 N/A CALIFORNIA 2,189,879,543 1,555,919 2,191,435,462 0.07 1,151,840,630 50.00 2,303,681,260 1,635,614 1,555,919 777,960 N/A COLORADO 173,900,441 594,776 174,495,217 0.34 97,190,657 50.00 194,381,314 662,559 594,776 297,388 N/A CONNECTICUT 303,359,275 105,573,725 408,933,000 25.82 210,141,962 50.00 420,283,924 108,504,179 105,573,725 52,786,863 N/A DISTRICT OF COLUMBIA 39,532,234 6,545,136 46,077,370 14.20 64,355,975 70.00 91,937,107 13,059,358 6,545,136 4,581,595 N/A FLORIDA 184,468,014 149,714,986 334,183,000 33.00 210,141,962 58.08 361,814,673 119,398,842 119,398,842 69,346,847 N/A GEORGIA 407,343,557 0 407,343,557 0.00 282,378,262 65.56 430,717,300 0 0 0 N/A ILLINOIS 315,868,508 89,408,276 405,276,784 22.06 225,902,609 50.00 451,805,218 99,672,933 89,408,276 44,704,138 N/A INDIANA 79,960,783 153,566,302 233,527,085 33.00 224,589,223 67.16 334,409,206 110,355,038 110,355,038 74,114,444 N/A KANSAS 11,587,208 76,663,508 88,250,716 33.00 43,341,780 56.51 76,697,540 25,310,188 25,310,188 14,302,787 N/A KENTUCKY 158,804,908 37,443,073 196,247,981 19.08 152,352,923 70.55 215,950,281 41,202,167 37,443,073 26,416,088 N/A LOUISIANA 1,078,512,169 132,917,149 1,211,429,318 10.97 731,960,000 65.51 1,117,325,599 122,592,157 122,592,157 80,310,122 N/A MAINE 99,957,958 60,958,342 160,916,300 33.00 110,324,530 62.57 176,321,768 58,186,183 58,186,183 36,407,095 N/A MARYLAND 22,226,467 120,873,531 143,099,998 33.00 80,116,623 50.00 160,233,246 52,876,971 52,876,971 26,438,486 N/A MASSACHUSETTS 469,653,946 105,635,054 575,289,000 18.36 320,466,492 50.00 640,932,984 117,688,658 105,635,054 52,817,527 N/A MICHIGAN 133,258,800 304,765,552 438,024,352 33.00 278,438,100 66.39 419,397,650 138,401,225 138,401,225 91,884,573 N/A MISSISSIPPI 182,608,033 0 182,608,033 0.00 160,233,246 73.43 218,212,238 0 0 0 N/A MISSOURI 521,946,524 207,234,618 729,181,142 28.42 497,773,773 61.37 811,102,775 230,516,896 207,234,618 127,179,885 N/A NEVADA 73,560,000 0 73,560,000 0.00 48,595,328 59.74 81,344,707 0 0 0 N/A NEW HAMPSHIRE 92,675,916 94,753,948 187,429,864 33.00 168,217,088 50.00 336,434,176 111,023,278 94,753,948 47,376,974 N/A NEW JERSEY 736,742,539 357,370,461 1,094,113,000 32.66 676,394,441 50.00 1,352,788,882 441,861,843 357,370,461 178,685,231 N/A NEW YORK 2,418,869,368 605,000,000 3,023,869,368 20.01 1,687,702,633 50.00 3,375,405,266 675,333,468 605,000,000 302,500,000 N/A NORTH CAROLINA 193,201,966 236,072,627 429,274,593 33.00 309,959,394 65.51 473,148,212 156,138,910 156,138,910 102,286,600 N/A OHIO 535,731,956 93,432,758 629,164,714 14.85 426,850,861 63.58 671,360,272 99,698,919 93,432,758 59,404,548 N/A PENNSYLVANIA 388,207,319 579,199,682 967,407,001 33.00 589,710,881 54.28 1,086,423,878 358,519,880 358,519,880 194,604,591 N/A RHODE ISLAND 108,503,167 2,397,833 110,901,000 2.16 68,296,138 51.26 133,234,760 2,880,720 2,397,833 1,229,129 N/A SOUTH CAROLINA 366,681,364 72,076,341 438,757,705 16.43 344,107,463 70.43 488,580,808 80,260,965 72,076,341 50,763,367 N/A TENNESSEE 0 0 0 0.00 53,100,000 66.13 80,296,386 0 0 0 N/A TEXAS 1,220,515,401 292,513,592 1,513,028,993 19.33 1,004,741,257 59.30 1,694,336,015 327,565,642 292,513,592 173,460,560 N/A VERMONT 19,979,252 9,071,297 29,050,549 31.23 23,640,971 56.04 42,185,887 13,172,925 9,071,297 5,083,555 N/A VIRGINIA 129,313,480 7,770,268 137,083,748 5.67 92,050,138 50.00 184,100,276 10,435,289 7,770,268 3,885,134 N/A WASHINGTON 171,725,815 163,836,435 335,562,250 33.00 194,381,315 50.00 388,762,630 128,291,668 128,291,668 64,145,834 N/A WEST VIRGINIA 66,962,606 18,887,045 85,849,651 22.00 70,922,912 72.04 98,449,350 21,658,997 18,887,045 13,606,227 N/A Total 13,402,460,846 4,118,758,904 17,521,219,750 11,029,697,203 19,545,491,877 3,709,617,180 3,410,261,852 1,921,150,660 LOW DSH STATES ALASKA $2,506,827 $17,611,765 $20,118,592 33.00 $21,402,636 50.00 $42,805,272 $14,125,740 $14,125,740 $7,062,870 LOW DSH ARKANSAS 2,422,649 819,351 3,242,000 25.27 45,325,292 70.17 64,593,547 16,324,734 819,351 574,939 LOW DSH DELAWARE 0 7,069,000 7,069,000 33.00 9,512,282 55.67 17,086,909 5,638,680 5,638,680 3,139,053 LOW DSH HAWAII 0 0 0 0.00 10,240,000 51.86 19,745,469 0 0 0 LOW DSH IDAHO 2,081,429 0 2,081,429 0.00 17,271,044 71.00 24,325,414 0 0 0 LOW DSH IOWA 12,011,250 0 12,011,250 0.00 41,378,149 59.59 69,438,075 0 0 0 LOW DSH MINNESOTA 24,240,000 5,257,214 29,497,214 17.82 78,476,334 50.00 156,952,668 27,973,278 5,257,214 2,628,607 LOW DSH MONTANA 237,048 0 237,048 0.00 11,926,371 66.00 18,070,259 0 0 0 LOW DSH NEBRASKA 6,449,102 1,811,337 8,260,439 21.93 29,733,219 55.76 53,323,563 11,692,713 1,811,337 1,010,002 LOW DSH NEW MEXICO 6,490,015 254,786 6,744,801 3.78 21,402,636 69.07 30,986,877 1,170,535 254,786 175,981 LOW DSH NORTH DAKOTA 214,523 988,478 1,203,001 33.00 10,036,360 52.27 19,200,995 6,336,328 988,478 516,677 LOW DSH OKLAHOMA 20,019,969 3,273,248 23,293,217 14.05 38,049,129 64.00 59,451,764 8,354,379 3,273,248 2,094,879 LOW DSH OREGON 11,437,908 19,975,092 31,413,000 33.00 47,561,414 62.44 76,171,387 25,136,558 19,975,092 12,472,447 LOW DSH SOUTH DAKOTA 321,120 751,299 1,072,419 33.00 11,604,719 56.19 20,652,641 6,815,372 751,299 422,155 LOW DSH UTAH 3,621,116 934,586 4,555,702 20.51 20,612,808 69.61 29,611,849 6,074,765 934,586 650,565 LOW DSH WISCONSIN 6,609,524 4,492,011 11,101,535 33.00 99,326,563 59.74 166,264,752 54,867,368 4,492,011 2,683,527 LOW DSH WYOMING 0 0 0 0.00 237,807 50.00 475,614 0 0 0 LOW DSH Total Low DSH States 98,662,480 63,238,167 161,900,647 514,096,763 869,157,055 184,510,449 58,321,822 33,431,702 Total 13,501,123,326 4,181,997,071 17,683,120,397 11,543,793,966 20,414,648,932 3,894,127,630 3,468,583,674 1,954,582,362
    Key to Addendum 4—Preliminary IMD DSH Limits for FY 2015 [The preliminary FY 2015 IMD DSH Limits for the Non-Low DSH States are presented in the top section of this addendum and the preliminary FY 2015 IMD DSH Limits for the Low-DSH States are presented in the bottom section of the addendum] Column Description Column A State. Column B Inpatient Hospital Services FY 95 DSH Total Computable.
  • This column contains the States' total computable FY 1995 inpatient hospital DSH expenditures as reported on the Form CMS-64.
  • Column C IMD and Mental Health Services FY 95 DSH Total
  • Computable. This column contains the total computable FY 1995 mental health facility DSH expenditures as reported on the Form CMS-64 as of January 1, 1997.
  • Column D Total Inpatient Hospital & IMD & Mental Health FY 95 DSH Total
  • Computable, Col. B + C. This column contains the total computation of all inpatient hospital DSH expenditures and mental health facility DSH expenditures for FY 1995 as reported on the Form CMS-64 as of January 1, 1997 (representing the sum of Column B and Column C).
  • Column E Applicable Percentage, Col. C/D.
  • This column contains the “applicable percentage” representing the total Computable FY 1995 mental health facility DSH expenditures divided by total computable all inpatient hospital and mental health facility DSH expenditures for FY 1995 (the amount in Column C divided by the amount in Column D) Per section 1923(h)(2)(A)(ii)(III) of the Act, for FYs after FY 2002, the applicable percentage can be no greater than 33 percent.
  • Column F FY 2015 Federal Share DSH Allotment.
  • This column contains the states' preliminary FY 2015 DSH allotments from Column J Addendum 1.
  • Column G FY 2015 FMAP. Column H FY 2015 DSH Allotments in Total Computable, Col. F/G.
  • This column contains states' FY 2015 total computable DSH allotment (determined as Column F/Column G).
  • Column I Applicable Percentage Applied to FY 2015 Allotments in TC, Col E x Col H.
  • This column contains the applicable percentage of FY 2014 total computable DSH allotment (calculated as the percentage in Column E multiplied by the amount in Column H).
  • Column J FY 2015 TC IMD DSH Limit. Lesser of Col.
  • I or C. This column contains the total computable FY 2015 TC IMD DSH Limit equal to the lesser of the amount in Column I or Column C.
  • Column K FY 2015 IMD DSH Limit in Federal Share, Col. G × J.
  • This column contains the FY 2015 Federal Share IMD DSH limit determined by converting the total computable FY 2015 IMD DSH Limit from Column J into a federal share amount by multiplying it by the FY 2015 FMAP in Column G.
  • Addendum 4—Preliminary IMD DSH Limits for FY 2015 State Inpatient hospital services FY 95 DSH total computable IMD and mental health services FY 95 DSH total computable Total inpatient & IMD & mental health FY 95 DSH total computable Col B + C Applicable
  • percent
  • Col C/D
  • FY 2015 allotment in FS FY 2015 FMAPs
  • (percent)
  • FY 2015
  • allotments in TC Col. F/G
  • Applicable
  • percentage
  • applied to FY 2015
  • allotments in TC
  • Col E × Col H
  • FY 2015 TC IMD Limit (Lesser Of Col I or Col C) FY 2015 TC IMD limit in FS
  • Col G × J
  • MMA LOW DSH Status
    A B C D E F G H I J K L ALABAMA $413,006,229 $4,451,770 $417,457,999 1.07 $333,186,701 68.99 $482,949,269 $5,150,169 $4,451,770 $3,071,276 N/A ARIZONA 93,916,100 28,474,900 122,391,000 23.27 109,707,817 68.46 160,250,974 37,283,219 28,474,900 19,493,917 N/A CALIFORNIA 2,189,879,543 1,555,919 2,191,435,462 0.07 1,187,824,131 50.00 2,375,648,262 1,686,710 1,555,919 777,960 N/A COLORADO 173,900,441 594,776 174,495,217 0.34 100,226,893 51.01 196,484,793 669,729 594,776 303,395 N/A CONNECTICUT 303,359,275 105,573,725 408,933,000 25.82 216,706,796 50.00 433,413,592 111,893,849 105,573,725 52,786,863 N/A DISTRICT OF COLUMBIA 39,532,234 6,545,136 46,077,370 14.20 66,366,456 70.00 94,809,223 13,467,332 6,545,136 4,581,595 N/A FLORIDA 184,468,014 149,714,986 334,183,000 33.00 216,706,796 59.72 362,871,393 119,747,560 119,747,560 71,513,243 N/A GEORGIA 407,343,557 0 407,343,557 0.00 291,199,759 66.94 435,016,073 0 0 0 N/A ILLINOIS 315,868,508 89,408,276 405,276,784 22.06 232,959,806 50.76 458,943,668 101,247,749 89,408,276 45,383,641 N/A INDIANA 79,960,783 153,566,302 233,527,085 33.00 231,605,390 66.52 348,174,068 114,897,442 114,897,442 76,429,779 N/A KANSAS 11,587,208 76,663,508 88,250,716 33.00 44,695,778 56.63 78,925,972 26,045,571 26,045,571 14,749,607 N/A KENTUCKY 158,804,908 37,443,073 196,247,981 19.08 157,112,428 69.94 224,638,873 42,859,905 37,443,073 26,187,685 N/A LOUISIANA 1,078,512,169 132,917,149 1,211,429,318 10.97 743,671,360 62.05 1,198,503,400 131,498,927 131,498,927 81,595,084 N/A MAINE 99,957,958 60,958,342 160,916,300 33.00 113,771,068 61.88 183,857,576 60,673,000 60,673,000 37,544,452 N/A MARYLAND 22,226,467 120,873,531 143,099,998 33.00 82,619,466 50.00 165,238,932 54,528,848 54,528,848 27,264,424 N/A MASSACHUSETTS 469,653,946 105,635,054 575,289,000 18.36 330,477,865 50.00 660,955,730 121,365,252 105,635,054 52,817,527 N/A MICHIGAN 133,258,800 304,765,552 438,024,352 33.00 287,136,507 65.54 438,108,799 144,575,904 144,575,904 94,755,047 N/A MISSISSIPPI 182,608,033 0 182,608,033 0.00 165,238,933 73.58 224,570,444 0 0 0 N/A MISSOURI 521,946,524 207,234,618 729,181,142 28.42 513,324,226 63.45 809,021,633 229,925,432 207,234,618 131,490,365 N/A NEVADA 73,560,000 0 73,560,000 0.00 50,113,446 64.36 77,864,273 0 0 0 N/A NEW HAMPSHIRE 92,675,916 94,753,948 187,429,864 33.00 173,472,190 50.00 346,944,380 114,491,645 94,753,948 47,376,974 N/A NEW JERSEY 736,742,539 357,370,461 1,094,113,000 32.66 697,525,004 50.00 1,395,050,008 455,665,607 357,370,461 178,685,231 N/A NEW YORK 2,418,869,368 605,000,000 3,023,869,368 20.01 1,740,426,463 50.00 3,480,852,926 696,430,885 605,000,000 302,500,000 N/A NORTH CAROLINA 193,201,966 236,072,627 429,274,593 33.00 319,642,526 65.88 485,189,019 160,112,376 160,112,376 105,482,034 N/A OHIO 535,731,956 93,432,758 629,164,714 14.85 440,185,682 62.64 702,722,992 104,356,372 93,432,758 58,526,280 N/A PENNSYLVANIA 388,207,319 579,199,682 967,407,001 33.00 608,133,449 51.82 1,173,549,689 387,271,397 387,271,397 200,684,038 N/A RHODE ISLAND 108,503,167 2,397,833 110,901,000 2.16 70,429,709 50.00 140,859,418 3,045,575 2,397,833 1,198,917 N/A SOUTH CAROLINA 366,681,364 72,076,341 438,757,705 16.43 354,857,380 70.64 502,346,234 82,522,262 72,076,341 50,914,727 N/A TENNESSEE* 0 0 0 0.00 53,100,000 64.99 81,704,878 0 0 0 N/A TEXAS 1,220,515,401 292,513,592 1,513,028,993 19.33 1,036,129,374 58.05 1,784,891,256 345,072,669 292,513,592 169,804,140 N/A VERMONT** 19,979,252 9,071,297 29,050,549 31.23 24,379,515 56.21 43,372,202 13,543,363 9,071,297 5,098,976 N/A VIRGINIA 129,313,480 7,770,268 137,083,748 5.67 94,925,784 50.00 189,851,568 10,761,287 7,770,268 3,885,134 N/A WASHINGTON 171,725,815 163,836,435 335,562,250 33.00 200,453,788 50.03 400,667,176 132,220,168 132,220,168 66,149,750 N/A WEST VIRGINIA 66,962,606 18,887,045 85,849,651 22.00 73,138,544 71.35 102,506,719 22,551,624 18,887,045 13,475,907 N/A Total 13,402,460,846 4,118,758,904 17,521,219,750 11,361,451,030 20,240,755,414 3,845,561,828 3,471,761,983 1,944,527,968 LOW DSH STATES ALASKA 2,506,827 17,611,765 20,118,592 33.00 22,071,255 50.00 44,142,510 14,567,028 14,567,028 7,283,514 LOW DSH ARKANSAS 2,422,649 819,351 3,242,000 25.27 46,741,254 70.88 65,944,207 16,666,086 819,351 580,756 LOW DSH DELAWARE 0 7,069,000 7,069,000 33.00 9,809,445 53.63 18,290,966 6,036,019 6,036,019 3,237,117 LOW DSH HAWAII 0 0 0 0.00 10,559,898 52.23 20,218,070 0 0 0 LOW DSH IDAHO 2,081,429 0 2,081,429 0.00 17,810,592 71.75 24,823,125 0 0 0 LOW DSH IOWA 12,011,250 0 12,011,250 0.00 42,670,802 55.54 76,828,956 0 0 0 LOW DSH MINNESOTA 24,240,000 5,257,214 29,497,214 17.82 80,927,935 50.00 161,855,870 28,847,163 5,257,214 2,628,607 LOW DSH MONTANA 237,048 0 237,048 0.00 12,298,951 65.90 18,663,052 0 0 0 LOW DSH NEBRASKA 6,449,102 1,811,337 8,260,439 21.93 30,662,084 53.27 57,559,760 12,621,620 1,811,337 964,899 LOW DSH NEW MEXICO 6,490,015 254,786 6,744,801 3.78 22,071,255 69.65 31,688,808 1,197,050 254,786 177,458 LOW DSH NORTH DAKOTA 214,523 988,478 1,203,001 33.00 10,349,895 50.00 20,699,790 6,830,931 988,478 494,239 LOW DSH OKLAHOMA 20,019,969 3,273,248 23,293,217 14.05 39,237,784 62.30 62,981,997 8,850,460 3,273,248 2,039,234 LOW DSH OREGON 11,437,908 19,975,092 31,413,000 33.00 49,047,232 64.06 76,564,521 25,266,292 19,975,092 12,796,044 LOW DSH SOUTH DAKOTA 321,120 751,299 1,072,419 33.00 11,967,251 51.64 23,174,382 7,647,546 751,299 387,971 LOW DSH UTAH 3,621,116 934,586 4,555,702 20.51 21,256,752 70.56 30,125,782 6,180,197 934,586 659,444 LOW DSH WISCONSIN 6,609,524 4,492,011 11,101,535 33.00 102,429,524 58.27 175,784,321 58,008,826 4,492,011 2,617,495 LOW DSH WYOMING 0 0 0 0.00 245,236 50.00 490,472 0 0 0 LOW DSH Total Low DSH States 98,662,480 63,238,167 161,900,647 530,157,145 909,836,589 192,719,219 59,160,449 33,866,778 Total 13,501,123,326 4,181,997,071 17,683,120,397 11,891,608,175 21,150,592,003 4,038,281,047 3,530,922,432 1,978,394,746 * Tennessee's DSH allotment for FY 2015 determined under section 1923(f)(6)(A)(vi) of the Act. ** Vermont's FMAP for FY 2015 determined in accordance with section 1905(z)(1)(A) of the Act
    [FR Doc. 2016-01836 Filed 2-1-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1661-NC] Medicare Program; Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition AGENCY:

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

    ACTION:

    Notice with request for comment.

    SUMMARY:

    The Social Security Act (the Act) prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.

    DATES:

    Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 3, 2016.

    ADDRESSES:

    In commenting, please refer to file code CMS-1661-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    You may submit comments in one of four ways (please choose only one of the ways listed):

    1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

    2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1661-NC, P.O. Box 8010, Baltimore, MD 21244-8010.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1661-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses:

    a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

    (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

    b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

    Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

    FOR FURTHER INFORMATION CONTACT:

    [email protected]

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments

    All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

    We will allow stakeholders 30 days from the date of this notice to submit written comments. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of this notice, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, please phone 1-800-743-3951.

    I. Background

    Section 1877 of the Social Security Act (the Act), also known as the physician self-referral law—(1) prohibits a physician from making referrals for certain “designated health services” (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless the requirements of an applicable exception are satisfied; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those DHS furnished as a result of a prohibited referral.

    Section 1877(d)(2) of the Act provides an exception for physician ownership or investment interests in rural providers (the “rural provider exception”). In order for an entity to qualify for the rural provider exception, the DHS must be furnished in a rural area (as defined in section 1886(d)(2) of the Act) and substantially all the DHS furnished by the entity must be furnished to individuals residing in a rural area.

    Section 1877(d)(3) of the Act provides an exception, known as the hospital ownership exception, for physician ownership or investment interests held in a hospital located outside of Puerto Rico, provided that the referring physician is authorized to perform services at the hospital and the ownership or investment interest is in the hospital itself (and not merely in a subdivision of the hospital).

    Section 6001(a)(3) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (hereafter referred to together as “the Affordable Care Act”) amended the rural provider and hospital ownership exceptions to the physician self-referral prohibition to impose additional restrictions on physician ownership and investment in hospitals and rural providers. Since March 23, 2010, a physician-owned hospital that seeks to avail itself of either exception is prohibited from expanding facility capacity unless it qualifies as an “applicable hospital” or “high Medicaid facility” (as defined in sections 1877(i)(3)(E), (F) of the Act and 42 CFR 411.362(c)(2), (3) of our regulations) and has been granted an exception to the prohibition by the Secretary of the Department of Health and Human Services (the Secretary). Section 1877(i)(3)(A)(ii) of the Act provides that individuals and entities in the community in which the provider requesting the exception is located must have an opportunity to provide input with respect to the provider's application for the exception. For further information, we refer readers to the CMS Web site at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html.

    II. Exception Request Process

    On November 30, 2011, we published a final rule in the Federal Register (76 FR 74122, 74517 through 74525) that, among other things, finalized § 411.362(c), which specified the process for submitting, commenting on, and reviewing a request for an exception to the prohibition on expansion of facility capacity. We published a subsequent final rule in the Federal Register on November 10, 2014 (79 FR 66770) that made certain revisions. These revisions include, among other things, permitting the use of data from an external data source or data from the Hospital Cost Report Information System (HCRIS) for specific eligibility criteria.

    As stated in regulations at § 411.362(c)(5), we will solicit community input on the request for an exception by publishing a notice of the request in the Federal Register. Individuals and entities in the hospital's community will have 30 days to submit comments on the request. Community input must take the form of written comments and may include documentation demonstrating that the physician-owned hospital requesting the exception does or does not qualify as an “applicable hospital” or “high Medicaid facility,” as such terms are defined in § 411.362(c)(2) and (3). In the November 30, 2011 final rule (76 FR 74522), we gave examples of community input, such as documentation demonstrating that the hospital does not satisfy one or more of the data criteria or that the hospital discriminates against beneficiaries of Federal health programs; however, we noted that these were examples only and that we will not restrict the type of community input that may be submitted. If we receive timely comments from the community, we will notify the hospital, and the hospital will have 30 days after such notice to submit a rebuttal statement (§ 411.362(c)(5)(ii)).

    A request for an exception to the facility expansion prohibition is considered complete as follows:

    • If the request, any written comments, and any rebuttal statement include only HCRIS data: (1) The end of the 30-day comment period if CMS receives no written comments from the community; or (2) the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the physician-owned hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(i)).

    • If the request, any written comments, or any rebuttal statement include data from an external data source, no later than: (1) 180 days after the end of the 30-day comment period if CMS receives no written comments from the community; and (2) 180 days after the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the physician-owned hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(ii)).

    If we grant the request for an exception to the prohibition on expansion of facility capacity, the expansion may occur only in facilities on the hospital's main campus and may not result in the number of operating rooms, procedure rooms, and beds for which the hospital is licensed to exceed 200 percent of the hospital's baseline number of operating rooms, procedure rooms, and beds (§ 411.362(c)(6)). The CMS decision to grant or deny a hospital's request for an exception to the prohibition on expansion of facility capacity must be published in the Federal Register in accordance with our regulations at § 411.362(c)(7).

    III. Hospital Exception Request

    As permitted by section 1877(i)(3) of the Act and our regulations at § 411.362(c), the following physician-owned hospital has requested an exception to the prohibition on expansion of facility capacity:

    Name of Facility: Rockwall Regional Hospital, LLC, d/b/a Texas Health Presbyterian Hospital Rockwall.

    Location: 3150 Horizon Road, Rockwall County, Texas 75032-7805.

    Basis for Exception Request: Applicable Hospital.

    We seek comments on this request from individuals and entities in the community in which the hospital is located. We encourage interested parties to review the hospital's request, which is posted on the CMS Web site at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html. We especially welcome comments regarding whether the hospital qualifies as an applicable hospital. Under § 411.362(c)(2), an applicable hospital is a hospital that satisfies all of the following criteria:

    • The hospital is located in a county that has a percentage increase in population that is at least 150 percent of the percentage increase in population of the State in which the hospital is located during the most recent 5-year period for which data are available as of the date that the hospital submits its request.

    • The hospital has an annual percent of total inpatient admissions under Medicaid that is equal to or greater than the average percent with respect to such admissions for all hospitals located in the county in which the hospital is located during the most recent 12-month period for which data are available as of the date that the hospital submits its request. The most recent 12-month period for which data are available means the most recent 12-month period for which the data source used contains all data from the requesting hospital and each hospital located in the same county as the requesting hospital.

    • The hospital does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries.

    • The hospital is located in a State in which the average bed capacity in the State is less than the national average bed capacity during the most recent fiscal year for which HCRIS, as of the date that the hospital submits its request, contains data from a sufficient number of hospitals to determine a State's average bed capacity and the national average bed capacity.

    • The hospital has an average bed occupancy rate that is greater than the average bed occupancy rate in the State in which the hospital is located during the most recent fiscal year for which HCRIS, as of the date that the hospital submits its request, contains data from a sufficient number of hospitals to determine the requesting hospital's average bed occupancy rate and the relevant State's average bed occupancy rate.

    Individuals and entities wishing to submit comments on the hospital's request should review the DATES and ADDRESSES sections above and state whether or not they are in the community in which the hospital is located.

    IV. Collection of Information Requirements

    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

    V. Response to Public Comments

    Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

    Dated: January 6, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services.
    [FR Doc. 2016-01830 Filed 2-1-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0662] Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Valid or Will Not Be Infringed AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.

    DATES:

    Submit either electronic or written comments on the collection of information by April 4, 2016.

    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-2013-N-0662 for “Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications.” 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:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    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. “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 provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, 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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Applications for FDA Approval To Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed—OMB Control Number 0910-0513—Extension

    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as part of the NDA, “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” Section 505(c)(2) of the FD&C Act (21 U.S.C. 355(c)(2)) imposes a similar patent submission obligation on holders of approved NDAs when the NDA holder could not have submitted the patent information with its application. Under § 505(b)(1) of the FD&C Act, we publish patent information after approval of an NDA application in the list entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book). If patent information is submitted after NDA approval, § 505(c)(2) of the FD&C Act directs us to publish the information upon its submission.

    FDA regulations at §§ 314.50(h) (21 CFR 314.50(h)) and 314.53 (21 CFR 314.53) clarify the types of patent information that must and must not be submitted to FDA as part of an NDA, an amendment, or a supplement, and require persons submitting an NDA, an amendment, or a supplement, or submitting information on a patent after NDA approval, to make a detailed patent declaration using Form FDA 3542a and Form FDA 3542.

    The reporting burden for submitting an NDA, an amendment, or supplement in accordance with § 314.50 (a) through (f), and (k) has been estimated by FDA and the collection of information has been approved by OMB under OMB control number 0910-0001. We are not re-estimating these approved burdens in this document. Only the reporting burdens associated with patent submission and listing, as explained below, are estimated in this document.

    The information collection reporting requirements are as follows:

    Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent information described under § 314.53.

    Section 314.53 requires that an applicant submitting an NDA, an amendment, or a supplement, except as provided in § 314.53(d)(2), submit on Forms 3542 and 3542a, the required patent information described in this section.

    Compliance with the information collection burdens under §§ 314.50(h) and 314.53 consists of submitting with an NDA, an amendment, or a supplement (collectively referred to as “application”) the required patent declaration(s) on Form 3542a for each “patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product” (§ 314.53(b)). Such patents claim the drug substance (active ingredient), drug product (formulation and composition), or method of use. If a patent is issued after the application is filed with FDA, but before the application is approved, the applicant must submit the required patent information on Form 3542a as an amendment to the application, within 30 days of the date of issuance of the patent.

    Within 30 days after the date of approval of an application, the applicant must submit Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form 3542 must be submitted within 30 days of the date of issuance of the patent.

    FDA requests OMB approval for the following information collection:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR 314.50
  • (citing § 314.53)
  • Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Hours per
  • response
  • Total
  • hours
  • Form FDA 3542a 241 3.4 819 20 16,380 Form FDA 3542 200 3.4 680 5 3,400 Total 19,780 1 There are no capital costs, operating and maintenance costs associated with this collection of information.

    The numbers of patents submitted to FDA for listing in the Orange Book in 2012, 2013, and 2014 were 458, 509, and 617, respectively, for an annual average of 528 (458 patents + 509 patents + 617 patents)/3 years = 528 patents/year). Because many of these individual patents are included in multiple NDA submissions, there could be multiple declarations for a single patent. From our previous review of submissions, we believe that approximately 14 percent of the patents submitted are included in multiple NDA submissions, and thus require multiple patent declarations. Therefore, we estimate that 74 (528 patents × 14 percent) patents will be multiple listings, and there will be a total of 602 patents (528 patents + 74 patents = 602 patents) declared on Form FDA 3542. We approved 86, 94, and 107 NDAs in calendar years 2012, 2013, and 2014, respectively, of which we estimate based on our previous review that approximately 71 percent submitted patent information for listing in the Orange Book. The remaining NDAs submitted Form FDA 3542 as required and declared that there were no relevant patents. We also approved approximately 101, 101, and 110 NDA supplements in FYs 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required. We estimate there will be 200 instances (based on an average of 96 NDA approvals and 104 supplement approvals per year) where an NDA holder would be affected by the patent declaration requirements, and that each of these NDA holders would, on average, submit 3.4 declarations (602 patent declarations + 74 no relevant patent declarations)/200 instances = 3.4 declarations per instance) on Form FDA 3542. We filed 112, 116, and 113 NDAs in 2012, 2013, and 2014, respectively, and 112, 112, 156 NDA supplements in 2012, 2013, and 2014, respectively, for which submission of a patent declaration would be required. We estimate there will be 241 instances (based on an average of 114 NDAs filed and 127 NDA supplements filed per year) where an NDA holder would be affected by the patent declaration requirements. We estimate, based on a proportional increase from the number of declarations for approved NDAs, that there will be an annual total of 819 declarations (241 instances × 3.4 declarations per instance = 819 declarations) on Form FDA 3542a submitted with these applications. Based upon information provided by regulated entities and other information, we previously estimated that the information collection burden associated with § 314.50(h) (citing § 314.53) and Forms FDA 3542 and 3542a will be approximately 5 hours and 20 hours per response, respectively.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01782 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0129] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 8, 2015, the Agency submitted a proposed collection of information entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0719. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01783 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] The Arthritis Foundation—Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of workshop.

    SUMMARY:

    Osteoarthritis is the most common form of arthritis, and occurs when the cartilage that cushions the bones of the joint break down and the bones begin to rub together. This can cause pain, swelling, and loss of motion of the joint. The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co-sponsorship with the Arthritis Foundation is announcing a workshop entitled, “Accelerating OA Clinical Trials Workshop”. The purpose of the workshop is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis.

    DATES:

    The workshop will be held on February 24, 2016, from 8 a.m. to 5:30 p.m., and February 25, 2016, from 8 a.m. to 2 p.m.

    ADDRESSES:

    The workshop will be held at the Atlanta Airport Hilton, 1031 Virginia Ave., Atlanta, GA 30354.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Yim, Office of New Drugs, Center for Drug Evaluation and Research, email: [email protected]; Amanda Niskar, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, GA 30309, 404-964-7545, FAX: 404-965-7807, email: [email protected]; or Becky Bosworth, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, GA 30309, 404-965-7673, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The osteoarthritis (OA) community of clinicians, physicians and scientists have been challenged to get new treatments to market so that people with OA can benefit at the point of care. The Arthritis Foundation and FDA are convening experts to discuss alternative approaches to clinical trials in OA. Workshop objectives will include discussion and identification of promising innovations that could facilitate successful trials in OA, new approaches to recruitment for clinical trials, feasible and clinically meaningful trial endpoints, and approaches for reducing the time and cost of OA trials while maximizing the likelihood of success.

    Registration: There is no fee to attend the workshop, but attendees must register in advance. Space is very limited. Persons interested in attending this workshop may request to register by sending their resume and inquiry to [email protected] The registration deadline is February 2, 2016.

    II. Accommodations

    An online registration link and a meeting code will be provided through the registration process giving participants a reduced group rate for hotel accomodations, not including applicable taxes. No additional reservations are required. Industry and government attendees are responsible for the cost of their own accomodations. If you need special accommodations due to a disability, please contact Becky Bosworth at [email protected] at least 7 days in advance.

    III. Transcripts

    No transcripts will be available from the event, however, the event will be video taped for the purposes of the Arthritis Foundation. Speaker presentation materials, if permitted by the presenter, will be available on the Arthritis Foundation Web site following the workshop.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01789 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0145] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On November 30, 2015, the Agency submitted a proposed collection of information entitled “Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0726. The approval expires on January 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy
    [FR Doc. 2016-01785 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0275] Regulatory Site Visit Training Program AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

    DATES:

    Submit either an electronic or written request for participation in this program by March 3, 2016. The request should include a description of your facility relative to products regulated by CBER. Please specify the physical address(es) of the site(s) you are offering.

    ADDRESSES:

    If your biologics facility is interested in offering a site visit, submit either an electronic request to http://www.regulations.gov or a written request to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. If you previously responded to earlier requests to participate in this program and you continue to be interested in participating, please renew your request through a submission to the Division of Dockets Management.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Whitmarsh, Division of Manufacturers Assistance and Training, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, 240-402-8010, FAX: 301-595-1243, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    CBER regulates certain biological products including blood and blood products, vaccines, and cellular, tissue, and gene therapies. CBER is committed to advancing the public health through innovative activities that help ensure the safety, effectiveness, and availability of biological products to patients. To support this primary goal, CBER has initiated various training and development programs, including programs to further enhance performance of its compliance staff, regulatory review staff, and other relevant staff. CBER seeks to continuously enhance and update review efficiency and quality, and the quality of its regulatory efforts and interactions, by providing CBER staff with a better understanding of the biologics industry and its operations. Further, CBER seeks to enhance: (1) Its understanding of current industry practices and regulatory impacts and needs and (2) communication between CBER staff and industry. CBER initiated its RSVP in 2005. Through these annual notices, CBER is requesting that those firms that have previously applied and are still interested in participating reaffirm their interest. CBER is also requesting that new interested parties apply.

    II. RSVP A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the facility, small groups of CBER staff may observe operations of biologics establishments, including for example, blood and tissue establishments. The visits may include the following: (1) Packaging facilities, (2) quality control and pathology/toxicology laboratories, and (3) regulatory affairs operations. These visits, or any part of the program, are not intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but are meant to improve mutual understanding and to provide an avenue for open dialogue between the biologics industry and CBER.

    B. Site Selection

    CBER will be responsible for all travel expenses associated with the site visits. Therefore, selection of potential facilities will be based on the coordination of CBER's priorities for staff training as well as the limited available resources for this program. In addition to logistical and other resource factors to consider, a key element of site selection is a successful compliance record with FDA or another Agency with which we have a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract to the applicant, the other firm also needs to agree to participate in the program, as well as have a satisfactory compliance history. If you are a firm with multiple sites, please submit no more than three specific locations for consideration.

    III. Requests for Participation

    Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01780 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0908] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On September 22, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0581. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01781 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0609] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On September 21, 2015, the Agency submitted a proposed collection of information entitled “Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0806. The approval expires on December 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01784 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0075] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    On December 9, 2015, the Agency submitted a proposed collection of information entitled “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0807. The approval expires on January 31, 2019. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: January 25, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01786 Filed 2-1-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1855] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by March 3, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-NEW and title “Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Experimental Studies on Consumer Perceptions of Modified Risk Tobacco Products OMB Control Number 0910-NEW

    FDA's Center for Tobacco Products proposes to conduct experimental studies to develop generalizable scientific knowledge to help inform its implementation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387k), wherein FDA will be evaluating information submitted to the Agency about how consumers understand and perceive tobacco products marketed as modified risk tobacco products (MRTPs). Section 911 of the FD&C Act authorizes FDA to grant orders to persons to allow the marketing of MRTPs. The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. FDA must issue an order authorizing the marketing of an MRTP if the Agency determines that the product, as it is actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products (section 911(g)(1) of the FD&C Act).

    FDA may also issue an order authorizing the marketing of an MRTP that reduces or eliminates exposure to a harmful substance if, among other requirements, the Agency determines that the order would be appropriate to promote the public health, the issuance of the order is expected to benefit the population as a whole taking into account both users and nonusers of tobacco products, and the existing evidence demonstrates that a measurable and substantial reduction in morbidity and mortality among individual tobacco users is reasonably likely to be shown in subsequent studies (section 911(g)(2) of the FD&C Act). In addition, section 911 requires that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health related conditions associated with the use of tobacco products (section 911(h)(1) of the FD&C Act). The proposed research will inform the Agency's efforts to implement the provisions of the FD&C Act related to MRTPs.

    FDA proposes to conduct experimental studies in order to develop generalizable scientific information to better understand how consumers perceive and understand these products, how exposure to claims about modified risk or exposure influence intentions to try or purchase the product, and how individual characteristics such as current tobacco use and/or brand loyalty might influence these outcomes. Moreover, information from the experimental studies may assist FDA to determine the appropriate methods and measures for gathering such information from consumers.

    The impact of different claims pertaining to modified risk or exposure on understanding, perceptions, and use intentions will be evaluated by conducting a series of three studies that, in turn, will examine: The impact of claims about cigarette (Study 1) or smokeless tobacco products (Study 2) among young adult and adult current, former, or never users of tobacco; and the impact of claims on adolescents currently using, or susceptible to using, tobacco (Study 3). All three studies will assess individual-level factors that might influence the impact of claims on consumer responses, including: Brand loyalty, tobacco use history and behavior, concerns about health risks, and openness to new products.

    Across all studies, participants will be randomized to either see modified risk claims or not (control condition). In Studies 1 and 2, modified risk claims will be displayed on mock tobacco product packages and ads. For ethical reasons, adolescents (Study 3) will see modified risk claims displayed as statements alone, not attached to product packaging or ads. Consumer reactions to claims will be evaluated by measuring constructs such as: Understanding of the modified risk information in the claims, perceptions of harm and risk, beliefs about the product, quit intentions, and intention to try or purchase the product.

    In the Federal Register of November 19, 2014 (79 FR 68888), FDA published a 60-day notice requesting public comment on the proposed collection of information. Three comments were received, however only two were PRA related.

    (Comment) One commenter critiqued the inclusion of items assessing brand loyalty, asserting such constructs have “no practical utility” for MRTPA review and is beyond the FDA's statutory authority because it is not mentioned in the FD&C Act.

    (Response) FDA does not agree. Although concepts such as “brand loyalty” are not specifically mentioned in the FD&C Act, FDA seeks understanding of how attitudes toward one's preferred brand(s) may affect perceptions and understanding of modified risk information (section 911(h)(1)). The goal of the present experiments is to understand how consumers react to RM and EM claims, in order to inform FDA's ability to evaluate MRTPAs. Brand loyalty is widely regarded as an important driver of consumer behavior (Ref. 1). Moreover, psychological theory and evidence suggests that the source of information can affect how that information is processed—including whether or not it is perceived as believable and is persuasive (Ref. 2). Thus, consumers' brand attitudes are highly relevant to understanding how they interpret and respond to claims made by that brand. To omit this possible influence from our analyses would, in our assessment, limit our ability to fully understand consumer perceptions of MRTPs.

    (Comment) One commenter suggested that to assess the variable “purchase interest,” FDA should assign a hypothetical price to the product being studied.

    (Response) FDA acknowledges that price plays an important role in consumers' purchasing decisions. However, examination of the role of price is beyond the scope of the present studies. The experimental design of this study will enable comparisons between experimental conditions on intentions to use the product; thus, rather than evaluating absolute levels of interest, results will examine relative levels of interest across experimental conditions. Thus, the measure of intentions to use the product will assess consumer interest in the product without regard to cost.

    (Comment) One commenter noted that Study 1 proposes to focus on conventional cigarettes and asks how FDA proposes to address the issue of novel devices/products when considering consumer perceptions?

    (Response) FDA agrees that the current studies are not designed to assess interest in novel devices/products. Addressing questions related to consumer perceptions of novel devices/products, and reactions to claims about those products, is beyond the scope of the current set of studies.

    (Comment) One commenter asked for specificity regarding how FDA will define susceptibility to tobacco use among the adolescents in Study 3.

    (Response) FDA plans to use items from Pierce and colleagues (1996) to identify adolescents who are susceptible to using tobacco. These items are: (1) Do you think that you will smoke a cigarette soon? (2) Do you think you will smoke a cigarette at any time in the next year? and (3) If one of your best friends were to offer you a cigarette, would you smoke it? Response options are: (1) Definitely yes; (2) Probably yes; (3) Probably not; and (4) Definitely not. A respondent who selects a response of 1, 2, or 3 to any of these items is classified as susceptible.

    (Comment) One commenter sought clarification regarding which health warnings will be used (on the study stimuli) alongside the claims and how FDA intends to address the balance between MRTP claims and warnings.

    (Response) Study stimuli-images of tobacco product packages and ads-will display the warning labels currently mandated for each product category. The warnings will be rotated (between participants) so that all mandated warnings are used. Because the current studies are not intended to examine the relationship between warnings and claims (including potential interactions between the two), warning label assignment will not be an experimental factor in the study design. Instead, the warnings will be rotated throughout all conditions to control for any differences between them (alone or in combination with a particular claim).

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual
  • responses
  • Average
  • burden per
  • response
  • Total hours
    Adult Screener 24,000 1 24,000 0.03 (2 minutes) 720 Study 1 (Adults) 1,800 1 1,800 0.333 (20 minutes) 599 Study 2 (Adults) 600 1 600 0.333 (20 minutes) 200 Total Adult Hours 1,519 Youth Screener 6,000 1 6,000 0.03 (2 minutes) 180 Study 3 (Youth) 600 1 600 0.333 (20 minutes) 200 Total Youth Hours 380 Total Hours 1,899 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's burden estimate is based on prior experience with research that is similar to this proposed study. Approximately 30,000 respondents will complete a screener to determine eligibility for participation in a study, estimated to take approximately 2 minutes (0.03 hours), for a total of 900 hours for screening activities. Three thousand respondents will complete a full study, estimated to last 20 minutes (0.333 hours), for a total of 999 hours for completion of both adult studies and 1 youth study. The estimated total hour burden of the collection of information is 1,899 hours.

    References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov.

    1. Keller, Kevin L. and Donald R. Lehman, “Brands and Branding: Research Findings and Future Priorities,” Marketing Science, vol. 25, no. 6, pp. 740-759, 2006. 2. Eagly, Alice H. and Shelly Chaiken, “Process Theories of Attitude Formation and Change: Reception and Cognitive Responding,” The Psychology of Attitudes, Chapter 6, Harcourt Brace Jovanovich College Publishers, 1993. Dated: January 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-01788 Filed 2-1-16; 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, Member Conflict: Medical Imaging Investigations.

    Date: February 18, 2016.

    Time: 8:00 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: Mehrdad Mohseni, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-0484; [email protected]

    Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group, Diseases and Pathophysiology of the Visual System Study Section.

    Date: February 25-26, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301-435-1265; [email protected]

    Name of Committee: Oncology 2—Translational Clinical Integrated Review Group, Cancer Immunopathology and Immunotherapy Study Section.

    Date: February 25-26, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Dupont Hotel, 1500 New Hampshire Avenue NW., Washington, DC 20036.

    Contact Person: Denise R Shaw, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6158, MSC 7804, Bethesda, MD 20892, 301-435-0198; [email protected]

    Name of Committee: Oncology 1—Basic Translational Integrated Review Group, Tumor Progression and Metastasis Study Section.

    Date: March 2-3, 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: Rolf Jakobi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301-495-1718; [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Alcohol, Drugs and Neurotoxicology.

    Date: March 2-3, 2016.

    Time: 8:00 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301-435-1119; [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel, PAR-13- 327: Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care.

    Date: March 2, 2016.

    Time: 11:00 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.

    Contact Person: Zhang-Zhi Hu, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, (301) 594-2414; [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: January 27, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-01818 Filed 2-1-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Patient-Oriented Research Review Committee.

    Date: February 25-26, 2016.

    Time: 8:30 a.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Stephanie Johnson Webb, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301-435-0291, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: January 27, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-01816 Filed 2-1-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; PPG Review for Transfusion.

    Date: February 23, 2016.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817.

    Contact Person: Melissa E. Nagelin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7202, Bethesda, MD 20892, 301-435-0297, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Methods for Measuring Tissue Oxygenation.

    Date: February 25, 2016.

    Time: 12:00 p.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Giuseppe Pintucci, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892, 301-435-0287, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: January 27, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-01817 Filed 2-1-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY:

    Substance Abuse and Mental Health Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809).

    A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines.

    If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.

    This notice is also available on the Internet at http://www.samhsa.gov/workplace.

    FOR FURTHER INFORMATION CONTACT:

    Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice), 240-276-2610 (fax).

    SUPPLEMENTARY INFORMATION:

    The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.

    To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.

    Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.

    In accordance with the Mandatory Guidelines dated November 25, 2008 (73 FR 71858), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

    HHS-Certified Instrumented Initial Testing Facilities Dynacare, 6628 50th Street NW., Edmonton, AB Canada T6B 2N7, 780-784-1190 (Formerly: Gamma-Dynacare Medical Laboratories) HHS-Certified Laboratories ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585-429-2264 Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615-255-2400 (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc., Aegis Analytical Laboratories) Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-8989/800-433-3823 (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.) Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804-378-9130 (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.) Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock, AR 72209-7056, 501-202-2783 (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215-2802, 800-445-6917 DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-235-4890 Dynacare ,* 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-1630 (Formerly: Gamma-Dynacare Medical Laboratories) ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662-236-2609 Fortes Laboratories, Inc., 25749 SW., Canyon Creek Road, Suite 600, Wilsonville, OR 97070, 503-486-1023 Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713-856-8288/800-800-2387 Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908-526-2400/800-437-4986 (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919-572-6900/800-833-3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group) Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866-827-8042/800-233-6339 (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center) LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913-888-3927/800-873-8845 (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.) MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651-636-7466/800-832-3244 MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232, 503-413-5295/800-950-5295 Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088, Testing for Veterans Affairs (VA) Employees Only National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661-322-4250/800-350-3515 One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888-747-3774 (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory) Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800-328-6942 (Formerly: Centinela Hospital Airport Toxicology Laboratory) Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509-755-8991/800-541-7891x7 Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-5840

    * The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.

    Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 30, 2010 (75 FR 22809). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program.

    Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800-729-6432 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories) Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610-631-4600/877-642-2216 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories) Quest Diagnostics Incorporated, 8401 Fallbrook Ave., West Hills, CA 91304, 818-737-6370 (Formerly: SmithKline Beecham Clinical Laboratories) Redwood Toxicology Laboratory, 3700650 Westwind Blvd., Santa Rosa, CA 95403, 800-255-2159 Southwest Laboratories, 4625 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040, 602-438-8507/800-279-0027 STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800-442-0438 U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for Department of Defense (DoD) Employees Only
    Summer King, Statistician.
    [FR Doc. 2016-01819 Filed 2-1-16; 8:45 am] BILLING CODE 4160-20-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0087 Agency Information Collection Activities: Application for Citizenship and Issuance of Certificate Under Section 322, Form N-600K; Revision of a Currently Approved Collection AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until April 4, 2016.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0087 in the subject box, the agency name and Docket ID USCIS-2007-0019. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov under e-Docket ID number USCIS-2007-0019;

    (2) Email. Submit comments to [email protected];

    (3) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2007-0019 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies 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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; 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 of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application for Citizenship and Issuance of Certificate under Section 322.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-600K; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. This form provides an organized framework for establishing the authenticity of an applicant's eligibility and is essential for providing prompt, consistent and correct processing of such applications for citizenship under section 322 of the Immigration and Nationality Act.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-600K is 4,272 and the estimated hour burden per response is 2.0833 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 8,900 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $523,320.

    Dated: January 27, 2016. Elizabeth Zemlan, Acting Deputy Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2016-01794 Filed 2-1-16; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0082] Agency Information Collection Activities: Application to Replace Permanent Resident Card, Form I-90; Revision of a Currently Approved Collection AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day Notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on November 9, 2015 at 80 FR 69243, allowing for a 60-day public comment period. USCIS did receive eight comments in connection with the 60-day notice.

    DATES:

    The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 3, 2016. This process is conducted in accordance with 5 CFR 1320.10.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] Comments may also be submitted via fax at (202) 395-5806 (This is not a toll-free number). All submissions received must include the agency name and the OMB Control Number 1615-0082.

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Laura Dawkins, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2009-0002 in the search box. Written comments and suggestions from the public and affected agencies 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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; 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 Request: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application to Replace Permanent Resident Card.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-90; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Form I-90 is used by USCIS to determine eligibility to replace a Lawful Permanent Resident Card.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:

    485,298 respondents responding via the paper Form I-90 at an estimated1 hour and 45 minutes (1.75 hours) per response.

    326,532 respondents responding via the Electronic Immigration System (ELIS) requiring an estimated 1 hour and 25 minutes (1.42 hours) per response. This estimated time was previously reported as .50 hours per response.

    808,830 respondents requiring Biometric Processing at an estimated 1 hour and 10 minutes (1.17 hours) per response.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 2,259,277 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $206,656,065.

    Dated: January 20, 2016. Samantha Deshommes, Acting Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2016-01861 Filed 2-1-16; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0057] Agency Information Collection Activities: Application of Certificate of Citizenship, Form N-600, Form N-600; Revision of a Currently Approved Collection AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until April 4, 2016.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0057 in the subject box, the agency name and Docket ID USCIS-2006-0023. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov under e-Docket ID number USCIS-2006-0023;

    (2) Email. Submit comments to [email protected];

    (3) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2006-0023 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies 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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; 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 of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application of Certificate of Citizenship, Form N-600.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-600; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information on Form N-600 to make a determination that the citizenship eligibility requirements and conditions are met by the applicant so that a certificate of citizenship can be generated.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-600 is 61,279 and the estimated hour burden per response is 1.6 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 98,046 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $6,982,500.

    Dated: January 27, 2016. Elizabeth Zemlan, Acting Deputy Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2016-01793 Filed 2-1-16; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0100] Agency Information Collection Activities: Request for the Return of Original Documents (Form G-884); Revision of an Existing Information Collection; Comment Request AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day Notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the Federal Register on November 9, 2015, at 80 FR 69244, allowing for a 60-day public comment period. USCIS did not receive any comments in connection with the 60-day notice.

    DATES:

    The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 3, 2016. This process is conducted in accordance with 5 CFR 1320.10.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] Comments may also be submitted via fax at (202) 395-5806 (This is not a toll-free number). All submissions received must include the agency name and the OMB Control Number [1615-0100].

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0010 in the search box. Written comments and suggestions from the public and affected agencies 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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; 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 Request: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Request for the Return of Original Documents.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-884; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. The information will be used by USCIS to determine whether a person is eligible to obtain original documents(s) contained in an alien file.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection G-884 is 7,500 and the estimated hour burden per response is 0.5 hours (30 minutes).

    (6) An estimate of the total public burden (in hours) associated with the collection: The estimated total annual cost burden associated with this collection of information is $3,750.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $0.

    Dated: January 20, 2016. Samantha Deshommes, Acting Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2016-01860 Filed 2-1-16; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5909-N-05] 30-Day Notice of Proposed Information Collection: Disaster Management AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

    DATES:

    Comments Due Date: March 3, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at [email protected] or telephone 202-402-3400. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on November 9, 2015 at 80 FR 69245.

    A. Overview of Information Collection

    Title of Information Collection: Disaster Management.

    OMB Approval Number: 2502-0582.

    Type of Request: Extension of currently approved collection.

    Form Number: None.

    Description of the need for the information and proposed use: To provide an orderly and continuing means of assistance by the Federal Government to State and local governments in carrying out their responsibilities to alleviate the suffering and damage resulting from such disasters.

    Respondents: HUD staff and multifamily housing project owners who are subject to HUD regulations.

    Estimated Number of Respondents: 11,736.

    Estimated Number of Responses: 8.

    Frequency of Response: Upon Presidentially declared disasters involving individual assistance.

    Average Hours per Response: 1.75 hours.

    Total Estimated Burdens: 14.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Date: January 21, 2016. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2016-01791 Filed 2-1-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R3-ES-2016-N009; FXES11130300000-167-FF03E00000] Endangered and Threatened Wildlife and Plants; Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability of permit applications; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered or threatened species unless a Federal permit allows such activity. The Act requires that we invite public comment before issuing these permits.

    DATES:

    We must receive any written comments on or before March 3, 2016.

    ADDRESSES:

    Send written comments by U.S. mail to the Regional Director, Attn: Carlita Payne, U.S. Fish and Wildlife Service, Ecological Services, 5600 American Blvd. West, Suite 990, Bloomington, MN 55437-1458; or by electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Carlita Payne, (612) 713-5343.

    SUPPLEMENTARY INFORMATION:

    Background

    We invite public comment on the following permit applications for certain activities with endangered species authorized by section 10(a)(1)(A) of the Act (16 U.S.C. 1531 et seq.) and our regulations governing the taking of endangered species in the Code of Federal Regulations (CFR) at 50 CFR part 17. Submit your written data, comments, or request for a copy of the complete application to the mailing address or email address shown in ADDRESSES.

    Permit Applications Permit Application Number: TE35517B Applicant: Bryan Arnold, Illinois College, Jacksonville, IL

    The applicant requests a permit renewal, with amendments to the existing permit to take (capture and release, conduct nonlethal sampling, and radio-tag) Florida bonneted bat (Eumops floridanus) and add the State of Florida. Proposed activities are for the recovery and enhancement of survival of the species in the wild.

    Permit Application Number: 81974B Applicant: Eastern Illinois University, Charleston, IL

    The applicant requests a permit to take (conduct phylogeny studies) pallid sturgeon (Scaphirhynchus albus) and shovelnose sturgeon (S. platorynchus) in Illinois. Proposed activities are for the recovery and enhancement of survival of the species in the wild.

    Permit Application Number: 81973B Applicant: Chequamegon-Nicolet National Forest and Northern Research Station, Washburn, WI

    The applicant requests a permit to take (capture and release, conduct nonlethal sampling, band, and radio-tag) Indiana bat (Myotis sodalis) and northern long-eared bat (M. septentrionalis) in the States of Illinois, Iowa, Maine, Michigan, Minnesota, New Hampshire, New York, Pennsylvania, Vermont, and Wisconsin. Proposed activities are for the recovery and enhancement of survival of the species in the wild.

    Permit Application Number: 81968B Applicant: Curtis Hart, Hudson, MI

    The applicant requests a permit to take (capture and release, harass, conduct nonlethal sampling, band, trap, radio-tag, and salvage) Indiana bat (Myotis sodalis), northern long-eared bat (M. septentrionalis), Virginia big-eared bat (Corynorhinus townsendii virginianus), and Ozark big-eared bat (C. t. ingens) in the States of Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming. Proposed activities are for the recovery and enhancement of survival of the species in the wild.

    Permit Application Number: TE697830 Applicant: Assistant Regional Director, Ecological Services, U.S. Fish and Wildlife Service, Bloomington, MN

    The applicant requests a permit renewal to take listed species that occur within the States of Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, and Wisconsin for activities to recover the species and enhance the survival of the species in the wild.

    Request for Public Comments

    We seek public review and comments on these permit applications. Please refer to the permit number when you submit comments. Comments and materials we receive are available for public inspection, by appointment, during normal business hours at the address shown in the ADDRESSES section. 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: January 27, 2016. Lynn M. Lewis, Assistant Regional Director, Ecological Services, Midwest Region.
    [FR Doc. 2016-01840 Filed 2-1-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R6-ES-2015-N246]; [FXES11130600000-167-FF06E00000] Endangered and Threatened Wildlife and Plants; Recovery Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct activities intended to enhance the survival of endangered or threatened species.

    DATES:

    To ensure consideration, please send your written comments by March 3, 2016.

    ADDRESSES:

    You may submit comments or requests for copies or more information by any of the following methods. Alternatively, you may use one of the following methods to request hard copies or a CD-ROM of the documents. Please specify the permit you are interested in by number (e.g., Permit No. TE-XXXXXX).

    Email: [email protected] Please refer to the respective permit number (e.g., Permit No. TE-XXXXXX) in the subject line of the message.

    U.S. Mail: Ecological Services, U.S. Fish and Wildlife Service, P.O. Box 25486-DFC, Denver, CO 80225.

    In-Person Drop-off, Viewing, or Pickup: Call (719) 628-2670 to make an appointment during regular business hours at 134 Union Blvd., Suite 645, Lakewood, CO 80228.

    FOR FURTHER INFORMATION CONTACT:

    Kathy Konishi, Recovery Permits Coordinator, Ecological Services, (719) 628-2670 (phone); [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    Background

    The Act (16 U.S.C. 1531 et seq.) prohibits certain activities with endangered and threatened species unless authorized by a Federal permit. Along with our implementing regulations at 50 CFR 17, the Act provides for permits and requires that we invite public comment before issuing these permits for endangered species.

    A permit granted by us under section 10(a)(1)(A) of the Act authorizes the permittees to conduct activities with U.S. endangered or threatened species for scientific purposes, enhancement of propagation or survival, or interstate commerce (the latter only in the event that it facilitates scientific purposes or enhancement of propagation or survival). Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

    Applications Available for Review and Comment

    We invite local, State, and Federal agencies and the public to comment on the following applications. Documents and other information the applicants have submitted with their applications are available for review, subject to the requirements of the Privacy Act (5 U.S.C. 552a) and Freedom of Information Act (5 U.S.C. 552).

    Permit Application Number TE85057B

    Applicant: George Cunningham, Omaha, NE.

    The applicant requests a permit to conduct presence/absence surveys for Topeka shiner (Notropis topeka) in Nebraska, Kansas, and South Dakota to conduct presence/absence surveys for the purpose of enhancing the species' survival.

    Permit Application Number TE047288

    Applicant: National Park Service, Heartland Network, Republic, MO.

    The applicant requests a renewal to an existing permit to continue presence/absence surveys for Topeka shiner (Notropis topeka) in Kansas and Minnesota for the purpose of enhancing the species' survival.

    Permit Application Number TE85664B

    Applicant: Wingate Biological Solutions, LLC, Durango, CO.

    The applicant requests a permit to conduct survey and monitoring activities for the southwestern willow flycatcher (Empidonax traillii extimus) in Colorado, Utah, New Mexico, and Arizona for the purpose of enhancing the species' survival.

    Permit Application Number TE056001

    Applicant: East Dakota Water Development District, Brookings, SD.

    The applicant requests a renewal to an existing permit to continue presence/absence surveys for Topeka shiner (Notropis topeka) in Kansas and Minnesota for the purpose of enhancing the species' survival.

    National Environmental Policy Act

    In compliance with the National Environmental Policy Act (42 U.S.C. 4321 et seq.), we have made an initial determination that the proposed activities in these permits are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement (516 DM 6 Appendix 1, 1.4C(1)).

    Public Availability of Comments

    All comments and materials we receive in response to these requests will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section of this notice.

    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.

    Authority

    We provide this notice under section 10 of the Act (16 U.S.C. 1531 et seq.).

    Michael G. Thabault, Assistant Regional Director, Mountain-Prairie Region.
    [FR Doc. 2016-01834 Filed 2-1-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLCON00000 L10200000 DF0000.LXSS080C0000] Notice of Public Meetings, Northwest Resource Advisory Council Meeting AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Northwest Resource Advisory Council (RAC) will meet as indicated below.

    DATES:

    The Northwest RAC has scheduled meetings August 18 and December 8, 2016, from 8 a.m. to 3 p.m. with public comment periods regarding matters on the agenda at 10 a.m. and 2 p.m. A specific agenda for each meeting will be available prior to the meetings at http://www.blm.gov/co/st/en/BLM_Resources/racs/nwrac.html.

    ADDRESSES:

    The August 18 meeting will be held in Craig, Colorado, at the Craig Memorial Hospital on 750 Hospital Loop, Craig, CO 81625. The December 8 meeting will be held at the Courtyard by Marriott, 765 Horizon Drive, Grand Junction, CO 81506.

    FOR FURTHER INFORMATION CONTACT:

    Chris Joyner, Public Affairs Specialist, Grand Junction Field Office, 2815 H Road, Grand Junction, CO 81506, or by telephone at (970) 244-3097. 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. The FIRS is available 24 hours a day, seven 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 Northwest RAC advises the Secretary of the Interior, through the BLM, on a variety of public land issues in northwestern Colorado.

    Topics of discussion during Northwest RAC meetings may include management of Greater Sage-Grouse, working group reports, recreation, fire management, land use planning, invasive species management, energy and minerals management, travel management, wilderness, wild horse herd management, land exchange proposals, cultural resource management, and other issues as appropriate.

    These meetings are open to the public. Subcommittees under this RAC may meet this year regarding travel management in the White River Field Office. Active subcommittees report to the NW RAC at each council meeting. Subcommittee meetings are open to the public. More information is available at http://www.blm.gov/co/st/en/BLM_Resources/racs/nwrac.html. The public may present written comments to the RACs. Each formal RAC meeting will also have time, as identified above, allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited.

    Ruth Welch, BLM Colorado State Director.
    [FR Doc. 2016-01740 Filed 2-1-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORS00100.L63340000.PH0000.LXSSH1020000.16XL1116AF.HAG 16-0064] Notice of Meeting of the Northwest Oregon Resource Advisory Council AGENCY:

    Bureau of Land Management, Interior

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the Bureau of Land Management's (BLM) Northwest Oregon Resource Advisory Council (RAC) will meet as indicated below.

    DATES:

    The RAC will meet on Wednesday through Friday, March 9-11, 2016, from 9:00 a.m.-5:00 p.m. The RAC members will review and select Secure Rural Schools Title II project proposals for the counties in Northwest Oregon. The Wednesday and Thursday meetings will be held at the Willamette Heritage Center (Mission Mill), 1313 Mill Street SE., Salem, OR 97301. On Wednesday, March 9, the public comment period will occur from 10:00-10:30 a.m. On Thursday, March 10, the public comment period will occur from 9:00-9:30 a.m. On Friday, March 11, 2016, the RAC will meet at the Eugene BLM Office at 3106 Pierce Parkway, Suite E, Springfield, OR 97477.

    On Friday, March 11, the public comment period will occur from 1:00-1:30 p.m.

    FOR FURTHER INFORMATION CONTACT:

    Trish Hogervorst, Co-Coordinator for the Northwest Oregon RAC, 1717 Fabry Road SE., Salem, OR 97306, (503) 375-5657, [email protected] or Jennifer Velez, 3106 Pierce Parkway SE., Springfield, OR 97477, (541) 222-9241, [email protected]. 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 individuals during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individuals. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The fifteen-member Northwest Oregon RAC was chartered to serve in an advisory capacity concerning the planning and management of the public land resources located within the BLM's Salem and Eugene Districts. Members represent an array of stakeholder interests in the land and resources from within the local area and statewide. Planned agenda items include reviewing and voting on Secure Rural Schools project submissions for each county in Northwest Oregon. On each day of the three day meeting, members of the public will have the opportunity to make comments to the RAC during a public comment period. All advisory committee meetings are open to the public. Persons wishing to make comments during the public comment period should register in person with the BLM, at the meeting location, preceding that meeting day's comment period. Depending on the number of persons wishing to comment, the length of comments may be limited. The public may send written comments to the RAC at the Salem District office, 1717 Fabry Road SE., Salem, OR 97306. The BLM appreciates all comments.

    Kim Titus, Salem District Manager.
    [FR Doc. 2016-01839 Filed 2-1-16; 8:45 am] BILLING CODE 4310-33-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-SERO-RTCA-20119; PPMPSPD1T.Y00000;PPSESERO10] Wekiva River System Advisory Management Committee 2016 Meeting Schedule AGENCY:

    National Park Service, Interior.

    ACTION:

    Meeting notice.

    SUMMARY:

    Notice is hereby given in accordance with the Federal Advisory Committee Act, (5 U.S.C. Appendix 1-16), of the 2016 meeting schedule for the Wekiva River System Advisory Management Committee.

    DATES:

    The meetings are scheduled for: March 9, 2016; June 1, 2016; September 7, 2016; and November 9, 2016. (Eastern) All meetings will begin at 3:00 p.m. and will end by 5:00 p.m.

    ADDRESSES:

    All scheduled meetings will be held at the Wekiwa Springs State Park, 1800 Wekiwa Circle, Apopka, FL 32712. Call (407) 884-2006 or visit online at floridastateparks.org/wekiwasprings/ for additional information on this facility.

    FOR FURTHER INFORMATION CONTACT:

    Jaime Doubek-Racine, Community Planner and Designated Federal Official, Rivers, Trails, and Conservation Assistance Program, Florida Field Office, Southeast Region, 5342 Clark Road, PMB #123, Sarasota, Florida 34233, or via telephone (941) 685-5912.

    SUPPLEMENTARY INFORMATION:

    The Wekiva River System Advisory Management Committee was established by Public Law 106-299 to assist in the development of the comprehensive management plan for the Wekiva River System and provide advice to the Secretary of the Interior in carrying out management responsibilities of the Secretary under the Wild and Scenic Rivers Act (16 U.S.C. 1274). Efforts have been made locally to ensure that the interested public is aware of the meeting dates.

    The scheduled meetings will be open to the public. Each scheduled meeting will result in decisions and steps that advance the Wekiva River System Advisory Management Committee towards its objective of managing and implementing projects developed from the Comprehensive Management Plan for the Wekiva Wild and Scenic River.

    Any member of the public may file with the Committee a written statement concerning any issues relating to the development of the Comprehensive Management Plan for the Wekiva Wild and Scenic River. The statement should be addressed to the Wekiva River System Advisory Management Committee, National Park Service, 5342 Clark Road, PMB #123, Sarasota, Florida 34233.

    Before including your address, telephone number, email address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may 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: January 19, 2016. Alma Ripps, Chief, Office of Policy.
    [FR Doc. 2016-01814 Filed 2-1-16; 8:45 am] BILLING CODE 4310-EE-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-20046; PPWOCRADN0-PCU00RP16.R50000] Native American Graves Protection and Repatriation Review Committee; Meetings AGENCY:

    National Park Service, Interior.

    ACTION:

    Meeting notice.

    SUMMARY:

    Notice is hereby given in accordance with the Federal Advisory Committee Act, (5 U.S.C. Appendix 1-16), of four meetings of the Native American Graves Protection and Repatriation Review Committee (Review Committee). All meetings will be open to the public.

    DATES:

    The Review Committee will meet on April 19, 2016, from 2 p.m. until approximately 6 p.m. (Eastern); July 13-14, 2016, from 8:30 a.m. to 5:00 p.m. (Mountain) and July 15, 2016, from 8:30 a.m. to 12:00 p.m. (Mountain); September 13, 2016, from 2:00 p.m. until approximately 6:00 p.m. (Eastern); and, if necessary, December 6, 2016, from 2:00 p.m. until approximately 6:00 p.m. (Eastern). Related deadlines for participating in each meeting are detailed in this notice.

    ADDRESSES:

    The Review Committee will meet on July 13-July 15, 2016, at the Holiday Inn Missoula Downtown, 200 S. Pattee Street, Missoula, MT 59802. Electronic submissions of materials or requests are to be sent to [email protected]. Those who desire to participate via telephone should register at http://www.nps.gov/nagpra, to be provided the telephone access number for the meeting.

    SUPPLEMENTARY INFORMATION:

    The Review Committee was established in Section 8 of the Native American Graves Protection and Repatriation Act of 1990 (NAGPRA), 25 U.S.C. 3006.

    April 19, 2016

    The Review Committee will meet via teleconference on April 19, 2016, from 2:00 p.m. until approximately 6:00 p.m. (Eastern). This meeting will be open to the public. The agenda for this meeting will include a report from the National NAGPRA Program; the discussion of the Review Committee Report to Congress for 2016; subcommittee reports and discussion; and other topics related to the Review Committee's responsibilities under Section 8 of NAGPRA. In addition, the agenda may include requests to the Review Committee for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be culturally unidentifiable proceed; presentations by Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals; and public comment. The agenda and materials for this meeting will be posted on or before March 22, 2016, at http://www.nps.gov/nagpra.

    The Review Committee is soliciting presentations from Indian tribes, Native Hawaiian organizations, museums, and Federal agencies on the following two topics: (1) The progress made, and any barriers encountered, in implementing NAGPRA and (2) the outcomes of disputes reviewed by the Review Committee pursuant to 25 U.S.C. 3006(c)(4). The Review Committee also will consider other presentations from Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals. A presentation request must, at minimum, include an abstract of the presentation and contact information for the presenter(s). Presentation requests and materials must be received by March 15, 2016. Written comments will be accepted from any party and provided to the Review Committee. Written comments received by March 15, 2016, will be provided to the Review Committee before the meeting.

    The Review Committee will consider requests for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be culturally unidentifiable (CUI) proceed. A CUI disposition request must include the appropriate, completed form posted on the National NAGPRA Program Web site and, as applicable, the ancillary materials noted on the form. To access and download the appropriate form—either the form for CUI with a “tribal land” or “aboriginal land” provenience or the form for CUI without a “tribal land” or “aboriginal land” provenience—go to http://www.nps.gov/nagpra, and then click on “Request for CUI Disposition Forms.” CUI disposition requests must be received by March 8, 2016.

    Submissions and requests should be sent to [email protected] Such items are subject to posting on the National NAGPRA Program Web site prior to the meeting. Those who desire to attend the meeting should register at http://www.nps.gov/nagpra to be provided the telephone access number for the meeting. A transcript and minutes of the meeting will also appear on the Web site.

    July 13-July 15, 2016

    The Review Committee will meet on July 13-14, 2016, from 8:30 a.m. to 5:00 p.m. (Mountain) and July 15, 2016, from 8:30 a.m. to 12:00 p.m. (Mountain), at the Holiday Inn Missoula Downtown, Missoula, MT. This meeting will be open to the public. The agenda for this meeting will include a report from the National NAGPRA Program; the discussion of the Review Committee Report to Congress for 2016; subcommittee reports and discussion; and other topics related to the Review Committee's responsibilities under Section 8 of NAGPRA. In addition, the agenda may include requests to the Review Committee for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be culturally unidentifiable proceed; presentations by Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals; public comment; requests to the Review Committee, pursuant to 25 U.S.C. 3006(c)(3), for review and findings of fact related to the identity or cultural affiliation of human remains or other cultural items, or the return of such items; and facilitation of the resolution of disputes among parties convened by the Review Committee pursuant to 25 U.S.C. 3006 (c)(4). Presentation to the Review Committee by telephone may be requested but is not guaranteed. The agenda and materials for this meeting will be posted on or before June 15, 2016, at http://www.nps.gov/nagpra.

    The Review Committee is soliciting presentations from Indian tribes, Native Hawaiian organizations, museums, and Federal agencies on the following two topics: (1) The progress made, and any barriers encountered, in implementing NAGPRA and (2) the outcomes of disputes reviewed by the Review Committee pursuant to 25 U.S.C. 3006(c)(4). The Review Committee also will consider other presentations from Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals. A presentation request must, at minimum, include an abstract of the presentation and contact information for the presenter(s). Presentation requests and materials must be received by June 1, 2016. Written comments will be accepted from any party and provided to the Review Committee. Written comments received by June 8, 2016, will be provided to the Review Committee before the meeting.

    The Review Committee will consider requests for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be CUI proceed. A CUI disposition request must include the appropriate, completed form posted on the National NAGPRA Program Web site and, as applicable, the ancillary materials noted on the form. To access and download the appropriate form—either the form for CUI with a “tribal land” or “aboriginal land” provenience or the form for CUI without a “tribal land” or “aboriginal land” provenience—go to http://www.nps.gov/nagpra, and then click on “Request for CUI Disposition Forms.” CUI disposition requests must be received by May 4, 2016.

    The Review Committee will consider requests, pursuant to 25 U.S.C. 3006(c)(3), for review and findings of fact related to the identity or cultural affiliation of human remains or other cultural items, or the return of such items, where consensus among affected parties is unclear or uncertain. A request for findings of fact must be accompanied by a statement of the fact(s) at issue and supporting materials, including those exchanged by the parties to consultation concerning the Native American human remains and/or other cultural items. To access procedures for presenting findings of fact, go to http://www.nps.gov/nagpra/REVIEW/Procedures.htm. Requests for findings of fact must be received by March 2, 2016.

    The Review Committee will consider requests, pursuant to 25 U.S.C. 3006(c)(4), to convene parties and facilitate the resolution of a dispute, where consensus clearly has not been reached among affected parties regarding the identity or cultural affiliation of human remains or other cultural items, or the return of such items. A request to convene parties and facilitate the resolution of a dispute must be accompanied by a statement of the decision of the museum or Federal agency subject to the dispute resolution request, a statement of the issue, and the materials exchanged by the parties concerning the Native American human remains and/or other cultural items. To access procedures for presenting disputes, go to http://www.nps.gov/nagpra/REVIEW/Procedures.htm. Requests to convene parties and facilitate resolution of a dispute must be received by March 2, 2016.

    Submissions and requests should be sent to [email protected] Such items are subject to posting on the National NAGPRA Program Web site prior to the meeting.

    September 13, 2016

    The Review Committee will meet via teleconference on September 13, 2016, from 2:00 p.m. until approximately 6:00 p.m. (Eastern). This meeting will be open to the public. The agenda for this meeting will include a report from the National NAGPRA Program; the discussion of the Review Committee Report to Congress for 2016; subcommittee reports and discussion; and other topics related to the Review Committee's responsibilities under Section 8 of NAGPRA. In addition, the agenda may include requests to the Review Committee for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be culturally unidentifiable proceed; presentations by Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals; and public comment. The agenda and materials for this meeting will be posted on or before August 16, 2016, at http://www.nps.gov/nagpra.

    The Review Committee is soliciting presentations from Indian tribes, Native Hawaiian organizations, museums, and Federal agencies on the following two topics: (1) The progress made, and any barriers encountered, in implementing NAGPRA and (2) the outcomes of disputes reviewed by the Review Committee pursuant to 25 U.S.C. 3006(c)(4). The Review Committee also will consider other presentations from Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals. A presentation request must, at minimum, include an abstract of the presentation and contact information for the presenter(s). Presentation requests and materials must be received by August 2, 2016. Written comments will be accepted from any party and provided to the Review Committee. Written comments received by August 9, 2016, will be provided to the Review Committee before the meeting.

    The Review Committee will consider requests for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be CUI proceed. A CUI disposition request must include the appropriate, completed form posted on the National NAGPRA Program Web site and, as applicable, the ancillary materials noted on the form. To access and download the appropriate form—either the form for CUI with a “tribal land” or “aboriginal land” provenience or the form for CUI without a “tribal land” or “aboriginal land” provenience—go to http://www.nps.gov/nagpra, and then click on “Request for CUI Disposition Forms.” CUI disposition requests must be received by July 5, 2016.

    Submissions and requests should be sent to [email protected] Such items are subject to posting on the National NAGPRA Program Web site prior to the meeting. Those who desire to attend the meeting should register at http://www.nps.gov/nagpra to be provided the telephone access number for the meeting. A transcript and minutes of the meeting will also appear on the Web site.

    December 6, 2016

    The Review Committee will meet, if necessary, via teleconference on December 6, 2016, from 2:00 p.m. until approximately 6:00 p.m. (Eastern). This meeting will be open to the public. The agenda for this meeting will include a report from the National NAGPRA Program; the finalization of the Review Committee Report to Congress for 2016; subcommittee reports and discussion; and other topics related to the Review Committee's responsibilities under Section 8 of NAGPRA. In addition, the agenda may include requests to the Review Committee for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be culturally unidentifiable proceed; presentations by Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals; and public comment. The agenda and materials for this meeting will be posted on or before November 8, 2016, at http://www.nps.gov/nagpra.

    The Review Committee is soliciting presentations from Indian tribes, Native Hawaiian organizations, museums, and Federal agencies on the following two topics: (1) The progress made, and any barriers encountered, in implementing NAGPRA and (2) the outcomes of disputes reviewed by the Review Committee pursuant to 25 U.S.C. 3006 (c)(4). The Review Committee also will consider other presentations from Indian tribes, Native Hawaiian organizations, museums, Federal agencies, associations, and individuals. A presentation request must, at minimum, include an abstract of the presentation and contact information for the presenter(s). Presentation requests and materials must be received by October 25, 2016. Written comments will be accepted from any party and provided to the Review Committee. Written comments received by November 1, 2016, will be provided to the Review Committee before the meeting.

    The Review Committee will consider requests for a recommendation to the Secretary of the Interior that an agreed-upon disposition of Native American human remains determined to be CUI proceed. A CUI disposition request must include the appropriate, completed form posted on the National NAGPRA Program Web site and, as applicable, the ancillary materials noted on the form. To access and download the appropriate form—either the form for CUI with a “tribal land” or “aboriginal land” provenience or the form for CUI without a “tribal land” or “aboriginal land” provenience—go to http://www.nps.gov/nagpra, and then click on “Request for CUI Disposition Forms.” CUI disposition requests must be received by September 27, 2016.

    Submissions and requests should be sent to [email protected] Such items are subject to posting on the National NAGPRA Program Web site prior to the meeting. Those who desire to attend the meeting should register at http://www.nps.gov/nagpra to be provided the telephone access number for the meeting. A transcript and minutes of the meeting will also appear on the Web site.

    General Information

    Information about NAGPRA, the Review Committee, and Review Committee meetings is available on the National NAGPRA Program Web site at http://www.nps.gov/nagpra. For the Review Committee's meeting procedures, click on “Review Committee,” then click on “Procedures.” Meeting minutes may be accessed by going to the Web site, then clicking on “Review Committee,” and then clicking on “Meeting Minutes.” Approximately fourteen weeks after each Review Committee meeting, the meeting transcript is posted on the National NAGPRA Program Web site.

    Review Committee members are appointed by the Secretary of the Interior. The Review Committee is responsible for monitoring the NAGPRA inventory and identification process; reviewing and making findings related to the identity or cultural affiliation of cultural items, or the return of such items; facilitating the resolution of disputes; compiling an inventory of culturally unidentifiable human remains that are in the possession or control of each Federal agency and museum, and recommending specific actions for developing a process for disposition of such human remains; consulting with Indian tribes and Native Hawaiian organizations and museums on matters affecting such tribes or organizations lying within the scope of work of the Review Committee; consulting with the Secretary of the Interior on the development of regulations to carry out NAGPRA; and making recommendations regarding future care of repatriated cultural items. The Review Committee's work is carried out during the course of meetings that are open to the public.

    Before including your address, telephone number, email address, or other personal identifying information in your submission, you should be aware that your entire submission—including your personal identifying information—may be made publicly available at any time. While you may ask us to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Dated: January 19, 2016. Alma Ripps, Chief, Office of Policy.
    [FR Doc. 2016-01815 Filed 2-1-16; 8:45 am] BILLING CODE 4310-EE-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-468 and 731-TA-1166-1167 (Review)] Certain Magnesia Carbon Bricks From China and Mexico Determinations

    On the basis of the record 1 developed in the subject five-year reviews, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930, that revocation of the countervailing duty order on certain magnesia carbon bricks from China and the antidumping duty orders on certain magnesia carbon bricks from China and Mexico would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.

    1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).

    Background

    The Commission, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), instituted these reviews on August 3, 2015 (80 FR 46050) and determined on November 6, 2015 that it would conduct expedited reviews (80 FR 74799, November 30, 2015).

    The Commission made these determinations pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on January 15, 2016. The views of the Commission are contained in USITC Publication 4589 (January 2016), entitled Certain Magnesia Carbon Bricks from China and Mexico: Investigation Nos. 701-TA-468 and 731-TA-1166-1167 (Review).

    Issued: January 27, 2016.

    By order of the Commission.

    Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-01792 Filed 2-1-16; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Cooperative Research Group on CHEDE-VII

    Notice is hereby given that, on January 6, 2016, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (“the Act”), Southwest Research Institute: Cooperative Research Group on CHEDE-VII (“CHEDE-VII”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing (1) the identities of the parties to the venture and (2) the nature and objectives of the venture. The notifications were filed for the purpose of invoking the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances.

    Pursuant to section 6(b) of the Act, the identities of the parties to the venture are: Borgwarner, Inc., Auburn Hills, MI; Caterpillar Inc., Peoria, IL; Cummins, Columbus, IN; Federal-Mogul Corporation, Plymouth, MI; Honeywell International, Inc., Torrance, CA; Hyundai Motor Group, Seoul, REPUBLIC OF KOREA; Isuzu, Shanghai, PEOPLE'S REPUBLIC OF CHINA; Jacobs Vehicle Systems, Bloomfield, CT; Lubrizol Corporation, Wickliffe, OH Vandyne Superburbo, Inc., Loveland, CO; and Weichai Power Co. Ltd., Weifang, PEOPLE'S REPUBLIC OF CHINA. The general areas of CHEDE-VII's planned activities are: research activity for diesel combustion system improvements; research activity for dual fuel combustion system improvements; improved fuel efficiency for future diesel and alternative fueled heavy-duty engines; and improved emissions for future diesel and alternative fueled engines.

    Patricia A. Brink, Director of Civil Enforcement, Antitrust Division.
    [FR Doc. 2016-01870 Filed 2-1-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF JUSTICE [OMB Number 1122—NEW] Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Campus Program Grantee Needs and Progress Assessment Tool AGENCY:

    Office on Violence Against Women, Department of Justice.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice, Office on Violence Against Women (OVW) 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.

    DATES:

    Comments are encouraged and will be accepted for 60 days until April 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at 202-514-5430 or [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 agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; 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: New collection.

    (2) Title of the Form/Collection: Campus Program Grantee Needs and Progress Assessment Tool.

    (3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: 1122—NEW. U.S. Department of Justice, Office on Violence Against Women.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: The affected public includes current grantees under the Grants to Reduce Sexual Assault, Domestic Violence, Dating Violence, and Stalking on Campus Program. The Campus Program strengthens the response of institutions of higher education to the crimes of sexual assault, domestic violence, dating violence and stalking on campuses and enhances collaboration among campuses, local law enforcement, and victim advocacy organizations. Eligible applicants are institutions of higher education. The affected public includes the approximately 100 institutions of higher education currently funded through the Campus program.

    The Grantee Needs and Progress Assessment Tool will be used to determine the training and technical assistance needs of Campus Program grantees—both new and continuation grantees—throughout the life of the grant award as well measure the development of the capacity of grantees to respond and prevent violence against women on their campuses. In addition, the tool will help campuses and OVW document the impact of their grant-funded work, promote sustainability of important intervention and prevention activities, and provide outcome-based information throughout the life of the grant to help OVW-funded technical assistance providers and grantees make changes to the goals and objectives necessary to achieve the statutory intent when Congress authorized the Campus Program.

    There is a need for a more effective assessment tool that better achieves the following purposes: (1) Assess grantee needs and resources related to achieving the program's core competencies that are central to the goals of the Campus Program; (2) assess capacity building by the grantees over the three year grant period which will help campuses and OVW document the impact of their work and promote sustainability, (3) provide information throughout the grant cycle to help technical assistance providers and campuses work together to achieve key goals of the Campus Program. This data collection tool will promote matching the specific technical assistance needs of each campus and also reflection by the grantees on their goals for the grant. The questions will be given in an online survey platform. The questions are mainly multiple choice. The few narrative questions used are brief and require one or two sentence answers.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that it will take the approximately 100 respondents (Campus Program grantees) approximately 2 hours to complete an online assessment tool.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total annual hour burden to complete the data collection forms is 200 hours, that is 100 grantees completing a tool once a year with an estimated completion time for the form being 2 hours.

    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: January 27, 2016. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2016-01772 Filed 2-1-16; 8:45 am] BILLING CODE 4410-FX-P
    DEPARTMENT OF LABOR Employment and Training Administration Change of Address for the National Prevailing Wage Center: Prevailing Wage Determination Requests for Use in the E-3, H-1B, H-1B1, H-2B, and Permanent/“Green Card” Visa Programs AGENCY:

    Employment and Training Administration, Department of Labor.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (Department) is providing notice that the Office of Foreign Labor Certification's National Prevailing Wage Center, responsible for the processing of prevailing wage determination requests for use in the E-3 (Australia), H-1B, H-1B1 (Chile/Singapore), H-2B, and the permanent/“green card” visa programs is relocating within Washington, DC effective on January 11, 2016.

    DATES:

    Effective Date: This notice is effective on January 11, 2016.

    FOR FURTHER INFORMATION CONTACT:

    William W. Thompson, II, Acting Administrator, Office of Foreign Labor Certification, U.S. Department of Labor, 200 Constitution Avenue NW., Box 12-200, Washington, DC 20210-0001; Telephone: (202) 513-7350 (this is not a toll-free number).

    SUPPLEMENTARY INFORMATION: I. Background

    The Immigration and Nationality Act (INA) assigns specific responsibilities to the U.S. Secretary of Labor for the administration of certain employment-based immigration programs that require a labor certification, a labor condition application, or a labor attestation (LCA). In the case of a labor certification, these statutory responsibilities include, determining that there are not able, willing, qualified and available U.S. workers for a position and location for which certification is being requested, and that the employment of the foreign worker(s) will not have an adverse impact on similarly employed U.S. workers.

    Employers seeking to hire foreign workers in the D-1, E-3, H-1B, H-1B1, H-2A, H-2B, or the permanent/“green card” visa programs must first apply to the Secretary of Labor to obtain a labor certification or for the approval of a labor condition application, or a labor attestation. The Secretary has delegated the responsibilities for the administration of these programs to the Employment and Training Administration's (ETA) Office of Foreign Labor Certification (OFLC).

    Before obtaining a certification from the Department, most employers must first obtain a Prevailing Wage Determination (PWD) for the appropriate occupation and area of intended employment from OFLC. Since January 1, 2010, the receipt and processing of PWD requests for use in the E-3, H-1B, H-1B1, H-2B, and the permanent/“green card” programs has been centralized in OFLC's National Prevailing Wage Center (NPWC) in Washington, DC.

    The purpose of this Notice is to inform the public that the NPWC is relocating within Washington, DC and provide a new mailing address.

    II. NPWC Address

    Old Address: U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, National Prevailing Wage Center, 1341 G Street, Suite 201, NW., Washington, DC 20005-3105; Telephone: (202) 693-8200; Facsimile (202) 693-8260.

    New Address: U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, National Prevailing Wage Center, 200 Constitution Avenue NW.; Room N-5311, Washington, DC 20210; Telephone: (202) 693-8200; Facsimile (202) 693-8260.

    The NPWC is fully operational at the new address on January 11, 2016. Affected stakeholders should direct any mailed correspondence addressed to the NPWC at the new address on and after January 11, 2015. Currently, the vast majority of PWD requests and related correspondence are submitted electronically to the NPWC. However, to ensure a smooth transition to the new address, the NPWC will rely on the standard United States Postal Service for mail forwarding from the old to the new address after the effective date of this Notice.

    III. NPWC Email Help Desk

    The change in the physical address for the NPWC will not affect the NPWC Email Help Desk. Members of the public who require technical assistance with PWD requests and/or related matters may continue to direct their inquiries to the National Prevailing Wage Center Help Desk at [email protected]

    Portia Wu, Assistant Secretary, Employment and Training Administration.
    [FR Doc. 2016-01848 Filed 2-1-16; 8:45 am] BILLING CODE 4510-FP-P
    DEPARTMENT OF LABOR Employment and Training Administration Comment Request for Information Collection for the Trade Activity Participant Report (TAPR), Extension Without Revisions AGENCY:

    Employment and Training Administration (ETA), Labor.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.

    Currently, ETA is soliciting comments concerning the collection of data about the Trade Activity Participant Report (OMB No. 1205-0392), which provides information on participant activities and performance outcomes for those served under the Trade Adjustment Assistance Program, as authorized under the Trade Act of 1974, as amended.

    DATES:

    Written comments must be submitted to the office listed in the ADDRESSES section below on or before April 4, 2016.

    ADDRESSES:

    Submit written comments to Susan Worden, Office of Trade Adjustment Assistance Room N-5428, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: 202-693-3517 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD). Fax: 202-693-3585 Email: [email protected] A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed above.

    SUPPLEMENTARY INFORMATION: I. Background

    The Department uses information from the Trade Activity Participant Report Form completed by the states to establish state funding needs and evaluate the effectiveness of state administration of the Trade Adjustment Assistance Program under the Trade Act. The Department is requesting a three year extension of the currently approved collection in order to continue to meet reporting requirements in sections 239 and 249B of the Trade Act, as amended.

    II. Review Focus

    The Department is particularly interested in comments which:

    • 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 submissions of responses.

    III. Current Actions

    Type of Review: extension without changes.

    Title: Trade Activity Participant Report.

    OMB Number: 1205-0392.

    Affected Public: State, Local or Tribal Governments.

    Form(s): Trade Activity Participant Report.

    Total Annual Respondents: 50.

    Annual Frequency: Quarterly.

    Total Annual Responses: 200.

    Average Time per Response: 47.5 hours.

    Estimated Total Annual Burden Hours: 9,500.

    Total Annual Burden Cost for Respondents: $0.

    Comments submitted in response to this request will be summarized and/or included in the request for Office of Management and Budget approval of the ICR; they will also become a matter of public record.

    Portia Wu, Assistant Secretary for Employment and Training, Labor.
    [FR Doc. 2016-01849 Filed 2-1-16; 8:45 am] BILLING CODE 4510-FN-P
    LEGAL SERVICES CORPORATION Assessing the Goals in the Strategic Plan 2012-2016; Request for Comments; Correction AGENCY:

    Legal Services Corporation.

    ACTION:

    Correction notice.

    SUMMARY:

    On January 22, 2016, the Legal Services Corporation (LSC) published a notice in the Federal Register (81 FR 3836) titled “Assessing the Goals in the Strategic Plan 2012-2016; Request for Comments.” The contact information listed in the Supplementary Information section of the previous notice has an incorrect link to LSC's Strategic Plan. This document corrects the notice by correcting the link to LSC's Strategic Plan with the correct web link.

    DATES:

    This correction is effective January 22, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Rebecca Fertig Cohen, Chief of Staff, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007; (202) 295-1576; [email protected]

    SUPPLEMENTARY INFORMATION:

    The correct link to LSC's Strategic Plan is available at http://www.lsc.gov/about-lsc/who-we-are/strategic-plan.

    Dated: January 28, 2016. Katherine Ward, Executive Assistant to the Vice President for Legal Affairs and General Counsel.
    [FR Doc. 2016-01845 Filed 2-1-16; 8:45 am] BILLING CODE 7050-01-P
    OFFICE OF MANAGEMENT AND BUDGET Discount Rates for Cost-Effectiveness Analysis of Federal Programs AGENCY:

    Office of Management and Budget.

    ACTION:

    Revisions to Appendix C of OMB Circular A-94.

    SUMMARY:

    The Office of Management and Budget revised Circular A-94 in 1992. The revised Circular specified certain discount rates to be updated annually when the interest rate and inflation assumptions used to prepare the Budget of the United States Government were changed. These discount rates are found in Appendix C of the revised Circular. The updated discount rates are shown below. The discount rates in Appendix C are to be used for cost-effectiveness analysis, including lease-purchase analysis, as specified in the revised Circular. They do not apply to regulatory analysis.

    DATES:

    The revised discount rates will be in effect through December 2016.

    FOR FURTHER INFORMATION CONTACT:

    Gideon Lukens, Office of Economic Policy, Office of Management and Budget, (202) 395-3316.

    Devin O'Connor, Associate Director for Economic Policy, Office of Management and Budget. OMB Circular No. A-94 APPENDIX C (Revised November 2015) DISCOUNT RATES FOR COST-EFFECTIVENESS, LEASE PURCHASE, AND RELATED ANALYSES

    Effective Dates. This appendix is updated annually. This version of the appendix is valid for calendar year 2016. A copy of the updated appendix can be obtained in electronic form through the OMB home page at http://www.whitehouse.gov/omb/circulars_a094/a94_appx-c/. The text of the Circular is found at http://www.whitehouse.gov/omb/circulars_a094/, and a table of past years' rates is located at http://www.whitehouse.gov/sites/default/files/omb/assets/a94/dischist.pdf. Updates of the appendix are also available upon request from OMB's Office of Economic Policy (202-395-3316).

    Nominal Discount Rates. A forecast of nominal or market interest rates for calendar year 2016 based on the economic assumptions for the 2017 Budget is presented below. These nominal rates are to be used for discounting nominal flows, which are often encountered in lease-purchase analysis.

    Nominal Interest Rates on Treasury Notes and Bonds of Specified Maturities [in percent] 3-year 5-year 7-year 10-year 20-year 30-year 2.0 2.4 2.7 2.9 3.2 3.5

    Real Discount Rates. A forecast of real interest rates from which the inflation premium has been removed and based on the economic assumptions from the 2017 Budget is presented below. These real rates are to be used for discounting constant-dollar flows, as is often required in cost-effectiveness analysis.

    Real Interest Rates on Treasury Notes and Bonds of Specified Maturities [in percent] 3-year 5-year 7-year 10-year 20-year 30-year 0.3 0.6 0.8 1.0 1.2 1.5

    Analyses of programs with terms different from those presented above may use a linear interpolation. For example, a four-year project can be evaluated with a rate equal to the average of the three-year and five-year rates. Programs with durations longer than 30 years may use the 30-year interest rate.

    [FR Doc. 2016-01604 Filed 2-1-16; 8:45 am] BILLING CODE 3110-01-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: 16-004] Notice of Information Collection AGENCY:

    National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of information collection.

    SUMMARY:

    The National Aeronautics and Space Administration, 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 (Public Law 104-13, 44 U.S.C. 3506(c)(2)(A)).

    DATES:

    Consideration will be given to all comments received within 30 days from the date of this publication.

    ADDRESSES:

    Interested persons are invited to submit written comments regarding the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 7th Street NW., Washington, DC 20543. Attention: Desk Officer for NASA.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instruments and instructions should be directed to Ms. Frances Teel, NASA PRA Clearance Officer, NASA Headquarters, 300 E Street SW., Mail Code JF0000, Washington, DC 20546 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This is a request to reinstate OMB control number 2700-0092, with changes. This collection is required to ensure proper accounting of Federal funds and property provided under finanical assistance awards (grants and cooperative agreements). Reporting and recordkeeping are prescribed at 2 CFR 1800 for awards issued to non-profits, institutions of higher education, government, and commercial firms when cost sharing is not required and at 14 CFR part 1274 for awards issued to commercial firms when cost sharing is required. This information collection was formerly titled Cooperative Agreements with Commercial Firms. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record. The basis for calculating the estimated burden remain the same as reported in the November 30, 2015 Federal Register Notice (80 FR 74812); however, corrections were made to the total estimated hours and costs.

    II. Method of Collection

    NASA collects approximately 90% of this information via electronic media, which is the preferred manner. However, certain information may also be collected via mail or fax.

    III. Data

    Title: Financial Assistance Awards/Grants and Cooperative Agreements.

    OMB Control Number: 2700-0092.

    Type of Review: Reinstatement with Change of a Previously Approved Information Collection.

    Affected Public: Non-profits, institutions of higher educations, government, and commercial firms.

    Estimated Number of Respondents: 13,600.

    Estimated Total Annual Burden Hours: 717,281.

    Estimated Total Annual Cost: $23,950,013.

    IV. Request for Comments

    Comments are invited on (1) whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (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 respondents, including automated collection techniques or the use of other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.

    Frances Teel, NASA PRA Clearance Officer.
    [FR Doc. 2016-01853 Filed 2-1-16; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL CREDIT UNION ADMINISTRATION Request for Comment Regarding National Credit Union Administration Draft 2017-2021 Strategic Plan AGENCY:

    National Credit Union Administration (NCUA).

    ACTION:

    Notice and Request for comment.

    SUMMARY:

    On January 27, 2016 the Federal Register published a Notice and Request for Comment for the NCUA Draft 2017-2021 Strategic Plan (Citation 81 FR 4679). This Federal Register Notice repairs a hyperlink within the notice. The NCUA Board (Board) is requesting comment on its 2017-2021 Draft Strategic Plan. The NCUA Draft Strategic Plan 2017-2021 summarizes our analysis of the internal and external environment impacting NCUA; evaluates NCUA programs and risks; and provides goals and objectives for the next five years. While the Board welcomes all comments from the public and stakeholders, it specifically invites comments and input on the proposed goals and objectives of the strategic plan.

    DATES:

    Comments must be received on or before April 4, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments by any of the following methods (Please send comments by one method only):

    NCUA Web site: https://www.ncua.gov/about/pages/board-comments.aspx. Follow the instructions for submitting comments.

    Email: Address to [email protected] Include “[Your name]—Comments on NCUA 2017-2021 Draft Strategic Plan” in the email subject line.

    Fax: (703) 518-6319. Include your name and the following subject line: “Comments on NCUA 2017-2021 Draft Strategic Plan.”

    Mail: Address to Gerard Poliquin, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428.

    Hand Delivery/Courier: Same as mail address.

    Public Inspection: You can view all public comments on NCUA's Web site at https://www.ncua.gov/about/pages/board-comments.aspx as submitted, except for those we cannot post for technical reasons. NCUA will not edit or remove any identifying or contact information from the public comments submitted. You may inspect paper copies of comments at NCUA's headquarters at 1775 Duke Street, Alexandria, Virginia 22314, by appointment weekdays between 9 a.m. and 3 p.m. To make an appointment, call (703) 518-6570 or send an email to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Melissa Lowden, Performance Analyst, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428 or telephone: (703) 518-1182.

    Authority:

    5 U.S.C. 306.

    SUPPLEMENTARY INFORMATION:

    The Government Performance and Results Act of 1993 (GPRA) requires agencies to prepare strategic plans, annual performance plans and annual performance reports with measurable performance indicators to address the policy, budgeting and oversight needs of both Congress and agency leaders, partners/stakeholders, and program managers. In 2010, Congress passed the GPRA Modernization Act of 2010, which further requires a leadership-driven governance model with emphasis on quarterly reviews and transparency. The GPRA Modernization Act requires agencies to set priority goals linked to longer-term Agency strategic goals. Part 6 of Office of Management and Budget (OMB) Circular A-11 provides additional guidance and requirements for federal agencies to implement these laws.

    The NCUA Draft Strategic Plan 2017-2021 is issued pursuant to the GPRA, the GPRA Modernization Act, and OMB Circular A-11.

    It highlights the agency's three strategic goals and supporting strategic objectives, which reflect the outcome or greater impact of the broader strategic goals. The three strategic goals for 2017-2021 are to:

    • Ensure a Safe and Sound Credit Union System.

    • Promote Consumer Protection and Financial Literacy.

    • Cultivate an Inclusive, Collaborative Workplace at NCUA that Maximizes Productivity and Enhances Impact.

    On January 27, 2016 the Federal Register published a Notice and Request for Comment for the NCUA Draft 2017-2021 Strategic Plan (Citation 81 FR 4679). This Federal Register Notice repairs a hyperlink within the notice.

    The draft NCUA Draft Strategic Plan 2017-2021 is available at the following Web address: https://www.ncua.gov/About/Documents/Agenda%20Items/AG20160121Item2b.pdf.

    By the National Credit Union Administration Board on January 21, 2016. Gerard Poliquin, Secretary of the Board.
    [FR Doc. 2016-01777 Filed 2-1-16; 8:45 am] BILLING CODE P
    NATIONAL SCIENCE FOUNDATION Sunshine Act Meetings; National Science Board

    The National Science Board (NSB), pursuant to National Science Foundation (NSF) regulations (45 CFR part 614), the National Science Foundation Act, as amended, (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of a cancellation of one session and the addition of an agenda item in a plenary session during the National Science Board meetings on February 2-3, 2016, as shown below. The original notice appeared in the Federal Register on January 29, 2016 at 81 FR 70259.

    Cancelled Session:

    Plenary Board Meeting Open Session: 11:30-11:45 a.m. NSB Chair's remarks Guest speaker—Senator Gary Peters NSB Chair's closing remarks Amended Agenda:

    Plenary Board Meeting Open Session: 1:00-1:30 p.m. NSB Chair's remarks NSF Director's remarks Approval of open plenary minutes for November 2015 NEON update from the Chair of the ad hoc task force on NEON Performance and Plans Open committee reports Possible Board Vote on SEI's Recommendations, including draft Companion Brief and sense of the Board Statement on the Value of Higher Education [ADDED] NSB Chair's closing remarks UPDATES:

    Please refer to the National Science Board Web site for additional information. Meeting information and schedule updates (time, place, subject matter or status of meeting) may be found at http://www.nsf.gov/nsb/meetings/notices.jsp.

    AGENCY CONTACT:

    Ron Campbell, [email protected], 703-292-7000.

    Kyscha Slater-Williams, Program Specialist, National Science Board.
    [FR Doc. 2016-02015 Filed 1-29-16; 4:15 pm] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2016-0010] Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    License amendment request; opportunity to comment, request a hearing, and petition for leave to intervene; order.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of one amendment request. The amendment request is for Shearon Harris Nuclear Power Plant, Unit 1; and H. B. Robinson Steam Electric Plant, Unit No. 2. The NRC proposes to determine that the amendment request involves no significant hazards consideration. In addition, the amendment request contains sensitive unclassified non-safeguards information (SUNSI).

    DATES:

    Comments must be filed by March 3, 2016. A request for a hearing must be filed by April 4, 2016. Any potential party as defined in § 2.4 of title 10 of the Code of Federal Regulations (10 CFR), who believes access to SUNSI is necessary to respond to this notice must request document access by February 12, 2016.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0010. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Paula Blechman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-2242, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2016-0010 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0010.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2016-0010, facility name, unit number(s), application date, and subject in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as enters the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Background

    Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the NRC is publishing this notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

    This notice includes a notice of amendments containing SUNSI.

    III. Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing

    The Commission has made a proposed determination that the following amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated, or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish a notice of issuance in the Federal Register. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    A. Opportunity To Request a Hearing and Petition for Leave To Intervene

    Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/. If a request for a hearing or petition for leave to intervene is filed within 60 days, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order.

    As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.

    Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the basis for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies and procedures.

    Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii). If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    A State, local governmental body, Federally-recognized Indian tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by April 4, 2016. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).

    If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by April 4, 2016.

    B. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to request (1) a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a request or petition for hearing (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing the E-Submittal server are detailed in the NRC's “Guidance for Electronic Submission,” which is available on the agency's public Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.

    If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.

    Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format in accordance with NRC guidance available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the documents are submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system.

    A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free call at 1-866-672-7640. The NRC Meta System Help Desk is available between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday, excluding government holidays.

    Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.

    Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at http://ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the Commission, or the presiding officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. However, in some instances, a request to intervene will require including information on local residence in order to demonstrate a proximity assertion of interest in the proceeding. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission.

    For further details with respect to this amendment action, see the application for amendment which is available for public inspection at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the PDR's Reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]

    Duke Energy Progress, Inc., Docket No. 50-400, Shearon Harris Nuclear Power Plant, Unit 1 (SHNPP), Wake and Chatham Counties, North Carolina Duke Energy Progress, Inc., Docket No. 50-261, H. B. Robinson Steam Electric Plant, Unit No. 2 (HBRSEP), Darlington County, South Carolina

    Date of amendment request: August 19, 2015. A publicly-available version is in ADAMS under Accession No. ML15236A044.

    Description of amendment request: This amendment request contains sensitive unclassified non-safeguards information (SUNSI). The licensee requested plant-specific review and approval of a new reactor core design methodology report, DPC-NE-1008-P, Revision 0, “Nuclear Design Methodology Using CASMO-5/SIMULATE-3 for Westinghouse Reactors,” for adoption into the SHNPP and HBRSEP Technical Specifications.

    Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

    1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?

    Response: No.

    The proposed change requests review and approval of DPC-NE-1008-P, Revision 0, “Nuclear Design Methodology Using CASMO-5/SIMULATE-3 for Westinghouse Reactors,” to be applied to Shearon Harris Nuclear Power Plant (SHNPP) and H. B. Robinson Steam Electric Plant (HBRSEP). The CASMO-5 and SIMULATE-3 codes are not used in the operation of any plant equipment. The benchmark calculations performed confirm the accuracy of the codes and develop a methodology for calculating power distribution uncertainties for use in reload design calculations. The use of power distribution uncertainties in conjunction with predicted peaking factors ensures that thermal accident acceptance criteria are satisfied. The proposed use of this methodology does not affect the performance of any equipment used to mitigate the consequences of an analyzed accident. There is no impact on the source term or pathways assumed in accidents previously assumed. No analysis assumptions are violated and there are no adverse effects on the factors that contribute to offsite or onsite dose as the result of an accident.

    Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.

    2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?

    Response: No.

    The proposed change requests review and approval of DPC-NE-1008-P, Revision 0, “Nuclear Design Methodology Using CASMO-5/SIMULATE-3 for Westinghouse Reactors,” to be applied to Shearon Harris Nuclear Power Plant (SHNPP) and H. B. Robinson Steam Electric Plant (HBRSEP). It does not change any system functions or maintenance activities. The change does not involve physical alteration of the plant, that is, no new or different type of equipment will be installed. The software is not installed in any plant equipment, and therefore the software is incapable of initiating an equipment malfunction that would result in a new or different type of accident from any previously evaluated. The change does not alter assumptions made in the safety analyses but ensures that the core will operate within safe limits. This change does not create new failure modes or mechanisms which are not identifiable during testing, and no new accident precursors are generated.

    Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.

    3. Does the proposed change involve a significant reduction in a margin of safety?

    Response: No.

    Margin of safety is related to the confidence in the ability of the fission product barriers to perform their design functions during and following an accident. These barriers include the fuel cladding, the reactor coolant system, and the containment system. The proposed change requests review and approval of DPC-NE-1008-P, Revision 0, “Nuclear Design Methodology Using CASMO-5/SIMULATE-3 for Westinghouse Reactors,” to be applied to Shearon Harris Nuclear Power Plant (SHNPP) and H. B. Robinson Steam Electric Plant (HBRSEP). As with the existing methodology, the qualification of the methods therein and the use of power distribution uncertainties ensure the acceptability of analytical limits under normal, transient, and accident conditions. The use of the proposed methodology revision once it has been approved by the NRC will ensure that all applicable design and safety limits are satisfied such that the fission product barriers will continue to perform their design functions.

    Therefore, the proposed change does not involve a significant reduction in a margin of safety.

    The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

    Attorney for licensee: Lara S. Nichols, Deputy General Counsel, Duke Energy Corporation, 550 South Tyron Street, Mail Code DEC45A, Charlotte, North Carolina 28202.

    NRC Branch Chief: Benjamin G. Beasley.

    Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation Duke Energy Progress, Inc., Docket No. 50-400, Shearon Harris Nuclear Power Plant, Unit 1, Wake and Chatham Counties, North Carolina; and Duke Energy Progress, Inc., Docket No. 50-261, H. B. Robinson Steam Electric Plant, Unit No. 2, Darlington County, South Carolina

    A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing SUNSI.

    B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI is necessary to respond to this notice may request such access. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.

    C. The requester shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are [email protected] and [email protected], respectively.1 The request must include the following information:

    1 While a request for hearing or petition to intervene in this proceeding must comply with the filing requirements of the NRC's “E-Filing Rule,” the initial request to access SUNSI under these procedures should be submitted as described in this paragraph.

    (1) A description of the licensing action with a citation to this Federal Register notice;

    (2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and

    (3) The identity of the individual or entity requesting access to SUNSI and the requester's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly-available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.

    D. Based on an evaluation of the information submitted under paragraph C.(3) the NRC staff will determine within 10 days of receipt of the request whether:

    (1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and

    (2) The requestor has established a legitimate need for access to SUNSI.

    E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order 2 setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI by each individual who will be granted access to SUNSI.

    2 Any motion for Protective Order or draft Non-Disclosure Affidavit or Agreement for SUNSI must be filed with the presiding officer or the Chief Administrative Judge if the presiding officer has not yet been designated, within 30 days of the deadline for the receipt of the written access request.

    F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after the requestor is granted access to that information. However, if more than 25 days remain between the date the petitioner is granted access to the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline. This provision does not extend the time for filing a request for a hearing and petition to intervene, which must comply with the requirements of 10 CFR 2.309.

    G. Review of Denials of Access.

    (1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and need for access, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.

    (2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an administrative law judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) officer if that officer has been designated to rule on information access issues.

    H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed with the Chief Administrative Judge within 5 days of the notification by the NRC staff of its grant of access.

    If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.3

    3 Requesters should note that the filing requirements of the NRC's E-Filing Rule (72 FR 49139; August 28, 2007) apply to appeals of NRC staff determinations (because they must be served on a presiding officer or the Commission, as applicable), but not to the initial SUNSI request submitted to the NRC staff under these procedures.

    I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. Attachment 1 to this Order summarizes the general target schedule for processing and resolving requests under these procedures.

    It is so ordered.

    Dated at Rockville, Maryland, this 19th day of January, 2016.

    For the Nuclear Regulatory Commission.

    Annette L. Vietti-Cook, Secretary of the Commission.
    Attachment 1—General Target Schedule for Processing and Resolving Requests for Access to Sensitive Unclassified Non-Safeguards Information in this Proceeding Day Event/activity 0 Publication of Federal Register notice of hearing and opportunity to petition for leave to intervene, including order with instructions for access requests. 10 Deadline for submitting requests for access to Sensitive Unclassified Non-Safeguards Information (SUNSI) with information: supporting the standing of a potential party identified by name and address; describing the need for the information in order for the potential party to participate meaningfully in an adjudicatory proceeding. 60 Deadline for submitting petition for intervention containing: (i) Demonstration of standing; and (ii) all contentions whose formulation does not require access to SUNSI (+25 Answers to petition for intervention; +7 petitioner/requestor reply). 20 U.S. Nuclear Regulatory Commission (NRC) staff informs the requester of the staff's determination whether the request for access provides a reasonable basis to believe standing can be established and shows need for SUNSI. (NRC staff also informs any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information.) If NRC staff makes the finding of need for SUNSI and likelihood of standing, NRC staff begins document processing (preparation of redactions or review of redacted documents). 25 If NRC staff finds no “need” or no likelihood of standing, the deadline for petitioner/requester to file a motion seeking a ruling to reverse the NRC staff's denial of access; NRC staff files copy of access determination with the presiding officer (or Chief Administrative Judge or other designated officer, as appropriate). If NRC staff finds “need” for SUNSI, the deadline for any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information to file a motion seeking a ruling to reverse the NRC staff's grant of access. 30 Deadline for NRC staff reply to motions to reverse NRC staff determination(s). 40 (Receipt +30) If NRC staff finds standing and need for SUNSI, deadline for NRC staff to complete information processing and file motion for Protective Order and draft Non-Disclosure Affidavit. Deadline for applicant/licensee to file Non-Disclosure Agreement for SUNSI. A If access granted: Issuance of presiding officer or other designated officer decision on motion for protective order for access to sensitive information (including schedule for providing access and submission of contentions) or decision reversing a final adverse determination by the NRC staff. A + 3 Deadline for filing executed Non-Disclosure Affidavits. Access provided to SUNSI consistent with decision issuing the protective order. A + 28 Deadline for submission of contentions whose development depends upon access to SUNSI. However, if more than 25 days remain between the petitioner's receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline. A + 53 (Contention receipt +25) Answers to contentions whose development depends upon access to SUNSI. A + 60 (Answer receipt +7) Petitioner/Intervenor reply to answers. >A + 60 Decision on contention admission.
    [FR Doc. 2016-01373 Filed 2-1-16; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2016-0019] Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Biweekly notice.

    SUMMARY:

    Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.

    This biweekly notice includes all notices of amendments issued, or proposed to be issued from January 5, 2016, to January 15, 2016. The last biweekly notice was published on January 19, 2016.

    DATES:

    Comments must be filed by March 3, 2016. A request for a hearing must be filed by April 4, 2016.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

    • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0019. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected]

    • Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Janet Burkhardt, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1384, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2016-0019 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

    • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0019.

    • NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the SUPPLEMENTARY INFORMATION section of this document.

    • NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2016-0019, facility name, unit number(s), application date, and subject in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov, as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses and Proposed No Significant Hazards Consideration Determination

    The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the Code of Federal Regulations (10 CFR), this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, (2) create the possibility of a new or different kind of accident from any accident previously evaluated, or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.

    The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

    Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the Federal Register a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently.

    A. Opportunity To Request a Hearing and Petition for Leave To Intervene

    Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at http://www.nrc.gov/reading-rm/doc-collections/cfr/. If a request for a hearing or petition for leave to intervene is filed within 60 days, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order.

    As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.

    Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.

    Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies and procedures.

    Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).

    If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

    A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by April 4, 2016. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).

    If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by April 4, 2016.

    B. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.

    To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at [email protected], or by telephone at 301-415-1677, to request (1) a digital identification (ID) certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and (2) advise the Secretary that the participant will be submitting a request or petition for hearing (even in instances in which the participant, or its counsel or representative, already holds an NRC-issued digital ID certificate). Based upon this information, the Secretary will establish an electronic docket for the hearing in this proceeding if the Secretary has not already established an electronic docket.

    Information about applying for a digital ID certificate is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals/getting-started.html. System requirements for accessing the E-Submittal server are detailed in the NRC's “Guidance for Electronic Submission,” which is available on the agency's public Web site at http://www.nrc.gov/site-help/e-submittals.html. Participants may attempt to use other software not listed on the Web site, but should note that the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will not be able to offer assistance in using unlisted software.

    If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html.

    Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at http://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the documents are submitted through the NRC's E-Filing system. To be timely, an electronic filing must be submitted to the E-Filing system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an email notice confirming receipt of the document. The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel