| Page Range | 44489-44758 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 44584 - Sunshine Act Meeting Notice | |
| 81 FR 44608 - Environmental Impact Statements; Notice of Availability | |
| 81 FR 44672 - Sunshine Act Meeting | |
| 81 FR 44659 - Sunshine Act Meeting | |
| 81 FR 44609 - Sunshine Act Meeting | |
| 81 FR 44683 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PINKY; Invitation for Public Comments | |
| 81 FR 44644 - Proposed Collection; 60-Day Comment Request: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request | |
| 81 FR 44610 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 81 FR 44642 - Public Workshop-Iron Screening and Supplementation of Iron‐Replete Pregnant Women and Young Children | |
| 81 FR 44587 - Floor-Standing, Metal-Top Ironing Tables and Certain Parts Thereof From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results and Notice of Amended Final Results of the Antidumping Duty Administrative Review; 2006-2007 | |
| 81 FR 44588 - Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Certain Passenger Vehicle and Light Truck Tires From the People's Republic of China | |
| 81 FR 44607 - Innovative Solar 43, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 44665 - State, Local, Tribal, and Private Sector Policy Advisory Committee (SLTPS-PAC) | |
| 81 FR 44596 - Procurement List; Additions and Deletions | |
| 81 FR 44597 - Procurement List; Proposed Additions and Deletions | |
| 81 FR 44642 - Submission for OMB Review; 30-Day Comment Request National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD) | |
| 81 FR 44661 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 81 FR 44600 - Agency Information Collection Activities; Comment Request; Program for the International Assessment of Adult Competencies (PIAAC) 2017 National Supplement | |
| 81 FR 44601 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study of the Title III Native American and Alaska Native Children in School (NAM) Program | |
| 81 FR 44610 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 44603 - Agency Information Collection Activities; Comment Request; Native American Career and Technical Education Program (NACTEP) Performance Reports | |
| 81 FR 44602 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Magnet Schools Assistance Program Application for Grants (1894-0001) | |
| 81 FR 44662 - Advisory Council on Employee Welfare and Pension Benefit Plans; Nominations for Vacancies | |
| 81 FR 44670 - Dedication of Commercial-Grade Items for Use in Nuclear Power Plants | |
| 81 FR 44592 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting | |
| 81 FR 44591 - Pacific Fishery Management Council; Public Meeting (Webinar) | |
| 81 FR 44665 - Completion Date of Cyber Security Plan Implementation Milestone 8; Tennessee Valley Authority; Sequoyah Nuclear Plant, Units 1 and 2 | |
| 81 FR 44654 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Cape Lookout National Seashore Cultural Resource Values and Vulnerabilities Assessment | |
| 81 FR 44652 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Commercial Use Authorizations | |
| 81 FR 44657 - Information Collection Activities: Oil and Gas Well-Workover Operations; Proposed Collection; Comment Request | |
| 81 FR 44582 - Kenai Peninsula-Anchorage Borough Resource Advisory Committee | |
| 81 FR 44673 - Environmental Impact Statement: King County, Washington | |
| 81 FR 44609 - Notice of Termination; 10293, Haven Trust Bank Florida, Ponte Vedra Beach, Florida | |
| 81 FR 44614 - Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability | |
| 81 FR 44611 - Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability | |
| 81 FR 44675 - Agency Information Collection Activities; New Information Collection Request: 391.41 CMV Driver Medication Form | |
| 81 FR 44680 - Qualification of Drivers; Exemption Applications; Vision | |
| 81 FR 44674 - Driver Qualifications: Skill Performance Evaluation; Virginia Department of Motor Vehicles; Exemption Renewal for Virginia Department of Motor Vehicles | |
| 81 FR 44685 - Application of LIMA NY Corp. for Commuter Air Carrier Authority | |
| 81 FR 44685 - Application of Tropic Ocean Airways, LLC for Commuter Authority | |
| 81 FR 44671 - Proposed Collection; Comment Request | |
| 81 FR 44673 - Proposed Collection; Comment Request | |
| 81 FR 44535 - Civil Penalties Inflation Adjustments | |
| 81 FR 44600 - Intent To Prepare an Integrated Feasibility/Environmental Impact Statement for the Proposed Rota Harbor Modifications Project, Island of Rota, Commonwealth of the Northern Mariana Islands | |
| 81 FR 44599 - Intent To Prepare an Integrated Feasibility/Environmental Impact Statement for the Proposed Tinian Harbor Modifications Project, Island of Tinian, Commonwealth of the Northern Mariana Islands | |
| 81 FR 44541 - Drawbridge Operation Regulation; Housatonic River, Stratford, CT | |
| 81 FR 44663 - NASA Advisory Council; Science Committee; Meeting. | |
| 81 FR 44664 - NASA Advisory Council; Technology, Innovation and Engineering Committee; Meeting | |
| 81 FR 44662 - NASA Advisory Council; Ad Hoc Task Force on STEM Education Meeting | |
| 81 FR 44664 - NASA Advisory Council; Aeronautics Committee; Meeting | |
| 81 FR 44663 - NASA Advisory Council; Institutional Committee; Meeting | |
| 81 FR 44663 - NASA Advisory Council; Human Exploration and Operations Committee; Meeting | |
| 81 FR 44602 - Agency Information Collection Activities; Comment Request; IES Research Training Program Surveys | |
| 81 FR 44583 - Submission for OMB Review; Comment Request | |
| 81 FR 44591 - International Whaling Commission; 66th Meeting; Nominations | |
| 81 FR 44629 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability | |
| 81 FR 44616 - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability | |
| 81 FR 44592 - Submission for OMB Review; Comment Request | |
| 81 FR 44665 - Committee Management; Renewals | |
| 81 FR 44593 - Privacy Act of 1974; System of Records | |
| 81 FR 44584 - Privacy Act of 1974, System of Records | |
| 81 FR 44607 - Tennessee Gas Pipeline Company, L.L.C.; Notice of Schedule for Environmental Review of the Orion Project | |
| 81 FR 44606 - Black Canyon Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 81 FR 44604 - Owyhee Hydro LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 81 FR 44607 - FFP Missouri 12, LLC; Notice of Availability of Environmental Assessment | |
| 81 FR 44604 - Notice of Staff Attendance at the Southwest Power Pool Markets and Operations Policy Committee Meeting | |
| 81 FR 44605 - Notice of Commission Staff Attendance | |
| 81 FR 44671 - Product Change-Priority Mail Negotiated Service Agreement | |
| 81 FR 44580 - Notice of Request To Renew an Approved Information Collection (Accredited Laboratory Contact Update Form) | |
| 81 FR 44581 - Notice of Request To Renew an Approved Information Collection (Industry Responses to Noncompliance Records) | |
| 81 FR 44627 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act | |
| 81 FR 44686 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee | |
| 81 FR 44687 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee | |
| 81 FR 44686 - Open Meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee | |
| 81 FR 44685 - Open Meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee | |
| 81 FR 44628 - Regional Public Workshop on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q3D Implementation of Guideline for Elemental Impurities; Public Workshop | |
| 81 FR 44685 - Open Meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee | |
| 81 FR 44686 - Open Meeting of the Taxpayer Advocacy Panel Joint Committee | |
| 81 FR 44508 - Method of Accounting for Gains and Losses on Shares in Money Market Funds; Broker Returns With Respect to Sales of Shares in Money Market Funds | |
| 81 FR 44659 - Wooden Bedroom Furniture From China; Scheduling of a Full Five-Year Review | |
| 81 FR 44643 - National Institute of Diabetes and Digestive and Kidney Diseases: Notice of Closed Meetings | |
| 81 FR 44645 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 44645 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 44655 - Notice of September 19, 2016, Meeting for Cape Cod National Seashore Advisory Commission | |
| 81 FR 44656 - Notice of an Open Public Meeting for the National Park Service Alaska Region Subsistence Resource Commission Program | |
| 81 FR 44639 - Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Blockchain and Its Emerging Role in Healthcare and Health-related Research” | |
| 81 FR 44608 - Draft Guidance on Progress Tracking Metrics, Long-Term Strategies, Reasonable Progress Goals and Other Requirements for Regional Haze State Implementation Plans for the Second Implementation Period | |
| 81 FR 44741 - Applications for New Awards; Promise Neighborhoods Program-Implementation Grant Competition | |
| 81 FR 44682 - Notice of Application for Approval of Discontinuance or Modification of a Railroad Signal System | |
| 81 FR 44583 - Notice of Public Meeting of the Michigan Advisory Committee for a Meeting To Discuss Testimony Regarding Civil Rights and Civil Asset Forfeiture in the State | |
| 81 FR 44711 - Medication Assisted Treatment for Opioid Use Disorders | |
| 81 FR 44652 - Notice of Availability of the Final Environmental Impact Statement for the Bull Mountain Unit Master Development Plan, Gunnison County, CO | |
| 81 FR 44555 - North American Free Trade Agreement; Preference Override | |
| 81 FR 44515 - Victims of Crime Act Victim Assistance Program | |
| 81 FR 44576 - Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements | |
| 81 FR 44640 - Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder | |
| 81 FR 44683 - Hazardous Materials: Notice of Applications for Special Permits | |
| 81 FR 44684 - Hazardous Materials: Notice of Applications for Special Permits | |
| 81 FR 44689 - Companies Holding Certificates of Authority as Acceptable Sureties on Federal Bonds and as Acceptable Reinsuring Companies | |
| 81 FR 44651 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 81 FR 44557 - Premium Tax Credit NPRM VI | |
| 81 FR 44499 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 44496 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 44503 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 44489 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 44656 - Notice of Availability for the Final Environmental Impact Statement/Environmental Impact Report for the Mendota Pool Bypass and Reach 2B Improvements Project | |
| 81 FR 44492 - Airworthiness Directives; Pacific Aerospace Limited Airplanes | |
| 81 FR 44645 - Extension of the Designation of El Salvador for Temporary Protected Status | |
| 81 FR 44542 - Air Plan Approval; New Hampshire; Infrastructure Requirements for the 2010 Sulfur Dioxide National Ambient Air Quality Standards | |
| 81 FR 44494 - Airworthiness Directives; Beechcraft Corporation (Type Certificate Previously Held by Hawker Beechcraft Corporation; Raytheon Aircraft Company) Airplanes |
Food Safety and Inspection Service
Forest Service
National Agricultural Statistics Service
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Bureau of Safety and Environmental Enforcement
Land Management Bureau
National Park Service
Reclamation Bureau
Surface Mining Reclamation and Enforcement Office
Employee Benefits Security Administration
Information Security Oversight Office
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Maritime Administration
Pipeline and Hazardous Materials Safety Administration
Fiscal Service
Internal Revenue Service
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 superseding Airworthiness Directive (AD) 2012-18-12 for certain Airbus Model A318, A319, and A320 series airplanes. AD 2012-18-12 required modifying the off-wing escape slide (OWS) enclosures on the left-hand (LH) side and right-hand (RH) side of the fuselage. This new AD retains the requirements of AD 2012-18-12 and expands the applicability to all Airbus Model A318, A319, and A320 series airplanes. This AD was prompted by reports that additional OWS part numbers have been affected. We are issuing this AD to prevent off-wing exits on the LH and RH sides of the fuselage from becoming inoperative. During an emergency, inoperative off-wing exits could impair the safe evacuation of occupants, possibly resulting in personal injuries.
This AD becomes effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of October 22, 2012 (77 FR 57003, September 17, 2012).
For Airbus service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
For Air Cruisers service information identified in this final rule, contact Air Cruisers Company, Cage Code 70167, 1747 State Route 34, Wall Township, NJ 07727-3935; telephone 732-681-3527; fax 732-681-9163; Internet
For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2012-18-12, Amendment 39-17189 (77 FR 57003, September 17, 2012) (“AD 2012-18-12”). AD 2012-18-12 applied to certain Airbus Model A318, A319, and A320 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0025R1, dated May 26, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on all Airbus Model A318, A319, and A320 series airplanes. The MCAI states:
One operator reported a torn out aspirator during scheduled deployment (for on ground testing purposes) of the Left Hand (LH) off-wing [escape] slide (OWS). Investigation results revealed that the aspirator of the OWS system interfered with the extrusion lip of the OWS enclosure during the initial stage of the deployment sequence.
This condition, if not corrected, could lead to an off-wing exit, either LH or Right Hand (RH), becoming unserviceable, which, during an emergency situation, could impair the safe evacuation of occupants, possibly resulting in personal injuries.
To address this potential unsafe condition, Airbus issued Service Bulletin (SB) A320-25-1649 containing modification instructions for certain part number (P/N) OWS enclosures. Consequently, EASA issued [EASA] AD 2010-0210 [
Since that [EASA] AD was issued, several other OWS P/N[s] have been identified as potentially impacted.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2010-0210, which is superseded, expands the Applicability to all A318, A319 and A320 aeroplanes, and expands the batch of affected P/N[s] prohibited to be installed on an aeroplane.
For the reason described above, EASA issued AD 2014-0025, retaining the requirements of EASA AD 2010-0210, which was superseded, expanding the Applicability to all A318, A319 and A320 aeroplanes, and expanding the batch of affected P/N[s]
This [EASA] AD is revised to amend paragraphs (1) and (3) to restore the original applicability of [a Direction Générale de l'Aviation Civile] DGAC France AD and EASA AD 2010-0210, respectively, and to correct paragraph (2) to give credit for certain production modifications that were equivalent for the in-service actions previously required by [a] DGAC France AD.
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. The following presents the comment received on the NPRM and the FAA's response to the comment.
United Airlines (United) asked for clarification of the language in paragraph (k) of the proposed AD, which would prohibit the installation of OWS part numbers (P/Ns) including D31865-109, D31865-110, D31865-209, and D31865-210, as identified in paragraph (h)(2) of the proposed AD, but also specifies accomplishing the modification required by paragraph (g) of the proposed AD. United stated that the modification converts those part numbers into D31865-309, D31865-311, D31865-310, and D31865-312, respectively. Therefore, United suggested we remove any language allowing installation of P/Ns D31865-109, D31865-110, D31865-209, and D31865-210 from the proposed AD.
We agree that clarification is necessary. We have moved the language in paragraph (h)(1) of the proposed AD into paragraph (h) of this AD and removed paragraph (h)(2) from this AD. We have also removed the language in paragraph (k) of the proposed AD which specified “except as required by paragraph (h)(2) of this AD for the OWS enclosures identified in paragraph (h) of this AD.” And where paragraph (l)(2) of the proposed AD referred to “paragraph (h)(2),” we have changed this reference to paragraph (h) of this AD.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with the changes described previously, and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Airbus has issued the following service information.
• Airbus Service Bulletin A320-25-1156, Revision 03, dated December 5, 2001. This service information describes procedures for modifying OWS enclosures having P/Ns D31865-101, D31865-102, D31865-103, D31865-104, D31865-105, D31865-106, D31865-107, or D31865-108 of certain Airbus Model A319 and A320 series airplanes.
• Airbus Service Bulletin A320-25-1649, dated February 16, 2010. This service information describes procedures for modifying and installing OWS enclosures having P/Ns D31865-109, D31865-110, D31865-209, or D31865-210, on the LH and RH sides of the fuselage on certain Airbus Model A318, A319, and A320 series airplanes.
Air Cruisers has issued Service Bulletin A320 004-25-84, Revision 4, dated November 9, 2012. This service information describes procedures for modifying the LH and RH OWS.
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 851 airplanes of U.S. registry.
The actions required by AD 2012-18-12 and retained in this AD take about 14 work-hours per product, at an average labor rate of $85 per work-hour. Required parts will cost $0 per product. Based on these figures, the estimated cost of the actions that are required by AD 2012-18-12 is $1,190 per product.
We also estimate that it takes about 48 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 $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,472,080, or $4,080 per product.
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.
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 August 12, 2016.
This AD replaces (AD) 2012-18-12, Amendment 39-17189 (77 FR 57003, September 17, 2012) (“AD 2012-18-12”).
This AD applies to the Airbus airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category, all manufacturer serial numbers.
(1) Model A318-111, -112, -121, and -122 airplanes.
(2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(3) Model 320-211, -212, -214, -231, -232, and -233 airplanes.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings.
This AD was prompted by reports that additional OWS part numbers have been affected. We are issuing this AD to prevent off-wing exits on the left-hand (LH) and right-hand (RH) sides of the fuselage from becoming inoperative. During an emergency, inoperative off-wing exits could impair the safe evacuation of occupants, possibly resulting in personal injuries.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2012-18-12, with no changes. For airplanes equipped with OWS enclosures having part number (P/N) D31865-109, D31865-110, D31865-209, or D31865-210, except as provided by paragraph (i)(1) of this AD: Within 36 months after October 22, 2012 (the effective date of AD 2012-18-12), modify the OWS enclosures and install an OWS enclosure having P/N D31865-309, D31865-311, D31865-310, or D31865-312 on the LH side and RH side of the fuselage, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-25-1649, dated February 16, 2010.
For airplanes equipped with an OWS enclosure having P/N D31865-101, D31865-102, D31865-103, D31865-104, D31865-105, D31865-106, D31865-107, or D31865-108, except as provided by paragraph (i)(2) of this AD: Within 36 months after the effective date of this AD, modify the OWS enclosures and their aspirators in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-25-1156, Revision 03, dated December 5, 2001.
(1) Airplanes having Airbus Modification 30088 embodied in production using an OWS enclosure having P/N D31865-111 or D31865-112 are not affected by the requirements of paragraph (g) of this AD, unless a replacement OWS enclosure, having a part number listed in paragraphs (k)(9) through (k)(12) of this AD, has been installed on that airplane since first flight.
(2) Airplanes on which Airbus Modifications 24850, 25844, and 27275 have been embodied in production, or on which modifications of the LH and RH OWS enclosures and their aspirators have been accomplished using Airbus Service Bulletin A320-25-1156, Revision 01, dated February 2, 1999; or Revision 02, dated October 26, 1999; and Airbus Service Bulletin A320-25-1265, dated June 6, 2001, are compliant with the modification requirement of paragraph (h) of this AD.
Installing both LH and RH OWS that have been modified in accordance with the Accomplishment Instructions of Air Cruisers Service Bulletin A320 004-25-84, Revision 4, dated November 9, 2012, is an acceptable method of compliance with the modification required by paragraph (g) of this AD.
As of the effective date of this AD, do not install on any airplane an OWS enclosure having a part number listed in paragraphs (k)(1) through (k)(12) of this AD.
(1) D31865-101.
(2) D31865-102.
(3) D31865-103.
(4) D31865-104.
(5) D31865-105.
(6) D31865-106.
(7) D31865-107.
(8) D31865-108.
(9) D31865-109.
(10) D31865-110.
(11) D31865-209.
(12) D31865-210.
(1) This paragraph provides credit for the actions specified in paragraph (h) of this AD, if those actions were performed before the effective date of this AD using the service information identified in paragraph (l)(1)(i) or (l)(1)(ii) of this AD, which is not incorporated by reference in this AD.
(i) Airbus Service Bulletin A320-25-1156, Revision 01, dated February 2, 1999.
(ii) Airbus Service Bulletin A320-25-1156, Revision 02, dated October 26, 1999.
(2) This paragraph provides credit for the actions specified in paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-25-1265, dated June 6, 2001, which is not incorporated by reference in this AD.
(3) This paragraph provides credit for the actions specified in paragraph (j) of this AD, if those actions were performed before the effective date of this AD using the service information identified in paragraph (l)(3)(i), (l)(3)(ii), (l)(3)(iii), or (l)(3)(iv) of this AD, which is not incorporated by reference in this AD.
(i) Air Cruisers Service Bulletin A320 004-25-84, dated February 5, 2010.
(ii) Air Cruisers Service Bulletin A320 004-25-84, Revision 1, dated April 9, 2010.
(iii) Air Cruisers Service Bulletin A320 004-25-84, Revision 2, dated February 11, 2011.
(iv) Air Cruisers Service Bulletin A320 004-25-84, Revision 3, dated October 28, 2011.
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.
(ii) AMOCs approved previously for AD 2012-18-12 are approved as AMOCs for the corresponding provisions of paragraph (g) of this AD.
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0025R1, dated May 26, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(5), (o)(6), and (o)(7) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on August 12, 2016.
(i) Airbus Service Bulletin A320-25-1156, Revision 03, dated December 5, 2001.
(ii) Air Cruisers Service Bulletin A320 004-25-84, Revision 4, dated November 9, 2012.
(4) The following service information was approved for IBR on October 22, 2012 (77 FR 57003, September 17, 2012).
(i) Airbus Service Bulletin A320-25-1649, dated February 16, 2010.
(ii) Reserved.
(5) For Airbus service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(6) For Air Cruisers service information identified in this AD, contact Air Cruisers Company, Cage Code 70167, 1747 State Route 34, Wall Township, NJ 07727-3935; telephone 732-681-3527; fax 732-681-9163; Internet
(7) 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.
(8) 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.
We are superseding Airworthiness Directive (AD) 2006-13-05 for certain Pacific Aerospace Limited Model 750XL (type certificate previously held by Pacific Aerospace Corporation Ltd.) airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this AD to require actions to address the unsafe condition on these products.
This AD is effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of July 31, 2006 (71 FR 35509, June 21, 2006).
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email:
Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Pacific Aerospace Limited Model 750XL (type certificate previously held by Pacific Aerospace Corporation Ltd.) airplanes. That NPRM was published in the
Since we issued AD 2006-13-05, additional airplanes have been identified that need to be added to the applicability of the AD.
The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD No. DCA/750XL/7B, dated February 25, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
DCA/750XL/7B revised to introduce PACSB/XL/018 issue 4, dated 20 January 2016, which reduces the applicability to S/N 101 through to 131 with no change to the requirements. Aircraft with S/N 132 onwards have been modified in accordance with PACSB/XL/018 at manufacture, which is a terminating action for the requirements of this AD.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 21489, April 12, 2016) 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 the 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 (81 FR 21489, April 12, 2016) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (81 FR 21489, April 12, 2016).
We reviewed Pacific Aerospace Limited Service Bulletin PACSB/XL/018, Issue 4, dated January 20, 2016. The service bulletin describes procedures for removing rivets (part number (P/N) MS20470 DD6) and installing bolts (P/N NAS 6203-7X or NAS 6203-6X), washers (P/N AN960-10), and nuts (P/N MS21044N3) in place of the rivets to restore airplane to full take-off weight of 7,500 pounds. 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 will affect 9 products of U.S. registry. We also estimate that it will take about 32 work-hours per product to comply with the replacement requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $519 per product.
Based on these figures, we estimate the cost of this AD on U.S. operators to be $29,151, or $3,239 per product.
AD 2006-13-05 affected 8 of the 9 U.S.-registered airplanes reflected in the above cost information. This AD will only increase the cost already required by AD 2006-13-05 by one additional airplane. The FAA has a report that the additional airplane is already in compliance, thus this AD will impose no additional cost impact on U.S. operators.
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 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 airworthiness directive (AD) becomes effective August 12, 2016.
This AD replaces AD 2006-13-05, Amendment 39-14658 (71 FR 35509, June 21, 2006) (“AD 2006-13-05”).
This AD applies to the following Pacific Aerospace Limited Model 750XL airplanes (type certificate previously held by Pacific Aerospace Corporation Ltd.), that are certificated in any category.
(1)
(2)
Air Transport Association of America (ATA) Code 57: Wings.
This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this AD to add airplane serial numbers to the Applicability section, paragraph (c) of this AD, and to ensure wing ultimate load requirements are met. If wing ultimate load requirements are not met, wing failure could result with consequent loss of control.
Unless already done, do the following actions:
(1) Insert the following information into the Limitations section of the airplane flight manual (AFM) at the compliance time specified in paragraphs (f)(1)(i) and (ii) of this AD. You may do this by inserting a copy of this AD into the Limitations section of the AFM: “The maximum takeoff weight is reduced from 7,500 pounds to 7,125 pounds.” The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may do the flight manual changes requirement of this AD. Make an entry in the aircraft records showing compliance with this portion of the AD following section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).
(i)
(ii)
(2) Remove rivets, part number (P/N) MS20470 DD6, on the main spar web and
(i)
(ii)
(3)
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI Civil Aviation Authority (CAA) AD No. DCA/750XL/7B, dated February 25, 2016, for related information. You may examine the MCAI 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 the AD specifies otherwise.
(3) The following service information was approved for IBR on August 12, 2016.
(i) Pacific Aerospace Limited Service Bulletin PACSB/XL/018, Issue 4, dated January 20, 2016.
(ii) Reserved.
(4) The following service information was approved for IBR on July 31, 2006 (71 FR 35509, June 21, 2006).
(i) Pacific Aerospace Corporation Ltd. Service Bulletin PACSB/XL/018, Issue 3, dated December 23, 2005, and amended January 16, 2006.
(ii) Reserved.
(5) For Pacific Aerospace Limited service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email:
(6) You may view this service information at FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at
(7) 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), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Beechcraft Corporation Model BAe.125 Series 1000A and 1000B airplanes and Model Hawker 1000 airplanes. This AD was prompted by reports of inadvertent stowage of the thrust reversers, which can result in high forward engine thrust even though the throttle is commanding reverse thrust. This AD requires installing kits that include relays, associated wiring, and a thrust reverser fail annunciator. We are issuing this AD to prevent inadvertent stowage of the thrust reversers, which could cause a runway overrun during a rejected takeoff or landing, and consequent structural failure and possible injury to occupants.
This AD is effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 12, 2016.
For service information identified in this final rule, contact Beechcraft Corporation, TMDC, P.O. Box 85, Wichita, KS 67201-0085; telephone: 316-676-8238; fax: 316-671-2540; email:
You may examine the AD docket on the Internet at
Jeffrey Englert, Aerospace Engineer, Systems and Propulsion Branch, ACE-116W, FAA, Wichita Aircraft Certification Office (ACO), 1801 Airport Road, Room 100, Dwight D. Eisenhower
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Beechcraft Corporation Model BAe.125 series 1000A and 1000B airplanes and Model Hawker 1000 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
Mr. Kevin Maher expressed support for the NPRM.
Mr. Kenneth Rittenhouse of Becker Aviation LLC requested that we not require installation of the service kits, but leave the installation decision up to the individual owner/operator. Mr. Rittenhouse stated that the NPRM mentions that there have not been any issues reported involving Model BAe.125 airplanes but does mention that those airplanes have a similar engine/thrust reverser system to airplanes on which the problem was reported. Mr. Rittenhouse explained that if you examine the Learjet Model 60 and the Model Hawker 1000 systems, the Hawker 1000 is much more robust with redundant capabilities. Mr. Rittenhouse stated that he does not believe the unsafe condition has ever been an issue with the Model Hawker 1000 airplanes, and that it is extremely unjust to force operators to comply with this modification that costs 15 percent of the total value of the airplane.
We do not agree with the commenter's request. We recognize that maintaining airplanes in an airworthy condition is vital, but sometimes expensive. Installation of the service kit corrects a potential unsafe condition that could cause a runway overrun during a rejected takeoff or landing, and consequent structural failure and possible injury to occupants. The service kit was designed and proposed by the airplane original equipment manufacturer as its best correction option. The root cause of the unsafe condition is incorrect software logic within the engine's electronic control unit. We acknowledge the commenter's statement indicating that “the Hawker 1000 is much more robust with redundant capabilities,” however, the commenter did not submit any substantiating data to support that statement. We have determined that this unsafe condition exists on the Model Hawker 1000 airplanes as well as Beechcraft Corporation Model BAe.125 Series 1000A and 1000B airplanes. We might approve requests to revise the applicability of this AD if the request includes data that justifies such a revision and provides an acceptable level of safety. We have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Beechcraft Service Bulletin 78-4133, dated May 2015. The service information describes procedures for installing kits having part numbers 140-9005 and 140-9006, which include relays, associated wiring, and a thrust reverser fail annunciator. 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 38 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
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.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 is effective August 12, 2016.
None.
This AD applies to Beechcraft Corporation (type certificate previously held by Hawker Beechcraft Corporation; Raytheon Aircraft Company) airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Model BAe.125 series 1000A and 1000B airplanes, serial numbers 258151, 258159, and 259004 through 259042 inclusive.
(2) Model Hawker 1000 airplanes, serial numbers 259003 and 259043 through 259052 inclusive.
Air Transport Association (ATA) of America Code 78, Engine Exhaust.
This AD was prompted by reports of inadvertent stowage of the thrust reversers, which can result in high forward engine thrust even though the throttle is commanding reverse thrust. We are issuing this AD to prevent inadvertent stowage of the thrust reversers, which could cause a runway overrun during a rejected takeoff or landing, and consequent structural failure and possible injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Within 600 flight hours or 12 months after the effective date of this AD, whichever occurs first: Install kits having part numbers 140-9005 and 140-9006, in accordance with the Accomplishment Instructions of Beechcraft Service Bulletin 78-4133, dated May 2015, except as specified in paragraph (h) of this AD.
A note in the Accomplishment Instructions of Beechcraft Service Bulletin 78-4133, dated May 2015, instructs operators to contact Beechcraft Corporation if any difficulty is encountered in accomplishing the service bulletin. However, any deviation from the actions required by paragraph (g) of this AD must be approved as an alternative method of compliance (AMOC) under the provisions of paragraph (i)(1) of this AD.
(1) The Manager, Wichita Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (j) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Jeffrey Englert, Aerospace Engineer, Systems and Propulsion Branch, ACE-116W, FAA, Wichita ACO, 1801 Airport Road, Room 100, Dwight D. Eisenhower National Airport, Wichita, KS 67209; phone: 316-946-4167; fax: 316-946-4107; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Beechcraft Service Bulletin 78-4133, dated May 2015.
(ii) Reserved.
(3) For Beechcraft service information identified in this AD, contact Beechcraft Corporation, TMDC, P.O. Box 85, Wichita, KS 67201-0085; telephone: 316-676-8238; fax: 316-671-2540; 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.
We are adopting a new airworthiness directive (AD) for all Airbus Model A319, A320, and A321 series airplanes. This AD is intended to complete certain mandated programs intended to support the airplane reaching its limit of validity (LOV) of the engineering data that support the established structural maintenance program. This AD requires reinforcing the forward pressure bulkhead at a certain stringer on both the left-hand and right-hand sides, and doing related investigative and corrective actions if necessary. We are issuing this AD to prevent fatigue cracking of the forward pressure bulkhead, which could result in reduced structural integrity of the airplane.
This AD becomes effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 12, 2016.
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A319, A320, and A321 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0209, dated September 19, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on all Model A319, A320, and Model A321 series airplanes. The MCAI states:
During the A320 fatigue test campaign for Extended Service Goal (ESG), it was determined that fatigue damage could develop on the forward pressure bulkhead at Frame (FR) 35 on left hand (LH) side and right hand (RH) side.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
To address this potential unsafe condition, a reinforcement modification was developed, which has been published through Airbus Service Bulletin (SB) A320-53-1268 for in-service application to allow aeroplanes to operate up to the new ESG limit.
For the reasons described above, this [EASA] AD requires reinforcement of the centre fuselage forward pressure bulkhead at FR35.
The forward pressure bulkhead reinforcement includes related investigative actions of measuring the diameters of certain fastener holes, and if they are not oversized, doing a rotating probe inspection for cracking of the fastener holes.
Required corrective actions include cold expanding crack-free holes or repairing oversize or cracked holes by using a method approved by the FAA, EASA, or Airbus's EASA Design Organization Approval (DOA).
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. The following presents the comments received on the NPRM and the FAA's response to each comment.
American Airlines requested that we reference Revision 03 of Airbus Service Bulletin A320-53-1268, dated May 7, 2015, as the appropriate source of service information.
We agree with American Airlines' request. No additional work is specified by this revision for airplanes modified by any previous issue. We have revised paragraphs (g) and (h) of this AD to refer to Airbus Service Bulletin A320-53-1268, Revision 03, dated May 7, 2015; and revised paragraph (i) of this AD to also give credit for previous actions accomplished in accordance with Airbus Service Bulletin A320-53-1268, Revision 02, dated July 15, 2014.
United Airlines (UAL) stated that the effectivity of Airbus Service Bulletin A320-53-1268, Revision 02, dated July 15, 2014, does not match the NPRM applicability. UAL also stated that the NPRM applicability does not mention pre-modification 153832 airplanes, and that Airbus Service Bulletin A320-53-1268, Revision 02, dated July 15, 2014, is classified as Airbus Modification 153832.
UAL stated that several alternative methods of compliance (AMOCs) may be needed because Airbus will add to the effectivity of Airbus Service Bulletin A320-53-1268, Revision 02, dated July 15, 2014, after operators purchase an extended design service goal from Airbus.
We agree to clarify the applicability. The requirements of this AD apply to all airplanes identified in the applicability of the AD. If there is any conflict between the AD applicability and the service information effectivity, then the AD takes precedence. The applicability of this AD also matches the applicability of the corresponding MCAI AD.
If operators are planning to operate the airplane beyond the LOV of engineering data approved for the original type design, the actions specified in this AD must be done in order to address the identified unsafe condition. We acknowledge that AMOCs may be needed to allow the use of future revisions of the service information. Therefore, we encourage operators to coordinate with Airbus for effective planning and compliance with the AD requirements if they intend to operate their fleet beyond its LOV. We have not changed this final rule in this regard.
UAL questioned why there is no terminating action in the proposed AD. UAL stated that the reinforcement specified in this proposed AD is intended to prevent fatigue cracking of the forward pressure bulkhead but there is no reference to related inspection tasks or termination of existing Airworthiness Limitation Items (ALIs). UAL noted that, for example, ALI 533186 is applicable for pre-Mod 153832 (Airbus Service Bulletin A320-53-1268) airplanes. UAL stated this will cause confusion as to whether or not ALI inspections are required if there is no terminating action paragraph.
In regard to UAL's question on terminating action, ALI inspections
However, when the effectivity of an ALI inspection identifies pre-modification airplanes, then it is not applicable to airplanes in a post-modification configuration. Thus, ALI inspections that are identified as pre-Mod 153832 (Airbus Service Bulletin A320-53-1268) do not affect airplanes on which the reinforcement specified in Airbus Service Bulletin A320-53-1268 has been done. We have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued Service Bulletin A320-53-1268, Revision 03, dated May 7, 2015. The service information describes procedures for reinforcing the forward pressure bulkhead at frame 35, stringer 30, on both the left-hand and right-hand sides; and for doing repairs. 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 48 airplanes of U.S. registry.
We also estimate that it will take about 21 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $85,680, or $1,785 per product.
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
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.
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 August 12, 2016.
None.
This AD applies to the Airbus airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, all manufacturer serial numbers.
(1) Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(2) Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes.
(3) Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD is intended to complete certain mandated programs intended to support the airplane reaching its limit of validity (LOV) of the engineering data that support the established structural maintenance program. We are issuing this AD to prevent fatigue cracking of the forward pressure bulkhead, which could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Before the accumulation of 48,000 total flight cycles or 96,000 total flight hours, whichever occurs first: Reinforce the forward pressure bulkhead at frame 35, stringer 30, on both the left-hand and right-hand sides; and do all applicable related investigative and corrective actions; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-53-1268, Revision 03, dated May 7, 2015, except as provided by paragraph (h) of this AD. Do all applicable related investigative and corrective actions before further flight.
Although Airbus Service Bulletin A320-53-1268, Revision 03, dated May 7, 2015, specifies to contact Airbus for repair
This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using any of the Airbus service information specified in paragraphs (i)(1) through (i)(3) of this AD. This service information is not incorporated by reference in this AD.
(1) Airbus Service Bulletin A320-53-1268, dated January 8, 2013, which is not incorporated by reference in this AD.
(2) Airbus Service Bulletin A320-53-1268, Revision 01, dated July 23, 2013, which is not incorporated by reference in this AD.
(3) Airbus Service Bulletin A320-53-1268, Revision 02, dated July 15, 2014, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2014-0209, dated September 19, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (l)(3) and (l)(4) of this AD.
(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) Airbus Service Bulletin A320-53-1268, Revision 03, dated May 7, 2015.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; 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), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 airplanes. This AD was prompted by reports of water leakage from the potable water system due to improperly installed waterline couplings, and water leaking into the electronics equipment (EE) bays from above the floor in the main cabin, resulting in water on the equipment in the EE bays. This AD requires replacing the potable waterline couplings above the forward and aft EE bays with new, improved couplings. This AD also requires sealing the main cabin floor areas above the aft EE bay, installing drip shields and foam blocks, and rerouting the wire bundles near the drip shields above the equipment in the aft EE bay. We are issuing this AD to prevent a water leak from an improperly installed potable water system coupling, or main cabin water source, which could cause the equipment in the EE bays to become wet, resulting in an electrical short and potential loss of system functions essential for safe flight.
This AD is effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 12, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Susan L. Monroe, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6457; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
The Airline Pilots Association International stated that it concurs with the contents of the NPRM.
United Airlines (UAL) stated that it supports the compliance time of 60 months to accomplish the actions proposed by the NPRM.
Mr. Geoffrey Barrance requested that we revise the compliance times specified in the NPRM to before further flight. Mr. Barrance stated that, in view of the effect of common mode faults to nullify the safety design of critical avionic systems housed in the avionics bay, this matter needs to be treated with the greatest urgency and that the correction of the problem should be required with far greater urgency than the timescales proposed in the NPRM. Mr. Barrance stated an example of the automatic landing function of the automatic flight control system that does not and cannot take into account common mode faults such as water ingress into multiple line replaceable units (LRUs), which are present to provide functional redundancy and fault tolerance. Mr. Barrance stated that no probability can be assessed for unwanted behavior resulting from water ingress into multiple redundant LRUs.
UAL requested that we extend the proposed compliance time from 24 months to 30 months for accomplishing the actions specified in Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 001, dated March 26, 2015. UAL stated that if maintenance requires an unforeseen disassembly of the airplane for access or to correct a test failure, a 30-month period is required to schedule the clamp inspection and replacement in a heavy check.
We do not agree to revise the compliance times required by this AD. In developing appropriate compliance times for this AD, we considered not only the safety implications, including evaluation of the hazards associated with water ingress into multiple redundant LRUs, but the manufacturer's recommendations, the availability of required parts, and the practical aspect of accomplishing the required actions within an interval of time that corresponds to typical scheduled maintenance for affected operators. After considering all the available information, we have determined that the compliance times, as proposed, represent appropriate intervals of time in which the required actions can be performed in a timely manner within the affected fleet, while still maintaining an adequate level of safety. Operators are always permitted to accomplish the requirements of an AD at a time earlier than the specified compliance time. Operators wanting additional time to comply with the requirements of an AD may request adjustments to the compliance time under the provisions of paragraph (k) of this AD. We will consider requests for an adjustment of the compliance time if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety. We have not changed this AD in this regard.
UAL requested that we approve the use of flame retardant (FR) moisture barrier tapes Nitto 11611-MB polyurethane tape or BMS8-346 Type II, Class 4 tape (3M 8657) as alternates to the BMS8-346 Type 1, Class 1 moisture barrier tape (Patco D9100) specified in Boeing Alert Service Bulletin B787 81205 SB530029-00, Issue 001, dated March 26, 2015. UAL stated that during a supplemental type certificate test for a Model 737 airplane, burn testing was performed on the Patco D9100 tape by Zodiac Northwest Aerospace Technologies, and it failed the 12-second vertical test. UAL stated that, therefore, the Patco D9100 tape could not be certified to meet the 14 CFR 25.853 flammability requirements.
We do not agree with UAL's request. We have contacted Boeing who provided evidence that BMS8-346 Type 1, Class 1 moisture barrier tape (Patco D9100) material passed the 12-second vertical burn test. UAL did not submit specific evidence to substantiate that Nitto 11611-MB polyurethane tape or BMS8-346 Type II, Class 4 tape (3M 8657) is compliant and that BMS8-346 Type 1, Class 1 moisture barrier tape (Patco D9100) material is non-compliant. Under the provisions of paragraph (k) of this AD, we will consider requests for approval of an alternative method of compliance (AMOC) if sufficient data are submitted to substantiate that alternative tapes are compliant. We have not changed this AD in this regard.
Boeing and UAL requested that we revise the NPRM to refer to Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015; Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016; and
We agree with the commenters' requests to use the most current service information. We have revised this AD as described below.
• Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015, adds notes, revises the waiting time in the leak test, and corrects typographical errors. We have revised paragraphs (c) and (g) of this AD to reference this service information.
• Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016, extends the 24-month compliance time for sealing floor panels and seat tracks to 60 months; clarifies installation of components, revises tape requirements; revises sealant callouts; and corrects kit contents. We have revised paragraphs (c) and (h)(1) of this AD to reference this service information.
• Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016, extends the 24-month compliance time for installing drip shields and foam blocks to 60 months. This service information also revises the airplane groups into configurations to account for airplanes on which the drip shield between the floor beams at station (STA) 1233 and STA 1257 was not installed due to interference with wire bundles over the P100 panel. This service information also clarifies certain instructions, revises certain task hour estimates, and removes one airplane from the effectivity. This service information erroneously specifies “Group 6, Configuration 1” airplanes where it should specify “Group 7, Configuration 1” airplanes for Task 29 in multiple places. We have revised paragraphs (c) and (h)(2) of this AD to reference Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016. We have added new paragraph (i) to specify an exception for Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016.
We have also added new paragraph (j) of this AD to provide credit for actions done prior to the effective date of this AD using Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 001, dated March 26, 2015; Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 001, dated March 26, 2015; and Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 001, dated March 26, 2015; as applicable. We have redesignated subsequent paragraphs accordingly.
Mr. Geoffrey Barrance requested that we conduct an internal review and a review with the manufacturer as to why the airplane equipment bay design was not reviewed and required to protect the avionics LRUs from water ingress at the time of certification. Mr. Barrance stated that this is not a new issue and must be a standard check item on design reviews and certification signoff. Mr. Barrance stated that this is a design and certification omission, not primarily a problem with the quality of work by the people doing the installation of the potable waterlines.
We partially agree with Mr. Barrance's request. We agree that this is a design issue that increased the likelihood of mis-installation, and not primarily a problem with the quality of work by personnel installing the potable waterlines. We asked the manufacturer to conduct a root-cause analysis to determine how it permitted design issues that created the unsafe condition. We are working with the manufacturer to determine if their company processes must be updated to better identify these hazards. The actions required by this AD address only the results of that analysis that directly relate to the identified design issues, and mandate changes to correct those issues.
We disagree that the EE bay design was not reviewed and required to protect the avionics LRUs from water ingress at the time of certification. A hazard analysis was completed for these systems, as part of the certification process, which required known hazards to be addressed. This event shows that despite the hazard analysis during the design and certification phase, further improvement is needed to remove the unsafe condition. Airplane manufacturers are responsible for the safety of their products and services, and must be in compliance with applicable safety requirements. As a component of our safety management system, we verify that the safety systems of the design approval holder meet applicable requirements. Working with approval holders during the design development process, we strive to avoid unsafe conditions in the first place. The design for this system was evaluated during the certification process and found at the time to be compliant. We also verify that the approval holders' processes, products, and services continue to maintain safety of their product during the operational phases of their service life. In this regard, we have evaluated the issues related to this system and acted on them.
We are continuously evaluating our certification system and procedures and improving them when problems are found. In addition, if the FAA is made aware of issues occurring on a certificated product, we conduct an investigation, evaluate the manufacturer's root-cause analysis, and make a determination whether or not an unsafe condition exists. We then take appropriate action to mitigate the unsafe condition. We have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed the following service information.
• Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015.
• Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016.
• Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016.
This service information describes procedures for replacing the potable waterline couplings above the forward and aft EE bays with new, improved couplings; sealing the floors, seat tracks, and lavatories above the aft EE bay; installing drip shields and foam blocks; and rerouting the wire bundles adjacent to the drip shields above the aft EE bay. 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 17 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
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.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 is effective August 12, 2016.
None.
This AD applies to The Boeing Company Model 787-8 series airplanes, certificated in any category, as identified in the service information specified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015.
(2) Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016.
(3) Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016.
Air Transport Association (ATA) of America Code 38, Water/Waste; and Code 53, Fuselage.
This AD was prompted by reports of water leakage from the potable water system due to improperly installed waterline couplings, and water leaking into the electronics equipment (EE) bays from above the floor in the main cabin, resulting in water on the equipment in the EE bays. We are issuing this AD to prevent a water leak from an improperly installed potable water system coupling, or main cabin water source, which could cause the equipment in the EE bays to become wet, resulting in an electrical short and potential loss of system functions essential for safe flight.
Comply with this AD within the compliance times specified, unless already done.
Within 24 months after the effective date of this AD: Replace the existing potable waterline couplings located above the forward and aft EE bays with new, improved couplings, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015. Before further flight after doing the replacement, do a potable water system leak test and repair any leaks found before further flight, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015.
Within 60 months after the effective date of this AD: Do the actions specified in paragraphs (h)(1) and (h)(2) of this AD.
(1) Apply sealant to the main cabin floor areas located above the aft EE bay, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016.
(2) Install drip shields and foam blocks, and reroute the wire bundles above the equipment in the aft EE bay, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016, except as specified in paragraph (i) of this AD.
Where Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016, specifies “Group 6, Configuration 1” airplanes in reference to Task 29, the correct airplane group identification is “Group 7, Configuration 1” airplanes.
This paragraph provides credit for the corresponding actions specified in paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using the applicable service information specified in paragraphs (j)(1), (j)(2), and (j)(3) of this AD. This service information is not incorporated by reference in this AD.
(1) Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 001, dated March 26, 2015.
(2) Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 001, dated March 26, 2015.
(3) Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 001, dated March 26, 2015.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, alteration, or modification required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (k)(4)(i) and (k)(4)(ii) apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Susan L. Monroe, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6457; fax: 425-917-6590; email:
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(3) and (m)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin B787-81205-SB380009-00, Issue 002, dated December 9, 2015.
(ii) Boeing Alert Service Bulletin B787-81205-SB530029-00, Issue 002, dated January 26, 2016.
(iii) Boeing Alert Service Bulletin B787-81205-SB530031-00, Issue 002, dated March 16, 2016.
(3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(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), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. This AD was prompted by reports of a manufacturing oversight, in which a supplier omitted the required protective finish on certain bushings installed in the rear spar upper chord on horizontal stabilizers, which could lead to galvanic corrosion and consequent cracking of the rear spar upper chord. This AD requires an inspection or records check to determine if affected horizontal stabilizers are installed, related investigative actions, and for affected horizontal stabilizers, repetitive inspections for any crack of the horizontal stabilizer rear spar upper chord, and corrective action if necessary. We are issuing this AD to detect and correct cracking of the rear spar upper chord, which can result in the failure of the upper chord and consequent departure of the horizontal stabilizer from the airplane, which can lead to loss of control of the airplane.
This AD is effective August 12, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 12, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Gaetano Settineri, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6577; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
Air Line Pilots Association International (ALPA) stated that it supports the NPRM. Boeing stated that is concurs with the NPRM.
Aviation Partners Boeing stated that installation of winglets per Supplemental Type Certificate (STC) ST00830SE (
We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) and added new paragraph (c)(2) to this AD to state that installation of STC ST00830SE (
Airlines for America (A4A) requested that we revise the applicability of the proposed AD to state “This AD applies to all horizontal stabilizers with serial numbers identified in Boeing SB 737-55A1097.” A4A explained that the proposed AD is applicable to all Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes; however, Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, provides a list of affected horizontal stabilizers by serial number. A4A expressed that the physical plate inspections required by paragraph (g)(1)(ii) of the proposed AD are excessive and unneeded, as operators normally track serialized components without the need to physically inspect the airframe. A4A further reasoned that when paragraph (c) of the proposed AD is written against all Model 737 Next Generation airframes, the complexity of compliance reporting becomes more burdensome. The net result, stated A4A, is indefinite record keeping of AD compliance for airplanes that are not equipped with horizontal stabilizers affected by the manufacturing oversight.
We do not agree to revise the applicability of this AD as requested by the commenter. Paragraph (g)(1) of this AD gives operators the option of performing either a records check or an inspection. If the operator's records are sufficient to determine the serial number of the horizontal stabilizers on the affected airplane, then a physical inspection is not required. Furthermore, the affected horizontal stabilizers are rotable parts, so it is possible that an affected horizontal stabilizer could be installed on numerous airplanes during its service life, even on a new production airplane once it enters service. As specified in paragraph 2.B.(2) of Chapter 6 of the AD Manual, FAA-IR-M-8040.1C (
A4A requested that we revise paragraph (h)(2) of the proposed AD to allow removal of an affected horizontal stabilizer, and replacement with an unaffected or an affected horizontal stabilizer that is within the parameters of paragraph 1.E. “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. A4A explained that paragraph (g)(2) of the proposed AD requires that the inspection specified in Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, be accomplished on any horizontal stabilizer found to be within the effectivity of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, and the compliance times found in paragraph 1.E., “Compliance.” A4A expressed that if cracking is found, operators must repair in accordance with paragraph (h)(2) of the proposed AD; paragraph (h)(2) of the proposed AD requires repair in accordance with paragraph (j) of the proposed AD before further flight.
We agree. We have determined that removing a damaged horizontal stabilizer and replacing it with a serviceable horizontal stabilizer, as provided in paragraph (i) of this AD, addresses the identified unsafe condition. We have revised paragraph (h)(2) of this AD accordingly.
A4A requested that the FAA and Boeing review other non-destructive test (NDT) inspection options such as an ultrasound process to satisfy the proposed inspection requirements. A4A pointed out that paragraph (g)(2) of the proposed AD specifies a high frequency eddy current (HFEC) method for inspection of the rear spar upper chord. A4A explained that the FAA should be aware that other methods, specifically
We partially agree. We agree with the commenter that other inspection methods may be better NDT diagnostic techniques and note that alternative methods of compliance (AMOCs) have been granted to ADs when updated service information containing improved procedures to address an unsafe condition becomes available.
We disagree to include other inspection options in this final rule, because the inspection technique required in this AD adequately addresses the unsafe condition and is accompanied by service information, which includes detectable crack lengths and inspection intervals. If additional service information that provides alternative NDT inspection methods becomes available, under the provisions of paragraph (j) of this AD, we will consider requests for approval of an AMOC if sufficient data are submitted to substantiate that the inspection method would provide an acceptable level of safety. We have made no changes to this AD in this regard.
A4A requested that we reword paragraphs (g) and (i) of the proposed AD to allow operators to maintain or install any affected horizontal stabilizer on any airplane, provided that the horizontal stabilizer is, or will be, inspected as specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. A4A explained that paragraphs (i)(1) and (i)(2) of the proposed AD preclude installation of an affected horizontal stabilizer without accomplishing the required inspection. A4A explained further that other maintenance activity could cause a horizontal stabilizer to be removed and reinstalled prior to reaching the compliance times specified in Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. With the potential interpretation of paragraph (g)(2) of the proposed AD being to inspect immediately, the initial inspection would be significantly accelerated, and the inspection schedule would be altered for the remaining life of the component.
All Nippon Airways (ANA) requested that we clarify the parts installation restrictions specified in paragraph (i) of the proposed AD to reduce the burden for operators. ANA explained that parts installation is restricted based on its serial number, and that paragraph (i)(2)(i) of the proposed AD requires initial inspection specified in paragraph (g)(2) of the proposed AD before further flight. ANA expressed that this requirement is applicable if the flight cycles and/or the date of issuance the original certificate of airworthiness, or the original export certificate of airworthiness for the horizontal stabilizer are unknown or have already exceeded the proposed compliance time specified in paragraph (g)(2) of the proposed AD. ANA reasoned that, if the flight cycles and the date of issuance of the original certificate of airworthiness or the original export certificate of airworthiness of the horizontal stabilizer are known, and the flight cycles and years on the horizontal stabilizer are less than the compliance times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, operators may conduct the inspection specified in paragraph (g)(2) of this AD at the time specified in paragraph (g)(2) of this AD.
We agree to clarify. An affected horizontal stabilizer that has not reached the inspection threshold or the next repeat interval is still in compliance with this AD at the time it is installed on the airplane. We have revised paragraph (i)(2)(i) of this AD to read “Initial and repetitive HFEC inspections specified in paragraph (g)(2) of this AD are completed within the compliance times specified in paragraph (g)(2) of this AD.” We also agree to clarify that the 10-year compliance time specified in paragraph 1.E. “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, is measured using the airplane the affected horizontal stabilizer was delivered on.
A4A requested that repair instructions be provided either in a revision to the service information, or via the structural repair manual (SRM). A4A also requested that the proposed AD be revised to include a preventive, terminating action including the option to remove and replace the subject bushings in the upper chord fitting during a heavy check schedule. A4A expressed that the NPRM and Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, provide neither specific repair methods nor a means to terminate the inspections. A4A reasoned that the NPRM requires corrective action for any crack that is discovered, and that such action is to be performed in accordance with paragraph (j) of the proposed AD, which is the AMOC section. A4A said that, although no known inspections have revealed cracking, we (the FAA) must believe that findings will occur, and that operators would benefit by having guidance from Boeing without the need for an AMOC request. Similarly, A4A expressed, without a repair plan, there should also be a means of terminating the inspections entirely. A4A pointed to a recent experience concerning seat track cracking that exposed the difficulties of embarking upon a required inspection plan without a defined recovery path. A4A referred to AD 2013-23-04, Amendment 39-17659 (78 FR 68693, November 15, 2013) (“AD 2013-23-04”), and stated that AD also directed operators to the AMOC process.
We do not agree. An AD is issued to address an identified unsafe condition, as required by 14 CFR part 39. The determination of the unsafe condition, mitigating action, and compliance times in this AD has all been coordinated with Boeing. This AD is being issued to address the lack of corrosion protection on a critical structural element. As a result, dissimilar metal corrosion may cause cracking of the horizontal stabilizer rear spar upper chord. With no service history of cracking yet reported, it is expected that any cracking will be limited and not result in a significant disruption to affected operators. The inspections required by this AD provide an acceptable level of safety for the affected airplanes. We have reviewed with Boeing the implementation issues associated with AD 2013-23-04 and expect that Boeing will provide us with approvable data for repair and terminating actions in a timely manner to address any cracking found.
For these reasons, we do not consider that delaying this action until after the possible release of revised service information is warranted, since sufficient technology and service information currently exist to accomplish the required actions within the compliance time. However, under the provisions of paragraph (j) of this AD, we will consider requests for approval of AMOCs for revised service information, repairs, or terminating actions if sufficient data are submitted to substantiate they would provide an acceptable level of safety. For these reasons, we have made no changes to this AD in this regard.
ANA stated that paragraph (g)(1)(i) of the proposed AD should refer to Part 1, and paragraph (g)(1)(ii) of the proposed AD should refer to Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. ANA did not provide a reason for this request.
From these statements, we infer that ANA is requesting that we revise paragraphs (g)(1)(i) and (g)(1)(ii) of the proposed AD. We agree that the changes requested by ANA provide additional clarity. We have added “Part 1 of” to paragraph (g)(1)(i) and “Part 2 of” to paragraph (g)(1)(ii) of this AD.
A4A also requested that, prior to release of the AD, we assure that Boeing has sections of the rear spar available for the horizontal stabilizer including a typical splice repair plan for each affected 737-NG fleet. A4A also requested that Boeing also provide or have available, horizontal stabilizers that are service ready prior to the release of the AD.
We do not agree. We do not consider that delaying this action until Boeing has assured that replacement parts will be available is warranted. This AD is issued to address an identified unsafe condition, as required by 14 CFR part 39. The determination of the unsafe condition, mitigating action, and compliance times in this AD has all been coordinated with Boeing. This AD is being issued to address the lack of corrosion protection on a critical structural element. As a result, dissimilar metal corrosion may cause cracking of the horizontal stabilizer rear spar upper chord. With no service history of cracking yet reported, it is expected that any cracking will be limited and not be a significant disruption to affected operators. We understand that Boeing will make horizontal stabilizer parts and assemblies available as necessary for operators to address possible on-condition actions. However, since it is unknown how many repairs or replacements may be necessary and what parts would be necessary for each repair, we cannot estimate the type and number of parts needed. If parts availability becomes an issue, under the provisions of paragraph (j) of this AD, we may approve requests for adjustments to the compliance time for doing a repair or replacement if data are submitted to substantiate that such an adjustment would provide an acceptable level of safety. We have made no changes to this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Αre consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. The service information describes procedures for an inspection or records check to determine if affected horizontal stabilizers are installed, related investigative actions, HFEC inspections for any crack of the horizontal stabilizer rear spar upper chord, and corrective action if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 1,397 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary inspections that would be required based on the results of the inspection or records check. We have no way of determining the number of aircraft that might need these inspections:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
We have received no definitive data that would enable us to provide cost estimates for the on-condition repairs specified in this AD.
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
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 is effective August 12, 2016.
None.
(1) This AD applies to all The Boeing Company Model 737-600, -700, -700C, -800, -900, and 900ER series airplanes, certificated in any category.
(2) Installation of Supplemental Type Certificate (STC) ST00830SE (
Air Transport Association (ATA) of America Code 55, Stabilizers.
This AD was prompted by reports of a manufacturing oversight, in which a supplier omitted the required protective finish on certain bushings installed in the rear spar upper chord on horizontal stabilizers, which could lead to galvanic corrosion and consequent cracking of the rear spar upper chord. We are issuing this AD to detect and correct cracking of the rear spar upper chord, which can result in the failure of the upper chord and consequent departure of the horizontal stabilizer from the airplane, which can lead to loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Except as specified in paragraph (h)(1) of this AD, within the compliance time identified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, do the actions specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD.
(i) Do a records check to determine if an affected horizontal stabilizer is installed and if any horizontal stabilizer has been exchanged, and do all applicable related investigative actions, in accordance with Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. Affected horizontal stabilizers are identified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015.
(ii) Do an inspection of the horizontal stabilizer identification plate to determine if any affected horizontal stabilizer is installed, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015. Affected horizontal stabilizers are identified in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015.
(2) If, during any action required by paragraph (g)(1)(i) or (g)(1)(ii) of this AD, any affected horizontal stabilizer is found: Except as specified in paragraph (h)(1) of this AD, within the compliance time identified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, do a high frequency eddy current (HFEC) inspection for any crack of the horizontal stabilizer rear spar upper chord and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, except as required by paragraph (h)(2) of this AD. Repeat the inspection thereafter at intervals identified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015.
(1) Where Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) If any cracking is found during any inspection required by this AD, and Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (j) of this AD, or replace with a serviceable horizontal stabilizer as specified in paragraph (i) of this AD.
As of the effective date of this AD, no person may install a horizontal stabilizer on any airplane, except as specified in paragraphs (i)(1) and (i)(2) of this AD.
(1) A horizontal stabilizer may be installed if the part is inspected in accordance with “Part 2: Horizontal Stabilizer Identification Plate Inspection” of the Accomplishments Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, and no affected serial number is found.
(2) A horizontal stabilizer may be installed if the part is inspected in accordance with “Part 2: Horizontal Stabilizer Identification Plate Inspection” of the Accomplishments Instructions of Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015, and an affected serial number is found, provided that the actions specified in paragraphs (i)(2)(i) and (i)(2)(ii) of this AD are done, as applicable.
(i) Initial and repetitive HFEC inspections specified in paragraph (g)(2) of this AD are completed within the compliance times specified in paragraph (g)(2) of this AD.
(ii) All applicable corrective actions are done before further flight as required by paragraph (h)(2) of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (k) of this AD. Information may be
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Gaetano Settineri, Aerospace Engineer, Airframe Branch, ANM 120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6577; fax: 425-917-6590; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 737-55A1097, dated July 1, 2015.
(ii) Reserved.
(3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(4) You may view this service information at the FAA, 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:
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations that provide a simplified method of accounting for gains and losses on shares in money market funds (MMFs). The final regulations also provide guidance regarding information reporting requirements for shares in MMFs. The final regulations respond to Securities and Exchange Commission (SEC) rules that change the amount for which certain MMF shares are distributed, redeemed, and repurchased. The final regulations affect MMFs and their shareholders.
Grace Cho at (202) 317-6895 (not a toll-free number).
This document contains amendments to 26 CFR part 1 (Income Tax Regulations) under sections 446 and 6045 of the Internal Revenue Code (Code). The regulations provide a method of accounting for gain or loss on shares in MMFs and are intended to simplify tax compliance for holders of shares in MMFs affected by SEC regulations that impose liquidity fees or change how certain MMF shares are priced.
An MMF is a type of investment company registered under the Investment Company Act of 1940 (1940 Act) and regulated as an MMF under Rule 2a-7 under the 1940 Act (17 CFR 270.2a-7). MMFs have historically sought to keep stable the prices at which their shares are distributed, redeemed, and repurchased. The securities that Rule 2a-7 permits an MMF to hold generally result in no more than minimal fluctuations in the MMF's net asset value per share (NAV).
MMFs meeting the requirements of Rule 2a-7 have been permitted to value their assets based on the assets' cost, with certain adjustments (amortized cost method), and to price their shares by rounding the resulting NAV to the nearest 1 percent (penny rounding). These methods have enabled MMFs to maintain constant share prices in almost all circumstances. Because most MMFs target a $1.00 share price, an MMF that fails to maintain a constant share price is said to “break the buck.”
The SEC MMF Reform Rules generally bar the use of the amortized cost method and penny rounding for certain MMFs (floating-NAV MMFs) and require a floating-NAV MMF to value its assets using market factors and to round its price per share to the nearest basis point (the fourth decimal place, in the case of a fund with a $1.0000 share price). Certain government-security-focused MMFs (government MMFs) and certain MMFs the beneficial owners of which are limited to natural persons (retail MMFs) may continue to use the amortized cost method and penny rounding. (A government MMF or retail MMF that continues to use the amortized cost method and penny rounding is called a stable-NAV MMF.)
The SEC MMF Reform Rules also establish circumstances under which an MMF is permitted or required to impose a liquidity fee or is permitted to impose a redemption gate. When an MMF has a liquidity fee in effect, the liquidity fee reduces the proceeds received by all redeeming shareholders. A redemption gate is the temporary suspension of redemptions of shares in the MMF. Liquidity fees and redemption gates
The Treasury Department and the IRS published a notice of proposed rulemaking and notice of public hearing (REG-107012-14) in the
A request for a public hearing was received, and the hearing was held on November 19, 2014. The IRS received written comments responding to the proposed regulations regarding the method of accounting for gains and losses on shares in MMFs. The written comments are available for public inspection at
Under the proposed regulations, the NAV method would apply only to floating-NAV MMF shares. In the preamble to the proposed regulations, the Treasury Department and the IRS requested comments regarding whether the NAV method should be a permissible method of accounting for stable-NAV MMF shares.
Although stable-NAV MMFs seek to maintain constant share prices, there are circumstances in which shares in a stable-NAV MMF will give rise to gain or loss. On rare occasions, shares in a stable-NAV MMF may be redeemed at a price other than the target price, such as when the MMF breaks the buck. In addition, a stable-NAV MMF may impose liquidity fees, which will generally result in the realization of a loss by a redeeming shareholder. If the acquisition of other shares causes such a redemption to be a wash sale under section 1091, section 1091(d) will generally cause the basis of the acquired shares to exceed the cost of the shares. Because the price of a stable-NAV MMF share rarely changes, any disposition of those acquired, higher-basis shares will likely result in another loss, which also may be deferred by the wash sale rules. Therefore, even if a liquidity fee is in effect for only one redemption by a shareholder and the share price of the MMF remains constant, that fee may cause a difference between the basis and value of the shareholder's MMF shares that persists indefinitely. Determining gain or loss and basis on each transaction in a stable-NAV MMF, taking into account the wash sale rules, would impose significant burdens on shareholders under these circumstances. To eliminate those burdens, a shareholder might need to terminate the shareholder's entire interest in the affected MMF (and not initiate a new position until after the end of the period described in section 1091(a)).
Commenters recommended that the NAV method be applicable not only to shares in floating-NAV MMFs but also to shares in stable-NAV MMFs. The commenters added that many shareholders of stable-NAV MMFs may be retail shareholders (generally, individuals) who are likely to rely upon the cost basis reporting provided by funds or brokers for their other mutual funds. Those individuals are unlikely to have the systems necessary to record gains and losses and to track wash sales and the resulting basis adjustments.
The NAV method would reduce the complexity, and any tax-based motivation to terminate investments in MMFs, that would result from the imposition of a liquidity fee by a stable-NAV MMF. Under the NAV method, any loss that resulted from the imposition of a liquidity fee by an MMF would be determined for a shareholder's entire interest in the MMF (or in an account) for the appropriate taxable year (or computation period) rather than for a single transaction. Therefore, the wash sale rules would not defer the loss. The NAV method also requires fewer and simpler computations than traditional accounting, even if there are no wash sales. For the years after an MMF breaks the buck or imposes a liquidity fee, the NAV method simplifies recordkeeping, because the gain or loss for each year is based on changes in the NAV during that year. Therefore, the final regulations permit taxpayers to apply the NAV method to shares in stable-NAV MMFs.
The proposed regulations would provide that if a taxpayer applies the NAV method to shares in any MMF for a taxable year, the taxpayer must apply the NAV method to its shares in all MMFs for which that method is permissible.
Commenters requested that the final regulations permit taxpayers to apply different methods to shares in different MMFs or to shares in a single MMF held in different accounts. Commenters said that some taxpayers may receive sufficient information about their shares in certain MMFs to compute gain or loss realized on each transaction and that those taxpayers should be permitted to compute gain or loss realized on each transaction for those MMFs.
Commenters also noted that taxpayers may hold shares in a single MMF through different kinds of accounts (for example, an account with a broker and an account with the MMF itself) and may receive different information for the different accounts. The commenters recommended that, because of that possibility, taxpayers should be permitted to use different accounting methods for shares held in different accounts. Commenters also noted that many MMF shareholders will be large institutional investors, which might hold shares in the same MMF through separate accounts controlled by different divisions.
In response to these comments, the final regulations permit MMF shareholders to use different methods of accounting for shares in different MMFs or for shares in a single MMF held in different accounts.
Under the NAV method, computation periods are the periods that a taxpayer selects for computing gain and loss for an MMF. The proposed regulations would provide that computation periods may be the taxpayer's taxable year or a shorter period, provided that (i) computation periods are of approximately equal duration, (ii) every day during the taxable year falls within one, and only one, computation period,
Most regulated investment companies (RICs) must pay an excise tax under section 4982 if they do not make the required distribution described in section 4982(b) for a calendar year. The required distribution is generally 98 percent of the RIC's ordinary income for the calendar year, plus 98.2 percent of the RIC's capital gain net income for the one-year period ending on October 31 of the calendar year. A commenter requested clarification that a RIC that holds MMF shares may use the NAV method for excise tax computations. That commenter also requested that the Treasury Department and the IRS confirm that a RIC that uses the NAV method is permitted to use the one-year period from November 1 to October 31 as its computation period for excise tax purposes. The commenter explained that RICs generally account for items that are marked to market using two different one-year periods for income tax and excise tax purposes. The commenter explained that, under section 4982(e)(2)(A), the term “capital gain net income” when used in section 4982 is determined by treating the one-year period ending on October 31 of any calendar year as the company's taxable year.
The Treasury Department and the IRS agree that the NAV method should be applicable for purposes of the computations required by section 4982 and that the taxable year for purposes of those computations should be the relevant period under section 4982(e). The final regulations adopt this change.
The final regulations, however, require a RIC to be consistent in applying the NAV method to MMF shares for income tax and excise tax purposes. For each MMF in each account, the final regulations generally require a RIC to use the NAV method either for both income tax and excise tax computations or for neither computation. The final regulations also clarify how a RIC may change to or from the NAV method.
The final regulations require a RIC to use the same computation periods for purposes of both excise tax and income tax computations. Therefore, under the final regulations, a RIC using the NAV method for its shares in an MMF generally treats the one-year period for which gain or loss from the MMF would be included in the amount determined under section 4982(e)(2) or (e)(6) (the section 4982 period) like a taxable year in applying the NAV method to determine the RIC's required distribution under section 4982(b).
The final regulations eliminate the requirement that computation periods be of approximately equal duration. The Treasury Department and the IRS do not believe that this requirement is essential to the operation of the NAV method, and eliminating the requirement will allow taxpayers more flexibility. In particular, permitting computation periods of unequal duration will reduce the burden on RICs of complying with the requirement of consistent computation periods for income and excise tax purposes. For example, a RIC that applies the NAV method to its shares in an MMF (held as a capital asset) and that has an income tax year ending on January 31 may meet the consistency requirements with two computation periods of unequal duration—one ending on January 31 and the other on October 31. The RIC also may use additional computation periods ending on other dates, such as December 31.
Under the proposed regulations, gain and loss under the NAV method would be determined by reference to the fair market value of MMF shares. Commenters requested that the Treasury Department and the IRS clarify that the fair market value of an MMF share for this purpose is the NAV reported by the MMF. One commenter suggested that the fair market value of a share in an MMF should be the published NAV as of the end of the relevant day (or the next trading day, if the day in question is not a trading day). A second commenter suggested that, because MMFs may strike several NAVs throughout the day, the fair market value should be the next published NAV after a transaction.
In response to these comments, the final regulations clarify that the fair market value of a share in an MMF at the time of a transaction is presumed to be the published NAV (or other published amount for which the MMF would redeem the share, determined without regard to any liquidity fees (other redemption amount)). For purposes of computing the ending value for a computation period, the presumption applies to the last published NAV (or other redemption amount) in that computation period. For purposes of determining the fair market value of MMF shares surrendered or received in a redemption or exchange, the presumption generally applies to the NAV (or other redemption amount) used to determine the consideration received in the transaction, or if the consideration is not based on a published NAV (or other redemption amount), the first NAV (or other redemption amount) published for the MMF shares after the transaction. If no NAV (or other redemption amount) is published, or if facts and circumstances indicate that the NAV (or other redemption amount) does not represent the fair market value of a share in the MMF, the fair market value is determined on the basis of all the facts and circumstances.
Under the proposed regulations, a taxpayer's net investment in an MMF for a computation period would equal the aggregate cost of shares in the MMF purchased during the computation period, minus the aggregate amount received during the computation period in redemption of shares in the MMF, subject to certain adjustments. A commenter suggested that the final regulations clarify that the aggregate amount received is based on: (i) If cash is received, the cash proceeds, (ii) if shares in another MMF are received, the published NAV of the shares received as of the end of the day on which the redemption or exchange occurs (or the next trading day, if the day in question is not a trading day), or (iii) if other non-cash property is received, the NAV of the redeemed or exchanged shares as of the end of the day on which the redemption or exchange occurs (or the next trading day if the day in question is not a trading day or, if the fund will
The final regulations include provisions for determining the amount received for purposes of computing a taxpayer's net investment in an MMF for a computation period. If the consideration received in exchange for an MMF share consists only of cash, other MMF shares, or both, the amount received is the amount of any cash plus the fair market value of any MMF shares received. If the consideration includes any property other than cash or MMF shares, the amount received is determined by reference to the fair market value of the surrendered MMF shares.
The same commenter recommended that a phrase in § 1.446-7(b)(5)(i)(B) of the proposed regulations, “if the transaction is one in which gain or loss would be recognized,” be clarified to indicate that it refers to recognition of gain or loss other than pursuant to the NAV method. The final regulations make this clarification.
Under the proposed regulations, a taxpayer's net investment would increase if, during the computation period, the taxpayer acquired any shares in an MMF other than by purchase. In such cases, the net investment increases by the adjusted basis (for purposes of determining loss) of each such share immediately after its acquisition. The proposed regulations would also provide that if that adjusted basis would be determined by reference to the basis of one or more shares in an MMF that are being disposed of by the taxpayer in a transaction in which gain or loss is not recognized (exchanged basis), then the basis of each such disposed share is treated as being the fair market value of that share at the time of its disposition. A commenter noted that the proposed regulations do not address a situation in which the shareholder receives a transferred basis in MMF shares acquired from another person. The commenter suggested that, in that situation, if the person from whom the shareholder acquired the shares used the NAV method, then the adjusted basis of the acquired shares should be treated as the published NAV applicable to the acquisition date.
The final regulations clarify the effect on net investment of a share acquired from another person with a transferred basis. Similar to the commenter's suggestion, the final regulations provide that, if a shareholder receives a transferred basis in one or more acquired MMF shares and the person from whom the shareholder acquired the shares used the NAV method, then the adjusted basis of the acquired shares will be their fair market value at the time of the acquisition, which value is presumed to be the next NAV (or other redemption amount) published by the MMF.
The proposed regulations would provide that if a taxpayer uses the NAV method for shares in an MMF and each of those shares otherwise would give rise to capital gain or loss if sold or exchanged in a computation period, then the gain or loss from the shares in the MMF is treated as capital gain or loss under the NAV method. Likewise, if each of the shares otherwise would give rise to ordinary gain or loss if sold or exchanged in a computation period, then the gain or loss is treated as ordinary gain or loss. If, however, the sale of all of the shares in the MMF would give rise to a combination of ordinary gain or loss and capital gain or loss if sold or exchanged in a computation period, then all gain or loss from the shares in the MMF is treated as capital gain or loss.
A commenter noted that the proposed regulations do not explain why all gain or loss should be treated as capital in the case of an account containing MMF shares of mixed character. The commenter recommended that the character of gain or loss with respect to a mixed character account be bifurcated based on the portion of the shares that would generate gain or loss of each character.
The Treasury Department and the IRS believe that it is rare for a shareholder to hold shares of a single MMF the disposition of which would produce a mix of ordinary income and capital gain. Under that circumstance, a taxpayer may use different accounts to preserve the character of the shares that would produce ordinary income and capital gain. The purpose of the NAV method is to provide an alternative to traditional accounting for taxpayers seeking simplicity. The rationale for offering a method solely for MMFs is that the value of MMFs fluctuates so little that simplicity is more important than tracking each individual gain or loss. A rule that bifurcates gain or loss based on the value of the shares in a single account, when those values may change during a computation period, would make the NAV method more complex. That additional complexity is not warranted in light of the rarity of the circumstance the proposed bifurcation would address and the ability of shareholders to prevent the treatment of all gain or loss as capital by using separate accounts. Therefore, the final regulations retain the simplifying rule for mixed-character accounts.
Concurrently with the release of the proposed regulations, the Treasury Department and the IRS released Rev. Proc. 2014-45 (2014-34 IRB 388), which provides that the wash sale rules in section 1091 will not be applied to redemptions of shares in floating-NAV MMFs. Commenters requested that the wash sale exemption, which is limited to floating-NAV MMFs, be extended to stable-NAV MMFs that impose liquidity fees.
The final regulations permit shareholders of stable-NAV MMFs to use the NAV method. A shareholder who uses the NAV method would not require an exemption from the wash sale rules because under the NAV method, net gain or loss is determined for each computation period, and no gain or loss is determined for any particular redemption of a taxpayer's shares in an MMF. Without a determination of loss for a particular redemption, that redemption does not implicate the wash sale rules. Because taxpayers may use the NAV method to prevent wash sales, the Treasury Department and IRS are not extending the exemption in Rev. Proc. 2014-45 to stable-NAV MMFs.
A commenter requested that the Treasury Department and the IRS issue guidance regarding the tax treatment of an MMF's receipt of financial support from an investment adviser to raise the NAV of the MMF (determined without the amortized cost method or penny rounding) to $1.0000. In addition, the commenter requested guidance regarding the diversification requirements of section 817(h) for a segregated asset account that qualifies as, or invests in, a government MMF. On May 5, 2016, the Treasury Department and the IRS released guidance related to both of these requests.
The commenter also requested (and later withdrew its request) that the Treasury Department and the IRS issue guidance providing tax-free treatment for certain divisions of MMFs into retail and institutional MMFs. The Treasury Department and the IRS have
The commenter also requested that the Treasury Department and the IRS issue guidance setting forth the proper tax treatment by an MMF of liquidity fees that the MMF imposes. In addition, the commenter requested guidance providing that, if an MMF imposes liquidity fees and subsequently distributes to shareholders amounts that correspond to amounts that the MMF retained as liquidity fees, the MMF will be deemed to have sufficient earnings and profits to treat the distribution as a dividend. These requests do not relate directly to the NAV method or to the information reporting provision in the proposed regulations and so are not addressed in these final regulations. The Treasury Department and the IRS may consider guidance on these questions in the future.
As under the proposed regulations, a taxpayer may adopt the NAV method for shares in a floating-NAV MMF by use of the method in the Federal income tax return for the first taxable year in which both (1) the taxpayer holds shares in that MMF and (2) that MMF is a floating-NAV MMF.
The final regulations provide that a taxpayer seeking to change to or from the NAV method must secure the consent of the Commissioner in accordance with § 1.446-1(e). Simultaneously with the publication of these regulations, the Treasury Department and the IRS are issuing Rev. Proc. 2016-39 (2016-30 IRB), which provides the procedures by which a taxpayer may obtain automatic consent to change to or from the NAV method for shares in an MMF.
In certain circumstances, Rev. Proc. 2016-39 permits taxpayers to change to the NAV method on a federal tax return without filing a Form 3115, “Application for Change in Accounting Method.” This simplified procedure applies to a taxpayer that holds shares in a stable-NAV MMF and wants to change to the NAV method for a taxable year if (1) the taxpayer has not used the NAV method for shares in the MMF for any taxable year prior to the year of change, and (2) prior to the beginning of the year of change, either (a) the taxpayer's basis in each share of the MMF has been at all times equal to the MMF's target share price, or (b) the taxpayer has not realized any gain or loss with respect to shares in the MMF.
For certain other changes, Rev. Proc. 2016-39 provides automatic consent procedures that require a short Form 3115. For example, these automatic consent procedures apply to a taxpayer that (1) has adopted a realization method for shares in a floating-NAV MMF and wants to change to the NAV method for shares in that MMF, or (2) has adopted the NAV method for shares in a floating-NAV MMF and wants to change to a permissible realization method for shares in that MMF.
The final regulations concerning the NAV method apply to taxable years ending on or after July 8, 2016. For taxable years ending on or after July 28, 2014, and beginning before July 8, 2016, however, shareholders of MMFs may rely either on the rules concerning the NAV method in the proposed regulations or on the final regulations.
The final regulations concerning information reporting apply to sales of shares in calendar years beginning on or after July 8, 2016. Taxpayers and brokers (as defined in § 1.6045-1(a)(1)), however, may rely on the rules in the regulations concerning information reporting for sales of shares in calendar years beginning before July 8, 2016.
IRS Revenue Procedures cited in this preamble are published in the Internal Revenue Bulletin and are available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the proposed regulations preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small businesses. No comments were received.
The principal author of the final regulations is Grace Cho, IRS Office of the Associate Chief Counsel (Financial Institutions and Products). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
Section 1.446-7 also issued under 26 U.S.C. 446.
(a)
(b)
(1)
(i) Every day during the taxable year falls within one, and only one, computation period;
(ii) Each computation period contains days from only one taxable year; and
(iii) If the taxpayer is a regulated investment company (RIC) that is not described in section 4982(f)—
(A) The same computation periods are used for purposes of both income tax accounting under chapter 1 and excise tax computations under section 4982; and
(B) The requirements in paragraphs (b)(1)(i) and (ii) of this section are also satisfied if applied by substituting the RIC's section 4982 period for the RIC's taxable year.
(2)
(3)
(i)
(ii)
(iii)
(A) For purposes of determining the ending value of a taxpayer's shares in an MMF for a computation period under paragraph (b)(2) of this section, the last published redemption amount on the last day of that computation period;
(B) For purposes of determining the value of MMF shares received in a redemption or exchange described in paragraph (b)(5)(ii)(A) of this section, the published redemption amount for such MMF shares used to determine the consideration received in the redemption or exchange, or if the consideration received is not based on a published redemption amount, the first published redemption amount for such MMF shares after the redemption or exchange;
(C) For purposes of determining the amount received in a redemption or exchange described in paragraph (b)(5)(ii)(B) of this section in which the consideration received is based on a published redemption amount for the redeemed shares, that published redemption amount; and
(D) For purposes of determining the amount received in an exchange described in paragraph (b)(5)(ii)(B) of this section that is not described in paragraph (b)(3)(iii)(C) of this section, or the amount of any adjustment resulting from a disposition transaction described in paragraph (b)(5)(iii) of this section, the first published redemption amount for the exchanged or disposed of MMF shares after the exchange or other transaction.
(iv)
(4)
(5)
(A) The aggregate cost of shares in the MMF purchased during the computation period (including purchases through reinvestment of dividends); minus
(B) The aggregate amount received during the computation period in redemption of (or otherwise in exchange for) shares in the MMF in transactions in which gain or loss would be recognized if the taxpayer did not apply the NAV method to the shares.
(ii)
(A) If no property other than cash and shares in one or more other MMFs is received, the amount of any cash plus the fair market value of any MMF shares received; or
(B) If any property other than cash or shares in one or more other MMFs is received, the fair market value of the redeemed MMF share.
(iii)
(B)
(6)
(7)
(i) Except as provided in paragraph (b)(7)(ii) of this section, the ending value of the taxpayer's shares in the MMF for the immediately preceding computation period; or
(ii) For the first computation period in a taxable year, if the taxpayer did not use the NAV method for shares in the MMF for the immediately preceding taxable year, the aggregate adjusted basis of the taxpayer's shares in the MMF at the end of the immediately preceding taxable year.
(c)
(2)
(ii)
(iii)
(iv)
(3)
(ii) In the case of a taxpayer that applies the NAV method to shares in an MMF, the gain or loss with respect to those shares for a computation period is treated as ordinary gain or loss provided the sale or exchange of every one of those shares during the computation period would give rise to ordinary gain or loss if the taxpayer did not apply the NAV method to the shares.
(iii) See paragraph (c)(5) of this section for the treatment of shares in a single MMF held in more than one account.
(4)
(5)
(6)
(7)
(8)
(ii)
(B)
(d)
(i) Fund is an MMF. Shareholder is a person whose taxable year is the calendar year. On January 1 of Year 1, Shareholder owns 5,000,000 shares in Fund with an adjusted basis of $5,000,000.00. The price of Fund shares has not varied from $1.00 from the date Shareholder acquired the shares through January 1 of Year 1. During that period, Shareholder has engaged in multiple purchases and redemptions of Fund shares, but Shareholder has reported no gains or losses with respect to the shares because Shareholder realized an amount in each redemption equal to Shareholder's basis in the redeemed shares. During Year 1, the price of Fund shares begins to float. During Year 1, Shareholder receives $32,158.23 in taxable dividends from Fund and makes 120 purchases of additional shares in Fund (including purchases through the reinvestment of those dividends) totaling $1,253,256.37 and 28 redemptions totaling $1,124,591.71. The fair market value of Shareholder's shares in Fund at the end of Year 1 is $5,129,750.00. All of Shareholder's shares in Fund are held in a single account and as capital assets. There is no adjustment to the basis in Shareholder's shares in Fund under any provision of internal revenue law during Year 1.
(ii) Prior to Year 1, Shareholder has had no gains or losses to report with respect to the
(iii) If Shareholder had instead adopted the calendar month as its computation period, it would have used the NAV method for every month of Year 1, even though prices of Fund shares may have been fixed for some months.
(e)
(c) * * *
(3) * * *
(vi)
(B)
Office for Victims of Crime, Justice.
Final rule.
The Office for Victims of Crime (“OVC”) of the U.S. Department of Justice's Office of Justice Programs (“OJP”), publishes this final rule to implement the victim assistance formula grant program (“Victim Assistance Program”) authorized by the Victims of Crime Act of 1984 (“VOCA”). VOCA authorizes OVC to provide an annual grant from the Crime Victims Fund to each State and eligible territory for the financial support of services to crime victims by eligible crime victim assistance programs. The rule codifies and updates the existing VOCA Victim Assistance Program Guidelines (“Guidelines”) to reflect changes in OVC policy, needs of the crime victim services field, and VOCA itself.
Toni Thomas, Office for Victims of Crime, at (202) 307-5983.
The Victims of Crime Act of 1984 (VOCA) authorizes the Office for Victims of Crime (OVC) to provide an annual formula grant from the Crime Victims Fund to each State and eligible territory for the purpose of providing assistance to victims of crime.
Most provisions in this final rule are substantively the same as the corresponding provisions of the Guidelines. The final rule reorganizes the program rules into six major divisions: (1)
The rules in the
The
The revised
The
The
The
As discussed in more detail under the Executive Orders 12866 and 13563 (in the Regulatory Review discussion below), the rule clarifies and updates existing Guidelines, but does not alter the existing program structure. Updating the existing Guidelines to clearly and accurately reflect the statutory parameters will facilitate State compliance with VOCA, and thus avoid potentially costly non-compliance findings. The rule makes only a few substantive changes to the existing Guidelines, and most of the changes expand State flexibility in the use of VOCA funding. Some changes, like allowing more flexibility to coordinate and leverage community resources, and adopt alternative monitoring strategies, impose no costs but allow States to use existing funding more efficiently. Other changes, which allow States to allocate funding to services not presently allowable under the Guidelines, could expand the types of victim service organizations funded with VOCA funds and the services provided by existing organizations. Such allocations of funding, however, are not mandated under the rule, and each State will continue to make the final decision about whether to change its funding allocations. This is not a change from the present discretion that States have to allocate funding according to their priorities. OVC anticipates that most States will continue to allocate the majority of VOCA funding to victim services for certain types of crimes (
This rule implements OVC's Victim Assistance Program, a formula grant program authorized by Section 1404 of the Victims of Crime Act of 1984, Public Law 98-473, codified at 42 U.S.C. 10603. This section of VOCA authorizes OVC to provide an annual grant from the Crime Victims Fund to each State for the financial support of services to victims of crime by eligible crime victim assistance programs. This rule supersedes the VOCA Guidelines (published at 62 FR 19607) that have been in effect since April 22, 1997, and reflects changes in OVC policy, the needs of the crime victim services' field, and VOCA itself, as well as the comments submitted in response to the Notice of Proposed Rulemaking.
OVC's Victim Assistance Program is funded from the Crime Victims Fund. The Fund receives Federal criminal fines, penalties, and assessments, as well as certain gifts and bequests, but does not receive any general tax revenue. The Crime Victims Fund is administered by OVC and amounts that may be obligated therefrom are allocated each year according to the VOCA formula at 42 U.S.C. 10601. The amount annually available for obligation through the VOCA formula allocations typically has been set by statute, through limits in the annual DOJ appropriation act, at less than the total amount available in the Fund. The VOCA formula specifies that (in most years) the first $20M available in the Fund for that year will go toward child abuse prevention and treatment programs, with a certain amount to be set-aside for programs to address child abuse in Indian Country. After that, such sums as may be necessary are available to the Federal Bureau of Investigation and the U.S. Attorneys Offices to improve services to victims of Federal crime, and to operate a victim notification system. The remaining balance is allocated as follows: 47.5% for OVC's Victim Compensation Program, 47.5% for OVC's Victim Assistance Program, and 5% for the OVC Director to distribute in discretionary awards in certain statutorily defined categories. Generally, under the distribution rules for the Victim Compensation Program, if a portion of the 47.5% available for Compensation is not needed for that purpose, it is (per the statutory formula) made available to augment the Victim Assistance Program. The Victim Assistance Program distributes funds to States as mandated by VOCA, at 42 U.S.C. 10603. The VOCA statutory distribution formula provides each State with a base amount (presently $500,000 for each State and the District of Columbia; $200,000 for each eligible territory), and distributes the remainder proportionately, based on population.
OVC published the Final Program Guidelines, Victims of Crime Act, FY1997 Victim Assistance Program on April 22, 1997 (62 FR 19607). Those Guidelines were based on OVC experience with the Victim Assistance Program, legal opinions rendered since the inception of the program in 1986, and comments from the field on the Proposed Program Guidelines, which were published in the
On September 3, 2002, OVC published a notice of Proposed Program Guide at 67 FR 56444, seeking comments to refine the administration of the Victim Assistance Program further; thereafter, however, OVC chose not to issue final guidance to supersede the 1997 Guidelines. After receiving comments on the 2002 Proposed Program Guide, OVC instead decided to pursue the publication of codified program regulations rather than merely revise the guideline document. Throughout 2010, OVC sought preliminary input from the victim services field regarding improving victim services and potential modifications to the Victim Assistance Program rules that would facilitate such improvement.
OVC incorporated this input into a Notice of Proposed Rulemaking, which it published at 78 FR 52877 (Aug. 27, 2013), and OVC received 108 public comments over a 60 day period. OVC considered all comments submitted during the comment period in drafting this final rule.
The 1997 Guidelines have been outpaced by changes in VOCA, developments in the crime victim services field, technological advances, and new approaches to State administration of VOCA funding. This rule updates the program Guidelines to account for developments over the last decade and a half, and to reflect more accurately program parameters applicable to each participating entity. In so doing, OVC hopes to allow administering agencies and victim service providers fully to leverage the progress that the field has made over the last decade in knowledge of victim needs, victim service strategies, and efficient program administration, with the end goal of assisting crime victims more effectively. Many of the provisions in the existing Guidelines have been retained in substance, though the text has been reformatted in some cases. OVC describes below the main substantive changes to the program Guidelines, and the comments received.
The rule reorganizes the provisions of the Guidelines, primarily to accommodate the requirements for publication in the Code of Federal Regulations (CFR), but also to organize information more logically. The rule omits repetition of statutory language, except where needed for context and ease of use. OVC notes that the rule is drafted to be read
Some commenters expressed concern that the proposed rule conflated provisions applicable to VOCA-funded projects in some cases with provisions relating to a VOCA-eligible program, and several endorsed the National Association of Victim Assistance Administrators' (NAVAA) suggestions for reorganizing it. In the final rule, OVC more clearly distinguishes between the two concepts, and adopts most of the NAVAA's helpful suggestions for reorganizing the rule.
In connection with reorganizing the provisions of the final rule for greater logical consistency and clarity, OVC has moved or renumbered many of the sections of the proposed rule. In order to assist readers, a derivation table is included listing the sections of the final rule and the corresponding section or sections of the proposed rule. The public comments on provisions of the proposed rule are discussed below according to where those provisions are codified in the final rule.
Many commenters expressed their desire that the Crime Victims Fund “cap” be raised substantially. As such a change requires legislative action, it is beyond the scope of OVC's authority to do so. However, we note that the Department of Justice Fiscal Years 2015 and 2016 Appropriation Acts did substantially increase—more than threefold—the cap for those years.
The general provisions of the final rule—including statement of purpose, future guidance, and construction and severability—are largely unchanged from the proposed rule. OVC added a paragraph describing the date on which SAAs must comply with the rule. The rule applies upon its effective date to all OVC grants made after that date, except for funding under such grants that was obligated before the effective date. Pre-award obligations are a standard practice of SAAs under the VOCA Assistance Program, as the annual appropriation cycle typically does not permit for awards to be made until late in the fiscal year. VOCA Assistance grants typically have an award period that extends retroactively to October 1st of the fiscal year of the award, thus there may be funds under grants made after the effective date that were obligated by the SAA prior to the effective date, and subsequently ratified by OVC's approval of the grant. The final rule does not apply retroactively, and thus it does not require that SAAs anticipate rules that are not in effect when making such obligations. However, OVC will permit SAAs to apply the provisions that expand SAA discretion in the use funds (
The final rule contains several terms and definitions that are used throughout. These are set out in section 94.102 for ease of reference.
The definition of
Some commenters liked the proposed definition, but others wanted OVC to include more examples in the definition to illustrate coverage of a broader range of harms. OVC kept the more conceptual definition from the proposed rule, as it is substantively the same as the long-standing Guideline definition and because—as one commenter pointed out—this definition has been sufficiently broad to encompass the harm from various crimes on a wide and diverse range of individuals.
OVC has added a definition of the term
A commenter noted that OVC did not propose to define “sub-recipient” or “VOCA project,” and asked that OVC define these terms so as to differentiate between a VOCA-funded project, and the organization that is eligible to receive VOCA funds to undertake the project. OVC agrees and adds these definitions, and has made conforming changes throughout the rule.
The final rule adds a definition of the statutory term
OVC received many comments on the proposed definition of child abuse. Many commenters supported the proposed definition. Other commenters supported the proposed definition, but recommended changes or expressed concerns about certain parts of it. One commenter worried that the inclusion of the concept of children exposed to violence may lead states to view a non-offending parent who cannot leave an abusive household as a co-offender. OVC notes that the definition of child abuse in this rule does not control (or affect) how a state views or treats potential offenders. Nonetheless, it is OVC's express intent that the definition should not be misconstrued to mean that failure to leave an abusive relationship, in the absence of other action constituting abuse or neglect, is itself abuse or neglect. A commenter asked that the definition encompass sex and labor trafficking, and several others asked OVC to include slurs and family rejection as examples of the emotional abuse of children encompassed by the definition. OVC notes that the definition of child abuse is sufficiently broad to encompass these harms without listing specific abusive activities, if States consider them to be child abuse. Some commenters worried that the inclusion of exposure to violence would dilute available resources, and confuse States operating victim assistance programs.
OVC acknowledges resource limitations facing many States, but keeps the expanded definition in the final rule to allow States to prioritize within the category based on local capacity and needs. The Department's own Defending Childhood initiative demonstrated the importance of services for children exposed to violence, and the new definition will permit services addressing this. OVC, in response to several comments, has clarified in the definition that it encompasses harm to children, and is not meant to include adults who were victimized as children. This does not, however, preclude States from funding services to adults victimized as children; it merely means that States cannot count such services under the child-abuse priority category.
Section 94.103(a) sets forth the purpose of OVC's annual VOCA formula grants to the States. Several commenters asked that OVC re-draft the language to make it less confusing. OVC agrees and has done so. Commenters also asked that OVC add a statement about State discretion in determining sub-award recipients and amounts. OVC agrees and has added a sentence accordingly.
Section 94.103(b) sets forth the general rules for State eligibility certifications required by VOCA. OVC requires States to submit these certifications annually in their applications for funding. Reporting and technical requirements specific to a given fiscal year are set out in the annual program solicitation, or in supplemental OVC communications if time does not permit publication in the solicitation.
Section 94.103(c) clarifies that a SAA may award its VOCA funds to another organization to distribute—known as pass-through administration—and highlights SAA obligations with regard to use of administrative and training funds, monitoring, and reporting should this method be used. Several commenters supported pass-through administration, but advocated that pass-through entities should have specific expertise and experience related to the use of the funding (
A commenter was concerned that the proposed rule eliminated language in the guidelines about things that States should consider in strategic planning and asked that OVC add it back to the final rule. OVC agrees that the language is desirable and has added a new paragraph (d) with this language. Finally, several commenters expressed concern that OVC did not highlight the need for States to consider sustainability of services in strategic planning. OVC agrees that sustainability is an important consideration, and has added this to paragraph (d).
Section 94.103(g) sets forth that SAAs shall, upon request, and consistent with 2 CFR 200.336, permit OVC access to all records related to the use of VOCA funding. Access to SAAs' records is subject to the provision of the government-wide grant rules at 2 CFR 200.336, which permits access to the true names of crime victims only in extraordinary and rare circumstances, not for routine monitoring, and requires protection of sensitive information by all agencies involved if access is granted.
OVC moved the provisions of proposed section 94.104,
In the final rule, section 94.104,
Section 94.104(c) sets out the criteria by which SAAs must identify (for allocation of funds, reporting, and compliance purposes) services that assist previously underserved populations of victims of violent crime. SAAs must identify such a service for underserved victims of violent crime by the type of crime they experience (
A commenter asked that OVC add economic crimes, such as identity theft, to the list of examples of underserved victims. OVC notes that, for the underserved victim category, VOCA requires funding be allocated to projects serving “previously underserved populations of victims of
A commenter asked that OVC increase the percentage of funding required to be allocated to underserved populations. OVC has kept the mandated percentage at its present level, which balances the need for stability in state victim assistance funding with the need to ensure State victim assistance programs are responsive to emerging needs. The commenter also asked that OVC clarify that the exception allowing States to deviate from the underserved and priority percentages should be used sparingly. OVC notes that such requests are extremely rare (OVC has record of only one); thus, as a practical matter, an additional limitation of the exception is unnecessary. Other commenters asked OVC to require States to consult with sub-recipients prior to requesting approval to change allocations. As explained above, OVC anticipates such requests will be extremely rare, and declines to add such a requirement. The same commenter asked that OVC not tie exceptions for allocations for the sexual-assault priority category to overall crime rates, explaining that crime rates in a given time period are not necessarily reflective of victim service needs during the corresponding time period, as victims may not seek services immediately. OVC agrees, and the final rule allows other types of data to be used in supporting an exemption request.
A commenter asked that OVC require States to consult with rape crisis centers and sexual assault coalitions about the needs of sexual violence victims. OVC agrees that such consultation may be useful, but declines to include such a requirement in the rule, as OVC prefers to allow States to consult with a wide variety of stakeholders as appropriate.
Section 94.104(e) sets for the minimum requirements for SAAs sub-award process. It requires that SAAs have a documented methodology for selecting sub-recipients, follow DOJ grant rules regarding conflicts of interest, and encourages SAAs to fund eligible sub-recipients through a competitive process, which is described.
The proposed rule would have required competition of all sub-awards. Some commenters liked the proposed competition requirement, but others were opposed to it. Several commenters noted that requiring competition could increase administrative costs for SAAs, and could destabilize small victim assistance programs that would no longer be able to rely on consistent funding. Commenters noted that this may decrease the availability of services in rural areas where there are not many providers. A commenter from a SAA explained that it uses a conduit funding process in which it distributes funds to local victim witness units based on a formula, and these units then sub-award
OVC appreciates the thoughtful comments submitted in response to this proposal, and recognizes the importance of allowing States discretion in determining which organizations receive funds and in what amounts. Due to the potential administrative burden of requiring competition (particularly in jurisdictions with a limited number of SAA staff), OVC has not included such a requirement, though OVC does encourage SAAs to use a competitive process where feasible.
Many commenters expressed their opinion that VOCA funding should not be used as seed money for new organizations. OVC notes that any organization funded with VOCA Assistance funding—even through a competitive process—must meet the statutory program eligibility criteria, which requires either a record of effective victim services and financial support from non-VOCA funding, or substantial support from non-VOCA funding. One commenter asked that OVC require States to have a strategic state plan for allocating funding. The final rule encourages States to develop a funding strategy, and requires States to have a documented method of making funding decisions.
OVC renumbered this section from 94.106 in the proposed rule to 94.105 in the final rule. This section sets out SAA reporting requirements. The two key reports—subgrant award reports and performance reports—are the same reports required by the Guidelines, and the proposed rule. The rule does not specify time or manner in which these reports are to be submitted. The Government Performance and Results Modernization Act of 2010, Public Law 111-352 (Jan. 4, 2011), shifted many federal performance reporting requirements to a quarterly default, and OVC has changed the default performance reporting period in the rule accordingly. OVC will communicate the technical details of each year's reporting requirements to grantees via annual program solicitations and supplemental guidance.
A commenter noted that multiple budget revisions may occur during the grant period, and that the proposed requirement that SAAs update the subgrant award report within 30 days of such revisions would be burdensome. The commenter requested that OVC retain its current practice of allowing SAAs to submit a revised subgrant award report before project closeout. In response, OVC notes that the subgrant award report contains only minimal budget information, and the importance of having accurate and timely information on subawards outweighs the minimal additional burden of updating this report within the specified timeframe. Recent upgrades to OVC's performance reporting systems should reduce the burden on SAAs as subrecipients now have the ability to enter SAR data directly. The final rule keeps the thirty-day reporting requirement.
Another commenter suggested that OVC should require additional reporting, specifically on unmet needs of victims and the estimated costs of providing such services. OVC declines to add such a requirement to the rule. One commenter suggested that the final rule should allow flexibility for OVC to change the reporting period for the performance report; OVC agrees and has added this but keeps the Federal fiscal year as the default reporting period.
OVC renumbered this section from 94.107 in the proposed rule to 94.106 in the final. This section sets out the SAA's obligation to monitor its sub-awards. Many commenters complained that the proposed two-year on-site monitoring timeframe would be too burdensome and would be difficult for large jurisdictions to implement, and may lead to unintended consequences, such as SAAs' making fewer awards but of larger dollar amounts. Commenters pointed out that many states use risk assessment tools to determine priority for on-site monitoring, and some requested that OVC make the default rule three years instead of two years. Another commenter asked that OVC clarify that SAAs may request alternative monitoring plans as well as alternative monitoring frequency.
The final rule requires SAAs to develop and implement monitoring plans based on a default of regular desk monitoring, and biennial on-site monitoring, of all sub-awards. OVC also adds a requirement that such monitoring plans contain a risk assessment plan. The rule, consistent with 2 CFR 200.331(b), (d) and (e), continues to permit SAAs to develop and implement alternative monitoring plans (
OVC renumbered this section from 94.110 in the proposed rule to 94.107 in the final rule. This section is substantively unchanged from the proposed rule, except that OVC clarifies that SAAs must certify, pursuant to VOCA, at 42 U.S.C. 10604(h), in the notification of use of training/administrative funds, that they will not use VOCA funds to supplant State or local government funding. (The substantive rules regarding supplantation are set out in the next section, section 94.108.)
Overall, this section makes the program rules match the statutory provisions, which had changed after issuance of the Guidelines. VOCA limits administrative and training costs to five percent total for the combined costs of administration and training at the SAA level.
OVC renumbered this section from 94.111 in the proposed rule, to 94.108 in the final rule, and re-titled it to more accurately reflect what the section addresses. (Proposed section 94.108(a) is moved to section 94.121 in the final rule. Proposed section 94.108(b) through (e) is moved to section 94.112 in the final rule.) Section 94.108 sets out the rules for SAA use of VOCA funds for administrative costs and prohibits supplantation of State and local government funding with VOCA funding.
One commenter asked whether the baseline is to be established and documented on a one-time basis or each year of the grant. OVC currently requires SAAs to document a baseline each fiscal
OVC renumbered this section from 94.112 in the proposed rule, to 94.109 in the final rule. (Proposed section 94.109 is moved to section 94.117 in the final rule.) Section 94.109 sets out allowable administrative costs.
Several commenters asked OVC to add a category for “activities that impact the delivery and quality of services to crime victims throughout the state,” including training managers of victim service agencies, State-wide victim notification systems, and support for victims' rights compliance programs. OVC has added these activities. (OVC notes that direct service funding also may be used to support victim notification systems as well.) Direct service provider manager training is allowed, but categorized as a training expense under section 94.110. Several commenters expressed concern that allowing program evaluation would divert funding from direct services. OVC notes that the provision does not require evaluation, but merely allows it; furthermore, the total amount of funding for administrative costs is already capped by VOCA.
OVC renumbered this section from 94.113 in the proposed rule, to 94.110 in the final rule. (Proposed section 94.110 is moved to section 94.107 in the final rule.) This section sets out allowable uses of training funds.
A commenter asked OVC to clarify that the allowable training costs are not limited by the two listed examples. In response, OVC edited the text to clearly state that such costs “generally include, but are not limited to” the two listed examples; these are merely examples and not limitations. Commenters also asked OVC to clarify that SAAs may use training funds to train managers and board members of victim service agencies, as is permitted under the current Guidelines. OVC has added this to the final rule. Several commenters asked OVC to raise the percentage limits on administrative and training costs; as these are statutory requirements, however, OVC has no authority to do so.
Sections 94.111 through 94.115 of the final rule set out the requirements that an entity must meet to be an “eligible crime victim assistance program.” (Sections 94.111 through 94.114 of the proposed rule are moved to section 94.108, 94.109, 94.110, and 94.116, respectively, of the final rule. Section 94.115(a) through (d) of the proposed rule is moved to section 94.112 of the final rule; and 94.115(e) of the proposed rule is moved to section 94.117 of the final rule. The responses to comments addressing those provisions of the proposed rule are found in the discussions of the corresponding sections as set forth in the final rule.)
Several commenters suggested that OVC reorganize the rule such that the requirements for eligibility as a sub-recipient entity versus the requirements for operating a sub-recipient project, are clearly delineated. OVC agrees, and has created a new heading “Sub-Recipient Program Requirements” and moved the requirements in the proposed rule section 94.104
VOCA establishes the criteria for an “eligible crime victim assistance program,” and the final rule merely provides clarifying interpretation needed for practical implementation. Section 94.111 of the final rule sets out the basic principle that the SAA may fund only eligible programs, and contains a provision requiring compliance with additional SAA criteria and reporting requirements. Several commenters asked that OVC strengthen language (in proposed section 94.115(d)) requiring sub-recipients to follow reporting requirements of the SAA. OVC has done so in section 94.111.
This section sets out the general types of eligible entities, and special considerations for specific types of entities (moved from proposed section 94.108), as well as criteria for determining the organizational capacity of the entity's program.
In section 94.112(a)(3) of the final rule, OVC modifies the proposed provision (proposed section 94.108(e)) on victim assistance organizations located in an adjacent state to eliminate unnecessarily bureaucratic requirements in the Guidelines, while keeping the requirement to provide notice to the SAA where the organization is located, and encouraging co-ordination on various award oversight matters. Several commenters asked for clarification of the rules for SAA programs operating direct services projects with VOCA funds (proposed section 94.108(d)). In response, OVC has modified section 94.112(a)(4) of the final rule to clarify these points by eliminating confusing and redundant text that reiterated the statutory requirement that SAAs use no more than five percent of VOCA funds for administrative and training costs.
With regard to determining the organizational capacity of a sub-recipient, under section 94.112(b) of the final rule, the SAA determines what constitutes “a record of effective services to victims of crime,” and this may vary depending on the State, and community served, and the entity providing services. Though this provision is reworded slightly for clarity, OVC leaves unchanged in the final rule the non-exclusive list of considerations that SAAs may take into account when making this determination. The SAA should be able to articulate the basis for its determination, should OVC request it. SAAs may also consider additional factors, such as the type of victim the entity's services address, the type of services provided, best practices within that service field, and the characteristics of the entity (
Commenters urged OVC to make it clear that the mandated use-of-volunteers provision, at section 94.115(a) of the proposed rule, applies as an eligibility requirement for sub-recipient organizations (programs), not as a requirement for individual projects. OVC agrees with the commenters that the use-of-volunteers provision applies to programs, not individual projects, and has thus placed the final rule provision addressing waiver of this
Commenters asked that OVC clarify proposed section 94.115(c), to state that a sub-recipient may comply with the VOCA requirement to assist victims in applying for compensation by providing referrals. OVC agrees and has made this clarification in section 94.113(d) of the final rule.
A commenter asked that OVC add additional requirements to the VOCA mandate that sub-recipients assist victims in applying for victim compensation by requiring that sub-recipients also assist victims in understanding their State and federal rights, how to assert those rights, and what to do if their rights are not considered or denied. OVC has not added such a mandate, as these are not eligibility criteria mandated by VOCA, but OVC does encourage all victim assistance organizations to assist victims in understanding their rights, or providing referrals to organizations that can do so, where appropriate. A commenter asked that OVC clarify that victim assistance programs should also assist victims of federal crime in applying for compensation. OVC agrees, and has added language accordingly.
OVC received several comments on proposed section 94.104(h) (now section 94.114 of the final rule), which stated “The VOCA non-discrimination provisions specified at 42 U.S.C. 10604(e) shall be implemented in accordance with 28 CFR part 42, and guidance from the Office for Civil Rights within the Office of Justice Programs.” Several commenters advocated that OVC add explicit regulatory language prohibiting discrimination based on sexual orientation and gender identity to the final rule and offered several reasons why such a provision would benefit victims. OVC acknowledges that people who identify as lesbian, gay, bisexual, transgender, or questioning/queer (“LGBTQ”) suffer disproportionately from violence and its effects, and often do not have access to informed services to help them recover in the aftermath of a crime. However, because OVC did not include in the proposed rule a definition that discrimination based on sex includes discrimination based on sexual orientation, and because OVC anticipates that the law will continue to evolve on this issue, OVC declines to include such language at this time. OVC will continue to monitor legal developments in this area. With respect to gender identity, the Department of Justice has concluded that statutory prohibitions on discrimination on the basis of sex encompass discrimination based on gender identity in other contexts. See,
Several commenters noted that OVC had not included a provision regarding confidentiality in the proposed rule, and suggested that OVC add such a provision. The commenters noted that the 2013 reauthorization of the Violence Against Women Act contained a provision, 42 U.S.C. 13935(b)(2), that many VOCA-funded organizations would have to comply with as a condition of their VAWA funding, and suggested that OVC model its provision on that. OVC agrees and has done this in section 94.115 of the final rule.
OVC renumbered section 94.114 of the proposed rule as section 94.116 of the final rule, under the heading “Sub-Recipient Project Requirements” instead of “Sub-Recipient Program Requirements.” (Section 94.116 of the proposed rule is moved to section 94.118 of the final rule.) This section sets forth a brief statement of the purpose of VOCA sub-awards. The proposed provision was confusing, and OVC has attempted to draft the statement more clearly in the final rule.
Additionally, the requirement in the Guidelines (sec. IV.B.11) that sub-recipients must provide services to victims of federal crimes on the same basis as to victims of crimes under State or local law is added to the final rule, as it was inadvertently omitted from the proposed rule but is a long-standing principle applicable to federal victim assistance funding. The final rule also sets forth OVC's policy clarification that victim eligibility for direct services under the VOCA Assistance Program is not dependent on the victim's immigration status. This principle derives from the nature of services provided by most VOCA-funded victim service providers in light of the Personal Responsibility Work Opportunity Reconciliation Act of 1996, and was communicated to all VOCA Assistance (and Compensation) SAAs in a June 28, 2010, OVC Director Memorandum.
This section sets forth the rules for VOCA-funded projects that will charge for victim services. (Section 94.117 of the proposed rule is moved to section 94.119 of the final rule.) OVC has long held that VOCA-funded victim services should be free of charge for victims where possible, although it recognizes that in some situations a service provider may be justified in charging for services or otherwise generating program income.
The provisions in section 94.117 of the final rule are adapted from sections 94.115(e) and 94.109 of the proposed rule. A commenter suggested that this section be moved to a new division setting out VOCA project requirements; OVC has done this. Commenters also suggested that OVC re-word the provision to be more direct. OVC has done this, as well. OVC also simplified the provision to state that program income must be used consistently with Federal grant rules and the DOJ Grants Financial Guide (available on the Office of Justice Programs' Web site, at
A commenter requested that OVC add a requirement that sub-recipients provide proof or certification of compliance with the program income requirements when seeking reimbursement from State compensation programs. OVC declines to add such a requirement to this rule, as this type of requirement is more appropriately created in the application requirements and collateral source verification procedures for victim compensation programs, or as an arrangement among State agencies.
This section is renumbered from 94.116 in the proposed rule to 94.118 in the final rule, and moved under the “Sub-recipient Project Requirements” heading, as commenters correctly pointed out that match is applicable to the VOCA project, not the program. (Section 94.118 of the proposed rule is moved to section 94.120 of the final rule.)
Some commenters suggested eliminating match all together, while others suggested various different levels for match. OVC has kept a match
Some commenters recommended that OVC consider allowing match at the State level, rather than on a sub-recipient by sub-recipient basis, as this would bring VOCA grant rules into harmony with match requirements under other programs (
A commenter asked that OVC modify the proposed requirement that match be used for the same uses and timing as the project's VOCA funding. OVC declines to do so, as this rule is long-standing and consistent with similar rules that apply to other OVC and federal awards. OVC does note, however, that non-cash contributions—for example, professional services—may be counted as match.
Commenters also questioned why Native American and Alaskan Native sub-recipients and projects on tribal lands, as well as projects in U.S. territories and possessions (excluding Puerto Rico), are not required to provide match. Some commenters asked OVC to keep the 5% match for tribes, while other commenters asked that OVC keep the rule as proposed. OVC has found that these communities often lack victim services, have great victim service needs, and are more often likely to have difficulty meeting match requirements. Match serves the purpose of encouraging collaboration among service providers, and creating a local stake in project outcomes, but it also can present a barrier to applying for VOCA assistance funding in tribal and territorial communities that have relatively few victim service organizations, and have not traditionally been supported by resources available to organizations operating in states. Not requiring match as a default for such communities is designed to streamline application requirements in these areas where, in OVC's experience, the benefits of a match requirement are outweighed by its burdens. OVC agrees that other areas of the country may face similar circumstances, and, therefore, the final rule provides that OVC will consider exceptions to match upon SAA request, and sets forth generally how OVC will evaluate such requests.
This section is renumbered from 94.117 in the proposed rule to 94.119 in the final rule. (Section 94.119 of the proposed rule is moved to section 94.121 of the final rule.) This section sets forth allowable direct service costs for VOCA projects. Most of these allowable costs (and the parameters under which the direct services may be provided) are essentially the same as those in the existing Guidelines and in the proposed rule, but there are some differences, which are discussed below.
The commenter also asked that OVC clarify that all services provided by VOCA-funded projects are voluntary and should not be contingent upon the client participating in certain support services. OVC is unclear what support services the commenter refers to and so declines to make a change to the rule based on this comment but notes that there are existing rules in place (
Many of the comments opined that the proposed provision on allowable legal assistance was either too broad or too narrow in what it allowed. One commenter asked that OVC state expressly that legal services for divorce, child support, criminal defense, and tort lawsuits are not appropriate uses of VOCA funding. Other commenters asked that OVC clarify that criminal defense services may be appropriate where it is directly related to intimate partner violence.
OVC has clarified the rule to state expressly which costs are unallowable—those for criminal defense and tort lawsuits. This clarification makes the program consistent with the OVW Legal Assistance for Victims program (many organizations receive both OVC and OVW funding), which also does not fund criminal defense or tort lawsuits, and also creates a bright-line rule that is more easily administered. OVC notes that some jurisdictions allow victims to file a motion to vacate and/or expunge certain convictions based on their status of being victims. OVC has clarified that such services are allowable with VOCA
Many commenters wanted OVC to expand its examples of allowable legal assistance costs in the proposed rule to include specific examples relevant to the organization commenting. On the other hand, some commenters expressed concern that some organizations may misinterpret the examples in the proposed rule as limits. OVC has carefully considered these comments and, in the final rule, has opted to move most of the examples into the preamble of the rule. OVC will issue supplementary guidance as may be needed to further clarify the applicability of the rule in specific factual scenarios.
The following are examples (which are merely illustrative, and not meant to be a comprehensive listing) of some circumstances where civil legal services may be appropriate: Proceedings for protective/restraining orders or campus administrative protection/stay-away orders; family, custody, contract, housing, and dependency matters, particularly for victims of intimate partner violence, child abuse, sexual assault, elder abuse, and human trafficking; immigration assistance for victims of human trafficking, sexual assault, and domestic violence; intervention with creditors, law enforcement (
The final rule does not include the provision in proposed section 94.117(a)(8)(iv), which would have disallowed VOCA funding used to supplant other funding available for forensic interviews, including criminal justice funding. OVC believes that providing States additional flexibility to meet this important victim need (which, if unsupported, may lead to re-traumatization of the victim) outweighs potential concerns that victim service funding will supplant law enforcement funding for this activity.
A commenter cautioned that forensic interviews should be conducted by child advocacy center forensic interviewers who have training and adhere to the National Child Advocacy Center guidelines. OVC believes this comment is well intentioned, but notes that not all victims needing specialized forensic interviews are children—for example, some victims are adults with disabilities. Moreover, the Federal Bureau of Investigation and some States use alternative standards. Therefore, OVC defers to SAAs to determine what organizations appropriately may provide this service.
In this final rule, OVC simply removes the prohibition on perpetrator rehabilitation and counseling, as the prohibition unnecessarily prevents States and communities from fully leveraging all available resources to provide services to these victims, who have been shown to have a great need for such services. States and VOCA-funded sub-recipients may set eligibility criteria for their victim service projects, and thereby determine, in accordance with VOCA and this rule, whether and how such victims might be served by VOCA-funded projects. Correspondingly, OVC does not include any provision under allowable costs addressing services to incarcerated victims, as the costs permitted for direct services to incarcerated victims are the same as those permitted for such services to any crime victim.
OVC received a wide range of comments on this provision. Many were supportive of the removal of the prohibition on providing services to incarcerated victims. Some commenters wanted OVC to affirmatively encourage States to permit sub-grantees to use VOCA funding for such services. Some commenters expressed the sentiment that the prison system should be responsible for addressing victim services for incarcerated persons, in the same way that it provides medical care and other services. OVC agrees that the government agencies that oversee detention/correctional facilities have responsibilities for the care of victims within their custody, but believes that prohibiting VOCA-funded organizations from providing services to incarcerated victims deprives such victims of, and communities of, experienced victim service resources. Indeed, such organizations are often the only organizations able to provide such services in some communities.
A commenter noted that the restriction causes agencies routinely to deny services to incarcerated victims but provides the exact same services for the exact same crime to those assaulted just outside the facility. OVC recognizes that victim service resources are finite, but believes that States are best positioned to make resource allocation decisions. Removing the prohibition on serving incarcerated victims will allow States to serve all victims better and more efficiently leverage the expertise of victim service organizations.
Several commenters expressed concern that the proposed rule may trigger the Prison Rape Elimination Act (PREA) provision requiring a reduction or reallocation of federal funding available to a State for “prison purposes” if the State fails to certify compliance with the Department's National Standards to Prevent, Detect, and Respond to Prison Rape.
The final rule, in response to these concerns, does not require that services to incarcerated victims must be provided, or how such services should be provided, but merely removes the express prohibition on such services that existed in the Guidelines. As noted in section 94.103 of the final rule, SAAs have sole discretion to determine what organizations will receive funds, and in what amounts, subject to the minimum requirements of this final rule and VOCA. Nothing in VOCA, or this final rule, allows VOCA funding to be diverted to “prison purposes;” rather, VOCA funding is expressly limited by statute to victim services and associated activities. A letter issued to State governors by OVC and OVW on February 11, 2014, did not list any VOCA programs as being available for prison purposes.
For example, shelters for victims of domestic violence or human trafficking would be allowable uses of VOCA funds. Similarly, it would be allowable in the case of sexual assault, where a victim needs to move. To the extent SAAs choose to permit VOCA funds to be used for transitional housing purposes, OVC anticipates that these agencies would focus on those victims with the most need.
Some commenters liked the proposed rules on transitional housing and relocation, while others opposed them. A commenter noted that VOCA-funded programs may not have the experience or resources to monitor housing programs. OVC recognizes that some SAAs will not have such experience, but the rule merely
One commenter wanted OVC to clarify that state limits on types of victims eligible for transitional housing assistance must not violate VOCA non-discrimination provisions. OVC agrees that States may not violate the non-discrimination provision when prescribing limits on allowable costs for transitional housing. The commenter also requested that OVC define “dependent child” to include dependents of all LGBTQ survivors. OVC strongly agrees that dependents of LGBTQ victims should be eligible for such assistance to the same extent as dependents of non-LGBTQ victims, if such assistance is provided. The VOCA rule establishes the basic rules for State administration of VOCA funds, however, and prescribing detailed rules for eligibility for particular types of assistance projects, as the commenter suggests, is beyond the scope of the rule.
A commenter suggested that OVC add language setting out factors that States should consider when setting limits on transitional housing expenses. OVC declines to include these in the rule, but notes that States may choose to consider the factors mentioned, which include the availability of affordable alternative and rental housing; other sources of support and housing for the victim, such as Section 8 housing vouchers in the immediate locale of the victim; and waiting lists for Section 8 housing in the area.
A commenter suggested that OVC use OVW's transitional housing program as a model. OVC is not setting detailed parameters for transitional housing costs in this rule. To the extent they find the OVW model is useful, the final rule allows States to follow that model.
A commenter requested that OVC advise States to use their VOCA Compensation funds to meet transitional housing needs, before accessing VOCA Assistance funding for this purpose. OVC notes that it does not anticipate States using VOCA Assistance funding to create new programs for transitional housing, though this would be permissible. Instead, OVC anticipates that States may allow VOCA-funded service providers to expand the range of services offered to victims, and supported by the VOCA subaward, to include transitional housing. OVC further notes that each State Compensation program determines coverage of crimes and expenses for its jurisdiction. Therefore, some State Compensation programs may not cover transitional housing needs. OVC wishes to allow States the flexibility to access either VOCA Assistance or Compensation funding for transitional housing related needs, as would best serve victims and is permissible in their jurisdictions, and therefore declines to recommend that States access VOCA Compensation funds prior to accessing VOCA Assistance funds.
Additionally, the final rule omits the reference in the proposed rule to providing “mortgage assistance”, due to the complicated nature of administering such assistance. Thus, under the final rule, while relocation expenses are allowable, mortgage expenses are not allowable.
OVC renumbered this section from 94.118 in the proposed rule to 94.120 in the final rule, setting forth allowable activities that support direct services.
One commenter asked (with regard to co-ordination activities, automated systems and technology, and volunteer trainings) whether these are allowable as stand-alone projects that may be funded by a State, or whether they must be part of a direct service project. OVC intends that these may be funded by a State in either manner. If they are funded as stand-alone activities, however, they should be activities that leverage resources for direct victim services (
A commenter requested that OVC add coalitions to support and assist victims to the list of allowable activities, and OVC has done this.
The final rule provides that a victim's opportunity to withdraw must be inherent in any restorative justice effort supported by program funds, whereas the Guidelines had merely included this as one of several criteria that SAAs should consider when deciding whether to fund such efforts. Lastly, the Guidelines included as another criteria the benefit or therapeutic value to the victim, while the final rule requires that SAAs also consider the costs in relation to the benefit or therapeutic value to the victim, as restorative justice efforts can be expensive and those costs may not be justified under certain circumstances.
Section 94.121 of the final rule sets out allowable sub-recipient administrative costs. These are substantively the same as those in the existing Guidelines, and as in proposed section 94.119.
A commenter noted that there was a discrepancy in the proposed rule, in that training costs were allowed for non-VOCA-funded service providers, but travel costs to attend trainings were
Several commenters suggested that evaluation costs in section 94.121(j) should be capped at a percentage of the grant. OVC believes that evaluation is an important part of improving victim services by developing data-driven improvements to programs and does not cap evaluation costs in the rule. OVC does note that the rule does not prevent SAAs from capping such costs (on a State-wide or project-by-project basis, as appropriate), or limiting such costs to amounts that are reasonable given State goals and funding constraints.
OVC has renumbered proposed 94.120 as section 94.122 of the final rule, setting forth expressly unallowable project costs. Most of these provisions are the same as those in the existing Guidelines, and the proposed rule, with the following exceptions:
In the Guidelines, and the proposed rule at 94.120(f), liability insurance on buildings, and body guards (which OVC understands to mean security guards, as it is listed as a capital expense), were not allowable. OVC removes these from the list of unallowable costs in the final rule, as these costs may be allowable under the revised government-wide grant rules in 2 CFR part 200, if appropriately allocated to an award either directly or indirectly.
In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Office for Victims of Crime has reviewed this regulation and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. The OVC Victim Assistance Program distributes funding to States pursuant to the VOCA formula, a statutory provision, which is not affected by this regulation. The VOCA formula sets out the allocation of grant funds among States, and designates the States that will receive grant funds—the regulation alters neither the allocation of Federal funding, nor the designation of which States will receive annual funding pursuant to that allocation. Moreover, VOCA affords substantial latitude to the States in determining where to allocate the formula funding within each jurisdiction. This rule, to the extent that it creates certain set asides and permissible areas of emphasis for State victim assistance programs, only applies to federally provided funding. As a rule governing a Federal grant program to States and major U.S. territories, the only economic impact on small entities is that of potential financial assistance, as the rule would not apply to any entity that was not a recipient of VOCA funding under this program. This regulation, therefore, will not have a significant economic impact on a substantial number of small entities.
This rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), Principles of Regulation, and in accordance with Executive Order 13563 “Improving Regulation and Regulatory Review” section 1(b), General Principles of Regulation.
The Office of Justice Programs has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget.
Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitative values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
The rule merely clarifies and updates the existing Guidelines, but does not alter the existing program structure at all. Updating the existing Guidelines to clearly and accurately reflect the statutory parameters will facilitate State compliance with VOCA requirements, and thus avoid potentially costly non-compliance findings. The rule makes some substantive changes to the existing Guidelines, but most of these would be of a permissive, not restrictive or mandatory, nature. Some changes, like allowing more flexibility to co-ordinate and leverage community resources, and adopt alternative monitoring strategies, would impose no costs but will potentially allow States to use existing funding more efficiently. Other changes that allow States to allocate funding to services not presently allowable could change the allocation of VOCA funding among victim services provided by sub-recipient organizations, and among victim service organizations. Such reallocations of funding, however, are not mandated and each State would make the ultimate decision with regard to whether to change its current funding allocations, if it chooses to do so at all. This is not a change from the present discretion that States have to allocate funding according to State priorities. Any potential reallocations would be relatively minor (even when taken in aggregate across States) in comparison to the overall mix of allowable victim services, and thus they are unlikely to create new costs or significant fund transfers. In any event, the benefits of additional services for underserved and un-served victims are significant.
The provision allowing alternative risk-based monitoring procedures imposes no new costs on States that choose to retain their existing procedures, but will allow States that wish to implement more cost effective alternatives to do so.
The elimination of match for American Indian and Alaskan Native tribes and projects on tribal lands will permit victim service organizations in these communities, many of which do not have the resources to provide matching funds, the ability to more easily seek VOCA funding for victim services. This will benefit victims in these communities, many of whom are underserved. This change is unlikely to impose new costs on States, as there is no requirement that the administering agencies fund American Indian or Alaskan Native tribes or organizations at a particular level, and the amount of funding allocated to these organizations historically is a very small percentage of overall VOCA funding.
All of the changes to the provisions governing allowable and unallowable costs are in the nature of granting States
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government, as the rule only affects the eligibility for, and use of, federal funding under this program. The rule will not impose substantial direct compliance costs on State and local governments, or preempt any State laws. Therefore, in accordance with Executive Order No. 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
This rule meets the applicable standards set forth in sections 3(a) & (b)(2) of Executive Order No. 12988. Pursuant to section 3(b)(1)(I) of the Executive Order, nothing in this or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the Program that is the subject of this rule is intended to create any legal or procedural rights enforceable against the United States, except as the same may be contained within subpart B of part 94 of title 28 of the Code of Federal Regulations.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. The VOCA Victim Assistance Program is a formula grant program that provides funds to States to provide financial support to eligible crime victim assistance programs. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign- based companies in domestic and export markets.
This rule does not propose any new, or changes to existing, “collection[s] of information” as defined by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
OVC sets forth a requirement, in section 94.105 of the final rule that SAAs update their subgrant award report information within 30 days of a change in such information. This requirement does not change the overall burden of the subgrant award report, which is estimated to take approximately three minutes to complete. It merely provides a reasonable timeframe for updating information that changes during a grant period. As the report contains only high level summary data, not detailed budget data, OVC estimates that the burden of requiring updates of this report throughout the grant period will be minimal.
Administrative practice and procedure, Formula grant program, Victim assistance.
Accordingly, for the reasons set forth in the preamble, Title 28, part 94, of the Code of Federal Regulations is amended as follows:
42 U.S.C. 10603, 10603c, 10604(a), 10605.
(a)
(b)
(c)
(d)
As used in this subpart:
(1) Respond to the emotional, psychological, or physical needs of crime victims;
(2) Assist victims to stabilize their lives after victimization;
(3) Assist victims to understand and participate in the criminal justice system; or
(4) Restore a measure of security and safety for the victim.
(a)
(b)
(1) Priority will be given to programs providing assistance to victims of sexual assault, spousal abuse, or child abuse;
(2) Funds will be made available to programs serving underserved victims;
(3) VOCA funds awarded to the State, and by the State to eligible crime victim assistance programs, will not be used to supplant State and local government funds otherwise available for crime victim assistance.
(c)
(d)
(e)
(f)
(g)
(a)
(b)
(1) Sexual assault,
(2) Spousal abuse and
(3) Child abuse.
(c)
(d)
(e)
(2) SAAs are encouraged to award funds through a competitive process, when feasible. Typically, such a process entails an open solicitation of applications and a documented determination, based on objective criteria set in advance by the SAA (or pass-through entity, as applicable).
(f)
(a)
(b)
(c)
(1) Promptly notify OVC of any formal allegation or finding of fraud, waste, abuse, or similar misconduct involving VOCA funds;
(2) Promptly refer any credible evidence of such misconduct to the Department of Justice Office of the Inspector General; and
(3) Apprise OVC, in timely fashion, of the status of any on-going investigations
(a)
(b)
(c)
(a)
(b)
(c)
(d)
(e)
(a)
(b)
(1) Establish and document a baseline level of non-VOCA funding required to administer the State victim assistance program, based on SAA expenditures for administrative costs during that fiscal year and the previous fiscal year, prior to expending VOCA funds for administration; and
(2) Submit the certification required by 42 U.S.C. 10604(h), which, as of July 8, 2016, requires an SAA to certify here that VOCA funds will not be used to supplant State funds, but will be used to increase the amount of such funds that would, in the absence of VOCA
(a) Funds for administration may be used only for costs directly associated with administering a State's victim assistance program. Where allowable administrative costs are allocable to both the crime victim assistance program and another State program, the VOCA grant may be charged no more than its proportionate share of such costs. SAAs may charge a federally-approved indirect cost rate to the VOCA grant, provided that the total amount charged does not exceed the amount prescribed by VOCA for training and administration.
(b) Costs directly associated with administering a State victim assistance program generally include the following:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
VOCA funds may be used only for training activities that occur within the award period, and all funds for training must be obligated prior to the end of such period. Allowable training costs generally include, but are not limited to, the following:
(a) Statewide/regional training of personnel providing direct assistance and allied professionals, including VOCA funded and non-VOCA funded personnel, as well as managers and Board members of victim service agencies; and
(b) Training academies for victim assistance.
SAAs may award VOCA funds only to crime victim assistance programs that meet the requirements of VOCA, at 42 U.S.C. 10603(b)(1), and this subpart. Each such program shall abide by any additional criteria or reporting requirements established by the SAA.
(a)
(1)
(2)
(3)
(4)
(b)
(1)
(2)
(a)
(b)
(c)
(d)
(a) The VOCA non-discrimination provisions specified at 42 U.S.C. 10604(e) shall be implemented in accordance with 28 CFR part 42.
(b) In complying with VOCA, at 42 U.S.C. 10604(e), as implemented by 28 CFR part 42, SAAs and sub-recipients shall comply with such guidance as may be issued from time to time by the Office for Civil Rights within the Office of Justice Programs.
(a)
(1) Any personally identifying information or individual information collected in connection with VOCA-funded services requested, utilized, or denied, regardless of whether such information has been encoded, encrypted, hashed, or otherwise protected; or
(2) Individual client information, without the informed, written, reasonably time-limited consent of the person about whom information is sought, except that consent for release may not be given by the abuser of a minor, incapacitated person, or the abuser of the other parent of the minor. If a minor or a person with a legally appointed guardian is permitted by law to receive services without a parent's (or the guardian's) consent, the minor or person with a guardian may consent to release of information without additional consent from the parent or guardian.
(b)
(c)
(1) Non-personally identifying data in the aggregate regarding services to their clients and non-personally identifying demographic information in order to comply with reporting, evaluation, or data collection requirements;
(2) Court-generated information and law-enforcement-generated information contained in secure governmental registries for protection order enforcement purposes; and
(3) Law enforcement- and prosecution-generated information necessary for law enforcement and prosecution purposes.
(d)
(1) A crime victim be required to provide a consent to release personally identifying information as a condition of eligibility for VOCA-funded services;
(2) Any personally identifying information be shared in order to comply with reporting, evaluation, or data-collection requirements of any program;
(e)
VOCA funds shall be available to sub-recipients only to provide direct services and supporting and administrative activities as set out in this subpart. SAAs shall ensure that VOCA sub-recipients obligate and expend funds in accordance with VOCA and this subpart. Sub-recipients must provide services to victims of federal crimes on the same basis as to victims of crimes under State or local law. Sub-recipients may provide direct services regardless of a victim's participation in the criminal justice process. Victim eligibility under this program for direct services is not dependent on the victim's immigration status.
(a)
(b)
(a)
(b)
(1) Sub-recipients that are federally-recognized American Indian or Alaska Native tribes, or projects that operate on tribal lands;
(2) Sub-recipients that are territories or possessions of the United States (except for the Commonwealth of Puerto
(3) Sub-recipients other than those described in paragraphs (b)(1) and (2) of this section, that have applied (through their SAAs) for, and been granted, a full or partial waiver from the Director. Waiver requests must be supported by the SAA and justified in writing. Waivers are entirely at the Director's discretion, but the Director typically considers factors such as local resources, annual budget changes, past ability to provide match, and whether the funding is for new or additional activities requiring additional match versus continuing activities where match is already provided.
(c)
(1)
(2)
(3)
(4)
(5)
(d)
(e)
(f)
Direct services for which VOCA funds may be used include, but are not limited to, the following:
(a)
(1) Crisis intervention services;
(2) Accompanying victims to hospitals for medical examinations;
(3) Hotline counseling;
(4) Safety planning;
(5) Emergency food, shelter, clothing, and transportation;
(6) Short-term (up to 45 days) in-home care and supervision services for children and adults who remain in their own homes when the offender/caregiver is removed;
(7) Short-term (up to 45 days) nursing-home, adult foster care, or group-home placement for adults for whom no other safe, short-term residence is available;
(8) Window, door, or lock replacement or repair, and other repairs necessary to ensure a victim's safety;
(9) Costs of the following, on an emergency basis (
(10) Emergency legal assistance, such as for filing for restraining or protective orders, and obtaining emergency custody orders and visitation rights;
(b)
(1) Working with a victim to assess the impact of the crime;
(2) Identification of victim's needs;
(3) Case management;
(4) Management of practical problems created by the victimization;
(5) Identification of resources available to the victim;
(6) Provision of information, referrals, advocacy, and follow-up contact for continued services, as needed; and
(7) Traditional, cultural, and/or alternative therapy/healing (
(c)
(d)
(e)
(1) Advocacy on behalf of a victim;
(2) Accompanying a victim to offices and court;
(3) Transportation, meals, and lodging to allow a victim who is not a witness to participate in a proceeding;
(4) Interpreting for a non-witness victim who is deaf or hard of hearing, or with limited English proficiency;
(5) Providing child care and respite care to enable a victim who is a caregiver to attend activities related to the proceeding;
(6) Notification to victims regarding key proceeding dates (
(7) Assistance with Victim Impact Statements;
(8) Assistance in recovering property that was retained as evidence; and
(9) Assistance with restitution advocacy on behalf of crime victims.
(f)
(1) Those (other than criminal defense) that help victims assert their rights as victims in a criminal proceeding directly related to the victimization, or otherwise protect their safety, privacy, or other interests as victims in such a proceeding;
(2) Motions to vacate or expunge a conviction, or similar actions, where the jurisdiction permits such a legal action based on a person's being a crime victim; and
(3) Those actions (other than tort actions) that, in the civil context, are reasonably necessary as a direct result of the victimization;
(g)
(h)
(1) Results of the interview will be used not only for law enforcement and prosecution purposes, but also for identification of needs such as social services, personal advocacy, case management, substance abuse treatment, and mental health services;
(2) Interviews are conducted in the context of a multi-disciplinary investigation and diagnostic team, or in a specialized setting such as a child advocacy center; and
(3) The interviewer is trained to conduct forensic interviews appropriate to the developmental age and abilities of children, or the developmental, cognitive, and physical or communication disabilities presented by adults.
(i)
(j)
(k)
(l)
Supporting activities for which VOCA funds may be used include, but are not limited to, the following:
(a) Coordination
(b)
(c)
(d)
(e)
(1) Whether such procurement will enhance direct services;
(2) How any acquisition will be integrated into and/or enhance the program's current system;
(3) The cost of installation;
(4) The cost of training staff to use the automated systems and technology;
(5) The ongoing operational costs, such as maintenance agreements, supplies; and
(6) How additional costs relating to any acquisition will be supported;
(f)
(g)
(1) The safety and security of the victim;
(2) The cost versus the benefit or therapeutic value to the victim;
(3) The procedures for ensuring that participation of the victim and offenders are voluntary and that the nature of the meeting is clear;
(4) The provision of appropriate support and accompaniment for the victim;
(5) Appropriate debriefing opportunities for the victim after the meeting; and
(6) The credentials of the facilitators.
Administrative costs for which VOCA funds may be used by sub-recipients include, but are not limited to, the following:
(a)
(b)
(c)
(d)
(e)
(f)
(1) Supplies;
(2) Equipment use fees;
(3) Property insurance;
(4) Printing, photocopying, and postage;
(5) Courier service;
(6) Brochures that describe available services;
(7) Books and other victim-related materials;
(8) Computer backup files/tapes and storage;
(9) Security systems;
(10) Design and maintenance of Web sites and social media; and
(11) Essential communication services, such as web hosts and mobile device services.
(g)
(1) Completing VOCA-required time and attendance sheets and programmatic documentation, reports, and statistics;
(2) Collecting and maintaining crime victims' records;
(3) Conducting victim satisfaction surveys and needs assessments to improve victim services delivery in the project; and
(4) Funding the prorated share of audit costs.
(h)
(i)
(j)
Notwithstanding any other provision of this subpart, no VOCA funds may be used to fund or support the following:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Office of Surface Mining Reclamation and Enforcement, Interior.
Interim final rule.
Pursuant to the Federal Civil Penalties Inflation Adjustment Act
This rule is effective on August 1, 2016. Comments will be accepted until September 6, 2016.
You may submit comments by any of the following methods:
•
•
Adrienne Alsop, Office of Surface Mining Reclamation and Enforcement, South Interior Building MS-203, 1951 Constitution Avenue NW., Washington, DC 20240; Telephone (202) 208-2818.
Section 518 of SMCRA, 30 U.S.C. 1268, authorizes the Secretary of the Interior to assess civil monetary penalties (CMPs) for violations of SMCRA. The Office of Surface Mining Reclamation and Enforcement (OSMRE) regulations implementing the CMP provisions of section 518 are located in 30 CFR parts 723, 724, 845, and 846. We are adjusting CMPs in four sections—30 CFR 723.14, 724.14, 845.14, and 846.14.
On November 2, 2015, the President signed the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Public Law 114-74) (“the Act”) into law. The Act requires that Federal agencies promulgate rules to adjust the level of civil monetary penalties (“CMPs”) to account for inflation. The Act requires agencies to enact an initial “catch-up” adjustment by August 1, 2016. The Act also authorizes agencies to make subsequent annual adjustments to civil monetary penalties to account for inflation. These adjustments are aimed at maintaining the deterrent effect of civil penalties and furthering the policy goals of the statutes which authorize them.
Pursuant to SMCRA, this rule adjusts the following civil penalties:
The Office of Management and Budget (OMB) issued guidance on calculating the catch-up adjustment.
The OMB guidance defines “civil monetary penalty” as “any assessment with a dollar amount that is levied for a violation of a Federal civil statute or regulation, and is assessed or enforceable through a civil action in Federal court or an administrative proceeding.” It further instructs that a civil monetary penalty “does not include a penalty levied for violation of a criminal statute, or fees for services, licenses, permits, or other regulatory reviews.” The guidance also specifies that agencies should calculate the catch-up adjustment by determining the percent change between the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October in the calendar year of the previous adjustment (or in the year of establishment, if no adjustment has been made) and the October 2015 CPI-U. OSMRE used this guidance to identify applicable civil monetary penalties and calculate the required catch-up adjustments.
Generally, OSMRE assigns points to a violation as described in 30 CFR 723.13 and 845.13. The CMP owed is based on the number of points received, ranging from one point to seventy points. For 2016, the Act requires that OSMRE adjust the civil penalty amounts for violations of SMCRA and provides the adjustment timing. The Act instructs OSMRE to use the maximum civil penalty amount as last adjusted by a provision of law other than the Federal Civil Penalties Inflation Adjustment Act of 1990 (Public Law 104-410) (FCPIA of 1990) when calculating the 2016 civil penalty adjustment. The maximum civil penalty amounts for violations of SMCRA have not been adjusted by a provision of law other than the FCPIA of 1990 since the penalties were established in SMCRA in 1977. Because the penalties were first published in the
OSMRE directly regulates surface coal mining and reclamation activities within a State or on tribal lands if the
State regulatory programs are not required to mirror all of the penalty provisions of our regulations.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements, to the extent permitted by statute.
The Regulatory Flexibility Act (FRA) requires an agency to prepare a regulatory flexibility analysis for all rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule.
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
This rule does not impose an unfunded mandate on State, local, or tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
This rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630. A takings implication assessment is not required.
Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.
This rule complies with the requirements of Executive Order 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required.
This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501
This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of an administrative nature. (For further information see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.
This rule is not a significant energy action under the definition in Executive
We are required by Executive Orders 12866 (section 1 (b)(12)), 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use common, everyday words and clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you believe that we have not met these requirements, send us comments by one of the methods listed in the
In developing this rule, we did not conduct or use a study, experiment, or survey requiring peer review under the Data Quality Act (Pub. L. 106-554).
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to publish interim final rules by July 1, 2016, with an effective date for the adjusted penalties no later than August 1, 2016. To comply with the Act, we are issuing these regulations as an interim final rule and are requesting comments post-promulgation. Section 553(b) of the Administrative Procedure Act (APA) provides that, when an agency for good cause finds that “notice and public procedure . . . are impracticable, unnecessary, or contrary to the public interest,” the agency may issue a rule without providing notice and an opportunity for prior public comment. 5 U.S.C. 553(b).
OSMRE finds that there is good cause to promulgate this rule without first providing for public comment. It would not be practicable to meet the deadlines imposed by the Act if we were to first publish a proposed rule, allow the public sufficient time to submit comments, analyze the comments, and publish a final rule. Also, OSMRE is promulgating this final rule to implement the statutory directive in the Act, which requires agencies to publish an interim final rule and to update the civil penalty amounts by applying a specified formula. OSMRE has no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, it would serve no purpose to provide an opportunity for pre-promulgation public comment on this rule. Thus, OSMRE finds pre-promulgation notice and public comment to be impracticable and unnecessary.
Also, OSMRE finds that there is good cause for publishing this rule less than thirty days before its effective date, since the Act requires agencies to publish interim final rules with an effective date no later than August 1, 2016. 5 U.S.C. 553(d). OSMRE has no discretion to provide for an effective date that is later than August 1, 2016.
Administrative practice and procedure, Penalties, Surface mining, Underground mining.
Administrative practice and procedure, Penalties, Surface mining, Underground mining.
Administrative practice and procedure, Law enforcement, Penalties, Reporting and recordkeeping requirements, Surface mining, Underground mining.
Administrative practice and procedure, Penalties, Surface mining, Underground mining.
For the reasons given in the preamble, the Department of the Interior amends 30 CFR parts 723, 724, 845, and 846 as set forth below.
28 U.S.C. 2461, 30 U.S.C. 1201
(b) In addition to the civil penalty provided for in paragraph (a) of this section, whenever a violation contained in a notice of violation or cessation order has not been abated within the abatement period set in the notice or order or as subsequently extended pursuant to section 521(a) of the Act, 30 U.S.C. 1271(a), a civil penalty of not less than $2,372 will be assessed for each day during which such failure to abate continues, except that:
28 U.S.C. 2461, 30 U.S.C. 1201
(b) The penalty will not exceed $17,395 for each violation. * * *
28 U.S.C. 2461, 30 U.S.C. 1201
(b) In addition to the civil penalty provided for in paragraph (a) of this section, whenever a violation contained in a notice of violation or cessation order has not been abated within the abatement period set in the notice or order or as subsequently extended pursuant to section 521(a) of the Act, a civil penalty of not less than $2,372 will be assessed for each day during which such failure to abate continues, except that:
28 U.S.C. 2461, 30 U.S.C. 1201
(b) The penalty will not exceed $17,395 for each violation. * * *
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Metro-North Devon Bridge across the Housatonic River, mile 3.9, at Stratford, Connecticut. This deviation is necessary to allow the bridge owner to perform timber ties replacement and steel repairs at the bridge.
This deviation is effective from 8 a.m. on September 6, 2016 to 8 a.m. on September 19, 2016.
The docket for this deviation, [USCG-2016-0633] is available at
If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email
The Metro-North Devon Bridge, mile 3.9, across the Housatonic River, has a vertical clearance in the closed position of 19 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.207(b).
The waterway is transited by seasonal recreational vessels.
The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform timber ties replacement and steel repairs at the bridge.
Under this temporary deviation, the Metro-North Devon Bridge will operate according to the schedule below:
a. From 8 a.m. on September 6, 2016 through 4 a.m. on September 9, 2016, the bridge will not open to marine traffic.
b. From 4 a.m. on September 9, 2016 through 8 a.m. on September 12, 2016, the bridge will open fully on signal upon 24 hr advance notice.
c. From 8 a.m. on September 12, 2016 through 4 a.m. on September 16, 2016, the bridge will not open to marine traffic.
d. From 4 a.m. on September 16, 2016 through 8 a.m. on September 19, 2016, the bridge will open fully on signal upon 24 hr advance notice.
Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving elements of State Implementation Plan (SIP) submissions from New Hampshire regarding the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 sulfur dioxide National Ambient Air Quality Standards (NAAQS). EPA is also updating the classification for two of New Hampshire's air quality control regions for sulfur dioxide based on recent air quality monitoring data collected by the state. Last, we are conditionally approving certain elements of New Hampshire's submittal relating to prevention of significant deterioration requirements.
The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.
This final rule is effective on August 8, 2016.
EPA has established a docket for this action under Docket ID Number EPA-R01-OAR-2012-0950. All documents in the docket are listed in the
Donald Dahl, (617) 918-1657, or by email at
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Organization of this document. The following outline is provided to aid in locating information in this preamble.
On June 22, 2010 (75 FR 35520), EPA promulgated a revised NAAQS for the 1-hour primary SO
On September 13, 2013, the New Hampshire Department of Environmental Services (NH DES) submitted a SIP revision addressing infrastructure elements specified in section 110(a)(2) of the CAA to implement, maintain, and enforce the 2010 sulfur dioxide NAAQS. On July 17, 2015 (80 FR 42446), EPA published a notice of proposed rulemaking (NPR) for the State of New Hampshire proposing approval of New Hampshire's submittal. In the NPR, EPA proposed approval of the following infrastructure elements: Section 110(a)(2)(A), (B), (C) (enforcement and minor new source review), (D)(i)(II) (Visibility Protection), (D)(ii) (International Pollution Abatement), (E)(i) and (ii), (F), (G), (H), (J) (consultation, public notification, and visibility protection), (K), (L), and (M), or portions thereof. EPA also proposed to approve the PSD program relating to infrastructure elements (C)(ii), D(i)(II), D(ii), and (J)(iii), except to conditionally approve the aspect of the PSD program relating to notification to neighboring states. Within the same NPR, EPA also proposed taking similar action on New Hampshire's infrastructure SIP submittals for the 2008 lead, 2008 ozone, and the 2010 nitrogen dioxide standards. EPA has already finalized its action on the infrastructure SIPs for the 2008 lead, 2008 ozone, and the 2010 nitrogen dioxide standards (80 FR 78139, December 16, 2015).
In New Hampshire's September 13, 2013 infrastructure SIP for the SO
The rationale supporting EPA's proposed rulemaking action, including the scope of infrastructure SIPs in general, is explained in the published NPR. The NPR is available in the docket for this rulemaking at
EPA received comments from the Sierra Club on the August 17, 2015 proposed rulemaking action on New Hampshire's 2010 SO
The Commenter states the main objective of the infrastructure SIP process “is to ensure that all areas of the country meet the NAAQS” and states that nonattainment areas are addressed through “nonattainment SIPs.” The Commenter asserts the NAAQS “are the foundation upon which air emissions limitations and standards for the entire country are set,” including specific emission limitations for most large stationary sources, such as coal-fired power plants. The Commenter discusses the CAA's framework whereby states have primary responsibility to assure air quality within the state, which the states carry out through SIPs such as infrastructure SIPs required by section 110(a)(2). The Commenter also states that on its face the CAA requires infrastructure SIPs “to prevent exceedances of the NAAQS.” In support, the Commenter quotes the language in section 110(a)(1), which requires states to adopt a plan for implementation, maintenance, and enforcement of the NAAQS, and the language in section 110(a)(2)(A), which requires SIPs to include enforceable emissions limitations as may be necessary to meet the requirements of the CAA, which the Commenter claims includes attainment and maintenance of the NAAQS. The Commenter also notes the use of the word “attain” in section 110(a)(2)(H)(ii) and suggests this is further evidence that the emission limits provided for in section 110(a)(2)(A) must ensure attainment of the NAAQS.
EPA interprets infrastructure SIPs as more general planning SIPs, consistent with the CAA as understood in light of its history and structure. When Congress enacted the CAA in 1970, it did not include provisions requiring states and the EPA to label areas as attainment or nonattainment. Rather, states were required to include all areas of the state in “air quality control regions” (AQCRs) and section 110 set forth the core substantive planning provisions for these AQCRs. At that time, Congress anticipated that states would be able to address air pollution quickly pursuant to the very general planning provisions in section 110 and could bring all areas into compliance with a new NAAQS within five years. Moreover, at that time, section 110(a)(2)(A)(i) specified that the section 110 plan provide for “attainment” of the NAAQS and section 110(a)(2)(B) specified that the plan must include “emission limitations, schedules, and timetables for compliance with such limitations, and such other measures as may be necessary to insure attainment and maintenance [of the NAAQS].”
In 1977, Congress recognized that the existing structure was not sufficient and many areas were still violating the NAAQS. At that time, Congress for the first time added provisions requiring states and EPA to identify whether areas of a state were violating the NAAQS (
Thus, section 110 of the CAA is only one provision of the complicated overall structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and must be interpreted in the context of that structure and the historical evolution of that structure. In light of the revisions to section 110 since 1970 and the later promulgated and more specific planning requirements of the CAA, EPA reasonably interprets the requirement in section 110(a)(2)(A) of the CAA that the plan provide for “implementation, maintenance and enforcement” to mean that the SIP must contain enforceable emission limits that will aid in attaining and/or maintaining the NAAQS and that the state demonstrate that it has the necessary tools to implement and enforce a NAAQS, such as adequate state personnel and an enforcement program. EPA has interpreted the requirement for emission limitations in section 110 to mean that a state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. Finally, as EPA has stated in the 2013 Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2) (“2013 Infrastructure SIP Guidance”), which specifically provides guidance to states in addressing the 2010 SO
In
The decision in
At issue in
Two of the other cases the Commenter cites,
EPA does not believe any of these court decisions addressed required measures for infrastructure SIPs and believes nothing in the opinions addressed whether infrastructure SIPs need to contain measures to ensure attainment and maintenance of the NAAQS.
Although EPA was explicit that it was not establishing requirements interpreting the provisions of new “Part D” of the CAA, it is clear the regulations being restructured and consolidated were intended to address control strategy plans. In the preamble, EPA clearly stated that 40 CFR 51.112 was
The Commenter contends that the New Hampshire 2010 SO
The requirements for emission reduction measures for an area designated nonattainment for the 2010 primary SO
For the area designated nonattainment in New Hampshire in August 2013, the attainment SIP was due by April 4, 2015 and must contain a demonstration that the area will attain the 2010 SO
As noted in EPA's preamble for the 2010 SO
In conclusion, EPA disagrees with the Commenter's statements that EPA must disapprove New Hampshire's infrastructure SIP submission because it does not establish specific enforceable SO
In acting to approve or disapprove an infrastructure SIP, EPA is not required to make findings regarding current air quality status of areas within the state, such area's projected future air quality status, or whether existing emissions limits in such area are sufficient to meet a NAAQS in the area. The attainment planning process detailed in part D of the CAA, including sections 172 and 191-192 attainment SIPs, is the appropriate place for the state to evaluate measures needed to bring in-state nonattainment areas into attainment with a NAAQS and to impose additional emission limitations such as SO
EPA had initially recommended that states submit substantive attainment demonstration SIPs based on air quality modeling in the final 2010 SO
The Commenter, citing administrative law principles regarding consideration of comments provided during a rulemaking process,
While EPA does not believe that infrastructure SIP submissions are
While EPA does agree that the averaging time is a critical consideration for purposes of substantive SIP revisions, such as attainment demonstrations, the averaging time of existing rules in the SIP is not relevant for determining that the State has met the applicable requirements of section 110(a)(2) with respect to the infrastructure elements addressed in the present SIP action.
Because New Hampshire did not make a submission in its September 13, 2013 SIP submittal to address the requirements of section 110(a)(2)(D)(i)(I), EPA is not required to have proposed or to take final SIP approval or disapproval action on this element under section 110(k) of the CAA. In this case, there has been no substantive submission for EPA to evaluate under section 110(k). Nor does the lack of a submission addressing section 110(a)(2)(D)(i)(I) require EPA to disapprove New Hampshire's September 13, 2013 SIP submittal as to the other elements of section 110(a)(2). EPA interprets its authority under section 110(k)(3) of the CAA as affording EPA the discretion to approve, or conditionally approve, individual elements of New Hampshire's infrastructure SIP submissions, separate and apart from any action with respect to the requirements of section 110(a)(2)(D)(i)(I) of the CAA. EPA views discrete infrastructure SIP requirements in section 110(a)(2), such as the requirements of 110(a)(2)(D)(i)(I), as severable from the other infrastructure elements and interprets section 110(k)(3) as allowing it to act on individual severable measures in a plan submission.
On August 21, 2012, the D.C. Circuit issued a decision in
Pursuant to CAA section 110(c)(1), EPA is authorized and obligated to promulgate a FIP, if EPA takes any of the following actions: (1) Finds that a state has failed to make a required SIP submission; (2) finds that a required submission was incomplete; or (3) disapproves a required SIP submission in whole or in part. With respect to the 2010 SO
EPA is approving a SIP submission from New Hampshire certifying the state's current SIP is sufficient to meet the required infrastructure elements under sections 110(a)(1) and (2) for the 2010 SO
In the above table, the key is as follows:
Additionally, we are updating the classification of two air quality control regions in New Hampshire at 40 CFR 52.1521. The classification of the Androscoggin Valley Interstate control region is being revised from Priority 1A to Priority III and the Merrimack Valley—Southern New Hampshire Interstate control region is being revised from Priority I to Priority III based on recent air quality monitoring data collected by the state.
EPA is conditionally approving an aspect of New Hampshire's SIP revision submittals pertaining to the state's PSD program. The outstanding issue with the PSD program concerns the lack of a requirement that neighboring states be notified of the issuance of a PSD permit by the New Hampshire Department of Environmental Services. On September 25, 2015, we conditionally approved New Hampshire's PSD program for this reason. See 80 FR 57722. Accordingly, we are also conditionally approving this aspect of New Hampshire's infrastructure SIP revisions for the 2010 SO
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 6, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur dioxides.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(a) * * *
(11) 2010 Sulfur Dioxide NAAQS: The 110(a)(2) infrastructure SIP submitted on September 13, 2013, is conditionally approved for Clean Air Act (CAA) elements 110(a)(2)(C)(ii), (D)(i)(II), D(ii), and (J)(iii) only as it relates to the aspect of the PSD program pertaining to providing notification to neighboring states of certain permitting activity being considered by New Hampshire. This conditional approval is contingent upon New Hampshire taking actions to address these requirements as detailed within a final conditional approval dated September 25, 2015.
(e) * * *
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking.
The United States, Canada and Mexico have agreed to liberalize provisions of the North American Free Trade Agreement (NAFTA) preference rules of origin that relate to certain goods, including certain spices. However, such liberalization cannot take effect unless U.S. Customs and Border Protection (CBP) amends its regulations to allow the NAFTA preference override to apply to certain spice products and other food products. This document proposes such an amendment.
Comments must be received on or before September 6, 2016.
You may submit comments, identified by docket number, by
•
•
Monika Brenner, Chief, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade, (202) 325-0038.
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rulemaking. Comments that will provide the most assistance to CBP will reference a specific portion of the proposed rulemaking, explain the reason for any recommended change, and include data, information, or authority that support such recommended change. See
On December 17, 1992, the United States, Canada, and Mexico (the parties) entered into the North American Free Trade Agreement (NAFTA). The provisions of the NAFTA were adopted by the United States with enactment of the North American Free Trade Agreement Implementation Act, Public Law 103-182, 107 Stat. 2057 (December 8, 1993). Under Article 401 of the NAFTA, an imported good qualifies as an originating good of a NAFTA party if: (1) It is wholly obtained or produced in one or more of the NAFTA parties; (2) it is produced entirely in one or more of the NAFTA parties exclusively from materials that originate in those parties; or (3) each of the non-originating materials used in the production of the good undergoes an applicable change in tariff classification as a result of production occurring entirely in the territory of one or more of the parties and satisfies any other applicable requirement (which may include a regional value-content requirement). The NAFTA preference change in tariff classification (or “tariff-shift”) rules are set forth in General Note 12(t) of the Harmonized Tariff Schedule of the United States (HTSUS).
General Note 12(a), HTSUS, provides that an imported good is eligible for preferential tariff treatment under the NAFTA only if it is an originating good of a NAFTA party
Thus in certain instances § 102.19 allows the originating status of a good to “override” a determination that it is not a good of Canada or Mexico. In other words, it allows NAFTA preferential tariff treatment to be granted to certain goods that otherwise would be ineligible for such treatment due to the General Note 12(a)'s requirement that originating goods qualify to be marked as goods of Canada or Mexico under the NAFTA Marking Rules. However, under § 102.19, as it currently reads, minor processing would not be a type of production that would qualify a good to be labeled as a product of the country in which the labeling took place and thus would not enable the good to take advantage of NAFTA tariff preferences.
Since the NAFTA entered into effect, the three parties to the Agreement have agreed to liberalizations to the NAFTA preference rules of origin for various goods. As a result, a lesser degree of processing in a NAFTA party is required to constitute “production” which will confer originating status to certain non-NAFTA materials. The United States took steps to implement these changes by amending the NAFTA preference tariff-shift rules in General Note 12(t), HTSUS, through Presidential Proclamations 7870 dated February 9, 2005 (published in the
For spices and certain other food products, Presidential Proclamation 7870 specifically liberalized various rules of origin in General Note 12(t) to permit minor processing operations in a NAFTA party, such as packaging, to confer originating status on a good. For example, the NAFTA preference rule for tea (heading 0902, HTSUS) was changed to permit blending and/or packaging to confer NAFTA originating status. Similarly, changes to the preference rules of origin for products such as peppers (subheading 0904.12, HTSUS), cloves (heading 0907, HTSUS), poppy seeds (subheading 1207.91, HTSUS), and certain other spices were also liberalized by Proclamation 7870 to allow these goods to become NAFTA originating as a result of packaging operations in a NAFTA party. It is noted that blending is considered to be more than a minor processing operation for purposes of the NAFTA Marking Rules.
However, contrary to the intentions of the NAFTA parties, these goods are not receiving NAFTA preferential tariff treatment when imported into the United States from Canada or Mexico because they do not qualify to be marked as goods of Canada or Mexico under the NAFTA Marking Rules in 19 CFR part 102, as required by General Note 12(a), HTSUS. This anomalous result stems, in part, from the fact that, in regard to those goods that obtain originating status as a result of minor processing in a NAFTA party, the pertinent NAFTA marking rules in 19 CFR 102.20 are more stringent than the comparable liberalized NAFTA preference rules set forth in General Note 12(t), HTSUS. As discussed above, the NAFTA preference override provision in § 102.19(a) fails to resolve this problem since, as discussed above, this provision overrides a determination that a good is not a good of Canada or Mexico only in situations in which the good undergoes production other than minor processing, in a NAFTA country.
CBP notes that 19 CFR 102.17 provides that a foreign material will not be considered to have undergone an applicable change in tariff classification specified in § 102.20 or § 102.21 or to have met any other applicable requirements of those sections merely by reason of having been subjected to certain specified operations, including “[s]imple packing, repacking or retail packaging without more than minor processing.” This provision clearly is not an impediment to the proposed amendment set forth in this document as the “non-qualifying operations” specified in § 102.17 relate only to the application of the rules set forth in §§ 102.20 and 102.21 and not to the NAFTA preference override in § 102.19.
CBP understands that, as a result of actions taken or interpretations adopted by the Governments of Canada and Mexico, the above-referenced spices and other food products subject to the NAFTA liberalizations are receiving NAFTA preferential tariff treatment when imported from the United States into Canada and Mexico (assuming compliance with all applicable requirements). To rectify the problem discussed above with respect to imports from Canada and Mexico, CBP is proposing to amend § 102.19 by adding a new paragraph (c) to allow the NAFTA preference override to apply to these specific goods. This proposed change, if finalized, will give effect to the intentions of the NAFTA parties by extending NAFTA preferential tariff treatment to certain goods imported from Canada and Mexico that, under the liberalized rules of origin in General Note 12(t), are considered NAFTA originating as a result of minor processing operations (
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rulemaking is not a “significant regulatory action,” under section 3(f) of the Executive Order 12866. Accordingly, OMB has not reviewed this proposed rule.
This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 601
The proposed rule, if finalized, will extend NAFTA preferential tariff treatment to certain goods imported from Mexico and Canada that currently are not receiving such treatment, despite the fact that these goods presently qualify as NAFTA originating under General Note 12(t), HTSUS. Therefore, the proposed amendment would benefit importers of such goods from Canada and Mexico by eliminating the customs duties and merchandise processing fees that presently are due for these importations. To the extent that this rulemaking affects small entities, these entities would experience a cost savings. Therefore, CBP certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities.
As there is no collection of information proposed in this document, the provisions of the Paperwork Reduction Act (44 U.S.C. 3507) are inapplicable.
This document is being issued in accordance with § 0.1(a)(1) of the CBP Regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain customs revenue functions.
Canada, Customs duties and inspections, Imports, Mexico, Reporting and recordkeeping requirements, Trade agreements.
For the reasons set forth above, part 102 of title 19 of the Code of Federal Regulations (19 CFR part 102) is proposed to be amended as set forth below.
19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624, 3314, 3592.
(c) If a good classifiable under heading 0907, 0908, 0909, or subheading 0910.11, 0910.12, 0910.30, 0910.99 or 1207.91, HTSUS, is originating within the meaning of section 181.1(q) of this chapter, but is not determined under section 102.11(a) or (b) to be a good of a single NAFTA country, the country of origin of such good is the last NAFTA country in which that good underwent production, provided that a Certificate of Origin (see § 181.11 of this Chapter) has been completed and signed for the good.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations relating to the health insurance premium tax credit (premium tax credit) and the individual shared responsibility provision. These proposed regulations affect individuals who enroll in qualified health plans through Health Insurance Exchanges (Exchanges, also called Marketplaces) and claim the premium tax credit, and Exchanges that make qualified health plans available to individuals and employers. These proposed regulations also affect individuals who are eligible for employer-sponsored health coverage and individuals who seek to claim an exemption from the individual shared responsibility provision because of unaffordable coverage. Although employers are not directly affected by rules governing the premium tax credit, these proposed regulations may indirectly affect employers through the employer shared responsibility provisions and the related information reporting provisions.
Written (including electronic) comments and requests for a public hearing must be received by September 6, 2016.
Send submissions to: CC:PA:LPD:PR (REG-109086-15), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-109086-15), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Shareen Pflanz, (202) 317-4727; concerning the submission of comments and/or requests for a public hearing, Oluwafunmilayo Taylor, (202) 317-6901 (not toll-free calls).
The collection of information contained in this notice of proposed rulemaking has been submitted to the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, SE:W:CAR:MP:T:T:SP, Washington, DC 20224. Comments on the collection of information should be received by September 6, 2016. Comments are specifically requested concerning:
Whether the proposed collection of information is necessary for the proper performance of the functions of the IRS, including whether the information will have practical utility;
How the quality, utility, and clarity of the information to be collected may be enhanced;
How the burden of complying with the proposed collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology; and
Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
The collection of information in these proposed regulations is in § 1.36B-5. The collection of information is necessary to reconcile advance payments of the premium tax credit and determine the allowable premium tax credit. The collection of information is required to comply with the provisions of section 36B of the Internal Revenue Code (Code). The likely respondents are Marketplaces that enroll individuals in qualified health plans.
The burden for the collection of information contained in these proposed regulations will be reflected in the burden on Form 1095-A,
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.
Beginning in 2014, under the Patient Protection and Affordable Care Act,
The Affordable Care Act also added section 5000A to the Code. Section 5000A was subsequently amended by the TRICARE Affirmation Act of 2010, Public Law 111-159 (124 Stat. 1123 (2010)) and Public Law 111-173 (124 Stat. 1215 (2010)). Section 5000A provides that, for months beginning after December 31, 2013, a nonexempt individual must have qualifying healthcare coverage (called minimum essential coverage) or make an individual shared responsibility payment.
To be eligible for a premium tax credit, an individual must be an applicable taxpayer. Among other requirements, under section 36B(c)(1) an applicable taxpayer is a taxpayer whose household income for the taxable year is between 100 percent and 400 percent of the Federal poverty line (FPL) for the taxpayer's family size (or is a lawfully present non-citizen who has income below 100 percent of the FPL and is ineligible for Medicaid). A taxpayer's family size is equal to the number of individuals in the taxpayer's family. Under section 36B(d)(1), a taxpayer's family consists of the individuals for whom the taxpayer claims a personal exemption deduction under section 151 for the taxable year. Taxpayers may claim a personal exemption deduction for themselves, a spouse, and each of their dependents.
Under section 1412 of the Affordable Care Act, advance payments of the premium tax credit (advance credit payments) may be made directly to insurers on behalf of eligible individuals. The amount of advance credit payments made on behalf of a taxpayer in a taxable year is determined by a number of factors including projections of the taxpayer's household income and family size for the taxable year. Taxpayers who receive the benefit of advance credit payments are required to file an income tax return to reconcile the amount of advance credit payments made during the year with the amount of the credit allowable for the taxable year.
Under § 1.36B-2(b)(6), in general, a taxpayer whose household income for a taxable year is less than 100 percent of the applicable FPL is nonetheless treated as an applicable taxpayer if (1) the taxpayer or a family member enrolls in a qualified health plan, (2) an Exchange estimates at the time of enrollment that the taxpayer's household income for the taxable year will be between 100 and 400 percent of the applicable FPL, (3) advance credit payments are authorized and paid for one or more months during the taxable year, and (4) the taxpayer would be an applicable taxpayer but for the fact that the taxpayer's household income for the taxable year is below 100 percent of the applicable FPL.
Under section 36B(a), a taxpayer's premium tax credit is equal to the premium assistance credit amount for the taxable year. Section 36B(b)(1) and § 1.36B-3(d) generally provide that the premium assistance credit amount is the sum of the premium assistance amounts for all coverage months in the taxable year for individuals in the taxpayer's family. The premium assistance amount for a coverage month is the lesser of (1) the premiums for the month for one or more qualified health plans that cover a taxpayer or family member (enrollment premium), or (2) the excess of the adjusted monthly premium for the second lowest cost silver plan (as described in section 1302(d)(1)(B) of the Affordable Care Act (42 U.S.C. 18022(d)(1)(B)) offered through the Exchange for the rating area where the taxpayer resides that would provide coverage to the taxpayer's coverage family (the benchmark plan), over 1/12 of the product of the taxpayer's household income and the applicable percentage for the taxable year (the contribution amount). In general, the benchmark plan's adjusted monthly premium is the premium an insurer would charge for the plan adjusted only for the ages of the covered individuals. The applicable percentage is provided in a table that is updated annually and represents the portion of a taxpayer's household income that the taxpayer is expected to pay if the taxpayer's coverage family enrolls in the benchmark plan. See, for example, Rev. Proc. 2014-62, 2014-2 C.B. 948 (providing the applicable percentage table for taxable years beginning in 2016) and Rev. Proc. 2014-37, 2014-2 C.B. 363 (providing the applicable percentage table for taxable years beginning in 2015). A taxpayer's coverage family refers to all members of the taxpayer's family who enroll in a qualified health plan in a month and are not eligible for minimum essential coverage as defined in section 5000A(f) (other than coverage in the individual market) for that month.
Under section 1301(a)(1)(B) of the Affordable Care Act, a qualified health plan must offer the essential health benefits package described in section 1302(a). Under section 1302(b)(1)(J) of the Affordable Care Act, the essential health benefits package includes pediatric services, including oral and vision care. Section 1302(b)(4)(F) of the Affordable Care Act provides that, if an Exchange offers a plan described in section 1311(d)(2)(B)(ii)(I) of the Affordable Care Act (42 U.S.C. 13031(d)(2)(B)(ii)(I)) (a stand-alone dental plan), other health plans offered through the Exchange will not fail to be qualified health plans solely because the plans do not offer pediatric dental benefits.
For purposes of calculating the premium assistance amount for a taxpayer who enrolls in both a qualified health plan and a stand-alone dental plan, section 36B(b)(3)(E) provides that the enrollment premium includes the portion of the premium for the stand-alone dental plan properly allocable to pediatric dental benefits that are included in the essential health benefits required to be provided by a qualified health plan.
Section 36B(b)(3)(B) provides that the benchmark plan with respect to an applicable taxpayer is the second lowest cost silver plan offered by the Marketplace through which the applicable taxpayer (or a family member) enrolled and which provides (1) self-only coverage, in the case of unmarried individuals (other than a surviving spouse or head of household) who do not claim any dependents, or any other individual who enrolls in self-only coverage, and (2) family coverage, in the case of any other applicable taxpayer. Section 1.36B-1(l) provides that self-only coverage means health insurance that covers one individual. Section 1.36B-1(m) provides that family coverage means health insurance that covers more than one individual.
Under § 1.36B-3(f)(3), if there are one or more silver-level plans offered through the Exchange for the rating area where the taxpayer resides that do not cover all members of a taxpayer's
Section 1.36B-3(d)(2) provides that, if a qualified health plan is terminated before the last day of a month or an individual is enrolled in coverage effective on the date of the individual's birth, adoption, or placement for adoption or in foster care, or on the effective date of a court order, the premium assistance amount for the month is the lesser of the enrollment premiums for the month (reduced by any amounts that were refunded) or the excess of the benchmark plan premium for a full month of coverage over the full contribution amount for the month.
Under section 36B(c)(2)(A) and § 1.36B-3(c)(1), a coverage month is generally any month for which the taxpayer or a family member is covered by a qualified health plan enrolled in through an Exchange on the first day of the month and the premium is paid by the taxpayer or through an advance credit payment. However, section 36B(c)(2) provides that a month is not a coverage month for an individual who is eligible for minimum essential coverage other than coverage in the individual market. Under section 36B(c)(2)(B)(ii), minimum essential coverage is defined by reference to section 5000A(f). Minimum essential coverage includes government-sponsored programs such as most Medicaid coverage, Medicare part A, the Children's Health Insurance Program (CHIP), most TRICARE programs, most coverage provided to veterans under title 38 of the United States Code, and the Nonappropriated Fund Health Benefits Program of the Department of Defense. See section 5000A(f)(1) and § 1.5000A-2(b). Section 1.36B-2(c)(3)(i) provides that, for purposes of section 36B, the government-sponsored programs described in section 5000A(f)(1)(A) are not considered eligible employer-sponsored plans.
Under § 1.36B-2(c)(2)(i), an individual generally is treated as eligible for government-sponsored minimum essential coverage as of the first day of the first full month that the individual meets the criteria for coverage and is eligible to receive benefits under the government program. However, under § 1.36B-2(c)(2)(v) an individual is treated as not eligible for Medicaid, CHIP, or a similar program for a period of coverage under a qualified health plan if, when the individual enrolls in the qualified health plan, an Exchange determines or considers (within the meaning of 45 CFR 155.302(b)) the individual to be ineligible for such program. In addition, § 1.36B-2(c)(2)(iv) provides that if an individual receiving the benefit of advance credit payments is determined to be eligible for a government-sponsored program, and that eligibility is effective retroactively, then, for purposes of the premium tax credit, the individual is treated as eligible for the program no earlier than the first day of the first calendar month beginning after the approval.
Coverage under an eligible employer-sponsored plan is minimum essential coverage. In general, an eligible employer-sponsored plan is coverage provided by an employer to its employees (and their dependents) under a group health plan maintained by the employer.
Under section 36B(c)(2)(C) and § 1.36B-2(c)(3)(i), except as provided in the next paragraph of this preamble, an individual is treated as eligible for coverage under an eligible employer-sponsored plan only if the employee's share of the premium is affordable and the coverage provides minimum value. Under section 36B(c)(2)(C), an eligible employer-sponsored plan is treated as affordable for an employee if the amount of the employee's required contribution (within the meaning of section 5000A(e)(1)(B)) for self-only coverage does not exceed a specified percentage of the employee's household income. The affordability of coverage for individuals related to an employee is determined in the same manner. Thus, under section 36B(c)(2)(C)(i) and § 1.36B-2(c)(3)(v)(A)(2), an eligible employer-sponsored plan is treated as affordable for an individual eligible for the plan because of a relationship to an employee if the amount of the employee's required contribution for self-only coverage does not exceed a specified percentage of the employee's household income.
Under § 1.36B-2(c)(3)(v)(A)(3), an eligible employer-sponsored plan is not considered affordable if, when an individual enrolls in a qualified health plan, the Marketplace determines that the eligible employer-sponsored plan is not affordable. However, that rule does not apply for an individual who, with reckless disregard for the facts, provides incorrect information to a Marketplace concerning the employee's portion of the annual premium for coverage under the eligible employer-sponsored plan. In addition, under section 36B(c)(2)(C)(iii) and § 1.36B-2(c)(3)(vii)(A), an individual is treated as eligible for employer-sponsored coverage if the individual actually enrolls in an eligible employer-sponsored plan, even if the coverage is not affordable or does not provide minimum value.
Section 1.36B-2(c)(3)(iii)(A) provides that, subject to the rules described above, an employee or related individual may be considered eligible for coverage under an eligible employer-sponsored plan for a month during a plan year if the employee or related individual could have enrolled in the plan for that month during an open or special enrollment period. Under § 1.36B-2(c)(3)(ii), plan year means an eligible employer-sponsored plan's regular 12-month coverage period (or the remainder of a 12-month coverage period for a new employee or an individual who enrolls during a special enrollment period).
Although coverage in the individual market is minimum essential coverage under section 5000A(f)(1)(C), under section 36B(c)(2)(B)(i), an individual who is eligible for or enrolled in coverage in the individual market (whether or not obtained through the Marketplace) nevertheless may have a coverage month for purposes of the premium tax credit.
Under section 36B(c)(2)(C) and § 1.36B-2(c)(3)(v)(A)(
Section 5000A provides that, for each month, taxpayers must have minimum essential coverage, qualify for a health coverage exemption, or make an individual shared responsibility
Notice 2015-87, 2015-52 I.R.B. 889, provides guidance on determining the affordability of an employer's offer of eligible employer-sponsored coverage for purposes of sections 36B, 5000A, and 4980H (and the related information reporting under section 6056).
As Notice 2015-87 explains, the Treasury Department and the IRS have determined that it is generally appropriate to treat an opt-out payment that is made available under an unconditional opt-out arrangement in the same manner as a salary reduction contribution for purposes of determining an employee's required contribution under sections 36B and 5000A and any related consequences under sections 4980H(b) and 6056. Accordingly, Notice 2015-87 provides that the Treasury Department and the IRS intend to propose regulations reflecting this rule and to request comments on those regulations. For this purpose, an unconditional opt-out arrangement refers to an arrangement providing payments conditioned solely on an employee declining coverage under employer-sponsored coverage and not on an employee satisfying any other meaningful requirement related to the provision of health care to employees, such as a requirement to provide proof of coverage through a plan of a spouse's employer.
Notice 2015-87 also provides that the Treasury Department and the IRS anticipate requesting comments on the treatment of conditional opt-out arrangements, meaning opt-out arrangements under which payments are conditioned not only on the employee declining employer-sponsored coverage but also on satisfaction of one or more additional meaningful conditions (such as the employee providing proof of enrollment in coverage provided by a spouse's employer or other coverage).
Notice 2015-87 provides that, until the applicability date of any final regulations (and in any event for plan years beginning before 2017), individuals may treat opt-out payments made available under unconditional opt-out arrangements as increasing the employee's required contribution for purposes of sections 36B and 5000A.
Notice 2015-87 included a request for comments on opt-out arrangements. The Treasury Department and the IRS received a number of comments, and the comments are discussed in section 2.f. of this preamble entitled “
Section 36B(f)(3) provides that Exchanges must report to the IRS and to taxpayers certain information required to administer the premium tax credit. Section 1.36B-5(c)(1) provides that the information required to be reported annually includes (1) identifying information for each enrollee, (2) identifying information for the coverage, (3) the amount of enrollment premiums and advance credit payments for the coverage, (4) the premium for the benchmark plan used to calculate the amount of the advance credit payments made on behalf of the taxpayer or other enrollee, if advance credit payments were made, and the benchmark plan premium that would apply to all individuals enrolled in the coverage if advance credit payments were not made, and (5) the dates the coverage started and ended. Section 1.36B-5(c)(3)(i) provides that an Exchange must report this information for each family enrolled in the coverage.
Except as otherwise provided in this section, these regulations are proposed to apply for taxable years beginning after December 31, 2016. As indicated in
To avoid repayments of advance credit payments for taxpayers who experience an unforeseen decline in income, the existing regulations provide that if an Exchange determines at enrollment that the taxpayer's household income will be at least 100 percent but will not exceed 400 percent of the applicable FPL, the taxpayer will not lose his or her status as an applicable taxpayer solely because household income for the year turns out to be below 100 percent of the applicable FPL. To reduce the likelihood that individuals who recklessly or intentionally provide inaccurate information to an Exchange will benefit from an Exchange determination, the proposed regulations provide that a taxpayer whose household income is below 100 percent of the FPL for the taxpayer's family size is not treated as an applicable taxpayer if, with intentional or reckless disregard for the facts, the taxpayer provided incorrect information to an Exchange for the year of coverage.
Similar to the rule for taxpayers who received the benefit of advance credit payments but ended the taxable year with household income below 100 percent of the applicable FPL, the existing regulations do not require a repayment of advance credit payments for taxpayers with household income within the range for eligibility for certain government-sponsored programs if an Exchange determined or considered (within the meaning of 45 CFR 155.302(b)) the taxpayer or a member of the taxpayer's family to be ineligible for the program. To reduce the likelihood that individuals who recklessly or intentionally provide inaccurate information to an Exchange will benefit from an Exchange determination, the proposed regulations provide that an individual who was determined or considered by an Exchange to be ineligible for Medicaid, CHIP, or a similar program (such as a Basic Health Program) may be treated as eligible for coverage under the program if, with intentional or reckless disregard for the facts, the individual (or a person claiming a personal exemption for the individual) provided incorrect information to the Exchange.
The existing regulations under section 36B provide that government-sponsored programs described in section 5000A(f)(1)(A), which include the Nonappropriated Fund Health Benefits Program of the Department of Defense, established under section 349 of the National Defense Authorization Act for Fiscal Year 1995 (Public Law 103-337; 10 U.S.C. 1587 note), are not eligible employer-sponsored plans. However, § 1.5000A-2(c)(2) provides that, because the Nonappropriated Fund Health Benefits Program (Program) is offered by an instrumentality of the Department of Defense to its employees, the Program is an eligible employer-sponsored plan. The proposed regulations conform the section 36B regulations to the section 5000A regulations and provide that the Program is treated as an eligible employer-sponsored plan for purposes of determining if an individual is eligible for minimum essential coverage under section 36B. Thus, if coverage under the Program does not provide minimum value (under § 1.36B-2(c)(3)(vi)) or is not affordable (under § 36B-2(c)(3)(v)) for an individual who does not enroll in the coverage, he or she is not treated as eligible for minimum essential coverage under the Program for purposes of premium tax credit eligibility.
The existing regulations under section 36B provide that an individual is eligible for minimum essential coverage through an eligible employer-sponsored plan if the individual had the opportunity to enroll in the plan and the plan is affordable and provides minimum value. The Treasury Department and the IRS are aware that in some instances individuals may not be allowed an annual opportunity to decide whether to enroll in eligible employer-sponsored coverage. This lack of an annual opportunity to enroll in employer-sponsored coverage should not limit an individual's annual choice from available coverage options through the Marketplace with the possibility of benefitting from the premium tax credit. Thus, the proposed regulations clarify that if an individual declines to enroll in employer-sponsored coverage for a plan year and does not have the opportunity to enroll in that coverage for one or more succeeding plan years, for purposes of section 36B, the individual is treated as ineligible for that coverage for the succeeding plan year or years for which there is no enrollment opportunity.
Under section 36B and § 1.36B-2(c)(3)(vii)(A), an individual is treated as eligible for minimum essential coverage through an eligible employer-sponsored plan if the individual actually enrolls in the coverage, even if the coverage is not affordable or does not provide minimum value. Although health coverage that consists solely of excepted benefits may be a group health plan and, therefore, is an eligible employer-sponsored plan under section 5000A(f)(2) and § 1.5000A-2(c)(1), section 5000A(f)(3) provides that health coverage that consists solely of excepted benefits is not minimum essential coverage. Therefore, individuals enrolled in a plan consisting solely of excepted benefits still must obtain minimum essential coverage to satisfy the individual shared responsibility provision. The proposed regulations clarify that for purposes of section 36B an individual is considered eligible for coverage under an eligible employer-sponsored plan only if that plan is minimum essential coverage. Accordingly, an individual enrolled in or offered a plan consisting solely of excepted benefits is not denied the premium tax credit by virtue of that excepted benefits offer or coverage. Taxpayers may rely on this rule for all taxable years beginning after December 31, 2013.
Sections 1.36B-2(c)(3)(v) and 1.5000A-3(e)(3)(ii)(A) provide that, in determining whether employer-sponsored coverage is affordable to an employee, an employee's required contribution for the coverage includes the amount by which the employee's salary would be reduced to enroll in the
Notice 2015-87 requested comments on the proposed treatment of opt-out arrangements outlined in Q&A-9 of that notice. Several commenters objected to the proposal that the amount of an available unconditional opt-out payment increases the employee's required contribution on the basis that forgoing opt-out payments as part of enrolling in coverage has not traditionally been viewed by employers or employees as economically equivalent to making a salary reduction election and that such a rule would discourage employers from making opt-out payments available. None of the commenters, however, offered a persuasive economic basis for distinguishing unconditional opt-out payments from other compensation that an employee must forgo to enroll in employer-sponsored coverage, such as a salary reduction. Because forgoing an unconditional opt-out payment is economically equivalent to forgoing salary pursuant to a salary reduction election, and because §§ 1.36B-2(c)(3)(v) and 1.5000A-3(e)(3)(ii)(A) provide that the employee's required contribution includes the amount of any salary reduction, the proposed regulations adopt the approach described in Notice 2015-87 for opt-out payments made available under unconditional opt-out arrangements and provide that the amount of an opt-out payment made available to the employee under an unconditional opt-out arrangement increases the employee's required contribution.
Notice 2015-87 provides that, for periods prior to the applicability date of any final regulations, employers are not required to increase the amount of an employee's required contribution by amounts made available under an opt-out arrangement for purposes of section 4980H(b) or section 6056 (in particular Form 1095-C,
Some commenters requested clarification that an unconditional opt-out arrangement that is required under the terms of a collective bargaining agreement in effect before December 16, 2015, should be treated as having been adopted prior to December 16, 2015, and that amounts made available under such an opt-out arrangement should not be included in an employee's required contribution for purposes of sections 4980H(b) or 6056 through the expiration of the collective bargaining agreement that provides for the opt-out arrangement. The Treasury Department and the IRS now clarify that, under Notice 2015-87, for purposes of sections 4980H(b) and 6056, an unconditional opt-out arrangement that is required under the terms of a collective bargaining agreement in effect before December 16, 2015, will be treated as having been adopted prior to December 16, 2015. In addition, until the later of (1) the beginning of the first plan year that begins following the expiration of the collective bargaining agreement in effect before December 16, 2015 (disregarding any extensions on or after December 16, 2015), or (2) the applicability date of these regulations with respect to sections 4980H and 6056, employers participating in the collective bargaining agreement are not required to increase the amount of an employee's required contribution by amounts made available under such an opt-out arrangement for purposes of sections 4980H(b) or 6056 (Form 1095-C). The Treasury Department and the IRS further adopt these commenters' request that this treatment apply to any successor employer adopting the opt-out arrangement before the expiration of the collective bargaining agreement in effect before December 16, 2015 (disregarding any extensions on or after December 16, 2015). Commenters raised the issue of whether other types of agreements covering employees may need a similar extension of the relief through the end of the agreement's term. The Treasury Department and the IRS request comments identifying the types of agreements raising this issue due to their similarity to collective bargaining agreements because, for example, the agreement is similar in scope to a collective bargaining agreement, binding on the parties involved for a multi-year period, and subject to a statutory or regulatory regime.
Several commenters suggested that, notwithstanding the proposal on unconditional opt-out arrangements, the amount of an opt-out payment made available should not increase an employee's required contribution if the opt-out payment is conditioned on the employee having minimum essential coverage through another source, such as a spouse's employer-sponsored plan. These commenters argued that the amount of such a conditional opt-out payment should not affect the affordability of an employer's offer of employer-sponsored coverage for an employee who does not satisfy the applicable condition because that employee is ineligible to receive the opt-out payment. Moreover, commenters argued that an employee who satisfies the condition (that is, who has alternative minimum essential coverage) is ineligible for the premium tax credit and does not need to determine the affordability of the employer's coverage offer. Thus, the commenters asserted, an amount made available under such an arrangement should be excluded from the required contribution.
While it is clear that the availability of an unconditional opt-out payment increases an individual's required
Similarly, another way to view opt-out payments that are conditioned on alternative coverage is that, rather than raising the cost to the employee of the employer's coverage, they reduce the cost to the employee of the alternative coverage. However, because employers generally do not have information about the existence and cost of other options available to the individual, it is not practical to take into account any offer of coverage other than the offer made by the employer in determining the required contribution with respect to the employer coverage (that is, the coverage that the employee must decline to receive the opt-out payment).
While commenters indicated that the required contribution with respect to the employer coverage does not matter for an individual enrolled in any other minimum essential coverage because the individual would be ineligible for the premium tax credit, this statement is not true if the other coverage is individual market coverage. In particular, while enrollment in most types of minimum essential coverage results in an individual being ineligible for a premium tax credit, that is not the case for coverage in the individual market. Moreover, for individual market coverage offered through a Marketplace, the required contribution with respect to the employer coverage frequently will be relevant in determining whether the individual is eligible for a premium tax credit. In such cases, as in the case of an unconditional opt-out payment, the availability of a conditional opt-out payment effectively increases the cost to the individual of enrolling in the employer coverage (at least relative to Marketplace coverage).
Further, an opt-out arrangement that is conditioned on an employee's ability to obtain other coverage (if that coverage can be coverage in the individual market, whether inside or outside the Marketplace) does not generally raise the issues described earlier in this section of the preamble regarding the difficulty of ascertaining which individuals could meet the condition under a conditional opt-out arrangement. This is because generally all individuals are able to obtain coverage in the individual market, pursuant to the guaranteed issue requirements in section 2702 of the PHS Act. Thus, in the sense that all individuals can satisfy the applicable condition, such an opt-out arrangement is similar to an unconditional opt-out arrangement.
In an effort to provide a workable rule that balances these competing concerns, the proposed regulations provide that amounts made available under conditional opt-out arrangements are disregarded in determining the required contribution if the arrangement satisfies certain conditions (an “eligible opt-out arrangement”), but otherwise the amounts are taken into account. The proposed regulations define an “eligible opt-out arrangement” as an arrangement under which the employee's right to receive the opt-out payment is conditioned on (1) the employee declining to enroll in the employer-sponsored coverage and (2) the employee providing reasonable evidence that the employee and all other individuals for whom the employee reasonably expects to claim a personal exemption deduction for the taxable year or years that begin or end in or with the employer's plan year to which the opt-out arrangement applies (employee's expected tax family) have or will have minimum essential coverage (other than coverage in the individual market, whether or not obtained through the Marketplace) during the period of coverage to which the opt-out arrangement applies. For example, if an employee's expected tax family consists of the employee, the employee's spouse, and two children, the employee would meet this requirement by providing reasonable evidence that the employee, the employee's spouse, and the two children, will have coverage under the group health plan of the spouse' s employer for the period to which the opt-out arrangement applies.
The Treasury Department and the IRS invite comments on this proposed rule, including suggestions for other workable rules that result in the required contribution more accurately reflecting the individual's cost of coverage while minimizing undesirable consequences and incentives.
For purposes of the proposed eligible opt-out arrangement rule, reasonable evidence of alternative coverage includes the employee's attestation that the employee and all other members of the employee's expected tax family, if any, have or will have minimum essential coverage (other than coverage in the individual market, whether or not obtained through the Marketplace) or other reasonable evidence. Notwithstanding the evidence of alternative coverage required under the arrangement, to qualify as an eligible opt-out arrangement, the arrangement must also provide that any opt-out payment will not be made (and the payment must not in fact be made) if the employer knows or has reason to know that the employee or any other member of the employee's expected tax family does not have (or will not have) the required alternative coverage. An eligible opt-out arrangement must also require that the evidence of coverage be provided no less frequently than every plan year to which the eligible opt-out arrangement applies, and that the evidence be provided no earlier than a reasonable period before the commencement of the period of coverage to which the eligible opt-out arrangement applies. Obtaining the reasonable evidence (such as an attestation) as part of the regular annual open enrollment period that occurs within a few months before the commencement of the next plan year of employer-sponsored coverage meets this reasonable period requirement. Alternatively, the eligible opt-out arrangement would be permitted to require evidence of alternative coverage to be provided later, such as after the plan year starts, which would enable the employer to require evidence that the employee and other members of the
Commenters on Notice 2015-87 generally stated that typical conditions under an opt-out arrangement include a requirement that the employee have alternative coverage through employer-sponsored coverage of a spouse or another relative, such as a parent. Provided that, as required under the opt-out arrangement, the employee provided reasonable evidence of this alternative coverage for the employee and the other members of the employee's expected tax family, and met the related conditions described in this preamble, these types of opt-out arrangements would be eligible opt-out arrangements, and opt-out payments made available under such arrangements would not increase the employee's required contribution.
The Treasury Department and the IRS did not receive comments on opt-out arrangements indicating that the meaningful conditions imposed include any requirement other than one relating to alternative coverage. Therefore, the proposed rules do not address other opt-out conditions and would not treat an opt-out arrangement based on other conditions as an eligible opt-out arrangement. However, the Treasury Department and the IRS invite comments on whether opt-out payments are made subject to additional types of conditions in some cases, whether those types of conditions should be addressed in further guidance, and, if so, how.
One commenter suggested that, if opt-out payments conditioned on alternative coverage are not included in an employee's required contribution, rules will be needed for cases in which an employee receives an opt-out payment and that employee's alternative coverage subsequently terminates. The commenter suggested that, in that case, the termination of the alternative coverage should have no impact on the determination of the employee's required contribution for the employer-sponsored coverage from which the employee opted out. In response, under the proposed regulations, provided that the reasonable evidence requirement is met, the amount of an opt-out payment made available under an eligible opt-out arrangement may continue to be excluded from the employee's required contribution for the remainder of the period of coverage to which the opt-out payment originally applied. The opt-out payment may be excluded for this period even if the alternative coverage subsequently terminates for the employee or any other member of the employee's expected tax family, regardless of whether the opt-out payment is required to be adjusted or terminated due to the loss of alternative coverage, and regardless of whether the employee is required to provide notice of the loss of alternative coverage to the employer.
The Treasury Department and the IRS are aware that the way in which opt-out arrangements affect the calculation of affordability is important not only to an employee and the other members of the employee's expected tax family in determining whether they may be eligible for a premium tax credit or whether an individual may be exempt under the individual shared responsibility provisions, but also to an employer subject to the employer shared responsibility provisions under section 4980H in determining whether the employer may be subject to an assessable payment under section 4980H(b). An employer subject to the employer shared responsibility provisions will be subject to a payment under section 4980H(b) only with respect to a full-time employee who receives a premium tax credit, and an employee will not be eligible for the premium tax credit if the employer's offer of coverage was affordable and provided minimum value.
Some commenters requested exceptions for special circumstances from the general rule that the employee's required contribution is increased by the amount of an opt-out payment made available. These circumstances include (1) conditional opt-out payments that are required under the terms of a collective bargaining agreement and (2) opt-out payments that are below a de minimis amount. Regarding opt-out arrangements contained in collective bargaining agreements, the Treasury Department and the IRS anticipate that the proposed treatment of eligible opt-out arrangements, generally, will address the concerns raised in the comments. Accordingly, the Treasury Department and the IRS do not propose to provide a permanent exception for opt-out arrangements provided under collective bargaining agreements. Earlier in this section of the preamble, however, the Treasury Department and the IRS clarify and expand the transition relief provided under Notice 2015-87 for opt-out arrangements provided under collective bargaining agreements in effect before December 16, 2015. As for an exception for de minimis amounts, the Treasury Department and the IRS decline to adopt such an exception because there is neither a statutory nor an economic basis for establishing a de minimis threshold under which an unconditional opt-out payment would be excluded from the employee's required contribution.
Section 36B and the regulations under section 36B provide that an individual who may enroll in minimum essential coverage outside the Marketplace (other than individual market coverage) for a month is generally not allowed a premium tax credit for that month. Consequently, individuals enrolled in a qualified health plan with advance credit payments must return to the Exchange to report eligibility for other minimum essential coverage so the Exchange can discontinue the advance credit payments for Marketplace coverage. Similarly, individuals enrolled in a qualified health plan with advance credit payments may be determined eligible for coverage under a government-sponsored program, such as Medicaid. In some cases, individuals may inform the Exchange of their opportunity to enroll in other minimum essential coverage or receive approval for coverage under a government-sponsored program after the time for which the Exchange can discontinue advance credit payments for the next
Under § 1.36B-3(c)(1)(ii), a month in which an individual who is enrolled in a qualified health plan is a coverage month for the individual only if the taxpayer's share of the premium for the individual's coverage for the month is paid by the unextended due date of the taxpayer's income tax return for the year of coverage, or the premium is fully paid by advance credit payments.
One of the functions of an Exchange is to make determinations as to whether an individual who enrolls in a qualified health plan is eligible for advance credit payments for the coverage. If an Exchange determines that the individual is not eligible for advance credit payments, the individual may appeal that decision. An individual who is initially determined ineligible for advance credit payments, does not enroll in a qualified health plan under the contested determination, and is later determined to be eligible for advance credit payments through the appeals process, may elect to be retroactively enrolled in a health plan through the Exchange. In that case, the individual is treated as having been enrolled in the qualified health plan from the date on which the individual would have enrolled had he or she initially been determined eligible for advance credit payments. If retroactively enrolled, the deadline for paying premiums for the retroactive coverage may be after the unextended due date for filing an income tax return for the year of coverage. Consequently, the proposed regulations provide that a taxpayer who is eligible for advance credit payments pursuant to an eligibility appeal for a member of the taxpayer's coverage family who, based on the appeals decision, retroactively enrolls in a qualified health plan, is considered to have met the requirement in § 1.36B-3(c)(1)(ii) for a month if the taxpayer pays the taxpayer's share of the premium for coverage under the plan for the month on or before the 120th day following the date of the appeals decision. Taxpayers may rely on this rule for all taxable years beginning after December 31, 2013.
Section 1.36B-3(d)(2) provides that if a qualified health plan is terminated before the last day of a month, the premium assistance amount for the month is the lesser of the enrollment premiums for the month (reduced by any amounts that were refunded), or the excess of the benchmark plan premium for a full month of coverage over the full contribution amount for the month. Section 1.36B-3(c)(2) provides that an individual whose enrollment in a qualified health plan is effective on the date of the individual's birth or adoption, or placement for foster care, or upon the effective date of a court order, is treated as enrolled as of the first day of the month and, therefore, the month of enrollment may be a coverage month. The regulations, however, do not expressly address how the premium assistance amount is computed when a covered individual disenrolls before the last day of a month but the plan is not terminated because other individuals remain enrolled. For purposes of the premium tax credit, the premium assistance amount for an individual who is not enrolled for an entire month should be the same regardless of the circumstances causing the partial-month coverage, provided that the individual was enrolled, or is treated as enrolled, as of the first day of the month (that is, so long as the month is a coverage month). Accordingly, to provide consistency for all individuals who have a coverage month that is less than a full calendar month, the proposed regulations provide that the premium assistance amount for a month is the lesser of the enrollment premiums for the month (reduced by any amounts that were refunded), or the excess of the benchmark plan premium over the contribution amount for the month. Taxpayers may rely on this rule for all taxable years beginning after December 31, 2013.
The rules relating to the benchmark plan in this section are proposed to apply for taxable years beginning after December 31, 2018.
Under section 1311(d)(2)(B) of the Affordable Care Act, only qualified health plans, including stand-alone dental plans offering pediatric dental benefits, may be offered through a Marketplace. In general, a qualified health plan is required to provide coverage for all ten essential health benefits described in section 1302(b) of the Affordable Care Act, including pediatric dental coverage. However, under section 1302(b)(4)(F), a plan that does not provide pediatric dental benefits may nonetheless be a qualified health plan if it covers each essential health benefit described in section 1302(b) other than pediatric dental benefits and if it is offered through a Marketplace in which a stand-alone dental plan offering pediatric dental benefits is offered as well.
Section 36B(b)(3)(E) and § 1.36B-3(k) provide that if an individual enrolls in both a qualified health plan and a stand-alone dental plan, the portion of the premium for the stand-alone dental plan properly allocable to pediatric dental benefits is treated as a premium payable for the individual's qualified health plan. Thus, in determining a taxpayer's premium assistance amount for a month in which a member of the taxpayer's coverage family is enrolled in a stand-alone dental plan, the taxpayer's enrollment premium includes the portion of the premium for the stand-alone dental plan allocable to pediatric dental benefits. The existing regulations do not provide a similar adjustment for the taxpayer's applicable benchmark plan premium to reflect the cost of pediatric dental benefits in cases where the second-lowest cost silver plan does not provide pediatric dental benefits.
Section 36B(b)(3)(B) provides that the applicable benchmark plan with respect
Under the existing regulations, the references in section 36B(b)(3)(B) to plans that provide self-only coverage and family coverage are interpreted to refer to all qualified health plans offered through the applicable Marketplace, regardless of whether the coverage offered by those plans includes all ten essential health benefits. Because qualified health plans that do not offer pediatric dental benefits tend to be cheaper than qualified health plans that cover all ten essential health benefits, the second lowest-cost silver plan (and therefore the premium tax credit) for taxpayers purchasing coverage through a Marketplace in which stand-alone dental plans are offered is likely to not account for the cost of obtaining pediatric dental coverage.
The Treasury Department and the IRS believe that the current rule frustrates the statute's goal of making coverage that provides the essential health benefits affordable to individuals eligible for the premium tax credit. Accordingly, the proposed regulations reflect a modification in the interpretation of the terms “self-only coverage” and “family coverage” in section 36B(b)(3)(B) to refer to coverage that provides each of the essential health benefits described in section 1302(b) of the Affordable Care Act. This coverage may be obtained from either a qualified health plan alone or from a qualified health plan in combination with a stand-alone dental plan. In particular, self-only coverage refers to coverage obtained from such plans where the coverage family is a single individual. Similarly, family coverage refers to coverage obtained from such plans where the coverage family includes more than one individual.
Consistent with this interpretation, the proposed regulations provide that for taxable years beginning after December 31, 2018, if an Exchange offers one or more silver-level qualified health plans that do not cover pediatric dental benefits, the applicable benchmark plan is determined by ranking (1) the premiums for the silver-level qualified health plans that include pediatric dental benefits offered by the Exchange and (2) the aggregate of the premiums for the silver-level qualified health plans offered by the Exchange that do not include pediatric dental benefits plus the portion of the premium allocable to pediatric dental benefits for stand-alone dental plans offered by the Exchange. In constructing this ranking, the premium for the lowest-cost silver plan that does not include pediatric dental benefits is added to the premium allocable to pediatric dental benefits for the lowest cost stand-alone dental plan, and similarly, the premium for the second lowest-cost silver plan that does not include pediatric dental benefits is added to the premium allocable to pediatric dental benefits for the second lowest-cost stand-alone dental plan. The second lowest-cost amount from this combined ranking is the taxpayer's applicable benchmark plan premium.
Under § 1.36B-3(f), a taxpayer's applicable benchmark plan is the second lowest cost silver plan offered at the time a taxpayer or family member enrolls in a qualified health plan through the Exchange for the rating area where the taxpayer resides. Under § 1.36B-3(f)(4), if members of a taxpayer's family reside in different states and enroll in separate qualified health plans, the premium for the taxpayer's applicable benchmark plan is the sum of the premiums for the applicable benchmark plans for each group of family members living in the same state.
Referring to the residence of the taxpayer to establish the cost for a benchmark health plan is appropriate when the taxpayer and all members of the taxpayer's coverage family live in the same location because it reflects the cost of available coverage for the taxpayer's coverage family. However, because premiums and plan availability may vary based on location, the existing rule for a taxpayer whose family members reside in different locations in the same state may not accurately reflect the cost of available coverage. In addition, the rules for calculating the premium tax credit should operate the same for families residing in multiple locations within a state and families residing in multiple states. Accordingly, § 1.36B-3(f)(4) of the proposed regulations provides that if a taxpayer's coverage family members reside in multiple locations, whether within the same state or in different states, the taxpayer's benchmark plan is determined based on the cost of available coverage in the locations where members of the taxpayer's coverage family reside. In particular, if members of a taxpayer's coverage family reside in different locations, the taxpayer's benchmark plan premium is the sum of the premiums for the applicable benchmark plans for each group of coverage family members residing in different locations, based on the plans offered to the group through the Exchange for the rating area where the group resides. If all members of a taxpayer's coverage family reside in a single location that is different from where the taxpayer resides, the taxpayer's benchmark plan premium is the premium for the applicable benchmark plan for the coverage family, based on the plans offered to the taxpayer's coverage family through the Exchange for the rating area where the coverage family resides.
Section 1.36B-3(f)(3) provides that if one or more silver-level plans offered through an Exchange do not cover all members of a taxpayer's coverage family under one policy (for example, because an issuer will not cover a taxpayer's dependent parent on the same policy the taxpayer enrolls in), the premium for the applicable benchmark plan may be the premium for a single policy or for more than one policy, whichever is the second lowest-cost silver option. This rule does not specify which combinations of policies must be taken into account for this purpose, suggesting that all such combinations must be considered, which is unduly complex for taxpayers, difficult for Exchanges to implement, and difficult for the IRS to administer. Accordingly, to clarify and simplify the benchmark premium determination for situations in which a silver-level plan does not cover all the members of a taxpayer's coverage family under one policy, the proposed regulations delete the existing rule and provide a new rule in its place.
Under the proposed regulations, if a silver-level plan offers coverage to all members of a taxpayer's coverage family who reside in the same location under a single policy, the plan premium taken into account for purposes of determining the applicable benchmark plan is the premium for that policy. In contrast, if a silver-level plan would require multiple policies to cover all members of a taxpayer's coverage family who reside in the same location, the plan premium taken into account for purposes of determining the applicable benchmark plan is the sum of the premiums for self-only policies under the plan for each member of the coverage family who resides in the same location. Under the proposed regulations, similar rules would apply to the portion of premiums for stand-alone dental plans allocable to pediatric
Comments are requested on the rule contained in the proposed regulations, as well as on an alternative rule under which the plan premium taken into account for purposes of determining a taxpayer's applicable benchmark plan would be equal to the sum of the self-only policies under a plan for each member of the taxpayer's coverage family, regardless of whether all members of the taxpayer's coverage family could be covered under a single policy under the plan.
Section 1.36B-3(f)(5) provides that if a qualified health plan is closed to enrollment for a taxpayer or a member of the taxpayer's coverage family, that plan is disregarded in determining the taxpayer's applicable benchmark plan. Similarly, § 1.36B-3(f)(6) provides that a plan that is the applicable benchmark plan for a taxpayer does not cease to be the applicable benchmark plan solely because the plan or a lower cost plan terminates or closes to enrollment during the taxable year. Because stand-alone dental plans are considered in determining a taxpayer's applicable benchmark plan under the proposed regulations, the proposed regulations provide consistency in the treatment of qualified health plans and stand-alone dental plans that are closed to enrollment or that terminate during the taxable year.
In general, § 1.36B-3(f)(1) provides that a taxpayer's applicable benchmark plan is the second lowest-cost silver-level plan available to the taxpayer for self-only or family coverage. However, for taxpayers who reside in certain locations, only one silver-level plan providing such coverage may be available. Section 1.36B-3(f)(8) of the proposed regulations clarifies that if there is only one silver-level qualified health plan offered through the Exchange that would cover all members of the taxpayer's coverage family (whether under one policy or multiple policies), that silver-level plan is used for purposes of the taxpayer's applicable benchmark plan. Similarly, if there is only one stand-alone dental plan offered through the Exchange that would cover all members of the taxpayer's coverage family (whether under one policy or multiple policies), the portion of the premium of that plan that is allocable to pediatric dental benefits is used for purposes of determining the taxpayer's applicable benchmark plan.
Section 301.6011-8 provides that a taxpayer who receives the benefit of advance credit payments must file an income tax return for that taxable year on or before the due date for the return (including extensions of time for filing) and reconcile the advance credit payments. In addition, the regulations under section 36B provide that if advance credit payments are made for coverage of an individual for whom no taxpayer claims a personal exemption deduction, the taxpayer who attests to the Exchange to the intention to claim a personal exemption deduction for the individual as part of the determination that the taxpayer is eligible for advance credit payments for coverage of the individual must reconcile the advance credit payments.
Questions have been raised concerning how these two rules apply, and consequently which individual must reconcile advance credit payments, when a taxpayer (a parent, for example) attests that he or she will claim a personal exemption deduction for an individual, the advance payments are made with respect to coverage for the individual, the taxpayer does not claim a personal exemption deduction for the individual, and the individual does not file a tax return for the year. The intent of the existing regulation is that the taxpayer, not the individual for whose coverage advance credit payments were made, must reconcile the advance credit payments in situations in which a taxpayer attests to the intention to claim a personal exemption for the individual and no one claims a personal exemption deduction for the individual. Consequently, the proposed regulations clarify that if advance credit payments are made for coverage of an individual for whom no taxpayer claims a personal exemption deduction, the taxpayer who attests to the Exchange to the intention to claim a personal exemption deduction for the individual, not the individual for whose coverage the advance credit payments were made, must file a tax return and reconcile the advance credit payments.
Section 1.36B-3(h) provides that if a qualified health plan covers more than one family under a single policy (for example, a plan covers a taxpayer and the taxpayer's child who is 25 and not a dependent of the taxpayer), the premium tax credit is computed for each applicable taxpayer covered by the plan. In addition, in computing the tax credit for each taxpayer, premiums for the qualified health plan the taxpayers purchase (the enrollment premiums) are allocated to each taxpayer in proportion to the premiums for each taxpayer's applicable benchmark plan.
The existing regulations provide that the Exchange must report the enrollment premiums for each family, but do not specify the manner in which the Exchange must divide the enrollment premiums among the families enrolled in the policy. Consequently, the proposed regulations clarify that when multiple families enroll in a single qualified health plan and advance credit payments are made for the coverage, the enrollment premiums reported by the Exchange for each family is the family's allocable share of the enrollment premiums, which is based on the proportion of each family's applicable benchmark plan premium.
The existing regulations do not specify how the enrollment premiums and benchmark plan premiums are reported in cases in which one or more individuals is enrolled or disenrolled in coverage mid-month. To ensure that this reporting is consistent with the rules for calculating the premium assistance amounts for partial months of coverage, the proposed regulations provide that, if an individual is enrolled in a qualified health plan after the first day of a month, generally no value should be reported for the individual's enrollment premium or benchmark plan premium for that month. However, if an individual's coverage in a qualified health plan is terminated before the last day of a month, or an individual is enrolled in coverage after the first day of a month and the coverage is effective on the date of the individual's birth, adoption, or placement for adoption or in foster care, or on the effective date of a court order, an Exchange must report the premium for the applicable benchmark plan for a full month of coverage (excluding the premium allocated to benefits in excess of essential health benefits). In addition, the proposed regulations provide that the Exchange must report the enrollment premiums for the month (excluding the premium allocated to benefits in excess of essential health benefits), reduced by any amount that was refunded due to the plan's termination.
Section 301.6011-2(b) provides that if the use of certain forms, including the Form 1095 series, is required by the applicable regulations or revenue procedures for the purpose of making an information return, the information required by the form must be submitted on magnetic media. Form 1095-A should not have been included in § 301.6011-2 because Form 1095-A is not an information return. Consequently, the proposed regulations replace the general reference in § 301.6011-2(b) to the forms in the 1095 series with specific references to Forms 1095-B and 1095-C, but not Form 1095-A.
Except as otherwise provided, these regulations are proposed to apply for taxable years beginning after December 31, 2016. In addition, taxpayers may rely on certain provisions of the proposed regulations for taxable years ending after December 31, 2013, as indicated earlier in this preamble. In addition, rules relating to the benchmark plan described in section 4 of this preamble are proposed to apply for taxable years beginning after December 31, 2018.
Notwithstanding the proposed applicability date, nothing in the proposed regulations is intended to limit any relief for opt-out arrangements provided in Notice 2015-87, Q&A 9, or in section 2.f of the preamble to these proposed regulations (regarding opt-out arrangements provided for in collective bargaining agreements). For purposes of sections 36B and 5000A, although under the proposed regulations amounts made available under an eligible opt-out arrangement are not added to an employee's required contribution, for periods before the final regulations are applicable and, if later, through the end of the most recent plan year beginning before January 1, 2017, an individual who can demonstrate that he or she meets the condition for an opt-out payment under an eligible opt-out arrangement is permitted to treat the opt-out payment as increasing the employee's required contribution.
For purposes of the consequences of these regulations under sections 4980H and 6056 (and in particular Form 1095-C), the regulations regarding opt-out arrangements are proposed to be first applicable for plan years beginning on or after January 1, 2017,
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.
It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that the information collection required under these regulations is imposed under section 36B. Consistent with the statute, the proposed regulations require a person that provides minimum essential coverage to an individual to file a return with the IRS reporting certain information and to furnish a statement to the responsible individual who enrolled an individual or family in the coverage. These regulations merely provide the method of filing and furnishing returns and statements under section 36B. Moreover, the proposed regulations attempt to minimize the burden associated with this collection of information by limiting reporting to the information that the IRS requires to verify minimum essential coverage and administer tax credits.
Based on these facts, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required.
Pursuant to section 7805(f) of the Code, this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are submitted timely to the IRS as prescribed in this preamble under the
The principal authors of these proposed regulations are Shareen S. Pflanz and Stephen J. Toomey of the Office of Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the IRS and the Treasury Department participated in the development of the regulations.
Income taxes, Reporting and recordkeeping requirements.
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR parts 1 and 301 are proposed to be amended as follows:
26 U.S.C. 7805 * * *
The revisions and additions read as follows:
(b) * * *
(6) * * *
(i) In general.
(ii) Exceptions.
(c) * * *
(3) * * *
(v) * * *
(A) * * *
(
(
(
(
(
(
(
(
(4) Special eligibility rules.
(i) Related individuals not claimed as a personal exemption deduction.
(ii) Exchange unable to discontinue advance credit payments.
(A) In general.
(B) Medicaid or CHIP.
(c) * * *
(4) Appeals of coverage eligibility.
(d) * * *
(1) Premium assistance amount.
(2) Examples.
(f) * * *
(3) Silver-level plan not covering pediatric dental benefits.
(4) Family members residing in different locations.
(5) Single or multiple policies needed to cover the family.
(i) Policy covering a taxpayer's family.
(ii) Policy not covering a taxpayer's family.
(6) Plan not available for enrollment.
(7) Benchmark plan terminates or closes to enrollment during the year.
(8) Only one silver-level plan offered to the coverage family.
(9) Effective date.
(10) Examples.
(c) * * *
(3) * * *
(iii) Partial month of coverage.
(A) In general.
(B) Certain mid-month enrollments.
(l)
(m)
(o)
(b) * * *
(6)
(A) The taxpayer or a family member enrolls in a qualified health plan through an Exchange for one or more months during the taxable year;
(B) An Exchange estimates at the time of enrollment that the taxpayer's household income will be at least 100 percent but not more than 400 percent of the Federal poverty line for the taxable year;
(C) Advance credit payments are authorized and paid for one or more months during the taxable year; and
(D) The taxpayer would be an applicable taxpayer if the taxpayer's household income for the taxable year was at least 100 but not more than 400 percent of the Federal poverty line for the taxpayer's family size.
(ii)
(c) * * *
(2) * * *
(v) * * * This paragraph (c)(2)(v) does not apply for an individual who, with intentional or reckless disregard for the facts, provides incorrect information to an Exchange for the year of coverage. A reckless disregard of the facts occurs if the taxpayer makes little or no effort to determine whether the information provided to the Exchange is accurate under circumstances that demonstrate a substantial deviation from the standard of conduct a reasonable person would observe. A disregard of the facts is intentional if the taxpayer knows that information provided to the Exchange is inaccurate.
(3) * * *
(i)
(iii) * * *
(A)
(v) * * *
(A) * * *
(
(
(
(
(
(
(
(
Taxpayer B is an employee of Employer X, which offers its employees coverage under an eligible employer-sponsored plan that requires B to contribute $3,000 for self-only coverage. X also makes available to B a payment of $500 if B declines to enroll in the eligible employer-sponsored plan. Therefore, the $500 opt-out payment made available to B under the opt-out arrangement increases B's required contribution under X's eligible employer-sponsored plan from $3,000 to $3,500, regardless of whether B enrolls in the eligible employer-sponsored plan or declines to enroll and is paid the opt-out payment.
The facts are the same as in
The facts are the same as in
Taxpayer D is married and is employed by Employer Z, which offers its employees coverage under an eligible employer-sponsored plan that requires D to contribute $2,000 for self-only coverage. Z also makes available to D a payment of $300 if D declines to enroll in the eligible employer-sponsored plan and provides reasonable evidence no earlier than the regular annual open enrollment period for the next plan year that D is or will be enrolled in minimum essential coverage through another source (other than coverage in the individual market, whether or not obtained through the Marketplace); the opt-out arrangement is not conditioned on whether the other members of D's expected tax family have other coverage. This opt-out arrangement is not an eligible opt-out arrangement because it does not condition the right to receive the opt-out payment on D providing reasonable evidence that D and the other members of D's expected tax family have (or will have) minimum essential coverage (other than coverage in the individual market, whether or not obtained through the Marketplace). Therefore, the $300 opt-out payment made available to D under the opt-out arrangement increases D's required contribution under Z's eligible employer-sponsored plan. D's required contribution for self-only coverage under Z's eligible employer-sponsored plan is $2,300.
(4)
(ii)
(B)
(e)
(2) Paragraph (b)(6)(ii), the last three sentences of paragraph (c)(2)(v), paragraph (c)(3)(i), paragraph (c)(3)(iii)(A), the last three sentences of paragraph (c)(3)(v)(A)(
(c) * * *
(4)
(d) * * *
(1)
(i) The premiums for the month, reduced by any amounts that were refunded, for one or more qualified health plans in which a taxpayer or a member of the taxpayer's family enrolls (enrollment premiums); or
(ii) The excess of the adjusted monthly premium for the applicable benchmark plan (benchmark plan premium) over 1/12 of the product of a taxpayer's household income and the applicable percentage for the taxable year (the taxpayer's contribution amount).
(2)
Taxpayer Q is single and has no dependents. Q enrolls in a qualified health plan with a monthly premium of $400. Q's monthly benchmark plan premium is $500, and his monthly contribution amount is $80. Q's premium assistance amount for a coverage month is $400 (the lesser of $400, Q's monthly enrollment premium, and $420, the difference between Q's monthly benchmark plan premium and Q's contribution amount).
(i) Taxpayer R is single and has no dependents. R enrolls in a qualified health plan with a monthly premium of $450. The difference between R's benchmark plan premium and contribution amount for the month is $420. R's premium assistance amount for a coverage month is $420 (the lesser of $450 and $420).
(ii) The issuer of R's qualified health plan is notified that R died on September 20. The issuer terminates coverage as of that date and refunds the remaining portion of the September enrollment premiums ($150) for R's coverage.
(iii) Under paragraph (d)(1) of this section, R's premium assistance amount for September is the lesser of the enrollment premiums for the month, reduced by any amounts that were refunded ($300 ($450 − $150)) or the difference between the benchmark plan premium and the contribution amount for the month ($420). R's premium assistance amount for September is $300, the lesser of $420 and $300.
The facts are the same as in Example 2 of this paragraph (d)(2), except that the qualified health plan issuer does not refund any enrollment premiums for September. Under paragraph (d)(1) of this section, R's premium assistance amount for September is $420, the lesser of $450 and $420.
(f)
(i) Self-only coverage for a taxpayer—
(A) Who computes tax under section 1(c) (unmarried individuals other than surviving spouses and heads of household) and is not allowed a deduction under section 151 for a dependent for the taxable year;
(B) Who purchases only self-only coverage for one individual; or
(C) Whose coverage family includes only one individual; and
(ii) Family coverage for all other taxpayers.
(2)
(3)
(i) The silver-level qualified health plans that provide pediatric dental benefits offered by the Exchange to the members of the coverage family;
(ii) The lowest-cost silver-level qualified health plan that does not provide pediatric dental benefits offered by the Exchange to the members of the coverage family in conjunction with the lowest-cost portion of the premium for a stand-alone dental plan (within the meaning of section 1311(d)(2)(B)(ii) of the Affordable Care Act (42 U.S.C. 13031(d)(2)(B)(ii)) offered through the Exchange to the members of the coverage family that is properly allocable to pediatric dental benefits determined under guidance issued by the Secretary of Health and Human Services; and
(iii) The second-lowest-cost silver-level qualified health plan that does not provide pediatric dental benefits offered by the Exchange to the members of the coverage family in conjunction with the second-lowest-cost portion of the premium for a stand-alone dental plan (within the meaning of section 1311(d)(2)(B)(ii) of the Affordable Care Act (42 U.S.C. 13031(d)(2)(B)(ii)) offered through the Exchange to the members of the coverage family that is properly allocable to pediatric dental benefits determined under guidance issued by the Secretary of Health and Human Services.
(4)
(5)
(ii)
(6)
(7)
(8)
(9)
(ii) The monthly premiums, and the portion of the premium allocable to pediatric dental benefits, for the two dental plans are as follows:
(iii) Under paragraph (f)(3) of this section, D's applicable benchmark plan is the second lowest cost option among the following offered by the rating area in which D resides: silver-level qualified health plans providing pediatric dental benefits ($1,250 for S1 and $1,200 for S2); the lowest-cost silver-level qualified health plan not providing pediatric dental benefits, in conjunction with the lowest-cost portion of the premium for a stand-alone dental plan properly allocable to pediatric dental benefits ($1,180 for S3 in conjunction with $25 for DP1 = $1,205); and the second lowest cost silver-level qualified health plan not providing pediatric health benefits, in conjunction with the second lowest-cost portion of the premium for a stand-alone dental plan allocable to pediatric dental benefits ($1,180 for S3 in conjunction with $40 for DP2 = $1,220). Under paragraph (f)(8) of this section, S3, as the lone silver-level qualified health plan not providing pediatric dental benefits offered by the Exchange, is treated as the second lowest-cost silver-level qualified health plan not providing pediatric dental benefits. Under paragraph (e) of this section, the adjusted monthly premium for D's applicable benchmark plan is $1,205.
(ii) Because no one in D's coverage family is eligible for pediatric dental benefits, $0 of the premium for a stand-alone dental plan is allocable to pediatric dental benefits in determining A's applicable benchmark plan. Consequently, under paragraphs (f)(1), (f)(2), and (f)(3) of this section, D's applicable benchmark plan is the second lowest-cost option among the following options offered by the rating area in which D resides: silver-level qualified health plans providing pediatric dental benefits ($1,210 for S1 and $1,190 for S2), the lowest-cost silver-level qualified health plan not providing pediatric dental benefits, in conjunction with the lowest-cost portion of the premium for a stand-alone dental plan properly allocable to pediatric dental benefits ($1,180 for S3 in conjunction with $0 for DP1 = $1,180), and the second lowest cost silver-level qualified health plan not providing pediatric health benefits, in conjunction with the second lowest-cost portion of the premium for a stand-alone dental plan allocable to pediatric dental benefits ($1,180 for S3 in conjunction with $0 for DP2 = $1,180). Under paragraph (e) of this section, the adjusted monthly premium for D's applicable benchmark plan is $1,180.
(ii) Under paragraph (f)(4) of this section, because the members of N's coverage family reside in different locations, the monthly premium for N's applicable benchmark plan is the sum of $1,000, the monthly premiums for the applicable benchmark plan for N, O, and P, who reside together, and $220, the monthly applicable benchmark plan premium for Q, who resides in a different location than N, O, and P. Consequently, the premium for N's applicable benchmark plan is $1,220.
(ii) Under paragraph (f)(5) of this section, Issuer C's silver-level plan that covers R, S, and T under one policy ($1,200 monthly premium) and Issuer A's and Issuer B's silver-level plans that do not cover R, S and T under one policy are considered in determining R's and S's applicable benchmark plan. In addition, under paragraph (f)(5)(ii) of this section, in determining R's and S's applicable benchmark plan, the premium taken into account for Issuer A's plan is $1,450 (the aggregate premiums for self-only policies covering R ($400), S ($450), and T ($600) and the premium taken into account for Issuer B's plan is $1,000 (the aggregate premiums for self-only policies covering R ($250), S ($300), and T ($450). Consequently, R's and S's applicable benchmark plan is the Issuer C silver-level plan covering R's and S's coverage family and the premium for their applicable benchmark plan is $1,200.
(ii) Under paragraph (f)(5)(ii) of this section, because multiple policies are required to cover U and V, the members of U's coverage family who reside together in Location 1, the premium taken into account in determining U's benchmark plan is $1,000, the sum of the premiums for the second-lowest aggregate cost of self-only policies covering U ($400) and V ($600) offered by the Exchange to U and V for the rating area in which U and V reside. Under paragraph (f)(5)(i) of this section, because all silver-level plans offered by the Exchange in which W and X reside cover W and X under a single policy, the premium for W and X's coverage that is taken into account in determining U's benchmark plan is $500, the second-lowest cost silver policy covering W and X that is offered by the Exchange for the rating area in which W and X reside. Under paragraph (f)(4) of this section, because the members of U's coverage family reside in different locations, U's monthly benchmark plan premium is $1,500, the sum of the premiums for the applicable benchmark plans for each group of family members residing in different locations ($1,000 for U and V, who reside in Location 1, plus $500 for W and X, who reside in Location 2).
(ii) Under paragraphs (f)(1), (f)(2), (f)(3), and (f)(7) of this section, the silver-level plan that BB and CC use to determine their applicable benchmark plan for all coverage months during the year is Plan 2. The applicable benchmark plan that DD uses to determine DD's applicable benchmark plan is Plan 3, because Plan 2 is not open to enrollment through the Exchange when the DD family enrolls.
(n)
(2) Paragraphs (c)(4) and (d)(2) apply to taxable years beginning after December 31, 2016. Paragraphs (f)(1), (f)(3), (f)(4), (f)(6), (f)(7), (f)(8), and (f)(9) of this section apply to taxable years beginning after December 31, 2018. Paragraphs (c)(4) and (d)(2) of § 1.36B-3 as contained in 26 CFR part I edition revised as of April 1, 2016, apply to taxable years ending after December 31, 2013, and beginning before January 1, 2017. Paragraphs (f)(1), (f)(3), (f)(4), (f)(6), and (f)(7) of § 1.36B-3 as contained in 26 CFR part I edition revised as of April 1, 2016, apply to taxable years ending after December 31, 2013, and beginning before January 1, 2019.
(c) * * *
(3) —* * *
(i) * * * If advance credit payments are made for coverage under the plan, the enrollment premiums reported to each family under paragraph (c)(1)(viii) of this section are the premiums allocated to the family under § 1.36B-3(h) (allocating enrollment premiums to each taxpayer in proportion to the premiums for each taxpayer's applicable benchmark plan).
(iii)
(B)
(h)
(e) * * *
(3) * * *
(ii) * * *
(G)
(
(
(
(
(
(c)
(2) Paragraph (e)(3)(ii)(G) of § 1.5000A-3 applies to months beginning after December 31, 2016.
(a)
(b)
Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.
Supplemental notice of proposed rulemaking.
On March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA). On July 6, 2016, HHS published a final rule based on the NPRM but delayed finalizing the reporting requirements outlined in the NPRM. In this Supplemental Notice of Proposed Rulemaking (SNPRM), HHS seeks further comment on the same reporting requirements outlined in the NPRM. These reporting requirements would require annual reporting by practitioners who are approved to treat up to 275 patients under subpart F to help HHS ensure compliance with the requirements of the “Medication Assisted Treatment for Opioid Use Disorders” final rule published elsewhere in this issue of the
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 8, 2016.
You may submit comments, identified by Regulatory Information Number (RIN) 0930-AA22, by any of the following methods:
•
•
•
Jinhee Lee, Pharm.D., Public Health Advisor, Center for Substance Abuse Treatment, 240-276-0545, Email address:
The purpose of this Supplemental Notice of Proposed Rulemaking (SNPRM) is to solicit additional comment on the proposed reporting requirements in the U.S. Department of Health and Human Services (HHS) March 30, 2016 Notice of Proposed Rulemaking (NPRM) on Medication Assisted Treatment for Opioid Use Disorders under section 303(g)(2) of the Controlled Substances Act (CSA) (81 FR 17639). These requirements will assist HHS in ensuring practitioner compliance with the requirements of 42 CFR part 8, subpart F.
These proposed regulatory provisions, which amend § 8.635 of 42 CFR part 8, subpart F, would establish annual reporting requirements for practitioners who are approved to treat up to 275 patients under 42 CFR part 8, subpart F.
A summary of the anticipated impact of the reporting requirements, along with the other provisions of 42 CFR part 8, subpart F, was provided in the NPRM, dated March 30, 2016. Please see the NPRM, I. Executive Summary, Paragraph C (Summary of Impacts) for a summary of impacts of the reporting requirements in the context of 42 CFR part 8, subpart F.
HHS invites interested parties to submit comments on all aspects of this proposal. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable and/or confidential information that is included in a comment. We post all comments received as soon as possible after they have been received on the following Web site:
Comments received before the close of the comment period will also be available for public inspection, generally beginning approximately 3 weeks after publication of the proposed rule, at the headquarters of the Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857, Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, call 240-276-1660.
We will consider all comments we receive by the date and time specified in the
On March 30, 2016 HHS issued a Notice of Proposed Rulemaking (NPRM) entitled “Medication Assisted Treatment for Opioid Use Disorders” in the
The proposed regulatory provisions in this SNPRM will help HHS assess practitioner compliance with the requirements of 42 CFR part 8, subpart F.
In the NPRM, HHS proposed 42 CFR, part 8, subpart F, § 8.635 to describe the reporting requirements for practitioners whose Request for Patient Limit Increase is approved under § 8.625. The purpose of the reporting requirements is to help HHS assess practitioner compliance with the additional responsibilities of practitioners who are authorized to treat up to the higher patient limit, as outlined in the MAT final rule published elsewhere in this issue of the
In addition, HHS seeks comment on the following questions:
Are there different or additional elements that should be reported in order to assist HHS in ensuring compliance with the final rule?
Are there ways in which some elements can be combined that will lessen the burden for reporting practitioners while maintaining the important function of collecting information that ensure compliance with the final rule?
Are there other ways that HHS can collect the necessary information to ensure compliance with the final rule?
Would it be less burdensome to report on the number of patients in treatment for each month of the reporting period that:
(i) Were provided counseling services at the same location as the practitioner, and how frequently those patients utilized the counseling services;
(ii) the practitioner referred for counseling services at a different location?
Would it be less burdensome to report on the number of patients at the end of the reporting year who had terminated utilization of covered medications?
Are there other suggested changes that would be less burdensome while maintaining the important function of collecting information that ensure compliance with the final rule?
Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to
1. Whether the information collection is necessary and useful to carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information collection burden;
3. The quality, utility, and clarity of the information to be collected; and
4. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered in rulemaking. We explicitly seek, and will consider, public comment on our assumptions as they relate to the PRA requirements summarized in this section. This proposed rule includes changes to information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, as defined under the PRA (5 CFR part 1320). Some of the provisions would involve changes from the information collections set out in the previous regulations.
Information collection requirements would be:
Annual burden estimates for these requirements are summarized in the following table:
For more detailed estimates, please refer to the public docket, which includes a copy of the draft supporting statement submitted as part of the NPRM and associated with this information collection.
HHS has examined the impact of this proposed rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on Federalism (August 4, 1999) and included it in the NPRM published on March 30, 2016. Please refer to the NPRM for this analysis (81 FR 17639).
Health professions, Methadone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, HHS proposes to amend 42 CFR part 8 as follows:
21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.
(a) All practitioners whose Request for Patient Limit Increase is approved under § 8.625 must submit reports to SAMHSA, along with documentation and data, as requested by SAMHSA, to demonstrate compliance with § 8.620, applicable eligibility requirements specified in § 8.610, and all attestation requirements in § 8.620(b).
(b) Reporting requirements may include a request for information regarding:
(1) The average monthly caseload of patients receiving buprenorphine-based MAT, per year.
(2) Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to:
(i) Treatment initiation.
(ii) Change in clinical status.
(3) Percentage of patients who had a prescription drug monitoring program query in the past month; and
(4) Number of patients at the end of the reporting year who:
(i) Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery.
(ii) Are not being seen by the provider due to referral by the provider to a more or less intensive level of care.
(iii) No longer desire to continue use of buprenorphine.
(iv) Are no longer receiving buprenorphine for reasons other than paragraphs (b)(4)(i) through (iii) of this section.
(c) The report must be submitted within twelve months after the date that a practitioner's Request for Patient Limit Increase is approved under § 8.625, and annually thereafter.
(d) SAMHSA may check reports from practitioners prescribing under the higher patient limit against other existing data sources, such as PDMPs. If discrepancies between reported information and other existing data are identified, SAMHSA may require additional documentation from
(e) Failure to submit reports under this section, or deficient reports, may be deemed a failure to satisfy the requirements for a patient limit increase, and may result in the withdrawal of SAMHSA's approval of the practitioner's Request for Patient Limit Increase.
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to renew the approved information collection regarding the accredited laboratory contact update form. The approval for this information collection will expire on December 31, 2016.
Submit comments on or before September 6, 2016.
FSIS invites interested persons to submit comments on this information collection. Comments may be submitted by one of the following methods:
•
•
•
Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, South Building, Washington, DC 20250; (202) 720-5627.
In addition, the Food, Agriculture, Conservation, and Trade Act of 1990, as amended, (7 U.S.C. 138-138i) provides authority for the accreditation of non-Federal laboratories. Under these provisions, FSIS accredits non-Federal laboratories as eligible to perform analysis on official regulatory meat and poultry samples.
Non-Federal laboratories that are part of the FSIS Accredited Laboratory Program complete the FSIS Accredited Laboratory Program Annual Contact Update Form annually. FSIS will use the information collected by the form to maintain necessary contact information for responsibly connected personnel at the laboratories (see 9 CFR 439.20(e) and 9 CFR 439.1(w)). The completed FSIS Accredited Laboratory Program Annual Contact Update Form will also inform the Agency if a laboratory, or responsibly connected person or entity, has been charged, indicted, or convicted of any crime listed in 9 CFR 439.52. If a laboratory or a responsibly connected person or entity has been charged or indicted of such a crime, FSIS will suspend the laboratory from the Accredited Laboratory Program (9 CFR 439.52). If a laboratory or a responsibly connected person or entity has been convicted of such a crime, FSIS will revoke the laboratory's accreditation (9 CFR 439.53).
The approval for this information collection will expire on December 31, 2016. There are no changes to the existing information collection. FSIS has made the following estimates on the basis of an information collection assessment.
Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence SW., 6065, South Building, Washington, DC 20250; (202) 720-5627.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Food Safety and Inspection Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to renew the approved information collection regarding industry responses to noncompliance records. The approval for this information collection will expire on December 31, 2016.
Submit comments on or before September 6, 2016.
FSIS invites interested persons to submit comments on this information collection. Comments may be submitted by one of the following methods:
•
•
•
Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, South Building, Washington, DC 20250; (202) 720-5627.
FSIS is requesting a renewal of the previously approved information collection addressing paperwork requirements related to the collection of information on official meat or poultry establishment and egg products plant responses to noncompliance records. The noncompliance record, FSIS Form 5400-4, serves as FSIS's official record of noncompliance with one or more regulatory requirements. Inspection program personnel use the form to document their findings and provide written notification of the official establishment's or plant's failure to comply with regulatory requirements. The establishment or plant management receives a copy of the form and has an opportunity to respond in writing using the noncompliance record form.
The OMB approval of this information collection will expire on December 31, 2016. The number of estimated burden hours for this requested renewal has decreased because of a decrease in the
FSIS has made the following estimates on the basis of an information collection assessment:
Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence SW., 6065, South Building, Washington, DC 20250; (202) 720-5627.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253.
Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Forest Service, USDA.
Notice of meeting.
The Kenai Peninsula-Anchorage Borough Resource Advisory Committee (RAC) will meet in Girdwood, Alaska. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with title II of the Act. RAC information can be found at the following Web site:
The meeting will be held August 6, 2016, at 10:00 a.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at Glacier Ranger District Office, 145 Forest Station Road Girdwood, Alaska 99587. A conference line will be available, if you would like to attend the meeting via conference call, please contact the person listed under
Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Glacier Ranger District. Please call ahead to facilitate entry into the building.
Nancy O'Brien, RAC Coordinator, by phone at 907-424-4722 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to discuss and vote on project proposals.
The meeting is open to the public. The agenda will include time for people
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by August 8, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC, 20503. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Michigan Advisory Committee (Committee) will hold a meeting on Tuesday, July 19, 2016, at 10:00 a.m. EDT for the purpose of discussing civil rights topics emerging from testimony regarding civil asset forfeiture practices in the state.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-438-5524, conference ID: 3344476. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plans. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-
Member of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
The meeting will be held on Tuesday, July 19, 2016, at 10:00 a.m. EDT.
Carolyn Allen at
United States Commission on Civil Rights.
Notice of Commission business meeting.
Friday, July 15, 2016, at 10:00 a.m. EST.
Latrice Foshee, Acting Media Advisor at telephone: (202) 376-8371 or email:
This business meeting is open to the public. If you would like to listen to the business meeting, please contact the above for the call-in information. Persons with hearing impairments, please contact the above for how to access the Federal Relay Service for the meeting.
National Oceanic and Atmospheric Administration, U.S. Department of Commerce.
Notice of a revised Privacy Act System of Records: COMMERCE/NOAA-12, Marine Mammals, Endangered and Threatened Species, Permits and Authorizations, Applicants.
This notice announces the Department of Commerce's (Department's) proposal to amend a System of Records under the 1974 Privacy Act. The National Oceanic and Atmospheric Administration's (NOAA's) National Marine Fisheries Service (NMFS) is amending their system of records for marine mammal and threatened and endangered species permit and authorization programs. Information will be collected from individuals and entities under the authority of the Marine Mammal Protection Act and the Endangered Species Act. This record system is necessary to identify permit and authorization applicants and to evaluate the qualifications of the applicants.
To be considered, written comments must be submitted on or before August 8, 2016. Unless comments are received, the amended system of records will become effective as proposed on August 17, 2016. If comments are received, the Department will publish a subsequent notice in the
Comments may be mailed to Amy Sloan, Deputy Chief, Permits and Conservation Division, NOAA, National Marine Fisheries Service, Office of Protected Resources, 1315 East-West Highway, F/PR1 Room 13824, Silver Spring, MD 20910.
Amy Sloan (Phone: 301-427-8401; Email:
NMFS is amending its system of applicant records for use with marine mammal and threatened and endangered species permit and authorization programs to make minor administrative updates including updating addresses where records are located and how records are stored. The Marine Mammal Protection Act, Fur Seal Act, and Endangered Species Act prohibit certain actions affecting marine mammals and endangered and threatened species, with limited exceptions. Permits involving marine mammals and endangered and threatened species can be obtained for scientific research, enhancing the survival or recovery of a species or stock, commercial and educational photography, and import and capture for public display. Authorizations can be obtained for scientific research that involves minimal disturbance. Also U.S. citizens may request and obtain, authorizations for the incidental taking of marine mammals for specified activities other than commercial fishing. Owners of a commercial vessel or non-vessel gear engaging in a Category I or II fishery must obtain a marine mammal authorization certificate from NOAA Fisheries, or a designated agent, to lawfully incidentally take a marine mammal in a commercial fishery. NMFS collects information from individuals in order to issue, amend, or renew permits or authorizations.
COMMERCE/NOAA-12, Marine Mammals, Endangered and Threatened Species, Permits and Authorizations Applicants.
None.
a. NMFS, Office of Protected Resources, 1315 East West Highway, Silver Spring, MD 20910.
b. NMFS, Greater Atlantic Regional Fisheries Office. 55 Great Republic Drive, Gloucester, MA 01930-2276.
c. NMFS, Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701.
d. NMFS, West Coast Region, Sustainable Fisheries Division, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
e. NMFS, West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
f. NMFS, Southwest Fisheries Science Center, 8604 La Jolla Shores Drive, La Jolla, CA 92037.
g. NMFS, Pacific Islands Region, Ford Island Honolulu at 1845 Wasp Blvd., Building 176, Honolulu, HI 96818.
h. NMFS, Alaska Region, 709 West Ninth Street, Juneau, AK 99802-1668.
Researchers, wildlife managers, photographers, holders of marine mammals in captivity, corporations, partnerships, associations, organizations, Federal, state, local or tribal governments and other members of the public seeking exceptions to prohibited activities related to marine mammals and endangered and threatened species, and owners of commercial fishing vessels engaged in Category I or II fisheries seeking an exception to prohibited activities on marine mammals and endangered and threatened species.
For the marine mammal authorization program (MMAP), if a commercial fisherman has a state or Federal fishery license, they are not required to submit information to NMFS. Their registration is automatically renewed by mail and their registration information is not stored in this system, but in the applicable regional Sustainable Fisheries Permit Office. For those without a state or Federal fishery license, the following information is included: Name, address, and telephone number of the owner(s) of a vessel or non-vessel gear and name and address of the operator if other than the owner; name and length of the vessel, home port, United States Coast Guard (USCG) documentation number or State registration number, State commercial license number of the fishing vessel which will operate under the authorization, and for a non-vessel fishery, a description of the gear and state commercial license number; a list of the fishery(s) in which the fisher will be engaged; for an individual, social security number and date of birth of the owner(s) of a vessel or non-vessel gear; and for a business, corporation name, employer identification number and date of incorporation. Any time there is an incidental or intentional mortality or injury to a marine mammal during commercial fishing activities, the following information must be submitted by all authorized fisheries (electronically or by mail): Name of vessel owner/operator or permit holder, mailing address, vessel name, fishery gear type and target species, and information about the marine mammal mortality/injury incident.
The Marine Mammal Protection Act, 16 U.S.C. 1361
This information will allow NMFS to identify applicants and holders of permits and authorizations, identify vessel owners, evaluate requests by applicants, or agency actions, related to the issuance, renewal, revocation, suspension or modification of a permit or authorization.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the Department. These records or information contained therein may specifically be disclosed as a routine use as stated below. The Department will, when so authorized, make the determination as to the relevancy of a record prior to its decision to disclose a document.
1. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or
2. A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
3. A record in this system of records may be disclosed to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
4. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether the Freedom of Information Act (5 U.S.C. 552) requires disclosure thereof.
5. A record in this system may be disclosed to the Department of Homeland Security for the purposes of determining the admissibility of certain marine mammal or threatened or endangered species or species parts imports into the United States.
6. A record in this system will be disclosed to the Department of Treasury for the purpose of reporting and recouping delinquent debts owed the United States pursuant to 31 U.S.C. 7701 (this applies to MMAP permittees only).
7. A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract, but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
8. A record in this system of records may be disclosed to appropriate agencies, entities, and persons when: (1) It is suspected or determined that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identify theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
9. A record from this system of records may be disclosed, as a routine use, to a Federal, state or local agency maintaining civil, criminal or other relevant enforcement information or other pertinent information, such as current licenses, if necessary to obtain information relevant to a Department decision concerning the assignment, hiring or retention of an individual, the issuance of a security clearance, the letting of a contract, or the issuance of a license, grant or other benefit.
10. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.
11. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.
12. A record in this system may be transferred, as a routine use, to the Office of Personnel Management: For personnel research purposes; as a data source for management information; for the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained; or for related manpower studies.
13. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (
None.
Online application system (Authorizations and Permits for Protected Species only for scientific research permits and authorizations;
Records are organized and retrieved by NMFS internal identification number or permit or authorization number; name of entity or vessel name or identification number. Records can be accessed by any file element or any combination thereof.
The paper systems of records are stored in buildings with doors that are locked during and after business hours. Visitors to the facilities must register with security guards and must be accompanied by Federal personnel at all times. The electronic systems of records are stored on the agency's network servers. Electronic records containing Privacy Act information are protected by a user identification/password.
All electronic information disseminated by NOAA adheres to the standards set out in Appendix III, Security of Automated Information Resources, OMB Circular A-130; the Computer Security Act (15 U.S.C. 278g-3 and 278g-4); and the Government Information Security Reform Act, Public Law 106-398; and follows NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems; NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems; and NIST SP 800-53, Recommended Security and Privacy Controls for Federal Information Systems and Organizations.
All records are retained and disposed of in accordance with National Archive and Records Administration regulations
For records at location a.: Office of Protected Resources, NMFS Headquarters, 1315 East-West Highway, Silver Spring, MD 20910.
For records at location b.: Office of Protected Resources, NMFS Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2276.
For records at location c.: Office of Protected Resources, NMFS Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701.
For records at location d.: Office of Protected Resources, West Coast Region, Sustainable Fisheries Division, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
For records at locations e and f.: Office of Protected Resources, NMFS West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
For records at location g.: Office of Protected Resources, NMFS, Pacific Islands Region, Ford Island Honolulu at 1845 Wasp Blvd., Building 176, Honolulu, HI 96818.
For records at location h.: Office of Protected Resources, NMFS Alaska Region, 709 West Ninth Street, Juneau, AK 99802-1668.
Individuals seeking to determine whether information about them is contained in this system should address written inquiries to the national or regional Privacy Act Officer:
Privacy Act Officer, NOAA, 1315 East-West Highway, Room 9719, Silver Spring, MD 20910.
Privacy Act Officer, NMFS, 1315 East-West Highway, Room 13706, Silver Spring, MD 20910.
Privacy Act Officer, Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930-2276.
Privacy Act Officer, NMFS Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701.
Privacy Act Officer, NMFS West Coast Region, 7600 Sand Point Way NE., Bldg. #1, Seattle, WA 98115.
Privacy Act Officer, NMFS West Coast Region, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802.
Privacy Act Officer, NMFS Pacific Islands Region, Ford Island Honolulu at 1845 Wasp Blvd., Building 176, Honolulu, HI 96818.
Privacy Act Officer, NMFS Alaska Region, P.O. Box 21668, Juneau, Alaska 99802, or delivered to the Federal Building, 709 West 9th Street, Juneau, Alaska, 99802-1668.
Written requests must be signed by the requesting individual. Requestor must make the request in writing and provide his/her name, address, and date of the request and record sought. All such requests must comply with the inquiry provisions of the Department's Privacy Act rules which appear at 15 CFR part 4, appendix A.
Requests for access to records maintained in this system of records should be addressed to the same address given in the Notification Procedure section.
The Department's rules for access, for contesting contents, and appealing initial determinations by the individual concerned are provided for in 15 CFR part 4, appendix A.
Information in this system will be collected from individuals or entities applying for a permit or authorization.
None.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On April 28, 2016, the United States Court of International Trade (the CIT or the Court) issued final judgment in
Michael J. Heaney or Robert James, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4475 or (202) 482-0649, respectively.
On March 16, 2009, the Department published its
On September 27, 2010, the Court remanded this matter.
Upon consideration of the
On May 31, 2013, in
On February 18, 2015, in
On April 28, 2016, the Court sustained the Department's
In its decision in
Because there is now a final court decision, the Department is amending the
For Since Hardware, the cash deposit rate will remain the rate established in the
In the event the Court's ruling is not appealed, or if appealed and upheld by the Federal Circuit, the Department will instruct CBP to assess antidumping duties on entries of the subject merchandise exported by Since Hardware using the revised assessment rate calculated by the Department in the
This notice is issued and published in accordance with sections 516(A)(e), 751(a)(1), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is initiating a changed circumstances review (CCR) of the antidumping duty (AD) order on certain passenger vehicle and light truck tires (passenger tires) from the People's Republic of China (PRC) with regard to Sailun Jinyu Group (HONG KONG) Co., Limited (Sailun Jinyu HK). We preliminarily determine that Sailun Jinyu HK is the successor-in-interest to Jinyu International Holding Co., Limited (Jinyu HK) for purposes of determining AD liability. Interested parties are invited to comment on these preliminary results.
Toni Page, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1398.
On August 10, 2015, the Department published in the
The products covered by the scope of this order are passenger vehicle and light truck tires. Passenger vehicle and light truck tires are new pneumatic tires, of rubber, with a passenger vehicle or light truck size designation. Tires covered by these orders may be tube-type, tubeless, radial, or non-radial, and they may be intended for sale to original equipment manufacturers or the replacement market.
Subject tires have, at the time of importation, the symbol “DOT” on the sidewall, certifying that the tire conforms to applicable motor vehicle safety standards. Subject tires may also have the following prefixes or suffix in their tire size designation, which also appears on the sidewall of the tire:
Prefix designations:
Suffix letter designations:
All tires with a “P” or “LT” prefix, and all tires with an “LT” suffix in their sidewall markings are covered by this investigation regardless of their intended use.
In addition, all tires that lack a “P” or “LT” prefix or suffix in their sidewall markings, as well as all tires that include any other prefix or suffix in their sidewall markings, are included in the scope, regardless of their intended use, as long as the tire is of a size that is among the numerical size designations listed in the passenger car section or light truck section of the Tire and Rim Association Year Book, as updated annually, unless the tire falls within one of the specific exclusions set out below.
Passenger vehicle and light truck tires, whether or not attached to wheels or rims, are included in the scope. However, if a subject tire is imported attached to a wheel or rim, only the tire is covered by the scope.
Specifically excluded from the scope are the following types of tires:
(1) Racing car tires; such tires do not bear the symbol “DOT” on the sidewall and may be marked with “ZR” in size designation;
(2) new pneumatic tires, of rubber, of a size that is not listed in the passenger car section or light truck section of the Tire and Rim Association Year Book;
(3) pneumatic tires, of rubber, that are not new, including recycled and retreaded tires;
(4) non-pneumatic tires, such as solid rubber tires;
(5) tires designed and marketed exclusively as temporary use spare tires for passenger vehicles which, in addition, exhibit each of the following physical characteristics:
(a) the size designation and load index combination molded on the tire's sidewall are listed in Table PCT-1B (“T” Type Spare Tires for Temporary Use on Passenger Vehicles) of the Tire and Rim Association Year Book,
(b) the designation “T” is molded into the tire's sidewall as part of the size designation, and,
(c) the tire's speed rating is molded on the sidewall, indicating the rated speed in MPH or a letter rating as listed by Tire and Rim Association Year Book, and the rated speed is 81 MPH or a “M” rating;
(6) tires designed and marketed exclusively for specialty tire (ST) use which, in addition, exhibit each of the following conditions:
(a) the size designation molded on the tire's sidewall is listed in the ST sections of the Tire and Rim Association Year Book,
(b) the designation “ST” is molded into the tire's sidewall as part of the size designation,
(c) the tire incorporates a warning, prominently molded on the sidewall, that the tire is “For Trailer Service Only” or “For Trailer Use Only”,
(d) the load index molded on the tire's sidewall meets or exceeds those load indexes listed in the Tire and Rim Association Year Book for the relevant ST tire size, and
(e) either
(i) the tire's speed rating is molded on the sidewall, indicating the rated speed in MPH or a letter rating as listed by Tire and Rim Association Year Book, and the rated speed does not exceed 81 MPH or an “M” rating; or
(ii) the tire's speed rating molded on the sidewall is 87 MPH or an “N” rating, and in either case the tire's maximum pressure and maximum load limit are molded on the sidewall and either
(1) both exceed the maximum pressure and maximum load limit for any tire of the same size designation in either the passenger car or light truck section of the Tire and Rim Association Year Book; or
(2) if the maximum cold inflation pressure molded on the tire is less than any cold inflation pressure listed for that size designation in either the passenger car or light truck section of the Tire and Rim Association Year Book, the maximum load limit molded on the tire is higher than the maximum load limit listed at that cold inflation pressure for that size designation in either the passenger car or light truck section of the Tire and Rim Association Year Book;
(7) tires designed and marketed exclusively for off-road use and which, in addition, exhibit each of the following physical characteristics:
(a) the size designation and load index combination molded on the tire's sidewall are listed in the off-the-road, agricultural, industrial or ATV section of the Tire and Rim Association Year Book,
(b) in addition to any size designation markings, the tire incorporates a warning, prominently molded on the sidewall, that the tire is “Not For Highway Service” or “Not for Highway Use”,
(c) the tire's speed rating is molded on the sidewall, indicating the rated speed in MPH or a letter rating as listed by the Tire and Rim Association Year Book, and the rated speed does not exceed 55 MPH or a “G” rating, and
(d) the tire features a recognizable off-road tread design.
The products covered by the orders are currently classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4011.10.10.10, 4011.10.10.20, 4011.10.10.30, 4011.10.10.40, 4011.10.10.50, 4011.10.10.60, 4011.10.10.70, 4011.10.50.00, 4011.20.10.05, and 4011.20.50.10. Tires meeting the scope description may also enter under the following HTSUS subheadings: 4011.99.45.10, 4011.99.45.50, 4011.99.85.10, 4011.99.85.50, 8708.70.45.45, 8708.70.45.60, 8708.70.60.30, 8708.70.60.45, and 8708.70.60.60. While HTSUS subheadings are provided for convenience and for customs purposes, the written description of the subject merchandise is dispositive.
Pursuant to section 751(b)(1)(A) of the Act and 19 CFR 351.216(d), the Department will conduct a CCR upon receipt of a request from an interested party for a review of an AD order which shows changed circumstances sufficient to warrant a review of the order. The information submitted by Sailun Jinyu HK supporting its claim that it is the successor-in-interest to Jinyu HK demonstrates changed circumstances sufficient to warrant such a review.
In accordance with the above-referenced regulation, the Department is initiating a CCR to determine whether Sailun Jinyu HK is the successor-in-interest to Jinyu HK. When it concludes that expedited action is warranted, the Department may publish the notice of initiation and preliminary results for a CCR concurrently.
In determining whether one company is the successor-in-interest to another, the Department examines a number of factors including, but not limited to, changes in management, production facilities, supplier relationships, and customer base.
In its February 23, 2016, and April 18, 2016 submissions, Sailun Jinyu HK provided information to demonstrate that it is the successor-in-interest to Jinyu HK. Sailun Jinyu HK states that there were no changes to the company's ownership, employees, managers, customers, or suppliers. To support its claims, Sailun Jinyu HK submitted the following documents: (1) A copy of Jinyu HK Internal Work Approval Sheet, dated October 29, 2015 explaining the reason for the name change from Jinyu HK to Sailun Jinyu HK; (2) a copy of a Department memorandum regarding Sailun Group Co., Ltd.'s Affiliation Single Entity Status, dated January 14, 2015; (3) a Notice of Change of Company Name, dated December 4, 2015 filed with the Hong Kong Companies Registry; (4) a Certificate of Change of Name, dated December 21, 2015, issued by the Hong Kong Companies Registry; (5) business registrations for both Jinyu HK (dated October 24, 2015) and Sailun Jinyu HK (dated October 24, 2015); (6) a listing of the company's customers before and after its name change; and (7) a letter sent to all customers explaining the name change.
Based on the evidence on the record, we preliminarily find that Sailun Jinyu HK is the successor-in-interest to Jinyu HK. We find that Sailun Jinyu HK operates as the same business entity as Jinyu HK and that its ownership, management, production facilities, supplier relationships, and customers have not changed as a result of its name change. Thus, we preliminarily find that Sailun Jinyu HK should receive the same AD cash deposit rate with respect to the subject merchandise as Jinyu HK, its predecessor company.
Should our final results remain the same as these preliminary results, we will instruct U.S. Customs and Border Protection to suspend entries of subject merchandise exported by Sailun Jinyu HK at Jinyu HK's cash deposit rate, effective on the publication date of our final results.
Interested parties may submit case briefs and/or written comments not later than 14 days after the publication of this notice.
Interested parties that wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 14 days of publication of this notice.
Consistent with 19 CFR 351.216(e), we intend to issue the final results of this changed circumstance review no later than 270 days after the date on which this review was initiated, or within 45 days of publication of these preliminary results if all parties agree to our preliminary finding.
We are issuing and publishing this finding and notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act, and 19 CFR 351.216 and 351.221(c)(3)(ii).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for nominations.
This notice is a call for nominees for the U.S. Delegation to the October 2016 International Whaling Commission (IWC) meeting. The non-federal representative(s) selected as a result of this nomination process is (are) responsible for providing input and recommendations to the U.S. IWC Commissioner representing the positions of non-governmental organizations.
The IWC is holding its 66th meeting from October 20-28, 2016, at the Convention Center of the Grand Hotel Bernardin in Portorož, Slovenia. All written nominations for the U.S. Delegation to the IWC meeting must be received by August 26, 2016.
All nominations for the U.S. Delegation to the IWC meeting should be addressed to Mr. Ryan Wulff, Deputy U.S. Commissioner to the IWC, and sent to Jordan Carduner via email:
Jordan Carduner at
The Secretary of Commerce is responsible for discharging the domestic obligations of the United States under the International Convention for the Regulation of Whaling, 1946. The U.S. IWC Commissioner has responsibility for the preparation and negotiation of U.S. positions on international issues concerning whaling and for all matters involving the IWC. The U.S. IWC Commissioner is staffed by the Department of Commerce and assisted by the Department of State, the Department of the Interior, the Marine Mammal Commission, and by other agencies. The non-federal representative(s) selected as a result of this nomination process is (are) responsible for providing input and recommendations to the U.S. IWC Commissioner representing the positions of non-governmental organizations. Generally, only one non-governmental position is selected for the U.S. Delegation.
Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting (webinar).
The Pacific Fishery Management Council's (Pacific Council's) Coastal Pelagic Species Management Team (CPSMT) will meet via webinar to discuss potential management options for the northern anchovy. The meeting is open to the public.
The webinar meeting will take place from 10 a.m. to 12 p.m. Pacific Daylight Time, August 3, 2016.
The meeting will be held via webinar. A public listening station will also be provided at the Pacific Council office.
Kerry Griffin, Staff Officer; telephone: (503) 820-2409.
The primary purpose of the webinar is to solicit comments and questions on a draft white paper being developed by the Pacific Council's CPSMT. The Council will consider the white paper at its September 15-20 meeting in Boise, ID. Public comments during the webinar
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR Data Best Practices Standing Panel Webinar.
The SEDAR Data Best Practices Panel will develop, review, and evaluate best practice recommendations for SEDAR Data Workshops. See
The SEDAR Data Best Practices Standing Panel webinar will be held on Thursday, July 21, 2016, from 10 a.m. to 12 p.m. (EST).
The meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact Julia Byrd at SEDAR (see
Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: Data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The SEDAR Data Best Practices Standing Panel is charged with developing, reviewing, and evaluating best practice recommendations for SEDAR Data Workshops. This will be the second meeting of this group. The items of discussion for this webinar are as follows:
1. Finalize terms of reference that specify the Panel's purpose and approach.
2. Continue discussions on SEDAR Data Best Practices living document.
3. Discuss Data Issue Inventory Format
4. Other business.
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 identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
The Magnuson-Stevens Act (16 U.S.C. 1801) provides that the Secretary of Commerce is responsible for the conservation and management of marine fisheries resources in Exclusive Economic Zone (3-200 miles) of the United States (U.S.). NOAA Fisheries, West Coast Region—Northwest manages the Pacific Coast Groundfish Fishery in the Exclusive Economic Zone (EEZ) off Washington, Oregon, and California under the Pacific Coast Groundfish Fishery Management Plan. The regulations implementing the Pacific Groundfish Fishery require that those vessels participating in the limited entry fishery to be registered to a valid limited entry permit. Participation in the fishery and access to a limited entry permit has been restricted to control the overall harvest capacity. The regulations implementing the limited entry program are found at 50 CFR part 660, subpart G.
NOAA Fisheries seeks comment on the extension of permit information collections required for: (1) Renewal and transfer of Pacific Coast Groundfish limited entry permits; (2) implementation of certain provisions of the sablefish permit stacking program as provided for at 50 CFR 660.231 and 660.25; and (3) issuing and fulfilling the terms and conditions of certain exempted fishing permits (EFPs).
Also, NOAA Fisheries requires an information collection to implement certain aspects of the sablefish permit stacking program which prevents excessive fleet consolidation. As part of the annual renewal process, NOAA Fisheries requires a corporation or partnership that owns or holds (as vessel owner) a sablefish endorsed permit to provide a complete ownership interest form listing all individuals with ownership interest in the entity. Similarly, any sablefish endorsed permit transfer involving registration of a business entity requires an ownership interest form if either the permit owner or vessel owner is a corporation or partnership. This information is used to determine if individuals own or hold sablefish permits in excess of the limit of 3 permits. Also, for transfer requests made during the sablefish primary season (April 1st through October 31st), the permit owner is required to report the remaining tier pounds not yet harvested on the sablefish endorsed permit at the time of transfer.
Applicants for an exempted fishing permit (EFP) must submit written information that allows NOAA Fisheries and the Pacific Fishery Management Council to evaluate the proposed exempted fishing project activities and weigh the benefits and costs of the proposed activities. The Council makes a recommendation on each EFP application and for successful applicants, NOAA Fisheries issues the EFPs which contains terms and conditions for the project including various reporting requirements. The information included in an application is specified at 50 CFR 600.745(b)(2) and the Council Operating Procedure #19. Permit holders are required to file preseason harvest plans, interim and/or final summary reports on the results of the project and in some cases individual vessels and other permit holders are required to provide data reports (logbooks and/or catch reports The results of EFPs are commonly used to explore ways to reduce effort on depressed stocks, encourage innovation and efficiency in the fishery, provide access to constrained stocks which directly measuring the bycatch associated with such strategies and evaluate/revise current and proposed management measures.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Oceanic and Atmospheric Administration, U.S Department of Commerce.
Notice of a New Privacy Act System of Records: COMMERCE/NOAA-21, Financial Systems Division.
This notice announces the Department of Commerce's (Department's) proposal for a new system of records under the Privacy Act. The National Oceanic and Atmospheric Administration's (NOAA's) National Marine Fisheries Service (NMFS) is creating a new system of records for the Financial Services Division's financial assistance programs. Information will be collected from individuals and businesses under the authority of title XI of the Merchant Marine Act of 1936, as amended and codified, and the Magnuson-Stevens Fishery Conservation and Management Act, as amended. This new record system is necessary to determine whether applicants for program financing, Fishermen's Contingency claims, or participants in Capital Construction Fund accounts or Fishery Capacity Reduction programs are eligible and are creditworthy.
To be considered, written comments must be submitted on or before August 8, 2016. Unless comments are received, the new system of records will become effective as proposed on August 17, 2016. If comments are received, the Department will publish a subsequent notice in the
Comments may be mailed to: Paul Marx, Chief, Financial Services Division, National Marine Fisheries Service, 1315 East West Highway, Silver Spring, MD 20910.
Paul Marx, Chief, Financial Services Division, National Marine Fisheries Service, 1315 East West Highway, Silver Spring, MD 20910.
NMFS will use the information contained in this system of records to determine whether applicants for the Fisheries Financing Program (FFP) are both
The information collection is requested from individuals and businesses under the authority of title XI of the Merchant Marine Act of 1936, as amended and codified, and the Magnuson-Stevens Fishery Conservation and Management Act, as amended. The information collection includes collecting each applicant's Tax Identification Number (TIN), either an Employer Identification Number (EIN) or Social Security Number (SSN). Collection of a TIN is required under 31 U.S.C. 7701. The primary purpose for requesting the TIN is to correctly identify the applicant for background and credit investigations and program eligibility, and may be used to report or collect any delinquent amounts arising out of an applicant's relationship with the Government.
COMMERCE/NOAA-21, Financial Services Division.
Moderate.
a. NMFS Northeast Financial Services Branch, MB51, 55 Great Republic Drive, Suite 02-700, Gloucester, MA 01930-2209.
b. NMFS Southeast Financial Services Branch, MB52, 263-13th Avenue South, St. Petersburg, FL 33702-2432.
c. NMFS Northwest Financial Services Branch, MB53, 7600 Sand Point Way NW., Bin C15700, Building #1, Seattle, WA 98115.
d. NMFS Financial Services Division, 1315 East West Highway, Silver Spring, MD 20910.
Applicants for Fisheries Finance Program financial assistance, including: Direct loans for vessels, shoreside facilities, aquaculture, mariculture, and individual fishing quota (IFQ) loans; applicants for Capital Construction Fund (CCF) accounts; fishers and fish buyers participating in Capacity Reduction loan (Buyback) programs; and claimants under the Fishermen's Contingency Fund.
The system will include general personal and financial data including: The loan applicant's identity (including full name, address, and, as applicable, the SSN or EIN); the amount of financing applied for, the purpose of the loan; an appraisal of the vessel, facility or project being financed; Coast Guard documentation or Abstracts of title to vessels; income and financial information, including the applicant's last three Federal tax returns; LLC or Partnership agreements; a list of creditors and buyers with relevant credit terms; identification of authorized representatives (accountant, attorney, insurance agent); loan servicing actions and financial transactions; and the applicant's legal and credit history (status regarding bankruptcy, litigation, delinquency on debt, etc.). This information will be collected and maintained by the Financial Services Division and its branches.
The system will also include the CCF account holder's identity (including full name, address, and as applicable, the SSN or EIN); the nature of the account, banking information, the description of the project for which the account is to be created; income, business and financial information including the applicant and/or account holder's tax return, LLC and Partnership agreements; Coast Guard documentation, bills of sale, mortgages, etc.; identification of authorized representatives (accountant, attorney); and reports of account activity including all deposits and withdrawals. The system of records will include FCF claimants' identity (including full name, address, and, as applicable, the SSN or EIN); Vessel name and characteristics; fishing results for the three most recent trips; receipts for gear and equipment replaced; and information about the claimant's prior claims. The system of records will include Capacity Reduction program participants' identity (including full name, address, and, as applicable, the SSN or EIN); processor number, fish ticket information, receipt and payment information, and banking information.
Title XI of the Merchant Marine Act of 1936 as amended and codified, 46 U.S.C. 1177 and 46 U.S.C. 53701
This information will allow NMFS to identify applicants and program participants and evaluate them for Financial Services Division financial assistance.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside of the Department. These records or information contained therein may specifically be disclosed as a routine use as stated below. The Department will, when so authorized, make the determination as to the relevancy of a record prior to its decision to disclose a document.
1. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature and whether arising by general statute or particular program statute or contract, rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, State, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, contract or rule, regulation or order issued pursuant thereto, or protecting the interests of the Department.
2. A record from this system of records may be disclosed in the course
3. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether the Freedom of Information Act (5 U.S.C. 552) requires disclosure thereof.
4. A record from this system of records may be disclosed, as a routine use, to a Federal, state, local, or international agency, in response to its request, in connection with the assignment, hiring or retention of an individual, the issuance of a security clearance, the reporting of an investigation of an individual, the letting of a contract, or the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision on the matter.
5. A record in this system will be disclosed to the Department of Treasury for the purpose of reporting and recouping delinquent debts owed to the United States pursuant to the Debt Collection Improvement Act of 1996.
6. A record in this system of records may be disclosed to a contractor of the Department having need for the information in the performance of the contract but not operating a system of records within the meaning of 5 U.S.C. 552a(m).
7. A record in this system of records may be disclosed to appropriate agencies, entities, and persons when: (1) It is suspected or confirmed that the security of confidentiality of information in the system of records has been compromised; (2) the Department has determined that, as a result of the suspected or confirmed compromise, there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
8. A record or information in this system of records may be disclosed to private sector appraisers, marine architects, attorneys, accountants, banks, lending institutions, real estate agents, brokers, title companies, state or local agencies, commercial registries, credit bureaus, rating agencies, and/or other persons and entities for the purpose of making credit and eligibility evaluations; lender due diligence investigations; CCF account validations; FCF claim adjustments; and/or the creation, attachment, perfection, maintenance, realization, or foreclosure of security interests.
9. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.
10. A record in this system of records may be disclosed, as a routine use, to the Office of Management and Budget in connection with the review of private relief legislation as set forth in OMB Circular No. A-19 at any stage of the legislative coordination and clearance process as set forth in that Circular.
11. A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services Administration (GSA), or his designee, during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (
Disclosure pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) and the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
All electronic information disseminated by NOAA adheres to the standards set out in Appendix III, Security of Automated Information Resources, OMB Circular A-130; the Computer Security Act (15 U.S.C. 278g-3 and 278g-4); and the Government Information Security Reform Act, Public Law 106-398; and follows NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems; NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems; and NITS SP 800-53, Recommended Security Controls for Federal Information Systems.
Individuals or businesses seeking to determine whether information about themselves is contained in this system should address written inquiries to the NOAA Privacy Act Officer: Privacy Act Officer, NOAA, 1315 East West
Written requests must be signed by the requesting individual. Requestor must make the request in writing and provide his/her name, address, and date of the request and the nature of the record sought. All such requests must comply with the inquiry provisions of the Department's Privacy Act rules which appear at 15 CFR part 4, Appendix A.
Requests for access to records maintained in this system of records should be addressed to the same address given in the Notification section above.
The Department's rules for access, for contesting content, and for appealing initial determinations by the individual or business concerned are provided for in 15 CFR part 4, Appendix A.
Information in this system will be collected from individuals and businesses applying for Financial Systems Division financial assistance.
None.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the Procurement List.
This action adds products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 3/25/2016 (81 FR 16145-16146) and 6/3/2016 (81 FR 35749-35750), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and service and impact of the additions on the current or most recent contractors, the Committee has determined that the products and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. The action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service proposed for addition to the Procurement List.
Accordingly, the following products and service are added to the Procurement List:
On 6/3/2016 (81 FR 35749-35750), 6/10/2016 (81 FR 37581-37582), and 6/17/2016 (81 FR 39630), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the product(s) and/or service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and services deleted from the Procurement List.
Accordingly, the following products and services are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add a product and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and delete services previously furnished by such agencies.
8/7/2016.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the product and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following product and services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following services are proposed for deletion from the Procurement List:
Department of Defense.
Notice of availability; notice of public meeting; request for comments.
The Department of Defense (DoD) announces the availability of the Draft Environmental Impact Statement (EIS) as part of the environmental planning process for the East Campus Integration Program at Fort George G. Meade, Maryland (hereafter referred to as Fort Meade). The DoD proposes to continue to develop operational complex and headquarters space at the National Security Agency's (NSA) East Campus on Fort Meade for use by NSA and the Intelligence Community. The purpose of the Proposed Action is to provide facilities that are fully supportive of the Intelligence Community's function and to continue to integrate the East Campus with the NSA Main Campus. The need for the action is to meet mission requirements, both internally at the NSA and within the Intelligence Community.
This notice announces a 45-day comment period and provides information on how to participate in the public review process. The public comment period for the Draft EIS will officially end 45 days after publication of the Notice of Availability in the
There will be an open house at 4:30 p.m. followed by a public meeting from 5:00 p.m. to 7:00 p.m. on August 3, 2016. The public meeting may end earlier or later than the stated time depending on the number of persons wishing to speak. All materials that are submitted in response to the Draft EIS should be received by August 22, 2016 to provide sufficient time to be considered in preparation of the Final EIS.
Copies of the Draft EIS are available for your review at the Medal of Honor Memorial Library, 4418 Llewellyn Avenue, Fort Meade, MD 20755; the Glen Burnie Regional Library, 1010 Eastway, Glen Burnie, MD 21060; the Odenton Regional Library, 1325 Annapolis Road, Odenton, MD 21113; and the Severn Library, 2624 Annapolis Road, Severn, Maryland 21144. You may also call 301-688-2970 or send an email to
The open house and public meeting will be held at the Severn Library, 2624 Annapolis Road, Severn, Maryland 21144. Verbal and written comments will be accepted at the public meeting. You can also submit written comments to “East Campus Integration Program EIS” c/o HDR, 2600 Park Tower Drive, Suite 100, Vienna, VA 22180 or submit by email to
Mr. Jeffrey Williams at 301-688-2970, or email
Alternatives identified include four options for emergency power generation and various pollution control systems, two options for building heating systems, four options for locations of parking facilities, and acquisition of additional space at two existing, offsite leased locations. Emergency power generation alternatives are generators and combined generators and combustion turbines. Building heating system alternatives are packaged boilers and a hybrid building heating system consisting of packaged boilers and ground source heat pumps. Parking facility alternatives consist of at least three of the following locations: East Campus Parking Structure 2, Bravo parking lot, N8/N9 parking lot, and Building 9817. Use of multi-level parking facilities were considered in lieu of surface parking. In conjunction with some construction and demolition on the East Campus, lease of space outside of Fort Meade at National Business Park and Annapolis Junction Business Park (Alternatives 1 and 2, respectively) were considered. The No Action Alternative (not undertaking the East Campus Integration Program) is also analyzed in detail.
Generally, construction and demolition would result in some ground disturbance and increased traffic congestion at intersections near the installation and proximal to the build
Copies of the Draft EIS are available for public review at local repositories and by request (see
The DoD will consider all comments received and then prepare the Final EIS. As with the Draft EIS, DoD will announce the availability of the Final EIS and once again give you an opportunity for review and comment.
Department of the Army, U.S. Army Corps of Engineers (USACE), DoD.
Notice of Intent.
Pursuant to the section 102(2) (C) of the National Environmental Policy Act (NEPA) of 1969; the U.S. Army Corps of Engineers and the Commonwealth of the Northern Mariana Islands (CNMI), Municipality of Tinian (Municipality)/Commonwealth Ports Authority (CPA) gives notice that an Integrated Feasibility/Environmental Impact Statement (F/EIS) is being prepared for the Proposed Tinian Harbor Modifications Project, Island of Tinian, CNMI. This project is authorized under section 209 of the Rivers and Harbors Act of 1962 (Pub. L. 87-874) and will consider the implementation of navigation improvements at Tinian Harbor.
In order to be considered in the Draft F/EIS, comments and suggestions should be received within 30 days after the last public scoping meeting. Two public scoping meetings will be held in Saipan and Tinian in mid/late July 2016. A separate notice will be published for meeting times and places.
Mail written comments concerning this notice to: Mr. Milton Yoshimoto, Project Manager, Civil and Public Works Branch, Honolulu District, U.S. Army Corps of Engineers, Civil and Public Works Branch, Bldg 230, Fort Shafter, Hawaii 96858. Comment letters should include the commenter's physical mailing address and the project title in the subject line.
Mr. Milton Yoshimoto, Civil and Public Works Branch, Honolulu District, U.S. Army Corps of Engineers, Bldg 230, Fort Shafter, Hawaii 96858, (808) 835-4034, Email:
In accordance with NEPA, the Corps intends to prepare an F/EIS report. The primary Federal actions under consideration are: (1) Navigation improvement measures that expand the turning basin; (2) surge reduction measures by constructing protective structures at both harbors; and (3) dredging harbor sediments to allow larger vessels access to the harbor. The F/EIS reports shall meet the requirements of NEPA, including all applicable federal regulations implementing those statutes.
Evaluation will examine the costs and benefits of this project, as well as the environmental impacts of modifying the maintained dimensions of the existing harbor. The purpose of this effort is to conduct a study to assess the technical, environmental and economic feasibility in the implementation of navigation improvement at Tinian Harbor.
Department of the Army, U.S. Army Corps of Engineers (USACE), DoD.
Notice of intent.
Pursuant to the section 102(2) (C) of National Environmental Policy Act (NEPA) of 1969; the U.S. Army Corps of Engineers and the Commonwealth of the Northern Mariana Islands (CMNI), Municipality of Rota (Municipality)/Commonwealth Ports Authority (CPA) gives notice that an Integrated Feasibility/Environmental Impact Statement (F/EIS) report is being prepared for the Proposed Rota Harbor Modifications Project, Island of Rota, CNMI. This project is authorized under section 209 of the Rivers and Harbors Act of 1962 (Pub. L. 87-874) and will consider the implementation of navigation improvements at Rota Harbor.
In order to be considered in the Draft F/EIS, comments and suggestions should be received within 30 days after the last public scoping meeting. Two public scoping meetings will be held in Saipan and Rota in mid/late July 2016. A separate notice will be published for meeting times and places.
Mail written comments concerning this notice to: Mr. Milton Yoshimoto, Project Manager, Civil and Public Works Branch, Honolulu District, U.S. Army Corps of Engineers, Bldg. 230, Fort Shafter, Hawaii 96858. Comment letters should include the commenter's physical mailing address and the project title in the subject line.
Mr. Milton Yoshimoto, Project Manager, Civil and Public Works Branch, Honolulu District, U.S. Army Corps of Engineers, Bldg. 230, Fort Shafter, Hawaii 96858, (808) 835-4034, E-Mail:
In accordance with NEPA, the Corps intends to prepare an F/EIS report. The primary Federal actions under consideration are: (1) Navigation improvement measures that expand the federal turning basin; (2) surge reduction measures by constructing protective structures at both harbors; and (3) expand and deepen the harbor basin and entrance channel to accommodate larger vessels by dredging. The F/EIS reports shall meet the requirements of NEPA, including all applicable federal regulations implementing those statutes.
Evaluation will examine the costs and benefits of this project, as well as the environmental impacts of modifying the maintained dimensions of the existing Federal project within its authorized limits. The purpose of this effort is to conduct a study to assess the technical, environmental, and economic feasibility in the implementation of navigation improvement at Rota Harbor.
National Center for Education Statistics (NCES), 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 September 6, 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 NCES Information Collections at
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.
Office of Planning, Evaluation and Policy Development (OPEPD), 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 August 8, 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 Joanne Bogart, 202-205-7855.
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.
Office of Innovation and Improvement (OII), 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 August 8, 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 Justis Tuia, 202-453-6654.
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.
Institute of Education Sciences (IES), 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 September 6, 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 Meredith Larson, 202-219-2025.
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.
Office of Career, Technical, and Adult Education (OCTAE), 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 September 6, 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 Braden Goetz, 202-245-7405.
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.
On June 30, 2016, Owyhee Hydro LLC filed a revised application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Owyhee Pumped Storage Project (Owyhee Project or project) to be located on Lake Owyhee near Adrian in Malheur County, Oregon. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A new 1,200-foot-long zoned earth and rockfill or concrete-face rockfill dam forming a lined upper reservoir with a surface area of 109 acres and a storage capacity of 4,035 acre-feet at a maximum surface elevation of 4,320 feet mean sea level (msl); (2) an existing 833 foot-long concrete arch dam forming the existing Lake Owyhee (lower reservoir) with a surface area of 13,900 acres and a storage capacity of 1,120,000 acre-feet at a maximum surface elevation of 2,650 msl; (3) a new 14,100 foot-long conduit connecting the upper and lower reservoirs consisting of a 2,200 foot-long, 17.1 foot-diameter concrete lined low-pressure tunnel, a 7,100 foot-long, 17.1 foot-diameter concrete and steel-lined pressure shaft, and a 4,800-foot-long, 20.5 foot-diameter concrete-lined tailrace; (4) a new 80 feet long by 280 feet wide by 120 feet high powerhouse containing four reversible pump-turbine units rated at 125 megawatts (MW) each for a total capacity of 500 MW; (5) either 2.6 or 8 miles of 500-kilovolt transmission line interconnecting with the Boardman-Hemingway Line, depending on design of infrastructure; and (6) appurtenant facilities. The estimated annual generation of the Owyhee Project would be 1,533,000 megawatt-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
The Federal Energy Regulatory Commission hereby gives notice that members of its staff may attend the meeting of the Southwest Power Pool, Inc. Markets and Operations Policy Committee as noted below. Their attendance is part of the Commission's ongoing outreach efforts.
The meeting will be held on July 12, 2016 from 8:00 a.m. to 5:00 p.m. and July 13, 2016 from 8:00 a.m. to 3:00 p.m. Mountain Time. The location of the meeting is at the Rushmore Plaza Holiday Inn, 505 North Fifth St., Rapid City, SD 57701. The hotel phone number is (605) 348-4000.
The discussions may address matters at issue in the following proceedings:
For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the New York Independent System Operator, Inc.
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 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 meetings 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
On June 13, 2016, the Black Canyon Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Seminoe Pumped Storage Project (project) to be located at the U.S. Bureau of Reclamation's (Reclamation) Seminoe Reservoir on the North Platte River, near Rawlins, Carbon County, Wyoming. The project would occupy lands managed by the U.S. Bureau of Reclamation and the U.S. Bureau of Land Management. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) Two new intake structures located in Reclamation's 20,291-acre Seminoe Reservoir; (2) two new concrete-faced, rock-fill upper reservoirs—one 85 acres and one 63 acres—located on either side of, and about 1,000 feet above, Seminoe Reservoir; (3) a 3,000-foot-long, 18.8-foot diameter, low pressure tunnel and 1,250-foot-long, 18.8-foot-diameter, pressure shaft leading to a 250-foot-long, 65-foot-wide, 170-foot-high powerhouse located 1,300 feet east of Seminoe Reservoir in an underground cavern with a 2,800-foot-long access tunnel and a 1,300-foot-long, 22.6-foot wide tailrace; (5) a 1,300-foot-long, 22.6-foot-diameter, low pressure tunnel and 1,800-foot-long, 16.1-foot-diameter pressure shaft leading to a 220-foot-long, 55-foot-wide, 120-foot-high powerhouse located 2,800 feet north-northwest of Seminoe reservoir in an underground cavern with a 800-foot-long access tunnel and a 2,800-foot-long, 19.3-foot-diameter tailrace; (6) three 133.3-megawatt (MW) adjustable-speed, reversible pump turbines in the east powerhouse; and (7) three 100-MW adjustable-speed reversible pump-turbines in the west powerhouse. The project would also include a double-circuit, 230-kilovolt (kV) transmission line connecting either at PacifiCorp's planned Aeolus Substation located northwest of Medicine Bow, Wyoming, or the planned northern terminal for the TransWest Express DC Line near Sinclair, Wyoming. If the Aeolus interconnection alternative is built, the line would parallel the existing Western Area Power Administration's (WAPA) Miracle Mile-Cheyenne-Ault 230-kV transmission line. If the TransWest interconnection alternative is built, the line would parallel or consist of a rebuild of the existing WAPA Miracle Mile-Sinclair, 115 kV transmission line. The estimated annual generation would be 1,839,600 MW-hours.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
This is a supplemental notice in the above-referenced proceeding of Innovative Solar 43, 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 July 20, 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 Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC) regulations, 18 Code of Federal Regulations part 380, Office of Energy Projects staff has reviewed the application for original license for the Allegheny Lock and Dam 2 Hydroelectric Project (FERC No. 13755-002) on the Allegheny River.
The Allegheny Lock and Dam 2 Hydroelectric Project would be located at an existing lock and dam owned by the U.S. Army Corps of Engineers on the Allegheny River between the boroughs of Sharpsburg and Aspinwall, Pennsylvania, in Allegheny County at river mile 6.7. The project would occupy 3.23 acres of federal land.
Staff has prepared this environmental assessment (EA) that analyzes the potential environmental effects of the project and concludes that constructing and operating the project, with appropriate environmental protection measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Any comments should be filed within 30 days from the date of this notice. The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Nicholas Ettema at (202) 502-6565 or by email at
On October 9, 2015, Tennessee Gas Pipeline Company, L.L.C. (Tennessee) filed an application in Docket No. CP16-4-000 requesting a Certificate of Public Convenience and Necessity pursuant to section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project is known as the Orion Project (Project), and would deliver an additional 135,000 dekatherms per day of natural gas to meet needs of three contracted shippers in the northeast United States.
On October 26, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's
Issuance of EA—August 23, 2016.
90-day Federal Authorization Decision Deadline—November 21, 2016.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
Tennessee proposes to construct and operate pipeline facilities, modify existing aboveground facilities, and add new tie-in facilities in Wayne and Pike Counties, Pennsylvania.
The Project would consist of the following facilities:
• Approximately 12.9 miles of new 36-inch-diameter looping
• a new internal pipeline inspection (“pig”)
• a new pig receiver, crossover, and connecting facilities at the end of the proposed pipeline loop in Pike County; and
• modifications at Tennessee's existing Compressor Station 323, including rewheeling/restaging of an existing compressor and other piping and appurtenant modifications.
On November 23, 2015, the Commission issued a
The U.S. Army Corps of Engineers is a cooperating agency in the preparation of the EA.
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Revision to FR Notice Published06/10/2016; Extending Review Period from 07/11/2016 to 08/11/2016.
Environmental Protection Agency (EPA).
Notice of availability and public comment period.
Notice is hereby given that the Environmental Protection Agency (EPA) has posted on its Web site a draft guidance document titled, “Draft Guidance on Progress Tracking Metrics, Long-Term Strategies, Reasonable Progress Goals and Other Requirements for Regional Haze State Implementation Plans for the Second Implementation
Comments must be received on or before August 22, 2016. Please refer to
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0289, at
For general questions concerning this draft guidance document, please contact Phil Lorang, U.S. EPA, Office of Air Quality Planning and Standards, Air Quality Policy Division, C539-04, Research Triangle Park, NC 27711, telephone (919) 541-5463, email at
The purpose of the draft document on which the EPA is inviting public comment is to provide useful background information and guidance to states on how to develop and submit regional haze state implementation plans (SIPs) for the second implementation period (2018-2028), which under a proposed revision to the Regional Haze Rule published on May 4, 2016,
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2.
• Identify the draft guidance by docket number and other identifying information (subject heading,
• Follow directions.
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
The EPA has also established a Web site for this draft guidance at
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10293, Haven Trust Bank Florida, Ponte Vedra Beach, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Haven Trust Bank Florida (Receivership Estate); the Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective July 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Federal Election Commission.
Tuesday, July 12, 2016 at 10:00 a.m.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109. Matters concerning participation in civil actions or proceeding, or arbitration. Information the premature disclosure of
Judith Ingram, Press Officer; Telephone: (202) 694-1220.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 4, 2016.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to
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Centers for Medicare & Medicaid Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by September 6, 2016.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
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2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep
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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.” This draft guidance document describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA's regulatory review of next generation sequencing (NGS)-based tests. This draft guidance further outlines the process by which administrators of genetic variant databases could voluntarily apply to FDA for recognition, and how FDA would review such applications and periodically reevaluate recognized databases. This draft guidance is not final nor is it in effect at this time.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 6, 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
An electronic copy of the guidance document is available for download from the Internet. See the
Personalized Medicine Staff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4546, Silver Spring, MD 20993-0002, 301-796-7561,
This draft guidance document describes one part of FDA's effort to create a flexible regulatory approach to the oversight of NGS-based tests as part of the White House's Precision Medicine Initiative (PMI). FDA held two workshops on this issue: “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants” on November 13, 2015, and “Patient and Medical Professional Perspectives on the Return of Genetic Test Results” on March 2, 2016. The goal of this effort is to help ensure patients receive accurate and meaningful results, while promoting innovation in test development. This draft guidance document describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to support the clinical validity of genotype-phenotype relationships in FDA's regulatory review of NGS-based tests. FDA is also issuing a draft guidance entitled “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” which is being released concurrently elsewhere in this issue of the
NGS can enable rapid, broad, and deep sequencing of a portion of a gene, entire exome(s), or a whole genome and may be used clinically for a variety of diagnostic purposes, including risk prediction, diagnosis, and treatment selection for a disease or condition. The rapid adoption of NGS-based tests in both research and clinical practice is leading to identification of an increasing number of genetic variants (
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological
Under the Paperwork Reduction Act of 1995 (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.
The draft guidance document “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes FDA's considerations in determining whether a genetic variant database is a source of valid scientific evidence that could support the clinical validity of an NGS-based test. This draft guidance further outlines the process by which administrators
Based on our experience and the nature of the information, we estimate that it will take an average of 80 hours to complete and submit an application for recognition. We estimate that maintenance of recognition activities will take approximately one-fourth of that time (20 hours) annually. We estimate that it will take approximately 1 hour to post the information on the Web site.
Respondents are administrators of genetic databases. Our estimate of five respondents per year is based on the current number of databases that may meet FDA recommendations for recognition and seek such recognition.
FDA estimates the burden of this collection of information as follows:
This draft guidance also refers to previously approved collections of information. These collections of information are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756. The collections of information regarding premarket submissions have been approved as follows: The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231.
The Agency invites comments on the draft guidance document entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics,” in general, and on the following questions, in particular:
1. Should the quality recommendations outlined in the guidance apply equally to databases of somatic variants and to germline variants?
2. While this document applies to NGS-based tests, FDA expects that it may also be relevant to genetic tests that use other technologies (
3. FDA recognizes that the evidence linking specific variants to diseases or conditions will change over time, and as such, assertions about those variants may also change. If an assertion regarding a variant changes over time, how should FDA assess what regulatory actions may be appropriate with respect to in IVDs supported by such assertions? How often should FDA conduct ongoing review of an FDA-recognized database?
4. FDA notes that databases may have “discordant calls” with other databases, where the assertions for a variant in each database vary. While FDA believes that these discordant calls often arise because one database has information the other does not and our proposed policy will mitigate these issues over time; what, if any, action should FDA take when it learns about discordant calls between two databases with respect to database recognition or IVDs supported by such calls in FDA-recognized databases?
5. FDA has requested information regarding conflicts of interest for curators and personnel of databases seeking FDA recognition. FDA acknowledges that many personnel involved with variant curation and interpretation may have some connection to NGS test developers. What type of information should FDA collect and what policies should it implement to mitigate such potential conflicts of interest in FDA-recognized databases?
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases.” As part of the White House's Precision Medicine Initiative (PMI),
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 6, 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.”
•
An electronic copy of the guidance document is available for download from the Internet. See the
Personalized Medicine Staff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4544, Silver Spring, MD 20993-0002, 301-796-6206; or
As part of the PMI, FDA is committed to implementing a flexible and adaptive regulatory oversight approach, which fosters innovation and simultaneously assures that patients have access to accurate and meaningful test results. FDA held two public workshops on this issue: “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop” held on February 20, 2015, and “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests” held on November 12, 2016. This guidance document, when finalized, provides recommendations for designing, developing, and validating for targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions (hereinafter referred to as “NGS-based tests for germline diseases” or “NGS-based tests”). It also outlines considerations for possibly classifying certain NGS-based tests for germline diseases in class II and exempting them from premarket notification requirements. Upon finalization of this guidance, these recommendations should be used as guidelines for test developers for premarket submissions. However, the longer-term goal is for these recommendations to form the basis for standards that FDA could recognize or for special controls and/or conditions for premarket notification (510(k)) exemption. FDA is also issuing a draft guidance entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” which is being issued concurrently elsewhere in this issue of the
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on use of standards in FDA regulatory oversight of NGS-based IVDs used for diagnosing germline diseases. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 and 21 CFR 809.10, regarding labeling, have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820, regarding the quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.
The Agency invites comments on the draft guidance document entitled “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases,” in general, and on the following questions, in particular:
1. Does the draft guidance content adequately address the analytical performance of targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions (referred to as “NGS-based tests for germline diseases” or “NGS-based tests” in the guidance)? For example, do the recommendations outlined in the draft guidance adequately address the analytical performance of NGS-based tests used as an aid in diagnosis of patients with signs and symptoms of developmental delay or intellectual disability, undiagnosed diseases, or hereditary cancer syndromes? If not, what additional test design, development, or validation activities are necessary for analytical validation of such tests? Are there specific indications within this broad intended use that require different or additional test design, development, or validation activities from those described in the draft guidance?
2. Do the recommendations in the draft guidance adequately address the analytical validation of NGS-based tests that use targeted panels or WES? Targeted sequencing panels? Are there differences between the use of targeted panels and WES that were not adequately distinguished in the recommendations described in the draft guidance?
3. The recommendations in this document focus on WES and targeted NGS-based tests for germline diseases. Are the recommendations outlined in the guidance sufficient to address analytical validation for whole genome sequencing (WGS) NGS-based tests for germline diseases? If not, what additional test design, development, and validation activities are needed to address the analytical validation of such tests?
4. Accuracy is generally described using an agreement, typically positive and negative percent agreement (PPA and NPA), between a new test and an accepted reference method. For NGS-based tests, positive predictive value (PPV) may be a more meaningful metric than NPA when calculating the likelihood that a variant call detected by the test is a true positive. If PPV is calculated using only analytical results without taking into account prevalence in a population, it is sometimes called “technical” PPV (TPPV) to distinguish it from prevalence-based PPV. What are the benefits and weaknesses to assessing NGS-based test accuracy using TPPV in addition to PPA and NPA, or instead of NPA?
5. Are the minimum performance thresholds presented in this draft guidance appropriate, or are alternative thresholds more appropriate? Are there “best ways” to determine acceptable thresholds for each metric? Are there performance metrics that do not require minimum thresholds? Are there test scenarios where minimum thresholds are not useful or relevant?
6. How can bias and over-fitting be minimized or accounted for if known “reference” samples are used as comparators in accuracy studies?
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Biocartis NV. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health
The Authorization is effective as of May 26, 2016.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security under section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On September 22, 2006, then-Secretary of DHS, Michael Chertoff, determined that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) subject to the terms of the Authorization. The Authorization in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act:
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 September 6, 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, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852,
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 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation, to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices.
Respondents to this information collection are businesses or other for-profit organizations.
FDA receives an average of one application for accreditation for third-party review per year. According to FDA's data, the number of 510(k)s submitted for third-party review is approximately 260 annually, which is 26 annual reviews per each of the 10 accredited reviewers. Third-party reviewers are required to keep records of their review of each submission.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing a public workshop entitled: Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities. The purpose of the public workshop is to elaborate key aspects of the ICH Guideline Q3D: Guideline on Elemental Impurities in order facilitate a harmonized interpretation and implementation by industry and regulators. It is not intended to provide additional guidance beyond the scope of Q3D. The meeting will take place on the FDA campus and also be broadcast on the Web allowing participants to join in person or via the Web.
The public workshop will be held on August 22 and 23, from 9 a.m. to 5 p.m., EST. See the
The public workshop will be held at 10903 New Hampshire Ave., Bldg. 31, Rm. 1503B/C, Silver Spring, MD 20993. The entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
Amanda Roache, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796-4548, email:
The ICH brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. The ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. The ICH Q3D Guideline was developed by the ICH to provide a global policy for limiting elemental impurities qualitatively and quantitatively in drug products and ingredients. Following finalization of this Guideline, an Implementation Working Group was established to develop a comprehensive training program and supporting documents sponsored by ICH to ensure the proper interpretation and effective utilization
The U.S. regional workshop is intended to clarify key aspects of ICH Q3D: Guideline on Elemental Impurities by elaborating on those key topics. It will include: (1) A discussion of how to apply Q3D concepts to routes of administration, not addressed in Q3D, (2) justification for elemental impurity levels higher than an established permissible daily exposure (PDE) (3) application of Q3D concepts to determine safe levels of elements not included in Q3D, (4) discussion of the rationale for limits on large volume parenterals, (5) elaboration of the concepts outlined in the Q3D Sections on Risk Assessment and Control of Elemental Impurities and (6) options for converting between PDEs and concentrations.
In addition, case studies may be presented to illustrate the concepts described previously, and frequently asked questions will be discussed. The presentation of the material will follow the modules that are available on the ICH Web site,
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Hologic, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
The Authorization is effective as of June 17, 2016.
Submit written requests for single copies of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Carmen Maher, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad,
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.
On February 26, 2016, the Secretary of HHS determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the determination and declaration of the Secretary was published in the
An electronic version of this document and the full text of the Authorization are available on the Internet at
Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of Zika virus subject to the terms of the Authorization. The Authorization in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act:
Office of the National Coordinator for Health Information Technology, HHS.
Notice.
The “Blockchain and Its Emerging Role in Healthcare and Health-related Research.” Ideation Challenge solicits white papers on the topic of Blockchain Technology and the potential use for Healthcare. Winners will be invited to present their submission at an upcoming industry-wide workshop co-hosted with the National Institute of Standards and Technology (NIST). The statutory authority for this Challenge is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
• Submission period begins: June 20.
• Submission period ends: July 29.
• Evaluation begins: August 1.
• Evaluation ends: August 16.
• Winners notified: August 17.
• Winners Announced: August 20.
• Winner Presentation: September 26th-27th.
Debbie Bucci,
A blockchain is a data structure that can be timed-stamped and signed using a private key to prevent tampering. There are generally three types of blockchain: Public, private and consortium. Potential uses include:
• Digitally sign information,
• Computable enforcement of policies and contracts (smart contracts),
• Management of Internet of Things devices,
• Distributed encrypted storage, and
• Distributed trust.
Proponents of blockchain suggest that it could be used to address concerns regarding the privacy, security and the scalability of health records. Critics ascertain that it would take enormous processing power and specialized equipment that far exceeds the benefits. Although most would acknowledge blockchain's potential it is still evolving and maturing, especially with respect to its applicability to the health care.
This Ideation Challenge solicits White Papers on the topic of Blockchain Technology and the Potential for Its Use in Health IT and/or Healthcare Related Research Data.
This nationwide call may be addressed by an individual investigator or a investigator team. Interested parties should submit a White Paper no longer than 10 pages describing the proposed subject. Investigators or co-investigators may participate in no more than three submissions. A limited number of these submissions will be selected. The selection of a White Paper will result in an invitation to present at an upcoming industry-wide workshop on September 26th-27th at NIST Headquarters in Gaithersburg, MD.
The goal of this Ideation Challenge is to solicit White Papers that investigate the relationship between blockchain technology and its use in Health IT and/or Health Related research. The paper should discuss the cryptography and underlying fundamentals of blockchain technology, examine how the use of blockchain can advance industry interoperability needs expressed in the Nationwide Interoperability Roadmap, patient centered outcomes research (PCOR), precision medicine, and other health care delivery needs, as well as provide recommendations for blockchain's implementation.
In lieu of a monetary award, challenge winners will be provided the opportunity to present their White Papers at an industry-wide “Blockchain & Healthcare Workshop” co-hosted by ONC and NIST.
Include a White Paper, not longer than ten (10) pages in length, that:
• Educates its audience on the technology; and
• Can be used to determine whether there is a place in Health IT and/or Healthcare related Research for the technology.
• The paper should:
○ Describe the value of blockchain to the health-care system;
○ Identify potential gaps;
○ Discuss the effectiveness of the solution and the solutions ability to function in the “real world.” This discussion may include information regarding meeting privacy and security standards, implementation and potential performance issues, and cost implications. Risk analysis and mitigation would be appropriate to include here as well.
○ Discuss the solution's link to the stated objectives in the Nationwide Interoperability Roadmap, PCOR, precision medicine and other national health care delivery priorities.
Challenge participants will have five (5) weeks from the date of the posting of this Notice. Those submissions must comply with the requirements provided above. Up to eight submissions may be selected as winners. The names of the winners will be posted on the
To be eligible to win a prize under this Challenge, an individual or entity:
1. Shall have registered to participate in the Challenge under the rules promulgated by the Office of the National Coordinator for Health Information Technology.
2. Shall have complied with all the stated requirements of the Blockchain and Its Emerging Role in Healthcare and Health-related Research Challenge.
3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.
4. May not be a Federal entity or Federal employee acting within the scope of their employment.
5. Shall not be an HHS employee working on their applications or Submissions during assigned duty hours.
6. Shall not be an employee of the Office of the National Coordinator for Health Information Technology.
7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award.
8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge Submission.
An individual or entity shall not be deemed ineligible because the
In order for a Submission to be eligible to win this Challenge, it must meet the following requirements:
1. No HHS or ONC logo—The Solution must not use HHS' or ONC's logos or official seals and must not claim endorsement.
2. Functionality/Accuracy—A Solution may be disqualified if it fails to function as expressed in the description provided by the participant, or if it provides inaccurate or incomplete information.
To register for this Challenge, participants can access
Winners will be provided the following:
• Opportunity to present their paper at a Blockchain & Healthcare Workshop Hosted at NIST
• Paid travel to the Workshop;
• Paid room and board for the Workshop; and
• Paid Per Diem.
Prize will be paid by contractor.
The evaluation process will begin by removing those that are not responsive to this Challenge or not in compliance with all rules for eligibility. Judges will examine all responsive and compliant submissions, and rate the entries. Judges will determine the most meritorious submissions, based on these ratings and select up to eight (8) finalists. Honorable Mentions may be included and announced, along with the winners on Challenge.gov.
The judging panel will rate each submission based upon the effectiveness of the overall concept to help foster transformative change in the HealthIT culture, the viability of the proposed recommendations, the innovativeness of the approach, and its potential for achieving the objectives of ONC.
Up to eight (8) submissions will be selected as winners. Winners will be awarded with the opportunity to present their White Paper at a two-day Blockchain & Healthcare Workshop. In lieu of a monetary prize, finalists will be provided with full expenses for travel to the Workshop, which will be held at the NIST Headquarters in Gaithersburg, MD.
At the end of the submission period, Submissions will be posted on the challenge Web site and will be reviewed, graded, and voted on by a steering committee.
By entering the Challenge, each applicant represents, warrants and covenants as follows:
(a) Participant is the sole author, creator, and owner of the Submission;
(b) The Submission is not the subject of any actual or threatened litigation or claim;
(c) The Submission does not and will not violate or infringe upon the intellectual property rights, privacy rights, publicity rights, or other legal rights of any third party;
Participants must indemnify, defend, and hold harmless the Federal Government from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to or arising from participant's Submission or any breach or alleged breach of any of the representations, warranties, and covenants of participant hereunder. The Federal Agency sponsors reserve the right to disqualify any Submission that, in their discretion, deems to violate these Official Rules, Terms & Conditions.
15 U.S.C. 3719.
Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS.
Request for information.
Deaths from drug overdose have risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesics—a class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic pain—have been increasingly implicated in drug overdose deaths over the last decade. Alarmingly, deaths related to opioid analgesic overdose have quadrupled since 1999, and this increase in deaths has been linked to parallel increases in opioid prescribing. As part of its comprehensive response to the opioid epidemic, HHS is actively working to stem overprescribing of opioids in a number of ways, including by providing clinicians with the tools and education they need to make informed prescribing decisions. In particular, HHS has developed a number of activities that support opioid analgesic prescriber education. This Request for Information (RFI) seeks comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them.
Comments must be received at one of the addresses provided below, no later than 5 p.m. on September 6, 2016.
Written comments may be submitted through any of the methods specified below. Please do not submit duplicate comments.
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Office of the Assistant Secretary for Planning and Evaluation, 202-690-7858.
Education and training in pain management and appropriate opioid analgesic prescribing, including how to identify patients who may be at risk for opioid misuse and ensuring patients treated with opioids receive the appropriate dose and quantity of medication for their condition, are key elements of the response to the opioid epidemic. Surveys of healthcare providers indicate that they receive inadequate training on pain management, and many feel uncomfortable managing patients with pain. In addition, research has identified significant gaps and fragmentation in pain education in health professional schools, and the National Pain Strategy indicates that health professional education is a central component of advancing a system of care in which all people receive high quality and evidence-based pain care.
To improve education and training on pain management and appropriate opioid prescribing, HHS has developed programs that engage prescribers throughout their training and professional career. For example, in an effort to educate health professional students, the National Institutes on Drug Abuse (NIDA) coordinates the National Institutes of Health Pain Consortium's Centers of Excellence in Pain Education that develop and distribute pain management curriculum resources for medical, dental, nursing, and pharmacy schools.
Many HHS training initiatives target practicing clinicians throughout their learning and practice lifecycles. Some programs, such as NIDA's NIDAMED program, offer opioid and pain management training as continuing education credit opportunities. Additionally, the Food and Drug Administration (FDA) has put in place a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. The ER/LA Opioid Analgesic REMS requires manufacturers to make prescriber training available through accredited continuing education (CE) programs funded by the ER/LA sponsors. To assure that the training is balanced and to protect from industry influence, the training is based upon the FDA blueprint for Prescriber Education for ER/LA opioids and is made available through third-party CE providers.
Other programs utilize a peer-to-peer mentoring model. The Substance Abuse and Mental Health Services Administration's Providers' Clinical Support System for Opioid Therapies (PCSS-O) is one such model that offers colleague support and mentoring as well as evidence-based educational resources on how to effectively utilize opioid analgesics for patients with pain and patients with opioid use disorders. And, other resources are intended to support decision making during an active patient encounter. The Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain facilitates providers' decision-making regarding appropriate pain treatment for patients 18 years and older in the primary care setting.
This RFI is seeking comment on the range of approaches to educating and training providers on pain management and appropriate opioid analgesic prescribing, including identifying patients at risk for abuse and prescribing the appropriate dose and quantity of medication for their condition. As noted above HHS has undertaken several programs to engage providers on these topics, and this RFI is meant to solicit input not only on those but also on other approaches. For example, HHS seeks comment on the impact of non-federal prescriber training policies or programs on opioid analgesic prescriber competency:
• How states have developed, promoted, and made pain management and opioid analgesic prescriber education available,
• whether state requirements for mandatory pain management and opioid prescribing training have led to any changes in prescriber behavior and/or other outcomes as a result of these programs,
• the challenges opioid education providers have faced in implementing opioid prescriber education initiatives,
• which measures education providers use to evaluate the success of their interventions, or
• how health information technology has been implemented to assist the prescriber in appropriate opioid prescribing and pain management.
HHS also is soliciting suggestions for additional activities the Department could implement to ensure universal prescriber education on appropriate pain management and opioid prescribing. For example, additional HHS activities could include:
• Adding new opioid prescriber education to Medicare Conditions of Participation and/or to Medicare enrollment requirements,
• adding quality measures around safe opioid use to the specialty core measures that clinicians may choose to report under the Merit-based Incentive Payment System (MIPS), or
• revising the ER/LA Opioid Analgesic REMS to require that prescribers of opioids receive appropriate training on pain management and safe opioid use before being able to prescribe specific opioids.
Finally, HHS seeks feedback through this RFI on the ability of existing HHS education and training programs to educate all opioid analgesic prescribers on appropriate pain management and opioid prescribing including comments on the development and delivery of the content and on efforts to assess the impact of the training initiatives.
Because of the large number of public comments we normally receive on
The Office of Dietary Supplements at the National Institutes of Health (NIH) is sponsoring an open public workshop titled, “Iron Screening and Supplementation of Iron-replete Pregnant Women and Young Children,” September 28-29, 2016, on the NIH main campus in Bethesda, Maryland. It will also be available to be viewed live or later on-demand as a videocast. The workshop discussions will focus on the U.S. and developed countries and will serve to specify data gaps and research needs by (1) exploring current understanding of iron homeostasis in pregnant women and in young children (6‐24 months); (2) identifying the challenges associated with measuring iron status and with screening practices; and (3) considering emerging issues associated with routine supplementation of iron‐replete individuals. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference.
September 28-29, 2016; 8:30 to 5:15 p.m. (Eastern Time) on the first day and 8:00 to 12:30 p.m. on the second day.
National Institutes of Health, William H. Natcher Building; Natcher Conference Center, Building 45, Bethesda, Maryland, 20892.
Ms. Cindy Rooney, Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892-7523, Email:
The conference is sponsored by the NIH Office of Dietary Supplements along with co-sponsors from other federal agencies. Information about the conference agenda, registration procedures, and videocast arrangements can be found at:
Through its Iron Initiative, the National Institutes of Health (NIH) Office of Dietary Supplements leads efforts to advance scientific understanding of iron and health:
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Mr. Boehlert may be contacted via email at
The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized by section 487A of the Public Health Service Act (42 U.S.C. 288-1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP) is authorized by section 487E (42 U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is authorized by section 487C of the Public Health Service Act (42 U.S.C. 288-3); the Clinical Research Loan Repayment Program (LRP-CR) is authorized by section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment Program (PR-LRP) is authorized by
The Loan Repayment Programs can repay up to $35,000 per year toward a participant's extant eligible educational loans, directly to financial institutions. The information proposed for collection will be used by the Division of Loan Repayment to determine an applicant's eligibility for participation in the program.
Questions, required information, and requested documents remain largely unchanged. Improvements were made to the structure and appearance of online forms to provide applicants with a better user experience. Recommenders will no longer be asked to complete a recommendation form, but to write a reference letter that comments on the research skills and the abilities of the applicant. A general eligibility checklist (NIH 2674-20) was added at the start of the application to reduce the likelihood of ineligible individuals working through the application only to learn of their disqualification after submitting the application. Redundant questions or statements were eliminated. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 33,242.
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.
Proposed Collection: National Institute of Neurological Disorders and Stroke Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Access Request, 0925-0677, Expiration Date 08/31/2016—Reinstatement without change, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH).
There are two scenarios for completing the form. The first is where the Principal Investigator (PI) completes the entire FITBIR Informatics System Data Access Request form, and the second where the PI has the Research Assistant begins filling out the form and PI provides the final reviews and signs it. The estimated annual burden hours to complete the data request form are listed below.
OMB approval reinstatement is requested for 3 years. The total estimated annualized burden hours are 63.
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
Notice.
Through this Notice, the Department of Homeland Security (DHS) announces that the Secretary of Homeland Security (Secretary) is extending the designation of El Salvador for Temporary Protected Status (TPS) for 18 months from September 10, 2016 through March 9, 2018.
The extension allows currently eligible TPS beneficiaries to retain TPS through March 9, 2018, so long as they otherwise continue to meet the eligibility requirements for TPS. The Secretary has determined that an extension is warranted because the conditions in El Salvador supporting the TPS designation continue to be met. There continues to be a substantial, but temporary, disruption of living conditions in El Salvador resulting from a series of earthquakes in 2001, and El Salvador remains unable, temporarily, to handle adequately the return of its nationals.
Through this Notice, DHS also sets forth procedures necessary for nationals of El Salvador (or aliens having no nationality who last habitually resided in El Salvador) to re-register for TPS and to apply for renewal of their Employment Authorization Documents (EAD) with U.S. Citizenship and Immigration Services (USCIS). Re-registration is limited to persons who have previously registered for TPS under the designation of El Salvador and whose applications have been granted. Certain nationals of El Salvador
For individuals who have already been granted TPS under the El Salvador designation, the 60-day re-registration period runs from July 8, 2016 through September 6, 2016. USCIS will issue new EADs with a March 9, 2018 expiration date to eligible El Salvador TPS beneficiaries who timely re-register and apply for EADs under this extension. Given the timeframes involved with processing TPS re-registration applications, DHS recognizes that not all re-registrants will receive new EADs before their current EADs expire on September 9, 2016. Accordingly, through this Notice, DHS automatically extends the validity of EADs issued under the TPS designation of El Salvador for 6 months, through March 9, 2017, and explains how TPS beneficiaries and their employers may determine which EADs are automatically extended and their impact on Employment Eligibility Verification (Form I-9) and the E-Verify processes.
The 18-month extension of the TPS designation of El Salvador is effective September 10, 2016, and will remain in effect through March 9, 2018. The 60-day re-registration period runs from July 8, 2016 through September 6, 2016. (
• For further information on TPS, including guidance on the application process and additional information on eligibility, please visit the USCIS TPS Web page at
• You can also contact Jerry Rigdon, Chief of the Waivers and Temporary Services Branch, Service Center Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Washington, DC 20529-2060; or by phone at 202-272-1533 (this is not a toll-free number).
• Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
• Further information will also be available at local USCIS offices upon publication of this Notice.
• TPS is a temporary immigration status granted to eligible nationals of a country designated for TPS under the Immigration and Nationality Act (INA), or to persons without nationality who last habitually resided in the designated country.
• During the TPS designation period, TPS beneficiaries are eligible to remain in the United States, may not be removed, and are authorized to work and obtain EADs, so long as they continue to meet the requirements of TPS.
• TPS beneficiaries may also be granted travel authorization as a matter of discretion.
• The granting of TPS does not result in or lead to permanent resident status.
• When the Secretary terminates a country's TPS designation through a separate
On March 9, 2001, the Attorney General designated El Salvador for TPS based on an environmental disaster within that country, specifically the devastation resulting from a series of earthquakes that occurred in 2001. See
Section 244(b)(1) of the INA, 8 U.S.C. 1254a(b)(1), authorizes the Secretary, after consultation with appropriate U.S. Government agencies, to designate a foreign state (or part thereof) for TPS if the Secretary finds that certain country conditions exist.
At least 60 days before the expiration of a country's TPS designation or extension, the Secretary, after consultation with appropriate Government agencies, must review the conditions in a foreign state designated for TPS and determine whether the conditions for the TPS designation continue to be met.
DHS and the Department of State (DOS) have reviewed conditions in El Salvador. Based on these reviews and after consulting with DOS, the Secretary has determined that an 18-month extension is warranted because the conditions supporting El Salvador's 2001 designation for TPS persist.
El Salvador was originally designated for TPS following two separate earthquakes in 2001. The first earthquake, on January 13, registered 7.6 in magnitude on the standard seismic scale; the second, on February 13, measured 6.6 in magnitude. Over 3,000 aftershocks hit El Salvador in the aftermath of the earthquakes, including those with 5.1 and 5.6 magnitudes in late February 2001.
Together, the earthquakes killed over 1,000 people, caused approximately 8,000 injuries, and affected approximately 1.5 million people. Of 262 municipalities in El Salvador, 165 suffered serious damage in the first quake. The earthquakes caused significant damage to transportation infrastructure, housing, education and health services, small and medium businesses, and the environment.
Recovery from the earthquakes has been slow and encumbered by subsequent natural disasters and environmental challenges, including hurricanes and tropical storms, heavy rains and flooding, volcanic and seismic activity, an ongoing coffee rust epidemic, and a prolonged regional drought that is impacting food security. The regional drought currently affecting El Salvador has made the country the driest it has been in 35 years. The drought is projected to cause more than $400 million in losses from corn, beans, coffee, sugar cane, livestock, and vegetables, resulting in subsistence farmers facing malnutrition and pressure to migrate. Due to the drought and a regional coffee rust epidemic, coffee production for the 2015-2016 harvest is projected to be 30-percent lower than the previous season, and the U.S. Department of Agriculture expects next year's harvests to be the smallest in 80 years. Further, environmental and social conditions have contributed to an outbreak of mosquito borne illnesses, including chikungunya and dengue.
Although progress has been made in repairing physical damage caused by the 2001 earthquakes, infrastructure challenges remain. El Salvador faces a housing deficit of approximately 630,000 houses, created in part because 340,000 homes destroyed in the 2001 earthquakes still have not been rebuilt. A lack of potable water and electricity remain serious problems; more than 10 percent of El Salvador's total population lacks access to potable water. Water contamination and shortages are of particular concern in the San Salvador metropolitan area, where they have affected the day-to-day activities of the population and have reportedly led to conflicts over water. In March 2016, extortion demands from gangs caused an almost weeklong temporary bottled water shortage and halting of some water deliveries in San Salvador. Insecurity and water shortages have contributed to increased inflation, which is generally low due to El Salvador's dollarized economy.
Increasing violence and insecurity is also a major constraint to economic growth. According to a study released in April 2016 by El Salvador's Central Bank and the United Nations Development Program, Salvadoran citizens paid $756 million in extortion payments to gangs in 2014, representing about three percent of Gross Domestic Product (GDP). The study estimates the total cost of violence, including the amount households spend on extra security and the lost income from people deterred from working, is nearly 16 percent of GDP, the highest level in Central America. Hampered by limited financial resources, the government continues to struggle to respond adequately to increasing levels of crime, and there is little confidence the security situation will improve in the short term.
The fiscal, unemployment, and security situations in El Salvador also remain poor. El Salvador's economy is experiencing significant challenges. Around a third of the country's work force is underemployed or unable to find full-time work. In 2014, almost a third of all Salvadorans (31.9 percent) lived in poverty. Murder, extortion, and robbery rates are high, and the government struggles to respond adequately to crime, including significant criminal gang activity. The police suffer from insufficient staffing, corruption, and inadequate training. The judicial system is also weak, with a low criminal conviction rate and high levels of corruption, creating an environment of impunity.
Based upon this review and after consultation with appropriate U.S. Government agencies, the Secretary finds that:
• The conditions supporting the March 9, 2001 designation of El Salvador for TPS continue to be met.
• There continues to be a substantial, but temporary, disruption of living conditions in El Salvador as a result of an environmental disaster.
• El Salvador continues to be unable, temporarily, to handle adequately the return of its nationals (or aliens having no nationality who last habitually resided in El Salvador).
• The designation of El Salvador for TPS should be extended for an additional 18-month period from September 10, 2016 through March 9, 2018.
• There are approximately 195,000 current El Salvador TPS beneficiaries who are expected to file for re-registration and may be eligible to retain their TPS under the extension.
By the authority vested in me as Secretary under INA section 244, 8 U.S.C. 1254a, I have determined, after consultation with the appropriate U.S. Government agencies, that the conditions that prompted the designation of El Salvador for TPS in 2001 continue to be met.
To register or re-register for TPS based on the designation of El Salvador, an applicant must submit each of the following two applications:
1. Application for Temporary Protected Status (Form I-821).
• If you are filing an application for late initial registration, you must pay the fee for the Application for Temporary Protected Status (Form I-821).
• If you are filing an application for re-registration, you do not need to pay the fee for the Application for
2. Application for Employment Authorization (Form I-765).
• If you are applying for late initial registration and want an EAD, you must pay the fee for the Application for Employment Authorization (Form I-765) only if you are age 14 through 65. No fee for the Application for Employment Authorization (Form I-765) is required if you are under the age of 14 or are 66 and older and applying for late initial registration.
• If you are applying for re-registration, you must pay the fee for the Application for Employment Authorization (Form I-765) only if you want an EAD, regardless of age.
• You do not pay the fee for the Application for Employment Authorization (Form I-765) if you are not requesting an EAD, regardless of whether you are applying for late initial registration or re-registration.
You must submit both completed application forms together. If you are unable to pay for the Application for Employment Authorization (Form I-765) and/or biometrics fee, you may apply for a fee waiver by completing a Request for Fee Waiver (Form I-912) or submitting a personal letter requesting a fee waiver, and by providing satisfactory supporting documentation. For more information on the application forms and fees for TPS, please visit the USCIS TPS Web page at
Biometrics (such as fingerprints) are required for all applicants 14 years of age or older. Those applicants must submit a biometric services fee. As previously stated, if you are unable to pay for the biometric services fee, you may apply for a fee waiver by completing a Request for Fee Waiver (Form I-912) or by submitting a personal letter requesting a fee waiver, and providing satisfactory supporting documentation. For more information on the biometric services fee, please visit the USCIS Web site at
USCIS urges all re-registering applicants to file as soon as possible within the 60-day re-registration period so that USCIS can process the applications and issue EADs promptly. Filing early will also allow those applicants who may receive denials of their fee waiver requests to have time to re-file their applications before the re-registration deadline. If, however, an applicant receives a denial of his or her fee waiver request and is unable to re-file by the re-registration deadline, the applicant may still re-file his or her application. This situation will be reviewed to determine whether the applicant has established good cause for late re-registration. However, applicants are urged to re-file within 45 days of the date on their USCIS fee waiver denial notice, if at all possible.
Mail your application for TPS to the proper address in Table 1.
If you were granted TPS by an Immigration Judge (IJ) or the Board of Immigration Appeals (BIA), and you wish to request an EAD, or are re-registering for the first time following a grant of TPS by an IJ or the BIA, please mail your application to the appropriate address in Table 1. When submitting a re-registration application and/or requesting an EAD based on an IJ/BIA grant of TPS, please include a copy of the IJ or BIA order granting you TPS with your application. This will aid in the verification of your grant of TPS and processing of your application, as USCIS may not have received records of your grant of TPS by either the IJ or the BIA.
You cannot electronically file your application when re-registering or submitting an initial registration for El Salvador TPS. Please mail your application to the mailing address listed in Table 1.
The filing instructions on the Application for Temporary Protected Status (Form I-821) list all the documents needed to establish basic eligibility for TPS. You may also find information on the acceptable documentation and other requirements for applying or registering for TPS on the USCIS Web site at
If one or more of the questions listed in Part 4, Question 2 of the Application for Temporary Protected Status (Form I-821) applies to you, then you must submit an explanation on a separate sheet(s) of paper and/or additional documentation.
To get case status information about your TPS application, including the status of a request for an EAD, you can check Case Status Online at
Provided that you currently have TPS under the designation of El Salvador, this Notice automatically extends your EAD by 6 months if you:
• Are a national of El Salvador (or an alien having no nationality who last habitually resided in El Salvador);
• Received an EAD under the last extension of TPS for El Salvador; and
• Have an EAD with a marked expiration date of September 9, 2016, bearing the notation “A-12” or “C-19” on the face of the card under “Category.”
Although this Notice automatically extends your EAD through March 9, 2017, you must re-register timely for TPS in accordance with the procedures described in this Notice if you would like to maintain your TPS.
You can find a list of acceptable document choices on the “Lists of Acceptable Documents” for Employment Eligibility Verification (Form I-9). You can find additional detailed information on the USCIS I-9 Central Web page at
You may present any document from List A (reflecting both your identity and employment authorization) or one document from List B (reflecting identity) together with one document from List C (reflecting employment authorization). Or you may present an acceptable receipt for List A, List B, or List C documents as described in the Employment Eligibility Verification (Form I-9) Instructions. An EAD is an acceptable document under “List A.” Employers may not reject a document based on a future expiration date.
If your EAD has an expiration date of September 9, 2016, and states “A-12” or “C-19” under “Category,” it has been extended automatically for 6 months by virtue of this
Even though EADs with an expiration date of September 9, 2016, that state “A-12” or “C-19” under “Category” have been automatically extended for 6 months by this
By March 9, 2017, the expiration date of the automatic extension, your employer must reverify your
No. When completing Employment Eligibility Verification (Form I-9), including re-verifying employment authorization, employers must accept any documentation that appears on the “Lists of Acceptable Documents” for Employment Eligibility Verification (Form I-9) that reasonably appears to be genuine and that relates to you or an acceptable List A, List B, or List C receipt. Employers may not request documentation that does not appear on the “Lists of Acceptable Documents.” Therefore, employers may not request proof of Salvadoran citizenship or proof of re-registration for TPS when completing Employment Eligibility Verification (Form I-9) for new hires or reverifying the employment authorization of current employees. If presented with EADs that have been automatically extended, employers should accept such EADs as valid List A documents so long as the EADs reasonably appear to be genuine and to relate to the employee. Refer to the
After March 9, 2017, employers may no longer accept the EADs that this
When using an automatically extended EAD to complete Employment Eligibility Verification (Form I-9) for a new job prior to March 9, 2017, you and your employer should do the following:
1. For Section 1, you should:
a. Check “An alien authorized to work;”
b. Write your alien number (USCIS number or A-number) in the first space (your EAD or other document from DHS will have your USCIS number or A-number printed on it; the USCIS number is the same as your A-number without the A prefix); and
c. Write the automatically extended EAD expiration date (March 9, 2017) in the second space.
2. For Section 2, employers should record the:
a. Document title;
b. Document number; and
c. Automatically extended EAD expiration date (March 9, 2017).
By March 9, 2017, employers must reverify the employee's employment authorization in Section 3 of the Employment Eligibility Verification (Form I-9).
If you are an existing employee who presented a TPS-related EAD that was valid when you first started your job, but that EAD has now been automatically extended, your employer may need to reinspect your automatically extended EAD if your employer does not have a copy of the EAD on file, and you and your employer should correct your previously completed Employment Eligibility Verification (Form I-9) as follows:
1. For Section 1, you should:
a. Draw a line through the expiration date in the second space;
b. Write “March 9, 2017” above the previous date;
c. Write “TPS Ext.” in the margin of Section 1; and
d. Initial and date the correction in the margin of Section 1.
2. For Section 2, employers should:
a. Draw a line through the expiration date written in Section 2;
b. Write “March 9, 2017” above the previous date;
c. Write “TPS Ext.” in the margin of Section 2; and
d. Initial and date the correction in the margin of Section 2.
By March 9, 2017, when the automatic extension of EADs expires, employers must reverify the employee's employment authorization in Section 3.
E-Verify automated the verification process for employees whose TPS status was automatically extended in a
Employers are reminded that the laws requiring proper employment eligibility verification and prohibiting unfair immigration-related employment practices remain in full force. This Notice does not supersede or in any way limit applicable employment verification rules and policy guidance, including those rules setting forth reverification requirements. For general questions about the employment eligibility verification process, employers may call USCIS at 888-464-4218 (TTY 877-875-6028) or email USCIS at
For general questions about the employment eligibility verification process, employees may call USCIS at 888-897-7781 (TTY 877-875-6028) or email at
To comply with the law, employers must accept any document or combination of documents from the Lists of Acceptable Documents if the documentation reasonably appears to be genuine and to relate to the employee, or an acceptable List A, List B, or List C receipt described in the Employment Eligibility Verification (Form I-9) Instructions. Employers may not require extra or additional documentation beyond what is required for Employment Eligibility Verification (Form I-9) completion. Further, employers participating in E-Verify who receive an E-Verify case result of “Tentative Nonconfirmation” (TNC) must promptly inform employees of the TNC and give such employees an opportunity to contest the TNC. A TNC case result means that the information entered into E-Verify from Employment Eligibility Verification (Form I-9) differs from Federal or State government records.
Employers may not terminate, suspend, delay training, withhold pay, lower pay or take any adverse action against an employee based on the employee's decision to contest a TNC or because the case is still pending with E-Verify. A Final Nonconfirmation (FNC) case result is received when E-Verify cannot verify an employee's employment eligibility. An employer may terminate employment based on a case result of FNC. Work-authorized employees who receive an FNC may call USCIS for assistance at 888-897-7781 (TTY 877-875-6028). An employee that believes he or she was discriminated against by an employer in the E-Verify process based on citizenship or immigration status, or based on national origin, may contact OSC's Worker Information Hotline at 800-255-7688 (TTY 800-237-2515). Additional information about proper nondiscriminatory Employment Eligibility Verification (Form I-9) and E-Verify procedures is available on the OSC Web site at
While Federal Government agencies must follow the guidelines laid out by the Federal Government, State and local government agencies establish their own rules and guidelines when granting certain benefits. Each State may have different laws, requirements, and determinations about what documents you need to provide to prove eligibility for certain benefits. Whether you are applying for a Federal, State, or local government benefit, you may need to provide the government agency with documents that show you are a TPS beneficiary and/or show you are authorized to work based on TPS. Examples are:
(1) Your unexpired EAD that has been automatically extended or your EAD that has not expired;
(2) A copy of this
(3) A copy of your Application for Temporary Protected Status Notice of Action (Form I-797) for this re-registration;
(4) A copy of your past or current Application for Temporary Protected Status Notice of Action (Form I-797), if you received one from USCIS; and/or
(5) If there is an automatic extension of work authorization, a copy of the fact sheet from the USCIS TPS Web site that provides information on the automatic extension.
Check with the government agency regarding which document(s) the agency will accept. You may also provide the agency with a copy of this
Some benefit-granting agencies use the USCIS Systematic Alien Verification for Entitlements Program (SAVE) to verify the current immigration status of applicants for public benefits. If such an agency has denied your application based solely or in part on a SAVE response, the agency must offer you the opportunity to appeal the decision in accordance with the agency's procedures. If the agency has received and acted upon or will act upon a SAVE verification and you do not believe the response is correct, you may make an InfoPass appointment for an in-person interview at a local USCIS office. Detailed information on how to make corrections, make an appointment, or submit a written request to correct records under the Freedom of Information Act can be found at the SAVE Web site at
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7262, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with the December 12, 1988 court order in
Bureau of Land Management, Interior.
Notice.
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, and the Mineral Leasing Act of 1920 (MLA), as amended, the Bureau of Land Management (BLM) prepared a Final Environmental Impact Statement (EIS) for the Bull Mountain Unit Master Development Plan (MDP) and by this notice is announcing its availability.
The BLM will not issue a final decision on the proposal for a minimum of 30 days after the date the Environmental Protection Agency publishes its Notice of Availability for the Bull Mountain MDP Final EIS in the
Copies of the Bull Mountain MDP Final EIS are available for public inspection at the Uncompahgre Field Office, 2465 South Townsend Ave., Montrose, CO 81401. Interested persons may also review the Final EIS on the project Web site at
Gina Jones, Southwest District NEPA Coordinator; telephone (970) 240-5300; Uncompahgre Field Office, 2465 South Townsend Ave., Montrose, CO 81401; email
SG Interests I, Ltd. (SGI) submitted a master development plan proposal, the Bull Mountain MDP, to the BLM's Uncompahgre Field Office for its Bull Mountain Unit. The MDP covers natural gas exploration and development within the Bull Mountain Unit. An MDP provides information common to multiple planned wells, including drilling plans, Surface Use Plans of Operations, and plans for future production in order to guide that development going forward. The MDP allows SGI to exercise their lease rights, while drilling in a manner that limits the impacts to natural resources in the area.
The Bull Mountain Unit MDP Final EIS analyzed the environmental impacts of the exploration and development of up to 146 natural gas wells, four water disposal wells, and associated infrastructure on Federal and private mineral leases within a federally unitized area known as the Bull Mountain Unit. SGI developed the unit after exploration wells demonstrated the potential for economically viable reserves of natural gas.
The Bull Mountain Unit is located within the Colorado River basin, approximately 30 miles northeast of the town of Paonia, and is bisected by State Highway 133. The boundaries of the unit encompass approximately 19,670 acres of Federal and private oil and gas mineral estate in Gunnison County, CO. The unit consists of 440 acres of federally owned surface lands and mineral estate administered by the BLM; 12,900 acres of split-estate lands, consisting of private surface and BLM-administered Federal mineral estate; and 6,330 acres of fee land, consisting of private surface and private mineral estate.
Work on the MDP began with a preliminary Environmental Assessment (EA) in 2008. In 2012, the BLM determined that an EIS was necessary, due to potential significant impacts to air quality in nearby Class I air sheds, water, socioeconomics, and wildlife. The BLM released the Draft EIS for a 45-day public comment period on January 16, 2015. The comment period was subsequently extended for an additional 45 days and closed on April 16, 2015. The BLM held one public meeting on February 10, 2015, and received 565 unique comment letters and 83 form letters. The BLM carefully reviewed and responded to those comments as part of the development of the Final EIS.
To comply with the Endangered Species Act, the BLM consulted with the U.S. Fish and Wildlife Service (USFWS) for two threatened species—greenback cutthroat trout and the Canada Lynx. The USFWS concurred with the BLM's finding that the proposed action “may affect, but is not likely to adversely affect” the greenback cutthroat trout and the Canada Lynx, or designated habitat for either species. To comply with Section 106 of the National Historic Preservation Act, the BLM consulted with the Colorado State Historic Preservation Office (SHPO) and interested Indian Tribes. The SHPO concurred with the BLM's finding of no effect on historic properties.
The Final EIS analyzes a reasonable range of alternatives, including a No Action Alternative (Alternative A), the proposed action (Alternative B), and a modified action (Alternative C). Based on the public comment received, additional internal reviews were completed by the BLM; updated information was provided by SGI; the BLM added clarifying text to the Final EIS; and the BLM developed an additional alternative, Alternative D, which was selected as the preferred alternative. Alternative D includes additional design features that specifically address impacts to air resources and air quality-related resource values, water resources, and wildlife.
Alternative D is also the environmentally preferred alternative, because it best achieves the following:
• Satisfies statutory requirements (true for all alternatives);
• Represents what the BLM believes to be the best combination of action alternatives analyzed in the EIS and best meets the purpose and need for action, as described in Chapter 1 of the Final EIS;
• Provides the best approach to address key resource and planning issues;
• Provides resource protection and a viable strategy for development of the mineral resources in the area;
• Responds to the public comments received; and
• Reflects input from cooperating agencies, stakeholders, the public, and BLM resource specialists.
Alternative D is within the scope of the Alternatives analyzed in the Draft EIS.
40 CFR 1506.6, 40 CFR 1506.10.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This IC is scheduled to expire on August 31, 2016. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.
You must submit comments on or before August 8, 2016.
Send your comments and suggestions on this information collection to the Desk Officer for the Department of the Interior at OMB—OIRA at (202) 395-5806 (fax) or
To request additional information about this ICR, contact Samantha Towery, National Park Service, 12795 West Alameda Parkway, Lakewood, CO 80228; by fax at (303) 987-6901; or via email at
The purpose of this information collection is to assist the NPS in managing the Commercial Use Authorization Program. Conducting commercial operations in a unit of the National Park System without a contract, permit, commercial use authorization, or some other written agreement is prohibited. Section 418, Public Law 105-391 (54 U.S.C. 101925) gives the Secretary of the Interior the authority to authorize a private person, corporation, or other entity to provide services to visitors in units of the National Park System through a Commercial Use Authorization (CUA). Such authorizations are not considered concession contracts. We authorize commercial operations that originate and operate entirely within a park (in-park); commercial operations that provide services originating and terminating outside of the park boundaries; organized children's camps, outdoor clubs, and nonprofit institutions; and other uses as the Secretary determines appropriate. The commercial operations include a range of services, such as mountain climbing guides, boat repair services, transportation services and tours, canoe livery operations, hunting guides, retail sales, equipment rentals, catering services, and dozens of other visitor services.
Section 418 limits CUAs to:
• Commercial operations with annual gross receipts of not more than $25,000 resulting from services originating and provided solely within a unit of the National Park System;
• Incidental use of resources of the unit by commercial operations which provide services originating and terminating outside of the boundaries of the unit; or
• Uses by organized children's camps, outdoor clubs and nonprofit institutions (including back country use) and such other uses as the Secretary determines appropriate.
The legislative mandate of the NPS, found at 54 U.S.C. 1100101, is to preserve America's natural wonders unimpaired for future generations, while also making them available for the enjoyment of visitors. Meeting this mandate requires the NPS to balance preservation with use. Maintaining a good balance requires both information and limits. The information requested will allow the unit manager to evaluate requests for a commercial use to determine impact on the resources and the appropriateness of the activity.
We collect information on the CUA Application (Form 10-550), the CUA Annual Report (Form 10-660), and CUA Monthly Report (Form 10-660A). We use the information from these forms to:
• Manage the program and operations.
• Determine the qualifications and abilities of the commercial operators to provide a high quality, safe, and enjoyable experience for park visitors.
• Determine the impact on the parks natural and cultural resources.
• Manage the use and impact of multiple operators.
The information requested will allow the NPS to evaluate requests for a commercial use authorization and determine the suitability of the applicants to safely and effectively provide an appropriate service to the visiting public. It will also enable the NPS to manage the activity in a manner that protects the natural and cultural resources and the park visitor. Management includes, but is not limited to, managing the number of permits issued, determining the location and time that the activity occurs, and requiring the appropriate visitor protections including insurance, equipment, training, and procedures.
On January 11, 2016, we published in the
Additionally, in Katmai National Park only, CUA holders that provide transportation are required to submit the CUA Monthly report in addition to the CUA Annual Report. The vast majority of visitors access the park by plane or boat operated by authorized commercial service providers and there are no entrance stations to track the number of visitors. The CUA Monthly reports provide the only means of securing an accurate visitor count and are used to influence short-term resource management decisions. By requiring only those authorized transportation providers to submit the CUA Monthly report, duplicate reporting is eliminated. The decision to limit the requirement of monthly reporting to only those CUA holders providing transportation was reached after public meetings held with current and prospective CUA holders. The NPS did not make any changes to our information collection based on these comments.
We also received a comment from Jean Public. The commenter did not address the information collection requirements, but stated that the Government should charge CUA holders fees to operate on public lands. NPS is legally required to charge a fee for commercial operations [section 418, Pub. L. 105-391 (54 U.S.C. 101925)]. Parks, at a minimum, charge a fee to recover costs associated with the management and administration of CUAs. We did not make any changes to our information collection based on this comment.
We again invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden of the collection of information on respondents.
Comments that you submit in response to this notice are a matter of public record. 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 OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.
To ensure that your comments on this ICR are considered, OMB must receive them on or before August 8, 2016.
Please direct all written comments on this ICR directly to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior, to
Phadrea Ponds, Information Collection Coordinator, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or
Managers of Cape Lookout National Seashore (CALO) are interested in identifying ways to reduce the risk of damage to coastal buildings and sensitive species from storm surge, sea level rise, and shoreline erosion anticipated over the next 20 to 30 years. Of specific interest to managers are contemporary cultural resource values and perceptions of cultural resource vulnerability and feasible adaptation strategies to sustain its cultural resources for future generations. The National Park Service will conduct a survey with members of CALO's partner organizations and cultural resource experts from federal and state agencies and nongovernmental organizations.
The collection will be used to understand the values these stakeholders place on cultural resources within the historic districts, and perceptions of strategies to adapt and respond to changes in cultural resource conditions from storms, flooding, and erosion. The information from this collection will provide NPS managers with information that can be used to prepare resource management planning documents.
A notice was published in the
We again invite comments concerning this information collection on:
• Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful;
• The accuracy of the agency's estimate of the burden of the proposed collection of information;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. 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 OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
National Park Service, Interior.
Meeting notice.
This notice sets forth the date of the 303rd Meeting of the Cape Cod National Seashore Advisory Commission.
The public meeting of the Cape Cod National Seashore Advisory Commission will be held on Monday, September 19, 2016, at 1:00 p.m. (EASTERN).
The 303rd meeting of the Cape Cod National Seashore Advisory Commission will take place on Monday, September 19, 2016, at 1:00 p.m., in the conference room at park headquarters, 99 Marconi Site Road, Wellfleet, Massachusetts 02667 to discuss the following:
Further information concerning the meeting may be obtained from George E. Price, Jr., Superintendent, Cape Cod National Seashore, 99 Marconi Site, Wellfleet, Massachusetts 02667, or via telephone at (508) 771-2144 or by email at
The Commission was reestablished pursuant to Public Law 87-126, as amended by Public Law 105-280. The purpose of the Commission is to consult with the Secretary of the Interior, or her designee, with respect to matters relating to the development of Cape Cod National Seashore, and with respect to carrying out the provisions of sections 4 and 5 of the Act establishing the Seashore.
The meeting is open to the public. It is expected that 15 persons will be able to attend the meeting in addition to Commission members. Interested persons may make oral/written presentations to the Commission during the business meeting or file written statements. Such requests should be made to the park superintendent prior to the meeting. Before including your address, telephone 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 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.
As required by the Federal Advisory Committee Act (16 U.S.C. Appendix 1-16), the National Park Service (NPS) is hereby giving notice that the Denali National Park Subsistence Resource Commission (SRC) will hold a public meeting to develop and continue work on NPS subsistence program recommendations, and other related regulatory proposals and resource management issues. The NPS SRC program is authorized under title VIII, section 808 of the Alaska National Interest Lands Conservation Act, Public Law 96-487.
The Denali National Park SRC will meet from 10:30 a.m. to 5:00 p.m. or until business is completed on Tuesday, August 2, 2016.
The Denali National Park SRC will meet at Friday Creek at the Kantishna Yurt in Denali National Park, AK.
For more detailed information regarding this meeting, or if you are interested in applying for SRC membership, contact Designated Federal Official Donald Striker, Superintendent, at (907) 683-9581, or via email at
SRC meeting locations and dates may change based on inclement weather or exceptional circumstances. If the meeting date and location are changed, the Superintendent will issue a press release and use local newspapers and radio stations to announce the rescheduled meeting.
The meetings are open to the public and will have time allocated for public testimony. The public is welcome to present written or oral comments to the SRC. SRC meetings will be recorded and meeting minutes will be available upon request from the Superintendent for public inspection approximately six weeks after the meeting. Before including your address, telephone 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 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.
Bureau of Reclamation, Interior.
Notice.
The Bureau of Reclamation and the California State Lands Commission have prepared the Mendota Pool Bypass and Reach 2B Improvements Project Final Environmental Impact Statement/Environmental Impact Report (EIS/EIR). The Mendota Pool Bypass and Reach 2B Improvements Project is a component of Phase 1 of the San Joaquin River Restoration Program which seeks to restore flows to the San Joaquin River from Friant Dam to the confluence of the Merced River, and restore a self-sustaining Chinook salmon fishery in the river while reducing or avoiding adverse water supply impacts associated with restoration flows. The Project includes the construction, operation, and maintenance of the Mendota Pool Bypass and improvements in the San Joaquin River channel in Reach 2B to contribute to achieving the San Joaquin River Restoration Program's Restoration Goal.
The Bureau of Reclamation (Reclamation) will not issue a final decision on the proposed action until at least 30 days after the date that the Environmental Protection Agency releases the Final EIS/EIR. After the EIS/EIR has been available for 30 days, Reclamation will complete a Record of Decision. The Record of Decision will state the action that Reclamation will implement and will discuss all factors considered in the decision.
Send written correspondence or requests for copies or a compact disc of the Final EIS/EIR to Ms. Becky Victorine, Bureau of Reclamation, San Joaquin River Restoration Program, 2800 Cottage Way, Room W-1727, Sacramento, California
The Final EIS/EIR may be viewed on Reclamation's Web site at
Ms. Katrina Harrison, Program Engineer, Bureau of Reclamation, via email at
The San Joaquin River Restoration Program (SJRRP) was established in late 2006 to implement the Stipulation of Settlement (Settlement) in
The EIS/EIR analyzes five alternatives. Under the No-Action Alternative, the Project would not be implemented. Although future conditions would not include the components described below in the Action Alternatives, other components of the SJRRP would be implemented following completion and receipt of appropriate environmental reviews and approvals, as necessary. Likely future conditions include implementation of the other components of the SJRRP selected alternative, as described in the 2012 Record of Decision and analyzed in the SJRRP Program EIS/EIR, including Restoration Flows similar to those that started January 2014, and other reasonably foreseeable actions expected to occur in the Project area.
Four Action Alternatives are analyzed in the EIS/EIR: Alternative A (Compact Bypass with Narrow Floodplain and South Canal), Alternative B (Compact Bypass with Consensus-Based Floodplain and Bifurcation Structure), Alternative C (Fresno Slough Dam with Narrow Floodplain and Short Canal), and Alternative D (Fresno Slough Dam with Wide Floodplain and North Canal). All four Action Alternatives are designed to provide conveyance of at least 4,500 cfs in Reach 2B and through the Mendota Pool Bypass, and diversion and screening of up to 2,500 cfs from Reach 2B into Mendota Pool. Constructed elements common to the Action Alternatives include the provision of fish habitat and passage, seepage control measures, removal of existing levees and structures, and levee and structure construction and modification, among other activities.
Alternative B (Compact Bypass with Consensus-Based Floodplain and Bifurcation Structure) [PREFERRED ALTERNATIVE], would construct the Compact Bypass Channel between Reach 2B and Reach 3 to bypass the Mendota Pool. Restoration Flows would enter Reach 2B at the Chowchilla Bifurcation Structure, flow through Reach 2B, then downstream to Reach 3 via the Compact Bypass Channel. The existing Chowchilla Bifurcation Structure would continue to divert San Joaquin River flows into the Chowchilla Bypass during flood operations, and a fish passage facility and control structure modifications would be included at the San Joaquin River control structure at the Chowchilla Bypass. A bifurcation structure would be built at the head of the Compact Bypass Channel to control diversions into Mendota Pool. Fish passage facilities would be built at the Compact Bypass bifurcation structure to provide passage around the structure and prevent fish being entrained in the diversion. The San Mateo Avenue crossing would be removed.
A Notice of Availability for the Draft EIS/EIR was published in the
Copies of the Final EIS/EIR are available for public review at the following locations:
1. Bureau of Reclamation, Mid-Pacific Region, Regional Library, 2800 Cottage Way, Sacramento, CA 95825.
2. Natural Resources Library, U.S. Department of the Interior, 1849 C Street NW., Main Interior Building, Washington, DC 20240-0001.
Before including your address, phone number, email address, or other personal identifying information in any communication, you should be aware that your entire communication—including your personal identifying information—may be made publicly available at any time. While you can ask us in your communication to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
60-Day notice.
To comply with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Safety and Environmental Enforcement (BSEE) is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns renewal to the paperwork requirements in the regulations under Subpart F,
You must submit comments by September 6, 2016.
You may submit comments by either of the following methods listed below.
•
•
Kelly Odom, Regulations and Standards Branch at (703) 787-1775 to request additional information about this ICR.
Section 5(a) of the OCS Lands Act requires the Secretary to prescribe rules and regulations “to provide for the prevention of waste, and conservation of the natural resources of the Outer Continental Shelf, and the protection of correlative rights therein” and to include provisions “for the prompt and efficient exploration and development of a lease area.” These authorities and responsibilities are among those delegated to BSEE to ensure that operations in the OCS will meet statutory requirements; provide for safety and protection of the environment; and result in diligent exploration, development, and production of OCS leases. This information collection (IC) request addresses the regulations at 30 CFR 250, subpart F, Oil and Gas Well-Workover Operations, and any associated supplementary Notices to Lessees and Operators (NTLs) intended to provide clarification, description, or explanation of these regulations.
In addition to the general rulemaking authority of the OCSLA at 43 U.S.C. 1334, section 301(a) of the Federal Oil and Gas Royalty Management Act (FOGRMA), 30 U.S.C. 1751(a), grants authority to the Secretary to prescribe such rules and regulations as are reasonably necessary to carry out FOGRMA's provisions. While the majority of FOGRMA is directed to royalty collection and enforcement, some provisions apply to offshore operations. For example, section 108 of FOGRMA, 30 U.S.C. 1718, grants the Secretary broad authority to inspect lease sites for the purpose of determining whether there is compliance with the mineral leasing laws. Section 109(c)(2) and (d)(1), 30 U.S.C. 1719(c)(2) and (d)(1), impose substantial civil penalties for failure to permit lawful inspections and for knowing or willful preparation or submission of false, inaccurate, or misleading reports, records, or other information. Because the Secretary has delegated some of the authority under FOGRMA to BSEE, 30 U.S.C. 1751 is included as additional authority for these requirements.
The regulations at 30 CFR 250, Subpart F, Oil and Gas Well-Workover Operations are the subject of this collection. Specifically, BSEE uses the information collected to:
• Review log entries of crew meetings to verify that safety procedures have been properly reviewed.
• Review well-workover procedures relating to hydrogen sulfide (H2S) to ensure the safety of the crew in the event of encountering H2S.
• Review well-workover diagrams and procedures to ensure the safety of well-workover operations.
• Verify that the crown block safety device is operating and can be expected to function and avoid accidents.
• Assure that the well-workover operations are conducted on well casing that is structurally competent.
The BSEE will protect proprietary information according to the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR 2); 30 CFR 250.197,
Agencies must also estimate the non-hour paperwork cost burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have other than hour burden costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. For further information on this burden, refer to 5 CFR 1320.3(b)(1) and (2), or contact the Bureau representative listed previously in this notice.
We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB.
United States International Trade Commission.
July 12, 2016 at 9:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. No. 731-TA-298 (Fourth Review) (Porcelain-on-Steel Cooking Ware from China). The Commission is currently scheduled to complete and file its determination and views of the Commission on July 22, 2016.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of a full review pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty order on wooden bedroom furniture from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. The Commission has determined to exercise its authority to extend the review period by up to 90 days.
Amy Sherman (202-205-3289), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
The Commission has determined that this review is extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C.1675(c)(5)(B).
This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of The Chamberlain Group, Inc. (“CGI”) on July 5, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain access control systems and components thereof. The complaint names as respondents Techtronic Industries Co. Ltd of Hong Kong; Techtronic Industries North America, Inc. of Hunt Valley, MD; One World Technologies Inc. of Anderson, SC; OWT Industries Inc. of Pickens, SC; Ryobi Technologies, Inc. of Anderson, SC; and Et Technology (Wuxi) Co., Ltd. of China. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3162”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Section 512 of the Employee Retirement Income Security Act of 1974 (ERISA), 88 Stat. 895, 29 U.S.C. 1142, provides for the establishment of an Advisory Council on Employee Welfare and Pension Benefit Plans (the Council), which is to consist of 15 members to be appointed by the Secretary of Labor (the Secretary) as follows: Three representatives of employee organizations (at least one of whom shall be a representative of an organization whose members are participants in a multiemployer plan); three representatives of employers (at least one of whom shall be a representative of employers maintaining or contributing to multiemployer plans); one representative each from the fields of insurance, corporate trust, actuarial counseling, investment counseling, investment management, and accounting; and three representatives from the general public (one of whom shall be a person representing those receiving benefits from a pension plan). No more than eight members of the Council shall be members of the same political party.
Council members shall be persons qualified to appraise the programs instituted under ERISA. Appointments are for terms of three years. The prescribed duties of the Council are to advise the Secretary with respect to the carrying out of his or her functions under ERISA, and to submit to the Secretary, or his or her designee, recommendations with respect thereto. The Council will meet at least four times each year.
The terms of five members of the Council expire at the end of this year. The groups or fields they represent are as follows: (1) Employee organizations; (2) employers; (3) insurance; (4) accounting; and (5) the general public. The Department of Labor is committed to equal opportunity in the workplace and seeks a broad-based and diverse Council.
Accordingly, notice is hereby given that any person or organization desiring to nominate one or more individuals for appointment to the Advisory Council on Employee Welfare and Pension Benefit Plans to represent any of the groups or fields specified in the preceding paragraph may submit nominations to Larry Good, Council Executive Secretary, Frances Perkins Building, U.S. Department of Labor, 200 Constitution Avenue NW., Suite N-5623, Washington, DC 20210, or as email attachments to
Nominations, including supporting letters, should:
• State the person's qualifications to serve on the Council.
• State that the candidate will accept appointment to the Council if offered.
• Include which of the five positions (representing groups or fields) the candidate is nominated to fill.
• Include the nominee's full name, work affiliation, mailing address, phone number, and email address.
• Include the nominator's full name, mailing address, phone number, and email address.
• Include the nominator's signature, whether sent by email or otherwise.
In selecting Council members, the Secretary of Labor will consider individuals nominated in response to this
Nominees will be contacted to provide information on their political affiliation and their status as registered lobbyists. Anyone currently subject to federal registration requirements as a lobbyist is not eligible for appointment. Nominees should be aware of the time commitment for attending meetings and actively participating in the work of the Council. Historically, this has meant a commitment of at least 20 days per year. The Department of Labor has a process for vetting nominees under consideration for appointment.
Signed at Washington, DC.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Ad Hoc Task Force on Science, Technology, Engineering and Mathematics (STEM) of the NASA Advisory Council (NAC). This Task Force reports to the NAC.
Tuesday, July 26, 2016, 10:00 a.m.-5:15 p.m., Local Time.
Ohio Aerospace Institute, 3rd Floor Conference Room, 22800 Cedar Point Road, Cleveland, Ohio 44142, from 10:00 a.m. to 3:15 p.m. From 3:15 p.m. to 5:15 p.m., a joint session with the NAC Science Committee will take place in Industry Room B.
Dr. Beverly Girten, Executive Secretary for the NAC Ad Hoc Task Force on STEM Education, NASA Headquarters, Washington, DC 20546, (202) 358-0212, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. From the start of the meeting on July 26 at 10:00 a.m. until 3:15 p.m., please use the following information: The meeting will be held in the 3rd Floor Conference Room. Any person interested in joining the meeting may dial the toll free access number 844-467-6272 or toll access number 720-259-6462, and then the numeric participant passcode: 329152 followed by the # sign. If dialing in, please “mute” your telephone. To join via WebEx, the link is
The agenda for the July 26 meeting will include the following:
Attendees will be required to sign a register. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Institutional Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Tuesday, July 26, 2016, 8:30 a.m.-5:00 p.m., Local Time; and Wednesday, July 27, 2016, 8:15 a.m.-10:00 a.m., Local Time.
Ohio Aerospace Institute, NASA Safety Center (NSC) Conference Room, 22800 Cedar Point Road, Cleveland, Ohio 44142.
Mr. Todd Mullins, Executive Secretary for the NAC Institutional Committee, NASA Headquarters, Washington, DC 20546; (202) 358-3831, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any person interested in joining the meeting may dial the toll free access number (844) 467-6272 or toll access number (720) 259-6462, and then the numeric participant passcode: 180093 followed by the # sign. If dialing in, please “mute” your telephone. To join via WebEx on July 26, the web link is
The agenda for the meeting includes the following topics:
Attendees will be required to sign a register. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Monday, July 25, 2016, 1:00 p.m.-5:30 p.m., Local Time; Tuesday, July 26, 2016, 8:45 a.m.—5:15 p.m.; Local Time; and Wednesday, July 27, 2016, 8:30 a.m.-10:00 a.m., Local Time.
Ohio Aerospace Institute, Industry Room B, 22800 Cedar Point Road, Cleveland, Ohio 44142.
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0750, fax (202) 358-2779, or
The meeting will be open to the public up to the capacity of the room. This meeting will also be available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any person interested in joining the meeting may call the USA toll free conference call number 1-888-790-1716, passcode 4101817, or toll number 1-212-287-1654, passcode 4101817, for all three days. If dialing in, please “mute” your telephone. The WebEx link is
Attendees will be required to sign a register. It is imperative that this meeting be held on these dates to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Human Exploration and Operations
Monday, July 25, 2016, 9:30 a.m.-4:30 p.m.; and Tuesday, July 26, 2016, 8:00 a.m.-2:00 p.m., Local Time.
Ohio Aerospace Institute, President's Room, 22800 Cedar Point Road, Cleveland, Ohio 44142.
Dr. Bette Siegel, Executive Secretary for the NAC HEO Committee, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2245, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person in joining the meeting may dial the toll free access number 1-888-455-6733 or toll access number 1-210-839-8935, and then the numeric participant passcode: 4213809 followed by the #sign. If dialing in, please “mute” your telephone. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be required to sign a register. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Technology, Innovation and Engineering (TI&E) Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Tuesday, July 26, 2016, 8:00 a.m.-12:15 p.m.; and 3:30 p.m.-5:00 p.m., Local Time.
Ohio Aerospace Institute, Board Room (Second Floor), 22800 Cedar Point Rd, Cleveland, Ohio 44142.
Mr. Mike Green, Executive Secretary for the NAC TI&E Committee, Space Technology Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-4710, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any person interested in joining the meeting may call the USA toll-free conference number 1-844-467-6272, passcode 102421 followed by the # sign. If dialing in, please “mute” your telephone. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be required to sign a register. It is imperative that this meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.
Tuesday, July 26, 2016, 10:00 a.m.-4:30 p.m., Local Time.
Ohio Aerospace Institute, Industry Room A, 22800 Cedar Point Road, Cleveland, Ohio 44142
Ms. Irma Rodriguez, Executive Secretary for the NAC Aeronautics Committee, NASA Headquarters, Washington, DC 20546, (202) 358-0984, or
The meeting will be open to the public up to the capacity of the room. This meeting will also be available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any person interested in joining the meeting by telephone and WebEx should contact Ms. Irma Rodriguez at (202) 358-0984 for the toll-free number, Web link and passcode. The agenda for the meeting includes the following topics:
Attendees will be required to sign a register. It is imperative that the meeting be held on this date to accommodate the
National Archives and Records Administration (NARA).
Notice of Advisory Committee Meeting.
In accordance with the Federal Advisory Committee Act (5 U.S.C. app 2) and implementing regulation 41 CFR 101-6, NARA announces the following committee meeting.
The meeting will be on July 27, 2016, from 10:00 a.m. to 12:00 p.m. EDT.
National Archives and Records Administration; 700 Pennsylvania Avenue NW.; Jefferson Room; Washington, DC 20408.
Robert J. Skwirot, Senior Program Analyst, by mail at ISOO, National Archives Building; 700 Pennsylvania Avenue NW.; Washington, DC 20408, by telephone at (202) 357-5398, or by email at
The purpose of this meeting is to discuss matters relating to the Classified National Security Information Program for State, Local, Tribal, and Private Sector Entities. The meeting is open to the public. However, due to space limitations and access procedures, you must submit the name and telephone number of individuals planning to attend to the Information Security Oversight Office (ISOO) no later than Friday, July 22, 2016. ISOO will provide additional instructions for entering the building.
The National Science Foundation (NSF) management officials having responsibility for the advisory committees listed below have determined that renewing these groups for another two years is necessary and in the public interest in connection with the performance of duties imposed upon the Director, National Science Foundation (NSF), by 42 U.S.C. 1861
Effective date for renewal is July 1, 2016. For more information, please contact Crystal Robinson, NSF, at (703) 292-8687.
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) is considering issuance of amendments to Facility Operating License Nos. DPR-77 and DPR-79, issued to the Tennessee Valley Authority, for operation of the Sequoyah Nuclear Plant (SQN), Units 1 and 2. The proposed amendments would revise the SQN, Units 1 and 2, Cyber Security Plan (CSP) implementation schedule for Milestone 8 and would revise the associated license condition in the Facility Operating Licenses. The amendment request contains sensitive unclassified non-safeguards information (SUNSI).
Submit comments by August 8, 2016. Requests for a hearing or petition for leave to intervene must be filed by September 6, 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
Andrew Hon, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-8480, email:
Please refer to Docket ID NRC-2016-0130 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-2016-0130 and “Sequoyah Nuclear Plant, Units 1 and 2, application dated May 16, 2016, license amendment request to change the completion date of Cyber Security Plan Implementation Milestone 8,” 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 will post 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 NRC is considering issuance of amendments to Facility Operating License Nos. DPR-77 and DPR-79, issued to the Tennessee Valley Authority, for operation of the SQN, Units 1 and 2, located in Hamilton County, Tennessee. The proposed amendments would revise the SQN, Units 1 and 2, CSP implementation schedule for Milestone 8 and would revise the associated license condition in the Facility Operating Licenses.
Before any issuance of the proposed license amendments, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations.
The NRC has made a proposed determination that the license amendment request involves no significant hazards consideration. Under the NRC's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendments 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. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:
1. Does the proposed amendment involve a significant increase in the probability or consequence of an accident previously evaluated?
Response: No.
The proposed change revises the CSP Milestone 8 implementation date. This change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change is an extension to the completion date of implementation Milestone 8, that in itself does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and have no impact on the probability or consequences of an accident previously evaluated.
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 revises the CSP Implementation Schedule. This proposed change to extend the completion date of implementation Milestone 8 does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems and components relied upon to mitigate the consequences of postulated accidents. This change also does not create the possibility of a new or different kind of accident from any accident previously evaluated.
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 amendment involve a significant reduction in a margin of safety?
Response: No.
Plant safety margins are established through limiting conditions for operation, limiting safety system settings, and safety limits specified in the technical specifications. The proposed change extends the CSP Implementation Schedule. Because there is no change to these established safety margins as result of this change, the proposed change does not involve a significant reduction in a margin of safety.
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 license amendment request involves a No Significant Hazards Consideration.
The NRC is seeking public comments on this proposed determination that the license amendment request involves no significant hazards consideration. 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 amendments until 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 amendments to the subject facility operating licenses or combined licenses. 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 amendments 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 amendments and make them immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendments. 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 amendments 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 September 6, 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
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 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
For further details with respect to this action, see the license amendment request dated May 16, 2016.
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 to 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 dates the petitioner is granted access to the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline. This provision does not extend the time for filing a request for a hearing and petition to intervene, which must comply with the requirements of 10 CFR 2.309.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and need for access, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an administrative law judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) officer if that officer has been designated to rule on information access issues.
H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed with the Chief Administrative Judge within 5 days of the notification by the NRC staff of its grant of access.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
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.
Draft regulatory guide; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1292, “Dedication of Commercial-Grade Items for Use in Nuclear Power Plants.” This DG proposes new guidance that describes methods that the NRC staff considers acceptable in meeting regulatory requirements for dedication of commercial-grade items used in nuclear power plants.
Submit comments by September 6, 2016. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Although a time limit is given, comments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specified subject):
•
•
For additional direction on accessing information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Richard Laura, Office of New Reactors, telephone: 301-415-1837, email:
Please refer to Docket ID NRC-2016-0133 when contacting the NRC about the availability of information regarding this action. You may obtain publically-available information related to this action, by any of the following methods:
•
•
•
Please include Docket ID NRC-2016-0133 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 NRC is issuing for public comment a DG in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, techniques that the staff uses in evaluating specific issues or postulated events, and data that the staff needs in its review of applications for permits and licenses. The DG, entitled, “Dedication of Commercial-Grade Items for Use in Nuclear Power Plants,” is a proposed new guide temporarily identified by its task number, DG-1292. It proposes new guidance that describes acceptance methods that the NRC staff considers acceptable in meeting regulatory requirements for dedication of commercial-grade items used in nuclear power plants.
DG-1292 describes a method that the staff of the NRC considers acceptable for dedication of commercial-grade items for use in nuclear power plants. Issuance of this DG, if finalized, would not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) and would not otherwise be inconsistent with the issue finality provisions in 10 CFR part 52. As discussed in the “Implementation” section of this DG, the NRC has no current intention to impose this DG, if finalized, on holders of current operating licenses or combined licenses.
For the Nuclear Regulatory Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 1, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 1, 2016, it filed with the Postal Regulatory Commission a
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.
In Canada, as in the United States, individuals can invest a portion of their earnings in tax-deferred retirement savings accounts (“Canadian retirement accounts”). These accounts, which operate in a manner similar to
Once in the United States, however, these participants historically have been unable to manage their Canadian retirement account investments. Most securities that are “qualified investments” for Canadian retirement accounts are not registered under the U.S. securities laws. Those securities, therefore, generally cannot be publicly offered and sold in the United States without violating the registration requirement of the Securities Act of 1933 (“Securities Act”).
The Commission issued a rulemaking in 2000 that enabled Canadian-U.S. Participants to manage the assets in their Canadian retirement accounts by providing relief from the U.S. registration requirements for offers of securities of foreign issuers to Canadian-U.S. Participants and sales to Canadian retirement accounts.
Rule 237 requires written offering documents for securities offered and sold in reliance on the rule to disclose prominently that the securities are not registered with the Commission and are exempt from registration under the U.S. securities laws. The burden under the rule associated with adding this disclosure to written offering documents is minimal and is non-recurring. The foreign issuer, underwriter, or broker-dealer can redraft an existing prospectus or other written offering material to add this disclosure statement, or may draft a sticker or supplement containing this disclosure to be added to existing offering materials. In either case, based on discussions with representatives of the Canadian fund industry, the staff estimates that it would take an average of 10 minutes per document to draft the requisite disclosure statement.
The Commission understands that there are approximately 3,619 Canadian issuers other than funds that may rely on rule 237 to make an initial public offering of their securities to Canadian-U.S. Participants.
The staff therefore estimates that during each year that rule 237 is in effect, approximately 36 respondents
In addition, issuers from foreign countries other than Canada could rely on rule 237 to offer securities to Canadian-U.S. Participants and sell securities to their accounts without becoming subject to the registration requirements of the Securities Act. However, the staff believes that the number of issuers from other countries that rely on rule 237, and that therefore are required to comply with the offering document disclosure requirements, is negligible.
These burden hour estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
Compliance with the collection of information requirements of the rule is mandatory and is necessary to comply with the requirements of the rule in general. 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 control number. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
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 an Open Meeting on Tuesday, July 12, 2016, at 1:00 p.m.,
On June 27, 2014, the law judge found that Aesoph and Bennett engaged in “improper professional conduct” under Commission Rule of Practice 102(e) and Section 4C of the Securities Exchange Act of 1934, during their service as the engagement partner and senior manager of KPMG, LLP's audit of the 2008 financial statements of TierOne Corporation, a holding company for TierOne Bank. The law judge suspended Aesoph from appearing or practicing before the Commission as an accountant for one year, and suspended Bennett from appearing or practicing before the Commission as an accountant for six months.
Respondents appealed the law judge's findings of liability and the sanctions imposed; the Division cross-appealed the sanctions imposed. The issues likely to be considered at oral argument include, among other things, whether Respondents engaged in “improper professional conduct” as alleged and, if so, the extent to which they should be sanctioned. Also likely to be considered at oral argument is whether these administrative proceedings violate the U.S. Constitution.
For further information, please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17a-1 requires that every national securities exchange, national securities association, registered clearing agency, and the Municipal Securities Rulemaking Board keep on file for a period of not less than five years, the first two years in an easily accessible place, at least one copy of all documents, including all correspondence, memoranda, papers, books, notices, accounts, and other such records made or received by it in the course of its business as such and in the conduct of its self-regulatory activity, and that such documents be available for examination by the Commission.
There are 29 entities required to comply with the rule: 19 national securities exchanges, 1 national securities association, 8 registered clearing agencies, and the Municipal Securities Rulemaking Board. The Commission staff estimates that the average number of hours necessary for compliance with the requirements of Rule 17a-1 is 52 hours per year. In addition, 4 national securities exchanges notice-registered pursuant to Section 6(g) of the Act (15 U.S.C. 78f(g)) are required to preserve records of determinations made under Rule 3a55-1 under the Act (17 CFR 240.3a55-1), which the Commission staff estimates will take 1 hour per exchange, for a total of 4 hours. Accordingly, the Commission staff estimates that the total number of hours necessary to comply with the requirements of Rule 17a-1 is 1,512 hours. The total internal cost of compliance for all respondents is $98,280, based on an average cost per hour of $65.
Written comments are invited on (a) 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; (b) the accuracy of the Commission's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email to:
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of intent to prepare an environmental impact statement.
The FHWA is issuing this notice to advise the public that an environmental impact statement (EIS) will be prepared for a proposed project in King County, Washington.
The FHWA, in cooperation with WSCC, will prepare an EIS on the Washington State Convention Center Addition Project to construct an addition to the Washington State Convention Center. The project requires FHWA approvals for closure of access to an Interstate ramp and use of Interstate airspace (air and ground lease), and related breaks in access.
Preliminary alternatives under consideration include: (1) Taking no action; (2) construct approximately 1.50 million square feet of gross floor area composed of approximately 1.26 million square feet of addition to the convention
The FHWA along with WSCC are holding a public scoping meeting on July 20, 2016, from 5:30 p.m. to 7 p.m. at the Washington State Convention Center, 800 Convention Place, Room 206, Seattle, WA to solicit public comments regarding the scope of issues to be addressed in the NEPA EIS. The public will be notified by a flyer that will be mailed to interested agencies, organizations, and individuals affected by the project, as well as published in The Seattle Times and the Daily Journal of Commerce. In addition, notice of the EIS Scoping meeting will be posted at locations on the project site. The meeting will include a brief presentation followed by public comments.
Agencies, Tribes, and the public are encouraged to submit comments on the purpose and need and preliminary range of alternatives during the scoping period. Comments must be received by July 26, 2016, to be included in the formal scoping record. To ensure that the full range of issues related to this proposed action is addressed, and all the significant issues identified, comments and suggestions are invited from interested parties during the scoping period. Comments concerning this proposal will be accepted at the public meeting or can be sent by mail to: Lindsey Handel, Urban Area Engineer, Federal Highway Administration, 711 South Capitol Way, Suite 501, Olympia, WA 98501; telephone: (360) 753-9550; email:
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemption; request for comments.
FMCSA announces its decision to renew the Virginia Department of Motor Vehicles (DMV) exemption on behalf of truck and bus drivers who are licensed in the Commonwealth of Virginia and need a Skill Performance Evaluation (SPE) certificate from FMCSA to operate commercial motor vehicles (CMV) in interstate commerce. The exemption enables interstate CMV drivers who are licensed in Virginia and are subject to the Federal SPE requirements under 49 CFR 391.49 to continue to fulfill the Federal requirements with a State-issued SPE and to operate CMVs in interstate commerce anywhere in the United States.
This decision is effective July 9, 2016, and will expire July 9, 2018, and may be renewed. Comments must be received on or before August 9, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) number FMCSA-2013-0147 by any of the following methods:
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Ms. Eileen Nolan, Office of Carrier, Driver and Vehicle Safety, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs) for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute allows the Agency to renew exemptions at the end of the 2-year period.
On July 8, 2014, FMCSA granted Virginia a 2-year exemption that enables interstate CMV drivers licensed in Virginia who are subject to the Federal SPE requirements under 49 CFR 391.49 to fulfill the Federal requirements with a State-issued SPE (79 FR 38659). The requirements of the exemption were outlined in this notice and will therefore not be repeated. Virginia has established its own SPE program that is essentially identical to the current FMCSA SPE program to include an application process modeled on the FMCSA process. In addition, State personnel who have completed SPE training identical to that of FMCSA personnel currently administer the SPE program and conduct the skill
The Agency's decision regarding this exemption is based on the fact that Virginia's SPE program is essentially identical to the current FMCSA program. Virginia continues to adhere to the application process modeled on the FMCSA process. State personnel who conduct the skill evaluation complete the same training as FMCSA personnel conducting the test and follow the same procedures and testing criteria used by FMCSA. FMCSA has conducted ongoing monitoring and onsite SPE program reviews and Virginia continues to maintain records of applications, testing, and certificates issued for periodic review by FMCSA. At the time Virginia DMV submitted its request for exemption renewal to the Agency, it had issued 13 new and 25 renewal SPE certificates. Based upon FMCSA's analyses of the applications and the program as a whole, FMCSA has determined that no safety vulnerabilities are associated with Virginia's renewal request. The renewal of the exemption is granted.
Consequently, FMCSA has concluded that renewing the exemption allows the Virginia SPE program to achieve the level of safety required by 49 U.S.C. 31315.
If a Virginia-licensed driver would prefer not to opt for the streamlined SPE process, the driver may still apply for an FMCSA-issued SPE. However, FMCSA may still exercise its discretion and call upon Virginia DMV to provide assistance in conducting the road evaluation needed to complete an SPE application, depending on the volume of applications.
The FMCSA grants the renewal of the exemption to allow the Virginia DMV to conduct SPE's on drivers who have experienced an impairment or loss of a limb and are licensed in the Commonwealth of Virginia. The following terms and conditions apply to the State and any drivers who receive a State-issued SPE certificate:
• Virginia must establish and maintain its own SPE program that is essentially identical to the current FMCSA program.
• The State must maintain an application process modeled on the FMCSA process and submit information concerning the application process to FMCSA's Medical Programs Division for review, as required.
• State personnel who conduct the skill test must complete SPE training identical to that of FMCSA personnel currently administering the Federal SPE program.
• The skill evaluation and scoring for the SPE must be done using the same procedures and testing criteria used by FMCSA.
• Virginia must maintain records of applications, testing, and certificates issued for periodic review by FMCSA.
• Virginia must submit a monthly report to FMCSA listing the names and license number of each driver tested by the State and the result of the test (pass or fail).
• Each driver who receives a State-issued SPE must carry a copy of the certificate when driving for presentation to authorized Federal, State, or local law enforcement officials.
An exemption granted under the authority of 49 U.S.C. 31315(b) preempts State laws and regulations that conflict with or are inconsistent with the exemption. The decision to grant Virginia's request amounts to automatic Federal ratification of the State issued SPE certificate and therefore prohibits other jurisdictions from requiring a separate FMCSA-issued SPE. The State-issued certificate must be treated as if it had been issued by FMCSA. Virginia-licensed drivers who receive the State-issued SPE are allowed to operate CMVs in interstate commerce anywhere in the United States.
Interested parties possessing information that would otherwise show that granting this exemption is not achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence summited, and if safety is being compromised or if continuation of exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoked the Virginia DMV exemption.
The Agency does not intend its decision to pressure other States to take action to implement State-run SPE programs. Virginia is the first State to submit an application on behalf of its drivers to provide an alternative to the Federal SPE process. Other States are welcome to make similar applications if they believe it is appropriate to do so and they have the resources to meet terms and conditions comparable to those provided in this exemption.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment on the approval of a new Information Collection (IC) titled,
Please send your comments to this notice by August 8, 2016. OMB must receive your comments by this date to act quickly on the ICR.
All comments should reference Federal Docket Management System (FDMS) Docket Number FMCSA-2015-0180. Interested persons are invited to submit written comments on the proposed IC to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/Federal Motor Carrier Safety Administration, and sent via electronic mail to
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Information used to determine and certify driver medical fitness must be collected in order for our highways to be safe. FMCSA is the Federal government agency authorized to require the collection of this information and the authorizing regulations are located at 49 CFR parts 390-399. FMCSA is required by statute to establish standards for the physical qualifications of drivers who operate CMVs in interstate commerce for non-excepted industries [49 U.S.C. 31136(a)(3) and 31502(b)]. The regulations discussing this collection are outlined in the Federal Motor Carrier Safety Regulations (FMCSRs) at 49 CFR part 390-399. FMCSRs at 49 CFR 391.41 set forth the physical qualification standards that interstate CMV drivers who are subject to part 391 must meet, with the exception of commercial driver's license/commercial learner's permit (CDL/CLP) drivers transporting migrant workers (who must meet the physical qualification standards set forth in 49 CFR 398.3). The FMCSRs covering driver physical qualification records are found at 49 CFR 391.43, which specify that a medical examination be performed on CMV drivers subject to part 391 who operate in interstate commerce. The results of the examination shall be recorded in accordance with the requirements set forth in that section.
49 CFR 391.41(b)(12) states that a person is physically qualified to drive a CMV if that person does not use any drug or substance identified in 21 CFR 1308.11 Schedule I, an amphetamine, a narcotic, or other habit-forming drug and does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in § 382.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a CMV.
In 2006, FMCSA's Medical Review Board (MRB) deliberated on the topic of the use of Schedule II medications. The MRB considered information provided in a 2006 FMCSA sponsored Evidence Report and a subsequent Medical Expert Panel (MEP) to examine the relationship between the licit use of Schedule II medications and the risk for a motor vehicle crash. In 2013, FMCSA tasked the MRB with updating the opinions and recommendations of the 2006 Evidence Report and MEP.
On September 10, 2013, the MRB and Motor Carrier Safety Advisory Committee (MCSAC) met jointly to hear presentations on the licit use of Schedule II medications and their regulation, and on U.S. Department of Transportation drug and alcohol testing protocols. Subsequently, the committees engaged in a discussion on the issue as it applies to CMV drivers. On September 11, 2013, the MRB discussed the issue in greater detail as its task to present a report to the Agency relating to CMV drivers and Schedule II medication use and to develop a form for MEs on the National Registry of Certified Medical Examiners (National Registry) to send to treating clinicians of CMV drivers to expound on the use of these medications by driver applicants. On October 22, 2013, the MRB submitted their recommendations to FMCSA. A MEP convened to provide an updated opinion on
1. Questionnaire should be titled
2. Questionnaire should request the following information:
a. Identifying name and date of birth of the CMV driver.
b. Introductory paragraph stating purpose of the CMV Driver Medication Report.
c. Statements of § 391.41(b)(12) (Physical Qualifications of Drivers relating to driver use of scheduled substances) and The Driver's Role, as found in the Medical Examination Report form found at the end of
d. Name, state of licensure, signature, address and contact information of the prescribing healthcare provider, as well as the date the form was completed.
e. Name, signature, date, address and contact information of the certified ME.
3. Report should include the following information:
a. 1—List all medications and dosages that you have prescribed to the above named individual.
b. 2—List any other medications and dosages that you are aware have been prescribed to the above named individual by another treating healthcare provider.
c. 3—What medical conditions are being treated with these medications?
d. 4—It is my medical opinion that, considering the mental and physical requirements of operating a CMV and with awareness of a CMV driver's role (consistent with
The public interest in, and right to have, safe highways requires the assurance that drivers of CMVs can safely perform the increased physical and mental demands of their duties. FMCSA's medical standards provide this assurance by requiring drivers to be examined and medically certified as physically and mentally qualified to drive.
The purpose for collecting this information is to assist the ME in determining if the driver is medically qualified under 49 CFR 391.41 and to ensure that there are no disqualifying medical conditions that could adversely affect their safe driving ability or cause incapacitation constituting a risk to the public. 49 CFR 391.41(b)(12) states that a person is physically qualified to drive a CMV if that person does not use any drug or substance identified in 21 CFR 1308.11 Schedule I, an amphetamine, a narcotic, or other habit-forming drug and does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in § 382.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a CMV.
The use of this IC is at the discretion of the ME to facilitate communication with treating healthcare professionals who are responsible for prescribing certain medications so that the ME fully understands the reasons the medications have been prescribed. This information will assist the ME in determining whether the underlying medical condition and the prescribed medication will impact the driver's safe operation of a CMV. Therefore, there is no required collection frequency.
The
The information collected from the
In response to the
The first area of comments involved the effectiveness of the
Five commenters expressed support for the ICR and two commenters explicitly opposed the ICR. The remaining seven neither supported nor opposed the ICR, but raised concerns or provided suggestions for changes to the optional form.
The following sections provide details regarding specific issues raised by the commenters.
ACOEM acknowledged that the current process used by MEs is clearly inadequate but also feels that the form falls far short of being able to adequately assess whether a driver will be impaired by medications or an underlying medical condition. They also stated that many healthcare providers do not fully understand the safety risks and responsibilities of the CMV driver and would rely on the patient's statement that the medication does not impair the driver's ability to safely operate a CMV. Therefore, they believe that the prescribing healthcare provider statements would not be reliable. ACOEM also believes that the form does not go far enough to address the use of opioids by drivers and the rapid increase in adverse effects of opioid use and suggests that FMCSA strive for a form that becomes the standard of
Others commented that some physicians have no problem stating that their patient is safe to drive a CMV while taking these medications leaving the ME that disagrees and is not willing to issue the driver a MEC with a driver that is angry based on the differing opinions. OOIDA stated that the form would be a direct challenge to the treating physician according to § 391.41(b)(12)(ii) that states “A person is physically qualified to drive a commercial motor vehicle if that person does not use any non-Schedule I drug or substance that is identified in the other Schedules in 21 CFR part 1308 except when the use is prescribed by a licensed medical practitioner, as defined in § 392.107, who is familiar with the driver's medical history and has advised the driver that the substance will not adversely affect the driver's ability to safely operate a commercial vehicle.” They believe that this form challenges the opinion of the driver's treating physician and puts it in the hands of a stranger with no knowledge of the driver's background and who is unfamiliar with the driver's medical history.
FMCSA is providing the
The information obtained by the ME when utilizing the optional
Several commenters expressed concern that prescribing healthcare providers would not respond in a timely manner or at all, and that delays would be costly to drivers and motor carriers. ATA stated that FMCSA should consider the impact of potential delays to driver recertification, because the form does not advise prescribing healthcare providers to complete and return the form to the requesting ME within a specific timeframe, nor does it require MEs to certify a driver who is medically qualified even in the absence of the completed form. They expressed concern that the lack of such language could result in unnecessary and costly delays that would penalize qualified drivers due to circumstances that are out of their control. ATA recommended that if a prescribing healthcare provider is unable to return the form to a ME in a timely manner, FMCSA should advise MEs to continue to use their own judgement and certify drivers in these circumstances if they find them to be medically qualified.
Others commented that MEs will find the proposed form to be too restrictive and excessive explaining that although a full list of medications seems to be a good idea, it could significantly increase the effort required by the prescribing healthcare providers which is counterproductive to obtaining their assistance. Suggestions were made to ask the prescribing healthcare provider a single question such as is the driver taking any other medications that may be a risk to safe driving, to list only those medications that would negatively affect the ability of the driver to safely operate a CMV, or to only ask about medications that are of concern that the patient reported. Dr. Michael Megehee recommended including a statement that FMCSA guidelines require the ME to ask the prescribing healthcare provider for assistance in determining whether the driver is safe to operate a CMV and they meet the FMCSRs and that although the ME considers the opinions of treating physicians, the ME is responsible for making the final medical qualification determination.
ATA stated that while this IC may be a useful tool to many MEs in determining whether a driver is medically qualified, in certain cases, it will not always be necessary. They believe that in most situations, the ME should be able to verify the accuracy of the information provided by the driver and the need for the medication based upon their training and experience in performing medical examinations and a robust conversation with the driver. They suggested that to avoid any unnecessary and costly delays to drivers and carriers alike, FMCSA should emphasize to MEs that the form is strictly voluntary and not a de facto standard when performing medical examinations. They also suggested that the form be consistent with the newly revised MER Form, MCSA-5875 by limiting its inquiry into medications that the driver is currently prescribed and that the prescribing healthcare provider should only report those medications that they can confirm have been prescribed. They stated that asking for all prescribed medications imposes a burden on healthcare providers without any significant positive impact on safety and suggested asking healthcare providers to list those medications that a driver is currently prescribed and would negatively affect their ability to safely operate a CMV will dramatically limit the collection burden without diminishing the quality of the information being collected.
OOIDA stated that there will be an increase in the number of inconsistencies in the medical certification process as MEs with no personal relationship with the driver attempt to evaluate a great deal of long-term medication usage. They stated that the proposed use of the
FMCSA does not believe that the form will add any time to the certification decision nor is it necessary to advise the ME to make a certification decision at any specified time after sending the
As previously stated, the form was specifically designed to address any prescription medications that a driver is taking that may impair his/her ability to safely operate a CMV. Therefore, the Agency does not believe that the form is too restrictive or excessive nor will it significantly increase the effort required by the prescribing healthcare providers. Instead, the Agency believes that the form will be a useful resource for MEs in making a medical certification decision of drivers that are taking prescribed medications.
Because the prescribing healthcare provider is not trained regarding the FMCSRs and may not be a certified ME, FMCSA does not believe that asking the prescribing healthcare provider a single question such as is the driver taking any other medications that may be a risk to safe driving, to list only those medications that would negatively affect the ability of the driver to safely operate a CMV, or to only ask about medications that are of concern that the patient reported would provide reliable information to assist the ME in making a medical certification decision. FMCSA is not requiring MEs to use the
FMCSA continues to emphasize that the
Interstate CMV drivers are required to use a certified ME listed on the National Registry for their medical examination and certification. Therefore, in many cases the driver is going to a ME that they do not have a personal relationship with. The use of the optional
A number of respondents submitted comments on topics that were outside the scope of what was proposed in this notice. This notice specifically requested comments related to the proposed IC and optional form to be used as an IC tool.
OOIDA disputed the fact that there is moderate evidence of increased risk due to Schedule II drug use and stated that the paucity of data shows that few CMV drivers have had problems with licit Schedule II drug use, or even prescription medications. They also stated that studies do not show that a significant number of CMV operators are crashing due to prescription medication use and that because insufficient data exists regarding the use of Schedule II drugs by CMV drivers should be an indication to the MRB and FMCSA that there are very few CMV drivers who have had problems with licit Schedule II drug usage.
Dr. Kurt T. Hegmann stated that this form should not be adopted for opioids/Schedule II medications, because this form is not evidence-based, not validated, there is no objective test to figure out who is unsafe and will crash if using opioids/Schedule II medications, and the form will cause a false sense of security that both endorses narcotics-using truck drivers and a method to sign the form to approve them to drive under the influence, and is likely to inadvertently further increase fatalities. He also stated that the form appears to evade the FDA-supported advice on opioid prescription labels that uniformly warn against vehicle operation and suggested we adopt the 2006 MEP recommendation to eliminate the potential exception that a prescriber who thought someone could drive, would be allowed to drive on opioids. Dr. Hegamann believes that this form will not help the Agency meet its primary mission. Instead he states that individuals using opioids should not drive trucks and instead should be tapered and/or de-toxed and then resume driving off those medications.
On the other hand, ACOEM, stated that the form does not go far enough to address the use of opioids by drivers and the rapid increase in adverse effects of opioid use. They pointed out that the original proposed version of this form goes back to the 2006 Schedule II Medication Panel and had significantly more content, which would have given the treating provider and the ME a clearer understanding of the impairment risks of the medications. They suggested any form incorporate some of the recommendations from the MRB and MCSAC joint Task 14-3: Schedule II Controlled Substances and CMV Drivers including the recommendation that a driver should not be medically qualified to operate a CMV while he/she is under treatment with narcotics or any narcotic derivative without exception. They go
Although optional use of the
Several commenters stated that a ME might not be qualified to make a medical qualification decision if the driver uses Schedule II medications, because of a lack of training in pharmacology.
OOIDA stated that the personal physician is best equipped to review a driver's medical history and suggested that a personal physician be the one to review the driver's medical history and make the decision whether a medication will adversely affect the driver's ability to safely operate a CMV.
Dr. Hegmann advocated for implementation of the MRB's recommendation that ME eligibility be limited to those medically trained (
FMCSA responded to the question of who is qualified to be a ME in the National Registry of Certified Medical Examiners final rule (77 FR 24106, April 20, 2012), and is not considering a change to the regulation in 49 CFR 390.103, Eligibility requirements for medical examiner certification in this notice. Therefore, these comments are outside the scope of this notice.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 19 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). They are unable to meet the vision requirement in one eye for various reasons. The exemptions will enable these individuals to operate commercial motor vehicles (CMVs) in interstate commerce without meeting the prescribed vision requirement in one eye. The Agency has concluded that granting these exemptions will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these CMV drivers.
The exemptions were granted January 21, 2016. The exemptions expire on January 21, 2018.
Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at
On December 21, 2015, FMCSA published a notice of receipt of exemption applications from certain individuals, and requested comments from the public (80 FR 79414). That notice listed 19 applicants' case histories. The 19 individuals applied for exemptions from the vision requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate commerce.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for a 2-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the 2-year period. Accordingly, FMCSA has evaluated the 19 applications on their merits and made a determination to grant exemptions to each of them.
The vision requirement in the FMCSRs provides:
A person is physically qualified to drive a commercial motor vehicle if that person has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber (49 CFR 391.41(b)(10)).
FMCSA recognizes that some drivers do not meet the vision requirement but have adapted their driving to accommodate their vision limitation and demonstrated their ability to drive safely. The 19 exemption applicants listed in this notice are in this category. They are unable to meet the vision requirement in one eye for various reasons, including amblyopia, central serous chorioretinopathy, central vision loss, complete loss of vision, optic atrophy, optic neuropathy, partial optic atrophy, phthisis, prosthetic eye, pseudophakia, refractive amblyopia, and retinal detachment. In most cases, their eye conditions were not recently developed. Ten of the applicants were either born with their vision impairments or have had them since childhood. The 9 individuals that sustained their vision conditions as adults have had it for a range of 5 to 42 years.
Although each applicant has one eye which does not meet the vision requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected vision in the other eye, and in a doctor's opinion, has sufficient vision to perform all the tasks necessary to operate a CMV. Doctors' opinions are supported by the applicants' possession of valid commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before issuing CDLs, States subject drivers to knowledge and skills tests designed to evaluate their qualifications to operate a CMV.
All of these applicants satisfied the testing requirements for their State of residence. By meeting State licensing requirements, the applicants demonstrated their ability to operate a CMV, with their limited vision, to the satisfaction of the State.
While possessing a valid CDL or non-CDL, these 19 drivers have been authorized to drive a CMV in intrastate commerce, even though their vision disqualified them from driving in interstate commerce. They have driven CMVs with their limited vision in careers ranging for 3 to 38 years. In the past three years, no drivers were involved in crashes, and 2 drivers were convicted of moving violations in a CMV.
The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the December 21, 2015 notice (80 FR 79414).
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. Without the exemption, applicants will continue to be restricted to intrastate driving. With the exemption, applicants can drive in interstate commerce. Thus, our analysis focuses on whether an equal or greater level of safety is likely to be achieved by permitting each of these drivers to drive in interstate commerce as opposed to restricting him or her to driving in intrastate commerce.
To evaluate the effect of these exemptions on safety, FMCSA considered the medical reports about the applicants' vision as well as their driving records and experience with the vision deficiency.
To qualify for an exemption from the vision requirement, FMCSA requires a person to present verifiable evidence that he/she has driven a commercial vehicle safely with the vision deficiency for the past 3 years. Recent driving performance is especially important in evaluating future safety, according to several research studies designed to correlate past and future driving performance. Results of these studies support the principle that the best predictor of future performance by a driver is his/her past record of crashes and traffic violations. Copies of the studies may be found at Docket Number FMCSA-1998-3637.
FMCSA believes it can properly apply the principle to monocular drivers, because data from the Federal Highway Administration's (FHWA) former waiver study program clearly demonstrate the driving performance of experienced monocular drivers in the program is better than that of all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996). The fact that experienced monocular drivers demonstrated safe driving records in the waiver program supports a conclusion that other monocular drivers, meeting the same qualifying conditions as those required by the waiver program, are also likely to have adapted to their vision deficiency and will continue to operate safely.
The first major research correlating past and future performance was done in England by Greenwood and Yule in 1920. Subsequent studies, building on that model, concluded that crash rates for the same individual exposed to certain risks for two different time periods vary only slightly (See Bates and Neyman, University of California Publications in Statistics, April 1952). Other studies demonstrated theories of predicting crash proneness from crash history coupled with other factors. These factors—such as age, sex, geographic location, mileage driven and conviction history—are used every day by insurance companies and motor vehicle bureaus to predict the probability of an individual experiencing future crashes (See Weber, Donald C., “Accident Rate Potential: An Application of Multiple Regression Analysis of a Poisson Process,” Journal of American Statistical Association, June 1971). A 1964 California Driver Record Study prepared by the California Department of Motor Vehicles concluded that the best overall crash predictor for both concurrent and nonconcurrent events is the number of single convictions. This study used 3 consecutive years of data, comparing the experiences of drivers in the first 2 years with their experiences in the final year.
Applying principles from these studies to the past 3-year record of the 19 applicants, no drivers were involved in crashes, and 2 drivers were convicted of moving violations in a CMV. All the applicants achieved a record of safety while driving with their vision impairment, demonstrating the likelihood that they have adapted their driving skills to accommodate their condition. As the applicants' ample driving histories with their vision deficiencies are good predictors of future performance, FMCSA concludes their ability to drive safely can be projected into the future.
We believe that the applicants' intrastate driving experience and history provide an adequate basis for predicting their ability to drive safely in interstate commerce. Intrastate driving, like interstate operations, involves substantial driving on highways on the interstate system and on other roads built to interstate standards. Moreover, driving in congested urban areas exposes the driver to more pedestrian and vehicular traffic than exists on interstate highways. Faster reaction to traffic and traffic signals is generally required because distances between them are more compact. These conditions tax visual capacity and
We recognize that the vision of an applicant may change and affect his/her ability to operate a CMV as safely as in the past. As a condition of the exemption, therefore, FMCSA will impose requirements on the 19 individuals consistent with the grandfathering provisions applied to drivers who participated in the Agency's vision waiver program.
Those requirements are found at 49 CFR 391.64(b) and include the following: (1) That each individual be physically examined every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirement in 49 CFR 391.41(b)(10) and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must have a copy of the certification when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
FMCSA received no comments in this proceeding.
Based upon its evaluation of the 19 exemption applications, FMCSA exempts the following drivers from the vision requirement in 49 CFR 391.41(b)(10), subject to the requirements cited above (49 CFR 391.64(b)):
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for 2 years unless revoked earlier by FMCSA. The exemption will be revoked if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
If the exemption is still effective at the end of the 2-year period, the person may apply to FMCSA for a renewal under procedures in effect at that time.
In accordance with part 235 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C. 20502(a), this document provides the public notice that by a document dated May 25, 2016, Norfolk Southern Railway (NS) petitioned the Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of a signal system. FRA assigned the petition Docket Number FRA-2016-0059.
NS seeks approval of the modification of power-operated Switch 1723 at Control Point (CP) BATH, at Milepost (MP) SP 172.29, on the NS Frankfort District, at Muncie, IN. Switch 1723 will be converted to a hand-operated switch. The existing 120RC signal at BATH will be moved southeast so that the new hand-operated switch will be outside the CP limits. The switch is to be converted to a hand-operated switch to improve operations at this location.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by August 22, 2016 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the
Issued in Washington, DC.
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 August 8, 2016.
Comments should refer to docket number MARAD-2016-0069. 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 W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel PINKY is:
INTENDED COMMERCIAL USE OF VESSEL: Shuttle and Parasail Vessel.
GEOGRAPHIC REGION: “New York”.
The complete application is given in DOT docket MARAD-2016-0069 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.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before August 8, 2016.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before August 8, 2016.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Department of Transportation.
Notice of Order To Show Cause (Order 2016-7-1) Docket DOT-OST-2015-0014.
The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding LIMA NY Corp. fit, willing, and able, and awarding it commuter air carrier authority to conduct scheduled commuter service.
Persons wishing to file objections should do so no later than July 15, 2016.
Objections and answers to objections should be filed in Docket DOT-OST-2015-0014 and addressed to Docket Operations, (M-30, Room W12-140), U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, and should be served upon the parties listed in Attachment A to the order.
Barbara Snoden, Air Carrier Fitness Division (X-56, Room W86-471), U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 366-4834.
Department of Transportation.
Notice of Order to Show Cause (Order 2016-7-2), Docket DOT-OST-2015-0259.
The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding Tropic Ocean Airways, LLC, fit, willing, and able, and awarding it Commuter Air Carrier Authorization.
Persons wishing to file objections should do so no later than July 15, 2016.
Objections and answers to objections should be filed in Docket DOT-OST-2015-0259 and addressed to U.S. Department of Transportation, Docket Operations, (M-30, Room W12-140), 1200 New Jersey Avenue SE., West Building Ground Floor, Washington, DC 20590, and should be served upon the parties listed in Attachment A to the order.
Damon D. Walker, Air Carrier Fitness Division (X-56, Room W86-465), U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590, (202) 366-7785.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, August 11, 2016.
Donna Powers at 1-888-912-1227 or (954) 423-7977.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be held Thursday, August 11, 2016, at 1:00 p.m.. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Donna Powers. For more information please contact: Donna Powers at 1-888-912-1227 or (954) 423-7977 or write: TAP Office, 1000 S. Pine Island Road, Plantation, FL 33324 or contact us at the Web site:
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
The Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will conduct an open meeting and will solicit public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, August 10, 2016.
Otis Simpson at 1-888-912-1227 or 202-317-3332.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be held Wednesday, August 10, 2016, at 2:00 p.m. Eastern Time. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Otis Simpson. For more information please contact: Otis Simpson at 1-888-912-1227 or 202-317-3332, TAP Office, 1111 Constitution Avenue NW., Room 1509, National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing various issues related to the Taxpayer Assistance Centers and public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, August 17, 2016.
Linda Rivera at 1-888-912-1227 or (202) 317-3337.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be held Wednesday, August 17, 2016, at 2:30 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Linda Rivera. For more information please contact: Ms. Rivera at 1-888-912-1227 or (202) 317-3337, or write TAP Office, 1111 Constitution Avenue NW., Room 1509, National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing Toll-free issues and public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, August 18, 2016.
Antoinette Ross at 1-888-912-1227 or (202) 317-4110.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be held Thursday, August 18, 2016, at 2:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Antoinette Ross. For more information please contact: Antoinette Ross at 1-888-912-1227 or (202) 317-4110, or write TAP Office, 1111 Constitution Avenue NW., Room 1509, National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing various issues related to Taxpayer Communications and public input is welcome.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, August 31, 2016.
Kim Vinci at 1-888-912-1227 or 916-974-5086.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Wednesday, August 31, 2016, at 1:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. For more information please contact: Kim Vinci at 1-888-912-1227 or 916-974-5086, TAP Office, 4330 Watt Ave., Sacramento, CA 95821, or contact us at the Web site:
The agenda will include various committee issues for submission to the IRS and other TAP related topics. Public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, August 24, 2016.
Theresa Singleton at 1-888-912-1227 or 202-317-3329.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be held Wednesday, August 24, 2016, at 12:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Theresa Singleton. For more information please contact: Theresa Singleton at 1-888-912-1227 or 202-317-3329, TAP Office, 1111 Constitution Avenue NW., Room 1509-National Office, Washington, DC 20224, or contact us at the Web site:
The agenda will include a discussion on various letters, and other issues related to written communications from the IRS.
This Circular is published annually for the information of Federal bond-approving officers and persons required to give bonds to the United States consistent with 31 CFR 223.16. (Interim changes are published in the
The most current list of Treasury authorized companies is always available through the Internet at
The following companies have complied with the law and the regulations of the U.S. Department of the Treasury. Those listed in the front of this Circular are acceptable as sureties and reinsurers on Federal bonds under Title 31 of the United States Code, Sections 9304 to 9308 [See Note (a)]. Those listed in the back are acceptable only as reinsurers on Federal bonds under 31 CFR 223.3(b) [See Note (e)].
If we can be of any assistance, please feel free to contact the Surety Bond Section at (202) 874-6850.
(a) All Certificates of Authority expire June 30, and are renewable July 1, annually. Companies holding Certificates of Authority
(b) The Underwriting Limitations published herein are on a
(c) A surety company
License information in this Circular is provided to the Treasury Department by the companies themselves.
(d) FEDERAL PROCESS AGENTS: Treasury-approved surety companies are required to appoint Federal process agents in accord with 31 U.S.C. 9306 and 31 CFR 224.
(e) Companies holding Certificates of Authority as acceptable reinsuring companies are acceptable only as reinsuring companies on Federal bonds and may not directly write Federal bonds.
(f) Some companies may be Approved
Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.
Final rule.
This final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the United States Code. Section 303(g)(2) of the Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA). Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients under section 303(g)(2) of the CSA. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted.
Jinhee Lee, Pharm.D., Public Health Advisor, Center for Substance Abuse Treatment, 240-276-2700.
This
Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA) for use in maintenance and detoxification treatment without registering as an opioid treatment program (OTP). Buprenorphine is a schedule III controlled substance under the CSA. To qualify to treat any patients with buprenorphine, the practitioner must be a physician, possess a valid license to practice medicine, be a registrant of the Drug Enforcement Administration (DEA), have the capacity to refer patients for appropriate counseling and other necessary ancillary services, and have completed required training.
The CSA also imposes a limit on the number of patients a practitioner may treat with certain types of FDA-approved narcotic drugs, such as buprenorphine, at any one time. Specifically, Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time.
Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to change the patient limit by regulation.
On March 30, 2016, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), entitled, “Medication Assisted Treatment for Opioid Use Disorders”, in the
The final rule adopts the same basic structure and framework as the proposed rule: Subpart A sets forth the general provisions of the rule; current subparts A, B, and C would change to subparts B, C, and D, respectively; the titles of these subparts would be revised to make it clear that they apply only to OTPs; subpart E is reserved and subpart F contains the final rule. Subpart A, § 8.1 details the scope of the rule and explains that the proposed rules in the new subpart F pertain only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) with a patient limit of 101 to 275. Subpart A, § 8.2 provides the definitions that apply to the entirety of part 8 and § 8.3 discusses opioid treatment programs. Subpart F discusses the authorization to increase the patient limit to 275 patients. Subpart F, § 8.610 describes which practitioners are qualified for a patient limit of 275; subpart F, § 8.615 describes a qualified practice setting; subpart F, § 8.620 discusses the process to request a patient limit of 275; subpart F, § 8.625 details how a request will be processed; subpart F, § 8.630 describes what a practitioner must do to maintain the 275 patient limit; subpart F, § 8.635 is reserved; subpart F, § 8.640 details the renewal process for practitioners who desire to keep their 275 patient limit; subpart F, § 8.645 discusses the responsibilities of practitioners whose renewal request for the 275 patient limit was denied or who did not request for a renewal of the 275 patient limit; subpart F, § 8.650 details the conditions under which SAMHSA can suspend or revoke a patient limit increase approval; and subpart F, § 8.655 provides the rules applicable to patient limit increases in emergency situations.
HHS has made some changes to the proposed rule's provisions, based on the comments we received. Among the significant changes are the following.
HHS has changed the highest patient limit from 200 to 275.
HHS also changed § 8.610 by revising the language in this section. This change will allow additional addiction specialists to treat up to 275 patients by including all practitioners with additional credentialing as defined in § 8.2.
HHS has decided to delay the finalization of the proposed reporting requirements in § 8.635 and is publishing elsewhere in this issue of the
HHS has responded to the comments received on the proposed rule, and provided an explanation of each of the
HHS received a number of comments that expressed general support and advocacy for the proposed rule. Many of these comments pointed to the lives that will be saved and the long waitlists for MAT that will be shortened. Commenters also noted that the rule provides parity with other conditions/medications and that the rule will help provide a research-based understanding of addiction.
There were also some comments that expressed disagreement with the proposed rule. These commenters said that MAT was not as effective as traditional models and that buprenorphine is a drug of diversion and misuse, and could result in poor outcomes. Some commenters cited a need for more providers rather than higher prescribing limits. Several commenters suggested that the application and renewal procedure and the recordkeeping and reporting requirements will dissuade physicians from applying for the higher patient limit.
A comment also suggested that very few additional patients will receive addiction treatment with buprenorphine as a result of the proposed rule, due to the small number of subspecialists eligible to treat an additional 100 patients each, unclear criteria for what constitutes a qualified practice setting, and continued poor reimbursement.
Given the evidence supporting buprenorphine-based MAT as an effective treatment for opioid use disorder and the magnitude of the opioid crisis, this rule is intended to increase access to buprenorphine-based MAT, prevent diversion, and ensure quality services are provided. With respect to the comment specifically related to the issues of subspecialty board certification and unclear criteria for a qualified practice setting, the final rule addresses these issues by replacing the “board certification” definition with an “additional credentialing” definition and also provides further clarity regarding the criteria for a qualified practice setting. HHS appreciates that increasing the patient limit for certain MAT providers is a complex issue and is not the only avenue for addressing the opioid public health crisis. HHS is promoting access to all forms of MAT for opioid use disorder through multiple activities included in the Secretary's Opioid Initiative. Given the Secretary's authority to increase the patient limit on treatment under 21 U.S.C. 823(g)(2) by rulemaking, the rule is an essential element of a comprehensive approach to increasing access to MAT.
HHS also received a wide variety of comments related to the issue of MAT that did not specifically relate to a section of the proposed rule, but generally fell into five main categories. The categories and comments are as follows.
Many commenters wrote about the eligibility and role of nurse practitioners and/or physician assistants in prescribing buprenorphine. The vast majority of these commenters suggested that nurse practitioners and physician assistants should be allowed to prescribe buprenorphine under the new regulation. Two major associations wrote in support of registered nurses with addiction specialty training to be able to prescribe. Numerous comments stated that HHS needed to include other practitioners especially in order to reach rural and medically underserved regions.
HHS also received several comments opposed to allowing nurse practitioners and physician assistants to prescribe buprenorphine.
Questions related to expanding eligible prescribers are outside the scope of this rulemaking; the statute limits who is eligible to prescribe buprenorphine for MAT. 21 U.S.C. 823(g)(2) limits the practitioners eligible for waiver in this context to physicians, and, therefore, HHS is not authorized to include other types of providers in this rule. However, HHS recognizes the issues raised by commenters and the President's FY 2017 Budget proposes a buprenorphine demonstration program to allow advance practice providers to prescribe buprenorphine. This would allow HHS to begin testing other ways to improve access to buprenorphine throughout the country.
In the NPRM, HHS proposed that the Secretary would establish a process by which patients who are treated with medications covered under 21 U.S.C. 823(g)(2)(C), that have features that enhance safety or reduce diversion, as determined by the Secretary, may be counted differently toward the prescribing limit established in the proposed rule. Such medications are referred to here as “new formulations.” HHS also proposed that the criteria for determining which if any of these new formulations may be considered, and how these patients will be counted toward the patient limit, will be based on the following principles: (a) The relative risk of diversion associated with medications that become covered under 21 U.S.C. 823(g)(2)(C) after the effective date of the proposed rule; and (b) the time required to monitor patient safety, assure medication compliance and effectiveness, and deliver or coordinate behavioral health services.
HHS did not receive any comments that provided specific criteria to be used to count new formulations differently under the patient limit. One commenter suggested that abuse-deterrent labeling should not be a requirement. HHS did receive a small number of comments about new formulations which recommended that patients being treated with these new formulations not be counted against a patient limit. One commenter stated that HHS should establish a process for counting the patients differently if there is a risk to public health. Another commenter recommended the establishment of a process for evaluating new formulations that would be triggered by a petition from a product manufacturer, trade association, practitioner, State or local agency, or representatives of opioid use disorder patients or their families.
HHS received a number of comments recommending a cautious approach, including one suggestion to not count patients as fractions and another to consider the potential impact of a formulation-based counting methodology on practitioners and patient-driven recovery. One commenter expressed concern that new formulations that require less oversight from a practitioner may result in the reduction of psychosocial and other support services. HHS also received a comment that it is too soon to determine how patients treated with the new formulations should be counted.
HHS will review new formulations as they are approved by FDA for use in the treatment of opioid use disorder and is strongly supportive of innovative formulations that increase access to MAT.
With respect to the comments suggesting that no limit apply to patients treated with new formulations, HHS does not believe that raising the limit beyond that specified in this rule is warranted at this time.
After reviewing the comments, HHS has determined under the final rule, all patients treated with medications covered under 21 U.S.C. 823(g)(2)(C), including new formulations, will be counted against the patient limit established by this rule in the same
HHS received several comments describing insurance-related issues that commenters believe affect access to treatment with buprenorphine. These comments, which are outside the scope of this rulemaking, focused on topics such as varying formats for requesting approval for treatment services and prescription coverage, reimbursement rates, coverage criteria, pharmacy practices, implementation of substance use disorder parity laws, and use of quality metrics. HHS received comments stating that the proposed rule does not address the many reasons why providers are not prescribing MAT to the fullest extent of their current waivers, including concerns about public and private insurer reimbursement for the additional reporting, documentation, and counseling as well as concerns about on-site DEA inspections.
HHS appreciates these comments and is aware of the issues associated with access to buprenorphine. However, these issues are beyond the scope of this rulemaking given HHS' regulatory authority under 21 U.S.C. 823(g)(2)(B)(iii).
HHS received many comments that related to prescribing practices. One comment recommended that a prescriber of buprenorphine not be permitted to make a diagnosis of opioid use disorder or dependency in order to prevent the development of “pill mills.” Another comment stated that Vivitrol® should be offered along with buprenorphine and another stated that it should be prescribed in place of buprenorphine.
Several commenters focused on limiting prescriptions of opioids. Others proposed limiting the allowable dosing of buprenorphine. One commenter recommended that the number of patients allowed for treatment by a waivered practitioner should be tied to the recommended dose in order to incentivize physicians to prescribe appropriate doses of buprenorphine in an effort to decrease diversion. The commenter also stated that a physician treating 200 patients should not be allowed to prescribe more than an average of 2,800 mg of buprenorphine per day. HHS also received a comment that practitioners prescribing buprenorphine up to a higher patient limit should be required to see patients at least once a month.
HHS received a comment recommending that physicians obtain a written agreement from each patient stating that the patient: Will receive an initial assessment and treatment plan; will be subject to medication adherence and substance use monitoring; and understands all available treatment options, including all FDA-approved drugs for treatment of opioid use disorder and their potential risks and benefits. One commenter suggested that HHS issue firm recommendations on safe medication renewal quantities and weaning and reduction timeframes. Another commenter suggested taking into consideration the individual's age, gender, ethnicity, and culture during treatment.
HHS recognizes that there are multiple approaches to addressing opioid use disorder. However, many of these issues are beyond the scope of this rule.
Many comments provided suggestions on how to broadly address the problem of opioid use disorder. HHS received several comments noting that, despite being able to prescribe buprenorphine to only a limited number of patients, practitioners are not subject to any limits when prescribing opioids for pain. Some commenters recommended that either the limit to prescribe buprenorphine be removed or that an opioid prescribing limit be established. One commenter asked that if HHS believes that there should be a limit on the number of patients treated with buprenorphine, why HHS is not also seeking a limit on the number of patients prescribed schedule II opioids for chronic pain. And another commenter suggested that physicians who prescribe opioids should be required to offer treatment for opioid use disorders.
HHS also received a few comments that concerned treatment using antidepressants, anxiolytics, and antipsychotics where patient limits do not apply. The commenters felt the same concept should be applied to buprenorphine.
A buprenorphine patient limit was introduced in statute. HHS' rulemaking is intended to implement the statutory provisions. With respect to opioid prescribing, the Centers for Disease Control and Prevention (CDC) recently released the Guideline for Prescribing Opioids for Chronic Pain and SAMHSA supports the Providers' Clinical Support System-Opioid program, which is a national training and mentoring project that makes available at no cost continuing medical education (CME) programs on the safe and effective use of opioids for treatment of chronic pain and safe and effective treatment of opioid use disorder. HHS received comments focused on the system of treatment for opioid use disorders, including the integration of behavioral health into primary care; screening for substance use disorders and connecting to treatment via Screening, Brief Intervention, and Referral to Treatment (SBIRT); reimbursement issues; and use of opioid antagonists such as naloxone in preventing opioid overdose.
A comment stated that the organization wanted to make sure patients receive long-term evidence-based care to treat opioid use disorder. HHS also received several comments stating that it needed to ensure that a full continuum of care is available for patients. While ongoing work is occurring throughout HHS on improving access to treatment, these specific issues are outside the scope of this rulemaking.
HHS also received a comment recommending that we consider additional strategies to incentivize primary care providers to apply for waivers to prescribe buprenorphine, including educational campaigns to address any misperceptions related to buprenorphine prescribing and DEA audits, greater dissemination of research and data regarding evidence-based MAT, and continual engagement with stakeholders to ensure the legal and regulatory framework is appropriate and effective. Another commenter also expressed the need for a national educational campaign about misuse of prescription opioid analgesics. One commenter recommended that HHS work with other local, State and Federal entities, including the Centers for Medicare & Medicaid Services (CMS), FDA, CDC, and DEA to develop education for the public that is both comprehensive and targeted to address the knowledge gaps of relevant stakeholders. HHS received comments expressing the importance of increasing the number of resources, training, and qualified personnel to prescribe buprenorphine and administer and monitor patients. Another commenter also felt that we should consider additional measures to educate physicians about best practices to minimize the risk of diversion, including the distribution of best practice guidance documents. An additional comment expressed concerns that clinics owned and operated by non-physicians, or employing part-time newly waivered physicians, with no full-time addiction physician oversight
HHS also received a comment expressing concerns that raising the limit will not sufficiently address improving access to individuals located in geographic regions where buprenorphine or other MAT medications are currently unavailable, because only a third of buprenorphine-waivered physicians are qualified to treat 100 patients at a time.
HHS shares the commenters' concern that some populations are geographically disadvantaged in terms of access to MAT. HHS believes this final rule will help address this concern by expanding the ability for physicians in all areas, including rural areas, to treat patients with opioid use disorder while minimizing the risk of diversion. In addition, the shift in policy from allowing a practitioner with a waiver to treat up to 200 patients in the NPRM to allowing a practitioner with a waiver to treat up to 275 patients is likely to have a significant impact in rural areas which are currently served by smaller numbers of practitioners with waivers.
HHS appreciates the many comments aiming to more broadly address the issue of opioid use. While this rule is more limited in scope, HHS is working to address some of the ideas expressed in the comments through other actions taken to implement the Secretary's Opioid Initiative.
HHS received several comments estimating the number of practitioners who would seek a waiver for the higher patient limit. For example, one comment stated that between 8 and 15 Vermont physicians would seek the additional waiver to treat 200 patients, noting that it would have the potential to increase access to office-based outpatient treatment services by between 25 and 50 percent from its current utilization rate. HHS considered these estimates as it calculated the Regulatory Impact Analysis (RIA) for the rule.
HHS received a comment asking why there were different rules for methadone and another one that asked why the rules were different than the rules in Canada.
Methadone is not included as part of this rule because methadone is a Schedule II drug, while the only medications covered under this rule are in Schedule III, IV, or V, pursuant to 21 U.S.C. 823(g)(2)(C). In addition, the United States and Canada regulate opioid use disorder treatment under different laws.
HHS received a comment stating that impaired decision-making, especially for safety sensitive professions (
While this issue is beyond the scope of this rule, HHS encourages all practitioners to fully inform their patients about MAT, whether it is appropriate for an individual patient and, if so, which FDA-approved medications may be most appropriate for that patient.
Another commenter requested guidance on what constitutes an appropriate course of treatment and how “recovery” should be determined, which will enable them to meet the reporting requirements more successfully. An additional commenter requested that guidance specify whether or not an in-office induction is required.
HHS appreciates these comments and will bear them in mind as it develops guidance documents after the final rule goes into effect.
In the proposed rule, HHS proposed increasing the highest available patient limit for qualified practitioners to receive a waiver from 100 to 200. This proposed higher patient limit was intended to significantly increase patient capacity for practitioners qualified to prescribe at this level while also ensuring that waivered practitioners would be able to provide comprehensive treatment associated with MAT.
Under the final rule, practitioners authorized to treat up to 275 patients will be required to meet infrastructure requirements that exceed those required for practitioners who have a waiver to treat 100 or fewer patients. HHS proposed additional criteria and responsibilities for practitioners to be able to treat up to the higher patient limit with the specific aims of ensuring quality of care and minimizing diversion. Importantly, the additional criteria and responsibilities were not intended to be unduly burdensome to practitioners who wish to expand their MAT treatment practice. Also, the rule does not add these additional requirements to practitioners who have a waiver to treat up to 100 patients under 21 U.S.C. 823(g)(2). The rule also creates an option for an increased patient limit for practitioners responding to emergency situations that require immediate, increased access to medications covered under 21 U.S.C. 823(g)(2)(C). In addition, HHS included key definitions that will help practitioners understand and implement the requirements of this rule.
As proposed in the NPRM, this rule will be added to 42 CFR part 8 as subpart F. Accordingly, changes to part 8 were necessary to integrate the contents of the new regulations established by this rule into part 8. For example, part 8, subparts A, B, and C, had to be reordered as subparts B, C, and D, respectively. The titles of these subparts were revised to make it clear that they apply only to OTPs.
The comments and HHS' responses are set forth below.
For the reasons set forth above and considering the comments and additional information received, we have changed the proposed patient limit of 200 to 275 patients per practitioner for practitioners who meet the requirements laid out in the final rule.
HHS proposed that the scope of part 8 would cover rules that are applicable to OTPs, and to waivered practitioners who seek to treat more than 100 patients with applicable medications. New subparts B through D under the final rule contain the rules relevant to OTPs. Subpart E is reserved and Subpart F contains the new final rule. Section 8.1 also explains that the rules in the new subpart F pertain only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) with a patient limit of 101 to 275.
HHS did not receive any comments on this provision. Therefore, for the reasons set forth in the proposed rule, we are finalizing the provisions as proposed in § 8.1 without modification.
HHS proposed definitions that would apply to the entirety of part 8. HHS also proposed revising definitions that would apply only to OTPs. Two definitions were proposed for elimination: “Registered opioid treatment program” and “opiate addiction.”
HHS proposed a revised definition of “patient.” At present, the definition of “patient” in § 8.2 is limited to those individuals receiving treatment at an OTP, which excludes those individuals receiving office-based opioid treatment with buprenorphine,
HHS proposed a revised definition of patient to make it inclusive of all persons receiving MAT with an opioid medication, consistent with the expanded scope of proposed revisions to 42 CFR part 8. HHS proposed that patient “means any individual who receives MAT from a practitioner or program subject to this part.” Upon further review, we determined that modifications to the proposed definition of “patient” were needed to clarify the scope of patients covered under this rule (for purposes of the patient limit), and to distinguish such patients from opioid treatment program patients for which no patient limit applies. We are now defining patient as, for purposes of subparts B-E, meaning any individual who receives maintenance or detoxification treatment in an opioid treatment program. For purposes of subpart F patient means any individual who is dispensed or prescribed covered medications by a practitioner. The patient definition modifications reflected in the final rule are consistent with the intention of the NPRM. As we explained in the NPRM, if a practitioner, for example, provides cross-coverage for another practitioner and in the course of that coverage the covering practitioner provides a prescription for buprenorphine, the patient counts towards the cross-covering practitioner's patient limit until the prescription or medication has expired. However, if a cross-covering practitioner is merely available for consult but does not dispense or prescribe buprenorphine while the prescribing practitioner is away, the patients being covered do not count
HHS proposed that the rule include the following definition of patient limit: “the maximum number of individual patients a practitioner may treat at any time using covered medications.” Given the changes to the definition of “patient,” the definition for “patient limit” was modified to mean the maximum number of individual patients that a practitioner may dispense or prescribe covered medications to at any one time. This modification ensures alignment between the definition of “patient” and “patient limit.”
Taken together, the definitions of “patient” and “patient limit” provide clear and fair guidance for regulatory enforcement and are expected to reduce undercounting of patients by practitioners. These definitions are also intended to clarify that patients who are not dispensed or prescribed medication covered by this rule should not be counted against a practitioner's patient limit. Accordingly, waivered practitioners will be able to provide reciprocal cross-coverage to patients of other practitioners (assuming the dispensing or prescribing of covered medication is not involved) for brief periods, such as weekends or vacations, without requiring such patients to be added to the patient count of the practitioner who is providing cross-coverage.
Other new definitions proposed include “behavioral health services,” “emergency situation,” “nationally recognized evidence-based guidelines,” “practitioner incapacity” and “waivered practitioner.”
HHS proposed to define “nationally recognized evidence-based guidelines” to mean a document produced by a national or international medical professional association, public health entity, or governmental body with the aim of ensuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions. Some examples include the American Society of Addiction Medicine (ASAM) National Practice Guidelines for the Use of Medications in the Treatment of Addiction Involving Opioid Use; SAMHSA's Treatment Improvement Protocol 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction; the World Health Organization Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence; the Department of Veterans Affairs/Department of Defense/Clinical Practice Guideline on Management of Substance Use Disorder; and the Federation of State Medical Boards' Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. HHS expects that guidelines meeting this definition may change over time but does not plan to keep a list for practitioners to consult.
The definitions of “practitioner” and “practitioner incapacity” were modified to remove the term “waivered” since that term does not appear in the regulatory text. In addition, the definition of “certification” was renamed “opioid treatment program certification” to clarify that the definition in § 8.2 specifically applies to certification of OTPs.
In addition, the final rule includes a definition of Medication-Assisted Treatment (MAT) that was provided in the preamble of the NPRM, but that was not inserted into the rule text of the NPRM. Accordingly, “Medication-Assisted Treatment” is now defined in the text of the final rule.
The final rule also replaced “board certification” with “additional credentialing” due to the removal of the term “subspecialty” with respect to practitioners that can request a higher limit outside of a qualified practice setting.
The comments and our responses are set forth below.
For the reasons set forth in the proposed rule and after considering the comments received, HHS is modifying several of the proposed definitions in § 8.2 to enhance clarity and consistency with the scope of 21 U.S.C. 823(g)(2). Specifically, HHS has modified the definitions for “patient” and “patient limit,” and modified the terms “practitioner” and “practitioner incapacity.” Finally, HHS removed the term “board certification” and added “additional credentialing” to clarify that all practitioners who currently qualify to treat up to 100 patients are eligible for the higher patient limit if they are included as specialists as described in 21 U.S.C. 823 (g)(2)(G)(ii)(I)-(III).
HHS proposed retitling subparts B, C, and D §§ 8.3 through 8.34 so as to implement the addition of subpart F. We proposed changes to these sections limited to changing the mailing address for program certification and accreditation body approval and updating terms, such as “opiate” and
The comments and our responses are set forth below.
HHS did not receive any comments related to §§ 8.3 through 8.34 that were capable of being addressed in the final rule. Therefore, for the reasons set forth in the proposed rule, HHS is finalizing the provisions §§ 8.3 through 8.34 without modification.
Proposed § 8.610 described how practitioners can qualify for the 200 patient limit. Such practitioners would be required to possess subspecialty board certification in addiction medicine or addiction psychiatry or practice in a qualified practice setting as defined in the rule. In either case, practitioners with the higher limit would have to possess a waiver to treat 100 patients for at least 1 year in order to gain experience treating at the higher limit. The purpose of offering the 200 patient limit to practitioners in these two categories was to recognize the benefit offered to patients by either: (1) The advanced training, knowledge, and skill of practitioners with a subspecialty board certification; or (2) the higher level of direct service provision and care coordination envisioned in the qualified practice setting. This approach would restrict access to the 200 patient limit to a subset of the practitioners waivered to provide care up to 100 patients. In addition to ensuring higher quality of care, the criteria for the higher limit would be intended to minimize the risk of diversion of controlled substances to illicit use and accidental exposure that could result from increased prescribing of buprenorphine. A practitioner with board certification in an addiction subspecialty would have to have the training and experience necessary to recognize and address behaviors associated with increased risk of diversion. In the qualified practice settings, HHS believes that the care team and practice systems will function to help ensure this same level of care. HHS requested comments on this proposed approach, including comments on whether there are other ways for HHS to ensure quality and safety while encouraging practitioners to take on additional patients.
The comments and HHS responses are set forth below.
For the reasons set forth in the proposed rule and considering the comments received, HHS replaced “board certification” with “additional credentialing” in § 8.2 which will allow additional practitioners to become eligible for the 275-patient limit. At the beginning of § 8.610, we replaced the text that states that “A practitioner is eligible for a patient limit of 200,” with language that states the total number of patients that a practitioner may dispense or prescribe covered medications to at any one time for purposes of 21 U.S.C. 823(g)(2)(B)(iii) is 275. Other than increasing the applicable patient limit to 275 (the basis for which has been discussed elsewhere in this preamble) the modified language does not reflect an intention to substantively change any other aspect of the patient limit from that which was proposed in the NPRM. Rather, the language modification is intended to align the final rule's text with the terminology used in 21 U.S.C. 823(g)(2)(B)(iii).
HHS proposed § 8.615 to describe the necessary elements of a qualified practice setting, which can include practices with as few as one waivered provider as long as these criteria are met, and can include both private practices and community-based clinics. Necessary elements of a qualified practice setting would include: (1) The ability to offer patients professional coverage for medical emergencies during hours when the practitioner's practice is closed; this does not need to involve another waivered practitioner, only that coverage be available for patients experiencing an emergency even when the office is closed; (2) the ability to ensure access to patient case-management services including behavioral health services; (3) health information technology (health IT) systems such as electronic health records, when practitioners are required to use it in the practice setting in which he or she practices; (4) participation in a prescription drug monitoring program (PDMP), where operational, and in accordance with State law. PDMP means a statewide electronic database that collects designated data on substances dispensed in the State. For practitioners providing care in their capacity as employees or contractors of a Federal government agency, participation in a PDMP would be required only when such participation is not restricted based on State law or regulation based on their State of licensure and is in accordance with Federal statutes and regulations; and (5) employment, or a contractual obligation to treat patients in a setting that has the ability to accept third-party payment for costs in providing health services, including written billing, credit and collection policies and procedures, or Federal health benefits.
The elements were identified as common to many high-quality practice settings, which includes both private practices as well as federally qualified health centers and community mental health centers, and therefore worthy of replication. The elements would be expected to be common to OTPs, and OTPs currently in operation but not providing MAT under 21 U.S.C. 823(g)(2). Taken together, this would facilitate additional opportunities to expand access to MAT. Another consideration in the selection of these elements was the need to limit the expansion of group practices formed for the sole purpose of pooling the individual practitioner limits to maximize revenue but which fail to
The comments and HHS responses are set forth below.
For the reasons set forth in the proposed rule, and considering the comments received, HHS is finalizing the provisions as proposed in § 8.615 without modification.
HHS proposed § 8.620 to describe the process to request a patient limit of 200. Similar to the waiver process for the 30 and 100 patient limits, the process would begin with filing a form, in this case, a Request for Patient Limit Increase. A proposed draft of the Request for Patient Limit Increase was posted along with the NPRM and has been submitted to the Office of Management and Budget for final review. The higher patient limit would carry with it greater responsibility for behavioral health services, care coordination, diversion control, and continuity of care in emergencies and for transfer of care in the event that the practitioner does not request renewal of the higher patient limit or the practitioner's renewal request is denied. The new Request for Patient Limit Increase process would require providers to affirm that they would meet these requirements. HHS proposed definitions of “behavioral health services,” “diversion control plan,” “emergency situation,” “nationally recognized evidence-based guidelines,” and “practitioner incapacity” in § 8.2 to assist practitioners in understanding what is expected of them in making these attestations. These responsibilities would be aligned with the standards of ethical medical and business practice and are not expected to be burdensome to practitioners. Single State Authorities, State Opioid Treatment Authorities and other resources/entities exist to help in the development of patient placement in the event that transfer to other addiction treatment would be required, for example, if a practitioner chose to no longer practice at the higher patient limit. HHS proposed that practitioners approved at the higher limit would also be required to reaffirm their ongoing eligibility to fulfill these requirements every 3 years as described in § 8.640.
The comments and our responses are set forth below.
For the reasons set forth in the proposed rule, and considering the comments received, HHS is finalizing the provisions as proposed in § 8.620 without modification.
HHS proposed § 8.625 to describe how SAMHSA will process a Request for Patient Limit Increase. The process
After considering this process, the Department has made a minor modification to § 8.625(c) by replacing the word “will” with the word “may” in the last sentence of this paragraph. This modification gives SAMHSA the flexibility to approve a practitioner's Request for Patient Limit Increase, if, for example, relevant deficiencies are resolved to the satisfaction of SAMHSA shortly after the expiration of the designated time period.
The comments and HHS responses are set forth below.
For the reasons set forth in the proposed rule and considering the comment HHS received, HHS is finalizing the provisions as proposed in § 8.625 with the exception of the word change noted in § 8.625(c).
HHS proposed § 8.630 to describe the conditions for maintaining a waiver for each 3-year period for which waivers are valid, including maintenance of all eligibility requirements specified in § 8.610, and all attestations made in accordance with § 8.620(b). Compliance with the requirements specified in § 8.620 would have to be continuous.
HHS did not receive any comments specific to § 8.630.
HHS did not receive any comments on this provision. Therefore, for the reasons set forth in the proposed rule, HHS is finalizing the provisions as proposed in § 8.630 without modification.
HHS proposed § 8.635 to describe the reporting requirements for practitioners whose Request for Patient Limit Increase is approved under § 8.625. HHS requested comments on whether the proposed reporting periods and deadline could be combined with other, existing reporting requirements in a way that would make reporting less burdensome for practitioners. HHS proposed the following reporting requirements:
The comments and HHS responses are set forth below.
HHS received a number of comments on these requirements. Many commenters expressed concern that the reporting requirements were burdensome and could decrease practitioners' interest in reaching the higher patient limit. Some commenters said that the reporting requirements would not ensure the appropriate level of behavioral health care. There were other concerns that the requirements were not consistent between practitioners who had waivers to treat up to 100 patients and practitioners with the higher patient limit. In addition, there was confusion about the periodicity of the reporting requirements. Overall, many commenters requested clarity.
HHS proposed to include reporting requirements as part of its approach to increasing access to MAT while ensuring that patients receive the full array of services that comprise evidence-based MAT and minimizing the risk that the medications provided for treatment are misused or diverted. HHS appreciates the comments received and, in light of them, has decided to delay finalizing this section of the proposed rule and to publish elsewhere in this issue of
HHS is reserving § 8.635
We proposed § 8.640 to describe the process for a practitioner renewing his or her approval for the higher patient limit. In order for a practitioner to renew an approval, he or she would have to submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of the approval term.
The comments and HHS responses are set forth below.
For the reasons set forth in the proposed rule, and considering the comments received, HHS is finalizing the provisions as proposed in § 8.640 without modification.
HHS proposed § 8.645 to describe the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase or whose renewal request is denied. Under § 8.620(b)(7), practitioners would notify all patients affected above the 100 patient limit that the practitioner would no longer be able to provide MAT services using covered medications and would make every effort to transfer patients to other addiction treatment.
HHS did not receive any comments on this provision. Therefore, for the reasons set forth in the proposed rule, HHS is finalizing the provisions as proposed in § 8.645 without modification.
HHS proposed § 8.650 to describe under what circumstances SAMHSA would suspend or revoke a practitioner's patient limit increase of 200. If SAMHSA had reason to believe that immediate action would be necessary to protect public health or safety, SAMHSA would suspend the practitioner's patient limit increase of 200. If SAMHSA determined that the practitioner had made misrepresentations in his or her Request for Patient Limit Increase, or if the practitioner no longer satisfied the requirements of this subpart, or he or she had been found to have violated the CSA pursuant to 21 U.S.C. 824(a), SAMHSA would revoke the practitioner's patient limit increase of 200. It should be noted that DEA has independent enforcement authority and this rule in no way affects that authority or changes the way in which DEA and SAMHSA interact with respect to waivers.
The comments and HHS responses are set forth below.
The proposed language under § 8.650 provided only one circumstance under which SAMHSA could suspend a practitioner's Patient Limit Increase approval, and three instances under which SAMHSA could revoke this approval. After further consideration, HHS has modified the language in § 8.650 in an effort to allow the Secretary to suspend or revoke a practitioner's Request for Patient Limit Increase approval on the basis of any of
HHS proposed § 8.655 to describe the process, including the information and documentation necessary, for a practitioner with an approved 100 patient limit to request approval to temporarily treat up to 200 patients in an emergency situation. The intention of this provision is to help assure continuity of care for patients whose care might otherwise be abruptly terminated due to the death or disability of their practitioner. This provision would also help communities respond rapidly to a sudden increase in demand for medication-assisted treatment. Sudden increases in demand for treatment may be experienced when there is a local disease outbreak associated with drug use, or when a natural or human-caused disaster either displaces persons in treatment from their practitioner or program or destroys program infrastructure. The emergency provision generally would not be intended to correct poor resource deployment due to lack of planning. The emergency provision of the proposed rule would only be considered if other options for addressing the increased demand for medication-assisted treatment could not address the situation.
HHS proposed that the practitioner must provide information and documentation that: (1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the emergency qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit; (2) identifies a period of time in which the higher patient limit should apply, and provides a rationale for the period of time requested; and (3) describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to the higher patient limit expires. Prior to taking action on a practitioner's request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authorities in order to determine whether the emergency situation that a practitioner describes justifies an immediate increase in the higher patient limit. If, after consultation with the governmental authorities, SAMHSA determines that a practitioner's request under this section should be granted, SAMHSA will notify the practitioner that his or her request has been approved. The period of such approval shall not exceed six months. A practitioner wishing to receive an extension of the approval period granted must submit a request to SAMHSA at least 30 days before the expiration of the six month period and certify that the emergency situation continues. Except as provided in this section and § 8.650, requirements in other sections under subpart F do not apply to practitioners receiving waivers in this section.
The comments and HHS responses are set forth below.
For the reasons set forth in the proposed rule, and considering the comments received, HHS is finalizing the provisions as proposed in § 8.655 without modification.
The NPRM called for new collections of information under the Paperwork Reduction Act of 1995. The final rule calls for the most of the same collections of information as the NPRM. As defined in implementing regulations, “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other similar actions. In this section, we first identify and describe the types of information applicants and waivered practitioners must collect and report, and then we provide an estimate of the total annual burden. The estimate covers the employees' time for reviewing and posting the collections required.
• Completed 3-page Request for Patient Limit Increase Form, a draft of which was posted in the public docket along with the NPRM;
• Statement certifying that the practitioner:
○ Will adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders;
○ Will provide patients with necessary behavioral health services as defined in § 8.2 or will provide such services through an established formal agreement with another entity to provide behavioral health services;
○ Will provide appropriate releases of information, in accordance with Federal and State laws and regulations, including the Health Information Portability and Accountability Act Privacy Rule and part 2, if applicable, to permit the coordination of care with behavioral health, medical, and other service practitioners;
○ Will use patient data to inform the improvement of outcomes;
○ Will adhere to a diversion control plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use;
○ Has considered how to assure continuous access to care in the event of practitioner incapacity or an emergency situation that would impact a patient's access to care as defined in § 8.2; and
○ Will notify all patients above the 100 patient level, in the event that the request for the higher patient limit is not renewed or the renewal request is denied, that the practitioner will no longer be able to provide MAT services using buprenorphine to them and make every effort to transfer patients to other addiction treatment.
Annual burden estimates for these requirements are summarized in the following table:
Note that these estimates differ from those found in the RIA because the estimates here are wage cost estimates while the estimates in the RIA are resource cost estimates which incorporate costs associated with overhead and benefits.
HHS received several comments regarding the Collection of Information.
One commenter wanted to include in the Request for Patient Limit Increase information that required the implementation of random tablet/film counts and urine screens. Another commenter wanted mandatory Point-of-Care Urine Drug Screens on each visit to document the presence of buprenorphine/naloxone and the absence of other opioids. HHS also received a comment recommending that drug testing be included as part of treatment with buprenorphine and thus noted in the information that would be collected in the Request for Patient Limit Increase.
HHS believes that drug screens are likely part of a practitioner's diversion control plan and part of the data that will inform the practitioner's ability to help the patient achieve better outcomes. Thus, HHS is not revising the information to be collected as part of the Request for Patient Limit Increase.
HHS received a comment recommending that pharmacists be included in the pool of practitioners to which a release of information should be considered.
HHS believes it may be appropriate to release certain information to pharmacists if the patient provides consent. HHS declines to require that pharmacists be included in the pool of practitioners to which information may be released.
HHS has examined the impact of this final rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on Federalism (August 4, 1999).
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. HHS expects that this final rule will have an annual effect on the economy of $100 million or more in at least 1 year and therefore is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act (RFA) requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as: (1) A proprietary firm meeting the size standards of the Small Business Administration; (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000 (States and individuals are not included in the definition of “small entity”). HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue. HHS anticipates that the final rule will not have a significant economic impact on a substantial number of small entities. We provide supporting analysis in section F.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) implicit price deflator for the gross domestic product. HHS expects this final rule to result in expenditures that would exceed this amount.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments or has federalism implications. HHS has determined that the final rule does not contain policies that would have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. The changes in the rule represent the Federal Government regulating its own program. Accordingly, HHS concludes that the final rule does not contain policies that have federalism implications as defined in Executive Order 13132 and, consequently, a federalism summary impact statement is not required.
Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows individual practitioners to dispense and prescribe Schedule III, IV, or V controlled substances that have been approved by the FDA specifically for use in
Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial NOI to treat a maximum of 30 patients at a time. After one year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. To qualify, the practitioner must be a physician, possess a valid license to practice medicine, be a registrant of the DEA, have the capacity to refer patients for appropriate counseling and other appropriate ancillary services, and have completed required training. The training requirement may be satisfied in several ways: one may hold board certification in addiction psychiatry from the American Board of Medical Specialties or addiction medicine from the American Osteopathic Association; hold an addiction certification from the American Society of Addiction Medicine (ASAM); complete an 8-hour training provided by an approved organization; have participated as an investigator in one or more clinical trials leading to the approval of a medication that qualifies to be prescribed under 21 U.S.C. 823(g)(2); or complete other training or have such other experience as the State medical licensing board or Secretary of HHS considers to demonstrate the ability of the practitioner to treat and manage persons with opioid use disorder.
Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to promulgate regulations that change the total number of patients that a practitioner may treat at any one time.
The laws pertaining to the utilization of buprenorphine were last revised approximately ten years ago at a time when the extent of the opioid public health crisis was less well-documented. The purpose of the final rule is to expand access to MAT with buprenorphine while encouraging practitioners administering buprenorphine to ensure their patients can receive the full array of services that comprise evidence-based MAT and to minimize the risk of drug diversion. The final rule revises the highest patient limit from 100 patients per practitioner with an existing waiver (waivered practitioner) to 275 patients for practitioners who meet certain criteria in addition to those established in statute. Practitioners who have had a waiver to treat 100 patients for at least one year could obtain approval to treat up to 275 patients if they meet the requirements defined in this final rule and after submitting a Request for Patient Limit Increase to SAMHSA. Practitioners approved to treat up to 275 patients will also be required to accept greater responsibility for providing behavioral health services and care coordination, and ensuring quality assurance and improvement practices, diversion control, and continuity of care in emergencies. The higher limit also requires regularly reaffirming the practitioner's ongoing eligibility and participating in data reporting and monitoring as required by SAMHSA. In addition, practitioners in good standing with a current waiver to treat up to 100 patients (
The United States is facing an unprecedented increase in prescription opioid misuse, heroin use, and opioid-related overdose deaths. In 2014, 18,893 overdose deaths involved prescription opioids and 10,574 involved heroin.
Beyond the increase in overdose deaths, the health and economic consequences of opioid use disorders are substantial. In 2011, the most recent year data are available, an estimated 660,000 emergency department visits were due to the misuse or abuse of prescription opioids, heroin, or both.
Beginning around 2006, the United States started to experience a significant increase in the rate of hepatitis C virus infections. The available epidemiology indicates this increase is largely due to the increased injection of prescription opioids and heroin.
There is robust literature documenting the effectiveness and cost-effectiveness of the use of buprenorphine in the treatment of opioid use disorder. Buprenorphine has been shown to increase treatment retention and to reduce opioid use, relapse risk, and risk behaviors that transmit HIV and hepatitis.
Despite these well-documented benefits, buprenorphine treatment for opioid use disorder is significantly underutilized and often does not incorporate the full scope of recommended clinical practices that make up evidence-based MAT. Generally, there is significant unmet need for MAT treatment among individuals with opioid use disorders.
Evidence suggests that utilization of buprenorphine is limited directly by the existence of treatment limits. Practitioners currently providing MAT with buprenorphine under 21 U.S.C. 823(g)(2) report that being limited to treating not more than 100 patients at a time is a barrier to expanding treatment.
In addition to direct barriers to treating additional patients imposed by the patient limit, there are indirect barriers to expanding treatment capacity. In particular, increases in a practitioner's ability to expand his or her patient base will allow the practitioner to take advantage of economies of scale to increase the practice's efficiency. For example, a practitioner with a larger practice is more likely to be able to afford to hire specialized support staff, which allows the practitioner to reduce time spent on tasks best suited for another individual. This may help to enable the provision of the full complement of ancillary services that make up evidence-based MAT. Increasing a practitioner's maximum capacity for treatment has the potential to make treating patients with buprenorphine more economically feasible, with the likelihood of increasing capacity to prescribe buprenorphine.
The statutory change implemented in 2007 that increased the limit on the number of buprenorphine patients a practitioner could treat from 30 to 100, after having a 30 patient limit for 1 year, was associated with a significant increase in the use of buprenorphine.
This final rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine, as they will now have the potential to treat up to 275 patients with buprenorphine. We believe that this may translate to a financial opportunity for these physicians, depending on the costs associated with treating these additional patients.
Relatedly, this final rule may increase the value of the waiver to treat opioid use disorder under 21 U.S.C. 823(g)(2). The final rule requires practitioners to have a waiver to treat 100 patients for 1 year and to have additional credentialing as defined in § 8.2 or to practice in a qualified practice setting as defined in the rule in order to request approval to treat up to 275 patients. If getting to the 275-patient limit provides sufficient benefits to practitioners, this final rule may also increase incentives for other practitioners to apply for the lower patient limit waivers, insofar as they are milestones towards the 275-patient limit. In addition, this rule may also make it more valuable for practitioners to have additional credentialing as defined in § 8.2, or to practice in a qualified practice setting. The final rule, then, may increase the number of practitioners in these categories and thus the number of practitioners eligible for the 275-patient limit in the future.
Permitting practitioners to treat up to 275 patients will only be successful if it results in practitioners serving additional patients. As discussed previously, there are many reasons to expect this to happen as a result of the publication of this final rule. In addition, we expect that other factors could amplify the impact of the changes in the rule. First, following the implementation of the Affordable Care Act, health insurance coverage has expanded dramatically in the United States. The uninsured rate among adults age 18-64 declined from 22.3 percent in 2010 to 12.7 percent during the first 6 months of 2015.
Lack of practitioner time to treat patients with opioid use disorder, which includes a patient exam, medication consultation, counseling, and other appropriate treatment services, and lack of behavioral health staff to provide these treatment services, are additional barriers to providing MAT with buprenorphine in the office-based setting.
Discussions with stakeholders about approaches to expanding access to MAT, including the use of buprenorphine-based MAT, suggest that expanding the patient limit in general will result in increased efficiencies in treating opioid use disorder patients. It will allow treating practitioners to provide the physician-appropriate services consistent with their waiver. It will provide more efficient supportive care, not related to prescribing or administering buprenorphine-containing products, by allowing the treating practitioner to supervise this care, which can be provided by physician assistants, nurse practitioners, nurse case managers, and other behavioral health specialists.
Following publication of this final rule, SAMHSA will work to educate providers about the requirements and opportunities for requesting and obtaining approval to treat up to 275 patients under 21 U.S.C. 823(g)(2). SAMHSA will prepare materials summarizing the changes as a result of
We expect that practitioners potentially affected by this policy change will process the information and decide how to respond. In particular, they will likely evaluate the requirements and opportunities associated with the ability to treat up to 275 patients, and decide whether or not it is advantageous to pursue approval to treat up to 275 patients and make any necessary changes to their practice, such as obtaining additional credentialing as defined in § 8.2, or the ability to treat patients in a qualified practice setting.
We estimate that practitioners may spend an average of thirty minutes processing the information and deciding what action to take. According to the U.S. Bureau of Labor Statistics,
Practitioners who want to treat up to 275 patients at a given time are required to submit a Request for Patient Limit Increase form to SAMHSA. The form is three pages in length. We estimate that the form takes a practitioner an average of 1 hour to complete the first time it is completed, implying a cost of $187.48 per submission after adjusting upward by 100 percent to account for overhead and benefits. A draft Request for Patient Limit Increase form is available in the docket. We did not receive public comment on these assumptions when proposed, and as a result they remain unchanged from those appearing in the proposed rule. We do not have ideal information with which to estimate the number of practitioners who will submit a Request for Patient Limit Increase form in response to this final rule, and we therefore acknowledge uncertainty regarding the estimate of the total associated cost. However, based on the experience with the patient limit increase from 30 to 100 implemented in 2007,
After approval, a practitioner would need to be resubmit a Request for Patient Limit Increase every 3 years to maintain his or her waiver to treat up to 275 patients. A practitioner would use the same 3-page Request for Patient Limit Increase used for an initial waiver request. We estimate that this will take 30 minutes because practitioners will be more familiar with the Request for Patient Limit Increase. Consistent with the physician wage estimate above, we estimate that resubmissions will require a practitioner an average of 30 minutes to complete, implying a cost of $93.74 per resubmission. To calculate costs associated with resubmission, we assume that all physicians who submit a Request for Patient Limit Increase will
Practitioners may also be interested in the ability to eventually treat up to 275 patients, and may make changes toward achieving that goal. As discussed previously, these changes may increase the number of practitioners who apply for a waiver to treat 30 or 100 patients. This would require practitioners to complete the required training, possess a valid license to practice medicine, be a registrant of DEA, and have the capacity to refer patients for appropriate counseling and other appropriate ancillary services. In addition, these changes could increase the number of practitioners who seek additional credentialing as defined in § 8.2 or meet the requirements for practicing in a qualified practice setting as outlined in the final rule. This would likely include practice experience requirements, fees and time associated with preparing for and taking an exam, time and fees for continuing medical education requirements, and payment of certification fees. We lack information to estimate the number of practitioners who will change behavior along these dimensions, and did not receive this information through the public comment process. Thus, we do not provide estimates of costs and benefits.
In addition to the costs associated with practitioners seeking approval for the higher patient limit, costs will be incurred by SAMHSA and DEA in order to process the additional Requests for Patient Limit Increase generated by the final rule. For purposes of analysis, and based on contractor estimates, SAMHSA estimates that it will pay a contractor $100 to process each waiver. As discussed previously, we estimate that between 500 and 1,800 practitioners will request approval to treat up to 275 patients within the first year of the rule, and between 100 and 300 additional practitioners will request approval to treat up to 275 patients in each of the subsequent 4 years. In addition, we estimate that physicians will resubmit 500 to 1,800 renewals in year 4, and 100 to 300 renewals in year 5. As a result, we estimate costs to SAMHSA to process these waivers of $50,000-$180,000 in year 1, $10,000-$30,000 in year 2, $10,000-$30,000 in year 3, $60,000-$210,000 in year 4, and $20,000-$60,000 in year 5 following publication of the final rule. We estimate that DEA will allocate the equivalent of 1 FTE at the GS-11 level to process the additional requests coming to DEA for issuance of a new DEA number designating the physician as eligible to prescribe buprenorphine for the treatment of opioid use disorder as a result of this final rule. We estimate the associated cost is $144,238, which we arrive at by multiplying the salary of a GS-11 employee at step 5, which is $72,219 in 2015, by two to account for overhead and benefits.
Once requests to treat up to 275 patients generated by the final rule are processed, approved practitioners would be able to increase the number of patients they treat with buprenorphine. These patients, then, could utilize additional medical services that are consistent with the expectations for high-quality, evidence-based MAT in the rule. We estimate the cost for buprenorphine and these additional medical services, including behavioral health and psychosocial services, as a result of the final rule to total $4,349 per patient per year, as described below.
This estimate was derived using claims data from the 2009-2014 Truven Health MarketScan® database. According to the MarketScan® data, the annual cost of buprenorphine prescriptions and ancillary psychosocial services received totaled $3,500 for individuals with private insurance and $3,410 for individuals with Medicaid. Specifically, the average annual cost of buprenorphine prescriptions was $2,100 for commercial insurance based on receipt of an average of seven buprenorphine prescriptions annually and $2,600 for Medicaid based on receipt of an average of 10 buprenorphine prescriptions annually. We use estimates from commercial insurance and Medicaid in order to capture the range of costs per patient across different insurance programs. However, we note that the rule will impact patients with and incur costs to not only commercial insurance and Medicaid but also other public and private insurers.
According to the MarketScan® data, approximately 69 percent of Medicaid patients and 45 percent of privately insured patients received an outpatient psychosocial service related to substance use disorder in addition to their buprenorphine prescription. The average number of visits among those who received any psychosocial service was eight for privately insured patients at an average cost of $3,000 per year and 10 for Medicaid patients at an average cost of $1,100 per year. We assumed that the quality of care would increase among patients treated by practitioners with the 275-patient limit due to the extra oversight and quality of care requirements in the final rule. Specifically, we assumed that 80 percent of patients would receive outpatient psychosocial services.
The cost of providing MAT with buprenorphine, including prescriptions, ancillary, and psychosocial services, is estimated at $4,590 for commercial insurance and $3,525 for Medicaid beneficiaries. Based on data from IMS Health, it is estimated that approximately 18 percent of individuals receiving MAT with buprenorphine are Medicaid enrollees. Thus, we arrived at the estimated average cost for individuals new to the treatment system as a result of the final rule to be $4,350 per patient per year.
The total resource costs associated with additional treatment is the product of additional treatment costs per person and the number of people who will receive additional treatment as a result of the final rule. For purposes of analysis, we assume that each practitioner who requests approval to treat up to 275 patients will treat between 20 and 50 additional patients each year. This is based on the
Evidence suggests that the benefits associated with additional buprenorphine utilization are likely to exceed their cost. One study estimates the costs and Quality Adjusted Life Year (QALY) gains associated with long-term office-based treatment with buprenorphine-naloxone for clinically stable opioid-dependent patients compared to no treatment. The authors estimate total treatment costs over 2 years of $7,700 and an associated 0.22 QALY gain compared to no treatment in their base case.
While we expect many benefits associated with this final rule, it is possible that there would be unintended negative consequences. First, prior research looked at Utah statewide increases in buprenorphine use and the number of reported unintentional pediatric exposures, and found that as buprenorphine use increased between 2002 and 2011, the number of unintentional pediatric exposures in the State increased.
It is important to note that studies have found that the motivation to divert buprenorphine is often associated with lack of access to treatment or using the medication to manage withdrawal—as opposed to diversion for the medication's psychoactive effect.
Moreover, to reduce the risk of diversion, one of the additional requirements placed on providers who seek the 275-patient limit is implementation of a diversion control plan. However, it is possible that State and local law enforcement could incur additional costs if diversion increases as a result of this final rule. We do not have sufficient information to estimate the extent to which these unintended consequences could occur, and did not receive any through public comment.
As discussed elsewhere in the preamble, HHS has decided to issue concurrently a Supplemental Notice of Proposed Rulemaking to seek additional comments on the proposed reporting requirements and is therefore delaying the finalization of the reporting requirements proposed in § 8.635 of the NPRM. At this time, we lack the information necessary to estimate the costs associated with future reporting requirements, and as a result do not estimate them here.
Under the final rule, practitioners in good standing with a current waiver to treat up to 100 patients may request temporary approval to treat up to 275 patients in specific emergency situations. As discussed previously, we anticipate that qualifying emergency situations will occur very infrequently. We estimate that practitioners will request ten of these waivers in each year. We estimate that requesting this waiver would require approximately 1 hour of physician time and 2 hours of administrative time, and responding to the request would require resources approximately equivalent to responding the three Requests for Patient Limit Increase submissions, which is $300. As a result, we estimate that this requirement is associated with costs of approximately $7,000 in each year following publication of the final rule.
The final rule's impacts will take place over a long period of time. As discussed previously, we expect the existence of the waiver to treat up to 275 patients will increase the desirability of waivers to treat 30 and 100 patients. This implies that more practitioners will work toward fulfilling the requirements associated with receiving these waivers. Further, this may make practitioners early in their career more likely to choose addiction medicine or addiction psychiatry as their specialty. All of this implies that the final rule will have a growing impact on capacity to prescribe buprenorphine as time passes. Since the lack of capacity to treat patients using buprenorphine is a barrier to its utilization, this suggests that the final rule will lead to growing increases in the utilization of buprenorphine, and growing increases in the associated positive health and economic effects.
The following table presents these costs and benefits over the first 5 years of the final rule.
The total estimated benefits of the changes here are sensitive to assumptions regarding the number of practitioners who will seek a waiver to treat up to 275 patients as a result of the final rule, the number of individuals who will receive MAT as a result of the final rule, the average per-person health benefits associated with this additional treatment, and the dollar value of these health improvements. We estimate that 500 to 1,800 practitioners will apply for a waiver to treat up to 275 patients in the first year, and 100 to 300 practitioners will apply for a waiver to treat up to 275 patients in subsequent years following publication of the final rule, with central estimates at the midpoint of each range. For alternative estimates in these ranges using a 3 percent discount rate, all else equal, we estimate annualized benefits ranging from $855 million to $2,934 million and annualized costs ranging from $107 million to $364 million.
We estimate that practitioners who receive a waiver to treat up to 275 patients will treat between 20 and 50 additional patients each year, with a central estimate of an average of 35 additional patients. For alternative estimates of 20 to 50 additional patients per year, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $1,082 million to $2,706 million and annualized costs ranging from $135 million to $336 million over the 5 years following implementation.
We estimate that individuals who receive MAT as a result of the final rule will experience average health improvements equivalent to approximately 0.08 QALYs. For alternative estimates of these health improvements between 0.04 and 0.12 QALYs, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $991 million to $2,973 million over the 5 years following implementation. To estimate the dollar value of health benefits, we use a value of approximately $460,000 per QALY. For alternative values per QALY between $300,000 and $600,000, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $1,235 million to $2,469 million over the 5 years following implementation.
Alternative assumptions along these four dimensions, when varied together, using a 3 percent discount rate, imply annualized benefit estimates ranging from $167 million to $8,576 million and annualized cost estimates ranging from $61 million to $519 million. We note that, in all scenarios discussed in this section, annualized benefits substantially exceed annualized costs. There are, however, uncertainties not reflected in this sensitivity analysis, which might lead to net benefits results that are smaller or larger than the range of estimates summarized in the following table.
We carefully considered the option of not pursuing regulatory action. However, existing evidence indicates that opioid use disorder and its related health consequences is a substantial and increasing public health problem in the United States, and it can be addressed by increasing access to effective treatment. As discussed previously, the lack of sufficient access to treatment is directly affected by the existing limit on the number of patients each practitioner with a waiver can currently treat using buprenorphine, and removing this barrier to access is very likely to increase the provision of this treatment. Finally, the provision of MAT with buprenorphine provides tremendous benefits to the individual who experiences health gains associated with treatment, as well as to society which bears smaller costs associated with the negative effects of opioid use disorders. These benefits are expected to greatly exceed the costs associated with increases in treatment. As a result, we expect the benefits of this regulatory action to exceed its costs.
We also considered allowing practitioners waivered to treat up to 100 patients to apply for the higher prescribing limit without having to meet the additional credentialing as defined in § 8.2 or qualified practice setting requirements as defined in the final rule. One important objective of this final rule is to expand access while mitigating the risks associated with expanded access. In addition, the effects of this rule are difficult to project, leading us to adopt a measured approach to increasing access. Given the complexity of the condition, the increased potential for diversion associated with a higher prescribing limit, and the need to ensure high quality care, it was determined that addiction specialist physicians and those with the infrastructure and capacity to deliver the full complement of services recommended by clinical practice guidelines would be best suited to balance these concerns.
Finally, we considered the alternative of having no reporting requirement for physicians with the 275-patient limit. Although this alternative would reduce the 1 hour of physician time and 2 hours of administrative time estimated
As discussed above, the RFA requires agencies that issue a regulation to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. The categories of entities affected most by this final rule will be offices of practitioners and hospitals. We expect that the vast majority of these entities will be considered small based on the Small Business Administration size standards or non-profit status, and assume here that all affected entities are small. According to SAMHSA data, as of March 2016, there were 32,123 practitioners with a waiver to prescribe buprenorphine for the treatment of opioid use disorder. This group of practitioners is most likely to be impacted by the final rule, but we lack information on the total number of associated entities. We acknowledge that some practitioners with a waiver may provide services at multiple entities, many entities may employ multiple practitioners with a waiver, and some entities currently unaffiliated with these practitioners will be impacted by this final rule. As a result, we estimate that approximately 32,123 small entities will be affected by this final rule.
HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue. As discussed above, the final rule imposes a small burden on entities. This burden is primarily associated with processing information disseminated by SAMHSA, opting to completing the waiver process to treat additional patients, and submitting information after receiving a waiver to treat 275 patients, which are estimated to take a maximum of 4 hours per practitioner in any given year. This represents less than 1 percent of hours worked for an individual working full-time. Further, this final rule does not require practitioners to undertake these burdens, as this rulemaking does not require practitioners to seek a waiver to treat 275 patients. As a result, we anticipate that this final rule will not have a significant impact on a substantial number of small entities.
Health professions, Methadone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, HHS amends 42 CFR part 8 as follows:
21 U.S.C. 823; 42 U.S.C. 257a, 290bb-2a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.
(a) Subparts A through C of this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether a practitioner is qualified under section 303(g) of the Controlled Substances Act (CSA) (21 U.S.C. 823(g)) to dispense opioid drugs in the treatment of opioid use disorders. The regulations also establish the Secretary's standards regarding the appropriate quantities of opioid drugs that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(g)(1)). Under these regulations, a practitioner who intends to dispense opioid drugs in the treatment of opioid use disorder must first obtain from the Secretary or, by delegation, from the Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA), a certification that the practitioner is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the practitioner obtaining accreditation from an accreditation body that has been approved by SAMHSA. These regulations establish the procedures whereby an entity can apply to become an approved accreditation body. This part also establishes requirements and general standards for accreditation bodies to ensure that practitioners are consistently evaluated for compliance with the Secretary's standards for treatment of opioid use disorder with an opioid agonist treatment medication.
(b) The regulations in subpart F of this part establish the procedures and requirements that practitioners who are authorized to treat up to 100 patients pursuant to a waiver obtained under section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to treat up to 275 patients with medications covered under section 303(g)(2)(C) of the CSA.
The revisions and additions read as follows:
(b)
The total number of patients that a practitioner may dispense or prescribe covered medications to at any one time for purposes of 21 U.S.C. 823(g)(2)(B)(iii) is 275 if:
(a) The practitioner possesses a current waiver to treat up to 100 patients under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) and has maintained the waiver in accordance with applicable statutory requirements without interruption for at least one year since the practitioner's notification of intent (NOI) under section 303(g)(2)(B) to treat up to 100 patients was approved;
(b) The practitioner:
(1) Holds additional credentialing as defined in § 8.2; or
(2) Provides medication-assisted treatment (MAT) utilizing covered medications in a qualified practice setting as defined in § 8.615;
(c) The practitioner has not had his or her enrollment and billing privileges in the Medicare program revoked under § 424.535 of this title; and
(d) The practitioner has not been found to have violated the Controlled Substances Act pursuant to 21 U.S.C. 824(a).
A qualified practice setting is a practice setting that:
(a) Provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed;
(b) Provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;
(c) Uses health information technology (health IT) systems such as electronic health records, if otherwise required to use these systems in the practice setting. Health IT means the electronic systems that health care professionals and patients use to store, share, and analyze health information;
(d) Is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with Federal and State law. PDMP means a statewide electronic database that collects designated data on substances dispensed in the State. For practitioners providing care in their capacity as employees or contractors of a Federal government agency, participation in a PDMP is required only when such participation is not restricted based on their State of licensure and is in accordance with Federal statutes and regulations;
(e) Accepts third-party payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or Federal health benefits.
In order for a practitioner to receive approval for a patient limit of 275, a practitioner must meet all of the requirements specified in § 8.610 and submit a Request for Patient Limit Increase to SAMHSA that includes all of the following:
(a) Completed Request for Patient Limit Increase form;
(b) Statement certifying that the practitioner:
(1) Will adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders;
(2) Will provide patients with necessary behavioral health services as defined in § 8.2 or through an established formal agreement with another entity to provide behavioral health services;
(3) Will provide appropriate releases of information, in accordance with Federal and State laws and regulations, including the Health Information Portability and Accountability Act Privacy Rule (45 CFR part 160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if applicable, to permit the coordination of care with behavioral health, medical, and other service practitioners;
(4) Will use patient data to inform the improvement of outcomes;
(5) Will adhere to a diversion control plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use;
(6) Has considered how to assure continuous access to care in the event of practitioner incapacity or an emergency situation that would impact a patient's access to care as defined in § 8.2; and
(7) Will notify all patients above the 100 patient level, in the event that the request for the higher patient limit is not renewed or the renewal request is denied, that the practitioner will no longer be able to provide MAT services using buprenorphine to them and make every effort to transfer patients to other addiction treatment;
(c) Any additional documentation to demonstrate compliance with § 8.610 as requested by SAMHSA.
(a) Not later than 45 days after the date on which SAMHSA receives a practitioner's Request for Patient Limit Increase as described in § 8.620, or renewal Request for Patient Limit Increase as described in § 8.640, SAMHSA shall approve or deny the request.
(1) A practitioner's Request for Patient Limit Increase will be approved if the practitioner satisfies all applicable requirements under §§ 8.610 and 8.620. SAMHSA will thereafter notify the
(2) SAMHSA may deny a practitioner's Request for Patient Limit Increase if SAMHSA determines that:
(i) The Request for Patient Limit Increase is deficient in any respect; or
(ii) The practitioner has knowingly submitted false statements or made misrepresentations of fact in the practitioner's Request for Patient Limit Increase.
(b) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal), SAMHSA shall notify the practitioner of the reasons for the denial.
(c) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal) based solely on deficiencies that can be resolved, and the deficiencies are resolved to the satisfaction of SAMHSA in a manner and time period approved by SAMHSA, the practitioner's Request for Patient Limit Increase will be approved. If the deficiencies have not been resolved to the satisfaction of SAMHSA within the designated time period, the Request for Patient Limit Increase may be denied.
(a) A practitioner whose Request for Patient Limit Increase is approved in accordance with § 8.625 shall maintain all eligibility requirements specified in § 8.610, and all attestations made in accordance with § 8.620(b), during the practitioner's 3-year approval term. Failure to do so may result in SAMHSA withdrawing its approval of a practitioner's Request for Patient Limit Increase.
(b) [Reserved]
(a) Practitioners who intend to continue to treat up to 275 patients beyond their current 3 year approval term must submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of their approval term.
(b) If SAMHSA does not reach a final decision on a renewal Request for Patient Limit Increase before the expiration of a practitioner's approval term, the practitioner's existing approval term will be deemed extended until SAMHSA reaches a final decision.
Practitioners who are approved to treat up to 275 patients in accordance with § 8.625, but who do not renew their Request for Patient Limit Increase, or whose renewal request is denied, shall notify, under § 8.620(b)(7) in a time period specified by SAMHSA, all patients affected above the 100 patient limit, that the practitioner will no longer be able to provide MAT services using covered medications and make every effort to transfer patients to other addiction treatment.
(a) SAMHSA, at any time during a practitioner's 3 year approval term, may suspend or revoke its approval of a practitioner's Request for Patient Limit Increase under § 8.625 if it is determined that:
(1) Immediate action is necessary to protect public health or safety;
(2) The practitioner made misrepresentations in the practitioner's Request for Patient Limit Increase;
(3) The practitioner no longer satisfies the requirements of this subpart; or
(4) The practitioner has been found to have violated the CSA pursuant to 21 U.S.C. 824(a).
(b) [Reserved]
(a) Practitioners with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients under § 8.610 may request a temporary increase to treat up to 275 patients in order to address emergency situations as defined in § 8.2 if the practitioner provides information and documentation that:
(1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the situation qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit;
(2) Identifies a period of time, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the period of time requested; and
(3) Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 275 patients expires.
(b) Prior to taking action on a practitioner's request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authorities in order to determine whether the emergency situation that a practitioner describes justifies an immediate increase in the higher patient limit.
(c) If SAMHSA determines that a practitioner's request under this section should be granted, SAMHSA will notify the practitioner that his or her request has been approved. The period of such approval shall not exceed six months.
(d) If a practitioner wishes to receive an extension of the approval period granted under this section, he or she must submit a request to SAMHSA at least 30 days before the expiration of the six month period, and certify that the emergency situation as defined in § 8.2 necessitating an increased patient limit continues. Prior to taking action on a practitioner's extension request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authorities in order to determine whether the emergency situation that a practitioner describes justifies an extension of an increase in the higher patient limit.
(e) Except as provided in this section and § 8.650, requirements in other sections under subpart F of this part do not apply to practitioners receiving waivers in this section.
Office of Innovation and Improvement, Department of Education.
Notice.
Promise Neighborhoods Program—Implementation Grant Competition.
Notice inviting applications for new awards for fiscal year (FY) 2016.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.215N (Implementation).
On December 10, 2015, the President signed into law the Every Student Succeeds Act (ESSA), Public Law 114-95, which reauthorized the ESEA. Beginning in FY 2017, the ESEA, as amended by the ESSA, will serve as the statutory authority for future Promise Neighborhoods competitions.
The purpose of the Promise Neighborhoods program is to significantly improve the educational and developmental outcomes of children and youth in our most distressed communities and to transform those communities by—
(1) Identifying and increasing the capacity of eligible organizations (as defined in this notice) that are focused on achieving results for children and youth throughout an entire neighborhood;
(2) Building a complete continuum of cradle-through-college-to-career solutions (continuum of solutions) (as defined in this notice) of both education programs and family and community supports (both as defined in this notice), with great schools at the center. All strategies in the continuum of solutions must be accessible to children with disabilities (CWD) (as defined in this notice) and English learners (ELs) (as defined in this notice);
(3) Integrating programs and breaking down agency “silos” so that solutions are implemented effectively and efficiently across agencies;
(4) Developing the local infrastructure of systems and resources needed to develop, implement, and sustain effective interventions to improve education outcomes and enhance family and community well-being across the broader region beyond the initial neighborhood; and
(5) Learning about the overall impact of the Promise Neighborhoods program and about the relationship between particular strategies in Promise Neighborhoods and student outcomes, including through an evaluation of the program, particular elements within the continuum of solutions, or both.
The vision of the Promise Neighborhoods program is that all children and youth living in our most distressed communities have access to great schools and strong systems of family and community support that will prepare them to attain an excellent education and successfully transition to college and a career.
A Promise Neighborhood is both a place and a strategy. A place eligible to become a Promise Neighborhood is a geographic area
Children and youth who are from low-income families and grow up in neighborhoods of concentrated poverty face educational and life challenges above and beyond the challenges faced by children who are from low-income families who grow up in neighborhoods without a high concentration of poverty. A Federal evaluation of the reading and mathematics outcomes of elementary students in 71 schools in 18 districts and 7 States found that even when controlling for individual student poverty, there is a significant negative association between school-level poverty and student achievement.
A Promise Neighborhood strategy addresses the complex, interconnected issues in the distressed community it serves. Promise Neighborhoods are led by organizations that work to ensure that all children and youth in the target geographic area have access to services that lead to improved educational and developmental outcomes from cradle-to-career; are based on the best available evidence and designed to learn about the impact of approaches, for which there is less evidence; are linked and integrated seamlessly; and include education programs as well as programs that provide family and community supports. Promise Neighborhoods enable children and youth within targeted distressed communities to participate in the full range of cradle-to-career supports that are necessary for them to realize their potential. Our expectation is that over time, a greater proportion of the neighborhood residents receive these supports, and that ultimately neighborhood indicators show significant progress. For this reason, each Promise Neighborhood must demonstrate several core features: (1) Significant need in the neighborhood; (2) a strategy to build a continuum of solutions with strong schools at the center; and (3) the organizational and relational capacity to achieve results.
In developing strategies to build a continuum of solutions, communities face the challenge of implementing a comprehensive suite of interconnected services that ensure continuous engagement with community members. Since its inception in 2010, the Promise Neighborhoods program has supported planning and implementation efforts in 47 communities across the country. In particular, the experiences of the 12 Promise Neighborhoods implementation grantees provide valuable information about the conditions that are most critical for successful implementation of a Promise Neighborhoods strategy. To date, Promise Neighborhoods grantees have provided meaningful service coordination across a range of public and private entities; in so doing, they are building out the ongoing community-based infrastructure necessary to coordinate supports and transform outcomes over time. These successes have helped validate the core value of a comprehensive neighborhood approach.
While they have had success in many areas, Promise Neighborhoods grantees have struggled to collect the full range of data necessary to effectively employ comprehensive case and longitudinal data management systems and conduct meaningful evaluation activities. Such data systems are critical to effectively coordinating a range of services for high-need students and their families within a Promise Neighborhood. In order to address this challenge, we encourage applicants to carefully consider the data-related expectations for Promise Neighborhood grantees outlined in this notice, and in particular, to commit to establishing the conditions for effective data management at the onset of the grant period.
In order to help all applicants understand how to effectively set up and utilize appropriate data systems that are critical to grantee success, the Department's applicant outreach materials and Webinars associated with this year's competition—all of which will be made publicly available on our Web site—will discuss effective practices for data collection and management. In addition, recognizing the prior difficulties associated with collecting and managing data related to Promise Neighborhoods, the Department has developed recommended data collection and management strategies for Promise Neighborhoods grantees. These recommendations are intended to guide Promise Neighborhoods grantees in meeting the program's data expectations. This document is available on the Department's Web site at:
There are four competitive preference priorities for this competition. Given the Promise Neighborhoods program's focus on coordinating education and community services, this competition prioritizes applicants that are focused on driving greater collaboration within their communities through the competitive preference priorities. Building on prior Promise Neighborhoods grantees' work to enhance high-quality early learning opportunities, this year's competition includes a competitive preference priority intended to improve coordination among early learning providers and ensure alignment between early learning systems and elementary education systems. We continue to recognize and highlight solutions for catalyzing change in distressed communities through the Neighborhood Revitalization Initiative (NRI). Thus, we prioritize applicants or an applicant's partner who received a Choice or HOPE VI grant from the U.S. Department of Housing and Urban Development (HUD) via a competitive preference priority focused on Quality Affordable Housing. The NRI is a place-based approach to help neighborhoods in distress transform themselves into neighborhoods of opportunity. Additional information pertaining to the NRI may be found at
In addition, we also include a competitive preference priority that gives preference to applicants working in designated Promise Zones.
As Promise Neighborhoods grantees implement comprehensive transformation plans in their communities, we expect them to build out the full continuum of cradle through college to career solutions. We emphasize the importance of robust strategies for the college and career portion of the Promise Neighborhoods pipeline and for this reason, we include a fourth competitive preference priority for applicants that choose to prioritize postsecondary or technical education and career development. In proposing strategies, we encourage applicants to be mindful of the importance of ensuring that all students and their families have an opportunity to benefit from the services and supports provided.
Each of the three absolute priorities constitutes its own funding category. Assuming that applications in each funding category are of sufficient quality, the Secretary intends to award grants under each absolute priority. These priorities are:
To meet this priority, an applicant must submit a plan to create a Promise Neighborhood. The plan must describe the need in the neighborhood, a strategy to build a continuum of solutions, and the applicant's capacity to achieve results. Specifically, an applicant must—
(1) Describe the geographically defined area (neighborhood) to be served and the level of distress in that area based on indicators of need (as defined in this notice) and other relevant indicators. The statement of need in the neighborhood must be based, in part, on results of a comprehensive needs assessment and segmentation analysis (as defined in this notice). Applicants may propose to serve multiple, non-contiguous geographically defined areas. In cases where target areas are not contiguous, the applicant must explain its rationale for including non-contiguous areas;
(2) Describe the applicant's strategy for building a continuum of solutions over time that addresses neighborhood challenges as identified in the needs assessment and segmentation analysis. The applicant must also describe how it has built community support for and involvement in the development of the plan. The continuum of solutions must be based on best available evidence including, where available strong or moderate evidence (as defined in this notice), and be designed to significantly improve educational outcomes and to support the healthy development and well-being of children and youth in the neighborhood. The strategy must be designed to ensure that over time, a greater proportion of children and youth in the neighborhood who attend the target school or schools have access to a complete continuum of solutions, and must ensure that over time, a greater proportion of children and youth in the neighborhood who do not attend the target school or schools have access to solutions within the continuum of solutions. The strategy must also ensure that, over time, students not living in the neighborhood who attend the target school or schools have access to solutions within the continuum of solutions.
The success of the applicant's strategy to build a continuum of solutions will be based on the results of the project, as measured against the project indicators as defined in this notice and described in Table 1 and Table 2. In its strategy, the applicant must propose clear and measurable annual goals during the grant period against which improvements will be measured using the indicators. The strategy must—
(a) Identify each solution that the project will implement within the proposed continuum of solutions, and must include—
(i) High-quality early learning programs and services designed to improve outcomes across multiple domains of early learning (as defined in this notice) for children from birth through third grade;
(ii) Ambitious, rigorous, and comprehensive education reforms that are linked to improved educational outcomes for children and youth in preschool through the 12th grade. Public schools served through the grant may include persistently lowest-achieving schools (as defined in this notice) or low-performing schools (as defined in this notice) that are not also persistently lowest-achieving schools. An applicant (or one or more of its partners) may serve an effective school or schools (as defined in this notice) but only if the applicant (or one or more of its partners) also serves at least one low-performing school (as defined in this notice) or persistently lowest-achieving school (as defined in this notice). An applicant must identify in its application the public school or schools it would serve and describe the current status of reforms in the school or schools, including, if applicable, the type of intervention model being implemented. In cases where an applicant operates a school or partners with a school that does not serve all students in the neighborhood, the applicant must partner with at least one additional school that also serves students in the neighborhood. An applicant proposing to work with a persistently lowest-achieving school must include in its strategy one of the four school intervention models (turnaround model, restart model, school closure, or transformation model) described in Appendix C of the Race to the Top (RTT) notice inviting applications for new awards for FY 2010 that was published in the
An applicant proposing to work with a or low-performing school must include in its strategy ambitious, rigorous, and comprehensive interventions to assist, augment, or replace schools, which may include implementing one of the four school intervention models, or may include another model of sufficient ambition, rigor, and comprehensiveness to
(iii) Programs that prepare students to be college- and career-ready; and
(iv) Family and community supports (as defined in this notice).
To the extent feasible and appropriate, the applicant must describe, in its plan, how the applicant and its partners will leverage and integrate high-quality programs, related public and private investments, and existing neighborhood assets into the continuum of solutions. An applicant must also include in its application an appendix that summarizes the evidence supporting each proposed solution and describes how the solution is based on the best available evidence, including, where available, strong or moderate evidence (as defined in this notice). An applicant must also describe in the appendix how and when—during the implementation process—the solution will be implemented; the partners that will participate in the implementation of each solution (in any case in which the applicant does not implement the solution directly); the estimated per-child cost, including administrative costs, to implement each solution; the estimated number of children, by age, in the neighborhood who will be served by each solution and how a segmentation analysis was used to target the children and youth to be served; and the source of funds that will be used to pay for each solution. In the description of the estimated number of children to be served, the applicant must include the percentage of all children of the same age group within the neighborhood proposed to be served with each solution, and the annual goals required to increase the proportion of children served to reach scale over time.
An applicant must also describe in its plan how it will identify Federal, State, or local policies, regulations, or other requirements that would impede its ability to achieve its goals and how it will report on those impediments to the Department and other relevant agencies.
As appropriate, considering the time and urgency required to dramatically improve outcomes of children and youth in our most distressed neighborhoods and to transform those neighborhoods, applicants must establish both short-term and long-term goals to measure progress.
As part of the description of its strategy to build a continuum of solutions, the applicant must also describe how it will participate in, organize, or facilitate, as appropriate, communities of practice for Promise Neighborhoods;
(b) Establish clear, annual goals for evaluating progress in improving systems, such as changes in policies, environments, or organizations that affect children and youth in the neighborhood. Examples of systems change could include a new school district policy to measure the results of family and community support programs, a new funding resource to support the Promise Neighborhoods strategy, or a cross-sector collaboration at the city level to break down municipal agency “silos” and partner with local philanthropic organizations to drive achievement of a set of results; and
(c) Establish clear, annual goals for evaluating progress in leveraging resources, such as the amount of monetary or in-kind investments from public or private organizations to support the Promise Neighborhoods strategy. Examples of leveraging resources are securing new or existing dollars to sustain and scale up what works in the Promise Neighborhood or integrating high-quality programs in the continuum of solutions. Applicants may consider, as part of their plans to scale up their Promise Neighborhood strategy, serving a larger geographic area by partnering with other applicants to the Promise Neighborhoods program from the same city or region;
(3) Explain how it used its needs assessment and segmentation analysis to determine the children with the highest needs and explain how it will ensure that children in the neighborhood receive the appropriate services from the continuum of solutions. In this explanation of how it used the needs assessment and segmentation analysis, the applicant must identify and describe in its application the educational indicators and family and community support indicators that the applicant used to conduct the needs assessment. Whether or not the implementation grant applicant received a Promise Neighborhoods planning grant, the applicant must describe how it—
(a) Collected data for the educational indicators listed in Table 1 and used them as both program and project indicators;
(b) Collected data for the family and community support indicators in Table 2 and used them as program indicators; and
(c) Collected data for unique family and community support indicators, developed by the applicant, that align with the goals and objectives of the project and used them as project indicators or used the indicators in Table 2 as project indicators.
An applicant must also describe how it will collect at least annual data on the indicators in Tables 1 and 2; establish clear, annual goals for growth on indicators; and report those data to the Department.
(i) The number and percentage of children who participate in high-quality learning activities during out-of-school hours or in the hours after the traditional school day ends;
(ii) The number and percentage of students who are suspended or receive discipline referrals during the year;
(iii) The share of housing stock in the geographically defined area that is rent-protected, publicly assisted, or targeted for redevelopment with local, State, or Federal funds; and
(iv) The number and percentage of children who are homeless or in foster care and who have an assigned adult advocate.
(4) Describe the experience and lessons learned, and describe how the applicant will build the capacity of its management team and project director in all of the following areas:
(a) Working with the neighborhood and its residents, including parents and families that have children or other members with disabilities or ELs, as well as with the schools described in paragraph (2) of this priority; the LEA in which the school or schools are located; Federal, State, and local government leaders; and other service providers.
(b) Collecting, analyzing, and using data for decision-making, learning, continuous improvement, and accountability. The applicant must describe—
(i) Progress towards developing, launching, and implementing a longitudinal data system that integrates student-level data from multiple sources in order to measure progress on educational and family and community support indicators for all children in the neighborhood, disaggregated by the subgroups listed in section 1111(b)(3)(C)(xiii) of the ESEA;
(ii) How the applicant has linked or made progress to link the longitudinal data system to school-based, LEA, and State data systems; made the data accessible to parents, families, community residents, program partners, researchers, and evaluators while abiding by Federal, State, and other privacy laws and requirements; and managed and maintained the system;
(iii) How the applicant has used rapid-time (as defined in this notice) data in prior years and, how it will continue to use those data once the Promise Neighborhood strategy is implemented, for continuous program improvement; and
(iv) How the applicant will document the implementation process, including by describing lessons learned and best practices.
(c) Creating and strengthening formal and informal partnerships, for such purposes as providing solutions along the continuum of solutions and committing resources to sustaining and scaling up what works. Each applicant must submit, as part of its application, a memorandum of understanding, signed by each organization or agency with which it would partner in implementing the proposed Promise Neighborhood. The memorandum of understanding must describe—
(i) Each partner's financial and programmatic commitment; and
(ii) How each partner's existing vision, theory of change (as defined in this notice), theory of action (as defined in this notice), and current activities align with those of the proposed Promise Neighborhood; and
(d) The governance structure proposed for the Promise Neighborhood, including a system for holding partners accountable, how the eligible entity's governing board or advisory board is representative of the geographic area proposed to be served (as defined in this notice), and how residents of the geographic area would have an active role in the organization's decision-making.
(e) Integrating funding streams from multiple public and private sources from the Federal, State, and local level. Examples of public funds include Federal resources from the U.S. Department of Education, such as the 21st Century Community Learning Centers program and title I of the ESEA, and from other Federal agencies, such as the U.S. Departments of Health and Human Services, Housing and Urban Development, Justice, Labor, and Treasury.
(5) Describe the applicant's commitment to work with the Department, and with a national evaluator for Promise Neighborhoods or another entity designated by the Department, to ensure that data collection and program design are consistent with plans to conduct a rigorous national evaluation of the Promise Neighborhoods program and of specific solutions and strategies pursued by individual grantees. This commitment must include, but need not be limited to—
(a) Ensuring that, through memoranda of understanding with appropriate entities, the national evaluator and the Department have access to relevant program and project data sources (
(b) Developing, in consultation with the national evaluator, an evaluation strategy, including identifying a credible comparison group (as defined in this notice); and
(c) Developing, in consultation with the national evaluator, a plan for identifying and collecting reliable and valid baseline data for both program participants and a designated comparison group of non-participants.
To meet this priority, an applicant must propose to implement a Promise Neighborhood strategy that (1) meets all of the requirements in Absolute Priority 1; and (2) serves one or more rural communities only.
To meet this priority, an applicant must propose to implement a Promise Neighborhood strategy that (1) meets all of the requirements in Absolute Priority 1; and (2) serves one or more Indian tribes (as defined in this notice).
These priorities are:
Projects that are designed to improve early learning and development outcomes across one or more of the essential domains of school readiness (as defined in this notice) for children from birth through third grade (or for any age group within this range) through a focus on improving the coordination and alignment among early learning and development systems and between such systems and elementary education systems, including coordination and alignment in engaging and supporting families and improving transitions for children along the birth-through-third grade continuum, in accordance with applicable privacy laws.
To meet this priority, an applicant must propose to serve geographic areas that were the subject of an affordable housing transformation pursuant to a Choice Neighborhoods or HOPE VI grant awarded by the U.S. Department of Housing and Urban Development during FY 2009 or later years. To be eligible under this priority, the applicant must either: (1) Be able to demonstrate that it
This priority is for projects that are designed to serve and coordinate with a federally designated Promise Zone.
Increasing the number and proportion of high-need students (as defined in this notice) who are academically prepared for, enroll in, or complete on time college, other postsecondary education, or other career and technical education.
The definitions of “large sample,” “logic model,” “multi-site sample,” “moderate evidence of effectiveness,” “relevant outcomes,” “strong theory,” and “What Works Clearinghouse (WWC) Evidence Standards” are from 34 CFR 77.1. The definitions of “essential domains of school readiness,” “high-minority school,” “high-need students,” and “regular high school diploma” are from the Supplemental Priorities. All other definitions are from the 2011 Promise Neighborhoods NFP. We may apply these definitions in any year in which this program is in effect.
The following definitions apply to this program:
(1) Include programs, policies, practices, services, systems, and supports that result in improving educational and developmental outcomes for children from cradle through college to career;
(2) Are based on the best available evidence, including, where available, strong or moderate evidence (as defined in this notice);
(3) Are linked and integrated seamlessly (as defined in this notice); and
(4) Include both education programs and family and community supports.
(1) High-quality early learning programs or services designed to improve outcomes across multiple domains of early learning for young children. Such programs must be specifically intended to align with appropriate State early learning and development standards, practices, strategies, or activities across as broad an age range as birth through third grade so as to ensure that young children enter kindergarten and progress through the early elementary school grades demonstrating age-appropriate functioning across the multiple domains;
(2) For children in preschool through the 12th grade, programs, inclusive of related policies and personnel, that are linked to improved educational outcomes. The programs—
(a) Must include effective teachers and effective principals;
(b) Must include strategies, practices, or programs that encourage and facilitate the evaluation, analysis, and use of student achievement, student growth (as defined in this notice), and other data by educators, families, and other stakeholders to inform decision-making;
(c) Must include college- and career-ready standards, assessments, and practices, including a well-rounded
(d) May include creating multiple pathways for students to earn regular high school diplomas (
(3) Programs that prepare students for college and career success, which may include programs that—
(a) Create and support partnerships with community colleges, four-year colleges, or universities and that help instill a college-going culture in the neighborhood;
(b) Provide dual-enrollment opportunities for secondary students to gain college credit while in high school;
(c) Provide, through relationships with businesses and other organizations, apprenticeship opportunities to students;
(d) Align curricula in the core academic subjects with requirements for industry-recognized certifications or credentials, particularly in high-growth sectors;
(e) Provide access to career and technical education programs so that individuals can attain the skills and industry-recognized certifications or credentials for success in their careers;
(f) Help college students, including CWD and ELs from the neighborhood to transition to college, persist in their academic studies in college, graduate from college, and transition into the workforce; and
(g) Provide opportunities for all youth (both in and out of school) to achieve academic and employment success by improving educational and skill competencies and providing connections to employers. Such activities may include opportunities for on-going mentoring, supportive services, incentives for recognition and achievement, and opportunities related to leadership, development, decision-making, citizenship, and community service.
(1) Significantly closed the achievement gaps between subgroups of students (as identified in section 1111(b)(3)(C)(xiii) of the ESEA) within the school or district; or
(2)(a) Demonstrated success in significantly increasing student academic achievement in the school for all subgroups of students (as identified in section 1111(b)(3)(C)(xiii) of the ESEA) in the school; and (b) made significant improvements in other areas, such as graduation rates (as defined in this notice) or recruitment and placement of effective teachers and effective principals.
(1) Is representative of the geographic area proposed to be served;
(2) Is one of the following:
(a) A nonprofit organization that meets the definition of a nonprofit under 34 CFR 77.1(c), which may include a faith-based nonprofit organization.
(b) An institution of higher education as defined by section 101(a) of the Higher Education Act of 1965, as amended.
(c) An Indian tribe (as defined in this notice);
(3) Currently provides at least one of the solutions from the applicant's proposed continuum of solutions in the geographic area proposed to be served; and
(4) Operates or proposes to work with and involve in carrying out its proposed project, in coordination with the school's LEA, at least one public elementary or secondary school that is located within the identified geographic area that the grant will serve.
(1) Child and youth health programs, such as physical, mental, behavioral, and emotional health programs (
(2) Safety programs, such as programs in school and out of school to prevent, control, and reduce crime, violence, drug and alcohol use, and gang activity; programs that address classroom and school-wide behavior and conduct; programs to prevent child abuse and neglect; programs to prevent truancy and reduce and prevent bullying and harassment; and programs to improve the physical and emotional security of the school setting as perceived, experienced, and created by students, staff, and families;
(3) Community stability programs, such as programs that—
(a) Increase the stability of families in communities by expanding access to quality, affordable housing, providing legal support to help families secure clear legal title to their homes, and providing housing counseling or housing placement services;
(b) Provide adult education and employment opportunities and training to improve educational levels, job skills and readiness in order to decrease unemployment, with a goal of increasing family stability;
(c) Improve families' awareness of, access to, and use of a range of social services, if possible at a single location;
(d) Provide unbiased, outcome-focused, and comprehensive financial education, inside and outside the classroom and at every life stage;
(e) Increase access to traditional financial institutions (
(f) Help families increase their financial literacy, financial assets, and savings; and
(g) Help families access transportation to education and employment opportunities;
(4) Family and community engagement programs that are systemic, integrated, sustainable, and continue through a student's transition from K-12 school to college and career. These programs may include family literacy programs and programs that provide adult education and training and opportunities for family members and other members of the community to support student learning and establish high expectations for student educational achievement; mentorship programs that create positive relationships between children and adults; programs that provide for the use of such community resources as libraries, museums, television and radio stations, and local businesses to support improved student educational outcomes; programs that support the engagement of families in early learning programs and services; programs that provide guidance on how to navigate through a complex school system and how to advocate for more and improved learning opportunities; and programs
(5) 21st century learning tools, such as technology (
(1) Education need, which means—
(a) All or a portion of the neighborhood includes or is within the attendance zone of a low-performing school that is a high school, especially one in which the graduation rate (as defined in this notice) is less than 60 percent or a school that can be characterized as low-performing based on another proxy indicator, such as students' on-time progression from grade to grade; and
(b) Other indicators, such as significant achievement gaps between subgroups of students (as identified in section 1111(b)(3)(C)(xiii) of the ESEA) within a school or LEA, high teacher and principal turnover, or high student absenteeism; and
(2) Family and community support need, which means—
(a) Percentages of children with preventable chronic health conditions (
(b) Immunization rates;
(c) Rates of crime, including violent crime;
(d) Student mobility rates;
(e) Teenage birth rates;
(f) Percentage of children in single-parent or no-parent families;
(g) Rates of vacant or substandard homes, including distressed public and assisted housing; or
(h) Percentage of the residents living at or below the Federal poverty threshold.
(1) Developmental assets that allow residents to attain the skills needed to be successful in all aspects of daily life (
(2) Commercial assets that are associated with production, employment, transactions, and sales (
(3) Recreational assets that create value in a neighborhood beyond work and education (
(4) Physical assets that are associated with the built environment and physical infrastructure (
(5) Social assets that establish well-functioning social interactions (
(1) Any school receiving assistance through Title I that is in improvement, corrective action, or restructuring and that—
(a) Is among the lowest-achieving five percent of Title I schools or the lowest-achieving five Title I schools in in the State, whichever number of schools is greater; or
(b) Is a high school that has had a graduation rate, that is less than 60 percent over a number of years.
For a State with an approved request for flexibility under the Elementary and Secondary Education Act of 1965, as amended (ESEA), Priority Schools or Tier I and Tier II Schools that have been identified under the School Improvement Grants program. For any other State, Tier I and Tier II Schools that have been identified under the School Improvement Grants program. 79 FR 73425, 73454 (Dec. 10, 2014).
We are providing this flexibility because a State that received ESEA flexibility was not required to identify schools in corrective action or restructuring under the ESEA; but rather, the State identified priority and focus schools. Moreover, consistent with final regulations issued under the School Improvement Grants program (80 FR 7223), the definition of Tier I and Tier II Schools includes persistently lowest-achieving schools.
(1) Residents who live in the geographic area proposed to be served, which may include residents who are representative of the ethnic and racial composition of the neighborhood's residents and the languages they speak;
(2) Residents of the city or county in which the neighborhood is located but who live outside the geographic area proposed to be served, and who are low-income (which means earning less than 80 percent of the area's median income as published by the Department of Housing and Urban Development);
(3) Public officials (as defined in this notice) who serve the geographic area proposed to be served (although not more than one-half of the governing board or advisory board may be made up of public officials); or
(4) Some combination of individuals from the three groups listed in paragraphs (1), (2), and (3) of this definition.
(1) Is served by an LEA that is currently eligible under the Small Rural School Achievement (SRSA) program or the Rural and Low-Income School (RLIS) program authorized under Title VI, Part B of the ESEA. Applicants may determine whether a particular LEA is eligible for these programs by referring to information on the following Department Web sites. For the SRSA program:
(2) Includes only schools designated with a school locale code of 42 or 43. Applicants may determine school locale codes by referring to the following Department Web site:
(1) For tested grades and subjects:
(a) A student's score on the State's assessments under the ESEA; and, as appropriate,
(b) Other measures of student learning, such as those described in paragraph (2) of this definition, provided they are rigorous and comparable across classrooms and programs.
(2) For non-tested grades and subjects: alternative measures of student learning and performance, such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across classrooms.
These estimated available funds are only for Implementation grants under the Promise Neighborhoods program. Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY2017 from the list of unfunded applications from this competition.
The maximum award amount is $6,000,000 per 12-month budget period. We will not fund an annual budget exceeding $6,000,000 per 12-month budget period.
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Eligible sources of matching include sources of funds used to pay for solutions within the continuum of solutions, such as Head Start programs, initiatives supported by the LEA, or public health services for children in the neighborhood. At least 10 percent of an implementation applicant's total match must be cash or in-kind contributions from the private sector, which may include philanthropic organizations, private businesses, or individuals.
Implementation applicants must demonstrate a commitment of matching funds in the applications. The applicants must specify the source of the funds or contributions and in the case of a third-party in-kind contribution, a description of how the value was determined for the donated or contributed goods or service. Applicants must demonstrate the match commitment by including letters in their applications explaining the type and quantity of the match commitment with original signatures from the executives of organizations or agencies providing the match. The Secretary may consider decreasing the matching requirement in the most exceptional circumstances, on a case-by-case basis.
An applicant that is unable to meet the matching requirement must include in its application a request to the Secretary to reduce the matching requirement, including the amount of the requested reduction, the total remaining match contribution, and a statement of the basis for the request. An applicant should review the Department's cost-sharing and cost-matching regulations, which include specific limitations, in 2 CFR 200.306 and the cost principles regarding donations, capital assets, depreciations and allowable costs, set out in subpart E of 2 CFR part 200.
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To obtain a copy via the Internet, use the following address:
To obtain a copy from ED Pubs, write, fax, or call the following: Education Publications Center, P.O. Box 22207,
You can contact ED Pubs at its Web site, also:
If you request an application from ED Pubs, be sure to identify this program as follows: CFDA number 84.215N. To obtain a copy from the program office, contact: Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202-5970. Telephone: (202) 453-5638 or by email:
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.a.
The Department will be able to develop a more efficient process for reviewing grant applications if it has a better understanding of the number of entities that intend to apply for funding under this competition. Therefore, the Secretary strongly encourages each potential applicant to notify the Department of the applicant's intent to submit an application for funding by completing a Web-based form. When completing this form, applicants will provide (1) the applicant organization's name and address, and (2) information on the competitive preference priority or priorities under which the applicant intends to apply. Applicants may access this form online at
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative. Text in charts, tables, figures, and graphs may be single-spaced.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts is strongly encouraged: Times New Roman, Courier, Courier New, or Arial.
• Include page numbers at the bottom of each page in your application narrative.
The suggested page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section.
2.b.
Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.
Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).
3.
Applications Available: July 8, 2016.
Deadline for Notice of Intent to Apply: July 25, 2016.
Date of Pre-Application Webinar: Promise Neighborhoods intends to hold Pre-Application Webinars to provide technical assistance to interested applicants. Detailed information regarding Pre-Application Webinar times will be provided on the Web site at
Deadline for Transmittal of Applications: September 6, 2016. Applications for grants under this competition must be submitted electronically using the
We do not consider an application that does not comply with the deadline requirements. Please note, due to a scheduled systems shutdown, applicants will not be able to submit applications for the Promise Neighborhoods competition between 9:00 p.m. on Wednesday, July 20, 2016 until 6:00 a.m. on Monday, July 25, 2016 and from 9:00 p.m. on Wednesday, July 27, 2016 until 6:00 a.m. on Monday, August 1, 2016.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
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 Contract 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 in to 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.
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
7.
a.
Applications for grants under Promise Neighborhoods, CFDA number 84.215N, must be submitted electronically using the Governmentwide
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 Promise Neighborhoods program at
Please note the following:
• When you enter the
• Applications received by
• 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
• You should review and follow the Education Submission Procedures for submitting an application through
• 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: The 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
This notification indicates receipt by
Once your application is successfully validated by
These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by
• 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
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202-5970. FAX: (202) 453-5638.
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 84.215N), 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.
We will not consider applications postmarked after the application 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 84.215N), 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.
(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 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.
1. Selection Criteria: The selection criteria are from 34 CFR 75.210 and the 2011 Promise Neighborhood NFP (76 FR 39590). All of the selection criteria are listed in this section and in the application package. The maximum score for all of the selection criteria is 100 points. The maximum score for each criterion is included in parentheses following the title of the specific selection criterion. Each criterion also includes the factors that reviewers will consider in determining the extent to which an applicant meets the criterion.
Points awarded under these selection criteria are in addition to any points an applicant earns under the competitive preference priorities in this notice. The maximum score that an application may receive under the competitive preference priorities and the selection criteria is 108 points.
(a)
The Secretary considers the need for the proposed project. In determining the need for the proposed project, the Secretary considers:
(1) The magnitude or severity of the problems to be addressed by the proposed project as described by indicators of need (as defined in this notice) and other relevant indicators identified in part by the needs assessment and segmentation analysis. (2011 Promise Neighborhoods NFP)
(2) The extent to which the geographically defined area has been described. (2011 Promise Neighborhoods NFP)
(3) The extent to which specific gaps or weaknesses in services, infrastructure, or opportunities have been identified and will be addressed by the proposed project, including the nature and magnitude of those gaps or weaknesses. (34 CFR 75.210); and
(b)
The Secretary reviews each application to determine the quality of the project design. In determining the quality of the design of the proposed project, the Secretary considers the following factors:
(1) The extent to which the applicant describes an implementation plan to create a complete continuum of solutions, including early learning through grade 12, college- and career-readiness, and family and community supports, without time and resource gaps, that will prepare all children in the neighborhood to attain an excellent education and successfully transition to college and a career, and that will significantly increase the proportion of students in the neighborhood that are served by the complete continuum to reach scale over time (2011 Promise Neighborhoods NFP);
(2) The extent to which the applicant documents that proposed solutions are based on the best available evidence including, where available, strong or moderate evidence (2011 Promise Neighborhoods NFP);
(3) The extent to which the applicant identifies existing neighborhood assets and programs supported by Federal, State, local, and private funds that will be used to implement a continuum of solutions (2011 Promise Neighborhoods NFP);
(4) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible (34 CFR 75.210); and
(5) The extent to which the proposed project is supported by strong theory (as defined in this notice). (34 CFR 75.210)
(c)
The Secretary considers the quality of the services to be provided by the proposed project. In determining the quality of the project services, the Secretary considers:
(1) The likelihood that the services to be provided by the proposed project will lead to improvement in the achievement of students as measured against rigorous academic standards. (34 CFR 75.210)
(2) Creating formal and informal partnerships, including the alignment of the visions, theories of action, and theories of change described in its memorandum of understanding, and creating a system for holding partners accountable for performance in accordance with the memorandum of understanding. (2011 Promise Neighborhoods NFP);
(d)
The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:
(1) Working with the neighborhood and its residents; the schools described in paragraph (2)(b) of Absolute Priority 1; the LEA in which those schools are located; Federal, State, and local government leaders; and other service providers
(2) Collecting, analyzing, and using data for decision-making, learning, continuous improvement, and accountability, including whether the applicant has a plan to build, adapt, or expand a longitudinal data system that integrates student-level data from multiple sources in order to measure progress while abiding by privacy laws and requirements
(e)
The Secretary considers the adequacy of resources for the proposed project. In determining the adequacy of resources for the proposed project, the Secretary considers:
(1) The extent to which the costs are reasonable in relation to the number of persons to be served and to the anticipated results and benefits
(2) The extent to which the applicant demonstrates that it has the resources to operate the project beyond the length of the grant, including a multi-year financial and operating model and accompanying plan; the demonstrated commitment of any partners; evidence of broad support from stakeholders (
2.
The Department will use independent reviewers from various backgrounds and professions including: Pre-kindergarten-12 teachers and principals, college and university educators, researchers and evaluators, social entrepreneurs, strategy consultants, grant makers and managers, and others with community development and education expertise. The Department will thoroughly screen all reviewers for conflicts of interest to ensure a fair and competitive review process.
Reviewers will read, prepare a written evaluation, and score the applications assigned to their panel, using the
For applications addressing Absolute Priority 1, Absolute Priority 2, and Absolute Priority 3, the Secretary prepares a rank order of applications for each absolute priority based solely on the evaluation of their quality according to the selection criteria. The Department may use more than one tier of reviews in determining grantees, including possible site visits for Implementation grant applicants. Additional information about the review process will be posted on the Department's Web site.
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
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 multiyear 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
4.
(a) Project indicators;
(b) Improving systems; and
(c) Leveraging resources.
All grantees will be required to submit annual performance reports documenting their contribution in assisting the Department in measuring the performance of the program against this indicator as well as other information requested by the Department.
5.
In making a continuation award, 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).
Adrienne Hawkins, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W256, Washington, DC 20202. Telephone: (202) 453-5638 or by email:
If you use a TDD or TTY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
| 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 |