| Page Range | 5365-5571 | |
| FR Document |
| Page and Subject | |
|---|---|
| 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 2015 | |
| 81 FR 5489 - Sunshine Act Meetings; National Science Board | |
| 81 FR 5418 - Initiation of Five-Year (“Sunset”) Review | |
| 81 FR 5440 - Revised Filing Window Dates for FCC Form 175 Application To Participate in the Forward Auction (Auction 1002) | |
| 81 FR 5419 - Availability of Seats for National Marine Sanctuary Advisory Councils | |
| 81 FR 5506 - Sunshine Act Meeting | |
| 81 FR 5520 - West Los Angeles VA Medical Center; Draft Master Plan | |
| 81 FR 5447 - Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs; Extension of Comment Period | |
| 81 FR 5507 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 81 FR 5507 - Connecticut Disaster #CT-00037 | |
| 81 FR 5506 - Military Reservist Economic Injury Disaster Loans Interest Rate for Second Quarter FY 2016 | |
| 81 FR 5508 - Small Business Investment Companies-Early Stage SBICs | |
| 81 FR 5507 - Region III-Charleston, WV; Regulatory Fairness Hearing | |
| 81 FR 5514 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel HAWK; Invitation for Public Comments | |
| 81 FR 5511 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NN59; Invitation for Public Comments | |
| 81 FR 5515 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PAU HANA; Invitation for Public Comments | |
| 81 FR 5512 - Inventory of U.S.-Flag Launch Barges | |
| 81 FR 5484 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on CHEDE-VII | |
| 81 FR 5515 - Request for Comments of a Previously Approved Information Collection | |
| 81 FR 5514 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel Altitude Adjustment (Traveller); Invitation for Public Comments | |
| 81 FR 5475 - Agency Information Collection Activities: Application to Replace Permanent Resident Card, Form I-90; Revision of a Currently Approved Collection | |
| 81 FR 5477 - Agency Information Collection Activities: Request for the Return of Original Documents (Form G-884); Revision of an Existing Information Collection; Comment Request | |
| 81 FR 5505 - Submission for OMB Review; Comments Request | |
| 81 FR 5424 - DoD Board of Actuaries; Notice of Federal Advisory Committee Meeting | |
| 81 FR 5423 - DoD Medicare-Eligible Retiree Health Care Board of Actuaries; Notice of Federal Advisory Committee Meeting | |
| 81 FR 5488 - Notice of Information Collection | |
| 81 FR 5442 - LabMD, Inc. Oral Argument Before the Commission | |
| 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 Area | |
| 81 FR 5486 - Comment Request for Information Collection for the Trade Activity Participant Report (TAPR), Extension Without Revisions | |
| 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 Programs | |
| 81 FR 5487 - Assessing the Goals in the Strategic Plan 2012-2016; Request for Comments; Correction | |
| 81 FR 5431 - Agency Information Collection Activities; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection | |
| 81 FR 5420 - Pacific Fishery Management Council; Public Meeting | |
| 81 FR 5421 - New England Fishery Management Council; Public Meeting | |
| 81 FR 5478 - Endangered and Threatened Wildlife and Plants; Permit Applications | |
| 81 FR 5480 - Notice of Meeting of the Northwest Oregon Resource Advisory Council | |
| 81 FR 5516 - Office of the Assistant Secretary for Research and Technology; University Transportation Centers Program Competition | |
| 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 Limits | |
| 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 Locations | |
| 81 FR 5479 - Endangered and Threatened Wildlife and Plants; Recovery Permit Applications | |
| 81 FR 5442 - Statement of Organization, Functions, and Delegations of Authority | |
| 81 FR 5425 - Applications for New Awards; Educational Opportunity Centers Program | |
| 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 Prohibition | |
| 81 FR 5527 - Commission on Care | |
| 81 FR 5520 - Sanctions Actions Pursuant to Executive Orders 13224 | |
| 81 FR 5420 - Marine Mammals; File No. 15510 | |
| 81 FR 5518 - Proposed Collection; Comment Request; Bank Secrecy Act Currency Transaction Report (BCTR) Revised Layout and Proposed Additional Data Fields | |
| 81 FR 5439 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 5441 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 5439 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 5440 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 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 Agencies | |
| 81 FR 5472 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 5473 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 81 FR 5473 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 5481 - Native American Graves Protection and Repatriation Review Committee; Meetings | |
| 81 FR 5481 - Wekiva River System Advisory Management Committee 2016 Meeting Schedule | |
| 81 FR 5378 - Transferring Certain Dispute Resolution Service Matters to the Commission's Landowner Helpline | |
| 81 FR 5435 - Green Mountain Power Corporation; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 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 Meeting | |
| 81 FR 5432 - Notice of Commission Staff Attendance | |
| 81 FR 5434 - Bethel Wind Farm LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 5432 - Notice of Commission Half-Day Closing | |
| 81 FR 5438 - Notice Concerning Submissions Made During Federal Government Closures | |
| 81 FR 5438 - NRG Wholesale Generation LP; Seward Generation, LLC: Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 81 FR 5436 - Cheniere Corpus Christi Pipeline, L.P.; Notice of Request Under Blanket Authorization | |
| 81 FR 5438 - Iroquois Gas Transmission System, L.P.; Notice of Application | |
| 81 FR 5436 - Combined Notice of Filings #1 | |
| 81 FR 5433 - Combined Notice of Filings #2 | |
| 81 FR 5437 - Combined Notice Of Filings #1 | |
| 81 FR 5434 - Columbia Gulf Transmission, LLC; Notice of Initiation of Section 5 Proceeding | |
| 81 FR 5432 - Iroquois Gas Transmission System, L.P.; Notice of Initiation of Section 5 Proceeding | |
| 81 FR 5436 - Empire Pipeline, Inc.; Notice of Initiation of Section 5 Proceeding | |
| 81 FR 5436 - Tuscarora Gas Transmission Company; Notice of Initiation of Section 5 Proceeding | |
| 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 Collection | |
| 81 FR 5476 - Agency Information Collection Activities: Application of Certificate of Citizenship, Form N-600, Form N-600; Revision of a Currently Approved Collection | |
| 81 FR 5484 - Certain Magnesia Carbon Bricks From China and Mexico | |
| 81 FR 5478 - 30-Day Notice of Proposed Information Collection: Disaster Management | |
| 81 FR 5397 - Medicare Program: Expanding Uses of Medicare Data by Qualified Entities | |
| 81 FR 5467 - The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop | |
| 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 Products | |
| 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 Plants | |
| 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 Capacities | |
| 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 Notification | |
| 81 FR 5467 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions; Section 351(k) Biosimilar Applications | |
| 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 Infringed | |
| 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 Committees | |
| 81 FR 5468 - Regulatory Site Visit Training Program | |
| 81 FR 5423 - Agency Information Collection Activities; Submission for OMB Review; Comment Request-Baby Bouncers and Walker-Jumpers | |
| 81 FR 5369 - Commission Participation and Commission Employee Involvement in Voluntary Standards Activities | |
| 81 FR 5488 - Request for Comment Regarding National Credit Union Administration Draft 2017-2021 Strategic Plan | |
| 81 FR 5421 - Agency Information Collection Activities Under OMB Review | |
| 81 FR 5422 - Agency Information Collection Activities Under OMB Review | |
| 81 FR 5484 - Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Campus Program Grantee Needs and Progress Assessment Tool | |
| 81 FR 5495 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 81 FR 5395 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
| 81 FR 5367 - Airworthiness Directives; Bell Helicopter Textron Canada Limited | |
| 81 FR 5365 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
| 81 FR 5480 - Notice of Public Meetings, Northwest Resource Advisory Council Meeting | |
| 81 FR 5383 - Coordination of Federal Authorizations for Electric Transmission Facilities | |
| 81 FR 5487 - Discount Rates for Cost-Effectiveness Analysis of Federal Programs | |
| 81 FR 5529 - Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health | |
| 81 FR 5505 - Nanotechnology Commercialization Success Stories | |
| 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 Information | |
| 81 FR 5380 - Revitalization of the AM Radio Service |
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Land Management Bureau
National Park Service
Antitrust Division
Employment and Training Administration
Federal Aviation Administration
Maritime Administration
Financial Crimes Enforcement Network
Foreign Assets Control Office
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.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
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.
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.
You may examine the AD docket on the Internet at
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:
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.
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
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
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.
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).
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
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
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.
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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective March 8, 2016.
None.
This AD applies to Bombardier, Inc. Model BD-100-1A10 (Challenger 300) airplanes, certificated in any category, serial numbers 20003 through 20500 inclusive.
Air Transport Association (ATA) of America Code 34, Navigation.
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.
Comply with this AD within the compliance times specified, unless already done.
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.
As of the effective date of this AD, no person may install a pitot-static probe, P/N 0856WC1 or 0856WC2, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
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
(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:
(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:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters
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.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
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
Matt Fuller, Senior Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
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.
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.
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
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
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.
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.
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.
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.
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.
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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
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.
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.
This AD becomes effective February 2, 2016.
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.
(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.
(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
(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.
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
Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor System.
(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
(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:
Consumer Product Safety Commission.
Final rule.
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”).
The final rule will become effective on March 3, 2016.
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;
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.
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.
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).
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:
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.
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.
CPSC received 14 comments regarding the NPR that address 29 separate issues. Comments submitted in response to the NPR are available at:
Under the final rule, CPSC staff could be nominated and appointed to leadership roles
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.
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.
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.
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.
• 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.
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.
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.
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.
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.
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
Business and industry, Consumer protection, Voluntary standards.
For the reasons stated in the preamble, the Commission amends 16 CFR part 1031 as follows:
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).
(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. * * *
(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) 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.
The revision reads as follows:
(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.
Federal Energy Regulatory Commission, Department of Energy (DOE).
Final rule.
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.
This rule will become effective March 3, 2016.
Thomas Sharp, Office of the General Counsel, 888 First Street NE., Washington, DC 20426, 202-502-6461,
1. 1. By this instant Final Rule, the Commission is revising its regulations
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.
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'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.
5. Going forward, the above-described DRS responsibilities will be handled by the new OALJDR Landowner Helpline.
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.
7. Office of Management and Budget (OMB) regulations require OMB to approve certain information collection requirements imposed by agency rule.
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.
9. The Regulatory Flexibility Act of 1980 (RFA)
10. In addition to publishing the full text of this document in the
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
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.
Investigations.
Administrative practice and procedure, Electric utilities, Natural gas, Pipelines, Reporting and recordkeeping requirements.
Administrative practice and procedure, Natural gas, Reporting and recordkeeping requirements.
Environmental impact statements, Reporting and recordkeeping requirements.
By the Commission.
In consideration of the foregoing, the Commission amends Parts 1b, 2, 157, and 380, Chapter I, Title 18,
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.
(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
(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.
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.
(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.
15 U.S.C. 717-717z.
(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.
42 U.S.C. 4321-4370h, 7101-7352; E.O. 12009, 3 CFR 1978 Comp., p. 142.
(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.
Federal Communications Commission.
Final rule; announcement of effective date.
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
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 additional information contact Cathy Williams,
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
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
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:
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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
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.
Effective 1200 hours, Alaska local time (A.l.t.), January 29, 2016, through 1200 hours, A.l.t., September 1, 2016.
Josh Keaton, 907-586-7228.
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.
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
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.
16 U.S.C. 1801
Office of Electricity Delivery and Energy Reliability, Department of Energy.
Notice of proposed rulemaking.
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.
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.
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
2. Send email to
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
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
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
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).
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
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,
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.
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,
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).
Section 900.3 defines terms for this part.
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 (
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
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.
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 (
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).
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.
Section 900.5 provides a mechanism for the identification and selection of a NEPA Lead Agency responsible for meeting Federal environmental review requirements
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.
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,
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.
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
The Regulatory Flexibility Act (5 U.S.C. 601
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).
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
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.,
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.
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.
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.
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.
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.
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.
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
The Secretary of Energy has approved the publication of this proposed rule.
Electric power, Electric utilities, Energy, Reporting and record keeping requirements.
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:
16 U.S.C. 824p(h).
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.
(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)
(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.
As used in this part:
(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.
(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)).
(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)
(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)
(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 (
(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)
(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)
(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)
(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 (
(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
(k)
(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)
(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
(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 (
(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.
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
(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.
(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.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
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.
We must receive comments on this proposed AD by April 4, 2016.
You may send comments by any of the following methods:
•
•
•
•
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.
You may examine the AD docket on the Internet at
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:
We invite you to send any written relevant data, views, or arguments about this NPRM. Send your comments to an address listed under the
We will post all comments we receive, without change, to
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
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
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
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.
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.
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.
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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 4, 2016.
None.
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.
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.
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.
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.
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:
(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-
(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
(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.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
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.
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.
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.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
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
Allison Oelschlaeger, (202) 690-8257. Kari Gaare, (410) 786-8612.
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.
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
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.
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.
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.
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.
MACRA imposes a number of limitations on qualified entities with
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
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
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.
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.
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
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.
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
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.
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).
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.
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.
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
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
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
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
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.
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.
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.
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.
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
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.
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.
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.
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.
Section 105(a)(8) of MACRA expands the information that a qualified entity must report annually to the Secretary if
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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
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.
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
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• 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
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
If you comment on these information collection and recordkeeping requirements, please submit your comments electronically as specified in the
Comments must be received on/by April 4, 2016.
Because of the large number of public comments we normally receive on
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
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
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
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.
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
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.
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.
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.
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.
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.
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.
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:
Secs. 1102, 1871, and 1874(e) of the Social Security Act (42 U.S.C. 1302,
(j)
(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)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(s)
(t)
(u)
(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
(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.
(a)
(b)
(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)
(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.
(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.
(a)
(b)
(2)
(c)
(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)
(A)
(
(
(
(B)
(
(
(
(
(
(C)
(
(
(D) The standards set for the qualified entity in this paragraph are binding, except to the extent that—
(
(
(ii)
(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:
(
(
(
(
(F) The means by which the qualified entity may pay the amount if they do not intend to request a hearing.
(iii)
(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)
(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)
(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
(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.
(a) * * *
(7) Fails to ensure authorized users comply with their QE DUAs or analysis use agreements.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
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
The Department official identified in the
The Department's procedures for the conduct of Sunset Reviews are set forth in its
In accordance with 19 CFR 351.218(c), we are initiating Sunset Reviews of the following antidumping and countervailing duty orders:
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:
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.
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).
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
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
If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that
This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice and request for applications.
ONMS is seeking applications for vacant seats for five of its 13 national marine sanctuary advisory councils (advisory councils). Vacant seats, including positions (
Applications are due by February 29, 2016.
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
• 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
• 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
• 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
• 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
For further information on a particular national marine sanctuary advisory council, please contact the individual identified in the
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
The following is a list of the vacant seats, including positions (
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).
16 U.S.C. 1431,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
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.
The meeting will be held Thursday, March 10, 2016, from 8 a.m. to 5 p.m. Pacific Standard Time.
The meeting will be held at the Doubletree by Hilton Sacramento, Yuba River Room, 2001 Point West Way, Sacramento, CA 95815.
Kerry Griffin, Staff Officer; telephone: (503) 820-2409.
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.
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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
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.
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.
Rosa L. González or Amy Sloan, (301) 427-8401.
On December 8, 2015, notice was published in the
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 (
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
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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
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).
This meeting will be held on Monday, February 22 and Tuesday, February 23, 2016, beginning at 8:30 a.m. both days.
The workshop will be held at the Crowne Plaza, 801 Greenwich Ave., Warwick, RI 02886; telephone: (401) 732-6000.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
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.
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.
16 U.S.C. 1801
Commodity Futures Trading Commission.
Notice.
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.
Comments must be submitted on or before March 3, 2016.
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
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
Tom Guerin, Division of Market Oversight, Commodity Futures Trading Commission, (202) 734-4194, email:
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
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.
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.
44 U.S.C. 3501
Commodity Futures Trading Commission.
Notice.
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.
Comments must be submitted on or before March 3, 2016.
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
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
Adam Kezsbom, Special Counsel, Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, (202) 418-5372, email:
44 U.S.C. 3501
Consumer Product Safety Commission.
Notice.
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
Written comments on this request for extension of approval of information collection requirements should be submitted by March 3, 2016.
Submit comments about this request by email:
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:
CPSC has submitted the following currently approved collection of information to OMB for extension:
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.
DoD.
Meeting notice.
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.
Friday, July 29, 2016, from 10:00 a.m. to 12:00 p.m.
4800 Mark Center Drive, Conference Room 19, Level B1, Alexandria, VA 22350.
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:
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:
Approve actuarial assumptions and methods needed for calculating:
Actuarial assumptions and methods needed for calculating:
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:
DoD.
Meeting notice.
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.
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.
4800 Mark Center Drive, Conference Room 18, Level B1, Alexandria, VA 22350.
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:
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:
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:
Office of Postsecondary Education, Department of Education.
Notice.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.066A.
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.
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
The competitive preference priorities are:
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).
The Secretary gives priority to projects that are designed to address the needs of military- or veteran-connected students (as defined in this notice).
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.
For the purpose of this competition, only subpart (b) of this definition is applicable, and the term “students” in this definition includes prospective students.
The regulations in 34 CFR part 79 apply to all applicants except Federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to IHEs only.
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.
• 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.
The Department is not bound by any estimates in this notice.
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3.
1.
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 (
2.
• 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
• 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.
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
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
4.
5.
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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:
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.
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
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:
7.
a.
Applications for grants under the EOC Program, CFDA number 84.066A, must be submitted electronically using the Governmentwide Grants.gov Apply site at
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
You may access the electronic grant application for the EOC Program at
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
• 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 (
• 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.
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
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.
• 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
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.
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.
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.
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.
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.
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(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
(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.
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.
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If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(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
(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.
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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).
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:
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before April 4, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact John Cheek, 202-401-0274.
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.
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
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.
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.
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 above-referenced meeting will be via web conference and teleconference.
The above-referenced meeting is open to stakeholders.
Further information may be found at:
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:
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:
The discussions at the meeting described above may address matters at issue in the following proceedings:
For more information, contact James Eason, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-8622 or
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
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 (
Register online at
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
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.
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:
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
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.
The meeting will be recorded by a stenographer. The transcript will be placed in the public record for the project.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
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:
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.
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
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the
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
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
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
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
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.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
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:
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.
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.
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
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
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
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
Take notice that the Commission received the following electric rate filings:
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:
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
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:
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
Comment Date: 5:00 p.m. Eastern Time on February 1, 2016.
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.
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
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
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.
Federal Communications Commission.
Notice and request for comments.
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.
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.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
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.
Notice and request for comments.
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.
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.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
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.
Notice.
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).
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.
This is a summary of the
The
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as
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.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
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.
Notice and request for comments.
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.
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.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Trade Commission.
Oral argument; open meeting.
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.
Oral argument is scheduled for March 8, 2016 at 1:00 p.m.
Federal Trade Commission Building, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Donald S. Clark, Secretary, Office of the Secretary, 600 Pennsylvania Avenue NW., Washington, DC 20580, 202-326-2515.
(1) Oral Argument In the Matter of LabMD, Inc., Docket No. 9357.
(2) Executive Session to follow Oral Argument In the Matter of LabMD, Inc., Docket No. 9357.
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.
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.
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 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.
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
Delete in its entirety the title and function statement for the
Delete in its entirety the title and function statement for the
(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
Centers for Medicare & Medicaid Services (CMS), HHS.
Extension of temporary moratoria.
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.
Belinda Gravel, (410) 786-8934. News media representatives must contact CMS' Public Affairs Office at (202) 690-6145 or email them at
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
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
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)).
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).
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.
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
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.
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
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
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
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.
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:
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.
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
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
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.
Sections 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35.
Centers for Medicare & Medicaid Services (CMS), HHS.
Request for information; extension of comment period.
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.
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.
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.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
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.
Lisa Marie Gomez, (410) 786-1175.
On December 31, 2015, we published a request for information in the
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.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
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.
This notice is effective March 3, 2016. The final allotments and limitations set forth in this notice are effective for the fiscal years specified.
Stuart Goldstein, (410) 786-0694 and Richard Cuno, (410) 786-1111.
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
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.
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
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.
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
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
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.
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.
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
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
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
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.
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.
As required by OMB Circular A-4 (available at
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
In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice with request for comment.
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.
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.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
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.
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:
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.
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
On November 30, 2011, we published a final rule in the
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
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
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:
• 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
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
Because of the large number of public comments we normally receive on
Food and Drug Administration, HHS.
Notice.
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
Submit either electronic or written comments on the collection of information by April 4, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• 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”).
Submit written/paper submissions as follows:
•
• 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.”
• 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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
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.
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:
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.
Food and Drug Administration, HHS.
Notice.
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.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
Food and Drug Administration, HHS.
Notice of workshop.
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.
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.
The workshop will be held at the Atlanta Airport Hilton, 1031 Virginia Ave., Atlanta, GA 30354.
Sarah Yim, Office of New Drugs, Center for Drug Evaluation and Research, email:
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.
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
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.
Food and Drug Administration, HHS.
Notice.
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.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
Food and Drug Administration, HHS.
Notice.
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.
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.
If your biologics facility is interested in offering a site visit, submit either an electronic request to
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:
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
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.
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.
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
Food and Drug Administration, HHS.
Notice.
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.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
Food and Drug Administration, HHS.
Notice.
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.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
Food and Drug Administration, HHS.
Notice.
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.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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
Food and Drug Administration, HHS.
Notice.
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.
Fax written comments on the collection of information by March 3, 2016.
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
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
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
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
(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:
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.
The following references are on display in the Division of Dockets Management (see
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.
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.
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.
Substance Abuse and Mental Health Services Administration, HHS.
Notice.
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
A notice listing all currently HHS-certified laboratories and IITFs is published in the
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
Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice), 240-276-2610 (fax).
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
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:
* 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 (
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
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
Comments are encouraged and will be accepted for 60 days until April 4, 2016.
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
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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
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
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,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day Notice.
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
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.
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
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
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
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(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,
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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.
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
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
Comments are encouraged and will be accepted for 60 days until April 4, 2016.
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
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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
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
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,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day Notice.
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
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.
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
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
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
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(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,
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Office of the Chief Information Officer, HUD.
Notice.
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.
Comments Due Date: March 3, 2016.
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:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
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,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of availability of permit applications; request for comments.
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.
We must receive any written comments on or before March 3, 2016.
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
Carlita Payne, (612) 713-5343.
We invite public comment on the following permit applications for certain
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 (
The applicant requests a permit to take (conduct phylogeny studies) pallid sturgeon (
The applicant requests a permit to take (capture and release, conduct nonlethal sampling, band, and radio-tag) Indiana bat (
The applicant requests a permit to take (capture and release, harass, conduct nonlethal sampling, band, trap, radio-tag, and salvage) Indiana bat (
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.
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
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
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.
To ensure consideration, please send your written comments by March 3, 2016.
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 (
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Kathy Konishi, Recovery Permits Coordinator, Ecological Services, (719) 628-2670 (phone);
The Act (16 U.S.C. 1531
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.
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).
The applicant requests a permit to conduct presence/absence surveys for Topeka shiner (
The applicant requests a renewal to an existing permit to continue presence/absence surveys for Topeka shiner (
The applicant requests a permit to conduct survey and monitoring activities for the southwestern willow flycatcher (
The applicant requests a renewal to an existing permit to continue presence/absence surveys for Topeka shiner (
In compliance with the National Environmental Policy Act (42 U.S.C. 4321
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
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.
We provide this notice under section 10 of the Act (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of public meeting.
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.
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
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.
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.
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
Bureau of Land Management, Interior
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act and the Federal Advisory
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.
Trish Hogervorst, Co-Coordinator for the Northwest Oregon RAC, 1717 Fabry Road SE., Salem, OR 97306, (503) 375-5657,
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.
National Park Service, Interior.
Meeting notice.
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.
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.
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
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.
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.
National Park Service, Interior.
Meeting notice.
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.
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.
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
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.
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
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
Submissions and requests should be sent to
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
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
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
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
Submissions and requests should be sent to
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
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
Submissions and requests should be sent to
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
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
Submissions and requests should be sent to
Information about NAGPRA, the Review Committee, and Review
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.
On the basis of the record
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
By order of the Commission.
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
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.
Office on Violence Against Women, Department of Justice.
60-Day notice.
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.
Comments are encouraged and will be accepted for 60 days until April 4, 2016.
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
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,
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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.
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Employment and Training Administration, Department of Labor.
Notice.
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.
Effective Date: This notice is effective on January 11, 2016.
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).
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
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.
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.
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
Employment and Training Administration (ETA), Labor.
Notice.
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.
Written comments must be submitted to the office listed in the
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:
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.
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,
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.
Legal Services Corporation.
Correction notice.
On January 22, 2016, the Legal Services Corporation (LSC) published a notice in the
This correction is effective January 22, 2016.
Rebecca Fertig Cohen, Chief of Staff, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007; (202) 295-1576;
The correct link to LSC's Strategic Plan is available at
Office of Management and Budget.
Revisions to Appendix C of OMB Circular A-94.
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.
The revised discount rates will be in effect through December 2016.
Gideon Lukens, Office of Economic Policy, Office of Management and Budget, (202) 395-3316.
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
National Aeronautics and Space Administration (NASA).
Notice of information collection.
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)).
Consideration will be given to all comments received within 30 days from the date of this publication.
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.
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
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
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.
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.
National Credit Union Administration (NCUA).
Notice and Request for comment.
On January 27, 2016 the
Comments must be received on or before April 4, 2016 to be assured of consideration.
You may submit comments by any of the following methods (Please send comments by one method only):
•
•
•
•
•
Melissa Lowden, Performance Analyst, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428 or telephone: (703) 518-1182.
5 U.S.C. 306.
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
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
The draft
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
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
Ron Campbell,
Nuclear Regulatory Commission.
License amendment request; opportunity to comment, request a hearing, and petition for leave to intervene; order.
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).
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
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Paula Blechman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-2242, email:
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:
•
•
•
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
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.
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.
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
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
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
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.
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
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the
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
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
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
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
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.
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
(1) A description of the licensing action with a citation to this
(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
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
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.
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.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Biweekly notice.
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.
Comments must be filed by March 3, 2016. A request for a hearing must be filed by April 4, 2016.
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
• 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
Janet Burkhardt, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1384, email:
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
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• 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.
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
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.
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
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
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
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.
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
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
Information about applying for a digital ID certificate is available on the NRC's public Web site at
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
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
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
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
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).
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change to the reactor steam dome pressure in the LSCS Reactor Core Safety Limits TS 2.1.1.1 and 2.1.1.2 does not alter the use of the analytical methods used to determine the safety limits that have been previously reviewed and approved by the NRC. The proposed change is in accordance with an NRC approved critical power correlation methodology, and as such, maintains required safety margins. The proposed change does not adversely affect accident initiators or precursors, nor does it alter the design assumptions, conditions, or configuration of the facility or the manner in which the plant is operated and maintained.
The proposed change does not alter or prevent the ability of structures, systems, and components (SSCs) from performing their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed change does not require any physical change to any plant SSCs nor does it require any change in systems or plant operations. The proposed change is consistent with the safety analysis assumptions and resultant consequences.
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 reduction in the reactor dome pressure safety limit from 785 psig to 685 psig is a change based upon previously approved documents and does not involve changes to the plant hardware or its operating characteristics. As a result, no new failure modes are being introduced.
There are no hardware changes nor are there any changes in the method by which any plant systems perform a safety function. No new accident scenarios, failure mechanisms, or limiting single failures are introduced as a result of the proposed change.
The proposed change does not introduce any new accident precursors, nor does it involve any physical plant alterations or changes in the methods governing normal plant operation. Also, the change does not impose any new or different requirements or eliminate any existing requirements. The change does not alter assumptions made in the safety analysis.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The margin of safety is established through the design of the plant structures, systems, and components, and through the parameters for safe operation and setpoints for the actuation of equipment relied upon to respond to transients and design basis accidents.
Evaluation of the 10 CFR part 21 condition by General Electric determined that since the Minimum Critical Power Ratio improves during the PRFO [Pressure Regulator Failure Maximum Demand (Open)] transient, there is no decrease in the safety margin and therefore there is not a threat to fuel cladding integrity.
The proposed change in reactor dome pressure supports the current safety margin, which protects the fuel cladding integrity during a depressurization transient, but does not change the requirements governing operation or availability of safety equipment assumed to operate to preserve the margin of safety. The change does not alter the behavior of plant equipment, which remains unchanged.
The proposed change to Reactor Core Safety Limits 2.1.1.1 and 2.1.1.2 is consistent with and within the capabilities of the applicable NRC approved critical power correlation for the fuel designs in use at LSCS, Units 1 and 2. No setpoints at which protective actions are initiated are altered by the proposed change.
The proposed change does not alter the manner in which the safety limits are determined. This change is consistent with plant design and does not change the TS operability requirements; thus, previously evaluated accidents are not affected by this proposed change.
Therefore, the proposed changes do 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 requested amendments involve no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change will revise SR 3.8.1.6 by adding a note to allow for procedurally controlled simple manual actions associated with the fuel oil transfer system without having to declare the EDG inoperable [under] administrative control. The fuel oil transfer system is required to support continuous operation of standby power sources. The surveillance provides assurance that the fuel oil transfer system is OPERABLE. The fuel oil transfer system is not an initiator of any event previously evaluated. Therefore, the probability of any accident previously evaluated is not increased.
In the event of an accident, if simple manual actions were necessary to restore the automatic feature of the EDG day tank fill, analysis shows that significant margin exists to ensure that EDG operability would not be adversely affected. Although the proposed change to allow simple manual actions could introduce additional potential malfunctions, such that human error could result in the potential to improperly realign the fuel oil transfer system during a DBA [design-basis accident], the improper realignment would be detected when the transfer of fuel oil from the storage tank to the day tank did not occur as expected and the error would be corrected prior to having a significant impact.
The proposed change does not involve any physical changes to the structures, systems, or components (SSCs) in the plant. Further the proposed change does not alter or prevent the ability of SSCs from performing their intended function to mitigate the consequences of an event.
The proposed change is consistent with NRC regulatory requirements regarding the content of plant TS as identified in 10 CFR 50.36. Additionally, the proposed change is consistent with NUREG-1433, “Standard Technical Specifications General Electric BWR/4 Plants,” in that the word `automatically' is bracketed (
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 does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. Accordingly, the change does not introduce any new accident initiators, nor does it reduce or adversely affect the capabilities of any plant structure, system, or component to perform their safety function. Consequently, there are no new initiators that could result in a new or different kind of accident.
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.
The proposed change conforms to NRC regulatory guidance regarding the content of plant Technical Specifications. The proposed change does not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. The proposed change has no adverse impact on current Safety Limits, Limiting Safety System Settings, Limiting Control Settings, Limiting Conditions for Operation, Surveillance Requirements, Design Features, or Administrative Controls.
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.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes do not adversely affect the operation of any systems or equipment inside or outside the auxiliary building that could initiate or mitigate abnormal events,
Therefore, the proposed activity does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes do not change the design function of the auxiliary building or of any of the systems or equipment in the auxiliary building or elsewhere within the Nuclear Island structure. These proposed changes do not introduce any new equipment or components that would result in a new failure mode, malfunction or sequence of events that could affect safety-related or nonsafety-related equipment. This activity will not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that would result in significant fuel cladding failures.
Therefore, this activity does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The margin of safety for the design of the auxiliary building is maintained through continued use of the current codes and standards as stated in the UFSAR and adherence to the assumptions used in the analyses of this structure and the events associated with this structure. The auxiliary building will continue to maintain a seismic Category I rating which preserves the current structural safety margins. The 3-hour fire rating requirements for the impacted auxiliary building walls are maintained. The Wall 11 upper vents are not credited in the subcompartment pressurization analysis and the remaining vents and pressure relief devices provide sufficient venting to maintain the MSIV compartment pressures below the design limit and design basis. The credit of turbine building Wall 11.2 as a HELB barrier provides protection of Wall 11 from selected dynamic effects, which in turn provides that essential SSCs remain protected from the effects of postulated HELB events. The credit of the seismic Category II turbine building first bay and associated missile barriers to provide protection of Wall 11 openings from tornado missiles provides sufficient protection for the essential SSCs located in the auxiliary building in the vicinity of Wall 11 from the effects of external missiles. Thus the requested changes will not adversely affect any safety-related equipment, design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the requested change, thus, no margin of safety is reduced.
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
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The design functions of the nuclear island structures are to provide support, protection, and separation for the seismic Category I mechanical and electrical equipment located in the nuclear island. The nuclear island structures are structurally designed to meet seismic Category I requirements as defined in Regulatory Guide 1.29.
The use of [American Concrete Institute (ACI)] 349 and [American Institute of Steel Construction (AISC)] N690 provides criteria for the design, qualification, fabrication, and inspection of composite steel beam floors and roof in the auxiliary building. These structures continue to meet the applicable portions of ACI 349 and AISC N690. The proposed change does not have an adverse impact on the response of the nuclear island structures to safe shutdown earthquake ground motions or loads due to anticipated transients or postulated accident conditions. The change does not impact the support, design, or operation of mechanical and fluid systems. There is no change to plant systems or the response of systems to postulated accident conditions. There is no change to the predicted radioactive releases due to normal operation or postulated accident conditions. The plant response to previously evaluated accidents or external events is not adversely affected, nor does the change described create any new accident precursors.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change revises the description of the construction of composite steel beam floors and roof in the auxiliary building. The proposed change does not change the design function, support, design, or operation of mechanical and fluid systems. The proposed change does not result in a new failure mechanism for the pertinent structures or new accident precursors. As a result, the design function of the structures is not adversely affected by the proposed change.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed change is consistent with ACI 349 and AISC N690. The design and construction of the auxiliary building floors and roof remain in conformance with the requirements in ACI 349 and AISC N690.
Therefore, the proposed amendment 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.
On June 1, 2015, the NRC staff issued an amendment changing the name on the SSES license from PPL Susquehanna, LLC to Susquehanna Nuclear, LLC. This amendment was issued subsequent to an order issued on April 10, 2015, to SSES, approving an indirect license transfer.
1. Does the proposed change involve a significant increase in the probability or consequences of any accident previously evaluated?
Response: No.
The proposed changes to the EAL scheme to adopt the NRC-endorsed guidance in NEI 99-01, Revision 6, “Development of Emergency Action Levels for Non-Passive Reactors,” [and the additional plant-specific Emergency Plan changes] do not reduce the capability to meet the emergency planning requirements established in 10 CFR 50.47 and 10 CFR 50, Appendix E. The proposed changes do not reduce the functionality, performance, or capability of the ERO [Emergency Response Organization] to
The probability of a reactor accident requiring implementation of Emergency Plan EALs has no relevance in determining whether the proposed changes to the EALs reduce the effectiveness of the Emergency Plan. As discussed in Section I.D, “Planning Basis,” of NUREG-0654, Revision 1, “Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants”;
. . . The overall objective of emergency response plans is to provide dose savings (and in some cases immediate life saving) for a spectrum of accidents that could produce offsite doses in excess of Protective Action Guides (PAGs). No single specific accident sequence should be isolated as the one for which to plan because each accident could have different consequences, both in nature and degree. Further, the range of possible selection for a planning basis is very large, starting with a zero point of requiring no planning at all because significant offsite radiological accident consequences are unlikely to occur, to planning for the worst possible accident, regardless of its extremely low likelihood. . . .
Therefore, risk insights are not considered for any specific accident initiation or progression in evaluating the proposed changes.
The proposed changes do not involve any physical changes to plant equipment or systems, nor do they alter the assumptions of any accident analyses. The proposed changes do not adversely affect accident initiators or precursors nor do they alter the design assumptions, conditions, and configuration or the manner in which the plants are operated and maintained. The proposed changes do not adversely affect the ability of Structures, Systems, or Components (SSCs) to perform their intended safety functions in mitigating the consequences of an initiating event within the assumed acceptance limits.
Therefore, the proposed changes do 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 changes to the EAL scheme to adopt the NRC-endorsed guidance in NEI 99-01, Revision 6, [and the additional plant-specific Emergency Plan changes] do not involve any physical changes to plant systems or equipment. The proposed changes do not involve the addition of any new plant equipment. The proposed changes will not alter the design configuration, or method of operation of plant equipment beyond its normal functional capabilities. All ERO functions will continue to be performed as required. The proposed changes do not create any new credible failure mechanisms, malfunctions, or accident initiators.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from those that have been previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed changes to the EAL scheme to adopt the NRC-endorsed guidance in NEI 99-01, Revision 6, [and the additional plant-specific Emergency Plan changes] do not alter or exceed a design basis or safety limit. There is no change being made to safety analysis assumptions, safety limit, or limiting safety system settings that would adversely affect plant safety as a result of the proposed changes. There are no changes to setpoints or environmental conditions of any SSC or the manner in which any SSC is operated. Margins of safety are unaffected by the proposed changes to adopt the NEI 99-01, Revision 6 EAL scheme guidance. The applicable requirements of 10 CFR 50.47 and 10 CFR 50, Appendix E will continue to be met.
Therefore, the proposed changes do not involve any 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.
1. Does the proposed amendment involve a significant increase in the probability or consequence of an accident previously evaluated?
Response: No.
The ice condenser is a passive heat removal plant feature. The proposed amendment to the TS 3.6.12 does not change the design, physical features or the function of the ice condenser or the ice condenser doors. The ice condenser is not an accident initiator, thus the proposed amendment does not increase the probability of an accident previously evaluated.
The ice condenser is credited in mitigating the consequences of postulated Design Basis Accidents (DBAs) and remains capable of performing its design basis functions. The proposed amendment to the SRs during the first cycle of WBN Unit 2 operation does not change the ice condenser configuration or how it behaves in the event of a DBA. Thus it is concluded that a significant increase in the consequences of an accident previously evaluated will not occur as a result of the proposed amendment.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated. The proposed amendment does not introduce any new modes of plant operation, change the design function of the ice condenser or any other Structure System or Component (SSC), or change the mode of operation of the ice condenser or any other SSC. There are no new equipment failure modes or malfunctions created as the ice condenser and ice condenser lower inlet doors continue to operate in the same manner assumed in the accident analysis. The ice condenser is a passive post-accident heat removal feature that is not an accident initiator.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Ice condensers have been in-service at nine nuclear units in the United States for many years. Operating experience has shown that an 18-month surveillance frequency for evaluating operability is appropriate for the lower inlet doors. The proposed amendment to perform a revised schedule of lower inlet door surveillances in the first cycle before transitioning to the standard 18-month surveillance frequency does not result in a significant reduction in the margin of safety.
Therefore, since there is no adverse impact of this amendment on the WBN Unit 2 safety analysis, there is no significant reduction in the margin of safety of the plant.
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.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated January 8, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated December 30, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated January 5, 2016.
The Commission's related evaluation of the amendment is contained in the Safety Evaluation dated December 17, 2015. The supplemental letter dated May 28, 2015, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination as published in the
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated January 5, 2016.
Specifically, the amendment revised the current sets of TS Figures 3.4.9-1, “Pressure/Temperature Limits for Mechanical Heatup, Cooldown following Shutdown, and Reactor Critical Operations,” and 3.4.9-2, “Pressure/Temperature Limits for Reactor In-Service Leak and Hydrostatic Testing.” The amendment replaced the current set valid up to 20 effective full-power years (EFPYs) with a new set valid up to 38 EFPYs, and replaced the current set valid up to 28 EFPYs with a new set valid up to 54 EFPYs.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated January 7, 2016.
For the Nuclear Regulatory Commission.
Overseas Private Investment Corporation (OPIC).
Notice and request for comments.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35), agencies are required to publish a Notice in the
The proposed change to OPIC-162 clarifies existing questions, incorporates sector-specific development impact questions and eliminates ineffective questions in an effort to harmonize development impact indicators with other Development Finance Institutions (“DFIs”). OPIC is a signatory to a “Memorandum of Understanding” with 25 partnering DFIs to harmonize development impact metrics where possible. The goal of this effort is to reduce the reporting burden on clients that receive financing from multiple DFIs and to instill best practices in the collection and the reporting on OPIC's developmental impacts. To minimize the reporting burden on respondents, OPIC has designed OPIC-162 as an electronic form with questions populating only if they relate to a project.
Comments must be received within sixty (60) calendar days of publication of this Notice.
Mail all comments and requests for copies of the subject form to OPIC's Agency Submitting Officer: James Bobbitt, Overseas Private Investment Corporation, 1100 New York Avenue NW., Washington, DC 20527. See
OPIC Agency Submitting Officer: James Bobbitt, (202) 336-8558.
All mailed comments and requests for copies of the subject form should include form number OPIC-162 on both the envelope and in the subject line of the letter. Electronic comments and requests for copies of the subject form may be sent to
Request for information.
The purpose of this Request for Information (RFI) is to seek examples of commercialization success stories stemming from U.S. Government-funded nanotechnology research and development (R&D) since the inception of the National Nanotechnology Initiative (NNI) in 2001. The information gathered in response to this RFI may be used as examples to highlight the impact of the Initiative or to inform future activities to promote the commercialization of federally funded nanotechnology R&D. Depending on the nature of the feedback, responses may be used to shape the agenda for a workshop to share best practices and showcase commercial nanotechnology-enabled products and services. Commercial entities, academic institutions, government laboratories, and individuals who have participated in federally funded R&D; collaborated with Federal laboratories; utilized federally funded user facilities for nanoscale fabrication, characterization, and/or simulation; or have otherwise benefited from NNI agency resources are invited to respond.
Responses are requested by February 29, 2016.
You may submit responses by any of the following methods (email is preferred):
•
•
Mike Kiley, (703) 292-4399,
One of the four goals of the NNI is to
The feedback received may be used to inform strategic activities to further foster nanotechnology commercialization. Depending on the nature of the feedback, responses may also be used to shape the agenda for a workshop to share best practices and showcase examples of successful transfer of nanotechnology from lab to market, and respondents may be invited to this and other events related to nanotechnology commercialization. In addition, information gained from this RFI may be used to update commercialization activities and goals in the 2016 NNI Strategic Plan, and may be incorporated into future NNI reports, publications, public remarks, and other materials.
• Description of the nanotechnology-enabled product or service.
• Success story details, which may include but are not limited to: Companies formed; jobs created; collaborations with larger companies or research institutions; revenues; patent applications or patents granted; and/or awards.
• Role of the U.S. Government in commercial success. The Government role could include direct funding of research and development; collaboration with Federal laboratories; use of federally funded user facilities for nanoscale fabrication, characterization, and/or simulation; or other benefits from NNI agency resources.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, February 4, 2016 at 12 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Piwowar, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Adjudicatory matters;
Opinion; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
In accordance with the Code of Federal Regulations 13—Business Credit and Assistance § 123.512, the following interest rate is effective for Military Reservist Economic Injury Disaster Loans approved on or after January 22, 2016.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before March 3, 2016.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
Small Business Administration Surety Bond Guarantee Program was created to encourage surety companies to issue bonds for small contractors. The information collected on these forms from Small Business contractors or surety companies/agents is used to evaluate the eligibility of program application. One form is used by surety companies to request claims payments or report recoveries related to defaulted contractors.
U.S. Small Business Administration.
Notice
This is a notice of an Administrative declaration of a disaster for the State of Connecticut dated 01/21/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14599 5 and for economic injury is 14600 0.
The States which received an EIDL Declaration # are Connecticut, New York.
U.S. Small Business Administration (SBA).
Notice of open Hearing of Region III Small Business Owners in Charleston, WV.
The SBA, Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Charleston, WV Regulatory Fairness Hearing. This hearing is open to the public.
The hearing will be held on Friday, February 19, 2016, from 9:30 a.m. to 12:30 p.m. (EST).
The hearing will be at the Charleston Area Alliance, 1116 Smith Street, Charleston, WV 25301.
The hearing is open to the public; however, advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation at the Charleston, WV hearing must contact Yolanda Swift by February 15th in writing or by fax or email in order to be placed on the agenda. For further information, please contact Yolanda Swift, Deputy National Ombudsman, Office of the National Ombudsman, 409 3rd Street SW., Suite 3316, Washington, DC 20416, by phone (202) 205-6918 and
For more information on the Office of the National Ombudsman, see our Web site at
Pursuant to the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), Sec. 222, SBA announces the hearing for Small Business Owners, Business Organizations, Trade Associations, Chambers of Commerce and related organizations serving small business concerns to report experiences regarding unfair or excessive Federal regulatory enforcement issues affecting their members.
U.S. Small Business Administration.
Call for early stage fund managers.
This call for proposals (“Call”) invites experienced early stage fund managers to submit the preliminary materials discussed in Section II below, in the form of the Small Business Investment Company (“SBIC”) Management Assessment Questionnaire (“MAQ”), for consideration by the Small Business Administration (“SBA”) to be licensed as Early Stage Small Business Investment Companies. Licensed Early Stage SBICs may receive SBA-guaranteed debenture leverage of up to 100 percent of their Regulatory Capital, up to a maximum of $50 million. However, Early Stage SBICs may, and most existing Early Stage SBICs do, request less than 100 percent of their Regulatory Capital. Importantly, Early Stage SBICs must invest at least 50% of their investment dollars in early stage small businesses. For the purposes of this initiative, an “early stage” business is one that has never achieved positive cash flow from operations in any fiscal year. By licensing and providing SBA guaranteed leverage to Early Stage SBICs, SBA seeks to expand entrepreneurs' access to capital and encourage innovation as part of President Obama's Start-Up America Initiative launched on January 31, 2011. More information on the Early Stage SBIC Initiative and the regulations governing these SBICs may be found at
The following table provides the key milestones for the Early Stage SBIC Initiative.
Visit
SBA invites early stage fund managers to submit the preliminary materials, as discussed in Section II below, in the form of a Management Assessment Questionnaire (“MAQ”) for the formation and management of an Early Stage SBIC. In 2012, SBA introduced the Early Stage Initiative. Early Stage SBICs represent a new sub-category of SBICs that will focus on making investments in early stage small businesses. Go to
The first required submission in the Early Stage Licensing process is SBA's MAQ. The MAQ consists of two forms that cover qualitative and quantitative information on the management team, the proposed strategy for the SBIC, the principals' investment track record, and the proposed fund structure and economics. The MAQ consists of SBA Form 2181 and Exhibits A-F of SBA Form 2182.
Should SBA issue you a “Green Light letter,” you must submit the SBIC License Application, consisting of SBA Forms 2181, 2182 and 2183 (each of SBA Forms 2181 and 2182 updated to reflect any changes), for the final licensing phase. Exhibit O in SBA Form 2183 includes the fund's limited partnership agreement (“LPA”). Applicants should review this notice for special instructions associated with the LPA for Early Stage SBICs.
There are four stages in SBA's Early Stage Licensing Process: (A) Call Period;
A.
B.
1. Submit MAQ. SBA must receive your completed MAQ no later than September 30, 2016. SBA will send a confirmation that it has received your MAQ within three (3) business days of your submission.
2. Due Diligence. SBA will review all MAQs against the evaluation criteria identified in this notice. SBA may engage a contractor to assist in evaluating MAQs received in response to this Call. The Investment Committee (composed of senior managers from the Office of Investment and Innovation) will consider each MAQ, and if the Investment Committee concludes that the management team may be qualified for an Early Stage SBIC license, the entire team will be invited to SBA Headquarters at 409 Third Street SW., Washington, DC for an interview. Those applicants not invited for interviews will be notified. SBA will provide feedback upon request to applicants not selected for an interview.
3. Interview. SBA's invitation for an interview will identify a 1-hour time block, along with the topics that the applicant should be prepared to address. SBA will conduct interviews at SBA Headquarters.
4. Green Light Letter. Following the interview, the SBA will issue a Green Light letter to an applicant that has met the criteria identified in this notice, as determined by the Investment Committee. Applicants approved by the Investment Committee can expect to receive the Green Light letter via email within a few days of the Investment Committee's decision. The Green Light letter formally invites an applicant to submit its application for an SBIC License. The Green Light letter is only an invitation to proceed to the next stage in the process, not a guarantee that a fund will be issued an Early Stage SBIC license. Those applicants that do not receive a Green Light letter will also be notified by email within a few days of the Investment Committee's decision.
C.
1. Raise Regulatory Capital. An Early Stage SBIC applicant must have signed capital commitments for at least $20 million in Regulatory Capital prior to filing its license application.
2. SBIC Education. All principals of the Early Stage SBIC applicant must attend a one-day SBIC Regulations training class. This training is held quarterly in Washington, DC The purpose of this class is to familiarize principals with the SBIC rules, regulations and compliance procedures. Although an applicant may receive a license before all principals have completed the training, a majority of principals must do so before licensing and all must do so before a licensed Early Stage SBIC will be permitted to draw leverage. Information concerning registration for classes can be obtained at
3. Finalize Documents & Perform Checklist. The following items must be completed and submitted in order to proceed to the Licensing phase:
D.
1. SBA acceptance of license application. Upon receipt of the application, SBA will acknowledge receipt by email. Within three business days, SBA will determine whether the application is complete, meets the minimum capital requirements and satisfies management ownership diversity requirements. If so, SBA will send the applicant an acceptance letter. If not, SBA will ask the applicant to resolve the issues identified.
2. Background and Documentation Review. Once the application has been accepted, SBA will forward the fingerprint cards and Statements of Personal History to SBA's Office of Inspector General for processing by the FBI. Following a review of the application and legal documents, SBA will provide the applicant with a “comment letter.” Applicants must respond in writing to the comment letter. Applicants should respond as quickly as possible, but in any event within 30 days. Failure to address all comments to SBA's satisfaction will slow down the licensing process. Please note that pre-licensing investments, which SBA must review and approve before they are closed, will also add to the licensing time.
3. Divisional Licensing Committee. After SBA's licensing staff and Office of General Counsel have completed their review, the license application is presented to the Divisional Licensing Committee. This committee is composed of the senior managers of the Office of Investment and Innovation. If approved by the Divisional Licensing Committee, the application is presented to the Agency Licensing Committee which consists of certain senior managers of SBA. Prior to consideration by the Agency Licensing Committee, an applicant must provide a signed, up-to-date capital certificate showing that it has at least $2.5 million in Leverageable Capital, consisting of cash on deposit, approved pre-licensing investments funded with partners' contributed capital, and/or approved organizational and operational expenses paid out of partners' contributed capital, and at least $20 million in Regulatory Capital. The applicant's bank must certify that the requisite funds are in the applicant's account and unencumbered.
4. Agency Licensing Committee and Administrator Approval. If the Agency Licensing Committee recommends approval of your license application, it will be forwarded to the SBA Administrator or her designee for final
5. Leverage Commitments. As noted above, the Early Stage initiative is scheduled to terminate at the end of FY 2016, but during FY 2016 SBA intends make certain modifications to the Early Stage regulations and make clear SBA's intent to continue making Early Stage leverage commitments to current and newly licensed Early Stage SBICs.
A.
1. SBA encourages applicants to adhere to the Model LPA to the maximum extent possible. The entire agreement is subject to SBA's approval.
2. Conditions or restrictions on the ability of the general partner to call private capital commitments are limited to those permitted by the Model LPA.
3. Withdrawal rights are limited to those permitted by the Model LPA.
4. Applicants must adhere to SBA's management fee policies available at
5. The designation of fund expenses and expenses to be paid out of the management fee must be consistent with SBIC program regulations (see 13 CFR 107.520) and policies.
a. Organizational costs, expenses incurred in applying for a license and forming the SBIC and its entity general partner (but not its parent fund or any other affiliate), are considered a partnership expense. Organizational expenses typically include items such as the licensing fee, cost of legal and other professional and consulting services, travel and other fundraising expenses, costs of preparing, printing and distributing the private placement memorandum or other offering materials, and other related expenses such as telephone and supply costs. SBA strongly encourages, and may require, applicants to include in the LPA a reasonable cap on the total organizational costs to be paid by the applicant. Costs that SBA deems excessive can be paid by an affiliate of the applicant or deducted from the applicant's Regulatory Capital prior to licensing (Regulatory Capital must still be at least $20 million after the deduction).
b. Unreimbursed expenses on investments in small businesses that do not close may be designated as a partnership expense but must be capped at a reasonable level.
6. Right of limited partners to remove general partner—Provisions allowing removal of the general partner without cause (“no-fault divorce” provisions) are permitted only after the Early Stage SBIC has repaid all outstanding leverage and any other amounts payable to SBA and has surrendered its SBIC license.
7. Any amendments to the limited partnership agreement required by SBA must be executed before licensing. Any amendments initiated by the applicant during the licensing process must be submitted to SBA in draft form as early as possible.
B.
1. Applicant cannot be a BDC or other public entity or a subsidiary of any such entity.
2. All provisions governing the operation of the SBIC must be included in the limited partnership agreement. While SBA does not encourage the use of side letters, SBA recognizes that side letters form the basis of the understanding of the investment in an SBIC for certain investors, and, in particular, certain investors subject to regulatory oversight. If an investor requests a side letter provision that is of general interest to all investors (
3. Applicant must adopt SBA Model Valuation Guidelines.
4. Drop-down SBICs
a. The drop-down structure should be used only when it has a clear business purpose:
i. Example 1—Parent fund has already raised capital and begun operating and wants to commit a portion of its capital to an Early Stage SBIC.
ii. Example 2—Substantial capital will be retained for investment at the parent level (SBA suggests that managers consider the alternative of structuring a non-SBIC fund side by side with the SBIC).
b. Drop-down funds must have one parent fund only and the parent fund must be a U.S. entity.
c. Parent must qualify as a traditional investment company based on established SBA precedent.
d. Parent must disclose the identity of all of its investors.
e. All of the investors in the parent fund (the SBIC's “Class A” limited partner) must agree to be “Class B” limited partners of the SBIC with an obligation to fund the Early Stage SBIC capital calls if the Class A limited partner does not. The obligation of the Class B limited partners to the Early Stage SBIC is reduced dollar for dollar as the parent fund contributes capital to the SBIC. The Model LPA contains required provisions for drop-down funds.
f. The Class B limited partners' commitments to the SBIC applicant must be expressed as a specific dollar amount (not just as the “proportionate share” of parent fund's commitment).
g. The total dollar amount of Class B commitments must be equal to the Class A limited partner's unfunded commitment to the SBIC. SBA will not require Class B commitments if the SBIC's Regulatory Capital will not include any unfunded commitments from the Class A limited partner.
C.
1. Capital commitments from limited partners must be made directly to the SBIC (and its parent fund, in the case of a drop-down) with no intermediaries involved.
2. The Early Stage SBIC applicant must have the unconditional ability to legally enforce collection of each capital commitment.
3. Capital Certificate. Capital commitments must be documented in the capital certificate (Exhibit K of SBA Form 2183) and comply with the following:
a. A signed Capital Certificate must be submitted with the license application.
b. SBA will permit only the sole following condition on private capital commitments: the receipt of an Early Stage SBIC license.
c. Individual investors must list primary residence address, not a business address.
d. Street addresses are required (no P.O. Box addresses).
4. A dual commitment may be obtained to back up the commitment of any direct investor in the SBIC who is not an Institutional Investor.
5. Capital commitments by the principals, general partner, or their affiliates must be payable in cash when called (cannot be satisfied with notes or management fee waivers).
D.
1. All principals must:
a. Hold direct ownership interests in and be the direct individual managers of the general partner, with no intervening entities.
b. Receive carried interest directly from the general partner; for drop-down SBICs, carried interest may be received from the parent fund's general partner.
2. A maximum of 25% of the carried interest may be allocated to non-principals.
3. Any provision to remove or terminate a principal must be spelled out within the general partner's organizational document and must not be tied to events occurring under other agreements (
E.
1. Power to remove or terminate other principals.
2. Power to change the composition of the Early Stage SBIC's investment committee.
A.
B.
C.
1. Vintage Year Diversification. Vintage year has a major impact on the return expectations of a fund and excessive concentration in a single year could substantially increase program risk. Therefore, SBA reserves the right, when licensing Early Stage SBICs, to maintain diversification across vintage years. If SBA receives an extraordinary number of qualified applicants in FY 2016, it may not approve all such applicants in the same Fiscal Year.
2. Geographic Diversification. All Early Stage SBICs must first meet SBA's basic licensing criteria. After those criteria are met, SBA reserves the right to maintain diversification among Early Stage SBICs with respect to the geographic location in which the Early Stage SBIC expects to invest.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before March 3, 2016.
Comments should refer to docket number MARAD-2016-0001. Written comments may be submitted by
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-465, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel NN59 is:
The complete application is given in DOT docket MARAD-2016-0001 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Inventory of U.S.-flag launch barges.
The Maritime Administration is updating its inventory of U.S.-flag launch barges. Additions, changes and comments to the list are requested. Launch barge information may be found at
Any comments on this inventory should be submitted in writing to the contact person by March 3, 2016.
Michael Hokana, Office of Cargo and Commercial Sealift, Maritime Administration, MAR-620, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone 202-366-0760; email:
Pursuant to 46 CFR part 389 (Docket No. MARAD-2008-0045) Determination of Availability of Coastwise-Qualified Vessels for the Transportation of Platform Jackets, the Final Rule requires that the Maritime Administration publish a notice in the
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before March 3, 2016.
Comments should refer to docket number MARAD-2016-0004. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel HAWK is:
Intended Commercial Use of Vessel: “6-pack charters and sightseeing trips.”
Geographic Region: “California.”
The complete application is given in DOT docket MARAD-2016-0004 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before March 3, 2016.
Comments should refer to docket number MARAD-2016-0003. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended
The complete application is given in DOT docket MARAD-2016-0003 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration (MARAD), Department of Transportation.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before March 3, 2016.
Michael Hokana, 202-366-0760, Office of Cargo and Commercial Sealift, Maritime Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW., Washington, DC 20503.
Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimate of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
The Paperwork Reduction Act of 1995; 44 U.S.C. chapter 35, as amended; and 49 CFR 1.93.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before March 3, 2016.
Comments should refer to docket number MARAD-2016-0002. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-465, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel PAU HANA is:
The complete application is given in DOT docket MARAD-2016-0002 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Office of the Assistant Secretary for Research and Technology (OST-R), DOT.
Notice.
The United States Department of Transportation (the Department) is publishing this notice to give eligible nonprofit institutions of higher learning advance notice that they will have an opportunity to submit grant applications for the University Transportation Centers (UTCs) program (Catalog of Federal Domestic Assistance number 20.701).
Funds for this grant program are authorized beginning on October 1, 2015. In the near future, the Department, via the Office of the Assistant Secretary for Research and Technology, will release a grant solicitation through Grants.gov, also posted on the UTC Program's Web site,
Dr. Kevin Womack, Director, Office of Research, Development and Technology, mail code RDT-10, Office of the Assistant Secretary for Research and Technology (OST-R), 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone Number (405) 954-7312 or Email
The Fixing America's Surface Transportation Act (FAST Act; Pub. L. 114-94, Sec. 6002(a)(5); December 4, 2015) authorizes $72.5 million for Federal fiscal year 2016 (FY 2016), $75 million for fiscal years 2017 (FY 2017) and 2018 (FY 2018), and $77.5 million for fiscal years 2019 (FY 2019) and 2020 (FY 2020) for up to 35 competitive grants for UTCs. The FY 2016 through FY 2020 funds are subject to appropriations and to an annual obligation limitation. The amount of budget authority available in a given year may be less than the amount authorized for that fiscal year.
The FAST Act authorizes the Secretary of Transportation to make grants to eligible nonprofit institutions of higher education to establish and operate UTCs. Nonprofit institutions of higher education may include qualifying two-year institutions (20 U.S.C. 1001(a)). OST-R will manage the UTC Program for the Department. The Department will solicit competitive grant applications for National University Transportation Centers, Regional University Transportation Centers and Tier 1 University Transportation Centers as set forth in the FAST Act. UTCs will be selected by the Secretary, in consultation as appropriate with the Assistant Secretary for Research and Technology, and the Administrator of the Federal Highway Administration and other modal administrators as appropriate. (49 U.S.C. 5505(b)(4)(B) as amended by Pub. L 114-94, Sec. 6016).
The Department plans to competitively select five National UTCs with annual awards for five years of between $2 and $4 million each, ten Regional UTCs with annual awards of between $1.5 and $3 million each, and up to 20 Tier 1 UTCs with annual awards of between $1 and $2 million each.
The role of each UTC is to advance transportation expertise and technology in the varied disciplines that comprise the field of transportation through education, research, and technology transfer activities; to provide for a critical transportation knowledge base outside of the Department of Transportation; and to address critical workforce needs and educate the next generation of transportation leaders.
A UTC must be located in the United States or territories. A change in the UTC Program from prior authorizations is that each UTC must be a consortium of two or more nonprofit institutions of higher learning (49 U.S.C. 5505(b)(1) as amended by Pub. L. 114-94, § 6016).
A Regional UTC must be located in the region for which the grant is sought. (49 U.S.C. 5505(c)(3)(B)(ii) as amended by Pub. L. 114-94, § 6016). All members of a Regional UTC consortium must be located in the region for which the grant is sought.
Institutions may collaborate with state and local departments of transportation, Metropolitan Planning Organizations, the private sector, and non-governmental organizations; however, these organizations or others that are not U.S. nonprofit institutions of higher learning may not be considered members of a consortium. A change from previous UTC Program competitions is that two-year institutions may be members of a consortium if they meet the definition of “institution of higher learning” in 20 U.S.C. 1001(a). The grantee institution (lead institution of a consortium of institutions) will be the direct and primary recipient of UTC program
Applicants may apply for more than one type of grant, but the FAST Act limits the circumstances in which an institution may receive more than one grant. (49 U.S.C. 5505(b)(2)(A) as amended by Pub. L. 114-94, § 6016). The restriction is:
• A lead institution of a consortium of nonprofit institutions of higher education may only receive one grant per fiscal year for each type of Center. Thus, a lead institution may receive grants as a National Center, a Regional Center, and a Tier 1 Center, but not more than one grant in each category.
Each UTC is required to obtain matching funds from non-federal sources. The amount of matching funds required for a National or Regional UTC is 100 percent of the Federal award. The amount of matching funds required for a Tier 1 UTC is 50 percent of the Federal award. The matching amounts may include the amounts made available to a grant recipient under 23 U.S.C. 504(b) or 505.
A. Improving mobility of people and goods;
B. Reducing congestion;
C. Promoting safety;
D. Improving the durability and extending the life of transportation infrastructure;
E. Preserving the environment; and
F. Preserving the existing transportation system.
The Secretary will select nonexclusive candidate topic areas that will fall within these six priority areas. Each UTC will be awarded a grant based on its ability to address one of these six priorities and the topic areas that fall within the priority area selected.
National UTCs: The Department intends to select National UTCs to lead research in five of these priority areas.
Regional UTCs: One UTC will be selected in each of ten Standard Federal Regions. Regional UTCs are required to focus on transportation research and education (49 U.S.C. 5505(c)(3)(B) as amended by Public Law 114-94, § 6016). Regional UTCs must be able to conduct research in an area of focus from among nonexclusive candidate topic areas established by the Secretary that address the research priorities identified in section 6503, Subtitle III of title 49 as amended by Public Law 114-94, § 6016. One of the Regional Centers must focus on “comprehensive transportation safety, safety, congestion, connected vehicles, connected infrastructure, and autonomous vehicles” as its main research effort (49 U.S.C. 5505(c)(3)(E) as amended by Public Law 114-94, § 6016). An applicant for a Regional UTC must designate the region in which it is applying.
Tier 1 UTCs: Based on the statute's general selection criteria, the Tier 1 UTCs (no more than 20 UTCs) must focus on nonexclusive candidate topic areas that address the research priorities identified in section 6503, Subtitle III of title 49 as amended by Public Law 114-94, 6016. In making awards to Tier 1 UTCs, consideration will be given to minority institutions, as defined by section 365 of the Higher Education Act of 1965 (20 U.S.C. 1067k), or consortia that include such institutions that have demonstrated an ability in transportation-related research.
The Department seeks a balanced portfolio of UTCs across the 35 to be selected through this competition that supports the Department's Strategic Goals, contains different types and/or sizes of nonprofit institutions of higher education, and focuses on improving overall system performance using multiple transportation resources that address multimodal needs.
• The category of grant for which the applicant will apply (National, Regional, Tier I); and
• The chosen priority area in which to focus research, based on section 6503, Subtitle III of title 49 as amended by Public Law 114-94, § 6016.
Letters of intent will be required so that the Department's review panels, comprising relevant subject-matter experts drawn from inside and outside the Department, may be organized in advance of receipt of final proposals. If an institution intends to apply for more than one UTC grant, a separate letter of intent must be submitted for each intended application.
“(i) the demonstrated ability of the recipient to address each specific topic area described in the research and strategic plans of the recipient;
“(ii) the demonstrated research, technology transfer, and education resources available to the recipient to carry out this section;
“(iii) the ability of the recipient to provide leadership in solving immediate and long-range national and regional transportation problems;
“(iv) the ability of the recipient to carry out research, education, and technology transfer activities that are multimodal and multidisciplinary in scope;
“(v) the demonstrated commitment of the recipient to carry out transportation workforce development programs through—
“(I) degree-granting programs or programs that provide other industry-recognized credentials; and
“(II) outreach activities to attract new entrants into the transportation field including women and underrepresented populations;
“(vi) the demonstrated ability of the recipient to disseminate results and spur the implementation of transportation research and education programs through national or statewide continuing education programs;
“(vii) the demonstrated commitment of the recipient to the use of peer review principles and other research best practices in the selection, management, and dissemination of research projects;
These criteria apply to the evaluation and selection of all three categories of UTCs. The following additional selection criteria apply to Regional UTCs and Tier I UTCs:
Regional UTCs. The lead institution in a Regional consortium must have a
Tier 1 UTCs. Consideration will be given to minority institutions, as defined by section 365 of the Higher Education Act of 1965 (20 U.S.C. 1067k), or consortia that include such institutions that have demonstrated an ability in transportation-related research.
Past Performance. The Department is required by 2 CFR 200,
External Stakeholders. The Department will consult with external stakeholders (including the Transportation Research Board of the National Academy of Sciences, among others), to the maximum extent practicable, to evaluate and review all proposals. (49 U.S.C. 5505(b)(6) as amended by Public Law 114-94, 6016).
UTCs will be selected by the Secretary, in consultation as appropriate with the Assistant Secretary for Research and Technology, the Administrator of the Federal Highway Administration and other modal administrators as appropriate. Awards will be made no later than December 4, 2016, with Federal FY16 funds awarded at that time. Subsequent Federal FY17-FY20 funding will be awarded approximately annually after that date, subject to availability of funds and grantee compliance with grant terms and conditions.
Grantees will have until September 30, 2022 to expend all funds, assuming availability of annual appropriations.
Financial Crimes Enforcement Network (“FinCEN”), Treasury.
Notice and request for comments.
FinCEN published the revised Bank Secrecy Act Currency Transaction Report (“BCTR”) in March 2011. The BCTR was designed to facilitate financial institutions reporting the most frequently encountered transaction scenarios. Since that time, FinCEN has become aware that the current report is not configured to allow for alternative reporting models that have developed in the last few years, such as reports filed by a parent company on behalf of its subsidiary. To remedy some of the limitations of the current BCTR, FinCEN now proposes an amended report. This notice does not propose any new regulatory requirements or changes to the requirements related to currency transaction reporting, but rather seeks input on technical matters designed to improve the layout and reporting of the BCTR. This request for comments covers 31 CFR 1010.310. This request for comments is made pursuant to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).
Written comments are welcome and must be received on or before April 4, 2016.
Written comments should be submitted to: Office of Regulatory Policy, Financial Crimes Enforcement Network, Department of the Treasury, P.O. Box 39, Vienna, Virginia 22183, “Attention: PRA Comments—BCTR Revision.”
Comments also may be submitted by electronic mail to the following Internet address:
FinCEN Resource Center at 1-800-767-2825 or 1-703-905-3591 (not a toll free number) and select option 3 for regulatory questions. Email inquiries can be sent to
The Secretary of the Treasury was granted authority in 1970, with the enactment of 31 U.S.C. 5313, to require financial institutions to report currency transactions exceeding $10,000. The information collected on the “report” is required to be provided pursuant to 31 U.S.C. 5313 as implemented by FinCEN regulations found at 31 CFR 1010.310. The information collected under this requirement is made available to appropriate agencies and organizations as disclosed in FinCEN's Privacy Act
In response to these identified deficiencies, FinCEN is proposing the following adjustments to the BCTR. To support recording the dollar amount of the transaction at the transaction location, cash-in and cash-out fields have been added to Part III. A new Part IV, has been added to record the entity actually filing the report through the BSA E-Filing System. A check box has been added to Part III to indicate when the information in Part IV is the same for Part III. This change will reduce the burden for filing the BCTR in those cases where the filer and transaction locations are the same. In Part I, Item 2d has been changed from “Courier Service (Private)” to “Common carrier” to reflect defined terminology. FinCEN has been advised by several non-bank financial institutions that the reference to “teller(s)” in the instructions is confusing and misleading since non-bank financial institutions normally do not employ “tellers.” FinCEN appreciates this feedback and proposes to define “teller” for the purpose of completing a BCTR as follows:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Records required to be retained under the BSA must be retained for five years.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; (e) estimates of capital or start-up costs and costs of operation, maintenance and purchase of services to provide information; and (f) the proposed definition of the word “teller.”
The added or updated data items for the BCTR are as follows:
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing the names of 1 individual and 1 entity whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten To Commit, or Support Terrorism.”
OFAC's actions described in this notice are effective on January 7, 2016.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On January 7, 2016, OFAC blocked the property and interests in property of the following 1 individual and 1 entity pursuant to E.O. 13224, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism”:
1. CHARARA, Ali Youssef (a.k.a. SHARARA, Ali Youssef; a.k.a. SHARARA, 'Ali Yusuf), Ghobeiry Center, Mcharrafieh, Beirut, Lebanon; Verdun 732 Center, 17th Floor, Verdun, Rachid Karameh Street, Beirut, Lebanon; Al-Ahlam, 4th Floor, Embassies Street, Bir Hassan, Beirut, Lebanon; DOB 25 Sep 1968; POB Sidon, Lebanon; Gender Male (individual) [SDGT] (Linked To: HIZBALLAH).
1. SPECTRUM INVESTMENT GROUP HOLDING SAL (a.k.a. SPECTRUM INTERNATIONAL INVESTMENT HOLDING SAL; a.k.a. SPECTRUM INVESTMENT GROUP HOLDING; a.k.a. SPECTRUM INVESTMENT GROUP SAL HOLDING; a.k.a. SPECTRUM INVESTMENT HOLDING; a.k.a. “SPECTRUM HOLDING”), Floor 17, Verdun 732 Building, Rachid Karameh Street, Verdun, Beirut, Lebanon; Verdun 732 Center, Rachid Karame Street, Beirut, Lebanon; P.O. Box 113-5333, Beirut, Lebanon; Business Registration Document # 1990106 (Lebanon) [SDGT] (Linked To: CHARARA, Ali Youssef).
Department of Veterans Affairs.
Notice.
This
On October 22, 2015, the Department of Veterans Affairs (VA) published a notice in the
A key purpose for VA to solicit the public comments was to inform the Department's ongoing process to revitalize the campus and make it more Veteran focused (particularly for homeless, severely disabled, aging, and female Veterans); help end Veterans homelessness in greater Los Angeles, in coordination with key stakeholders (including former plaintiffs in the Valentini v. McDonald lawsuit, pertinent federal, state, and local authorities, legislators, Veteran Service Organizations, Veterans, local community partners, outside experts, and philanthropic entities); receive input to determine ways to make the campus more of a welcoming and thriving environment for Veterans and their families, whether living on or off campus, as they engage with one another on a peer-to-peer level, and receive the healthcare, benefits, and other services that they earned for serving our country; improve the processes and procedures regarding the review, execution, and administration of third-party land use agreements on campus, to ensure that those agreements that are not Veteran focused and not central to VA's mission and operations are as appropriate, modified, or terminated in support of VA's ongoing campus revitalization efforts.
We are pleased to advise that as a result of this public process, VA received a record number of comments: 1,002. They contained invaluable feedback on a range of issues pertinent to the campus, notably regarding: the enhancement of arts, entertainment, and recreation facilities and opportunities; ways to improve campus circulation, parking, security, and transportation; ideas for improving campus integration with the surrounding community; suggestions for increased and expanded clinical care including therapeutic and holistic approaches; housing and campus restoration; ways to improve and address third-party when you see agreements on campus; ways to improve benefits and memorial services on campus, as well as other amenities such as childcare services, legal counseling services, financial management services, and parking; operational issues including improvements to the organizational and leadership structures for the campus, to maximize the potential and desire to better connect Veterans to the campus and give them more opportunities to provide true insight and feedback; emphasis on improving transparency and accountability regarding the spectrum of healthcare, benefits, memorial service, and third-party activities throughout the campus; options to improve access, reintegration, employment, counseling, family well-being, and other services for Veterans on the campus and within the surrounding community.
VA has received numerous letters of support for legislation that Senator Dianne Feinstein and Congressman Ted Lieu have introduced in Congress to support VA's plan to revitalize the campus. The bill is known as S. 2013 and HR 3484, and is title the “Los Angeles Homeless Veterans Act of 2015.” The legislation would enable VA
As we proceed towards adoption of the Draft Master Plan and commence its implementation, we envision the GLA campus serving as an exemplary model for other VA facilities nationwide. We also look forward to working with all stakeholders to ensure that this campus transformation coincides with VA's I care values of integrity, commitment, advocacy, respect, and excellence, relative to VA's overriding objective of putting Veterans in control of how, when, and where they want to receive their healthcare and services. With your continued support we are confident that VA will be able to fulfill President Abraham Lincoln's promise: “to care for him who she'll have born the battle, and for his widow, and his orphan,” by serving and honoring the men and women who are America's Veterans.
To most efficiently review and respond to the 1,002 comments in the
In addition to the nine categories addressed in this document there were 124 categorizations of non-specific comments expressing general support for the Draft Master Plan and revitalization of the GLA campus, and 31 categorizations of comments expressing general discontent with VA.
The public submitted comments on a breadth of topics under the umbrella of Arts, Entertainment, and Recreation. These comments most prominently covered the type and availability of recreational activities on the Greater Los Angeles campus. Recreation-related comments generally fell under a couple different categories. The first category was comments seeking a centrally located recreation center and other athletic, recreational, rehabilitative, and therapeutic facilities established on campus. These comments will be taken into consideration in the development of the Zone 5 outer ring of the campus, and in each development which has been set aside for development into recreational facilities. The Master Plan focuses on developing supportive housing in conjunction with a healthy assortment of recreational facilities, to serve the future resident population on campus.
The second category was comments seeking the development of meditative gardens and walking paths for Veterans, their families, and their visitors. VA received several comments requesting arts and entertainment options available on campus, as well. Comments focusing on the arts either requested a centrally located arts facility or an artistic means of honoring Veterans on campus. Commenters requested that the former allow space to make and refine art, including but not limited to screening rooms, audition rooms, makeup studios, a graphic design lab, studio space, and hobby shops. As with the requested recreational facilities described above, an arts facility could be developed in Zone 4 of the campus. Commenters focusing on the latter requested either that artist installations honoring Veterans be placed throughout the campus or a public memorial be placed on campus to allow Veterans to reflect, while also educating the public on the Veterans' sacrifices. The feasibility of artist installations throughout the campus will be explored and expanded, but the Grand Lawn in the southwest corner of the north campus is intended to be a quiet memorial space where Veterans and the general public can come to reflect and learn. The last major topic focused directly on the entertainment options to be available on campus. These comments were dedicated mainly to development of three venues: An outdoor concert space, a movie theatre, and an auditorium. The Greater Los Angeles VA can provide these spaces, by leveraging existing and future facilities. These issues are further addressed in the Chapter II, Section B section of the Master Plan.
Definition of Campus Circulation subcategory: Any comments discussing transportation within and around the campus.
Campus Circulation concerns the movement of people and vehicles around, to, and from the GLA campus. Many comments noted deficiencies in the internal circulation of the campus, the lack of signage, and problems of way-finding throughout the campus. Commentators believe that the campus can be improved in its spatial organization to create a more easily legible plan. Overall, the majority of comments concerning internal circulation on campus asked for a variety of transportation modes and supporting infrastructure including pedestrian and bicycle pathways or routes; an improved, reliable shuttle to connect the various campus centers with convenient stop locations; and sufficient parking distributed throughout the campus.
There were also many comments voicing concern for circulation beyond the GLA campus. Commentators noted that in the attempt to make the campus
Responses to the Preliminary Draft Final Master Plan commented on the poor quality of walkways, grade management, and visible bus stops. Many requests were made to improve roadway infrastructure in the surrounding areas particularly for safe and accessible bus/shuttle stops as well as safer and better-designed entrance/exit ramps, bicycle lanes and pedestrian infrastructure along Wilshire Boulevard.
Lastly, a number of comments to the
Circulation is one of the key factors in the Draft Master Plan even in its earliest conceptual development. Circulation considerations include road, bike, shuttle and pedestrian networks; it also considers site features, programming, security and accessibility concerns. The Draft Master Plan evaluates all of the existing conditions both inside and around the GLA campus based on available data. There are a number of further studies that the plan recommends in order to optimize the GLA campus circulation network designs, including a more in-depth traffic study. Still, the circulation plan must aspire to optimize development of the site and contribute to restoring the campus to its legacy as a Soldier's Home.
A key priority of the Draft Master Plan is to include various forms of transportation and to accommodate all Veteran needs on campus. Therefore, the Draft Master Plan includes campus network designs for pedestrian, bicycle, shuttle routes as well as a newly designed road network. The campus will be able to be navigated by pedestrian, bicycle, shuttle and vehicle routes. The design of these routes creates zones with different levels of accessibility and security. The road networks were designed to establish a hierarchy of routes that will allow the campus to be efficiently connected and navigated. The Draft Master Plan includes a design for a shuttle system with four routes that provide transportation to each end of the campus as well as beyond the campus boundaries. The shuttle routes radiate from key areas of Veteran services and interaction, such as the Town Center and each of the neighborhood centers.
The site's topography, including features such as the bluff and arroyo, had a great influence on the Draft Master Plan's road network design. The grade change throughout the campus was a concern for pedestrian circulation throughout the site. It was important that pedestrian circulation have a wide range of foot paths including routes that pedestrians with physical disabilities would be able to move throughout the campus. The Draft Master Plan proposed a pedestrian “spine” that runs to each end of the campus, including a pedestrian bridge over Wilshire Boulevard, that maintains a maximum grade change of 5%, serving as an important mode of accessibility.
The Draft Master Plan also proposed a 2.5 mile loop dedicated to non-vehicular traffic. This loop will provide much needed recreational space for the campus as well as contribute to the transportation network of the campus. Apart from the loop, the plan provides over 5 additional miles of bicycle routes or lanes throughout the campus.
The Draft Master Plan adds an access point to the campus along the north side and locates this point south of the Barrington Post Office in order to reduce impact on the already high traffic intersections around Brentwood Village. The Draft Master Plan adds access points along the west side of campus, both from the north campus onto Bringham Avenue and from the south campus onto Federal Avenue. The Draft Master Plan also uses the Constitution Avenue entrance from Sepulveda Boulevard for direct access into a proposed Reintegration Zone within the Industrial District on the east side. Lastly, there are additional access points to the south campus that run parallel to the existing access point from Ohio Avenue, offering alternative access to the southbound I-405 freeway. The update plan now includes a proposal for the Transit Authority to have a station stop on the campus that will have passenger portals with access to the medical section of the campus and to the industrial and cultural district of the campus.
To address the surrounding community's concerns about traffic, the plan aims to reduce potential negative impact of campus development by providing multiple points of entry and egress to distribute traffic among multiple route options. The Draft Master Plan encourages multiple forms of transportation to reduce the dependency on the car. The objective is for the campus to be completely accessible for all Veterans without use of a private vehicle.
Definition of Clinical subcategory: Any comments discussing the GLA Medical Center clinical care as well as any comments discussing expanding clinical care to include therapeutic and/or holistic approaches to Veteran care.
VA received numerous comments on clinical care and Veteran services on the GLA campus. The majority of comments that fell under this category focused on specific service areas, including: Self-care instruction and volunteerism; peer-support specialist services (including a concierge); family and caregiver support (including child-care); housing (emergency, triage, bridge, transitional and permanent supportive); integrative (non-traditional, alternative) healthcare; rehabilitative services and healing arts; forums for traditional and non-traditional spiritual practice; education, vocational training and job placement; benefits, financial coaching and a full range of legal services; on-site employment and entrepreneurism, and recreation (individual/team sports, entertainment and leisure. Veteran comments consistently requested enhancements to these service areas to provide a holistic, 21st Century approach to Veteran care.
As VA revitalizes and reinvigorates the physical plan of the GLA campus, it must also add to the service plan both on the campus and in the community. The goal is to create a vibrant, welcoming, Veteran-focused, outcomes-driven model for Veterans and their families. The services must be strength-based, holistic, and aimed at helping the Veteran and the Veteran's family beyond the traditional medical models. Practically speaking, it means “how”, “when” and “where” services are delivered must conform to the needs of the Veteran. This is particularly relevant for Veterans who are aging, disadvantaged, and suffering from chronic debilitating illnesses like schizophrenia and other psychotic disorders, Post-Traumatic Stress Disorder (PTSD), addictions and/or
Services must also be delivered in partnership with VA's academic affiliates, including UCLA, and other VA partners who have expertise in caring for homeless and other vulnerable Veteran populations. As part of the service enhancements, it will be critical to create improved access processes through not only more effective staff and volunteer efforts, but also through a resource center and the use of Veteran peer supports (concierges) that improves the ease with which various parts of the campus can be navigated.
VA also received numerous comments related to existing services provided at the GLA campus (
For more information on proposed Veteran services' enhancements, please refer to Chapter II, Section B of the Draft Master Plan.
Definition of Connectivity subcategory: Any comment on integrating the campus into the surrounding community, or public access to the campus.
There were some conflicting ideas on campus/public connectivity submitted to the
At 388 acres, the campus is big enough to accommodate a wide variety of needs and conditions, but it must be used to service the Veteran community. This includes the facilitation of reintegration and community building desired by so many Veterans. The VA campus has provided valued resources for the communities of Los Angeles for decades. However, it is important that the Draft Master Plan focus on providing an accessible, community rich, therapeutic space for Veterans. The Draft Master Plan includes a variety of places that can create a sense of security and safety for Veterans, and other more permeable spaces that can be shared with others as appropriate in order to “emphasize community, not campus”.
The Draft Master Plan focuses on making the campus a destination for all Veterans. The site is meant to be a home and a community. The planning process recognizes 21st century models for re-integration that connect with the community-at-large and the Draft Master Plan was devised to build connections not just in spatial design but also in the programming of supportive services on campus. The plan includes major advancements in campus programming aimed at drawing in Veterans of all demographics, as well as to give Veterans the opportunity to create programs that can include members of the public, working together to enhance the Veteran community on campus. For example, beyond the need for Veteran housing and services, the plan proposed to incorporate cultural activities, community spaces, recreation and entertainment, and Veteran employment opportunities. The intent is to discourage the isolation of Veterans by designating physical zones on campus that have directed purposes and uses with varying degrees of public and Veteran permeability.
The Draft Master Plan proposed five zones within the campus. The most open and accessible of the zones, Zone 5, forms a ring around Zones 2, 3, and 4 that hold the majority of non-medical Veteran services including most of the campus housing. This peripheral zone includes the campus recreational areas and green space as well as the campus industrial district and is intended to be the permeable outer ring of the campus. Although accessible and open, the outer ring also acts as a subtle barrier, wrapping the Veteran community within the exclusive core. The inner zones will be more exclusive areas that limit public access and even create some spaces only accessible to resident Veterans.
To address security concerns, the plan utilizes organizational and landscaping techniques to create soft barriers throughout the campus. This landscape and organization of the campus separates programs and areas that are exclusive to Veterans such as supportive housing and some counseling services. The organization of space as well as the use of landscape divides these spaces from the more permeable areas of the campus. In some particular situations, times or areas, a gate or access cards may be employed to further strengthen security of areas of the campus and select buildings.
The Veteran Vocational Enterprise and Cultural Center should be an important part of Veteran reintegration through public interface. This area of the campus should serve as a center of reintegration services and will include education, training and career counseling as well as entrepreneurial, employment and community spaces. As it is part of a public access zone, the area would include public infrastructure such as parking to accommodate its new uses. This area should utilize public interest and volunteers to form an urban space that will help to ease Veterans into civilian life in the Los Angeles area.
Also in Zone 5 is recreational and open space on the north end of the campus. Already acting as green space, with a more efficient use of space this area can provide the Veteran community and possibly the neighboring communities with open space, gardens and fields. For example, the area that is currently designated as the Veteran's parking lot servicing Brentwood Village, can be utilized by Veteran-owned businesses and still provide parking to the neighboring community. Central to this concept of public access is that it is Veteran-owned and Veteran controlled and the public is welcome to share it by invitation.
Definition of Housing & Campus Restoration subcategory: Any comments discussing housing development on campus, methods to foster a sense of community among the campus residents, or the physical revitalization of the campus.
VA received numerous
Some common housing themes in the comments received include (1) increase the amount of housing over the total units originally proposed (2) add housing units as quickly as possible (3) ensure all housing is low cost and affordable to Veterans (4) various types of housing (
VA committed to bringing affordable housing for Veterans to the GLA campus, and the Draft Master Plan now includes housing for the projected need of 1200 units, based on the Housing Needs and Analysis contained in Chapter II. This accounts for 300 more units than was identified in the initial plan. Chapter II of the Draft Master Plan identifies specific target populations (severely disabled Veterans, including chronically homeless Veterans; aging Veterans; and female Veterans with and without dependents), but would be available to all Veterans in need. The Draft Master Plan has planned for this housing to be developed with a sense of `community', which is described in detail in Chapter V of the Draft Master Plan.
Definition of Land Use Agreements subcategory: Any comments discussing existing use of or proposing future use of land by a third party organization including UCLA, Brentwood School, Barrington Park operators, and the Westside Breakers.
Feedback provided to VA during this master planning process from Veterans, Veterans Service Organizations, local authorities, congressional delegates, philanthropic organizations, the local community, and other stakeholders, expressed a consistent desire for the campus to: maximize the potential to reflect a transformed, strategic, and informed configuration and implementation focused on Veterans and their families; provide convenient access to facilities and resources via all pertinent modes of transportation; function effectively with appropriate levels and types of VA and non-VA care and staffing in pertinent and underpopulated disciplines; extend an inviting, warm, and welcoming environment to attract Veterans and their families across all spectrums; function effectively and in harmony with the surrounding community and business activities; and foster employment and career opportunities to help Veterans improve their lives and continue as productive members of society—all as envisioned in the 1888 deed that conveyed the campus to the United States.
Consistent with this appreciated feedback, VA's vision for the campus includes a goal to provide various types of housing on campus for Veterans and their families, particularly homeless, severely disabled, aging, and female Veterans. This will improve the choice for Veterans to either live on or off campus, in dignified facilities reflective of the sacrifices they have made for their country. If enacted, the Los Angeles Homeless Veterans Leasing Act of 2015 (
VA's EU Lease authority as contained in 38 U.S.C. 8161-8169, would enable us to outlease parcels on the campus to selected lessees for terms of up to 75 years, to develop, operate, and maintain “supportive housing” for Veterans and their families. The types of housing would be a myriad of housing options to strategically serve Veterans in need, regardless of era of service. Such housing types would consist of transitional housing, single room occupancy housing, congregate living housing, independent living housing, assisted living housing, and other modalities of housing. When using this authority, VA would be expressly prohibited from disposing of the land and improvements involved in the projects at the GLA campus. At the end of the lease term, the real property would revert back to VA. Currently at other VA campuses nationwide, VA has 1,909 units of EU Lease housing currently operational, 1,046 units under construction, and 494 units planned, for a total of 3,994 units.
These two bills would also help VA revitalize the campus, by allowing VA to grant leases for terms of up to 50 years, to provide amenities and services, where Veterans can engage with one another and their families, and pursue a wide range of activities centered on their social, entertainment, healing, spiritual, employment, recreational, and rehabilitative interests and well-being.
Examples include spaces to accommodate Veteran and family interaction, peer support, restaurants, eateries, child care, legal and benefits assistance, movie and play theaters, art studios, a Veteran employment center, sports fields, a gymnasium, swimming pool, golf course, bike paths, parking spaces, dog park and kennel, church services, weddings, funerals, internments, non-profit Veteran support centers, hotel, dentist office, motorcycle training, a metro stop, and retail areas.
The two bills would also allow VA to grant a lease to institutions of the state of California, for a term of up to 10 years, in return for the provision of services to Veterans. Such services may include activities to directly support the medical, clinical, therapeutic, dietary, rehabilitative, legal, mental, spiritual, physical, recreational, research, and counseling needs of Veterans and their families. In an effort to maximize that opportunity, VA will explore the viability of further leverages to the current medical and academic affiliation with the University of California Los Angeles (UCLA). The providing of such services for Veterans and their families on and off the Greater Los Angeles campus, including through sports, recreational, educational, employment, and entertainment activities at the existing Jackie Robinson baseball stadium, will be a force multiplier in VA's efforts to revitalize the campus.
It will enable UCLA to confirm and demonstrate its firm commitment going forward, to ensure that its relationship with VA, Veterans, the local community, and other stakeholders, is one of true unwavering significance and substance in those areas for Veterans, as well as for educating future generations of doctors, nurses, researchers, and academics at VA and UCLA sites of care. This synergy could provide a framework and model to improve other academic and medical affiliations between VA and other medical schools and educational institutions nationwide, and provide benefits that transcend the paradigm of VA, the universities, institutions, and Veterans involved. For example, it could assist VA with its other potential partners such as: The Brentwood School, which has offered to provide therapy and recreational opportunities on its campus, along with scholarships for children of Veterans; the Red Cross, which has offered to assist VA in its disaster preparedness responsibilities and obligations, which will help improve campus capabilities and ensure
While working to achieve this vision for the campus, VA will evaluate existing and future land use agreements to ensure they are “Veteran focused.” This means the arrangements must provide direct benefits to Veterans and their families, and provide negotiated fair market rent to VA. VA will also continue its ongoing efforts to terminate any existing third party use arrangements, which fall outside of providing direct benefits to Veterans. VA will do so in a manner that takes into account the legal parameters for doing so, based on the underlying contract provisions at issue, and the need for VA to be stewards of tax payer resources. And it will be VA's objective going forward, to work with Congress to ensure that if S. 2013 or H.R. 1543 is enacted, the revenues paid to VA from Veteran focused land use arrangements, will be directed to help renovate the GLA campus. Doing so will help us maintain and renovate the campus in accordance with applicable law and regulations, along with funding that VA receives through other prioritization, budgetary, congressional authorization and appropriation legislative, and enactment processes.
We will also effectuate these land use activities in a way that fosters ongoing engagement with and input from Veterans, Veteran Service Organizations, the local community, and other stakeholders, and ensures the continued safety of Veterans, VA personnel, and other persons traversing on and off the campus. And it is worth repeating that such reuse activities will not include VA selling or disposing of any of the land at the campus to third party entities. And the land use projects and activities will comply with all pertinent laws and regulations. This includes those regarding environmental and historic preservation, such as the National Environmental Policy Act (42 U.S.C. 4321-4370h); the National Historic Preservation Act (16 U.S.C. 470,
Going forward, VA's efforts to revitalize the campus will only include `Veteran focused' agreements, or agreements that result in additional healthcare, benefits, services, or resources being provided directly to Veterans and/or their families on the GLA campus. Monetary proceeds paid to VA alone will not constitute an acceptable agreement. Neither will agreements that only benefit the public at large, versus Veterans and their families. This concept will be a key consideration in terms of how existing and any future land use agreements are evaluated for approval, rejection, or termination.
VA's review of any proposed third party land use agreements will entail a linear, multilayered process, to ensure adequate due diligence occurs. At a minimum, each agreement will receive input from the following VA personnel:
This Veteran focused intent for all land use agreements at GLA going forward is absolutely appropriate and warranted, particularly given the lessons learned from the August 2013 District Court for Central District of California decision in the
All land use agreements at the GLA campus, including the above nine agreements, have or are being reviewed, to determine whether they are or can be made sufficiently Veteran focused (thru fair market value rent to VA and services directly benefitting Veterans and their families), and fit within the overall needs and vision for a revitalized campus. To date, the terminated agreements include Richmark Entertainment; various filming agreements; Sodexo laundry agreement; 20th Century Fox; Westside Breakers; TCM Farmer's Market; and Veterans Garden (Rancho Santa Ana). VA is also in negotiations with the principals of certain existing land use arrangements (
Definition of Parking subcategory: Any comments discussing current or potential parking issues on campus including the Brentwood Village parking lot.
VA received a number of
VA is aware of the need for adequate parking at the main hospital building and throughout the campus, and as part of the implementation of the Draft Master Plan VA plans to improve the efficiency of the existing parking assets. Moreover, a critical component of the New Bed Care Tower (Replacement Hospital) project will be associated parking that should accommodate all parking demand for Veterans, employees, and visitors at the GLA Medical Center.
VA would not be opposed to keeping the Brentwood Village parking lot
To maintain flexibility for the potential of continued public use, VA has edited the Preliminary Draft Final Master Plan by relocating the campus access point that had previously required the demolition of the Brentwood Village parking lot. Additional information regarding the proposed parking can be found the Draft Master Plan, Chapter V, Section B—Master Plan Framework, Subsection Campus Mobility Plan.
Definition of Transparency & Accountability subcategory: Any comments discussing or raising issues to the VISN or VAMC level leadership as well as any comment proposing the implementation of an external campus oversight council.
A number of Transparency & Accountability comments raised concerns regarding the transparency of VISN and VAMC during strategic decision making processes. These comments generally requested that procedures be put into place to ensure that VA leadership keep the local Veteran population apprised of developing changes within the VISN and on GLA campus. The other common thread among these comments stressed that VISN and VAMC level leadership must hold poorly performing employees accountable. Many of these comments were general in nature, but noted past unpleasant experiences at VISN 22 facilities or at GLA campus specifically. They asked that VISN and VAMC level leadership open themselves to criticism more frequently and respond quickly.
To address concerns over transparency, VA plans to augment its current efforts to provide stakeholder updates and open the floor to Veteran and civilian input through regular VSO meetings, congressional meetings, and Town Halls. The first of such meetings will be planned for 90 days after VA Secretary Robert McDonald adopts the Draft Master Plan. In collaboration with Veteran groups, community partners and other stakeholders, VA will periodically review and reevaluate the Draft Master Plan every three years, to ensure the plan continues to meet the evolving needs of Veterans. The feedback process will be continued as VA selects new leadership for the GLA Campus (
To more promptly respond to criticisms of provided services, VA plans to strengthen the MyVA communities in the Los Angeles area. MyVA Communities are a collaborative network of Veterans, advocates, resources, and other stakeholders who organize through community Veteran Engagement Boards, to improve outcomes for Veterans, and their communities. The MyVA Communities model enables Veteran advocates, service providers, Veterans, and stakeholders to have a voice in providing input and feedback to VA, and identifying their goals and ways to engage and improve service delivery for Veterans and their families. The Los Angeles area Veteran Engagement Boards will carry the visions of the Draft Master Plan forward. Building and sustaining these avenues for continued Veteran feedback is a critical component of maintaining the Draft Master Plan, as a guiding resource for revitalizing and enhancing the GLA campus. All of this will be done to ensure appropriate oversight and Veteran collaboration while increasing transparency and accountability.
The Draft Master Plan document introduces the Community Veterans Engagement Board which is a collaborative, coordinated process to amplify the Veterans voice in matters that affect how, where, and when they receive care and services. Additional information can be found in Chapter III of the Draft Master Plan.
Definition of Veteran Access subcategory: Any comments emphasizing the need to promote access of specific Veteran populations on campus or requesting additional services to eliminate barriers to accessing the campus. These comments also include various other operational requests to promote and enhance Veteran access to the campus such as Veteran employment and education opportunities, family services, Veteran Benefits assistance, Transition Center, legal counsel services, emergency preparedness services, extended hours of operations, etc.
The public comments suggested that there should be no VA sale of any portions of the campus, to third parties for commercial uses. Other comments indicated a desire for a facility to add a focus aimed at assisting with the transition of active-duty military personnel to Veteran status. Other comments regarded the need to expand existing mental health, addition services, and transition services for active duty members entering the VA system. Comments also expressed desire for VA to collocate VBA onto the campus for improved ease to conduct business relating to VA's benefits system. Others want VA to establish a wellness or well-being center on campus, where Veterans can engage in peer to peer interaction and socializing, each other and their families. Other comments involved a need for support and special housing facilities for Veterans comprising the underserved populations—namely those that are homeless, severely disabled, aging, and women—particularly females with children, to assist in the recovery for those that have suffered sexual trauma, mental or physical abuse, or PTSD.
In response to these comments received, it is first important to note that neither VA nor the Draft Master Plan contemplated VA selling or disposing of any of the land and improvements at the Greater Los Angeles campus. VA envisions the development of supportive housing on campus pursuant to legislation Congress recently introduced in both houses of Congress—specifically, the Los Angeles homeless Veterans leasing act of 2015 (Senate Bill S. 2013 and corresponding house Bill HR 3484). VA has a phased development plan of 1,200 supportive housing units on the campus. The proposed timeline involves developing 60 units within the next 12 months, 150 units over the next 24 to 30 months, 280 units over the next 30 months, 280 units over the next 4 to 5 years, and 430 units over the next 6 to 10 years—all totaling 1,200 units. VA plans for those units to have special emphasis on homeless, severely disabled, aging, and female Veterans. The goal will be to strategically locate units designated for those underserved populations, in a manner to provide convenient access to the pertinent care and services that they will need, in a safe setting and environment. Along with development of those units would be Veteran focused supportive service leases, geared towards Veteran Health and wellness, nutrition and spiritual wellness, education, vocational training, skills building, peer activities, socialization, and physical recreation, assistance with legal issues and federal benefits,
Regarding the issue of helping active-duty service members to transition to Veteran status, VA plans to offer and provide transition services in the southwest corner of the VA campus, near the U.S. Army Reserve Center and Army National Guard Recruiter facilities adjacent to the GLA campus. VA understands that service members often encounter a series of needs as they transition out of the military. Such needs could include securing employment and housing, addressing physical or mental health issues, and adjusting to civilian culture. The ease through which this transition is made has a profound impact on post service well-being. To complement the planned transition services, VA has also established a new Welcome Center in Building 257, where Veterans have access to a facility and setting that facilitates peer to peer interaction and socialization, and VA and non-VA support providers. Improved transition into VA will heighten the existing need for expanded primary care and targeted hiring. VA plans to address those needs through more targeted VA hiring at the campus, and improved options for Veteran care through the Choice Act. For more information on these issues, see Chapter IV, Figure V-7, and Chapter V of the Draft Master Plan.
The Draft Master Plan is available to the public at
Notice of Meeting
In accordance with the Federal Advisory Committee Act, 5 U.S.C., App. 2, the Commission on Care gives notice that it will meet on Tuesday, February 9, 2016, at the American Legion National Headquarters Office, 1608 K Street NW., 7th Floor Conference Room, Washington, DC, 20006. The meeting will convene at 8:30 a.m. and end no later than 5:30 p.m. This meeting notice is being provided with less than 15 calendar days of notice due to inclement weather, which delayed the meeting's final confirmation. The meeting is open to the public.
The purpose of the Commission, as described in section 202 of the Veterans Access, Choice, and Accountability Act of 2014, is to examine the access of veterans to health care from the Department of Veterans Affairs and strategically examine how best to organize the Veterans Health Administration, locate health care resources, and deliver health care to veterans during the next 20 years.
No time will be allocated at this meeting for receiving oral presentations from the public. The public may submit written statements for the Commission's review to
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit.
Exception for State Legislation.—In the case of a State plan under title XIX of the Social Security Act (42 U.S.C. 1396
Ali Smilow, (410) 786-0790.
This final rule implements section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) (Pub. L. 111-148), which adds the requirement that physicians document the occurrence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes when ordering home health services. More specifically, section 6407(b) of the Affordable Care Act applies to Medicaid face-to-face encounter requirements set forth in the Medicare statute. Additionally, on April 16, 2015, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), became law. Section 504 of this law amended the underlying Medicare requirements at section 1834(a)(11)(B)(ii) of the Social Security Act (the Act) to allow certain authorized non-physician practitioners (NPP) to document the face-to-face encounter. This final rule adopts in large part the provisions proposed in the proposed rule issued on July 12, 2011 (76 FR 41032), but includes conforming changes to the provisions of the proposed rule to reflect the revisions made by MACRA to the underlying Medicare face-to-face encounter requirements. In addition, this final rule clarifies that Medicaid home health services and items are not limited to home settings, and makes additional changes to the requirements for coverage of medical supplies, equipment and appliances under the home health benefit.
The final rule requires that for the initial ordering of home health services, the physician must document that a face-to-face encounter that is related to the primary reason the beneficiary requires home health services occurred no more than 90 days before or 30 days after the start of services. The final rule requires that for the initial ordering of certain medical equipment, the physician or authorized NPP must document that a face-to-face encounter that is related to the primary reason the beneficiary requires medical equipment occurred no more than 6 months prior to the start of services. The face-to-face encounter for home health and medical equipment may be performed by the physician or certain authorized NPPs. The final rule maintains the role of the physician in ordering Medicaid home health services and medical equipment.
The rule also codifies current Medicaid policies for coverage of home health services, including clarifying in the definition of medical supplies, equipment, and appliances that items must be suitable for use in any setting in which normal life activities take place, other than a hospital; nursing facility, intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board. Additionally, the rule defines home health supplies, equipment, and appliances, to better align with the Medicare program's definition of durable medical equipment (DME) at § 414.202.
The rule codifies the policies set forth in September 4, 1998 guidance, about the use of lists or other presumptions in determining coverage of items under the home health benefit for medical equipment, including the following three points: (1) States may have a list of preapproved medical equipment, supplies and appliances for administrative ease, but not as an absolute limit on coverage; (2) States must provide and make available to individuals a reasonable and meaningful procedure for beneficiaries to request medical equipment, supplies or appliances not on the list based on a showing of medical necessity; and (3) Individuals must be informed of their
These clarifications reflect the principles embodied in the holdings of
Title XIX of the Act requires that, to receive federal Medicaid matching funds, a state must offer certain basic services to the categorically needy populations specified in the Act. Home health care is a mandatory services for Medicaid-eligible individuals who are entitled to nursing facility services, which includes the basic categorically needy populations who receive the standard Medicaid benefit package, and can also include medically needy populations if nursing facility services are offered to the medically needy within a state. Home health services include nursing services, home health aide services, medical supplies, equipment, and appliances, and may include therapy services (physical therapy, occupational therapy, speech pathology and audiology services). For a state to receive federal Medicaid matching payments for such services, current Medicaid regulations require a beneficiary's physician to order home health services as part of a written plan of care reviewed every 60 days.
At section 6407 of the Affordable Care Act, new Medicare requirements were set forth for face-to-face encounters to support claims for home health services, and for DME, which were also made applicable to Medicaid.
Specifically, sections 1814(a)(2)(C) of the Act under Part A of the Medicare program, and section 1835(a)(2)(A) of the Act under Part B of the Medicare program were amended to require that the physician, or certain allowed NPPs, document a face to-face encounter with the individual (including through the use of telehealth, subject to the requirements in section 1834(m) of the Act), before making a certification that home health services are required under the Medicare home health benefit. Section 1814(a)(2)(C) of the Act indicates that in addition to a physician, a nurse practitioner (NP) or clinical nurse specialist (CNS) (as those terms are defined in section 1861(aa)(5) of the Act) who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a physician assistant (PA) (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician, may conduct the face-to-face encounters before the start of home health services.
Section 6407 of the Affordable Care Act also amended section 1834(a)(11)(B) of the Act to require that physician orders for DME must be supported by documentation by the physician of a similar face-to-face encounter with a physician or specified NPPs. The NPPs authorized to conduct a face-to-face encounter on behalf of a physician are the same for DME as for home health services, except that certified nurse-midwives are not included.
The timing of the face-to-face encounter for either home health or DME is specified as being within the 6-month period preceding the written order for DME, or other reasonable timeframe specified by the Secretary.
Section 6407(d) of the Affordable Care Act, provides that the requirements for face-to-face encounters in the provisions described above shall apply in the case of physicians making certifications for home health services under title XIX of the Act in the same manner and to the same extent as such requirements apply in the case of physicians making such certifications under title XVIII of such Act.
The purpose of this regulation is to implement this statutory directive in the Medicaid program.
In the proposed rule, we sought to implement the face-to-face requirements of section 6407 of the Affordable Care Act in a manner consistent with existing Medicaid requirements and practices. For example, in implementing the face-to-face encounter requirements of section 6407 of the Affordable Care Act with respect to home health services generally, we took into consideration the longstanding regulatory requirements under § 440.70 that provide that a physician must order an individual's services under the Medicaid home health benefit. We read the term “order” to be synonymous with the Medicare term “certify.” For purposes of this rule, we used the term “order” in place of the Affordable Care Act's use of “certify.”
We did not view implementation of section 6407 of the Affordable Care Act as supplanting these existing Medicaid regulatory requirements related to physician orders; the new face-to-face process is consistent with those requirements. We proposed amending the Medicaid regulations at § 440.70 to incorporate both the general home health and the medical equipment face-to-face requirements. Because DME is
As previously indicated, we proposed that for home health services, the face-to-face encounter occurred no more than 90 days before or 30 days after the start of services. To align with Medicare timing requirements at § 424.22(a)(1)(v), we revised the timeframes for medical equipment and the final rule requires that for the initial ordering of medical equipment, the physician must document that a face-to-face encounter that is related to the primary reason the beneficiary requires medical equipment occurred no more than 6 months prior to the start of services. These timeframes are applicable to face-to-face encounters performed through telehealth.
Under sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act, face-to-face encounters for home health services may be conducted by a NP or CNS (as those terms are defined in section 1861(aa)(5) of the Act) who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a PA (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician. A similar definition of NPPs applies for DME under section 1834(a)(11)(B) of the Act, with one exception: Certified nurse-midwives are not included in the list of NPPs.
We proposed that home health services may not be subject to a requirement that the individual be “homebound.” In addition, we proposed that home health services cannot otherwise be restricted to services furnished in the home itself. These policies reflect longstanding CMS interpretations of the scope of the home health policy and were discussed in a July 25, 2000 letter to State Medicaid Directors, Olmstead Update No. 3 setting forth federal interpretations of applicable law relevant to state efforts to comply with the requirements of the Americans with Disabilities Act (ADA) in light of the Supreme Court decision in
We also proposed that Medicaid home health services may not be limited to services furnished in the home. This policy reflects the principles set forth in prior court cases on whether home health services and private duty nursing can be limited to services furnished in the home. In
An important component of the Medicaid home health benefit is coverage of medical supplies, equipment, and appliances, under § 440.70(b)(3). The current regulation does not further define the terms, except to indicate that the items should be suitable for use in the home. Although CMS has read this phrase to refer only to the type of items included in the benefit (excluding those types of items that are only furnished in institutional or provider settings), it has been susceptible to reading as a prohibition on use of covered items outside the home. We proposed revisions to this section to clarify that it is not a limitation on the location in which items are used, but rather refers to items that are necessary for everyday activities and not specialized for an institutional setting. Thus, we proposed to indicate that the items must be suitable for use in any non-institutional setting in which normal life activities take place. This would clarify that although states may continue to establish medical necessity criteria to determine the authorization of the items, states may not deny requests for the items based on the grounds that they are for use outside of the home.
Current Medicaid regulations do not contain any specific definition of medical supplies, equipment, and appliances under the home health benefit, other than the language discussed in the prior paragraph. States have adopted reasonable definitions of those terms, for example, based on the Medicare definition. But in the absence of a generally applicable definition of the term, there has been confusion as to the proper scope of the benefit.
We believe that greater alignment of the definitions of home health medical supplies, equipment and appliances with the Medicare definition of DME will help to streamline beneficiaries' access to receive needed items and provide clear and consistent guidance to states to ensure the use of the appropriate benefit category. Therefore, we proposed to define home health supplies, equipment, and appliances, to better align with the Medicare program's definition of DME at § 414.202, as items that are primarily and customarily used to serve a medical purpose, generally not useful to an individual in the absence of an illness or injury, can withstand repeated use, and can be reusable or removable. Unlike Medicare, however, we did not propose to define the expected life of a piece of equipment and did not propose to limit equipment to items used in the home. We also proposed to define supplies as health care related items that are consumable or disposable, or cannot withstand repeated use by more than one individual, based loosely on Medicare principles, but we did not propose to require that supplies be incidental to other covered services.
The proposed standard definitions were intended to ensure that such items
In the proposed rule, we noted that we were considering whether other clarifications to the home health regulations were warranted. In particular, we invited comments on whether it would be useful to include language to reflect the policies set forth in a September 4, 1998 letter to State Medicaid Directors, responding in part to a Second Circuit decision in
In addition, in the May 5, 2010
We received a total of 94 timely items of correspondence from home health provider representatives and other professional associations, State Medicaid Directors, states, beneficiaries, and other individuals. Comments ranged from general support or opposition to the proposed rule, to specific questions and detailed comments and recommendations regarding the proposed changes. A summary of the public comments and our responses are set forth below.
Additionally, states may place limits on the amount and duration of medical equipment, supplies and appliances, but the limits must meet sufficiency requirements set forth at § 440.230. And, as with all Medicaid services, states are not required to cover medically unnecessary services, and have the discretion to develop medical necessity criteria, but these must be based on accepted medical practices and standards.
We added this clarification to the regulatory text at § 440.70(b).
Upon consideration of public comments received, we are finalizing § 440.70 with the following revisions:
• We are revising § 440.70(b) to state that home health services cannot be contingent upon the beneficiary needing nursing or therapy services.
• We are revising § 440.70(b) to codify that items and services that meet the criteria for coverage under the home health benefit must be covered according to home health coverage parameters.
• We are incorporating into § 440.70(b)(3)(v), three basic points set forth in our 1998 guidance relating to the
• We are revising § 440.70(c)(1) to codify our longstanding policy that home health services may not be subject to a requirement that the individual be homebound.
Section 440.70(b)(3) proposed to revise the wording of the regulation to further define medical equipment, supplies, and appliances as suitable for use in any non-institutional setting in which normal life activities take place. We also proposed in § 440.70(b)(3)(i) and (ii) more detailed definitions of the terms “medical supplies, equipment, and appliances”.
In response to the commenter's concern about the implication that some home modifications may be mandatory through the home health benefit, we would like to clarify that costs of structural home modifications are not covered under the home health benefit because they would not be within the new regulatory definition of medical equipment, but instead would be costs of shelter. Similarly, vehicular modifications are not within the definition of medical equipment; they are a component of a vehicle that is not medical in nature.
In addition, we are clarifying that states may implement standards to determine coverage of equipment based on presumptions about medical necessity and utilization control, but must provide for an opportunity for individuals to have an individualized medical necessity analysis that takes into consideration the individual's person-centered plan of care. While a state can use presumptions in making applying medical necessity and utilization control criteria, which CMS does not review, the state must provide an opportunity for an individualized hearing as to whether the item is medically necessary in the particular circumstances.
After consideration of the public comments, this section is being finalized without revisions.
In § 440.70(b)(3)(i) and (ii), we proposed to revise the current regulation text to define what constitutes medical supplies, equipment, and appliances.
In response to the further comment, the home health benefit is distinct from items and services that may be available through HCBS waiver programs. Medicaid coverage of medical supplies, equipment, and appliances under the home health benefit is mandatory and must be provided under the state plan to HCBS waiver enrollees. To the extent that items are not included under the approved state plan, extended coverage could be provided under section 1915(c) waiver programs. We also reiterate our statement from the proposed rule that items meeting the state plan definition of a medical supply, equipment or appliance must be provided under the home health benefit, and may not be restricted to enrollees under a section 1915(c) HCBS waiver.
Upon consideration of the public comments received, we are finalizing § 440.70(b)(3)(ii) with revisions. We are revising the definition of equipment and appliances to include the term “disability” and to specify that state Medicaid programs are not restricted to the items covered under DME in the Medicare program. Additionally, we have clarified that structural or home modifications are not covered under the Medicaid home health benefit and that states may not limit access to equipment eligible for coverage under home health benefits by restricting some items to only those who qualify for section 1915(i) or (c) programs. States may implement standards to determine coverage of the specific items previously funded under sections 1915(c) or (i), such as ceiling lifts or chair lifts, that could now be seen in appropriate circumstances to meet the home health definition and be medically necessary for an individual. We have also clarified that medical equipment and appliances already coverable under the home health benefit will continue to be covered. Not all medical equipment and appliances currently coverable under section 1915(c) and section 1915(i) will be coverable under the state plan under the standards set forth in this rule.
To reflect the principles expressed by the courts in both the
Another commenter stated that the regulation would require that certain programs revise or update existing policies to reflect that home health services cannot otherwise be restricted to services furnished in the home itself.
Upon consideration of the public comments received, we are revising § 440.70(c)(1) to indicate that a homebound requirement is not permitted. Additionally, we are clarifying the settings in which individuals may receive home health services. Specifically, individuals may receive home health services in any setting in which normal life activities take place, other than a hospital, nursing facility; intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board.
Section 440.70(f)(1) specifies that for the initial ordering of home health services, the physician must document that a face-to-face encounter that is related to the primary reason the individual requires home health services has occurred no more than 90 days before the start of services. We recognize, however, that there may be circumstances when it may not be possible to meet this general requirement, and the individual's access to needed services must be protected. To account for these circumstances, we proposed to allow an opportunity to meet the face-to-face encounter requirement through an encounter with the beneficiary within 30 days after the start of home health services.
Another commenter urged CMS to give specific guidance to states maximizing the flexibility in timing of face-to-face encounters, allowing the timeline to be extended, and allowing states to provide a good cause exceptions process in cases where beneficiaries have not been able to meet this requirement. One commenter viewed good cause exemptions as extremely important and urged that they be put in place immediately. Such good cause exemptions might include, but not be limited to, situations where the state or federal government declares a state of emergency such as a natural disaster or terrorist attack. In such a circumstance, lack of electricity, phones and equipment, and navigable roads might delay the achievement of a face-to-face encounter for more than 30 days. Another commenter indicated that there needs to be more flexibility in the timeframes after the start of care.
After consideration of the public comments, we are revising this section to clarify that for the initial ordering of Medicaid medical equipment, the physician must document that a face-to-face encounter that is related to the primary reason the beneficiary requires medical equipment occurred no more than 6 months prior to the start of services. Additionally, we are clarifying that a face-to-face encounter is required for initial ordering of both home health services and medical equipment. Furthermore, for home health services, a face-to-face encounter is required for the initial order and for all episodes initiated with the completion of a Start-of-Care OASIS assessment. We have also delayed compliance with the rule for up to one year if the state's legislature has met in that year, otherwise 2 years. Our expectation is that states and providers are compliant with the requirements of the final rule based on the timeframes explained above.
The statute describes NPPs who may perform this face-to-face encounter as an NP or CNS, as those terms are defined in section 1861(aa)(5) of the Act, who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a PA (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician. The statutory provision allows the permitted NPPs to perform the face-to-face encounter and inform the physician, who documents the encounter. Based on the reasoning outlined in the Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2012; Final Rule (76 FR 68525), for beneficiaries admitted to home health upon discharge from a hospital or post-acute setting, we proposed to also allow the physician who attended to the beneficiary in the hospital or post-acute setting to inform the ordering physician regarding their encounters with the beneficiary to satisfy the face-to-face encounter requirement, much like an NPP. We proposed to add a new § 440.70(f)(2) to list the practitioners that may perform the face-to-face encounters.
Upon consideration of the public comments received, we are revising this section to clarify that any physician, including the physician who attended to the beneficiary in the hospital or post-acute setting may serve as the ordering physician for home health services provided that, in accordance with § 440.70, the ordering physician also completes the written plan of care.
We proposed to add § 440.70(f)(3) to indicate that if an attending acute or post-acute physician or allowed NPP conducts the face-to-face visit, the attending acute or post-acute physician or NPP is required to communicate the
After consideration of the public comments and to align with Medicare's requirements we are finalizing this section with clarifications. Specifically, we are clarifying that we are not prescribing the communication between the NPP who performed the face-to-face encounter and the physician, rather the requirement that the clinical findings of the face-to-face encounter are communicated to the ordering physician. This information can be included in clinical and progress notes and discharge summaries. Additionally, we have clarified that attending acute or post-acute physicians may serve as the ordering physician of home health services.
In § 440.70(f)(5)(i), we proposed to require that the physician's documentation of the face-to-face encounter must be either a separate and distinct area on the written order, an addendum to the order that is easily identifiable and clearly titled, or a separate document easily identifiable and clearly titled in the beneficiary's medical record. The documentation must also describe how the health status of the beneficiary at the time of the face-to-face encounter is related to the primary reason the beneficiary requires home health services. In § 440.70(f)(5)(ii), we proposed to require that the physician's documentation of the face-to-face encounter be clearly titled, and state that either the physician himself or herself, or the applicable NPP, has conducted a face-to-face encounter with the beneficiary and include the date of that encounter.
After consideration of the public comments and to better align with Medicare requirements, this section is being finalized with the following revisions:
• We are revising the documentation requirements to remove the requirement that the documentation be either a separate and distinct area on the written order, an addendum to the order that is easily identifiable and clearly titled, or a separate document easily identifiable and clearly titled in the beneficiary's medical record.
• We are clarifying the documentation requirements and specify what is required which is described in § 440.70(f)(5)(i) and (ii).
• We are clarifying that for medical equipment, in addition to the physician, the allowed NPP, as described in
Proposed § 440.70(f)(6) outlined that the face-to-face encounters may be performed through the use of telehealth.
After consideration of the public comments, this section is being finalized as proposed.
As proposed, § 440.70(g) applies all of the requirements of § 440.70(f) to the provision of medical supplies, equipment and appliances as described in § 440.70(b)(3), to the extent that a face-to-face encounter would be required under the Medicare program for DME, with one exception from the requirements at § 440.70(f). Per the statute, as amended by the Affordable Care Act, certified nurse midwives are not permitted to conduct face-to-face encounters required for the items, as proposed at § 440.70(g)(2). To maximize consistency between the Medicaid and Medicare programs and reduce the administrative burden on the provider community, we proposed to limit the face-to-face requirements to items that would be subject to such requirements as DME under the Medicare program. Thus, we would only require that, for items of DME specified by CMS under the Medicare program as subject to a face-to-face encounter requirement, the physician must document that a face-to-face encounter that is related to the primary reason the beneficiary requires the item has occurred no more than 90 days before the order is written or within 30 days after the order is written. Medical supplies, equipment and appliances for which a face-to-face encounter would not be required under the Medicare program as DME, would not require a face-to-face encounter before the ordering of items under the Medicaid program. The items will be of a smaller dollar value, and at a decreased risk for fraud, waste, and abuse.
Any medical supplies, equipment, and appliances provided under the home health benefit must meet the face-to-face requirement. If the state is providing supplies, equipment or appliances under a benefit category other than home health, such as the therapy services authorized at § 440.110, or prosthetics authorized under § 440.120, the state would need to adhere to the requirements of that particular benefit. In response to the concern that we clarify that the final rule will not apply to medical equipment under the Medicaid program until we have issued a final Medicare face-to-face rule, Medicare's DME face-to-face rule was effective on July 1, 2013. Our alignment of the scope of items requiring the face-to-face encounter with Medicare does not depend on Medicare regulation. The list of DME items subject to the face-to-face encounter can be found at
After consideration of the public comments, this section is being finalized with revisions to the timeframes for the face-to-face encounter for DME. Specifically, we are adding § 440.70(f)(5)(ii) which indicates that for the initiation of DME, the face-to-face encounter must be related to the primary reason the beneficiary requires home health services and must occur no more than 6 months prior to the start of services.
Additionally, as previously indicated, we are using this rule to conform with the Medicare Access and CHIP Reauthorization Act of 2015 and clarifying that for medical equipment, in addition to the physician, the allowed NPPs, as described in paragraph (f)(3)(ii) through (v) are authorized to document the face-to-face encounter.
For the most part, this final rule incorporates the July 12, 2011 provisions of the proposed rule. Those provisions of this final rule that differ from the proposed rule are as follows:
• We are revising § 440.70(b) introductory text to state that coverage of home health services cannot be contingent upon the beneficiary needing a nursing or therapy services.
• We are amending § 440.70(b)(3)(ii) to include the term “disability” to the definition of equipment and appliances and to clarify that state Medicaid programs are not restricted to the items covered under DME in the Medicare program.
• We are adding § 440.70(b)(3)(v), to state that states can have a list of preapproved medical equipment supplies and appliances for administrative ease, but not as an absolute limit on coverage; states must provide and make available to individuals a reasonable and meaningful procedure for individuals to request items not on the list; and individuals are informed of their right to a fair hearing.
• We are revising § 440.70(c)(1) to codify the homebound prohibition for Medicaid home health services; home health services may not be subject to a requirement that the individual be “homebound.” Additionally, we are clarifying the settings in which home health services may be provided. Specifically, we are adding the clarification that home health services may be provided in settings where normal life activities take place, other than a hospital, nursing facility; intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board.
• We are adding 440.70(f)(5)(i) and (ii) to specify that the ordering physician must document the face-to-face encounter which is related to the primary reason the patient requires home health services, occurred within the required timeframes prior to the start of home health services; must indicate the practitioner who conducted the encounter, and the date of the encounter.
• We are adding § 440.70(f)(2) which indicates that for the initiation of DME, the face-to-face encounter must be related to the primary reason the beneficiary requires home health services and must occur no more than 6 months prior to the start of services.
Under the Paperwork Reduction Act of 1995 (PRA), we are required to publish a 60-day notice in the
To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) 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 burden estimates.
• The quality, utility, and clarity of the information to be collected.
• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.
On July 12, 2011 (76 FR 41032), we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). See below for a summary of the PRA-related comments along with our response.
Subsequent to the publication of the proposed rule, we have revised our cost estimates by using the most current U.S. Bureau of Labor Statistics' wage estimates along with our fringe benefit adjustment factor. An additional change is discussed in Collection of Information section V.B.2.
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2014 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
Section 440.70(f) and (g) requires that physicians (or for medical equipment, authorized non-physician practitioners (NPPs) including nurse practitioners, clinical nurse specialists and physician assistants) document that there was a face-to-face encounter with the Medicaid beneficiary. The burden associated with this requirement is the time and effort to complete and maintain this documentation. The documentation must clearly demonstrate that the face-to-face encounter occurred within the required timeframes and indicate the practitioner who conducted the encounter along with the date of the encounter. The burden also includes writing, typing, or dictating the face-to-face documentation and signing/dating the documentation. In this regard, we estimate 10 minutes for each encounter. We also estimate that there are approximately 1,143,443 initial home health episodes in a given year (this estimate is based on our 2008 claims data which is also our most recent data). Due to the lack of data for each provider type, we are dividing our 1,143,443 episode estimate into 3 equal parts of 381,147.67 for each of the three respondent types (family and general practitioners, nurse practitioners, and physician assistants). Our estimated burden for documenting, signing, and dating the beneficiary's face-to-face encounter is 190,574 hours (this estimate is based on our CY 2011 data which is also our most recent data). We acknowledge that this figure is inflated by instances in which the physician conducted the face-to-face encounter with the beneficiary, making this second 10-minute documentation burden unnecessary.
The estimated cost to document the face-to-face encounter, which varies by practitioner, consists of $29.74 (0.167 hr × $179.16/hr) for a family and general practitioner, $15.64 (0.167 hr × $94.22/hr) for a nurse practitioner, and $15.52 (0.167 hr × $93.54/hr) for a physician assistant. We estimate an aggregated cost of $23,355,067 (see the burden table in section V.C. of this final rule). The requirements and burden will be submitted to OMB under control number: 0938-1188 (CMS-10434).
Upon consideration of the public comments received, we are finalizing this section as proposed.
Section 440.70(f)(4) requires that NPPs and attending acute or post-acute physicians communicate the clinical findings of the face-to-face encounter to the ordering physician. The clinical findings must be incorporated into a written or electronic document that is included in the beneficiary's medical record. While we set out burden in the proposed rule, we believe the requirement and burden are exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). Specifically, we believe that the time, effort, and financial resources to communicate the findings of the encounter would be incurred by persons during the normal course of their activities and, therefore, should be considered a usual and customary business practice.
We have submitted a copy of this rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS' Web site at
We invite public comments on these potential information collection requirements. If you wish to comment, please identify the rule (CMS-2348-F) the ICR's CFR citation, CMS ID number and OMB control number, and submit your comments to the OMB desk officer via one of the following transmissions:
ICR-related comments are due March 3, 2016.
Section 6407(a) of the Affordable Care Act (as amended by section 10605) added new requirements to section 1814(a)(2)(C) of the Act under Part A of the Medicare program, and section 1835(a)(2)(A) of the Act, under Part B of the Medicare program, that the physician, or certain allowed NPPs, document a face-to-face encounter with the beneficiary (including through the use of telehealth, subject to the requirements in section 1834(m) of the Act), before making a certification that home health services are required under the Medicare home health benefit. Section 1814(a)(2)(C) of the Act indicates that in addition to a physician, a NP or CNS (as those terms are defined in section 1861(aa)(5) of the Act) who is working in collaboration with the physician in accordance with state law, or a certified nurse-midwife (as defined in section 1861(gg) of the Act, as authorized by state law), or a PA (as defined in section 1861(aa)(5) of the Act), under the supervision of the physician, may conduct the face-to-face encounters before the start of home health services.
Section 6407(b) of the Affordable Care Act amended section 1834(a)(11)(B) of the Act to require documentation of a similar face-to-face encounter with a physician or specific NPPs by a physician ordering DME. The NPPs authorized to conduct a face-to-face encounter on behalf of a physician are the same for this provision as for the provision described above, with one exception. Certified nurse-midwives are not permitted to conduct the face-to-face encounter before the physician ordering DME. The timing of this face-to-face encounter is specified as being within the 6-month period preceding the written order for DME, or other reasonable timeframe specified by the Secretary. This provision also maintains the role of the physician in the actual ordering of DME.
The Affordable Care Act applied both of the provisions to the Medicaid program.
After consideration of the public comments, this section is being finalized without revisions. However, as previously indicated, to allow time for budgetary planning and operational changes, we are allowing states up to one year to come into compliance with this rule if the state's legislature has met in that year, otherwise 2 years.
We have examined the impacts of this rule 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), and 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and, therefore, is a major rule under the Congressional Review Act. Accordingly, we have prepared a final Regulatory Impact Analysis which to the best of our ability presents the costs and benefits of the rulemaking.
According to the CMS Actuarial estimates, section 6407 of the Affordable Care Act would bring an estimated $920 million in savings to the Medicare program from 2010-2014 and $2.29 billion in savings from 2010-2019. Although this provision applies to Medicaid in the same manner and to the same extent as the Medicare program, there were no estimates (costs or savings) generated for the Medicaid program as data to determine these estimates is unavailable.
The certification of the need for home health care by a physician would be a covered physician service or, at state option, could be covered as a component part of home health care services. States have substantial flexibility to design payment methodologies for covered services. These payment methodologies can be tailored by benefit and/or provider type. Therefore, there may be an increase in costs, but the scope of these increases are not measurable due to state flexibilities.
Although there is no quantitative data to arrive at a specific dollar figure to attribute to the additional medical supplies, equipment, and appliances that may now be authorized in accordance with § 440.70(b)(3), we acknowledge the potential for this provision to surpass the threshold for economic significance. We wish to note however, that this provision may result in offsetting benefits to both beneficiaries and state budgets, including the ability for beneficiaries to return to or enter the workforce, thereby increasing the pool of taxpayers, and decreasing reliance on other Medicaid benefits, including institutional care. Although there is no specific estimate regarding the benefits, they nonetheless should be taken into account. In the proposed rule, we specifically solicited comment regarding the potential increased costs and benefits associated with this provision, as well as the various sections throughout the RIA. After consideration of public comments, we are finalizing the burden costs estimates associated with the provisions in this regulation with no revision.
The RFA requires agencies to analyze options for regulatory relief for small entities, 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 government jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.5 million to $38.5 million in any 1 year. For details, see the Small Business Administration's final rule that set forth size standards for health care industries, (65 FR 69432, November 17, 2000). 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 final rule will not have a significant economic impact on a substantial number of small entities. Entities affected by this rule should already be administering these changes for Medicare purposes as the statutory change was effective in 2010. Entities should already have systems in place to accommodate this change for the Medicaid population.
In addition, section 1102(b) of the Social Security 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 Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because 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 (UMRA) of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any one year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that threshold level is $144 million. This final rule will not result in an impact of $144 million or more 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 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. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
We estimate that this final rule will be “economically significant” as measured by the $100 million threshold as set forth by Executive Order 12866, as well
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Grant programs-health, Medicaid.
The Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as follows:
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
The revisions and additions read as follows:
(b) Home health services include the following services and items. Paragraphs (b)(1), (2) and (3) of this section are required services and items that must be covered according to the home health coverage parameters. Services in paragraph (b)(4) of this section are optional. Coverage of home health services cannot be contingent upon the beneficiary needing nursing or therapy services.
(3) Medical supplies, equipment, and appliances suitable for use in any setting in which normal life activities take place, as defined at § 440.70(c)(1).
(i) Supplies are health care related items that are consumable or disposable, or cannot withstand repeated use by more than one individual, that are required to address an individual medical disability, illness or injury.
(ii) Equipment and appliances are items that are primarily and customarily used to serve a medical purpose, generally are not useful to an individual in the absence of a disability, illness or injury, can withstand repeated use, and can be reusable or removable. State Medicaid coverage of equipment and appliances is not restricted to the items covered as durable medical equipment in the Medicare program.
(v) States can have a list of preapproved medical equipment supplies and appliances for administrative ease but States are prohibited from having absolute exclusions of coverage on medical equipment, supplies, or appliances. States must have processes and criteria for requesting medical equipment that is made available to individuals to request items not on the State's list. The procedure must use reasonable and specific criteria to assess items for coverage. When denying a request, a State must inform the beneficiary of the right to a fair hearing.
(c) * * *
(1) Nothing in this section should be read to prohibit a beneficiary from receiving home health services in any setting in which normal life activities take place, other than a hospital, nursing facility; intermediate care facility for individuals with intellectual disabilities; or any setting in which payment is or could be made under Medicaid for inpatient services that include room and board. Home health services cannot be limited to services furnished to beneficiaries who are homebound.
(2) Additional services or service hours may, at the State's option, be authorized to account for medical needs that arise in the settings home health services are provided.
(f) No payment may be made for services referenced in paragraphs (b)(1) through (4) of this section, unless the physician referenced in paragraph (a)(2) of this section or for medical equipment, the allowed non-physician practitioner, as described in paragraph (f)(3)(ii) through (v), with the exception of certified nurse-midwives, as described in paragraph (f)(3)(iii) documents that there was a face-to-face encounter with the beneficiary that meets the following requirements:
(1) For the initiation of home health services, the face-to-face encounter must be related to the primary reason the beneficiary requires home health services and must occur within the 90 days before or within the 30 days after the start of the services.
(2) For the initiation of medical equipment, the face-to-face encounter must be related to the primary reason the beneficiary requires medical equipment and must occur no more than 6 months prior to the start of services.
(3) The face-to-face encounter may be conducted by one of the following practitioners:
(i) The physician referenced in paragraph (a)(2) of this section;
(ii) A nurse practitioner or clinical nurse specialist, as those terms are defined in section 1861(aa)(5) of the Act, working in collaboration with the physician referenced in paragraph (a) of this section, in accordance with State law;
(iii) A certified nurse midwife, as defined in section 1861(gg) of the Act, as authorized by State law;
(iv) A physician assistant, as defined in section 1861(aa)(5) of the Act, under the supervision of the physician referenced in paragraph (a) of this section; or
(v) For beneficiaries admitted to home health immediately after an acute or post-acute stay, the attending acute or post-acute physician.
(4) The allowed non-physician practitioner, as described in paragraph (f)(3)(ii) through (v) of this section, performing the face-to-face encounter must communicate the clinical findings of that face-to-face encounter to the ordering physician. Those clinical findings must be incorporated into a written or electronic document included in the beneficiary's medical record.
(5) To assure clinical correlation between the face-to-face encounter and the associated home health services, the physician responsible for ordering the services must:
(i) Document the face-to-face encounter which is related to the primary reason the patient requires home health services, occurred within the required timeframes prior to the start of home health services.
(ii) Must indicate the practitioner who conducted the encounter, and the date of the encounter.
(6) The face-to-face encounter may occur through telehealth, as implemented by the State.
(g)(1) No payment may be made for medical equipment, supplies, or appliances referenced in paragraph (b)(3) of this section to the extent that a face-to-face encounter requirement would apply as durable medical equipment (DME) under the Medicare program, unless the physician referenced in paragraph (a)(2) of this section or allowed non-physician practitioner, as described in paragraph (f)(3)(ii) through (v) of this section documents a face-to-face encounter with
(2) The face-to-face encounter may be performed by any of the practitioners described in paragraph (f)(3) of this section, with the exception of certified nurse-midwives, as described in paragraph (f)(3)(iii) of this section.
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |