Page Range | 52173-52373 | |
FR Document |
Page and Subject | |
---|---|
80 FR 52274 - Pesticide Cumulative Risk Assessment; Framework for Screening Analysis; Notice of Availability and Request for Comment; Extension of Comment Period | |
80 FR 52351 - Vermont Yankee Nuclear Power Station; Kewaunee Power Station | |
80 FR 52294 - Medicare Program; Solicitation of Nominations to the Advisory Panel on Hospital Outpatient Payment | |
80 FR 52357 - Meeting: RTCA Program Management Committee (PMC) | |
80 FR 52368 - Notice of Lithium Battery Safety Public Meeting and Request for Information | |
80 FR 52358 - Agency Information Collection Activities: Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB): B4UFLY Smartphone App | |
80 FR 52174 - FOIA Fee Schedule Update | |
80 FR 52236 - Stream Protection Rule | |
80 FR 52265 - Sunshine Act Notice | |
80 FR 52295 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Protection and Advocacy for Assistive Technology (PAAT) Program Performance Report | |
80 FR 52236 - Revisions to California State Implementation Plan; Bay Area Air Quality Management District; Stationary Sources Permits | |
80 FR 52255 - Marine Mammals; File No. 19439 | |
80 FR 52269 - Records Governing Off-the-Record Communications; Public Notice | |
80 FR 52268 - Eric S. Morris v. North American Electric Reliability Corporation, SERC Reliability Corporation; Notice of Complaint | |
80 FR 52269 - Combined Notice of Filings #1 | |
80 FR 52194 - Michigan: Final Authorization of State Hazardous Waste Management Program Revision | |
80 FR 52272 - Creation of a New System of Records Notice: Eventbrite | |
80 FR 52296 - Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability | |
80 FR 52224 - Designation of Official Names and Proper Names for Certain Biological Products | |
80 FR 52271 - Notice of Availability of the Environmental Protection Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone National Ambient Air Quality Standard (NAAQS) | |
80 FR 52270 - Amendments, Extensions, and/or Issuances of Experimental Use Permits | |
80 FR 52273 - Environmental Impact Statements; Notice of Availability | |
80 FR 52325 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
80 FR 52326 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
80 FR 52327 - Collection of Information Under Review by Office of Management and Budget | |
80 FR 52188 - Safety Zone; Upper Mississippi River MM 180.0 to 180.5; St. Louis, MO | |
80 FR 52187 - Drawbridge Operation Regulation; Housatonic River, Stratford, CT | |
80 FR 52247 - Notice of Public Meeting of the Texas State Advisory Committee for the Purpose of Planning Project Activity | |
80 FR 52188 - Drawbridge Operation Regulation; Newark Bay, Newark, NJ | |
80 FR 52372 - Advisory Committee on Homeless Veterans, Notice of Meeting | |
80 FR 52282 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
80 FR 52338 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; National Agriculture Workers Survey | |
80 FR 52340 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Survey of Working Women | |
80 FR 52339 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Demonstration and Evaluation of the Short-Time Compensation Program | |
80 FR 52257 - Procurement List; Additions | |
80 FR 52345 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978 | |
80 FR 52345 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
80 FR 52372 - Submission for OMB Review; Comment Request | |
80 FR 52344 - Notice of Permits Issued Under the Antarctic Conservation Act of 1978 | |
80 FR 52337 - Everglades General Management Plan/East Everglades Wilderness Study, Final Environmental Impact Statement, Everglades National Park, Florida | |
80 FR 52336 - Notice of Intent To Prepare a Draft Environmental Impact Statement for a Transportation Plan for Acadia National Park, Maine | |
80 FR 52250 - Notice of Availability of a Draft Programmatic Environmental Assessment for Fisheries Research Conducted and Funded by the National Marine Fisheries Service, Northwest Fisheries Science Center | |
80 FR 52258 - Guidelines for Carrying Out Section 221(a)(4) of the Flood Control Act of 1970, as Amended | |
80 FR 52324 - Findings of Research Misconduct | |
80 FR 52331 - Agency Information Collection Activities: Request for Comments | |
80 FR 52254 - North Pacific Fishery Management Council; Public Meeting | |
80 FR 52255 - New England Fishery Management Council; Public Meeting | |
80 FR 52254 - New England Fishery Management Council; Public Meeting | |
80 FR 52252 - South Atlantic Fishery Management Council (SAFMC); Public Meetings | |
80 FR 52373 - Advisory Committee on Homeless Veterans, Notice of Meeting | |
80 FR 52348 - Watts Bar Nuclear Plant, Unit No. 1; Application and Amendment to Facility Operating License Involving Proposed No Significant Hazards Consideration Determination | |
80 FR 52287 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 52289 - Proposed Data Collections Submitted for Public Comment and Recommendations | |
80 FR 52292 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 52291 - Proposed Data Collections Submitted for Public Comment and Recommendations | |
80 FR 52266 - Agency Information Collection Activities; Comment Request; High School Longitudinal Study of 2009 (HSLS:09) Second Follow-up Main Study and 2018 Panel Maintenance | |
80 FR 52332 - Tribal Education Department Grant Program | |
80 FR 52333 - Sovereignty in Indian Education | |
80 FR 52365 - Agency Information Collection Activities: Reinstatement of a Previously Approved Collection of Information | |
80 FR 52371 - Agency Information Collection; Activity Under OMB Review; Airline Service Quality Performance-Part 234 | |
80 FR 52274 - Agency Information Collection Activities: Proposed Collection Revision and Renewal; Comment Request (3064-0072) | |
80 FR 52342 - Agency Information Collection Activities: Request for Comments for Reinstatement With Change of a Previously Approved Collection, Banks Conversions and Mergers | |
80 FR 52344 - Agency Information Collection Activities: Request for Comments for Reinstatement With Change of a Previously Approved Collection, Organization and Operation of a Federal Credit Union Loan Participation | |
80 FR 52245 - Agency Information Collection Activities: Revision and Extension of Approved Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
80 FR 52247 - Census Advisory Committees | |
80 FR 52363 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LIONHEART K18; Invitation for Public Comments | |
80 FR 52324 - National Committee on Vital and Health Statistics: Meeting | |
80 FR 52334 - Public Land Order No. 7838; Withdrawal of National Forest System Land Adjacent to Jewel Cave National Monument; South Dakota | |
80 FR 52361 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel KWIAT NIGHTS II; Invitation for Public Comments | |
80 FR 52362 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LYNX; Invitation for Public Comments | |
80 FR 52267 - Environmental Management Site-Specific Advisory Board, Portsmouth | |
80 FR 52362 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel PRIVATEER; Invitation for Public Comments | |
80 FR 52206 - Energy Conservation Standards for Central Air Conditioners and Heat Pumps: Availability of Provisional Analysis Tools | |
80 FR 52337 - Agency Information Collection Activities Under OMB Review; Renewal of a Currently Approved Information Collection (OMB Control Number 1006-0014) | |
80 FR 52210 - Energy Conservation Program for Consumer Products: Energy Conservation Standards for Commercial Prerinse Spray Valves | |
80 FR 52268 - Notice of Public Hearings for the Draft Northern Pass Transmission Line Project Environmental Impact Statement (DOE/EIS-0463) | |
80 FR 52364 - Massachusetts Department of Transportation-Acquisition Exemption-Certain Assets of Pan Am Southern LLC | |
80 FR 52279 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
80 FR 52279 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
80 FR 52338 - Meeting of the Judicial Conference Committee on Rules of Practice and Procedure | |
80 FR 52359 - Petition for Exemption; Summary of Petition Received; American Airlines, Inc. | |
80 FR 52357 - Petition for Exemption; Summary of Petition Received; Chevron Aircraft Operations | |
80 FR 52249 - Submission for OMB Review; Comment Request | |
80 FR 52345 - Instructions for Recording and Reporting Occupational Radiation Dose Data | |
80 FR 52346 - Protection Against Extreme Wind Events and Missiles for Nuclear Power Plants | |
80 FR 52295 - Submission for OMB Review; Comment Request | |
80 FR 52173 - Default Investment Fund | |
80 FR 52372 - Surety Companies Acceptable On Federal Bonds: National Liability & Fire Insurance Company | |
80 FR 52256 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Fisheries Research | |
80 FR 52267 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual State Application Under Part B of the Individuals With Disabilities Education Act | |
80 FR 52352 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Consisting of Amendments to MSRB Rule A-12, on Registration, and MSRB Rule A-13, on Underwriting and Transaction Assessments for Brokers, Dealers and Municipal Securities Dealers | |
80 FR 52217 - Update of Overflight Fee Rates | |
80 FR 52335 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
80 FR 52326 - Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting | |
80 FR 52275 - Privacy Act of 1974; System of Records | |
80 FR 52249 - Cryogenic Flow Meter Calibrations: Request for Information and Notice of Public Workshop | |
80 FR 52248 - Submission for OMB Review; Comment Request | |
80 FR 52360 - Limitation on Claims Against Proposed Public Transportation Projects | |
80 FR 52215 - Airworthiness Directives; SOCATA Airplanes | |
80 FR 52264 - Notice of Availability (NOA) of the Draft Environmental Impact Statement (DEIS) and the Announcement of a Public Hearing for the Installation of a Terminal Groin Structure at the Eastern End of Holden Beach, Extending into the Atlantic Ocean, West of Lockwood Folly Inlet (Brunswick County, NC) | |
80 FR 52328 - Agency Information Collection Activities: Nonimmigrant Petition Based on Blanket L Petition, Form I-129S; Revision of a Currently Approved Collection. | |
80 FR 52342 - Notice of Information Collection; Notice (15-072) | |
80 FR 52341 - Notice of Information Collection | |
80 FR 52329 - 30-Day Notice of Submission of Proposed Information Collection for HUD Generic Clearance for Collection of Qualitative Feedback on Proposed New HUD Services or Products | |
80 FR 52325 - Proposed Collection; 60-day Comment Request: A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) | |
80 FR 52204 - Fisheries of the Exclusive Economic Zone Off Alaska; Several Groundfish Species in the Bering Sea and Aleutian Islands Management Area | |
80 FR 52299 - Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order; Guidance for Tobacco Retailers; Availability | |
80 FR 52231 - Reportable Transactions Penalties Under Section 6707A | |
80 FR 52285 - Submission to OMB for Review; OMB Control No. 3090-00XX; Wireless Telecommunications Company Application | |
80 FR 52211 - Airworthiness Directives; BAE Systems (Operations) Limited Airplanes | |
80 FR 52300 - 340B Drug Pricing Program Omnibus Guidance | |
80 FR 52212 - Airworthiness Directives; Continental Motors, Inc. Reciprocating Engines | |
80 FR 52177 - Airworthiness Directives; Pratt & Whitney Turbofan Engines | |
80 FR 52185 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
80 FR 52190 - Approval and Promulgation of Air Quality Implementation Plans; Missouri; 2013 Missouri State Implementation Plan for the 2008 Lead Standard | |
80 FR 52198 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Quotas | |
80 FR 52331 - Federal Property Suitable as Facilities To Assist the Homeless | |
80 FR 52359 - Environmental Impact Statement: Hidalgo County, Texas | |
80 FR 52175 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
80 FR 52179 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
80 FR 52182 - Airworthiness Directives; Airbus Airplanes | |
80 FR 52245 - Superior National Forest, Minnesota; School Trust Land Exchange | |
80 FR 52363 - Office of Hazardous Materials Safety; Notice of Applications for Modification of Special Permit |
Forest Service
Census Bureau
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Geological Survey
Indian Affairs Bureau
Land Management Bureau
National Park Service
Reclamation Bureau
Surface Mining Reclamation and Enforcement Office
Federal Aviation Administration
Federal Highway Administration
Federal Transit Administration
Maritime Administration
Pipeline and Hazardous Materials Safety Administration
Surface Transportation Board
Transportation Statistics Bureau
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 Retirement Thrift Investment Board.
Final rule.
The Federal Retirement Thrift Investment Board (Agency) is amending its regulations to change the default investment fund for certain participants in the Thrift Savings Plan (TSP).
This rule is effective September 5, 2015.
Austen Townsend at (202) 864-8647.
The Agency administers the TSP, which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a tax-deferred retirement savings plan for Federal civilian employees, members of the uniformed services, and spouse beneficiaries. The TSP is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)).
On July 13, 2015, the Agency published a proposed rule with request for comments in the
I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect Federal civilian employees and spouse beneficiaries who participate in the Thrift Savings Plan, which is a Federal defined contribution retirement savings plan created under the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514, and which is administered by the Agency.
I certify that these regulations do not require additional reporting under the criteria of the Paperwork Reduction Act.
Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under section 1532 is not required.
Pursuant to 5 U.S.C. 810(a)(1)(A), the Agency submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States before publication of this rule in the
Government employees, Pensions, Retirement.
For the reasons stated in the preamble, the Agency amends 5 CFR chapter VI as follows:
5 U.S.C. 8351, 8432(a), 8432(b), 8432(c), 8432(j), 8432d, 8474(b)(5) and (c)(1).
The Board shall furnish all new employees and all rehired employees covered by the automatic enrollment program a notice that accurately describes:
(c) The fund in which the default employee and agency contributions will be invested unless the employee makes a contribution allocation;
(d) The employee's ability to request a refund of any default employee contributions (adjusted for allocable gains and losses) and the procedure to request such a refund; and
(e) That an investment in any fund other than the G Fund is made at the employee's risk, that the employee is not protected by the United States Government or the Board against any loss on the investment, and that neither the United States Government nor the Board guarantees any return on the investment.
5 U.S.C. 8351, 8432d, 8438, 8474(b)(5) and (c)(1).
(a) * * *
(3) A uniformed services participant or a participant enrolled prior to September 5, 2015 who elects for the first time to invest in a TSP Fund other than the G Fund must execute an acknowledgement of risk in accordance with § 1601.33;
(4) All deposits made on behalf of a participant enrolled prior to September 5, 2015 or a uniformed services participant who does not have a contribution allocation in effect will be invested in the G Fund. A participant who is enrolled prior to September 5, 2015 and subsequently rehired on or after September 5, 2015 and has a
(5) All deposits made on behalf of a participant first enrolled on or after September 5, 2015 who does not have a contribution allocation in effect will be invested in the age-appropriate TSP Lifecycle Fund; and
(6) Once a contribution allocation becomes effective, it remains in effect until it is superseded by a subsequent contribution allocation or the participant's account balance is reduced to zero. If a rehired participant has a positive account balance and a contribution allocation in effect, then the participant's contribution allocation will remain in effect until a new allocation is made. If, however, the participant has a zero account balance, then the participant's contributions will be allocated to the age-appropriate TSP Lifecycle Fund until a new allocation is made.
(a) A uniformed services participant or a participant enrolled prior to September 5, 2015 who wants to invest in a TSP Fund other than the G Fund must execute an acknowledgement of risk for that fund. * * *
5 U.S.C. 8424(d), 8432d, 8432(j), 8433(e), 8435(c)(2), 8474(b)(5) and 8474(c)(1).
(d) * * * The account will accrue earnings at the G Fund rate in accordance with 5 CFR part 1645 until it is paid out or a beneficiary participant account is established under this part.
(a) * * * Regardless of the allocation of the deceased participant's account balance at the time of his or her death, each beneficiary participant account, once established, will be allocated 100 percent to the age-appropriate TSP Lifecycle Fund based on the beneficiary participant's date of birth. * * *
Defense Nuclear Facilities Safety Board.
Establishment of FOIA Fee Schedule.
The Defense Nuclear Facilities Safety Board is publishing its Freedom of Information Act (FOIA) Fee Schedule Update pursuant to the Board's regulations.
Effective September 1, 2015.
Mark T. Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (202) 694-7060.
The FOIA requires each Federal agency covered by the Act to specify a schedule of fees applicable to processing of requests for agency records. 5 U.S.C. 552(a)(4)(A)(i). On July 9, 2015 the Board published for comment in the
Pursuant to 10 CFR 1703.107(b)(6) of the Board's regulations, the Board's General Manager will update the FOIA Fee Schedule once every 12 months. The previous Fee Schedule Update went into effect on June 1, 2014. 79 FR 31848.
Accordingly, the Board issues the following schedule of updated fees for services performed in response to FOIA requests:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. This AD requires replacing the oxygen hose assembly with a new, improved assembly. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby.
This AD becomes effective October 2, 2015.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 2, 2015.
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7318; fax (516) 794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, has issued Canadian Airworthiness Directive CF-2014-37, dated October 17, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:
Design review found that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, is lower than the opening pressure of the high-pressure relief valve. This could cause the flexible hose to burst before it is able to vent the excess oxygen overboard. If an ignition source is present, the accumulation of oxygen in an enclosed space may result in an uncontrolled oxygen-fed fire.
This [Canadian] AD mandates the replacement of the oxygen hose assembly with a new design oxygen hose assembly.
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 (80 FR 19574, April 13, 2015) and the FAA's response to each comment.
Mesa Airlines and Envoy Air Inc. asked that the compliance time specified in paragraph (g) of the proposed AD (80 FR 19574, April 13, 2015) be changed.
Mesa Airlines stated that the current compliance time would immediately ground 78 airplanes on the effective date of the AD, and with increased demand for replacement parts it would be difficult to recover. Mesa Airlines asked that we change the compliance time to “Within 6,000 flight hours, or within 44 months after the effective date of this AD, whichever occurs first.” Mesa Airlines added that this would allow for scheduling with heavy maintenance inspection and parts procurement.
Envoy Air Inc. stated that a large number of affected airplanes have flown more than 5,800 total flight hours. Envoy Air Inc. noted that the proposed compliance time “before the accumulation of 5,800 total flight hours” would mean that most of the affected airplanes would be required to comply with this AD prior to the effective date to remain in compliance. Envoy Air Inc. asked that we change the compliance time to “Within 5,800 flight hours or 44 months, whichever occurs first, from the effective date of the AD.” Envoy Air Inc. stated that this would more clearly communicate the desired compliance time for this AD.
We partially agree with the requests. We have changed the compliance time in paragraph (g) of this AD to “Within 5,800 flight hours or 44 months after the effective date of this AD, whichever occurs first.” This change matches the compliance time listed in the MCAI, and will allow operators to remain in compliance.
We do not agree that the compliance time should be extended to “Within 6,000 flight hours, or within 44 months after the effective date of this AD, whichever occurs first.” After
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the change described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM (80 FR 19574, April 13, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 19574, April 13, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Bombardier has issued Service Bulletin 670BA-35-013, Revision B, dated May 20, 2015, including Appendix A, dated May 21, 2013. The service information describes procedures for replacing the oxygen hose assembly with a new, improved assembly. 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 400 airplanes of U.S. registry.
We also estimate that it takes about 10 work-hours per product to comply with the basic requirements of this AD. Required parts will cost about $0 per product. 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 $340,000, or $850 per airplane.
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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective October 2, 2015.
None.
This AD applies to the airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, serial numbers 10002 through 10336 inclusive.
(2) Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705), and Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers 15001 through 15297 inclusive.
(3) Bombardier, Inc. Model CL-600-2E25 (Regional Jet Series 1000) airplanes, serial numbers 19001 through 19038 inclusive.
Air Transport Association (ATA) of America Code 35, Oxygen.
This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby.
Comply with this AD within the compliance times specified, unless already done.
Within 5,800 flight hours or 44 months after the effective date of this AD, whichever occurs first: Replace all oxygen hose assemblies having part number (P/N) S6946-01 with new, improved assemblies having P/N BA670-44025-001, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-35-013, Revision B, dated May 20, 2015, including Appendix A, dated May 21, 2013. For airplanes on which Supplemental Type Certificate ST01648NY (
This paragraph provides credit for the replacement specified in paragraph (g) of this AD, if that action was performed before the effective date of this AD using Bombardier Service Bulletin 670BA-35-013, dated May 21, 2013; or Bombardier Service Bulletin 670BA-35-013, Revision A, dated September 23, 2013; which are not incorporated by reference in this AD.
As of the effective date of this AD, no person may install an oxygen hose assembly, P/N S6946-01, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-37, dated October 17, 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) Bombardier Service Bulletin 670BA-35-013, Revision B, dated May 20, 2015, including Appendix A, dated May 21, 2013.
(ii) Reserved.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all Pratt & Whitney (PW) PW4164-1D, PW4168-1D, PW4168A-1D and PW4170 engines, and certain PW4164, PW4168, and PW4168A turbofan engines. This AD was prompted by fuel nozzle-to-fuel supply manifold interface fuel leaks. This AD requires inspecting fuel nozzles for signs of leakage, replacing hardware as required, and torqueing to specified requirement. We are issuing this AD to prevent fuel leaks which could result in engine fire and damage to the airplane.
This AD is effective October 2, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 2, 2015.
For service information identified in this AD, contact Pratt & Whitney, 400 Main St., East Hartford, CT 06108; phone: 860-565-8770; fax: 860-565-4503. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at
You may examine the AD docket on the Internet at
Katheryn Malatek, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7747; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all PW PW4164-1D, PW4168-1D, PW4168A-1D and PW4170 engines, and certain PW4164, PW4168, and PW4168A turbofan engines. The NPRM
We reviewed PW Alert Service Bulletin (ASB) No. PW4G-100-A73-44, Revision 1, dated February 12, 2015. This ASB describes procedures for fuel supply manifold inspection and re-torque of the B-nut connection. 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 gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 22140, April 21, 2015) and the FAA's response to each comment.
Korean Air requested that this AD mandate following PW ASB No. PW4G-100-A73-44 Revision 1, dated February 12, 2015 instead of PW ASB No. PW4G-100-A73-44, dated October 10, 2014. Korean Air would like to receive credit for service performed in accordance with the latest revision of the ASB.
We agree. We changed this AD to include PW ASB No. PW4G-100-A73-44 Revision 1, dated February 12, 2015 and added a Credit for Previous Action section to provide credit when PW ASB No. PW4G-100-A73-44, dated October 10, 2014 is followed, before the effective date of this AD.
Korean Air requested that engines incorporating Special Instruction (SI) 129F-14 meet the requirement for compliance with this AD since SI 129F-14 provides the same instructions as PW ASB No. PW4G-100-A73-44, dated October 10, 2014 and PW ASB No. PW4G-100-A73-44 Revision 1, dated February 12, 2015.
We agree. We added SI 129F-14 to the Credit for Previous Action section.
Korean Air requested that the Mandatory Terminating Action section be changed to state that the actions listed are closing actions to the repetitive inspections defined in the Compliance section.
We agree. We changed the Mandatory Terminating Action section by adding, “As terminating action to the repetitive inspection requirements in paragraph (e)(1) of this AD do the following:”.
PW requested that engines incorporating PW Service Bulletin (SB) No. PW4G-100-72-220, Revision 4, dated September 30, 2011 be added to the Applicability section.
We disagree. Engines incorporating PW SB No. PW4G-100-72-220, Revision 4, dated September 30, 2011 are identified in the Applicability section by model designation. We did not change this AD.
PW requested that the definition of cycles be changed from “cycles since new or cycles since the incorporation of PW SB No. PW4G-100-72-214, dated December 15, 2011 or SB No. PW4G-100-72-219, Revision 1, dated October 5, 2011” to “since new (1st run) or since last torque application to the B-nuts on the fuel nozzle installation.” The justification for this request is that the B-nuts could have been torqued subsequent to the incorporation of the service bulletins.
We agree. We changed the Definition paragraph to define cycles as “. . . since new or cycles since last torque application to the B-nuts on the fuel nozzle installation.”
Asiana Airlines requested that the compliance time listed in this AD match the dates listed in the ASB. Asiana believes the compliance time listed in this AD is more restrictive than the dates listed in the ASB.
We disagree. Using cycles since the effective date of this AD instead of calendar dates provides greater fleet management flexibility to the operator while acceptably resolving the unsafe condition.
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.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We estimate that this AD would affect about 72 engines installed on airplanes of U.S. registry. The average labor rate is $85 per hour. We estimate that parts replacement will cost about $1,356 per engine. Based on these figures, we estimate the cost of this AD on U.S. operators to be $391,392.
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 to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective October 2, 2015.
None.
This AD applies to all Pratt & Whitney (PW) PW4164-1D, PW4168-1D, PW4168A-1D and PW4170 engines; and all PW4164, PW4168, and PW4168A turbofan engines that have incorporated either PW Service Bulletin (SB) No. PW4G-100-72-214, dated December 15, 2011 or PW SB No. PW4G-100-72-219, Revision 1, dated October 5, 2011.
This AD was prompted by fuel nozzle-to-fuel supply manifold interface fuel leaks. We are issuing this AD to prevent fuel leaks which could result in engine fire and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 800 flight hours after the effective date of this AD, and within every 800 flight hours since last inspection thereafter, inspect all fuel nozzle-to-fuel supply manifold interfaces for evidence of fuel leaks, soot, and coke formation. Use the Accomplishment Instructions, Part A, of PW Alert Service Bulletin (ASB) No. PW4G-100-A73-44, Revision 1, dated February 12, 2015 to do the inspections.
(2) Replace hardware that fails an inspection. Use the Accomplishment Instructions, Part A, of PW ASB No. PW4G-100-A73-44, Revision 1, dated February 12, 2015 to do the replacement.
As terminating action to the repetitive inspection requirements in paragraph (e)(1) of this AD do the following:
(1) Inspect all fuel nozzle-to-fuel supply manifold interfaces for fuel leaks, soot, and coke formation, replace hardware that fails inspection, and re-torque all fuel nozzle-to-fuel supply manifold B-nuts as follows:
(i) For engines with fewer than 1,500 cycles on the effective date of this AD, before accumulating another 650 cycles, not to exceed 1,900 cycles.
(ii) For engines with 1,500 cycles or more, but less than 2,500 cycles on the effective date of this AD, before accumulating another 400 cycles, not to exceed 2,700 cycles.
(iii) For engines with 2,500 cycles or more on the effective date of this AD, before accumulating another 200 cycles.
(2) Use the Accomplishment Instructions, Parts B through E, of PW ASB No. PW4G-100-A73-44, Revision 1, dated February 12, 2015 to do the inspection, replacement, and retorqueing.
This paragraph provides credit for the actions required by paragraphs (e) and (f) of this AD, if the actions were performed before the effective date of this AD, using the procedures specified in PW ASB No. PW4G-100-A73-44, dated October 10, 2014 or Special Instruction 129F-14.
For the purpose of this AD “cycles” is defined as cycles since new or cycles since last torque application to the B-nuts on the fuel nozzle installation.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
For more information about this AD, contact Katheryn Malatek, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7747; fax: 781-238-7199; 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) Pratt & Whitney (PW) ASB No. PW4G-100-A73-44, Revision 1, dated February 12, 2015.
(ii) Reserved.
(3) For PW service information identified in this AD, contact Pratt & Whitney, 400 Main St., East Hartford, CT 06108; phone: 860-565-8770; fax: 860-565-4503.
(4) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(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 certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. This AD requires replacing the oxygen hose assembly with a new, improved assembly. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby.
This AD becomes effective October 2, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 2, 2015.
You may examine the AD docket on the Internet at
For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone (516) 228-7318; fax (516) 794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, has issued Canadian Airworthiness Directive CF-2014-36, dated October 17, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:
Design review found that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, is lower than the opening pressure of the high-pressure relief valve. This could cause the flexible hose to burst before it is able to vent the excess oxygen overboard. If an ignition source is present, the accumulation of oxygen in an enclosed space may result in an uncontrolled oxygen-fed fire.
This [Canadian] AD mandates the replacement of the oxygen hose assembly with a new design oxygen hose assembly.
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 19570, April 13, 2015) and the FAA's response to each comment.
Mesa Airlines asked that the compliance time specified in paragraph (g) of the NPRM (80 FR 19570, April 13, 2015) be changed. Mesa Airlines stated that the current compliance time would immediately ground airplanes on the effective date of the AD. Mesa Airlines asked that we change the compliance time to “Within 6,000 flight hours, or within 44 months after the effective date of this AD, whichever occurs first.” Mesa Airlines added that this would allow for scheduling with heavy maintenance inspection and parts procurement.
We partially agree with the request. We have changed the compliance time in paragraph (g) of this AD to “Within 5,800 flight hours or 44 months after the effective date of this AD, whichever occurs first.” This change matches the compliance time in the MCAI, and will allow operators to remain in compliance.
We do not agree that the compliance time should be extended to “Within 6,000 flight hours, or within 44 months after the effective date of this AD, whichever occurs first”. After considering all the available information, we have determined that the compliance time represents an appropriate interval 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. In developing an appropriate compliance time, we considered the safety implications, parts availability, and normal maintenance schedules for timely accomplishment of the replacement. However, if additional data are presented that would justify a longer compliance time, we may consider further rulemaking on this issue. We have not changed the AD in this regard.
Richard Rupslauskas asked that we include Bombardier Service Bulletin 601R-35-018, Revision A, in the NPRM (80 FR 19570, April 13, 2015), and give credit for Bombardier Service Bulletin 601R-35-018, dated May 21, 2013. The commenter stated that Revision A should be distributed very soon, and added that no additional work will be required on aircraft that have had the modification incorporated using the original issue of the service information. The commenter added that the NPRM should recognize that either the original or Revision A of the service information is acceptable as a method of compliance.
We do not agree to reference Bombardier Service Bulletin 601R-35-018, Revision A, because that revision has not yet been issued. However, after Revision A is issued, affected operators may request approval to use that revision of the referenced service bulletin as an alternative method of compliance, under the provisions of paragraph (i)(1) of this AD.
Richard Rupslauskas stated that the parts cost is $835 per airplane, and added that since 575 airplanes are affected, the total cost for parts is $480,125.
We infer that the commenter wants the parts cost included in the “Costs of Compliance” section of this AD. We agree to include the parts cost of $835 in that section. We have changed this AD accordingly.
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 (80 FR 19570, April 13, 2015) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 19570, April 13, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Bombardier has issued Service Bulletin 601R-35-018, dated May 21, 2013. The service information describes procedures for replacing the oxygen hose assembly with a new, improved assembly. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. This service information is reasonably available because the interested parties have access to it
We estimate that this AD affects 575 airplanes of U.S. registry.
We also estimate that it takes about 2 work-hours per product to comply with the basic requirements of this AD. Required parts will cost about $835 per product. 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 $577,875, or $1,005 per airplane.
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.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective October 2, 2015.
None.
This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category, serial numbers 7003 and subsequent.
Air Transport Association (ATA) of America Code 35, Oxygen.
This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby.
Comply with this AD within the compliance times specified, unless already done.
Within 5,800 flight hours or 44 months after the effective date of this AD, whichever occurs first: Replace all oxygen hose assemblies having part number (P/N) 38026-4-0280-000 with new, improved assemblies having P/N 601R44045-1, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 601R-35-018, dated May 21, 2013.
As of the effective date of this AD, no person may install an oxygen hose assembly, P/N 38026-4-0280-000, on any airplane.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-36, dated October 17, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Bombardier Service Bulletin 601R-35-018, dated May 21, 2013.
(ii) Reserved.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus Model A319, A320, and A321 series airplanes. This AD was prompted by reports that during a full scale fatigue test, several broken frames in certain areas of the cargo compartment have been found, especially on the cargo floor support fittings and open tack holes on the left-hand side. This AD requires a rototest inspection of the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, including doing all applicable related investigative actions, and repair if necessary. We are issuing this AD to detect and correct cracking in the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, which could affect the structural integrity of the airplane.
This AD becomes effective October 2, 2015.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of October 2, 2015.
You may examine the AD docket on the Internet at
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
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 2013-0310, dated December 20, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A319, A320, and A321 series airplanes. The MCAI states:
During a full scale fatigue test, several broken frames in the cargo compartment area between Frame (FR) 50 and FR 63, have been found, especially on the cargo floor support fittings and open tack holes on [the] left hand side.
This condition, if not detected and corrected, could affect the structural integrity of the aeroplane.
For the reason described above, this [EASA] AD requires repetitive inspections of the frames in the cargo compartment area and of the cargo floor support fittings and open tack holes on the left hand (LH) side, and depending on findings, the accomplishment of applicable corrective action(s). This [EASA] AD also requires a modification, which constitutes terminating action for the repetitive inspections required by this [EASA] AD.
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (79 FR 42716, July 23, 2014) and the FAA's response to each comment.
Delta Air Lines (DAL), United Airlines (UAL), and US Airways requested that certain service information be removed from the NPRM (79 FR 42716, July 23, 2014) as it is not applicable to the U.S. fleet.
DAL stated that Airbus Service Bulletin A320-53-1261, dated December 21, 2012, which provides a terminating modification for the repetitive inspections specified in the NPRM (79 FR 42716, July 23, 2014), is one of eight structural modification service bulletins required to operate Model A320 airplanes beyond 48,000 flight cycles/96,000 flight hours (referred to as extended service goal (ESG)). DAL stated that Airbus Service Bulletin A320-53-1261, dated December 21, 2012, does not affect DAL or any other U.S. operator, since Airbus only recognizes airplane effectivity for those operators that have accomplished this service bulletin (which can only be purchased from Airbus) through ESG embodiment.
UAL and US Airways stated that, in paragraph (h) of the proposed AD (79 FR 42716, July 23, 2014), modification of the fuselage in accordance with Airbus
We agree with these commenters' requests. Airbus Service Bulletin A320-53-1261, dated December 21, 2012, does not apply to the U.S. fleet because the terminating action is not applicable for all manufacturer serial numbers. Therefore, we have deleted the modification requirement that was specified in paragraph (h) of the proposed AD (79 FR 42716, July 23, 2014), and have redesignated subsequent paragraphs accordingly.
DAL also requested that the FAA ask Airbus to update the Effectivity in Airbus Service Bulletin A320-53-1261, dated December 21, 2012, along with the other structural modification service information required for operation beyond 48,000 total flight cycles/96,000 total flight hours.
We disagree with this request. As we stated previously, we have deleted the modification requirement that was specified in paragraph (h) of the proposed AD (79 FR 42716, July 23, 2014). In addition, we do not agree with delaying this action for mitigating safety risks addressed in this AD until after the release of the manufacturer's additional planned service bulletin(s). We have not changed this AD in this regard.
DAL requested that a separate AD be issued that would specify all required service information for the modification in paragraph (h) of the proposed AD (79 FR 42716, July 23, 2014), which must be accomplished prior to operation beyond 48,000 total flight cycles/96,000 total flight hours for affected manufacturer serial numbers.
We disagree with issuing a separate AD action that would require all modifications associated with operations exceeding 48,000 total flight cycles/96,000 total flight hours (referred to as ESG). ESG is not related to the unsafe condition in this AD. ESG is not a requirement, but an option to operate with an extended operational limit of 60,000 total flight cycles/120,000 total flight hours and is contingent on accomplishment of specific modifications. This AD is specific to mitigating the risks associated with the identified unsafe condition, which were identified during full scale fatigue testing. Choosing the option to operate airplanes exceeding 48,000 total flight cycles/96,000 total flight hours lies with the operator and has no bearing on the mitigation of the unsafe condition identified in this AD. We have not changed this AD in this regard.
DAL and UAL requested a statement in the NPRM (79 FR 42716, July 23, 2014) to specify the actions that are required for compliance (RC) in Airbus Service Bulletin A320-53-1257, dated December 21, 2012.
UAL stated that paragraph 3.C. of the Accomplishment Instructions of Airbus Service Bulletin A320-53-1257, dated December 21, 2012, meets the technical intent of the inspection in the service information as that paragraph specifies removal of the affected fasteners, accomplishment of the rototest inspection, and re-installation of the fasteners. UAL stated that the access and close-up actions may then be specified by the operator as deemed necessary. UAL commented that paragraph (g) of the proposed AD (79 FR 42716, July 23, 2014) could specify that the inspection be performed in accordance with paragraph 3.C. of the Accomplishment Instructions of Airbus Service Bulletin A320-53-1257, dated December 21, 2012.
DAL stated that the FAA issued Advisory Circular (AC) 20-176 in December 2011 and AC 20-176A in June 2014 (
DAL also requested that the FAA evaluate service bulletins for adherence to the guidance provided in AC 20-176A, dated June 16, 2014 (
We agree with the concept of minimizing AD requirements when appropriate. The FAA released AC 20-176A, dated June 16, 2014 (
However for this AD, we reviewed Airbus Service Bulletin A320-53-1257, dated December 21, 2012, and determined that the procedures in paragraph 3.C., “Procedure,” are necessary to address the identified unsafe condition. All other steps in the Accomplishment Instructions may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an alternative method of compliance (AMOC), provided the procedures in paragraph 3.C., “Procedures,” can be done and the airplane can be put back in a serviceable condition. We have revised paragraph (g) of this AD to refer to procedures in paragraph 3.C., “Procedures,” of the Accomplishment Instructions of Airbus Service Bulletin A320-53-1257, dated December 21, 2012.
We reviewed the relevant data, considered the comments received, and
• Are consistent with the intent that was proposed in the NPRM (79 FR 42716, July 23, 2014) for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 42716, July 23, 2014).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Airbus Service Bulletin A320-53-1257, dated December 21, 2012. The service information describes procedures for a rototest inspection of the open tack holes and rivet holes at the cargo floor support fittings between frame (FR) 50 and FR 63 (left-hand side only) for Model A320 and A321 series airplanes and FR 53 and FR 63 (left-hand side only) for Model A319 series airplanes of the fuselage, including other actions, and repair 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 847 airplanes of U.S. registry.
We also estimate that it would take about 471 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts (for the modification) would cost about $6,570 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $39,474,435, or $46,605 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions 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 the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective October 2, 2015.
None.
This AD applies to Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes; certificated in any category; all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports that, during a full scale fatigue test, several broken frames in certain areas of the cargo compartment have been found, especially on the cargo floor support fittings and open tack holes on the left-hand (LH) side. We are issuing this AD to detect and correct cracking in the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, which could affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable compliance times specified in paragraphs (g)(1) through (g)(3) of this AD: Do a rototest inspection for cracking of the open tack holes and rivet holes at the cargo floor support fittings of the fuselage between frame (FR) 50 and FR 63 left-hand (LH) side only for Model A320 series airplanes, and A321 series airplanes; and between FR 53 and FR 63 LH side only for Model A319 series airplanes; in accordance with paragraph 3.C., “Procedures,” of the Accomplishment Instructions of Airbus Service Bulletin A320-53-1257, dated December 21, 2012. Repeat the inspection thereafter at intervals not to exceed 5,000 flight cycles or 10,000 flight hours, whichever occurs first.
(1) For airplanes that have equal to or more than 45,000 total flight cycles or 90,000 total flight hours as of the effective date of this AD: Do the rototest inspection within 1,000 flight cycles or 2,000 flight hours after the effective date of this AD, whichever occurs first.
(2) For airplanes that have equal to or more than 36,200 total flight cycles or 72,400 total flight hours, but less than 45,000 total flight cycles or 90,000 total flight hours as of the
(3) For airplanes that have less than 36,200 total flight cycles or 72,400 total flight hours as of the effective date of this AD: Do the rototest inspection before exceeding 38,200 total flight cycles or 76,400 total flight hours, whichever occurs first.
If any crack is found during any inspection required by this AD: Before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
The following provisions also apply to this AD:
(1)
(2)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0310, dated December 20, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A320-53-1257, dated December 21, 2012.
(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 Turbomeca S.A. Arrius 2F turboshaft engines with a certain part number oil pump installed. This AD requires inspection, and if necessary, replacement before further flight of the oil pump driver assembly and/or the oil pump shaft, or the oil pump itself. This AD was prompted by cases of deterioration of the gas generator front bearing due to a link loss between the pump driver and the oil pump shaft. We are issuing this AD to prevent link loss between the pump driver and the oil pump shaft, which could lead to an engine in-flight shutdown, forced landing, and damage to the helicopter.
This AD becomes effective October 2, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of October 2, 2015.
For service information identified in this AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; telex: 570 042; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at
You may examine the AD docket on the Internet at
Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the
A risk of an in-flight shutdown (IFSD) has been identified on an ARRIUS 2F engine, due to deterioration of gas generator front bearing. This could be the result of lack of lubrication,
This condition, if not detected and corrected, could lead to cases of IFSD, possibly resulting in forced landing with consequent damage to the helicopter and injury to occupants.
Turbomeca S.A. has issued Mandatory Service Bulletin (MSB) No. 319 79 4834, Version B, dated October 21, 2014. The MSB describes procedures for inspecting the oil pump driver assembly on the oil pump shaft, the pump driver splines, and the oil pump splines. 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 gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 29224, May 21, 2015).
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.
We estimate that this AD affects about 96 engines installed on helicopters of U.S. registry. We also estimate that it would take about two hours per engine to comply with this AD. The average labor rate is $85 per hour. Required parts would cost about $17,312 per engine. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,678,272.
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 to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective October 2, 2015.
None.
This AD applies to all Turbomeca S.A. Arrius 2F turboshaft engines with oil pump, part number (P/N) 0319155050, installed, except for:
(1) Engines, equipped with an oil pump, P/N 0319155050, that were overhauled in a Turbomeca repair center after January 1, 2013, and
(2) Engines with a serial number of 34776 or higher, provided that the oil pump was not replaced on that engine since the first flight of that engine on a helicopter.
This AD was prompted by cases of deterioration of the gas generator front bearing due to a link loss between the pump driver and the oil pump shaft. We are issuing this AD to prevent link loss between the pump driver and the oil pump shaft, which could lead to an engine in-flight shutdown, forced landing, and damage to the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Inspect the pump driver assembly on the oil pump shaft, the pump driver splines, and the oil pump splines, using paragraph 2.4.2, Operating Instructions, of Turbomeca S.A. Mandatory Service Bulletin (MSB) No. 319 79 4834, Version B, dated October 21, 2014, as follows:
(i) For engines with fewer than 250 engine hours (EH), accumulated since new, since last overhaul, or since last installation of an affected oil pump, whichever occurred later, inspect before exceeding 300 EH, accumulated since new, since last overhaul, or since last installation of an affected oil pump, as applicable.
(ii) For engines with 250 EH or more, but fewer than 300 EH, accumulated since new, since last overhaul, or since last installation of an affected oil pump, whichever occurred later, inspect within 50 EH.
(iii) For engines with 300 EH or more, but fewer than 800 EH, accumulated since new, since last overhaul, or since last installation of an affected oil pump, whichever occurred later, inspect within 100 EH.
(iv) For engines with 800 EH or more, accumulated since new, since last overhaul, or since last installation of an affected oil pump, whichever occurred later, inspect during the next scheduled 500 EH inspection.
(2) If any oil pump drive assembly and/or oil pump shaft, or the oil pump itself, fails the inspection required by this AD, then before further flight, replace the failed part(s) with part(s) eligible for installation.
(3) The instruction to report inspection results and the instruction to return a compliance certificate to Turbomeca S.A. as stated in paragraph 2.4.2, Operating Instructions, of Turbomeca S.A. MSB No. 319 79 4834, Version B, dated October 21, 2014, are not required by this AD.
If you inspected the oil pump driver assembly on the oil pump shaft, the pump driver splines, and the oil pump splines, and replaced any part(s) with part(s) eligible for installation before the effective date of this AD in accordance with Turbomeca S.A. MSB No. 319 79 4834, Version A, dated November 25, 2013, you met the requirements of this AD.
The Manager, Engine Certification Office, FAA, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Philip Haberlen, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7770; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0049, dated March 17, 2015 (Corrected May 7, 2015), for more information. You may examine the MCAI in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Turbomeca S.A. MSB No. 319 79 4834, Version B, dated October 21, 2014.
(ii) Reserved.
(3) For service information identified in this proposed AD, contact Turbomeca, S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; telex: 570 042; fax: 33 (0)5 59 74 45 15.
(4) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information 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:
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Devon Bridge, across the Housatonic River, mile 3.9, at Stratford, CT. This deviation is necessary to perform superstructure repairs and timber ties replacement. This deviation allows the bridge to remain in the closed position for 50 days.
This deviation is effective from 8 a.m. on October 5, 2015 to 8 a.m. on November 23, 2015.
The docket for this deviation, [USCG-2015-0772] is available at
If you have questions on this temporary deviation, contact Ms. Judy K. Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email
The Devon Bridge, mile 3.9, across 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.
Connecticut DOT requested this temporary deviation from the normal operating schedule to perform superstructure repairs and timber ties replacement.
Under this temporary deviation, the Devon Bridge will operate according to the schedule below:
a. From 8 a.m. on October 5, 2015 through 4 a.m. on October 9, 2015, the bridge will not open to marine traffic.
b. From 4 a.m. on October 9, 2015 through 8 a.m. on October 12, 2015, the bridge will open fully on signal upon 24 hour advance notice.
c. From 8 a.m. on October 12, 2015 through 4 a.m. on October 16, 2015, the bridge will not open to marine traffic.
d. From 4 a.m. on October 16, 2015 through 8 a.m. on October 19, 2015, the bridge will open fully on signal upon 24 hour advance notice.
e. From 8 a.m. on October 19, 2015 trough 4 a.m. on October 23, 2015, the bridge will not open to marine traffic.
f. From 4 a.m. on October 23, 2015 through 8 a.m. on October 26, 2015, the bridge will open fully on signal upon 24 hour advance notice.
g. From 8 a.m. on October 26, 2015 through 4 a.m. on October 30, 2015, the bridge will not open to marine traffic.
h. From 4 a.m. on October 30, 2015 through 8 a.m. on November 2, 2015, the bridge will open fully on signal upon 24 hour advance notice.
i. From 8 a.m. on November 2, 2015 through 4 a.m. on November 6, 2015, the bridge will not open to marine traffic.
j. From 4 a.m. on November 6, 2015 through 8 a.m. on November 9, 2015, the bridge will open fully on signal upon 24 hour advance notice.
k. From 8 a.m. on November 9, 2015 through 4 a.m. on November 13, 2015, the bridge will not open to marine traffic.
l. From 4 a.m. on November 13, 2015 through 8 a.m. on November 16, 2015, the bridge will open fully on signal upon 24 hour advance notice.
m. From 8 a.m. on November 16, 2015 through 4 a.m. on November 20, 2015, the bridge will not open to marine traffic.
n. From 4 a.m. on November 20, 2015 through 8 a.m. on November 23, 2015, the bridge will open fully on signal upon 24 hour advance notice.
The bridge will not be able to open in the event of an emergency. There is no alternate route for vessel traffic; however, vessels that can pass under the closed draws during this closure may do so at any time.
The Coast Guard will inform the users of the waterway through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessels 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
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Lehigh Valley Drawbridge, across Newark Bay, mile 4.3, at Newark, New Jersey. This deviation is necessary to replace bridge timbers and miter rails. This deviation allows the bridge to remain in the closed position for 10 hours for two days.
This deviation is effective from 7 a.m. to 5 p.m. on September 13, 2015 and from 7 a.m. to 5 p.m. on September 14, 2015, with a rain date on September 20, 2015 from 7 a.m. to 5 p.m.
The docket for this deviation, [USCG-2015-0807] is available at
If you have questions on this temporary deviation, contact Mr. Joe M. Arca, Project Officer, First Coast Guard District, telephone (212) 514-4336, email
The Lehigh Valley Drawbridge, mile 4.3, across Newark Bay has a vertical clearance in the closed position of 35 feet at mean high water and 39 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.5.
The waterway has commercial oil barge traffic of various sizes and recreational vessels.
Consolidated Rail Corporation requested this temporary deviation from the normal operating schedule to facilitate essential maintenance repairs.
Under this temporary deviation, the Lehigh Valley Drawbridge will operate according to the schedule below:
a. From 7 a.m. through 5 p.m. on September 13, 2015 the bridge will not open to marine traffic.
b. From 7 a.m. through 5 p.m., on September 14, 2015 the bridge will not open for marine traffic.
c. Should a rain date be necessary, from 7 a.m. through 5 p.m. on September 20, 2015 the bridge will not open to marine traffic.
The bridge will not be able to open in the event of an emergency. There is no alternate route for vessel traffic; however, vessels that can pass under the closed draws during this closure may do so at any time.
The Coast Guard will inform the users of the waterway through our Local Notice to Mariners of the change in operating schedule for the bridge so that vessels 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.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all waters of the Upper Mississippi River, surface to bottom, between mile 180.0 and 180.5. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during Lumiere Place Fireworks displays. During the periods of enforcement, no vessels may be located within the Coast Guard safety zone. Entry into this Coast Guard safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or other designated representative.
This rule is effective from 9:30 p.m. to 10:30 p.m. on August 29, 2015.
Documents mentioned in this preamble are part of docket USCG-2015-0704. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LCDR S.M. Peterson, Chief of Prevention, U.S. Coast Guard; telephone (314) 269-2332, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a
For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
A fireworks display is scheduled for August 29, 2015. This display will feature fireworks being launched from a barge located in the navigable channel between miles 180.0 and 180.5 on the Upper Mississippi River in the St. Louis Harbor. The Coast Guard determined that a safety zone is necessary to keep persons and property clear of any potential hazards associated with the launching of fireworks on or over the waterway.
The legal basis and authorities for this rule are found in 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation no. 0170.1, which collectively authorize the Coast Guard to establish and define safety zones.
The purpose of the rule is to establish the necessary temporary safety zone to provide protection for persons and property, including spectators, commercial and recreational vessels, and others that may be in the area during the noticed fireworks display times from the hazards associated with the fireworks display on and over the waterway.
The Coast Guard is establishing a temporary safety zone from 9:30 p.m. to 10:30 p.m. on August 29, 2015, for the Lumiere Place fireworks display. The fireworks will be launched from a barge located within the navigational channel and the safety zone will include all waters between Upper Mississippi River miles 180.0 and 180.5. The Coast Guard will enforce the temporary safety zone and may be assisted by other federal, state and local agencies and the Coast Guard Auxiliary. During the periods of enforcement, no vessels may transit into, through, or remain within this Coast Guard safety zone. Deviation from this safety zone may be requested by contacting the COTP Upper Mississippi River or other designated representative. Deviations will be considered on a case-by-case basis.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. This temporary final rule establishes a safety zone that will be enforced for a limited time period. During the enforcement period, vessels are prohibited from entering into or remaining within the safety zone unless specifically authorized by the COTP Upper Mississippi River or other designated representative. Based on the location, limited safety zone size, and short duration of the enforcement period, this rule does not pose a significant regulatory impact. Additionally, notice of this safety zone or any changes in the planned schedule will be made via Broadcast Notice to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts as appropriate. Deviation from this rule may be requested from the COTP Sector Upper Mississippi River and will be considered on a case-by-case basis.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This safety zone would be activated, and thus subject to enforcement, for only one hour. Although the safety zone would apply to the entire width of the river, traffic may be allowed to pass through the zone with the permission of the COTP. Before the activation of the zone, we would issue maritime advisories widely available to users of the river.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a temporary safety zone to protect persons and property from potential hazards associated with the scheduled Lumiere Place Fireworks display taking place on or over the Upper Mississippi River. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, AND 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Persons or vessels requiring entry into, departure from, or movement within a regulated area must request permission from the COTP Upper Mississippi River or a designated representative. They may be contacted on VHF-FM Channel 16, or through Coast Guard Sector Upper Mississippi River at (314) 269-2332.
(3) All persons and vessels shall comply with the instruction of the COTP Upper Mississippi River and designated on-scene personnel.
(d)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to
In this action, EPA is also finalizing its approval of a revision to the Missouri SIP to incorporate an amendment to an existing Missouri regulation to restrict lead emissions from specific sources. The amendment revises certain throughput and emissions limits applicable to the Buick Resource Recycling Facility (BRRF) in the Buick/Viburnum Trend lead nonattainment area. Approval of this rule ensures consistency between the state and Federally-approved rules, and ensures Federal enforceability of the revised state rule.
This final rule is effective on September 28, 2015.
EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2015-0223. All documents in the docket are listed on the
Stephanie Doolan, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7719, or by email at
Throughout this document “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:
In this document, EPA is granting final approval of Missouri's SIP for the lead NAAQS nonattainment area of Buick/Viburnum Trend. The applicable standard addressed in this action is the lead NAAQS promulgated by EPA in 2008 (73 FR 66964). EPA is also granting final approval to portions of a revision to the State of Missouri Code of State Regulations (CSR) 10-6.120, “Restriction of Emissions of Lead from Specific Lead Smelter-Refinery Installations”. This revision pertains to throughput limits applicable to the BRRF, which is the primary source of lead emissions in the Buick/Viburnum Trend nonattainment area. EPA's proposal containing the background information for this action can be found at 80 FR 30965, June 1, 2015.
The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of the docket, the revision meets the substantive SIP requirements of the CAA, including Section 110 and implementing regulations.
The public comment period on EPA's proposed rule opened June 1, 2015, the date of its publication in the
Comment 1: The commenter states that in the June 1, 2015, proposed approval that the nomenclature for the Buick/Viburnum Trend nonattainment area is inconsistent. Doe Run requests that the term “Buick/Viburnum Trend” be used throughout. Doe Run also states that the secondary lead smelter nomenclature is incorrectly stated as “the Doe Run Buick Resource Recycling Facility (BRRF)” and requests EPA to correct the nomenclature to use “The Buick Resource Recycling Facility (BRRF)” throughout.
Response 1: This comment recommends typographical corrections to the proposed rule that EPA has not relied upon in its decision making for this final action, and EPA is therefore not changing its final action based on this comment.
Comment 2: Doe Run states that the heading for section V.A.1. in the proposal is titled “BRRF Process Description,” but that it contains both the BRRF process description and a discussion of the mine activities. Doe Run requests that the section be retitled as “Buick/Viburnum Trend Process Description.”
Response 2: See Response 1.
Comment 3: Doe Run notes that section V.A.1. states “BRRF operates as a secondary smelter of lead, lead-containing materials including spent lead acid batteries, lead bullets and shot, lead-containing glass from cathode ray tubes, and lead-based paint chips from lead abatement projects.” Doe Run requests that the statement be revised to more accurately reflect the facility operations by stating that “BRRF operates as a secondary lead smelter of lead, utilizing lead-containing materials including spent lead acid batteries, lead bullets and shot, lead-containing glass from cathode ray tubes, lead-based paint chips from lead abatement projects, and other lead bearing materials.”
Response 3: EPA notes that the process information provided in section V of the proposal was reproduced from Missouri's attainment SIP which was made available for a 30-day public comment period before the document was submitted to EPA. EPA appreciates this comment as it clarifies process-related information. However, this comment does not substantively impact the decision to approve the attainment SIP, and EPA is therefore not changing its proposed action based on this comment.
Comment 4: Doe Run notes that in the first paragraph of section V.A.1., EPA states that “Crushed and concentrated lead containing ore was formerly processed at the Herculaneum primary lead smelter, but since that facility ceased primary lead smelting in December 2013, the ore gets shipped out of the U.S. for overseas processing.” Doe Run requests this statement to instead read, “The processed ore, called lead concentrate was formerly processed at the Herculaneum primary lead smelter, but since that facility ceased primary
Response 4: Please see Response 3.
Comment 5: Doe Run requests that EPA revise the third paragraph of section V.A.1. from “BRRF's production is limited to 175,000 tons of total lead production each year . . .” to “175,000 tons of total
Response 5: EPA disagrees. Section V.A.1. refers to the lead production limit in Missouri regulation 10 Code of State Regulation (CSR) 10-6.120, which states that “This installation [BRRF] shall limit total lead production to one hundred seventy-five thousand (175,000) tons per year.” 10 CSR 10-6.120 does not make a distinction between total lead production and total refined lead production.
Comment 6: In paragraph three of section V.A.1., EPA states that “Spent batteries are stored in a battery bunker until processed in a shredder.” Doe Run requests that the statement read: “Spent batteries are stored in the containerized storage area until processed in the battery shredder.”
Response 6: Please see Response 3.
Comment 7: In section V.A.1., EPA states that “The batteries further undergo a separation process under which the lead and metal parts are separated from the plastic and other debris.” Doe Run requests that this statement be revised as follows: “The batteries further undergo a separation process under which the lead and metal parts are separated from the plastic and other materials.” Doe Run also requests EPA to change “The plastic and other debris are skimmed off and sent to recycling facilities” to “The plastic is skimmed off and sent to recycling facilities.”
Response 7: Please see Response 3.
Comment 8: In section V.A.1, the fifth paragraph states that “The lead sulfate paste is passed through a filter press and neutralized with hydrated lime to form calcium sulfate . . .” Doe Run requests that this statement be revised to read: “The lead sulfate paste is passed through a filter press . . .”
Response 8: Please see Response 3.
Comment 9: Regarding the first paragraph in section V.A.2, Doe Run disagrees with EPA's statement that the annual lead emissions from the Casteel Mine and the K & D Crushing Operations are “significant” to the total emissions of 18.34 tons per year. Doe Run further requests a change in EPA's statement from “processing of lead containing rock until it becomes wet concentrate that is shipped to other customers,” to “processing of lead containing rock to produce lead concentrate to be shipped to customers.”
Response 9: The commenter makes two separate comments in its “Ninth” comment per the progression of its comment letter. For consistency in numbering, EPA is also addressing these comments together.
Regarding Doe Run's comment that the Casteel Mine and the K & D Crushing Operations are not “significant” to the total emissions of 18.34 tons per year, EPA disagrees. In Section 3, Emissions Inventory, of Missouri's attainment SIP, four facilities, including the Casteel Mine and K & D Crushing, are listed that reported more than 0.01 tpy lead for inventory years 2009 through 2011. Missouri has determined that these facilities are significant and required modeling in order to determine their impacts at the monitor. This comment does not substantively impact the decision to approve the attainment SIP, and EPA is therefore not changing its proposed action based on this comment.
As summarized above, Doe Run has commented on the wording of the third sentence in the first paragraph of section V.A.2. Please see Response 1.
Comment 10: In the third paragraph of section V.A.2, EPA states that “At the Buick Mine and Mill, ore is hauled from the active mining faces to a central crusher where it is crushed . . .” Doe Run requests this sentence to be revised to state, “At the Buick Mine and Mill, ore is hauled from the active mining faces to an
Additionally, in this same paragraph, EPA states that “After being crushed aboveground to less than
Response 10: Please see Response 1.
Comment 11: In the fourth paragraph of section V.A.2., EPA states “As stated above, the Herculaneum facility ceased operations smelting operations in December 2013; thus, the concentrate is shipped overseas to primary lead smelting operations or other customers.” Doe Run requests this sentence be revised to state “As stated above, the Herculaneum facility ceased smelting operations in December 2013; thus, the concentrate is shipped overseas to customers' primary lead smelting operations or other customers.”
Response 11: Please see Response 1.
Comment 12: Doe Run commented that “mg/m
Response 12: EPA checked the
Comment 13: Section V.D.f. states that “By February 4, 2013, install a dry lime SO
Response 13: EPA agrees but notes that the requirement is not in the Consent Decree but rather is found in paragraph V, item 6.F. of the 2013 Consent Judgment (appendix M of the attainment SIP). As stated in the proposal, Section V.D. contains a brief discussion of the control measures. This comment further describes those control measures, but does not substantively impact the decision to approve the attainment SIP, and EPA is therefore not changing its proposed action based on this comment.
Comment 14: Doe Run comments that section V.D.i. references item a.; however, it should reference item b.
Response 14: EPA agrees. EPA notes that Section 5.1, Consent Judgment Measures, of Missouri's attainment SIP also references item A. However, as depicted in the process flow diagram on page A-7 in Appendix A of Missouri's attainment SIP, for the reverberatory furnace, EPA notes that Doe Run is correct; the Dry Scrubber Baghouse CD37 follows the exit gases from the reverberatory furnace and is not part of the South Refinery described in item a. (depicted on page A-9 of Missouri's attainment SIP). This comment does not substantively impact the decision to approve the attainment SIP, and EPA is therefore not changing its proposed action based on this comment.
Comment 15: Section V.D.j. states that “By October 31, 2014, install “batwing” style ventilation covers to improve . . .” Doe Run requests that this language be revised to state “By October 31, 2014, install “batwing” style ventilation covers, or covers with equivalent or better capture efficiency to improve . . .”
Response 15: As stated in the proposal, Section V.D. contains a brief discussion of the control measures. This comment further describes those control measures, but does not substantively
Comment 16: The fourth paragraph of section V. E. refers to the “mines and mills.” The statement should be revised to refer specifically to the “Buick Mine and Mill and the Casteel Mine.”
Response 16: Please see Response 1.
Comment 17: In section V.H.a., EPA states that the negative pressure requirement is in “inches Hg.” Doe Run comments that the correct units are “mm Hg.”
Response 17: Please see Response 1.
Comment 18: Doe Run requests EPA to refer in the first paragraph of section VI.B.to the limits of Missouri regulation 10-6.120 as “175,000 tons of
Response 18: With regard to 10 CSR 10-6.120, please see Response 5. With regard to the use the words “lead” and “Pb,” interchangeably, please see Response 1.
Comment 19: In the third paragraph of section VI.B., EPA states that “The modeled total emissions in the attainment demonstration SIP are 176,482 tons of Pb produced per year.” Doe Run requests that this sentence be revised to state “The modeled total emissions in the attainment demonstration SIP are
Response 19: EPA agrees that the sentence should indicate that the “modeled total emissions in the attainment demonstration SIP are based on 176,482 tons of lead produced per year. As discussed above in Responses 5 and 18, the language “refined” is not found in the Missouri regulation.
EPA is taking final action to amend the Missouri SIP to approve Missouri's SIP for the Buick/Viburnum Trend lead NAAQS nonattainment area near Boss, Missouri. The applicable standard addressed in this action is the lead NAAQS promulgated by EPA in 2008 (73 FR 66964). EPA is also granting final approval to portions of a revision to the State of Missouri CSR 10-6.120, “Restriction of Emissions of Lead from Specific Lead Smelter-Refinery Installations”.
In this action, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Missouri Rule 10 CSR 10-6.120 (with the exclusions of Paragraph 10-6.120 (3)(B)1. and Table 1, and the 0.00087 gr/dscf main stack emissions limit for BRRF) described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). This action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
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).
This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). Thus Executive Order 13132 does not apply to this action. This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rulemaking also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) because it approves a state rule implementing a Federal standard.
In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a state submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA when it reviews a state submission, to use VCS in place of a state submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Congressional Review Act, 5 U.S.C. 801
A major rule cannot take effect until 60 days after it is published in the
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 27, 2015. Filing a petition for reconsideration by the Administrator of this proposed rule does not affect the finality of this rulemaking 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
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:
42 U.S.C. 7401
(c) * * *
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
Michigan applied to the Environmental Protection Agency (EPA) for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). On March 31, 2015, EPA published a proposed rule to authorize the changes and opened a public comment period under Docket ID No. EPA-R05-RCRA-2014-0689. The comment period closed on June 1, 2015. EPA received no comments on the proposed rule. EPA has decided that the changes to Michigan's program satisfy all requirements necessary to qualify for final authorization, and EPA is
Final authorization for the changes to the hazardous waste program in Michigan will be effective at 1 p.m. EST on August 28, 2015.
Judith Greenberg, U.S. EPA, Region 5, Land and Chemicals Division, 77 West Jackson Blvd., Mail Code LR-8J, Chicago, Illinois 60604, email:
States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the federal program. As the federal program changes, states must change their programs and ask EPA to authorize the changes. Changes to state programs may be necessary when federal or state statutory or regulatory authority is modified or when certain other changes occur. Most commonly, states must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 266, 268, 270, 273 and 279.
EPA has made a final determination that Michigan's revisions to its authorized hazardous waste management program meet all of the statutory and regulatory requirements established by RCRA for authorization. Therefore, EPA is authorizing the revised State of Michigan hazardous waste management program, as described in the Attorney General's Statement in the June 2014 authorization revision application, and as discussed in section E of this rule. Michigan has responsibility for permitting treatment, storage and disposal facilities (TSDFs) within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program covered by its revised program application, subject to the limitations of RCRA, including the Hazardous and Solid Waste Amendments of 1984 (HSWA). New federal requirements and prohibitions imposed by federal regulations that EPA promulgates under the authority of HSWA take effect in authorized states before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in Michigan, including issuing permits, until the State is granted authorization to do so.
Michigan's hazardous waste management program received final authorization effective on October 16, 1986 (51 FR 36804-36805, October 16, 1986). Subsequently, EPA authorized revisions to the State's program effective January 23, 1990 (54 FR 48608, November 24, 1989); January 24, 1991 (56 FR 18517, January 24, 1991); November 30, 1993 (58 FR 51244, October 1, 1993); January 13, 1995 (60 FR 3095, January 13, 1995); April 8, 1996 (61 FR 4742, February 8, 1996); November 14, 1997 (62 FR 61775, November 14, 1997); June 1, 1999 (64 FR 10111, March 2, 1999); July 31, 2002 (67 FR 49617, July 31, 2002); March 9, 2006 (71 FR 12141, March 9, 2006); January 7, 2008 (73 FR 1077, January 7, 2008); and March 2, 2010 (75 FR 9345, March 2, 2010).
The effect of this decision is that a facility in Michigan subject to RCRA has to comply with the authorized state requirements in lieu of the corresponding federal requirements in order to comply with RCRA, and those authorized requirements will be federally enforceable. Additionally, such persons must comply with any applicable federal requirements, such as, for example, HSWA requirements issued by EPA for which the state has not received authorization, and RCRA requirements that are not supplanted by authorized state-issued requirements. Michigan continues to have enforcement responsibilities under its state hazardous waste program for violations of such program, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, and any other applicable statutory and regulatory provisions, which include, among others, authority to:
• Perform inspections; require monitoring, tests, analyses or reports;
• Enforce RCRA requirements; suspend, terminate, modify or revoke permits; and
• Take enforcement actions regardless of whether the State has taken its own actions.
This final action approving these revisions does not impose additional requirements on the regulated community because the regulations for which Michigan is authorized are already effective under state law and are not changed by EPA's final action.
This final rule addresses a program revision application that Michigan submitted to EPA in June 2014, in accordance with 40 CFR 271.21, seeking authorization of changes to the state program. On March 31, 2015, EPA published a proposed rule (80 FR 17021) stating the Agency's intent to grant final authorization for revisions to Michigan's hazardous waste management program. The public comment period on this proposed rule ended on June 1, 2015. EPA received no comments during the public comment period.
EPA has determined that Michigan's changes to its program satisfy all of the requirements necessary to qualify for final authorization. With this final action, EPA authorizes Michigan for the following federal rules (a table with a list of the State analogs is provided in the March 31, 2015, proposed rule) and the following state-initiated changes:
• NESHAP: Final Standards for Hazardous Waste Combustors (Phase I Final Replacement Standards and Phase II) Amendments, 73 FR 18970, April 8, 2008, Checklist 217.
• F019 Exemption for Wastewater Treatment Sludges from Auto Manufacturing Zinc Phosphating Processes, June 4, 2008, 73 FR 31756, Checklist 218.
• Academic Laboratories Generator Standards, December 1, 2008, 73 FR 72912, Checklist 220.
• OECD Requirements: Export Shipments of Spent Lead-Acid Batteries, January 8, 2010, 75 FR 1236, Checklist 222.
• Hazardous Waste Technical Corrections and Clarifications Rule, as amended, March 16, 2010, 75 FR 12989; and June 4, 2010, 75 FR 31716, Checklist 223.
• Removal of Saccharin and Its Salts, December 17, 2010, 75 FR 78918, Checklist 225.
• Corrections to the Academic Generator Standards, December 20, 2010, 75 FR 79304, Checklist 226.
• Revisions of the Treatment Standards for Carbamate Wastes, June 13, 2011, 75 FR 34147, Checklist 227.
• Hazardous Waste Technical Corrections and Clarifications, April 13, 2012, 77 FR 22229, Checklist 228.
• Equivalent state-initiated changes:
Michigan administrative rules R 299.9102 (definition of “construction permit” removed), R 299.9106(e) (definition of “operating license” modified), R 299.9224, R 299.9225, R 299.9304(2)(b), R 299.9409(4), R 299.9501 (except second sentence only of paragraph (3)(d)), R 299.9505, R 299.9524, R 299.9603, R 299.9604(2), R 299.9605, R 299.9609, R 299.9610(3), R 299.9612, R 299.9615, R 299.9616, R 299.9623, R 299.9629, R 299.9640, R 299.9707, R 299.9708, R 299.9808, and R 299.9821, effective November 5, 2013.
The most significant differences between the state rules we are authorizing and their analogous federal rules are summarized below. It should be noted that this summary does not describe every difference or every detail regarding the differences that are described. Members of the regulated community are advised to read the complete rules to ensure that they understand the requirements with which they will need to comply.
EPA has found that aspects of the Michigan program are more stringent than the federal program. All of these more stringent requirements are part of the federally enforceable RCRA program authorized by the EPA and must be complied with in addition to the state requirements which track the minimum federal requirements. These more stringent requirements are found at:
Michigan's rules at (references are to the Michigan Administrative Code):
R 299.9601(1), (2), (2)(b), (c), (d), (e), (f), (g), (h) and (i); R 299.9608(1), (6) and (8); R 299.9615; and R 299.9702(1) are more stringent than the federal analogs at 40 CFR §§ 265.56(b), 265.71, 265.72, 265.142(a), 265.174, 265.190(a), 265.193, 265.194, 265.197, 265.201, and 265.340(b)(1) since the State rules include provisions that require compliance with standards equivalent to 40 CFR part 264 rather than 40 CFR part 265.
Michigan's rules at R 299.9601(2)(a) and R 299.9602 are more stringent since the rules impose requirements regarding environmental and human health standards generally.
Michigan's rules at R 299.9615(4) are more stringent since the State rules require tank systems to also comply with Michigan 1941 Act 207 standards (which govern above-ground storage tanks).
Michigan's rules at R 299.9623(9) are more stringent since the State rules require incinerators to comply with Michigan Part 55 standards (which address air pollution).
Michigan does not allow containment buildings, making the state requirements more stringent than the federal requirements at 40 CFR 262.10(f), (k)(1) and (k); 262.11(d); 262.41(b); 263.12; 40 CFR part 264 subpart DD; 40 CFR 265 subpart DD; and 40 CFR part 264 appendix I, Tables 1 and 2.
Michigan's rules at R 299.9629(7)-(7)(c) are more stringent, since the State rules require (1) timely notification of an exceedance of a groundwater/surface water interface standard based on acute toxicity and established pursuant to part 201 and part 31 of Act 451; and (2) implementation of interim measures to prevent exceedance at the monitoring wells along with a proposal and schedule for completing corrective action to prevent a discharge that exceeds the standard.
Michigan's rules at R 299.11002(1) and (2) are more stringent than the federal analogs at 40 CFR 260.11(d) and (d)(1) since the State adopts updated versions of the “Flammable and Combustible Liquids Code.”
EPA has also found that aspects of Michigan's revised program are broader in scope than the federal program. State provisions that EPA determines are broader in scope are not part of the federally authorized program and are not federally enforceable. Michigan's program revisions include the following rules that are broader in scope than the federal program (references are to the Michigan Administrative Code): R 299.9226, R 299.9501(3)(d) (second sentence only) and R 299.9507, as amended effective November 5, 2013.
The following Michigan administrative rules that were broader in scope than the federal program were rescinded effective November 5, 2013: R 299.9221 (Table 203b), R 299.9223 (Table 204b), R 299.9904, R 299.9905, R 299.9906, and R 299.11101, R 299.11102, R 299.11103, R 299.11104, R 299.11105, R 299.11106, and R 299.11107.
EPA does not authorize States to administer federal import and export functions in any section of the RCRA hazardous waste regulations. Although states do not receive authorization to administer the federal government's import and export functions, found in 40 CFR part 262, subparts E, F and H, state programs are still required to adopt the federal import and export provisions to maintain their equivalency with the federal program. The State amended the following state import and export rules to include the federal rule on Organization for Economic Cooperation and Development (OECD) Requirements; Export Shipments of Spent Lead-Acid Batteries (75 FR 1236, January 8, 2010): R 299.9301(7); R 299.9309(1), (3) and (4); R 299.9312(1) and (2); R 299.9401(5); R 299.9601(2)(c), (3) and (9); R 299.9605(1) and (4); R 299.9608(1), (4) and (8); R 299.9804(7) and (8); and R 299.11003(1)(k), (m), (n) and (p) and (2).
Michigan will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which EPA issued prior to the effective date of the final authorization until they expire or are terminated. EPA will not issue any more new permits or new portions of permits for the provisions listed above after the effective date of the final authorization. EPA will continue to implement and issue permits for HSWA requirements for which Michigan is not yet authorized.
Michigan is not authorized to carry out its hazardous waste program in Indian Country within the State, as
1. All lands within the exterior boundaries of Indian reservations within the State of Michigan;
2. Any land held in trust by the U.S. for an Indian tribe; and
3. Any other land, whether on or off an Indian reservation that qualifies as Indian Country.
Therefore, authorizing Michigan for these revisions does not affect Indian Country in Michigan. EPA continues to implement and administer the RCRA program in Indian Country. It is EPA's long-standing position that the term “Indian lands” used in past Michigan hazardous waste approvals is synonymous with the term “Indian Country.”
Codification is the process of placing a state's statutes and regulations that comprise a state's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized state rules in 40 CFR part 272. Michigan's rules, up to and including those revised October 19, 1991, have previously been codified through incorporation-by-reference effective April 24, 1989 (54 FR 7421, February 21, 1989); as amended effective March 31, 1992 (57 FR 3724, January 31, 1992). We reserve the amendment of 40 CFR part 272, subpart X, for the codification of Michigan's program changes until a later date.
This proposed rule only authorizes hazardous waste requirements pursuant to RCRA section 3006 and imposes no requirements other than those imposed by state law (see
The Office of Management and Budget has exempted this rule from its review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821 January 21, 2011).
This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This rule authorizes state requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those required by state law. Accordingly, I certify that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it 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).
Executive Order 13132 (64 FR 43255, August 10, 1999) does not apply to this rule because it will not have federalism implications (
Executive Order 13175 (65 FR 67249, November 9, 2000) does not apply to this rule because it will not have tribal implications (
This rule is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant as defined in Executive Order 12866 and because the EPA does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
This rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action as defined in Executive Order 12866.
EPA approves state programs as long as they meet criteria required by RCRA, so it would be inconsistent with applicable law for EPA, in its review of a state program, to require the use of any particular voluntary consensus standard in place of another standard that meets the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply to this rule.
As required by Section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct.
EPA has complied with Executive Order 12630 (53 FR 8859, March 18, 1988) by examining the takings implications of the rule in accordance with the Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings issued under the executive order.
Because this rule proposes authorization of pre-existing state rules and imposes no additional requirements beyond those imposed by state law and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994).
EPA will submit a report containing this rule and other information required by the Congressional Review Act (5 U.S.C. 801
Environmental protection; Administrative practice and procedure; Confidential business information; Hazardous materials transportation; Hazardous waste; Indians—lands; Intergovernmental relations; Penalties; Reporting, and Recordkeeping requirements.
This action is issued under the authority of Sections 2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912(a), 6926, 6974(b).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; notice of adjusted 2015 Purse Seine and Reserve category quotas.
NMFS hereby modifies the baseline annual U.S. quota and subquotas for Atlantic bluefin tuna (BFT). Specifically for 2015, NMFS augments the Reserve category quota with available underharvest of the 2014 adjusted U.S. BFT quota and also recalculates the Purse Seine and Reserve category quotas that were announced earlier this year (consistent with the Amendment 7 annual reallocation process) to reflect the increased U.S. quota. Furthermore, NMFS makes minor modifications to the regulations regarding Atlantic tunas purse seine auxiliary vessel activity under the “transfer at sea” provisions. This action is necessary to implement binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT), as required by the Atlantic Tunas Convention Act (ATCA), and to achieve domestic management objectives under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Effective September 26, 2015.
Supporting documents such as the Environmental Assessments and Fishery Management Plans described below may be downloaded from the HMS Web site at
Sarah McLaughlin or Brad McHale, 978-281-9260.
Atlantic bluefin tuna, bigeye tuna, albacore tuna, yellowfin tuna, and skipjack tuna (hereafter referred to as “Atlantic tunas”) are managed under the dual authority of the Magnuson-Stevens Act and ATCA. As an active member of ICCAT, the United States implements binding ICCAT recommendations. ATCA authorizes the Secretary of Commerce (Secretary) to promulgate regulations, as may be necessary and appropriate to carry out ICCAT recommendations. The authority to issue regulations under the Magnuson-Stevens Act and ATCA has been delegated from the Secretary to the Assistant Administrator for Fisheries, NMFS.
Background information about the need to modify the U.S. BFT base quota and the subquotas for all domestic fishing categories, as well as the regulatory text regarding Atlantic tunas purse seine auxiliary vessel activity under the “transfer at sea” provisions, were provided in the preamble to the proposed rule (80 FR 33467, June 12, 2015) and most of that information is not repeated here.
In this final rule, NMFS is changing text at § 635.27(a)(4)(ii), to reflect the equal allocation of the baseline Purse Seine category quota that is finalized in this action among the five individual Purse Seine category participants. NMFS inadvertently omitted this calculation in the regulatory text for the proposed rule. Specifically, in the proposed rule, NMFS proposed updating the baseline Purse Seine quota to 184.3 mt (§ 635.27(a)(4)(i)) to reflect the increased U.S. quota. However, NMFS did not carry this change through to the codified text in § 635.27(a)(4)(ii) to reflect the division of that Purse Seine category quota equally among the five individual Purse Seine fishery participants. The existing regulatory text specifies that annually, NMFS will make equal allocations of the baseline Purse Seine category quota described under paragraph (a)(4)(i) of the section to individual Purse Seine participants. To reflect the increase in the baseline Purse Seine category quota to 184.3 mt for each Purse Seine category participant, NMFS is updating the amount in the regulatory text at § 635.27(a)(4)(ii) to 36.9 mt (
At its November 2014 meeting, ICCAT adopted a western Atlantic BFT TAC of 2,000 mt annually for 2015 and 2016 after considering the results of the 2014 BFT stock assessment and following negotiations among Contracting Parties (ICCAT Recommendation 14-05). This TAC, which is an increase from the 1,750-mt TAC that has applied annually since 2011, is consistent with scientific advice from the 2014 stock assessment, which indicated that annual catches of less than 2,250 mt would have a 50-percent probability of allowing the spawning stock biomass to be at or above its 2013 level by 2019 under either recruitment scenario, and that annual catches of 2,000 mt or less would continue to allow stock growth under both the low and high recruitment scenarios for the remainder of the rebuilding program. All TAC, quota, and weight information discussed in this notice are whole weight amounts.
For 2015 and 2016, the ICCAT Recommendation also makes the following allocations from the western BFT 2,000-mt TAC for bycatch related to directed longline fisheries in the Northeast Distant gear restricted area (NED): 15 mt for Canada and 25 mt for the United States. Following subtraction of these allocations from the TAC, the recommendation allocates the remainder to the United States (54.02 percent), Canada (22.32 percent) Japan (17.64 percent), Mexico (5.56 percent), UK (0.23 percent), and France (0.23 percent). For the United States, 54.02 percent of the remaining 1,960 mt is 1,058.79 mt annually for 2015 and 2016. This represents an increase of approximately 135 mt (approximately 14 percent) from the U.S. baseline BFT
As a method for limiting fishing mortality on juvenile BFT, ICCAT continued to recommend a tolerance limit on the annual harvest of BFT measuring less than 115 cm (straight fork length) to no more than 10 percent by weight of a Contracting Party's total BFT quota over the 2015 and 2016 fishing periods. The United States implements this provision by limiting the harvest of school BFT (measuring 27 to less than 47 inches (68.5 to less than 119 cm curved fork length)) as appropriate to not exceed the 10-percent limit over the two-year period.
The table below shows the final baseline quotas and subquotas that result from applying the process established in Amendment 7 to the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan (Amendment 7) to the higher U.S. BFT quota that ICCAT recommended in 2014. These quotas are codified at § 635.27(a) and will remain in effect until changed (for instance, if any new ICCAT western BFT TAC recommendation is adopted). Because ICCAT adopted TACs for 2015 and 2016 in Recommendation 14-05, NMFS currently anticipates that these annual base quotas would be in effect through 2016, but they will remain in place unless and until a new TAC is adopted by ICCAT.
The proposed rule described how Amendment 7 also changed the way that NMFS adjusts the U.S. annual quota for any previous year's underharvest. Rather than publishing proposed and final quota specifications annually to adjust the quota for the underharvest as NMFS has in the past, NMFS will automatically augment the Reserve category quota to the extent that underharvest from the previous year is available. Such adjustment will be consistent with ICCAT limits and will be calculated when complete BFT catch information for the prior year is available and finalized. Consistent with the quota regulations, NMFS may allocate any portion of the Reserve category quota for inseason or annual adjustments to any fishing category quota pursuant to regulatory determination criteria described at 50 CFR 635.27(a)(8), or for scientific research.
In the proposed rule, NMFS stated that the preliminary 2014 landings and dead discard estimate (
Consistent with the process adopted in the Amendment 7 implementing regulations, NMFS calculated at the beginning of the year the quota available to individual Atlantic Tunas Purse Seine category fishery participants for 2015 based on BFT catch (landings and dead discards) by those fishery participants in 2014. Based on that information, 87.4 mt of the baseline Purse Seine category quota of 159.1 mt was reallocated to the Reserve category for the 2015 fishing year. This process resulted in a total of 71.7 mt for Purse Seine fishery participants for 2015 and 108.8 mt (
NMFS recently implemented two inseason transfers from the Reserve category for 2015 (34 mt to the Longline category and 40 mt to the Harpoon category), so the adjusted 2015 Reserve category quota as of publication of this action, including the allowable underharvest described above, would be 24.8−34−40 + 101.4 + 94.9 = 147.1 mt (80 FR 45098, July 29, 2015 and 80 FR 46516, August 5, 2015, respectively).
Currently, HMS regulations specify that an owner or operator of a vessel for which an Atlantic Tunas Purse Seine category permit has been issued may transfer large medium and giant BFT at sea from the net of the catching vessel to another vessel for which an Atlantic Tunas Purse Seine category permit has been issued, provided the amount transferred does not cause the receiving vessel to exceed its currently authorized vessel allocation, including incidental catch limits. NMFS is making minor modifications to this regulatory text to clarify that this text was not meant to allow “transfer at sea,” which clearly is prohibited by ICCAT Recommendation 14-05, but is only meant to allow the routine, limited operations of an auxiliary vessel (
NMFS received two written comments on the proposed rule, as well as two verbal comments through the public conference call/webinar. Few of the comments NMFS received focused specifically on the proposed rule. Below, NMFS summarizes and responds to all comments made specifically on the proposed rule during the comment period. The comments that were outside the scope of this rule are summarized under “Other Issues” below.
In addition to the above comments specifically on the content of the proposed rule, other commenters raised
Although outside the scope of this rulemaking, NMFS is noting here that it carefully considers the regulatory determination regarding inseason adjustments before making an inseason quota transfer. These criteria include the effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments. Thus, NMFS would consider, among other things, how such a transfer would optimize fishing opportunity and contribute to full accounting for landings and dead discards, while still supporting the broader objectives of the fishery management plan. NMFS considered these and other requisite factors in its recently published inseason action transferring 34 mt of quota from the Reserve to the Longline category (80 FR 45098, July 29, 2015). NMFS will report on the progress of Amendment 7 implementation (including the IBQ program and vessel catch reporting) at upcoming meetings of the HMS Advisory Panel, and these presentations and transcripts will be publically accessible through the HMS Web site (see
The NMFS Assistant Administrator has determined that this final rule is consistent with the 2006 Consolidated HMS FMP and its amendments, the Magnuson-Stevens Act, ATCA, and other applicable law.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
In compliance with section 604 of the Regulatory Flexibility Act (RFA), a Final Regulatory Flexibility Analysis (FRFA) was prepared for this rule. The FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS responses to those comments, and a summary of the analyses completed to support the action. The full FRFA and analysis of economic and ecological impacts are available from NMFS (see
In compliance with section 604(a)(1) of the Regulatory Flexibility Act, the purpose of this rulemaking is, consistent with the 2006 Consolidated HMS FMP objectives, the Magnuson-Stevens Act, and other applicable law, to analyze the impacts of the alternatives for implementing and allocating the ICCAT-recommended U.S. quota for 2015 and 2016; and to clarify the purse seine transfer at sea regulations for Atlantic tunas.
Section 604(a)(2) of the RFA requires agencies to summarize significant issues raised by the public in response to the IRFA, a summary of the agency's assessment of such issues, and a statement of any changes made as a result of the comments. NMFS received a few comments on the proposed rule (80 FR 33467, June 12, 2015) during the comment period. A summary of these comments and the Agency's responses are included in Section 13 of the EA/RIR/FRFA and are included in this final rule. However, NMFS did not receive comment specifically on the IRFA.
Section 604(a)(3) of the RFA requires agencies to provide an estimate of the number of small entities to which the rule would apply. The Small Business Administration (SBA) has established size criteria for all major industry sectors in the United States, including fish harvesters. This final rule is expected to directly affect commercial and for-hire fishing vessels that possess an Atlantic Tunas permit or Atlantic HMS Charter/Headboat permit. In general, the HMS Charter/Headboat category permit holders can be regarded as small entities for RFA purposes. HMS Angling (recreational) category permit holders are typically obtained by individuals who are not considered small entities for purposes of the RFA. The SBA has established size criteria for all major industry sectors in the United States including fish harvesters (79 FR 33647; June 12, 2014). A business involved in fish harvesting is classified as a “small business” if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts (revenue) not in excess of $20.5 million for all of its affiliated operations worldwide (NAICS code 114111, finfish fishing). NAICS is the North American Industry Classification System, a standard system used by business and government to classify business establishments into industries, according to their economic activity. The United States government developed NAICS to collect, analyze, and publish data about the economy. In addition, the SBA has defined a small charter/party boat entity (NAICS code 487210, for-hire) as one with average annual receipts (revenue) of less than $7.5 million.
As described in the final rule to implement Amendment 7 to the 2006 Consolidated HMS FMP (79 FR 71510, December 2, 2014), the average annual gross revenue per active pelagic longline vessel was estimated to be $187,000 based on the 170 active vessels between 2006 and 2012 that produced an estimated $31.8 million in revenue annually. The maximum annual revenue for any pelagic longline vessel during that time period was less than $1.4 million, well below the SBA size threshold of $20.5 million in combined annual receipts. Therefore, NMFS considers all Atlantic Tunas Longline category permit holders to be small entities. NMFS is unaware of any other Atlantic Tunas category permit holders that potentially could earn more than $20.5 million in revenue annually. NMFS is also unaware of any charter/headboat businesses that could exceed the $7.5 million thresholds for those small entities. HMS Angling category permit holders are typically obtained by individuals who are not considered small entities for purposes of the RFA. Therefore, NMFS considers all Atlantic Tunas permit holders and HMS Charter/Headboat permit holders subject to this action to be small entities.
This action would apply to all participants in the Atlantic BFT fishery,
NMFS has determined that this action would not likely directly affect any
Under section 604(a)(4) of the Regulatory Flexibility Act, agencies are required to describe any new reporting, record-keeping, and other compliance requirements. There are no new reporting or recordkeeping requirements in any of the alternatives considered for this action.
Under section 604(a)(5) of the RFA, agencies are required to describe any alternatives to the rule which accomplish the stated objectives and which minimize any significant economic impacts. These alternatives and their impacts are discussed below. Additionally, the Regulatory Flexibility Act (5 U.S.C. 603 (c) (1)-(4)) lists four general categories of significant alternatives that would assist an agency in the development of significant alternatives. These categories of alternatives include: (1) Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) use of performance rather than design standards; and, (4) exemptions from coverage of the rule for small entities.
In order to meet the objectives of this rule, consistent with the Magnuson-Stevens Act, ATCA, and the ESA, NMFS cannot exempt small entities or change the reporting requirements only for small entities because all the entities affected are considered small entities. Thus, no alternatives are discussed that fall under the first and fourth categories described above. Amendment 7 implemented criteria for determining the availability of quota for Purse Seine fishery category participants and IBQs for the Longline category. Both of these and the eligibility criteria for IBQs and access to the Cape Hatteras GRA for the Longline category can be considered individual performance standards. NMFS has not yet found a practical means of applying individual performance standards to the other quota categories while, concurrently, complying with the Magnuson-Stevens Act. Thus, there are no alternatives considered under the third category. In this rulemaking, NMFS analyzed two quota implementation alternatives: First, the status quo U.S. baseline quota and quotas established in 2011, and second, the preferred alternative to implement the U.S. quota to domestic categories in accordance with the 2014 ICCAT Recommendation, Amendment 7, and implementing regulations. NMFS considered a third quota alternative, which would use an allocation scheme other than the one recently established in Amendment 7 for the purpose of implementing BFT fishing category subquotas, but did not analyze this alternative further because it would not satisfy the purpose and need of the action (
NMFS has estimated the average impact that establishing the increased baseline annual U.S. BFT quota for all domestic fishing categories would have on each quota category and the vessels within those categories. As mentioned above, the 2014 ICCAT recommendation increased the annual U.S. baseline BFT quota for each of 2015 and 2016 to 1,058.79 mt and provides 25 mt annually for incidental catch of BFT related to directed longline fisheries in the NED. The baseline annual subquotas would be adjusted consistent with the process established in Amendment 7 (79 FR 71510, December 2, 2014), and these amounts would be codified.
To calculate the average ex-vessel revenues under this action, NMFS first estimated potential category-wide revenues. The most recent ex-vessel average price per pound information for each commercial quota category is used to estimate potential ex-vessel gross revenues under each of the subquotas (
No affected entities would be expected to experience negative, direct economic impacts as a result of the preferred alternative. On the contrary, each of the quota categories would increase relative to the baseline quotas that applied in 2011 through 2014 and the quotas finalized in Amendment 7. To the extent that Purse Seine fishery participants and IBQ participants could receive additional quota as a result of Amendment 7-implemented allocation formulas being applied to increases in available Purse Seine and Longline category quota, those participants would receive varying increases, which would result in direct benefits from either increased fishing opportunities or quota leasing.
To estimate potential average ex-vessel revenues that could result from this action, NMFS divides the potential annual gross revenues for the General, Harpoon, Purse Seine, and Trap category by the number of permit holders. For the Longline category, NMFS divides the potential annual gross revenues by the number of active vessels as defined in Amendment 7. This is an appropriate approach for BFT fisheries, in particular because available landings data (weight and ex-vessel value of the fish in price-per-pound) allow NMFS to calculate the gross revenue earned by a fishery participant on a successful trip. The available data (particularly from non-Longline participants) do not, however, allow NMFS to calculate the effort and cost associated with each successful trip (
Success rates vary widely across participants in each category (due to extent of vessel effort and availability of commercial-sized BFT to participants where they fish) but for the sake of estimating potential revenues per vessel, category-wide revenues can be divided by the number of permitted vessels in each category. For the Longline fishery, the number of permits authorized for IBQ shares is used, and actual revenues would depend, in part, on each vessel's IBQ in 2015. Although HMS Charter/Headboat vessels may fish commercially under the General category quota and retention limits, because it is unknown what portion of HMS Charter/Headboat permit holders actively participate in the BFT fishery, NMFS is estimating potential General category ex-vessel revenue changes using the number of General category vessels only.
Estimated potential 2015 revenues on a per vessel basis, considering the number of permit holders listed above and the final subquotas, could be $2,441 for the General category; $43,703 for the Harpoon category; $387,618 for the Purse Seine category; $12,549 for the Longline category, using the 136 permits authorized for IBQ shares; and $3,836 for the Trap category. Thus, all of the entities affected by this rule are considered to be small entities for the purposes of the RFA.
Consistent with Amendment 7 regulations, NMFS calculated the quota available to Purse Seine fishery participants for 2015 and then reallocated the remaining 87.4 mt of available Purse Seine category quota to the Reserve category (80 FR 7547, February 11, 2015). NMFS has recalculated those amounts based on the final U.S. baseline BFT quota and subquotas in this rule, with an increase of 11.2 mt and 17.4 mt for the Purse Seine and Reserve categories, respectively.
Because the directed commercial categories have underharvested their subquotas in recent years, the potential increases in ex-vessel revenues above may overestimate the probable economic impacts to those categories relative to recent conditions. Additionally, there has been substantial interannual variability in ex-vessel revenues per category in recent years due to recent changes in BFT availability and other factors.
The modifications to the regulatory text concerning Atlantic tunas purse seine transfer at sea are intended to clarify the prohibition on transfer at sea. They apply to the five Purse Seine fishery participants only and are not expected to have significant economic impacts as they are administrative in nature, reflect current practice, and would not result in changes to Atlantic tunas purse seine operations.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, NMFS has prepared a brochure summarizing fishery information and regulations for Atlantic tuna fisheries for 2015. This brochure also serves as the small entity compliance guide. Copies of the compliance guide are available from NMFS (see
Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.
For the reasons set out in the preamble, 50 CFR part 635 is amended as follows:
16 U.S.C. 971
(a)
(1) * * *
(i) Catches from vessels for which General category Atlantic Tunas permits have been issued and certain catches from vessels for which an HMS Charter/Headboat permit has been issued are counted against the General category quota in accordance with § 635.23(c)(3). Pursuant to paragraph (a) of this section, the amount of large medium and giant bluefin tuna that may be caught, retained, possessed, landed, or sold under the General category quota is 466.7 mt, and is apportioned as follows, unless modified as described under paragraph (a)(1)(ii) of this section:
(A) January 1 through the effective date of a closure notice filed by NMFS announcing that the January subquota is reached, or projected to be reached under § 635.28(a)(1), or through March 31, whichever comes first—5.3 percent (24.7 mt);
(B) June 1 through August 31—50 percent (233.3 mt);
(C) September 1 through September 30—26.5 percent (123.7 mt);
(D) October 1 through November 30—13 percent (60.7 mt); and
(E) December 1 through December 31—5.2 percent (24.3 mt).
(2)
(i) After adjustment for the school bluefin tuna quota held in reserve (under paragraph (a)(7)(ii) of this section), 52.8 percent (46.6 mt) of the school bluefin tuna Angling category quota may be caught, retained, possessed, or landed south of 39°18′ N. lat. The remaining school bluefin tuna Angling category quota (41.7 mt) may be caught, retained, possessed or landed north of 39°18′ N. lat.
(ii) An amount equal to 52.8 percent (43.5 mt) of the large school/small medium bluefin tuna Angling category quota may be caught, retained, possessed, or landed south of 39°18′ N. lat. The remaining large school/small medium bluefin tuna Angling category quota (38.9 mt) may be caught, retained, possessed or landed north of 39°18′ N. lat.
(iii) One third (1.5 mt) of the large medium and giant bluefin tuna Angling category quota may be caught retained, possessed, or landed, in each of the three following geographic areas: North of 39°18′ N. lat.; south of 39°18′ N. lat., and outside of the Gulf of Mexico; and in the Gulf of Mexico. For the purposes of this section, the Gulf of Mexico region includes all waters of the U.S. EEZ west and north of the boundary stipulated at 50 CFR 600.105(c).
(3)
(4)
(ii)
(5)
(6)
(7) * * *
(i) The total amount of bluefin tuna that is held in reserve for inseason or annual adjustments and research using quota or subquotas is 24.8 mt, which may be augmented by allowable underharvest from the previous year, or annual reallocation of Purse Seine category quota as described under paragraph (a)(4)(v) of this section. Consistent with paragraphs (a)(8) through (10) of this section, NMFS may allocate any portion of the Reserve category quota for inseason or annual adjustments to any fishing category quota.
(ii) The total amount of school bluefin tuna that is held in reserve for inseason or annual adjustments and fishery-independent research is 18.5 percent (20.1 mt) of the total school bluefin tuna Angling category quota as described under paragraph (a)(2) of this section. This amount is in addition to the amounts specified in paragraph (a)(7)(i) of this section. Consistent with paragraph (a)(8) of this section, NMFS may allocate any portion of the school bluefin tuna Angling category quota held in reserve for inseason or annual adjustments to the Angling category.
(c) An owner or operator of a vessel for which an Atlantic Tunas Purse Seine category permit has been issued under § 635.4 may use an auxiliary vessel (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; apportionment of reserves; request for comments.
NMFS apportions amounts of the non-specified reserve to the initial total allowable catch (ITAC) of Bering Sea and Aleutian Islands (BSAI) northern rockfish, BSAI squids, Bering
Effective August 27, 2015, through 2400 hrs, Alaska local time, December 31, 2015. Comments must be received at the following address no later than 4:30 p.m., Alaska local time, September 11, 2015.
You may submit comments on this document, identified by FDMS Docket Number NOAA-NMFS-2014-0134 by any of the following methods:
•
•
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the (BSAI) exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2015 ITAC of BSAI northern rockfish was established as 2,763 metric tons (mt), the 2015 ITAC of BSAI squids was established as 340 mt, the 2015 ITAC of BS Greenland turbot was established as 2,081 mt, and the 2015 ITAC of BS Pacific ocean perch was established as 6,818 mt by the final 2015 and 2016 harvest specifications for groundfish of the BSAI (80 FR 11919, March 5, 2015). In accordance with § 679.20(a)(3) the Regional Administrator, Alaska Region, NMFS, has reviewed the most current available data and finds that the ITACs for BSAI northern rockfish, BSAI squids, BS Greenland turbot, and BS Pacific ocean perch need to be supplemented from the non-specified reserve to promote efficiency in the utilization of fishery resources in the BSAI and allow fishing operations to continue.
Therefore, in accordance with § 679.20(b)(3), NMFS apportions from the non-specified reserve of groundfish 3,500 mt to the BSAI northern rockfish ITAC, 1,630 mt to the BSAI squids ITAC, 105 mt to the BS Greenland turbot ITAC, and 1,203 mt to the BS Pacific ocean perch ITAC. These apportionments are consistent with § 679.20(b)(1)(i) and do not result in overfishing of any target species because the revised ITACs and total allowable catch (TAC) are equal to or less than the specifications of the acceptable biological catch in the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015).
The harvest specification for the 2015 ITACs and TACs included in the harvest specifications for groundfish in the BSAI are revised as follows: The ITAC and TAC is increased to 6,263 mt for BSAI northern rockfish and 1,970 mt for BSAI squids. The ITAC is increased to the full TAC of 2,448 mt for BS Greenland turbot, including 262 tons of Community Development Quota. And, the ITAC is increased to the full TAC of 8,021 mt for BS Pacific ocean perch.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and § 679.20(b)(3)(iii)(A) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the apportionment of the non-specified reserves of groundfish to the BSAI northern rockfish, BSAI squids, BS Greenland turbot, and BS Pacific ocean perch fisheries in the BSAI. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet and processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 21, 2015.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
Under § 679.20(b)(3)(iii), interested persons are invited to submit written comments on this action (see
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801,
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of data availability.
The U.S. Department of Energy (DOE) has completed a provisional analysis of the potential economic impacts and energy savings that could result from promulgating amended energy conservation standards for central air conditioners and heat pumps. At this time, DOE is not proposing any energy conservation standards for central air conditioners and heat pumps. Instead, this analysis will be used in support of the Appliance Standards Federal Rulemaking Advisory Committee (ASRAC) central air conditioners and heat pumps working group, which has been established to negotiate potential proposed amended energy conservation standards for central air conditioners and heat pumps standards and to discuss certain aspects of the proposed Federal test procedure. The analysis for this NODA is available at:
DOE will accept comments, data, and other information regarding this NODA and its related analyses no later than December 31, 2015. See section IV, “Submission of Comments,” of this NODA for further details.
Any comments submitted must identify the NODA on Energy Conservation Standards for Central Air Conditioners and Heat Pumps, and provide docket number EERE-2014-BT-STD-0048 and/or Regulatory Identification Number (RIN) 1904-AD37. Comments may be submitted using any of the following methods:
1.
2.
3.
4.
No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section IV of this document (Submission of Comments).
A link to the docket Web page can be found at:
For detailed instructions on submitting comments and additional information on the rulemaking process, see section IV, “Submission of Comments,” of this document. For further information on how to submit a comment or review other public comments and the docket, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Mr. Antonio Bouza, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-4563. Email:
Mr. Eric Stas or Ms. Johanna Hariharan, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 5869507 or (202) 287-6307. Email:
For further information on how to review other public comments and the docket, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Title III, Part B
The National Appliance Energy Conservation Act of 1987 (NAECA), Public Law 100-12, included amendments to EPCA that established the original energy conservation standards for central air conditioners and heat pumps. (42 U.S.C. 6295(d)(1)-(2))
EPCA, as amended, also requires DOE to conduct two cycles of rulemakings to determine whether to amend the energy conservation standards for central air conditioners and heat pumps. (42 U.S.C. 6295(d)(3)) More recently, EPCA was amended to require DOE to review the standards for each of its consumer products not later than every six years to determine whether such standards should be amended. (42 U.S.C. 6295(m)(1)) Under this “six-year-lookback” authority, DOE must publish a notice of proposed rulemaking (NOPR) to propose amended standards for residential central air conditioners and heat pumps, or a notice of determination that the existing standards do not need to be amended.
EPCA provides criteria for prescribing amended energy conservation standards for residential central air conditioners and heat pumps. More specifically, DOE is required to consider standards that: (1) Achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified; and (2) result in significant conservation of energy. (42 U.S.C. 6295(o)(2)(A) and (o)(3)(B)) To determine whether a proposed standard is economically justified, DOE will, after receiving comments on the proposed standard, determine whether the benefits of the standard exceed its burdens by, to the greatest extent practicable, considering the following seven factors:
EPCA also directs that DOE may not prescribe an amended or new standard if the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States at the time that the standard is prescribed. (42 U.S.C. 6295(o)(4))
Before proposing a standard, DOE typically seeks public input on the analytical framework, models, and tools that DOE will use to evaluate standards for the product at issue and the results of preliminary analyses DOE performed for the product. This notice announces the availability of the preliminary analysis of the economic impacts and energy savings of potential amended energy conservation standards.
As noted above, EPCA, as amended, established energy conservation standards for central air conditioners and heat pumps, as well as requirements for DOE to conduct two cycles of rulemaking to determine whether these standards should be amended. (42 U.S.C. 6295(d)(1)-(3)) The first cycle culminated in a final rule published in the
Pursuant to the EPCA's six-year review requirement under 42 U.S.C. 6295(m)(1), DOE must publish a notice of proposed rulemaking to propose amended standards for residential air conditioners and heat pumps, or a notice of determination that the existing standards do not need to be amended, by June 6, 2017 (
The analyses described in this NODA were developed to support a potential energy conservation standard for central air conditioners and heat pumps. The Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC) recently established a working group in accordance with the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act (NRA) to negotiate proposed amended energy conservation standards for central air conditioners and heat pumps standards and to discuss certain aspects of the proposed Federal test procedure. 80 FR 40938 (July 14, 2015) The purpose of the working group will be to discuss and, if possible, reach consensus on a proposed rule for amended energy conservation standards for central air conditioners and heat pumps and provide recommendations to DOE regarding certain aspects of the proposed test procedure. The working group consists of representatives of parties having a defined stake in the outcome of the proposed standards and amended test procedure, and will consult as appropriate with a range of experts on technical issues.
To examine these issues, and others as necessary, DOE will provide to all parties in the negotiation data and an analytical framework complete and accurate enough to support their deliberations. DOE is publishing this analysis to inform a prospective negotiation.
In this NODA, DOE is not proposing any energy conservation standards for central air conditioners and heat pumps. DOE may revise the analyses presented in this NODA based on any new or updated information or data it obtains during the course of the negotiations. DOE encourages interested parties to provide any additional data or information that may improve the analysis.
DOE conducted provisional analyses of central air conditioners and heat pumps in the following areas: (1) Engineering; (2) consumer impacts (life-cycle cost and payback period); (3) national impacts (including energy savings); and (4) manufacturer impacts. The tools used in preparing these analyses and their respective results are available at:
DOE also prepared a technical support document (TSD) containing a detailed written account of the provisional analyses and the results generated from these analyses, which are described for the four major anlyses below. The TSD is available at:
The engineering analysis establishes the relationship between the manufacturer production cost (MPC) and efficiency levels of central air conditioners and heat pumps. This relationship serves as the basis for calculations performed in the other analytical tools to estimate the costs and benefits to individual consumers, manufacturers, and the Nation. The engineering analysis identifies representative baseline products, which is the starting point for analyzing technologies that provide energy efficiency improvements. “Baseline product” refers to a model or models having features and technologies typically found in minimally-efficient products currently available on the market and, for products already subject to energy conservation standards, a model that just meets the current standard. After identifying the baseline models, DOE estimated manufacturer selling prices by using a consistent methodology and pricing scheme that includes material costs and manufacturer markups.
The LCC and PBP analyses determine the economic impact of potential standards on individual consumers, starting in the compliance year. The LCC is the total cost of purchasing, installing, and operating a central air conditioner or heat pump over the course of its lifetime. The LCC analysis compares the LCCs of products designed to meet possible energy conservation standards with the LCC of the product likely to be installed in the absence of standards. DOE determines the LCC by considering: (1) The total installed cost to the consumer (which consists of manufacturer selling price, distribution channel markups, installation costs, and sales taxes); (2) the range of annual energy consumption of central air conditioners and heat pumps as they are used in the field; (3) the operating and maintenance costs of central air conditioners and heat pumps (
The PBP represents the number of years needed to recover the increase in purchase price (including installation costs) of higher-efficiency central air conditioners and heat pumps through savings in the operating cost. PBP is calculated by dividing the incremental increase in installed cost of the higher-efficiency product, compared to the baseline product, by the annual savings in operating costs.
For each considered standards case corresponding to each efficiency level, DOE measures the change in LCC relative to the no-standards case, which reflects the market in the absence of amended energy conservation standards, including market trends for products that exceed the current energy conservation standards.
DOE developed nationally-representative household samples for central air conditioners and heat pumps from the 2009 residential energy consumption survey (RECS). DOE analyzed the net effect of potential amended central air conditioner and heat pump standards on consumers by calculating the LCC savings and PBP for each household by efficiency level. Inputs to the LCC calculation include the installed cost to the consumer (purchase price, including sales tax where appropriate, plus installation cost), operating costs (energy expenses, repair costs, and maintenance costs), the lifetime of the product, and a discount rate. Inputs to the payback period calculation include the installed cost to the consumer and first-year operating costs.
DOE performed the LCC and PBP analyses using a spreadsheet model combined with Crystal Ball
For each potential standard level, the primary outputs of the LCC and PBP analyses are: (1) Average LCC; (2) average PBPs; (3) average LCC savings relative to the no-new-standards case; and (4) the percentage of consumers that experience a net cost.
The national impacts analysis (NIA) estimates the national energy savings (NES) and the net present value (NPV) of total consumer costs and savings expected to result from potential amended standards. DOE calculated NES and NPV for central air conditioners and heat pumps as the difference between a case without amended standards and each standards case.
DOE calculated the national annual energy consumption for each case using the appropriate per-unit annual energy use data multiplied by the projected central air conditioner and heat pump shipments for each year. Cumulative energy savings are the sum of the annual NES determined for the lifetime of central air conditioner or heat pumps shipped during a 30-year period assumed to start in the expected compliance year. The analysis period is 30 years, which is consistent with other
To develop the national NPV of consumer benefits from potential energy conservation standards, DOE calculated projected annual operating costs (energy costs and repair and maintenance costs) and annual installation costs for the no-new-standards case and the standards cases. DOE calculated annual energy expenditures from annual energy consumption using forecasted energy prices (based on the Energy Information Administration's most recent
The aggregate difference each year between operating cost savings and increased installation costs is the net savings or net costs. DOE multiplies the net savings in future years by a discount factor to determine their present value. The national NPV is the sum over time of the discounted net savings each year. Critical inputs to this analysis include shipments projections, estimated product lifetimes, product installed costs and operating costs, product annual energy consumption, the no-new-standard-case efficiency projection, and discount rates. DOE estimates the NPV of consumer benefits using both a 3-percent and a 7-percent real discount rate, in accordance with guidance provided by the Office of Management and Budget (OMB) to Federal agencies on the development of regulatory analysis.
DOE performed a manufacturer impact analysis (MIA) to estimate the potential financial impact of potential amended energy conservation standards on manufacturers of central air conditioners and heat pumps. The MIA relied on the Government Regulatory Impact Model (GRIM), an industry cash-flow model used to estimate changes in industry value as a result of amended energy conservation standards. The primary quantitative output of this model is the industry net present value (INPV), which DOE calculates as the sum of industry annual cash flows, discounted to the present day using an industry-specific weighted average cost of capital, or manufacturer discount rate. The GRIM estimates the impacts of more-stringent energy conservation standards on the industry by comparing changes in INPV between a no-new-standards case and standards cases.
Key GRIM inputs include manufacturer production cost estimates from the Engineering Analysis and annual shipments forecast estimates from the National Impact Analysis. As part of the MIA, DOE also develops an analysis of industry financial parameters (
Additionally, DOE develops multiple manufacturer markup scenarios in order to capture uncertainty surrounding manufacturer pricing strategy following amended standards. For the central air conditioner and heat pump industry, DOE modeled three standards-case markup scenarios: (1) A preservation of baseline markup scenario; (2) a preservation of per-unit operating profit markup scenario; and (3) a tiered markup scenario. These scenarios result in varying revenue and cash flow impacts.
DOE will accept comments, data, and information regarding all of the analyses described above, but no later than the date provided in the
However, your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Otherwise, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
DOE processes submissions made through
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, that are written in English, and
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
The Secretary of Energy has approved publication of this NODA.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Extension of public comment period.
This document announces an extension of the time period for submitting comments, data, and information concerning the notice of proposed rulemaking for commercial prerinse spray valves, published on July 9, 2015. The comment period is extended to September 22, 2015.
The comment period for the notice of proposed rulemaking for commercial prerinse spray valves, published on July 9, 2015 (80 FR 39486) is extended to September 22, 2015.
Interested persons may submit comments by any of the following methods:
•
•
•
•
All submissions received must include docket number EERE-2014-BT- STD-0027 and/or regulatory identification number (RIN) 1904- AD31.
Mr. James Raba, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-8654. Email:
In the Office of General Counsel, contact Mr. Peter Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-9496. Email:
On July 9, 2015, the U.S. Department of Energy (DOE) published a document in the
The Plumbing Manufacturers International requested, by letter dated August 13, 2015, an extension of the public comment period for the proposed rulemaking, in view of the scope of the proposed rulemaking, technical nature, and amount of data requested.
DOE has determined that an extension of the public comment period for the notice of proposed rulemaking is appropriate to allow interested parties additional time to submit comments for DOE's consideration. Thus, DOE is extending the comment period by 15 days. DOE will consider any comments received prior to September 23, 2015, to be timely submitted.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Proposed rule; withdrawal.
The FAA withdraws a notice of proposed rulemaking (NPRM) that proposed a new airworthiness directive (AD), which would have applied to all BAE Systems (Operations) Limited Model BAe 146 series airplanes and Model Avro 146-RJ series airplanes. The NPRM would have superseded AD 2011-24-06 and required revising the maintenance program to incorporate new airworthiness limitations for reduced safe life limits on certain nose landing gear fittings. Since the NPRM was issued, we have received new data indicating that the airworthiness limitations contained in section 5 of the aircraft maintenance manual has been revised to include additional tasks and limitations. Accordingly, the NPRM is withdrawn.
As of August 28, 2015, the proposed rule, which was published in the
You may examine the AD docket on the Internet at
Todd Thompson, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1175; fax 425-227-1149.
We proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with a notice of proposed rulemaking (NPRM) for a new AD for all BAE Systems (Operations) Limited Model BAe 146 series airplanes and Model Avro 146-RJ series airplanes. The NPRM published in the
• Subject 05-10-15, “Aircraft Equipment Airworthiness Limitations,” of Chapter 05, “Time Limits/Maintenance Checks,” of BAe 146 Series/AVRO 146-RJ Series Aircraft Maintenance Manual, Revision 105, dated July 15, 2011.
• Subject 05-20-02, “Airframe Scheduled Maintenance—Landing/Calendar Life Extended,” of Chapter 05, “Time Limits/Maintenance Checks,” of BAe 146 Series/AVRO 146-RJ Series Aircraft Maintenance Manual, Revision 105, dated July 15, 2011.
• Subject 05-20-05, “Airframe Scheduled Maintenance—Life Extension Programme Landings Life Extended,” of Chapter 05, “Time Limits/Maintenance Checks,” of BAe 146 Series/AVRO 146-RJ Series Aircraft Maintenance Manual, Revision 105, dated July 15, 2011.
The NPRM was prompted by a determination that reduced safe life limits on certain nose landing gear NLG fittings were necessary. Analysis of these fittings showed the presence of forging indications in the flash line, which could reduce the life limits of these fittings. The proposed actions were intended to prevent fatigue cracking of certain structural elements, which could adversely affect the structural integrity of the airplane.
Since we issued the NPRM (78 FR 44469, July 24, 2014), BAE Systems (Operations) Limited has revised Chapter 05, “Time Limits/Maintenance Checks,” of the BAe 146 Series/AVRO 146-RJ Series Aircraft Maintenance Manual (AMM). Therefore, the NPRM proposal to incorporate new airworthiness limitations with reduced safe life limits on certain nose landing gear fittings contained in a previous issue of the AMM are no longer relevant.
Upon further consideration, we have determined that the changes to the AMM proposed in the NPRM (78 FR 44469, July 24, 2013) are no longer relevant and there is no benefit to proceeding with the publication of a final rule. Accordingly, the NPRM is withdrawn. The FAA is considering issuing a different rulemaking action to require implementation of the current revision of BAE Systems (Operations) Limited Chapter 05, “Time Limits/Maintenance Checks,” of the BAe 146 Series/AVRO 146-RJ Series AMM.
Withdrawal of the NPRM (78 FR 44469, July 24, 2013) does not preclude the FAA from issuing another related action or commit the FAA to any course of action in the future.
Since this action only withdraws an NPRM (78 FR 44469, July 24, 2013), it is neither a proposed nor a final rule and therefore is not covered under Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979).
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, we withdraw the NPRM, Docket No. FAA-2013-0627, Directorate Identifier 2012-NM-021-AD, which was published in the
Federal Aviation Administration (FAA), DOT.
Supplemental notice of proposed rulemaking (NPRM); reopening of comment period.
We are revising an earlier proposed airworthiness directive (AD) for certain Airmotive Engineering Corp. (AEC) replacement parts manufacturer approval (PMA) cylinder assemblies marketed by Engine Components International Division (ECi). We subsequently issued an initial supplemental NPRM (SNPRM) that proposed to modify the schedule for removal of the affected cylinder assemblies, added that overhauled affected cylinder assemblies be removed within 80 hours, eliminated a reporting requirement, and removed a requirement for initial and repetitive inspections. This second SNPRM reopens the comment period to allow the public the chance to comment on additional information added to the docket of this proposed rule. We are proposing this SNPRM to prevent failure of the cylinder assemblies, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.
We must receive comments on this SNPRM by September 28, 2015.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
• Federal eRulemaking Portal: Go to
• Fax: 202-493-2251.
• Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Engine Components International Division, 9503 Middlex Drive, San Antonio, TX 78217; phone: 210-820-8101; Internet:
You may examine the AD docket on the Internet at
Jurgen E. Priester, Aerospace Engineer, Delegation Systems Certification Office, FAA, Rotorcraft Directorate, 2601 Meacham Blvd., Fort Worth, TX 76137; phone: 817-222-5190; fax: 817-222-5785; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain AEC replacement PMA cylinder assemblies marketed by ECi. These assemblies are used on Continental Motors, Inc. (CMI) model 520 and 550 reciprocating engines, and all other CMI engine models approved for the use of models 520 and 550 cylinder assemblies such as the CMI model 470 when modified by STC. The NPRM published in the
We subsequently issued an SNPRM which published in the
Since we issued the SNPRM (80 FR 1008, January 8, 2015), we received numerous additional comments on the proposed rule. After reviewing the comments, we decided to reopen the docket so that we could provide additional information to explain the rationale for this AD action. We also wanted to provide commenters with the opportunity to comment on this additional information. We added the following information to Docket No. FAA-2012-0002: (1) The risk analysis conducted by the FAA's Chief Scientific and Technical Adviser, Aircraft Safety Analysis; (2) a risk analysis using the Small Airplane Risk Analysis methods; (3) a June 2011, presentation by Airmotive Engineering to the FAA
In addition, we met with National Transportation Safety Board (NTSB) representatives on June 9, 2015, to clarify the NTSB's basis for its comments of FAA's actions in this proposed rule.
We are taking this opportunity to respond to a limited number of comments. Specifically, we found that numerous commenters cited differences between the FAA's proposed action and the NTSB's recommendations in NTSB Safety Recommendation A-12-7. We will respond to remaining comments to the initial SNPRM (80 FR 1008, January 8, 2015) and to this second SNPRM when we issue the final rule.
Danbury Aerospace, Inc., and others in their comments to the SNPRM (80 FR 1008, January 8, 2015), requested that we provide additional information that supports this AD action.
We agree. We added our risk analyses and other technical information, such as the list of cylinder failures noted above and ECi Technical Report 1102-13 that supports this proposed rule, to Docket No. FAA-2012-0002 to help commenters and the general public understand the need for this proposed rule.
Several operators, maintenance organizations, and private citizens asked that we withdraw the SNPRM (80 FR 1008, January 8, 2015) because the affected ECi cylinder assemblies have an equivalent, or lower, failure rate than that of cylinder assemblies manufactured by the original equipment manufacturer (OEM).
We disagree. We found that the failure rate for ECi cylinder assemblies is much higher than for OEM cylinder assemblies over the same period. Accident data confirms, that engines and airplanes may not always continue to operate safely with a separated cylinder and that separated cylinders have been the precipitating event in at least two fatal accidents. This accident data is included in the risk analyses that we uploaded to the docket (see NTSB Accident Identifiers NYC02FA178 and ERA11WA008, which are cited in these analyses). We did not withdraw this proposed rule.
The NTSB commented that the comparison between failure rates of OEM and ECi cylinder assemblies was not valid because the cylinder heads represented substantially different designs.
We disagree that the comparison between OEM and ECi cylinder assemblies is not valid. The ECi PMA design was reverse engineered by ECi from earlier vintage OEM cylinders, and uses the same time between overhaul (TBO) as the OEM cylinders. Since these ECi cylinder assemblies are approved to the same TBO as the OEM cylinders, the ECi cylinders should have durability that is equivalent to the OEM cylinders. Our comparison of ECi cylinder assembly service history with the OEM cylinder assembly history showed that the rate of separation for the affected ECi cylinder assemblies is at least 32 times greater than that of OEM cylinder assemblies over the same period. We uploaded this data for commenter review. It may be viewed in Docket No. FAA-2012-0002. We did not change this proposed AD.
The NTSB commented that it has not investigated any cases involving engines with cylinder assemblies ranging from serial number (S/N) 1 through S/N 1043. The NTSB indicated that cylinder assemblies in this S/N range should not be affected by the AD.
We disagree. Cylinder assemblies with S/N 1 through S/N 1043 have the same design as noted in this SNPRM, exhibit the same unsafe condition, and therefore must be included in the applicability. We did not change this proposed AD.
The NTSB also commented that AD 2004-08-10, which was issued on May 5, 2004, requires replacement before further flight of ECi cylinder assemblies ranging from S/N 1044 through S/N 7708 installed on CMI 520 and 550 series engines. According to AD 2004-08-10, ECi identified a manufacturing discrepancy that occurred between September 2002 and May 2003 affecting cylinder assemblies S/N 1044 through S/N 7708, which resulted in an over-hardened condition that would reduce the fatigue strength of the aluminum cylinder head. The NTSB commented, therefore, that cylinder assemblies S/N 1044 through S/N 7708 should not be included in the proposed AD.
We disagree. AD 2004-08-10 does not apply to all cylinder assemblies S/N 1044 through S/N 7708; it applies only to cylinder assemblies having specific cast markings. Cylinder assemblies S/N 1004 through S/N 7708 have the same design as noted in this SNPRM, exhibit the same unsafe condition, and therefore must be included in the applicability. We did not change this proposed AD.
The NTSB also commented that, based on its review of the additional seal band interference fit data provided by ECi, action is only required for 165 cylinder assemblies S/N 36210 through S/N 61176.
We disagree. We have received reports of separations of cylinder assemblies S/N 36210 through S/N 61176 that were not among the 165 cylinders that ECi claimed may be at risk for separation due to insufficient head to barrel interference fit. We have uploaded information in Docket No. FAA-2012-0002 that identifies S/Ns of failed cylinder assemblies that were not among the 165 cylinder assemblies identified by ECi. We did not change this proposed AD.
The NTSB commented that the applicability represented by the SNPRM—S/N 1 through S/N 61176—represents a much larger number of affected cylinder assemblies than is supported by its investigations.
We disagree. ECi's next increase in the design interference fit was incorporated beginning with S/N 61177. Consequently, all cylinder assemblies S/N 1 through S/N 61176 are at risk for separation in the first thread due to insufficient interference fit. We, therefore, find that based on service failure data, identified in the docket as “U.S. DOT/FAA—04 ECi 520-550 Cylinder Separations,” and ECI's implementation of design improvements, this proposed AD must apply to cylinder assemblies S/N 1 through S/N 61176. We did not change this proposed AD.
The NTSB commented that we should impose a repetitive inspection requirement for certain ECi cylinder assemblies and their removal once they reach the manufacturer's recommended TBO. This repetitive inspection requirement was part of the NPRM (78
The NTSB observed that the FAA had published Special Airworthiness Information Bulletin (SAIB) NE-07-09R1, dated March 21, 2007, and approved ECi Mandatory Service Bulletin 06-2, Revision 2, dated October 26, 2006. Both of these documents emphasize the importance of conducting periodic inspections of ECi cylinder assemblies.
We disagree. We have found, based on service experience since the publication of SAIB NE-07-09R1, that the inspection and tests are not reliable in detecting cracked cylinders and the cost associated with such ongoing tests outweighs the safety benefit. In addition, the crack propagation growth rate is unknown. As a result, we have received field reports of separated cylinders that occurred within the repetitive 50-hour compression test and leak check inspection intervals proposed by the NPRM. We did not change this proposed AD.
The NTSB also noted that repetitive inspections are not perfect but are still effective in detecting cracks that have propagated through the cylinder wall. These inspections provide an added level of safety from the time of the issuance of the final rule AD until the required removal of the cylinder assembly.
We disagree. We find that repetitive inspections until TBO are inconsistent with the serious hazard represented by cylinder assembly failures. See the “U.S. DOT/FAA-01 Risk Analysis White Paper” for 2011-NE-42-AD that we uploaded to the AD docket on June 23, 2015. Therefore, we are requiring removal of affected cylinder assemblies from service prior to TBO. We did not change this proposed AD.
We are proposing this SNPRM to allow the public the opportunity to comment on additional information we added to the docket of this proposed rule.
As proposed in the first SNPRM published on January 8, 2015 (80 FR 1008), this second SNPRM would require removal of the affected cylinder assemblies, including overhauled cylinder assemblies, according to a phased removal schedule.
We estimate that this proposed AD would affect about 5,000 CMI models IO-520, TSIO-520, IO-550, and IOF-550 reciprocating engines and all other CMI engine models approved for the use of CMI models 520 and 550 cylinder assemblies (such as the CMI model 470 when modified by STC), installed on airplanes of U.S. registry. The average labor rate is $85 per hour. We estimate that about 18 hours would be required to replace all six cylinder assemblies during overhaul maintenance. We estimate the pro-rated value of the cost of replacement of six cylinder assemblies to be about $4,202 per engine. Based on these figures, we estimate the total cost of this proposed AD to U.S. operators to change all ECi cylinder assemblies to be $28,660,000. Our cost estimate is exclusive of possible warranty coverage.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by September 28, 2015.
None.
This AD applies to all Continental Motors, Inc. (CMI) model 520 and 550 reciprocating engines, and to all other CMI engine models approved for the use of model 520 and 550 cylinder assemblies such as the CMI model 470 when modified by supplemental type certificate (STC), with Airmotive Engineering Corp. replacement parts manufacturer approval (PMA) cylinder assemblies, marketed by Engine Components International Division (hereinafter referred to as ECi), part number (P/N) AEC631397, with ECi Class 71 or Class 76, serial number (S/N) 1 through S/N 61176, installed.
This AD was prompted by multiple failure reports of cylinder head-to-barrel separations and cracked and leaking aluminum cylinder heads. We are issuing this AD to prevent failure of the cylinder assemblies, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Review the engine maintenance records to determine if any affected cylinder assemblies are installed.
(2) If you cannot determine based on review of engine maintenance records if any affected cylinder assemblies are installed, comply with paragraph (e)(4) of this AD.
(3) If you do not have any of the affected ECi cylinder assemblies installed on your engine, no further action is required.
(i) Check the cylinder assembly P/N and Class number. The ECi cylinder assembly, P/N AEC631397, Class 71 or Class 76, is stamped on the bottom flange of the cylinder barrel. Guidance on the P/N and Class number description and location can be found in ECi Service Instruction No. 99-8-1, Revision 9, dated February 23, 2009.
(ii) If you cannot see the cylinder assembly P/N when the cylinder assembly is installed on the engine, you may use the following alternative method of identification:
(A) Remove the cylinder assembly rocker box cover.
(B) Find the letters ECi, cast into the cylinder head between the valve stems.
(C) Check the cylinder head casting P/N. Affected cylinder assemblies have the cylinder head casting P/N, AEC65385, cast into the cylinder head between the valve stems.
(D) Find the cylinder assembly S/N as specified in paragraph (e)(4)(iii) or (e)(4)(iv) of this AD, as applicable.
(iii) For ECi cylinder assemblies, P/N AEC631397, manufactured through 2008, find the cylinder assembly S/N stamped on the intake port boss two inches down from the top edge of the head.
(iv) For ECi cylinder assemblies, P/N AEC631397, manufactured on or after January 1, 2009, find the cylinder assembly S/N stamped just below the top edge of the head on the exhaust port side.
(i) For any affected cylinder assembly with 680 or fewer operating hours time-in-service (TIS) since new on the effective date of this AD, remove the cylinder assembly from service before reaching 1,000 operating hours TIS since new.
(ii) For any affected cylinder assembly with more than 680 operating hours TIS since new and 1,000 or fewer operating hours TIS since new on the effective date of this AD, remove the cylinder assembly from service within the next 320 operating hours TIS or within 1,160 operating hours TIS since new, whichever occurs first.
(iii) For any affected cylinder assembly with more than 1,000 operating hours TIS since new on the effective date of this AD, remove the cylinder assembly from service within the next 160 operating hours or at next engine overhaul, whichever occurs first.
(iv) For any affected cylinder assembly that has been overhauled, remove the cylinder assembly from service within the next 80 operating hours TIS after the effective date of this AD.
After the effective date of this AD:
(1) Do not repair, or reinstall onto any engine, any cylinder assembly removed per this AD.
(2) Do not install any affected ECi cylinder assembly that has been overhauled, into any engine.
(3) Do not install any engine that has one or more affected overhauled ECi cylinder assemblies, onto any aircraft.
(4) Do not return to service any aircraft that has an engine installed with an ECi cylinder assembly subject to this AD, if the cylinder assembly has 1,000 or more operating hours TIS.
The Manager, Delegation Systems Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request.
(1) For more information about this AD, contact Jurgen E. Priester, Aerospace Engineer, Delegation Systems Certification Office, FAA, Rotorcraft Directorate, 2601 Meacham Blvd., Fort Worth, TX 76193; phone: 817-222-5190; fax: 817-222-5785; email:
(2) For ECi Service Instruction No. 99-8-1, Revision 9, dated February 23, 2009, contact Engine Components International Division, 9503 Middlex Drive, San Antonio, TX 78217; phone: 210-820-8101; Internet:
(3) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for SOCATA Models TB 9, TB 10, TB 20, TB 21, and TB 200 airplanes. This proposed 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 corrosion of the horizontal stabilizer. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by October 13, 2015.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact SOCATA, Direction des Services, 65921 Tarbes Cedex 9, France; telephone: 33 (0)5 62.41.73.00; fax: 33 (0)5 62.41.76.54; or SOCATA North America, North Perry Airport, 7501 S Airport Rd., Pembroke Pines, Florida 33023, telephone: (954) 893-1400; fax: (954) 964-4141; Internet:
You may examine the AD docket on the Internet at
Albert J. Mercado, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4119; fax: (816) 329-4090; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued AD No.: 2015-0130, dated July 7, 2015 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
During accomplishment of SOCATA Service Bulletin (SB) SB10-152-55 at original issue, some operators reported finding heavy corrosion of the horizontal stabilizer (HS) spar.
The results of the technical investigation have identified that the corrosion was caused by humidity ingress in the HS on aeroplanes subject to severe environmental conditions.
This condition, if not detected and corrected, could result in buckling and permanent HS distortion, possibly resulting in reduced control of the aeroplane.
To address this unsafe condition, SOCATA issued SB 10-152-55 Revision 1 to provide instructions for inspection and corrective action.
For the reasons described above, this AD requires repetitive inspections of the affected area of the HS and, depending on findings, accomplishment of applicable corrective action(s).
You may examine the MCAI on the Internet at
SOCATA has issued DAHER-SOCATA TB Aircraft Mandatory Service Bulletin SB 10-152, Amendment 1, dated April 2015. The service information describes procedures for inspection for corrosion on horizontal stabilizer spar and repair, 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
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD will affect 195 products of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $33,150, or $170 per product.
In addition, we estimate that any necessary follow-on actions would take about 15 to 38 work-hours and require parts costing $250 to $400 depending on the type of repair, for a cost of $2,325 to $4,280 per product. The cost may vary depending on the extent of damage found. We have no way of determining the number of products that may need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by October 13, 2015.
None.
This AD applies to SOCATA Models TB 9, TB 10, TB 20, TB 21, and TB 200 airplanes, all manufacturer serial numbers, certificated in any category.
Air Transport Association of America (ATA) Code 55: Stabilizers.
This AD was prompted by 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 humidity in the horizontal stabilizer on airplanes subject to severe environmental conditions. We are issuing this AD to detect and correct corrosion of the horizontal stabilizer (HS) spar, which could lead to result in buckling and permanent HS distortion, possibly resulting in reduced control.
Unless already done, do the actions in paragraphs (f)(1) through (f)(5) of this AD:
(1) Within 13 months after the effective date of this AD and repetitively thereafter at intervals not to exceed 72 months, do a special detailed inspection of the HS spar following the instructions of DAHER-SOCATA TB Aircraft Mandatory Service Bulletin SB 10-152, Amendment 1, dated April 2015.
(2) If no discrepancy is detected during any inspections required by paragraph (f)(1) of this AD, protect the HS spar following the instructions of DAHER-SOCATA TB Aircraft Mandatory Service Bulletin SB 10-152, Amendment 1, dated April 2015.
(3) If any discrepancy is detected during any inspection required by paragraph (f)(1) of this AD, before further flight, do the applicable corrective action(s) following the instructions of DAHER-SOCATA TB Aircraft Mandatory Service Bulletin SB 10-152, Amendment 1, dated April 2015.
(4) Accomplishment of protection or corrective actions on an airplane as required by paragraph (f)(2) or (f)(3) of this AD, as applicable, does not constitute terminating action for the repetitive inspections as required by paragraph (f)(1) of this AD for that airplane.
(5) Inspections and corrective actions on an airplane, done before the effective date of this AD following the instructions of DAHER-SOCATA TB Aircraft Recommended Service Bulletin SB 10-152, dated May 2013, are acceptable to comply with the requirements of this AD for that airplane. After the effective date of this AD, repetitive inspections and applicable corrective actions, as required by this AD, must be done as required by paragraph (f)(1) of this AD following the instructions of DAHER-SOCATA TB Aircraft Mandatory Service Bulletin SB 10-152, Amendment 1, dated April 2015.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI European Aviation Safety Agency (EASA) AD No. 2015-0130, dated July 7, 2015; and DAHER-SOCATA TB Aircraft Recommended Service Bulletin SB 10-152, dated May 2013, for related information. You may examine the MCAI on the Internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This proposed rule would update existing overflight fee rates using more current FAA cost accounting and air traffic activity data. Overflight fees are charges for aircraft flights that transit U.S.-controlled airspace, but neither land in nor depart from the United States. Overflight fee rates were last updated in 2011. As a result, the FAA is not recovering the full cost of the services it provides. The FAA proposes to increase the rates for Enroute and Oceanic overflights based on fiscal year 2013 cost and air traffic activity data. The FAA proposes to phase in this rate increase over three years in equal percentage terms. This is a less burdensome approach than the alternative of phasing in the new rates in equal absolute terms, and is the same methodology used in the previous rulemaking. Finally, the FAA proposes several organizational and clarifying revisions to the overflight fee requirements.
Send comments on or before October 27, 2015.
Send comments identified by docket number FAA-2015-3597 using any of the following methods:
•
•
•
•
For technical questions concerning this action, contact Aleksandra Damsz, Financial Analyst, Office of Financial Analysis, AFA-400, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-8055; email
For legal questions concerning this action, contact Jonathan Cross, Office of the Chief Counsel, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-7173; email
The FAA's authority to issue rules establishing fees is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Chapter 453, Section 45301
The FAA proposes to increase the rates for Enroute and Oceanic overflights over a 3-year period to bring cost recovery from Fiscal Year (FY) 2008 recovery to FY 2013 recovery. The following table shows the proposed increases.
The International Civil Aviation Organization (ICAO) recommends that the “cost to be shared is the full cost of providing the air navigation services” and that the “approach toward the recovery of full costs should be a gradual progression.”
The FAA also proposes several organizational and content revisions to part 187 to clarify the overflight fees requirements.
The higher overflight rates based on FY 2013 unit costs would allow the FAA to move closer to full cost recovery of air traffic control services already being provided to operators. The present value of the projected fee increases through FY 2018—when the full increase in rates would have taken place—would be $9,560,692 for foreign operators and $141,888 for domestic operators. The updated fees would provide greater incentives for foreign and domestic operators to economize on U.S. air traffic control facilities and U.S.-controlled airspace, thus increasing the efficient allocation of resources.
The FAA's overflight fees were initially authorized in section 273 of the Federal Aviation Reauthorization Act of 1996.
The FAA established and chartered an Overflight Fees Aviation Rulemaking Committee (ARC) consisting of foreign air carriers (and trade associations of those carriers) that are subject to the FAA's overflight fees. The ARC was chartered on May 1, 2013, with the task to provide the FAA a report detailing recommendations for tasks moving forward with the overflight fees update process.
The ARC met with the FAA on June 12, 2013, and on January 23, 2014. On February 14, 2014, the ARC submitted several recommendations on future overflight rate updates.
The ARC recommended that the FAA increase overflight rates annually from FY 2016 (beginning October 1, 2015) through FY 2018 (beginning October 1, 2017) at the compounded annual growth rate (CAGR) of FY 2008 through FY 2013 FAA costs, calculated separately for the Enroute and Oceanic rates. Calculations from CAS show this would result in an annual increase of 1.72% for Enroute fees, and an annual increase of 3.76% for Oceanic fees. In other words, the ARC proposed that the FAA phase in the rate increases using equal annual percentage increases as done in the 2011 final rule. The final proposed fees are listed in the table below:
The ARC stated that while it does not challenge the use of CAS as a basis for setting the fee, it does not endorse the current methodology as a whole and recommends that the cost base exclude certain elements of the FAA's overhead and other non-overflight related costs.
Similar recommendations were proffered in comments leading to the 2011 final rule.
The ARC industry members recommended that the FAA include all traffic receiving services from the FAA ATO personnel in Enroute and Oceanic Air Route Traffic Control Centers (ARTCCs) in the determination of the flight miles that are used in the rate calculation. The ARC contended that currently only filed flight plans (IFR/VFR) are used in the fee calculation while a significant portion of the traffic consists of the unfiled VFR traffic using flight following or being actively separated from IFR.
For this rulemaking, the ARC recommendation is consistent with the FAA's approach to determine the total miles used to calculate the overflight fee rate. VFR aircraft, which use flight-following services without filing a flight plan, are assigned discrete beacon codes and included as part of the total miles used to determine the fee rates.
The ARC industry members also recommended that the FAA continue to engage in meaningful financial discussions with its stakeholders and provide full transparency on its cost development through CAS. The industry members recommended that the FAA provide the industry (including the non-ARC members) on an annual basis with year-to-year comparisons of costs and traffic, and that any major changes in allocations between cost centers are accompanied by the high level summary justifying the changes. The industry members also asked that a new ARC be convened in three years to analyze the costs and air traffic activity data and determine the need for a future change of rates for FY 2019 and beyond based on the updated cost and traffic data.
The FAA generally supports continued engagement with industry members. The FAA will consider reconvening an ARC for future rate updates and will continue to provide cost and activity data through the rulemaking process.
Finally, the ARC industry members recommended that the FAA set a target on its cost development that remains below inflation and takes into consideration the expected development of traffic.
The FAA believes forecasting based on projected traffic is more appropriate than using arbitrary cost targets. Each year the FAA publishes a 10-year Aerospace Forecast that includes anticipated levels of activity. FAA hiring and capital investments are based on forecasted levels of traffic activity.
The FAA proposes to update overflight fee rates based on final CAS data and TFMS data for FY 2013, which are the most recent cost and air traffic activity data available. This update uses the same general methodology, calculation, and data sources as those used for the last update in 2011.
Separate overflight rates have been established, and are currently in effect, for flights that transit U.S.-controlled airspace in each of two operational environments (Enroute and Oceanic airspace) without taking off from or landing in the United States.
As in the 2011 update, the FAA proposes to phase in the rate increases. This approach is consistent with ICAO's principle of gradualism. The FAA proposes a 3-year phase-in for this fee increase. The FAA intends the first increase would occur beginning on October 1, 2015, and proceed according to the following schedule:
The FAA has considered the ARC recommendation. While the FAA believes the ARC's approach is not unreasonable, the FAA has decided to not move forward with the ARC recommendation since the methodology to increase rates based on the CAGR between FY 2008 through FY 2013 allows only a partial recovery of the FY 2013 costs that the FAA is authorized to recover. Using that methodology, the FAA would have recovered slightly less than 60% for Enroute and 50% for Oceanic of the total increase between FY 2015 rates (based on FY 2008 costs) and rates using FY 2013 data. The FAA is instead moving forward with the same basic approach that was used in the FY 2011 final rule, which would recover the FY 2013 cost basis beginning in FY 2018.
The FAA also proposes organizational changes to part 187 to clarify the overflight fee requirements. The FAA proposal replaces current Appendix B of part 187 with new §§ 187.3 (Definitions), 187.51 (Applicability of overflight fees), 187.53 (Calculation of overflight fees), and 187.55 (Overflight fees billing and payment procedures). Except as discussed in the following paragraphs, the FAA proposes no changes to the substance of current requirements.
In § 187.1, the FAA proposes to remove the duplicate reference to Appendix A, remove the reference to Appendix B because Appendix B is being removed, and add a reference to Appendix C that inadvertently had not been added when Appendix C (computation of fees for production certification-related services performed outside the United States) was added. The FAA proposes a new § 187.3 to contain definitions relevant to part 187. The terms overflight, overflight through Enroute airspace, overflight through Oceanic airspace, and U.S.-controlled airspace had been defined in Appendix B. The FAA proposes to revise the definition for U.S.-controlled airspace to be more consistent with the definition under international treaties, ICAO standards and guidance, customary law, and Presidential Proclamation Number 5928.
In new § 187.51, the FAA proposes a new paragraph (d) to address fees for flights through U.S.-controlled airspace covered by an FAA agreement or other binding arrangement. The FAA periodically enters into agreements with foreign States, regional groups of States, or foreign air navigation services providers to set the terms for the FAA's management or control of foreign airspace among other air navigation services provided by the FAA. Generally, these agreements include specific terms for how the FAA recovers costs for the services it provides. This paragraph would avoid a potential conflict between such an agreement or arrangement and FAA regulations as well as ensure that overflight fee regulations apply uniform conditions and are non-discriminatory as required under the Chicago Convention. The FAA also proposes to remove the exception from overflight fees for Canada-to-Canada flights because those flights would continue to be addressed under proposed paragraph (d).
In new § 187.53, the FAA proposes to retain the formula for calculating overflight fees from existing Appendix B but also proposes to clarify the explanation of calculating that fee. The total fee for a particular flight would be the sum of the Enroute and Oceanic fees. The Enroute and Oceanic fees would be calculated by multiplying the Enroute or Oceanic rate (per 100 nautical miles), respectively, by the number of miles flown through each segment of Enroute or Oceanic airspace, respectively. Miles flown through each segment of airspace would be calculated, using great circle distance (GCD), from the point of entry into U.S.-controlled airspace to the point of exit from U.S.-controlled airspace. As under the current rule, the FAA would use the best available flight data to calculate the entry and exit points. The FAA is considering removing the formula because it is redundant and has created confusion. The FAA requests comments on whether the formula still is necessary in light of the narrative explanation.
The proposed billing and payment procedures in new § 187.55 are unchanged from those in existing Appendix B.
Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate
Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this proposed rule. The reasoning for this determination follows.
This proposed rule would institute a 3-year phase-in of rate increases for Oceanic and Enroute overflights, with rates per 100 nautical miles increasing in FY 2016-2018 to $23.15, $24.77, and $26.51 for Oceanic flights, and to $58.45, $60.07, and $61.75 for Enroute flights. The final FY 2018 rate of $26.51 for Oceanic services is derived from the FAA's FY 2013 total cost of providing these services divided by the total nautical miles flown by operators (overflights and non-overflights) in Oceanic airspace. An analogous calculation is made to obtain the FY 2018 rate of $61.75 for Enroute services. These higher rates based on FY 2013 unit costs would allow the FAA to move closer to full cost recovery of air traffic control services already being provided to operators.
Tables 4 and 5 show estimates of the increase in overflight fees for domestic operators and foreign operators for FY 2016, FY 2017, and FY 2018, using FY 2013 overflight mileage totals assuming no annual growth. As the tables show, the present value of the projected fee increases through FY 2018—when the full increase in rates would have taken place—would be $141,888 for domestic operators and $9,560,692 for foreign operators. The updated fee rates would provide greater incentives for foreign and domestic operators to economize on U.S. air traffic control facilities and U.S.-controlled airspace, thus increasing the efficient allocation of resources.
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule will not result in a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
For FY 2013 there were 469 domestic operators who overflew U.S.-controlled airspace, many of whom appear to be small entities. As Table 4 shows, however, after the phase-in of fee increases has been completed, in FY 2018, overflight billings to domestic operators would have increased by just $173,819. Dividing this figure by the number of FY 2013 domestic overflights, 4762, the FAA estimates that the average increase in overflight billings would be $36.50 per operation. Accordingly, the proposed rule would not have a significant economic impact on a substantial number of small entities.
Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities. The FAA solicits comments regarding this determination.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. ICAO standards allow providers of navigation services to require users of these services to pay their share of the related costs. The FAA has determined that this proposed rule primarily affects foreign commercial operators. The proposal to recover costs of providing air navigation services is consistent with ICAO standards and international practice. Foreign operators would be charged a fee only if they use U.S.-controlled airspace without taking off or landing in the U.S., and U.S. operators would be charged in the same manner. Accordingly, the FAA does not believe this proposal would create an unnecessary obstacle to the foreign commerce of the United States.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $151.0 million in lieu of $100 million. This proposed rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this rule. The information used to track overflights (including the information collection necessary to implement this rule) can be accessed from flight plans filed with the FAA. The collection of information from the Domestic and International Flight Plans is approved under OMB information collection 2120-0026.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to ICAO Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these proposed regulations.
The ICAO guidance document on aviation fees and charges, ICAO Document 9082 (Ninth Edition—2012), ICAO's Policies on Charges for Airports and Air Navigation Services, recommends consultations before imposing fees. In addition, Article 12 of the Air Transport Agreement between the United States of America and the European Union and its Member States (April 30, 2007, as amended June 24, 2010) encourages consultation.
By convening an ARC, presenting updated cost and traffic data to the ARC, and considering the ARC's recommendation, the FAA consulted with system users prior to proposing this overflight fee update. Additionally, the FAA invites comments on this proposal, which permits participation by all interested parties in the rulemaking process.
FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312f and involves no extraordinary circumstances.
The FAA has analyzed this proposed rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.
The FAA analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The agency also invites
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The agency may change this proposal in light of the comments it receives.
Under 14 CFR 11.35(b), if the FAA is aware of proprietary information filed with a comment, the agency does not place it in the docket. It is held in a separate file to which the public does not have access, and the FAA places a note in the docket that it has received it. If the FAA receives a request to examine or copy this information, it treats it as any other request under the Freedom of Information Act (5 U.S.C. 552). The FAA processes such a request under Department of Transportation procedures found in 49 CFR part 7.
An electronic copy of rulemaking documents may be obtained from the Internet by—
1. Searching the Federal eRulemaking Portal (
2. Visiting the FAA's Regulations and Policies Web page at
3. Accessing the Government Printing Office's Web page at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.
All documents the FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced above.
Administrative practice and procedure, Air transportation.
In consideration of the foregoing, the Federal Aviation Administration proposes to amend chapter I of title 14, Code of Federal Regulations as follows:
31 U.S.C. 9701; 49 U.S.C. 106(f), 106(g), 106(l)(6), 40104-40105, 40109, 40113-40114, 44702, 45301.
This part prescribes fees only for FAA services for which fees are not prescribed in other parts of this chapter or in 49 CFR part 7. The fees for services furnished in connection with making information available to the public are prescribed exclusively in 49 CFR part 7. Appendix A to this part prescribes the methodology for computation of fees for certification services performed outside the United States. Appendix C to this part prescribes the methodology for computation of fees for production certification-related services performed outside the United States.
For the purpose of this part:
(a) Except as provided in paragraphs (c) or (d) of this section, any person who conducts an overflight through either Enroute or Oceanic airspace must pay a fee as calculated in section 187.53.
(b)
(1) Air traffic management.
(2) Communications.
(3) Navigation.
(4) Radar surveillance, including separation services.
(5) Flight information services.
(6) Procedural control.
(7) Emergency services and training.
(c) The FAA does not assess a fee for any military or civilian overflight operated by the United States Government or by any foreign government.
(d) Fees for overflights through U.S.-controlled airspace covered by a written FAA agreement or other binding arrangement are charged according to the terms of that agreement or arrangement unless the terms are silent on fees.
(a) The FAA assesses a total fee that is the sum of the Enroute and Oceanic calculated fees.
(1)
(2)
(b) Distance flown through each segment of Enroute or Oceanic airspace is based on the great circle distance (GCD) from the point of entry into U.S.-controlled airspace to the point of exit from U.S.-controlled airspace based on FAA flight data. Where actual entry and exit points are not available, the FAA will use the best available flight data to calculate the entry and exit points.
(c) The rate for each 100 nautical miles flown through Enroute or Oceanic airspace is:
(d) The formula for the total overflight fee is:
(e) The FAA will review the rates described in this section at least once every 2 years and will adjust them to reflect the current costs and volume of the services provided.
(a) The FAA will send an invoice to each user when fees are owed to the FAA. If the FAA cannot identify the user, then an invoice will be sent to the registered owner. Users will be billed at the address of record in the country where the aircraft is registered, unless a billing address is otherwise provided.
(b) The FAA will send an invoice if the monthly (based on Universal Coordinated Time) fees equal or exceed $250.
(c) Payment must be made by one of the methods described in § 187.15(d).
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo-filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.
Submit either electronic or written comments on the proposed rule by November 12, 2015. See section IV of this document for the proposed effective date of any final rule that may publish based on this proposal.
You may submit comments by any of the following methods.
Submit electronic comments in the following way:
•
Submit written submissions in the following ways:
•
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-796-2500.
With the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which established an abbreviated licensure pathway for products demonstrated to be biosimilar to or interchangeable with an FDA-licensed reference product, a growing number of biological products will be entering the marketplace.
Section 351(k) of the Public Health Service Act (the PHS Act) (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. Section 351(i) of the PHS Act defines biosimilarity to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (section 351(i)(2) of the PHS Act). To meet the additional standard of interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch (section 351(k)(4) of the PHS Act). Interchangeable products may be substituted for the reference product by a pharmacist without the intervention of the prescribing health care provider (section 351(i)(3) of the PHS Act).
During FDA's implementation of the BPCI Act, the Agency has opened several dockets to solicit comments on issues related to the naming of biological products licensed under section 351(k) of the PHS Act.
FDA also has received several citizen petitions directed to the nonproprietary naming of biosimilar products. The citizen petition submitted by Johnson & Johnson requests that FDA require biosimilar products to bear nonproprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars (see Docket No. FDA-2014-P-0077, available at
In a separate notice published elsewhere in this issue of the
While the draft guidance describes a naming convention in which the designated suffixes would be devoid of meaning, the notice of availability for the draft guidance invites comment not only on that naming convention but also on the benefits and challenges of alternate approaches, including meaningful suffixes such as a suffix derived from the name of the license holder.
The draft guidance describes FDA's rationale for the proposed naming convention and requests public comment on FDA's intention to apply this convention to biological products previously licensed and newly licensed under section 351(a) or section 351(k) of the PHS Act. The draft guidance explains that FDA is continuing to consider the most effective regulatory approach to implement the naming convention for previously licensed biological products, and FDA encourages interested parties to submit comments on biological product naming issues to the public docket established for the draft guidance (Docket No. FDA-2013-D-1543, available at
For the reasons described in the following section, FDA believes it is necessary at this time to designate official names and proper names for the
This proposed rule would designate the official names and the proper names of six biological products that fall under one of the following categories: (1) A reference product for an approved or publicly disclosed section 351(k) application (
Section 508 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 358), which applies to biological products pursuant to section 351(j) of the PHS Act, provides FDA with authority to designate official names for drugs if it determines that such action is necessary or desirable in the interest of usefulness and simplicity. Section 508 further specifies that any official name designated under that section shall be the only official name of that drug used in any official compendium published after such name has been prescribed or for any other purpose of this chapter. Under § 299.4(e) (21 CFR 299.4(e)), FDA will publish official names under the provisions of section 508 of the FD&C Act when the Agency determines, among other bases, that the USAN or other official or common or usual name is unduly complex or is not useful for any other reason.
For biological products licensed under the PHS Act, FDA designates the proper name in the license for use upon each package of the biological product (see section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k)). The proper name of a biological product reflects certain scientific characteristics of the product, such as chemical structure and pharmacological properties. Among other things, the proper name of a biological product helps health care providers identify the product's drug substance and distinguish biological products from one another. Although FDA typically designates the proper name of a product upon its licensure, FDA also has the authority to designate proper names for biological products through regulation (see,
Biological products generally consist of large, complex molecules and can raise unique safety concerns related to immunogenicity. FDA believes that the nonproprietary naming convention for the biological products described in this proposed rule should help prevent inadvertent substitution, which may lead to unintended switching or alternating of biological products that have not been determined by FDA to be interchangeable with each other. FDA believes this naming convention will help to facilitate safe use and protect the safety of patients.
Inadvertent switching between biological products that have not been shown to be interchangeable may affect immune response. For example, in some instances, immune responses to therapeutic proteins may pose safety and efficacy issues (Ref. 1). For example, immune responses can lead to significant clinical consequences, such as pure red cell aplasia; inhibition of the efficacy of therapeutics; and reactions, including serum sickness and anaphylaxis (Ref. 1). Individual patients can vary in their immune responses to protein products, and these differences can be caused by the same genetic components that have an impact on sensitivity to small changes in structure (Ref. 2). Thus, switching or alternating of biological products not determined by FDA to be interchangeable may raise unique safety concerns related to immunogenicity.
If originator biological products, related biological products, and biosimilar products share the same proper name, a patient could receive a product different from what was intended to be prescribed, leading to medication errors. For example, this could occur if a biosimilar product were licensed for fewer than all of the indications and routes of administration for which its reference product is licensed, or is packaged in a different delivery system (
Thus, FDA has determined that designation of a proper name containing a distinguishing identifier for these six biological products is the best mechanism to facilitate their safe use. FDA believes that incorporating a distinguishing suffix into the nonproprietary names of these six biological products will increase the likelihood that the intended biological product will be prescribed and will not be inadvertently substituted at the dispensing or product administration level. Specifically, FDA believes that incorporation of these suffixes into the nonproprietary product names listed in prescribing, ordering, and dispensing systems will assist prescribers in selecting the specific intended product, pharmacists in dispensing the correct product, and health care providers in administering the correct product.
Health care providers and information technology specialists who program electronic databases can consult the Purple Book (Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations), an online resource that lists all FDA-licensed biological products by their nonproprietary name and clearly identifies products that have been approved as biosimilar to or interchangeable with a particular reference product.
The Agency considers appropriate pharmacovigilance fundamentally important for all biological products. Although safety of drug and biological products is rigorously assessed prior to approval, safety issues that are specific to a manufacturer may arise after approval with any marketed product. Therefore, a robust pharmacovigilance program is essential to help ensure patient safety. To ensure continued safety of a biological product, appropriate pharmacovigilance necessitates that FDA be able to track adverse events to a specific manufacturer (and, as appropriate, site or lot for a particular biological product), and that surveillance systems be able to detect safety signals throughout the lifecycle of a product, so that the Agency and the manufacturer
Pharmacovigilance systems, both active and passive, vary in their use of identifiers to differentiate among biological products; these identifiers may include the brand (proprietary) name, proper (nonproprietary) name, manufacturer, national drug code (NDC) number, lot number, and billing codes. Successful use of active pharmacovigilance systems (such as FDA's Sentinel system) for adverse event tracking relies on the standardized coding systems for capturing drug information in administrative and health care claims and billing records. These coding systems may vary based on the setting in which a drug is dispensed. Many therapeutic biological products are administered in settings, such as physician offices, clinics, or hospitals, where the administrative and billing data do not routinely include product identifiers such as brand name, manufacturer, NDC number, or lot number (Refs. 3 and 4). Thus, active pharmacovigilance systems that use administrative and billing data currently have limited ability to track biological products that share the same nonproprietary name to the manufacturer.
Similarly, in many passive pharmacovigilance systems, proprietary names and NDC numbers are often not included in adverse event reports (Refs. 5 and 6). FDA uses the FDA Adverse Event Reporting System, a “passive” surveillance system that compiles mandatory adverse event reports from manufacturers and voluntary reports submitted directly to FDA by health care professionals and patients. FDA requires manufacturers and others with mandatory reporting obligations to submit an adverse event report to FDA when a minimum of four elements (identifiable patient, identifiable reporter, suspect product, and an event or fatal outcome) are present, even if other required elements, such as NDC numbers, are not available. It is well known that many reports lack key information and that the information identifying products in spontaneous reports can be unreliable (Ref. 6). Proprietary names, even when included, may not reliably identify products in spontaneous adverse event reports since misattribution can occur with adverse event reporting. Furthermore, because national health care systems, health care professional organizations, and patient safety organizations recommend the use of nonproprietary names for prescribing and listing of drug products, the nonproprietary name may be the name used by some reporters to identify the drug products in the adverse event reports (Refs. 7 and 8). In addition, although NDC numbers can be used to identify manufacturer-specific information about a product, they are infrequently provided in spontaneous adverse event reports, and may not be available to the reporter at the time of reporting, or during followup with the reporter. As a result, the use of distinct proprietary names or NDC numbers is currently insufficient to address all concerns regarding pharmacovigilance. Distinguishable nonproprietary names for the biological products in this rulemaking would provide another critical tool in uniquely identifying these biological products. Use of such names for the biological products in this rulemaking would preserve the ability to detect both product-specific safety signals and class effects, and would facilitate prompt evaluation of safety signals in passive and active postmarketing surveillance systems.
Although FDA believes the use of distinguishable nonproprietary names for originator biological products, related biological products, and biosimilar products could improve pharmacovigilance, FDA is interested in comments addressing whether any potential alternative approaches such as increased use of NDC numbers and/or other tracking information would also improve pharmacovigilance of these products.
FDA believes that it is important to initiate and encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for these six biological products. The designated suffix would provide a consistent, readily available, and recognizable mechanism for health care professionals (including providers and pharmacists) and patients to correctly identify these biological products, regardless of their licensure pathway. The consistent use of a designated suffix for these biological products would remove ambiguity about the identity of the intended biological product. If a core name was used without such identifier, it may be unclear whether the originator product, a related biological product, or a biosimilar product was intended to be ordered, prescribed, dispensed, administered, or reported.
This naming convention would have the added benefit of avoiding inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. The safety and effectiveness of biological products is rigorously assessed before approval. A number of comments have expressed concern that requiring distinguishable proper names only for biosimilar products would adversely affect health care provider and patient use of these new products (Ref. 9). FDA shares the concern that such an approach could lead to inaccurate and scientifically unfounded assertions of inferiority or clinically meaningful differences of an approved biosimilar product for its approved indications. FDA anticipates that use of proper names with designated suffixes for these originator biological products, related biological products, and biosimilar products, irrespective of their licensure pathway, would help avoid any inaccurate perceptions of the safety and effectiveness of biological products based on licensure pathway and thus address concerns raised by the comments.
We are proposing to add subpart B on Designated Names and proposed § 299.20 (21 CFR 299.20) to designate the official names and proper names of certain biological products. The six biological products included in proposed § 299.20 have been selected because they fall under one of the following categories: (1) Reference product for an approved or publicly disclosed section 351(k) application (
We are proposing to designate the official name of “filgrastim-jcwp” for the biological product licensed under BLA 103353, held by Amgen, Inc. (Amgen) and to change the proper name designated in the license from “filgrastim” to “filgrastim-jcwp.” Filgrastim, marketed as NEUPOGEN, is the reference product for ZARXIO (filgrastim-sndz), a biosimilar product recently licensed under section 351(k) of the PHS Act.
We also are proposing to designate the official name of “filgrastim-vkzt” for the biological product licensed under BLA 125294, held by Sicor Biotech, UAB, and to change the proper name designated in the license from “tbo-filgrastim” to “filgrastim-vkzt.” Tbo-filgrastim, marketed as GRANIX, is a related biological product. FDA has
In addition, we are proposing to designate the official name of “filgrastim-bflm” for the biological product licensed under BLA 125553, held by Sandoz, Inc., and to change the proper name designated in the license from “filgrastim-sndz” to “filgrastim-bflm.” Filgrastim-sndz, marketed as ZARXIO, is a biosimilar product recently licensed under section 351(k) of the PHS Act, and the distinguishing suffix designated at the time of licensure was derived from the name of the license holder. In light of FDA's current proposal to designate official names and proper names for five other biological products that would include distinguishing suffixes devoid of meaning, in the interest of usefulness and simplicity the name “filgrastim-bflm” should be designated as the official name and the proper name and codified with the names designated for filgrastim and tbo-filgrastim in proposed § 299.20.
We are proposing to designate the official names and change the proper names for three other reference products for section 351(k) applications that have been publicly disclosed. These reference products are epoetin alfa (BLA 103234), infliximab (BLA 103772), and pegfilgrastim (BLA 125031). We are proposing to designate the official name of “epoetin alfa-cgkn” for the biological product licensed under BLA 103234, held by Amgen and marketed as EPOGEN and PROCRIT, and to change the proper name designated in the license from “epoetin alfa” to “epoetin alfa-cgkn.” We also are proposing to designate the official name of “infliximab-hjmt” for the biological product licensed under BLA 103772, held by Janssen Biotech, Inc. and marketed as REMICADE, and to change the proper name designated in the license from “infliximab” to “infliximab-hjmt.” Finally, we are proposing to designate the official name of “pegfilgrastim-ljfd” for the biological product licensed under BLA 125031, held by Amgen and marketed as NEULASTA, and to change the proper name designated in the license from “pegfilgrastim” to “pegfilgrastim-ljfd.”
FDA has determined that the current names of “epoetin alfa,” “infliximab,” and “pegfilgrastim” are not useful within the meaning of section 508 of the FD&C Act. Considerations similar to those described for filgrastim and tbo-filgrastim warrant the designation of official names and proper names that include distinguishing suffixes for pegfilgrastim, epoetin alfa, and infliximab. These products are the reference products for publicly disclosed applications under section 351(k) of the PHS Act (Ref. 10). FDA believes that it is important to initiate and encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for these products. Also, in the event that a biosimilar product is approved that relies upon one of these products as a reference product, assignment of designated suffixes to the reference products would help avoid potential inaccurate perceptions that any biosimilar product with a proper name that features a distinguishing suffix differs in a clinically meaningful way or is inferior for its approved conditions of use. Accordingly, in the interest of usefulness and simplicity, FDA is proposing to designate official names with designated suffixes that would also be designated as the proper names for these products.
The official names and proper names in proposed § 299.20 include designated suffixes composed of four lowercase letters. The official names and proper names, if finalized, will appear on all labeling and marketing materials for these products where the product's proper name or drug substance name is provided.
In addition, FDA also has determined that the following alternative names that include distinguishing suffixes devoid of meaning may be acceptable for these products: epoetin alfa-mkdv, filgrastim-gknh, filgrastim-kbhj, filgrastim-zbdt, infliximab-djfg, and pegfilgrastim-vjbk.
FDA is also considering an alternative nonproprietary naming format for biological products in which the suffix attached to the core name would be derived from the name of the license holder listed on the license. Under this alternative naming format, the official names and proper names for the six products that are the subject of this proposed rule could be as follows:
Each of the official names and proper names in proposed § 299.20 and each the alternative official names and proper names discussed previously was rigorously evaluated and determined unlikely to be a source of errors. Each of these official names and proper names (core name-suffix) would be sufficiently distinct from the nonproprietary names of other products. The designated suffixes are distinct from other drug substance names, do not look similar to the names of other currently marketed products, are sufficiently distinct from other suffix designations, and do not include any abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order.
While alternative official names and proper names are described in this preamble to the proposed rule, the final rule would designate a single official name that also would be designated as the proper name for each product.
FDA invites comment on the proposed official names and proper names for these products, including the alternative names listed previously and any other proposed names containing suffixes composed of four lowercase letters that would accomplish the objectives stated in this document. In particular, FDA invites comment on the benefits and challenges of designating a distinguishing suffix that is unique to each of these six biological products versus designating a distinguishing suffix that is shared by each product manufactured by a single license holder (
Following approval of a BLA supplement to update product labeling with the official name and proper name designated in any final rule, FDA would take steps to ensure that its drug listings that interface with other databases and systems reflect the newly designated nonproprietary name. FDA also would work with other governmental organizations and external stakeholders that play a role in national drug naming or listings to help ensure that the official name and proper name for the product is displayed accurately in drug listing systems. We invite comment on the best means of coordinating with external stakeholders that play a role in drug naming and listing to achieve this objective considering, among other things, any transition period before market availability of products labeled with the newly designated nonproprietary names.
Section 508 of the FD&C Act and section 351 of the PHS Act serve as the principal legal authorities for this proposed rule. Section 508 of the FD&C Act, which applies to biological products pursuant to section 351(j) of the PHS Act, provides FDA with authority to designate official names for drugs if it determines that such action is necessary or desirable in the interest of usefulness and simplicity. For the reasons described previously, FDA has determined that the interest of usefulness and simplicity warrants the designation of official names for the products included in this rulemaking. FDA also has authority under section 351(a) of the PHS Act to designate the proper name of a biological product and may do so through rulemaking. FDA is exercising this authority to designate matching proper names for these products.
Thus, section 508 of FD&C Act and section 351 of the PHS Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), provide legal authority for this proposed rule.
FDA proposes that any final rule that may be issued based on this proposal become effective 90 days after the date of its publication in the
The Agency has determined under 21 CFR 25.30(h) and (k) and 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Office of Management and Budget (OMB) has determined that this proposed rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule imposes one-time relabeling costs on one small business, the Agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.
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 $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.
We estimate the one-time costs of learning about the rule; submitting labeling supplements, forms, and revised marketing materials to FDA; changing labeling on affected products; FDA review of labeling supplements, forms, and revised marketing materials; and activities to educate practitioners about name changes. The one-time costs range from $0.78 million to $3.04 million. Over 10 years, the annualized costs range from $0.10 million to $0.40 million with a 7 percent discount rate, and from $0.09 million to $0.35 million with a 3 percent discount rate.
We expect the rule would have other costs that are not yet included in these estimated costs. Additional costs to industry may include costs updating prescribing and reimbursement systems to reflect the new names and changing marketing materials to reflect the new names.
We lack data to quantify the benefits of the proposed rule. In the event of biosimilar entry, the name changes for certain products that would be required by this proposed rule may help mitigate a potential competitive disadvantage for
The Economic Analysis of Impacts of the proposed rule performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is available at
FDA tentatively concludes that this proposed rule contains no new collection of information. The official names and proper names of each of these biological products, as designated by the proposed rule, would be information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public, and the public disclosure of such information is not a “collection of information” within the meaning of the Paperwork Reduction Act of 1995 (the PRA). See 5 CFR 1320.3(c)(2). Therefore, clearance by the OMB under the PRA (44 U.S.C. 3501-3520) is not required.
The discussion of effective date in the preamble (section IV) to this proposed rule references certain actions that would be taken by manufacturers and applicants for the specific approved biological products for which this proposed rule would designate official names and proper names, in order to comply with existing FDA regulations that contain collections of information that are subject to review by OMB under the PRA.
Specifically, prior to the effective date of any final rule based on this proposal, a prior approval supplement would be submitted in accordance with § 601.12 (21 CFR 601.12) for each of six specific BLAs referenced in this rule, to update the labeling of the product (which includes the immediate container label and outer container or package) with the designated official name and proper name. The submission of supplements to approved license applications under § 601.12 is approved under OMB control number 0910-0338. We estimate that this rulemaking would result in the one-time submission of six supplements. In conjunction with our previously approved collection of information under § 601.12, we estimated that each such supplement would incur a burden of 40 hours.
The discussion of effective date also acknowledges that these applicants would revise their labeling, which includes the immediate container label and outer container or package, to reflect the newly designated official names and proper names. (As noted, disclosing the official names and proper names of each of these biological products to the public is not a “collection of information” within the meaning of the PRA. See 5 CFR 1320.3(c)(2).) The design and testing of prescription drug labeling required under §§ 201.56 and 201.57 (21 CFR 201.56 and 201.57) (including § 201.56(a)(2)) is approved under OMB control number 0910-0572. Concerning the immediate container label and outer container or package, in the
Interested persons may submit either electronic comments regarding this document to
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects 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. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references have been placed on display in the Division of Dockets Management (see
Drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, FDA proposes to amend 21 CFR part 299 as follows:
21 U.S.C. 331, 351, 352, 355, 358, 360b, 371; 42 U.S.C. 262.
(a) The Food and Drug Administration has designated official names under section 508 of the Federal Food, Drug, and Cosmetic Act for the biological products licensed under section 351 of the Public Health Service Act in the biologics license applications provided in the following list. The official name shall be the proper name designated in the license for use upon each package of the product.
(b) [Reserved]
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking.
This document contains proposed regulations that provide guidance regarding the amount of the penalty under section 6707A of the Internal Revenue Code (Code) for failure to include on any return or statement any information required to be disclosed under section 6011 with respect to a reportable transaction. The proposed regulations are necessary to clarify the amount of the penalty under section 6707A, as amended by the Small Business Jobs Act of 2010. The proposed regulations would affect any taxpayer who fails to properly disclose participation in a reportable transaction.
Written or electronic comments and requests for a public hearing must be received by November 27, 2015.
Send submissions to: CC:PA:LPD:PR (REG-103033-11), Room 5205, 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-103033-11), 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, Melissa Henkel, (202) 317-6844; concerning submissions of comments or requests for a public hearing, Oluwafunmilayo (Funmi) Taylor, (202) 317-6901 (not toll-free numbers).
This document contains proposed amendments to 26 CFR part 301 under section 6707A of the Internal Revenue Code. Section 6707A was added to the Code by section 811(a) of the American Jobs Creation Act of 2004 (Pub. L. 108-357, 118 Stat. 1418) and was amended
The following is a summary of the proposed changes to the existing regulations relating to the penalties under section 6707A.
Treas. Reg. § 1.6011-4 establishes that a taxpayer whose amended return or application for tentative refund reflects participation in a reportable transaction has the same disclosure obligation as a taxpayer whose original return reflects participation in a reportable transaction. Treas. Reg. § 301.6707A-1, published on September 11, 2011, clarifies that a taxpayer's failure to disclose participation in a reportable transaction will trigger a penalty under section 6707A regardless of whether the participation is reflected on an original return, an amended return, or an application for tentative refund. In its current state, the regulation generally refers to original returns, amended returns, and applications for tentative refund in every case where all three terms are relevant. The proposed regulations streamline these references by defining the term “return” to include all three. This change simplifies sentences throughout the regulation without changing their meaning.
Subject to certain minimum and maximum amounts, “the amount of the penalty under subsection (a) with respect to any reportable transaction shall be 75 percent of the decrease in tax shown on the return as a result of such transaction (or which would have resulted from such transaction if such transaction were respected for Federal tax purposes).” Section 6707A(b)(1). The proposed regulations define this decrease in tax generally as the difference between the amount of tax reported on the return as filed and the amount of tax that would be reported on a hypothetical return where the taxpayer did not participate in the reportable transaction. The amount of tax shown on the hypothetical return will reflect adjustments that result mechanically from backing out the reportable transaction, such as tax items affected by an increase in adjusted gross income resulting from non-participation in the reportable transaction.
In some situations, a taxpayer's participation in a listed transaction creates a liability for a tax that would not exist absent participation in the transaction. For example, a taxpayer engaging in a listed abusive Roth IRA transaction may be subject to an excise tax on excess IRA contributions. If the taxpayer fails to report the excise tax on his excess IRA contributions, this amount of tax would not appear on the return filed by the taxpayer that reflected his participation in the reportable transaction. The excise tax would also not appear on a return filed by the taxpayer if he had not engaged in the transaction, because there would be no excess contribution on which excise tax would be imposed. Therefore, the difference between these two returns would result in no decrease in tax attributable to the unreported tax. To capture this tax, the proposed regulations include in the definition of the decrease in tax “any other tax that results from participation in the reportable transaction but was not reported on the taxpayer's return.” Example 1 in § 301.6707A-1(d)(2) illustrates this rule.
Listed transactions and transactions of interest are identified in published guidance.
Section 6707A(e) generally requires certain taxpayers who must pay penalties under sections 6707A, 6662A (accuracy-related penalty on understatements with respect to reportable transactions), or 6662(h) (accuracy-related penalty on underpayments attributable to gross valuation misstatements) to disclose their liability for these penalties in filings with the SEC. The flush language of section 6707A(e) provides that “[f]ailure to make a disclosure in accordance with the preceding sentence shall be treated as a failure to which the penalty under subsection (b)(2) applies.” However, as discussed in the Background section of this preamble, subsection (b)(2) was amended in 2010. Prior to enactment of the Jobs Act, section 6707A(b)(2) provided that the amount of the penalty for failure to disclose participation in a listed transaction was $100,000 for natural persons and $200,000 in any other case. After the 2010 amendments, section 6707A(b)(2) now provides that “[t]he amount of the penalty under subsection (a) with respect to any reportable transaction shall not exceed— (A) in the case of a listed transaction, $200,000 ($100,000 in the case of a natural person), or (B) in the case of any other reportable transaction, $50,000 ($10,000 in the case of a natural person).”
Treasury and the Service do not believe that Congress intended its reference to subsection (b)(2) to impose the maximum penalty on violations of section 6707A(e). This would be contrary to the purpose of the 2010 amendments to section 6707A, which sought to make the penalty proportionate to the tax benefit derived by the transaction. A reference solely to subsection (b)(2) does not make sense in terms of describing the amount of the penalty, as subsection (b)(2) merely caps the amount of the penalty that can be imposed on a failure to disclose and does not provide a particular amount for the penalty. It seems likely that the intent was to reference the amount of the penalty generally under subsection (b). The proposed regulations clarify this point.
In each case giving rise to an obligation to disclose liability in filings with the SEC, there must be a reportable transaction for the relevant penalty to arise. The amount of the penalty for a violation of section 6707A(e), therefore, will be 75 percent of the decrease in tax, as provided in section 6707A(b). In addition to being consistent with the language of section 6707A(e), the proposed regulations are also consistent with the Congressional intent of the 2010 amendments to section 6707A to render proportionality between the amount of the penalty and the tax benefit derived from the reportable transaction.
Pursuant to section 6707A(b)(2), “[t]he amount of the penalty under subsection (a) with respect to any reportable transaction shall not exceed” certain specified dollar values. Likewise, under section 6707A(b)(3), “[t]he amount of the penalty under subsection (a) with respect to any transaction shall not be less than” certain specified dollar values. Under the proposed regulations, these minimum and maximum limits on the amount of the penalty would be applied separately to each individual penalty under section 6707A(a). The limitations in sections 6707A(b)(2) and (3) apply expressly to “[t]he amount of the penalty under subsection (a).” Because, as provided in § 301.6707A-1(c), each separate failure to disclose a reportable transaction gives rise to a new penalty under section 6707A(a), the minimum and maximum limits on the amount of the penalty apply separately to each failure to disclose.
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866 of, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to the proposed regulations. Because the proposed regulations would 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 Internal Revenue 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 businesses.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written or electronic comments that are submitted timely to the IRS. The Treasury Department and the IRS request comments on all aspects of the proposed regulations. All comments will be available for public inspection and copying at
The principal authors of the proposed regulations are Melissa Henkel of the Office of the Associate Chief Counsel (Procedure and Administration) and Spence Hanemann, formerly of the Office of the Associate Chief Counsel (Procedure and Administration).
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 301 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
The revisions and additions read as follows:
(b) * * *
(3)
(d)
(ii)
(iii)
(iv)
(2) No tax required to be shown on return. For returns with respect to which disclosure is required but on which no tax is required to be shown (for example, returns of passthrough entities), the minimum penalty amount will be imposed for failures to disclose.
(3)
Taxpayer X, a natural person, filed a return reflecting participation in an abusive Roth IRA transaction listed in Notice 2004-8, 2004-1 I.R.B. 333 (Jan. 26, 2004). As described in the notice, X's Roth IRA acquired shares of a wholly owned corporation and then X sold assets to the corporation at less than fair market value, effectively transferring value to the corporation comparable to a contribution to the Roth IRA. X failed to disclose his participation in the listed transaction as required by the regulations under section 6011. As a result of the transaction, X was liable under section 4973 for a $10,000 excise tax for excess contributions to his Roth IRA. On his return, X correctly reported $25,000 of income tax, none of which was attributable to the listed transaction, but failed to report the excise tax. If X had not participated in the listed transaction, the excise tax under section 4973 would not have applied and his income tax would have remained $25,000. There would, therefore, be no difference between the tax on his return as filed and the tax on his return if it did not reflect participation in the transaction. The excise tax, however, is another tax that resulted from participation in the transaction but was not reported on X's return, as described in paragraph (d)(1)(i)(B) of this section. Therefore, the decrease in tax resulting from the listed transaction is $10,000, which amount is the sum of zero (the excess of the amount of tax that would be shown on X's return if the return did not reflect X's participation in the transaction over the tax X actually reported on the return reflecting X's participation in the transaction) and $10,000 (the amount of excise tax that resulted from participation in the transaction but was not reported on the return). The amount of the penalty will be $7,500, which amount is 75 percent of the $10,000 decrease in tax.
Taxpayer X participated in a listed transaction that resulted in a $40,000 decrease in the tax shown on its return. X failed to disclose its participation and is, therefore, subject to a penalty under section 6707A. After weighing litigating hazards and other costs of litigation, the IRS Office of Appeals agreed to settle X's deficiency for $20,000. For purposes of calculating the amount of the penalty, the settlement does not affect the decrease in tax shown on X's return as a result of the listed transaction, which remains $40,000. The amount of X's penalty will be $30,000, which amount is 75 percent of the $40,000 decrease in tax.
Taxpayer X, a natural person, participated in a nonlisted reportable transaction and, because he failed to disclose his participation, is subject to a penalty under section 6707A. After offsetting gross income with the losses generated in the reportable transaction, X's return reported adjusted gross income of $100,000. The return also reported $12,000 of medical expenses, $2,000 of which were deductible after applying the 10 percent floor in section 213(a). If X's return had not reflected participation in the reportable transaction, his adjusted gross income would have been $140,000. The decrease in tax shown on X's return as a result of the transaction would take into account both the tax on the $40,000 difference in adjusted gross income and the tax on the $2,000 adjustment to X's deductible medical expenses under section 213(a) caused by the increase in adjusted gross income.
Taxpayer X, a natural person, timely filed his 2014 return and reported income tax of $40,000. X did not participate in a reportable transaction in 2014. X participated in a listed transaction in 2015, but failed to file a complete and proper disclosure statement with his 2015 return as required by the regulations under section 6011. As filed, the 2015 return reports that X owes no tax and has a loss of $10,000. If the tax consequences of the listed transaction were not reflected on the 2015 return, the return would show income tax of $15,000 and no loss. X files an amended return for his 2014 tax year on which its only amendment is to carry back the $10,000 loss reported on its 2015 tax return to the 2014 tax year, which decreases X's tax liability for 2014 by $3,000. X fails to file a complete and proper disclosure statement with the 2014 amended return as required by the regulations under section 6011. X will be assessed two penalties under section 6707A: one for his failure to disclose participation in a listed transaction reflected on his 2015 tax return and another for his failure to disclose participation in the same listed transaction reflected on his 2014 amended return. The decrease in tax on the 2015 tax return resulting from the listed transaction is $15,000, which amount is the excess of the
Taxpayer X, a corporation, timely files its 2012 and 2013 tax returns, each of which reflects participation in the same transaction. In 2015, the transaction becomes a listed transaction and X fails to file a complete and proper disclosure statement as required by the regulations under section 6011. X was required to file a single disclosure statement reflecting its participation in the listed transaction for all years which had open periods of limitation on assessment at the time the transaction became listed. When the transaction at issue became listed, the periods of assessment on X's 2012 and 2013 tax years were open. Pursuant to paragraph (d)(1)(ii) of this section, the amount of the penalty for X's single failure to disclose its participation in the transaction in 2012 and 2013 is computed by aggregating the decrease in tax shown on the 2012 return and the decrease in tax shown on the 2013 return. The decreases in tax shown on the returns as a result of X's participation in the transaction are $265,000 in tax year 2012 and $7,000 in tax year 2013. The total decrease in tax shown on both returns is $272,000, and 75 percent of that amount is $204,000. Because X is a corporation, the amount of the penalty will be limited to the maximum amount of $200,000 under § 301.6707A-1(a) and section 6707A(b)(2)(A).
The 2014 return of Taxpayer X, a natural person, reflects participation in a nonlisted reportable transaction, but X fails to file a complete and proper disclosure statement as required by the regulations under section 6011. The decrease in tax shown on X's 2014 return as a result of participation in the reportable transaction is $20,000. X subsequently files an amended 2014 return to include a net operating loss carried forward from a prior year, which X inadvertently failed to include when he filed his original return. The amended return reflects participation in the same reportable transaction, but X again fails to file a complete and proper disclosure statement. The decrease in tax shown on the amended 2014 return as a result of participation in the transaction is also $20,000. X is subject to two separate penalties: one for each failure to disclose. Seventy-five percent of the $20,000 decrease in tax shown on each of the original 2014 return and the amended 2014 return is $15,000 for each return. Because X is a natural person, the amount of the penalty for failure to disclose with respect to the original return will be limited to the maximum amount of $10,000 under § 301.6707A-1(a) and section 6707A(b)(2)(B). The amount of the penalty for failure to disclose with respect to the amended return will also be limited to the maximum amount of $10,000.
Partnership M is required to attach Form 8886, Reportable Transaction Disclosure Statement, to its Form 1065, U.S. Return of Partnership Income, for the 2014 taxable year. It fails to do so and is, therefore, subject to a penalty under section 6707A. The amount of the penalty will be the minimum penalty of $10,000 under § 301.6707A-1(a) and section 6707A(b)(3) because Form 1065 is a return that does not show an amount of tax that would be decreased as a result of participation in the reportable transaction. The partners of Partnership M may have separate disclosure obligations as required by the regulations under section 6011 and would be subject to separate section 6707A penalties if they fail to comply with the disclosure requirements.
In tax year 2014, Taxpayer X participated in a listed transaction that resulted in a $150,000 deduction. X's gross income for 2014 before the listed transaction deduction is $100,000. X uses $100,000 of the deduction to offset $100,000 of gross income and reports tax of zero for 2014. X also has a $50,000 net operating loss for 2014. X timely elects to waive the carryback period and carry over the 2014 net operating loss to tax year 2015. X's gross income for tax year 2015 is $200,000 but as a result of the $50,000 net operating loss carryover, X reports $150,000 adjusted gross income. Pursuant to § 1.6011-4, X is required to disclose participation in the listed transaction for both 2014 and 2015, but X fails to make the required disclosures and is therefore subject to the section 6707A penalty for each failure. The decrease in tax on the 2014 return is the amount of tax on $100,000 because that is the difference between the amount of tax that would have been shown on the return if it did not reflect participation in the reportable transaction and the tax actually reported. No other tax resulted from X's participation in the listed transaction. The amount of the penalty with respect to X's failure to disclose with respect to 2014 will be 75 percent of the decrease in tax. The decrease in tax on the 2015 return is the difference between the tax shown on the return as filed and the tax that would be shown if the $50,000 net operating loss was not used, including any changes to the amount of tax that are only indirectly connected with the listed transaction. The amount of the penalty with respect to X's failure to disclose with respect to 2015 will be 75 percent of the decrease in tax.
In tax year 2014, Taxpayer X, a natural person, participated in a listed transaction that resulted in a $50,000 deduction. X's gross income for 2014 before the listed transaction deduction is $100,000. X also has a net operating loss carryover of $150,000 from 2013. X uses the deduction of $50,000 and a portion of the net operating loss carryover to offset $100,000 of gross income and reports adjusted gross income of zero for 2014. X carries over the remaining net operating loss to tax year 2015. X's gross income for 2015 is $250,000, but as a result of the net operating loss carryover, X reports reduced adjusted gross income of $150,000. Pursuant to § 1.6011-4, X is required to disclose participation in the listed transaction for both 2014 and 2015, but X fails to make the required disclosures and is subject to the section 6707A penalty for each failure. The decrease in tax on the 2014 return that results from the reportable transaction is zero. Because X has $150,000 of a net operating loss carryover not attributable to the reportable transaction, X's tax without the benefits of the reportable transaction is the same as the tax shown on the 2014 return as filed. Because X is a natural person, the minimum penalty of $5,000 under § 301.6707A-1(a) and section 6707A(b)(3) will apply for the failure to disclose the listed transaction with the 2014 return. The decrease in tax on the 2015 return is the difference between the tax shown on the return as filed and the tax that would be shown if X had only $50,000 of net operating loss to carry over to 2015 (
In tax year 2014, Taxpayer X, a corporation, engaged in a nonlisted reportable transaction and is subject to a penalty under section 6662A because its 2014 return resulted in a reportable transaction understatement. As a result of X's involvement in the transaction, it reported tax of $10,000 for 2014; if X had not engaged in the transaction, it would have reported tax of $200,000. X disclosed its involvement in the transaction as required by the regulations under section 6011, and thus was not subject to a penalty under section 6707A(a). As a person who is required to file periodic reports under section 13 or 15(d) of the Securities Exchange Act of 1934, however, X was also required, pursuant to section 6707A(e), to disclose the penalty imposed under section 6662A to the Securities and Exchange Commission, which X failed to do. X's failure to disclose the section 6662A penalty is treated as a failure to disclose to which section 6707A(b) applies. Thus, X will be subject to a penalty under section 6707A(e), which will equal 75 percent of the decrease in tax resulting from the transaction. The decrease in tax resulting from the nonlisted reportable transaction was $190,000, 75 percent of which is $142,500. Because X is a corporation, the amount of the penalty will be limited to $50,000 under § 301.6707A-1(a) and section 6707A(b)(2)(B).
(g) * * *
(1) This section applies to penalties assessed after the date that these regulations are published as final regulations in the
(2) For penalties assessed before the date that these regulations are published as final regulations in the
Office of Surface Mining Reclamation and Enforcement, Department of the Interior.
Notice of public hearings.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are announcing the schedule for public hearings on the proposed Stream Protection Rule and the accompanying Draft Environmental Impact Statement (DEIS).
We will be holding public hearings on the proposed rule and DEIS on September 1, 3, 10, 15, and 17, 2015 at the locations listed in the
See the
The proposed rule, announced on July 16, 2015 and published on July 27, 2015 (80 FR 44436-44698), would modernize rules that are 32 years old in order to better protect people, water quality, and the environment from the adverse effects of coal mining. We will hold public hearings on the proposed Stream Protection Rule and the accompanying DEIS at the following locations on the listed dates:
Tuesday, September 1, 2015: Jefferson County Fairgrounds Event Center, 15200 W. 6th Ave., Golden, CO 80401.
Thursday, September 3, 2015: Lexington Convention Center, 430 W. Vine St., Lexington, KY 40507.
Thursday, September 10, 2015: St. Charles Convention Center, 1 Convention Center Plaza, St. Charles, MO 63303.
Thursday, September 10, 2015: DoubleTree by Hilton Hotel Pittsburgh, 500 Mansfield Ave., Pittsburgh, PA 15205.
Tuesday, September 15, 2015: Mountain Empire Community College, 3441 Mt. Empire Rd., Big Stone Gap, VA 24219.
Thursday, September 17, 2015: Charleston Civic Center, 200 Civic Center Dr., Charleston, WV 25301
All hearings are scheduled to begin at 5 p.m. and end at 9 p.m. We will provide opportunities for interested parties to deliver or write comments onsite at each public hearing. We will also provide an opportunity for participants to speak with a court reporter who will transcribe their verbal comments for the written record. Additionally, the public will be able to speak in a public hearing format. Those speaking in the public hearing format must register to do so at the hearing, and will be called on a first-come, first-served basis as time allows. Verbal comments will be limited to two minutes in order to allow as many people to speak as possible. People are encouraged to provide their complete detailed comments in writing.
The primary purpose of the hearings is to obtain input on the proposed rule and DEIS. Therefore, we encourage you to limit your testimony to the merits of the provisions of the proposed rule and DEIS.
At the hearing, a court reporter will record and prepare a verbatim transcription of all comments presented. This written record will be made part of the docket for the DEIS and/or proposed rule. If you have a written copy of your comments, we encourage you to provide a copy to the moderator to assist the court reporter in preparing the written record.
If you are a disabled individual who needs reasonable accommodations to attend a public hearing, please contact the person listed under
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing a limited approval and limited disapproval of Regulation 2, Rules 1 and 2 for the Bay Area Air Quality Management District (BAAQMD or District) portion of the California State Implementation Plan (SIP) submitted on April 22, 2013. These revisions consist of significant updates to rules governing the issuance of permits for stationary sources, including review and permitting of major sources and major modifications under parts C and D of title I of the Clean Air Act (CAA). The intended effect of this proposed limited approval and limited disapproval action is to update the applicable SIP with current BAAQMD permitting rules and to set the stage for remedying certain deficiencies in these rules. If finalized as proposed, this limited disapproval action would trigger an obligation for EPA to promulgate a Federal Implementation Plan unless California submits and we approve SIP revisions that correct the deficiencies within two years of the final action, and for certain deficiencies the limited disapproval would also trigger sanctions under section 179 of the CAA unless California submits and we approve SIP revisions that correct the deficiencies within 18 months of final action.
Any comments must arrive by September 28, 2015.
Submit comments, identified by docket number EPA-R09-OAR-2015-0280, by one of the following methods:
1.
2.
3.
Shaheerah Kelly, EPA Region 9, (415) 947-4156,
Throughout this document, the terms “we,” “us,” and “our” refer to EPA.
For the purpose of this document, we are giving meaning to certain words or initials as follows:
• The word or initials
• The word or initials
• The initials
• The words
• The initials
• The initials
• The initials
• The initials or words
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
• The initials
On April 22, 2013, CARB submitted amended rules, BAAQMD Regulation 2, Rules 1 and 2 for approval as a revision to the BAAQMD portion of the California SIP under the CAA. Regulation 2 contains the District's air quality permitting programs. Regulation 2, Rule 1 contains general requirements that apply to all District air quality permitting programs. Regulation 2, Rule 2 contains the District's New Source Review (NSR) permit programs for both attainment and nonattainment pollutants. This SIP revision submittal represents a comprehensive revision to BAAQMD's preconstruction review and permitting program and is intended to satisfy the requirements of part C (PSD) and part D (nonattainment NSR) of title I of the Act as well as the general preconstruction review requirements for minor sources
Table 1 lists the rules addressed by this proposal with the dates that they were adopted by BAAQMD and submitted to EPA by CARB, which is
On June 26, 2013, the April 22, 2013 submittal of Regulation 2, Rules 1 and 2 was deemed to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. The submittal includes evidence of public notice and adoption of the amended rules. While we can act only on the most recently submitted version of each regulation (which supersedes earlier submitted versions), we have reviewed materials provided with previous submittals. Our TSD provides additional background information on our evaluation of Regulation 2, Rules 1 and 2.
The existing SIP-approved NSR program for new or modified stationary sources in the Bay Area consists of the rules identified below in Table 2. Collectively, these rules establish the NSR requirements for both major and minor stationary sources under BAAQMD jurisdiction in California, including requirements for the generation and use of emission reduction credits in nonattainment areas.
Consistent with the District's stated intent to have the submitted NSR rules replace the existing SIP-approved NSR program in its entirety, EPA's approval of the regulations identified above in Table 1 would have the effect of entirely superseding our prior approval of these two rules (including a prior approval of a single subsection) in the current SIP-approved program. Table 2 lists the existing rules in the California SIP governing NSR for stationary sources under BAAQMD jurisdiction.
The purpose of this proposed rule is to present our evaluation under the CAA and EPA's regulations of the amended NSR rules submitted by CARB on April 22, 2013, as identified in Table 1. We provide our reasoning in general terms below but provide a more detailed analysis in our TSD, which is available in the docket for this proposed rulemaking.
EPA has reviewed BAAQMD Regulation 2, Rules 1 and 2 for compliance with the CAA's general requirements for SIPs in CAA section 110(a)(2), part C of title I (sections 160 through 169) for the PSD program, and part D of title I (sections 172, 173, 182(a) and 189(e)) for the nonattainment NSR program. EPA also evaluated the rules for compliance with the CAA requirements for SIP revisions in CAA sections 110(l), 193 and 302(z). In addition, EPA evaluated the submitted rules for consistency with the regulatory provisions of 40 CFR part 51, subpart I (Review of New Sources and Modifications) (
Among other things, section 110 of the Act requires that SIP rules be enforceable, and provides that EPA may not approve a SIP revision if it would interfere with any applicable requirements concerning attainment and reasonable further progress or any other requirement of the CAA. Section 110(a)(2) and section 110(l) of the Act require that each SIP or revision to a SIP submitted by a State must be adopted after reasonable notice and public hearing.
Section 110(a)(2)(C) of the Act requires each SIP to include a program to regulate the modification and construction of any stationary source within the areas covered by the SIP as necessary to assure attainment and maintenance of the NAAQS. In addition to the permit programs required under parts C and D of title I of the Act for PSD and nonattainment NSR sources, respectively, EPA's regulations at 40 CFR 51.160-51.164 provide general programmatic requirements to implement this statutory mandate commonly referred to as the “minor NSR program.”
Part C of title I of the Act establishes the general statutory requirements for a PSD permit program. Additionally, 40 CFR 51.166 sets forth EPA's regulatory requirements for a SIP-approved PSD program. 40 CFR 52.21 is EPA's FIP containing regulatory requirements to implement a PSD program and its provisions may be incorporated by reference into a SIP-approved PSD program.
Part D of title I of the Act contains certain procedural requirements for developing and revising SIPs, and establishes general statutory requirements for a nonattainment NSR permit program. Subpart 4 of part D of title I of the Act includes section 189(e), which requires the control of major stationary sources of PM
Our TSD, which can be found in the docket for this rule, contains a more detailed evaluation and discussion of the approval criteria. As described below, EPA is proposing a limited approval and limited disapproval of the submitted NSR rules.
With respect to procedural requirements, CAA sections 110(a)(2) and 110(l) require that revisions to a SIP be adopted by the State after reasonable notice and public hearing. EPA has promulgated specific procedural requirements for SIP revisions in 40 CFR part 51, subpart F. These requirements include publication of notices, by prominent advertisement in the relevant geographic area, of a public hearing or notice of an opportunity for a public hearing on the proposed revisions, and a public comment period of at least 30 days.
Based on our review of the public process documentation included in the April 22, 2013 submittal, we find that the BAAQMD has provided sufficient evidence of public notice, and an opportunity for comment and a public hearing prior to adoption and submittal of these rules to EPA.
With respect to substantive requirements, we have evaluated Regulation 2, Rules 1 and 2, in accordance with the CAA and regulatory requirements that apply to: (1) General preconstruction review programs for minor sources under section 110(a)(2)(C) of the Act, (2) PSD permit programs under part C of title I of the Act, and (3) nonattainment NSR permit programs under part D of title I of the Act. For the most part, the submitted NSR rules satisfy the applicable requirements for these three permit programs and will strengthen the applicable SIP by updating the rules and adding requirements to address new or revised NSR permitting provisions promulgated by EPA in the last several years. However, the submitted NSR rules also contain a few deficiencies which prevent full approval. Below, we discuss generally our evaluation of BAAQMD's submitted rules and the deficiencies that are the basis for our proposed limited disapproval of these rules. Our TSD contains a more detailed evaluation and recommendations for program improvements.
Section 110(a)(2)(C) of the Act requires that each SIP include a program to provide for “regulation of the modification and construction of any stationary source within the areas covered by the plan as necessary to assure that national ambient air quality standards are achieved, including a permit program as required in parts C and D” of title I of the Act. Thus, in addition to the permit programs required in parts C and D of title I of the Act, which apply to new or modified major stationary sources of pollutants, each SIP must include a program to regulate the construction and modification of any stationary source within the area as necessary to assure that the NAAQS are achieved. These general pre-construction requirements are commonly referred to as “minor NSR” and are subject to EPA's implementing regulations in 40 CFR 51.160-51.164. Regulation 2, Rules 1 and 2 satisfy most of the statutory and regulatory requirements for minor NSR programs, but we have identified the following three deficiencies that form part of the basis for our proposed limited disapproval.
First, the definition of “Agricultural Source” in section 2-1-239 and the provision concerning the loss of an exemption in section 2-1-424 cross-reference and rely on requirements in other District rules that are not approved in the SIP. Specifically, subsection 2-1-239.1 and section 2-1-424 rely on requirements in Regulation 2, Rule 10 (Large Confined Animal Facility Operations). In addition, subsection 2-1-239.3 relies on requirements in Regulation 2, Rule 6 (Major Facility),
Second, section 2-2-308 specifies that the District's APCO shall not issue an Authority to Construct (ATC) for a new or modified emission unit or stationary source that will result in a “significant net increase” (
Lastly, the rule submittal is deficient because it does not contain a prohibition on the issuance of an ATC if the project does not meet all applicable requirements of the control strategy as required in 40 CFR 51.160(a).
Compared to the provisions in the existing SIP that are used to implement the minor NSR program, the submitted rule revisions represent an overall strengthening of BAAQMD's minor NSR program. For example, the rule revisions include: (1) more specific criteria for permit applications and conditions for permit issuance, (2) new provisions to prevent emissions from new or modified sources from causing or contributing to a violation of a NAAQS, (3) new provisions for public notification and comment for minor NSR projects that result in a significant net emission increase, and (4) new and revised provisions that clarify what new and modified sources are exempt from obtaining an ATC permit. Overall, we expect the submitted revisions will allow for more effective implementation and enforcement of the requirements applicable to minor stationary sources in the Bay Area.
Part C of title I of the Act contains the provisions for the prevention of significant deterioration of air quality in areas designated “attainment” or “unclassifiable” for the NAAQS, including preconstruction permit requirements for new major sources or major modifications proposing to construct in such areas. EPA's regulations for PSD permit programs are found in 40 CFR 51.166. EPA's FIP implementing the PSD program in areas without a SIP-approved program is found at 40 CFR 52.21. BAAQMD is currently designated as “attainment” or “unclassifiable/attainment” for all NAAQS pollutants, except for the 2008 8-hour ozone (marginal) and 2006 24-hour PM
Regulation 2, Rules 1 and 2 contain the requirements for review and permitting of PSD sources. Regulation 2, Rule 1 contains some general NSR definitions, the major modification applicability determination procedures, and certain administrative requirements that apply to the issuance of all permits covered under Regulation 2, including PSD permits. Regulation 2, Rule 2 contains most of the NSR and PSD definitions, and all of the substantive
First, subsection 2-1-234.2.2 provides an adequate definition of major modification by incorporating 40 CFR 51.166(b)(2) by reference. However, the second sentence of section 2-1-234.2 attempts to satisfy these requirements by incorporating by reference the substantive requirements of the PSD applicability procedures for determining if a project will result in a major modification. (See 40 CFR 51.166(a)(7)) The BAAQMD rules cannot incorporate 40 CFR 51.166(a)(7) by reference because it consists of instructions to the State and not requirements for an applicant seeking a PSD permit. When provisions are incorporated by reference, the exact wording of the provision is read into the text of the rule. Therefore, the text of 40 CFR 51.166(a)(7) does not contain the necessary wording to require a source to perform the calculations required by the PSD applicability procedures in 40 CFR 51.166(a)(7). Similarly, the recordkeeping provisions required when projected actual emissions are used to determine emission increases are set forth in 40 CFR 51.166(r)(6) and (r)(7). For the same reason, these provisions cannot be incorporated by reference. These deficiencies may be resolved by incorporating by reference the provisions contained in 40 CFR 52.21 for specifying the applicability procedures, applicable definitions, and recordkeeping requirements.
Second, the definition of “PSD Pollutant” in section 2-2-223 begins by referencing EPA's definition of a regulated NSR pollutant in 40 CFR 52.21(b)(50). However, section 2-2-223 then excludes from the definition any pollutants for which the Bay Area has been designated as nonattainment for a NAAQS. Excluding nonattainment pollutants conflicts with the federal definition of “regulated NSR pollutant” in 40 CFR 52.21(b)(50) which includes all NAAQS pollutants, regardless of attainment status. Because this definition is used for determining whether a source is a “Major PSD Facility,” as defined in subsection 2-2-224.1, the rule is deficient for PSD applicability purposes. A stationary source is considered a major stationary source if
Third, the air quality analysis and modeling requirements in subsection 2-2-305.3 provide that where an air quality model specified in 40 CFR part 51, appendix W (Guideline on Air Quality Models) is inappropriate, the model may be modified or another model substituted upon written approval by the Air Pollution Control Officer (APCO) after public notice and opportunity for public comment under the procedures set forth in section 2-2-404. This provision is deficient because subsection 3.2.2 of 40 CFR 51, appendix W, regarding the use of alternative models, requires written approval by the Administrator prior to using any modification or substitution of a model, and subsection 2-2-305.3 does not require this approval. The District may resolve this deficiency by revising subsection 2-2-305.3 such that it requires approval by the EPA, as well as the APCO.
Finally, the fugitive emission calculation procedure in Section 2-2-611 provides that fugitive emissions shall be included only if the facility is in one of the 28 source categories listed in section 169(1) of the Act. However, 40 CFR 51.166(b)(1)(iii)(aa) includes an additional source category: “any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act.” Therefore, we find that Regulation 2, Rule 2 is deficient for PSD purposes because it does not require fugitive emissions from all listed source categories.
Although BAAQMD's existing SIP rules in Regulation 2, Rule 2 contained certain PSD-related provisions, the District has never had a SIP-approved PSD permitting program. The BAAQMD has been conducting PSD evaluations and issuing PSD permits under a delegation agreement between the District and the EPA pursuant to 40 CFR 52.21(u).
Approval of Regulation 2, Rules 1 and 2 represents an overall strengthening of BAAQMD's SIP rules because it includes updated PSD provisions, is mostly consistent with EPA's requirements in the CAA and 40 CFR 51.166, and results in a SIP-approved PSD program to regulate new or modified major stationary sources of attainment or unclassifiable NAAQS pollutants.
Part D of title I of the Act contains the general requirements for areas designated “nonattainment” for a NAAQS, including preconstruction permit requirements for new major sources or major modifications proposing to construct in such nonattainment areas, commonly referred to as “Nonattainment New Source Review” or “NSR.” EPA's regulations for NSR permit programs are found in 40 CFR 51.165. BAAQMD is currently designated nonattainment for the 2008 8-hour ozone (marginal) and 2006 24-hour PM
Regulation 2, Rules 1 and 2 contain the NSR requirements for review and permitting of major sources and major modifications located in the Bay Area. Similar to the District's PSD program, Regulation 2, Rule 1 contains some general NSR definitions, the major modification applicability procedures, and certain administrative requirements that apply to the issuance of all permits covered under Regulation 2, including major nonattainment NSR permits. Regulation 2, Rule 2 contains most of the NSR-specific definitions, and most
First, the language in subsection 2-1-234.2.1 for nonattainment pollutants fails for the same reasons discussed above for the PSD program. Specifically, while it is appropriate to incorporate 40 CFR 51.165(a)(1)(v) by reference, the second sentence of this subsection cannot incorporate the applicability procedures in 40 CFR 51.165(a)(2) by reference because it provides direction to States rather than to applicants seeking a nonattainment NSR permit. For the same reason, the recordkeeping requirements of 40 CFR 51.165(a)(6) and (a)(7) cannot be incorporated by reference. These deficiencies may be resolved by including the specific requirements contained in 40 CFR 51.165(a)(2), as well as (a)(6), and (a)(7). Our TSD has a further discussion of this issue and potential remedies.
Second, subsection 2-2-401.4 requires any application for a new major stationary source or major modification located in or within 100 km of a Class I area, to provide an analysis of potential impacts to air quality related values (including visibility) for each affected Class I area. However, Regulation 2, Rule 2 is deficient because it only requires a visibility analysis for sources that are located within 100 km of a Class I area, rather than for any source that “may have an impact on visibility in any mandatory Class I Federal Area,” as required by 40 CFR 51.307(b)(2). The NSR program must include this requirement as it pertains to any new major stationary source or major modification subject to nonattainment NSR permitting.
Third, subsection 2-2-411.2, pertaining to offset refunds, allows the District to provide an “offset refund” to a stationary source if excess offsets were provided at the time of permit issuance or for an emission unit that has not been constructed (or is constructed but never operated) and for which offsets have been provided. The provision does not specify a time after which a stationary source can no longer obtain an offset refund. It would not be appropriate to allow a source to request such a refund years after the project has been completed or canceled. To correct this deficiency, BAAQMD must remove this provision or amend the rule to provide an appropriate timeframe for obtaining an offset refund.
Fourth, the “Demonstration of NO
Fifth, subsection 2-2-605.2 is deficient because it allows existing “fully-offset” sources to generate ERCs based on the difference between the post-modification PTE and the surplus adjusted pre-modification PTE. ERCs intended to be used as offsets for emissions from new major sources or major modifications are only creditable if they are reductions of
Sixth, subsection 2-2-606.2 is deficient as it applies to major modifications because it allows “fully-offset” sources to calculate the emission increases from a proposed modification based on the difference between the post-modification PTE and pre-modification adjusted PTE. 40 CFR 51.165(a)(3)(ii)(J) requires that offsets must be provided for the actual increase in emissions from a major modification based on an actual to PTE emissions increase test. BAAQMD may resolve this deficiency by developing separate procedures based on the difference between the allowable emissions (
Finally, for the same reasons stated above in our evaluation of the PSD program, we find that section 2-2-611 of Regulation 2, Rule 2 is deficient because it does not require fugitive emissions from all listed source categories to be included when determining major source applicability for major nonattainment NSR review.
Compared to the provisions in the existing SIP, the submitted rule revisions represent an overall strengthening of BAAQMD's nonattainment NSR program. For example, the rule revisions include: (1) Incorporation of new requirements (
We are proposing to find that Regulation 2, Rules 1 and 2 satisfy the requirements of section 110(a)(2)(C) and parts C and D of title I of the Act. Section 110(l) of the CAA states that each SIP revision submitted by a State shall be adopted by such State after reasonable notice and public hearing. It also states that the Administrator shall not approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress, or any other CAA applicable requirement.
With respect to the procedural requirements of CAA section 110(l), based on our review of the public process documentation included in the April 22, 2013 SIP submittal package, we find that BAAQMD has provided sufficient evidence of public notice and opportunity for comment and public hearings prior to adoption and submittal of these rules to EPA. See the TSD for additional details.
With respect to the substantive requirements of section 110(l), we have determined that our approval of the BAAQMD NSR SIP submittal, as described in more detail in our TSD, represents a strengthening of BAAQMD's NSR program as compared to the District's current SIP-approved NSR program that was approved on January 26, 1999 (64 FR 3850), and that our limited approval of this SIP submittal would not interfere with any applicable requirement concerning attainment and RFP or any other applicable requirement of the Act. Therefore we are proposing limited approval and limited disapproval of the BAAQMD SIP revision under section 110(l) of the Act.
CAA title I, Part D, subpart 4 includes section 189(e), which requires the control of major stationary sources of PM
With respect to VOC and NO
Because Regulation 2, Rule 2 contains control and offset requirements for VOC, NO
The only PM
First, the District's EI letter indicates that the magnitude of actual ammonia emissions from major sources in the San Francisco Bay Air Basin is small. There are only three major sources of ammonia emissions (
Second, the District's 189(e) letter states that the District evaluated the impacts that ammonia emissions within the Bay Area may have on secondary particulate matter formation. The District conducted a modeling study in 2009 to evaluate this issue, and based on that study the District concluded that ammonia was not a significant contributor to secondary particulate matter formation that warranted inclusion in the District's NSR program at the time of the study.
Third, based on EPA's PM
As noted above, section 189(e) of the Act requires nonattainment NSR to apply to major stationary sources of PM
Section 193 of the Act, which was added by the Clean Air Act Amendments of 1990, includes a savings clause which provides, in pertinent part: “No control requirement in effect, or required to be adopted by an order, settlement agreement, or plan in effect before November 15, 1990, in any area which is a nonattainment area for any air pollutant may be modified after November 15, 1990, in any manner unless the modification insures equivalent or greater emission reductions of such air pollutant.”
We have reviewed the provisions included in BAAQMD's NSR SIP submittal and find that they would ensure equivalent or greater emission reductions compared to the current SIP-approved NSR program. The BACT and offset requirements, which are the primary control requirements of a NSR program, are equivalent or more stringent in the submitted rules as are contained in the existing SIP approved NSR rules. Therefore, we can approve the submitted NSR program under section 193 of the Act. Our TSD contains a more detailed evaluation.
Because the rule deficiencies described above are inappropriate for inclusion in the SIP, EPA cannot grant full approval of this rule under section 110(k)(3) of the Act. Pursuant to section 110(k)(3) of the Act, EPA is proposing a limited approval and limited disapproval of the submitted rules. We are proposing to approve the submitted rules based on our determination that the most of the rules satisfy the applicable statutory and regulatory provisions governing regulation of stationary sources under CAA section 110(a)(2)(C), including the permitting requirements for major stationary sources in parts C and D of title I of the Act. In support of this proposed action, we have concluded that our limited approval of the submitted rules would comply with sections 110(l) and 193 of the Act because the amended rules as a whole would not interfere with continued attainment of the NAAQS in the Bay Area, and do not relax control technology and offset requirements. We recommend limited disapproval to correct the deficiencies listed above. The intended effect of our proposed limited approval and limited disapproval action is to update the applicable SIP with current BAAQMD rules and to set the stage for remedying the rule deficiencies. If we finalize this action as proposed, our action would be codified through revisions to 40 CFR 52.220 (identification of plan).
If finalized as proposed, our limited disapproval action would trigger an obligation on EPA to promulgate a Federal Implementation Plan unless the deficiencies are corrected, and EPA approves the related plan revisions, within two years of the final action. Additionally, for those deficiencies that relate to the nonattainment NSR requirements under part D of title I of the Act, the offset sanction in CAA section 179(b)(2) would apply in the Bay Area nonattainment area 18 months after the effective date of a final limited disapproval, and the highway funding sanctions in CAA section 179(b)(1) would apply six months after the offset sanction is imposed. Neither sanction will be imposed under the CAA if California submits and we approve, prior to the implementation of the sanctions, SIP revisions that correct the deficiencies that we identify in our final action.
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference BAAQMD Regulation 2, Rule 1 (Permits, General Requirements) and BAAQMD Regulation 2, Rule 2 (Permits, New Source Review) which are discussed in section I.A. of this preamble. The EPA has made, and will continue to make, this document generally available electronically through
This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., because this proposed SIP disapproval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new information collection burdens but simply disapproves certain State requirements for inclusion into the SIP. Burden is defined at 5 CFR 1320.3(b).
The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant impact on a substantial number of small entities. This rule does not impose any requirements or create impacts on small entities. This proposed SIP disapproval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new requirements but simply disapproves certain State requirements for inclusion into the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome compliance or reporting requirements or timetables or exemptions from all or part of the rule. The fact that the Clean Air Act prescribes that various consequences (
We continue to be interested in the potential impacts of this proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. EPA has determined that the proposed disapproval action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This action proposes to disapprove pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”
This action does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132, because it merely disapproves certain State requirements for inclusion into the SIP and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, Executive Order 13132 does not apply to this action.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP EPA is proposing to disapprove would not apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This proposed SIP disapproval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new regulations but simply disapproves certain State requirements for inclusion into the SIP.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
The EPA believes that this action is not subject to requirements of Section 12(d) of NTTAA because application of those requirements would be inconsistent with the Clean Air Act.
Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA lacks the discretionary authority to address environmental justice in this rulemaking.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Animal and Plant Health Inspection Service, USDA.
30-Day notice of submission of information collection approval from the Office of Management and Budget and request for comments.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has submitted a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Comments must be submitted September 28, 2015.
Written comments may be submitted to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503;
To request additional information, please contact Ruth Brown (202) 720-8958 or Charlene Parker (202) 720-8681.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
The Agency received one comments in response to the 60-day notice published in the
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 Office of Management and Budget control number.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The purpose and need for the land exchange is: the Superior National Forest would acquire land inside the Boundary Waters Canoe Area Wilderness (BWCAW) from the Minnesota School Trust with outstanding wilderness/scenic/recreational opportunities, which will consolidate ownership and eliminate the risk of development or uses incompatible with wilderness values and management. The federal land located outside the BWCAW conveyed to the Minnesota School Trust would allow the State to manage lands outside the wilderness to generate revenue to
In February 2015, a scoping process for this project was initiated by the Forest Supervisor. The scoping period lasted until May 15, 2015 and included notification to a wide range of interested persons, adjacent landowners, state, local and tribal government, and organizations. In addition, five open houses were held in the project area and Saint Paul, MN. Over 1,600 comment letters were received from interested persons, adjacent landowners, state, local and tribal government, and organizations. Upon review of scoping comments, the Forest Supervisor decided to prepare an Environmental Impact Statement (EIS).
While further scoping comments will be accepted, it is anticipated that the scoping comments already received have thoroughly described the range of issues of interest to the public, agencies, organizations and governments. Scoping comments already received during the February-May 2015 scoping period are being considered, are part of the project record, and will provide standing to object per requirements of 36 CFR 218.
Any additional comments concerning the scope of the analysis must be received by September 30, 2015. The Draft Environmental Impact Statement is expected January 2016, and the Final Environmental Impact Statement is expected September 2016.
Send written comments to Brenda Halter, Forest Supervisor, RE: School Trust Land Exchange EIS, at 8901 Grand Avenue Place, Duluth, MN 55808. Comments may also be sent via email to
Peter Taylor, Forest Environmental Coordinator, at (218) 626-4368 or
The Superior National Forest would acquire land with outstanding wilderness/scenic/recreational opportunities, which will consolidate ownership and eliminate the risk of development or uses incompatible with wilderness values and management. This exchange is part of the long term strategy for acquiring all county and state lands in the BWCAW to resolve the long standing issue of wilderness restrictions limiting use of nonfederal lands. The acquisition of these lands is considered Priority 1 under Forest Plan Guideline G-LA-2 (p. 2-51).
The exchange would meet Forest Plan Land Adjustment Goal G-LA-5 (p. 2-52) for acquisition of Minnesota State School Trust Lands in the BWCAW through land exchange. This exchange has the potential to reduce and/or eliminate over 30 complex special use permits/easements reducing the cost of special use permit administration on the Forest. The authorized activities would continue but would be managed by the State. This would meet the intent of Forest Plan Guideline G-LA-3(e) (p. 2-52).
The conveyance of Federal land would reduce boundary management and landline costs. Federal parcels proposed for exchange were specifically identified to consolidate federal and state ownership patterns. This would meet the intent of Forest Plan Guideline G-LA-3(d) (p. 2-52).
The land conveyed would allow the State to actively manage lands outside the wilderness to generate revenue to benefit the MN public school system. The State would manage the conveyed land to provide for a wide variety of goods, uses and services similar to management under federal ownership. This would meet the intent of Forest Plan Guideline G-LA-3(b) (p. 2-52).
The Forest Service proposes to exchange federal lands of equal value from a pool of approximately 39,075 acres for approximately 30,000 acres of State lands. The final acres to be exchanged would reflect equal market values based on an appraisal compliant with federal standards. The possibility that all of the federal land will be necessary or that the federal land list will be inadequate is relatively low.
The Forest Service would also transfer authority and administration of special use permits located within the federal parcels to the Minnesota DNR. Many of these permits and easements involve both short and long-term authorizations for roads and trails, phone lines, electrical lines, fiber optics, and a county canister transfer station. These permits are located across the Forest and are administered by five ranger districts.
The State Constitution requires the State to reserve mineral rights in an exchange of School Trust lands. (Minn. Const. Art. XI Section 10.) The United States would reserve mineral rights on the 150 parcels where federal minerals occur.
Consideration of issues raised in scoping comments will be documented in the Draft Environmental Impact Statement.
Consideration of alternatives raised in scoping comments will be documented in the Draft Environmental Impact Statement.
Forest Supervisor, Superior National Forest.
The decision to be made is whether to exchange federal lands of equal value from a pool of approximately 39,075 acres for approximately 30,000 acres of State lands. The decision will include:
1. What actions would be used to address the purpose and need;
2. Where and when those actions would take place;
3. Any other actions that would be required.
In February 2015, a scoping process for this project was initiated by the Forest Supervisor. The scoping period lasted until May 15, 2015 and included notification to a wide range of interested persons, adjacent landowners, state, local and tribal government, and organizations. In addition, five open houses were held in the project area and Saint Paul, MN. Over 1,600 comment letters were received from interested persons, adjacent landowners, state, local and tribal government, and organizations. Upon review of scoping comments, the Forest Supervisor decided to prepare an EIS.
While further scoping comments will be accepted, it is anticipated that the scoping comments already received have thoroughly described the range of issues of interest to the public, agencies, organizations and governments. Scoping comments already received during the February-May 2015 scoping period are being considered, are part of the project record, and will provide standing to object per requirements of 36 CFR 218.
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and
The School Trust Land Exchange decision is subject to objections following Forest Service regulations at 36 CFR 218, Subparts A and B. Only individuals or organizations who submit timely and specific written comments as defined at 36 CFR 218.2 regarding the proposed project during a public comment period established by the Responsible Official are eligible to file an objection to the School Trust Land Exchange. Scoping comments already received during the February-May 2015 scoping period provide commenters with standing to object per requirements of 36 CFR 218.2. The opportunity to object will be provided when a draft decision on the project is published.
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 (FACA) that a meeting of the Texas State Advisory Committee (Committee) to the Commission will be held on Friday, September 18, 2015, at 1:30 p.m. for the purpose of planning projects on school discipline and voting rights.
This meeting is available to the public through the following toll-free call-in number: 888-503-8169, conference ID: 5785668. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments in the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by October 28, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angelica Trevino, Civil Rights Analyst, Western Regional Office, at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Friday, September 18, 2015,
Peter Minarik, DFO, at (213) 894-3437 or
Bureau of the Census, Department of Commerce.
Notice of Public Meeting.
The Bureau of the Census (Census Bureau) is giving notice of a meeting of the National Advisory Committee on Racial, Ethnic and Other Populations (NAC). The NAC will address census policies, research and methodology, tests, operations, communications/messaging, and other activities to ascertain needs and best practices to improve censuses, surveys, operations, and programs. The NAC will meet in a plenary session on October 8-9, 2015. Last-minute changes to the schedule are possible, which could prevent giving advance public notice of schedule adjustments. Please visit the Census Advisory Committee's Web site for the most current meeting agenda at:
October 8-9, 2015. On October 8, the meeting will begin at approximately 8:30 a.m. and end at approximately 5:00 p.m. On October 9, the meeting will begin at approximately 8:30 a.m. and end at approximately 1:30 p.m.
The meeting will be held at the U.S. Census Bureau, 4600 Silver Hill Road, Suitland, Maryland 20746.
Kim Collier, Assistant Division Chief for Stakeholders, Customer Liaison and Marketing Services Office,
The NAC comprises up to thirty-two members. The Committee provides an organized and continuing channel of communication between race, ethnic, and other populations and the Census Bureau. The Committee advises the Director of the Census Bureau on the full range of economic, housing, demographic, socioeconomic, linguistic, technological, methodological, geographic, behavioral, and operational variables affecting the cost, accuracy, and implementation of Census Bureau programs and surveys, including the decennial census. The Committee is established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2, Section 10(a)(b)).
All meetings are open to the public. A brief period will be set aside at the meeting for public comment on October 9. However, individuals with extensive questions or statements must submit them in writing to:
If you plan to attend the meeting, please register by Monday, October 5. You may access the online registration from the following link (please use Mozilla Firefox as your browser):
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Committee point of contact as soon as possible, preferably two weeks prior to the meeting.
Due to increased security and for access to the meeting, please call 301-763-9906 upon arrival at the Census Bureau on the day of the meeting. A photo ID must be presented in order to receive your visitor's badge. Visitors are not allowed beyond the first floor.
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).
These data are collected from the universe of school districts using uniform definitions and concepts of revenue, expenditure, debt, and assets as defined by the Financial Accounting for Local and State School Systems. This survey and the Annual Surveys of State and Local Government Finances (OMB No. 0607-0585) are conducted as part of the Census Bureau's State and Local Government Finance program. Data collected from cities, counties, states, and special district governments are combined with data collected from local school systems to produce state and national totals of government spending. Local school system spending comprises a significant portion of total government spending. In 2012, public elementary-secondary expenditures accounted for 33.6 percent of local government spending.
This comprehensive and ongoing, time series collection of local education agency finances maintains historical continuity in the state and local government statistics community. Elementary-secondary education related spending is the single largest financial activity of state and local governments. Education finance statistics provided by the Census Bureau allow for analyses of how public elementary-secondary school systems receive and spend funds. Increased focus on education has led to a demand for data reflecting student performance, graduation rates, and school finance policy—all of which are related to the collection of this local education finance data. State legislatures, local leaders, university researchers, and parents increasingly rely on data to make substantive decisions about education. School district finance is a vital sector of the education data spectrum used by stakeholders to form policy and to develop new education strategies.
The Census Bureau uses an announcement letter and form to collect state and local government public education finance data. We mail the letter electronically to respondents at the beginning of each survey period soliciting the assistance of the state education agencies (SEAs) in providing data centrally for their public school systems. The letter officially announces the opening of the collection period and requests administrative data, such as estimated date of submission, changes to reporting format from prior year, and updated contact information for the state coordinator. Census Bureau staff use the response to this letter to plan for the processing of state education agency data submissions. The form (F-33) contains the elementary-secondary education finance items. In practice, this form serves more as a data processing guide rather than as a data collection instrument. The Census Bureau relies heavily on collecting this public school system finance data centrally from state education agencies. All states provide significant amounts of these data centrally to the Census Bureau via the Internet using File Transfer Protocol (FTP). Supplemental forms are sent to school systems in states where the state education agency cannot provide information on assets (F-33-L1), indebtedness (F-33-L2), or both (F-33-L3).
The Census Bureau facilitates central collection by accepting states' data in one of two formats. Currently, 21 states provide the Census Bureau electronic copies of state-specific detailed education finance data files. The Census Bureau maintains programs for converting these data from the state agency format to the Census Bureau F-33 format. Thirty states reformat state-specific data files into the Census Bureau's format prior to submitting the data electronically to the Census Bureau.
The education finance data collected and processed by the Census Bureau are an essential component of the agency's state and local government finance collection and provide unique products for users of education finance data.
The Bureau of Economic Analysis (BEA) uses data from the survey to develop figures for the Gross Domestic Product (GDP). F-33 data items specifically contribute to the estimates for National Income and Product Accounts (NIPA), Input-Output accounts (I-O), and gross domestic investments. BEA also uses the data to assess other public fiscal spending trends and events.
The Census Bureau's Government Finances program has disseminated comprehensive and comparable public fiscal data since 1902. School finance data, which comprised 33.6 percent of all local government spending in 2012, is currently incorporated into the local government statistics reported on the Annual Surveys of State and Local Government Finances. The report contains benchmark statistics on public revenue, expenditure, debt, and assets. They are widely used by economists, legislators, social and political scientists, and government administrators.
The Census Bureau makes available detailed files for all school systems from
The NCES use these annual data as part of the Common Core of Data (CCD) program. The education finance data collected by the Census Bureau are the sole source of school district fiscal information for the CCD. NCES data users utilize electronic tools to search CCD databases for detailed fiscal and non-fiscal variables. Additionally, NCES uses F-33 education finance files to publish annual reports on the fiscal state of education.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
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 purpose of this collection is to gather information requested on behalf of the NIST SURF Program for both Gaithersburg and Boulder locations. The information is submitted by the university on behalf of the student applicants. The student information is utilized by laboratory program coordinators and technical evaluators to determine student eligibility, select students to appropriate research projects, which match their needs, interests, and academic preparation, and ultimately, make offers to participate in the program. The information includes: Student name, host institution, email address/contact information, permanent address, choice of SURF-specific location (Boulder and/or Gaithersburg), class standing, research preference for NIST laboratories/projects they wish to apply to (for Boulder, 6 project choices and for Gaithersburg, 2 laboratory choices), previous SURF participation/mentor identification, academic major/minor, current overall GPA, need for housing and gender (for housing purposes only), special skills (laboratory, computer programming etc.), availability dates, resume, personal statement of commitment and research interests, two letters of recommendation, academic transcripts, ability to verify U.S. citizenship or permanent legal residency, acknowledgement of housing request, background check, and requirements for REAL ID Act.
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 Institute of Standards and Technology, Commerce.
Notice; request for information.
The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, plans to discontinue the operation of its Cryogenic Flow Measurement Facility (Facility), located on NIST's campus in Boulder, Colorado, on September 30, 2015. NIST publishes this notice to request information on the industry's interest and needs in (1) cryogenic flow calibrations, (2) research areas of mutual interest to advance cryogenic flow calibrations, and (3) the re-establishment of the Facility at a different location. NIST will hold a public workshop to discuss these issues on Monday, September 28, 2015, on NIST's campus in Boulder, Colorado. Members of the public may register to participate in the public workshop in person or virtually by web conferencing.
NIST will accept responses to this request for information until 11:59 p.m. Eastern Time on September 28, 2015. No proprietary information should be included in the written responses to this request for information. The public workshop will be held on Monday, September 28, 2015, from 9:00 a.m. to 4:00 p.m. Mountain Time. Interested parties must register to participate in the public workshop by 5:00 p.m. Eastern Time on
Written responses to this request for information should be submitted to Dr. Michael Moldover, Sensor Science Division of the Physical Measurement Laboratory at the National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8440, Gaithersburg, Maryland 20899, or by electronic mail to
For further information, please contact Dr. Michael Moldover by mail to 100 Bureau Drive, Mail Stop 8440, Gaithersburg, Maryland 20899, or by electronic mail to
NIST's Cryogenic Flow Measurement Facility (Facility), located on NIST's campus in Boulder, Colorado, provides the public with the service of calibrating and testing flow meters using a closed loop liquid-nitrogen flow system. The Facility uses a dynamic weighing system to measure liquid mass and to calculate total mass and volume flow rates through a meter under test conditions. All measurements are traceable to the International System of Units using standards maintained at NIST. Upon completion of a meter calibration, NIST provides the customer with a final report, tabulated data, and plots summarizing the results.
The Facility has been in operation at NIST for nearly fifty years under the NIST Quality System (in conformance with ISO/TEC 17025). The calibration of cryogenic flow meters is listed among the NIST Calibration and Measurement Capabilities (CMC) within the key comparison database (KCDB) of the Bureau International des Poids et Mesures (BIPM). While it provides an important and unique service, NIST plans to discontinue the operation of the Cryogenic Flow Measurement Facility in Boulder at the end of September 2015. The Facility's current location will be used for NIST's new Communication Technology Laboratory.
The purpose of this request for information is to determine the level of interest and the needs of the industry for this type of calibration service. NIST is seeking information that responds to the questions listed below.
(1) What is your opinion of the quality and utility of the calibration services performed by the Facility?
(2) What are the benefits of continuing the calibration services?
(3) What are your ideas about how to collaborate with members of the industry or research organizations to further the research efforts in the field of cryogenic flow measurement, including the development of methods to allow cryogenic flow meters to be calibrated at room temperatures?
(4) What is your opinion of the creation of a new research consortium for cryogenic flow measurement that would be led by NIST?
(5) What is your opinion of the current or future need for the development of dynamic weighing techniques for the calibration of cryogenic flow meters beyond what is currently used by industry?
(6) What is your opinion about whether the Facility should be re-established, either at NIST's campus in Gaithersburg, Maryland, or at a different location?
Multiple responses from the same organization are permitted. No business proprietary information should be included in any correspondence to NIST in response to this request for information. NIST will not treat any information provided in response to this request for information as proprietary information. Any information received by NIST in response to this request may be used to communicate with the responders regarding future projects.
Public Workshop: NIST will hold a public workshop to lead an open discussion with participants regarding the questions listed above. The meeting will be held at NIST's campus in Boulder, Colorado on Monday, September 28, 2015. Participants may attend the public workshop in person or may participate virtually via web conferencing. All participants who wish to attend in person are required to register by 5:00 p.m. Eastern Time on Friday, September 25, 2015, at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of a Draft Programmatic Environmental Assessment; request for comments.
NMFS announces the availability of the “Draft Programmatic Environmental Assessment (DPEA) for Fisheries Research Conducted and Funded by the Northwest Fisheries Science Center (NWFSC).” Publication of this notice begins the official public comment period for this DPEA. The purpose of the DPEA is to evaluate, in compliance with the National Environmental Policy Act (NEPA), the potential direct, indirect, and cumulative impacts of conducting and funding fisheries and ecosystem research along the U.S. West Coast, including the Northern California Large Marine Ecosystem (NCLME), Puget Sound, and the Lower Columbia River Research Area (LCRRA).
Comments and information must be received no later than September 28, 2015.
Comments on the DPEA should be addressed to Kurt Fresh, Manager, Estuarine and Ocean Ecology Program, NMFS, Northwest Fisheries Science Center. The mailbox address for providing physical comments is 2725 Montlake Boulevard, East Seattle, WA
Kurt Fresh, Northwest Fisheries Science Center, NMFS, (206) 860-3200.
An electronic copy of the DPEA may be obtained by writing to the address specified above (see
The NWFSC is the research arm of NMFS in the Northwest Region of the Continental United States. The NWFSC conducts research and provides scientific advice to manage fisheries and conserve protected species in the Pacific Ocean (primarily the Continental Shelf Region of the Pacific Coast), Puget Sound, and Lower Columbia River Estuary (below Bonneville Dam). Research is aimed at monitoring fish stock recruitment, survival and biological rates, abundance and geographic distribution of species and stocks, and providing other scientific information needed to improve our understanding of complex marine ecological processes. Primary research activities include: Studies of early marine life and mortality processes of juvenile Pacific salmonids, bottom trawl surveys to support assessments of multiple groundfish species, stock assessments of Pacific hake, studies to support salmon recovery efforts in Puget Sound and the Columbia River Estuary, telemetry studies of numerous species, and extensive cooperative research projects designed to address current or emerging information needs of the commercial fishing industry such as bycatch reduction efforts. Many research activities also include active acoustic systems, plankton nets, and other oceanographic equipment that provide important data on the status and trends of marine ecosystems important for various fisheries and natural resource management processes.
NMFS has prepared the DPEA under NEPA to evaluate several alternatives for conducting and funding fisheries and ecosystem research activities as the primary Federal action. Additionally in the DPEA, NMFS evaluates a secondary Federal action—also called a “connected action” under 40 CFR 1508.25 of the Council on Environmental Quality's regulations for implementing the procedural provisions of NEPA (42 U.S.C. 4321
The following four alternatives are evaluated in the DPEA:
1. No-Action/Status Quo Alternative—Conduct Federal Fisheries and Ecosystem Research with Scope and Protocols Similar to Past Effort;
2. Preferred Alternative—Conduct Federal Fisheries and Ecosystem Research (New Suite of Research) with Mitigation for MMPA and ESA Compliance;
3. Modified Research Alternative—Conduct Federal Fisheries and Ecosystem Research (New Suite of Research) with Additional Mitigation; and
4. No Research Alternative—No Fieldwork for Federal Fisheries and Ecosystem Research Conducted or Funded by NWFSC.
The first three alternatives include a program of fisheries and ecosystem research projects conducted or funded by the NWFSC as the primary Federal action. Because this primary action is connected to a secondary Federal action to consider authorizing incidental take of marine mammals under the MMPA, NMFS must identify as part of this evaluation “(t)he means of effecting the least practicable adverse impact on the species or stock and its habitat.” (Section 101(a)(5)(A) of the MMPA [16 U.S.C. 1361
NMFS is also evaluating a second type of no-action alternative that considers no federal funding for fieldwork on fisheries and ecosystem research activities. This is called the No Research Alternative to distinguish it from the No-Action/Status Quo Alternative. The No-Action/Status Quo Alternative will be used as the baseline to compare all of the other alternatives.
Potential direct and indirect effects on the environment are evaluated under each alternative in the DPEA. The environmental effects on the following resources are considered: physical environment, special resource areas, fish, marine mammals, birds, sea turtles, invertebrates, and the social and economic environment. Cumulative effects of external actions and the contribution of fisheries research activities to the overall cumulative impact on the aforementioned resources is also evaluated in the DPEA for the geographic regions in which NWFSC surveys are conducted.
NMFS requests comments on the DPEA for Fisheries Research Conducted and Funded by the National Marine Fisheries Service, Northwest Fisheries Science Center. Please include, with your comments, any supporting data or literature citations that may be informative in substantiating your comment.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The South Atlantic Fishery Management Council (Council) will hold meetings of the Habitat Protection and Ecosystem-Based Management Committee; Protected Resources Committee; Dolphin Wahoo Committee; Personnel Committee (Closed Session); Advisory Panel Selection Committee (Closed Session); Southeast Data, Assessment and Review (SEDAR) Committee (partially Closed Session); King and Spanish Mackerel Committee; Snapper Grouper Committee; Data Collection Committee; Law Enforcement Committee; Executive Finance Committee; and a meeting of the Full Council. The Council will also hold a Council Member Visioning Workshop for the Snapper Grouper Fishery. The Council will take action as necessary. The Council will also hold a formal public comment session.
The Council meeting will be held from 8:30 a.m. on Monday, September 14, 2015 until 12 noon on Friday, September 18, 2015.
Kim Iverson, Public Information Officer, SAFMC; phone (843) 571-4366 or toll free (866) SAFMC-10; fax (843) 769-4520; email:
The items of discussion in the individual meeting agendas are as follows:
1. Council members will receive a recap of the June 2015 Visioning Workshop, review public input on the draft Vision Blueprint, discuss planning for the October Council Visioning Workshop, and provide guidance to staff.
1. The committee will review the status of the Fishery Ecosystem Plan II development and receive updates on Ecosystem modelling, and Essential Fish Habitat.
2. The committee will discuss the gear stowage language in Coral Amendment 8 and the rulemaking to implement the amendment. The committee will provide recommendations for Council consideration.
1. The Committee will receive updates on protected resource-related issues, receive an overview of the Biological Opinion for the Coastal Migratory Pelagic fishery, and updates on the status of the Endangered Species Act/Magnuson-Stevens Act Integration Agreement and issues from the U.S. Fish and Wildlife Service.
1. The committee will receive an update on the status of commercial and recreational catches versus annual catch limits (ACLs), a presentation on recent landings and quota monitoring issues in 2014 and 2015, and an overview of commercial catches and past consideration of trip limits.
2. The committee will discuss issues and provide guidance to staff.
1. The committee will review the staff retirement health insurance proposal and receive an update on the search for a new Executive Director.
1. The committee will review applications for open advisory panel seats and develop recommendations for Council consideration.
1. The committee will appoint goliath grouper reviewers for the SEDAR 47 Review Workshop (Closed Session)
2. The committee will review and approve the Terms of References for the golden tilefish stock assessment update and goliath grouper workshop, review and approve the Council's Research Plan, receive an update on the Headboat Data Evaluation from NOAA Fisheries, and develop 2017-19 assessment priorities.
3. The committee will provide recommendations for Council consideration.
1. The committee will receive an update on the status of commercial and recreational catches versus ACLs and an update on the status of amendments under Formal Review.
2. The committee will receive a report on the Gulf of Mexico Fishery Management Council actions relative to the Coastal Migratory Pelagics FMP.
3. The committee will review Coastal Migratory Pelagics Amendment 26 addressing king mackerel ACLs, allocations, stock boundary options, and sales provisions, modify the amendment as necessary and select preferred alternatives.
1. The committee will receive updates from NOAA Fisheries on the status of catches versus annual catch limits and the status of amendments currently under formal Secretarial review.
2. The committee will receive a report from the Scientific and Statistical Committee, discuss measures for blueline tilefish including the development of a regulatory amendment to modify the Acceptable Biological Catch (ABC) and Annual Catch Limit (ACL). The committee will modify the draft document, select preferred management alternatives and approve for public hearings. The committee will also review the Options Paper for Amendment 38 to the Snapper Grouper Fishery Management Plan (FMP) for blueline tilefish and provide guidance to staff.
3. The committee will review public hearing comments for Snapper Grouper Regulatory Amendment 16 (black sea bass pot closure), develop recommendations for modifying the document, select preferred management alternatives, and approve actions in the amendment.
4. The committee will receive an update of the Southeast Reef Fish
5. The committee will review public scoping comments on Amendment 37 to the Snapper Grouper FMP addressing measures for hogfish, discuss and provide direction to staff.
6. The committee will receive an overview of Snapper Grouper Regulatory Amendment 23 addressing management measures for golden tilefish, black sea bass and the Jacks Complex, review public scoping comments, discuss and provide direction to staff.
7. The committee will also review draft Amendment 41 to the FMP addressing measures for mutton snapper and provide direction to staff.
8. The committee will review the second round of public hearing comments for Snapper Grouper Amendment 36 (Spawning Special Management Zones), modify the document as appropriate and provide recommendations relative to actions in the amendment to the Council.
9. The committee will receive an overview of the Joint South Atlantic and Gulf of Mexico South Florida Amendment, develop recommendations for modifying the document as appropriate, and provide guidance to staff.
10. The committee will receive an overview of a possible approach for a Red Snapper Amendment for the 2016 red snapper season, provide recommendations on approving the amendment for public scoping, and provide guidance to staff.
11. The committee will review recommendations from the Oculina Evaluation Team Report and provide guidance to staff. The committee will also receive an update on approaches to monitor recreational harvest of deepwater species, discuss, and provide guidance to staff.
1. The committee will make appointments for the Council's Citizen Science Workshop (Closed Session).
2. The committee will receive an update on the status of bycatch work from NOAA Fisheries, a presentation on the National Observer Program and an overview of the Comprehensive Ecosystem-Based Amendment addressing bycatch. The Committee will discuss the amendment and provide guidance to staff.
3. The committee will receive an overview of the Implementation Plan for Commercial Logbook Reporting and take action as appropriate. The committee will also receive an update on NOAA Fisheries' Commercial Logbook Pilot Study.
4. The committee will receive an overview of the joint Gulf of Mexico Council and South Atlantic Council Generic Charterboat Reporting Amendment, review the document, select preferred alternatives, and approve the amendment for public hearings.
1. The committee will receive a presentation on the use of Operator Permits in the Southeast as it relates to enforcement operations, discuss and provide guidance to staff.
1. The committee will receive an update on the status of Calendar-Year 2015 budget expenditures.
2. Address the Council Follow-up and priorities.
3. Discuss the webinar format used in recent public input sessions, provide direction to staff, and address other issues as appropriate.
Documents regarding these issues are available from the Council office (see
Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. 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 Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The North Pacific Fishery Management Council (Council) Crab Plan Team (CPT) will meet September 14 through September 17, 2015.
The meeting will be held on Monday, September 14 through Thursday, September 17, 2015, from 9 a.m. to 5 p.m.
The meeting will be held at the Alaska Fishery Science Center Traynor Room, 7600 Sand Point Way NE., Building 4, Seattle, WA 98115. Webex information will be posted on the agenda at
Diana Stram, Council staff; telephone: (907) 271-2809.
The agenda includes final overfishing limits and acceptable biological catch limits for snow crab, Tanner crab, Bristol Bay red king crab, Saint Matthew blue king crab, Pribilof Island blue king crab, Pribilof Island red king crab; model recommendations for Norton Sound red king crab, Aleutian Islands golden king crab; discussion of a generalized model application to Bristol Bay red king crab; review of an Exempted Fishing Permit for a closure in Bristol Bay; Essential Fish Halibut five year review; and final Stock Assessment and Fishery Evaluation (SAFE) report for Bearing Sea and Aleutian Islands Crab. The Agenda is subject to change, and the latest version will be posted at
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
The meeting will be held on Monday, September 14, 2015 at 9:30 a.m.
The meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789; fax: (617) 561-0798.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Advisory Panel (AP) plans to review the Draft 2016-18 Atlantic Herring Fishery Specifications Package and develop AP recommendations regarding the selection of final 2016-2018 Atlantic herring fishery specifications; the 2016-18 specifications will address overfishing levels and acceptable biological catch, management uncertainty, optimum yield and a stock-wide annual catch limit (ACL) for Atlantic herring, Domestic Annual Harvest, Domestic Annual Processing, U.S. At-Sea Processing, Border Transfer, sub-ACLs (quotas) for each of the four Atlantic herring management areas, seasonal (monthly) sub-ACL allocations, research set-asides, set-asides for fixed gear fisheries, and annual gear/area-specific catch caps for river herring/shad (RH/S). They also plan to review/discuss the Draft Environmental Assessment for the NMFS-led omnibus Industry-Funded Monitoring (IFM) Amendment; review options under consideration to establish IFM in the Atlantic herring fishery and
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 the meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Herring Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
The meeting will be held on Tuesday, September 15, 2015 at 9:30 a.m.
The meeting will be held at the Hilton Garden Inn, 100 Boardman Street, Boston, MA 02128; phone: (617) 567-6789; fax: (617) 561-0798.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The committee will receive a report from the September 14, 2015 Herring Advisory Panel (AP) meeting and consider the Herring AP recommendations. They also plan to review the Draft 2016-18 Atlantic Herring Fishery Specifications Package and develop committee recommendations regarding the selection of final 2016-18 Atlantic herring fishery specifications (anticipated at the September 2015 Council meeting). The committee will also review/discuss the Draft Environmental Assessment for the NMFS-led omnibus Industry-Funded Monitoring (IFM) Amendment and develop recommendations regarding the selection of a Preferred Alternative for the options to establish IFM in the Atlantic herring fishery. Additionally, the committee will provide an opportunity for the public to submit scoping comments on Amendment 8 to the Atlantic Herring Fishery Management Plan. They will also discuss other business as necessary.
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 the meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Daniel P. Costa, Ph.D., University of California at Santa Cruz, Long Marine Laboratory, 100 Shaffer Road, Santa Cruz, CA 95064, has applied in due form for a permit to conduct research on pinnipeds in Antarctica.
Written, telefaxed, or email comments must be received on or before September 28, 2015.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Amy Sloan or Brendan Hurley, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The purpose of this research is to understand the foraging ecology,
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for letter of authorization; request for comments and information.
NMFS' Office of Protected Resources has received a request from the NMFS Northwest Fisheries Science Center (NWFSC) for authorization to take small numbers of marine mammals incidental to conducting fisheries research, over the course of five years from the date of issuance. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the NWFSC's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the NWFSC's application and request.
Comments and information must be received no later than September 28, 2015.
Comments on the applications should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.
An electronic copy of the NWFSC's application may be obtained by visiting the Internet at:
Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361
Incidental taking shall be allowed if NMFS finds that the taking will have a negligible impact on the species or stock(s) affected and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses, and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such taking are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.” Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: “Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”
On August 10, 2015, NMFS received an application from the NWFSC
The Federal Government has a responsibility to conserve and protect living marine resources in U.S. federal waters and has also entered into a number of international agreements and treaties related to the management of living marine resources in international waters outside the United States. NOAA has the primary responsibility for managing marine fin and shellfish species and their habitats, with that responsibility delegated within NOAA to NMFS.
In order to direct and coordinate the collection of scientific information needed to make informed management decisions, Congress created six Regional Fisheries Science Centers, each a distinct organizational entity and the scientific focal point within NMFS for region-based federal fisheries-related research. This research is aimed at monitoring fish stock recruitment, abundance, survival and biological rates, geographic distribution of species and stocks, ecosystem process changes, and marine ecological research. The NWFSC is the research arm of NMFS in the Pacific Northwest.
Research is aimed at monitoring fish stock recruitment, survival and biological rates, abundance and geographic distribution of species and stocks, and providing other scientific information needed to improve our understanding of complex marine ecological processes. The NWFSC proposes to administer and conduct these survey programs over the five-year period. Several of these surveys also use active acoustic devices.
Interested persons may submit information, suggestions, and comments concerning the NWFSC's request (see
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to 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.
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 6/19/2015 (80 FR 35320-35321), 6/26/2015 (80 FR 36772) and (80 FR 36773-36774) and 7/2/2015 (80 FR 38179), 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:
United States Army Corps of Engineers, Department of Defense.
Notice.
The U.S. Army Corps of Engineers (Corps) has updated the existing guidance for providing in-kind credit under Section 221(a)(4) of the Flood Control Act of 1970, as further amended by Section 1018 of the Water Resources Reform and Development Act of 2014.
Written comments must be submitted on or before September 28, 2015.
You may submit comments, identified by docket number COE-2015-0013 by any of the following methods:
Janice E. Rasgus, Planning and Policy Division, Washington, DC at 202-761-7674.
Section 1018(d) of WRRDA 2014 requires the Corps to update and publish this draft of ER 1165-2-208 in the
1.
2.
3.
a. The Section 221 crediting provisions apply to the study, design, and construction of water resources development projects authorized in the Water Resources Development Act of 1986 or later laws, including projects initiated after November 16, 1986 without specific authorization in law. In addition, the crediting provisions apply to the correction of design deficiencies for projects authorized prior to the Water Resources Development Act of 1986. Finally, these provisions are also applicable to a project under the an environmental infrastructure assistance program.
(1) For a project with a project partnership agreement (PPA) that was executed on or after November 8, 2007, such PPA may be amended to include work by the non-Federal sponsor that
(2) Furthermore, in general, the crediting provisions of Section 221 will be used in lieu of Section 104 of WRDA 1986 and Section 215 of the Flood Control Act of 1968. However, any eligibility for credit under Section 104 of WRDA 1986 that was approved previously by the Secretary will be honored.
b. The authority for credit under Section 221 credit is in addition to any other authority to provide credit for in-kind contributions. Section 221 credit may be applied in lieu of other crediting provisions if requested by the non-federal sponsor.
4.
a.
b.
c.
d.
(1)
(a)
(i) Whether the proposed work is a modification of an existing Federal project;
(ii) Whether the proposed work will follow an existing levee alignment in the case of a flood risk management project;
(iii) Whether the proposed work balances and integrates the wise use of flood plains to ensure public safety;
(iv) Whether the proposed work significantly reduces flood damage risk to human life, property or critical infrastructure; and
(iv) Whether the proposed work will likely be included in the final project recommendation.
(b)
(2)
(3)
(a)
(b)
(4) Any work undertaken by a non-Federal sponsor pursuant to an In-Kind MOU is at its own risk and responsibility. An In-Kind MOU provides no assurance that the non-Federal sponsor's work will be determined to be integral to the Federal project or that any construction undertaken by the non-Federal sponsor will be included as part of any ultimately recommended Federal project. Execution of an In-Kind MOU in no way obligates the Corps to enter
(5) MSC Commanders may approve a District Engineer's execution of Model In-Kind MOUs for Construction or for Design, provided that the MOUs do not include any deviations. Any proposed deviations must be submitted to HQUSACE for approval prior to execution. Models for the In-kind MOU for construction, including design work, and for design work only are available at
e.
(1) Section 221 provides that credit may be afforded only if the Secretary determines that the material or service provided as an in-kind contribution by a non-Federal sponsor is integral to the study or project.
(2) The approval of integral determinations is delegated to the MSC Commander. The approval authority delegated to the MSC Commander is subject to the full compliance of each integral determination to law and policy and may not be further delegated within the MSC or to the District Commander. A separate integral determination is not required for planning activities included in the project management plan, approved by the MSC Commander, as required for the study effort.
f.
(1) The amount of in-kind contributions that may be eligible for inclusion in shared costs for cost sharing purposes under the applicable cost sharing agreement will be subject to an audit by the Government to determine the reasonableness, allocability, and allowability of such amount.
(2) The creditable amount is the lesser of the costs incurred by the non-Federal sponsor to obtain such materials or services; the market value of such materials or services as of the date that the non-Federal sponsor provides such materials or services for use in the study or project; or the Government's estimate of the cost for such work if it had been accomplished by the Government. This amount is not subject to interest charges or to adjustment to reflect changes in price levels between the time the in-kind contributions were completed and the time the amount is credited.
(3) Any in-kind contributions performed or paid for by the non-Federal sponsor using funds provided by another Federal agency (as well as any non-Federal matching share or contribution that was required by such Federal agency for such program or grant) are not eligible for credit unless the Federal agency providing the Federal portion of such funds verifies in writing that the funds are authorized to be used to carry out the study or project.
(4) After execution of the applicable FCSA, DA, or PPA, the non-Federal sponsor will submit to the Government (not less frequently than every 6 months) credit request(s) for eligible in-kind contributions under that agreement. The credit requests will contain the following: (a) Written certification by the non-Federal sponsor of the payments made to contractors, suppliers, or employees for in-kind contributions; (b) copies of all relevant invoices and evidence of such payments; (c) written identification of costs that have been paid with funds or grants provided by a Federal agency as well as any non-Federal matching share or contribution that was required by such Federal agency for such program or grant; and (d) a written request for credit of a specific amount not in excess of such specified payments. Failure to provide sufficient documentation supporting the credit request will result in a denial of credit in accordance with the terms of the applicable cost sharing agreement.
(5) In-kind contributions are subject to a review (for feasibility level and design activities) or on-site inspection (construction), as applicable, and certification by the Government that the work was accomplished in a satisfactory manner and in accordance with applicable Federal laws, regulations, and policies. The Government will not include in the costs to be shared under the applicable cost sharing agreement or afford credit for any work the Government determines was not accomplished in a satisfactory manner or in accordance with applicable Federal laws, regulations, and policies.
(6) In general, the amount of credit for in-kind contributions that can be afforded under a FCSA or a PPA is limited to the amount of the non-Federal sponsor's cost share under that agreement. As the costs of design under a Design Agreement (DA) are included in total project costs under a PPA, credit for in-kind contributions under a DA is carried over to the PPA, and the maximum of amount of credit for in-kind contributions under a PPA is limited to the non-Federal sponsor's required cost share under the PPA. Credit for in-kind contributions may not be afforded toward the required 5 percent cash payment for structural flood damage reduction projects or the additional 10 percent cash payment for navigation projects.
(7) Credit for in-kind contributions for planning is limited to credit that can be afforded under a specific FCSA. In other words, excess credit may not be carried over to design or construction of the project. Credit for planning work by the non-Federal sponsor is limited to its 50 percent of planning costs and will be done in accordance with the PMP, under the terms and conditions in the FCSA.
(8) Credit for in-kind contributions provided by a non-Federal sponsor for the construction of a project, or separable element thereof, that are in excess of the non-Federal cost share for an authorized separable element of a project may be applied toward the non-federal cost share for a different authorized separable element of the same project. Additional Federal appropriations will be required to offset the application of any excess credit to another separable element.
(9) If the value of eligible in-kind contributions exceeds the amount of credit that can be afforded pursuant to the provisions of a PPA (
(10) No reimbursements are authorized for in-kind contributions under Section 221 except as provided in paragraph 4 g., below.
g.
(1) Previously, credit for in-kind contributions was afforded only toward the non-Federal sponsor's required cash contribution after consideration of the value of LERRDs provided by the non-Federal sponsor. WRRDA 2014 changes how credit for in-kind contributions is calculated. For projects other than navigation projects, to the extent that credit for LERRDs combined with credit for the value of in-kind contributions exceed the non-Federal share of the cost of a project, WRRDA 2014 provides that the Secretary, subject to the availability of funds, shall enter into a separate reimbursement agreement to reimburse the non-Federal sponsor for the difference between creditable LERRDs and in-kind contributions and the non-Federal cost share. Therefore, at the final accounting for the project, to the extent funds for the project remain available, the Secretary shall execute an agreement with the non-Federal sponsor for reimbursement of the difference.
(2) If funds remaining on a project are insufficient to provide full reimbursement under paragraph f.(1), the non-Federal sponsor may request reimbursement. The Secretary shall prioritize such requests, and enter into reimbursements agreements, in the order the requests were received, as funds become available for reimbursements.
5.
a. If the value of eligible in-kind contributions is less than the non-Federal sponsor's share of design costs, the non-Federal sponsor must contribute sufficient funds to equal its share of total design costs.
b. If the value of eligible in-kind contributions is greater than the non-Federal sponsor's share of total design costs, then no cash payment from the non-Federal sponsor is required. The value of all of the non-Federal sponsor's eligible in-kind contributions (including those in excess of its share of total design costs) will be included in total project costs in the PPA. The maximum amount of credit that may be afforded pursuant to the PPA is limited to the non-Federal sponsor's cost share under that agreement.
6.
a. To be eligible for credit, in-kind contributions prior to execution of the PPA must have been provided or performed after execution of an In-Kind MOU. Credit for in-kind contributions will not be afforded toward the non-Federal sponsor's requirement to provide in cash 5 percent of the costs for structural flood damage reduction projects (either specifically authorized or implemented pursuant to Continuing Authority Program Sections 14, 205, or 208 projects); the non-Federal sponsor's requirement to pay for betterments or any other work performed by the Government on behalf of the non-Federal sponsor; the non-Federal sponsor's requirement to provide lands, easements, rights-of-way, relocations, or improvements to enable the disposal of dredged or excavated material required for the project or separable element of the project; or the non-Federal sponsor's additional payment of 10 percent of the cost of general navigation features for a navigation project.
b. The non-Federal sponsor may not initiate construction following execution of a PPA until the designs, detailed plans and specifications, and arrangements for the prosecution of such work have been approved by the Government. In addition, any proposed changes to approved designs and plans and specifications must be approved by the Government in advance of such construction. Upon completion of construction, the non-Federal sponsor will furnish to the Government a copy of all final as-built drawings.
c. For CAP authorities and regional authorities that are implemented with a single agreement covering design and implementation, if a non-Federal sponsor proposes to provide or perform all or a portion of the design for a project as in-kind contributions, a PPA addressing both design and construction is required.
(4) Credit for in-kind contributions.
(A) In general. A partnership agreement described in paragraph (1) may provide with respect to a project that the Secretary shall credit toward the non-Federal share of the cost of the project, including a project implemented without specific authorization in law or a project under an environmental infrastructure assistance program, the value of in-kind contributions made by the non-Federal interest, including—
(i) the costs of planning (including data collection), design, management, mitigation, construction, and construction services that are provided by the non-Federal interest for implementation of the project;
(ii) the value of materials or services provided before execution of the partnership agreement, including efforts on constructed elements incorporated into the project; and
(iii) the value of materials and services provided after execution of the partnership agreement.
(B) Condition. The Secretary may credit an in-kind contribution under subparagraph (A) only if the Secretary determines that the material or service provided as an in-kind contribution is integral to the project.
(C) Work performed before partnership agreement.
(i) Construction.
(I) In general. In any case in which the non-Federal interest is to receive credit under subparagraph (A) for the cost of construction carried out by the non-Federal interest before execution of a partnership agreement and that construction has not been carried out as of November 8, 2007, the Secretary and the non-Federal interest shall enter into an agreement under which the non-Federal interest shall carry out such work and shall do so prior to the non-Federal interest initiating construction or issuing a written notice to proceed for the construction.
(II) Eligibility. Construction that is carried out after the execution of an agreement to carry out work described in subclause (I) and any design activities that are required for that construction, even if the design activity is carried out prior to the execution of the agreement to carry out work, shall be eligible for credit.
(ii) Planning.
(I) In general. In any case in which the non-Federal interest is to receive credit
(II) Eligibility. Planning that is carried out by the non-Federal interest after the execution of an agreement to carry out work described in subclause (I) shall be eligible for credit.
(D) Limitations. Credit authorized under this paragraph for a project—
(i) shall not exceed the non-Federal share of the cost of the project;
(ii) shall not alter any other requirement that a non-Federal interest provide lands, easements, relocations, rights-of-way, or areas for disposal of dredged material for the project;
(iii) shall not alter any requirement that a non-Federal interest pay a portion of the costs of construction of the project under sections 101(a)(2) and 103(a)(1)(A) of the Water Resources Development Act of 1986 (33 U.S.C. 2211(a)(2); 33 U.S.C. 2213(a)(1)(A)) of the Water Resources Development Act of 1986 (33 U.S.C. 2211; 33 U.S.C. 2213); and
(iv) shall not exceed the actual and reasonable costs of the materials, services, or other things provided by the non-Federal interest, as determined by the Secretary.
(E) Analysis of costs and benefits. In the evaluation of the costs and benefits of a project, the Secretary shall not consider construction carried out by a non-Federal interest under this subsection as part of the future without project condition.
(F) Transfer of credit between separable elements of a project. Credit for in-kind contributions provided by a non-Federal interest that are in excess of the non-Federal cost share for an authorized separable element of a project may be applied toward the non-Federal cost share for a different authorized separable element of the same project.
(G) Application of credit.
(i) In general. To the extent that credit for in-kind contributions, as limited by subparagraph (D), and credit for required land, easements, rights-of-way, dredged material disposal areas, and relocations provided by the non-Federal interest exceed the non-Federal share of the cost of construction of a project other than a navigation project, the Secretary, subject to the availability of funds, shall enter into a reimbursement agreement with the non-Federal interest, which shall be in addition to a partnership agreement under subparagraph (A), to reimburse the difference to the non-Federal interest.
(ii) Priority. If appropriated funds are insufficient to cover the full cost of all requested reimbursement agreements under clause (i), the Secretary shall enter into reimbursement agreements in the order in which requests for such agreements are received.”; and
(H) Applicability.
(i) In general. This paragraph shall apply to water resources projects authorized after November 16, 1986, including projects initiated after November 16, 1986, without specific authorization in law, and to water resources projects authorized prior to the date of enactment of the Water Resources Development Act of 1986 (Public Law 99-662) [enacted June 10, 2014], if correction of design deficiencies is necessary.
(ii) Authorization as addition to other authorizations. The authority of the Secretary to provide credit for in-kind contributions pursuant to this paragraph shall be in addition to any other authorization to provide credit for in-kind contributions and shall not be construed as a limitation on such other authorization. The Secretary shall apply the provisions of this paragraph, in lieu of provisions under other crediting authority, only if so requested by the non-Federal interest.
(a) In General.—Section 221(a)(4) of the Flood Control Act of 1970 (42 U.S.C. 1962d-5b(a)(4)) is amended—
(1) in subparagraph (A), in the matter preceding clause (i), by inserting “or a project under an environmental infrastructure assistance program” after “law”;
(2) in subparagraph (C) by striking “In any case” and all that follows through the period at the end and inserting the following:
“(i) CONSTRUCTION.—
“(I) In General.—In any case in which the non-Federal interest is to receive credit under subparagraph (A) for the cost of construction carried out by the non-Federal interest before execution of a partnership agreement and that construction has not been carried out as of November 8, 2007, the Secretary and the non-Federal interest shall enter into an agreement under which the non-Federal interest shall carry out such work and shall do so prior to the non-Federal interest initiating construction or issuing a written notice to proceed for the construction.
“(II) Eligibility.—Construction that is carried out after the execution of an agreement to carry out work described in subclause (I) and any design activities that are required for that construction, even if the design activity is carried out prior to the execution of the agreement to carry out work, shall be eligible for credit.
“(ii) PLANNING.—
“(I) In General.—In any case in which the non-Federal interest is to receive credit under subparagraph (A) for the cost of planning carried out by the non-Federal interest before execution of a feasibility cost-sharing agreement, the Secretary and the non-Federal interest shall enter into an agreement under which the non-Federal interest shall carry out such work and shall do so prior to the non-Federal interest initiating that planning.
“(II) Eligibility.—Planning that is carried out by the non-Federal interest after the execution of an agreement to carry out work described in subclause (I) shall be eligible for credit.”;
(3) in subparagraph (D)(iii) by striking “sections 101 and 103” and inserting “sections 101(a)(2) and 103(a)(1)(A) of the Water Resources Development Act of 1986 (33 U.S.C. 2211(a)(2); 33 U.S.C. 2213(a)(1)(A))”;
(4) by redesignating subparagraph (E) as subparagraph (H);
(5) by inserting after subparagraph (D) the following:
“(E) Analysis of Costs and Benefits.—In the evaluation of the costs and benefits of a project, the Secretary shall not consider construction carried out by a non-Federal interest under this subsection as part of the future without project condition.
“(F) Transfer of Credit Between Separable Elements of a Project.—Credit for in-kind contributions provided by a non-Federal interest that are in excess of the non-Federal cost share for an authorized separable element of a project may be applied toward the non-Federal cost share for a different authorized separable element of the same project.
“(G) APPLICATION OF CREDIT.—
“(i) In General.—To the extent that credit for in-kind contributions, as limited by subparagraph (D), and credit for required land, easements, rights-of-way, dredged material disposal areas, and relocations provided by the non-Federal interest exceed the non-Federal share of the cost of construction of a project other than a navigation project, the Secretary, subject to the availability of funds, shall enter into a reimbursement agreement with the non-Federal interest, which shall be in addition to a partnership agreement
“(ii) Priority.—If appropriated funds are insufficient to cover the full cost of all requested reimbursement agreements under clause (i), the Secretary shall enter into reimbursement agreements in the order in which requests for such agreements are received.”; and
(6) in subparagraph (H) (as redesignated by paragraph (4))—
(A) in clause (i) by inserting “, and to water resources projects authorized prior to the date of enactment of the Water Resources Development Act of 1986 (Public Law 99-662), if correction of design deficiencies is necessary” before the period at the end; and
(B) by striking clause (ii) and inserting the following:
“(ii) Authorization As Addition to Other Authorizations.—The authority of the Secretary to provide credit for in-kind contributions pursuant to this paragraph shall be in addition to any other authorization to provide credit for in-kind contributions and shall not be construed as a limitation on such other authorization. The Secretary shall apply the provisions of this paragraph, in lieu of provisions under other crediting authority, only if so requested by the non-Federal interest.”.
(b) Applicability.—Section 2003(e) of the Water Resources Development Act of 2007 (42 U.S.C. 1962d-5b note) is amended—
(1) by inserting “, or construction of design deficiency corrections on the project,” after “construction on the project”; and
(2) by inserting “, or under which construction of the project has not been completed and the work to be performed by the non-Federal interests has not been carried out and is creditable only toward any remaining non-Federal cost share,” after “has not been initiated”.
(c) Effective Date.—The amendments made by subsections (a) and (b) take effect on November 8, 2007.
(d) Guidelines.—
(1) In General.— Not later than 1 year after the date of enactment of this Act, the Secretary shall update any guidance or regulations for carrying out section 221(a)(4) of the Flood Control Act of 1970 (42 U.S.C. 1962d-5b(a)(4)) (as amended by subsection (a)) that are in existence on the date of enactment of this Act or issue new guidelines, as determined to be appropriate by the Secretary.
(2) Inclusions.— Any guidance, regulations, or guidelines updated or issued under paragraph (1) shall include, at a minimum—
(A) the milestone for executing an in-kind memorandum of understanding for construction by a non-Federal interest;
(B) criteria and procedures for evaluating a request to execute an in-kind memorandum of understanding for construction by a non-Federal interest that is earlier than the milestone under subparagraph (A) for that execution; and
(C) criteria and procedures for determining whether work carried out by a non-Federal interest is integral to a project.
(3) Public and Stakeholder Participation.— Before issuing any new or revised guidance, regulations, or guidelines or any subsequent updates to those documents, the Secretary shall—
(A) consult with affected non-Federal interests;
(B) publish the proposed guidelines developed under this subsection in the
(C) provide the public with an opportunity to comment on the proposed guidelines.
(e) Other Credit.—Nothing in section 221(a)(4) of the Flood Control Act of 1970 (42 U.S.C. 1962d-5b(a)(4)) (as amended by subsection (a)) affects any eligibility for credit under section 104 of the Water Resources Development of 1986 (33 U.S.C. 2214) that was approved by the Secretary prior to the date of enactment of this Act.
C-1. Determining if In-Kind Contributions Are Integral to the Study/Project. Establishing and allowing credit is a two step process whereby: 1) eligibility is determined by performing the integral determination, and 2) actual affording of credit is accomplished by audit of the non-Federal work by the District Engineer under the terms of the FCSA, DA, or PPA, as appropriate. The Government must determine that the in-kind contributions are integral to the study or project for those contributions to be considered eligible for credit.
a. Approval Level of Integral Determinations. Under the terms of Paragraph 4.e.. of this regulation, approval of integral determinations is delegated to the MSC Commander. This authority may not be further delegated.
b. Timing of Integral Determinations.
(1) The integral determination must be completed immediately prior to review and approval of a DA or PPA, or amendment as applicable, that provides for the affording of credit. The integral determination for planning efforts is accomplished as part of the development of the PMP. An integral determination is not required prior to execution of an In-Kind MOU for design or construction.
(2) Include at least 30 days in the project schedule for processing at the MSC of the Integral Determinations by the MSC Commander. These times are recommended for scheduling purposes and should be extended if processing identifies significant issues requiring resolution.
c. Procedures for Processing.
(1) For a feasibility study, planning activities, including data collection, must be included in the approved Project Management Plan in order for those contributions to be eligible for credit.
(2) The District will prepare an Integral Determination Report (IDR) for design and construction work that includes at a minimum the information contained in the following paragraphs. A suggested format for an IDR can be found at
(3) The district will submit the IDR to the MSC District Support Team for action. The MSC District Support Team will perform the MSC review of the IDR. The MSC review team also will include members from the MSC Office of Counsel and from the MSC Planning Community of Practice (CoP), MSC
(4) The Integral Determination approval memo will state whether the work identified in the IDR, or a portion thereof, has been determined to be integral to the project. In addition, the memo should state that determination of the actual value of the in-kind contributions and affording credit for such amount will be accomplished by the Government in accordance with the limitations, conditions, and terms of the applicable cost sharing agreement.
C-2. The following may be accepted as integral:
The proposed in-kind contributions are a part of the Federal project.
b. The proposed in-kind contributions consist of work that the Government would have otherwise provided or performed for the project, except for performance of activities that are inherently Governmental responsibilities (see paragraph C-3 below). Examples of activities that are acceptable in-kind contributions: performance of design of all or a portion of the Federal project, including data collection related to design work; demolition of buildings on lands required for the project; performance of design or construction related studies for historic preservation activities; performance of cost shared monitoring and adaptive management; and construction of a portion of the project.
c. For proposed in-kind contributions performed prior to execution of the applicable cost sharing agreement, the in-kind contributions have been reviewed or inspected, as applicable, and certified by the Government that the work was accomplished in a satisfactory manner and in accordance with applicable Federal laws, regulations, and policies.
d. For any proposed in-kind contributions proposed to be performed after execution of the PPA, the plans and specifications will be approved by the District Commander prior to initiation of the construction work.
e. For materials provided for use in construction work managed by the Government, the materials meet the minimum Government requirements for materials and any substitute materials have been determined to be a functional equivalent in accordance with policies governing contractor substitution of materials.
C-3. The following will not be accepted as integral:
a. The proposed in-kind contributions are not part of the Federal project.
b. The proposed in-kind contributions consist of performance of activities that are inherently Governmental responsibilities (
c. The proposed in-kind contributions are features or obligations that are a 100 percent non-Federal sponsor responsibility (
d. The proposed in-kind contributions have or will create a hazard to human life or property.
e. The proposed in-kind contributions have been determined to be environmentally unacceptable.
f. For proposed in-kind contributions performed prior to execution of the applicable cost sharing agreement, after review or inspection, as applicable, the Government cannot certify the proposed in-kind contributions were accomplished in a satisfactory manner and in accordance with applicable Federal laws, regulations, and policies.
g. For proposed in-kind contributions performed prior to execution of the applicable cost sharing agreement, the non-Federal sponsor has not performed the necessary operation, maintenance, repair, rehabilitation, or replacement.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of availability.
The U.S. Army Corps of Engineers (USACE), Wilmington District, Wilmington Regulatory Field Office has received a request for Department of the Army authorization, pursuant to Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbor Act, from the Town of Holden Beach to install a terminal groin structure on the east end of Holden Beach, extending into the Atlantic Ocean, just west of Lockwood Folly Inlet.
Written comments on the DEIS will be received until 5 p.m., October 13, 2015.
Copies of comments and questions regarding the DEIS may be submitted to: U.S. Army Corps of Engineers (Corps), Wilmington District, Regulatory Division, c/o Mrs. Emily Hughes. ATTN: File Number SAW-2011-01914, 69 Darlington Avenue, Wilmington, NC 28403.
Questions about the proposed action and DEIS can be directed to Mrs. Emily Hughes, Wilmington Regulatory Field Office, telephone: (910) 251-4635, facsimile (910) 251-4025, or email at
1.
The seaward section of the groin would be constructed with loosely placed 4- to 5-ft-diameter granite armor stone to facilitate the movement of sand past the structure, and would have a crest width of ~5 ft and a base width of ~40 ft, while the underlying geo-textile base layer would have a slightly greater width of ~45 ft. The shore anchorage segment would be entirely buried at the completion of groin construction and would remain buried so long as the position of the MHW line remains seaward of the initial post-construction primary dune line. The intermediate groin would be designed to be a relatively low-profile structure to maximize sand overpassing and to minimize impacts to beach recreation and aesthetics.
The proposed terminal groin is one of four such structures approved by the General Assembly to be constructed in North Carolina following passing of Senate Bill (SB) 110. The U.S. Army Corps of Engineers (USACE) determined that there is sufficient information to conclude that the project would result in significant adverse impact on the human environment, and has prepared a DEIS pursuant to the National Environmental Policy Act (NEPA) to evaluate the environmental effects of the alternatives considering the project's purpose and need. The purpose and need of the proposed Holden Beach East End Shore Protection Project is to provide shoreline protection that would mitigate ongoing chronic erosion on the eastern portion on the Town's oceanfront shoreline so as to preserve the integrity of its public infrastructure, provide protection to existing development, and ensure the continued public use of the oceanfront beach along this area.
2.
a. Potential impacts to marine biological resources (burial of benthic organisms, passageway for fish and other marine life) and Essential Fish Habitat.
b. Potential impacts to threatened and endangered marine mammals, reptiles, birds, fish, and plants.
c. Potential for effects/changes to Holden Beach, Oak Island, Lockwood Folly inlet, and the AIWW respectively.
d. Potential impacts to navigation.
e. Potential effects on federal navigation maintenance regimes, including the Federal project.
f. Potential effects of shoreline protection.
g. Potential impacts on public health and safety.
h. Potential impacts to recreational and commercial fishing.
i. Potential impacts to cultural resources.
j. Potential impacts to future dredging and nourishment activities.
3.
a. Alternative 1—No Action (Continue Current Management Practices);
b. Alternative 2—Abandon and Retreat;
c. Alternative 3—Beach Nourishment Only;
d. Alternative 4—Inlet Management and Beach Nourishment;
e. Alternative 5—Short Terminal Groin with Beach Nourishment;
f. Alternative 6—Intermediate Terminal Groin with Beach Nourishment/Applicants Preferred Alternative.
4.
The Corps will initiate consultation with the United States Fish and Wildlife Service pursuant to the Endangered Species Act and the Fish and Wildlife Coordination Act. The Corps will also consult with the National Marine Fisheries Service pursuant to the Magnuson-Stevens Act and Endangered Species Act. The Corps will coordinate with the State Department of Cultural Resources pursuant to Section 106 of the National Historic Preservation Act.
Potential water quality concerns will be addressed pursuant to Section 401 of the Clean Water Act through coordination with the North Carolina Divisions of Coastal Management (DCM) and Water Resources (DWR). This coordination will ensure consistency with the Coastal Zone Management Act and project compliance with water quality standards. The Corps has coordinated closely with DCM in the development of the DEIS to ensure the process complies with State Environmental Policy Act (SEPA) requirements, as well as the NEPA requirements. The DEIS has been designed to consolidate both NEPA and SEPA processes to eliminate duplications.
5.
Defense Nuclear Facilities Safety Board.
Hearing and meeting notice; correction.
The Defense Nuclear Facilities Safety Board (Board) published a notice in the
Mark Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.
In the
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 October 27, 2015.
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 Kashka Kubzdela, (202) 502-7411.
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 Special Education and Rehabilitative Services (OSERS), 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 28, 2015.
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 Rebecca Walawender, (202) 245-7399.
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.
Department of Energy (DOE).
Notice of Open Meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Thursday, September 17, 2015, 6:00 p.m.
Ohio State University, Endeavor Center, 1862 Shyville Road, Piketon, Ohio 45661.
Greg Simonton, Alternate Deputy Designated Federal Officer, Department of Energy Portsmouth/Paducah Project Office, Post Office Box 700, Piketon, Ohio 45661, (740) 897-3737,
U.S. Department of Energy.
Notice of public hearings.
The U.S. Department of Energy (DOE) announces public hearings to receive comments on the Draft EIS. The Draft EIS evaluates the environmental impacts of DOE's proposed Federal action of issuing a Presidential permit to the Applicant: Northern Pass LLC, to construct, operate, maintain, and connect a new electric transmission line across the U.S./Canada border in northern New Hampshire.
Written comments on the Draft EIS must be received by October 29, 2015. See
Written comments should be sent to:
See
Mr. Brian Mills at the addresses above, or at 202-586-8267.
DOE will conduct public hearings to receive oral comments on the draft EIS at the following locations commencing at the times identified:
Requests to pre-register to provide oral comments at a public hearing should be addressed to the Northern Pass EIS Team at this email address:
DOE invites interested Members of Congress, state and local governments, other Federal agencies, American Indian tribal governments, organizations, and members of the public to provide comments on the Draft EIS during the 90-day public comment period. The public comment period started on July 31, 2015, with the publication in the
Comments on the draft EIS can be submitted verbally during public hearings or in writing to Mr. Brian Mills using the methods set out in the
Take notice that on August 21, 2015, pursuant to sections 306 of the Federal Power Act, 16 U.S.C. 825(e) and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Eric S. Morris (Complainant) filed a formal complaint against the North American Electric Reliability Corporation (NERC) and SERC Reliability Corporation (SERC) (collectively, Respondents), alleging that the Respondents violated the NERC on Rules of Procedure Appendix 4B Sanction Guidelines in NERC Full Notice of Penalty regarding Entergy, FERC Docket No. NP15-31 filed July 30, 2015.
Eric S. Morris certifies that copies of the complaint were served on the contacts for NERC and SERC as listed on
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.
Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Environmental Protection Agency (EPA).
Notice.
EPA has granted amendments, extensions, and/or issuances of experimental use permits (EUPs) to the pesticide applicants described in Unit II. of the
Robert McNally, Director, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
This action is directed to the public in general. Although this action may be of particular interest to those persons who conduct or sponsor research on pesticides, EPA has not attempted to describe all the specific entities that may be affected by this action.
The dockets for these actions, identified by the docket identification (ID) numbers as shown in the body of this document, are available at
EPA has issued the following EUPs:
1.
2.
3.
4.
5.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice; extension of public comment period.
The Environmental Protection Agency (EPA) is announcing that the period for providing public comments on the “Notice of Availability of the Environmental Protection Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone National Ambient Air Quality Standard (NAAQS)” is being extended by 30 days.
For questions on the emissions data and on how to submit comments on the emissions data and related methodologies, contact Alison Eyth, Air Quality Assessment Division, Environmental Protection Agency, C339-02, 109 T.W. Alexander Drive, Research Triangle Park, NC 27709; telephone number: (919) 541-2478; fax number: (919) 541-1903; email:
The EPA is extending the public comment period for an additional 30 days. The public comment period will end on October 23, 2015, rather than September 23, 2015. This will ensure that the public has sufficient time to review and comment on all of the available information.
U.S. Environmental Protection Agency.
Notice.
The U.S. Environmental Protection Agency's (EPA) Office of the Chief Financial Officer is giving notice that it proposes to create a new system of records pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a). This system of records contains personally identifiable information (PII) collected from individuals registering to attend EPA-hosted meetings and events.
Persons wishing to comment on this system of records notice must do so by October 7, 2015.
Submit your comments, identified by Docket ID No. EPA-HQ-OEI-2014-0776, by one of the following methods:
•
•
•
•
•
Jessica Orquina, U.S. EPA, 202-564-0446.
The U.S. Environmental Protection Agency (EPA) plans to create a Privacy Act system of records for the online registration tool, Eventbrite. Eventbrite is a free, online registration tool that can be used to collect basic information for meetings and other events. Agency users can customize the registration page to a certain degree and upload images, such as a company logo or seal. For official EPA business, Agency users are permitted to upload the EPA logo or seal, and follow the format,
Each Eventbrite registration Web site has a unique “URL” or Web site address associated with it. The URL can only be accessed by individuals who receive it from the event organizer. There will be no publicly accessible Web site that will list invitation-only events and so there will not be an opportunity for anyone other than the intended audience to register for such events. Registration information will be saved on the password-protected Eventbrite.com Web site and only the designated organizer for a given event will be authorized and
Eventbrite.
Records are located in EPA offices, on computer servers in Headquarters, Regional Offices and at the third-party location.
Any individual that registers for an EPA-organized event using Eventbrite.com.
Information to be collected for purposes of creating an attendee roster for a specific event. Information collected may include name, title, organization, mailing address, email address, phone number, and special accommodations (such as visual or hearing impairment).
Section 2 of the E-Government Act of 2002 (Pub. L. 107-347, 44 U.S.C. 3601 n.); Section 2 of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3501)
The purpose of the Eventbrite tool is to collect information on meeting attendees that can be used for a head count, attendee roster, or printed materials, such as nametags and tent cards.
General routine uses B, H, I, J, K, and L apply to this system. (A detailed description of these routine uses can be found in the Agency's Systems of Records Web site at
•
•
•
•
Acting Associate Director of Web Communications and Social Media Lead, OPA/OWC, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460.
Any individual who wants to know whether this system of records contains a record about him or her, who wants access to his or her record, or who wants to contest the contents of a record, should make a written request to the EPA FOIA Office, Attn: EPA Privacy Officer, MC2822T, 1200 Pennsylvania Avenue NW., Washington, DC 20460.
Individuals seeking access to information in this system of records about themselves are required to provide adequate identification (
Requests for correction or amendment must identify the record to be changed and the corrective action sought. The EPA's procedures for making a Privacy Act request can be found in EPA's Privacy Act regulations at 40 CFR part 16.
The information stored in the system will be provided by the individuals registering for an EPA event.
None.
Notice: 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:
Environmental Protection Agency (EPA).
Notice; extension of comment period.
EPA issued a notice in the
Comments, identified by docket identification (ID) number EPA-HQ-OPP EPA-HQ-OPP-2015-0422, must be received on or before September 28, 2015.
Follow the detailed instructions provided under
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
This document extends the public comment period established in the
To submit comments, or access the docket, please follow the detailed instructions provided under
FFDCA section 408(b) [21 U.S.C. 346a(b)].
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the revision and renewal of an existing collection of information, as required by the Paperwork Reduction Act of 1995. Currently, the FDIC is soliciting comment on the renewal of the collection of information described below.
Comments must be submitted on or before October 27, 2015.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Gary A. Kuiper or John W. Popeo, at the FDIC address above.
Proposal to revise and renew the following currently-approved collection of information:
FDIC Form 3700/59, Fair Inclusion of Minorities and Women, is a contract clause implementing Section 342 (c)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5452). The contract clause seeks a commitment from an FDIC Contractor to ensure, to the maximum extent possible consistent with applicable law, the fair inclusion of minorities and women in its workforce and the workforces of its applicable subcontractors. Further, the clause asserts the FDIC's right to request documentation from the Contractor that demonstrates the Contractor's good faith effort to include minorities and women in its workforce and subcontractors' workforces, and requires the Contractor to annually certify that it has made such good faith efforts.
FDIC Form 3700/04A, Contractor Representations and Certification, must be completed by any offeror that responds to a solicitation for an award over $100,000. The Form is being revised to add two certifications, “Certification Regarding Fair Inclusion of Minorities and Women” and “Representation by Corporations Regarding an Unpaid Delinquent Federal Tax Liability.” The “Certification Regarding Fair Inclusion of Minorities and Women” implements § 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (12 U.S.C. 5452) and requires an offeror to certify to its commitment to equal opportunity in employment and contracting and that it has made and will continue to make a good faith effort to ensure, to the maximum extent possible, the fair inclusion of minorities and women in its workforce and in the workforce of its applicable subcontractors. The “Representation by Corporations Regarding an Unpaid Delinquent Federal Tax Liability” implements Section 744 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235)), by requiring an offeror to represent whether it is or is not “a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.”
Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the collections 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 collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
Federal Housing Finance Agency.
Notice of revision to an existing system of records; request for comments.
In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), the Federal Housing Finance Agency (FHFA) is reissuing the system of records entitled “National Mortgage Database Project” (FHFA-21). FHFA is re-issuing this notice in response to comments received on the Notice published on April 16, 2014 at 79 FR 21458. In reissuing this notice, FHFA requests further comments on the below revisions to the existing system of records.
This revised system of records covers the National Mortgage Database Project (“Project”), which is comprised of three components: (1) The National Mortgage Database (“NMDB”); (2) the information used to create the NMDB but will not be contained within the NMDB; and (3) National Surveys of Mortgage Borrowers (“Surveys”). The Project is designed to satisfy the Congressionally-mandated requirements of section 1324(c) of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended by the Housing and Economic Recovery Act of 2008. Under this statutory provision, FHFA must, through surveys of the mortgage market, collect information on the characteristics of individual mortgages, including those that are eligible for purchase by the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac) as well as those that are not, and subprime and nontraditional mortgages, including information on the creditworthiness of those borrowers sufficient to determine whether they would have qualified for prime lending.
To be assured of consideration, comments must be received on or before October 27, 2015. The revisions to the existing system will become effective on November 6, 2015 unless comments necessitate otherwise. FHFA will publish a new notice if, in order to review comments, the effective date is delayed or if changes are made based on comments received.
Submit comments, identified by “2015-N-07,” using only one of the following methods:
•
•
•
•
See
Forrest Pafenberg, Program Manager, National Mortgage Database Project,
FHFA seeks public comments on the revised system of records for the National Mortgage Database Project (FHFA-21) and will take all comments into consideration.
All comments received will be posted without change on the FHFA Web site at
This revised system of records covers the National Mortgage Database Project (“Project”), which is comprised of three components: (1) The National Mortgage Database (“NMDB”); (2) the information used to create the NMDB but will not be contained within the NMDB; and (3) National Surveys of Mortgage Borrowers (“Surveys”). Each of these components is described below.
The revised system of records, “National Mortgage Database Project” (FHFA-21), will contain records related to the creation of the NMDB. The core data for the NMDB are drawn from data maintained by one of the three national credit repositories as well as data to be drawn from: (1) Administrative data sources including existing mortgage data from Fannie Mae, Freddie Mac, the Federal Home Loan Banks (Banks), the Federal Housing Administration (FHA), the United States Department of Veterans Affairs (VA), and other government agencies; (2) Home Mortgage Disclosure Act (HMDA) data; and (3) other commercially available mortgage, property, and appraisal sources. Data from these various sources will be used to create and update the NMDB. Once the NMDB has been created from these sources, the input datasets will be permanently deleted and will not be maintained by the Project. The NMDB does not contain and is not a credit report or set of credit reports as defined under the Federal Credit Report Act, 15 U.S.C. 1681
Any information on borrower(s) in the NMDB that is available to FHFA, the Consumer Financial Protection Bureau (CFPB), or other authorized users of the NMDB is de-identified and does not include directly-identifiable information, such as borrower/co-borrower name, address, Social Security number or date of birth.
Construction of the NMDB begins with a random 1-in-20 sample of all first lien mortgages in the credit repository's files that were outstanding at any time between January 1998 (the start date of the data collection at the credit repository) and June 2012 (the start date of the Project). Each quarter a random 1-in-20 sample of mortgages that are newly reported to the credit repository is added. Currently the NMDB has been updated with this credit repository data through June 2015 and it will continue to be updated in the future. Mortgages remain in the NMDB until they terminate through prepayment (including refinancing), foreclosure or maturity. Information from credit repository files on each borrower associated with the mortgages in the NMDB will be collected from one year prior to origination to one year after termination of the mortgage.
In addition to the creation of the NMDB, the Project includes voluntary surveys of mortgage borrowers as part of the Surveys. The Surveys' target universe is first-lien closed-end residential mortgages and the associated borrowers. The Surveys supplement the NMDB with information not currently available through existing data sources. To achieve this objective, the Surveys draw their samples from mortgages that are part of the NMDB.
Responses to the Surveys will be maintained in de-identified form as part of the Project. Individuals contacted by the Surveys may choose to opt out of any future communications about the Surveys. Participation in the Surveys and opt-out list is voluntary and the opt-out list is kept separate from the NMDB by a third party vendor. The opt-out list contains the name and address of those individuals who have opted out of receiving communications about the Surveys in order to ensure that these individuals do not receive any future communications about the Surveys after opting out. FHFA and CFPB employees will not have access to this list.
This notice satisfies the Privacy Act requirement that an agency publishes a system of records notice in the
As required by the Privacy Act, 5 U.S.C. 552a(r), and pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (61 FR 6427, 6435 (February 20, 1996)), FHFA has submitted a report describing the system of records covered by this notice to the Committee on Oversight and Government Reform of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, and the Office of Management and Budget.
The revised system of records notice is set out in its entirety and described in detail below. The revisions from the previous SORN that FHFA issued in April 2014 include: (1) Deleting certain data fields that will not be collected and will not be part of the Project (
National Mortgage Database Project.
Sensitive but unclassified.
Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, and Experian Information Solutions Inc., 475 Anton Blvd., Costa Mesa, CA 92626.
Across the three components of the National Mortgage Database Project, information about individuals in the system will contain records that have been collected from: (1) Credit repository data; (2) administrative data sources including existing mortgage data from the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac), the Federal Home Loan Banks (Banks), the Federal Housing Administration (FHA), the United States Department of Veterans Affairs (VA), and other government agencies; (3) Home Mortgage Disclosure Act (HMDA) data; (4) members of the public as part of the National Surveys of Mortgage Borrowers; and (5) other commercially available mortgage, property, and appraisal sources.
This revised system of records covers the National Mortgage Database Project (“Project”), which is comprised of three components: (1) The National Mortgage Database (“NMDB”); (2) the information used to create the NMDB but will not be contained within the NMDB; and (3) National Surveys of Mortgage Borrowers (“Surveys”). Across these three components of the NMDB Project, records include five forms of loan-level data: mortgage record, real estate transaction, household demographic data on the borrower(s), physical characteristics of the house and neighborhood, and performance data on the mortgage and credit lines (
Under the first component and when the development phase of the NMDB is completed, the NMDB will contain de-identified records of borrowers and properties associated with a 1-in-20 nationally representative random sample of mortgages. These de-identified records may include: (1) Borrower(s) information (age, ZIP Code, race/ethnicity, gender, presence of children by various age categories, household income, credit score(s) of borrower(s) at origination, deceased indicator, and marital status); (2) Mortgage Information (current balance, actual monthly payment, delinquency grid, scheduled monthly payment, refinanced amount, and bankruptcy information); (3) Credit card/other loan information (account type, credit amount, account balance amount, account past due amount, account minimum payment amount, account actual payment amount, account high balance amount, account charge off amount, and second mortgage); (4) Property Attributes (property type, number of bedrooms and bathrooms, square footage, lot size, year built/age of structure, units in structure, most recent assessed value (per tax roll), year of most recent assessed value, effective age of structure, project name, and neighborhood name); (5) Real Estate Transaction Attributes (sales price, down payment, occupancy status (own, rent), new versus existing home, county, census tract, and date purchased); and (6) Mortgage Characteristics Attributes (mortgage product and purpose, origination date, acquisition date, amount of mortgage, refinanced amount, amount of down payment, term of mortgage, interest rate of mortgage, source of mortgage/mortgage channel, mortgage insurance type, loan to value at origination, origination amount/credit limit, originator, servicer(s), debt to income ratio at origination, number of borrower(s), number of units covered by the mortgage and the total number of units in the associated property, presence of prepayment penalty, origination points paid by borrower(s), discount points paid by borrower(s), balloon payment date/amount, percent of down payment, and secondary market indicator).
Under the second component, and solely for the purposes of matching records in the NMDB with other datasets as part of the construction of the NMDB, records may include: borrower(s) information such as name, address, Social Security number, date of birth, and mortgage account number. Records with direct identifying information, including name, address, Social Security numbers, date of birth, and mortgage account numbers, will be used solely by a credit repository behind a firewall for purposes of matching the records with other datasets, which will better enable FHFA to perform the statutory functions identified below. FHFA and Consumer Financial Protection Bureau (CFPB) employees will not have access to this direct identifying information.
The matching will be conducted by a credit repository. The matching will be conducted behind a firewall using a blind matching process on a 1-in-20 nationally representative random sample. FHFA and CFPB employees will not have access to this blind matching process.
After the matching is complete, the records with direct identifying information (name, Social Security number, date of birth, and mortgage account number) will be permanently destroyed by the credit repository and will not be maintained. A de-identified dataset, as described above, will be used for conducting research on and analysis of the mortgage markets.
FHFA may obtain updates or supplements to this de-identified dataset and, in those circumstances, may use record locaters unique to the source providing the update in order to update or supplement records. In these instances, FHFA's credit repository vendor may retain property address solely for the purpose of updating matches or conducting future matches with new data sets. FHFA and CFBP employees will not have access to this information.
Under the third component, the Surveys will collect and maintain records on demographic information from a subset of individuals who voluntarily respond to the Surveys to include: education status, military status, financial events and life events in the last couple of years, and assets and wealth. An opt-out list will be maintained by a third party vendor containing the name and address for those individuals who have opted-out in order to ensure that they do not receive future communications from the Surveys. FHFA and CFPB employees will not have access to this list.
12 U.S.C. 4511, 4513, 4543, and section 1324 of the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) as amended by section 1125 of the Housing and Economic Recovery Act of 2008 (12 U.S.C. 4544 and 4544(c)).
The records in this system of records are collected and maintained in order to facilitate mandatory reporting under the
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 FHFA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
(1) When (a) it is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; (b) FHFA 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 FHFA or another agency or entity) that rely upon the compromised information; and (c) the disclosure is made to such agencies, entities, and persons who are reasonably necessary to assist in connection with FHFA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(2) To members of advisory committees that are created by FHFA or by Congress to render advice and recommendations to FHFA or to Congress, to be used solely in connection with their official, designated functions.
(3) To contractor personnel and other authorized individuals working on a contract, cooperative agreement, or project for FHFA or CFPB related to the NMDB.
(4) To the Office of Management and Budget, Department of Justice, Department of Homeland Security, or other federal financial regulatory agencies to obtain advice regarding statutory, regulatory, policy, and other requirements related to the purpose for which FHFA collected the records.
(5) To the National Archives and Records Administration or other federal agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
(6) To a federal agency, organization, or individual for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
(7) To an FHFA regulated entity.
(8) De-identified, anonymized data with the CFPB in order to facilitate reporting under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203), as well as to conduct research, performance modeling, and market monitoring.
(9) De-identified, anonymized data to federal financial regulators and other U.S. Government agencies for conducting research and analysis related to the mortgage markets and for supervisory purposes; servicers are not identified and information cannot be used for enforcement actions against servicers.
None.
Records are maintained in electronic format, paper form, and magnetic disk or tape. Electronic records are stored in computerized databases. Paper and magnetic disk or tape records are stored in locked file rooms, locked file cabinets, or locked safes.
For the purposes of compiling data from the data sources under the second component of the Project, the records may contain anonymized personal identifiers (
Records are safeguarded in a secured environment. Buildings where records are stored have security cameras and 24-hour security guard service. Computerized records are safeguarded through use of access codes and other information technology security measures. Paper records are safeguarded by locked file rooms, locked file cabinets, or locked safes. Access to the records is restricted to those individuals who require access to the records in the performance of official duties related to the purposes for which the system is maintained and who have agreed, in writing, to maintain the confidentiality and integrity of the data.
Records are maintained in accordance with National Archives and Records Administration and FHFA retention schedules. Records are disposed of according to accepted techniques.
Project Manager, National Mortgage Database Project, Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024.
Direct inquiries as to whether this system contains a record pertaining to an individual to the Privacy Act Officer. Inquiries may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, or electronically at
Direct requests for access to the Privacy Act Officer. Requests may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 Seventh Street SW., Washington, DC 20024, or can be submitted electronically at
Direct requests to contest or appeal an adverse decision for a record to the Privacy Act Appeals Officer. Requests may be mailed to the Privacy Act Appeals Officer, Federal Housing
The information in this system will be obtained from: (1) Credit repository data; (2) administrative data sources, including mortgage data from Fannie Mae, Freddie Mac, the Banks, FHA, VA, and other government agencies; (3) HMDA data; (4) other commercially-available mortgage, property, and appraisal sources; and (5) individuals who voluntarily respond to the Surveys.
None.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than September 14, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
B. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166-2034:
1.
C. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
Regulation E applies to all financial institutions. In addition, certain provisions in Regulation E apply to entities that are not financial institutions, including those that act as service providers or automated teller machine (ATM) operators, merchants and other payees that engage in electronic check conversion (ECK) transactions, the electronic collection of returned item fees, or preauthorized transfers, issuers and sellers of gift cards and gift certificates, and remittance transfer providers.
1.
The information collection requirements associated with Regulation W comprise four notices: (1) the Loan Participation Renewal notice (12 CFR 223.15(b)(4)), which is a condition to an exemption for renewals of loan participations involving problem loans; (2) the Acquisition notice (12 CFR 223.31(d)(4)), which is a condition to an exemption for a depository institution's acquisition of an affiliate that becomes an operating subsidiary of the institution after the acquisition; (3) the Internal Corporate Reorganization Transactions notice (12 CFR 223.41(d)(2)), which is a condition to an exemption for internal corporate reorganization transactions; and (4) the Section 23A Additional Exemption notice (12 CFR 223.43(b)),which provides procedures for requesting additional exemptions from the requirements of section 23A. These notifications are event-generated and must be provided to the appropriate federal banking agency and, if applicable, the Federal Reserve Board within the time periods established by the law and regulation.
2.
3.
A bank is required to comply with the advanced approaches framework if it meets either of two independent threshold criteria: (1) consolidated total assets of $250 billion or more, as reported on the most recent year-end regulatory reports; or (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end.
A BHC is required to comply with the advanced approaches framework if the BHC has (1) Consolidated total assets (excluding assets held by an insurance underwriting subsidiary) of $250 billion or more, as reported on the most recent year-end regulatory reports; (2) consolidated total on-balance sheet foreign exposure of $10 billion or more at the most recent year-end; or (3) a subsidiary depository institution (DI) that is meets the criteria to be subject to the advanced approaches rule, or elects to adopt the advanced approaches. As of September 30, 2014, 13 BHCs meet the
Also, some banks or BHCs may voluntarily decide to adopt the advanced approaches framework. Both mandatory and voluntary respondents are required to meet certain qualification requirements before they can use the advanced approaches framework for risk-based capital purposes.
The Pillar 2 Guidance sets the expectation that respondents maintain certain documentation as described in paragraphs 37, 41, 43, and 46 of this portion of the guidance. Details of the expectations for each section are provided below.
Paragraph 37. In analyzing capital adequacy, a banking organization should evaluate the capacity of its capital to absorb losses. Because various definitions of capital are used within the banking industry, each banking organization should state clearly the definition of capital used in any aspect of its internal capital adequacy assessment process (ICAAP).
Paragraph 41. A banking organization should maintain thorough documentation of its ICAAP to ensure transparency. At a minimum, this should include a description of the banking organization's overall capital-management process, including the committees and individuals responsible for the ICAAP; the frequency and distribution of ICAAP-related reporting; and the procedures for the periodic evaluation of the appropriateness and adequacy of the ICAAP. In addition, where applicable, ICAAP documentation should demonstrate the banking organization's sound use of quantitative methods (including model selection and limitations) and data-selection techniques, as well as appropriate maintenance, controls, and validation. A banking organization should document and explain the role of third-party and vendor products, services and information—including methodologies, model inputs, systems, data, and ratings—and the extent to which they are used within the ICAAP. A banking organization should have a process to regularly evaluate the performance of third-party and vendor products, services and information. As part of the ICAAP documentation, a banking organization should document the assumptions, methods, data, information, and judgment used in its quantitative and qualitative approaches.
Paragraph 43. The board of directors and senior management have certain responsibilities in developing, implementing, and overseeing the ICAAP. The board should approve the ICAAP and its components. The board or its appropriately delegated agent should review the ICAAP and its components on a regular basis, and approve any revisions. That review should encompass the effectiveness of the ICAAP, the appropriateness of risk tolerance levels and capital planning, and the strength of control infrastructures. Senior management should continually ensure that the ICAAP is functioning effectively and as intended, under a formal review policy that is explicit and well documented. Additionally, a banking organization's internal audit function should play a key role in reviewing the controls and governance surrounding the ICAAP on an ongoing basis.
Paragraph 46. As part of the ICAAP, the board or its delegated agent, as well as appropriate senior management, should periodically review the resulting assessment of overall capital adequacy. This review, which should occur at least annually, should include an analysis of how measures of internal capital adequacy compare with other capital measures (such as regulatory, accounting-based or market-determined). Upon completion of this review, the board or its delegated agent should determine that, consistent with safety and soundness, the banking organization's capital takes into account all material risks and is appropriate for its risk profile. However, in the event a capital deficiency is uncovered (that is, if capital is not consistent with the banking organization's risk profile or risk tolerance) management should consult and adhere to formal procedures to correct the capital deficiency.
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
1.
2.
3.
4.
5.
6.
7.
8.
9.
For Edge corporations engaged in banking, current Schedules RC-M (with the exception of item 3) and RC-V are held confidential pursuant to Section (b)(4) of FOIA (5 U.S.C. 552(b)(4)). For investment Edge corporations, only information collected on Schedule RC-M (with the exception of item 3) are given confidential treatment pursuant to Section (b)(4) of FOIA (5 U.S.C. 552(b)(4)).
In addition, the information provided in the Patriot Act Contact Information section may be withheld as confidential under FOIA to prevent unauthorized individuals from falsely posing as an institution's point-of-contact in order to gain access to the highly sensitive and confidential communications sent by email between the Financial Crimes Enforcement Network or federal law enforcement officials and the Patriot Act point-of-contact. The identity and contact information of private individuals, which is collected and maintained for law enforcement purposes under the Patriot Act, appears exempt from disclosure pursuant to exemption 7(C) of FOIA (5 U.S.C. 552(b)(7)(C)).
Public Buildings Service, General Services Administration (GSA).
Notice of request for public comments regarding a new Office of Management and Budget (OMB) information clearance.
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), GSA will be submitting to OMB for review and approval a new information collection request concerning the Wireless Telecommunications Company Application. GSA will also be requesting from OMB approval to characterize this form as a common form, meaning that GSA will only request approval for its own use of the form, rather than aggregating the burden estimate across all Federal agencies that may use this form. A previous notice relating to the Wireless Telecommunications Company Application was published in the
Submit comments on or before September 28, 2015.
Submit comments identified by Information Collection 3090-00XX regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
Ms. Mary Ann Hillier, National Outlease Program Manager, PBS, GSA, at telephone 202-208-6139, or via email to
The purpose of this application is to streamline the business information collection process to accelerate the approval process between the Federal Government and a commercial wireless telecommunications company wishing to install a wireless antenna on a Federal asset for the expansion of the company's wireless network. Federal executive agencies with landholding authority will use this form.
One respondent submitted multiple comments on the request to approve the new information collection. The analysis of the public comments is summarized as follows:
If the application is being used for a system that does not require an FCC license, the carrier can notify the agency and the agency can, in turn, confirm with the FCC that a license is not required for the proposed installation.
With regard to the Potential Document Check List, item No. 1 refers to the business license that most, if not all, states require for a commercial business to be conducted in their state. Item No. 7 refers to the contractual requirement that lessees must comply with all applicable Federal, state, local government, and municipal laws, statutes, ordinances, rules, regulations, codes, decrees, orders and other such requirements, including, without limitation, those laws regarding wages and hours, health, safety, building codes, emergencies, and security.
Respondents:
Responses per Respondent:
Total Response Hours:
Hours per Response:
Total Burden Hours:
Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; ways to enhance the quality, utility and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond through the use of appropriate technological collection techniques or other forms of information technology.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems.
Written comments must be received on or before October 27, 2015.
You may submit comments, identified by Docket No. CDC-2015-0073 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems (OMB Control Number 0920-0960, Expiration 3/31/2016)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
In the United States (U.S.), drinking water distribution systems are designed to deliver safe, pressurized drinking water to our homes, hospitals, schools and businesses. However, the water distribution infrastructure is 50-100 years old in much of the U.S. and an estimated 240,000 water main breaks occur each year. Failures in the distribution system such as water main breaks, cross-connections, back-flow, and pressure fluctuations can result in potential intrusion of microbes and other contaminants that can cause health effects, including acute gastrointestinal and respiratory illness.
Approximately 200 million cases of acute gastrointestinal illness occur in the U.S. each year, but we lack reliable data to assess how many of these cases are associated with drinking water. Further, data are even more limited on the human health risks associated with exposure to drinking water during and after the occurrence of low pressure events (such as water main breaks) in drinking water distribution systems. A study conducted in Norway from 2003-2004 found that people exposed to low pressure events in the water distribution system had a higher risk for gastrointestinal illness. A similar study is needed in the United States.
The purpose of this data collection is to conduct an epidemiologic study in the U.S. to assess whether individuals exposed to low pressure events in the water distribution system are at an increased risk for acute gastrointestinal or respiratory illness. This study would be, to our knowledge, the first U.S. study to systematically examine the association between low pressure events and acute gastrointestinal and respiratory illnesses. Study findings will inform the Environmental Protection Agency (EPA), CDC, and other drinking water stakeholders of the potential health risks associated with low pressure events in drinking water distribution systems and whether additional measures (
We will conduct a cohort study among households that receive water from six water utilities across the U.S. The water systems will be geographically diverse and will include both chlorinated and chloraminated systems. These water utilities will provide information about low pressure events that occur during the study period using a standardized form (approximately 11 events per utility). Utilities will provide address listings of households in areas exposed to the low pressure event and comparable households in an unexposed area to CDC staff, who will randomly select participants and send them an introductory letter and questionnaire. Consenting household respondents will be asked about symptoms and duration of any recent gastrointestinal or respiratory illness, tap water consumption, and other exposures including international travel, daycare attendance or employment, animal contacts, and recreational water exposures. Study participants may choose between two methods of survey response: A mail-in paper survey and a web-based survey.
Participation in this study will be voluntary. No financial compensation will be provided to study participants. The study duration is anticipated to last 30 months. An estimated 6,750 individuals will be contacted and we anticipate 4,050 utility customers (18 years of age or older) will consent to participate in this study. The total estimated annualized hours associated with this study is expected to be 548.
There are no costs to respondents other than their time.
The Centers for Disease Control and Prevention (CDC).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the information collection entitled
To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to
Written comments must be received on or before October 27, 2015.
You may submit comments, identified by Docket No. CDC-2015-0072 by any of the following methods:
•
•
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
The Gonococcal Isolate Surveillance Project (GISP), (OMB No.0920-0307 exp. 08/31/2016)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
The objectives of GISP are: (1) To monitor trends in antibiotic resistance of
GISP is the only source in the United States of national, regional, and site-specific gonococcal antibiotic resistance information. GISP provides information to support informed and scientifically-based treatment recommendations.
GISP was established in 1986 as a voluntary surveillance project and now involves 5 regional laboratories and 30 publicly funded sexually transmitted disease (STD) clinics around the country. The STD clinics submit up to 25 gonococcal specimens (or isolates) per month to the regional laboratories, which measure the ability of the specimens to resist the effects of multiple antibiotics. Limited demographic and clinical information corresponding to the isolates (and that do not allow identification of the patient) are submitted directly by the clinics to CDC.
During 1986-2015, GISP has demonstrated the ability to effectively achieve its objectives. The emergence of resistance in the United States to penicillin, tetracyclines, and fluoroquinolones among
Under the GISP protocol, each of the 30 clinics submit an average of 20 isolates per clinic per month (
Each of the five Regional laboratories receives and processes an approximately 20 isolates from each referring clinic per month (
The total estimated annual burden hours are 8,628. Respondents receive federal funds to participate in this project. There are no additional costs to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Ambulatory Medical Care Survey (NAMCS) on Culturally and Linguistically Appropriate Services (CLAS) Survey. The purpose of the NAMCS CLAS survey is to describe the awareness, training, adoption, and implementation of the Enhanced Standards for CLAS in Health and Health Care among office-based physicians.
Written comments must be received on or before October 27, 2015.
You may submit comments, identified by Docket No. CDC-2015-0074 by any of the following methods:
• Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.
Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention,1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
National Ambulatory Medical Care Survey (NAMCS) on Culturally and Linguistically Appropriate Services (CLAS) Survey—New—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
As the population of the United States becomes increasingly diverse, it is important that health care providers deliver culturally and linguistically competent services. Culturally and linguistically appropriate services (CLAS) are respectful of and responsive to individual cultural health beliefs and practices, preferred languages, health literacy levels, and communication needs. The National CLAS Standards in Health and Health Care were established in 2000 by the Office of Minority Health (OMH), Department of Health and Human Services (DHHS) to advance health equity, improve quality, and eliminate health care disparities. In 2013, OMH published the Enhanced Standards for CLAS in Health and Health Care to revise the National CLAS Standards in order to reflect advancements made since 2000, expand their scope and improve their clarity to ensure better understanding and implementation. Although there has been increased awareness and efforts to train culturally and linguistically competent health care providers, there has not been a systematic evaluation of the level of adoption or implementation of the National CLAS Standards among physicians. Due to the limited understanding of how the Standards are adopted and implemented, it is difficult to know what goals have been achieved and which need more work.
OMH came to NCHS' Division of Health Care Statistics with this project because of our expertise collecting data from physicians in the NAMCS. The NAMCS CLAS project meets two of the Division's missions: Conduct multidisciplinary research directed towards development of new scientific knowledge on the provision, use, quality, and appropriateness of ambulatory care; and develop and sustain collaborative partnerships internally within DHHS and externally with public, private, domestic and international entities on health care statistics programs. The purpose of the NAMCS CLAS survey is to describe the awareness, training, adoption, and implementation of the Enhanced Standards for CLAS in Health and Health Care among office-based physicians. The information will be collected directly from physician
The target universe of the CLAS survey includes non-federally employed physicians who were classified by the American Medical Association or the American Osteopathic Association as providing “office-based, patient care.” The target universe excludes physicians in the specialties of anesthesiology, radiology, and pathology. The survey sample of 2,400 physicians will be used as the basis to provide regional and national estimates. Participation in the CLAS survey is voluntary. There will be no financial incentive to participate.
The CLAS survey will be a self-administered online questionnaire, with paper form and telephone administration as follow-up alternatives for non-respondents. A three-year approval will be requested.
There is no cost to the respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collect project entitled
Written comments must be received on or before October 27, 2015.
You may submit comments, identified by Docket No. CDC-2015-0071 by any of the following methods:
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing
Balance After Baby Intervention: Phase 2 (BABI2)—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
The CDC Division of Reproductive Health (DRH) is focused on understanding and preventing complications due to pregnancy and the development of chronic diseases in reproductive age women. Similarly, the CDC established the National Diabetes Prevention Program (NDPP), administered through the Division of Diabetes Translation (DDT), to make strategies for preventing type 2 diabetes broadly available to individuals at high risk of developing diabetes. Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications in the US, affecting approximately 3-13% of pregnancies, or approximately 200,000 cases annually. As defined by the American Diabetes Association (2003), GDM is glucose intolerance that first presents during pregnancy after the first trimester. Women with a history of GDM have a substantially increased risk of developing type 2 diabetes mellitus (T2DM) within 5 to 16 years after their index pregnancy. It has also been shown that many women with a history of GDM gain weight after pregnancy, increasing their risk for obesity, which itself is a strong risk factor for repeat GDM and T2DM. Because of this, as US obesity prevalence continues to increase, there is a concurrent rise in the incidence and prevalence of GDM and T2DM, resulting in a large disease burden on individuals, families, and society. To assist in reducing this national disease burden, it is critical to develop and implement successful interventions that reduce the annual number of newly diagnosed T2DM cases, especially in increased risk populations, such as women with a history of GDM. As part of this Healthy People 2020 objective, the Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention (16 face-to-face sessions over a 24-week period) promoting physical activity, healthy eating, and weight reduction significantly decreased T2DM incidence by 58% in high risk patients. However, the DPP included predominantly older individuals whose ability to attend group meetings and adopt healthy lifestyle changes is different than younger postpartum women. For this reason, successful adaptations of the DPP that address barriers in postpartum women with recent GDM, such as limited time and resources, fatigue, and childcare demands, must be identified and tested.
This BABI2 data collection request aims to address these barriers through the conduct of a randomized, controlled intervention trial of a Web site-based lifestyle program, Balance after Baby (BAB) that is adapted from the DPP and tailored specifically for postpartum women with recent GDM.
The project aims to screen 293 (98 annualized over 3 years) women with a recent GDM pregnancy for enrollment into the study, followed by assessments at the following five post-partum time points: 6-weeks, 6-months, 12-months, 18-months, and 24-months. Of the estimated 190 (63 annualized) women who will meet eligibility requirements and attend the first study visit, approximately half will be assigned to the control group and will receive standard postpartum follow-up, while those assigned to the intervention group will have access to the BAB informational Web site and a lifestyle coach. For all participants, the BABI2 study visits will involve the completion of visit-specific questionnaires, laboratory testing, and the collection of physical measurements such as height and weight. Collected data will be used by CDC and BABI2 investigators to assess the impact and effectiveness of the BABI2 intervention as a potential public health weight loss tool for women at increased T2DM risk.
For the calculation of the estimated burden hours per study visit detailed in the table below, a constant 5% rate of exclusion and attrition was applied between visits. The burden table provides a participant estimate, which will be evenly distributed across control and intervention groups for each information collection step, annualized over a 3-year collection period. Therefore, of the 190 women (63 annualized) who attend the 6-week visit, the estimated number of participants returning for the 6-month visit is reduced to 180 (60 annualized), followed by 172 (57 annualized), 162 (54 annualized), and 154 (51 annualized) for the 12-, 18-, and 24-month visits respectively. The average burden per questionnaire ranges from 8 minutes for the BABI2 Screener Questionnaire up to 36 minutes for the BABI2 6-month Questionnaire.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice solicits nominations for up to seven new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There will be vacancies on the Panel for four-year terms that begin during Calendar Year 2016.
The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services.
The Secretary re-chartered the Panel in 2014 for a 2-year period effective through November 6, 2016.
Please submit nominations electronically to the following email address:
Persons wishing to nominate individuals to serve on the Panel or to obtain further information may contact Carol Schwartz at the following email address:
The Secretary of the Department of Health and Human Services (the Secretary) is required by section 1833(t)(9)(A) of the Social Security Act (the Act), and section 222 of the Public Health Service Act (PHS Act) to consult with an expert outside advisory panel regarding the clinical integrity of the Ambulatory Payment Classification (APC) groups and relative payment weights that are components of the Medicare Hospital Outpatient Prospective Payment System (OPPS), and the appropriate supervision level for hospital therapeutic outpatient services. The Advisory Panel on Hospital Outpatient Payment (HOP, the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. The Panel may consider data collected or developed by entities and organizations (other than the Department of Health and Human Services) as part of their deliberations.
The Charter provides that the Panel shall meet up to 3 times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the following Calendar Year (CY).
The Panel shall consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS. For supervision deliberations, the Panel shall also include members that represent the interests of Critical Access Hospitals (CAHs), who advise the Centers for Medicare & Medicaid Services (CMS) only regarding the level of supervision for hospital outpatient therapeutic services. (For purposes of the Panel, consultants or independent contractors are not considered to be full-time employees in these organizations.)
The current Panel members are as follows:
(
• E.L. Hambrick, M.D., J.D., Chair, a CMS Medical Officer.
• Karen Borman, M.D., F.A.C.S.* (July 2016)
• Dawn L. Francis, M.D., M.H.S.
• Ruth Lande
• Jim Nelson, M.B.A., C.P.A., F.H.F.M.A.* (January 2016)
• Leah Osbahr, M.A., M.P.H.* (January 2016)
• Jacqueline Phillips* (February 2016)
• Johnathan Pregler, M.D.
• Traci Rabine* (January 2016)
• Michael Rabovsky, M.D.
• Wendy Resnick, F.H.F.M.A.
• Michael K. Schroyer, R.N.
• Marianna V. Spanaki-Varelas M.D., Ph.D., M.B.A.* (February 2016)
• Norman Thomson, III, M.D.
• Gale Walker* (January 2016)
• Kris Zimmer
Panel members serve on a voluntary basis, without compensation, according to an advance written agreement; however, for the meetings, CMS reimburses travel, meals, lodging, and related expenses in accordance with standard Government travel regulations. CMS has a special interest in ensuring, while taking into account the nominee pool, that the Panel is diverse in all respects of the following: Geography; rural or urban practice; race, ethnicity, sex, and disability; medical or technical specialty; and type of hospital, hospital health system, or other Medicare provider subject to the OPPS.
Based upon either self-nominations or nominations submitted by providers or interested organizations, the Secretary, or her designee, appoints new members to the Panel from among those candidates determined to have the required expertise. New appointments are made in a manner that ensures a balanced membership under the FACA guidelines. For 2016, we anticipate doing one solicitation for nominees. Our appointment schedule will assure that we have the full complement of members for each Panel meeting. Current members' terms expire at different times throughout the year; therefore, we will add new members throughout the year as terms expire.
The Panel must be fairly balanced in its membership in terms of the points of view represented and the functions to be performed. Each panel member must be employed full-time by a hospital, hospital system, or other Medicare provider subject to payment under the OPPS (except for the CAH members, since CAHs are not paid under the OPPS). All members must have technical expertise to enable them to participate fully in the Panel's work. Such expertise encompasses hospital payment systems; hospital medical care delivery systems; provider billing systems; APC groups; Current Procedural Terminology codes; and alpha-numeric Health Care Common Procedure Coding System codes; and the use of, and payment for, drugs, medical devices, and other services in
It is not necessary for a nominee to possess expertise in all of the areas listed, but each must have a minimum of 5 years experience and currently have full-time employment in his or her area of expertise. Generally, members of the Panel serve overlapping terms up to 4 years, based on the needs of the Panel and contingent upon the rechartering of the Panel. A member may serve after the expiration of his or her term until a successor has been sworn in.
Any interested person or organization may nominate one or more qualified individuals. Self-nominations will also be accepted. Each nomination must include the following:
• Letter of Nomination stating the reasons why the nominee should be considered.
• Curriculum vitae or resume of the nominee that includes an email address where the nominee can be contacted.
• Written and signed statement from the nominee that the nominee is willing to serve on the Panel under the conditions described in this notice and further specified in the Charter.
• The hospital or hospital system name and address, or CAH name and address, as well as all Medicare hospital and or Medicare CAH billing numbers of the facility where the nominee is employee.
To obtain a copy of the Panel's Charter, we refer readers to our Web site at
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Cost per respondent is $40 estimated at 2 hours x $20.00 per hour.
Administration for Community Living, HHS.
Notice.
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for
Submit written comments on the collection of information by September 28, 2015.
Submit written comments on the collection of information by email to by fax 202-395-5806 or by email to
Clare Barnett, Administration for Community Living, Administration on Intellectual and Developmental Disabilities, Office of Program Support, One Massachusetts Avenue NW., Room 4204, Washington, DC 20201, 202-357-3426.
Federal statute requires the Protection and Advocacy (P&A) System in each State to annually prepare and submit to the Secretary a report that includes documentation of the progress made. AIDD reviews the program performance report (PPR) for compliance and for program outcomes. AIDD will aggregate the information in the PPRs into a national profile of programmatic activities and accomplishments, and permit AIDD to track accomplishments against goals and formulate areas of technical assistance and compliance with Federal requirements.
ACL estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products.” The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.
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 on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance, including responses to the questions in this notice, by October 27, 2015. Submit either electronic or written comments on the collection of information by October 27, 2015.
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Submit electronic comments on the draft guidance to
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Nonproprietary Naming of Biological Products.” The draft guidance describes our current thinking on the need for biological products licensed under section 351(a) or 351(k) of the PHS Act (42 U.S.C. 262(a) or 262(k)), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act),
By differentiating biological products from one another that have not been determined by the FDA to be interchangeable, this naming convention is intended to help minimize inadvertent substitution. Inadvertent substitution may lead to unintended alternating or switching of biological products that have not been determined by FDA to be interchangeable. A naming convention that differentiates among biological products also could help facilitate pharmacovigilance for all biological products. By applying this naming convention to all biological products, this approach is intended to: (1) Encourage routine use of designated suffixes in ordering, prescribing, dispensing, and recordkeeping practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathways.
The draft guidance provides information to industry, the health care community, other regulatory agencies, and the public on our rationale for this naming convention. The draft guidance also is intended to assist applicants and application holders in proposing the suffix to be used as part of a biological product's nonproprietary name. The nonproprietary name designated by FDA in the license for a biological product licensed under the PHS Act is its “proper name,” and the term “proper name” is used throughout the draft guidance (see section 351(a)(1)(B)(i) of the PHS Act and 21 CFR 600.3(k)).
We invite comment on the draft guidance, including potential approaches for designating and incorporating suffixes retrospectively and prospectively into the nonproprietary names of all biological products. We also solicit comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products. In providing comments, please consider the following:
1. What are the potential benefits and challenges of designating a suffix in the proper name of a biological product that is:
○ Devoid of meaning versus meaningful (
○ unique to each biological product versus unique to each license holder and shared by each biological product manufactured by that license holder.
In your comments, please address how each option would impact the following: Safe use of biological products; pharmacovigilance; and market acceptance and uptake for certain products.
2. What would be the potential benefits and challenges for an interchangeable product
3. Would there be additional benefits or challenges if the suffix designated in the proper name of a biosimilar product that is subsequently determined to be interchangeable were changed to that of the reference product upon a determination of interchangeability? Would there be benefits or challenges to allowing the manufacturer of the biosimilar product that is subsequently determined to be interchangeable to have the option of retaining its original suffix or adopting the same suffix as the reference product?
4. How could FDA and/or other Federal partners improve active pharmacovigilance systems for purposes of monitoring the safety of biological products? For example, because NDC numbers are not routinely recorded in billing and patient records in many clinical settings in which biological products are dispensed and administered, are there other identifiers besides distinguishable nonproprietary names that are routinely accessible by active pharmacovigilance systems and could enable as good as or better pharmacovigilance? How can FDA and/or other Federal partners help ensure that a distinguishable identifier for each biological product would be captured at the point of dispensing or administration to the patient and be routinely accessible in systems used for pharmacovigilance?
5. What process and reasonable timeframe should FDA use to designate a suffix to include in the nonproprietary name of a previously licensed biological product?
6. What criteria should FDA use to prioritize retrospective application of this naming convention to previously licensed biological products?
7. What are the expected time frames for sponsors of previously licensed biological products to distribute products that conform to this naming convention after approval of a labeling supplement?
8. What strategies could FDA use to enhance stakeholders' understanding of and education about this naming convention?
9. FDA notes that this naming convention (
We are continuing to consider the transition provisions of section 7002(e)(2) through (e)(4) of the BPCI Act that apply to biological products submitted or approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including how those provisions may impact the nonproprietary naming of products to which those provisions apply. We invite comment from all stakeholders on the application of this naming convention to biological products approved under the FD&C Act.
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 nonproprietary naming of biological products, including biosimilar products and interchangeable products. 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.
Interested persons may submit either electronic comments regarding this document to
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 proposes a new collection of information by requesting information from applicants and application holders to propose a suffix composed of four lowercase letters to be included in the “proper name.” The “proper name” is designated by FDA at the time of licensure for biological products submitted under section 351(a) of the PHS Act and for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act. The applicant should also include information that the proposed suffix meets the factors described in the draft guidance. For the prospective application of this naming convention, our evaluation will generally occur during the investigational new drug application phase and will also be incorporated into the review of the marketing application.
The draft guidance also refers to a previously approved collection of information found in FDA regulations that is expected to change as a result of the draft guidance and the retrospective application of the naming convention. The collection of information is related to the following: The submission of a biologics license application (BLA) and changes to an approved application, which is covered under part 601 (21 CFR part 601) and approved under OMB control number 0910-0338. As a result of the draft guidance, the estimated number of additional responses for the annual burden for changes to an approved application under § 601.12 would be increased by approximately 25 responses.
The draft guidance also refers to previously approved collections of information found in FDA regulations that are not expected to change as a result of the draft guidance. The collection of information is related to the following: The submission of a BLA under section 351(k) of the PHS Act (biosimilar products and interchangeable products), which is approved under OMB control number 0910-0719.
FDA estimates the burden of this collection of information for the prospective application of the naming convention as follows:
As indicated in table 1, we estimate that we will receive a total of approximately 40 requests annually for the proposed “proper name” for biological products submitted under section 351(a) of the PHS Act and 6 requests annually for the proposed “proper name” for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act. The average burden per response (hours) is based on the Agency's experience with similar information collection requirements.
Persons with access to the Internet may obtain the document at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for tobacco retailers entitled “Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.” The guidance represents FDA's current thinking with respect to imposing no-tobacco-sale orders (NTSOs) on retailers who have committed repeated violations of certain restrictions on the sale and distribution of tobacco products. This guidance discusses, among other things, the period of time covered by an NTSO and a retailer's compliance with an NTSO.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, 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 guidance may be sent. See the
Submit electronic comments on the guidance to
Colleen Maschal, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877-287-1373,
FDA is announcing the availability of a guidance for tobacco retailers entitled “Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order.” On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to give FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. Section 906(d) of the FD&C Act (21 U.S.C. 387f(d)) authorizes FDA to issue regulations that restrict the sale and distribution of tobacco products if FDA determines such regulations would be appropriate for the protection of the public health. Section 303(f)(8) of the FD&C Act (21 U.S.C. 333(f)(8)) authorizes FDA to impose an NTSO against a person found to have committed repeated violations, at a particular retail outlet, of restrictions on the sale and distribution of tobacco products issued under section 906(d) of the FD&C Act, such as FDA's “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (21 CFR part 1140). The term “no-tobacco-sale order” refers to an order prohibiting the sale of tobacco products at a retail outlet indefinitely or for a specified period of time under section 303(f)(8) of the FD&C Act. A “repeated violation” means “at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation . . .” (section 103(q)(1)(A) of the Tobacco Control Act).
FDA conducts inspections of retail outlets to evaluate compliance with the requirements of the FD&C Act and its implementing regulations. This guidance discusses the period of time to be covered by an NTSO where there is evidence of “repeated violations” at a particular retail outlet. It also discusses a retailer's compliance with an NTSO. This guidance is meant to supplement FDA's guidances entitled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers” and “Civil Money Penalties for Tobacco Retailers and No-Tobacco-Sale Orders: Responses to Frequently Asked Questions.”
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA with respect to the period of time to be covered by NTSOs and retailers' compliance with NTSOs. 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.
Interested persons may submit either electronic comments regarding this document to
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Please note that your name, contact information, and other information identifying you will be posted on
Persons with access to the Internet may obtain an electronic version of the guidance at either
Health Resources and Services Administration, HHS.
Notice.
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the “340B Drug Pricing Program” or the “340B Program.” This notice proposes guidance for covered entities enrolled in the 340B Program and drug manufacturers that are required by section 340B of the PHSA to make their drugs available to covered entities under the 340B Program. When finalized after consideration of public comments solicited by this notice, the guidance is intended to assist 340B covered entities and drug manufacturers in complying with the statute.
Submit comments on or before October 27, 2015.
You may submit comments, identified by the Regulatory Information Number (RIN) 0906-AB08, by any of the following methods. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions. The first is the preferred method.
•
•
•
All submitted comments will be available to the public in their entirety.
CDR Krista Pedley, Director, OPA, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, Maryland 20857, or by telephone at (301) 594-4353.
Section 602 of Public Law 102-585, the “Veterans Health Care Act of 1992,” enacted section 340B of the Public Health Service Act (PHSA) “Limitation on Prices of Drugs Purchased by Covered Entities,” codified at 42 U.S.C. 256b. The intent of the 340B Program is to permit covered entities “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” H.R. REP. No. 102-384(II), at 12 (1992). Eligible covered entity types are defined in section 340B(a)(4) of the PHSA, and only include health care organizations that have certain Federal designations or receive funding from specific Federal programs. These include Federally Qualified Health Centers, Ryan White HIV/AIDS Program grantees, and certain types of hospitals and specialized clinics. Section 7101 of the Patient Protection and Affordable Care Act (Pub. L. 111-148) (“Affordable Care Act”) expanded the types of covered entities eligible to participate in the 340B Program. As of January 1, 2015, there were 11,530 registered covered entities participating in the 340B Program.
Section 340B of the PHSA instructs HHS to enter into a pharmaceutical pricing agreement (PPA) with certain drug manufacturers. If a drug manufacturer signs a PPA, it agrees that the prices charged for covered outpatient drugs to covered entities will not exceed 340B ceiling prices as defined by statute. HRSA calculates the ceiling prices quarterly using pricing data reported to the Centers for Medicare & Medicaid Services (CMS). Pursuant to section 340B(a)(1) of the PHSA, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount from the Average Manufacturer Price. As of January 1, 2015, there were 644 drug manufacturers participating in the 340B Program.
When an eligible entity voluntarily decides to enroll and participate in the 340B Program, it accepts responsibility for ensuring compliance with all provisions of the 340B Program, including all associated costs. Since 1992, HHS has interpreted the statutory requirements of the 340B Program through guidances published in the
In September 2010, HHS published two advanced notices of proposed rulemaking in the
Section 340B(a)(4) of the PHSA (42 U.S.C. 256b(a)(4)) lists the entity types eligible to participate in the 340B Program and further requires that such entities must meet the requirements of section 340B(a)(5) of the PHSA. An entity participating in the 340B Program is referred to as a covered entity. HHS lists all covered entity sites registered for the 340B Program on the public 340B database.
Non-hospital covered entities described in sections 340B(a)(4)(A) through (K) of the PHSA include entities that receive certain Federal grants, Federal contracts, Federal designations, or establish Federal projects. HHS will list non-hospital covered entities on the public 340B database if they demonstrate eligibility and provide information related to their qualifying grant, contract, designation, or project.
A non-hospital covered entity also may include associated health care delivery sites located at a different address. These associated health care delivery sites will be listed on the public 340B database as able to purchase and use 340B drugs for their eligible patients if the non-hospital covered entity (“parent site”) registers the associated sites and provides information demonstrating that each site is performing services under the main qualifying grant, contract, designation, or project. Once registered, the associated sites of a covered entity parent site are termed “child sites.” For example, if a covered entity sexually transmitted disease (STD) clinic demonstrates that an off-site location receives Federal funds, and is performing services within the scope of their grant, HHS will list that location on its database as a child site of the main clinic. HHS will list sites that are sub-recipients of Federal grants, but seeking their own 340B identification numbers separate from a parent entity, if those entities provide information demonstrating their receipt of eligible Federal funds, or in-kind contributions purchased with eligible Federal funds, as well as the grant number under which they receive those funds.
Section 340B(a)(4)(L) of the PHSA defines the 340B Program eligibility requirements for hospitals defined in section 1886(d)(1)(B) of the Social Security Act (commonly referred to as “subsection (d) hospitals”). Section 340B(a)(4)(L)(i) specifies three categories of hospital eligibility.
The first category of hospital eligibility under section 340B(a)(4)(L)(i) of the PHSA requires hospital ownership or operation by a State or local government. HHS will list hospitals qualifying under this category if they are wholly owned by a State or local government and recognized as such in Internal Revenue Service filings and acknowledgements, if applicable, or other documentation from Federal entities. HHS also will list hospitals operated through an arrangement where the State or local government is the sole operating authority of a hospital.
The second category of hospital eligibility under section 340B(a)(4)(L)(i) of the PHSA requires a hospital to be a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government. HHS will list hospitals qualifying under this provision if they are formally granted a power usually exercised by the State or local government through State or local statute or regulation, through creation of a public corporation, or through development of a hospital authority or district to provide health care to a community on behalf of the government. Examples of governmental powers include, but are not limited to, the power to tax, issue government bonds, and act on behalf of the government. HHS interprets section 340B(a)(4)(L)(i) of the PHSA as excluding hospitals that have been granted powers generally granted to private persons or corporations upon meeting of licensure requirements, such as a license to practice medicine or provide health care services commercially. HHS will list a hospital qualifying under this provision when it submits, as a part of its registration: (1) The name of the government entity granting the governmental power to the hospital; (2) a description of the governmental power granted to the hospital and a brief explanation as to why the power is considered to be governmental; and (3) a copy of any official documents issued by the State or local government to the hospital that reflect the formal grant of governmental power.
The third category of hospital eligibility under section 340B(a)(4)(L)(i) of the PHSA includes a private non-profit hospital which has a contract with a State or local government to provide health care services to low-income individuals who are not eligible for Medicare or Medicaid. HHS will list hospitals qualifying under this provision that provide a signed certification by the hospital's 340B Program authorizing official and an appropriate government official (such as the governor, county executive, mayor, or an individual authorized to represent and bind the governmental entity). The signed certification indicates that a contract is currently in place between the private, non-profit hospital and the State or local government to provide health care services to low-income individuals who are not entitled to Medicare or Medicaid. For the purposes of the 340B Program, such contract should create enforceable expectations for the hospital for the provision of health care services, including the provision of direct medical care.
Sections 340B(a)(4)(M) through (O) of the PHSA extend the 340B Program eligibility requirements under section 340B(a)(4)(L)(i) of the PHSA to children's hospitals, freestanding cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, and establish the criteria by which these entity types are eligible to participate.
In addition to the requirements of section 340B(a)(4)(L)(i) of the PHSA, certain hospitals are required to exceed a Medicare disproportionate share hospital adjustment percentage to be eligible for the 340B Program. Calculation of the disproportionate share adjustment percentage is described in section 1886(d)(5)(F) of the Social Security Act. Disproportionate share hospitals (DSH), children's hospitals, and freestanding cancer hospitals must have a Medicare disproportionate share adjustment percentage greater than 11.75 or be a “Pickle hospital” as described in section 1886(d)(5)(F)(i)(II) of the Social Security Act to be eligible for the 340B Program (sections 340B(a)(4)(L) and (M) of the PHSA). Rural referral centers and sole community hospitals must have a disproportionate share adjustment percentage equal to or greater than 8.0
HHS will list any hospital qualifying under this provision whose latest filed Medicare cost report demonstrates that its disproportionate share adjustment percentage meets the statutorily required threshold to be eligible for the 340B Program. HHS will list children's hospitals that do not submit a Medicare cost report if they provide a statement from a qualified independent auditor certifying that that the hospital would meet one or both of the criteria in section 340B(a)(4)(L)(ii) of the PHSA and including the basis for that conclusion.
All off-site outpatient facilities and clinics (child sites) not located at the same physical address as the parent hospital covered entity will be listed on the public 340B database, and are able to purchase and use 340B drugs for eligible patients, if the hospital covered entity provides its most recently filed Medicare cost report demonstrating that: (1) Each of the facilities or clinics is listed on a line of the cost report that is reimbursable under Medicare; and (2) the services provided at each of the facilities or clinics have associated outpatient Medicare costs and charges. These facilities and clinics will be listed individually even if they share the same physical address and/or common off-site location. HHS may also review other documentation as necessary to verify eligibility (
HHS does not list the outpatient clinics or departments within the same building (
HHS will list an outpatient facility of a children's hospital when the registration submitted by the hospital demonstrates that the requested outpatient facility: (1) Is an integral part of the hospital, and (2) would be correctly included on a reimbursable line with associated Medicare costs and charges on a Medicare cost report, if filed.
HHS is actively seeking comments on alternatives to demonstrating the eligibility of an off-site outpatient facility or clinic. In considering alternatives, HHS has explored use of provider-based standards (42 CFR 413.65); however, many hospitals choose not to seek provider-based designation for their departments or facilities for unrelated reasons even though these facilities may qualify for the designation. Comments on previously proposed guidance at 72 FR 1543 (January 12, 2007), highlighted the difficulty in verifying whether outpatient facilities and clinics meet provider-based standards. HHS has also previously considered use of form CMS 855A, Medicare Enrollment Application for Institutional Providers, which is used by hospitals to apply to enroll in the Medicare program or make a change in the hospital's enrollment information. HHS has found this form insufficient as an accurate indicator of the facility's reimbursement under Medicare for purposes of 340B Program administration. For those parties proposing forms submitted to CMS, please include information regarding the deadline for submission of the proposed form, the proposed form's relationship to Medicare reimbursement, and other key factors.
In all scenarios, the covered entity must immediately notify HHS regarding any changes in eligibility for itself or a child site. When a covered entity loses 340B Program eligibility, HHS will list that date on the public 340B database as the termination date. HHS will update the public 340B database as soon as the entity notifies HHS or HHS becomes aware that it no longer meets a 340B eligibility requirement. If a parent covered entity site is terminated, all child sites and contract pharmacy arrangements will be removed from the public 340B database with the same termination date. A covered entity is liable to manufacturers for repayment for the 340B discounts on any drugs purchased for itself, any child site, or any contract pharmacy when the covered entity was ineligible for the 340B Program for any reason. A non-hospital covered entity would lose 340B Program eligibility immediately upon loss of its qualifying Federal grant, contract, designation, or project or upon closing of the entity. A child site's 340B Program eligibility is tied to the eligibility of the parent covered entity; if a non-hospital parent covered entity loses eligibility to participate in the 340B Program, all registered child sites will simultaneously lose eligibility and must cease purchasing and using 340B drugs. A child site of a non-hospital covered entity will always lose eligibility if the child site closes, or if the child site no longer qualifies under the parent covered entity's grant, project, designation, or contract. If a parent or child site is registered under multiple covered entity types, loss of eligibility for any one covered entity type requires the parent and child sites to stop purchasing and using 340B drugs under the covered entity type for which the sites are no longer eligible. For example, if a site is registered for the 340B Program as a Federally qualified health center (FQHC) and tuberculosis (TB) clinic, and the parent site loses TB funding, both the parent and child sites must immediately stop purchasing and using 340B drugs under the TB grant and must have its TB 340B identification number terminated. The sites may continue purchasing and using 340B drugs under its registered FQHC 340B ID for eligible patients.
In all scenarios, the covered hospital entity must immediately notify HHS regarding any changes in eligibility for itself or an off-site outpatient facility or clinic. When a covered entity loses 340B Program eligibility, HHS will list that date on the public 340B database as the termination date. HHS will update the public 340B database as soon as the entity notifies HHS or HHS becomes aware that it no longer meets a 340B eligibility requirement. If a parent covered entity site is terminated, all off-site outpatient facilities or clinics or contract pharmacies will be removed from the public 340B database with the same termination date. If any non-eligible entity purchased 340B drugs after the date of loss of eligibility, it will be noted in the public 340B database. Pursuant to section 340B(a)(4)(L)(ii) of the PHSA, a hospital covered entity loses 340B Program eligibility immediately upon filing of a Medicare cost report that demonstrates the hospital's disproportionate share adjustment percentage has fallen below the required threshold for the hospital type for which it is registered. For example, if a freestanding cancer hospital files its cost report on May 30, 2016, with a disproportionate share percentage of 10 percent (which is below the required threshold for freestanding cancer hospitals, 11.75 percent), that hospital and all of its child sites and contract pharmacies will be terminated effective May 30, 2016;
A hospital covered entity eligible on the basis of having a contract with a State or local government will lose 340B Program eligibility if its contract with a State or local government expires or is terminated. A critical access hospital would lose its eligibility for the 340B Program upon losing its critical access hospital designation from CMS. In addition, a hospital subject to the group purchasing organization prohibition will lose 340B Program eligibility as described in this proposed guidance if it fails to comply with the prohibition.
An off-site outpatient facility's eligibility to participate in the 340B Program is tied to the eligibility of the parent hospital. If a parent hospital loses eligibility to participate in the 340B Program, all registered child sites will simultaneously lose eligibility and must immediately cease purchasing and using 340B drugs. A child site may lose eligibility separately from the parent covered entity in certain circumstances. An off-site hospital outpatient facility registered as a child site will lose 340B Program eligibility immediately upon closing, sale or transfer of the outpatient facility, or the parent covered entity's filing of a Medicare cost report which demonstrates the facility is no longer reimbursable or services provided at the facility no longer have associated outpatient costs and charges under Medicare. Additionally, a child site may lose eligibility separately from the parent hospital covered entity if the child site violates the group purchasing organization prohibition.
A parent covered entity may be liable for repayment to manufacturers for any 340B drug purchase made after the child site loses eligibility. A parent covered entity must immediately notify HHS of any change in eligibility.
Once enrolled in the 340B Program, the covered entity must comply with all 340B Program statutory requirements as of the covered entity participation start date listed on the public 340B database. The covered entity must continue to meet all eligibility requirements for the entity type for which it is registered and listed on the public 340B database. A parent covered entity and its authorizing official will be responsible for the compliance of any related child sites. A covered entity is also responsible for the compliance of contract pharmacy sites that dispense drugs on behalf of the covered entity.
Sections 340B(d)(2)(B)(i), (ii), and (iv) of the PHSA authorize HHS to maintain a single, universal, and standardized identification system listing participating covered entities. HHS lists covered entities, including any registered associated sites, on its public 340B database. The registered covered entity is listed as the “parent” site and the registered off-site outpatient facility, clinic, eligible off-site location or associated site is listed as the “child” site. The list of covered entity sites on the public 340B database assists manufacturers in verifying eligibility for 340B drug purchases. The public 340B database includes the name, location, eligibility type, and eligibility date for each covered entity, including parent and child sites and, when applicable, the date and reason for termination. The parent covered entity is given a unique 340B identification number and any child site is designated by the same 340B identification number followed by a letter or letters (
HHS publishes the conditions and procedures for registration and registration deadlines in the
HHS lists a covered entity on its public 340B database after receiving the entity's registration from an appropriate authorizing official, such as a chief executive officer, chief operating officer, chief financial officer, or an employee who can legally bind the covered entity. During registration, the authorizing official attests to the covered entity meeting the eligibility criteria and its ability to comply with the 340B Program requirements.
HHS will not list a covered entity on the public 340B database when the information submitted pursuant to 340B Program registration does not demonstrate the entity is eligible for the 340B Program according to the statutory requirements. HHS will not list a non-hospital covered entity if the appropriate HHS operating division that administers the statutory programs to which eligibility is linked does not verify the entity's eligibility. HHS will not list covered entities that are hospitals if their latest filed Medicare cost reports (or such documentation described for children's hospitals that do not file a Medicare cost report) do not verify eligibility of the hospital and off-site outpatient facilities or clinics at issue.
Eligibility for the 340B Program is limited to the categories of entities specified in statute. Inclusion of a covered entity in a larger organization such as a health system or an Accountable Care Organization does not make the entire larger organization eligible for the 340B Program or automatically qualify all of the individuals receiving services from the larger organization as patients of the covered entity for 340B Program purposes. Likewise, if covered entity eligibility is limited to a distinct part of a hospital, HHS will not list the hospital as a covered entity unless the hospital is otherwise eligible and registers for the 340B Program. For example, if a covered entity hemophilia treatment center (HTC) is part of a hospital, HHS will not list the hospital as a covered entity for the 340B Program unless otherwise eligible and registered as such.
A non-hospital covered entity is listed by HHS under each of its eligible entity types, and is able to purchase and use 340B drugs under each of its eligible entity types, if the covered entity registers accordingly. For example, a covered entity site with the same address that is eligible as sexually transmitted disease (STD) and TB clinics will register and be listed with a 340B identification number for both STD and TB entity types.
If a hospital is eligible for the 340B Program as more than one hospital entity type, HHS will only list the entity as one hospital type. HHS will change the entity type under which a hospital is listed if the hospital terminates the previous registration, submits a new registration during regular enrollment periods as set forth by HHS, and abides by the statutory requirements of the new covered entity type. HHS will list contract pharmacies that have written agreements with the new entity type if the entity registers these pharmacies as part of its new registration.
HHS lists covered entities on the public 340B database on the condition that the entity will immediately update the public 340B database information or submit updates to HHS for any changes to any portion of its covered entity database record, including changes in its child site or contract pharmacy and authorized shipping address information.
The PHSA does not include pharmacies as an entity type that is eligible to participate in the 340B Program. HHS lists in-house pharmacies owned and operated by the covered entity as an authorized shipping address (
HHS lists covered entities on its public 340B database on the condition that the covered entity will regularly review and update its information on the database. Upon loss of eligibility of a parent site, child site, or termination of any contract pharmacy arrangement, the covered entity must immediately notify HHS and stop purchasing and using 340B drugs at the terminated site(s). HHS requests that the covered entity provide the reason for the loss of eligibility, the effective date for the loss of eligibility, and the date of the last 340B drug purchase for a terminated covered entity, child site, or contract pharmacy. A covered entity is liable to manufacturers for repayment for the 340B discounts on any drugs purchased for itself, any child site, or any contract pharmacy when the covered entity was ineligible for the 340B Program for any reason.
HHS is proposing to clarify when a covered entity can re-enroll in the 340B Program once removed for violation of an eligibility requirement, including the requirement not to use a group purchasing organization. A covered entity removed from the 340B Program would be able to re-enroll in the 340B Program during the next regular enrollment period after it has satisfactorily demonstrated to HHS that it will comply with all statutory requirements moving forward and has completed, or is in the process of offering repayment to affected manufacturers as necessary. HHS is seeking comments on what type of information a covered entity would submit to HHS to demonstrate compliance to re-enroll in the 340B Program. For example, if removed for violation of the group purchasing organization prohibition, a hospital could demonstrate it has set up appropriate purchasing accounts and, if applicable, software programmed to allocate drug purchases to the correct purchasing accounts; it could also submit policies and procedures directing proper purchase allocations and a self-audit report confirming correct purchasing. Or, hospitals that lost eligibility based on DSH percentage, but subsequently won an appeal to have the DSH percentage changed, could submit documentation of the appeal.
Sections 340B(d)(2)(B)(i) and (ii) of the PHSA require the development of procedures for covered entities to update 340B Program database information annually, and for HHS to verify the accuracy of this information. HHS will list covered entities on its public 340B database that annually certify the accuracy of their database information and their compliance with 340B Program statutory requirements. HHS reviews and verifies this information through HHS Operating Divisions, where appropriate, and will terminate a covered entity from the 340B Program if it is ineligible by informing the entity and noting this in the public 340B database. By certifying compliance with all 340B Program requirements, a covered entity attests that it employs effective business practices to ensure and monitor ongoing compliance, including self-audits where appropriate; maintains accurate 340B database information; and notifies HHS in the event the entity is no longer eligible for the 340B Program or has violated any 340B Program requirement, subject to HHS audit.
A covered entity may voluntarily terminate its 340B Program participation (or the participation of a child site or contract pharmacy arrangement) during the annual recertification process or at any other time. When a covered entity removes itself, its child site, or contract pharmacy arrangement from the 340B Program, the covered entity is expected to provide an explanation and documentation of the termination, the timing of the termination, and the date the covered entity has ceased or plans to cease purchasing and using 340B drugs under the 340B Program. Failure to provide this information will be considered in any determination regarding the covered entity's liability to manufacturers, and if the organization seeks to re-enroll as a covered entity.
A covered entity removed for failure to recertify would be able to re-enroll for the 340B Program during the next regular enrollment period after the covered entity has demonstrated to HHS its ability to comply with all 340B Program requirements.
To be eligible for the 340B Program, disproportionate share hospitals (DSH), children's hospitals, and freestanding cancer hospitals in the 340B Program are subject to the GPO prohibition in section 340B(a)(4)(L)(iii) of the PHSA, which states that to be eligible, these hospital covered entities do not “obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.” Section 340B(b)(2)(A) defines “covered outpatient drug” as the definition in section 1927(k) of the Social Security Act (42 U.S.C. 1396r-8(k)). Section 340B of the PHSA does not limit GPO participation for inpatient drug purchases. A GPO may only be used by one of the affected covered entities to purchase drugs dispensed to inpatients or to purchase drugs which do not meet the definition of covered outpatient drug. This prohibition extends to any pharmacy owned or operated by these covered entities, and takes effect as of the start date of enrollment in the 340B Program. The prime vendor program established pursuant to section 340B(a)(8) of the PHSA is not considered a GPO subject to this prohibition.
During registration for the 340B Program, the authorizing official registering a DSH, children's hospital, or freestanding cancer hospital attests it will comply with the statutory GPO prohibition. These hospitals also attest to compliance with this prohibition during the annual recertification process.
The proposed guidance clarifies specific situations which would not violate the GPO statutory prohibition. First, the proposed guidance clarifies that a GPO account may be used at an off-site outpatient facility (
Under no circumstances may the specific situations noted in these exceptions be used to circumvent the GPO prohibition to supply GPO-purchased covered outpatient drugs to parts of the hospital subject to the GPO prohibition.
A large number of hospitals use replenishment models to operationalize the 340B Program. HHS clarified its position in a February 2013 Policy Release No. 2013-1,
Newly enrolled covered entities subject to the GPO prohibition must stop purchasing covered outpatient drugs through a GPO before the first day the covered entity is listed on the public 340B database as eligible to purchase 340B drugs (“start date”). However, if a covered entity has GPO-purchased covered outpatient drugs remaining in inventory on or after the covered entity start date for the 340B Program, those drugs may be used until expended.
HHS is aware that manufacturers and covered entities may currently work together to identify and correct errors in GPO purchasing within 30 days of the initial purchase through a credit and rebill process as a standard business practice. HHS encourages manufacturers and covered entities to continue this practice. This collaboration necessitates a covered entity's frequent monitoring of compliance to identify GPO purchasing errors within 30 days of the erroneous purchase.
Under this proposed guidance, HHS proposes to extend the notice and hearing process, as described in Part H, to covered entities found in violation of the GPO prohibition. As part of the notice and hearing process, the covered entity could demonstrate that the GPO violation was an isolated error as opposed to a systematic violation. If the covered entity were to demonstrate the GPO violation was an isolated incident and the covered entity is currently in compliance, the covered entity will be permitted to remain in the 340B Program upon submission of a corrective action plan.
If, after notice and hearing, the covered entity's GPO violation was determined not to be isolated, the covered entity would be deemed ineligible for the 340B Program as of the date of the violation and immediately removed. A covered entity removed from the 340B Program would be required to offer repayment to affected manufacturers for any 340B drug purchase made after the first date of violation of the GPO prohibition.
If a parent site were deemed ineligible by HHS due to GPO prohibition violation, the parent site, all child sites, and all contract pharmacy arrangements would be removed from the 340B Program. In the case of a violation that HHS determines is isolated to a child site, the child site would be removed from the 340B Program. The parent site may be able to remain in the 340B Program if it can demonstrate that the GPO prohibition violation was isolated to the child site and that the parent site did not violate the GPO prohibition. GPO participation cannot be limited to a child site if the parent site also purchases drugs on the same account as the child site.
Pursuant to section 340B(a) of the PHSA, a manufacturer participating in the 340B Program must offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price. The term covered outpatient drug is defined in section 1927(k)(2) of the Social Security Act and is limited by paragraph (3) which states:
“The term `covered outpatient drug' does not include any drug, biological product, or insulin provided as part of, or as incident to and in the same setting as, any of the following
HHS published guidance on May 7, 1993, which stated that a covered outpatient drug does not include any drug, biological product, or insulin that meets this limiting definition (58 FR 27289, 27291). HHS published
The limiting definition includes two parts which, if both are met, exclude a drug, biological product, or insulin mentioned in section 1927(k)(2) of the Social Security Act as a covered outpatient drug. First, the drug is “provided as part of, or as incident to and in the same setting as” the services listed in section 1927(k)(3) and second, the payment for such service may be made under Title XIX of the Social Security Act and not as direct reimbursement for the drug. This guidance proposes that a drug that satisfies both conditions will not qualify as a covered outpatient drug in the 340B Program.
Further, the limiting definition in section 1927(k)(3) to exclude covered outpatient drugs for purposes of the 340B Program only applies when the drug is bundled for payment under Medicaid as part of a service in the settings described in the limiting definition. In contrast, a drug provided as part of a hospital outpatient service which is billed to any other third party or directly billed to Medicaid would still qualify as a covered outpatient drug. Covered entities that purchase drugs through the 340B Program which do not meet the definition of covered outpatient drug would be subject to repayment to affected manufacturers.
Hospital covered entities subject to the GPO prohibition in section 340B(a)(4)(L)(iii) of the PHSA must ensure that drugs that meet the definition of covered outpatient drug described in section 1927(k) of the Social Security Act are purchased using the correct accounts to comply with the GPO prohibition. A covered entity must maintain auditable records pursuant to section 340B(a)(5)(C) of the PHSA which pertain to compliance with this provision.
In accordance with section 340B(a)(1) of the PHSA, a manufacturer may not condition the sale of a covered outpatient drug on covered entity compliance with this provision. Remedies for violations would be imposed under the enforcement provisions of the 340B Program, but manufacturers may not unilaterally deny sales based on such violations.
Section 340B(a)(5)(B) of the PHSA prohibits covered entities from reselling or transferring drugs purchased under the 340B Program to individuals who are not patients of the covered entity. HHS is proposing a clarified definition of patient for purposes of the 340B Program. In its clarification of what constitutes a violation of section 340B(a)(5)(B) of the PHSA, HHS also is proposing its interpretation of section 340B(a)(5)(D) of the PHSA. Section 340B(a)(5)(D) of the PHSA states a covered entity violating section 340B(a)(5)(B) of the PHSA shall be liable to the manufacturer of the covered outpatient drug that is the subject of the violation in an amount equal to the reduction in the price of the drug. The sale or transfer of 340B drugs to an individual not meeting the criteria in this section of the proposed guidance is considered diversion.
HHS has proposed a number of guidances that have addressed the definition of a patient. The current guidance, issued in 1996, outlined a three-part test which state that an “individual is a `patient' of a covered entity only if:
An individual will not be considered a `patient' of the entity for purposes of 340B if the only health care received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.
An individual registered in a State operated or funded AIDS drug purchasing assistance program receiving financial assistance under Title XXVI of the PHSA will be considered a `patient' of the covered entity for purposes of this definition if so registered as eligible by the State program.” (61 FR 55157-8, October 24, 1996).
The development of this proposed guidance is meant to address the diverse set of 340B covered entities, and was informed by 340B Program audits, through which HHS has learned more about how the definition of patient is applied in different health care settings.
Under this proposed guidance, an individual will be considered a patient of a covered entity, on a prescription-by-prescription or order-by-order basis, if all of the following conditions are met:
(1)
HHS interprets the statute such that a 340B eligible patient receives a health care service from the covered entity, and the covered entity is medically responsible for the care provided to the individual. An individual who sees a physician in his or her private practice which is not listed on the public 340B database or any other non-340B site of a covered entity, even as follow-up to care at a registered site, would not be eligible to receive 340B drugs for the services provided at these non-340B sites. The use of telemedicine involving the issuance of a prescription by a covered entity provider is permitted, as long as the practice is authorized under State or Federal law and the drug purchase otherwise complies with the 340B Program.
An individual will not be considered a patient of the covered entity if the individual's health care is provided by another health care organization that has an affiliation arrangement with the covered entity, even if the covered entity has access to the affiliated organization's records. Access to an individual's records by a covered entity, by itself, does not make the individual a patient of that covered entity.
(2)
Faculty practice arrangements and established residency, internship, locum tenens, and volunteer health care provider programs are examples of covered entity-provider relationships that would meet this standard. Simply having privileges or credentials at a covered entity is not sufficient to demonstrate that an individual treated by that privileged provider is a patient of the covered entity for 340B Program purposes.
If a patient is referred from the covered entity for care at an outside
(3)
An individual will be considered a patient of a covered entity if the health care service received results in a drug order or prescription. The use of telemedicine, telepharmacy, remote, and other health care service arrangements (
An individual would not be considered a patient of a covered entity whose only relationship to the individual is the dispensing or infusion of a drug. The dispensing of or infusion of a drug alone, without a covered entity provider-to-patient encounter, does not qualify an individual as a patient for purposes of the 340B Program. However, if the covered entity infuses a drug and meets all other criteria as defined in this section, an individual may be classified as a patient for purposes of 340B.
(4)
In the case of a covered entity with 340B eligibility based on receipt of a Federal grant, Federal project, Federal designation, or Federal contract, individuals will be considered patients only if they are receiving health care at a covered entity site from a covered entity provider which is consistent with the health care service or range of services designated in the Federal grant, project, designation, or contract. These criteria extend to each child site of a covered entity. If a child site's scope of grant, project, or contract is more limited than that of the parent site, individuals will be considered patients if they are receiving health care at the child site which is consistent with the health care service or range of services delegated to the child site. For example, if a child site of an FQHC is limited in its scope of grant to treating pediatric individuals, then only individuals receiving pediatric care meeting the limitations specified in the child site scope of grant would be eligible to receive 340B drugs.
A covered entity registered as one of the hospital covered entity categories is not subject to this limitation. However, a hospital that is only enrolled in the 340B Program on the basis of a Federal grant, contract, or project is subject to this limitation. For example, a hospital that is not enrolled as one of the hospital covered entity types may instead receive a grant for a family planning project. In this case, the hospital cannot access 340B drugs for patients receiving care outside of those facilities and outside the scope of the Federal family planning project.
With respect to Indian Tribes or Tribal Organizations whose 340B Program eligibility arises solely from the Indian Self-Determination and Education Assistance Act, Public Law 93-638 (ISDEAA), use of 340B drugs is limited to those individuals that the tribe or tribal organization is authorized to serve under its ISDEAA contract, in accordance with the requirements in Section 813 of the Indian Health Care Improvement Act.
(5)
Section 340B(a)(1) of the PHSA establishes the 340B Program as a drug discount program for covered entities furnishing covered outpatient drugs. Therefore, an individual cannot be considered a patient of the entity furnishing outpatient drugs if his or her care is classified as inpatient. An individual is considered a patient if his or her health care service is billed as outpatient to the patient's insurance or third party payor. The covered entity should maintain auditable records documenting any changes in patient status due to insurer determinations.
The outpatient status of individuals who are self-pay, uninsured, or whose care is provided by the hospital covered entity's charity care program, would be determined by the covered entity's documented, auditable policies and procedures. We expect that most such policies include categorizing a patient as inpatient or outpatient based on how the services would have been billed to Medicare or another third party payer, if such patient were eligible.
(6)
An individual will be considered a patient if he or she has an established relationship such that the covered entity maintains auditable health care records that demonstrate the covered entity has a provider-to-patient relationship for the health care service that results in the order or prescription and that the covered entity retains responsibility for care that results in every 340B drug ordered, dispensed, or prescribed to an individual.
Pursuant to section 340B(a)(5)(C) of the PHSA, which requires covered entities to permit audits of records directly pertaining to compliance, covered entities must maintain records that demonstrate that all of the criteria above were met for every prescription or order resulting in a 340B drug being dispensed or accumulated through a replenishment model.
The 340B Program does not serve as a general employee pharmacy benefit or self-insured pharmacy benefit. HHS guidance has always specified, and this proposed guidance continues to make explicit, that only individuals who are patients of the covered entity are eligible for drugs purchased through the 340B Program. Employees of covered entities do not become eligible to receive 340B drugs solely by being employees, but by being a patient as defined in this guidance. Covered entities that solely have financial responsibility for employees' health care, and contract with prescribing health care professionals loosely affiliated or unaffiliated with the covered entity, would not meet the level of responsibility for health care services as outlined in this guidance. A covered entity would be acting primarily as the insurance provider for these individuals and not as the health care provider of these individuals. For 340B Program purposes, there is a fundamental difference between the individuals for whom the covered entity provides direct health care services and meets all criteria in this section and employees for whom a covered entity only provides insurance coverage.
HHS proposes to reaffirm its long standing position that an individual enrolled in a Ryan White HIV/AIDS Program AIDS Drug Assistance Program funded by Title XXVI of the PHSA will be considered a patient of the covered entity for purposes of this definition.
HHS proposes to recognize the unique circumstances that arise during a public health emergency declared by the Secretary and to allow certain flexibilities for demonstrating that an individual is a patient of a covered
Covered entities use replenishment models to manage drug inventory, including 340B drugs, which is permissible if the covered entity remains in compliance with all 340B requirements. For example, a 340B covered entity that sees many different types of patients (
If the covered entity improperly accumulates or tallies 340B drug inventory, even if it is prior to placing an order, the covered entity has effectively sold or transferred drugs to a person who is not a patient, in violation of section 340B(a)(5)(B) of the PHSA. A similar violation would occur if the recorded number of 340B drugs does not match the actual number of 340B drugs in inventory, if the covered entity maintains a virtual or separate physical inventory.
HHS is aware that manufacturers and covered entities currently work together to identify and correct errors in purchasing within 30 days of the initial purchase through a credit and rebill process. HHS encourages manufacturers and covered entities to continue this practice. This collaboration requires a covered entity's frequent monitoring of compliance to identify purchasing errors within 30 days of the erroneous purchase and communicating with the manufacturer.
On occasion covered entities have attempted to retroactively look back over long periods of time at drug purchases not initially identified as 340B eligible, sometimes looking back at drug purchases over several years. Covered entities then attempt to re-characterize these purchases as 340B eligible and then purchase 340B drugs on the basis of these previous transactions. This practice is sometimes referred to as “banking.” Covered entities are responsible for requesting 340B pricing at the time of the original purchase. If a covered entity wishes to re-characterize a previous purchase as 340B, covered entities should first notify manufacturers and ensure all processes are fully transparent with a clear audit trail that reflects the actual timing and facts underlying a transaction.
Regular reviews of 340B drug inventory ensure that any inventory discrepancy is accounted for and properly documented to demonstrate that 340B drugs are not diverted. A covered entity should follow standard business procedures to return unused or expired 340B drugs and appropriately account for waste of 340B drugs (
Covered entities must comply with section 340B(a)(5)(D) of the PHSA, which assigns liability to a covered entity if it violates the diversion prohibition in section 340B(a)(5)(B) of the PHSA. Covered entities are expected to work with manufacturers regarding repayment within 90 days of identifying the violation. A manufacturer retains discretion as to whether to request repayment based on its own business considerations, provided that, when exercising its discretion, the manufacturer complies with applicable law, including the Federal anti-kickback statute (42 U.S.C. 1320a-7b(B)). For example, a manufacturer may prefer not to accept payments below a
The covered entity is responsible for reporting a summary of its corrective actions taken to HHS for transparency, compliance, and audit purposes (see Part H).
Under section 340B(a)(1) of the PHSA, manufacturers are required to provide a discounted 340B price to a covered entity for a covered outpatient drug. Under section 1927 of the Social Security Act, manufacturers must generally provide a rebate to a State for a covered outpatient drug provided to a Medicaid patient. However, section 340B(a)(5)(A)(i) of the PHSA prohibits duplicate discounts whereby a State obtains a rebate on a drug provided to a Medicaid patient when that same drug was discounted under the 340B Program. While Medicaid drug rebates were previously limited to Medicaid fee-for-service (FFS) drugs, section 2501(c) of the Affordable Care Act amended the Social Security Act, extending Medicaid drug rebate eligibility to certain Medicaid Managed Care covered outpatient drugs. Section 2501(c) further amended the Social Security Act to specify that covered outpatient drugs dispensed by Medicaid Managed Care Organizations (MCOs) are not subject to a rebate if also subject to a discount under section 340B of the PHSA.
Pursuant to section 340B(a)(5)(A)(ii) of the PHSA, HHS established the 340B Medicaid Exclusion File as the mechanism to prevent duplicate discounts. The 340B Medicaid Exclusion File is posted on the public 340B database to enable 340B covered entities, States, and manufacturers to determine whether a covered entity purchases 340B drugs for its Medicaid FFS patients.
Under this proposed guidance, a covered entity will be listed on the public 340B database if it notifies HHS at the time of registration whether it will purchase and dispense 340B drugs to its Medicaid FFS patients (carve-in) and bill the State, or whether it will purchase drugs for these patients through other mechanisms (carve-out). A covered entity electing carve-in will then have their Medicaid billing number, National Provider Identifier (NPI), or both listed on HHS' 340B Medicaid Exclusion File. Covered entities must provide any Medicaid
The covered entity may make a different determination regarding carve-in or carve-out status for MCO patients than it does for FFS patients. An entity can make different decisions by covered entity site and by MCO, but must provide to HRSA identifying information of the covered entity site, the associated MCO, and the decision to carve-in or carve-out. This information may be made available on a 340B Medicaid Exclusion file. HRSA seeks comments on the utility of this billing information for other stakeholders, as well as the format through which it is made public.
While the proposed use of a 340B Medicaid Exclusion File would identify the covered entity billing practices used for MCO patients, HHS encourages covered entities, States, and Medicaid MCOs to work together to establish a process to identify 340B claims. First, covered entities should have mechanisms in place to be able to identify MCO patients. Second, covered entities and States should continue to work together on various methods to prevent duplicate discounts on Medicaid MCO drugs. Currently, covered entities report using Bank Identification Numbers, Processor Control Numbers, and National Council for Prescription Drug Programs (NCPDP) codes, among other methods, to identify Medicaid MCO patients and 340B claims. In some cases, States may require covered entities to follow additional steps to prevent duplicate discounts, including use of certain modifiers and codes which identify individual claims as associated with 340B drugs and therefore not eligible for rebate. Such billing instructions are beyond the scope of the 340B Program.
After enrollment, a covered entity can change its election to purchase and dispense 340B drugs for Medicaid FFS and/or MCO patients by notifying HHS. While changes to how a covered entity uses 340B drugs for its Medicaid FFS and MCO patients can be submitted at any time, the changes are only effective on a quarterly basis. A covered entity should ensure the changes are correctly reflected on the 340B Medicaid Exclusion File prior to implementation to permit full transparency for the State, MCO, and manufacturers, thus ensuring the avoidance of duplicate discounts.
HHS is seeking comments regarding alternative mechanisms to supplement the 340B Medicaid Exclusion File to allow covered entities to take a more nuanced approach to purchasing, for example, only using 340B drugs for Medicaid FFS and MCO patients when appropriate for service delivery but maintaining practices that prevent the statutorily prohibited duplicate discounts. HHS seeks information about current state arrangements that could be adapted for use as Federal standards for these supplements or alternatives.
Risk of duplicate discounts can increase with certain drug purchasing and distribution systems, including covered entity contract pharmacy arrangements. Therefore, in accordance with the statutory requirement under 340B(a)(5)(B)(ii) to establish a mechanism to prevent duplicate discounts, HHS will examine those systems and determine if adjustments have to be made to the system to prevent duplicate discounts. Due to these heightened risks of duplicate discounts, when a contract pharmacy is listed on the public 340B database it will be presumed that the contract pharmacy will not dispense 340B drugs to Medicaid FFS or MCO patients. If a covered entity wishes to purchase 340B drugs for its Medicaid FFS or MCO patients and dispense 340B drugs to those patients utilizing a contract pharmacy, the covered entity will provide HHS a written agreement with its contract pharmacy and State Medicaid agency or MCO that describes a system to prevent duplicate discounts. Once approved, HHS will list on the public 340B database a contract pharmacy as dispensing 340B drugs for Medicaid FFS and/or MCO patients.
HHS and approved manufacturer 340B Program audits include the review of covered entity compliance with the duplicate discount prohibition. If the information provided to HHS does not reflect the covered entity's actual billing practices, the covered entity can be found in violation of the duplicate discount prohibition and may be required to repay manufacturers if duplicate discounts have occurred due to the inaccurate information.
In the event that a covered entity is unable to use a 340B drug for a Medicaid FFS or MCO patient in a particular instance, it should have a mechanism in place to notify the State Medicaid agency and MCO. HHS encourages States, MCOs, and covered entities to work together to ensure records are accurate and auditable.
Section 340B(a)(5)(C) of the PHSA requires a covered entity to permit the Secretary and certain manufacturers to audit covered entity records that pertain to the entity's compliance with 340B Program requirements. Documentation of compliance would include records of contract pharmacies used by covered entities to dispense 340B drugs. Failure to maintain the records necessary to permit such auditing is failure to meet the requirements of section 340B(a)(5) of the PHSA. A covered entity's failure to maintain auditable records is grounds for losing eligibility to participate in the 340B Program.
340B Program stakeholders have requested a standard for records retention, and HHS agrees that it is important, especially in assisting covered entities and manufacturers in preparing for audits and understanding the time and scope limitations of 340B Program audits. Therefore, HHS is proposing a record retention standard for all 340B Program records for a period of not less than 5 years, which HHS believes appropriately balances the need for a covered entity to document its compliance with 340B Program requirements and the covered entity's effort and expense required to maintain records for an extended period of time. This standard would also apply to records pertaining to all child sites and contract pharmacies. In the case of termination, a terminated covered entity or associated site is expected to maintain records pertaining to compliance with 340B statutory requirements for five years after the date of termination. If during an audit, HHS finds a pattern of failure to comply with 340B Program statutory requirements, this provision does not preclude HHS from accessing existing records prior to the 5-year period for its review.
In accordance with the statute, a covered entity's failure to provide required records is grounds for termination from the 340B Program. This guidance further clarifies associated repayment to manufacturers, as well as restrictions on when an entity can re-enroll in the 340B Program. However, HHS proposes to use discretion for those entities whose failure to retain records is non-systematic. A non-systematic recordkeeping violation would occur if the covered entity generally has
Any failure to retain records that prevents the auditing of compliance would constitute a violation under section 340B(a)(5)(C) of the PHSA. This systematic failure could result in a determination of ineligibility and the covered entity may be liable for repayment to manufacturers for periods of ineligibility. Prior to removal, a covered entity would be entitled to notice and hearing pursuant to this guidance regarding removal from the 340B Program for failure to meet a statutory 340B Program eligibility requirement. A covered entity removed for systematic failure to maintain records would be able to re-enroll in the 340B Program during the next regular registration period after the covered entity has demonstrated to HHS its ability to comply with all 340B Program requirements, including the requirement to maintain auditable records.
Section 340B(a)(4) of the PHSA specifies the types of entities eligible to participate in the 340B Program, but does not specify how a covered entity may provide or dispense such drugs to its patients. The diverse nature of eligible entity types (
In 1996, HHS issued guidance recognizing covered entity use of contract pharmacy arrangements, which are permitted under State law, to dispense 340B drugs. The 340B statute does not prohibit the use of contract pharmacies. The guidance permitted covered entities to use a single contract pharmacy arrangement in addition to any in-house covered entity pharmacy service and outlined other requirements (61 FR 43549, August 23, 1996). Beginning in 2001, HHS permitted certain covered entities to conduct Alternative Methods Demonstration Projects (AMDP) to use and develop multiple contract pharmacy arrangements to access 340B drug pricing. HHS issued revised guidance in 2010 which permitted a covered entity to use multiple contract pharmacy arrangements, to include multiple contract pharmacy locations (75 FR 10772, March 5, 2010). Congress intended the benefits of the 340B Program to accrue to participating covered entities. Each covered entity should carefully evaluate its relationships with contract pharmacies (
A covered entity may contract with one or more licensed pharmacies to dispense 340B drugs to the covered entity's patients, instead of or in addition to an in-house pharmacy. If permitted under applicable State and local law, a covered entity may contract with one or more pharmacies on behalf of its child sites, or a child site may contract directly with a pharmacy. A covered entity may contract with a pharmacy location (or pharmacy corporation to include multiple pharmacy locations) as an individual covered entity and for its child sites. The contracts establishing these arrangements are expected to meet the standards identified in this proposed guidance and all applicable Federal, State, and local laws. A covered entity contracting with a pharmacy to dispense 340B drugs should be aware of the Federal anti-kickback statute and how such provisions could apply to arrangements with contract pharmacies. HHS will continue its policy of referring cases of suspected violations of the anti-kickback statute to the HHS Office of Inspector General (OIG). A covered entity whose 340B eligibility is based on the receipt of a Federal grant, Federal project, Federal designation, or Federal contract must also ensure that no grant, project, designation, or contract conditions are violated in its contract pharmacy arrangements.
The 340B registration deadlines and effective dates, announced in the
HHS only lists contract pharmacy locations on a covered entity's 340B database record once a written contract exists between the covered entity and contract pharmacy and the covered entity registers those arrangements. The written contract should include all locations of a single pharmacy company the covered entity plans to use and all child sites that plan to use the contract pharmacies. The written contract should also set forth the requirements contained in this proposed guidance. Pursuant to 340B statutory auditing requirements, the contract should be available to HHS upon request.
To further strengthen 340B Program integrity, registration of a contract pharmacy will only be accepted from a covered entity. Pursuant to section 340B(a)(5)(B) of the PHSA, which prohibits covered entities from reselling or otherwise transferring drugs to persons who are not patients of the covered entity, a parent covered entity may contract with a pharmacy only on its own behalf as an individual covered entity and for its child sites. Groups or networks of covered entities may not register or contract for pharmacy services on behalf of their individual covered entity members.
Under this proposed guidance, required documentation for registration would include a series of compliance requirements and a covered entity's attestation regarding its arrangement with the contract pharmacy. Manufacturers and wholesalers are required to ship only to the authorized shipping addresses listed for the covered entity in the public 340B database. The contract pharmacy may only provide 340B drugs to patients of the covered entity after the contract pharmacy's start date in the public 340B database. Likewise, the contract pharmacy location must cease dispensing 340B drugs on behalf of the covered entity on or before the date that contract pharmacy location is terminated. Any changes to existing contract pharmacy arrangements should be reflected on the covered entity record in the public 340B database and requested by submitting an online change request form.
A covered entity can request additional contract pharmacy locations under a public health emergency declared by the Secretary. Special registration instructions and
Through audits of covered entities' arrangements with contract pharmacies, HHS has observed that not all covered entities have sufficient mechanisms in place to ensure their contract pharmacies' compliance with all 340B Program requirements. To ensure compliance with 340B statutory requirements, HHS is proposing compliance mechanisms for covered entities that contract with pharmacies to dispense 340B drugs. The covered entity would retain complete responsibility for contract pharmacy compliance with 340B Program requirements.
If noncompliance is occurring within contract pharmacy arrangements, it is essential that any issues be promptly identified and corrected. HHS is proposing standards for audit and quarterly reviews to ensure that compliance efforts related to contract pharmacies result in the early identification of problems, implementation of corrections, and the prevention of future compliance issues. The 2010 contract pharmacy guidance recommended annual audits of contract pharmacies; this proposed guidance further clarifies the expectations of this recommendation.
HHS believes that covered entities that do not regularly review and audit contract pharmacy operations are at an increased risk for compliance issues. An annual audit of each contract pharmacy location will provide covered entities a regular opportunity to review and reconcile pertinent 340B patient eligibility information at the contract pharmacy and help prevent diversion. Conducting these audits using an independent auditor will ensure the pharmacy is following all 340B Program requirements. Additionally, as a separate compliance mechanism, the covered entity should compare its 340B prescribing records with the contract pharmacy's 340B dispensing records at least quarterly to ensure that neither diversion nor duplicate discounts have occurred. A covered entity should correct any instances of diversion or duplicate discounts found during either the annual audit or quarterly review and report corrective action to HHS.
A patient is not required to use the covered entity's in-house pharmacy, where such service exists, or a covered entity's contract pharmacy to receive a prescription drug. A drug manufacturer would not be required to offer the covered entity a 340B priced-drug when a 340B-eligible patient chooses to have a prescription filled at a non-contract pharmacy or a contract pharmacy location not listed on the covered entity's 340B database record.
HHS may remove a contract pharmacy location from the 340B Program if HHS finds that the contract pharmacy is not complying with 340B Program requirements. A covered entity is liable for diversion or duplicate discounts which occur at any of the covered entity's contract pharmacy locations, including potential repayments to manufacturers.
A manufacturer that has entered into a Medicaid Drug Rebate Agreement pursuant to section 1927(a) of the Social Security Act (42 U.S.C. 1936r-8(a)) is required, pursuant to section 1927(a)(5), to enter into a Pharmaceutical Pricing Agreement (PPA) with the Secretary as described in section 340B(a) of the PHSA. Under the PPA, a manufacturer must offer all covered outpatient drugs, as defined in section 1927(k) of the Social Security Act, from each of the manufacturer's labeler codes to covered entities participating in the 340B Program at no more than the statutory 340B ceiling price. A manufacturer that is not subject to a Medicaid Drug Rebate Agreement may voluntarily enter into a PPA for all of its covered outpatient drugs, as defined in section 1927(k) of the Social Security Act.
The PPA incorporates 340B Program statutory obligations and records a manufacturer's agreement to abide by them. By executing the PPA when it enrolls in the 340B Program, a manufacturer agrees to all 340B Program statutory requirements, including statutory and regulatory changes that occur after execution of the PPA. In the event of a transfer of ownership of the manufacturer, the PPA is automatically assigned to the new owner.
In addition, the following expectations apply to participating manufacturers:
(a) For a manufacturer whose 340B Program participation is required by virtue of its participation in the Medicaid Drug Rebate Program, sign a PPA within 30 days of enrolling in the Medicaid Drug Rebate Program;
(b) submit timely updates to its 340B database record and PPA to ensure that any new covered outpatient drug is added to the 340B Program;
(c) maintain auditable records demonstrating 340B Program compliance for no less than five years and provide such records when requested; and
(d) permit HHS to audit manufacturer compliance.
If a manufacturer withdraws from the Medicaid Drug Rebate Program, the manufacturer may continue to participate in the 340B Program voluntarily. If a manufacturer withdraws from the Medicaid Drug Rebate Program, HHS will presume continued participation in the 340B Program unless and until the manufacturer advises HHS otherwise. A manufacturer that has voluntarily entered into a PPA and does not participate in the Medicaid Drug Rebate Program may terminate its PPA by notifying HHS during the annual recertification process or at any other time, in accordance with the terms of the PPA. When a manufacturer voluntarily participating in the 340B Program requests termination, the manufacturer should provide an explanation and documentation of the termination, the timing of the termination, and the date the manufacturer will cease offering covered outpatient drugs under the 340B Program.
A manufacturer that terminates a PPA should maintain auditable 340B Program records for 5 years after the termination pertaining to compliance with all 340B Program statutory requirements during the time that the manufacturer had a PPA. Refunds and credits specified under this proposed guidance may still be imposed on a terminated manufacturer for 340B drugs sold above the ceiling price during the time that the manufacturer had a PPA in effect.
Pursuant to section 340B(a)(1) of the PHSA, a manufacturer subject to a PPA must offer all covered outpatient drugs at no more than the 340B ceiling price to a covered entity listed on the public 340B database. For manufacturers signing their first PPA by virtue of participating in the Medicaid Drug Rebate Program, the effective date for 340B pricing for covered outpatient drugs to any covered entity is the same date the drug is first included in the Medicaid Drug Rebate Program, or the date of enactment of section 340B of the PHSA, if inclusion in the Medicaid Drug Rebate Program preceded November 4, 1992. For manufacturers voluntarily signing a PPA, the effective date for 340B pricing is the date the agreement
Pursuant to section 340B(a)(1) of the PHSA, a manufacturer shall rely on the information in the public 340B database to determine whether the manufacturer must offer the 340B price and not base its offer on a covered entity's assurance of compliance with the 340B Program. HHS will continue to provide communications and Web site notices to manufacturers to alert them to covered entity additions or deletions in the public 340B database that occur during a calendar quarter due to special circumstances (
Certain covered outpatient drugs may be required to be dispensed by specialty pharmacies (
The manufacturer may develop a limited distribution plan when a covered outpatient drug must be handled in a special manner (
HHS may publish all submitted limited distribution plans on the 340B Web site. If HHS has concerns about the plan, it will work with the manufacturer to incorporate mutually agreed upon revisions to the plan prior to posting the plan on the 340B Web site. Covered entities that have concerns regarding the manner in which a particular plan is implemented are first encouraged to resolve them in good faith with manufacturers. Where such issues are not resolved, covered entities should contact HHS for appropriate action or involvement of other federal agencies (
Pursuant to section 340B(a)(10) of the PHSA, a manufacturer may choose to sell a covered outpatient drug below the ceiling price to a covered entity. Such pricing is voluntary and need not be offered to all covered entities.
Pursuant to section 340B(d)(1)(B) of the PHSA, this proposed guidance establishes clarity around the procedures for issuing refunds and credits in the event that there is an overcharge. HHS also outlines its proposed oversight of this process to ensure that refunds are issued accurately and within a reasonable period of time, both in routine instances of retroactive adjustment to relevant pricing data as well as exceptional circumstances such as erroneous or intentional overcharging for covered outpatient drugs.
If a manufacturer charges a covered entity more than the 340B ceiling price, the manufacturer must refund or credit that covered entity an amount equal to the price difference between the sale price and the correct 340B price for that drug, multiplied by the units purchased. A refunds or credits may also be necessary in the case of a drug price restatement by manufacturers. This refund or credit is expected to occur within 90 days of the determination by the manufacturer or HHS that an overcharge occurred. Multiple price calculations will be required if the 340B price changed during the affected period of overcharges. A manufacturer may only calculate the refund by NDC, and would not be allowed to calculate refunds in any other manner, including (but not limited to) aggregating purchases,
Pursuant to section 340B(d)(1)(B)(ii) of the PHSA, a manufacturer must submit to HHS, along with the price recalculation information, an explanation of why the overcharge occurred, how the refund will be calculated, and to whom refunds or credits will be issued.
The 2010 amendments to section 340B(d)(1)(A) of the PHSA provide for improvements in manufacturer compliance with 340B Program pricing requirements. Pursuant to this authority, HHS is proposing a manufacturer recertification process. Under this proposed guidance, HHS will list manufacturers as participating in the 340B Program if they annually review and update 340B database information. A manufacturer should provide HHS with any changes to 340B database information as changes occur. HHS may also request additional documentation to verify the information provided.
HHS understands that manufacturers may transfer ownership and control of labeler codes or NDCs after signing a PPA. Annual recertification for manufacturers with a PPA will ensure that all stakeholders have the most up-to-date information regarding the covered outpatient drugs subject to the 340B price, particularly for manufacturers that have voluntarily
HHS proposes to continue the long-standing practice of providing the option for AIDS Drug Assistance Programs (ADAPs) to participate in the 340B Program through a rebate model. Section 340B(a)(1) of the PHSA provides that the amount paid to a manufacturer for covered outpatient drugs takes into account any rebate or discount, as provided by the Secretary. The ADAP rebate option has been operational since 1998, after a proposed notice sought comment on the option (62 FR 45823 (August 29, 1997)), and a final notice was published in the
HHS expects ADAPs seeking to pursue the rebate mechanism to take three actions. First, the ADAP is expected to inform HHS during the registration process whether it will participate using direct purchase, a rebate option, or both. Second, the ADAP is expected to make a qualified payment, as defined in this proposed guidance. Third, the ADAP is expected to submit claims-level data to a manufacturer in support of each qualified payment to receive a rebate from that manufacturer.
ADAPs will be expected to submit claims-level data to manufacturers to support the ADAPs' rebate requests. HHS will provide subsequent guidance regarding the data to be provided in support of rebate requests. Data elements may include: The ADAP name and state, medication name/label name, medication national drug code, the package size, the date of dispensing, the ADAP payment for the medication (to include the amount paid to the dispensing pharmacy as a payment, copayment, or deductible), an assurance that the claim is not for a drug subject to a Medicaid rebate, and, when applicable, an assurance that the ADAP paid the patient's health insurance premium (which, in turn, paid for the medication). HHS welcomes public comment regarding this proposed data submission, especially regarding the suitability of the claims-level data elements mentioned above for ADAP submission to manufacturers for purposes of receiving a rebate.
Under this proposed guidance, ADAPs make a qualified payment of covered outpatient drugs in two circumstances. First, the ADAP purchase of a covered outpatient drug at a price greater the 340B ceiling price constitutes a qualified payment. Second, the ADAP purchase of the ADAP client's insurance, in addition to the ADAP payment of the copayment, coinsurance, or deductible, constitutes a qualified payment for a covered outpatient drug.
Section 2615(a) of the PHSA allows ADAPs to use a portion of their grant funds to purchase health insurance policies that, at a minimum, include at least one drug in each class of core antiretroviral therapeutics from the HHS Clinical Guidelines for the Treatment of HIV/AIDS, and coverage for other essential medical benefits. After the implementation of the rebate option for ADAPs, Congress further specified under the Ryan White CARE Act Amendments of 2000, Public Law 106-345, that certain statutory requirements imposed by title XXVI of the PHSA must be met by ADAPs when purchasing health insurance policies. Section 2616(f) of the PHSA indicates that such health insurance coverage must include a full range of therapeutics to treat HIV/AIDS, including measures for the prevention and treatment of opportunistic infections, and that the costs of the health insurance must not exceed the costs of otherwise providing the therapeutics. ADAP funds may be used to cover any costs associated with the health insurance policy, including copayments, coinsurance, deductibles, and premiums. Therefore, it is the view of HHS that the use of ADAP funds to make a qualified payment as outlined above, after the ADAP has engaged in the necessary cost-effectiveness analysis demonstrating that the costs of the health insurance do not exceed the costs of otherwise providing the therapeutics, constitutes a purchase of necessary drugs for ADAP clients that is consistent with the statutory eligibility for State-operated AIDS drug purchasing assistance programs and the statutory provision allowing the program to purchasethe drugs through an insurance mechanism rather than a direct purchase. Recognizing this mechanism gives full effect to both statutes: Section 340B of the PHSA and the Ryan White HIV/AIDS Program statute.
After careful analysis, HHS has determined that the payment by the ADAP of a copayment, coinsurance, or deductible, in the absence of also paying for the health insurance premium, is too attenuated within the context of the 340B Program to constitute a “purchase.” Therefore, implementation of this proposed guidance would result in manufacturers, upon request of the ADAP, providing rebates only when the ADAP purchases drugs directly, or when the ADAP purchases health insurance, through payment of the health insurance premium, and pays the copayment, coinsurance, or deductible that covers the drug purchases at issue. HHS recognizes that ADAPs can cover the cost of health insurance (
To ensure that particular drugs have been paid for by the ADAP's purchased health insurance, HHS is proposing that the ADAP document the transaction, as demonstrated by the ADAP's payment of a copayment or deductible, or such other auditable evidence that links the drug purchase at issue to the ADAP's purchased insurance policy. In this situation, the rebate would be paid regardless of how the ADAP expenditure compares to the 340B ceiling price for the drug.
While this proposed guidance is subject to comment and finalization, HHS encourages ADAPs and drug manufacturers to work together to minimize any disruptions in current rebate practices.
HHS is aware that ADAP clients may also be patients of other covered entities. Therefore, pursuant to the 340B statute, HHS proposes that no covered entity may obtain 340B pricing (either through a rebate or through a direct purchase) on a drug purchased by another covered entity at or below the
Nothing in this proposed guidance prohibits a manufacturer from voluntarily extending additional discounts or rebates on 340B drugs.
Pursuant to section 340B(a)(5)(C) of the PHSA, an ADAP participating in the 340B Program, whether through the rebate option, direct purchase option, or both, is subject to a 340B Program audit by HHS, as detailed in Part H of this proposed guidance.
Pursuant to a manufacturer's obligation under section 340B(a)(1) of the PHSA to charge no more than the ceiling price for covered outpatient drugs (taking into account any rebate or discount, as provided by the Secretary), a manufacturer with a PPA would pay a rebate on a claim submitted for a qualified payment for a covered outpatient drug to an ADAP registered for the 340B Program under the rebate option or the hybrid option.
The question has arisen as to the determination of the appropriate level of rebates in cases where the ADAP paid the health insurance premium and the copayment, coinsurance, or deductible. In formulation of this proposed guidance, HHS considered a percentage rebate whereby an ADAP would be entitled to a percentage of the rebate on a dispensed drug contingent on the percentage of the total cost of the drug borne by the ADAP. Upon review of the approach, HHS concluded that this mechanism would be so operationally burdensome as to be inoperable. Percentage calculations would entail increased administrative costs and require access to pricing information about the total amounts paid and total cost of the drug that may not be available to ADAPs. The accounting requirements of such an approach would decrease the efficiency and effectiveness of the program even if the necessary information were readily available.
This proposed guidance specifies that the rebate owed to the ADAP is equal to the Medicaid drug rebate amount described in section 1927(c) of the Social Security Act. In accordance with section 340B(a) of the PHSA, requiring that “the amount to be paid . . . to manufacturers . . . for covered outpatient drugs . . . does not exceed” the 340B ceiling price, the rebate option is equivalent to the direct purchase option.
HHS supports an approach that allows for a rebate for drugs where ADAPs have directly expended funds to purchase a covered outpatient drug for an eligible patient. Under this approach, the ADAP is entitled to a rebate for each of the units purchased with a direct payment of ADAP funds. In cases involving health insurance coverage, the ADAP is entitled to a rebate on each unit of covered outpatient drugs when it has paid for the ADAP client's health insurance and the drug copayment, coinsurance, or deductible. This approach avoids additional unnecessary accounting requirements that would be required in percentage-of-cost approaches.
Manufacturers are expected to maintain records that provide sufficient documentation to determine the correct rebate amounts to be paid to ADAPs as part of auditable records.
Under section 340B(a)(5)(C) of the PHSA, HHS has the authority to audit (acting in accordance with procedures established by the Department) covered entities to monitor their compliance with the statutory prohibition of duplicate discounts (section 340B(a)(5)(A) of the PHSA) and diversion (section 340B(a)(5)(B) of the PHSA). The audits permit HHS to assess a covered entity's compliance with the 340B Program. These audits also help HHS and participating covered entities identify and mitigate program risk as well as identify best practices regarding compliance. HHS reserves the right to refer matters to other Federal agencies as appropriate.
A covered entity participating in the 340B Program is subject to audit by HHS to determine whether it is complying with 340B statutory requirements. Pursuant to section 340B(a)(5)(C) of the PHSA, HHS must be provided access to all records pertaining to compliance, including those of any child site or pharmacy which is under contract with the covered entity. Failure to provide records can result in termination from the 340B Program. To reduce burden on covered entities, HHS will ensure that only one 340B Program audit of a covered entity is conducted or ongoing at any time. HHS will notify the covered entity of its intent to audit for 340B compliance. Pursuant to authority vested in HHS to maintain an accurate and up-to-date list of covered entities (section 340B(d)(2)(B) of the PHSA), HHS will review covered entity eligibility and 340B database information as part of an audit. HHS may audit the parent covered entity site, any child site, and any pharmacy under contract with that covered entity. Additionally, HHS may audit other 340B identification numbers associated with the parent or child site. An HHS audit may include either an on-site review, an off-site review of documentation requested by HHS, or both. To the extent possible, HHS will perform a 340B Program audit at a time and in a manner which minimizes disruption to the covered entity's operations and maximizes the ability to conduct a thorough 340B Program review. HHS may make public any final audit findings.
Pursuant to section 340B(a)(5)(D) of the PHSA, HHS is proposing a notice and hearing process under which a covered entity has the opportunity to respond to adverse audit findings and other instances of noncompliance or to respond to the proposed loss of 340B Program eligibility. The notice and hearing process will be conducted based on the written submissions of the involved parties. HHS proposes to initiate the notice and hearing process by providing written notice to a covered entity of a proposed finding of noncompliance with specific 340B Program requirements. This notice will be sent to the covered entity's authorizing official as listed on the public 340B database and specify a 30-day response deadline. The covered entity responds in writing to each issue of noncompliance, providing details and documentation where appropriate. Failure to respond by the deadline specified will be construed as the covered entity's agreement with the specific allegations of noncompliance included in the notice. HHS will then proceed to make final findings of noncompliance and to take appropriate actions. If a covered entity anticipates the inability to respond by a particular deadline, it is expected to request an extension. HHS will consider such requests on a case-by-case basis.
HHS will review all documents and information submitted by the covered entity regarding its position on the covered entity's noncompliance. HHS will issue a final written notice with its final determination regarding noncompliance. In the case of HHS's 340B Program audits, the initial notice and final notice will include a 340B Program audit report.
If a final determination of noncompliance is made, the covered entity may have to submit a corrective action plan as outlined in this proposed guidance. If HHS's final determination of noncompliance includes a finding that the covered entity is no longer eligible for the 340B Program (
If a covered entity submits a corrective action plan that addresses all findings of noncompliance, HHS may determine that the covered entity can continue to participate in the 340B Program. A corrective action plan should include, at minimum: The correction of each finding of noncompliance, the implementation of measures to prevent future occurrences of noncompliance, plans to make offers of repayment to affected manufacturers for discounts improperly received or to work with State Medicaid offices regarding duplicate discounts, if applicable, and a timeline for corrective actions to be taken.
HHS will work with a covered entity to specify the time frame for the submission of the corrective action plan based on the scope of the findings and will determine if the submitted corrective plan is acceptable. HHS may verify a covered entity's compliance with its HHS-approved corrective action plan at any time. A corrective action plan and its subsequent implementation are considered auditable records and should be maintained as such. Failure of an entity to correct compliance issues or submit a corrective action plan may result in further HHS action, including termination from the 340B Program.
Under section 340B(a)(5)(C) of the PHSA, a drug manufacturer participating in the 340B Program is authorized to audit a covered entity's compliance with the statutory prohibitions against duplicate discounts and diversion of 340B drugs (sections 340B(a)(5)(A) and (B) of the PHSA). The statute does not permit a manufacturer to audit covered entity's compliance with 340B Program eligibility requirements (
This section proposes a “reasonable cause” standard, by which a manufacturer, prior to audit, documents to HHS's satisfaction that a reasonable person could conclude, based on reliable evidence, that a covered entity, its child sites, or contract pharmacies may have violated either section 340B(a)(5)(A) or (B) of the PHSA. Examples of reasonable cause include, but are not limited to: (1) Significant changes in quantities of specific drugs ordered by a covered entity without adequate explanation by the covered entity; (2) significant deviations from national averages of inpatient or outpatient use of certain drugs without adequate explanation by the covered entity; and (3) evidence of duplicate discounts provided by manufacturers or State Medicaid agencies. A covered entity's refusal to respond to manufacturer questions related to 340B drug diversion and duplicate discounts may also be construed as reasonable cause.
To ensure that the audits pertain to compliance with the prohibitions against duplicate discounts and diversion, HHS proposes that a manufacturer submit an audit work plan for HHS approval prior to conducting such an audit. The manufacturer may consult with HHS on its grounds for reasonable cause prior to submitting documentation or a work plan. HHS will review the reasonable cause documentation and the scope of the audit work plan. HHS may limit the scope of the audit to ensure that the audit is conducted with the least possible disruption to the covered entity. If HHS has concerns regarding the audit work plan, it may require manufacturers to revise certain audit procedures.
General standards for manufacturers conducting a 340B Program audit include the use of an independent certified public accountant to perform the audit in accordance with Government Auditing Standards, the protection of confidential patient information, and a total audit duration of not more than 1 year. Pursuant to section 340B(a)(5)(C) of the PHSA, a covered entity must provide records pertaining to compliance of the covered entity, child sites, and any related contract pharmacy with the prohibition against duplicate discounts and diversion. Failure of a covered entity to provide auditable records within 30 days of the request is a violation of section 340B(a)(5)(C) of the PHSA. A covered entity and manufacturer must continue to meet all 340B Program requirements during an audit. At the completion of the audit, the auditors prepare a final audit report and submit it to HHS. The cost of the audit shall be borne by the manufacturer.
Section 340B(d)(1)(B)(v) of the PHSA authorizes HHS to audit a manufacturer or wholesaler to ensure 340B Program compliance. In this guidance, HHS is proposing standards for audits of a manufacturer or wholesaler that manufactures, processes, or distributes covered outpatient drugs in the 340B Program. The HHS audit may include either an on-site review, an off-site review of documentation requested by HHS, or both. HHS will notify the manufacturer of its intent to audit for 340B Program compliance.
HHS audits all relevant records retained by the manufacturer or any of its contractors (such as wholesalers) to assess its compliance with 340B Program requirements. Failure to provide or give access to records or respond to requests for information within HHS-specified time frames may result in further action by HHS or referral for investigation (
After the conclusion of the audit, if HHS determines that a manufacturer has violated the 340B Program, the manufacturer will be provided opportunity for notice and hearing. HHS will send the manufacturer written notification of any audit findings and will notify the manufacturer of the deadline to respond with its agreement or disagreement with each proposed finding. If a manufacturer fails to respond to the proposed findings within the required deadlines and fails to request an extension, HHS will conclude the manufacturer has concurred with all findings. HHS will review any documentation submitted in making a final determination and will advise the manufacturer of its final
A manufacturer's corrective action plan is expected to include correction of past instances of noncompliance, implementing measures to prevent future occurrences, refunds of overpriced 340B drugs to affected covered entities pursuant to this proposed guidance, when applicable, and a timeline for corrective actions to be completed. HHS will specify the time frame for the submission of this corrective action plan and determine if the submitted corrective plan is acceptable. HHS will also determine when an audit is closed. HHS may verify a manufacturer's compliance with its HHS-approved corrective action plan at any time.
Section 340B(a)(4) of the Public Health Service Act (PHSA) (42 U.S.C. 256b(a)(4)) lists the entity types eligible to participate in the 340B Program and further requires that such entities must meet the requirements of section 340B(a)(5) of the PHSA. An entity participating in the 340B Program is referred to as a covered entity. There are two main categories of covered entities: (1) Non-hospital covered entities described in sections 340B(a)(4)(A) through (K) of the PHSA and (2) hospital covered entities described in sections 340B(a)(4)(L) through (O) of the PHSA.
(a)
HHS interprets the provisions in section 340B(a)(4)(L), (M), (N), or (O) of the PHSA in the following manner:
For a children's hospital which does not file a Medicare cost report, HHS will list an off-site outpatient facility if the parent hospital authorizing official submits a signed statement which certifies the requested outpatient facility:
(1) Is an integral part of the children's hospital whose patients meet the requirements of this guidance; and
(2) Would be correctly included on a reimbursable line with associated Medicare outpatient costs and charges on a Medicare cost report, if filed.
(1) Immediately upon closing of the clinic or facility or when sold or transferred to any entity.
(2) Upon filing of a Medicare cost report that demonstrates that the site is not listed as reimbursable, or the services no longer have associated outpatient costs and charges reimbursed by Medicare.
(3) For hospitals subject to the GPO prohibition, immediately upon use of a GPO for covered outpatient drugs as specified in this guidance.
HHS will not list a pharmacy on its public 340B database nor assign it a 340B identification number, as a pharmacy is not an eligible covered entity under the PHSA. HHS will list a covered entity-owned and operated pharmacy as an authorized shipping address for the parent and any child sites.
HHS may provide a special registration opportunity for entities during a public health emergency declared by the Secretary. The geographic scope and time period limitations of the Secretary's public health emergency notice will govern limits for this special registration.
A covered entity removed from the 340B Program would be able to re-enroll to the 340B Program during the next regular enrollment period after it has satisfactorily demonstrated to HHS that it will comply with all statutory requirements moving forward and is in the process of offering repayment to affected manufacturers, if necessary.
In order to continue to be listed as an eligible covered entity and purchase 340B drugs, a covered entity annually recertifies that the covered entity, its child sites, and its contract pharmacy arrangements meet all 340B Program eligibility and compliance requirements. This recertification shall be carried out in a manner and time frame specified by HHS. If a covered entity cannot attest to compliance or is no longer eligible, the covered entity shall cease purchasing and using 340B drugs and terminate its listing and that of any child site, or associated contract pharmacy arrangement which is no longer eligible or for which compliance cannot be attested. A covered entity which voluntarily terminates its listing and that of any child site, or any contract pharmacy arrangement from the 340B Program, is expected to provide information and documentation for voluntary termination and whether it purchased 340B drugs during a period of ineligibility. The covered entity is responsible for repayment to manufacturers in the amount of the discounts for 340B Program drug purchases made after the date the covered entity or child site became ineligible for the 340B Program. HHS may review submissions during recertification or at any time to determine if the covered entity remains eligible and may remove the covered entity from the public 340B database for failure to meet 340B Program eligibility requirements.
Covered entities subject to the group purchasing organization (GPO) prohibition in section 340B(a)(4)(L)(iii) of the PHSA shall not obtain any covered outpatient drugs (including covered outpatient drugs given to non-340B patients) through a GPO or other group purchasing arrangement on or after the start date of enrollment in the 340B Program, including any pharmacy owned or operated by the covered entity, except in circumstances described in paragraph (a) of this section. Violations of the statutory prohibition concerning the use of GPOs are addressed in paragraph (d) of this section. A prime vendor program established pursuant to section 340B(a)(8) of the PHSA is not considered a GPO or group purchasing arrangement under this section. Inclusion of off-site outpatient facilities and clinics in the entity's 340B database record demonstrates that these facilities and clinics are subject to the GPO prohibition.
(1) An off-site outpatient clinic of a 340B hospital covered entity if the outpatient clinic is located at a separate physical address from the 340B parent covered entity, is not participating in the 340B Program or listed on the public 340B database, and purchases drugs through a separate account from the 340B parent covered entity;
(2) A GPO-purchased drug provided to an inpatient who, upon subsequent review (
(3) A hospital which can only access a covered outpatient drug through a GPO account. In such case, the hospital is expected to document attempts to purchase the drug at the 340B price and wholesale acquisition cost price and report the circumstances to HHS, including drug name, manufacturer, and summary of attempts made to acquire the drug.
If a GPO prohibition violation occurs at a parent site, and the parent site is terminated from the 340B Program, all child sites registered through the parent covered entity will be removed from the 340B Program. If the GPO prohibition violation can be limited to certain child sites, only those child sites where the violation occurred will be removed, but repayment for periods of ineligibility must be offered. GPO violations by child sites may only be limited if the child site has auditable records which show that the child site:
(1) Is located in a building separate from the parent site and other child sites; and
(2) All drug purchasing for the sites occur using separate purchase accounts from the parent site and other child sites.
A covered outpatient drug, as defined in section 1927(k)(2) and (3) of the Social Security Act, is eligible for purchase under the 340B Program. For purposes of the 340B Program, only drugs bundled for and receiving such bundled reimbursement under Title XIX of the Social Security Act described in section 1927(k)(3) will be considered excluded from the definition of covered outpatient drug.
(1) The individual receives a health care service at a covered entity site which is registered for the 340B Program and listed on the public 340B database;
(2) The individual receives a health care service from a health care provider employed by the covered entity or who is an independent contractor of the covered entity such that the covered entity may bill for services on behalf of the provider.
(3) An individual receives a drug that is ordered or prescribed by the covered entity provider as a result of the service described in (2). An individual will not be considered a patient of the covered entity if the only health care received by the individual from the covered entity is the infusion of a drug or the dispensing of a drug.
(4) The individual receives a health care service that is consistent with the covered entity's scope of grant, project, or contract;
(5) The individual is classified as an outpatient when the drug is ordered or prescribed. The patient's classification status is determined by how the services for the patient are billed to the insurer (
(6) The individual has a relationship with the covered entity such that the covered entity maintains access to auditable health care records which demonstrate that the covered entity has a provider-to-patient relationship, that the responsibility for care is with the covered entity, and that each element of this patient definition in this section is met for each 340B drug.
Section 340B(a)(5)(A)(i) of the PHSA prohibits duplicate discounts whereby a State obtains a rebate on a drug provided to a Medicaid fee-for-service or managed care organization patient when that same drug was discounted under the 340B Program.
A covered entity must maintain auditable records demonstrating compliance with all 340B Program requirements for itself, any child site, and any contract pharmacy for 5 years from the date the 340B drug was ordered or prescribed, regardless of whether the entity continues to participate in the 340B Program. 340B Program records must be made available to HHS at any time and to certain manufacturers pursuant to an audit. If an entity, any child site, or any contract pharmacy terminates its 340B Program participation, an entity must maintain applicable auditable records for 5 years after the date of termination.
Regardless of the availability of an in-house pharmacy, a covered entity may contract with one or more licensed pharmacies to dispense 340B drugs to eligible patients of the covered entity (as defined in this guidance) provided the arrangement is in accordance with all other statutory 340B Program requirements and applicable Federal, State, and local laws, including the Federal anti-kickback statute (42 U.S.C. 1320a-7b(B)). In the case of a covered entity whose 340B Program eligibility is based on a Federal grant, Federal contract, Federal designation or Federal project, any contract pharmacy arrangement must comply with all grant, contract, or project requirements. A covered entity may contract with one or more pharmacies on behalf of child sites if permitted by law in the applicable jurisdiction and the relationship is recognized and reflected in the covered entity's 340B database record. A child site may contract directly with a pharmacy if not prohibited by Federal, State, or local law.
HHS may remove a contract pharmacy from the 340B Program if HHS finds that the contract pharmacy is not complying with 340B Program requirements. The covered entity is responsible for offering repayment in the amount of the 340B discount to a manufacturer for 340B drugs dispensed by a contract pharmacy that has not adhered to 340B Program requirements.
Pursuant to the statutory requirements of section 340B(a)(1) of the PHSA, a manufacturer that has entered into a Medicaid Drug Rebate Agreement pursuant to section 1927(a) of the Social Security Act must also enter into a pharmaceutical pricing agreement (PPA) pursuant to section 340B(a) of the PHSA. Under the PPA, a manufacturer must offer all covered outpatient drugs, as defined in section 1927(k) of the Social Security Act, from each of the manufacturer's labeler codes to covered entities participating in the 340B Program at no more than the statutory 340B ceiling price. A manufacturer that does not have a Medicaid Drug Rebate Agreement may voluntarily enter into a PPA. By signing the PPA, a manufacturer agrees to comply with all 340B Program statutory requirements, including statutory and regulatory changes that occur after execution of the PPA. In the event of a transfer of ownership of the manufacturer, the PPA is automatically assigned to the new owner. The following expectations apply to participating manufacturers:
(1) For a manufacturer whose 340B Program participation is required by virtue of its participation in the Medicaid Drug Rebate Program, sign a PPA within 30 days of enrolling in the Medicaid Drug Rebate Program;
(2) Submit timely updates to its 340B database record and PPA such that any new covered outpatient drug is added to the 340B Program;
(3) Maintain auditable records demonstrating 340B Program compliance for no less than 5 years and provide such records to HHS when requested; and
(4) Permit HHS to audit manufacturer compliance.
A manufacturer that has voluntarily signed a PPA with the Secretary may terminate its 340B Program participation at any time in accordance with the terms of the PPA. When a manufacturer voluntarily participating in the 340B Program requests termination, the manufacturer should provide an explanation and documentation of the termination, the timing of the termination, and the date the manufacturer will cease offering covered outpatient drugs under the 340B Program.
Pursuant to section 340B(a)(1), a manufacturer subject to a PPA must offer all covered outpatient drugs at no more than the ceiling price to a covered entity listed on the public 340B database. The public 340B database provides information to allow manufacturers to determine if a covered entity is participating in the 340B Program or for any changes to eligibility.
(1) An explanation of the product's limited supply or special distribution requirements and the rationale for restricted distribution among all purchasers;
(2) An assurance that the manufacturers will impose these restrictions equally on both 340B covered entities and non-340B purchasers;
(3) Specific details of the drug distribution plan, including a mechanism that allocates sales to both covered entities and non-340B purchasers with no previous purchase history of the restricted drug;
(4) The dates the alternative distribution begins and concludes; and
(5) A plan for notification of wholesalers and 340B covered entities of the restricted plan.
Pursuant to section 340B(d)(1)(B)(ii) of the PHSA, which requires HHS to establish procedures for manufacturers to issue refunds, a manufacturer must refund or credit a covered entity when there is an overcharge in an amount equal to the price difference between the sale price and the correct 340B price for that drug, multiplied by the number of units. The refund or credit is expected occur within 90 days of the determination by the manufacturer or HHS that an overcharge occurred.
A participating manufacturer should review and update 340B database information on an annual basis
A State AIDS Drug Assistance Program eligible to participate in the 340B Program under section 340B(a)(4)(E) of the PHSA may register for and participate in the 340B Program through this rebate option. 340B Program participation by an AIDS Drug Assistance Program via the rebate option or the hybrid option (participation in the 340B Program both through the direct purchase option and the rebate option) is subject to all the same applicable obligations, requirements, and duties imposed on other covered entities.
(1) Only an AIDS Drug Assistance Program registered under the rebate option or the hybrid option and listed on the public 340B database may request rebates pursuant to this section.
(2) An AIDS Drug Assistance Program is expected to make a qualified payment, as defined in paragraph (b) of this section, for an eligible patient, as defined in this guidance.
(3) An AIDS Drug Assistance Program is expected to submit claims-level data to manufacturers which document a qualified payment was made to support each request for a rebate.
(1) A direct purchase by the AIDS Drug Assistance Program of a covered outpatient drug at a price greater than the 340B ceiling price; or
(2) A payment by the AIDS Drug Assistance Program of the health insurance premiums that cover the covered outpatient drug purchases at issue and payment of a copayment, coinsurance, or deductible for the covered outpatient drug.
(e)
Pursuant to section 340B(a)(5)(C) of the PHSA, a covered entity participating in the 340B Program, including all its child sites and contract pharmacies, is subject to audit by HHS to determine if it is complying with all 340B Program requirements. HHS will ensure that only one 340B Program audit of a covered entity, its child sites, and contract pharmacies is in process at any given time, including a 340B Program audit by a manufacturer. HHS will notify the covered entity of its intent to audit. HHS will have the option to conduct an on-site review, a review of documentation submitted to HHS, or both.
Pursuant to section 340B(a)(5)(C) of the PHSA, a drug manufacturer participating in the 340B Program may audit the records of a covered entity, its child sites, and its contract pharmacies regarding compliance with the 340B Program requirements that prohibit duplicate discounts and diversion of the manufacturer's drugs if the manufacturer has reasonable cause to believe the entity is not complying with these requirements. Drug manufacturer concerns regarding the 340B Program eligibility of a covered entity or compliance with 340B Program requirements other than diversion and duplicate discounts may be referred to HHS for investigation. A covered entity must permit an HHS-approved audit to
(1) Audit objectives, scope, and methodology;
(2) Skill and knowledge of the auditor's personnel including supervisors, and any intended use of consultants, experts, and specialists;
(3) Tests and procedures to be used to assess a covered entity's system of internal controls;
(4) Procedures to be used to determine the 340B purchases questioned as potential violations of section 340B(a)(5)(A) or (B) of the PHSA; and
(5) Procedures to be used to protect patient confidentiality consistent with HIPAA requirements at 45 CFR parts 160, 162, and 164, and the covered entity's proprietary information.
Pursuant to section 340B(d)(1)(B)(v) of the PHSA, a manufacturer (or its contractors, including wholesalers) participating in the 340B Program may be subject to audit by HHS to determine whether it is complying with 340B Program requirements in statute, regulations, and the PPA. HHS will notify the manufacturer or wholesaler in writing of HHS's intent to audit for 340B Program compliance.
Office of the Secretary, HHS.
Notice.
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:
ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data reported in two poster presentations, several laboratory meetings, and progress reports associated with NIDA, NIH, grant R01 DA012460.
Specifically, ORI found that the Respondent knowingly presented falsified and/or fabricated data indicating that twelve non-human primates (either rhesus or cynomolgus monkeys) responded to anti-abuse nicotinic acetylcholine and/or dopamine receptor selective compounds in self-selectivity assays for cocaine, methamphetamines, or nicotine when the compounds were never given to the monkeys per protocol.
Respondent has not applied for or engaged in U.S. Public Health Service (PHS)-supported research within the last three (3) years and has stated that she has no intention of engaging in PHS-supported research in the future.
Ms. Blaylock has entered into a Voluntary Settlement Agreement and has voluntarily agreed:
(1) That if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed to have her research supervised for a period of three (3) years beginning on the date of her employment in a position in which she receives or applies for PHS support and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agreed to maintain responsibility for compliance with the agreed upon supervision plan;
(2) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that for a period of three (3) years beginning on the data of her employment in a position in which she receives or applies for PHS support, any institution employing her shall submit in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and
(3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning on August 4, 2015.
Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.
The times shown above are for the full Committee meeting. Subcommittee issues will be included as part of the Full Committee schedule.
Should you require reasonable accommodation, please contact the CDC Office of Equal Employment
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.
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,086.
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on September 28, 2015. The topic for this meeting will be “New Opportunities for Clinical Research on Type 2 Diabetes.” The meeting is open to the public.
The meeting will be held on September 28, 2015 from 1:00 p.m. to 4:30 p.m. Individuals wanting to present oral comments must notify the contact person at least 10 days before the meeting date.
The meeting will be held in the Democracy 2 Building at 6707 Democracy Blvd., Bethesda, MD, in Conference Room 701.
For further information concerning this meeting, see the DMICC Web site,
The DMICC, chaired by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) comprising members of the Department of Health and Human Services and other federal agencies that support diabetes-related activities, facilitates cooperation, communication, and collaboration on diabetes among government entities. DMICC meetings, held several times a year, provide an opportunity for Committee members to learn about and discuss current and future diabetes programs in DMICC member organizations and to identify opportunities for collaboration. The September 28, 2015 DMICC meeting will focus on New Opportunities for Clinical Research on Type 2 Diabetes.
Any member of the public interested in presenting oral comments to the Committee should notify the contact person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives or organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present; oral comments and presentations will be limited to a maximum of 5 minutes. Printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the Committee by forwarding their statement to the contact person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Because of time constraints for the meeting, oral comments will be allowed on a first-come, first-serve basis.
Members of the public who would like to receive email notification about future DMICC meetings should register for the listserv available on the DMICC Web site,
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.
Coast Guard, DHS.
Thirty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard is forwarding the Information Collection Requests (ICRs), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval of a reinstatement, without change, of a previously approved collection for which approval has expired: 1625-0006, Shipping Articles and 1625-0018, Official Logbook. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Comments must reach the Coast Guard and OIRA on or before September 28, 2015.
You may submit comments identified by Coast Guard docket number [USCG-2015-0070] to the Docket Management Facility (DMF) at the U.S. Department of Transportation (DOT) and/or to OIRA. To avoid duplicate submissions, please use only one of the following means:
(1) Online: (a) To Coast Guard docket at
(2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. (b) To OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer for the Coast Guard.
(3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(4) Fax: (a) To DMF, 202-493-2251. (b) To OIRA at 202-395-6566. To ensure your comments are received in a timely manner, mark the fax, attention Desk Officer for the Coast Guard.
The DMF maintains the public docket for this Notice. Comments and material received from the public, as well as documents mentioned in this Notice as being available in the docket, will become part of the docket and will be available for inspection or copying at room W12-140 on the West Building Ground Floor, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find the docket on the Internet at
Copies of the ICRs are available through the docket on the Internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532 or fax 202-372-8405, for questions on these documents. Contact Ms. Cheryl Collins, Program Manager, Docket Operations, 202-366-9826, for questions on the docket.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection.
The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICRs referred to in this Notice.
We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG 2015-0070], and must be received by September 28, 2015. We will post all comments received, without change, to
If you submit a comment, please include the docket number [USCG-2015-0070]; indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online (via
You may submit comments and material by electronic means, mail, fax, or hand delivery to the DMF at the address under
To view comments, as well as documents mentioned in this Notice as being available in the docket, go to
OIRA posts its decisions on ICRs online at
Anyone can search the electronic form of comments received in 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 a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the
This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (80 FR 15233, March 23, 2015) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
1.
2.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day Notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until September 28, 2015. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information, please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Laura Dawkins, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number 202-272-8377. (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact
You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection described below to the Office of Management and Budget (OMB) for review and approval in accordance approval the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name, or the FR number shown above, and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section II.A. The first notice that solicited public comment on the information collection described in Section II.A for a period of 60 days (60-day Notice) was published on June 10, 2015, at 80 FR 32974.
Executive Order 12862, entitled “Setting Customer Service Standards,” requires that Federal agencies provide the highest quality service to their customers by identifying needed services and seeking feedback on offered services. The information proposed to be collected under this notice is designed by HUD to garner qualitative feedback from HUD customers in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.
In accordance with the Executive Order, the term “customer” means an individual or entity that is directly served by a department or agency. The term “qualitative feedback” refers to information that provides useful insights on perceptions and opinions, but does not constitute statistical surveys that yield quantitative results that can be generalized to the population of the study. The collections to be undertaken under this HUD proposed generic collection will allow for ongoing, collaborative, and actionable communications between HUD and its customers. The collections will also allow feedback to contribute directly to the improvement of HUD products and services, help identify where existing products and services may be lacking in some aspects, and whether there are additional products and services that could be offered by HUD. This notice informs the public that HUD is seeking approval from OMB
The 60-day Notice welcomed the submission of comments through HUD's docket at
HUD further advised that for the generic clearance that HUD seeks approval from OMB, the category of information that HUD is seeking pertains to feedback on new services or new products needed by HUD program participants or prospective participants. In the June 10, 2015, 60-day Notice, HUD provided a specific example of the type of solicitation of information that would fall under the generic clearance described in the June 10, 2015, notice and that example was the National Resource Network. As HUD stated in the June 10, 2015, notice: “An example of these types of services or products are the services offered by the National Resource Network that were initially determined best suited for cities with populations of 40,000 or more, and having, among other criteria, an annual average unemployment rate of 9 percent or more. (See
A generic collection, such as HUD is proposing through this notice, would allow HUD to survey its customers to determine whether HUD has identified appropriate eligibility criteria for new products and services under consideration, and correctly identified the categories of customers in need of these products or services. The areas of inquiry anticipated to be surveyed would be those seeking information about the specific customer being surveyed, for example, the public housing agency (PHA), State and local government, private housing provider, nonprofit organizations, or other organization participating in HUD programs. Of the category or categories of program participants surveyed, the survey would inquire about: The demographics of the populations the customer serves; the type of HUD subsidized housing that is provided; energy, other utility, technological, or other infrastructure needs of the housing provided; the need for better access to community assets, such as transportation, financial services, educational services (schools, libraries or computer facilities), and sports and exercise facilities; the availability of any federal, other governmental, and local resources to address identified needs if these resources were made available; and any demonstration of community or governmental support to improve the quality of the housing provided. HUD anticipates the survey will solicit basic information regarding the customer and current or anticipated needs for which brief responses will suffice. However, the survey would provide the opportunity for the customer to present additional information pertaining to these topics that customers may choose to note.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section II.A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
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
U.S. Geological Survey (USGS), Interior.
Notice of a new information collection: Use of Landsat satellite imagery in water resource management in the Western United States.
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC.
To ensure that your comments are considered, we must receive them on or before October 27, 2015.
You may submit comments on this information collection to the Information Collection Clearance Officer, U.S. Geological Survey, 12201 Sunrise Valley Drive MS 807, Reston, VA 20192 (mail); (703) 648-7197 (fax); or
Larisa Serbina, Economist, at (970) 222-9073 or
Water resources in the Western United States (U.S.) are scarce and recent droughts have only exacerbated disputes over water usage. As such, managing water resources effectively and efficiently is important for both private and public sector water users. However, monitoring water use comprehensively can be difficult using only on-the-ground techniques, due to the labor and time required for such efforts. Recent case studies initiated by the U.S. Geological Survey's (USGS) Land Remote Sensing (LRS) Program have indicated that Landsat satellite imagery plays an important role in Western U.S. water resource management. Landsat satellites are the only satellites to continuously collect the thermal imagery needed to measure evapotranspiration and provide it to the public at no cost. Evapotranspiration derived from thermal imagery can be used to objectively assess present and past water use on the landscape. For example, thermal data from Landsat satellites has been used in court cases to help settle water disputes. Landsat satellites also provide a range of other imagery which are used in water resource management. For example, the imagery can be used to identify different types of vegetation, such as agricultural crop types. There are unique considerations users must address in using Landsat imagery in water resources applications. The newest Landsat satellite, Landsat 8, launched in 2013, has two thermal spectral bands whereas the Landsat 7 satellite has one band. Thermal imagery from both Landsats 7 and 8 is also collected at a lower spatial resolution (60 meters and 100 meters, respectively) than the multispectral imagery collected by these satellites, though it is resampled to the same 30-meter resolution as the rest of the imagery.
While the handful of completed case studies have indicated the importance of Landsat imagery in water resource management, a broader picture of the use of the imagery by water resources users is not available. This makes it difficult for LRS to meet the needs of these users both now and in the future.
Given the consistency in water rights and the general scarcity of water in the Western U.S. as compared to the rest of the nation, we are proposing a survey that will focus specifically on the users who apply Landsat imagery in water resources in this region. Questions will be asked to determine the extent and type of use of Landsat imagery in water resource management projects, the preferred characteristics (
We are soliciting comments as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Please note that the comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public view, we cannot guarantee that we will be able to do so.
Bureau of Indian Education, Interior.
Notice of availability and request for proposals.
The Bureau of Indian Education (BIE) announces the availability of grants to tribes and their tribal education departments (TEDs) for projects defined under 25 U.S.C. 2020. This notice invites tribes with BIE-funded schools on or near Indian lands to submit grant proposals.
Grant proposals must be received by September 21, 2015, at 4:00 p.m. Eastern Time. BIE will hold pre-grant proposal training sessions. See
Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at this address:
Ms. Wendy Greyeyes, Bureau of Indian Education, Office of the BIE Director, (202) 208-5810;
The Secretary of the Interior, through the BIE, is soliciting grant proposals from federally recognized tribes and their TEDs for projects defined by 25 U.S.C. 2020. These funds will assist tribes in the development and operation of TEDs for the purpose of planning and coordinating all educational programs of the tribe. These funds will support the development of TEDs to improve educational outcomes for students and improve efficiencies and effectiveness in the operation of BIE-funded schools. Grant awards are subject to the availability of funds as appropriated by Congress.
Under 25 U.S.C. 2020, funds will support the program goals for the following areas that promote tribal education capacity building:
1. To provide for the development and enforcement of tribal educational codes, including tribal educational policies and tribal standards applicable to curriculum, personnel, students, facilities, and support programs;
2. To facilitate tribal control in all matters relating to the education of Indian children on reservations (and on former Indian reservations in Oklahoma);
3. To provide for the development of coordinated educational programs (including all preschool, elementary, secondary, and higher or vocational educational programs funded by tribal, Federal, or other sources) on reservations (and on former Indian reservations in Oklahoma) by encouraging tribal administrative support of all Bureau-funded educational programs as well as encouraging tribal cooperation and coordination with entities carrying out all educational programs receiving financial support from other Federal
Grant awards will range from $25,000 to $150,000 per fiscal year depending on the project, number of educational programs impacted, project design and expected outcomes. Subject to the availability of appropriated funds, a grant provided under this section shall be provided for a period of three years. If the performance of the grant recipient is satisfactory to the Secretary, the grant may be renewed for an additional two-year term. As prescribed by 25 U.S.C. 2020, top priority will be given to applications that meet the following:
• Serves three or more separate BIE-funded schools. Less priority will be given if applicant has less than three schools but with at least one BIE-funded school;
• Provides coordinating services and technical assistance to all relevant BIE-funded schools;
• Plans to monitor and audit these grant funds by or through the TED; and/or
• Provides a plan and schedule that:
○ Provides for:
The assumption, by the TED, of all assets and functions of the BIE agency office associated with the tribe, to the extent the assets and functions relate to education; and
the termination by the BIE of such functions and office at the time of such assumption; and
○ Provides that the assumption will occur over the term of the grant, unless mutually agreeable to the tribal governing body and the Assistant Secretary—Indian Affairs, the period in which such assumption is to occur may be modified, reduced, or extended after the initial year of the grant.
The BIE is seeking proposals from tribes that support the development and operation of TEDs for the purpose of planning and coordinating all educational programs of the tribe. Each proposal must include a project narrative, a budget narrative, a work plan outline, and a project coordinator, preferably the tribal education director or tribal council education committee member, to serve as the point of contact for the program. The project coordinator will: participate in monthly collaboration and update meetings, submit quarterly budget updates, ensure an annual report is submitted at the end of each project year, and ensure that the TED fulfills the obligations of the grant.
BIE is seeking proposals from tribes with at least one BIE funded school on their reservation/Indian lands that support the capacity building of TEDs to improve educational outcomes for students and improve efficiencies and effectiveness in the operation of BIE-funded schools. Grant recipients must submit quarterly budget updates and an annual report at the end of each project year to ensure that the TED fulfills the obligations of the grant. Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at the address in the
The grant proposal is due
Faxed grant proposals will NOT be accepted. Email submissions will be accepted at the address in the
Proposals submitted by Federal Express or Express Mail should be sent two or more days before the closing date to ensure receipt by the deadline. The proposal package should be sent to the address shown in the
Bureau of Indian Education, Interior.
Notice of availability and request for proposals.
The Bureau of Indian Education (BIE) announces the availability of enhancement funds to tribes and their tribal education agencies to promote tribal control and operation of BIE-funded schools on their reservations. This notice invites tribes with at least one BIE-funded school on their reservation/Indian land to submit grant proposals.
Grant proposals must be received by September 21, 2015, at 4:00 p.m. Eastern Time. BIE will hold pre-grant proposal training sessions. See
Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at this address:
Ms. Wendy Greyeyes, Bureau of Indian
In 2013, Secretary of the Interior and Secretary of Education convened an American Indian Education Study Group (Study Group) to diagnose the systemic challenges facing the Bureau of Indian Education (BIE) and to propose a comprehensive plan for reform to ensure all students attending BIE-funded schools receive a world-class education. The Study Group drafted a framework for reform based on several listening sessions in the fall of 2013 with tribal leaders, Indian educators and others throughout Indian Country on how to facilitate tribal sovereignty in American Indian education and how to improve educational outcomes for students at BIE-funded schools. Overall, the Study Group met with nearly 400 individuals and received nearly 200 comments that helped it prepare the draft framework for educational reform that became the subject of four tribal consultation sessions held in April and May of 2014. These efforts resulted in “Findings and Recommendations Prepared by the Bureau of Indian Education Study Group, dated June 27, 2014” (
Acting on the recommendations in the
Enhancement funding will range from $100,000 to $200,000 per fiscal year depending on the number of schools involved, number of students, complexity of creating a new tribally managed school system and the tribe's technical approach. These funds will provide funds for the tribe to:
• Research and develop an alternative definition of adequate yearly progress (AYP);
• Develop an implementation plan that will reform a tribe's current organizational structure towards an expert and independent tribal education agency that will support schools and students; and
• Cover the execution of the implementation plan with identified staffing, projected timelines, proposed budgets, and activities.
BIE is seeking proposals from tribes that support efforts to take control and operate BIE-funded schools located on the tribe's reservation. Each proposal must include a project narrative, a budget narrative, a work plan outline, and a Project Director to manage the execution of the grant. The Project Directors will participate in monthly collaboration meetings, submit quarterly budget updates, ensure an annual report is submitted at the end of each project year, and ultimately ensure that the tribal education agency fulfills the obligations of the grant. Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at the address in the
The grant proposal is due
Fax applications will NOT be accepted. Email submissions will be accepted at the address in the
Proposals submitted by Federal Express or Express Mail should be sent two or more days prior to the closing date. The proposal package should be sent to the address shown in the
Bureau of Land Management, Interior.
Public Land Order.
This order withdraws 2,387.22 acres of National Forest System land from location and entry under the United States mining laws for a period of 20 years on behalf of the United States Forest Service to protect the unique cave resources in the area adjacent to the Jewel Cave National Monument.
Valerie Hunt, U.S. Forest Service, Region 2, 740 Simms Street, Golden, Colorado 80401, 303-275-5071,
The United States Forest Service is managing the land to protect the significant cave ecosystems located within the Black Hills National Forest adjacent to Jewel Cave National Monument.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:
1. Subject to valid existing rights, the following described National Forest System land is hereby withdrawn from location and entry under the United States mining laws, but not from leasing under the mineral leasing laws, to protect the unique cave resources in the land adjacent to Jewel Cave National Monument:
The area described contains 2,387.22 acres in Custer County.
2. The withdrawal made by this order does not alter the applicability of the public land laws other than the mining laws.
3. This withdrawal will expire 20 years from the effective date of this order, unless, as a result of a review conducted before the expiration date pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be extended.
Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before August 8, 2015. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation. Comments may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service,1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447. Written or faxed comments should be submitted by September 14, 2015. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
A request to move has been received for the following resource:
A request for removal has been received for the following resources:
National Park Service, Interior.
Notice of Intent
The National Park Service (NPS) intends to prepare an environmental impact statement (EIS) for a Transportation Plan for Acadia National Park. The purpose of the Transportation Plan is to determine how best to provide safe and efficient transportation and a variety of high quality experiences to visitors within Acadia National Park while ensuring the protection of park resources and values. The NPS is soliciting input from interested parties on issues, concerns, and suggestions pertinent to transportation within and access to Acadia National Park.
The comment period for scoping and the date, time, and location of public meetings will be announced through the NPS Planning, Environment, and Public Comment (PEPC) Web site at
Scoping comments may be submitted through the PEPC Web site at
John Kelly, P.O. Box 177, Bar Harbor, ME 04609, (207) 288-8703,
Pursuant to the National Environmental Policy Act of 1969, the NPS intends to prepare an EIS for transportation planning at Acadia National Park. The Transportation Plan for Acadia National Park will address a number of key issues related to transportation in the park. Draft plan objectives include: (1) Establish desired conditions for natural and cultural resources and visitor experiences at destinations and travel corridors throughout the park; (2) identify strategies to address parking and roadway capacity limitations and associated impacts to resources, safety, and visitor experiences; (3) evaluate and establish guidance to improve safety and reduce conflicts between oversized vehicles (
Before including your address, phone number, email address, or other personal identifying information in any comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The responsible official for this Draft Transportation Plan/EIS is the Regional Director, NPS Northeast Region, U.S. Custom House, 200 Chestnut Street, Fifth Floor, Philadelphia, PA 19106.
National Park Service, Department of the Interior.
Notice of Availability.
The National Park Service (NPS) announces the availability of a Final Environmental Impact Statement for the General Management Plan/East Everglades Wilderness Study (EIS/GMP/EEWS) for Everglades National Park, Florida. The last comprehensive planning effort for Everglades National Park was completed in 1979. Much has changed since then—patterns and types of visitor use have changed, the Comprehensive Everglades Restoration Plan was approved, and in 1989 the East Everglades Addition (109,506 acres) was added to restore Northeast Shark River Slough. Recent studies have enhanced the NPS's understanding of resources, resource threats, and visitor use in the national park. This GMP will provide updated management direction for the entire park, including the East Everglades Addition. The EEWS provides a forum for evaluating lands within the East Everglades Addition for possible recommendation to Congress for inclusion in the national wilderness preservation system.
The NPS will execute a Record of Decision (ROD) no sooner than 30 days following publication by the Environmental Protection Agency`s Notice of Availability of the Final EIS in the
The document will be available for public review online at
Everglades National Park Supervisory Park Planner, Fred Herling, at the address and telephone number shown above, or via email at
Public scoping for the GMP was initiated in 2003. The EEWS was added to the scope of the project in 2006. Public meetings, five newsletters, and internet updates kept the public informed and involved throughout the planning process. The Draft GMP/EEWS/EIS was distributed to other agencies, interested organizations, and individuals for their review and comment in February of 2013. Nine public meetings and many additional stakeholder meetings were held on the draft plan in southern Florida. A wilderness hearing was held as part of each of the public meetings.
The draft document was revised as a result of public and agency feedback received during the public comment period. The Final GMP/EEWS/EIS provides a framework for management, use, and development options of the national park for the next 20 or more years. The EIS presents and analyzes the environmental impacts of four alternatives: alternative 1 (no action), alternative 2, the NPS preferred alternative and alternative 4. (Alternative 3 was dismissed from detailed analysis.) The alternatives present a range of resource protection directions, visitor opportunities, visitor facilities, and proposed wilderness.
• Alternative 1 (no action) provides a baseline for evaluating changes and impacts of the three action alternatives. Under this alternative the current management framework would continue and no wilderness would be proposed for the East Everglades Addition.
• Alternative 2 would strive to maintain and enhance visitor opportunities and protect natural systems while preserving many traditional routes and ways of visitor access. It proposes 39,500 acres for designation as wilderness within the East Everglades Addition.
• The NPS preferred alternative, would support restoration of natural systems while providing improved opportunities for quality visitor experiences. It proposes about 42,200 acres for designation as wilderness and about 43,100 acres for designation as potential wilderness within the East Everglades Addition. Elements of this alternative would support the resilience of the Everglades National Park to climate change concerns, such as sea level rise, coastal erosion, and higher storm surges, all of which may affect cultural and natural resources as well as visitor experience at the park.
• Alternative 4 would provide a high level of support for protecting natural systems while improving opportunities for certain types of visitor activities. Alternative 4 would eliminate commercial airboat tours within the park. It proposes 42,700 acres for designation as wilderness and 59,400 acres for designation as potential wilderness within the East Everglades Addition.
The responsible official for this Final EIS is the Regional Director, Southeast Region, NPS 100 Alabama Street SW., 1924 Building, Atlanta, Georgia 30303.
Bureau of Reclamation, Interior.
Notice and request for comments.
We, the Bureau of Reclamation, have forwarded the following Information Collection Request to the Office of Management and Budget (OMB) for review and approval: Lower Colorado River Well Inventory, OMB Control Number 1006-0014. The Information Collection Request describes the nature of the information collection and its expected cost burden.
OMB has up to 60 days to approve or disapprove this information collection request, but may respond after 30 days; therefore, public comments must be received on or before September 28, 2015.
Send written comments to the Desk Officer for the Department of the Interior at the Office of Management and Budget, Office of Information and Regulatory Affairs, via facsimile to (202) 395-5806, or email to
Paul Matuska at (702) 293-8164. You may also view the Information Collection Request at
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Pursuant to the Boulder Canyon Project Act (Public Law 70-642, 45 Stat. 1057), all diversions of mainstream Colorado River water must be in accordance with a Colorado River water entitlement. The Consolidated Decree of the United States Supreme Court in
A
We again invite comments concerning this information collection on:
(a) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical use;
(b) the accuracy of our burden estimate for the proposed collection of information, including the validity of the methodology and assumptions used;
(c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Reclamation will display a valid OMB control number on the form.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Judicial Conference of the United States, Advisory Committee on Rules of Bankruptcy Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Bankruptcy Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
October 1-2, 2015.
9:00 a.m. to 5:00 p.m.
Thurgood Marshall Federal Judiciary Building, Mecham Conference Center, One Columbus Circle NE., Washington, DC 20544.
Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Notice.
On August 31, 2015, the Department of Labor (DOL) will submit the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, “National Agriculture Workers Survey,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before September 30, 2015.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
44 U.S.C. 3507(a)(1)(D).
This ICR seeks OMB approval under the PRA for revisions to the National Agriculture Workers Survey (NAWS)—an employment-based survey of the demographic, employment, and health characteristics of hired crop farm workers, including workers brought to farms by labor intermediaries. In addition, point of contact information is obtained from farms. Interviews are conducted three times per year, in order to account for the seasonality of agricultural production and employment. This information collection has been classified as a revision, because the ETA seeks approval to add new questions to the NAWS on farm workers' education and training program participation; digital information devices access and use; acute, preventive, and dental health care utilization; living quarters location in relation to production agriculture; and housing type. Proposed changes also include: temporarily discontinuing questions on occupational injuries, musculoskeletal problems, and potential exposure to pesticides that have fulfilled their current purpose; deleting 17 other questions that either had too few responses to be useful for analysis, would be redundant with the addition of proposed questions, or are no longer valid; and modifying the stem and/or response options of six (6) questions to make them more useful. Wagner-Peyser Act section 15 authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the information collection request (ICR) proposal titled, “Demonstration and Evaluation of the Short-Time Compensation Program,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before September 28, 2015.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OASAM, Office of Management and
Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks PRA authority for the Demonstration and Evaluation of the Short-Time Compensation Program (STC) information collection. The STC program is an option within the Unemployment Insurance (UI) system that allows an employer to reduce the hours of workers, while permitting workers to receive partial UI benefits for the non-worked hours. The objective of STC is to avoid layoffs during periods of reduced labor demand and, thereby, allow businesses to maintain their operations, retain valued employees, and prevent company morale from deteriorating. The DOL seeks to conduct a rigorous demonstration and impact evaluation of STC programs in two states in order better to understand the reasons for low take-up of STC and to evaluate the effectiveness of interventions designed to increase employer use. More specifically, the DOL seeks OMB approval under the PRA for an information collection to conduct (1) in-depth interviews with state agency officials and employers and (2) employer surveys. These information collections are essential elements of the implementation study and the rigorous impact evaluation of the demonstration of the STC program. Middle Class Tax Relief and Job Creation Act of 2012 section 2166 authorizes this information collection.
This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the information collection request (ICR) proposal titled, “Survey of Working Women,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before September 28, 2015.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OS, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks PRA authority for the Survey of Working Women to identify women's current employment issues and
This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 30 calendar days from the date of this publication.
Interested persons are invited to submit written comments regarding the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 7th Street NW., Washington, DC 20543. Attention: Desk Officer for NASA.
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Frances Teel, NASA PRA Clearance Officer, NASA Headquarters, 300 E Street SW., Mail Code JF000, Washington, DC 20546, or
A federal grant is an award of financial assistance from a federal agency to a recipient to carry out a public purpose of support or stimulation authorized by a law of the United States. The NASA Procurement Office supports NASA research, science, and education communities through the award of research/education/and training grants in the science, technology, engineering, and math (STEM) fields. NASA has a continuing commitment to identify and address inequities associated with its grant review and awards processes. To support that commitment, NASA is implementing a process to collect demographic data from grant applicants for the purpose of analyzing demographic differences associated with its award processes. Information collected will include name, gender, race, ethnicity, disability status, and citizenship status.
Submission of the information is voluntary and is not a precondition of award. However, if the information is not submitted, it will undermine the usefulness of information received from others.
Electronic.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Public Law 104-13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 30 calendar days from the date of this publication.
Interested persons are invited to submit written comments regarding the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 7th Street NW., Washington, DC 20543. Attention: Desk Officer for NASA.
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Frances Teel, NASA PRA Clearance Officer, NASA Headquarters, 300 E Street SW., Mail Code JF000, Washington, DC 20546, or
NASA promotes activities to demonstrate innovative uses and practical benefits of NASA Earth science data, scientific knowledge, and technology. NASA's Applied Sciences Program established the DEVELOP National Program to research environmental management and public policy issues at the state and local level. Under the guidance of NASA and partner organization science advisors, DEVELOP enables participants to lead research projects that utilize NASA Earth observations to address community concerns and public policy issues. Through teams, DEVELOP participants gain experience by (1) utilizing NASA's Earth Science satellite and airborne resources, to include remote sensing and geographic information systems (GIS), and (2) communicating research results. DEVELOP projects serve the global community and extend NASA Earth Science research and technology to benefit society. A focus on both professional and personal development is central to DEVELOP's ten week sessions, which are conducted annually during the spring, summer, and fall.
The DEVELOP research opportunity is available to individuals 18 years and older and includes transitioning career professionals (including veterans of the Armed Forces), recent college/university graduates, and currently enrolled students. Information is collected through an online process from individuals interested in participating in the NASA DEVELOP Program for a ten week session. Information collected from individuals includes a completed application, academic transcript, resume, and two letters of recommendation references per applicant.
With the growing societal role of science and technology in today's global workplace, DEVELOP is fostering an adept corps of tomorrow's scientists and leaders.
Electronic.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.
National Credit Union Administration (NCUA).
Request for comments.
The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). The purpose of this notice is to allow for 60 days of public comment. The information collection relates to NCUA's regulation on conversions of federally insured credit unions (FICUs) to mutual savings banks (MSBs) and mergers of FICUs into banks. The regulation requires an insured credit union that proposes to convert to an MSB or merge into a bank to provide notice and disclosure of the proposal to members and NCUA and to conduct a membership vote.
Comments will be accepted until October 27, 2015.
Interested persons are invited to submit written comments to the NCUA Contact and the OMB Reviewer listed below:
Requests for additional information, a copy of the information collection request, or a copy of submitted comments should be directed to:
NCUA is requesting reinstatement, with change, of the previously approved collection of information for NCUA's regulation on Bank Conversions and Mergers, 12 CFR part 708a (Part 708a), which provides the requirements for conversions of FICUs to MSBs and mergers of FICUs into banks. Part 708a requires an insured credit union that proposes to convert to an MSB or to merge into a bank to provide notice and disclosure of the proposal to members and NCUA and to conduct a membership vote. These requirements are authorized under section 205(b)(2) of the Federal Credit Union Act, 12 U.S.C. 1785(b)(2). They are also necessary to ensure safety and soundness in the credit union industry, and to protect the interests of credit union members in the charter conversion and merger contexts. Submission of this information is designed to ensure NCUA has sufficient information to administer the member vote in an MSB conversion and to approve or disapprove a proposed merger into a bank. The information collection allows NCUA to ensure compliance with statutory and regulatory requirements for conversions and mergers. It also ensures that members of credit unions have sufficient and accurate information to exercise an informed vote concerning a proposed conversion or merger.
Subpart A of Part 708a (Subpart A) covers the conversion of insured credit unions to MSBs. Subpart A requires insured credit unions that intend to convert to MSBs to provide notice and disclosure of their intent to convert to their members and NCUA. It also requires insured credit unions to provide additional information to NCUA at various points in the conversion process.
Subpart C of Part 708a (Subpart C) covers the merger of insured credit unions into banks. Subpart C requires insured credit unions that intend to merge into banks (both mutual and stock banks) to determine the merger value of the credit union and provide notice and disclosure of their intent to merge to their members and NCUA. It also requires insured credit unions to provide additional information to NCUA at various points in the merger process.
The categories of burden and burden hours for credit unions complying with Part 708a may include the following:
Conversions to MSBs:
In the last five years, five credit unions have engaged in MSB conversion transactions. NCUA estimates it takes an average of approximately 300 hours to comply with the notice and disclosure requirements of Subpart A. Of the 300 hours, NCUA estimates that respondents will spend approximately 50 hours on recordkeeping, 42 hours on reporting, and 208 hours on third-party disclosure. Based on NCUA's experience, NCUA estimates that in the future one insured credit union will engage in an MSB conversion transaction in any given year, so that the total annual collection burden is estimated to be approximately 300 hours. The credit union is required to:
a. Publish advance notice of intent to convert (section 708a.103(a))—3 hours;
b. Solicit and review member comments on the advance notice (sections 708a.103(a) and (b))—4 hours;
c. Have the directors approve the conversion proposal (section 708a.103(c))—50 hours;
d. Notify NCUA of intent to convert (section 708a.105)—40 hours;
e. Prepare a directors' certification of support for the conversion proposal and submit to NCUA (section 708a.105(a)(2))—1 hour;
f. Prepare and mail notices to members and conduct a membership vote on the proposed conversion (sections 708a.104, 708a.106)—200 hours;
g. Transmit, upon request, a member's communication to the other members (section 708a.104(f))—1 hour; and
h. Prepare a member vote certification and submit to NCUA (section 708a.107)—1 hour.
Mergers into Banks:
In the last five years, no credit unions have engaged in bank merger transactions. If a credit union were to engage in a bank merger transaction in the future, NCUA estimates it would take approximately 410 hours to comply with the merger valuation, notice, and disclosure requirements of Subpart C. Of the 410 hours, NCUA estimates that respondents will spend approximately 100 hours on recordkeeping, 102 hours on reporting, and 208 hours on third-party disclosure. NCUA estimates that in the future one insured credit union will engage in a bank merger transaction in any given year, so that the total annual collection burden is estimated to be approximately 410 hours. The credit union is required to:
a. Obtain a merger valuation (section 708a.303(a))—50 hours;
b. Publish advance notice of intent to merge (section 708a.303(b))—3 hours;
c. Solicit and review member comments on the advance notice (section 708a.303(c))—4 hours;
d. Conduct due diligence and have the directors approve the merger proposal (sections 708a.303(d), 708a.304(d))—50 hours;
e. Prepare the Merger Plan and Notice of Intent to Merge and Request for NCUA Authorization and submit to NCUA (sections 708a.304(a) and (b))—100 hours;
f. Prepare a directors' certification of support for the merger proposal and submit to NCUA (section 708a.304(c))—1 hour;
g. Prepare and mail notices to members and conduct a membership vote on the proposed merger (sections 708a.305, 708a.306)—200 hours;
h. Transmit, upon request, a member's communication to the other members (section 708a.305(g))—1 hour; and
i. Prepare a member vote certification and submit to NCUA (section 708a.307)—1 hour.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
NCUA requests that you send your comments on this collection for part 708a to the location listed in the
National Credit Union Administration (NCUA).
Request for comment.
National Credit Union Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). This is related to NCUA's regulation 701.22 that outlines requirements for loan participation programs. The rule requires various information collections, which NCUA uses to ensure credit unions have implemented a safe and sound loan participation program.
Comments will be accepted until October 27, 2015.
Interested persons are invited to submit written comments on the information collection to:
Requests for additional information, a copy of the information collection request, or a copy of submitted comments should be directed to:
NCUA is requesting comments on the reinstatement of 3133-0141 Organization and Operations of Federal Credit Unions Loan Participation information collection. NCUA's regulation, 12 CFR 701.22 outlines loan participation requirements. Loan participations pose inherent risk to the NCUSIF due to the interconnectedness between participants. Section 741.225 extends the requirements of Section 701.22 of NCUA's regulations to Federally Insured State Chartered Credit Unions (FISCUs), noting there are strong indications of potential risk to the NCUSIF from FISCUs' loan participation activity. Section 701.22 includes three collection requirements (1) maintenance of a written policy, (2) requirements on the purchasing credit union to have a written loan participation agreement, (3) options to apply for waivers from concentration limits.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
NCUA requests that you send your comments on the information collection requirements under Part 701 to the locations listed in the addresses section. Your comments should address: (a) The necessity of the information collection for the proper performance of NCUA, including whether the information will have practical utility; (b) the accuracy of our estimate of the burden (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (c) ways we could enhance the quality, utility, and clarity of the information to be collected; and (d) ways we could minimize the burden of the collection of the information on the respondents such as through the use of automated collection techniques or other forms of information technology. It is NCUA's policy to make all comments available to the public for review.
National Science Foundation.
Notice of permits issued under the Antarctic Conservation of 1978, Public Law 95-541.
The National Science Foundation (NSF) is required to publish notice of permits issued under the
Li Ling Hamady, ACA Permit Officer, Division of Polar Programs, Rm. 755, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230. Or by email:
On June 22, 2015 the National Science Foundation published a notice in the
National Science Foundation.
Notice of permits issued under the Antarctic Conservation of 1978, Public Law 95-541.
The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.
Li Ling Hamady, ACA Permit Officer, Division of Polar Programs, Rm. 755, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230. Or by email:
On June 24, 2015 the National Science Foundation published a notice in the
National Science Foundation.
Notice of Permit Modification Request Received and Permit Issued Under the Antarctic Conservation Act of 1978, Public Law 95-541.
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated and permits issued under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at title 45 part 670 of the Code of Federal Regulations. This is the required notice of a requested permit modification and permit issued.
Li Ling Hamady, ACA Permit Officer, Division of Polar Programs, Rm. 755, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230. Or by email:
The Foundation issued a permit (ACA 2015-005) to Matthew Lazzara on September 17, 2014. The issued permit allowed the applicant to enter Cape Hallett (ASPA 106) to service and upgrade a weather station.
Now the applicant proposes a modification to his permit to enter ASPA 106 during the 2015-2016 season to complete the work that was unfinished during the 2014-2015 season. The Environmental Officer has reviewed the modification request and has determined that the amendment is not a material change to the permit, and it will have a less than a minor or transitory impact.
The permit modification was issued on August 24, 2015.
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-8030, “Instructions for Recording and Reporting Occupational Radiation Dose Data.” This proposed guide has been revised to incorporate additional information identified since revision 2 of Regulatory Guide (RG) 8.7 was issued. The proposed revision (revision 3) describes methods that the NRC staff considers acceptable for licensees to use for the preparation, retention, and reporting of records of occupational radiation doses. DG-8030, includes changes in the process a licensee needs to follow in order to determine monitoring for occupational exposure, determining prior doses, recording monitoring results, and reporting the results, when required. In addition, this revision references revised versions of NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a Monitoring Period,” as well as detailed instructions for completing these forms.
Submit comments by October 27, 2015. 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
Luis Benevides, telephone: 301-415-2457, email:
Please refer to Docket ID NRC-2015-0203 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document, by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0203 in the subject line of 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 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 draft regulatory guide entitled, “Instructions for Recording and Reporting Occupational Radiation Dose Data,” is temporarily identified by its task number, DG-8030 (ADAMS Accession No. ML15169A218). DG-8030 is proposed revision 3 of RG 8.7.
The NRC issued revision 2 of RG 8.7 in November 2005 (ADAMS Accession No. ML052970092), to provide guidance on acceptable program for the preparation, retention, and reporting of records of occupational radiation doses.
On December 4, 2007, the NRC made changes in part 19 of Title 10 of the
As a result of the definition change to the TEDE, there is a contradiction with the current regulatory guidance. The revised TEDE definition also affected the content of NRC Forms 4 and 5 in that the EDEX is now a quantity to be recorded when monitoring external dose. The term “total organ dose equivalent” (TODE) has also been added in the forms to denote the sum of the deep dose equivalent (DDE) and the committed dose equivalent (CDE) to the organ receiving the highest dose, to be consistent with the regulations described in 10 CFR 20.2106(a)(6).
The NRC staff has estimated that NRC Forms 4 and 5 will become effective in January 2016.
The first issuance of new guidance on a new rule provision does not constitute backfitting, inasmuch as the guidance on the new rule provision must be consistent with the regulatory requirements in the new rule provision, and the backfitting basis for the new rule provision should also be applicable to the issuance of guidance on that new rule provision. The statement of considerations for the 2007 revisions to parts 19 and 20 stated that the specific changes made to the regulations did not constitute “backfitting” as defined in 10 CFR 50.109.
Therefore, for licensees subject to the provisions of 10 CFR part 50 and/or part 52, the first issuance of guidance addressing new provisions of 10 CFR parts 19 and 20 (if finalized), would not constitute issuance of a new or different staff position within the meaning of the definition of “backfitting” in 10 CFR 50.109, or constitute an action inconsistent with any of the issue finality provisions in 10 CFR part 52. Accordingly, no further consideration of backfitting is needed to support issuance of this draft regulatory guide for public comment.
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-1313, “Protection Against Extreme Wind Events And Missiles For Nuclear Power Plants.” This proposed guide has been revised to incorporate additional information identified since revision 1
Submit comments by October 27, 2015. 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
Gordon Curran, Office of Nuclear Reactor Regulation, telephone: 301-415-1247, email:
Please refer to Docket ID NRC-2015-0202 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document, by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0202 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 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 such information as 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 problems or postulated accidents, and data that the staff needs in its review of applications for permits and licenses.
The draft regulatory guide, entitled, “Protection Against Extreme Wind Events and Missiles for Nuclear Power Plants,” is temporarily identified by its task number, DG-1313 (ADAMS Accession No. ML14356A107). DG-1313 is proposed revision 2 of RG 1.117. The guide describes an approach that the staff of the NRC considers acceptable for identifying those SSCs of light-water-cooled reactors that should be protected from the effects of the worst case extreme winds and wind-generated missiles, and remain functional.
Nuclear power plants must be designed so that they remain in a safe condition under extreme meteorological events, including those that could result in the most extreme wind events (tornadoes and hurricanes) that could reasonably be predicted to occur at the site. Tornado wind speeds may not bound hurricane wind speeds for certain portions of the Atlantic and gulf coasts at the wind speed frequencies of occurrence considered in revision 1 of RG 1.76, “Design-Basis Tornado and Tornado Missiles for Nuclear Power Plants,” (ADAMS Accession No. ML070360253). The SSCs should be designed to withstand the effects of the design basis hurricane and hurricane generated missiles so that they remain functional. The NRC will also address these extreme conditions on a case-by-case basis.
This draft regulatory guide describes methods and procedures that the staff considers acceptable for use in identifying those SSCs of light-water-cooled reactors that should be protected from the effects of the worst case extreme winds and wind-generated missiles, so that they remain functional. Although not expressly stated in DG-1313, the regulatory guidance in this regulatory guide is directed at applicants for nuclear power reactor construction permits and operating licenses under part 50 of Title 10 of the
This draft regulatory guide, if finalized, would not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) and is not otherwise inconsistent with the issue finality provisions in 10 CFR part 52, “Licenses,
Existing licensees and applicants of final design certification rules will not be required to follow the positions in DG-1313, if finalized, unless the licensee or design certification rule applicant seeks a voluntary change to its licensing basis with respect to the inclusion or exclusion of SSCs which must be protected against extreme winds and extreme wind effects. In such cases, backfitting and issue finality will not apply if the NRC determines that the safety review of the licensee or applicant-initiated change must include reconsideration of the methods and procedures used in identifying those SSCs. Further information on the staff's use of the draft regulatory guide, if finalized, is contained in the draft regulatory guide under Section D. Implementation.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License amendment request; opportunity to comment, request a hearing and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. NFP-90, issued to the Tennessee Valley Authority (the licensee), for operation of Watts Bar Nuclear Plant (WBN), Unit 1. The amendment request submitted on August 1, 2013, proposed revisions to Technical Specification (TS) 3.8.1, Surveillance Requirement (SR) 3.8.1.8, and the licensing basis as described in the Updated Final Safety Analysis Report (UFSAR). The NRC staff had previously made a proposed determination that the amendment involved no significant hazards consideration. By letters dated April 21, 2014, January 29, 2015, and June 12, 2015, the licensee provided additional information that expanded the scope of the amendment request to include proposed changes to the UFSAR, a new modification to SR 3.8.1.1, and proposed a new SR 3.8.1.22. The purpose of this document is to update the description of the amendment request and to make a proposed determination that the expanded scope of the amendment request involves no significant hanzards consideration.
Comments must be filed by September 28, 2015. A request for a hearing must be filed by October 27, 2015.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
• Federal Rulemaking Web site: Go to
• Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Jeanne A. Dion, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1349; email:
Please refer to Docket ID NRC-2013-0233 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
• Federal rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Please include Docket ID NRC-2013-0233 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 into ADAMS.
The NRC is considering issuance of an amendment to Facility Operating License No. NFP-90, issued to the Tennessee Valley Authority for operation of WBN, Unit 1, located in Spring City, Tennessee.
The proposed license amendment was submitted by letter dated August 1, 2013, and proposed revisions to TS 3.8.1 “Alternating Current Sources—Operating,” related SRs, and the licensing basis as described in the UFSAR for the available maintenance feeder for the Common Station Service Transformers (CSSTs) A and B. The proposed license amendment credited upgrades made to CSST A and B to provide two new sources of preferred Class 1E power supply feeds in addition to the two normal Class 1E power supply feeds. The NRC staff had previously made a proposed determination that the proposed amendment involved no significant hazards consideration (78 FR 64547; October 29, 2013). The proposed license amendment was supplemented by letters dated April 21, 2014, January 29, 2015, and June 12, 2015, and proposed additional changes to the UFSAR, a new modification to SR 3.8.1.1, and proposed a new SR 3.8.1.22.
The purpose of this document is to update the description of the amendment request and to make a proposed determination that the expanded scope of the amendment request involves no significant hanzards consideration.Before issuance of the proposed license amendment, the NRC will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
The NRC has made a proposed determination that the amendment request involves no significant hazards consideration. Under the NRC's regulations in § 50.92 of Title 10 of the
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes described in this TS amendment request, do not alter the safety functions of the WBN Offsite Power system. Design calculations document that CSSTs A and B have adequate capacity to supply all connected loads including one train of shutdown boards in all allowable alignments and meet the separation requirements for offsite power sources. The consequences of an accident are not changed when using CSST A or B to power the shutdown boards because these CSSTs are rated to carry all required loads for any design basis accidents. The failure of a CSST is not considered to be an initiator of a plant accident and therefore the probability or consequences of accidents or events previously evaluated, as described in the UFSAR, is not changed.
Therefore, this proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
As stated above, malfunctions of the CSSTs are not considered to be an initiator for plant accidents and the modifications to the offsite power system do not create a new or different kind of accident. The purpose of the offsite power system is to provide a source of power to the safety related equipment required to mitigate a design basis accident. CSSTs A and B have been physically upgraded and proven by design calculation to meet all required GDC [General Design Criterion] 17 requirements for separation and voltage stability. Using CSSTs A and B as alternate sources of shutdown power does not negatively affect the offsite power systems ability to meet its design function.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in the margin of safety?
Response: No.
CSSTs A and B have adequate design margin to meet all possible loading scenarios as long as both CSSTs A and B are operational prior to one being used as a source of offsite power. This requirement is added to the control room drawings, plant design criteria and the UFSAR in order to ensure acceptable margin is always available prior to CSSTs A or B being used as a source of offsite power.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves 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 amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license. 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
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 requestor/petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
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 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 ten (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 NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
For further details with respect to this amendment request, see the application for amendment dated August 1, 2013, as supplemented by letters dated April 21, 2014, January 29, 2015, and June 12, 2015, which are available for public inspection at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. Publicly-available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
10 CFR 2.206 request; receipt.
The U.S. Nuclear Regulatory Commission (NRC) is giving notice that by petition dated March 25, 2014 [sic], Mike Mulligan (the petitioner) has requested that the NRC take action with regard to the Vermont Yankee Nuclear Power Station (VY) and the Kewaunee Power Station (KPS), which have been permanently shut down and are currently undergoing decommissioning. The petitioner's requests are included in the
Please refer to Docket ID NRC-2015-0200 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Stephen S. Koenick, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-6631, email:
On March 25, 2014 [sic], the petitioner requested that the NRC take action with regard to VY and KPS (ADAMS Accession No. ML15090A487). On July 7, 2015, the petitioner provided supplemental information via email (ADAMS Accession No. ML15198A091). The petitioner requested a number of actions including:
• Conduct exigent and immediate full-scale ultrasonic inspections on the VY and the KPS reactor pressure vessels (RPVs), with similar or better technology, as conducted on the RPVs at Doel 3 and Tihange 2, which revealed thousands of cracks;
• Take large borehole samples out of both the Vermont Yankee and Kewaunee RPVs and transport them to a respected metallurgic laboratory for comprehensive offsite testing;
• Issue an immediate NRC report and hold a public meeting on any identified vulnerabilities; and
• Ultrasonically test all RPVs in U.S. plants within 6 months, if distressed and unsafe results are discovered at VY or KPS.
As the basis for this request, the petitioner states that the requested actions should be taken to determine whether foreign operating experience—specifically several thousand cracks that have been discovered during testing on the Doel 3 and Tihange 2 RPVs—could have implications on U.S. operating reactors.
The request is being treated pursuant to section 2.206, “Requests for action under this subpart,” of Title 10 of the
The petitioner met with the Petition Review Board on May 19, 2015, to discuss the petition; the transcript of that meeting is an additional supplement to the petition (ADAMS Accession No. ML15181A127). The results of that discussion and the July 7, 2015, supplemental email were considered in the board's determination regarding the petitioner's request for immediate action and in establishing the schedule for the review of the petition.
The NRC has denied the petitioner's request to conduct immediate ultrasonic inspections at VY and KPS because of the following reasons. Both the identified facilities have ceased operations and would not be subject to an enforcement-related action (
As provided by 10 CFR 2.206, appropriate action will be taken on the remaining requests within a reasonable time.
For the Nuclear Regulatory Commission.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The MSRB filed with the Commission a proposed rule change consisting of amendments to MSRB Rule A-12, on registration, and MSRB Rule A-13, on underwriting and transaction assessments for brokers, dealers and municipal securities dealers (“proposed rule change”). The MSRB designated the proposed rule change as “establishing or changing a due, fee or other charge” under section 19(b)(3)(A)(ii) of the Act
The text of the proposed rule change is available on the MSRB's Web site at
In its filing with the Commission, the MSRB included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The MSRB has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to adjust certain existing MSRB fees applicable to dealers and municipal advisors that engage in municipal securities and municipal advisory activities (collectively “regulated entities”) to continue to assess reasonable fees necessary to
The proposed rule change would amend Rule A-13 to decrease the existing underwriting fee from $.03 per $1,000 of par value to $.0275 per $1,000 of par value. Additionally, the proposed rule change would amend Rule A-12 to (i) increase the initial registration fee from $100 to $1,000 and (ii) increase the annual registration fee from $500 to $1,000. Further, the proposed rule change would amend Rule A-13(c)(iii) to clarify that securities issued pursuant to a commercial paper program are not subject to the transaction fee.
The MSRB assesses regulated entities various fees designed to defray the cost of its operations, including rulemaking, market transparency and educational initiatives that fulfill its Congressional mandate to, among other things, protect investors and municipal entities by promoting the fairness and efficiency of the $3.7 trillion municipal securities market. The MSRB provides investors, state and local governments and other market participants with free access to disclosure and transparency information in the municipal securities market through its Electronic Municipal Market Access (EMMA®)
Section 15B(b)(2)(J) of the Act
1. Municipal advisor professional fee (Rule A-11) $300 annual fee to be paid for each Form MA-I filed with the SEC by the municipal advisor;
2. Initial registration fee (Rule A-12) $100 one-time registration fee to be paid by each dealer to register with the MSRB prior to engaging in municipal securities activities and each municipal advisor to register with the MSRB prior to engaging in municipal advisory activities;
3. Annual registration fee (Rule A-12) $500 annual fee to be paid by each dealer and municipal advisor registered with the MSRB;
4. Underwriting fee (Rule A-13) .003% ($.03 per $1,000) of the par value to be paid by a dealer, except in limited circumstances, for all municipal securities purchased from an issuer by or through such dealer, whether acting as principal or agent, as part of a primary offering;
5. Transaction fee (Rule A-13) .001% ($.01 per $1,000) of the total par value to be paid by a dealer, except in limited circumstances, for inter-dealer sales and customer sales reported to the MSRB pursuant to MSRB Rule G-14(b);
6. Technology fee (Rule A-13) $1.00 paid by a dealer per transaction for each inter-dealer sale and for each sale to customers reported to the MSRB pursuant to MSRB Rule G-14(b); and
7. Examination fee (Rule A-16) $150 test development fee assessed per candidate for each MSRB examination.
In addition, the MSRB charges data subscription and service fees for subscribers, including dealers and municipal advisors, seeking direct electronic delivery of municipal trade data and disclosure documents associated with municipal bond issues.
Over the course of the current fiscal year, the Board has undertaken a holistic review of the fees assessed on regulated entities. The last such review occurred in 2010 and culminated with amendments to Rule A-13, specifically a transaction fee increase from $.005 to $.01 per $1,000 of the total par value of inter-dealer and customer sales reported to the MSRB and the establishment of a $1.00 technology fee per transaction for each inter-dealer and customer sale reported to the MSRB.
Since 2011, the MSRB has successfully reached and now exceeds the operating reserve target of twelve months of operating expenses and has accumulated the reserve target of three times the annual information technology depreciation expenses. The annual technology fee revenues exceed the annual information technology capital draws and have provided the funding to establish the targeted technology renewal fund. In fact, once the reserve target was met, excess revenues created a surplus over the reserve target, resulting in the Board approving a technology fee rebate of $3.6 million in July 2014.
The Board recognized that, with the current revenue and information technology capital spend rate for capitalized hardware and software, the surplus in the segregated technology fund would continue to grow. Meanwhile, the Board noted that operating reserves are projected to fall to 12 months of operating expenses in fiscal year 2017 and continue to decline thereafter because operating expenses continue to modestly rise annually while the current primary revenue sources to fund these operating expenses are projected to be effectively flat. This decline in reserves could accelerate if bond and trade volumes fall below projected levels causing funds from market activity fees to decrease. The inverse relationship between the projected growing surplus in the technology renewal fund and the potential erosion of operating reserves in the next few years was the catalyst for the Board to conduct a holistic fee review.
The Board evaluated the assessment of MSRB fees on regulated entities with the goal of better aligning revenue sources with operating expenses and all capital needs. The Board strives to diversify funding sources among regulated entities and other entities that fund MSRB services in a manner that ensures long-term sustainability, while continuing to strike an equitable balance among regulated entities and a fair allocation of the expenses of the regulatory activities, systems development and operational activities undertaken by the MSRB. Proxies used by the Board for fairly allocating to regulated entities the cost of MSRB regulation include, but are not limited to: Being registered to engage in municipal securities or municipal advisory activities; the level of dealer market activity as determined by the number of transactions executed and total par value of transactions executed;
The proposed changes resulting from the Board's holistic fee review are summarized below.
The current annual registration fee of $500 pursuant to Rule A-12 is paid by each of the over 2,000 regulated entities registered with the MSRB. While the annual fee amount has not been changed since 2009,
Similarly, the Board concluded that an increase in the initial registration fee under Rule A-12 from $100 to $1,000 was reasonable to help defray a significant portion of the administrative and operational costs associated with processing an initial registration. The fee for initial registration has not been increased since its inception in 1975 and, as a result, is low for an initial registration fee.
Together, the increase in the annual and initial fees would provide approximately $1 million in annual revenue. The MSRB believes the proposed increase in registration fees will equitably defray the expenses of MSRB operations and allow the MSRB to lower underwriting fees by an offsetting amount to achieve a more balanced distribution of fees.
The market activity fees (
With organizational reserves (operating reserves and the technology renewal fund) currently above targeted levels and future year financial pro formas indicating declines in aggregate reserve levels (while remaining slightly above targeted levels), coupled with the increase in registration fees, the Board determined to decrease the underwriting fee from .003% ($.03) to .00275% ($.0275) per $1,000 of the par value. Based on underwriting volume ranging from $300 billion to $400 billion annually, the decrease in the underwriting fee will reduce MSRB revenue by approximately $1 million annually.
The technology fee was implemented in January 2011 to fund capitalized hardware and software for the MSRB market transparency systems.
The Board evaluated reducing the technology fee because the target to maintain three-times the annual information technology depreciation expenses has been met. However, based on its analysis, the Board recognized that without proposing a new fee on regulated entities, the total revenue generated from all sources, excluding the technology fee, would be inadequate to fund projected operational expenses of the organization. When the technology fee was introduced in 2011, it was believed that assessing a fee on a per trade basis established a more balanced distribution of fees on dealers and their activities, which the Board continues to support. The Board determined during the holistic fee review that, if a new fee for regulated entities was proposed, assessing the fee based on the number of trades would be the appropriate measure. The Board considered the potential for additional operational and compliance costs to both dealers and the MSRB in implementing a new fee assessment and did not believe additional costs were warranted when, instead of implementing a new fee based on the number of trades, it would be reasonable to continue to assess the technology fee at its current amount, provided that the revenue collected would be available for funding all MSRB operations. Understanding that technology related expenses currently account for nearly 50% of the costs and expenses of operating and administering the MSRB, the Board concluded that all fees collected from regulated entities should be aggregated and available for the most appropriate organizational uses.
The transaction fee is assessed on the total par value of inter-dealer and customer sales reported to the MSRB by dealers under Rule G-14(b). Rule A-13(c)(iii) exempts from this fee sale transactions in municipal securities that have a final stated maturity of nine months or less or that, at the time of trade, may be tendered at the option of the holder to an issuer of such securities or its designated agent for redemption or purchase at par value or more at least as frequently as every nine months until maturity, earlier redemption, or purchase by an issuer or its designated agent. The Board continues to support such exemptions recognizing that, given the traditionally low short-term interest rates on such short-term instruments, charging fees on such instruments may impair the market for these products. While the transaction fee has never been applicable to commercial paper, which usually has a final stated maturity of nine months or less, there are occasions when the maturity date of commercial paper is extended past a nine-month maturity date, which raises a question as to whether the transaction fee would then apply. During its holistic fee review, the Board confirmed that, even in cases of the extended maturity date, commercial paper issues should remain exempt from the transaction fee. Accordingly, the proposed rule change adds language to the exemption provisions in MSRB Rule A-13(c)(iii) to clarify that the exemption from the transaction fee assessment also applies to securities issued pursuant to a commercial paper program.
The municipal advisor professional fee under Rule A-11 currently assesses $300 per professional for each Form MA-I filed with the Commission as of January 31 of each year.
The professional examination fees established under Rule A-16 were increased from $60 to $150 effective April 1, 2015.
Data subscription service fees were studied and examined in fiscal year 2014 and revised effective April 1, 2014.
The MSRB believes that the proposed rule change is consistent with section 15B(b)(2)(J) of the Act
The MSRB believes that its rules provide for reasonable dues, fees and other charges among registered entities. The MSRB believes that the proposed fees are reasonable and necessary to fund MSRB services in a manner that ensures long-term sustainability, seeking to achieve an equitable balance
Section 15B(b)(2)(C) of the Act
In considering these standards, the MSRB was guided by the Board's Policy on the Use of Economic Analysis. The MSRB does not believe that the proposed rule changes will impose additional burdens on competition that are not necessary or appropriate in furtherance of the purposes of the Act.
The Board believes the increase in the initial fee under Rule A-12 from $100 to $1,000 is necessary and appropriate to ensure that new registrants cover a significant portion of the MSRB administrative costs of processing an initial registration. The MSRB recognizes the possibility that these fees may represent an initial barrier to entry. The Board is not aware of data or other information that would allow for a quantification of the potential impact of this fee increase, but based on experience expects the impact to be small and unlikely to negatively impact the competitiveness of municipal securities or municipal advisor markets in which the registrants participate. Further, the Board notes that firms wishing to engage in municipal securities activities and/or municipal advisory activities face other costs associated with complying with applicable laws and regulations. Based on the Board's experience, the one-time initial fee for registration, even at its proposed new level of $1,000, represents a relatively small share of the typically associated legal and regulatory compliance costs. The MSRB anticipates that a potential market entrant who is actually deterred by this fee may likely find it difficult to fully comply with the other regulatory and legal requirements associated with the market in which it wishes to offer services.
The Board believes the increase in the annual fee under Rule A-12 from $500 to $1,000 is necessary and appropriate to ensure that MSRB registrants that do not regularly engage in the market activities assessed under Rule A-13, but nonetheless participate in the municipal securities market more broadly, share in the costs and expenses of operating and administering the MSRB. The MSRB recognizes that it is possible that these fees may cause a small number of firms with limited attachment to the municipal securities market to exit or further reduce their activity. The Board is not aware of data or other information that would allow for a quantification of this potential impact, but based on experience expects the impact to be small and unlikely to negatively impact the competitiveness of the municipal securities or municipal advisor markets in which registrants participate. Further, the Board notes that firms wishing to engage in municipal securities activities and/or municipal advisory activities face other costs associated with complying with applicable laws and regulations. Based on the Board's experience, the annual fee, even at its proposed new level of $1,000, represents a relatively small share of the typically associated annual legal and regulatory compliance costs. The MSRB anticipates that a registrant who is adversely impacted by a $500 per year increase may likely find it difficult to fully comply with the other regulatory and legal requirements associated with the market in which it wishes to offer services.
The Board is not making any changes to the municipal advisor professional fee under Rule A-11 at this time. Therefore, the only fee increase affecting small municipal advisors is that to the annual, per-firm registration fee. The MSRB recognizes that any fee that is assessed on a per firm basis, rather than activity basis, will likely represent a greater share of a small firm's revenue than it will a larger firm's revenue and that this could cause some small firms to exit the market. However, the Board believes that in most cases, the annual fee will represent a very small percentage of a firm's revenue. As noted above, the Board also believes that a firm that is adversely impacted by a $500 per year increase may find it difficult to fully comply with the other regulatory and legal requirements associated with the market in which it wishes to offer services. Further, as the SEC concluded in its final rule on the permanent registration of municipal advisors, the market would be likely to remain competitive despite the potential exit of some municipal advisors (including small entity municipal advisors), consolidation of municipal advisors, or lack of new entrants into the market.
Written comments were neither solicited nor received on the proposed rule change.
The forgoing rule change has become effective pursuant to section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.
All submissions should refer to File Number SR-MSRB-2015-08. This file number should be included on the
For the Commission, pursuant to delegated authority.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before September 17, 2015.
Send comments identified by docket number FAA-2014-1111 using any of the following methods:
• Federal eRulemaking Portal: Go to
• Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
• Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Fax: Fax comments to Docket Operations at 202-493-2251.
Keira Jones (202) 267-4025, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of RTCA Program Management Committee Meeting.
The FAA is issuing this notice to advise the public of a RTCA Program Management Committee meeting.
The meeting will be held September 22nd from 8:30 a.m.-4:30 p.m.
The meeting will be held at RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036, Tel: (202) 330-0680.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the RTCA Program Management Committee. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice.
The Federal Aviation Administration (FAA) is announcing an opportunity for the public to comment on FAA's intention to collect information from the public. In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our request to the Office of Management and Budget (OMB) for approval for an information collection. We are requesting an emergency review under 5 CFR part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review.
The FAA has documented over 675 pilot and law enforcement reports of unmanned aircraft `events' in 2015. In comparison, the FAA received 238 of these reports in the entirety of 2014. This increase in reports, particularly in close proximity to airports, suggests that many unmanned aircraft system (UAS) operators are unaware of safety guidelines and policies and are unaware of the potential hazards these operations may pose to manned aircraft operations. The FAA's B4UFLY smartphone app will provide situational awareness of flight restrictions—including locations of airports, restricted airspace, special use airspaces, and temporary flight restrictions—based on a user's current or planned flight location. The risk posed to the National Airspace System (NAS) by increasingly unsafe UAS operations makes the immediate release of this app vital.
Written comments should be submitted by September 28, 2015.
Interested persons are invited to submit written comments on the proposed information collection 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/FAA, and
Ronda Thompson at (202) 267-1416, or by email at:
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before September 17, 2015.
Send comments identified by docket number FAA-2015-3491 using any of the following methods:
•
•
•
•
Keira Jones (202) 267-4025, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Texas Department of Transportation (TxDOT), Federal Highway Administration (FHWA), Department of Transportation.
Federal notice of intent to prepare an Environmental Impact Statement (EIS).
Pursuant to 40 CFR 1508.22, FHWA, on behalf of TxDOT, is issuing this notice to advise the public that an EIS will be prepared for a proposed transportation project to construct State Highway (SH) 68 from Interstate (I)-2/United States Highway (US) 83 to I-69C/US 281 in Hidalgo County, Texas. Areas within the study area include the cities of Alamo, Pharr, Donna, Edinburg, San Juan, and San Carlos.
Homer Bazan, Jr., P.E., Director of Transportation Planning and Development—TxDOT Pharr District, 600 W. Interstate 2, Pharr, Texas, 78577; telephone: 956-702-6100; email:
The environmental review, consultation, and other actions required by applicable Federal environmental laws for this project are being, or have been, carried-out by TxDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT. TxDOT will prepare an EIS for the proposed SH 68 from I-2/US 83 to I-69C/US 281, listed in the 2015—2040 Hidalgo County Metropolitan Transportation Plan as a 4-lane divided rural highway facility with the potential for main lanes and overpasses. There is no existing facility; therefore, the project is proposed on new location.
The purpose of the project is to improve north/south mobility, increase travel capacity for local and regional traffic, and provide an alternate north-south evacuation routes during emergency events. The project need is a lack of sufficient north/south mobility for local and regional traffic and for additional emergency evacuation routes, which are the result of historical and continuing growth in the region's population as well as continued growth of traffic in the region.
The significance of impacts for the proposed SH 68 project was initially uncertain, so the process began by preparing an environmental assessment (EA). Based on preliminary analysis and feedback from the public, it was determined that an EIS should be prepared. The EIS will incorporate information collected during the EA process; in addition, public input gathered during the development of the EA will be considered in the EIS process. The EIS will develop and evaluate a range of alternatives including “No-action” (the no-build alternative), Transportation System Management (TSM)/Transportation Demand Management (TDM), rapid transit and roadway build alternatives. The EIS will analyze potential direct, indirect and cumulative impacts from construction and operation of proposed corridor improvements including, but not limited to, the following: transportation impacts; air quality and noise impacts; water quality impacts including storm water runoff; impacts to waters of the United States including wetlands; impacts to floodplains; impacts to historic and archeological resources; impacts to threatened and endangered species; socioeconomic impacts including environmental justice communities; impacts to and/or potential displacements of land use, vegetation, residents and businesses; and impacts to aesthetic and visual resources.
Public involvement is a critical component of the project development process and will occur throughout the planning and study phases. Letters describing the proposed action including a request for comments will be sent to appropriate Federal, State, and local agencies and to private organizations and citizens who have previously expressed or are known to have interest in this proposal. Agency and public scoping meetings are planned for late 2015. The purpose of the public scoping meetings is to identify significant and other relevant issues related to SH 68 mobility improvements as part of the National Environmental Policy Act process. The scoping meetings will provide opportunities for participating agencies, cooperating agencies, and the public to be involved in review and comment on the draft coordination plan, defining the need and purpose for the proposed project, and the range of alternatives to be considered in the EIS. In addition to the agency and public scoping meetings, a public hearing will be held. Public notice will be given of the time and place of the meetings and hearing. To ensure that the full range of issues related to this proposed action is addressed and all significant issues are identified, comments and suggestions are invited from all interested parties. Such comments or questions concerning this proposed action should be directed to TxDOT at the address provided above.
Federal Transit Administration (FTA), DOT.
Notice.
This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for projects in the Cities of Seattle, Shoreline, Mountlake Terrace, and Lynnwood, WA; New Orleans, LA; Tacoma, WA; and Fort Lauderdale, FL. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject projects and to activate the limitation on any claims that may challenge these final environmental actions.
By this notice, FTA is advising the public of final agency actions subject to Section 139(l) of Title 23, United States Code (U.S.C.). A claim seeking judicial review of FTA actions announced herein for the listed public transportation projects will be barred unless the claim is filed on or before January 25, 2016.
Nancy-Ellen Zusman, Assistant Chief Counsel, Office of Chief Counsel, (312) 353-2577 or Terence Plaskon, Environmental Protection Specialist, Office of Environmental Programs, (202) 366-0442. FTA is located at 1200 New Jersey Avenue SE., Washington, DC 20590. Office hours are from 9:00 a.m. to 5:30 p.m., Monday through Friday, except Federal holidays.
Notice is hereby given that FTA has taken final agency actions by issuing certain approvals for the public transportation projects listed below. The actions on the projects, as well as the laws under which such actions were taken, are described in the documentation issued in connection with the projects to comply with the National Environmental Policy Act (NEPA) and in other documents in the FTA administrative record for the projects. Interested parties may contact either the project sponsor or the relevant FTA Regional Office for more information on each project. Contact information for FTA's Regional Offices may be found at
This notice applies to all FTA decisions on the listed projects as of the issuance date of this notice and all laws under which such actions were taken, including, but not limited to, NEPA [42 U.S.C. 4321-4375], Section 4(f) of the
1.
2.
3.
4.
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 September 28, 2015.
Comments should refer to docket number MARAD-2015-0095. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel KWIAT NIGHTS II is:
The complete application is given in DOT docket MARAD-2015-0095 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 28, 2015.
Comments should refer to docket number MARAD-2015-0096. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel PRIVATEER is:
The complete application is given in DOT docket MARAD-2015-0096 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 28, 2015.
Comments should refer to docket number MARAD-2015-0097. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel LYNX is:
The complete application is given in DOT docket MARAD-2015-0097 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 28, 2015.
Comments should refer to docket number MARAD-2015-0098. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel LIONHEART K18 is:
The complete application is given in DOT docket MARAD-2015-0098 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 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 applications described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier
Comments must be received on or before September 18, 2015.
Send comments to: Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
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.
Donald Burger, 202-366-4314.
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 modification of 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)).
The Massachusetts Department of Transportation (MassDOT)
According to MassDOT, the acquisition of the Railroad Assets will promote continued use (and potential growth) of freight traffic due in part to physical plant improvements that MassDOT is already undertaking, and will facilitate use of the property for railroad passenger excursion operations.
MassDOT also states that it will not acquire the right, nor will it have the ability, to provide rail freight common carrier service over the Railroad Assets, and that PAS will retain a permanent, exclusive freight operating easement over the Railroad Assets.
MassDOT certifies that it would not conduct freight operations over the Railroad Assets, and therefore, MassDOT's prospective annual common carrier revenues will not result in the creation of a Class I or Class II carrier.
MassDOT also states that the parties intend to consummate the transaction on or about September 28, 2015, subject to a Board decision on the concurrently filed motion to dismiss. The earliest this transaction may be consummated is September 13, 2015 (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void
An original and ten copies of all pleadings, referring to Docket No. FD 35943, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Robert A. Wimbish, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 920, Chicago, IL 60606-2832.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Office of the Secretary (OST), U.S. Department of Transportation (DOT).
Notice and request for comments.
The Department of Transportation (DOT) invites public comments on a request to the Office of Management and Budget (OMB) to approve the reinstatement of a previously approved Information Collection Request (OMB Control # 2105-0563) in accordance with the requirements of the Paperwork Reduction Act of 1995 (Pub L. 104-13, 44 U.S.C. 3501
The previous approval granted the Department of Transportation authority to collect information involving National Infrastructure Investments or TIGER Discretionary Grants pursuant to Title I of the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act for 2010 (the “FY 2010 Appropriations Act). The Office of the Secretary of Transportation (“OST”) is referring to these grants as TIGER Discretionary Grants. The original collection of information was necessary in order to receive applications for grant funds pursuant to the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act of 2010 (“FY 2010 Appropriations Act”), Title I—Department of Transportation, Office of the Secretary, National Infrastructure Investments, Public Law 111-117, 123 Stat. 3034. The purpose of the TIGER Discretionary Grants program is to advance projects that will have a significant impact on the Nation, Metropolitan area or a region.
This request for reinstatement advances the previously approved request of an information collection. The information to be collected will be used to, receive applications for grant funds, to evaluate the effectiveness of projects that have been awarded grant funds and to monitor project financial conditions and project progress in support of the National Infrastructure Investments, referred to by the Department as “Grants for Transportation Investment Generating Economic Recovery”, or “TIGER” Discretionary Grants program authorized and implemented pursuant to the American Recovery and Reinvestment Act of 2009 (the “Recovery Act”) (OMB Control Number: 2105-0563) and the grants for National Infrastructure Investments under the FY 2010 Appropriations Act or TIGER Discretionary Grant programs include promoting economic recovery and supporting projects that have a significant impact on the Nation, a metropolitan area, or a region.
A 60-day
Written comments should be submitted by September 28, 2015.
You may submit comments [identified by Docket No. DOT-OST-2015-0061] to the DOT/OST Desk Officer through one of the following methods:
•
•
•
Robert Mariner, U.S. Department of Transportation, Office of the Assistant Secretary for Transportation Policy, at 202-366-8914, or
The following is detailed information and instructions regarding the specific reporting requirements for each report identified above:
TIGER Discretionary Grant program grantees will submit a Project Progress and Monitoring Report and the Federal Financial Report (SF-425) to the Government on a quarterly basis. Grantees should use the following structure when preparing the quarterly Project Progress and Monitoring Report.
•
○
○
○
○
○
1.
• Current total project cost (forecast) vs. latest budget vs. baseline budget. Include an explanation of the reasons for any deviations from the approved budget.
• Current overall project completion percentage vs. latest plan percentage.
• Any delays or exposures to milestone and final completion dates. Include an explanation of the reasons for the delays and exposures.
• A summary of the projected and actual dates for notices to proceed for significant contracts, start of construction, start of expenditure of TIGER Discretionary Grant funds, and project completion date. Include an explanation of the reasons for any discrepancies from the corresponding project milestone dates included in the Agreement.
• Any Federal obligations and/or TIFIA disbursements occurring during the month versus planned obligations or disbursements.
• Any significant contracts advertised, awarded, or completed.
• Any significant scope of work changes.
• Any significant items identified as having deficient quality.
• Any significant safety issues.
• Any significant Federal issues such as environmental compliance, Buy America/Buy American (whichever is applicable to this Project), Davis Bacon Act Prevailing Wage requirements,
2.
3.
4.
• Current overall project completion percentage vs. latest plan percentage.
• Completion percentages vs. latest plan percentages for major activities such as right-of-way, major or critical design contracts, major or critical construction contracts, and significant force accounts or task orders. A schedule status description should also be included for each of these major or critical elements.
• Any delays or potential exposures to milestone and final completion dates. The delays and exposures should be quantified and overall schedule impacts assessed. The reasons for the delays and exposures should be explained, and initiatives being analyzed or implemented in order to recover the schedule should be detailed.
5.
• Reasons for each line item deviation from the approved budget, impacts resulting from the deviations, and initiatives being analyzed or implemented in order to recover any cost overruns.
• Transfer of costs to and from contingency line items, and reasons supporting the transfers.
• Speculative cost changes that potentially may develop in the future, a quantified dollar range for each potential cost change, and the current status of the speculative change. Also, a comparison analysis to the available contingency amounts should be included, showing that reasonable and sufficient amounts of contingency remain to keep the project within the latest approved budget.
• Detailed cost breakdown of the general engineering consultant (GEC) services (if applicable), including such line items as contract amounts, task orders issued (amounts), balance remaining for tasks, and accrued (billable) costs.
• Federal obligations and/or TIFIA disbursements for the project, compared to planned obligations and disbursements.
6.
7.
8.
TIGER Discretionary Grant program grantees will submit an Annual Budget Review and Program Plan to the Government 60 days prior to the end of each Agreement year that they are receiving grant funds. Grantees should use the following structure when preparing the Annual Budget Review Report.
•
○
○
○
○
○
1.
2.
3.
4.
If there are no proposed deviations from the Approved Detailed Project Budget, the Annual Budget Review shall contain a statement stating such. The grantee will meet with the Government to discuss the Annual Budget Review and Program Plan. If there is an actual or projected project cost increase, the annual submittal should include a written plan for providing additional sources of funding to cover the project budget shortfall or supporting documentation of committed funds to cover the cost increase. To the extent the annual budget update deviates from the approved project budget by more than 10 percent, then work proposed under the Annual Budget Review and Program Plan shall not commence until written approval from the Government is received.
TIGER Discretionary Grant program grantees will submit Performance Measure Reports on the performance (or projected performance) of the project using the performance measures that the grantee and the Government selected through negotiations.
•
○
○
○
○
○
1.
2.
This request reinstates a previously approved information collection that is necessary to receive applications for grant funds, to evaluate the effectiveness of projects that have been awarded grant funds and to monitor project financial conditions and project progress.
The reporting requirements for the program are as follows:
Grantees will submit reports on the financial condition of the project and the project's progress. Grantees will submit progress reports and the Federal Financial Report (SF-425) to the Government on a quarterly basis, beginning on the 20th of the first month of the calendar-year quarter following the execution of a grant agreement, and on the 20th of the first month of each calendar-year quarter thereafter until completion of the project. The initial report will include a detailed description, and, where appropriate, drawings, of the items funded.
Grantees will also submit an Annual Budget Review and Program Plan to the Government via email 60 days prior to the end of each Agreement year that they are receiving grant funds. The Annual Budget Review and Program Plan will provide a detailed schedule of activities, estimate of specific performance objectives, include forecasted expenditures, and schedule of milestones for the upcoming year. If there is an actual or projected project cost increase, the Annual Budget Review will include a written plan for providing additional sources of funding to cover the project budget shortfall or supporting documentation of committed funds to cover the cost increase.
This information will be used to monitor grantees' use of Federal funds, ensuring accountability and financial transparency in the TIGER programs.
Grantees will also submit reports on the performance (or projected performance) of the project on performance measures that the grantee and the Government select through negotiations. The Grantees will submit a Pre-project Report that will consist of current baseline data for each of the performance measures specified in the Performance Measurement Table in the grant agreement negotiated between the grantee and the Government. The Pre-project Report will include a detailed description of data sources, assumptions, variability, and the estimated level of precision for each measure. The Grantees will submit interim Project Performance Measurement Reports to the Government for each of the performance measures specified in the Performance Measurement Table in the grant agreement negotiated between the grantee and the Government. Grantees will submit reports at each of the intervals identified for the duration of the time period specified in the Performance Measurement Table in the grant agreement negotiated between the grantee and the Government. The Grantees will submit a Project Outcomes Report after the project is completed that will consist of a narrative discussion detailing project successes and/or the influence of external factors on project expectations.
This information collected will be used to evaluate and compare projects and the monitor results that grant funds achieve, ensuring that grant funds achieved the outcomes targeted by the TIGER Discretionary Grant program.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 148.
Pipeline and Hazardous Materials Safety Administration, Federal Aviation Administration, Department of Transportation.
Notice of lithium battery safety public meeting and request for information.
The U.S. Department of Transportation, including the Federal Aviation Administration's (FAA) Office of Hazardous Materials Safety and the Pipeline and Hazardous Materials Safety Administration's (PHMSA) Office of Hazardous Materials Safety, announce a
The public meeting will be held on September 18, 2015, from 1:00 p.m. until 5:00 p.m. Written comments also may be submitted to docket no. DOT-OST-2015-0169 at
We are committed to providing equal access to this meeting for all participants. If you need alternative formats or other reasonable accommodations, please call (202) 267-9432 or email
A panel of representatives from the FAA and PHMSA will be present. The meeting is intended to be informal, non-adversarial, and to facilitate the public comment process. No individual will be subject to questioning by any other participant. Government representatives on the panel may ask questions to clarify statements. Unless otherwise stated, any statement made during the meetings by a panel member should not be construed as an official position of the U.S. government. The meeting will be open to all persons, subject to the capacity of the meeting room and phone lines available for those participating via conference call. Every effort will be made to accommodate all persons wishing to attend. We will try to accommodate all speakers, subject to time constraints.
You may submit comments by any of the following methods:
•
•
•
•
Questions for FAA regarding the meeting can be directed to Janet McLaughlin, Director, Office of Hazardous Materials Safety, ADG-2, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-9432; email:
The transportation by air of lithium cells and batteries to, from, or within the United States, and on U.S. registered aircraft operating anywhere in the world is subject to the U.S. Hazardous Materials Regulations (U.S. HMR).
The transportation of lithium batteries by air continues to raise significant safety concerns. Lithium batteries are known to be highly flammable and capable of self-ignition. Ignition of lithium batteries can be caused by a short circuit, overcharge, exposure to extreme temperatures, mishandling, or a defect. Once a battery is induced into such a state, either by internal failure or by external means such as heating or physical damage, the battery can generate sufficient heat to cause adjacent batteries to go into thermal runaway.
Testing conducted by the FAA William J. Hughes Technical Center (FAA Tech Center) has shown that heat and flames generated from thermal runaway in a single package can spread to adjacent packages. According to the International Coordinating Council of Aerospace Industries Association (ICCAIA), Boeing, and other aircraft manufacturers, once an event like this occurs, the fire suppression capabilities of an aircraft may be exceeded,
The FAA Tech Center research and findings, available at
• The potential for propagation of thermal runaway between cells or batteries in a package and between adjacent packages of batteries;
• The potential for uncontrolled lithium battery fires to overwhelm the capability of existing aircraft cargo fire protection systems, leading to a catastrophic failure of the airframe; and
• The potential for venting of combustible gases from lithium ion cells in thermal runaway, which could collect in an enclosed environment and cause an explosion even in the presence of a suppression agent.
In 2014, the ICAO DGP recognized that finding solutions to increase the safety of lithium battery transportation would require a multidisciplinary approach involving a wide range of experts, including those from the fields of dangerous goods (hazardous materials), aircraft operations, airworthiness, and battery manufacturing. This layered approach involves battery design, packaging standards, quantity limits, container capabilities, and fire suppression systems that can establish conditions in which lithium batteries may be transported without posing an unacceptable risk.
To that end, in 2014, the ICAO Air Navigation Bureau organized two International Multidisciplinary Lithium Battery Transport Coordination Meetings. The first was held from February 4-6, 2014, in Atlantic City, NJ, and the second was held from September 9-11, 2014, in Cologne, Germany. Discussions during the first meeting focused primarily on lithium metal batteries and the report from the first meeting, including recommendations, can be found at:
The second multidisciplinary working group meeting continued the work from the February 2014 meeting and developed fourteen recommendations related to enhancing the safety of air transportation of lithium batteries. These recommendations were forwarded by the multidisciplinary group to the ICAO Dangerous Goods, Flight Operations, and Airworthiness Panels for consideration. The report from the second meeting, including all of the recommendations, can be found at:
In April 2015, the ICAO DGP reviewed the recommendations of the multidisciplinary working group and prioritized the following efforts: (1) Developing a performance-based provision to limit the probability of propagation of thermal runaway between cells; (2) limiting lithium-ion cells to a 30% state of charge during transport as an interim means to reduce the probability of propagation of thermal runaway between cells; and (3) developing a performance-based packaging standard.
On July 28, 2015, a third multidisciplinary working group meeting was convened to facilitate a focused discussion on the prioritized recommendations and develop options for addressing the recommendations for consideration by the ICAO DGP during the October 2015 meeting regarding (1) performance-based packaging standards; (2) system safety assessments for cargo aircraft; and (3) short term/interim actions that may be necessary.
As a result of the July 2015 meeting of the multidisciplinary group, draft performance criteria were discussed to improve the air transportation of lithium batteries. In addition, the working group considered a recommendation that would require operators to perform safety risk assessments in order to establish whether they can manage the risk associated with the transport of lithium batteries as cargo on passenger or all cargo aircraft. With respect to the performance criteria, the group favored an approach that would provide layers of mitigation options to meet the performance criteria. The determination of how to meet the performance criteria could be tailored to individual circumstances and informed by a rigorous safety assessment. Finally the group discussed additional measures that could be taken while a performance standard is being developed.
The draft performance criteria are based on the principle that the hazardous effects associated with thermal runaway must remain within the package. The criteria specify that no hazardous quantities of flame and no hazardous fragments can exit the package. The surface temperature of the package also must be limited to prevent thermal runaway from spreading to adjacent packages and igniting adjacent packing material. Specific test methods remain to be developed.
The group recommended the following draft performance criteria, to be met at either the package level or the battery/cell level:
• No hazardous amount of flame would be allowed outside of the package.
• The external surface temperature of the package would not exceed the amount that would ignite packaging material or cause batteries or cells in adjacent packages to go into thermal runaway.
• No hazardous fragments would be able to exit the package and the package would need to maintain its structural integrity.
• The quantity of flammable vapor would need to be less than the amount of gas, that when mixed in air and ignited could cause a pressure rise in a [2.8 m3 compartment] volume that could dislodge the aircraft cargo compartment liners [3.44 kPa-6.89 kPa (.5 psi-1 psi)].
In addition to these criteria, the working group also considered whether performance criteria were necessary to address the risk associated with an external fire potentially compromising a package; however, there was no consensus reached on whether this should be part of a performance standard. The group recognized that the development of the means for compliance with the performance criteria could be done by either an ICAO working group or an external standards development organization.
Additionally, the group recommended that operators perform a safety risk assessment in order to establish if they could manage safely the risks associated with the transport of lithium batteries as cargo on passenger or all-cargo aircraft. In order to perform a safety risk assessment, information on the types and quantities of lithium batteries and cells being transported would need to be considered. The very limited capabilities of the fire protection system
Finally, the group was asked to consider additional interim measures that could reduce risk in air transport, including measures such as forbidding the carriage of lithium ion batteries as cargo on passenger aircraft, eliminating the exceptions for certain small batteries in Section II of the ICAO TI lithium battery packing instructions, and reducing the state of charge of the battery in transport. There was no consensus reached by the group on these additional measures and no new recommendations were developed; however, it is expected these topics may be discussed further within the relevant ICAO Panels this fall.
The DOT, FAA, and PHMSA request input from all industry stakeholders and interested individuals on strategies to enhance the safe transport of lithium batteries aboard passenger and cargo aircraft by air, to include the foregoing options which are now under consideration by the ICAO DGP, as well as the ICAO Operations and Airworthiness Panels. To the extent that any of these options are ultimately adopted as new standards or revisions to the ICAO TI, consistent with 49 U.S.C. 5120, the Department may consider adopting the standards or revised ICAO TI through a rulemaking action. Therefore, the Department requests input at the upcoming public meeting, as well as submissions to the docket on risk mitigation strategies, information, and data to help further inform our work in this area as we prepare to participate in the fall 2015 ICAO Panel meetings regarding these subjects.
Specifically, the Department invites comment and recommendations, as well as any relevant supporting data, in the following areas:
• The draft performance criteria recommended by the third multidisciplinary group and how the criteria might be met at the packaging level or at the battery level to address the aviation fire hazards that have been identified.
• The recommendation that operators be required to perform a safety risk assessment in order to ensure management of the risks associated with the transport of lithium batteries as cargo on passenger or all-cargo aircraft to an acceptable level of safety.
• Additional measures which the group did not reach full consensus on, including:
○ Consideration of the effects of an external fire as an element of the performance criteria to protect against the risks of a fire not initiated by a battery within a package.
○ Forbidding the carriage of lithium ion batteries as cargo on passenger aircraft, as an interim measure.
○ Eliminating the exceptions for certain small batteries in Section II of the ICAO TI lithium battery packing instructions or alternative means to identify the types and quantities of lithium batteries or cells being transported in order to effectively inform a safety risk assessment.
○ Reducing the state of charge of the battery in transport.
• Qualitative and quantitative information on the potential impacts of implementing the above recommendations and/or additional measures, such as:
○ Determination of the current level of exposure to these fire hazards—Data or information on the volumes of batteries currently transported on passenger aircraft or those utilizing the provisions of section II of the ICAO TI.
○ Establishment of the current baseline—Data or information regarding the effectiveness of the current requirements, evolution in the market, voluntary safety actions, and emerging safety risks.
○ Potential benefits—Data or information providing estimates of potential safety benefits related to the recommendations and additional measures under consideration by ICAO, as well as alternatives that provide comparable or greater safety benefits.
○ Potential costs—Data or information providing estimates of potential costs associated with the recommendations and additional measures under consideration by ICAO.
○ Studies or analysis on the effectiveness of the recommendations and additional measures—Any studies that address how lithium batteries in differing packaging types or at varying charge states behave in aviation fire scenarios.
Office of the Assistant Secretary for Research and Technology (OST-R), Bureau of Transportation Statistics (BTS), DOT.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Written comments should be submitted by September 28, 2015.
Cecelia Robinson, Office of Airline Information, RTS-42, Room E34-410, OST-R, BTS, 1200 New Jersey Avenue SE., Washington, DC 20590-0001, Telephone Number (202) 366-4405, Fax Number (202) 366-3383 or EMAIL
OMB Approval No. 2138-0041.
Part 234 gives air travelers information concerning their chances of
The Federal Aviation Administration uses Part 234 data to pinpoint and analyze air traffic delays. Wheels-up and wheels-down times are used in conjunction with departure and arrival times to show the extent of ground delays. Actual elapsed flight time, wheels-down minus wheels-up time, is compared to scheduled elapsed flight time to identify airborne delays. The reporting of aircraft tail number allows the FAA to track an aircraft through the air network, which enables the FAA to study the ripple effects of delays at hub airports. The data can be analyzed for airport design changes, new equipment purchases, the planning of new runways or airports based on current and projected airport delays, and traffic levels. The identification of the reason for delays allows the FAA, airport operators, and air carriers to pinpoint delays under their control.
The Confidential Information Protection and Statistical Efficiency Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to clearly identify information it collects for non-statistical purposes. BTS hereby notifies the respondents and the public that BTS uses the information it collects under this OMB approval for non-statistical purposes including, but not limited to, publication of both Respondent's identity and its data, submission of the information to agencies outside BTS for review, analysis and possible use in regulatory and other administrative matters.
Bureau of the Fiscal Service, Fiscal Service, Department of the Treasury.
Notice.
This is Supplement No. 1 to the Treasury Department Circular 570, 2015 Revision, published July 1, 2015, at 80 FR 37735.
Surety Bond Branch at (202) 874-6850.
A Certificate of Authority as an acceptable surety on Federal bonds is hereby issued under 31 U.S.C. 9305 to the following company:
National Liability & Fire Insurance Company (NAIC # 20052). Business Address: 3024 Harney Street, Omaha, NE., 68131-3580. PHONE: (402) 916-3000. Underwriting Limitation b/: $96,739,000. Surety Licenses c/: AL, AK, CA, CT, DE, DC, HI, ID, IL, IA, KS, KY, MD, MA, MI, MS, MO, NE., NH, NJ, NM, NY, ND, OH, OK, RI, SC, SD, TX, UT, VT,VA, WA, WY. Incorporated In: Connecticut.
Federal bond-approving officers should annotate their reference copies of the Treasury Circular 570 (“Circular”), 2015 Revision, to reflect this addition.
Certificates of Authority expire on June 30th each year, unless revoked prior to that date. The Certificates are subject to subsequent annual renewal as long as the companies remain qualified (
The Circular may be viewed and downloaded through the Internet at
Questions concerning this notice may be directed to the U.S. Department of the Treasury, Bureau of the Fiscal Service, Surety Bond Branch, 3700 East-West Highway, Room 6D22, Hyattsville, MD 20782.
Department of the Treasury.
Notice.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before September 28, 2015 to be assured of consideration.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission may be obtained by emailing
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 38 U.S.C. App. 2 that a meeting of the Advisory Committee on Homeless Veterans will be held October 19, 2015 through October 21, 2015. On October 19 and October 20, the Committee will meet at
The purpose of the Committee is to provide the Secretary of Veterans Affairs with an on-going assessment of the effectiveness of the policies, organizational structures, and services of VA in assisting homeless Veterans. The Committee shall assemble and review information related to the needs of homeless Veterans and provide advice on the most appropriate means of providing assistance to that subset of the Veteran population. The Committee will make recommendations to the Secretary regarding such activities.
The agenda will include briefings from local homeless service providers, officials at VA and other agencies regarding services for homeless Veterans. The Committee will also review the framework to complete the annual report that was developed after the last meeting of the Advisory Committee on Homeless Veterans and will identify a timeframe to complete this upcoming annual report that provides recommendations to the Secretary of Veterans Affairs.
No time will be allocated at this meeting for receiving oral presentations from the public. Interested parties should provide written comments on issues affecting homeless Veterans for review by the Committee to Ms. Lisa Pape, Designated Federal Officer, VHA Homeless Programs Office (10NC1), Department of Veterans Affairs, 90K NE., Washington, DC, or email to
Members of the public who wish to attend should contact Charles Selby or Timothy Underwood of the VHA Homeless Program Office by September 18, 2015, at
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 38 U.S.C. App. 2 that a meeting of the Advisory Committee on Homeless Veterans will be held September 25, 2015. On September 25, 2015 the Committee will meet via teleconference, from 1:00 p.m. to 4:00 p.m. Eastern Standard Time. The meeting will be open to the public.
The purpose of the Committee is to provide the Secretary of Veterans Affairs with an on-going assessment of the effectiveness of the policies, organizational structures, and services of VA in assisting homeless Veterans. The Committee shall assemble and review information related to the needs of homeless Veterans and provide advice on the most appropriate means of providing assistance to that subset of the Veteran population. The Committee will make recommendations to the Secretary regarding such activities.
The agenda will include the Committee beginning to finalize their site-visit agenda to Houston, Texas in October and topics for their upcoming annual report that will make recommendations to the Secretary of Veterans Affairs. No time will be allocated at this meeting for receiving oral presentations from the public. Interested parties should provide written comments on issues affecting homeless Veterans for review by the Committee to Ms. Lisa Pape, Designated Federal Officer, VHA Homeless Programs Office (10NC1), Department of Veterans Affairs, 90K NE., Washington, DC, or email to
Interested persons may attend the call by dialing 1-800-767-1750. At the prompt, enter access code 96303 then press #. Attendees who require reasonable accommodation should contact Charles Selby or Timothy Underwood of the VHA Homeless Program Office by September 24, 2015, at
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 |