80_FR_207
Page Range | 65605-65880 | |
FR Document |
Page and Subject | |
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80 FR 65877 - United Nations Day, 2015 | |
80 FR 65757 - Sunshine Act Notice | |
80 FR 65605 - Delegation of Authority Under Sections 110(c) and (d)(4) of the Trafficking Victims Protection Act of 2000 | |
80 FR 65757 - Government in the Sunshine Meeting Notice | |
80 FR 65822 - Sunshine Act Meeting Notice | |
80 FR 65850 - New York & Atlantic Railway Company-Discontinuance of Service Exemption-in Queens County, N.Y. | |
80 FR 65835 - Sunshine Act Meeting | |
80 FR 65822 - Performance Review Boards for Senior Executive Service | |
80 FR 65846 - 30-Day Notice of Proposed Information Collection: Petition to Classify Special Immigrant Under INA 203(b)(4) as Employee or Former Employee of the U.S. Government Abroad | |
80 FR 65845 - 60-Day Notice of Proposed Information Collection: ECA Exchange Student Surveys | |
80 FR 65844 - Imposition of Nonproliferation Measures Against Foreign Persons, Including a Ban on U.S. Government Procurement; Correction | |
80 FR 65847 - Foreign Affairs Policy Board Meeting Notice | |
80 FR 65845 - 60-Day Notice of Proposed Information Collection: Special Immigrant Visa Biodata Form | |
80 FR 65607 - General Schedule Locality Pay Areas | |
80 FR 65752 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information Collection Activities Associated With EPA's ENERGY STAR® Product Labeling; EPA ICR No. 2078.06, OMB Control No. 2060-0528 | |
80 FR 65700 - Welded Stainless Pressure Pipe From India: Initiation of Countervailing Duty Investigation | |
80 FR 65846 - Department of State Performance Review Board Members | |
80 FR 65738 - Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding Guidance for State and Tribal Response Programs for FY2016 | |
80 FR 65696 - Welded Stainless Pressure Pipe From India: Initiation of Antidumping Duty Investigation | |
80 FR 65670 - Proposed Establishment of the Lewis-Clark Valley Viticultural Area and Realignment of the Columbia Valley Viticultural Area; Comment Period Reopening | |
80 FR 65792 - 30-Day Notice of Proposed Information Collection: Promise Zones | |
80 FR 65649 - Changes To Facilitate Applicant's Authorization of Access to Unpublished U.S. Patent Applications by Foreign Intellectual Property Offices | |
80 FR 65621 - Extension of the Prohibition Against Certain Flights in the Simferopol (UKFV) and Dnipropetrovsk (UKDV) Flight Information Regions (FIRs) | |
80 FR 65646 - Application of the Fair Labor Standards Act to Domestic Service; Dates of Previously Announced 30-Day Period of Non-Enforcement | |
80 FR 65704 - Submission for OMB Review; Comment Request | |
80 FR 65756 - Notice to All Interested Parties of the Termination of the Receivership of 10342, Sunshine State Community Bank Port Orange, FL | |
80 FR 65805 - Child Labor, Forced Labor, and Forced or Indentured Child Labor in the Production of Goods in Foreign Countries and Efforts by Certain Foreign Countries To Eliminate the Worst Forms of Child Labor | |
80 FR 65637 - General Allocation and Accounting Regulations Under Section 141; Remedial Actions for Tax-Exempt Bonds | |
80 FR 65784 - National Institute on Aging; Notice of Closed Meeting | |
80 FR 65786 - National Heart, Lung, and Blood Institute Notice of Meeting | |
80 FR 65783 - National Heart, Lung, and Blood Institute Notice of Closed Meeting | |
80 FR 65783 - National Eye Institute Notice of Closed Meeting | |
80 FR 65785 - National Cancer Institute Notice of Meeting | |
80 FR 65785 - Center for Scientific Review Notice of Closed Meeting | |
80 FR 65786 - Center for Scientific Review; Notice of Closed Meetings | |
80 FR 65783 - National Institute of Allergy and Infectious Diseases Notice of Closed Meeting | |
80 FR 65670 - General Allocation and Accounting Regulations Under Section 141 | |
80 FR 65723 - Submission for OMB Review; Comment Request | |
80 FR 65718 - Proposed Collection; Comment Request; Withdrawal | |
80 FR 65750 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Stationary Compression Ignition Internal Combustion Engines (Renewal) | |
80 FR 65749 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Emission Guidelines for Existing Other Solid Waste Incineration Units (Renewal) | |
80 FR 65753 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Integrated Iron and Steel Manufacturing Facilities (Renewal) | |
80 FR 65751 - Proposed Information Collection Request; Comment Request; Part 70 State Operating Permit Program (Renewal) | |
80 FR 65748 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Public Water System Supervision Program | |
80 FR 65802 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Supplemental Information on Water Quality Considerations | |
80 FR 65803 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Office of Human Resources and Professional Development Student and Supervisor Training Validation Surveys | |
80 FR 65800 - Agency Information Collection Activities; Proposed eCollection eComments Requested; List of Responsible Persons | |
80 FR 65801 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Strategic Planning Environmental Assessment Outreach | |
80 FR 65802 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of an Approved Collection; Semi-annual Progress Report for Children and Youth Exposed to Violence Program | |
80 FR 65804 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of an Approved Collection; Certification of Compliance With the Statutory Eligibility Requirements of the Violence Against Women Act as Amended | |
80 FR 65647 - Safety Zone; Rich Passage, Manchester, WA | |
80 FR 65727 - Excess Uranium Management: Secretarial Determination of No Adverse Impact on the Domestic Uranium Mining, Conversion, and Enrichment Industries | |
80 FR 65761 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 65763 - Agency Forms Undergoing Paperwork Reduction Act Review | |
80 FR 65792 - Committee Name: Homeland Security Science and Technology Advisory Committee (HSSTAC) | |
80 FR 65726 - National Coal Council | |
80 FR 65727 - Environmental Management Site-Specific Advisory Board, Northern New Mexico | |
80 FR 65726 - Environmental Management Site-Specific Advisory Board, Northern New Mexico | |
80 FR 65687 - Syngenta Seeds Inc.; Availability of Preliminary Finding of No Significant Impact and Preliminary Decision for an Extension of a Determination of Nonregulated Status of Corn Genetically Engineered for Glyphosate and Glufosinate-Ammonium Resistance | |
80 FR 65612 - Removal of Transferred OTS Regulations Regarding Electronic Operations | |
80 FR 65756 - Designated Reserve Ratio for 2016 | |
80 FR 65692 - Notice of Request To Extend an Information Collection | |
80 FR 65693 - Submission for OMB Review; Comment Request | |
80 FR 65689 - Monsanto Co.; Determination of Nonregulated Status of Maize Genetically Engineered For Protection Against Corn Rootworm and Resistance to Glyphosate | |
80 FR 65756 - Appraisal Subcommittee Notice Of Meeting | |
80 FR 65850 - Wisconsin Central Ltd.-Abandonment Exemption-in Lincoln County, Wis. | |
80 FR 65851 - Quarterly Publication of Individuals, Who Have Chosen To Expatriate, as Required by Section 6039G | |
80 FR 65694 - Streamlining Summary Level 070 Tables in the 5-Year American Community Survey | |
80 FR 65754 - Deletion of Agenda Items From October 22, 2015 Open Meeting | |
80 FR 65755 - Information Collection Being Reviewed by the Federal Communications Commission | |
80 FR 65725 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
80 FR 65663 - Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area | |
80 FR 65696 - Submission for OMB Review; Comment Request | |
80 FR 65797 - Quarterly Status Report of Water Service, Repayment, and Other Water-Related Contract Actions | |
80 FR 65765 - Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | |
80 FR 65770 - Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket | |
80 FR 65781 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance; Availability | |
80 FR 65768 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability | |
80 FR 65666 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
80 FR 65635 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Vicks® VapoInhaler® | |
80 FR 65632 - Schedules of Controlled Substances: Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhaler/Vapor Inhaler | |
80 FR 65799 - Certain Toy Figurines and Toy Sets Containing the Same; Commission's Determination To Terminate the Investigation in Its Entirety Based Upon Consent Order Stipulations and Settlement Agreements; Issuance of Consent Orders | |
80 FR 65704 - Taking of Marine Mammals Incidental to Specified Activities; Front Street Transload Facility Construction | |
80 FR 65757 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
80 FR 65757 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
80 FR 65793 - Endangered and Threatened Wildlife and Plants; Gila Chub Draft Recovery Plan | |
80 FR 65683 - International Fisheries; Pacific Tuna Fisheries; Vessel Register Required Information, International Maritime Organization Numbering Scheme | |
80 FR 65843 - Privacy Act of 1974: New System of Records | |
80 FR 65795 - South Bay Salt Pond Restoration Project, Phase 2; Don Edwards San Francisco Bay National Wildlife Refuge; Draft Environmental Impact Statement/Environmental Impact Report | |
80 FR 65806 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Definition of Plan Assets-Participant Contributions | |
80 FR 65873 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings-November 2015 | |
80 FR 65734 - Records Governing Off-the-Record Communications; Public Notice | |
80 FR 65733 - Combined Notice of Filings #2 | |
80 FR 65736 - Combined Notice of Filings #1 | |
80 FR 65870 - Privacy Act of 1974, as Amended; System of Records | |
80 FR 65788 - Proposed Flood Hazard Determinations | |
80 FR 65787 - Final Flood Hazard Determinations | |
80 FR 65790 - Changes in Flood Hazard Determinations | |
80 FR 65874 - Privacy Act of 1974: Computer Matching Program | |
80 FR 65872 - Privacy Act of 1974; Report of Matching Program | |
80 FR 65761 - Information Collection; Evaluation of Export Offers | |
80 FR 65784 - Center for Scientific Review; Notice of Closed Meetings | |
80 FR 65875 - Advisory Committee on Prosthetics and Special-Disabilities Programs; Notice of Meeting | |
80 FR 65764 - Proposed Information Collection Activity; Comment Request | |
80 FR 65711 - Board of Visitors, United States Military Academy (USMA) | |
80 FR 65711 - Army Education Advisory Subcommittee Meeting Notice | |
80 FR 65796 - Draft Habitat Conservation Plan and Draft Environmental Assessment; Kaufman Properties, Thurston County, Washington; Correction | |
80 FR 65710 - Performance Review Board Membership | |
80 FR 65716 - TRICARE, Formerly Known as the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Fiscal Year 2016 Mental Health Rate Updates | |
80 FR 65719 - Privacy Act of 1974; System of Records | |
80 FR 65717 - Privacy Act of 1974; System of Records | |
80 FR 65712 - Privacy Act of 1974; System of Records | |
80 FR 65720 - Privacy Act of 1974; System of Records | |
80 FR 65714 - Privacy Act of 1974; System of Records | |
80 FR 65722 - Privacy Act of 1974; System of Records | |
80 FR 65724 - Privacy Act of 1974; System of Records | |
80 FR 65838 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Reporting of OTC Transactions in Exchange-Traded Managed Fund Shares (NextShares) to FINRA | |
80 FR 65830 - Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
80 FR 65826 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the NYSE Amex Options Fee Schedule | |
80 FR 65832 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 1.5(r), 11.1(a), 11.23, 14.6, 14.11, and 14.12 and Adopt Rule 11.1(a)(1) | |
80 FR 65828 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 11.25, Retail Order Attribution Program | |
80 FR 65823 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 1.5(r) and 11.1 and Adopt New Rule 11.1(a)(1) | |
80 FR 65824 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 11.24, Retail Price Improvement Program | |
80 FR 65833 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the NYSE Amex Options Fee Schedule Related to the Amex Customer Engagement Program | |
80 FR 65841 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees Schedule | |
80 FR 65835 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 1.5(s), 11.1(a)(1), 11.6 and 11.8 | |
80 FR 65823 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 1.5(s), 11.1(a)(1), 11.6 and 11.8 | |
80 FR 65836 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 11.11, Routing to Away Trading Centers | |
80 FR 65796 - Renewal of Agency Information Collection for Tribal Self-Governance Program | |
80 FR 65800 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Approval, With Change, of a Previously Approved Collection; Bioterrorism Preparedness Act: Entity/Individual Information | |
80 FR 65704 - Marine Mammals; File No. 14628 | |
80 FR 65875 - Proposed Information Collection (NCA: Legacy (Historic Resources Education Program Research)); Activity Under OMB Review | |
80 FR 65874 - Advisory Committee on the Readjustment of Veterans; Notice of Meeting | |
80 FR 65847 - Agency Information Collection Activities; Extension of a Currently-Approved Information Collection Request: Information Technology Services Survey Portal Customer Satisfaction Assessment (Formerly COMPASS Portal Consumer Satisfaction Assessment) | |
80 FR 65691 - Tongass National Forest Wrangell Ranger District; Alaska; Wrangell Island Project Environmental Impact Statement | |
80 FR 65784 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
80 FR 65784 - In Vitro | |
80 FR 65779 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing | |
80 FR 65774 - Medical Devices; Exemptions From Premarket Notifications; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System; Request for Comments | |
80 FR 65626 - Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System | |
80 FR 65770 - Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting | |
80 FR 65848 - Proposed Agency Information Collection Activities; Comment Request | |
80 FR 65758 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
80 FR 65690 - Submission for OMB Review; Comment Request | |
80 FR 65614 - Airworthiness Directives; Pratt & Whitney Division Turbofan Engines | |
80 FR 65736 - Combined Notice of Filings | |
80 FR 65731 - Combined Notice of Filings #1 | |
80 FR 65738 - Combined Notice of Filings | |
80 FR 65730 - Florida Gas Transmission Company, LLC; Notice of Request Under Blanket Authorization | |
80 FR 65735 - Dominion Transmission, Inc.; Notice of Availability of the Environmental Assessment for the Proposed New Market Project | |
80 FR 65736 - Notice of Meeting, Notice of Vote, Explanation of Action Closing Meeting and List of Persons To Attend | |
80 FR 65733 - Alaska Gasline Development Corporation, BP Alaska LNG, LLC, Conoco Phillips Alaska LNG Company, ExxonMobil Alaska LNG, LLC, TransCanada Alaska Midstream, LP; Supplemental Notice of Public Scoping Meetings for the Planned Alaska LNG Project | |
80 FR 65732 - Seneca Falls Power Corporation; C-S Canal Hydro, LLC; Notice of Application for Transfer of License and Soliciting Comments, Motions To Intervene, and Protests | |
80 FR 65730 - Blythe Solar 110, LLC; Supplemental Notice that Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
80 FR 65730 - Golden Hills Interconnection, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
80 FR 65735 - Jether Energy Research, Ltd.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
80 FR 65732 - PJM Interconnection, L.L.C.; Notice of Filing | |
80 FR 65655 - Air Plan Approval; OR; Portland, Medford, Salem; Clackamas, Multnomah, Washington Counties; Gasoline Dispensing Facilities | |
80 FR 65671 - Air Plan Approval; OR; Portland, Medford, Salem; Clackamas, Multnomah, Washington Counties; Gasoline Dispensing Facilities | |
80 FR 65675 - Air Plan Approval; Minnesota; Revision to Visibility Federal Implementation Plan | |
80 FR 65680 - Approval and Promulgation of Implementation Plans; Oregon: Interstate Transport of Ozone | |
80 FR 65683 - Outer Continental Shelf Air Regulations Consistency Update for Maryland | |
80 FR 65661 - Outer Continental Shelf Air Regulations Consistency Update for Maryland | |
80 FR 65672 - Approval and Promulgation of Implementation Plans; Washington: Interstate Transport of Ozone | |
80 FR 65618 - Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters | |
80 FR 65807 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
80 FR 65660 - Approval and Promulgation of Implementation Plans; Arizona; Phased Discontinuation of Stage II Vapor Recovery Program | |
80 FR 65616 - Airworthiness Directives; The Boeing Company Airplanes |
Animal and Plant Health Inspection Service
Food and Nutrition Service
Forest Service
Natural Resources Conservation Service
Rural Utilities Service
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Navy Department
Federal Energy Regulatory Commission
National Nuclear Security Administration
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Indian Affairs Bureau
Reclamation Bureau
Drug Enforcement Administration
Wage and Hour Division
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Surface Transportation Board
Alcohol and Tobacco Tax and Trade Bureau
Internal Revenue Service
United States Mint
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Office of Personnel Management.
Final rule.
The Office of Personnel Management is issuing final regulations on behalf of the President's Pay Agent. These final regulations link the definitions of General Schedule (GS) locality pay area boundaries to updated metropolitan area definitions established by the Office of Management and Budget (OMB) in February 2013. These final regulations also establish 13 new locality pay areas, which the Federal Salary Council recommended after reviewing pay levels in all “Rest of U.S.” metropolitan statistical areas and combined statistical areas with 2,500 or more GS employees.
The regulations are effective November 27, 2015. The regulations are applicable on the first day of the first pay period beginning on or after January 1, 2016.
Joe Ratcliffe, (202) 606-2838; fax: (202) 606-0824; email:
Section 5304 of title 5, United States Code (U.S.C.), authorizes locality pay for General Schedule (GS) employees with duty stations in the United States and its territories and possessions. Section 5304(f) authorizes the President's Pay Agent (the Secretary of Labor, the Director of the Office of Management and Budget (OMB), and the Director of the Office of Personnel Management (OPM)) to determine locality pay areas. The boundaries of locality pay areas must be based on appropriate factors, which may include local labor market patterns, commuting patterns, and the practices of other employers. The Pay Agent must give thorough consideration to the views and recommendations of the Federal Salary Council, a body composed of experts in the fields of labor relations and pay policy and representatives of Federal employee organizations. The President appoints the members of the Federal Salary Council, which submits annual recommendations on the locality pay program to the Pay Agent. The establishment or modification of locality pay area boundaries must conform to the notice and comment provisions of the Administrative Procedure Act (5 U.S.C. 553).
On June 1, 2015, OPM published a proposed rule in the
The proposed rule provided a 30-day comment period. The Pay Agent reviewed comments received through July 1, 2015. After considering those comments, the Pay Agent has decided to implement the locality pay area definitions in the proposed rule, with three additional changes. Those changes, which are further discussed below, are a name change for one locality pay area; the addition of Berkshire County, MA, to the Albany-Schenectady, NY, locality pay area; and the addition of Harrison County, OH, to the Cleveland-Akron-Canton, OH, locality pay area.
Based on questions OPM staff received on the definition of the “Harrisburg-York-Lebanon, PA” locality pay area defined in the proposed rule, the Pay Agent has decided to change the name of that locality pay area to “Harrisburg-Lebanon, PA.” The definition of the locality pay area remains the same as in the proposed rule, and the name change is intended to help clarify that York County, PA, is not included in the Harrisburg-Lebanon, PA, locality pay area. Before the name change, that locality pay area's name was based on the name of the February 2013 Harrisburg-York-Lebanon, PA, Combined Statistical Area, the OMB-defined metropolitan area to which the definition of the Harrisburg-Lebanon, PA, locality pay area is linked. However, York County, PA, which has been an area of application to the Washington-Baltimore locality pay area since January 2005, will remain in the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA, locality pay area.
In the proposed rule, the Pay Agent invited comment on how to address
Berkshire County, MA, and Harrison County, OH, if left in the “Rest of U.S.” locality pay area, would each have a land boundary more than 75 percent bordered by three separate locality pay areas. In addition, Berkshire and Harrison Counties each have commuting interchange rates, with the three locality pay areas they border, that sum to more than 7.5 percent. (The Pay Agent notes that the two completely surrounded locations included in separate locality pay areas under these final regulations—Kent County, MD, which will be included in the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA, locality pay area, and Lancaster County, PA, which will be included in the Harrisburg-Lebanon, PA, locality pay area—also have significant commuting interchange rates. Kent and Lancaster Counties each have commuting interchange rates of more than 7.5 percent with the locality pay area to which they will become areas of application under these final regulations.)
In analyzing counties almost but not completely surrounded by separate locality pay areas under the locality pay area definitions proposed in the proposed rule, the Pay Agent also considered the driving distance by road between an evaluated county's most populous duty station, in terms of GS employment, and the most populous duty station, in terms of GS employment, in the closest county within the adjacent locality pay area with the highest commuting interchange rate. (Driving distances and commuting interchange rates served different purposes in the analysis of locations almost but not completely surrounded by potentially higher-paying locality pay areas. While commuting interchange rates were used to indicate the extent to which a location is part of each adjacent locality pay area's local labor market, driving distances were considered as an indicator of the potential for GS employees to commute to a higher-paying locality pay area.) For both Berkshire County, MA, and Harrison County, OH, the driving distance is less than 50 miles between the county's most populous duty station, in terms of GS employment, and the most populous duty station, in terms of GS employment, in the closest county within the adjacent locality pay area with the highest commuting interchange rate.
The Pay Agent does not believe that a “Rest of U.S.” county being mostly bordered by separate locality pay areas necessarily warrants action unless there is evidence of a substantial labor market linkage with one or more neighboring locality pay areas. However, the Pay Agent believes the aforementioned information on commuting and driving distances for Berkshire County, MA, and Harrison County, OH, when considered along with the extent to which each of these counties is bordered by three separate locality pay areas, does warrant action. The other single-county “Rest of U.S.” locations bordered by three separate locality pay areas have a smaller percentage of land boundary bordered by separate locality pay areas and/or have lesser commuting or greater driving distances to the adjacent locality pay areas. (No single-county “Rest of U.S.” locations are bordered by more than three separate locality pay areas.) Individuals concerned about agency recruitment or retention capabilities in locations bordered by multiple separate locality pay areas and remaining in the “Rest of U.S.” locality pay area under these final regulations may provide testimony to the Federal Salary Council on locations of concern.
Using February 2013 OMB-defined metropolitan area definitions as the basis for locality pay area boundaries and using updated commuting patterns data to evaluate potential areas of application will add a number of counties now included in the “Rest of U.S.” locality pay area to separate locality pay areas, which will impact about 6,300 GS employees.
Establishing 13 new locality pay areas will impact about 102,000 GS employees. Implementing the 13 new locality pay areas will not automatically change locality pay rates now applicable in those areas because locality pay percentages are established by Executive order under the President's authority in 5 U.S.C. 5304 or 5304a, and the President decides each year whether to adjust locality pay percentages. When locality pay percentages are increased, past practice has been to allocate a percent of the total GS payroll for locality raises and to have the overall dollar cost for such pay raises be the same, regardless of the number of locality pay areas. If a percent of the total GS payroll is allocated for locality pay increases, the addition of new areas could result in a smaller amount to allocate for locality pay increases in existing areas. Implementing higher locality pay rates in the 13 new locality pay areas could thus result in relatively lower pay increases for employees in existing locality pay areas than they would otherwise receive.
OPM received 707 comments on the proposed rule. Most commenters supported the proposed changes in the definitions of locality pay areas.
Many commenters expressed the belief that various indicators of living costs should be considered in defining locality pay areas or in setting locality pay. Living costs are not directly considered in the locality pay program. Locality pay is not designed to equalize living standards for GS employees across the country. Under 5 U.S.C. 5304, locality pay rates are based on comparisons of GS pay and non-Federal pay at the same work levels in a locality pay area. Relative living costs may indirectly affect non-Federal pay levels, but living costs are just one of many factors that affect the supply of and demand for labor, and therefore labor costs, in a locality pay area.
Some commenters disagreed it is appropriate to establish 13 new locality pay areas. A number of those commenters expressed concern that existing locality pay areas' future pay levels could be set lower than they otherwise would, due to establishment of new locality pay areas. The President's Pay Agent continues to believe it is appropriate to establish the 13 new locality pay areas. The goal of the locality pay program is to reduce disparities between GS pay and non-Federal pay for the same levels of work in locations where such disparities are significant. The Federal Salary Council recommended the 13 new locality pay areas after reviewing pay levels in all “Rest of U.S.” metropolitan statistical areas and combined statistical areas with 2,500 or more GS employees. The Federal Salary Council found that the percentage difference between GS and non-Federal pay levels for the same levels of work—
Some commenters disagreed it is appropriate to use February 2013 OMB-defined metropolitan areas to define locality pay areas. Some of those commenters made living-cost comparisons between different portions of the February 2013 OMB metropolitan areas,
Prior to implementation of locality pay, the Federal Salary Council recommended, and the Pay Agent approved, the use of OMB-defined metropolitan areas as the basis for locality pay area boundaries, and OMB-defined metropolitan areas have been the basis for locality pay area boundaries since locality pay was implemented in 1994. (A detailed history of the use of OMB-defined metropolitan areas in the locality pay program can be found in the Federal Salary Council's January 2014 recommendations, which are posted on the OPM Web site at
The Pay Agent continues to believe it is appropriate to use OMB-defined metropolitan areas as the basis for locality pay area boundaries and has no evidence that it is appropriate to split an OMB-defined metropolitan area into separate locality pay areas. Since OMB-defined metropolitan areas will continue to serve as the basis for locality pay area boundaries, the Pay Agent believes it makes sense to update the metropolitan areas used in the locality pay program to the February 2013 OMB-defined metropolitan areas, since the definitions of those metropolitan areas reflect the most recent information on population distribution and commuting patterns. Departing from the practice of defining basic locality pay areas based on OMB-defined metropolitan areas or splitting those metropolitan areas into separate locality pay areas would be a significant change, and the implications would have to be carefully considered. Individuals interested in recommending alternatives to defining basic locality pay areas based on entire OMB-defined metropolitan areas may provide testimony to the Federal Salary Council.
Some commenters disagreed it is appropriate to establish new areas of application or maintain existing ones, with some commenters expressing concern that future locality pay levels could be set lower than they otherwise would due to including new areas of application in locality pay areas. Prior to implementation of locality pay, the Federal Salary Council recommended, and the Pay Agent agreed, that OMB-defined metropolitan areas not be the sole basis for defining locality pay areas. Ever since locality pay was implemented in 1994, criteria have been used in the locality pay program to evaluate, as potential areas of application, locations adjacent to the metropolitan area comprising the basic locality pay area. The Pay Agent continues to believe it is appropriate to establish areas of application when approved criteria for doing so are met.
Some commenters disagreed it is appropriate to retain, in their current locality pay area, locations that would otherwise move to a potentially lower-paying locality pay area as a result of using February 2013 OMB-defined metropolitan areas as the basis for locality pay area boundaries. The Pay Agent continues to believe it is appropriate to retain such locations in their current locality pay area. If such a location were moved to a lower-paying locality pay area, current GS employees in the location might be entitled to pay retention under 5 U.S.C. 5363 and 5 CFR part 536 and would not have a reduction in pay. GS employees hired after movement of the location to the lower-paying locality pay area would not be entitled to pay retention and would receive the lower locality pay rates that would be applicable in the location. The Pay Agent believes such an outcome would be disruptive for agencies and employees in affected locations.
A number of commenters objected that locations not included in a separate locality pay area were to remain in the “Rest of U.S.” locality pay area under the proposed rule. Some of those locations are metropolitan areas for which the Federal Salary Council has studied disparities between non-Federal pay and Federal pay (pay disparities) over several years of data and found that the pay disparities do not significantly exceed the pay disparity for the “Rest of U.S.” locality pay area over the same period. Other locations referred to in this category of comments do not meet the criteria for areas of application. In some cases, commenters cited possible recruitment and retention difficulties the commenters believe agencies may have in certain locations that would remain in the “Rest of U.S.” locality pay area when these final regulations are put into effect. The Pay Agent has no evidence that the changes these final regulations will make in locality pay area definitions will create recruitment and retention challenges for Federal employers. However, should recruitment and retention challenges exist in a location, Federal agencies have considerable administrative authority to address those challenges through the use of current pay flexibilities. Information on these flexibilities is posted on the OPM Web site at
A number of commenters expressed their views on pay levels in locality pay areas. Some commenters suggested specific locality pay percentages to apply to new or existing locality pay areas, and some commenters offered opinions on the extent to which pay increases are needed in some locality pay areas compared to others. Such comments as these are outside of the scope of these final regulations. The purpose of these final regulations is to define the boundaries of locality pay areas. The role of the Pay Agent with regard to locality pay percentages is to report annually to the President what locality pay percentages would go into effect under the Federal Employees Pay Comparability Act of 1990. The President establishes a base General Schedule and sets locality pay percentages each year by Executive order.
Some commenters expressed concern that certain Federal pay systems outside of the General Schedule would not benefit from the changes planned for
A number of comments reflected misunderstanding of the proposed rule's definitions of locality pay areas, with some comments indicating a belief that certain counties actually included in a proposed locality pay area were excluded. The definitions of locality pay areas are based on combined statistical areas (CSAs) and metropolitan statistical areas (MSAs). Because over time counties can be added to CSAs and MSAs, and because the Pay Agent wanted any such changes in CSAs and MSAs to be reflected automatically in the definitions of locality pay areas, rather than list every county in each locality pay area, these final regulations will define locality pay areas by listing the CSA and MSA comprising the basic locality pay area, with areas of application listed as single counties. These final regulations define
A number of comments concerned locations which, under the locality pay area definitions in the proposed rule, would remain in the “Rest of U.S.” locality pay area and be bordered by multiple locality pay areas. For the reasons discussed above in the “Supplementary Information” section of this final rule, after evaluating single-county locations bordered by multiple locality pay areas, the Pay Agent has decided to include, as areas of application, Berkshire County, MA, in the Albany-Schenectady, NY, locality pay area and Harrison County, OH, in the Cleveland-Akron-Canton, OH, locality pay area. Individuals concerned about locations that are bordered by multiple separate locality pay areas and remain in the “Rest of U.S.” locality pay area, under the locality pay area definitions implemented by these final regulations, may provide testimony to the Federal Salary Council on locations of concern.
Several commenters expressed concern that U.S. counties that are isolated off the coast of the U.S. mainland, and which do not meet criteria for areas of application, remain in the “Rest of U.S.” locality pay area under the changes these regulations will make in the definitions of locality pay areas. Some of these comments anecdotally referred to recruitment and retention challenges the commenters attributed to the locations being limited to “Rest of U.S.” locality pay. Federal agencies have considerable discretionary authority to provide pay and leave flexibilities to address significant recruitment and retention challenges, and information on these flexibilities is posted on the OPM Web site at
One commenter opposed any movement of “Rest of U.S.” locations to separate pay areas, and said the Government should find less costly alternatives, such as moving Federal employment sites to areas with lower living or labor costs and increasing the use of telework. The Pay Agent does not believe that the need to vary pay levels geographically based on labor costs can be substantially reduced in the near term by relocating Government agencies' duty stations or expanding telework programs. In addition, such a comment is outside the scope of these final regulations. The purpose of these regulations is to establish locality pay area boundaries the Pay Agent has determined to be appropriate.
One commenter suggested that adjacent locality pay areas be combined into single locality pay areas, with resultant cost savings to the Government. Such a change would be a significant departure from current practices in the locality pay program and could have significant implications. The implications for adjacent locality pay areas are unknown and would have to be carefully considered. Individuals interested in pursuing this idea may provide testimony to the Federal Salary Council.
Some comments reflected a mistaken belief that the calculation of commuting interchange rates in the locality pay program includes only commuting by Federal employees, rather than commuting by all types of workers in assessed locations. Some commenters expressed the opinion that commuting interchange rates including only commuting for Federal employees should be considered in defining locality pay areas. In evaluating locations adjacent to basic locality pay areas as potential areas of application, commuting by all types of workers, not just Federal employees, is used as a criterion. Commuting interchange rates used in the locality pay program are a measure of economic linkage between a basic locality pay area and an adjacent location. Commuting interchange rates used in the locality pay program are used to indicate the extent to which a location is part of the locality pay area's entire local labor market, not to indicate the extent to which Federal employees commute between locations.
OMB has reviewed this rule in accordance with E.O. 13563 and E.O. 12866.
I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would apply only to Federal agencies and employees.
Government employees, Law enforcement officers, Wages.
Accordingly, OPM is amending 5 CFR part 531 as follows:
5 U.S.C. 5115, 5307, and 5338; sec. 4 of Pub. L. 103-89, 107 Stat. 981; and E.O. 12748, 56 FR 4521, 3 CFR, 1991 Comp., p. 316; Subpart B also issued under 5 U.S.C. 5303(g), 5305, 5333, 5334(a) and (b), and 7701(b)(2); Subpart D also issued under 5 U.S.C. 5335 and 7701(b)(2); Subpart E also issued under 5 U.S.C. 5336; Subpart F also issued under 5 U.S.C. 5304, 5305, and 5941(a), E.O. 12883, 58 FR 63281, 3 CFR, 1993 Comp., p. 682 and E.O. 13106, 63 FR 68151, 3 CFR, 1998 Comp., p. 224.
(b) The following are locality pay areas for the purposes of this subpart:
(1) Alaska—consisting of the State of Alaska;
(2) Albany-Schenectady, NY—consisting of the Albany-Schenectady, NY CSA and also including Berkshire County, MA;
(3) Albuquerque-Santa Fe-Las Vegas, NM—consisting of the Albuquerque-Santa Fe-Las Vegas, NM CSA;
(4) Atlanta—Athens-Clarke County—Sandy Springs, GA-AL—consisting of the Atlanta—Athens-Clarke County—Sandy Springs, GA CSA and also including Chambers County, AL;
(5) Austin-Round Rock, TX—consisting of the Austin-Round Rock, TX MSA;
(6) Boston-Worcester-Providence, MA-RI-NH-CT-ME—consisting of the Boston-Worcester-Providence, MA-RI-NH-CT CSA, except for Windham County, CT, and also including Androscoggin County, ME, Cumberland County, ME, Sagadahoc County, ME, and York County, ME;
(7) Buffalo-Cheektowaga, NY—consisting of the Buffalo-Cheektowaga, NY CSA;
(8) Charlotte-Concord, NC-SC—consisting of the Charlotte-Concord, NC-SC CSA;
(9) Chicago-Naperville, IL-IN-WI—consisting of the Chicago-Naperville, IL-IN-WI CSA;
(10) Cincinnati-Wilmington-Maysville, OH-KY-IN—consisting of the Cincinnati-Wilmington-Maysville, OH-KY-IN CSA and also including Franklin County, IN;
(11) Cleveland-Akron-Canton, OH—consisting of the Cleveland-Akron-Canton, OH CSA and also including Harrison County, OH;
(12) Colorado Springs, CO—consisting of the Colorado Springs, CO MSA and also including Fremont County, CO, and Pueblo County, CO;
(13) Columbus-Marion-Zanesville, OH—consisting of the Columbus-Marion-Zanesville, OH CSA;
(14) Dallas-Fort Worth, TX-OK—consisting of the Dallas-Fort Worth, TX-OK CSA and also including Delta County, TX, and Fannin County, TX;
(15) Davenport-Moline, IA-IL—consisting of the Davenport-Moline, IA-IL CSA;
(16) Dayton-Springfield-Sidney, OH—consisting of the Dayton-Springfield-Sidney, OH CSA and also including Preble County, OH;
(17) Denver-Aurora, CO—consisting of the Denver-Aurora, CO CSA and also including Larimer County, CO;
(18) Detroit-Warren-Ann Arbor, MI—consisting of the Detroit-Warren-Ann Arbor, MI CSA;
(19) Harrisburg-Lebanon, PA—consisting of the Harrisburg-York-Lebanon, PA CSA, except for Adams County, PA, and York County, PA, and also including Lancaster County, PA;
(20) Hartford-West Hartford, CT-MA—consisting of the Hartford-West Hartford, CT CSA and also including Windham County, CT, Franklin County, MA, Hampden County, MA, and Hampshire County, MA;
(21) Hawaii—consisting of the State of Hawaii;
(22) Houston-The Woodlands, TX—consisting of the Houston-The Woodlands, TX CSA and also including San Jacinto County, TX;
(23) Huntsville-Decatur-Albertville, AL—consisting of the Huntsville-Decatur-Albertville, AL CSA;
(24) Indianapolis-Carmel-Muncie, IN—consisting of the Indianapolis-Carmel-Muncie, IN CSA and also including Grant County, IN;
(25) Kansas City-Overland Park-Kansas City, MO-KS—consisting of the Kansas City-Overland Park-Kansas City, MO-KS CSA and also including Jackson County, KS, Jefferson County, KS, Osage County, KS, Shawnee County, KS, and Wabaunsee County, KS;
(26) Laredo, TX—consisting of the Laredo, TX MSA;
(27) Las Vegas-Henderson, NV-AZ—consisting of the Las Vegas-Henderson, NV-AZ CSA;
(28) Los Angeles-Long Beach, CA—consisting of the Los Angeles-Long Beach, CA CSA and also including Kern County, CA, and Santa Barbara County, CA;
(29) Miami-Fort Lauderdale-Port St. Lucie, FL—consisting of the Miami-Fort Lauderdale-Port St. Lucie, FL CSA and also including Monroe County, FL;
(30) Milwaukee-Racine-Waukesha, WI—consisting of the Milwaukee-Racine-Waukesha, WI CSA;
(31) Minneapolis-St. Paul, MN-WI—consisting of the Minneapolis-St. Paul, MN-WI CSA;
(32) New York-Newark, NY-NJ-CT-PA—consisting of the New York-Newark, NY-NJ-CT-PA CSA and also including all of Joint Base McGuire-Dix-Lakehurst;
(33) Palm Bay-Melbourne-Titusville, FL—consisting of the Palm Bay-Melbourne-Titusville, FL MSA;
(34) Philadelphia-Reading-Camden, PA-NJ-DE-MD—consisting of the Philadelphia-Reading-Camden, PA-NJ-DE-MD CSA, except for Joint Base McGuire-Dix-Lakehurst;
(35) Phoenix-Mesa-Scottsdale, AZ—consisting of the Phoenix-Mesa-Scottsdale, AZ MSA;
(36) Pittsburgh-New Castle-Weirton, PA-OH-WV—consisting of the Pittsburgh-New Castle-Weirton, PA-OH-WV CSA;
(37) Portland-Vancouver-Salem, OR-WA—consisting of the Portland-Vancouver-Salem, OR-WA CSA;
(38) Raleigh-Durham-Chapel Hill, NC—consisting of the Raleigh-Durham-Chapel Hill, NC CSA and also including Cumberland County, NC, Hoke County, NC, Robeson County, NC, Scotland County, NC, and Wayne County, NC;
(39) Richmond, VA—consisting of the Richmond, VA MSA and also including Cumberland County, VA, King and Queen County, VA, and Louisa County, VA;
(40) Sacramento-Roseville, CA-NV—consisting of the Sacramento-Roseville, CA CSA and also including Carson City, NV, and Douglas County, NV;
(41) San Diego-Carlsbad, CA—consisting of the San Diego-Carlsbad, CA MSA;
(42) San Jose-San Francisco-Oakland, CA—consisting of the San Jose-San Francisco-Oakland, CA CSA and also including Monterey County, CA;
(43) Seattle-Tacoma, WA—consisting of the Seattle-Tacoma, WA CSA and also including Whatcom County, WA;
(44) St. Louis-St. Charles-Farmington, MO-IL—consisting of the St. Louis-St. Charles-Farmington, MO-IL CSA;
(45) Tucson-Nogales, AZ—consisting of the Tucson-Nogales, AZ CSA and also including Cochise County, AZ;
(46) Washington-Baltimore-Arlington, DC-MD-VA-WV-PA—consisting of the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA CSA and also including Kent County, MD, Adams County, PA, York County, PA, King George County, VA, and Morgan County, WV; and
(47) Rest of U.S.—consisting of those portions of the United States and its territories and possessions as listed in 5
Federal Deposit Insurance Corporation.
Final rule.
The Federal Deposit Insurance Corporation (“FDIC”) is adopting a final rule to rescind and remove from the Code of Federal Regulations the transferred regulation entitled “Electronic Operations.” This regulation was included in the regulations that were transferred to the FDIC from the Office of Thrift Supervision (“OTS”) on July 21, 2011, in connection with the implementation of applicable provisions of title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”). There is no corresponding FDIC Electronic Operations rule and the rule is deemed obsolete, unnecessary, and burdensome. Therefore, the FDIC has decided to rescind and remove the regulation in its entirety.
The final rule is effective on November 27, 2015.
Jennifer Maree, Legal Division, (202) 898-6543; Frederick Coleman, Division of Risk Management Supervision, (703) 254-0452.
Title III of the Dodd-Frank Act
Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations which would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC's Board of Directors approved a “List of OTS Regulations to be Enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.” This list was published by the FDIC and the OCC as a Joint Notice in the
Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank Act affected the FDIC's existing authority to issue regulations under the Federal Deposit Insurance Act (“FDI Act”) and other laws as the “appropriate Federal banking agency” or under similar statutory terminology. Section 312(c) of the Dodd-Frank Act amended the definition of “appropriate Federal banking agency” contained in section 3(q) of the FDI Act, 12 U.S.C. 1813(q), to add State savings associations to the list of entities for which the FDIC is designated as the “appropriate Federal banking agency.” As a result, when the FDIC acts as the designated “appropriate Federal banking agency” (or under similar terminology) for State savings associations, as it does here, the FDIC is authorized to issue, modify and rescind regulations involving such associations, as well as for State nonmember banks and insured branches of foreign banks.
As noted, on June 14, 2011, pursuant to this authority, the FDIC's Board of Directors reissued and redesignated certain transferring OTS regulations. These transferred OTS regulations were published as new FDIC regulations in the
One of the OTS rules transferred to the FDIC requires State savings associations to notify the FDIC at least 30 days before establishing a transactional Web site. The OTS rule, formerly found at 12 CFR part 555, subpart B (“part 555, subpart B”), was transferred to the FDIC with only technical changes and is now found in the FDIC's rules at 12 CFR part 390, subpart L (“part 390, subpart L”), entitled “Electronic Operations.” The FDIC has no such corresponding rule. After careful review of part 390, subpart L, the FDIC has decided to rescind part 390, subpart L, in its entirety, because, as discussed below, it is obsolete, unnecessary, and burdensome.
On July 21, 2014, the FDIC published a Notice of Proposed Rulemaking (“Proposed Rule”) regarding the removal of part 390, subpart L, which governs electronic operations of State savings associations.
The FDIC issued the Proposed Rule with a 60-day comment period, which closed on September 19, 2014. No comments on the Proposed Rule were received by the FDIC. Consequently, the final rule (“Final Rule”) is adopted as proposed without any changes.
As discussed in the Proposed Rule, the OTS enacted the Electronic Operations rule, part 390, subpart L,
In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number.
The Final Rule rescinds and removes from FDIC regulations part 390, subpart L, because it is obsolete, unnecessary, and burdensome. This rule was transferred with only nominal changes to the FDIC from the OTS when the OTS was abolished by title III of the Dodd-Frank Act. In republishing this rule, the FDIC made only technical changes to existing OTS regulations. The FDIC does not have a regulatory notice requirement similar to the Electronic Operations rule that requires insured depository institutions to notify the FDIC if they intend to set up transactional Web sites and, therefore, never established an information collection to account for the paperwork burden imposed on the public.
The Final Rule will neither create any new information collection nor modify any of the FDIC's existing information collections. Accordingly, the FDIC will not submit any information collection request to OMB.
The Regulatory Flexibility Act (“RFA”),
As discussed in the Proposed Rulemaking, part 390, subpart L, was transferred from part 555, subpart B, which governed notification provisions for savings associations that intended to establish transactional Web sites. Part 555, subpart B became effective on January 1, 1999, and all savings associations were required to comply with it. The FDIC's Final Rule rescinds and removes part 390, subpart L, because it is obsolete, unnecessary, and burdensome. Since the Electronic Operations rule is being rescinded, the Final Rule will reduce the paperwork and other regulatory burdens on State savings associations by eliminating the requirement to provide the FDIC with notice before establishing a transactional Web site. Therefore, the Final Rule will have no significant economic impact on any State savings association.
The Office of Management and Budget has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), 5 U.S.C. 801
Section 722 of the Gramm-Leach-Bliley Act, 12 U.S.C. 4809, requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the Proposed Rule, the FDIC invited comments on whether the Proposed Rule was clearly stated and effectively organized, and how the FDIC might make it easier to understand. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.
Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (“EGRPRA”), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions.
Banks, banking; electronic operations; savings associations.
For the reasons stated in the preamble, the Board of Directors of the FDIC amends 12 CFR part 390 of the Code of Federal Regulations as follows:
Subpart A also issued under
Subpart B also issued under
Subpart C also issued under
Subpart D also issued under
Subpart E also issued under
Subpart F also issued under
Subpart G also issued under
Subpart H also issued under
Subpart I also issued under
Subpart J also issued under
Subpart M also issued under
Subpart N also issued under
Subpart O also issued under
Subpart P also issued under
Subpart Q also issued under
Subpart R also issued under
Subpart S also issued under
Subpart T also issued under
Subpart U also issued under
Subpart V also issued under
Subpart W also issued under
Subpart X also issued under
Subpart Y also issued under 12 U.S.C. 1831o.
Subpart Z also issued under
By order of the Board of Directors.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all Pratt & Whitney Division (PW) PW4164, PW4168, PW4168A, PW4164C, PW4164C/B, PW4164-1D, PW4168-1D, PW4168A-1D, PW4170, PW4164C-1D, PW4164C/B-1D, PW4050, PW4052, PW4056, PW4060, PW4060A, PW4060C, PW4062, PW4062A, PW4152, PW4156, PW4156A, PW4158, PW4160, PW4460, PW4462, and PW4650 turbofan engines including models with a “-3” suffix with a low-pressure turbine (LPT) 4th stage inner air seal (IAS), part number (P/N) 51N038, installed. This AD was prompted by the discovery, during routine overhaul of the LPT, of cracks in the barrel section of the LPT 4th stage IAS. This AD requires removal of the LPT 4th stage IAS, P/N 51N038, according to a prescribed schedule. We are issuing this AD to prevent failure of the LPT 4th stage IAS, which could lead to an uncontained IAS release, damage to the engine, and damage to the airplane.
This AD is effective December 1, 2015.
For service information identified in this AD, contact Pratt & Whitney Division, 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.
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, PW4168, PW4168A, PW4164C, PW4164C/B, PW4164-1D, PW4168-1D, PW4168A-1D, PW4170, PW4164C-1D, PW4164C/B-1D, PW4050, PW4052, PW4056, PW4060, PW4060A, PW4060C, PW4062, PW4062A, PW4152, PW4156, PW4156A, PW4158, PW4160, PW4460, PW4462, and PW4650 turbofan engines including models with a “-3” suffix with an LPT 4th stage IAS, P/N 51N038, installed. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
The Boeing Company expressed support for the NPRM.
United Airlines and Delta Airlines requested that the Definitions paragraph be changed. United Airlines requested we change the definition of LPT overhaul from “maintenance which involves disassembly of the LPT rotor module” to “when the LPT module is disassembled sufficiently to gain access
We agree that the definition of an LPT overhaul should be clarified. We changed the definition of an LPT overhaul to “An LPT overhaul is defined as when all disks in the rotor are removed from the engine and the blades are removed.”
Delta Airlines requested changing the applicability to include models with any dash number suffix.
We agree with the intent of this request. We changed the Summary, Discussion, and Applicability sections by adding “. . . including models with a “-3” suffix . . .” following the listed engine models as required.
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 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 affects 72 engines installed on airplanes of U.S. registry. We also estimate that 9 of the engines will require replacement parts during shop visit, the pro-rated cost of these parts cost will be $23,805 per engine, and compliance with this AD will require about 49 hours of labor per engine. The average labor rate is $85 per hour. We also estimate that 63 of the engines will require replacement parts during LPT overhaul, the pro-rated replacement parts cost for these parts is $43,545 per engine, and that these 63 engines will require 0 additional hours of labor per engine since the parts are already exposed during LPT overhaul. Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,995,065.
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 December 1, 2015.
None.
This AD applies to:
(1) All Pratt & Whitney Division PW4164, PW4168, PW4168A, PW4164C, PW4164C/B, PW4164-1D, PW4168-1D, PW4168A-1D, PW4170, PW4164C-1D, and PW4164C/B-1D turbofan engines with a low-pressure turbine (LPT) 4th stage inner air seal (IAS), part number (P/N) 51N038, installed.
(2) All PW4050, PW4052, PW4056, PW4060, PW4060A, PW4060C, PW4062, PW4062A, PW4152, PW4156, PW4156A, PW4158, PW4160, PW4460, PW4462, and PW4650 turbofan engines including models with a “-3” suffix with an LPT 4th stage IAS, P/N 51N038, installed.
This AD was prompted by the discovery, during routine overhaul of the LPT, of cracks in the barrel section of the LPT 4th stage IAS which could, if not corrected, result in uncontained IAS release, damage to the engine, and damage to the aircraft. We are issuing this AD to prevent failure of the LPT 4th stage IAS, which could lead to an uncontained IAS release, damage to the engine, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done. For the engines listed in paragraph (c)(1) of this AD:
(1) At each LPT overhaul after the effective date of this AD, remove from service the LPT 4th stage IAS, P/N 51N038.
(2) At each engine shop visit after the effective date of this AD, remove from service the LPT 4th stage IAS, P/N 51N038, if it has more than 10,900 cycles since new.
(1) Do not install any LPT 4th stage IAS, P/N 51N038, with more than 0 flight cycles on any engine listed in paragraph (c)(1) of this AD.
(2) Do not install on any engine listed in paragraphs (c)(2) of this AD, any LPT 4th stage IAS, P/N 51N038, which was previously installed on any engine listed in paragraph (c)(1) of this AD.
For the purposes of this AD:
(1) An LPT overhaul is defined as when all disks in the rotor are removed from the engine and the blades are removed.
(2) An “engine shop visit” is the induction of an engine into the shop for maintenance involving the separation of pairs of major mating engine flanges (lettered flanges). The separation of engine flanges solely for the purpose of transportation without subsequent engine maintenance does not constitute an engine shop visit.
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:
None.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2007-16-08, which applied to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes. AD 2007-16-08 required repetitive inspections for cracking of the station 800 frame assembly, and repair if necessary. This new AD continues to require repetitive inspections for cracking of the station 800 frame assembly, and repair if necessary, and expands the inspection area. This AD was prompted by reports of cracks found at the forward and aft inner chord strap and angles on the station 800 frame on the left-side and right-side main entry doors. We are issuing this AD to detect and correct fatigue cracks that could extend and fully sever the frame, which could result in development of skin cracks that could lead to rapid depressurization of the airplane.
This AD is effective December 1, 2015.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 1, 2015.
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2007-16-08, Amendment 39-15147 (72 FR 44728, August 9, 2007). AD 2007-16-08 applied to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 16606, March 30, 2015) and the FAA's response to each comment.
Boeing stated that it concurred with the contents of the NPRM (80 FR 16606, March 30, 2015).
United Airlines stated that it has reviewed the NPRM (80 FR 16606, March 30, 2015), and has no comment to submit.
UPS requested that we add an additional statement to paragraph (i) of the proposed AD (“Exception to the Service Information,”) to clarify that the removal of fasteners is not required for performing the surface high-frequency eddy current (HFEC) inspections specified by paragraph (g) of the proposed AD (80 FR 16606, March 30, 2015). UPS stated that by adding the clarification that the removal of fasteners is not required, significant time and materials would be saved by operators when accomplishing this inspection and prevent unnecessary alternative method of compliance (AMOC) requests. UPS explained that Boeing agreed in a response to a service request that fastener removal is not required for performing surface HFEC inspections.
We agree because the clarification will reduce costs while ensuring the same level of safety. We have added the following sentence to paragraph (g) of this AD: “It is not necessary to remove fasteners while performing the surface HFEC inspections.”
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
• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 16606, March 30, 2015).
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014. The service information describes procedures for accomplishing repetitive inspections for cracking of the station 800 frame assembly, and repair. 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 124 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
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 have 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 DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 1, 2015.
This AD replaces AD 2007-16-08, Amendment 39-15147 (72 FR 44728, August 9, 2007).
This AD applies to all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of cracks found on the station 800 frame on the left-side and right-side main entry doors (MED), at the forward and aft inner chord strap and angles, which are outside the inspection area of AD 2007-16-08, Amendment 39-15147 (72 FR 44728, August 9, 2007). We are issuing this AD to detect and correct fatigue cracks that could extend and fully sever the frame, which could result in development of skin cracks that could lead to rapid depressurization of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (i) of this AD, at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014: Do a detailed inspection for cracking in the inner chord strap, angles, and exposed web adjacent to the inner chords, and do surface and open hole high-frequency eddy current (HFEC) inspections for cracking in the inner chord strap and angles of the station 800 frame assembly between stringer 14 and stringer 30, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014. It is not necessary to remove fasteners while performing the surface HFEC inspections. Repeat the inspections at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014.
If any cracking is found during any inspection required by paragraph (g) of this AD, before further flight, repair the cracking using a method approved in accordance with
(1) Where Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014, specifies a compliance time “after the Revision 2 date of this service bulletin,” this AD requires compliance within the specified time after the effective date of this AD.
(2) The Condition column of paragraph 1.E., “Compliance,” of the Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014, refers to total flight cycles “as of the Revision 2 date of this service bulletin.” This AD, however applies to airplanes with the specified total flight cycles or total flight hours as of the effective date of this AD.
This paragraph provides credit for the inspections and repairs of the inner chord strap and angles of the station 800 frame assembly between stringer 14 and stringer 18 required by paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 747-53A2451, Revision 1, dated November 10, 2005, which was incorporated by reference in AD 2006-12-12, Amendment 39-14638 (71 FR 33595, June 12, 2006).
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved for AD 2007-16-08, Amendment 39-15147 (72 FR 44728, August 9, 2007), are approved as AMOCs for the corresponding provisions of this AD.
(1) For more information about this AD, contact Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email:
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(3) and (m)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 747-53A2451, Revision 2, dated June 13, 2014.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
(4) You may view this service information at FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are superseding emergency airworthiness directive (AD) No. 2015-16-51 (Emergency AD 2015-16-51) for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. Emergency AD 2015-16-51 required inspections of each inboard and outboard tail rotor pitch link assembly for axial or radial bearing play, and if there was axial or radial bearing play, removing the tail rotor pitch link and inspecting for wear. Emergency AD 2015-16-51 was prompted by several reports of worn tail rotor pitch link spherical bearings. We are issuing this supersedure to retain the inspection requirements in Emergency AD 2015-16-51 while revising the applicability and compliance time to clarify that all Bell Model 429 helicopters require recurring inspections regardless of hours time-in-service (TIS) accumulated on the helicopter. These actions are intended to prevent pitch link failure and subsequent loss of control of the helicopter.
This AD becomes effective November 12, 2015.
We must receive comments on this AD by December 28, 2015.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
David Hatfield, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
Transport Canada, which is the aviation authority for Canada, issued Emergency AD No. CF-2015-16, dated July 2, 2015, to correct an unsafe condition for Bell Model 429 helicopters. Transport Canada advised that in-service reports showed that the tail rotor pitch link spherical bearings have experienced early and accelerated wear. On three occasions, bearings were found worn beyond limits during pre-flight inspections, showing a radial and axial play that was easily detectable. In one case, the spherical bearing separated from the tail rotor pitch link, resulting in damage to the tail rotor blade pitch horn assembly. In another case, the spherical bearing had been inspected and found acceptable during a maintenance inspection; about “1 hour air time” later, it was found worn beyond limits during a pre-flight inspection.
On August 6, 2015, we issued Emergency AD 2015-16-51, which was made immediately effective to all known U.S. owners and operators of Bell Model 429 helicopters. Emergency AD 2015-16-51 required, before further flight and thereafter at intervals not to exceed 50 hours TIS, inspecting each inboard and outboard tail rotor pitch link assembly for axial or radial bearing play. Emergency AD 2015-16-51 also required, if there was axial or radial bearing play, removing the tail rotor pitch link and performing a dimensional inspection for wear. Finally, Emergency AD 2015-16-51 required, if wear exceeded the allowable limits, replacing the tail rotor pitch link assembly.
On the same day that we issued Emergency AD 2015-16-51, Transport Canada issued a revised Emergency AD No. CF-2015-16R1, dated August 6, 2015, changing the applicability and compliance time to clarify that the inspections are required for all Model 429 helicopters. Transport Canada advises of the possibility that some operators would conclude that no action was required for low time helicopters. Transport Canada Emergency AD No. CF-2015-16R1 removes the following language from the applicability so that it applies to all Model 429 helicopters regardless of time: “that have accumulated 50 hours air time or more.” It also adds language to the compliance time so that the corrective actions must be accomplished within 10 hours air time “or before exceeding 60 hours air time since new, whichever occurs later.” Therefore, we are issuing this AD to make similar revisions.
These helicopters have been approved by Transport Canada and are approved for operation in the United States. Pursuant to our bilateral agreement with Canada, Transport Canada, its technical representative, has notified us of the unsafe condition described in its Emergency AD. We are issuing this AD because we evaluated all information provided by Transport Canada and determined the unsafe condition exists and is likely to exist or develop on other helicopters of this same type design.
Bell issued Alert Service Bulletin 429-15-16, dated February 18, 2015 (ASB) for Bell Model 429 helicopters, S/N 57001 and subsequent, which have accumulated more than 50 hours. The ASB specifies inspecting both inboard and outboard tail rotor pitch link assemblies for axial and radial play. If abnormal wear or bearing play is detected, the ASB specifies removing the affected tail rotor pitch link, performing a dimensional check of both axial and radial play, and replacing any tail rotor pitch link assembly 429-012-112-101 or -103 or pitch link bearing 429-312-107-103 that exceeds the allowable limits.
This AD retains the inspection requirements of Emergency AD 2015-16-51 but revises the applicability and compliance time. This AD applies to Model 429 helicopters regardless of accumulated TIS. The inspections in this AD are required before further flight for helicopters with 50 or more hours TIS and before accumulating 50 hours TIS for helicopters with less than 50 hours TIS.
The Transport Canada Emergency AD requires compliance within 10 hours TIS or before exceeding 60 hours air time, whichever occurs later. This AD requires compliance before further flight for helicopters with 50 or more hours TIS. For helicopters with less than 50 hours TIS, this AD requires compliance before the helicopter accumulates 50 hours TIS.
We consider this AD to be an interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this AD affects 54 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work hour. It will take about 2 work hours to do the inspections at an estimated cost of $170 per helicopter or $9,180 for the fleet per inspection cycle. Replacing a tail rotor pitch link assembly will take 4 work hours and required parts will cost $2,685 for a total cost of $3,025 per helicopter.
Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found and continue to find that the risk to the flying public justifies waiving notice and comment prior to adopting this rule because the previously described unsafe condition can adversely affect the controllability
Since it was found that immediate corrective action was required, notice and opportunity for prior public comment before issuing this AD were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by Emergency AD 2015-16-51, issued on August 6, 2015, to all known U.S. owners and operators of these helicopters. These conditions still exist and the Emergency AD is hereby superseded.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model 429 helicopters with a pitch link assembly part number 429-012-112-101 or -103 installed, certificated in any category.
This AD defines the unsafe condition as a worn pitch link. This condition, if not detected and corrected, could result in pitch link failure and subsequent loss of control of the helicopter.
This AD supersedes Emergency AD 2015-16-51, Directorate Identifier 2015-SW-23-AD, dated August 6, 2015.
This AD becomes effective November 12, 2015.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) For helicopters with 50 or more hours time-in-service (TIS), before further flight, and for helicopters with less than 50 hours TIS, before accumulating 50 hours TIS, inspect each inboard and outboard tail rotor pitch link assembly for axial or radial bearing play. If there is axial or radial bearing play, remove the tail rotor pitch link and perform a dimensional inspection for wear. If there is wear that exceeds the allowable limits, replace the tail rotor pitch link assembly.
(2) Thereafter, at intervals not to exceed 50 hours TIS, repeat the inspections required by paragraph (f)(1) of this AD.
(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: David Hatfield, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
(1) Bell Helicopter Alert Service Bulletin 429-15-16, dated February 18, 2015, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone (450) 437-2862 or (800) 363-8023; fax (450) 433-0272; or at
(2) The subject of this AD is addressed in Transport Canada Emergency AD No. CF-2015-16R1, dated August 6, 2015. You may view the Transport Canada Emergency AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 6720 Tail Rotor Control System.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
This action extends the prohibition against certain flight operations in the Simferopol (UKFV) and Dnipropetrovsk (UKDV) flight information regions (FIRs) by all United States (U.S.) air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. This action also revises the FAA approval process for proposed operations authorized by other U.S. Government departments, agencies, and instrumentalities to clarify the FAA's expectations regarding requests for approval and revises the approval conditions and information about requests for exemptions to reflect the termination of statutory authorization for the FAA's premium war risk insurance program. This action also makes minor non-substantive corrections to the wording of the rule. The FAA finds this action to be necessary to address a continuing hazard to persons and aircraft engaged in such flight operations.
This final rule is effective on October 22, 2015.
Michael Filippell, Air Transportation Division, AFS-220, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8166; email:
This action continues the prohibition on flight operations in the UKFV and UKDV FIRs by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. This action also revises the FAA approval process for proposed operations authorized by other U.S. Government departments, agencies, and instrumentalities to clarify the FAA's expectations regarding requests for approval and revises the approval conditions and information about requests for exemptions to reflect the termination of statutory authorization for the FAA's premium war risk insurance program. This action also makes minor non-substantive corrections to the wording of the rule. The FAA finds this action necessary to address a continuing hazard to persons and aircraft engaged in such flight operations.
Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” In this instance, the FAA finds that notice and public comment to this immediately adopted final rule, as well as any delay in the effective date of this rule, are contrary to the public interest due to the immediate need to address the hazard to U.S. civil aviation that continues to exist in the UKFV and UKDV FIRs, as described in the Background section of this rule.
The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49, U.S. Code. Subtitle I, section 106(f), describes the authority of the FAA Administrator. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security. This regulation is within the scope of that authority because it continues to prohibit the persons subject to paragraph (a) of SFAR No. 113, § 91.1607, from conducting flight operations in the UKFV and UKDV FIRs due to the hazard to the safety of such persons' flight operations, as described in the Background section of this rule.
On April 25, 2014, the FAA published SFAR No. 113, § 91.1607, which prohibited flight operations in a portion of the UKFV FIR by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons were operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators were foreign air carriers (79 FR 22862). At that time, the FAA viewed the possibility of civil aircraft receiving confusing and conflicting air traffic control instructions from both Ukrainian and Russian air traffic service providers when operating in the portion of the Simferopol (UKFV) FIR covered by SFAR No. 113, § 91.1607, as an unsafe condition that presented a potential hazard to U.S. civil flight operations in the disputed airspace. Because political and military tensions between Ukraine and the Russian Federation remained high, the FAA was also concerned that compliance with air traffic control instructions issued by the authorities of one country could result in a civil aircraft being misidentified as a threat and intercepted or otherwise engaged by air defense forces of the other country. The FAA continues to have these concerns.
On July 18, 2014 (UTC), the FAA expanded its flight prohibition through the issuance of Notice to Airmen (NOTAM) FDC 4/2182, due to ongoing safety concerns regarding U.S. civil flight operations in the entire UKFV and UKDV FIRs. The FAA determined that the ongoing conflict in the region posed a significant threat to U.S. civil aviation operations in these FIRs. In addition to a series of attacks on fixed-wing and rotary-wing Ukrainian military aircraft flying at lower altitudes, a Ukrainian An-26 flying at 21,000 feet southeast of Luhansk was shot down on July 14, 2014, and a Malaysia Airlines Boeing 777 was shot down on July 17, 2014,
The FAA has continued to evaluate the situation in the UKFV and UKDV FIRs and has determined there is a continuing significant flight safety hazard to U.S. civil aviation from the ongoing risk of skirmishes in the area. There is also a potential for larger-scale fighting in eastern Ukraine involving pro-Russian separatists, which could result in civil aircraft being misidentified as a threat and then intercepted or otherwise engaged, as demonstrated by the shoot down of Malaysia Airlines Flight 17 on July 17, 2014. Pro-Russian separatists have access to a variety of anti-aircraft weapons, to include man-portable air defense systems (MANPADS) and possibly more advanced surface-to-air-missiles (SAMs) that have the capability to engage aircraft at higher altitudes. Separatists have demonstrated their ability to use these anti-aircraft weapons by successfully shooting down a number of aircraft during the course of the fighting in eastern Ukraine in 2014. There is also continuing concern over the hazard to U.S. civil aviation from possible conflicting air traffic control instructions from Ukrainian and Russian air traffic service providers due to a dispute over responsibility for providing air navigation services in portions of the Simferopol (UKFV) FIR. In addition, there have been reported incidents of purposeful interference, including GPS jamming, in the UKFV and UKDV FIRs.
Due to the previously described continuing hazards to U.S. civil aviation operations, the FAA is extending the expiration date of SFAR No. 113, § 91.1607, to continue the prohibition on flight operations in the UKFV and UKDV FIRs by all U.S. air carriers; U.S. commercial operators; persons exercising the privileges of a U.S. airman certificate, except when such persons are operating a U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except when such operators are foreign air carriers. This rule extends the expiration date of SFAR No. 113, § 91.1607, from October 27, 2015, to October 27, 2016.
The FAA will continue to actively evaluate the area to determine to what extent U.S. civil aviation may be able to safely operate therein. Adjustments to this SFAR may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind this SFAR as necessary prior to its expiration date.
Additionally, the FAA is revising its approval process for proposed operations authorized by other U.S. Government departments, agencies, and instrumentalities to clarify the FAA's expectations regarding requests for approval. The FAA is also revising the approval conditions that will apply to operations authorized by other U.S. Government departments, agencies, and instrumentalities and approved by the FAA, and the information about requests for exemption, to reflect the termination of statutory authorization for the FAA premium war risk insurance program. Section 102 of Division L of the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235, December 16, 2014,
Because the circumstances described herein warrant immediate action by the FAA, I find that notice and public comment under 5 U.S.C. 553(b)(3)(B) are impracticable and contrary to the public interest. Further, I find that good cause exists under 5 U.S.C. 553(d) for making this rule effective immediately upon issuance. I also find that this action is fully consistent with the obligations under 49 U.S.C. 40105 to ensure that I exercise my duties consistently with the obligations of the United States under international agreements.
If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person covered under SFAR No. 113, § 91.1607, including a U.S. air carrier or a U.S. commercial operator, to conduct a charter to transport civilian or military passengers or cargo or other operations in either or both of the UKFV and UKDV FIRs, that department, agency, or instrumentality may request that the FAA approve persons covered under SFAR No. 113, § 91.1607, to conduct such operations. An approval request must be made directly by the requesting department, agency, or instrumentality of the U.S. Government to the FAA's Associate Administrator for Aviation Safety (AVS-1) in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. Requests for approval submitted to the FAA by anyone other than the requesting department, agency, or instrumentality will not be accepted and will not be processed. In addition, the senior official signing the letter requesting FAA approval on behalf of the requesting department, agency, or instrumentality must be sufficiently highly placed within his or her organization to demonstrate that the senior leadership of the requesting department, agency, or instrumentality supports the request for approval and is committed to taking all necessary steps to minimize operational risks to the proposed flights. The senior official must also be in a position to: (1) Attest to the accuracy of all representations made to the FAA in the request for approval and (2) ensure that any support from the requesting U.S. government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless exigent circumstances exist, requests for approval must be submitted to the FAA not less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the proposed operations, if approved by the FAA, to commence.
The letter must be sent by the requesting department, agency, or instrumentality to the Associate Administrator for Aviation Safety (AVS-1), Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166 to obtain the appropriate email address. A single letter may request approval from the FAA for multiple persons covered under SFAR No. 113, § 91.1607, and/or for multiple flight operations. To the extent known, the letter must identify the person(s) expected to be covered under the SFAR on whose behalf the U.S. Government department, agency, or instrumentality is seeking FAA approval, and it must describe—
• The proposed operation(s), including the nature of the mission being supported;
• The service to be provided by the person(s) covered by the SFAR;
• To the extent known, the specific locations in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs and the airports, airfields and/or landing zones at which the aircraft will take-off and land; and
• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (
The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or with whom its prime contractor has a subcontract(s)) for specific flight operations in either or both of the UKFV and UKDV FIRs. Additional operators may be identified to the FAA at any time after the FAA approval is issued. However, all additional operators must be identified to, and obtain an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, from, the FAA, for operations in either or both of the UKFV and UKDV FIRs before such operators commence such operations. The revised approval conditions discussed below will apply to any such additional operators. Updated lists should be sent to the email address to be obtained from the Air Transportation Division by calling (202) 267-8166.
If an approval request includes classified information, requestors may contact Aviation Safety Inspector Michael Filippell for instructions on submitting it to the FAA. His contact information is listed in the “For Further Information Contact” section of this final rule.
FAA approval of an operation under SFAR No. 113, § 91.1607, does not relieve persons subject to this SFAR of their responsibility to comply with all applicable FAA rules and regulations. Operators of civil aircraft must also comply with the conditions of their certificate, OpSpecs, and LOAs, as applicable. Operators must further comply with all rules and regulations of other U.S. Government departments and agencies that may apply to the proposed operation, including, but not limited to, the Transportation Security Regulations issued by the Transportation Security Administration, Department of Homeland Security.
If the FAA approves the request, the FAA's Aviation Safety Organization (AVS) will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:
(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.
(2) Before any approval takes effect, the operator must submit to the FAA:
(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses; and
(b) The operator's agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising from or related to the approved operations in either or both of the UKFV and UKDV FIRs.
(3) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs or LOAs, as applicable.
The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443 of title 49, United States Code.
If the proposed operation or operations are approved, the FAA will issue an OpSpec or an LOA, as applicable, to the operator authorizing the operation or operations, and will notify the department, agency, or instrumentality that requested the FAA's approval of any additional conditions beyond those contained in the approval letter. The requesting department, agency, or instrumentality must have a contract, grant, or cooperative agreement (or its prime contractor must have a subcontract) with the person(s) described in paragraph (a) of this SFAR No. 113, § 91.1607, on whose behalf the department, agency, or instrumentality requests FAA approval.
Any operations not conducted under an approval issued by the FAA through the approval process set forth previously must be conducted under an exemption from SFAR No. 113, § 91.1607. A request by any person covered under SFAR No. 113, § 91.1607, for an exemption must comply with 14 CFR part 11, and will require exceptional circumstances beyond those contemplated by the approval process set forth previously. In addition to the information required by 14 CFR 11.81, at a minimum, the requestor must describe in its submission to the FAA—
• The proposed operation(s), including the nature of the operation;
• The service to be provided by the person(s) covered by the SFAR;
• The specific locations in either or both of the Simferopol (UKFV) and Dnipropetrovsk (UKDV) FIRs where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the UKFV and/or UKDV FIRs and the airports, airfields and/or landing zones at which the aircraft will take-off and land); and
• The method by which the operator will obtain current threat information and an explanation of how the operator will integrate this information into all phases of its proposed operations (
Additionally, the release and agreement to indemnify, as referred to previously, will be required as a condition of any exemption that may be issued under SFAR No. 113, § 91.1607.
The FAA recognizes that operations that may be affected by SFAR No. 113, § 91.1607, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will process exemption requests for such operations on an expedited basis and prior to any private exemption requests.
Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 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), as codified in 5 U.S.C. 603
In conducting these analyses, FAA has determined this final rule has benefits that justify its costs. This rule is a significant regulatory action as defined in section 3(f) of Executive Order 12866, as it raises novel policy issues contemplated under that Executive Order; further, this rule is “significant” as defined in DOT's Regulatory Policies and Procedures. This rule will not have a significant economic impact on a substantial number of small entities. This rule will not create unnecessary obstacles to the foreign commerce of the United States. This rule will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector by exceeding the threshold identified above.
Department of Transportation (DOT) Order 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 a statement to that effect and the basis for it to 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 final rule. The reasoning for this determination follows.
This rule extends the existing prohibition against U.S. civil flight operations in the UKFV and UKDV FIRs. As we noted in the most recent previous amendment to SFAR No. 113, § 91.1607 (79 FR 77860, December 29, 2014), almost all U.S. operators already had voluntarily ceased their operations in these FIRs prior to the issuance of the FAA NOTAM on July 18, 2014 (UTC), prohibiting U.S. civil flight operations in these two FIRS in their entirety. Prior to the issuance of the July 18, 2014 (UTC) NOTAM, the FAA had already prohibited U.S. civil flight operations in a portion of the UKFV FIR due to a dispute between Ukraine and the Russian Federation over which country is responsible for providing air navigation services in the area, first via NOTAM and subsequently when the FAA initially published SFAR No. 113, § 91.1607, on April 25, 2014. Consequently, no U.S. operators were operating in that portion of the UKFV FIR at the time of the December 29, 2014 amendment to the rule.
Because of the continuing significant hazards to U.S. civil aviation discussed in the Background section of this final rule, the FAA believes that few, if any, U.S. operators presently wish to conduct operations in either of these two FIRS. Moreover, both the amendment published on December 29, 2014, and this rule, permit a U.S. Government department, agency, or instrumentality to request FAA approval on behalf of a person described in paragraph (a) of SFAR No. 113, § 91.1607, to conduct operations under a contract (or subcontract), grant, or cooperative agreement with that department, agency, or instrumentality. As no U.S. Government department, agency, or instrumentality has requested such approval since December 29, 2014, there is apparently little demand for such approvals. Finally, the possibility of obtaining an approval, should one be requested, lowers the expected cost of the extended rule. Accordingly, the FAA believes the incremental costs of this final rule will be minimal. These minimal costs will be exceeded by the benefits of avoiding the deaths, injuries, and/or property damage that would result from a U.S. operator's aircraft being shot down (or otherwise damaged) while operating in either or both of the UKFV and UKDV FIRs.
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 is not expected to have 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.
As described in the Regulatory Evaluation section of this preamble, the incremental costs of this rule are minimal. Therefore, as provided in § 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended, 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 this Act, 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.
The FAA has assessed the effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from a hazard outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act.
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
This final 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 immediately adopted final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this regulation.
FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act (NEPA) in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6f of this order and involves no extraordinary circumstances.
The FAA has reviewed the implementation of this SFAR and determined it is categorically excluded from further environmental review according to FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.6f. The FAA has examined possible extraordinary circumstances and determined that no such circumstances exist. After careful and thorough consideration of the action, the FAA finds that this Federal action does not require preparation of an Environmental Assessment or Environmental Impact Statement in accordance with the requirements of NEPA, Council on Environmental Quality (CEQ) regulations, and FAA Order 1050.1F.
The FAA has analyzed this immediately adopted final 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 immediately adopted final 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.
An electronic copy of rulemaking documents may be obtained from the Internet by—
• Searching the Federal eRulemaking Portal (
• Visiting the FAA's Regulations and Policies Web page at
• Accessing the Government Publishing Office's Web page at
Copies may also be obtained by sending a request (identified by docket or amendment number of the rule) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.
All documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced above.
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the
Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight, Ukraine.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations, as follows:
49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).
(a) * * *
(2) All persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and
(c)
(e)
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective October 27, 2015. The classification was applicable February 19, 2015.
Sunita Shukla, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4647, Silver Spring, MD 20993-0002, 301-796-6406.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, after receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.
23andMe, Inc., submitted a direct de novo request for classification of the 23andMe PGS Carrier Screening Test for Bloom Syndrome under section 513(f)(2)(A)(ii) of the FD&C Act, based on a determination that there is no legally marketed device on which to base a determination of substantial equivalence.
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. After review of the information submitted in the de novo request, FDA classified the device into class II because general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.
Therefore, on February 19, 2015, FDA issued an order to the requestor classifying the device into class II. The classification of the device will be codified at 21 CFR 866.5940.
The device is assigned the generic name autosomal recessive carrier screening gene mutation detection system, and it is identified as a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.
A gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with cystic fibrosis is separately classified under 21 CFR 866.5900—
FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks in table 1.
FDA believes that the following special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:
1. If the device is offered over-the-counter, the device manufacturer must provide information to a potential purchaser or actual test report recipient about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre-and post-test counseling.
2. The device must use a collection device that is FDA cleared, approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing.
3. The device's labeling must include a prominent hyperlink to the manufacturer's public Web site where the manufacturer shall make the information identified in this subsection publicly available. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. If the device can be purchased from the Web site or testing using the device can be ordered from the Web site, the same information must be found on the Web page for ordering the device or provided in a prominently placed and publicly accessible hyperlink on the Web page for ordering the device. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which would also have to be posted on the manufacturer's Web site. The information must include:
a. A detailed device description including:
i. Gene (or list of the genes if more than one) and variants the test detects (using standardized nomenclature, Human Genome Organization (HUGO) nomenclature, and coordinates);
ii. Scientifically established clinical validity of each variant detected and reported by the test, which must be well-established in peer-reviewed journal articles, authoritative summaries of the literature such as Genetics Home Reference (
A. Genotype-phenotype information for the reported mutations.
B. Relevant American College of Medical Genetics (ACMG) or American Congress of Obstetricians and Gynecologists (ACOG) guideline recommending testing of the specific gene(s) and variants the test detects and recommended populations, if available. If not available, a statement stating that professional guidelines currently do not recommend testing for this specific gene(s) and variants.
C. Table of expected prevalence of carrier status in major ethnic and racial populations and the general population.
iii. The specimen type (
iv. Assay steps and technology used;
v. Specification of required ancillary reagents, instrumentation, and equipment;
vi. Specification of the specimen collection, processing, storage, and preparation methods;
vii. Specification of risk mitigation elements and description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing;
viii. Information pertaining to the probability of test failure (
ix. Specification of the criteria for test result interpretation and reporting.
b. Information that demonstrates the performance characteristics of the device, including:
i. Accuracy (method comparison) of study results for each claimed specimen type.
A. Accuracy of the device shall be evaluated with fresh clinical specimens collected and processed in a manner consistent with the device's instructions for use. If this is impractical, fresh clinical samples may be substituted or supplemented with archived clinical samples. Archived samples shall have been collected previously in accordance with the device's instructions for use, stored appropriately, and randomly selected. In some instances, use of contrived samples or human cell line samples may also be appropriate; the contrived or human cell line samples shall mimic clinical specimens as much as is feasible and provide an unbiased evaluation of the device's accuracy.
B. Accuracy must be evaluated as compared to bidirectional sequencing or other methods identified as appropriate by FDA. Performance criteria for both the comparator method and device must be predefined and appropriate to the test's intended use. Detailed appropriate study protocols must be provided.
C. Information provided shall include the number and type of specimens, broken down by clinically relevant variants, that were compared to bidirectional sequencing or other methods identified as appropriate by FDA. The accuracy, defined as positive percent agreement (PPA) and negative percent agreement (NPA), must be measured; accuracy point estimates must be greater than 99 percent (both per reported variant and overall) and uncertainty of the point estimate must be presented using the 95 percent confidence interval. Clinical specimens must include both homozygous wild type and heterozygous genotypes. The number of clinical specimens for each variant reported that must be included in the accuracy study must be based on the variant prevalence. Common variants (greater than 0.1 percent allele frequency in ethnically relevant population) must have at least 20 unique heterozygous clinical specimens tested. Rare variants (less than or equal to 0.1 percent allele frequency in ethnically relevant population) shall have at least three unique mutant heterozygous specimens tested. Any no calls (
D. Information shall be reported on the clinical positive predictive value (PPV) and negative predictive value (NPV) for carrier status (and where possible, for each variant) in each population. Specifically, to calculate PPV and NPV, estimate test coverage (TC) and the percent of persons with variant(s) included in the device among all carriers: PPV = (PPA*TC * π)/(PPA*TC*π + (1 − NPA) * (1 − π)) and NPV = (NPA*(1 − π))/(NPA*(1 − π) + (1 − PPA*TC) * π) where PPA and NPA described either in paragraph (3)(b)(i)(D)(
ii. Precision (reproducibility): Precision data must be generated using multiple instruments and multiple operators, on multiple non-consecutive days, and using multiple reagent lots. The sample panel must include specimens with claimed sample type (
iii. Analytical specificity data: Data must be generated evaluating the effect on test performance of potential endogenous and exogenous interfering substances relevant to the specimen type, evaluation of cross-reactivity of known cross-reactive alleles and pseudogenes, and assessment of cross-contamination.
iv. Analytical sensitivity data: Data must be generated demonstrating the minimum amount of DNA that will enable the test to perform accurately in 95 percent of runs.
v. Device stability data: The manufacturer must establish upper and lower limits of input nucleic acid and sample stability that will achieve the claimed accuracy and reproducibility. Data supporting such claims must be described.
vi. Specimen type and matrix comparison data: Specimen type and matrix comparison data must be generated if more than one specimen type or anticoagulant can be tested with the device, including failure rates for the different specimen types.
c. If the device is offered over-the-counter, including cases in which the test results are provided direct-to-consumer, the manufacturer must conduct a study that assesses user comprehension of the device's labeling and test process and provide a concise summary of the results of the study. The following items must be included in the user study:
i. The test manufacturer must perform pre- and post-test user comprehension studies to assess user ability to understand the possible results of a carrier test and their clinical meaning. The comprehension test questions must directly evaluate the material being presented to the user in the test reports.
ii. The test manufacturer must provide a carrier testing education module to potential and actual test report recipients. The module must define terms that are used in the test reports and explain the significance of carrier status.
iii. The user study must meet the following criteria:
A. The study participants must be comprised of a statistically justified and demographically diverse population (determined using methods such as quota-based sampling) that is representative of the intended user population. Furthermore, the users must be comprised of a diverse range of age and educational levels that have no prior experience with the test or its manufacturer. These factors shall be well-defined in the inclusion and exclusion criteria.
B. All sources of bias (
C. The testing must follow a format where users have limited time to complete the studies (such as an onsite survey format and a one-time visit with a cap on the maximum amount of time that a participant has to complete the tests).
D. Users must be randomly assigned to study arms. Test reports given to users must: (1) Define the condition being tested and related symptoms, (2) explain the intended use and limitations of the test, (3) explain the relevant ethnicities regarding the variant tested, (4) explain carrier status and relevance to the user's ethnicity, (5) provide links to additional information pertaining to situations where the user is concerned about their test results or would like followup information as indicated in test labeling). The study shall assess participants' ability to understand the following comprehension concepts: The test's limitations, purpose, and results.
E. Study participants must be untrained, naive to the test subject of the study, and be provided only the materials that will be available to them when the test is marketed.
F. The user comprehension study must meet the predefined primary endpoint criteria, including a minimum of a 90 percent or greater overall comprehension rate (
iv. A summary of the user comprehension study must be provided and include the following:
A. Results regarding reports that are provided for each gene/variant/ethnicity tested.
B. Statistical methods used to analyze all data sets.
C. Completion rate, non-responder rate, and reasons for non-response/data exclusion, as well as a summary table of comprehension rates regarding comprehension concepts (purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report.
4. Your 21 CFR 809.10 compliant labeling and any test report generated must include the following warning and limitation statements, as applicable:
a. A warning that reads “The test is intended only for autosomal recessive carrier screening in adults of reproductive age.”
b. A statement accurately disclosing the genetic coverage of the test in lay terms, including, as applicable, information on variants not queried by the test, and the proportion of incident disease that is not related to the gene(s) tested. For example, where applicable, the statement would have to include a warning that the test does not or may not detect all genetic variants related to the genetic disease, and that the absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related. Or, where applicable, the statement would have to include a warning that the basis for the disease for which the genetic carrier status is being tested is unknown or believed to be non-heritable in a substantial number of people who have the disease, and that a negative test result cannot rule out the possibility that any offspring may be affected with the disease. The statement would have to include any other warnings needed to accurately convey to consumers the degree to which the test is informative for carrier status.
c. For prescription use tests, the following warnings that read:
i. “The results of this test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information.”
ii. “This device is not intended for disease diagnosis, prenatal testing of fetuses, risk assessment, prognosis or pre-symptomatic testing, susceptibility testing, or newborn screening.”
d. For over-the-counter tests, a statement that reads “This test is not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On its own, this test is also not intended to tell you anything about the health of your fetus, or your newborn child's risk of developing a particular disease later on in life.”
e. For over-the-counter tests, the following warnings that read:
i. “This test is not a substitute for visits to a healthcare provider. It is recommended that you consult with a healthcare provider if you have any questions or concerns about your results.”
ii. “The test does not diagnose any health conditions. Results should be used along with other clinical information for any medical purposes.”
iii. “The laboratory may not be able to process your sample. The probability that the laboratory cannot process your saliva sample can be up to [actual probability percentage].”
iv. “Your ethnicity may affect how your genetic health results are interpreted.”
f. For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 50 percent and more than 5 percent, a warning that reads “The positive result you obtained may falsely identify you as a carrier. Consider genetic counseling and followup testing.”
g. For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 5 percent, a warning that reads “The positive result you obtained is very likely to be incorrect due to the rarity of this variant. Consider genetic counseling and followup testing.”
5. The testing done to comply with paragraph 3 must show the device meets or exceeds each of the following performance specifications:
a. The accuracy must be shown to be equal to or greater than 99 percent for both PPA and NPA. Variants that have a point estimate for PPA or NPA of less than 99 percent (incorrect test results as compared to bidirectional sequencing or other methods identified as appropriate by FDA) must not be incorporated into test claims and reports.
b. Precision (reproducibility) performance must meet or exceed 99 percent for both positive and negative results.
c. The user comprehension study must obtain values of 90 percent or greater user comprehension for each comprehension concept.
6. The distribution of this device, excluding the collection device described in paragraph 2, shall be limited to the manufacturer, the manufacturer's subsidiaries, and laboratories regulated under the Clinical Laboratory Improvement Amendments.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA believes premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, is planning to exempt the device from the premarket notification requirements of the FD&C Act. Elsewhere in this issue of the
The Agency has determined under 21 CFR 25.34(b) 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.
This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(1) If the device is offered over-the-counter, the device manufacturer must provide information to a potential purchaser or actual test report recipient about how to obtain access to a board-certified clinical molecular geneticist or equivalent to assist in pre- and post-test counseling.
(2) The device must use a collection device that is FDA cleared, approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing.
(3) The device's labeling must include a prominent hyperlink to the manufacturer's public Web site where the manufacturer shall make the information identified in this section publicly available. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. If the device can be purchased from the Web site or testing using the device can be ordered from the Web site, the same information must be found on the Web page for ordering the device or provided in a prominently placed and publicly accessible hyperlink on the Web page for ordering the device. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which would also have to be posted on the manufacturer's Web site. The information must include:
(i) A detailed device description including:
(A) Gene (or list of the genes if more than one) and variants the test detects (using standardized nomenclature, Human Genome Organization (HUGO) nomenclature, and coordinates).
(B) Scientifically established clinical validity of each variant detected and reported by the test, which must be well-established in peer-reviewed journal articles, authoritative summaries of the literature such as Genetics Home Reference (
(
(
(
(C) The specimen type (
(D) Assay steps and technology used.
(E) Specification of required ancillary reagents, instrumentation, and equipment.
(F) Specification of the specimen collection, processing, storage, and preparation methods.
(G) Specification of risk mitigation elements and description of all additional procedures, methods, and practices incorporated into the directions for use that mitigate risks associated with testing.
(H) Information pertaining to the probability of test failure (
(I) Specification of the criteria for test result interpretation and reporting.
(ii) Information that demonstrates the performance characteristics of the device, including:
(A) Accuracy (method comparison) of study results for each claimed specimen type.
(
(
(
(
(
(
(B) Precision (reproducibility): Precision data must be generated using multiple instruments and multiple operators, on multiple non-consecutive days, and using multiple reagent lots. The sample panel must include specimens with claimed sample type (
(C) Analytical specificity data: Data must be generated evaluating the effect on test performance of potential endogenous and exogenous interfering substances relevant to the specimen type, evaluation of cross-reactivity of known cross-reactive alleles and pseudogenes, and assessment of cross-contamination.
(D) Analytical sensitivity data: Data must be generated demonstrating the minimum amount of DNA that will enable the test to perform accurately in 95 percent of runs.
(E) Device stability data: The manufacturer must establish upper and lower limits of input nucleic acid and sample stability that will achieve the claimed accuracy and reproducibility. Data supporting such claims must be described.
(F) Specimen type and matrix comparison data: Specimen type and matrix comparison data must be generated if more than one specimen type or anticoagulant can be tested with the device, including failure rates for the different specimen types.
(iii) If the device is offered over-the-counter, including cases in which the test results are provided direct-to-consumer, the manufacturer must conduct a study that assesses user comprehension of the device's labeling and test process and provide a concise summary of the results of the study. The following items must be included in the user study:
(A) The test manufacturer must perform pre- and post-test user comprehension studies to assess user ability to understand the possible results of a carrier test and their clinical meaning. The comprehension test questions must directly evaluate the material being presented to the user in the test reports.
(B) The test manufacturer must provide a carrier testing education module to potential and actual test report recipients. The module must define terms that are used in the test reports and explain the significance of carrier status.
(C) The user study must meet the following criteria:
(
(
(
(
(
(
(D) A summary of the user comprehension study must be provided and include the following:
(
(
(
(4) Your 21 CFR 809.10 compliant labeling and any test report generated must include the following warning and limitation statements, as applicable:
(i) A warning that reads “The test is intended only for autosomal recessive carrier screening in adults of reproductive age.”
(ii) A statement accurately disclosing the genetic coverage of the test in lay terms, including, as applicable, information on variants not queried by the test, and the proportion of incident disease that is not related to the gene(s) tested. For example, where applicable, the statement would have to include a warning that the test does not or may not detect all genetic variants related to the genetic disease, and that the absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related. Or, where applicable, the statement would have to include a warning that the basis for the disease for which the genetic carrier status is being tested is unknown or believed to be non-heritable in a substantial number of people who have the disease, and that a negative test result cannot rule out the possibility that any offspring may be affected with the disease. The statement would have to include any other warnings needed to accurately convey to consumers the degree to which the test is informative for carrier status.
(iii) For prescription use tests, the following warnings that read:
(A) “The results of this test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information.”
(B) “This device is not intended for disease diagnosis, prenatal testing of fetuses, risk assessment, prognosis or pre-symptomatic testing, susceptibility testing, or newborn screening.”
(iv) For over-the-counter tests, a statement that reads “This test is not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On its own, this test is also not intended to tell you anything about the health of your fetus, or your newborn child's risk of developing a particular disease later on in life.”
(v) For over-the-counter tests, the following warnings that read:
(A) “This test is not a substitute for visits to a healthcare provider. It is recommended that you consult with a healthcare provider if you have any questions or concerns about your results.”
(B) “The test does not diagnose any health conditions. Results should be used along with other clinical information for any medical purposes.”
(C) “The laboratory may not be able to process your sample. The probability that the laboratory cannot process your saliva sample can be up to [actual probability percentage].”
(D) “Your ethnicity may affect how your genetic health results are interpreted.”
(vi) For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 50 percent and more than 5 percent, a warning that reads “The positive result you obtained may falsely identify you as a carrier. Consider genetic counseling and followup testing.”
(vii) For a positive result in an over-the-counter test when the positive predictive value for a specific population is less than 5 percent, a warning that reads “The positive result you obtained is very likely to be incorrect due to the rarity of this variant. Consider genetic counseling and followup testing.”
(5) The testing done to comply with paragraph (b)(3) of this section must show the device meets or exceeds each of the following performance specifications:
(i) The accuracy must be shown to be equal to or greater than 99 percent for both PPA and NPA. Variants that have a point estimate for PPA or NPA of less than 99 percent (incorrect test results as compared to bidirectional sequencing or other methods identified as appropriate by FDA) must not be incorporated into test claims and reports.
(ii) Precision (reproducibility) performance must meet or exceed 99 percent for both positive and negative results.
(iii) The user comprehension study must obtain values of 90 percent or greater user comprehension for each comprehension concept.
(6) The distribution of this device, excluding the collection device described in paragraph (b)(2) of this section, shall be limited to the manufacturer, the manufacturer's subsidiaries, and laboratories regulated under the Clinical Laboratory Improvement Amendments.
Drug Enforcement Administration, Department of Justice.
Interim final rule.
The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the company name for the drug product Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams levmetamfetamine) to Aphena Pharma Solutions—New York, LLC. This over-the-counter, nonnarcotic drug product is excluded from the provisions of the Controlled Substances Act.
This interim final rule is effective on October 27, 2015. Interested persons may file written comments on this rule pursuant to 21 CFR 1308.21(c). Electronic comments must be submitted, and written comments must be postmarked, on or before December 28, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons are defined as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” 21 CFR 1300.01(b).
To ensure proper handling of comments, please reference “Docket No. DEA-409” on all electronic and written correspondence, including any attachments. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page
John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at
The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.
Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document and supplemental information to this interim final rule is available at
The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and they are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.
The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. 21 U.S.C. 801.
Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of all scheduled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).
The CSA states that the Attorney General shall by regulation exclude any nonnarcotic drug which contains a controlled substance from the application of the CSA, if such drug may, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), [21 U.S.C. 301
On December 10, 2013, pursuant to the application process of 21 CFR 1308.21, the DEA received correspondence from Aphena Pharma Solutions—New York, LLC (Aphena Pharma) stating that it had acquired Classic Pharmaceuticals LLC and requesting that the current exclusion for the drug product Nasal Decongestant Inhaler/Vapor Inhaler be transferred to Aphena Pharma. Aphena Pharma also stated that the manufacturing process (
Based on the application and other information received, the DEA has determined that this product may, under the FD&C Act, be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). In addition, the Deputy Assistant Administrator of the Office of Diversion Control finds that the active ingredient in this drug product (levmetamfetamine) is a schedule II controlled substance
This exclusion only applies to the finished drug product in the form of an inhaler (in the exact formulation detailed in the application for exclusion), which is lawfully sold under the FD&C Act over-the-counter without a prescription. The extraction or removal of the active ingredient (levmetamfetamine) from the inhaler shall negate this exclusion and result in the possession of a schedule II controlled substance.
An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if it is determined to be impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The DEA
The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this requirement need not apply for “a substantive rule which grants or recognizes an exemption or relieves a restriction” or “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(1). This rule continues the exclusion of a nonnarcotic drug product from the provisions of the CSA. Given that this amendment to the table of Excluded Nonnarcotic Products is technical in nature and thereby would not warrant any further delay, the DEA finds that there is good cause to make this rule effective immediately upon publication.
This regulation has been developed in accordance with the Executive Orders 12866, “Regulatory Planning and Review,” section 1(b) and Executive Order 13563, “Improving Regulation and Regulatory Review.” The DEA has determined that this rule is not a significant regulatory action, and accordingly this rule has not been reviewed by the Office of Management and Budget. This product was previously exempted under a different company name. This action will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform,” to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. This rule does not have substantial direct effects 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.
The DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501
This rule does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this interim final rule to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended to read as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
Drug Enforcement Administration, Department of Justice.
Interim final rule.
The Drug Enforcement Administration (DEA) is amending the table of Excluded Nonnarcotic Products to update the listing for Vicks® VapoInhaler®, containing 50 mg levmetamfetamine in a nasal decongestant inhaler, marketed by The Proctor & Gamble Company. This over-the-counter, non-narcotic drug product is excluded from provisions of the Controlled Substances Act.
This interim final rule is effective on October 27, 2015. Interested persons may file written comments on this rule pursuant to 21 CFR 1308.21(c). Electronic comments must be submitted, and written comments must be postmarked, on or before December 28, 2015. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons are defined as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).” 21 CFR 1300.01(b).
To ensure proper handling of comments, please reference “Docket No. DEA-367” on all electronic and written correspondence, including any attachments. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to
John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Please note that all comments received in response to this docket are considered part of the public record and will be made available for public inspection online at
The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.
Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document and supplemental information to this interim final rule is available at
The Drug Enforcement Administration (DEA) implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II.
The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring an adequate supply is available for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to
Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).
The CSA states that the Attorney General shall by regulation exclude any non-narcotic drug which contains a controlled substance from the application of the CSA, if such drug may, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), [21 U.S.C. 301
On February 9, 2012, pursuant to the application process of 21 CFR 1308.21, the DEA received correspondence from The Proctor & Gamble Company (“P&G”) notifying the DEA that it had reduced the quantity of
Based on the application and other information received, including the quantitative composition of the substance and labeling and packaging information, the DEA has determined that this product may, under the FD&C Act, be lawfully sold over-the-counter without a prescription. 21 U.S.C. 811(g)(1). In addition, the Deputy Assistant Administrator of the Office of Diversion Control finds that the active ingredient in this drug product (levmetamfetamine) is a schedule II controlled substance and is not a narcotic drug as defined by 21 U.S.C. 802(17). The Deputy Assistant Administrator of the Office of Diversion Control therefore finds and concludes that this product continues to meet the criteria for exclusion from the CSA pursuant to 21 U.S.C. 811(g)(1).
This exclusion only applies to the finished drug product in the form of an inhaler (in the exact formulation detailed in the application for exclusion), which is lawfully sold under the FD&C Act over-the-counter without a prescription. The extraction or removal of the active ingredient (levmetamfetamine) from the inhaler shall negate this exclusion and result in the possession of a schedule II controlled substance.
An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), including notice of proposed rulemaking and the pre-promulgation opportunity for public comment, if it is determined to be impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). The DEA finds for good cause that it is unnecessary to seek public comment prior to amending the table of Excluded Nonnarcotic Products to update the listing for this product, as the amendments are primarily technical in nature and would not result in any substantive change. The product was previously exempted under a different company name, which is no longer accurate due to acquisition of Vick Chemical Company by The Proctor & Gamble Company. Additionally, the product name has been modified and was reassigned a corresponding NDC number, and the nomenclature for the active ingredient has changed. Lastly, while the amount of the schedule II ingredient
The APA requires the publication of a substantive rule to be made not less than 30 days before its effective date. 5 U.S.C. 553(d). However, this requirement need not apply for “a substantive rule which grants or recognizes an exemption or relieves a restriction” or “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(1). This rule continues the exclusion of a nonnarcotic drug product from the provisions of the CSA. Given that these amendments to the table of Excluded Nonnarcotic Products are primarily technical in nature and thereby would not warrant any further delay, the DEA finds that there is good cause to make this rule effective immediately upon publication.
This regulation has been developed in accordance with the Executive Orders 12866, “Regulatory Planning and Review,” section 1(b) and Executive Order 13563, “Improving Regulation and Regulatory Review.” The DEA has determined that this rule is not a significant regulatory action, and accordingly this rule has not been reviewed by the Office of Management and Budget. This product is a modified version of a product that is currently exempted under the DEA's regulations. This action will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, “Civil Justice Reform,” to eliminate drafting errors and ambiguity, minimize
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. This rule does not have substantial direct effects 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.
The DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501
This rule does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this interim final rule to both Houses of Congress and to the Comptroller General.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations on allocation and accounting, and certain remedial actions, for purposes of the private activity bond restrictions under section 141 of the Internal Revenue Code that apply to tax-exempt bonds issued by State and local governments. The final regulations provide State and local governmental issuers of tax-exempt bonds with guidance for applying the private activity bond restrictions.
Johanna Som de Cerff or Zoran Stojanovic, (202) 317-6980 (not a toll-free number).
The collection of information contained in these regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-1451. The collection of information in these final regulations is in § 1.141-12(d)(3), which requires an issuer to make a declaration of official intent to remediate bonds. This collection of information is necessary for an issuer's redemption or defeasance of bonds to be treated as a remedial action under § 1.141-12 to preserve the tax-exempt status of the bonds. This collection of information is an increase in the total annual burden under control number 1545-1451. The respondents are State and local government issuers of tax-exempt bonds.
Estimated total annual reporting burden is 30,250 hours.
Estimated average annual burden per respondent is 3 hours.
Estimated number of respondents is 10,100.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally tax returns and tax return information are confidential, as required by section 6103.
In general, interest on State and local governmental bonds is excludable from gross income under section 103 upon satisfaction of certain requirements. Interest on a private activity bond, other than a qualified private activity bond within the meaning of section 141, is not excludable under section 103. Section 141 provides certain tests that are used to determine whether a State or local bond is a private activity bond. These tests include the private business use test and the private security or payment test in section 141(b), and the private loan financing test in section 141(c). Section 145 provides similar tests that apply in modified form to qualified 501(c)(3) bonds.
Final regulations (TD 8712) under section 141 were published in the
A notice of proposed rulemaking and notice of public hearing (REG-132483-03) was published in the
After consideration of the public comments, the Treasury Department and the IRS adopt the Proposed Regulations, with revisions, as final regulations (the Final Regulations). This section discusses significant aspects of the public comments and the revisions made in the Final Regulations.
The Proposed Regulations provided several allocation rules. Among these were rules regarding the allocation of proceeds of an issue of bonds that are obligations of a state or political subdivision under section 103(c)(1) (see § 1.150-1(b)) (proceeds) and all other sources of funds (other funds) to expenditures, to the project, and to the uses of the project (that is, governmental use or private business use). The Proposed Regulations provided that proceeds and other funds generally may be allocated to expenditures using any reasonable, consistently applied accounting method, and that the allocation of proceeds and other funds to expenditures must be consistent with the allocation of proceeds and other funds for purposes of the arbitrage investment restrictions under section 148.
Commenters expressed concern that the consistency requirement was in conflict with the allowance of more than one method for allocating proceeds and other funds to projects. Commenters further questioned whether allocations of proceeds to expenditures were necessary other than for purposes of the arbitrage investment restrictions. The Final Regulations clarify that the issuer's allocation of proceeds to expenditures for purposes of the arbitrage investment restrictions also apply to expenditures for purposes of the private activity bond tests.
The Proposed Regulations provided generally that proceeds and other funds allocated to capital expenditures for a capital project are treated as allocated ratably throughout the project in proportion to the relative amounts of proceeds and other funds spent on that project. The Proposed Regulations further provided that generally proceeds and other funds are allocated to both governmental use and private business use of the project in proportion to the relative amounts of each source of funding spent on the project. The Final Regulations adopt these general pro rata allocation rules as proposed.
The Proposed Regulations defined a project to include functionally related or
Commenters expressed various concerns about the definition of project in the Proposed Regulations. Some commenters were concerned that the narrow definition of project, which includes only geographically proximate facilities placed in service within a short period, is inconsistent with the private activity bond tests generally, which apply to all facilities financed by the proceeds of a single issue of bonds. Commenters also questioned how the definition of project would apply in the context of a capital improvement program financed by the proceeds of a single issue of bonds that involves multiple facilities in different locations (for example, different school buildings within a district) placed in service over more than 12 months. Conversely, other commenters expressed concern that the definition of project is so broad that it would allow properties that have different owners, types of ownership interests, or types of financing (that is, are financed from different sources) to be considered a single project.
Commenters inferred that the treatment of subsequent improvements meant that the funds, which could include proceeds and equity, for the original project and the subsequent improvements would be allocated throughout the original project and the subsequent improvements, possibly subjecting assets financed solely with equity to the private activity bond restrictions. They expressed concerns that the special allocation rules for mixed-use projects (discussed in section III. in this preamble) would be unavailable for these improvements due to the timing requirement applicable to the election.
The Final Regulations simplify the definition of project to cover all facilities or capital projects financed in whole or in part with proceeds of a single issue of bonds. This definition permits an issuer in its bond documents to identify as a single project all of the properties to be financed by proceeds of a single bond issue. Under this rule, issuers may identify specific properties or portions of properties regardless of the properties' locations or placed-in-service dates. This approach to the definition of project comports with the application of the private activity bond tests generally, which apply at the issue level. The Final Regulations also clarify through the examples that improvements financed with a later issue are a separate project.
Commenters requested clarification that, consistent with longstanding practice, each undivided ownership interest in an output facility be treated separately for purposes of applying the allocation rules. The Final Regulations provide this clarification.
Commenters also recommended extending the separate facility treatment for output facilities under the Proposed Regulations to other types of facilities. The Final Regulations do not adopt this recommendation because the use of output facilities is measured differently from the use of other facilities. The use of an output facility generally is measured in the amount of output purchased as a percentage of the facility's total available output. The amount of use by each user reflects the proportionate benefit of the available output to such user. Uses of other types of facilities are measured in various ways depending on how that use occurs (for example, in different discrete portions, at different times, or simultaneously) and may reflect simultaneous use by more than one user on a different, rather than proportionate, basis. Even without separate facility treatment, however, issuers may use proceeds to finance the governmental use portion of an eligible mixed-use project.
The Proposed Regulations provided special elective allocation rules for mixed-use projects. In general, these special rules gave effect to congressional intent to permit funding of mixed-use projects in part with tax-exempt bonds and in part with other funds using reasonable, proportionate allocation methods that reflect proportionate benefits to the various users.
The discrete portion method allowed for dividing a mixed-use project into physically discrete portions and allocating the different sources of funds to the various discrete portions using a reasonable, consistently applied method that reflects the proportionate benefit to be derived by the various users of the project. The discrete portion method had a number of limitations, including the physical constraints of a discrete portion under the proposed project definition, limitations on measurement of a discrete portion, limitations associated with the fair market value of a discrete portion, and comparability conditions on reallocations of discrete portions within a project.
Under the undivided portion allocation method, projects were divided into governmental use and private business use portions on a notional, rather than physical, basis with tax-exempt proceeds allocated to the governmental use portion and the other funds allocated to the private business use portion. The availability of the proposed undivided portion allocation method was limited to circumstances in which the issuer reasonably expected that governmental use and private business use of the project would occur simultaneously on the same basis, or at different times.
Commenters criticized the complexity of the Proposed Regulations' two special allocation methods and the administrative burdens associated with the election requirement for mixed-use allocations. Commenters also criticized the discrete portion method's overly rigid treatment of reallocations or “floating” allocations. To simplify these rules, commenters recommended expanding the availability of the undivided portion allocation method to include all measureable use, adopting the undivided portion allocation method as the general rule for allocating proceeds and other sources to the uses of a mixed-use project, and eliminating the discrete portion method.
The Final Regulations adopt the recommendation to expand the availability of the undivided portion allocation method to include all
Under the Final Regulations, the undivided portion allocation method is available for “eligible mixed use projects.” The Final Regulations define an “eligible mixed-use project” as a project that is financed with proceeds of bonds that purport to be governmental bonds when issued and qualified equity (discussed under
Under the Proposed Regulations, the undivided portion allocation method limited the targeting of qualified equity to private business use of the project to that percentage of the private business use equal to the percentage of capital expenditures of the project financed by the qualified equity, and similarly limited the targeting of proceeds to government use of the project to that percentage of the government use equal to the percentage of capital expenditures of the project financed by the proceeds. For projects other than output facilities, these limits applied to each one-year period of the measurement period. Commenters requested that unused qualified equity be carried over from one year to another or, in lieu of a carryover provision, revising the limit from an annual limit to one spanning the entire measurement period.
The Final Regulations do not adopt these recommendations. The general private business measurement rules, in contrast to those for use arising from output contracts, require a determination of the private business use of the proceeds on an annual basis as a preliminary step to determining the average private business use of the proceeds during the measurement period. When the amount of private business use of the project in any one-year period is less than the percentage of qualified equity, that qualified equity is not unused but, as the Final Regulations clarify, is allocated to governmental use of the project that is in excess of the percentage of proceeds. To allow carryover of private business use of the proceeds or in an amount determined solely over the measurement period would require revision of the measurement rules plus additional rules to prevent potentially abusive situations, thereby increasing complexity. The Final Regulations do, however, clarify that the annual limit only applies to use measured under the general measurement rules and not to use arising from output contracts.
The Proposed Regulations defined qualified equity to mean proceeds of taxable bonds and funds not derived from a borrowing that are spent on the same project as proceeds of the purported governmental bonds to which the private activity bond tests will be applied (the applicable bonds). The Proposed Regulations further provided that qualified equity does not include equity interests in real property or tangible personal property. Commenters suggested expanding the definition of qualified equity to include the value of contributed property not purchased with proceeds of tax-advantaged bonds, arguing that this contribution should be treated as the equivalent of cash. Commenters also suggested that qualified equity include funds used to redeem bonds.
The Final Regulations adopt the proposed definition of qualified equity, with modifications. In recognition of the advent of expanded types of bonds that provide a Federal tax benefit (a tax-advantaged bond), which include, for example, a qualified tax credit bond under section 54A on which the interest on the bond is taxable, the Final Regulations clarify that “taxable bonds” that give rise to qualified equity exclude any tax-advantaged bond. The Final Regulations do not adopt the suggestion to include contributions of existing property as qualified equity for a project because that treatment would raise difficult issues of valuation and administrability and would be inconsistent with the rules governing allocations of proceeds of reimbursement bonds.
The Final Regulations do not adopt the comment recommending that amounts (other than proceeds) used to redeem bonds be treated as qualified equity because permitting increased private business use for the redemption of bonds in the ordinary course would be inconsistent with the private activity bond restrictions on the issue of bonds being redeemed. The 1997 Final Regulations already address the use of funds to redeem bonds under certain conditions in which bond redemptions serve as a remedial action to cure violations of the private business use restrictions. Further, as discussed under
The definition of “project” in the Proposed Regulations required spending the proceeds and other sources on the properties pursuant to the same plan of financing. Commenters requested clarification of the meaning of the same plan of financing. The Final Regulations clarify that “same plan of financing” has the same meaning as in § 1.150-1(c)(1)(ii) and that qualified equity is spent under the same plan of financing as proceeds of the applicable bonds if the qualified equity is spent on capital expenditures of the project no earlier than the earliest date on which the expenditure would be eligible for reimbursement were the bonds from which the proceeds are derived issued as reimbursement bonds and no later than the date that is the beginning of the measurement period for the project (other than amounts retained for reasonable purposes relating to the project as defined under the arbitrage investment restrictions).
The Proposed Regulations provided that if proceeds of more than one issue are allocated to capital expenditures of a mixed-use project to which the issuer elects to apply the discrete physical portion or undivided portion allocation method, then proceeds of those issues
The Treasury Department and the IRS are concerned that a non-pro rata method of allocating proceeds of more than one issue to the uses of a project could not only lead to more private business use than when proceeds of a single issue are allocated, but would also be difficult to administer. Furthermore, this approach also would be inconsistent with the general allocation rule that allocates proceeds of two issues on a proportionate basis to the uses of a project that is not an eligible mixed-use project.
Commenters also suggested that the proposed multiple issue rule would create a barrier to tax-exempt financing of projects, such as airports, that traditionally have been financed with a combination of tax-exempt governmental bonds and qualified private activity bonds to reflect the governmental and qualified private business use occurring, respectively, in different discrete portions of a project, as neither type of bond would meet the criteria for tax-exempt status if the proceeds of both types were allocated to the same portions. The Treasury Department and the IRS recognize that certain projects contain portions that, if treated as separate facilities, would be eligible for financing with different types of tax-exempt bonds. The Final Regulations remove this barrier to tax-exempt financing of projects through the definition of “project,” which allows each issuer to identify the different projects financed by its separate issues of governmental bonds and qualified private activity bonds.
The Proposed Regulations generally treated a partnership as an entity that is a nongovernmental person for purposes of the private activity bond tests. However, if all of the partners in a partnership were governmental persons, the Proposed Regulations provided a limited exception that would treat the partnership as an aggregate of its partners (that is, as governmental persons) for these purposes. The preamble to the Proposed Regulations specifically requested comments on the usefulness of aggregate treatment for a partnership of governmental persons (or 501(c)(3) organizations for qualified 501(c)(3) bonds) and private businesses. The preamble to the Proposed Regulations further indicated that the Treasury Department and the IRS were considering aggregate treatment in at least the limited circumstance of partnerships involving a constant percentage (“straight up”) allocation of all partnership items. Commenters were in favor of aggregate treatment for such partnerships.
In recognition of the development of various financing and management structures for government (or 501(c)(3) organization) facilities that involve the participation of private businesses, to provide flexibility to accommodate public-private partnerships, and to remove barriers to tax-exempt financing of the government's (or 501(c)(3) organization's) portion of the benefit of property used in joint ventures, the Final Regulations provide aggregate treatment for all partnerships. The Final Regulations further provide a rule for measuring the private business use of financed property resulting from the use of the property by a partnership that includes a partner that is a nongovernmental person. The amount of such use is the nongovernmental partner's share of the amount of the use of the property by the partnership, with such share defined as the nongovernmental partner's greatest percentage share of any of the specified partnership items attributable to the time during the measurement period that the partnership uses the property. The Final Regulations also provide that an issuer may determine the nongovernmental partner's share under guidance published in the Internal Revenue Bulletin.
The definition of qualified 501(c)(3) bonds under section 145(a) includes the private activity bond tests (with certain modifications) and an ownership test under which the property financed with qualified 501(c)(3) bonds must be owned by a 501(c)(3) organization or a governmental unit. In applying the private activity bond tests for purposes of qualified 501(c)(3) bonds, the Proposed Regulations treated a partnership as an aggregate if each of the partners was either a governmental person or a 501(c)(3) organization. The Proposed Regulations, however, did not apply such aggregate treatment for purposes of the ownership test. Commenters recommended applying aggregate treatment to partnerships for purposes of the ownership test, seeing no reason to distinguish between ownership for purposes of the ownership test and for purposes of the private activity bond tests, which also look to ownership of the financed property. The Final Regulations adopt this comment.
The Proposed Allocation Regulations permitted proceeds of taxable bonds and funds not derived from borrowing that are used to retire tax-exempt governmental bonds to be treated as qualified equity under certain circumstances. This allows targeting of funds other than tax-exempt bond proceeds to finance portions of projects that are expected to be used for private business use in the future. The intent of this proposed rule is to encourage retirement of tax-exempt bonds before the occurrence of nonqualified use. The Proposed Allocation Regulations addressed when the bond must be retired, the issuer's reasonable expectations regarding use of the project, actual use of the project prior to the redemption, and the length of the term of the issue of which the bond to be retired is a part. Specifically, the bond to be redeemed was required to be retired at least five years before its otherwise-scheduled maturity date and within a period that starts one year before the deliberate act and ends 91 days before the deliberate act. Further, the issuer must not have expected that the project would be a mixed-use project. Thus, under the Proposed Allocation Regulations, an issuer could not use this anticipatory redemption for a project for which it had elected the special mixed-use allocation rules.
Most commenters stated that the proposed provision would be of limited use and that the eligibility requirements are contrary to the policy of encouraging redemption of tax-exempt bonds earlier rather than later. Commenters recommended that the conditions for anticipatory redemption not be stricter than those under the existing remedial action regime for private business use, which permits a curative redemption or defeasance of nonqualified bonds within 90 days of the deliberate action causing the private activity bonds tests to be met. Commenters further suggested adding a provision to the remedial action rules permitting an issuer to redeem or defease bonds at any
The Proposed Remedial Action Regulations included amendments relating to the amount and allocation of nonqualified bonds to be remediated as a result of a deliberate action causing the private business tests or the private loan financing test to be met. The Proposed Remedial Action Regulations provided that the amount of the nonqualified bonds is that portion of the outstanding bonds in an amount that, if the remaining bonds were issued on the date on which the deliberate action occurs, the remaining bonds would not meet the private business use test or private loan financing test, as applicable. For this purpose, the amount of private business use is the greatest percentage of private business use in any one-year period commencing with the one-year period in which the deliberate action occurs.
Commenters requested that the amount of nonqualified bonds be determined using the average amount of private business use over the entire measurement period rather than the highest private business use in any one-year period. The Final Regulations do not adopt this recommendation because this request is inconsistent with the limitations on annual allocations of proceeds and qualified equity to the uses of the project. The Final Regulations adopt the amendment to the provision regarding the amount of nonqualified bonds as proposed.
Commenters generally agreed with the proposed change that allows any bonds of any issue to be treated as the nonqualified bonds provided that the redemption or defeasance does not have the effect of extending the weighted average maturity (WAM) of the issue. Commenters, however, stated that some bond indentures require optional redemptions of a portion of a term bond to be used first to reduce the earliest mandatory sinking fund payments on the bond. In this case, the redemption or defeasance of the longest bonds would result in the extension of the WAM. Commenters recommended that the regulations permit bonds with longer maturities to be treated as the nonqualified bonds, as is permitted under the existing regulations. The Final Regulations adopt the rule as proposed, but provide a transition rule for outstanding bonds similar to that provided with respect to outstanding exempt facility bonds.
The Final Regulations reduce the amount of nonqualified bonds. An issuer who chooses to redeem or defease the nonqualified bonds need only redeem or defease sufficient bonds such that the remaining bonds would not meet the private business use or private loan financing test. Thus, unlike under the previous definition of nonqualified bonds, not all of the private business use or private loan, as calculated under the remedial action rules, necessarily will be remediated. To take into account any such remaining unremediated private business use or loan should a subsequent deliberate action occur, a conforming change is needed pertaining to continuing compliance. The Final Regulations include this change.
The Final Regulations generally apply to bonds sold on or after January 25, 2016. The rules regarding remedial actions, however, apply to deliberate actions that occur on or after January 25, 2016. The Final Regulations allow permissive application of (1) the partnership provisions, the allocation and accounting rules, and certain corresponding rules for qualified 501(c)(3) bonds in whole, but not in part, to bonds to which the 1997 Final Regulations apply; and (2) the multipurpose rule to bonds to which the refunding rules apply.
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that the collection of information in these regulations will not have a significant economic impact on a substantial number of small governmental jurisdictions. This certification is based upon the fact that few small governmental issuers are expected to take an anticipatory remedial action and that the amount of time required to meet the recordkeeping requirement is not significant. Therefore, a regulatory flexibility analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notices of proposed rulemaking preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small governmental jurisdictions. No comments were received.
The principal author of these regulations is Johanna Som de Cerff, Office of Associate Chief Counsel (Financial Institutions & Products), IRS. However, other personnel from the IRS and the Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
(e) Partnerships.
(a) Allocation of proceeds to expenditures, projects, and uses in general.
(1) Allocations to expenditures.
(2) Allocations of sources to a project and its uses.
(3) Definition of project.
(b) Special allocation rules for eligible mixed-use projects.
(1) In general.
(2) Definition of eligible mixed-use project.
(3) Definition of qualified equity.
(4) Same plan of financing.
(c) Allocations of private payments.
(d) Allocations of proceeds to common costs of an issue.
(e) Allocations of proceeds to bonds.
(f) Examples.
(d) * * *
(3) Anticipatory remedial action.
(4) Notice of defeasance.
(5) Special limitation.
(6) Defeasance escrow defined.
(b) * * *
(4) Certain remedial actions.
(e) * * *
(1) In general.
(2) Transition rule for pre-effective date bonds.
(l) Applicability date for certain regulations related to allocation and accounting.
(1) In general.
(2) Permissive application.
(m) Permissive retroactive application of certain regulations.
(e)
(g) * * *
(2) * * *
(v)
(B) An issuer may determine a nongovernmental partner's share of the partnership's use of the property under guidance published in the Internal Revenue Bulletin (see § 601.601(d)(2)(ii)(
(a)
(2)
(3)
(ii)
(b)
(2)
(3)
(4)
(c)
(d)
(e)
(f)
The revisions and additions read as follows:
(d) * * * (1) * * * Except as provided in paragraph (d)(3) of this section, if the bonds are not redeemed within 90 days of the date of the deliberate action, a defeasance escrow must be established for those bonds within 90 days of the deliberate action.
(3)
(i) * * *
(1) If a remedial action is taken under paragraph (d) of this section, the amount of private business use or private loans resulting from the deliberate action that is taken into account for purposes of determining whether the bonds are private activity bonds is that portion of the remaining bonds that is used for private business use or private loans (as calculated under paragraph (j) of this section);
(2) If a remedial action is taken under paragraph (e) or (f) of this section, the amount of private business use or private loans resulting from the deliberate action is not taken into account for purposes of determining
(j)
(2)
(i) The remaining weighted average maturity of the issue, determined as of the date on which the nonqualified bonds are redeemed or defeased (determination date), and excluding from the determination the nonqualified bonds redeemed or defeased by the issuer in accordance with this section, is not greater than
(ii) The remaining weighted average maturity of the issue, determined as of the determination date, but without regard to the redemption or defeasance of any bonds (including the nonqualified bonds) occurring on the determination date.
(k) * * *
(d)
(g) * * *
(ii) The facts are the same as in paragraph (i) of this
(iii) The facts are the same as in paragraph (ii) of this
The revisions and additions read as follows:
(a)
(b) * * *
(4)
(ii)
(e)
(i) Section 1.141-3(b)(4);
(ii) Section 1.141-3(b)(6); and
(iii) Section 1.141-12.
(2)
(i)
(1) Section 1.141-6;
(2) Section 1.141-7(f)(3); and
(3) Section 1.141-7(g).
(l)
(2)
(m)
(b) * * *
(4) References to
(5) References to
(c) * * *
(2)
(a) * * *
(1) Section 1.141-12(d)(4);
Wage and Hour Division, Department of Labor.
Policy statement.
The Department of Labor (Department) previously announced that it would not bring enforcement actions against any employer for violations of Fair Labor Standards Act (FLSA) obligations resulting from amendments to its domestic service regulations for 30 days after the U.S. Court of Appeals for the District of Columbia issued a mandate making effective its opinion affirming the validity of the regulatory changes. The Court issued its mandate on October 13, 2015; the Department's 30-day non-enforcement period will therefore conclude on November 12, 2015. From November 12, 2015 through December 31, 2015, the Department will exercise prosecutorial discretion pursuant to its previously announced time-limited non-enforcement policy.
The Department will not bring enforcement actions against any employer for FLSA violations resulting from the revised domestic service regulations before November 12, 2015.
Mary Ziegler, Assistant Administrator, Office of Policy, U.S. Department of Labor, Wage and Hour Division, 200 Constitution Avenue NW., Room S-3502, FP Building, Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number), email:
The Department's Final Rule amending FLSA regulations regarding domestic service employment, 78 FR 60454 (October 1, 2013), which extends minimum wage and overtime protections to most home care workers, had an effective date of January 1, 2015. The Department did not begin enforcement of the Final Rule on that date both because of its time-limited non-enforcement policy, 79 FR 60974 (October 9, 2014), and because it was a party to a federal lawsuit regarding the amended regulations in which the U.S. District Court for the District of Columbia issued opinions and orders vacating the rule's major provisions.
The Court of Appeals issued the mandate directing the district court to enter a new judgment in favor of the Department on October 13, 2015. The Department will therefore not bring enforcement actions against any employer for violations of FLSA obligations resulting from the amended domestic service regulations before November 12, 2015.
This 30-day non-enforcement policy does not replace or affect the timeline of the Department's existing time-limited non-enforcement policy announced in October 2014. 79 FR 60974. Therefore, from November 12, 2015 through December 31, 2015, the Department will exercise prosecutorial discretion in determining whether to bring enforcement actions, with particular consideration given to the extent to which States and other entities have made good faith efforts to bring their home care programs into compliance with the FLSA since the promulgation of the Final Rule. The Department will also continue to provide intensive technical assistance to the regulated community up to and after December 31, 2015, as it has since promulgation of the Final Rule.
This Policy Statement is guidance articulating considerations relevant to the Department's exercise of its enforcement authority under the FLSA. It is therefore exempt from the notice-and-comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b).
Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a). The Department has determined that this guidance does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone encompassing all navigable waters within a designed area in the vicinity of the Manchester Fuel Piers, Manchester, Washington. This safety zone is necessary to ensure the safety of the waterway users and participants of a maritime training exercise. The temporary safety zone will prohibit any person or vessel not involved in the training exercise from entering or remaining in the safety zone unless authorized by the Captain of the Port, Puget Sound (COTP) or his designated representative.
This rule is effective from 7 a.m. on November 2, 2015 until 6 p.m. on November 8, 2015. This rule shall be enforced during actual training operations occurring within the effective period while exercise participants are present in the safety zone.
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 Lieutenant Kate Haseley, Waterways Management Division, Coast Guard Sector Puget Sound; telephone 206-217-6051, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (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 notice of proposed rulemaking (NPRM) with respect to this rule publishing an NPRM would be impracticable as delayed promulgation may result in injury or damage to the maritime public and response vessels prior to conclusion of a notice and comment period.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard has authority to issue a rule under authority in 33 U.S.C. 1231. The Captain of the Port, Puget Sound has determined that potential hazards associated with the training exercise will be a safety concern for anyone transiting through the operational location of the exercise. A safety zone is needed to ensure the safety of the maritime public and emergency response vessels participating in the exercise by preventing collisions between exercising vessels and the maritime public, and by keeping the maritime public a safe distance away from elements associated with the exercise.
The Coast Guard is establishing a temporary safety zone that will encompass all navigable waters within an area established by the following points: 47°34′13″ N., 122°32′12″ W., thence southeast to 47°33′41″ N., 122°31′07″ W., thence southwest to 47°33′15″ N., 122°32′04″ W., thence south to 47°31′49 N., 122°31′47″ W., thence west to 47°31′55″ N., 122°32′28″ W., thence north to 47°33′20″ N., 122°32′29″ W., thence northeast to
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the limited nature of the size and duration of the temporary safety zone. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM Channel 16 about the safety zone and the rule allows vessels to seek permission to enter the safety zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. 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.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V above, this rule will not have a significant economic impact on any vessel owner or operator, because the zone established in this rule is limited in nature of size and duration.
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 E.O. 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 power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 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. If you believe this rule has implications for federalism or Indian tribes, please 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.
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 (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 a temporary safety zone lasting less than 29 days that will prohibit entry into various training exercise operations within the designated area. It 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
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
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)
United States Patent and Trademark Office, Commerce.
Final rule.
The electronic sharing of information and documents between intellectual property (IP) offices is critical for increasing the efficiency and quality of patent examination worldwide. Current examples of this sharing include the priority document exchange (PDX) program and the program by which U.S. search results are delivered to the European Patent Office (EPO). In support of electronic file sharing, the United States Patent and Trademark Office (Office) is revising its rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign IP office that is a party to an agreement with the Office access to all or part of the file contents of an unpublished U.S. patent application in order to satisfy a requirement for information imposed on a counterpart application filed with the foreign IP office. Previously, for unpublished U.S. patent applications, applicants followed one regulatory provision to provide the Office with authorization for a foreign IP office to access an application-as-filed and followed another regulatory provision to provide the Office with authorization to share the file contents with a foreign IP office. The final rule changes consolidate the specific provisions of the regulations by which applicants give the Office authority to provide a foreign IP office with access to an application in order to satisfy a requirement for information of the foreign IP office. The Office is also revising the rules of practice to indicate there is no fee for providing a foreign IP office with an electronic copy of an application-as-filed or an electronic copy of file contents pursuant to a bilateral or multilateral agreement. Additionally, along with changes to the application data sheet (ADS) form, the final rule changes simplify the process for how applicants provide the Office with the required authorization, thereby reducing the resources applicants must expend to comply with these foreign IP office requirements, and enhance the quality of patent examination.
Susy Tsang-Foster, Senior Legal Advisor (telephone (571) 272-7711; electronic mail message (
Executive Summary:
This final rule also revises the rules of practice to indicate that there is no fee for providing a foreign IP office with an electronic copy of an application-as-filed or an electronic copy of file contents pursuant to a bilateral or multilateral agreement. Previously, the regulations only indicated that there was no fee for providing a foreign IP office with a copy of an application-as-filed pursuant to a priority document exchange agreement.
Additionally, the Office is revising the ADS form (PTO/AIA/14) as well as the PTO/SB/39 and PTO/SB/69 forms to facilitate applicant's authorization of access to unpublished U.S. applications by foreign IP offices.
Due to the confidential nature of unpublished U.S. patent applications, set forth in 35 U.S.C. 122, an applicant must provide the Office with written authority in accordance with 37 CFR 1.14 to grant a foreign IP office access to an unpublished U.S. patent application. With this grant of authority, the Office may provide the U.S. patent application-as-filed or the requested file contents, such as information and documents, from the U.S. patent application to the foreign IP office on behalf of the applicant. Previously, applicants used former 37 CFR 1.14(h) to authorize the Office to allow a foreign IP office participating in a bilateral or multilateral priority document exchange agreement access to an unpublished U.S. priority application-as-filed. Former 37 CFR 1.14(h), however, did not contain a specific provision by which an applicant could authorize the Office to provide a foreign IP office access to an unpublished U.S. patent application's file contents. As a result, U.S. applicants, unprompted by the rules, found it necessary to provide written authority for access by a foreign IP office to an unpublished application's contents in accordance with 37 CFR 1.14(c) in order to satisfy a requirement for information by the foreign IP office.
Any information concerning an unpublished application or documents from an unpublished application will only be shared in accordance with the authority provided by applicant and in accordance with the terms of an agreement between the Office and respective foreign IP offices. The Office is not requiring any fee for this service. In addition, sharing of information and documents would be limited to those foreign IP offices where applicant has filed a counterpart application and provided written authority to give a foreign IP office access to all or part of the file contents of an unpublished U.S. application.
The changes to 37 CFR 1.14(h) emphasize the Office's continued support of work sharing efforts between IP offices to increase the quality of issued patents, as well as its commitment to assist in reducing the expenditure of resources of its applicants when complying with the requirements of a foreign IP office in a counterpart application.
In contrast to the previous version of the ADS form, the revised ADS form includes an “opt-out” check box for each access authorization and not an “opt-in” check box. Therefore, when an “opt-out” check box for a specific authorization is selected, the Office would not provide access to the contents of the application identified in the authorization.
The revised ADS form will make it easier for applicants to give the necessary authorization for access to an application, as well as afford an applicant the opportunity to inform the Office that the required authority to allow a foreign IP office specific access to an application has not been given. The “Authorization to Permit Access” section containing an opt-in check box for the PDX program in the previous version of the ADS form will be replaced by the “Authorization or Opt-Out of Authorization to Permit Access” section in the first release of the revised ADS form, which is intended to contain two subsections. The first subsection will contain the authorization to permit access to the application-as-filed (the PDX program) and the authorization to permit access to the search results by the EPO. The second subsection will contain the corresponding “opt-out” check box for each authorization in the first subsection.
Appropriate authorization language for access in any ADS generated by applicant must be the same as the authorization language provided in the Office's revised ADS form. Use of the same language will permit the Office to readily recognize that applicant has given the necessary authorization. If an applicant-generated ADS does not include the required authorization language for access by a foreign IP office, the ADS will be interpreted as not providing the authorization necessary to give a foreign IP office access.
The submission of a properly signed revised ADS form with the appropriate authorization language on filing of the patent application under 35 U.S.C. 111(a) would be a specific act authorizing access. In addition to an application filed under 35 U.S.C. 111(a), if an ADS is present upon the initial submission of a patent application under 35 U.S.C. 371, the submitted ADS containing authorization would be a specific act authorizing access. Where a revised ADS form, including the authorization language for access by foreign IP office(s) and signed in accordance with 37 CFR 1.14(c) and 1.33(b), has been submitted with an application, the Office would give the foreign IP office(s) access to the contents in accordance with the specific authorization language, upon request of the foreign IP office.
If, however, applicant files a corrected ADS form (
To avoid duplicative processing, the Office is removing the opt-in check box and associated authorization language for the PDX program from the inventor's oath or declaration form PTO/AIA/08 (for applications filed on or after September 16, 2012). Form PTO/SB/39 for the PDX authorization and Form PTO/SB/69 for the search results to the EPO authorization will remain available for applicants that do not use an ADS or have selected the check boxes for opting out of specific authorizations for access by a foreign IP office on the revised ADS form submitted with the application, but later decide to give a foreign IP office access to the application.
The changes to the Office's ADS form PTO/AIA/14 should reduce those instances where an applicant inadvertently fails to provide the authorization necessary to participate in PDX (by not selecting the opt-in check box for priority document exchange authorization on the previous version of the PTO/AIA/14 form submitted with the application) and, as a result, must expend resources to obtain and file a copy of a U.S. priority document with a foreign IP office. Similarly, this approach will help eliminate those instances where an applicant inadvertently fails to give the Office authority (by filing the former version of form PTO/SB/69) to provide the EPO with the search results from an unpublished U.S. priority application and, as a consequence, must expend resources to file the results with the EPO.
If applicant has not provided proper written authority for access, the Office will not deliver an unpublished priority document or file contents of an unpublished application to a foreign IP office, even where a counterpart application has been filed. As discussed above, the revised ADS form would need to be executed in accordance with 37 CFR 1.33(b), and if there is written authority for any access by a foreign IP office, the revised ADS form also must be executed in accordance with 37 CFR 1.14(c). Applicants should be aware of the differences in signature requirements under 37 CFR 1.33(b) and under 37 CFR 1.14(c). For example, under 37 CFR 1.33(b) in applications filed on or after September 16, 2012, the following individuals can sign:
• A patent practitioner of record;
• A patent practitioner not of record who acts in a representative capacity under the provisions of 37 CFR 1.34; or
• The applicant under 37 CFR 1.42. Unless otherwise specified, all papers submitted on behalf of a juristic entity must be signed by a patent practitioner.
By contrast, under 37 CFR 1.14(c) in applications filed on or after September 16, 2012, the following individuals can sign:
• The applicant;
• A patent practitioner of record;
• The assignee or an assignee of an undivided part interest;
• The inventor or a joint inventor; or
• A registered attorney or agent named in the papers accompanying the application papers filed under 37 CFR 1.53 or the national stage under 37 CFR 1.495, if a power of attorney has not been appointed under 37 CFR 1.32.
If the revised ADS form submitted with an application is not signed in accordance with the relevant rules, then applicant has not provided written authority for access by a foreign IP office to an application. As can be seen by a comparison of the individuals listed in both 37 CFR 1.33(b) and 37 CFR 1.14(c), in most instances an individual listed in 37 CFR 1.33(b) that can sign the revised ADS form can also give access to the application. For example, a patent practitioner of record can sign under both of these regulations. However, if a power of attorney has been appointed under 37 CFR 1.32, which was effective on filing, and a patent practitioner not of record who acts in a representative capacity under the provisions of 37 CFR 1.34 signs the revised ADS form that is submitted with the application, the Office will not recognize that the applicant has provided written authority for access in the revised ADS form. Where forms PTO/SB/39 for PDX authorization and PTO/SB/69 for search results to the EPO authorization are used instead of the revised ADS form, these forms must still be executed in accordance with 37 CFR 1.14(c) even though written authority is provided for under 37 CFR 1.14(h) as amended by this final rule.
The transaction of sharing documents and information from a U.S. application with a foreign IP office has several built in safeguards to ensure that only authorized sharing occurs. For example, in order for a foreign IP office to receive information about a U.S. application, the Office requires that the foreign IP office expressly identify the U.S. application number, along with other elements of bibliographic data for each U.S. application in its request, to ensure that only information pertaining to the correct U.S. application will be provided to the foreign IP office. Once the application is properly identified, the Office will then determine whether the requisite authorization for access exists in the U.S. application. The Office will only share information or other file content from a U.S. application with a foreign IP office when both the correct application is identified and the existence of proper authorization is confirmed. If an unpublished application, which has not been foreign filed, includes an unintended access authorization pursuant to revised 37 CFR 1.14(h), a foreign IP office would not obtain access because it would not have the information necessary to request access to that specific U.S. application.
Further, the U.S. application's filing receipt will indicate whether applicant has provided written authority for access pursuant to 37 CFR 1.14(h). Applicants should inspect the application filing receipt and request a corrected filing receipt if authorization for access under 37 CFR 1.14(h) was incorrectly captured from the revised ADS form or from an applicant-generated ADS filed along with the application. If authorization for access was inadvertently given, a request for rescission of the authorization can be made by filing either the PTO/SB/39 form or the PTO/SB/69 form in each application where the authorization has been recognized by the Office. The Office should be informed of such rescission as early as possible so the Office has time to recognize the request for rescission and act upon it.
Discussion of Specific Rules: The following is a discussion of the amendments to Title 37 of the Code of Federal Regulations, part 1, in this final rule.
Sections 1.14(h)(1)(i) and (ii) also are amended to include the term “bibliographic data” to reflect that “bibliographic data” is used to ensure the correct application-as-filed is being provided to the participating foreign IP office requesting access in any access to the application-as-filed transaction. The term bibliographic data as used in § 1.14(h)(1) covers certain bibliographic data set forth in WIPO standard ST.9 for bibliographic data. The bibliographic data used to confirm that the correct application-as-filed is being provided may include the patent document identification, filing data, priority data, publication data, data concerning technical information such as patent classification (international or domestic), and the title of the invention.
Section 1.14(h)(2) is revised to include a provision by which an applicant can authorize the Office to grant a foreign IP office access to the file contents of an application where a counterpart application has been filed with a foreign IP office that has imposed a requirement for information on a counterpart application filed with the foreign IP office. The Office would only provide access to the relevant portion or portions of an unpublished U.S. application's file contents necessary to satisfy any requirement for information by the foreign IP office, triggered by the U.S. applicant filing a counterpart application with the foreign IP office. The Office and the foreign IP office would also need to have a bilateral or multilateral agreement for the Office to provide the required information. The agreement would provide for the secure transmission and receipt of any shared information. Section 1.14(h)(2)(i) is amended to include the term “bibliographic data” to reflect that “bibliographic data” is used to ensure the information is from the correct application for which access has been requested by the foreign IP office in any access to the application. The term bibliographic data as used in § 1.14(h)(2) includes the same types of bibliographic data set discussed above with respect to § 1.14(h)(1).
Former 1.14(h)(2) has been moved to § 1.14(h)(3).
Section 1.14(h)(3) is amended to indicate that written authority provided under §§ 1.14(h)(1) and (h)(2) should be submitted before the filing of any subsequent foreign application in which priority is claimed to the application. Section 1.14(h)(3) also is amended to indicate that the written authority under §§ 1.14(h)(1) and (2) must include the title of the invention (§ 1.72(a)), comply with the requirements of § 1.14(c), and must be submitted on an application data sheet (§ 1.76) or on a separate document (§ 1.4(c)).
This rulemaking amends the rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents of an application, and thus pertains solely to the process for an applicant to provide a limited waiver of confidentiality under 35 U.S.C. 122(a) to allow a counterpart IP office access to all or part of the file contents of an application. Therefore, the changes in this final rulemaking involve rules of agency practice and procedure and/or interpretive rules.
Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law).
For the reasons set forth herein, the Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy of the Small Business Administration that changes in this final rule will not have a significant economic impact on a substantial number of small entities.
This rulemaking amends the rules of practice to include a specific provision by which an applicant can authorize the Office to give a foreign IP office access to all or part of the file contents of an application. This rulemaking consolidates and clarifies in one place—37 CFR 1.14(h)—existing procedures in both 37 CFR 1.14(c) and (h) relevant to authorizing the Office to provide a foreign IP office access to all or part of the file contents of an application or to an application-as-filed. Moreover, the use of the revised forms discussed (PTO/AIA/14; PTO/SB/39; and PTO/SB/69) will provide applicants that wish to provide a foreign IP office access to their applications greater ease and efficiency in transmitting the requisite authorization. The changes in this rulemaking do not require any applicant to provide the Office with this authority. There is no fee for this service. Therefore, the changes in this final rule will not have a significant economic impact on a substantial number of small entities.
This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).
The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.
This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).
This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).
This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).
This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).
This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).
This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).
Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
The changes set forth in this final rule do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969.
The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB control number.
Administrative practice and procedure, Courts, Freedom of information, Inventions and patents, Reporting and recordkeeping requirements, Small businesses.
For the reasons stated in the preamble, 37 CFR part 1 is amended as follows:
35 U.S.C. 2(b)(2).
(h)
(i) A copy of the application-as-filed and its related bibliographic data;
(ii) A copy of the application-as-filed of any application the filing date of which is claimed by the application in which written authority under this paragraph (h)(1) is filed and its related bibliographic data; and
(iii) The date of filing of the written authorization under this paragraph (h)(1).
(2) Access to the file contents of an application may be provided to a foreign intellectual property office that has imposed a requirement for information on a counterpart application filed with the foreign intellectual property office where the foreign intellectual property office is a party to a bilateral or multilateral agreement with the Office to provide the required information from the application filed with the Office and the application contains written authority granting such access. Written authority provided under this paragraph (h)(2) will be treated as authorizing the Office to provide the following to all foreign intellectual property offices in accordance with their respective agreements with the Office:
(i) Bibliographic data related to the application; and
(ii) Any content of the application file necessary to satisfy the foreign intellectual property office requirement for information imposed on the counterpart application as indicated in the respective agreement.
(3) Written authority provided under paragraphs (h)(1) and (h)(2) of this section must include the title of the invention (§ 1.72(a)), comply with the requirements of paragraph (c) of this section, and be submitted on an application data sheet (§ 1.76) or on a separate document (§ 1.4(c)). The written authority provided under these paragraphs should be submitted before filing any subsequent foreign application in which priority is claimed to the application.
(b) * * *
(1) * * *
(iv) If provided to a foreign intellectual property office pursuant to a bilateral or multilateral agreement (see § 1.14(h)): $0.00.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve three state implementation plan (SIP) revisions submitted by the State of Oregon Department of Environmental Quality (Oregon or ODEQ) and a specific portion of a fourth SIP submittal identified in a supplementary letter. These SIP submittals primarily include rule amendments related to control measures for volatile organic compounds from gasoline dispensing facilities in the Portland-Vancouver, Medford-Ashland, and Salem-Keizer Area Transportation Study air quality management areas, as well as all of Clackamas, Multnomah, and Washington counties. The EPA received the SIP submittals from the ODEQ on February 5, 2009, November 1, 2010, May 25, 2011, and April 20, 2015, and the supplementary letter on September 18, 2015. The EPA is approving the SIP submittals because they are consistent with the requirements of the Clean Air Act (Act or CAA).
This rule is effective on December 28, 2015, without further notice, unless the EPA receives adverse comment by November 27, 2015. If the EPA receives adverse comment, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2011-0799, by any of the following methods:
•
•
•
•
Claudia Vergnani Vaupel at (206) 553-6121,
Throughout this document wherever “we”, “us” or “our” is used, it is intended to refer to the EPA.
Section 110 of the CAA requires states to develop and submit to the EPA SIPs to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA-approved SIP provisions and control strategies are federally enforceable. States revise the SIP as needed and submit revisions to the EPA for review and approval.
This action primarily addresses Oregon's SIP submittals dated February 5, 2009, November 1, 2010, and May 25, 2011. These submittals include amendments to rules that control volatile organic compound (VOC) emissions from gasoline dispensing facilities in the Air Quality Management Areas (AQMAs) of Portland-Vancouver (which includes portions of Clackamas, Multnomah, and Washington counties), Medford-Ashland, and Salem-Keizer Area Transportation Study (SKATS), as well as all of Clackamas, Multnomah, and Washington counties. The VOC rules were previously approved into the Oregon SIP to address Reasonably Available Control Technology (RACT) requirements for ozone nonattainment areas. (
In general, the February 5, 2009 submittal amended the VOC rules to consolidate them with Oregon's then newly adopted rules that implemented the Federal National Emission Standards for Hazardous Air Pollutants (NESHAP) for gasoline dispensing facilities, (40 CFR part 63, subpart CCCCCC) (gasoline dispensing facility NESHAP). The effect of Oregon's rule amendments was to incorporate the substantive stage I VOC RACT rule requirements for gasoline dispensing facilities in Oregon Administrative Rules (OAR) 340 division 232 “Emission Standards for VOC Point Sources” and division 242 “Rules Applicable to the Portland Area” into division 244 “Oregon Federal Hazardous Air Pollutant Program,” and to incorporate the permitting requirements for these facilities into division 216 “Air Contaminant Discharge Permits.” The November 1, 2010 and May 25, 2011 submittals made additional amendments to the rules for gasoline dispensing facilities. These three submittals also include minor amendments to other rules in divisions 200 “State of Oregon Clean Air Act Implementation Plan,” 209 “Public Notice Categories and Timing,” and 210 “Registration in General”.
The April 20, 2015 submittal consists of comprehensive revisions to the ODEQ's air permitting and other air rules, including revisions to the rules for gasoline dispensing facilities in divisions 242 and 244. In a September 18, 2015 supplementary letter, the ODEQ requested that the EPA approve specific division 242 and 244 rules to ensure the most current version of the division 242 and 244 rules for gasoline dispensing facilities be approved into the SIP. Therefore, in this action, we are reviewing and acting only on the division 242 and 244 rule amendments in the April 20, 2015 submittal that were identified in the supplementary letter. We are not reviewing or acting on any other portion of the April 20, 2015 submittal at this time, but will address the remainder of that submittal in a future action. In addition, the ODEQ requested that the EPA approve the identified division 244 rules for gasoline dispensing facilities that replaced OAR 340-232-0070 and OAR 340-242-0520 in the February 5, 2009 submittal only to the extent they apply to sources in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs, as well as all of Clackamas, Multnomah, and Washington counties.
In the February 5, 2009 submittal, the ODEQ repealed the SIP-approved rule OAR 340-232-0070 that applied to gasoline dispensing facilities in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs. The ODEQ also removed references to stage I vapor balance systems from the SIP-approved rules OAR 340-242-0500 and -0520, which applied to gasoline dispensing facilities in Clackamas, Multnomah and Washington counties, but retained the stage II vapor collection system requirements in those rules. The stage I vapor balance requirements contained in OAR 340-232-0070, OAR 340-242-0500 and OAR 340-242-0520 were added to sections of new rules in division 244 (-0030, -0234, -0238, -0240, -0242, and -0244) and to amended sections of existing rules in division 216 (-0020, including tables 1 and 2, -0040, and -0060). The ODEQ made further amendments to the rules for gasoline dispensing facilities in the subsequent submittals, as explained in section II.
In addition to the VOC RACT gasoline dispensing facility rule amendments, the SIP submittals also include amendments to the following rules: OAR 340-200-0040, 340-209-0030, 340-210-0100, 340-210-0110, 340-210-0120, 340-216-0062, and 340-244-0020. A summary discussion of the rule amendments is provided below. A table that identifies which new rules address
As in the SIP-approved rules, the amended rules in OAR 340 divisions 244 and 216 continue to apply to the delivery of gasoline to a gasoline dispensing facility storage tank, require submerged filling and have specific piping requirements. The amended rules exempt all gasoline storage tanks with a capacity of less than 250 gallons from the submerged fill requirements. For tanks installed on or before October 14, 1999, this is more stringent than the SIP-approved rules which exempted tanks with a capacity of 1,500 gallons or less. However, the SIP-approved rules required submerged fill for all tanks installed after October 14, 1999. Thus, for those tanks with a capacity less than 250 gallons, the amended rules are less stringent. The ODEQ provided emissions estimates for these small tanks exempt from the submerged fill requirements under the amended rules and explained that, in general, such sources use the gasoline for their own equipment (
The vapor balance system requirements in the amended rules are similar to the SIP-approved rules, including requirements that equipment be vapor tight, maintained in good working order, and properly connected. Both the amended and the SIP-approved rules exempt tanks with floating roofs from the vapor balance system requirements. Similar to the SIP-approved rule, the amended rules require that vapor balance systems meet certain specifications and demonstrate compliance. The amended rules cite more recently adopted test methods for compliance than the SIP-approved test methods. In addition, the new rules require a compliance demonstration every three years after the initial compliance demonstration for gasoline dispensing facilities with a monthly throughput of 100,000 gallons of gasoline or more. This is more stringent than the SIP-approved rule. In the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs, the amended rules continue to exempt gasoline storage tanks that have a capacity of 1,500 gallons or less from the vapor balance system requirements. However, in Clackamas, Multnomah, and Washington counties, the requirements for vapor balance systems are slightly amended. In these counties, the SIP-approved rules required a vapor balance system for all tanks if the gasoline dispensing facility had an annual throughput of 120,000 gallons of gasoline or more regardless of the storage capacity of the tank. The amended rules exempt gasoline storage tanks that have a capacity less than 250 gallons from the vapor balance system requirements. The EPA does not consider this to be a relaxation of the SIP-approved rules because gasoline dispensing facilities that have an annual throughput of 120,000 gallons of gasoline or more would be expected to have storage tanks that are larger than 250 gallons.
The amended rules do not specify that training and written instructions be provided to the operators of gasoline dispensing facilities and gasoline transport vehicles as in the SIP-approved rules. The management practices for gasoline dispensing facilities and cargo tanks included in OAR 340-244-0242 tables 2 and 3 provide a similar level of assurance, however, that equipment is operated properly. In addition, the new rules for gasoline dispensing facilities in division 244 also include other requirements that are not currently in the SIP but are based on the requirements of the gasoline dispensing facility NESHAP. These include a specific timeframe for demonstrating initial compliance with the vapor balance system, demonstrating monthly throughput, general duties to minimize emissions, notifications, recordkeeping, and reporting. These requirements are consistent with the gasoline dispensing facility NESHAP and will either reduce VOC emissions or enhance the enforceability of VOC SIP requirements for gasoline dispensing facilities. Thus, while a few aspects of the amended requirements for gasoline dispensing facilities are less stringent than in the existing SIP, given the overall strengthening of the requirements for gasoline dispensing facilities in the identified areas under the amended rules, the EPA finds that the revisions to the requirements for gasoline dispensing facilities in the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs and in Clackamas, Multnomah, and Washington counties will not interfere with any applicable requirement concerning attainment or maintenance of the NAAQS or any other applicable CAA requirements. The EPA is therefore approving these requirements for the Portland-Vancouver, Medford-Ashland, and SKATS AQMAs as well as all of Clackamas, Multnomah, and Washington counties.
The General Air Contaminant Discharge Permits (ACDPs) rules in the amended OAR division 216 have replaced the vapor balance system (stage I) and stage II vapor collection permit requirements in the SIP-approved rules. The EPA has approved the submitted amendments to division 216 (
The February 5, 2009, November 1, 2010, and May 25, 2011 submittals also include amendments to other rules that
The EPA is taking the following action on the amendments to OAR Chapter 340 that were included in the February 5, 2009, November 1, 2010, and May 25, 2011 submittals and the division 242 and 244 rules in the April 20, 2015 submittal that were identified by the ODEQ for our review in the September 18, 2015 supplementary letter. We are acting on the most recent version of the rules in the submittal identified in parentheses below. Further action on the earlier adopted versions of these rules included in the submittals is not required because they are no longer in effect and have been superseded by the most recent submittal.
We are approving the following rule amendments: OAR 340-232-0070 (repeal) (February 5, 2009 submittal); OAR 340-242-0500, -0510, -0520 (April 20, 2015 submittal as identified in the September 18, 2015 supplementary letter);
As discussed above, we are not approving OAR 340-200-0040 (May 25, 2011); OAR 340-209-0030, OAR 340-210-0100, -0110, -0120, and OAR 340-216-0062, -0064 (November 1, 2010 submittal); OAR 340-216-0020, -0060 (May 25, 2011); or OAR 340-244-0020 (February 5, 2009 submittal).
In this rule, the EPA is approving regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is incorporating by reference the Oregon regulations (OAR Chapter 340) described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standard; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 28, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to the receipt of adverse comments, the Environmental Protection Agency (EPA) is withdrawing the September 2, 2015 direct final rule that approves a state implementation plan (SIP) revision related to the removal of “Stage II” vapor recovery equipment at gasoline dispensing facilities in the Phoenix-Mesa area. The EPA will address the comments in a subsequent final action based upon the proposed rulemaking action, also published on September 2, 2105. The EPA will not institute a second comment period on this action.
The direct final rule published at 80 FR 53001 on September 2, 2015 is withdrawn, effective October 27, 2015.
Jeffrey Buss, Air Planning Office (AIR-2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne, San Francisco, California 94105; (415) 947-4152;
On September 2, 2015 (80 FR 53001), the EPA published a direct final rule approving a SIP revision submitted by the Arizona Department of Environmental Quality (ADEQ). The revision provides for the phased removal of Stage II vapor recovery equipment at gasoline dispensing facilities in the Phoenix-Mesa area. Specifically, the revision eliminates the requirement to install and operate such equipment at new gasoline dispending facilities, and provides for the phased removal of such equipment at existing gasoline dispensing facilities from October 2016 through September 2018. In the direct final rule, the EPA stated that if adverse comments were received by October 2, 2015, the EPA would publish a timely withdrawal of the direct final rule and address the comments in a subsequent final rule. The EPA received adverse comments and is therefore withdrawing the direct final rule. The EPA will address these comments in a separate final action based on the proposed action also published on September 2, 2015 (80 FR 53086). The EPA will not open a second comment period for this action.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Accordingly, the amendment to 40 CFR 52.120 which published in the
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve an update to a portion of the Outer Continental Shelf (OCS) Air Regulations for Maryland. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by the Clean Air Act, as amended in 1990 (CAA or the Act). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which Maryland is the designated COA. The intended effect of approving the OCS requirements for the Maryland Department of the Environment is to regulate emissions from OCS sources in accordance with the requirements onshore.
This rule is effective on December 28, 2015 without further notice, unless EPA receives adverse written comment by November 27, 2015. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2014-0568 by one of the following methods:
A.
B.
C.
D.
Cathleen Van Osten, (215) 814-2746, or by email at
On September 4, 1992, EPA promulgated 40 CFR part 55 which established requirements to control air pollution from OCS sources in order to attain and maintain Federal and state ambient air quality standards and to comply with the provisions of part C of title I of the CAA. Forty CFR part 55 applies to all OCS sources offshore of the states except those locations in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the CAA requires that for such source locations within 25 miles of a state's seaward boundary, the requirements shall be the same as would be applicable if the source were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) requires that EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.
Pursuant to 40 CFR 55.12 of the OCS rule, consistency reviews will occur: (1) At least annually; (2) upon receipt of a Notice of Intent under 40 CFR 55.4; or (3) when a state or local agency submits a rule to EPA to be considered for incorporation by reference in 40 CFR part 55. This proposed action is being taken in response to requirements submitted by Maryland. Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. This limits EPA's flexibility in deciding which requirements will be incorporated into 40 CFR part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into 40 CFR part 55 that do not conform to all of EPA's state implementation
EPA reviewed Maryland's rules for inclusion in 40 CFR part 55 to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards or part C of title I of the CAA; that they are not designed expressly to prevent exploration and development of the OCS; and that they are applicable to OCS sources. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. In addition, EPA has excluded administrative or procedural rules
EPA is taking direct final action to incorporate the applicable provisions of the Code of Maryland Regulations into 40 CFR part 55 as required under section 328(a)(1) of the CAA. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Maryland Regulations described in the amendments to 40 CFR part 55 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore air control requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS consistency updates, EPA's role is to maintain consistency between OCS regulations and the regulations of onshore areas, provided that they meet the criteria of the Clean Air Act. Accordingly, this action simply updates the existing OCS requirements to make them consistent with requirements onshore, without the exercise of any policy discretion by EPA. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), 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, nor does it impose substantial direct compliance costs on tribal governments, nor preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
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 December 28, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are
Environmental protection, Administrative practice and procedures, Air pollution control, Hydrocarbons, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Nitrogen oxides, Outer Continental Shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping requirements, Sulfur oxides.
This document was received for publication by the Office of the Federal Register on October 21, 2015.
Accordingly, 40 CFR part 55 is amended as follows:
Section 328 of the Clean Air Act (42 U.S.C. 7401,
(d) * * *
(10) Maryland.
(i) 40 CFR part 52, subpart V.
(ii) [Reserved]
(e)
(10) Maryland.
(i) State requirements.
(A) State of Maryland Requirements Applicable to OCS Sources, January 8, 2014.
(B) [Reserved]
(ii) Local requirements.
(A) [Reserved]
Maryland:
(a) State requirements.
(1) The following State of Maryland requirements are applicable to OCS Sources, January 8, 2014, State of Maryland-Department of the Environment. The following sections of Code of Maryland Regulations (COMAR) Title 26 Subtitle 11:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is exchanging allocations of Amendment 80 cooperative quota (CQ) for Amendment 80 acceptable biological catch (ABC) reserves. This action is necessary to allow the 2015 total allowable catch of flathead sole, rock sole, and yellowfin
Effective October 27, 2015, through December 31, 2015.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) 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 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 11,035 metric tons (mt), 52,390 mt, and 118,962 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015). The 2015 flathead sole, rock sole, and yellowfin sole Amendment 80 ABC reserves are 43,019 mt, 101,868 mt, and 82,051 mt as established by the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015).
The Alaska Seafood cooperative has requested that NMFS exchange 600 mt of flathead sole and 1,350 mt of rock sole Amendment 80 allocations of the TAC for 1,950 mt of yellowfin sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 600 mt of flathead sole and 1,350 mt of rock sole Amendment 80 allocations of the TAC for 1,950 mt of yellowfin sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2015 and 2016 harvest specifications for groundfish in the BSAI (80 FR 11919, March 5, 2015) and as revised (80 FR 60073, October 5, 2015) are further revised as follows:
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Alaska Seafood cooperative the BSAI.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
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 Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM proposed to require revising the maintenance or inspection program to incorporate revised tasks specified in certain temporary revisions (TRs) to the airplane airworthiness limitations (AWLs). The NPRM was prompted by the need for more stringent inspection requirements for certain affected components. This action revises the NPRM by proposing to require revising the maintenance or inspection program to incorporate certain revised AWL tasks instead of TRs, and by proposing to require repairs of affected components. We are proposing this supplemental NPRM (SNPRM) to detect and correct fatigue cracking in the affected components, which could result in loss of structural integrity. Since these actions impose an additional burden over those proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.
We must receive comments on this SNPRM by December 11, 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, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
You may examine the AD docket on the Internet at
Jeffrey Zimmer, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7306; fax 516-794-5531.
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 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
Since we issued the NPRM (77 FR 63282, October 16, 2012), we have determined that a repair requirement should be added to this SNPRM to correct fatigue cracking in the affected components.
Bombardier Inc. has issued the following AWLs.
• AWL 52-11-131, “Passenger door—piano hinge half on door side,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 Maintenance Requirements Manual (MRM) CSP A-053. This AWL describes procedures for a detailed visual inspection of the piano hinge half on the passenger door side.
• AWL 53-11-122, “Windshield center post and bulkhead aft post at FS202.75,” of Appendix B—
• AWL 53-21-118, “Potable water servicing door cut-out and internal structure,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a detailed visual inspection of the potable water servicing door cut-out and internal structure.
• AWL 53-21-129, “Passenger door—piano hinge half on fuselage side,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a detailed visual inspection of the piano hinge half of the passenger door on the fuselage side.
• AWL 53-41-199, “FS409.0 +128 vertical posts at BL0.0 and BL18.0 left and right local to WL69.0,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the FS409.0 +128 left and right vertical posts at buttock line (BL) 0.0 and BL18.0 local to water line (WL) 69.0.
• AWL 53-41-200, “FS409.0 +128 frame cap aft and fwd splice angles at STR21 left and right,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a detailed visual inspection of the FS409.0 +128 frame cap aft and forward splice angles at stringer 21.
• AWL 53-41-201, “FS559.0 pressure bulkhead web and cap angle local to BL9.0 and BL18.0 left and right,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the left and right FS559.0 pressure bulkhead web and cap angle local to BL9.0 and BL18.0.
• AWL 53-61-156, “Rear pressure bulkhead forward face below floor,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the below floor forward face of the rear pressure bulkhead.
• AWL 54-10-105, “Pylon track and support fitting,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the pylon track and support fitting.
• AWL 54-10-106, “Pylon track and support fitting,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the pylon track and support fitting.
• AWL 57-21-105, “Lower wing skin, between BL0.0 to wing station (WS) 314.0,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a detailed visual inspection of the lower wing skin, between BL0.0 to WS314.0.
• AWL 57-21-112, “Lower wing plank splice joints at BL45.0, WS65.75, and WS148.0,” of Appendix B—Airworthiness Limitations, of Part 2 Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053. This AWL describes procedures for a special detailed inspection of the lower wing plank splice joints at BL45.0, WS65.75, and WS148.0.
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 proposed AD. We considered the comments received.
Skywest Airlines (Skywest) and Expressjet Airlines (Expressjet) requested that we reduce the number of inspections proposed by the NPRM (77 FR 63282, October 16, 2012) by specifying the AWLs in lieu of the TRs referenced in the NPRM. Skywest and Expressjet stated that many of the TRs have already been incorporated into the maintenance program; the proposed requirements would therefore create difficulty in tracking TRs for compliance because of the many anticipated alternative methods of compliance (AMOCs) that would be needed. Expressjet stated that the large number of proposed inspections will create a significant burden on the operator.
Bombardier requested that we specify the AWLs and cited an example of two TRs issued for the same AWL.
Air Wisconsin (AWI) provided specific references to TRs that have been superseded by subsequently published TRs and requested that we revise the NPRM (77 FR 63282, October 16, 2012) to reference revised TRs that address the identified AWLs.
We agree with the commenters' requests to specify the AWLs instead of the TRs. The entirety of each TR does not need to be mandated. By specifying the AWLs, we also eliminate AWI's concern over TRs that have been superseded. We have revised paragraph (g) of this SNPRM to remove the TRs and specify the AWLs that we propose to be incorporated into the maintenance or inspection program, as applicable.
AWI requested that, for those tasks without specific phase-in schedules, we change the compliance times to the times specified in the applicable TR, or “within 1,000 flight cycles after the effective date of this AD,” whichever occurs later. AWI stated that although most of the tasks have phase-in schedules, some do not; therefore, the ability to perform these tasks on an entire fleet within the 60 days specified in the NPRM (77 FR 63282, October 16, 2012) may not be realistic.
We agree with the commenter's request to specify phase-in schedules for the AWL tasks without specific phase-in schedules. As stated previously, we revised paragraph (g) of this SNPRM to reference the AWLs in lieu of the TRs. We revised paragraph (h) of this SNPRM to specify where to locate compliance times for tasks with phase-in schedules and for those without phase-in schedules. In addition, new paragraph (h)(2) of this SNPRM provides a grace period of “within 1,000 flight cycles after the effective date of this AD.”
AWI requested that we approve AMOCs for the intervals and/or methods contained in technical repair data,
Skywest and Expressjet requested that we allow previous AWL task repairs that have been approved by Bombardier, Inc.'s TCCA Design Approval Organization (DAO) in the inspection areas. Skywest and Expressjet stated that this will reduce the number of AMOCs needed for previous repairs.
We agree with the commenters' requests regarding previously approved repairs. We agree to include a provision in this SNPRM to allow for previously approved repairs in the inspection area that were approved by the Manager, New York Aircraft Certification Office, ANE-170, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. We have added this provision in paragraph (k) of this SNPRM.
Expressjet requested that we allow the use of future revisions of the identified AWL tasks, provided they are approved by TCCA.
We disagree to allow the use of future revisions of the identified AWL tasks as a method of compliance with this SNPRM. When referring to a specific document in an AD, using the phrase “or later approved revisions” violates Office of the Federal Register (OFR) regulations for approving materials that are incorporated by reference in rules. See 1 CFR 51.1(f). In general terms, we are required by these OFR regulations to either publish the service document contents as part of the actual AD language, or submit the service document to the OFR for approval as “referenced” material. In the latter case, we may only refer to such material in the text of an AD; the AD may refer to the service document only if the OFR approved it for incorporation by reference.
To allow operators to use later revisions of the referenced document (issued after publication of the AD), either we must revise the AD to reference specific later revisions, or operators must request approval to use later revisions as an AMOC under the provisions of paragraph (k) of this SNPRM. Therefore, affected operators may request approval to use a later revision of the referenced AWL tasks as an AMOC using the procedures specified in paragraph (k) of this SNPRM provided an adequate level of safety is maintained. We have not changed this SNPRM in this regard.
Skywest requested that we permit removal of the TR when the required maintenance action is incorporated into an MRM revision. Skywest stated that referring to each TR becomes problematic because a standard revision of the MRM, when published, states that the incorporated TRs are to be removed and discarded.
As stated previously, we have revised paragraph (g) of this SNPRM to remove the TRs and specify the AWLs that we propose to be incorporated into the maintenance or inspection program, as applicable. Therefore, it is unnecessary to change this SNPRM in this regard.
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 the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
Certain changes described above expand the scope of the NPRM (77 FR 63282, October 16, 2012). As a result, we have determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.
This SNPRM proposes to require revisions to certain operator maintenance documents to include new inspections. Compliance with these inspections is required by section 91.403(c) of the Federal Aviation Regulations (14 CFR 91.403(c)). For airplanes that have been previously modified, altered, or repaired in the areas addressed by these inspections, an operator might not be able to accomplish the inspections described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval of an AMOC in accordance with the provisions of paragraph (k) of this SNPRM. The request should include a description of changes to the required inspections that will ensure the continued damage tolerance of the affected structure.
We estimate that this SNPRM affects 575 airplanes of U.S. registry.
We estimate that it would take about 1 work-hour per product to comply with the requirements of this SNPRM. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this SNPRM on U.S. operators to be $48,875, or $85 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this 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 December 11, 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 05, Periodic inspections.
This AD was prompted by a revision to the airplane airworthiness limitations (AWLs) to introduce more stringent inspection requirements on certain affected components. We are issuing this AD to detect and correct fatigue cracking in the affected components and consequent loss of structural integrity.
Comply with this AD within the compliance times specified, unless already done.
Within 60 days after the effective date of this AD: Revise the maintenance or inspection program, as applicable, to incorporate the revised inspection requirements specified in the AWLs identified in paragraphs (g)(1) through (g)(12) of this AD.
(1) AWL 52-11-131, “Passenger door—piano hinge half on door side,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 Maintenance Requirements Manual (MRM) CSP A-053.
(2) AWL 53-11-122, “Windshield center post and bulkhead aft post at FS202.75,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(3) AWL 53-21-118, “Potable water servicing door cut-out and internal structure,” of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(4) AWL 53-21-129, “Passenger door—piano hinge half on fuselage side,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(5) AWL 53-41-199, “FS409.0 + 128 vertical posts at BL0.0 and BL18.0 left and right local to WL69.0,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(6) AWL 53-41-200, “FS409.0 + 128 frame cap aft and fwd splice angles at STR21 left and right,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(7) AWL 53-41-201, “FS559.0 pressure bulkhead web and cap angle local to BL9.0 and BL18.0 left and right,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(8) AWL 53-61-156, “Rear pressure bulkhead forward face below floor,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(9) AWL 54-10-105, “Pylon track and support fitting,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(10) AWL 54-10-106, “Pylon track and support fitting,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(11) AWL 57-21-105, “Lower wing skin, between BL0.0 to WS314.0,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(12) AWL 57-21-112, “Lower wing plank splice joints at BL45.0, WS65.75, and WS148.0,” of Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053.
(1) For tasks with phase-in schedules specified in the AWLs identified in paragraphs (g)(1) through (g)(12) of this AD: The initial compliance times are at the applicable times specified in the applicable AWL, or within 60 days after the effective date of this AD, whichever occurs later, except as specified in paragraph (h)(2) of this AD.
(2) For tasks with no phase-in schedules specified in the AWLs identified in paragraphs (g)(1) through (g)(12) of this AD: The initial compliance times are at the applicable times specified in Appendix B—Airworthiness Limitations, of Part 2, Airworthiness Requirements, Revision 9, dated June 10, 2013, of the Bombardier CL-600-2B19 MRM CSP A-053, or within 1,000 flight cycles after the effective date of this AD, whichever occurs later.
If any damage (including, but not limited to, cracking, corrosion, and wear) is found during any inspection required by any AWL specified in paragraph (g) of this AD: Before further flight, repair using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO).
After accomplishing the revisions required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(i) The repairs were accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO.
(ii) The repair approval refers to MCAI Canadian Airworthiness Directive CF-2012-13, dated April 10, 2012, and provides an inspection program (inspection threshold, method, and repetitive interval).
(iii) The operator has revised its maintenance or inspection program, as
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2012-13, dated April 10, 2012, for related information. You may examine the MCAI in the AD docket on the Internet at
(2) 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
Internal Revenue Service (IRS), Treasury.
Partial withdrawal of notice of proposed rulemaking.
This document withdraws a portion of the notice of proposed rulemaking published in the
As of October 27, 2015, the notice of proposed rulemaking published in the
Zoran Stojanovic, (202) 317-6980 (not a toll-free number).
On September 26, 2006, the Department of the Treasury and the IRS published in the
Income taxes, Reporting and recordkeeping requirements.
Accordingly, under the authority of 26 U.S.C. 7805, §§ 1.141-1(b) and 1.145-2(c)(3) of the notice of proposed rulemaking (REG-140379-02, REG-142599-02) published in the
Alcohol and Tobacco Tax and Trade Bureau, Treasury.
Notice of proposed rulemaking; Reopening of comment period.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is reopening the comment period for Notice No. 149, which concerned the proposed establishment of the approximately 306,650-acre “Lewis-Clark Valley” viticultural area in portions of Nez Perce, Lewis, Clearwater and Latah Counties in Idaho and Asotin, Garfield, and Whitman Counties in Washington. Notice No. 149 also proposed to modify the boundary of the existing Columbia Valley viticultural area to eliminate a potential overlap with the proposed Lewis-Clark Valley viticultural area. This reopening of the comment period solicits comments from the public on issues that were raised in public comments received in response to Notice No. 149.
For Notice No. 149, the proposed rule which published on April 14, 2015 (80 FR 19901), written comments are now due on or before November 27, 2015.
Please send your comments on this proposal to one of the following addresses:
•
•
•
See the Public Participation section of Notice No. 149 for specific instructions and requirements for submitting comments, and for information on how to request a public hearing or view or
You may view copies of the petition, Notice No. 149, selected supporting materials, and all public comments associated with this proposal within Docket No. TTB-2015-0005 at
Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; phone 202-453-1039, ext. 175.
TTB received a petition from Dr. Alan Busacca, a licensed geologist and founder of Vinitas Consultants, LLC, on behalf of the Palouse-Lewis Clark Valley Wine Alliance and the Clearwater Economic Development Association. The petition proposed to establish the approximately 306,650-acre “Lewis-Clark Valley” AVA and to modify the boundary of the existing “Columbia Valley” AVA (27 CFR 9.74). The proposed Lewis-Clark Valley AVA is located at the confluence of the Snake River and the Clearwater River and covers portions of Nez Perce, Lewis, Clearwater, and Latah Counties in northern Idaho and Asotin, Garfield, and Whitman Counties in southeastern Washington.
A small portion of the proposed Lewis-Clark Valley AVA would, if established, overlap the southeastern corner of the established Columbia Valley AVA. To eliminate the potential overlap, the petitioner proposed to modify the boundary of the Columbia Valley AVA so that the overlapping area (hereinafter referred to as the “proposed realignment area”) would be solely within the proposed Lewis-Clark Valley AVA. The proposed modifications would reduce the size of the approximately 11,370,320-acre Columbia Valley AVA boundary by approximately 57,020 acres.
TTB published Notice No. 149 in the
During the comment period, TTB received a comment from a vineyard owner within the proposed realignment area. According to the commenter, his vineyard is the estate vineyard for a winery that is also located within the proposed realignment area. The commenter stated that the proposed realignment area has characteristics similar to those of the Columbia Valley and should not be removed from that AVA. Specifically, the commenter stated, “The geology, soils, and climate of the proposed Lewis-Clark Valley AVA are quite similar to those of the Columbia Valley and mostly lay within the elevations affected by the Missoula floods.” The comment is posted as Comment 35 within Docket No. TTB-2015-0005 at
TTB reviewed all comments received in response to Notice No. 149 with reference to the original petition information. TTB believes that the comment period for Notice No. 149, which was open for 60 days, was adequate to obtain information on the initially proposed regulation. However, TTB notes that if the proposed realignment area were to be removed from the Columbia Valley AVA and placed into the proposed Lewis-Clark Valley AVA, wines made primarily from grapes grown within the proposed realignment area would no longer be eligible to be labeled with the “Columbia Valley” appellation of origin. Therefore, because of the potential effect on label holders if TTB were to adopt the proposed modification of the Columbia Valley AVA boundary, TTB has determined that it would be appropriate in this instance to re-open the comment period, for the specific purpose of obtaining further public comment on the proposed boundary modification, before taking any further regulatory action on this matter.
TTB is, therefore, re-opening the comment period on Notice No. 149 for an additional 30 days, in order to obtain additional comments on the characteristics of the proposed realignment area. Comments on Notice No. 149 are now due on or before November 27, 2015. TTB is specifically interested in comments on whether the evidence provided in the petition to establish the proposed Lewis-Clark Valley AVA and to modify the boundary of the Columbia Valley AVA adequately demonstrates that the characteristics of the proposed realignment area are more similar to those of the rest of the proposed Lewis-Clark Valley AVA than to the distinguishing features of the Columbia Valley AVA, which are described in T.D. TTB-ATF 190 (69 FR 44897, November 13, 1984) and summarized in both the proposed Lewis-Clark Valley AVA petition and Notice No. 149. Please provide any available specific information in support of your comments.
See the Public Participation section of Notice No. 149 for specific instructions and requirements for submitting comments, and for information on how to request a public hearing or view or obtain copies of the petition and supporting materials.
You may view copies of the petition, Notice No. 149, selected supporting materials, and all public comments associated with this proposal within Docket No. TTB-2015-0005 at
Karen A. Thornton of the Regulations and Rulings Division drafted this document.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve three state implementation plan (SIP) revisions submitted by the State of Oregon Department of Environmental Quality (Oregon or ODEQ) and a specific portion of a fourth SIP submittal identified in a supplementary letter. These SIP submittals primarily
Comments must be received on or before November 27, 2015.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2011-0799, by any of the following methods:
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•
•
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Claudia Vergnani Vaupel at (206) 553-6121,
For further information, please see the direct final action, of the same title, which is located in the Rules section of this
If the EPA receives adverse comments, the EPA will withdraw the direct final rule and it will not take effect. The EPA will address all public comments in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
Environmental Protection Agency (EPA).
Proposed rule.
The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On May 11, 2015, the State of Washington made a submittal to the Environmental Protection Agency (EPA) to address these requirements. The EPA is proposing to approve the submittal as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2008 ozone National Ambient Air Quality Standard (NAAQS) in any other state.
Written comments must be received on or before November 27, 2015.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2015-0334, by any of the following methods:
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Jeff Hunt at (206) 553-0256,
Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
Information is organized as follows:
On March 12, 2008, the EPA revised the levels of the primary and secondary 8-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436). The CAA requires states to submit, within three years after promulgation of a new or revised standard, SIPs meeting the applicable “infrastructure” elements of sections 110(a)(1) and (2). One of these applicable infrastructure elements, CAA section 110(a)(2)(D)(i), requires SIPs to contain “good neighbor” provisions to prohibit certain adverse air quality effects on neighboring states due to interstate transport of pollution. There are four sub-elements within CAA section 110(a)(2)(D)(i). This action addresses the first two sub-elements of the good neighbor provisions, at CAA section 110(a)(2)(D)(i)(I). These sub-elements require that each SIP for a new or revised standard contain adequate provisions to prohibit any source or other type of emissions activity within the state from emitting air pollutants that will “contribute significantly to nonattainment” or “interfere with maintenance” of the applicable air quality standard in any other state. We note that the EPA has addressed the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the eastern portion of the United States in several past regulatory actions.
In CSAPR, the EPA used detailed air quality analyses to determine whether an eastern state's contribution to downwind air quality problems was at or above specific thresholds. If a state's contribution did not exceed the specified air quality screening threshold, the state was not considered “linked” to identified downwind nonattainment and maintenance receptors and was therefore not considered to significantly contribute to or interfere with maintenance of the standard in those downwind areas. If a state exceeded that threshold, the state's emissions were further evaluated, taking into account both air quality and cost considerations, to determine what, if any, emissions reductions might be necessary. For the reasons stated below, we believe it is appropriate to use the same approach we used in CSAPR to establish an air quality screening threshold for the evaluation of interstate transport requirements for the 2008 ozone standard.
In CSAPR, the EPA proposed an air quality screening threshold of one percent of the applicable NAAQS and requested comment on whether one percent was appropriate.
In the final CSAPR, the EPA determined that one percent was a reasonable choice considering the combined downwind impact of multiple upwind states in the eastern United States, the health effects of low levels of fine particulate matter and ozone pollution, and the EPA's previous use of a one-percent threshold in CAIR. The EPA used a single “bright line” air quality threshold equal to one percent of the 1997 8-hour ozone standard, or 0.08 ppm.
CAA sections 110(a)(1) and (2) and section 110(l) require that revisions to a SIP be adopted by the State after reasonable notice and public hearing. The 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, a public comment period of at least 30 days, and an opportunity for a public hearing.
On May 11, 2015, Washington submitted a SIP to address the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS. The Washington submittal
With respect to the requirements in CAA section 110(a)(2)(D)(i)(I), the Washington submittal referred to applicable rules in the Washington SIP, 2011 National Emissions Inventory (NEI) data, and modeling conducted by the State using the Motor Vehicle Emission Simulator (MOVES2014, database version 20141021). Washington noted that efforts by the EPA and states to address ozone transport have historically been focused on reductions of nitrogen oxides (NO
The Washington submittal provided further information to support this conclusion by citing the stationary source permitting regulations approved into the Washington SIP that require new sources and modifications to protect the ambient air quality standards, including the 2008 ozone NAAQS. With respect to new or modified major stationary sources, the Prevention of Significant Deterioration (PSD) permitting program in the Washington SIP requires an owner or operator to demonstrate that the source will not contribute significantly to nonattainment or interfere with maintenance in another state.
On August 4, 2015, the EPA issued a Notice of Data Availability (NODA) containing air quality modeling data that applies the CSAPR approach to contribution projections for the year 2017 for the 2008 8-hour ozone NAAQS.
The modeling data released in the NODA on July 23, 2015, is the most up-to-date information the EPA has developed to inform our analysis of upwind state linkages to downwind air quality problems. For purposes of evaluating Washington's interstate transport SIP submittal with respect to the 2008 8-hour ozone standard, the EPA is proposing that states whose contributions are less than one percent to downwind nonattainment and maintenance receptors are considered non-significant. The modeling indicates that Washington's largest contribution to any projected downwind nonattainment site is 0.22 ppb and Washington's largest contribution to any projected downwind maintenance-only site is 0.09 ppb.
As discussed in Section II, Washington concluded that emissions from the State do not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state. The EPA's modeling, discussed in Section III, confirms this finding. Based on the modeling data and the information provided in Washington's May 11, 2015 submittal, we are proposing to approve the submittal for purposes of meeting the CAA section 110(a)(2)(D)(i)(I) requirements for the 2008 ozone standard. The EPA's modeling confirms the results of the State's analysis: Washington does not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to revise the Minnesota Federal implementation plan (FIP) for visibility, to establish emission limits for Northern States Power Company's (NSP's) Sherburne County Generating Station (Sherco), pursuant to a settlement agreement. The settlement agreement, signed by representatives of EPA, NSP, and three environmental groups, was for resolution of a lawsuit filed by the environmental groups for EPA to address any contribution from Sherco to reasonably attributable visibility impairment (RAVI) that the Department of Interior (DOI) certified was occurring at Voyageurs and Isle Royale National Parks.
Comments must be received on or before November 27, 2015.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0592, by one of the following methods:
1.
2.
3.
4.
5.
John Summerhays, Environmental Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6067,
This supplementary information section is arranged as follows:
Section 169A of the Clean Air Act provides for a visibility protection program and sets forth as a national goal “the prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas which impairment results from manmade air pollution.”
The visibility regulations also provide for periodic review, and revision as appropriate, of the long-term strategy for making reasonable progress toward the visibility goals, including review and revision as appropriate within three years of receipt of certification of RAVI from a Federal land manager (FLM). 40 CFR 51.306(c). The 36 affected states were required to submit revisions to their SIPs to comply with these requirements by September 2, 1981. 40 CFR 51.302(a)(1) (1981). See 45 FR 80084, 80091.
Most states did not meet the September 2, 1981 deadline for submitting a SIP revision to address visibility protection. A number of environmental groups sued EPA, alleging that the Agency had failed to perform a nondiscretionary duty under section 110(c) of the Clean Air Act to promulgate visibility FIPs. To settle the lawsuit, EPA agreed to promulgate visibility FIPs according to a specified schedule. On July 12, 1985, EPA promulgated a FIP for the visibility monitoring strategy and new source review (NSR) requirements at 40 CFR 51.304 and 51.307. 50 FR 28544. See also 51 FR 5504 (February 13, 1986) and 51 FR 22937 (June 24, 1986). These provisions have been codified at 40 CFR 52.26, 52.27 and 52.28. On November 24, 1987, EPA continued its visibility FIP rulemaking by promulgating its plan for meeting the general visibility plan requirements and long-term strategies of 40 CFR 51.302 and 51.306. 52 FR 45132. The long-term strategy provisions have been codified at 40 CFR 52.29; the provisions specifically pertaining to Minnesota are at 40 CFR 52.1236.
In the proposed rulemaking for the general visibility plan and long-term strategy requirements, EPA addressed certifications of existing visibility impairment submitted by the FLMs. 52 FR 7802 (March 12, 1987). EPA found that the information provided by the FLMs was not adequate to enable the Agency to determine whether the impairment was traceable to a single source or small number of sources and therefore addressable under the visibility regulations. For this reason, EPA determined that the implementation plans did not need to require best available retrofit technology (BART) or other control measures at that time. EPA also acknowledged, however, that the FLMs may certify the existence of visibility impairment at any time and that the FLMs therefore might provide additional information in the future on impairment that would allow EPA to attribute it to a specific source. EPA stated that in such cases, the information regarding impairment and the need for BART or other control measures would be reviewed and assessed as part of the periodic review of the long-term visibility strategy. 52 FR 7802, 7808. EPA affirmed these determinations in its final rulemaking. 52 FR 45136 (November 24, 1987).
Based on this history, unless and until Minnesota submits a plan that EPA approves as satisfying the RAVI-related visibility planning requirements, the current plan for addressing RAVI is a Federal plan, and EPA has the authority and obligation to review the RAVI plan for Minnesota periodically and to make any necessary revisions. The adoption of the emission limits being proposed here is an element of fulfilling that responsibility.
As will be discussed below, the settlement agreement regarding Sherco provides for the adoption of specified emission limits that address DOI's concerns that led to a RAVI certification at Voyageurs and Isle Royale National Parks. Because these emission limits will address the concerns DOI raised in its RAVI certification, there is no need for us to evaluate whether Sherco is the source of the impairment in Voyageurs or Isle Royale or to determine the emission levels that would be achieved by BART if BART were necessary.
On October 21, 2009, DOI certified to EPA that RAVI was occurring at the Voyageurs and Isle Royale National Parks, in Northern Minnesota and Northern Michigan, respectively. DOI cited numerous results from an analysis described in Minnesota's regional haze submittal, which in DOI's view demonstrated that Sherco was the source of this RAVI.
Separately, Minnesota submitted its regional haze plan on December 30, 2009, and submitted a proposed supplemental submission on January 5, 2012. In this plan as supplemented, Minnesota proposed no emission limits for Sherco (or for other electric generating units (EGUs) in Minnesota), relying instead on Federal trading program rules known as the Transport Rule to satisfy pertinent requirements for BART.
Minnesota submitted a final supplemental regional haze submittal on May 8, 2012. In this submittal, Minnesota submitted source-specific limits on sulfur dioxide (SO
On December 5, 2012, with subsequent amendments on March 25, 2015, the National Parks Conservation Association, Sierra Club, and the Minnesota Center for Environmental Advocacy filed a lawsuit in the U.S. District Court for the District of Minnesota seeking to compel action by EPA to address DOI's RAVI certification. On July 24, 2014, pursuant to action by the U.S. Court of Appeals for the Eighth Circuit, NSP gained standing as an intervenor in this case. These parties engaged in settlement discussions with EPA, leading to a draft settlement agreement that the parties signed on May 15, 2015. EPA published a notice soliciting comments on this settlement agreement on June 1, 2015, at 80 FR 31031. EPA received two sets of generally supportive comments, and on July 24, 2015, the Department of Justice notified the Eighth Circuit that the settlement agreement was final.
The terms of this settlement agreement require EPA to propose new SO
The settlement agreement further states that compliance with these emission limits must be determined on the basis of data obtained by a continuous emission monitor operated in accordance with 40 CFR part 75. Compliance with the limits, expressed as limits on 30-day average emissions, must be determined by dividing the sum of the SO
Finally, Paragraph 5 of the settlement agreement states that “Sherco Units 1 and 2 will achieve [its SO
Accordingly, under the proposed rule, the first compliance demonstration for Units 1 and 2 would be computed on October 1, 2015, using data from the immediately preceding 30 boiler-operating days. Similarly, the first compliance demonstration for Unit 3 would use data from the 30 boiler-operating days immediately preceding June 1, 2017. For example, under this proposed rule, if the boilers operate every day, the first 30-day period for which compliance at Units 1 and 2 is required is the period from September 1 to September 30, 2015, and the first 30-day period for which compliance at Unit 3 is required is May 2 to May 31, 2017.
EPA recognizes that the compliance deadline for Units 1 and 2 predates the prospective final rulemaking. Because NSP is a party to the settlement agreement, however, the company has had adequate notice that an initial demonstration of compliance with the limits for Units 1 and 2 would be required on October 1, 2015, notwithstanding provisions in the settlement agreement that would allow EPA to sign a final rulemaking as late as February 2016.
On August 11, 2015, DOI wrote to EPA regarding the settlement agreement. DOI recounted that its prior letter, dated October 21, 2009, had “identified visibility impairment at Voyageurs and Isle Royale National Parks likely attributable to [Sherco],” but noted that “a number of events have led or will lead to significant improvements in visibility at these Parks,” including the continued “trend of reducing sulfur dioxide emissions at Sherco” resulting from the settlement agreement. DOI concluded that “[a]lthough the settlement reaches a different result than the recommendation made in our [letter certifying RAVI], once implemented, the settlement achieves an outcome that addresses our visibility concerns at Voyageurs and Isle Royale National Parks.”
In light of this August 11, 2015 letter, EPA is proposing to find that the incorporation of these SO
In accordance with the settlement agreement signed on May 15, 2015, by representatives of EPA, three environmental groups, and NSP, EPA is
Additionally, in light of DOI's August 11, 2015 letter, EPA is proposing to find that the incorporation of these SO
This proposed action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). As discussed in detail in section IV.C below, the proposed FIP applies to only one source. It is therefore not a rule of general applicability.
This proposed action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute 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 organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of today's proposed 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 this proposed action on small entities, I certify that this proposed action will not have a significant economic impact on a substantial number of small entities. EPA's proposal adds additional controls to a certain source. The Regional Haze FIP revisions that EPA is proposing here would impose Federal control requirements to resolve concerns that one power plant in Minnesota is unduly affecting visibility at two national parks. The power plant and its owners are not small entities.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more (adjusted for inflation) in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 of UMRA do not apply when they are inconsistent with applicable law. Moreover, section 205 of UMRA allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
Under Title II of UMRA, EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures that exceed the inflation-adjusted UMRA threshold of $100 million by State, local, or Tribal governments or the private sector in any one year. In addition, this proposed rule does not contain a significant Federal
This rule 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 extends an existing FIP by promulgating emission limits for one source in accordance with a settlement agreement. Thus, Executive Order 13132 does not apply to this action. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
Executive Order 13175, entitled
Executive Order 13045:
This action 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 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.
The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.
Executive Order 12898 (59 FR 7629, February 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.
We have determined that this proposed rule, if finalized, will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Sulfur dioxide, Reporting and recordkeeping requirements, visibility protection.
40 CFR part 52 is proposed to be amended as follows:
42 U.S.C. 7401
(e)(1) On and after the 30-boiler-operating-day period ending on September 30, 2015, the owners and operators of the facility at 13999
(2) On and after the 30-boiler-operating-day period ending on May 31, 2017, the owners and operators of the facility at 13999 Industrial Boulevard in Becker, Sherburne County, Minnesota, shall not cause or permit the emission of SO
(3) The owners and operators of the facility at 13999 Industrial Boulevard in Becker, Sherburne County, Minnesota, shall operate continuous SO
(4) For each boiler operating day, compliance with the 30-day average limitations in paragraphs (e)(1) and (e)(2) of this section shall be determined by summing total emissions in pounds for the period consisting of the day and the preceding 29 successive boiler operating days, summing total heat input in MMBTU for the same period, and computing the ratio of these sums in lbs/MMBTU. Boiler operating day is used to mean a 24-hour period between 12 midnight and the following midnight during which any fuel is combusted at any time in the steam-generating unit. It is not necessary for fuel to be combusted the entire 24-hour period. A boiler operating day with respect to the limitation in paragraph (e)(1) of this section shall be a day in which fuel is combusted in either Unit 1 or Unit 2. Bias adjustments provided for under 40 CFR part 75 appendix A shall be applied. Substitute data provided for under 40 CFR part 75 subpart D shall not be used.
Environmental Protection Agency.
Proposed rule.
The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting air emissions that will have certain adverse air quality effects in other states. On June 28, 2010, the State of Oregon made a submittal to the Environmental Protection Agency (EPA) to address these requirements. The EPA is proposing to approve the submittal as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2008 ozone National Ambient Air Quality Standard (NAAQS) in any other state.
Written comments must be received on or before November 27, 2015.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2015-0259, by any of the following methods:
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•
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Kristin Hall at (206) 553-6357,
Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
Information is organized as follows:
On March 12, 2008, the EPA revised the levels of the primary and secondary 8-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436). The CAA requires states to submit, within three years after promulgation of a new or revised standard, SIPs meeting the applicable “infrastructure” elements of sections 110(a)(1) and (2). One of these applicable infrastructure elements, CAA section 110(a)(2)(D)(i), requires SIPs to contain “good neighbor” provisions to prohibit certain adverse air quality effects on neighboring states due to interstate transport of pollution. There are four sub-elements within CAA section 110(a)(2)(D)(i). This action
In CSAPR, the EPA used detailed air quality analyses to determine whether an eastern state's contribution to downwind air quality problems was at or above specific thresholds. If a state's contribution did not exceed the specified air quality screening threshold, the state was not considered “linked” to identified downwind nonattainment and maintenance receptors and was therefore not considered to significantly contribute to or interfere with maintenance of the standard in those downwind areas. If a state exceeded that threshold, the state's emissions were further evaluated, taking into account both air quality and cost considerations, to determine what, if any, emissions reductions might be necessary. For the reasons stated below, we believe it is appropriate to use the same approach we used in CSAPR to establish an air quality screening threshold for the evaluation of interstate transport requirements for the 2008 ozone standard.
In CSAPR, the EPA proposed an air quality screening threshold of one percent of the applicable NAAQS and requested comment on whether one percent was appropriate.
In the final CSAPR, the EPA determined that one percent was a reasonable choice considering the combined downwind impact of multiple upwind states in the eastern United States, the health effects of low levels of fine particulate matter and ozone pollution, and the EPA's previous use of a one-percent threshold in CAIR. The EPA used a single “bright line” air quality threshold equal to one percent of the 1997 8-hour ozone standard, or 0.08 ppm.
CAA sections 110(a)(1) and (2) and section 110(l) require that revisions to a SIP be adopted by the state after reasonable notice and public hearing. The 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, a public comment period of at least 30 days, and an opportunity for a public hearing.
On June 28, 2010, Oregon made a submittal to address the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the ozone NAAQS. The Oregon submittal included public process documentation on the interstate transport submittal, including a duly noticed public hearing held on December 22, 2009. Oregon subsequently notified the EPA that a clerical error was made and that all interstate transport SIP documents had not been attached to the June 28, 2010 cover letter. The State transmitted the remaining documents to the EPA on December 23, 2010. We find that the process followed by Oregon in adopting the SIP submittal complies with the procedural requirements for SIP revisions under CAA section 110 and the EPA's implementing regulations.
With respect to the requirements in CAA section 110(a)(2)(D)(i)(I), the Oregon submittal stated that the area of highest Oregon emission densities (Portland metropolitan area) is separated from the nearest ozone nonattainment areas (in Nevada and California) by significant distances and major mountain ranges up to approximately 7,000 feet. The submittal noted that the Portland metropolitan area shares a common airshed with Vancouver, Washington metropolitan area. This bi-state airshed historically violated the one-hour ozone standard and emissions in the area have been managed under the Portland-Vancouver ozone maintenance plan. The Portland-Vancouver area is in attainment with the 2008 ozone NAAQS.
The Oregon submittal stated that meteorology and prevailing wind direction, the effect of significant topography on transport of pollutants, and characteristics of emissions sources
The Oregon submittal also stated that Oregon Department of Environmental Quality consulted with air agencies in Washington, Idaho, Nevada, and California and other agencies to evaluate case-specific air quality problems that may involve regional transport of air pollution. These staff-level communications indicated no impacts on ozone concentrations in other states caused by transport from Oregon, and the submittal stated that this provided additional support for Oregon's assertion that emissions from Oregon sources do not significantly contribute to nonattainment in or interfere with maintenance of the 2008 ozone NAAQS in any other states.
On August 4, 2015, the EPA issued a Notice of Data Availability (NODA) containing air quality modeling data that applies the CSAPR approach to contribution projections for the year 2017 for the 2008 8-hour ozone NAAQS.
The modeling data released in the NODA on July 23, 2015, is the most up-to-date information the EPA has developed to inform our analysis of upwind state linkages to downwind air quality problems. For purposes of evaluating Oregon's interstate transport SIP with respect to the 2008 8-hour ozone standard, the EPA is proposing that states whose contributions are less than one percent to downwind nonattainment and maintenance receptors are considered non-significant. The modeling indicates that Oregon's largest contribution to any projected downwind nonattainment site is 0.65 ppb and Oregon's largest contribution to any projected downwind maintenance-only site is 0.65 ppb.
As discussed in Section II, Oregon concluded based on its own technical analysis that emissions from the State do not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state. The EPA's modeling, discussed in Section III, confirms this finding. Based on the modeling data and the information and analysis provided in Oregon's June 28, 2010 submittal, we are proposing to approve the submittal for purposes of meeting the CAA section 110(a)(2)(D)(i)(I) requirements for the 2008 ozone standard. The EPA's modeling confirms the results of the State's analysis: Oregon does not significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone standard in any other state.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because it does not involve technical standards; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to update a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by the Clean Air Act, as amended in 1990 (the Act). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which Maryland is the designated COA. In the Final Rules section of this
Comments must be received in writing by November 27, 2015.
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2014-0568 by one of the following methods:
A.
B.
C.
D.
Cathleen Van Osten, (215) 814-2746, or by email at
For further information, please see the information provided in the direct final action, with the same title, that is located in the “Rules and Regulations” section of this
This document was received for publication by the Office of the Federal Register on October 21, 2015.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes to implement a resolution adopted by the Inter-American Tropical Tuna Commission (IATTC) by requiring U.S. vessels, fishing for tuna and tuna-like species with a capacity equal to or greater than 100 gross resister tons (GRT), to have an International Maritime Organization (IMO) number. The IMO numbers will be included with information the United States sends to the IATTC for vessels authorized to fish in the IATTC Convention Area for tuna and tuna-like species, and will enable more effective tracking of vessels that may be engaging in illegal, unreported, and unregulated (IUU) fishing.
Comments must be submitted in writing by November 27, 2015. A public hearing will be held from 1 p.m. to 4 p.m. PST, on November 12, 2015, in Long Beach, CA.
You may submit comments on this proposed rule and supporting documents, including the Regulatory Flexibility Act certification and Regulatory Impact Review, identified by NOAA-NMFS-2015-0129, by any of the following methods:
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Chris Fanning, NMFS, West Coast Region, 562-980-4198.
NMFS is issuing a proposed rule under the authority of the Tuna Conventions Act of 1950, as amended (TCA), to implement the new regional vessel register (RVR) requirements in Resolution C-14-01 (
An IMO number is a unique vessel identifier that is permanently associated with the vessel hull, even if the vessel name changes or the vessel is reflagged to another nation. IMO numbers enable more effective tracking of vessels that may be engaging in IUU fishing. An estimated 120 U.S. vessels would be subject to this rule, of which approximately 90 percent already have an IMO number.
Resolution C-14-01 requires each member of the IATTC, including the United States, to maintain a record of its fishing vessels authorized to fish for tuna and tuna-like species in the IATTC Convention Area and to share the information in its record with the IATTC periodically for purposes of maintaining the RVR. In 2014, the IATTC decided to require an additional piece of information in members' records for fishing vessels of 100 GRT (or 100 gross tonnage (GT)) or greater: Either the IMO number or Lloyd's Register number. An IMO number, also known as an IMO ship identification number, is the number issued for a ship or vessel under the ship identification number scheme adopted by the IMO. As used in C-14-01, “Lloyd's Register number,” or “LR number,” has the same meaning as an IMO number except that an LR number refers to the number issued for a vessel not required to have an IMO number under IMO agreements. Accordingly, C-14-01 now requires IATTC members to ensure that IMO numbers or Lloyd's Register numbers are issued for such vessels. The administrator of the IMO ship identification number scheme issues both types of numbers using the same numbering scheme. Hereafter, “IMO number” is used to refer to both IMO numbers and Lloyd's Register numbers. IHS Maritime, located in Surrey, England, currently issues IMO numbers via their Web site at:
For each of the subject fishing vessels, the proposed rule would require that the owner of the fishing vessel either ensure that an IMO number has been issued for the vessel or apply to NMFS for an exemption from the requirement. Resolution C-14-01 (at footnote 1) allows for an exemption from the IMO number requirement in extraordinary circumstances if the vessel owner has followed all appropriate procedures to obtain a number. In the event that a fishing vessel owner, after following the instructions given by the designated manager of the IMO ship identification number scheme, is unable to ensure that an IMO number is issued for the fishing vessel, the fishing vessel owner may request an exemption from the requirement from the West Coast Regional Administrator. Upon receipt of a request for an exemption, the West Coast Regional Administrator will assist the fishing vessel owner in requesting an IMO number. If the West Coast Regional Administrator determines that the fishing vessel owner has followed all appropriate procedures and yet is unable to obtain an IMO number for the fishing vessel, he or she will issue an exemption from the requirements for the vessel and its owner, and notify the owner of the exemption. NMFS notes that IHS Maritime is a private third party, and it is conceivable that an eligible vessel may not be able to complete the necessary steps and supply the required information, resulting in a denied vessel number request.
To minimize the burden on affected U.S. businesses, NMFS is not proposing to require that vessel owners report the IMO numbers associated with their vessel to NMFS. NMFS will collect that information via data available from the United States Coast Guard and IHS Maritime directly.
The NMFS Assistant Administrator has determined that this proposed rule is consistent with the TCA and other applicable laws, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this action would not have a significant economic impact on a substantial number of small entities.
The small entities to which the proposed action would apply are all U.S. commercial fishing vessels that may target tuna and tuna-like species in the IATTC Convention Area. As of August 2015, there are 1,798 Pacific Highly Migratory Species permits. Of these, 118 vessels are 100 GRT or greater and 104 of the vessels have already been issued an IMO number. Thus, the proposed action would initially require 14 vessels to obtain IMO numbers. For these 14 vessels, the average annual revenue per vessel from all finfish fishing activities since 2010 has been $1.3 million, and less than $20.5 million when considering both an individual vessel or per vessel average. Complying with the IMO number requirement in this proposed action requires no out-of-pocket expenses because applications are free. The 30 minutes estimated to apply for an IMO number would not result in a significant opportunity cost to the fisherman considering it is a one-time occurrence for the life of the vessel hull. The rule is not expected to change fishery operations. Accordingly, the impact of this rule on the affected vessel owners' and operators' income is expected to be de minimis.
This proposed rule contains a collection-of-information requirement subject to the Paperwork Reduction Act (PRA), which has been approved by the Office of Management and Budget (OMB) under control numbers 0648-0387. A request for revision to account for the additional information that would be required pursuant this rule is under OMB review. Public reporting burden for obtaining an IMO number, or for making an IMO exemption request are each estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at:
Administrative practice and procedure, Fish, Fisheries, Fishing, Marine resources, Vessels, Reporting and record keeping requirements, Treaties.
For the reasons set out in the preamble, 50 CFR part 300, subpart C, is proposed to be amended as follows:
16 U.S.C. 951
(b) * * *
(3)
(ii)
(iii)
(iv)
(v)
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of corn events Bayer/Genective S.A.VCO-01981-5 (hereinafter Genective VCO-01981-5 corn) and Pioneer's DP-004114-3 (hereinafter Pioneer 4114 corn) to Syngenta's corn event MZHG0JG in response to a request from Syngenta Seeds Inc. MZHG0JG corn has been genetically engineered for resistance to the herbicide glyphosate using the same mechanism of action as Genective VCO-01981-5 and also to be resistant to the herbicide glufosinate using the same mechanism of action as Pioneer 4114. We are making available for public comment our preliminary finding of no significant impact for the proposed determination of nonregulated status.
We will consider all comments that we receive on or before November 27, 2015.
You may submit comments by either of the following methods:
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The Syngenta Seeds Inc. extension request, our preliminary finding of no significant impact, our preliminary determination, and any comments we receive on this docket may be viewed at
Supporting documents and any comments we received regarding our determination of nonregulated status of the antecedent organisms, Genective VCO-01981-5 corn and Pioneer 4114 corn, can be found at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147 Riverdale, MD 20737-1236; (301) 851-3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (PPA) (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Further, the regulations in § 340.6(e)(2) provide that a person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request must include information to establish the similarity of the antecedent organism and the regulated article in question.
On September 25, 2013,
As described in the extension request, MZHG0JG corn was developed through agrobacterium-mediated transformation to stably incorporate the transgenes
As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS evaluates the plant pest risk of the article. In section 403 of the PPA, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing.
APHIS completed plant pest risk assessments (PPRA) on the antecedent organisms in which we concluded that Genective VCO-01981-5 corn and Pioneer 4114 corn are unlikely to present plant pest risks. APHIS also prepared a plant pest risk similarity assessment (PPRSA) to compare MZHG0JG to the antecedents. As described in the PPRSA, the proteins expressed in MZHG0JG corn are similar to those expressed in Genective VCO-01981-5 corn and Pioneer 4114 corn, and APHIS has concluded that the proteins expressed in Genective VCO-01981-5 corn and Pioneer 4114 corn are unlikely to affect the plant pest risk of Genective VCO-01981-5 corn and Pioneer 4114 corn. Furthermore, the Environmental Protection Agency reviewed the safety of the proteins expressed in MZHG0JG corn and concluded that adverse effects will not occur to nontarget organisms. Therefore, based on our PPRAs for Genective VCO-01981-5 corn and Pioneer 4114 corn and the similarity between Genective VCO-01981-5 corn, Pioneer 4114 corn, and MZHG0JG corn as described in the PPRSA, APHIS has concluded that the proteins expressed in MZHG0JG corn are unlikely to pose a plant pest risk and that MZHG0JG corn is unlikely to pose a different plant pest risk than Genective VCO-01981-5 corn and Pioneer 4114 corn.
APHIS also prepared an environmental assessment (EA) for MZHG0JG corn based on our analysis of data submitted by Syngenta, a review of other scientific data, and field tests conducted under APHIS oversight. The EA was prepared to provide the APHIS decisionmaker with a review and analysis of any potential environmental impacts associated with the determination of nonregulated status for MZHG0JG corn. The EA was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
In addition, APHIS has carefully examined the existing NEPA documentation completed for Genective VCO-01981-5 corn and Pioneer 4114 corn and has concluded that Syngenta's request to extend a determination of nonregulated status to MZHG0JG corn encompasses the same scope of environmental analysis as Genective VCO-01981-5 corn and Pioneer 4114 corn. Therefore, based on the similarity of MZHG0JG corn to Genective VCO-01981-5 corn and Pioneer 4114 corn, APHIS has prepared a preliminary finding of no significant impact (FONSI) on MZHG0JG corn. APHIS is considering the following alternatives: (1) Take no action,
APHIS has analyzed information submitted by Syngenta, references provided in the extension request, peer-reviewed publications, and information in the EAs of the antecedent organisms. APHIS has also analyzed information in the PPRAs for the antecedent organisms, and other information. Based on APHIS' analysis of this information, the similarity of MZHG0JG corn to the antecedent organisms, our conclusion that the proteins expressed in MZHG0JG corn are unlikely to pose a plant pest risk, and our conclusion that MZHG0JG corn is unlikely to pose a different plant pest risk than Genective VCO-01981-5 corn and Pioneer 4114 corn, APHIS has determined that MZHG0JG corn is unlikely to pose a plant pest risk. We have therefore reached a preliminary decision to approve the request to extend the determination of nonregulated status of Genective VCO-01981-5 corn and Pioneer 4114 corn to MZHG0JG corn, whereby MZHG0JG corn would no longer be subject to our regulations governing the introduction of certain genetically engineered organisms.
Paragraph (e) of § 340.6 provides that APHIS will publish a notice in the
APHIS will accept written comments on the preliminary FONSI regarding a determination of nonregulated status of MZHG0JG corn for a period of 30 days from the date this notice is published in the
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information. All comments will be available for public review. After reviewing and evaluating the comments, if APHIS determines that no substantive information has been received that would warrant APHIS altering its preliminary regulatory determination or FONSI, our preliminary regulatory determination will become final and effective upon notification of the public through an announcement on our Web site at
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public of our determination that maize designated as event MON 87411, which has been genetically engineered for protection against corn rootworm and resistance to the herbicide glyphosate, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Monsanto Company in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notices announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
Effective October 27, 2015.
You may read the documents referenced in this notice and the comments we received at
Supporting documents are also available on the APHIS Web site at
Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email:
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 13-290-01p) from Monsanto Company (Monsanto) of St. Louis, MO, seeking a determination of nonregulated status of maize (
According to our process
APHIS received 423 comments on the petition. Issues raised during the comment period include the contamination of conventional crop production, the potential for disruption of trade due to the presence of unwanted genetically engineered commodities in exports, the potential for negative impacts to plant fitness and the environment, and health concerns. APHIS decided, based on its review of the petition and its evaluation and analysis of the comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises substantive new issues. According to our public review process for such petitions (see footnote 1), APHIS first solicits written comments from the public on a draft environmental assessment (EA) and a preliminary plant pest risk assessment (PPRA) for a 30-day comment period through the publication of a
APHIS sought public comment on a draft EA and a preliminary PPRA from June 1, 2015, to July 1, 2015.
After reviewing and evaluating the comments received during the comment period on the draft EA and preliminary PPRA and other information, APHIS has prepared a final EA. The EA has been prepared to provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the determination of nonregulated status of maize designated as event MON 87411. The EA was prepared in accordance with: (1) NEPA, as amended (42 U.S.C. 4321
Based on APHIS' analysis of field and laboratory data submitted by Monsanto, references provided in the petition, peer-reviewed publications, information analyzed in the EA, the PPRA, comments provided by the public, and information provided in APHIS' response to those public comments, APHIS has determined that maize designated as event MON 87411 are unlikely to pose a plant pest risk and therefore are no longer subject to our regulations governing the introduction of certain GE organisms.
Copies of the signed determination document, PPRA, final EA, FONSI, and response to comments, as well as the previously published petition and supporting documents, are available as indicated in the
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (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 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Corrected Notice of Intent to prepare an environmental impact statement.
A Notice of Intent (NOI) for this project was first published in the
Comments submitted previously will be considered in the analysis. This corrected NOI triggers a public comment opportunity during which persons wishing to obtain standing under the pre-decisional administrative review, or “objection” process (36 CFR 218, Subpart B), may submit timely, written comments regarding the project. New or additional comments should be received by the Wrangell Ranger District by November 27, 2015, 30 days from date of publication of this Corrected NOI in the
Send written comments to: Tongass National Forest, c/o Andrea Slusser, P.O. Box 51, Wrangell, AK 99929, Attn: Wrangell Island Project EIS. Comments may be hand-delivered to the Wrangell Ranger District, 525 Bennett Drive, Wrangell, AK 99929, Attn: Wrangell Island Project EIS. Comments may also be sent via email to:
In all correspondence, please include your name, address, and organization name if you are commenting as a representative of an organization.
Andrea Slusser, Team Leader; Wrangell Ranger District, P.O. Box 51, Wrangell, AK 99929, 907-874-2323.
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The purpose of the Wrangell Island Project is to respond to the goals and objectives identified by the Tongass Land and Resource Management Plan (Forest Plan) to guide timber management to support the local and regional economies of Southeast Alaska, while moving the Wrangell Island Project Area towards the desired future condition for all resources.
The underlying need for the Wrangell Island Project comes from the Forest Service's obligation, subject to applicable law, to seek to provide a supply of timber from the Tongass National Forest that meets market demand annually and for the planning cycle, and to restore and improve forest resources to a condition where they provide increased benefits to society.
This project would contribute to the orderly flow of timber to large and small timber purchasers, mill operators, and value-added wood product industries in Southeast Alaska and benefit the local and regional economies of Wrangell and Southeast Alaska while also improving forest resource conditions. This project would help provide a reliable, long-term supply of “bridge” timber that would support local jobs and facilitate the industry transition to a sustainable wood product industry based on young-growth management on the Tongass National Forest.
The Forest Service is proposing a multi-year project involving timber harvest and associated road construction and forest restoration activities. The proposed action includes the harvest of timber from approximately 5,290 acres of forested land. The harvest would produce an estimated 73 million board feet (MMBF) of sawtimber and utility wood that could be made available to industry. Timber harvest would occur with both even-aged (clearcut) and uneven-aged (partial cut) harvest using cable, helicopter and ground-based methods.
The timber harvest would require approximately 18 miles of National Forest Road construction, six miles of reconstruction and approximately 13 miles of temporary road construction. Existing road systems and log transfer facilities would also be used as needed to transport the timber.
Integrated restoration activities associated with the road system used for harvest would include road maintenance and improvements, invasive species treatments, erosion control, and fish passage improvements. All activities would be conducted in a
In addition to the proposed action and the no action alternative, the Forest Service is considering a range of action alternatives with varying levels of harvest and road construction based on public input received to date. Because the Forest Plan is now undergoing an amendment process, the project will not propose any project-specific Forest Plan amendments.
The responsible official for this project is M. Earl Stewart, Forest Supervisor, Tongass National Forest, Federal Building, 648 Mission Street, Ketchikan, Alaska 99901.
The responsible official will decide: (1) The estimated timber volume to make available from the project, as well as the location, design, and scheduling of timber harvest, road construction and reconstruction, and silvicultural practices used; (2) road and access management; (3) mitigation measures and monitoring requirements; and (4) whether there may be a significant restriction on subsistence uses.
The initial scoping identified preliminary issues and concerns which may be analyzed in the EIS to disclose potential effects of the project on the following: Timber supply, timber sale economics, supporting the timber industry through the transition from old-growth harvest to young-growth management, road and access management, economic and rural stability, wildlife habitat, aquatic habitat (fisheries/hydrology/watersheds), soil productivity and slope stability, invasive species, heritage resources, roadless area characteristics, scenery, recreation, subsistence use, and climate change and carbon cycling. Preliminary key issues identified include timber supply, timber demand, scenery, wildlife habitat and access management.
All necessary permits would be obtained prior to project implementation, and may include the following:
• Review Spill Prevention Control and Countermeasure Plan State of Alaska, Department of Environmental Conservation;
• Solid Waste Disposal Permit State of Alaska, Department of Natural Resources;
• Authorization for occupancy and use of tidelands and submerged lands.
The initial scoping period started when the NOI was published in 2010. This proposal has been listed on the Tongass National Forest Schedule of Proposed Actions since January, 2011. An updated scoping document has been posted on the Tongass National Forest public Web site at
It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions. Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record. Comments submitted anonymously will also be accepted and considered.
Natural Resources Conservation Service (NRCS), United States Department of Agriculture (USDA).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces NRCS' intent to request an extension for currently approved information collection, Volunteer Program—Earth Team. This information collection is set to expire December 31, 2015. NRCS is seeking to extend the expiration date for the volunteer Interest and Placement Summary form and the Timesheet form to December 31, 2018. The collected information helps NRCS to match the skills of individuals interested in volunteering for opportunities that will further the agency's mission. Information will be collected from potential volunteers who are 14 years of age or older.
Comments received by December 28, 2015 will be considered.
Comments should be submitted and identified by Docket Number NRCS-2015-0012, using either of the following methods:
•
•
NRCS will post comments on
Requests for additional information or copies of the information collection instrument should be directed to Michele Brown, National Volunteer Coordinator, 4407 121st Street, Urbandale, Iowa 50323; telephone: (515) 270-4864, ext. 102, and email:
Comments are invited on (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, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record.
The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (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 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Bureau of the Census, Commerce.
Notice of Final Program.
The Census Bureau hereby announces that it will streamline the production and release of American Community Survey (ACS) Summary Level 070 tables (state/county/county subdivision/place remainder (or part)) to the 15 tables necessary for the delineation of metropolitan, micropolitan, and related statistical areas as defined by the Office of Management and Budget (OMB). The ACS collects detailed demographic, social, economic, and housing data from about 3.5 million addresses in the United States and 36,000 in Puerto Rico each year. Annual data products are released in the form of 1-Year and 5-Year estimates with 5-Year estimates being produced for over 578,000 geographies by 87 different summary levels. Most summary levels and their corresponding geographies are then produced for approximately 1,000 detailed tables. As a cost-saving measure and to improve the usability of the estimates, the Census Bureau has decided to streamline the production and release of Summary Level 070 tables to the 15 tables necessary for delineation. Based on data user analytics, customer feedback, and responses from an earlier
This Notice will be effective on December 10, 2015.
KaNin Reese, Room 7H176F, U.S. Census Bureau, Social, Economic, and Housing Statistics Division, Washington, DC 20233, by phone at 301-763-3493 or via email at
Beginning with the 2010-2014 ACS 5-Year tables, the Census Bureau will streamline the production and release of Summary Level 070 tables (state/county/county subdivision/place remainder (or part)) to the 15 tables necessary for the delineation of metropolitan, micropolitan, and related statistical areas (particularly for identification of New England City and Town Area principal cities) by OMB, for other commuting analysis, and for basic demographic and housing analysis. The Census Bureau conducts the ACS program under 13 U.S.C. Sections 141 and 193. Streamlining the tables in this summary level will save the Census Bureau over $100,000 over a 5-Year period.
The Census Bureau has been reviewing and documenting the utility of releasing Summary Level 070 for all 1,000 tables for several years. In our last release, this summary level was produced for 69,939 unique geographies for about 1,000 tables with approximately 70 percent of all estimates produced as zero since place parts in county subdivisions represent very small areas. Not only is the data quality insufficient for many of the individual geographies, but very few data users are accessing the tables on American FactFinder or the summary files on the Census File Transfer Protocol (FTP) site. Further, based on user feedback, we have increasing concern that data users may be using the summary level incorrectly, mistaking these place parts in county subdivisions for place-level geographies.
Since the ACS was created as the replacement for the Census long-form, the ACS began by producing the same summary levels that were produced in Census 2000. The purpose of Summary Level 070 (state/county/county subdivision/place remainder (or part)) is for the delineation of metropolitan, micropolitan, and related statistical areas under OMB standards. However, not all of the 1,000 detailed tables being produced for this summary level are needed for delineation. The Census Bureau has identified ten commuting tables necessary for the delineation process and for other commuting analysis, and five basic demographic and housing tables necessary for the tabulation of the summary level.
1. B01001—Sex by Age
2. B01003—Total Population
3. B02001—Race
4. B08007—Sex of Workers by Place of Work—State and County Level
5. B08008—Sex of Workers by Place of Work—Place Level
6. B08009—Sex of Workers by Place of Work—Minor Civil Division Level for 12 Selected States (CT, ME, MA, MI, MN, NH, NJ, NY, PA, RI, VT, WI)
7. B08301—Means of Transportation to Work
8. B08302—Time Leaving Home to Go to Work
9. B08303—Travel Time to Work
10. B08601—Means of Transportation to Work for Workplace Geography
11. B08602—Time Arriving at Work from Home for Workplace Geography
12. B08603—Travel Time to Work for Workplace Geography
13. B08604—Worker Population for Workplace Geography
14. B25001—Housing Units
15. B25003—Tenure
Due to limited resources available to produce the full product package and limited user need, the Census Bureau has concluded that it will only produce the 15 tables above for Summary Level 070. If additional estimates are needed from this summary level, data users are encouraged to use block group or tract-level data, which will continue to be available on American FactFinder, the Census Application Programming Interface (API), and the summary files on the FTP site. Data are available at:
The Census Bureau published a Notice and Request for Comments on streamlining tables for Summary Level 070 in the
In response to the commenter, the Census Bureau explained that due to budgetary constraints to the ACS, we could not continue to produce all tables for a summary level with so many geographies that so few people were using when the majority of the estimates were zero. However, 15 tables will continue to be produced for that summary level, which will provide basic demographic, housing, and commuting analysis as well as those tables necessary for the delineation of metropolitan, micropolitan, and related statistical areas (particularly for identification of New England City and Town Area principal cities) by OMB. Based on the singular user response, the Census Bureau determined that the need for this summary level was not substantial enough to warrant expenditure of the resources needed to produce it. Therefore, the Census Bureau determined that the original 15 tables selected to continue to be produced in Summary Level 070 were sufficient, and no other tables were added.
The Census Bureau believes that these tables are sufficient for data user needs for this summary level. For data users who are accustomed to using Summary Level 070 tables, the Census Bureau suggests using block group or tract-level data, which will continue to be released annually through American FactFinder, Census API, and the summary files on the FTP site. By releasing only a few key demographic, social, and housing tables for this summary level, the Census Bureau believes that we are still meeting the true purpose, and maintaining the integrity, of Summary Level 070 tables while substantially reducing resources needed for the full production of the product.
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).
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
Enforcement and Compliance, International Trade Administration, Department of Commerce.
James Terpstra, at (202) 482-3965, or Alex Rosen, at (202) 482-7814, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On September 30, 2015, the Department of Commerce (“the Department”) received an antidumping duty (“AD”) petition concerning imports of welded stainless pressure pipe (“welded stainless pipe”) from India filed in proper form on behalf of Bristol Metals, LLC, Felker Brothers Corporation, Outokumpu Stainless Pipe, Inc., and Marcegaglia USA Inc. (collectively, “Petitioners”).
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the “Act”), Petitioners allege that imports of welded stainless pipe from India are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to Petitioners supporting their allegations.
The Department finds that Petitioners filed this Petition on behalf of the domestic industry because Petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that Petitioners have demonstrated sufficient industry support with respect to the initiation of the AD investigation that Petitioners are requesting.
Because the Petition was filed on September 30, 2015, pursuant to 19 CFR 351.204(b)(1), the period of investigation (“POI”) is July 1, 2014, through June 30, 2015.
The product covered by this investigation is welded stainless pipe from India. For a full description of the scope of the investigation,
During our review of the Petition, the Department issued questions to, and received responses from, Petitioners pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
The Department requests that any factual information the parties consider relevant to the scope of the investigation
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”).
The Department requests comments from interested parties regarding the appropriate physical characteristics of welded stainless pipe to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors and costs of production accurately as well as to develop appropriate product-comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, while there may be some physical product characteristics utilized by manufacturers to describe welded stainless pipe, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all comments on product characteristics must be filed by 5 p.m. Eastern Time on November 10, 2015. Rebuttal comments must be received by 5 p.m. Eastern Time on November 20, 2015. All comments and submissions to the Department must be filed electronically using ACCESS, as referenced above.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (“ITC”), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that welded stainless pipe constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether Petitioners have standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in Appendix I of this notice. To establish industry support, Petitioners provided their shipments of the domestic like product in 2014, and compared their shipments to the estimated total shipments of the domestic like product
Our review of the data provided in the Petition, General Issues Supplement, and other information readily available to the Department indicates that Petitioners have established industry support.
The Department finds that Petitioners filed the Petition on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act and they have demonstrated sufficient industry support with respect to the AD investigation that they are requesting the Department initiate.
Petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (“NV”). In addition, Petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
Petitioners contend that the industry's injured condition is illustrated by reduced market share; decline in shipments, production, and capacity utilization; underselling and price suppression or depression; inventory overhang; decreased employment, hours worked, and wages; lost sales and revenues; and negative impact on profitability.
The following is a description of the allegations of sales at less-than-fair-value upon which the Department based its decision to initiate an investigation of imports of welded stainless pipe from India. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the India AD Initiation Checklist.
Petitioners based U.S. price on Indian welded stainless pipe offered for sale in the United States.
Petitioners based normal value on a price quote obtained by a market researcher for welded stainless pipe produced and sold in India having the same specifications as the welded stainless pipe in the U.S. price quote.
Based on the data provided by Petitioners, there is reason to believe that imports of welded stainless pipe from India are being, or are likely to be, sold in the United States at less than fair value. Based on comparisons of EP to NV in accordance with section 773(a)(1) of the Act, the estimated dumping margins as calculated from data provided by the Petitioners and recalculated by the Department for welded stainless pipe from India is 32.06 percent.
Based upon the examination of the Petition on welded stainless pipe India, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating an AD investigation to determine whether imports of welded stainless pipe from India is being, or are likely to be, sold in the United States at less than fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no
On June 29, 2015, the President of the United States signed into law the Trade Preferences Extension Act of 2015, which made numerous amendments to the AD and CVD law.
Petitioners name 13 companies as producers/exporters of welded stainless pipe from India.
Interested parties wishing to comment regarding respondent selection must do so within seven business days of the publication of this notice. Comments must be filed electronically using ACCESS. An electronically-filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5 p.m. Eastern Time by the date noted above. We intend to make our decision regarding respondent selection within 20 days of publication of this notice.
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petition have been provided to the Government of India
We have notified the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of welded stainless pipe from India is materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10 a.m. Eastern Time on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to section 777(i) of the Act.
The merchandise covered by this investigation is circular welded austenitic stainless pressure pipe not greater than 14 inches in outside diameter. References to size are in nominal inches and include all products within tolerances allowed by pipe specifications. This merchandise includes, but is not limited to, the American Society for Testing and Materials (“ASTM”) A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications. ASTM A-358 products are only included when they are produced to meet ASTM A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications.
Excluded from the scope of the investigation are: (1) Welded stainless mechanical tubing, meeting ASTM A-554 or comparable domestic or foreign specifications; (2) boiler, heat exchanger, superheater, refining furnace, feedwater heater, and condenser tubing, meeting ASTM A-249, ASTM A-688 or comparable domestic or foreign specifications; and (3) specialized tubing, meeting ASTM A-269, ASTM A-270 or comparable domestic or foreign specifications.
The subject imports are normally classified in subheadings 7306.40.5005, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085 of the Harmonized Tariff Schedule of the United States (“HTSUS”). They may also enter under HTSUS subheadings 7306.40.1010, 7306.40.1015, 7306.40.5042, 7306.40.5044, 7306.40.5080, and 7306.40.5090. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce
Effective date: October 20, 2015
Laurel LaCivita at (202) 482-4243, or Mandy Mallott at (202) 482-6430, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On September 30, 2015, the Department of Commerce (“Department”) received a countervailing duty (“CVD”) petition concerning imports of welded stainless pressure pipe (“welded stainless pipe”) from India, filed in proper form on behalf of Bristol Metals, LLC, Felker Brothers Corp, Outokumpu Stainless Pipe, Inc., and Marcegaglia USA (collectively, “Petitioners”). The CVD petition was accompanied by an antidumping duty (“AD”) petition concerning imports of welded stainless pipe from India.
On October 2, 2015, the Department requested information and clarification for certain areas of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (“the Act”), Petitioners allege that the Government of India (“GOI”) is providing countervailable subsidies (within the meaning of sections 701 and 771(5) of the Act) to imports of welded stainless pipe from India, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 702(b)(1) of the Act, for those alleged programs in India on which we have initiated a CVD investigation, the Petition is accompanied by information reasonably available to Petitioners supporting their allegations.
The Department finds that Petitioners filed the Petition on behalf of the domestic industry because Petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that Petitioners demonstrated sufficient industry support with respect to the initiation of the CVD investigation that Petitioners are requesting.
The period of investigation is January 1, 2014, through December 31, 2014.
The product covered by this investigation is welded stainless pipe from India. For a full description of the scope of this investigation,
During our review of the Petition, the Department issued questions to, and received responses from, Petitioners pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.
The Department requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the record of the concurrent AD investigation.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”).
Pursuant to section 702(b)(4)(A)(i) of the Act, the Department notified representatives of the GOI of the receipt of the Petition. Also, in accordance with section 702(b)(4)(A)(ii) of the Act, the Department provided representatives of the GOI the opportunity for consultations with respect to the CVD petition. As the GOI did not request consultations prior to the initiation of this investigation, the Department and the GOI did not hold consultations.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (“ITC”), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that welded stainless pipe constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether Petitioners have standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in Appendix I of this notice. To establish industry support, Petitioners provided their shipments of the domestic like product in 2014, and compared their shipments to the estimated total shipments of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, General Issues Supplement, and other information readily available to the Department indicates that Petitioners have established industry support.
The Department finds that Petitioners filed the Petition on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act and they have demonstrated sufficient industry support with respect to the CVD investigation that they are requesting the Department initiate.
Because India is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from India materially injure, or threaten material injury to, a U.S. industry.
Petitioners allege that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In CVD petitions, section 771(24)(A)-(B) of the Act provides that imports of subject merchandise from developing and least developed countries must exceed the negligibility threshold of four percent. Petitioners demonstrate that subject imports from India, which has been designated as a least developed country,
Petitioners contend that the industry's injured condition is illustrated by reduced market share; decline in shipments, production, and capacity utilization; underselling and price suppression or depression; inventory overhang; decreased employment, hours worked, and wages; lost sales and revenues; and negative impact on profitability.
Section 702(b)(1) of the Act requires the Department to initiate a CVD investigation whenever an interested party files a CVD petition on behalf of an industry that: (1) Alleges the elements necessary for an imposition of a duty under section 701(a) of the Act; and (2) is accompanied by information reasonably available to Petitioners supporting the allegations.
Petitioners allege that producers/exporters of welded stainless pipe in India benefit from countervailable subsidies bestowed by the GOI. The Department examined the Petition and finds that it complies with the requirements of section 702(b)(1) of the Act. Therefore, in accordance with section 702(b)(1) of the Act, we are initiating a CVD investigation to determine whether manufacturers, producers, or exporters of welded stainless pipe from India receive countervailable subsidies from the GOI.
On June 29, 2015, the President of the United States signed into law the Trade Preferences Extension Act of 2015, which made numerous amendments to the AD and CVD law.
Based on our review of the petition, we find that there is sufficient information to initiate a CVD investigation on 25 of the 50 alleged programs in India. For a full discussion of the basis for our decision to initiate or not initiate on each program,
In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.
Petitioners named thirteen companies as producers/exporters of welded stainless pipe in India.
Comments must be filed electronically using ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS, by 5 p.m. ET by the date noted above. We intend to make our decision regarding respondent selection within 20 days of publication of this notice. Interested parties must submit
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOI
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of welded stainless pipe from India are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). The regulation requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties should review the regulations prior to submitting factual information in this investigation.
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act.
The merchandise covered by this investigation is circular welded austenitic stainless pressure pipe not greater than 14 inches in outside diameter. References to size are in nominal inches and include all products within tolerances allowed by pipe specifications. This merchandise includes, but is not limited to, the American Society for Testing and Materials (“ASTM”) A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications. ASTM A-358 products are only included when they are produced to meet ASTM A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications.
Excluded from the scope of the investigation are: (1) Welded stainless mechanical tubing, meeting ASTM A-554 or comparable domestic or foreign specifications; (2) boiler, heat exchanger, superheater, refining furnace, feedwater heater, and condenser tubing, meeting ASTM A-249, ASTM A-688 or comparable domestic or foreign specifications; and (3) specialized tubing, meeting ASTM A-269, ASTM A-270 or comparable domestic or foreign specifications.
The subject imports are normally classified in subheadings 7306.40.5005, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085 of the Harmonized Tariff Schedule of the United States (“HTSUS”). They may also enter under HTSUS subheadings 7306.40.1010, 7306.40.1015, 7306.40.5042, 7306.40.5044, 7306.40.5080, and 7306.40.5090. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of this investigation is dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that National Museum of Natural History (NMNH), Smithsonian Institution (Charles W. Potter, Responsible Party), PO Box 37012, Washington, DC 20013 has been issued a minor amendment to Scientific Research Permit No. 14628.
The amendment and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Jennifer Skidmore or Amy Sloan, (301) 427-8401.
The requested amendment has been granted under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
The original permit (No. 14628), issued on November 18, 2010 (75 FR 72794) authorizes the salvage, collection, importation, exportation, receipt, possession, archive, and analyses of marine mammal and endangered species parts under NMFS jurisdiction. No live animal takes and no incidental harassment of animals are authorized. Parts are archived by the NMNH and used to support research studies and incidental education. The minor amendment (No. 14628-01) extends the duration of the permit for one year, through November 30, 2016, but does not change any other terms or conditions of the permit.
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 NOAA Office of Education's Bay Watershed Education and Training (B-WET) program seeks to contribute to NOAA's mission by supporting education efforts to create an environmentally literate citizenry with the knowledge, attitudes, and skills needed to protect watersheds and related ocean, coastal, and Great Lakes ecosystems. B-WET currently funds projects in seven regions (California, Chesapeake Bay, Great Lakes, Gulf of Mexico, Hawaii, New England, and the Pacific Northwest). B-WET has created an across-region, internal evaluation system to provide ongoing feedback on program implementation and outcomes to ensure maximum quality and efficiency of the B-WET program. The evaluation system is sustained by B-WET staff with occasional assistance from an outside contractor.
B-WET awardees and the awardees' professional development teacher-participants are asked to voluntarily complete online survey forms to provide evaluation data. One individual from each awardee organization is asked to complete a form once per year of the award, and the teacher participants are asked to complete one form at the end of their professional development program and another form at the end of the following school year.
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 Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental take authorization.
In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the Bergerson Construction, Inc. (Bergerson) to take, by Level B harassment, small numbers of two species of marine mammals incidental to the Front Street Transload Facility construction project in Newport, Oregon, between November 1, 2015, and October 31, 2016.
Effective November 1, 2015, through October 31, 2016.
Requests for information on the incidental take authorization should be addressed to Jolie Harrison, Chief,
Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings 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.”
Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for a one-year authorization to incidentally take small numbers of marine mammals by harassment, provided that there is no potential for serious injury or mortality to result from the activity. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization.
On April 22, 2015, Bergerson submitted a request to NMFS requesting an IHA for the possible harassment of small numbers of Pacific harbor seal (
A detailed description of the Front Street Transload Facility construction project is provided in the
A notice of NMFS' proposal to issue an IHA to Bergerson was published in the
The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area are Pacific harbor seal (
General information on the marine mammal species found in Oregon coastal waters can be found in Caretta
The effects of underwater noise from in-water pile removal and pile driving associated with the construction activities for the Front Street Transload Facility in Newport, Oregon, has the potential to result in behavioral harassment of marine mammal species and stocks in the vicinity of the action area. The Notice of Proposed IHA included a discussion of the effects of anthropogenic noise on marine mammals, which is not repeated here. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of the construction activities given the strong likelihood that marine mammals would avoid the immediate vicinity of the pile driving area.
The primary potential impacts to marine mammals and other marine species are associated with elevated sound levels, but the project may also result in additional effects to marine mammal prey species and short-term local water turbidity caused by in-water construction due to pile removal and pile driving. These potential effects are
In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.
For the Front Street Transload Facility construction project, NMFS is requiring Bergerson to implement the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the in-water construction activities.
Work shall occur only during daylight hours, when visual monitoring of marine mammals can be conducted. In addition, all in-water construction will be limited to the period between November 1, 2015, and February 15, 2016.
Bergerson is required to install an air bubble curtain system around the pile during pile installation using an impact hammer.
Before the commencement of in-water pile driving activities, Bergerson shall establish Level A exclusion zones and Level B zones of influence (ZOIs). The received underwater sound pressure levels (SPLs) within the exclusion zone would be 190 dB (rms) re 1 µPa and above. The Level B ZOIs would encompass areas where received underwater SPLs are higher than 160 dB (rms) and 120 dB (rms) re 1 µPa for impulse noise sources (impact pile driving) and non-impulses noise sources (vibratory pile driving and mechanic dismantling), respectively.
Based on measurements conducted nearby in similar water depth and sediment type in the Yaquina Bay for the NOAA Marine Operation Center P Test Pile Program (Miner, 2010), average vibratory hammer sound pressure level for 24-inch steel pile at 10 meters from the pile is 157 dB re 1 μPa (Minor 2010; ICF Jones & Stokes and Illingworth and Rodkin 2009). Based on practical spreading model with a transmission loss constant of 15, the distance at which the sound pressure levels fall below the 120 dB (rms) re 1 μPa is approximately 1.8 miles from the pile (Miner, 2010).
Modeling of exclusion zone and ZOIs for impact pile driving source level are based on measurements conducted at the nearby Tongue Point Facility in Astoria, Oregon, for installation of 24-in steel pile with an impact hammer (Illingworth and Rodkin, 2009). The result shows that the SPL at 10 m from the pile is 182 dB (rms) re 1 µPa. Nevertheless, a conservative 190 dB (rms) re 1 µPa value at 10 m and a practical spreading with a transmission loss constant of 15 are used to establish the exclusion zone and ZOI. As a result, the distance at which the SPLs fall below the 160 dB (rms) re 1 µPa behavioral threshold for impact hammering is approximately 0.62 miles. With a bubble curtain and an estimated 10 dB reduction in sound levels, the distance at which the sound pressure levels fall below the 160 dB RMS behavioral threshold for impact hammering is approximately 707 feet. The exclusion zone with the air bubble curtain system would be 7 feet from the pile.
The exclusion zone for Level A harassment and ZOIs for Level B harassment are presented in Table 2 below.
A “soft-start” technique is intended to allow marine mammals to vacate the area before the pile driver reaches full power. Whenever there has been downtime of 30 minutes or more without pile driving, the contractor will initiate the driving with ramp-up procedures described below.
For impact pile driving, the contractor would provide an initial set of strikes from the impact hammer at reduced energy, followed by a 30-second waiting period, then two subsequent sets. (The reduced energy of an individual hammer cannot be quantified because of variations between individual drivers. Also, the number of strikes will vary at reduced energy because raising the hammer at less than full power and then releasing it results in the hammer “bouncing” as it strikes the pile resulting in multiple “strikes”).
For vibratory pile driving, the contractor will initiate noise from vibratory hammers for 15 seconds at reduced energy followed by a 30-second waiting period. The procedure shall be repeated two additional times.
Bergerson shall implement shutdown measures if a marine mammal is sighted approaching the Level A exclusion zone. In-water construction activities shall be suspended until the marine mammal is sighted moving away from the exclusion zone, or if the animal is not sighted for 30 minutes after the shutdown.
In addition, Bergerson shall implement shutdown measures to prevent a take if a marine mammal species or stock that is not authorized under the IHA enters a zone of influence, or if the take of a specific marine mammal species or stock has reached the take limit issued under the IHA.
NMFS has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:
• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals.
• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned .
• The practicability of the measure for applicant implementation.
Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving and pile removal or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving and pile removal, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an incidental take authorization (ITA) for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Bergerson submitted a marine mammal monitoring plan as part of the IHA application. It can be found at
Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:
(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below.
(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, temporary hearing threshold shift (TTS), or permanent hearing threshold shift (PTS).
(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
An increased knowledge of the affected species; and
An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
During pile removal and installation, two land-based protected species observers (PSOs) would monitor the area from the best observation points available. If weather conditions prevent adequate land-based observations of the entire ensonified zones, boat-based monitoring would be implemented.
The PSOs shall observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. If a PSO observes a marine mammal within or approaching the exclusion zone, the PSO shall notify the work crew to initiate shutdown measures. In addition, if a PSO observes a marine mammal species that is not authorized for take, or the take of such marine mammal species has reached the take limit, the PSO shall notify the work crew to initiate shutdown measures if the animal is approaching the zone of influence.
Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (
Data collection during marine mammal monitoring would consist of a count of all marine mammals by species, a description of behavior (if possible), location, direction of movement, type of construction that is occurring, time that pile replacement work begins and ends, any acoustic or visual disturbance, and time of the observation. Environmental conditions such as weather, visibility, temperature, tide level, current, and sea state would also be recorded.
Bergerson shall submit a final monitoring report within 90 days after completion of the construction work or the expiration of the IHA, whichever comes earlier. This report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the report, and if NMFS has comments, Bergerson shall address the comments and submit a final report to NMFS within 30 days.
In the unanticipated event that the construction activities clearly cause the take of a marine mammal in a manner prohibited by this Authorization, such as an injury, serious injury, or mortality, Bergerson shall immediately cease all
(i) Time, date, and location (latitude/longitude) of the incident;
(ii) Description of the incident;
(iii) Status of all sound source use in the 24 hours preceding the incident;
(iv) Environmental conditions (
(v) Description of marine mammal observations in the 24 hours preceding the incident;
(vi) Species identification or description of the animal(s) involved;
(vii) The fate of the animal(s); and
(viii) Photographs or video footage of the animal (if equipment is available).
Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with Bergerson to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Bergerson may not resume their activities until notified by NMFS via letter, email, or telephone.
In addition, NMFS requires Bergerson to notify NMFS' Office of Protected Resources and NMFS' Stranding Network within 48 hours of sighting an injured or dead marine mammal in the vicinity of the construction site. Bergerson shall provide NMFS with the species or description of the animal(s), the condition of the animal(s) (including carcass condition, if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available).
In the event that Bergerson finds an injured or dead marine mammal that is not in the vicinity of the construction area, Bergerson would report the same information as listed above to NMFS as soon as operationally feasible.
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].
As discussed above, in-water pile removal and pile driving (vibratory and impact) generate loud noises that could potentially harass marine mammals in the vicinity of Bergerson's proposed Front Street Transload Facility construction project.
As mentioned earlier in this document, currently NMFS uses 120 dB re 1 µPa and 160 dB re 1 µPa at the received levels for the onset of Level B harassment from non-impulse (vibratory pile driving and removal) and impulse sources (impact pile driving) underwater, respectively. Table 3 summarizes the current NMFS marine mammal take criteria.
As explained above, exclusion and ZOIs will be established that encompass the areas where received underwater sound pressure levels (SPLs) exceed the applicable thresholds for Level A and Level B harassments. In the case of Bergerson's proposed Front Street Transload Facility construction project, the Level B harassment ZOIs for impact and vibratory pile driving are at 215 m and 2,900 m from the source, respectively. The Level A harassment exclusion from impact pile driving is 2.1 m from the source.
Incidental take is calculated for each species by estimating the likelihood of a marine mammal being present within a ZOI during active pile removal/driving. Expected marine mammal presence is determined by past observations and general abundance near the Front Street Transload Facility during the construction window. Ideally, potential take is estimated by multiplying the area of the ZOI by the local animal density. This provides an estimate of the number of animals that might occupy the ZOI at any given moment. However, there are no density estimates for any Puget Sound population of marine mammals. As a result, the take requests were estimated using local marine mammal data sets, and information from state and federal agencies.
The calculation for marine mammal exposures is estimated by:
Estimates include Level B acoustical harassment during pile removal and driving. All estimates are conservative, as pile removal/driving would not be continuous during the work day. Using this approach, a summary of estimated takes of marine mammals incidental to Bergerson's Front Street Transload Facility construction work are provided in Table 4. The take calculation of California sea lion is described in Bergerson's IHA application. The take calculation of Pacific harbor seal is updated from Bergerson's IHA application and is described below.
Surveys done at the time of the construction of the NOAA MOC-P facility show that the number of harbor seals using haulouts in Yaquina Bay fluctuates widely from day to day; therefore, the average daily count of seals at the haulout was used to estimate the number of seals that would likely be present within the project area during the entire anticipated work period. Because there is no data on the counts of harbor seals using the haulouts in Sally's Bend, the average daily count of harbor seals using the finger jetty haulout was used to estimate the total number of potential harbor seals subject to Level B harassment throughout the project period. Survey results for harbor seals using the Oyster Dock haulout were also used to yield more conservative take estimates. It is estimated that an average daily take of 34 seals, with a total of 1,020 harbor seal takes by Level B harassment for the proposed work period.
Negligible impact is “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” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, this introductory discussion of our analyses applies to all the species listed in Table 4, given that the anticipated effects of Bergerson's Front Street Transload Facility construction on marine mammals are expected to be relatively similar in nature. There is no information about the nature or severity of the impacts, or the size, status, or structure of any species or stock that would lead to a different analysis for this activity, else species-specific factors would be identified and analyzed.
Bergerson's proposed Front Street Transload Facility construction project would involve vibratory pile removal and vibratory and impact pile driving activities. Elevated underwater noises are expected to be generated as a result of these activities. The exclusion zone for Level A harassment is extremely small (2.1 m from the source) with the use of an air bubble curtain system. The small exclusion zone combined with the implementation of the proposed monitoring and mitigation measures described above results in no expected Level A take of marine mammals. For vibratory pile removal and pile driving, noise levels are not expected to reach the level that may cause TTS, injury (including PTS), or mortality to marine mammals.
Additionally, the sum of noise from Bergerson's proposed Front Street Transload Facility construction activities is confined to a limited area by surrounding landmasses (as shown in Figure 1 of the IHA application), which blocks underwater sound propagation; therefore, the noise generated is not expected to contribute to increased ocean ambient noise. In addition, due to shallow water depths in the project area, underwater sound propagation of low-frequency sound (which is the major noise source from pile driving) is expected to be poor.
In addition, Bergerson's proposed activities are localized and of short duration. The entire project area is limited to Bergerson's Front Street Transload Facility construction work. The entire project would involve the removal of 25 existing piles and installation of 126 piles. The duration for pile removal and pile driving would be 30 days. These low-intensity, localized, and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease (Southall
The proposed project area is not a prime habitat for marine mammals, nor is it considered an area frequented by marine mammals. Therefore, behavioral disturbances that could result from anthropogenic noise associated with Bergerson's construction activities are expected to affect only a small number of marine mammals on an infrequent and limited basis.
The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from Bergerson's Front Street Transload Facility construction project will have a negligible impact on the affected marine mammal species or stocks.
Based on analyses provided above, it is estimated that approximately 750 harbor seals and 1,100 California sea lions could be exposed to receive noise levels that could cause Level B behavioral harassment from the proposed construction work at the Front Street Transload Facility in Newport, Oregon. These numbers represent approximately 4.6% and 3.7% of the populations of Pacific harbor seal and California sea lion, respectively, that could be affected by Level B behavioral harassment, respectively (see Table 5 above), which are small percentages relative to the total populations of the affected species or stocks.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, which are expected to reduce the
There are no subsistence uses of marine mammals in the proposed project area; and, thus, no subsistence uses impacted by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
NMFS has determined that issuance of the IHA will have no effect on listed marine mammals, as none are known to occur in the action area.
NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from the Front Street Transload Facility construction project. A Finding of No Significant Impact (FONSI) was signed in October 2015. A copy of the EA and FONSI is available upon request (see
NMFS has issued an IHA to Bergerson for the potential harassment of small numbers of two marine mammal species incidental to the Front Street Transload Facility construction project in Newport, Oregon, provided the previously mentioned mitigation.
Department of the Army, DoD.
Notice.
Notice is given of the names of members of a Performance Review Board for the Department of the Army.
Barbara Smith, Civilian Senior Leader Management Office, 111 Army Pentagon, Washington, DC 20310-0111.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service performance review boards. The boards shall review and evaluate the initial appraisal of senior executives' performance by supervisors and make recommendations to the appointing authority or rating official relative to the performance of these executives.
The Department of the Army Performance Review Board will be composed of a subset of the following individuals:
1. Ms. Lisha Adams, Executive Deputy to the Commanding General, United States Army Materiel Command.
2. LTG Thomas P. Bostick, Commanding General, United States Army Corps of Engineers.
3. Mr. Gabriel Camarillo, Principal Deputy Assistant Secretary of the Army for Acquisition, Policy and Logistics, Office of the Assistant Secretary of the Army (Acquisition, Logistics, and Technology).
4. Ms. Gwendolyn R. DeFilippi, Director, Civilian Senior Leader Management Office, Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
5. Ms. Sue A. Engelhardt, Director of Human Resources, United States Army Corps of Engineers.
6. Mr. Randall Exley, The Auditor General, Auditor General Office.
7. Mr. Kevin M. Fahey, Executive Director for Agile Acquisition, Office of the Assistant Secretary of the Army (Acquisition, Logistics and Technology).
8. Mr. Patrick K. Hallinan, Executive Director of the Army National Cemeteries Program, Dept of the Army.
9. Ms. Ellen M. Helmerson, Deputy Chief of Staff, G-8, United States Army Training and Doctrine Command.
10. Mr. David Jimenez, Executive Technical Director/Deputy to the Commander, United States Army Test and Evaluation Command.
11. MG Daniel I. Karbler, Commanding General, United States Army Test and Evaluation Command.
12. LTG Mary A. Legere, Deputy Chief of Staff, G-2, Office of the Deputy Chief of Staff, G-2.
13. Mr. Mark R. Lewis, Deputy Chief Management Officer, Office of the Under Secretary of the Army.
14. LTG Kevin W. Mangum, Deputy Commanding General/Chief of Staff, U.S. Army Training and Doctrine Command.
15. Mr. David Markowitz, Assistant Deputy Chief of Staff for Operations, G-3/5/7, Office of the Deputy Chief of Staff, G-3/5/7.
16. Ms. Kathleen S. Miller, Assistant Deputy Chief of Staff, G-4, Office of the Deputy Chief of Staff, G-4.
17. Mr. William Moore, Deputy Chief of Staff, G-1/8 (Personnel and Logistics), United Stated Army Training and Doctrine Command.
18. Mr. Levator Norsworthy Jr., Deputy General Counsel(Acquisition)/Senior Deputy General Counsel, Office of the General Counsel.
19. Mr. Gerald B. O'Keefe, Administrative Assistant to the Secretary of the Army, Office of the Administrative Assistant to the Secretary of the Army.
20. Mr Philip R. Park, Acting General Counsel, Office of the General Counsel.
21. Ms. Diane M. Randon, Deputy Assistant Chief of Staff for Installation Management, Office of the Assistant Chief of Staff for Installation Management.
22. Mr. Jeffrey N. Rapp, Assistant Deputy Chief of Staff, G-2 Office of the Deputy Chief of Staff, G-2.
23. Mr. J. Randall Robinson, Principal Deputy to the Assistant Secretary of the Army (Installations, Energy and Environment), Office of the Assistant Secretary of the Army (Installations and Environment).
24. Mr. Craig R. Schmauder, Deputy General Counsel (Installation, Environment and Civil Works), Office of the General Counsel.
25. Mr. Karl F. Schneider, Principal Deputy Assistant Secretary of the Army (Manpower and Reserve Affairs), Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
26. Honorable Heidi Shyu, Assistant Secretary of the Army (Acquisition, Logistics and Technology), Office of the Assistant Secretary of the Army (Acquisition, Logistics and Technology).
27. Ms. Caral Spangler, Principal Deputy Assistant Secretary of the Army (Financial Management and Comptroller).
28. MG Richard L. Stevens, Deputy Chief of Engineers/Deputy Commanding General, United States Army Corps of Engineers.
29. Mr. Lawrence Stubblefield, Deputy Assistant Secretary of the Army (Diversity and Leadership), Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
30. Mr. Donald C. Tison, Assistant Deputy Chief of Staff for Programs, G-8, Office of the Deputy Chief of Staff, G-8.
31. GEN Dennis L. Via, Commanding General, United States Army Materiel Command.
32. Honorable Debra S. Wada, Assistant Secretary of the Army (Manpower and Reserve Affairs), Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
33. LTG Michael E. Williamson, Deputy Assistant Secretary of the Army (Acquisition, Logistics and Technology), Office of the Assistant Secretary of the Army (Acquisition, Logistics and Technology).
34. LTG Larry Wyche, Deputy Commanding General, United States Army Material Command.
35. MG Mark W. Yenter, Deputy Commanding General for Military and International Operations, United States Army Corps of Engineers.
Department of the Army, DoD.
Notice of open committee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the USMA Board of Visitors (BoV). This meeting is open to the public. For more information about the BoV, its membership and its activities, please visit the BoV Web site at
The USMA BoV will meet from 1:00 p.m. until 4:30 p.m. on Monday, November 16, 2015. Members of the public wishing to attend the meeting will be required to show a government photo ID upon entering the Capitol Visitors Center in order to gain access to the meeting location. All members of the public are subject to security screening.
Capitol Visitors Center, Room HVC-200, the entrance is at the intersection of First Street SE. and East Capitol, Washington, DC 20515.
Mrs. Deadra K. Ghostlaw, the Designated Federal Officer for the committee, in writing at: Secretary of the General Staff, ATTN: Deadra K. Ghostlaw, 646 Swift Road, West Point, NY 10996; by email at:
The committee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
The committee Designated Federal Official and Chairperson may choose to invite certain submitters to present their comments verbally during the open portion of this meeting or at a future meeting. The Designated Federal Officer, in consultation with the committee Chairperson, may allot a specific amount of time for submitters to present their comments verbally.
Department of the Army, DoD.
Notice of open Subcommittee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Department of the Army Historical Advisory Subcommittee (DAHASC), a subcommittee of the Army Education Advisory Committee. This meeting is open to the public.
The Department of the Army Historical Advisory Subcommittee will meet from 8:40 a.m. to 3:30 p.m. on November 19, 2015.
Department of the Army Historical Advisory Subcommittee, U.S. Army Center of Military History, 102 4th Ave., Bldg. 35, Washington, DC 20319-5060.
Mr. Stephen W. Lehman, the Alternate Designated Federal Officer for the subcommittee, in writing at ATTN: AAMH-ZC U.S. Army Center of Military History, 102 4th Ave., Bldg. 35, Fort McNair, Washington, DC 20319-5060 by email at
The subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Defense Contract Audit Agency, DoD.
Notice to add a new System of Records.
The Defense Contract Audit Agency proposes to add a new system of records, RDCAA 900.1, entitled “DCAA Inspector General Records” to record information related to official DCAA Inspector General investigations and actions taken in investigative recommendations; to compile statistical information to disseminate to other components within the Department of Defense engaged in the Hotline Program; to provide prompt, responsive, and accurate information regarding the status of ongoing cases; and to provide a record of complaint disposition. Complaints appearing to involve criminal wrongdoing will be referred to
Comments will be accepted on or before November 27, 2015. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Mr. Keith Mastromichalis, DCAA FOIA/Privacy Act Management Analyst, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219, Telephone number: (703) 767-1022.
The Defense Contract Audit Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
DCAA Inspector General Records.
Office of Inspector General, Headquarters Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.
All persons (civilian, military, contractors, and/or members of the public) who have registered a complaint or request for assistance with the Defense Contract Audit Agency Inspector General. Individuals who are or have been involved in Inspector General Activities as participants, witnesses, subject matter experts, subjects or suspects.
Individual's name, case number, address, phone number, reports of investigations, statements of individuals, correspondence, inspections or inquiries pertaining to complaints made to or investigated by the Defense Contract Audit Agency Inspector General.
5 U.S.C. 301, Departmental Regulations; DoD Directive 5105.36, Defense Contract Audit Agency (DCAA); 5 U.S.C., Appendix 3, Inspector General Act of 1978, as amended; DoD Directive 5106.04, Defense Inspectors General; DoD Directive 5106.1, Inspector General of the Department of Defense (IG DoD); DoD Directive 7050.1, Defense Hotline Program; and E.O. 9397 (SSN), as amended.
To record information related to official DCAA Inspector General investigations and actions taken in investigative recommendations. To compile statistical information to disseminate to other components within the Department of Defense engaged in the Hotline Program. To provide prompt, responsive, and accurate information regarding the status of ongoing cases. To provide a record of complaint disposition. Complaints appearing to involve criminal wrongdoing will be referred to the Defense Criminal Investigative Service or other criminal investigative units of DoD components.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To Federal, state, and local agencies having jurisdiction over or investigative interest in the substance of the allegations for investigative, corrective action, debarment, or reporting purposes.
To Government contractors employing individuals who are subjects of a hotline.
The DoD Blanket Routine Uses set forth at the beginning of DCAAs compilation of systems of records notices may apply to this system.
The complete list of DoD blanket routine uses can be found online at:
Paper records and/or electronic storage media.
By individual's name, subject matter, and case number.
Access is limited to DCAA Inspector General staff. Records are accessed by properly screened and cleared personnel with a need-to-know. Paper records are stored in a secured room. Electronic media access is authenticated and validated through use of Common Access Cards (CACs) with encryption and user name and password verification.
Closed case files not referred includes anonymous or vague allegations not warranting an investigation are destroyed or deleted after 2 years.
Referred case files. Includes matters referred to U.S. Office of Special Counsel (OSC) or the DoD Inspector General (DODIG) for handling, and support files providing general information that may prove useful in the investigation. Records are cutoff at closure, destroyed or deleted after 10 years.
Completed case files includes complaint files, inquires, replies, comments, and other documents
Final Reports are destroyed or deleted when 10 years old.
Work papers and background material are destroyed or deleted when 10 years old.
Electronic copies created on electronic mail and word processing systems are deleted after a record keeping copy has been produced.
Automated and paper records are retained within the Office of the Inspector General for a period of 10 years after referral or closure.
Office of Inspector General, Headquarters Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.
Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Office of Inspector General, Headquarters Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.
The request must contain full name, complete return address, and daytime contact telephone number.
Individuals seeking access to information about themselves contained in this system of records should address written inquiries to the Office of Inspector General, Headquarters Defense Contract Audit Agency, 8725 John J. Kingman Road, Suite 2135, Fort Belvoir, VA 22060-6219.
The request must contain full name, complete return address, and daytime contact telephone number.
DCAA's rules for accessing records, for contesting contents and appealing initial agency determinations are published in DCAA Instruction 5410.10; 32 CFR part 317; or may be obtained from the system manager.
Information is provided by complainants, witnesses, subjects, suspects, investigators, inspectors general, members of Congress and members of other branches of Government, as required.
Investigatory material may be exempt pursuant to 5 U.S.C. 552a(k)(2). However, if an individual is denied any right, privilege, or benefit for which he would otherwise be entitled by Federal law or for which he would otherwise be eligible, as a result of the maintenance of the information, the individual will be provided access to the information, except to the extent that disclosure would reveal the identity of a confidential source.
Investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for federal civilian employment, military service, federal contracts, or access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), but only to the extent that such material would reveal the identity of a confidential source.
An exemption rule for this system has been promulgated in accordance with requirements of 5 U.S.C. 553(b)(1), (2), and 3, (c) and (e) and published in 32 CFR part 317. For more information, contact the system manager.
Defense Health Agency, DoD.
Notice to alter a System of Records.
The Defense Health Agency proposes to alter an existing system of records, EDTMA 02, entitled “Medical/Dental Care and Claims Inquiry Files” in its inventory of record systems subject to the Privacy Act of 1974, as amended.
This system provides information to maintain and control records pertaining to requests for information concerning an individual's TRICARE eligibility status, the medical or dental benefits provided under programs of TRICARE and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) and the processing of individual TRICARE and CHAMPVA claims.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
* Federal Rulemaking Portal:
* Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.
Ms. Linda S. Thomas, Chief, Defense Health Agency Privacy and Civil Liberties Office, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101, or by phone at (703) 681-7500.
The Defense Health Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on May 6, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) 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 (February 20, 1996, 61 FR 6427).
Medical/Dental Care and Claims Inquiry Files (November 18, 2013, 78 FR 69076)
Delete entry and replace with “Records Management, Administration and Management Directorate, 16401 East Centretech Parkway, Aurora, CO 80011-9066, and contractors under contract to the Defense Health Agency.
A listing of Managed Care Support contractors maintaining these records is available from the system manager.”
Delete entry and replace with “All individuals who seek information concerning health care under TRICARE and The Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA).”
Delete entry and replace with “Inquiries received from private individuals for information on TRICARE and CHAMPVA, and replies thereto; Congressional inquiries on behalf of constituents and replies thereto; and files notifying personnel of eligibility or termination of benefits. Information may include the name, Social Security Number (SSN) and/or DoD Identification Number (DoD ID Number) of the sponsor and/or beneficiary; beneficiary's relationship to sponsor; date of birth, case number, dates of treatment, medical/dental diagnosis; Defense Enrollment Eligibility Reporting System (DEERS) data, address, telephone number, marital status, adoption information, and sponsor name.”
Delete entry and replace with “10 U.S.C. Chapter 55, Medical and Dental Care; 38 U.S.C. Chapter 17, Hospital, Nursing Home, Domiciliary, and Medical Care; 32 CFR part 199, Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); and E.O. 9397 (SSN), as amended.”
Delete entry and replace with “To maintain and control records pertaining to requests for information concerning an individual's TRICARE eligibility status, the medical or dental benefits provided under programs of TRICARE and CHAMPVA and the processing of individual TRICARE and CHAMPVA claims.”
Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To the Departments of Health and Human Services and Veterans Affairs consistent with their statutory administrative responsibilities under TRICARE and CHAMPVA pursuant to 10 U.S.C. Chapter 55 and 38 U.S.C. Chapter 17.
Referral to Federal, state, local, or foreign governmental agencies, and to private business entities, including individual providers of care (participating and non-participating), on matters relating to eligibility, claims pricing and payment, fraud, program abuse, utilization review, quality assurance, peer review, program integrity, third-party liability, coordination of benefits, and civil or criminal litigation related to the operation of TRICARE.
Disclosure to the Department of Justice and the United States Attorneys in situations where the matter directly or indirectly involves the TRICARE program.
Disclosure to third-party contacts in situations where the party to be contacted has, or is expected to have, information necessary to establish the validity of evidence or to verify the accuracy of information presented by the individual concerning his or her entitlement, the amount of benefit payments, any review of suspected abuse or fraud, or any concern for program integrity or quality appraisal.
The DoD Blanket Routine Uses set forth at the beginning of the Defense Health Agency compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at:
This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) or any successor DoD issuances implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 45 CFR parts 160 and 164, Health and Human Services, General Administrative Requirements and Security & Privacy, respectively, applies to most such health information. DoD 6025.18-R or a successor issuance may place additional procedural requirements on uses and disclosures of such information beyond those found in the Privacy Act of 1974, as amended, or mentioned in this system of records notice.
Except as provided under 42 U.S.C. 290dd-2, records of identity, diagnosis, prognosis or treatment information of any patient maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by a department or agency of the United States will be treated as confidential and disclosed only for the purposes and under the circumstances expressly authorized under 42 U.S.C. 290dd-2.”
Storage:
Delete entry and replace with “Paper records and/or electronic storage media.”
Delete entry and replace with “Information is retrieved by the name, SSN and/or DoD ID Number of the sponsor or beneficiary.”
Delete entry and replace with “Electronic media, data and/or electronic records are maintained in a controlled area. Records are maintained in a secure, limited access, or monitored area. The computer system is accessible only to authorized personnel. Entry into these areas is restricted to those personnel with a valid requirement and authorization to enter. Physical entry is restricted by the use of locks, passwords which are changed periodically, and administrative procedures.
The system provides two-factor authentication through user IDs/passwords. Access to personal information is restricted to those who require the data in the performance of their official duties. All personnel whose official duties require access to the information are trained in the proper safeguarding and use of the information.
All of the records must be properly secured for the duration of their life cycle. The safeguards in place for the paper records include placing the documents in locked file cabinets and storage rooms with limited access and electronic security measures. In addition, some of the records are housed in secure facilities monitored by security guards and video surveillance.”
Delete entry and replace with “Close out at end of the calendar year in which received. Destroy 10 year(s) after cut off. When subject to one or more Litigation Holds, preserve records in compliance with the time restraints of the hold(s).”
Delete entry and replace with “Manager, Records Management,
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to Chief, Freedom of Information Act (FOIA) Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.
Requests should contain the full name and signature of the sponsor or beneficiary.
If requesting information about a minor or legally incompetent person, the request must be made by the custodial parent, legal guardian, or party acting in loco parentis of such individual. Written proof of that status may be required before the existence of any information will be confirmed.”
Delete entry and replace with “Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Chief, FOIA Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.
Written requests for information should include the full name and signature of the sponsor or beneficiary.
If requesting records about a minor or legally incompetent person, the request must be made by the custodial parent, legal guardian, or party acting in loco parentis of such individual. Written proof of that status may be required before any records will be provided.”
Delete entry and replace with “The Office of the Secretary of Defense (OSD) rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81, 32 CFR part 311, or may be obtained from the system manager.”
Delete entry and replace with “Contractors, Congressional offices, Beneficiary Counseling and Assistance Coordinators, all branches of the Uniformed Services, providers of care, consultants, sponsor and/or beneficiary.”
Department of Defense.
Notice of Updated Mental Health Rates for Fiscal Year 2016.
This notice provides the updated regional per-diem rates for low-volume mental health providers; the update factor for hospital-specific per-diems; the updated cap per-diem for high-volume providers; the beneficiary per-diem cost-share amount for low-volume providers; and, the updated per-diem rates for both full-day and half-day TRICARE Partial Hospitalization Programs for Fiscal Year 2016.
Defense Health Agency (DHA), Medical Benefits and Reimbursement Section, 16401 East Centretech Parkway, Aurora, CO 80011-9066.
Elan Green, Medical Benefits and Reimbursement Section, DHA, telephone (303) 676-3907.
The final rule published in the
Partial hospitalization rates for full-day programs also will be updated by 2.4 percent for Fiscal Year 2016. Partial hospitalization rates for programs of less than 6 hours (with a minimum of three hours) will be paid a per diem rate of 75 percent of the rate for a full-day program.
The cap amount for high-volume hospitals and units also will be updated by the 2.4 percent for Fiscal Year 2016.
The beneficiary cost share for low-volume hospitals and units also will be updated by the 2.4 percent for Fiscal Year 2016.
Per Title 32 Code of Federal Regulations (CFR), Part 199.14, the same area wage indexes used for the CHAMPUS Diagnosis-Related Group (DRG)-based payment system shall be applied to the wage portion of the applicable regional per-diem for each day of the admission. The wage portion shall be the same as that used for the CHAMPUS DRG-based payment system. For wage index values greater than 1.0, the wage portion of the regional rate subject to the area wage adjustment is 69.6 percent for Fiscal Year 2016. For wage index values less than or equal to 1.0, the wage portion of the regional rate subject to the area wage adjustment is 62.0 percent.
Additionally, 32 CFR part 199.14 requires that hospital specific and regional per-diems shall be updated by the Medicare update factor for hospitals and units exempt from the Medicare prospective payment system.
The following reflect an update of 2.4 percent for Fiscal Year 2016.
Beneficiary cost-share: Beneficiary cost-share (other than dependents of Active Duty members) for care paid on the basis of a regional per-diem rate is the lower of $229 per day or 25 percent of the hospital billed charges effective for services rendered on or after October 1, 2015. Cap Amount: Updated cap amount for hospitals and units with high TRICARE volume is $1,096 per day for services on or after October 1, 2015.
The following reflects an update of 2.4 percent for Fiscal Year 2016 for the full day partial hospitalization rates. Partial hospitalization rates for programs of less than 6 hours (with a minimum of three hours) will be paid a per diem rate of 75 percent of the rate for a full-day program.
The above rates are effective for services rendered on or after October 1, 2015.
Defense Finance and Accounting Service, DoD.
Notice to add a new System of Records.
The Defense Finance and Accounting Service proposes to add a new system of records, T4500c, entitled “DFAS Transportation Incentive Program System (TIPS)” to manage the mass transportation program for DFAS civilian and DFAS NAF employees applying for and in receipt of mass transit subsidies.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Mr. Gregory Outlaw, Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150 or at (317) 212-4591.
The Defense Finance and Accounting Service notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was
DFAS Transportation Incentive Program System (TIPS).
Defense Finance and Accounting Service, Indianapolis, 8899 East 56th Street, Indianapolis, IN 46249-0201.
DFAS civilian and DFAS NAF employees.
Name, date of birth, DoD ID Number, Employee ID Number, Point-to-point commuting expenses, commuting distance, type of mass transit used, home address, organizational affiliation of the individual, service, funding appropriation for benefit, office work number, work email address, duty/work address, transit authority card number, and usage from benefit provider.
10 U.S.C. 113, Secretary of Defense; 5 U.S.C. 301, Departmental regulations; 5 U.S.C. 7905, Programs to encourage commuting by means other than single-occupancy motor vehicles; DoD Instruction 1000.27, Mass Transportation Benefit Program (MTBP); E.O. 12191, Federal facility ridesharing program; and E.O. 13150, Federal Workforce Transportation.
This system will manage the mass transportation program for DFAS civilian and DFAS NAF employees applying for and in receipt of mass transit subsidies.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To the benefit provider for purposes of administering the Mass Transportation Benefit Program and/or verifying the eligibility of individuals to receive a fare subsidy pursuant to the transportation benefit program operated by DFAS.
The DoD Blanket Routine Uses published at the beginning of the DFAS compilation of systems of records notices may apply to this system. The complete list of DoD blanket routine uses can be found online at:
Paper records and electronic storage media.
Retrieved by name and/or Employee ID Number.
Records are maintained in a controlled facility. Physical entry is restricted by the use of locks, guards, and is accessible only to authorized personnel. Access to records is limited to person(s) responsible for servicing the record in the performance of their official duties and who are properly screened and cleared for need-to-know. Access to computerized data is limited to Common Access Card enabled users and restricted by passwords, which are changed according to agency security policy.
Records are to be cut off at the end of the fiscal year. Records will be destroyed 3 years after the cutoff by degaussing, shredding, or burning.
TIPS Program Manager, Defense Finance and Accounting Service-Indianapolis, 8899 East 56th Street, Indianapolis, IN 46249-0201.
Individuals seeking to determine whether information about themselves is contained in this record system should address written inquiries to the Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.
Requests should contain individual's full name, Employee ID Number for verification, current address to reply, and provide a reasonable description of what they are seeking.
Individuals seeking access to information about themselves contained in this record system should address written inquiries to Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.
Request should contain individual's full name, Employee ID Number verification, current address to reply, and telephone number.
The Defense Finance and Accounting Service (DFAS) rules for accessing records, for contesting contents and appealing initial agency determinations are published in Defense Finance and Accounting Service Regulation 5400.11-R, 32 CFR 324; or may be obtained from the Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.
From the individual.
None.
Office of the Under Secretary of Defense for Personnel and Readiness/National Security Education Program, DoD.
Notice; withdrawal.
On Friday, October 16, 2015 (80 FR 62523), the Department of Defense published a notice titled “Proposed Collection; Comment Request” for National Language Service Corps; DD Forms 2932, 2933, and 2934; OMB Control Number 0704-0449. Subsequent to the publication of the notice, the Department of Defense discovered that the notice was unnecessary as public comment had
The withdrawal of the notice is effective on October 27, 2015.
Defense Finance and Accounting Service, DoD.
Notice to alter a System of Records.
The Defense Finance and Accounting Service proposes to alter a system of records, T5500a, entitled “Congressional Inquiry File” in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system provides the ability to track and maintain a record of Congressional inquiries, and the Defense Finance and Accounting Service's responses.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Mr. Gregory L. Outlaw, Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-HKC/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150 or at (317) 212-4591.
The Defense Finance and Accounting Service notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
Congressional Inquiry File (February 23, 2009, 74 FR 8066).
Delete entry and replace with “T5545”.
Delete entry and replace with “This system provides the ability to track and maintain a record of Congressional inquiries, and the Defense Finance and Accounting Service's responses.”
Delete entry and replace with “Electronic storage media.”
Delete entry and replace with “Name and SSN.”
Delete entry and replace with “Records are maintained in a controlled facility. Physical entry is restricted by the use of locks, guards, and is accessible only to authorized personnel. Access to records is limited to person(s) responsible for servicing the record in the performance of their official duties and who are properly screened and cleared for need-to-know. Access to computerized data is limited to CAC enabled users and restricted by passwords, which are changed according to agency security policy.”
Delete entry and replace with “Military Pay Input Transaction records may be temporary in nature and destroyed when actions are completed, they are superseded, obsolete, or no longer needed. Source data records may be cut off at the end of the payroll year and destroyed 6 years and 3 months after cutoff.”
Delete entry and replace with “Defense Finance and Accounting Service—Columbus, Accounting Service, 4280 East Fifth Avenue, Columbus, OH 43219-1879.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this record system should address written inquiries to the Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.
Requests should contain individual's full name, SSN for verification, current address for reply, and provide a reasonable description of what they are seeking.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this record system should address written inquiries to Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.
Request should contain individual's full name, SSN for verification, current address for reply, and telephone number.”
Delete entry and replace with “The Defense Finance and Accounting Service (DFAS) rules for accessing records, for contesting contents and appealing initial agency determinations are published in Defense Finance and Accounting Service Regulation 5400.11-R, 32 CFR 324; or may be obtained from the Defense Finance and Accounting Service, Freedom of Information/Privacy Act Program Manager, Corporate Communications, DFAS-ZCF/IN, 8899 E. 56th Street, Indianapolis, IN 46249-0150.”
Defense Health Agency, DoD.
Notice to alter a System of Records.
The Defense Health Agency proposes to alter an existing system of records, EDTMA 04, entitled “Medical/Dental Claim History Files” in its inventory of record systems subject to the Privacy Act of 1974, as amended.
The Defense Health Agency and its contractors and DoD staff (including Military Treatment Facilities, clinics and TRICARE Regional Offices Staff) use the information to control and process health care benefits available under TRICARE and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA), including the processing of medical or dental claims, the control and approval of medical or dental treatments, issuance of deductible certificates, and necessary interface with providers of health care. The system also supports audits of contractor-processed claims to determine payment and occurrence accuracy of the contractor's adjudication process.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Ms. Linda S. Thomas, Chief, Defense Health Agency Privacy and Civil Liberties Office, Defense Health Agency, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101, or by phone at (703) 681-7500.
The Defense Health Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on May 6, 2015 to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) 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 (February 20, 1996, 61 FR 6427).
Medical/Dental Claim History Files (November 18, 2013, 78 FR 69076)
Delete entry and replace with “Records Management, Administration and Management Directorate, 16401 East Centretech Parkway, Aurora, CO 80011-9066, and contractors under contract to the Defense Health Agency.
A listing of Managed Care Support contractors maintaining these records is available from the system manager.”
Delete entry and replace with “Eligible beneficiaries and all individuals who seek health care under TRICARE and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA).”
Delete entry and replace with “File contains claims, billings for services, applications or approval forms, enrollment and disenrollment files, recoupment files, third-party liability files, fraud and abuse files, the name, Social Security Number (SSN) and/or DoD Identification Number (DoD ID Number) of the sponsor and/or beneficiary; beneficiary's relationship to sponsor, case management files, resource sharing files, utilization management/quality assurance files, payment files, medical/dental records, family history files, records of grievances with a medical/dental provider, appeals, hearings, or any other correspondence, memoranda, or reports which are acquired or utilized in the development and processing of TRICARE or CHAMPVA claims.
Records are also maintained on health care demonstration projects, including enrollment and authorization agreements, correspondence, memoranda, forms and reports, which are acquired or utilized during the projects.”
Delete entry and replace with “10 U.S.C. Chapter 55, Medical and Dental Care; 38 U.S.C. Chapter 17, Hospital, Nursing Home, Domiciliary, and Medical Care; 32 CFR part 199, Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); and E.O. 9397 (SSN), as amended.”
Delete entry and replace with “Defense Health Agency and its contractors and DoD staff (including Military Treatment Facilities, clinics and TRICARE Regional Offices Staff) use the information to control and process health care benefits available under TRICARE and CHAMPVA, including the processing of medical or dental claims, the control and approval of medical or dental treatments, issuance of deductible certificates, and
Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, these records may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To the Departments of Health and Human Services and Veterans Affairs consistent with their statutory administrative responsibilities under TRICARE and CHAMPVA pursuant to 10 U.S.C. Chapter 55; and 38 U.S.C. Chapter 17.
Referral to Federal, state, local, or foreign governmental agencies, and to private business entities, including individual providers of care (participating and non-participating), on matters relating to eligibility, claims pricing and payment, fraud, program abuse, utilization review, quality assurance, peer review, program integrity, third-party liability, coordination of benefits, and civil or criminal litigation related to the operation of TRICARE.
Disclosure to the Department of Justice and the United States Attorneys in situations where the matter directly or indirectly involves the TRICARE program.
Disclosure to third-party contacts in situations where the party to be contacted has, or is expected to have, information necessary to establish the validity of evidence or to verify the accuracy of information presented by the individual concerning his or her entitlement, the amount of benefit payments, any review of suspected abuse or fraud, or any concern for program integrity or quality appraisal.
The DoD Blanket Routine Uses set forth at the beginning of the Defense Health Agency compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at:
NOTE 1: This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) or any successor DoD issuances implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 45 CFR parts 160 and 164, Health and Human Services, General Administrative Requirements and Security & Privacy, respectively, applies to most such health information. DoD 6025.18-R or a successor issuance may place additional procedural requirements on uses and disclosures of such information beyond those found in the Privacy Act of 1974, as amended, or mentioned in this system of records notice.
NOTE 2: Except as provided under 42 U.S.C. 290dd-2, records of identity, diagnosis, prognosis or treatment information of any patient maintained in connection with the performance of any program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research, which is conducted, regulated, or directly or indirectly assisted by a department or agency of the United States will be treated as confidential and disclosed only for the purposes and under the circumstances expressly authorized under 42 U.S.C. 290dd-2.”
Delete entry and replace with “Paper records and/or electronic storage media.”
Delete entry and replace with “Information is retrieved by the name, SSN and/or DoD ID Number of the sponsor or beneficiary; name and SSN and/or Tax Identification Number of the provider; internal control number; classification of medical diagnosis; procedure code; geographical location of care provided; and selected utilization limits.”
Delete entry and replace with “Electronic media, data and/or electronic records are maintained in a controlled area. Records are maintained in a secure, limited access, or monitored area. The computer system is accessible only to authorized personnel. Entry into these areas is restricted to those personnel with a valid requirement and authorization to enter. Physical entry is restricted by the use of locks, passwords which are changed periodically, and administrative procedures.
The system provides two-factor authentication through user IDs/passwords. Access to personal information is restricted to those who require the data in the performance of their official duties. All personnel whose official duties require access to the information are trained in the proper safeguarding and use of the information.
All of the records must be properly secured for the duration of their life cycle. The safeguards in place for the paper records include placing the documents in locked file cabinets and storage rooms with limited access and electronic security measures. In addition, some of the records are housed in secure facilities monitored by security guards and video surveillance.”
Delete entry and replace with “Close out at end of the calendar year in which received. Destroy 10 years after cutoff. When subject to one or more Litigation Holds, preserve records in compliance with the time constraints of the hold(s).”
Delete entry and replace with “Manager, Records Management, Administration and Management Directorate, 16401 East Centretech Parkway, Aurora, CO 80011-9066.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to Chief, Freedom of Information Act (FOIA) Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.
Requests should contain the full name and signature of the sponsor or beneficiary.
If requesting information about a minor or legally incompetent person, the request must be made by the custodial parent, legal guardian, or party acting in loco parentis of such individual. Written proof of that status may be required before the existence of any information will be confirmed.”
Delete entry and replace with “Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Chief, FOIA Service Center, Defense Health Agency Privacy and Civil Liberties Office, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042-5101.
Written requests for information should include the full name and signature of the sponsor or beneficiary.
If requesting records about a minor or legally incompetent person, the request
Delete entry and replace with “The Office of the Secretary of Defense (OSD) rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81, 32 CFR part 311, or may be obtained from the system manager.”
Delete entry and replace with “Contractors, Beneficiary Counseling and Assistance Coordinators, other Components of the Department of Defense, all branches of the Uniformed Services, Congressional offices, providers of care, consultants, and sponsor and/or beneficiary.”
Office of the Secretary of Defense, DoD.
Notice to add a New System of Records.
The Office of the Secretary of Defense proposes to add a new system of records, DPA 02, entitled “AFNConnect (AFNC)” which will document the eligibility and continued validation of authorized individuals Outside the Continental United States (OCONUS) who register an American Forces Network satellite decoder. AFNConnect provides U.S. military commanders worldwide a means to communicate internal information to OCONUS users. Records may also be used as a management tool for statistical analysis, tracking, reporting, evaluating program effectiveness, and conducting research.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective the day following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
*
Ms. Cindy Allard, Chief, OSD/JS Privacy Office, Freedom of Information Directorate, Washington Headquarters Service, 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571) 372-0461.
The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on September 25, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) 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 (February 20, 1996, 61 FR 6427).
AFNConnect (AFNC)
American Forces Network—Broadcast Center (AFN-BC), 23755 Z Street, Riverside, CA 92518-2077.
Eligible military personnel (including retirees and reservists), DoD civilian employees, full time direct hire Department of State (DoS) employees, DoD contractors, and their Outside the Continental United States (OCONUS) family members, to include widows, maintaining an Armed Forces Network (AFN) satellite decoder.
First and last name, location (duty station address/residence country and locality), Unit Identification Code (UIC), DoD ID Number, sponsor/dependent status, home telephone number, address, personal cell phone number, email address, office telephone number, grade/rank, date of birth, organization assigned to (
10 U.S.C. 113, Secretary of Defense; DoD Directive (DoDD) 5122.05, Assistant Secretary of Defense for Public Affairs (ASD (PA)); DoDD 5105.74, Defense Media Activity (DMA); and DoD Instruction 5120.20, American Forces Radio and Television Service (AFRTS).
To document the eligibility and continued validation of authorized OCONUS individuals who register an AFN satellite decoder. AFNConnect provides U.S. military commanders worldwide a means to communicate internal information to OCONUS users. Records may also be used as a management tool for statistical analysis, tracking, reporting, evaluating program effectiveness, and conducting research.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained herein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To the Department of State to verify authorized personnel's use of an AFN satellite.
Law Enforcement Routine Use: If a system of records maintained by a DoD Component to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or by
Disclosures Required by International Agreements Routine Use: A record from a system of records maintained by a DoD Component may be disclosed to foreign law enforcement, security, investigatory, or administrative authorities to comply with requirements imposed by, or to claim rights conferred in, international agreements and arrangements including those regulating the stationing and status in foreign countries of DoD military and civilian personnel.
Congressional Inquiries Disclosure Routine Use: Disclosure from a system of records maintained by a DoD Component may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
Disclosure to the Department of Justice for Litigation Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to any component of the Department of Justice for the purpose of representing the Department of Defense, or any officer, employee or member of the Department in pending or potential litigation to which the record is pertinent.
Disclosure of Information to the National Archives and Records Administration Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to the National Archives and Records Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.
Data Breach Remediation Purposes Routine Use: A record from a system of records maintained by a Component may be disclosed to appropriate agencies, entities, and persons when (1) The Component suspects or has confirmed that the security or confidentiality of the information in the system of records has been compromised; (2) the Component has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Component or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Components efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
The DoD Blanket Routine Uses set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at:
Electronic storage media.
Records are retrieved by various combinations of first and last name, email address, location (duty station address/residence country and locality), date of birth, and/or decoder serial number.
Records are accessible only to personnel on a need-to-know basis to perform their duties. All records are maintained on a protected network. Access to the network where records are maintained requires a valid Common Access Card (CAC). Electronic files and databases are password protected with access restricted to authorized users and networks. Access to physical hardware (
Destroy/delete six (6) years after user account or access is terminated.
Director, American Forces Radio and Television Service, Defense Media Activity, 6700 Taylor Avenue, Fort Meade, Maryland 20755-7061.
Director, AFN-BC, Defense Media Activity, 23755 Z Street, Riverside, California 92518-2077.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Privacy Act Officer, Defense Media Activity, 6700 Taylor Avenue, Fort Meade, Maryland 20755-7061.
Signed, written requests should contain first and last name, duty station address, and home or office phone number for positive identification of requester.
Individuals seeking access to records about themselves contained in this system of records should address written inquiries to the Office of the Secretary of Defense/Joint Staff Freedom of Information Act Requester Service Center, 1155 Defense Pentagon, Washington, DC 20301-1155.
Signed, written requests should contain first and last name, home address and phone number for positive identification of requester and the name and number of this system of records notice.
The OSD rules for accessing records, for contesting content, and appealing initial agency determinations are contained in OSD Administrative Instruction 81, 32 CFR part 311, or may be obtained from the system manager.
Individual and Defense Enrollment Eligibility Reporting System (DEERS).
None.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by November 27, 2015.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Office of the Secretary of Defense, DoD.
Notice to alter a System of Records.
The Office of the Secretary of Defense proposes to alter a system of records notice DWHS D01, entitled “DoD National Capital Region Mass Transportation Benefit Program” to manage the DoD National Capital Region Mass Transportation Benefit Program for DoD military and civilian personnel applying for and in receipt of fare subsidies. Used as a management tool for statistical analysis, tracking, reporting, evaluating program effectiveness, and conducting research.
Comments will be accepted on or before November 27, 2015. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Ms. Cindy Allard, Chief, OSD/JS Privacy Office, Freedom of Information Directorate, Washington Headquarters Service, 1155 Defense Pentagon, Washington, DC 20301-1155, or by phone at (571)372-0461.
The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on October 15, 2015, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) 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 (February 20, 1996, 61 FR 6427).
DoD National Capital Region Mass Transportation Benefit Program (December 9, 2011, 76 FR 76959).
Delete entry and replace with “Name, DoD Identification Number (DoD ID Number), point-to-point commuting expenses, type of mass transit used, city, state, and ZIP+4 of residence, organizational affiliation of the individual, office work number, DoD email address, duty/work address, Smartrip card number, and monthly amount spent from Washington Metropolitan Area Transit Authority (WMATA). Note: Last four of the Social Security Number (SSN) is no longer being collected but will be maintained
Delete entry and replace with “To manage the DoD National Capital Region Mass Transportation Benefit Program for DoD military and civilian personnel applying for and in receipt of fare subsidies. Used as a management tool for statistical analysis, tracking, reporting, evaluating program effectiveness, and conducting research.”
Routine uses of records maintained in the system, including categories of users and the purposes of such uses:
Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained herein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To the Washington Metro Area Transit Authority for the purpose of crediting fare subsidies directly to the Smartrip Card of DoD military or civilian employees participating in the SmartBenefit program.
Law Enforcement Routine Use: If a system of records maintained by a DoD Component to carry out its functions indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or by regulation, rule, or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the agency concerned, whether federal, state, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute, rule, regulation, or order issued pursuant thereto.
Congressional Inquiries Disclosure Routine Use: Disclosure from a system of records maintained by a DoD Component may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
Disclosure to the Department of Justice for Litigation Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to any component of the Department of Justice for the purpose of representing the Department of Defense, or any officer, employee or member of the Department in pending or potential litigation to which the record is pertinent.
Disclosure of Information to the National Archives and Records Administration Routine Use: A record from a system of records maintained by a DoD Component may be disclosed as a routine use to the National Archives and Records Administration for the purpose of records management inspections conducted under authority of 44 U.S.C. 2904 and 2906.
Data Breach Remediation Purposes Routine Use: A record from a system of records maintained by a Component may be disclosed to appropriate agencies, entities, and persons when (1) The Component suspects or has confirmed that the security or confidentiality of the information in the system of records has been compromised; (2) the Component has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Component or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Components efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
The DoD Blanket Routine Uses set forth at the beginning of the Office of the Secretary of Defense (OSD) compilation of systems of records notices may apply to this system. The complete list of DoD Blanket Routine Uses can be found online at:
Delete entry and replace with “Individual's name and DoD ID Number.”
Delete entry and replace with “Records are maintained in a controlled facility. Physical entry is restricted by the use of locks, guards, and is accessible only to authorized personnel. Access to records is limited to person(s) responsible for servicing the record in performance of their official duties and who are properly screened and cleared for need-to-know. Access to computerized data is restricted by Common Access Card (CAC).”
Delete entry and replace with “Destroy applications of employees no longer in the program, superseded applications, vouchers, spreadsheets and other forms used to document the disbursement of subsidies when three (3) years old.”
Delete entry and replace with “Director, Facilities Services Directorate, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Director, Facilities Services Directorate, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155.
Written requests for information should contain the full name of the individual and DoD ID Number.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the Office of the Secretary of Defense/Joint Staff Freedom of Information Act Requester Service Center, 1155 Defense Pentagon, Washington, DC 20301-1155.
Signed, written requests for information should contain the full name of the individual, DoD ID Number, and include the name and number of this system of record notice.”
Delete entry and replace with “The OSD rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81; 32 CFR part 311; or may be obtained from the system manager.”
Department of the Navy, DoD.
Notice.
The inventions listed below are assigned to the United States Government, as represented by the
The following patent applications are available for licensing: Patent Application No. 62/156,092: PHOTONIC HYBRID RECEIVE ANTENNA for determining true time delay from each receiving element of an active electronically scanned array or a phased array antenna//Patent Application No. 62/141,977: RETRACTABLE SUPPRESSOR for gas generating systems such as a firearm//Patent Application No. 14/561,502: INTEGRAL MULTI-CHAMBERED VALVED SUPPRESSOR including a method of routing gas through baffled chambers and expansion chambers for reducing sound and flash//Patent Application No. 14/668,081: COMBINATION METAL OXIDE SEMI-CONDUCTOR FIELD EFFECT TRANSISTOR (MOSFET) AND JUNCTION FIELD EFFECT TRANSISTOR (JFET) OPERABLE FOR MODULATING CURRENT VOLTAGE RESPONSE OR MITIGATING ELECTROMAGNETIC OR RADIATION INTERFERENCE EFFECTS BY ALTERING CURRENT FLOW THROUGH THE MOSFETS SEMI-CONDUCTIVE CHANNEL REGION (SCR)//Patent Application No. 14/664,186: CONTROLLING CURRENT OR MITIGATING ELECTROMAGNETIC OR RADIATION INTERFERENCE EFFECTS USING MULTIPLE AND DIFFERENT SEMI-CONDUCTIVE CHANNEL REGIONS GENERATING STRUCTURES//Patent Application No. 14/724,267: APPARATUS AND METHODS FOR MODULATING CURRENT/VOLTAGE RESPONSE USING MULTIPLE SEMI-CONDUCTIVE CHANNEL REGIONS (SCR) PRODUCED FROM DIFFERENT INTEGRATED SEMICONDUCTOR STRUCTURES//Patent Application No. 14/230,486: PROCESS AND SYSTEM FOR GRAPHICAL RESOURCING DESIGN, ALLOCATION, AND/OR EXECUTION MODELING AND VALIDATION//Patent Application No. 14/873,739: APPARATUS AND METHODS FOR MODULATING CURRENT/VOLTAGE RESPONSE USING MULTIPLE SEMI-CONDUCTIVE CHANNEL REGIONS (SCR) PRODUCED FROM DIFFERENT INTEGRATED SEMICONDUCTOR STRUCTURES//Patent Application No. 14/873,680: CONTROLLING CURRENT OR MITIGATING ELECTROMAGNETIC OR RADIATION INTERFERENCE EFFECTS USING MULTIPLE AND DIFFERENT SEMI-CONDUCTIVE CHANNEL REGIONS GENERATING STRUCTURES.
Requests for copies of the patent applications cited should be directed to Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001.
Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, telephone 812-854-4100.
35 U.S.C. 207, 37 CFR part 404
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Thursday, November 12, 2015; 1:00 p.m.-4:30 p.m.
Cities of Gold Conference Center; 10-A Cities of Gold Road; Pojoaque, New Mexico 87506.
Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email:
Department of Energy.
Notice of open virtual meeting.
This notice announces a virtual meeting via WebEx of the National Coal Council (NCC). The Federal Advisory Committee Act (92, 86 Stat. 770) requires that public notice of these meetings be announced in the
Thursday, November 12, 2015; 11:00 a.m. to 12:30 p.m.
If you wish to join the meeting you must register on-line by close of business on November 6, 2015 at the following URL:
You are required to submit your name, organization, email address, telephone number and a request to join the meeting. The email address you
Dr. Robert J. Wright, U.S. Department of Energy, 4G-036/Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0001; Telephone: 202-586-0429.
A draft of the white paper will be available five days before the WebEx (November 5, 2015) on the National Coal Council Web site at the following URL:
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Wednesday, November 18, 2015; 1:00 p.m.-5:15 p.m.
New Mexico Highlands University Campus; 800 National Avenue; Las Vegas, New Mexico 87701.
Menice Santistevan, Northern New Mexico Citizens' Advisory Board (NNMCAB), 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email:
Tentative Agenda
National Nuclear Security Administration, Department of Energy
Notice.
On August 2, 2015, the Secretary of Energy issued a determination (“Secretarial Determination”) covering the sale or transfer of high-assay low enriched uranium for medical isotope development projects. The Secretarial Determination covers transfers of up to 25 kilograms uranium (kgU) per year of low enriched uranium (LEU) at up to 19.75 percent uranium-235 for transfers in the two years following approval of the determination to support molybdenum-99 producers in commercial research and isotope production applications. For the reasons set forth in the Department's “Analysis of Potential Impacts of Uranium Transfers on the Domestic Uranium Mining, Conversion, and Enrichment Industries,” which is incorporated into the determination, the Secretary determined that these transfers will not have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry.
Mr. Randy Howell, NNSA Mo-99 Domestic Project Support, U.S. Department of
The Department of Energy (DOE) holds inventories of uranium in various forms and quantities—including low-enriched uranium (LEU) and natural uranium—that have been declared as excess and are not dedicated to U.S. national security missions. Within DOE, the Office of Nuclear Energy (NE), the Office of Environmental Management (EM), and the National Nuclear Security Administration (NNSA) coordinate the management of these excess uranium inventories. NNSA down-blends excess highly-enriched uranium to high-assay low-enriched uranium—above the commercial level of 5 wt-% and up to about 19.75 wt-% of the isotope U-235—in support of its nonproliferation objectives and missions. Common applications of such high-assay materials are as fuels for domestic and foreign research reactors and as target materials for the production of medical isotopes.
This notice involves high-assay LEU transfers of this type to support molybdenum-99 producers in either and/or both of the above applications. These transfers fulfill a directive in the American Medical Isotope Production Act of 2012 (Pub. L. 112-239, Division C, Title XXXI, Subtitle F, 42 U.S.C. 2065) for the Department to carry out a program of assistance for the development of fuels, targets, and processes for domestic molybdenum-99 production that do not use highly enriched uranium. These transfers also support U.S. nuclear nonproliferation initiatives, by providing a path for down-blended highly enriched uranium (HEU) and encouraging the use of LEU in civil applications in lieu of HEU.
These transfers are conducted in accordance with the Atomic Energy Act of 1954 (42 U.S.C. 2011
On August 2, 2015, the Secretary of Energy issued a determination (“Secretarial Determination”) covering the sale or transfer of high-assay low enriched uranium for medical isotope development projects. The Secretarial Determination covers transfers of up to 25 kilograms per year of LEU at up to 19.75 percent uranium-235 for transfers in the two years following approval of the determination to support molybdenum-99 producers in commercial research and isotope production applications. The Secretary based his conclusion on the Department's “Analysis of Potential Impacts of Uranium Transfers on the Domestic Uranium Mining, Conversion, and Enrichment Industries,” which is incorporated into the determination. The Secretary considered,
Issued in Washington, DC.
Set forth below is the full text of the Secretarial Determination.
I determine that the transfer of up to the equivalent of 25 kgU of 19.75%-assay low enriched uranium per calendar year to support the development and demonstration of molybdenum-99 production capabilities will not have an adverse material impact on the domestic mining, conversion, or enrichment industry. I base my conclusions on the Department's “Analysis of Potential Impacts of Uranium Transfers on the Domestic Uranium Mining, Conversion, and Enrichment Industries,” which is incorporated herein. As explained in that document, I have considered,
DOE manages its excess uranium inventory in accordance with the Atomic Energy Act of 1954 (42 U.S.C. 2011
The USEC Privatization Act (Pub. L. 104-134, 42 U.S.C. 2297h
The American Medical Isotopes Production Act of 2012 (Pub. L. 112-239, Division C, Title XXXI, Subtitle F, 42 U.S.C. 2065) directs the Department to carry out a program to provide assistance for the development of fuels, targets, and processes for domestic molybdenum-99 production that do not use highly enriched uranium (HEU). The transfer of small quantities of high-assay low enriched uranium (LEU) (LEU enriched above 5 wt-%, but below 20 wt-% U-235) is appropriate and necessary to assist parties engaged in research and development (R&D) and
Consistent with the analytical approach outlined in the Department's prior Analysis of Potential Impacts of Uranium Transfers, 80 FR 26,366, 26,379-84 (May 7, 2015), this analysis evaluates two forecasts: one reflecting the state of the domestic uranium industries if DOE goes forward with the transfer and one reflecting the state of the domestic uranium industries if DOE does not go forward with the transfer. DOE compares these two forecasts to determine the relevant impacts on the domestic uranium industries. In conducting this comparison, DOE has developed a set of factors that this analysis considers in assessing whether DOE's uranium transfers will have an “adverse material impact” on the domestic uranium mining, conversion, or enrichment industries:
While no single factor is dispositive of the issue, DOE believes that these factors are representative of the types of impacts that the proposed transfers may have on the domestic uranium industries. Not every factor will necessarily be relevant on a given occasion or to a particular industry; DOE intends this list of factors only as a guide to its analysis.
There is currently no domestic commercial supplier of high-assay LEU. In particular, with the closing of the Paducah Gaseous Diffusion Plant in 2013, the only remaining operational uranium enrichment facility in the U.S. is that operated by Louisiana Energy Services, LLC, which is licensed by the Nuclear Regulatory Commission to possess LEU only up to 5 wt-% U-235,
Modern enrichment facilities are technologically able to produce such materials; however, due to the economics of enrichment, owners and operators of such enrichment facilities have thus far chosen not to pursue enrichment of high-assay LEU. To produce such LEU, a commercial supplier would need to secure an appropriate license or license amendment, a task that would require an investment of money and time. Projections of demand in the nuclear medicine industry lead to the forecast that the need for high-assay LEU in future years will range from tens to hundreds of kilograms. Compared to the thousands of metric tons of enriched uranium required by the commercial power industry, and given the costs required for licensing, the production of such small quantities of high-assay materials is not likely to be economically viable for private industry.
There also does not exist currently a foreign commercial producer or supplier of high-assay low enriched uranium for use in domestic research reactors or medical isotope production applications; what high-assay LEU is produced internationally, for example to convert Russian-supplied reactors from highly enriched uranium (HEU) cores, is produced by a state-owned enterprise for official purposes via down-blending excess HEU.
Given the specialized uses, designs, and regulatory requirements of the fuels and targets used for these isotope production purposes, it is not feasible to replace the DOE-sourced high-assay LEU used in research reactor fuel or targets with commercial-assay LEU because fuel or targets fabricated from commercial-assay LEU would generally not serve the intended purposes.
Given the lack of commercial production or supply of such materials, an analysis of the impact of transfers based on an assessment of the six factors listed in Section II is straightforward: since the transfer of DOE material would not displace primary production of uranium concentrates, conversion services, or enrichment services, there is no impact on the domestic uranium industries with respect to any of the factors.
Even if the DOE transfers would displace production among the domestic uranium mining, conversion, or enrichment industries, the amount is so small that the effects would be
Given how small DOE transfers are compared to either global reactor requirements or domestic production, DOE concludes that transfers at this level would have almost no impact on the domestic uranium mining, conversion, or enrichment industries with respect to any of the six factors listed in Section II.
DOE recently issued a determination that certain transfers of natural uranium in exchange for cleanup services at the Portsmouth Gaseous Diffusion Plant and of LEU in exchange for downblending services will not have an adverse material impact on the domestic uranium industries. The analysis supporting that determination also considered various other past transfers,
For the reasons discussed above, these transfers will not have an adverse material impact on the domestic uranium mining, conversion, or enrichment industry taking into account sales under the Russian HEU Agreement and Suspension Agreement.
This is a supplemental notice in the above-referenced proceeding of Golden Hills Interconnection, LLC.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 9, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding Blythe Solar 110 LLC.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 9, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on October 7, 2015, Florida Gas Transmission Company, LLC (FGT), 1300 Main St., Houston, TX 77002 filed a prior notice request pursuant to sections 157.205, 157.208 (b) and 157.216(b) of the Commission's regulations under the Natural Gas Act for authorization to replace approximately 3.39 miles of 8-inch lateral pipe and approximately 3.08 miles of 10-inch lateral pipe, and appurtenant facilities, with approximately 3.78 miles of new 12-
The filing may also be viewed on the web at
Any questions regarding this Application should be directed to Stephen Veatch, Senior Director of Certificates & Tariffs, Florida Gas Transmission Company, LLC, 1300 Main St., Houston, TX 77002, at phone (713) 989-2024 or facsimile (713) 989-1205, or via email to
Any person may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention. Any person filing to intervene or the Commission's staff may, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) file a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with he Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Description: Supplement to September 29, 2015 Panda Patriot LLC tariff filing.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On October 13, 2015, Seneca Falls Power Corporation (transferor) and C-S Canal Hydro, LLC (transferee) filed an application for transfer of license of the Seneca Falls Hydroelectric Project No. 2438. The project is located on the Seneca River in Seneca, Yates, Schuyler, and Ontario counties, New York.
The applicants seek Commission approval to transfer the license for the Seneca Falls Hydroelectric Project from the transferor to the transferee.
Deadline for filing comments, motions to intervene, and protests: 30 days from the date that the Commission issues this notice. The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
Take notice that on October 19, 2015, PJM Interconnection, L.L.C. filed Revisions to Operating Agreement, Schedule 1 RE FTR/ARR Revisions to be effective 1/1/2016.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
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
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will conduct additional public scoping meetings as part of their preparation of an environmental impact statement (EIS) for the Alaska LNG Project involving construction and operation of facilities by Alaska Gasline Development Corporation; BP Alaska LNG, LLC; Conoco Phillips Alaska LNG Company; ExxonMobil Alaska LNG, LLC; and TransCanada Alaska Midstream, LP (Applicants) in Alaska.
More information about the Commission's EIS and the Alaska LNG Project is available in
Additional information about the project is available from FERC's Office of External Affairs at (866) 208-FERC (3372) or on the FERC Web site (
The meetings will be recorded by a court reporter to ensure comments are accurately depicted on the public record. The Commission invites you to attend one of the following additional public scoping meetings in the project area.
Additional meetings in Nikiski, Houston, Trapper Creek, Kaktovik, Barrow, and Nuiqsut, Alaska, occurring during the week of October 26, 2015, were announced on October 8, 2015.
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
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the New Market Project, proposed by Dominion Transmission, Inc. (DTI) in the above-referenced docket. DTI requests authorization to construct and operate new compressors and associated improvements at new and existing facilities in several counties in New York.
The EA assesses the potential environmental effects of the construction and operation of the New Market Project in accordance with the requirements of the National Environmental Policy Act. The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major federal action significantly affecting the quality of the human environment.
The proposed New Market Project includes the following facilities:
• Construction of the new Horseheads Compressor Station in Chemung County;
• installation of gas coolers and filter/separator at the existing Borger Compressor Station in Tompkins County;
• construction of the new Sheds Compressor Station in Madison County;
• installation of gas coolers and filter/separator at the existing Utica Compressor Station in Herkimer County;
• installation of additional engine and turbine driven compressor units at the existing Brookman Corners Compressor Station in Montgomery County; and
• modifications to the existing West Schenectady Meter Station in Schenectady County.
The FERC staff mailed copies of the EA to federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; potentially affected landowners and other interested individuals and groups; newspapers and libraries in the project area; and parties to this proceeding. In addition, the EA is available for public viewing on the FERC's Web site (
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that the Commission has the opportunity to consider your comments prior to making its decision on this project, it is important that we receive your comments in Washington, DC on or before November 19, 2015.
For your convenience, there are three methods you can use to file your comments to the Commission. In all instances, please reference the project docket number (CP14-497) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature on the Commission's Web site (
(2) You can also file your comments electronically using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
This is a supplemental notice in the above-referenced proceeding of Jether Energy Research, Ltd.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 9, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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:
The following notice of meeting is published pursuant to Section 3(a) of the Government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission.
October 21, 2015, 11:30 a.m.
Restricted Area, 888 First Street NE., Washington, DC 20426.
Closed.
Non-Public Investigations and Inquiries, Enforcement Related Matters.
Kimberly D. Bose, Secretary, Telephone (202) 502-8400.
Chairman Bay and Commissioners Moeller, LaFleur, Clark, and Honorable voted to hold a closed meeting on less than the seven days' notice required by the Government in the Sunshine Act. The certification of the General Counsel explaining the action closing the meeting is available for public inspection in the Commission's Public Reference Room at 888 First Street NE., Washington, DC 20426.
The Chairman and the Commissioners, their assistants, the Commission's Secretary, the General Counsel and members of his staff, and members of the Nuclear Regulatory Commission are expected to attend the meeting. Other staff members from the Commission's program offices who will advise the Commissioners in the matters discussed will also be present.
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Comments/Protests Due: 5 p.m. ET 10/29/15.
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 date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) will accept requests, from December 1, 2015 through January 31, 2016, for grants to establish and enhance State and Tribal Response Programs. This notice provides guidance on eligibility for funding, use of funding, grant mechanisms and process for awarding funding, the allocation system for distribution of funding, and terms and reporting under these grants. EPA has consulted with state and tribal officials in developing this guidance.
The primary goal of this funding is to ensure that state and tribal response programs include, or are taking reasonable steps to include, certain elements of a response program and establishing a public record. Another goal is to provide funding for other activities that increase the number of response actions conducted or overseen by a state or tribal response program. This funding is not intended to supplant current state or tribal funding for their response programs. Instead, it is to supplement their funding to increase their response capacity.
For fiscal year 2016, EPA will consider funding requests up to a maximum of $1.0 million per state or tribe. Subject to the availability of funds, EPA regional personnel will be available to provide technical assistance to states and tribes as they apply for and carry out these grants.
This action is effective as of December 1, 2015. EPA expects to make non-competitive grant awards to states and tribes which apply during fiscal year 2016.
Mailing addresses for EPA Regional Offices and EPA Headquarters can be found at
EPA's Office of Solid Waste and Emergency Response, Office of Brownfields and Land Revitalization, (202) 566-2745 or the applicable EPA Regional Office listed at the end this Notice.
Section 128(a) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended, authorizes a noncompetitive $50 million grant program to establish and enhance state
The Catalogue of Federal Domestic Assistance entry for the section 128(a) State and Tribal Response Program cooperative agreements is 66.817. This grant program is eligible to be included in state and tribal Performance Partnership Grants under 40 CFR Part 35 Subparts A and B, with the exception of funds used to capitalize a revolving loan fund for brownfield remediation under section 104(k)(3); or purchase environmental insurance or developing a risk sharing pool, an indemnity pool, or insurance mechanism to provide financing for response actions under a State or Tribal response program.
Requests for funding will be accepted from December 1, 2015 through January 31, 2016. Requests EPA receives after January 31, 2016 will not be considered for FY2016 funding. Information that must be submitted with the funding request is listed in Section IX of this guidance. States or tribes that do not submit the request in the appropriate manner may forfeit their ability to receive funds. First time requestors are strongly encouraged to contact their Regional EPA Brownfields contacts, listed at the end of this guidance, prior to submitting their funding request. EPA will consider funding requests up to a maximum of $1.0 million per state or tribe for FY2016.
Requests submitted by the January 31, 2016 request deadline are preliminary; final cooperative agreement work plans and budgets will be negotiated with the regional offices once final funding allocation determinations are made. As in previous years, EPA will place special emphasis on reviewing a cooperative agreement recipient's use of prior section 128(a) funding in making allocation decisions and unexpended balances are subject to 40 CFR 35.118 and 40 CFR 35.518 to the extent consistent with this guidance. Also, EPA will prioritize funding for recipients establishing their response programs.
States and tribes requesting funds are required to provide a Dun and Bradstreet Data Universal Numbering System (DUNS) number with their cooperative agreement's final package. For more information, please go to
State and tribal response programs oversee assessment and cleanup activities at brownfields sites across the country. The depth and breadth of state and tribal response programs vary. Some focus on CERCLA related activities, while others are multi-faceted, addressing sites regulated by both CERCLA and the Resource Conservation and Recovery Act (RCRA). Many state programs also offer accompanying financial incentive programs to spur cleanup and redevelopment. In enacting CERCLA section 128(a),
This funding is intended for those states and tribes that have the management and administrative capacity within their government required to administer a federal grant. The primary goal of this funding is to ensure that state and tribal response programs include, or are taking reasonable steps to include, certain elements of an environmental response program and that the response program establishes and maintains a public record of sites addressed.
Subject to the availability of funds, EPA regional personnel will be available to provide technical assistance to states and tribes as they apply for and carry out section 128(a) cooperative agreements.
To be eligible for funding under CERCLA section 128(a), a state or tribe must:
1. Demonstrate that its response program includes, or is taking reasonable steps to include, the four elements of a response program described in Section V of this guidance;
2. maintain and make available to the public a record of sites at which response actions have been completed in the previous year and are planned to be addressed in the upcoming year, see CERCLA section 128(b)(1)(C).
States and tribes are
Section 128(a) recipients that do not have a VRP MOA with EPA must demonstrate that their response program includes, or is taking reasonable steps to include, the four elements. Achievement of the four elements should be viewed as a priority. Section 128(a) authorizes funding for activities necessary to establish and enhance the four elements, and to establish and maintain the public record requirement.
The four elements of a response program are described below:
1.
Given funding limitations, EPA will negotiate work plans with states and tribes to achieve this goal efficiently and effectively, and within a realistic time frame. For example, many of EPA's Brownfields Assessment cooperative agreement recipients conduct inventories of brownfields sites in their communities or jurisdictions. EPA encourages states and tribes to work with these cooperative agreement recipients to obtain the information that they have gathered and include it in their survey and inventory.
2.
a. A response action will protect human health and the environment, and be conducted in accordance with applicable laws; and
b. the state or tribe will complete the necessary response activities if the person conducting the response fails to complete the necessary response (this includes operation and maintenance and/or long-term monitoring activities).
3.
a. Public access to documents and related materials that a state, tribe, or party conducting the cleanup is relying on or developing to make cleanup decisions or conduct site activities;
b. prior notice and opportunity for meaningful public comment on cleanup plans and site activities, including the input into the prioritization of sites; and
c. a mechanism by which a person who is, or may be, affected by a release or threatened release of a hazardous substance, pollutant, or contaminant at a brownfields site—located in the community in which the person works or resides—may request that a site assessment be conducted. The appropriate state or tribal official must consider this request and appropriately respond.
4.
In order to be eligible for section 128(a) funding, states and tribes (including those with MOAs) must establish and maintain a public record system, as described below. The public record should be made available to provide a mechanism for meaningful public participation (refer to Section V.3 above). Specifically, under section 128(b)(1)(C), states and tribes must:
1. Maintain and update, at least annually or more often as appropriate, a record that includes the name and location of sites at which response actions have been completed during the previous year;
2. maintain and update, at least annually or more often as appropriate, a record that includes the name and location of sites at which response actions are planned in the next year; and
3. identify in the public record whether or not the site, upon completion of the response action, will be suitable for unrestricted use. If not, the public record must identify the institutional controls relied on in the remedy and include relevant information concerning the entity that will be responsible for oversight, monitoring, and/or maintenance of the institutional and engineering controls; and how the responsible entity is implementing those activities (see Section VI.C).
It is important to note that the public record requirement differs from the “timely survey and inventory” element described in the “Four Elements” section above. The public record addresses sites at which response actions have been completed in the previous year or are planned in the upcoming year. In contrast, the “timely survey and inventory” element, described above, refers to identifying brownfields sites regardless of planned or completed actions at the site.
EPA's goal is to enable states and tribes to make the public record and other information, such as information from the “survey and inventory” element, easily accessible. For this reason, EPA will allow states and tribes to use section 128(a) funding to make the public record, as well as other information, such as information from the “survey and inventory” element, available to the public via the internet or other means. For example, the Agency would support funding state and tribal efforts to include detailed location information in the public record such as the street address, and latitude and longitude information for each site.
In an effort to reduce cooperative agreement reporting requirements and increase public access to the public record, EPA encourages states and tribes to place their public record on the internet. If a state or tribe places the public record on the internet, maintains the substantive requirements of the public record, and provides EPA with the link to that site, EPA will, for purposes of cooperative agreement funding only, deem the public record reporting requirement met.
EPA encourages states and tribes to maintain public record information,
Section 128(a)(1)(B) describes the eligible uses of cooperative agreement funds by states and tribes. In general, a state or tribe may use funding to “establish or enhance” its response program. Specifically, a state or tribe may use cooperative agreement funds to build response programs that includes the four elements outline in section 128(a)(2). Eligible activities include, but are not limited to, the following:
• Developing legislation, regulations, procedures, ordinances, guidance, etc. that establish or enhance the administrative and legal structure of a response program;
• establishing and maintaining the required public record described in Section VI of this guidance;
• operation, maintenance and long-term monitoring of institutional controls and engineering controls;
• conducting site-specific activities, such as assessment or cleanup, provided such activities establish and/or enhance the response program and are tied to the four elements. In addition to the requirement under CERCLA section 128(a)(2)(C)(ii) to provide for public comment on cleanup plans and site activities, EPA strongly encourages states and tribes to seek public input regarding the priority of sites to be addressed and solicit input from local communities, especially potential environmental justice communities, communities with a health risk related to exposure to hazardous waste or other public health concerns, economically disadvantaged or remote areas, and communities with limited experience working with government agencies. EPA will not provide section 128(a) funds solely for assessment or cleanup of specific brownfields sites; site-specific activities must be part of an overall section 128(a) work plan that includes funding for other activities that establish or enhance the four elements;
• capitalizing a revolving loan fund (RLF) for brownfields cleanup under CERCLA section 104(k)(3). These RLFs are subject to the same statutory requirements and cooperative agreement terms and conditions applicable to RLFs awarded under section 104(k)(3). Requirements include a 20 percent match (can be in the form of a contribution of money, labor, material, or services from a non-federal source) on the amount of section 128(a) funds used for the RLF, a prohibition on using EPA cooperative agreement funds for administrative costs relating to the RLF, and a prohibition on using RLF loans or subgrants for response costs at a site for which the recipient may be potentially liable under section 107 of CERCLA. Other prohibitions contained in CERCLA section 104(k)(4) also apply; and
• purchasing environmental insurance or developing a risk-sharing pool, indemnity pool, or insurance mechanism to provide financing for response actions under a state or tribal response program.
Under CERCLA section 128(a), “establish” includes activities necessary to build the foundation for the four elements of a state or tribal response program and the public record requirement. For example, a state or tribal response program may use section 128(a) funds to develop regulations, ordinances, procedures, guidance, and a public record.
Under CERCLA section 128(a), “enhance” is related to activities that add to or improve a state or tribal response program or increase the number of sites at which response actions are conducted under a state or tribal response program.
The exact “enhancement” uses that may be allowable depend upon the work plan negotiated between the EPA regional office and the state or tribe. For example, regional offices and states or tribes may agree that section 128(a) funds may be used for outreach and training directly related to increasing awareness of its response program, and improving the skills of program staff. It may also include developing better coordination and understanding of other state response programs,
Note: EPA anticipates states and tribes will work with their EPA Brownfields Area-Wide Planning, Cleanup, and Revolving Loan Fund recipients to incorporate changing climate conditions in their reuse plans and clean up remedies, as appropriate.
Site-specific assessment and cleanup activities should establish and/or enhance the response program and be tied to the four elements. Site-specific assessments and cleanups can be both eligible and allowable if the activities is included in the work plan negotiated between the EPA regional office and the state or tribe, but activities must comply with all applicable laws and are subject to the following restrictions:
a. Section 128(a) funds can only be used for assessments or cleanups at sites that meet the definition of a brownfields site at CERCLA section 101(39). EPA
b. absent EPA approval, no more than $200,000 per site assessment can be funded with section 128(a) funds, and no more than $200,000 per site cleanup can be funded with section 128(a) funds;
c. absent EPA approval, the state/tribe may not use funds awarded under this agreement to assess and/or clean up sites owned or operated by the recipient or held in trust by the United States Government for the recipient; and
d. assessments and cleanups cannot be conducted at sites where the state/tribe is a potentially responsible party pursuant to CERCLA section 107, except:
• At brownfields sites contaminated by a controlled substance as defined in CERCLA section 101(39)(D)(ii)(I); or
• when the recipient would satisfy all of the elements set forth in CERCLA section 101(40) to qualify as a bona fide prospective purchaser except that the date of acquisition of the property was on or before January 11, 2002.
1. At brownfields sites contaminated by a controlled substance as defined in CERCLA section 101(39)(D)(ii)(I); or
2. when the recipient would satisfy all of the elements set forth in CERCLA section 101(40) to qualify as a bona fide prospective purchaser except that the date of acquisition of the property was on or before January 11, 2002.
States and tribes may use section 128(a) funds for site-specific activities that improve state or tribal capacity but the amount recipients may request for site-specific assessments and cleanups may not exceed 50% of the total amount of funding.
• Total amount requested for site-specific activities;
• percentage of the site-specific activities (assuming waiver is approved) in the total budget;
• site specific activities that will be covered by this funding. If known, provide site specific information and describe how work on each site contributes to the development or enhancement of your state/tribal site response program. EPA recognizes the role of response programs to develop and provide capacity in distressed, environmental justice, rural or tribal communities, and encourages prioritization for site-specific activities in those communities. Further explain how the community will be (or has been) involved in prioritization of site work and especially those sites where there is a potential or known significant environmental impact to the community;
• an explanation of how this shift in funding will not negatively impact the core programmatic capacity (
• an explanation as to whether the sites to be addressed are those for which the affected community(ies) has requested work be conducted (refer to Section VII.A Overview of Funding for more information).
States and tribes may use section 128(a) funds for activities that establish and enhance response programs addressing petroleum brownfield sites. Subject to the restrictions listed above (see Section VII.D.1) for all site-specific activities, the costs of site-specific assessments and cleanup activities at petroleum contaminated brownfields sites, defined at CERCLA section 101(39)(D)(ii)(II), are both eligible and allowable if the activity is included in the work plan negotiated between the EPA regional office and the state or tribe. Section 128(a) funds used to capitalize a Brownfields RLF may be used at brownfields sites contaminated by petroleum to the extent allowed under CERCLA section 104(k)(3).
Other eligible uses of funds for site-specific related include, but are not limited to, the following activities:
• Technical assistance to federal brownfields cooperative agreement recipients;
• development and/or review of quality assurance project plans (QAPPs); and
• entering data into the Assessment Cleanup and Redevelopment Exchange System (ACRES) database
Costs incurred for activities at non-brownfields sites,
Funding authorized under CERCLA section 128(a) is awarded through a
Subject to the availability of funds, EPA regional offices will negotiate and enter into section 128(a) cooperative agreements with eligible and interested states or tribes.
For Fiscal Year 2016, EPA will consider funding requests up to a maximum of $1.0 million per state or tribe. Please note the CERCLA 128(a) program's annual budget has remained relatively the same since 2003 while demand has increased over time. Due to the increasing number of entities requesting funding, it is likely that the FY16 states and tribal individual funding amounts will be less than the FY15 individual funding amounts.
States and tribes must define in their work plan the “section 128(a) response program(s)” to which the funds will be applied, and may designate a component of the state or tribe that will be EPA's primary point of contact for negotiations on their proposed work plan. When EPA funds the section 128(a) cooperative agreement, states and tribes may distribute these funds among the appropriate state and tribal agencies that are part of the section 128(a) response program. This distribution must be clearly outlined in their annual work plan.
If a portion of the section 128(a) grant funds requested will be used to capitalize a revolving loan fund for cleanup, pursuant to section 104(k)(3), two separate cooperative agreements must be awarded,
If a state or tribe chooses to use its section 128(a) funds to capitalize a revolving loan fund program, the state or tribe must have the lead authority to manage the program,
States and tribes may include section 128(a) cooperative agreements in their PPG 69 FR 51,756 (2004). Section 128(a) funds used to capitalize an RLF or purchase environmental insurance or develop a risk sharing pool, an indemnity pool, or insurance mechanism to provide financing for response actions under a state or tribal response program are not eligible for inclusion in the PPG.
EPA regional offices will determine the project period for each cooperative agreement. These may be for multiple years depending on the regional office's cooperative agreement policies. Each cooperative agreement must have an annual budget period tied to an annual work plan. While not prohibited, pre-award costs are subject to 40 CFR 35.113 and 40 CFR 35.513.
As part of the annual work plan negotiation process, states or tribes that do
Prior to funding a state's or tribe's annual work plan, EPA regional offices will verify and document that a public record, as described in Section VI and below, exists and is being maintained.
• states or tribes that received initial funding prior to FY15: Requests for FY16 funds will not be accepted from states or tribes that fail to demonstrate, by the January 31, 2016 request deadline, that they established and are maintaining a public record. (
• states or tribes that received initial funding in FY15: By the time of the actual FY16 award, the state or tribe must demonstrate that they established and maintained the public record (those states and tribes that do not meet this requirement will have a term and condition placed on their FY16 cooperative agreement that prohibits the drawdown of FY16 funds until the public record requirement is met).
States and tribes should be aware that EPA and its Congressional appropriations committees place
EPA Regional staff will review EPA's Financial Database Warehouse to identify the amount of remaining prior year(s) funds. The requestor should work, as early as possible, with both their own finance department, and with their Regional Project Officer to reconcile any discrepancy between the amount of unspent funds showing in EPA's system, and the amount reflected in the recipient's records. The recipient should obtain concurrence from the Region on the amount of unspent funds requiring justification by the deadline for this request for funding.
After the January 31, 2016, request deadline, EPA's Regional Offices will submit summaries of state and tribal requests to EPA Headquarters. Before submitting requests to EPA Headquarters, regional offices may take into account additional factors when determining recommended allocation amounts. Such factors include, but are not limited to, the depth and breadth of the state or tribal program; scope of the perceived need for the funding,
After receipt of the regional recommendations, EPA Headquarters will consolidate requests and make decisions on the final funding allocations.
EPA regional offices will work with interested states and tribes to develop their preliminary work plans and funding requests. Final cooperative agreement work plans and budgets will be negotiated with the regional office once final allocation determinations are made. Please refer to process flow chart below (dates are estimates and subject to change):
All states and tribes requesting FY16 funds must submit (to their regional brownfields contact) a summary of the planned use of the funds with associated dollar amounts. Please provide the request in the chart below. The amount of funding requested should be an amount that can be reasonably spent in one year. It is likely that the FY16 state and tribal individual funding amounts will be less than the FY15 individual funding amounts. The requestor should work, as early as possible, with their EPA Regional Program contact to ensure that the funding amount requested and related activities are reasonable.
States and tribes that received section 128(a) funds prior to FY15 must provide the amount of the prior years' funding including funds that recipients have not received in payments (
Please explain the programmatic effects of a reduction (to your current funding amount) on significant activities of your response program. Specifically, at what amount (
Cooperative agreements for state and tribal response programs will include programmatic and administrative terms and conditions. These terms and conditions will describe EPA's substantial involvement including technical assistance and collaboration on program development and site-specific activities. Each of the subsections below summarizes the basic terms and conditions, and related reporting that will be required if a cooperative agreement with EPA is awarded.
In accordance with 2 CFR 200.328 and any EPA specific regulations, state and tribes must provide progress reports as provided in the terms and conditions of the cooperative agreement negotiated with EPA regional offices. State and tribal costs for complying with reporting requirements are an eligible expense under the section 128(a) cooperative agreement. As a minimum, state or tribal progress reports must include both a narrative discussion and performance data relating to the state's or tribe's accomplishments and environmental outputs associated with the approved budget and workplan. Reports should also provide an accounting of section 128(a) funding. If applicable, the state or tribe must include information on activities related to establishing or enhancing the four elements of the state's or tribe's response program. All recipients must provide information related to establishing or, if already established, maintaining the public record.
1.
2.
• A narrative description and copies of applicable documents developed or under development to enable the response program to conduct enforcement and oversight at sites. For example:
○ Legal authorities and mechanisms (
○ policies and procedures to implement legal authorities; and other mechanisms;
• a description of the resources and staff allocated/to be allocated to the response program to conduct oversight and enforcement at sites as a result of the cooperative agreement;
• a narrative description of how these authorities or other mechanisms, and resources, are adequate to ensure that:
○ A response action will protect human health and the environment; and be conducted in accordance with applicable federal and state law; and if the person conducting the response action fails to complete the necessary response activities, including operation and maintenance or long-term monitoring activities, the necessary response activities are completed; and
• a narrative description and copy of appropriate documents demonstrating the exercise of oversight and enforcement authorities by the response program at a brownfields site.
3.
4.
• Number and frequency of oversight audits of licensed site professional certified cleanups;
• number and frequency of state/tribal oversight audits conducted;
• number of sites where staff conducted audits, provided technical assistance, or conducted other oversight activities; and
• number of staff conducting oversight audits, providing technical assistance, or conducting other oversight activities.
5.
6.
• Number and description of insurance policies purchased (
• the number of sites covered by the insurance;
• the amount of funds spent on environmental insurance (
• the amount of claims paid by insurers to policy holders.
The regional offices may also request that information be added to the progress reports, as appropriate, to properly document activities described by the cooperative agreement work plan.
EPA regions may allow states or tribes to provide performance data in appropriate electronic format.
The regional offices will forward progress reports to EPA Headquarters, if requested. This information may be used to develop national reports on the outcomes of CERCLA section 128(a) funding to states and tribes.
States and tribes must report, by January 31, 2016, a summary of the
• Environmental programs where CERCLA section 128(a) funds are used to support capacity building (general program support, non-site-specific work). Indicate as appropriate from the following:
• number of properties (or sites) enrolled in a response program during FY15;
• number of properties (or sites) where documentation indicates that cleanup work is complete and all required institutional controls (IC's) are in place, or not required;
• total number of acres associated with properties (or sites) in the previous bullet;
• number of properties where assistance was provided, but the property was not enrolled in the response program (OPTIONAL);
• date that the public record was last updated;
• Estimated total number of properties (or sites) in your brownfields inventory;
• Please provide a brief narrative explaining how you ensure that cleanup remedies (including engineering controls and institutional controls) are still protective in the future; and
• Did you develop or revise legislation, regulations, codes, guidance documents or policies related to establishing or enhancing your Voluntary Cleanup Program/Response Program during FY15? If yes, please indicate the type and whether it was new or revised.
EPA may require states/tribes to report specific performance measures related to the four elements that can be aggregated for national reporting to Congress. For example:
1. timely survey and inventory—estimated number of brownfields sites in the state or on tribal land;
2. oversight and enforcement authorities/mechanisms—number of active cleanups and percentage that received oversight; percentage of active cleanups not in compliance with the cleanup workplan and that received
3. public participation—percentage of sites in the response program where public meetings/notices were conducted regarding the cleanup plan and/or other site activities; number of site assessments requests, and responses to such requests; and
4. cleanup approval/certification mechanisms—total number of “no further action” letters or total number of certificates of completions.
This reporting requirement may include activities not funded with CERCLA section 128(a) funding, because such information may be helpful to EPA when evaluating whether recipients have met or are taking reasonable steps to meet the four elements of a response program pursuant to CERCLA section 128(a)(2).
All recipients must report, as specified in the terms and conditions of their cooperative agreement, and in Section VIII.I of this guidance, information related to establishing, or if already established, maintaining the public record, described above. States and tribes can refer to an already existing public record,
A list of sites at which response actions have been completed in the past year including:
• date the response action was completed;
• site name;
• name of owner at time of cleanup, if known;
• location of the site (street address, and latitude and longitude);
• whether an institutional control is in place;
• type of institutional control in place (
• nature of the contamination at the site (
• size of the site in acres.
A list of sites planned to be addressed by the state or tribal response program in the coming year including:
• site name and the name of owner at time of cleanup, if known;
• location of the site (street address, and latitude and longitude);
• to the extent known, whether an institutional control is in place;
• type of the institutional control in place (
• to the extent known, the nature of the contamination at the site (
• size of the site in acres
Applicants must ensure that they have the necessary processes and systems in place to comply with the subaward and executive total compensation reporting requirements established under OMB guidance at 2 CFR Part 170, unless they qualify for an exception from the requirements, should they be selected for funding.
Unless exempt from these requirements under OMB guidance at 2 CFR Part 25 (
1. Be registered in SAM prior to submitting an application or proposal under this announcement. SAM information can be found at
2. Maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or proposal under consideration by an agency, and
3. Provide its DUNS number in each application or proposal it submits to the agency. Applicants can receive a DUNS number, at no cost, by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711, or visiting the D&B Web site at:
If an applicant fails to comply with these requirements, it will, should it be selected for award, affect their ability to receive the award.
Please note that the CCR has been replaced by the System for Award Management (SAM). To learn more about SAM, go to SAM.gov or
All grant applications for non-competitive assistance agreements awards submitted on or after February 17, 2015 must be submitted using Grants.gov. Below is the information that the applicant will use to submit their State and Tribal Response Program Grant applications via Grants.gov:
An applicant that receives an award under this announcement is expected to manage assistance agreement funds efficiently and effectively, and make sufficient progress towards completing the project activities described in the work-plan in a timely manner. The assistance agreement will include terms and conditions related to implementing this requirement.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Because this action is not subject to notice and comment requirements under the Administrative Procedures Act or any other statute, it is not subject to the Regulatory Flexibility Act (5 U.S.C. 601
Environmental Protection Agency (EPA).
Notice.
The U.S. Environmental Protection Agency (EPA) has submitted an Information Collection Request (ICR) for the Public Water System Supervision Program (EPA ICR No. 0270.46, OMB Control No. 2040-0090) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA; 44 U.S.C. 3501
Additional comments may be submitted on or before November 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OW-2011-0443, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Kevin Roland, Drinking Water Protection Division, Office of Ground Water and Drinking Water, (4606M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-4588: fax number: 202-564-3755; email address:
Supporting documents which explain in detail the information that EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Emission Guidelines for Existing Other Solid Waste Incineration Units (40 CFR part 60, subpart FFFF) (Renewal)” (EPA ICR No. 2164.05, OMB Control No. 2060-0562), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before November 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0256, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Stationary Compression Ignition Internal Combustion Engines (40 CFR part 60, subpart IIII) (Renewal)” (EPA ICR No. 2196.05, OMB Control No. 2060-0590) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before November 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0264, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
There is a decrease in the estimated number of responses and the O&M cost due to corrections to the Agency's estimates. The decrease is not due to any program changes. The previous ICR incorrectly included responses for non-emergency operations, and had an inconsistency in calculating the O&M cost for selective enforcement audit.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), “Part 70 State Operating Permit Program (Renewal)” (EPA ICR No. 1587.13, OMB Control No. 2060-0243) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Comments must be submitted on or before November 27, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2004-0015, to (1) EPA online using
The EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information or other information whose disclosure is restricted by statute.
Dylan C. Mataway-Novak, Air Quality Policy Division, Office of Air Quality Planning and Standards, C504-05, U.S. Environmental Protection Agency, Research Triangle Park, NC; telephone number: (919) 541-5795; fax number: (919) 541-5509; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
In order to receive an operating permit for a major or other source subject to the permitting program, the applicant must conduct the necessary research, perform the appropriate analyses, and prepare the permit application with documentation to demonstrate that its facility meets all applicable statutory and regulatory requirements. Specific activities and requirements are listed and described in the Supporting Statement for the 40 CFR part 70 ICR.
Under 40 CFR part 70, state, local and tribal permitting authorities review permit applications, provide for public review of proposed permits, issue permits based on consideration of all technical factors and public input and review information submittals required of sources during the term of the permit. Also, under 40 CFR part 70, the EPA reviews certain actions of the permitting authorities and provides oversight of the programs to ensure that they are being adequately implemented and enforced. Consequently, information prepared and submitted by sources is essential for sources to receive permits, and for federal, state, local and tribal permitting authorities to adequately review the permit applications and thereby properly administer and manage the program.
Information that is collected is handled according to EPA's policies set forth in title 40, chapter 1, part 2, subpart B—Confidentiality of Business Information (
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “EPA's ENERGY STAR Product Labeling” (EPA ICR No. 2078.06, OMB Control No. 2060-0528) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before December 28, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2003-0033, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Kirsten Hesla, Climate Protection Partnerships Division, Office of Air and Radiation, Mailcode 6202J, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-2984; fax number: 202-343-2200 email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) 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,
Program participants submit signed Partnership Agreements indicating that they will adhere to logo-use guidelines and program requirements. Retail partners commit to selling, marketing and promoting ENERGY STAR certified products. Product brand owner partners, who are usually the manufacturer of the products, commit to having participating products certified to meet specified energy performance criteria based on a standard test method and EPA's third party certification requirements. These requirements for ENERGY STAR product certification also include provisions for verifying the performance of certified products through verification testing. The program's emphasis on testing and third-party product review ensures that consumers can trust ENERGY STAR certified products to deliver the energy savings promised by the label. In rare circumstances where product brand licensee's wish to partner with EPA, the Agency establishes the appropriate contacts and relationships for the brand owner and licensee through a joint brand owner and licensee template that both parties are required to sign.
As part of the Agency's contribution to the overall success of the program, EPA facilitates the sale of certified products by providing consumers with easy-to-use information about the products. To perform this function, EPA must obtain data on certified products. Prior to EPA adopting a third-party certification process, product brand owners were required to submit individual product information directly to the Agency. Now, product information is recorded by Certification Bodies and shared with EPA using XML-based web services that validate and save the information in EPA's database. EPA believes the improved
In order to monitor progress and support the best allocation of resources, EPA also asks manufacturers to submit annual shipment data for their ENERGY STAR qualifying products. EPA is flexible as to the methods by which manufacturers may submit unit shipment data. For example, many manufacturers are given the option of arranging for shipment data to be sent to EPA via this third party to ensure confidentiality. In using any shipment data received directly from a partner, EPA only shares aggregate information from multiple partners so as to protect confidentiality.
Finally, Partners that wish to receive recognition for their efforts in ENERGY STAR may submit an application for the Partner of the Year Award.
The estimated total cost for respondents is $3,908,125 and the hourly burden is approximately 59,407 hours. This cost includes an estimated burden cost of $3,890,840 and an estimated cost of $17,285 for capital investment or maintenance and operational costs. The estimated total cost for the Agency is $566,573 and the hourly burden is approximately 14,044 hours. This cost includes an estimated burden cost of $566,549.63 and an estimated cost of $23.37 for capital investment or maintenance and operational costs. A grand total of $4,474,698 and an hourly burden of approximately 73,451 hours are expected for all information collection activities under ENERGY STAR product labeling.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NESHAP for Integrated Iron and Steel Manufacturing Facilities (40 CFR part 63, subpart FFFFF) (Renewal)” (EPA ICR No. 2003.06, OMB Control No. 2060-0517), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before November 27, 2015.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2011-0271, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
The following items have been deleted from the list of Agenda items scheduled for consideration at the Thursday, October 22, 2015, Open Meeting and previously listed in the Commission's Notice of October 15, 2015. These items have been adopted by the Commission.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before December 28, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Under 47 CFR 64.1510 of the Commission's rules, telephone bills containing charges for interstate pay-per-call and other information services must include information detailing consumers' rights and responsibilities with respect to these charges.
Federal Deposit Insurance Corporation (FDIC).
Notice of Designated Reserve Ratio for 2016.
Pursuant to the Federal Deposit Insurance Act, the Board of Directors of the Federal Deposit Insurance Corporation designates that the Designated Reserve Ratio (DRR) for the Deposit Insurance Fund shall remain at 2 percent for 2016.
Munsell St. Clair, Chief, Banking and Regulatory Policy Section, Division of Insurance and Research, (202) 898-8967; Robert Grohal, Chief, Fund Analysis and Pricing Section, Division of Insurance and Research, (202) 898-6939; or, Nefretete Smith, Senior Attorney, Legal Division, (202) 898-6851.
By order of the Board of Directors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Appraisal Subcommittee of the Federal Financial Institutions Examination Council.
Notice of meeting.
Description: In accordance with Section 1104 (b) of Title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989, as amended, notice is hereby given that the Appraisal Subcommittee (ASC) will meet in open session for its regular meeting:
If you plan to attend the ASC Meeting in person, we ask that you send an email to
10 a.m., Wednesday, November 18, 2015.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will hear oral argument in the matter
Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
10 a.m., Thursday, November 19, 2015.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW., Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will consider and act upon the following in open session:
Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 12, 2015.
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 20, 2015.
A. Federal Reserve Bank of St. Louis (Yvonne Sparks, Community Development Officer) P.O. Box 442, St. Louis, Missouri 63166-2034:
1.
Board of Governors of the Federal Reserve System.
2:30 p.m. on Friday, October 30, 2015.
Marriner S. Eccles Federal Reserve Board Building, 20th Street entrance between Constitution Avenue and C Streets NW., Washington, DC 20551.
Open.
On the day of the meeting, you will be able to view the meeting via webcast from a link available on the Board's public Web site.
1. Proposed Rule establishing Total Loss-Absorbing Capacity and Buffers, Long-term Debt, and Clean Holding Company Requirements for U.S. Global Systemically Important Banking Organizations and U.S. Intermediate Holding Companies of Foreign Global Systemically Important Banking Organizations.
2. Final Rule regarding Margin and Capital Requirements for Uncleared Swaps.
Notes: 1. The staff memo to the Board will be made available to the public on the day of the meeting in paper and the background material will be made available on a compact disc (CD). If you require a paper copy of the entire document, please call Penelope Beattie on 202-452-3982. The documentation will not be available until about 20 minutes before the start of the meeting.
2. This meeting will be recorded for the benefit of those unable to attend. The webcast recording and a transcript of the meeting will be available after the meeting on the Board's public Web site
For more information please contact: Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202-452-2955.
You may access the Board's public Web site at
Federal Trade Commission (“FTC” or “Commission”).
Notice.
The FTC seeks public comments on proposed information requests to marketers of electronic cigarettes. These comments will be considered before the Commission submits a request for Office of Management and Budget (“OMB”) review under the Paperwork Reduction Act (“PRA”) of compulsory process orders to those marketers. The information sought from those companies would include, among other things, data on annual sales and marketing expenditures. The Commission intends to ask OMB for a three-year clearance to collect this information.
Comments on the proposed information requests must be received on or before December 28, 2015.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Requests for additional information should be addressed to Elizabeth Sanger or Shira Modell, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission. Telephone: (202) 326-2757 (Sanger) or (202) 326-3116 (Modell).
In the past few years, sales of battery-powered devices generally referred to as electronic cigarettes or “e-cigarettes” have grown rapidly in the United States. Rather than burn tobacco, these devices heat liquid containing flavorings and chemicals (usually including nicotine) to produce an aerosol that is inhaled, and then exhaled, by the user. E-cigarettes, which are sold both online and in brick-and-mortar stores, are available in both disposable and refillable models, in a range of nicotine strengths (including nicotine-free), and in a multitude of flavors;
Given the increasing prevalence of e-cigarettes alongside conventional cigarettes and smokeless tobacco, the Commission believes it is necessary for the agency to begin collecting information from e-cigarette marketers about their sales and marketing activities. The Commission intends to publish a report with the data it obtains,
The Commission plans to address its information requests to the ultimate U.S. parent of e-cigarette marketers (“industry members”) in order to ensure that no relevant data from affiliated or subsidiary companies go unreported. The Commission intends to issue information requests to approximately five large and ten small industry members. Even though this number does not represent the entire industry, the responses should provide valuable information about a reasonable percentage of the e-cigarette market, including its major players. Because the number of separately incorporated companies affected by the Commission's requests will exceed nine entities, the Commission intends to seek OMB clearance under the PRA before requesting any information from the industry members. Under the PRA, 44 U.S.C. 3501-3521, federal agencies must obtain approval from OMB for each “collection of information” they conduct or sponsor if posed to ten or more entities within any twelve-month period. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB authorize the proposed collection of information.
The FTC invites comments on: (1) Whether participation in the study is necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (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.
The Commission anticipates that its requests will seek the following categories of information: (1) Sales and give-aways of e-cigarettes and related products (
The Commission also invites comments on the following issues:
1. Should the FTC seek to collect data that are differentiated according to: (a) The various types of products sold and given away by industry members (
2. Should the Commission collect data on product sales separately from data on product give-aways?
3. If an e-cigarette is sold with more than one cartridge (or container of e-liquid), should all of those cartridges be considered part of the initial sale, or should some of them be considered refills? If some of them should be considered refills, which ones? Does it matter whether those cartridges are part of the same Stock Keeping Unit (“SKU”) as the e-cigarette device? Whether they are packaged with it in the same blister pack?
4. Should the Commission seek data on state-by-state sales of e-cigarettes and related products?
5. Is there other information the Commission should seek from the companies about sales and give-aways of their products?
6. Assuming that the Commission's collection and reporting of highly detailed data is necessary for understanding the e-cigarette industry—
7. Should the Commission collect data for each individual e-cigarette flavor sold by the companies, or should it identify various flavor categories (
The Commission anticipates that even if it provides models for the Excel datafiles the companies will be required to submit, recipients of its Orders will need substantial time to prepare a response the first time. Once an e-cigarette marketer has prepared its first response to a Commission Order, however, it will need less time in subsequent years to prepare its reports because it will know what information it will be required to produce, and will already have a template for its submission.
Accordingly, as an approximation, staff assumes a per company average of 200 hours for each recipient of the Commission's information requests the first year they have to comply with the Commission's Order. Staff anticipates that in subsequent years, the per company average will be 150 hours. Thus, the overall estimated burden for 15 recipients of the information requests is 3,000 hours for the first year and 2,250 for each of the two subsequent years, or a total of 7,500 hours. Thus, the average yearly burden, over the course of a prospective three-year clearance, per recipient (large and small), is 167 hours (rounded to the nearest whole number). These estimates include any time spent by separately incorporated subsidiaries and other entities affiliated with the ultimate parent company that has received the information request.
Staff believes that the capital or other non-labor costs associated with the information requests are minimal. Although the information requests may necessitate that industry members maintain the requested information provided to the Commission, they should already have in place the means to compile and maintain business records.
Because your comment will be made public, you are solely responsible for making sure that your comment doesn't include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information, such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you must follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Electronic Cigarettes: Paperwork Comment, FTC File No. P114504” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610
Visit the Commission Web site at
By direction of the Commission.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning “Information Collection 9000-0057, Evaluation of Export Offers.”
Submit comments on or before December 28, 2015.
Submit comments identified by Information Collection 9000-0057, Evaluation of Export Offers, by any of the following methods:
• Regulations.gov:
• Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0057, Evaluation of Export Offers.
Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, 202-501-4082 or via email at
Offers submitted in response to Government solicitations must be evaluated and awards made on the basis of the lowest laid down cost to the Government at the overseas port of discharge, via methods and ports compatible with required delivery dates and conditions affecting transportation know at the time of evaluation. FAR provision 52.247-51, “Evaluation of Export Offers,” is required for insertion in Government solicitations when supplies are to be exported through Contiguous United States (CONUS) ports and offers are solicited on a free onboard (f.o.b.) origin or f.o.b. destination basis. The provision has three alternates, to be used (1) when the CONUS ports of export are DoD water terminals, (2) when offers are solicited on an f.o.b. origin only basis, and (3) when offers are solicited on an f.o.b. destination only basis. The provision collects information regarding the vendor's preference for delivery ports. The information is used to evaluate offers [on the basis of shipment through the port resulting in the lowest cost to the Government.
Public comments are particularly invited on: Whether this collection of information is necessary; 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.
Please cite OMB Control Number “9000-0057, Evaluation of Export Offers” in all correspondence.
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
Written comments must be received on or before December 28, 2015.
You may submit comments, identified by Docket No. CDC-2015-0091 by any of the following methods:
• Federal eRulemaking Portal:
• Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.
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
Airline and Maritime Conveyance Manifest Orders—Existing Information Collection in use without an OMB Control Number—Division of Global Migration and Quarantine, National Center for Emerging Zoonotic and Infectious Diseases, Centers for Disease Control and Prevention (CDC).
Under the Public Health Service Act (42 United States Code 264) and under 42 Code of Federal Regulations (CFR) 71.32(b) and 42 CFR 70.2, CDC can order airlines and maritime lines operating conveyances arriving from another country or traveling between states to submit a record for passengers and crew that CDC believes were exposed to co-traveler infected with a communicable disease of public health concern.
Stopping a communicable disease outbreak—whether it is naturally occurring or intentionally caused—requires the use of the most rapid and effective public health tools available. Basic public health practices, such as collaborating with airlines in the identification and notification of potentially exposed contacts, are critical tools in the fight against the introduction, transmission, and spread of communicable diseases in the United States.
The collection of comprehensive, pertinent contact information enables Quarantine Public Health Officers in CDC's Division of Global Migration and Quarantine (DGMQ) to notify state and local health departments in order for them to make contact with individuals who may have been exposed to a contagious person during travel and identify appropriate next steps.
In the event that there is a confirmed case of communicable disease of public health concern aboard an aircraft or ship, CDC collects manifest information for those passengers and crew at risk for exposure. This specific manifest information collection differs depending on the communicable disease that is confirmed during air or maritime travel. CDC then uses this passenger manifest information to coordinate with state and local health departments so they can follow-up with residents who live or are currently located in their jurisdiction. In general, state and local health departments are responsible for the contact investigations. In rare cases, CDC may use the manifest data to perform the contact investigation directly. In either case, CDC works with state and local health departments to ensure individuals are contacted and provided appropriate public health follow-up.
CDC estimates that for each passenger manifest ordered, airlines require approximately six hours to review the order, search their records, and send those records to CDC. There is no cost to respondents other than their time perform these actions. CDC does not have a specified format for these submissions.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Workplace Violence Prevention Programs in NJ Healthcare Facilities (OMB Control No. 0920-0914, Expiration 2/29/2016)—Revision—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Through this information collection revision request, the National Institute for Occupational Safety and Health (NIOSH) is seeking an additional two-year OMB approval.
NIOSH originally received OMB approval to evaluate the legislation at 50 hospitals and 20 nursing homes, to conduct a nurse survey, and a home healthcare aide survey. Data collection is complete for the hospitals, the nurse survey, and the home healthcare aide survey. We were unable to conduct the 20 nursing home interviews. Therefore, we are requesting approval to revise the existing information collection in order to complete the 20 nursing home interviews, as well as include an additional 20 nursing homes (40 total) in the collection. The current approval also includes a survey that collects nursing home injury data. We would like to drop this survey and, instead, collect publicly available workers compensation data.
Healthcare workers are nearly five times more likely to be victims of violence than workers in all industries combined. While healthcare workers are not at particularly high risk for job-related homicide, nearly 60% of all nonfatal assaults occurring in private industry are experienced in healthcare. Six states have enacted laws to reduce violence against healthcare workers by requiring workplace violence prevention programs. However, little is understood about how effective these laws are in reducing violence against healthcare workers.
The long-term goal of the proposed project is to reduce violence against healthcare workers. The objective of the proposed study is: (1) To examine nursing home compliance with the New Jersey Violence Prevention in Health Care Facilities Act, and (2) to evaluate the effectiveness of the regulations in this Act in reducing assault injuries to nursing home workers. Our central hypothesis is that nursing homes with high compliance with the regulations will have lower rates of employee violence-related injury.
We will conduct face-to-face interviews with the nursing home administrators in 40 nursing homes (20 in New Jersey and 20 in Virginia) who are in charge of overseeing compliance efforts. The purpose of the interviews is to measure compliance to the state regulations: Violence prevention policies, reporting systems for violent events, violence prevention committee, written violence prevention plan, violence risk assessments, post incident response and violence prevention training. A contractor will conduct the interviews.
The table below shows the estimated annualized burden hours. Twenty respondents (nursing home administrators) will be interviewed each year. This will include 10 respondents from Virginia and 10 respondents from New Jersey. The abstraction form and the committee chair interview form will be used during each interview. Each
There are no costs to respondents other than their time.
NCEHS-CCP will support the effective implementation of new EHS-CCP grants by disseminating information through training and technical assistance (T/TA) and resources and materials. NCEHS-CCP is primarily targeted to T/TA providers working directly with the EHS-CCP grantees (including Office of Head Start (OHS) and Office of Child Care (OCC) National Centers, regional training and technical assistance (T/TA) specialists, and implementation planners and fiscal consultants). State and federal agencies (including OHS and OCC federal staff, Child Care and Development Fund (CCDF) administrators, Head Start State and National Collaboration directors), as well as EHS-CCP grantees will also find helpful information on partnerships through NCEHS-CCP's resources.
The NCEHS-CCP at ZERO TO THREE is proposing to conduct a descriptive study of NCEHS-CCP that will provide information that will document the activities and progress of NCEHS-CCP toward its goals and objectives. Findings from the evaluation will be translated into action steps to inform continuous quality improvement of NCEHS-CCP.
The proposed data collection activities for the descriptive study of NCEHS-CCP will include the following components:
•
•
This 60-Day Federal Register Notice covers the data collection activities for NCEHS-CCP and requests clearance for (1) the stakeholder survey, and (2) the stakeholder telephone interviews.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447,
The Department specifically requests comments 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) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice; establishment of public docket.
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs (503A bulks list). The Agency previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for FDA to evaluate them. FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to receive nominations of bulk drug substances that were not previously nominated for consideration for inclusion on the 503A bulks list. Interested parties can also submit comments on nominated substances via this docket.
Nominations and comments may be submitted to this docket at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Philantha Bowen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301-796-2466.
Section 503A of the FD&C Act (21 U.S.C. 353a) describes the conditions under which a compounded drug
Section 503A refers to the definition of “bulk drug substance” in FDA regulations at § 207.3(a)(4) (21 CFR 207.3(a)(4)). See section 503A(b)(1)(A) of the FD&C Act. As defined in § 207.3(a)(4), a “bulk drug substance” is any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
An “active ingredient” is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. See 21 CFR 210.3(b)(7).
Any component other than an active ingredient is an “inactive ingredient.” See 21 CFR 210.3(b)(8). Inactive ingredients used in compounded drug products, which commonly include flavorings, dyes, diluents, or other excipients, need not appear on the Secretary's list of bulk drug substances to be eligible for use in compounding drug products and will not be included on the list.
In a notice dated November 27, 2013 (the November 27, 2013, notice), published in the
In response to the July 2, 2014, request for nominations, approximately 740 unique substances were nominated. Of the nominated substances, approximately 275 are already eligible for use in compounding because they are either components of an approved drug or the subject of an applicable USP or NF monograph. At least nine of the nominated substances are not eligible for inclusion on the list because they are either a finished drug product, a biological product subject to licensure in a biologics license application (BLA), a radiopharmaceutical drug product, a substance with no currently accepted medical use that is included on Schedule I of the Controlled Substances Act (21 U.S.C. 812(c)), or they appear on the list published by FDA of substances that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Of the substances that are not components of an FDA-approved drug or the subject of an applicable USP or NF monograph, not biological products subject to licensure in a BLA, not radiopharmaceuticals, do not appear on Schedule I, and do not appear on the withdrawn or removed list, approximately 390 substances were nominated with insufficient supporting evidence for FDA to evaluate them.
As described in section III.B of the draft guidance entitled, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” FDA is establishing a public docket so that interested parties can comment on nominated bulk drug substances, nominate bulk drug substances that were not previously nominated for the 503A bulks list, or renominate with adequate supporting information bulk drug substances that were previously nominated but that were not supported by sufficient information for FDA to evaluate them. Docket No. FDA-2013-N-1525 is closed for comment. Therefore, this new docket can be used for commenting on nominations submitted to that docket as well as for submitting new nominations.
As stated previously, under section 503A(c)(2) of the FD&C Act, the criteria for determining which substances should appear on the 503A bulk drugs list shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify. Based on this statutory language and consultations with the USP and the Pharmacy Compounding Advisory Committee (PCAC),
Interested groups and individuals may nominate specific bulk drug substances for inclusion on the 503A bulks list, renominate previously nominated substances with additional information, or comment on nominated substances. Nominations will only be evaluated if they are for specific active ingredients that: (1) Meet the definition of a bulk drug substance in § 207.3(a)(4); (2) are not components of FDA-approved drug products; and (3) are not substances that are the subject of an applicable USP or NF monograph. To fully evaluate a bulk drug substance using the criteria identified above, FDA needs the following information about both the nominated bulk drug substance and the drug product(s) that will be compounded using such substance:
• A statement that the nominated substance is an active ingredient that meets the definition of “bulk drug substance” in § 207.3(a)(4), and an explanation of why the substance is considered an active ingredient when it is used in the identified compounded drug product(s), citing to specific sources that describe the active properties of the substance.
• A statement that the nominator has searched for the active ingredient in all three sections of the Orange Book (for prescription drug products, over-the-counter drug products, and discontinued drug products), available at
• A statement that the nominator has searched applicable USP and NF drug monographs, available at
• Ingredient name;
• Chemical name;
• Common name(s);
• Identifying codes, as available, from FDA's Unique Ingredient Identifiers (UNII) used in the FDA/USP Substance Registration System, available at
• Chemical grade of the ingredient;
• Description of the strength, quality, stability, and purity of the ingredient, and a copy of a certificate of analysis that is representative of the characteristics of the nominated ingredient;
• Information about how the ingredient is supplied (
• Information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to the USP for consideration of monograph development.
• Information about the dosage form(s) into which the bulk drug substance will be compounded;
• Information about the strength(s) of the compounded drug product(s);
• Information about the anticipated route(s) of administration of the compounded product(s);
• A bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available,
• Information about the past and proposed use(s) of the compounded drug product(s), including the rationale for its use and why the compounded product(s), as opposed to an FDA-approved product, is necessary. Information on the rationale for use of the bulk drug substance and why a compounded drug product is necessary must be specific to the compounded drug product at issue. General or boilerplate statements regarding the need for compounded drug products or the benefits of compounding generally will not be considered sufficient to address this issue.
Because the prior deadline for submitting nominations has passed, FDA is opening this docket so that interested persons can submit nominations of bulk drug substances and provide adequate support for FDA to evaluate whether those substances should be placed on the 503A bulks list. Bulk drug substances that were previously nominated and for which inadequate information was provided
For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in an editable Excel file. Specifically, nominators are encouraged to format their nominations as follows:
In addition to nominating new substances or renominating substances previously nominated without sufficient supporting information, individuals and organizations will be able to comment via the docket established by this notice on substances nominated for the 503A bulks list that have not yet been addressed in a Notice of Proposed Rulemaking (NPRM). Comments may be submitted regarding nominations submitted to both this docket and Docket No. FDA-2013-N-1525. Comments may provide any relevant information about particular bulk drug substances, including that in support of, or in opposition to, the placement of a nominated bulk drug substance on the 503A bulks list. However, comments submitted should not address the 503A bulks list generally or other matters related to the Agency's regulation of compounding. Comments about nominated substances that have been addressed by the Agency in an NPRM should be submitted to the docket for the proposed rulemaking in which the substance is addressed.
Please do not submit comments that have already been submitted to other dockets. Such submissions are duplicative and not helpful to the Agency. If comments on particular documents or issues are submitted to this docket rather than the docket specifically opened for the particular document or issue, the comment might not be considered as the specific documents are being finalized and issues considered. FDA will not respond to questions submitted to this docket.
Information in the docket will be publicly available. Therefore, we remind nominators and commenters not to submit personal or confidential information.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The draft guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance.
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 by December 28, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-796-3110.
FDA is announcing the availability of a draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” A new section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug Quality and Security Act (Pub. L. 113-54) in 2013, describes the conditions that must be satisfied for human drug products compounded by an outsourcing facility to be exempt from the following three sections of the FD&C Act: Section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security requirements). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility does not compound drug products using a bulk drug substance unless: (1) It appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (see section 503B(a)(2)(A)(i) of the FD&C Act) or (2) the drug product compounded from such bulk drug substances appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing (see section 503B(a)(2)(A)(ii) of the FD&C Act).
This guidance describes the conditions under which FDA does not intend to take action against an outsourcing facility for compounding a drug product from a bulk drug substance that does not appear on a list of bulk drug substances that may be used in compounding and is not used to compound a drug product that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, while FDA develops the list of bulk drug substances that can be used in compounding under section 503B(a)(2)(A)(i) of the FD&C Act.
Elsewhere in this issue of the
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Codeine is available by prescription and also through the over-the-counter (OTC) Drug Monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (21 CFR 341.14, 21 CFR 341.74, and 21 CFR 341.90).
The focus of the meeting will be the risk of serious adverse events, such as respiratory depression and death, including reports in children who are CYP2D6 ultra-rapid metabolizers. The committees will discuss whether the use of codeine in children should be restricted further beyond the current contraindication described previously and whether codeine should be available through the OTC Drug Monograph.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Cindy Hong at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of availability; establishment of public docket.
The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active ingredients) that can be used to compound drug products in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (the 503B bulks list). The Agency previously solicited nominations for the list, but some of the nominated substances were not supported by sufficient information for FDA to evaluate them. FDA is establishing a public docket where these substances can be renominated with sufficient supporting information or to
Nominations and comments may be submitted to this docket at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Philantha Bowen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5175, Silver Spring, MD 20993-0002, 301-796-2466.
Under the Drug Quality and Security Act (Pub. L. 113-54), which added a new section 503B to the FD&C Act (21 U.S.C. 353b), outsourcing facilities
Section 503B refers to the definition of “bulk drug substance” in FDA regulations at § 207.3(a)(4) (21 CFR 207.3(a)(4)). (See section 503B(a)(2) of the FD&C Act.) As defined in § 207.3(a)(4), a “bulk drug substance” is any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
An “active ingredient” is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (See § 210.3(b)(7) (21 CFR 210.3(b)(7)).)
Any component other than an active ingredient is an “inactive ingredient.” (See § 210.3(b)(8).) Inactive ingredients used in compounded drug products, which commonly include flavorings, dyes, diluents, or other excipients, need not appear on the Secretary's list of bulk drug substances to be eligible for use in compounding drug products and will not be included on the list.
In a document dated November 27, 2013, published in the
In response to the July 2, 2014, request for nominations, approximately 2,590 unique substances were nominated. Of the nominated substances, approximately 1,750 are not eligible for inclusion on the list because they are either a finished drug product, a biological product subject to licensure in a biologics license application (BLA), a radiopharmaceutical drug product, a substance with no currently accepted medical use that is included on Schedule I of the Controlled Substances Act (CSA) (21 U.S.C. 812(c)), or they appear on the list published by FDA of substances that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Of the substances that are not biological products subject to licensure in a BLA, finished drug products, radiopharmaceuticals, do not appear on Schedule I in the CSA, and do not appear on the withdrawn or removed list, approximately 650 substances were nominated with insufficient supporting evidence for FDA to evaluate them.
As described in section III.B of the draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” FDA is establishing a public docket so that interested parties can comment on nominated bulk drug substances, nominate bulk drug substances that were not previously nominated for the 503B bulks list, or renominate with adequate supporting information bulk drug substances that were previously nominated but that were not supported by sufficient information for FDA to evaluate them. Docket No. FDA-2013-N-1524 is closed for comment. Therefore, this new docket can be used for commenting on nominations previously submitted to that docket as well as for submitting new nominations.
In the
• A statement describing the medical condition(s) that the drug product to be compounded with the nominated bulk drug substances is intended to treat;
• A list of FDA-approved drug products, if any, that address the same medical condition;
• If there are any FDA-approved drug products that address the same medical condition, an explanation of why a compounded drug product is necessary;
• If the approved drug product is not suitable for a particular patient population, an estimate of the size of the population that would need a compounded drug product;
• A bibliography of safety and efficacy data for the drug product compounded using the nominated substance, if available, including any relevant peer-reviewed medical literature; and
• If there is an FDA-approved drug product that includes the bulk drug substance nominated, an explanation of why the drug product proposed to be compounded must be compounded from bulk rather than with the FDA-approved drug product.
Therefore, to be considered for placement on the 503B bulks list, this information should be submitted for each nominated substance.
Interested groups and individuals may nominate specific bulk drug substances for inclusion on the 503B bulks list, renominate previously nominated substances with additional information, or comment on nominated substances. Nominations will only be evaluated if they are for specific active ingredients that meet the definition of a bulk drug substance in § 207.3(a)(4). Nominated substances that do not meet this definition will not be included on the list. To fully evaluate a bulk drug substance using the criteria identified in this document, FDA needs the following information about both the nominated bulk drug substance and the drug product(s) that will be compounded using such substance:
• A statement that the nominated substance is an active ingredient that meets the definition of “bulk drug substance” in § 207.3(a)(4), and an explanation of why the substance is considered an active ingredient when it is used in compounded drug products, citing specific sources that describe the active properties of the substance.
• Ingredient name;
• chemical name;
• common name(s); and
• identifying codes, as available, from FDA's Unique Ingredient Identifiers (UNII) used in the FDA/USP Substance Registration System, available at
• Chemical grade of the ingredient;
• description of the strength, quality, stability, and purity of the ingredient, and a copy of a certificate of analysis that is representative of the characteristics of the nominated ingredient;
• information about how the ingredient is supplied (
• information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development.
For FDA to be able to meaningfully evaluate a substance, the information provided regarding the clinical need for compounding with a bulk drug substance must be specific to the particular substance nominated and
• A statement describing the medical condition(s) that the drug product to be compounded with the nominated bulk drug substances is intended to treat (
• a list of FDA-approved drug products, if any, that address the same medical condition;
• if there are FDA-approved drug products that address the same medical condition, an explanation of why a compounded drug product is necessary (
• if the approved drug product is not suitable for a particular patient population, an estimate of the size of the population that would need a compounded drug product (
• a bibliography of safety and efficacy data for the drug compounded using the nominated substance,
• if there is an FDA-approved drug product that includes the bulk drug substance nominated, an explanation of why the drug product proposed to be compounded must be compounded from bulk rather than with the FDA-approved drug product.
General or boilerplate statements regarding the need to compound from the bulk drug substance or the benefits of compounding generally will not be considered sufficient. Note that the Agency does not consider supply issues, such as backorders, that do not rise to the level of a drug shortage listed on FDA's drug shortage Web site as evidence of a clinical need for compounding with a bulk drug substance, and section 503B of the FD&C Act already allows compounding from bulk drug substances if the compounded drug product is on the FDA drug shortage list. Similarly, considerations of cost and convenience will not be considered indicators of clinical need.
• Information about the dosage form(s) into which the bulk drug substance will be compounded;
• information about the strength(s) of the compounded drug product(s);
• information about the anticipated route(s) of administration of the compounded drug product(s); and
• information about the previous use(s) of the compounded drug product(s).
Because the prior deadline for submitting nominations has passed, FDA is opening this docket so that interested persons can submit nominations of bulk drug substances and provide adequate support for FDA to evaluate whether those substances should be placed on the 503B bulks list. Bulk drug substances that were previously nominated and for which inadequate information was provided
For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in an editable Excel file. Specifically, nominators are encouraged to format their nominations as follows:
In addition to nominating new substances or renominating substances previously nominated without sufficient supporting information, individuals and organizations will be able to comment via the docket established by this notice on substances nominated for the 503B bulks list that have not yet been addressed in a
Please do not submit comments that have already been submitted to other dockets. Such submissions are duplicative and not helpful to the Agency. If comments on particular documents or issues are submitted to this docket rather than the docket specifically opened for the particular document or issue, the comment might not be considered as the specific documents are being finalized and issues considered. FDA will not respond to questions submitted to this docket.
Information in the docket will be publicly available. Therefore, we remind nominators and commenters not to submit personal or confidential information.
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing its intent to exempt from the premarket notification requirements autosomal recessive carrier screening gene mutation detection systems, subject to certain limitations. These devices are qualitative in vitro molecular diagnostic systems used for genotyping of clinically relevant variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens intended for prescription use or over-the-counter use. These devices are intended for autosomal recessive disease carrier screening in adults of reproductive age. These devices are not intended for copy number variation, cytogenetic, or biochemical testing. FDA is publishing this notice in order to obtain comments regarding the proposed exemption.
Submit electronic or written comments by November 27, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Steven Tjoe, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-5866.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807 subpart E, require persons who intend to market a device to submit and obtain FDA clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval.
On November 21, 1997, the President signed into law the FDA Modernization Act (FDAMA) (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section 510(m) to the FD&C Act. Section 510(m)(2) of the FD&C Act provides that, 1 day after the date of publication of the list under section 510(m)(1), FDA may exempt a device on its own initiative or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the
There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998,
On February 19, 2015, FDA completed its review of a de novo request for classification of the 23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome. FDA classified the 23andMe PGS Carrier Screening Test for Bloom Syndrome, and substantially equivalent devices of this generic type, into class II (special controls) under the generic name “Autosomal recessive carrier screening gene mutation detection system.” This type of device is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing. Elsewhere in this issue of the
Based on the analysis described in this document, FDA has determined that premarket notification for an autosomal recessive carrier screening gene mutation detection system is not necessary for assurance of the safety and effectiveness of the device, subject to the limitations described in section IV. FDA has assessed the need for 510(k) clearance for an autosomal recessive carrier screening gene mutation detection system against the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) and the January 21, 1998,
FDA has generally considered whether a type of device has had a significant history of false or misleading claims or of risks associated with inherent characteristics of the device,
To demonstrate clinical validity for this type of test, one must define an inheritance pattern of genetic disease and demonstrate the appropriate genetic patterns are present in an informative population that includes affected persons. The nature and level of scientific evidence necessary to establish autosomal recessive inheritance patterns makes it easily discernable whether such evidence establishes clinical validity or not. Thus, the special controls requiring that clinical validity be scientifically established and that evidence supporting such must be publicly posted on the manufacturer's Web site render the probability of false or misleading claims for autosomal recessive inheritance very low. Clinical validity must be well-established in peer reviewed journal articles, authoritative summaries of the literature, and/or professional society recommendations. If there is no professional guideline recommending testing of a certain gene or variant in the indicated population, the manufacturer's Web site must warn that no such recommendation currently exists.
When considering the risks associated with the inherent characteristics of tests of this type, FDA has considered the risks of both false positive and false negative results, as well as the applicable mitigations provided by the special controls, in combination with general controls. The probable risks posed by devices of this type are generally similar regardless of the genetic carrier condition to be detected, as explained in this document.
Autosomal recessive carrier screening is a type of genetic testing performed on people who display no symptoms for a recessive genetic disorder but may be at risk for passing it on to their children if they are detected to be a carrier. A carrier for a genetic disorder has inherited one normal and one abnormal allele for a gene associated with a disorder. Autosomal (non-sex chromosome-related) recessive disorders require that two abnormal copies of a gene, one inherited from each parent, be present in order for the disorder to be manifested. Therefore, to have a child with an autosomal recessive disorder, both parents must be carriers of an abnormal gene copy. When both parents are carriers for the abnormal copy, there is an
FDA believes that the risks posed by false positives are relatively low, and sufficiently mitigated by the applicable special controls, including requirements that establish minimum performance specifications, without the need for premarket notification. Although some autosomal recessive genetic diseases are more common in certain ethnic, racial, or geographically-bounded groups, even in these groups disease frequencies tend to be low. Most autosomal recessive genetic diseases are very rare with frequencies much less than 1 percent in the general population, and the respective carrier frequencies are likewise low in most populations. For reference, sickle cell trait (carrier of sickle cell mutation), which has one of the highest known carrier frequencies, is estimated to occur in about 1 of 13 African Americans, and cystic fibrosis carrier status is estimated to occur in about 1 of 25 Caucasians. Persons outside these groups have lower carrier frequencies for sickle cell and cystic fibrosis carrier status. Other autosomal recessive diseases are rarer and their carrier frequencies are correspondingly lower. Carrier screening is only intended to detect heterozygotes (carriers), so false positive results would only suggest that a person was a carrier of a mutation, and would not contain information that could lead to conclusions of disease for the tested person. Further, no conclusion about an individual's future children could be made given that the carrier status of the child's second parent would need to be known to reach such a conclusion, and even where both parents are truly positive the only conclusion that may be drawn is that the child has a 25 percent likelihood of manifesting the disease. The probability of a couple both receiving false positive carrier results from using a device of this type is vastly smaller than for a single false positive.
In this rare scenario, a couple both receiving false positive results could lead to the couple choosing not to get married or not to have children, or the results could lead to unnecessary fetal testing in current or future pregnancies. Fetal testing may consist of amniocentesis or chorionic villus sampling (CVS), neither of which is risk-free, although other risk factors during pregnancy, including age, often warrant such testing regardless of any carrier screening results. A false positive result for an individual may also potentially lead to adverse psychological effects, particularly if that individual does not fully understand the nature of autosomal recessive disorders (
Similarly, the applicable special controls, including labeling requirements and requirements that establish minimum performance specifications, sufficiently mitigate the risks posed by analytical false negatives for autosomal recessive carrier status without the need for premarket notification. Regardless of analytical accuracy, there exists a risk of a clinical false negative result for many carrier tests because not all clinically relevant mutations are known or tested for; therefore there will be a proportion of carriers who will not be detected. The proportion of people who are true carriers who would be detected by any test is known as the test's “coverage.” For many carrier conditions, clinical false negative rate due to “coverage” less than 100 percent is likely higher than the false negative rate from analytical failure or random error of a test. The clinical risks associated with false negative results generally occur when only one biological parent is tested and experiences a false negative result, since in that case it is unlikely the other biological parent will be tested. The risk of the false negative would only have consequence in the circumstance that the non-tested parent is also a carrier for the condition or disorder. In this case, there is a 25 percent chance that a future child would inherit the condition or disorder.
FDA believes that the special controls requiring certain warnings in the device labeling are sufficient to mitigate such risk without further premarket review. The special controls include requiring a
FDA has generally considered whether the characteristics of the device necessary for its safe and effective performance are well established. Given that autosomal recessive carrier screening gene mutation detection systems were initially classified on February 19, 2015, under the de novo process, a process by which FDA evaluates novel devices anew, FDA has considered other related factors, including whether the performance characteristics that are necessary for the safe and effective use of the device are addressed by the special controls, in combination with general controls.
Clinical validity is addressed through the special controls without the need for premarket notification. Generally, FDA accepts evidence of clinical validity of each variant queried and reported by a test as supported by peer-reviewed journal articles, authoritative summaries of the literature, and/or professional society recommendations during its premarket review. As discussed previously, given the level and nature of scientific evidence necessary to establish autosomal recessive inheritance patterns and corresponding ease of recognizing false or misleading clinical claims for this type of test, clinical validity is assured through the special controls requiring that clinical validity be scientifically well-established in peer-reviewed journal articles, authoritative summaries of the literature, and/or professional society recommendations and that evidence supporting such be publicly posted on the manufacturer's Web site.
Moreover, as discussed previously, applicable special controls help ensure that individuals for whom the tests are conducted are able to understand the testing prior to the test being performed, as well as provide context, including limitations, regarding the clinical validity of the variants reported. These special controls mitigate the risks posed by incorrect test results and the risk that test results are interpreted incorrectly or are misleading.
The special controls for devices of this type require rigorous analytical performance metrics and parameters to be met, which is what FDA would typically assess in its review of analytical performance in a premarket submission. The special control requiring this analytical performance information to be posted on the manufacturer's public Web site will allow FDA, as well as others, to review this information. Together these special controls, described in more detail in this document, obviate the need for premarket notification.
• First, the special controls provide a detailed listing of the protocol requirements and acceptance criteria for all analytical studies (
• Second, the special controls define how, in some cases, analyses must be performed and presented to the person from whom the tests are conducted.
• Third, a very high level of accuracy is prescribed in the special controls.
• Fourth, the special controls also require that devices of this type only use collection devices that are FDA cleared, FDA approved, or classified as 510(k) exempt, with an indication for in vitro diagnostic use in DNA testing. The use of a lawfully marketed collection device intended for such use provides assurances regarding the safety and effectiveness of that component of the device, which in turn helps to assure the safety and effectiveness of the device as a whole.
• Fifth, the special controls limit the distribution of devices of this type, excluding the collection device, to the manufacturer, manufacturer's subsidiaries, and laboratories subject to regulation under the Clinical Laboratory Improvement Amendments. This limitation mitigates risk through lowering the probability of inaccurate test results by ensuring that testing is performed by qualified individuals and in a manner that provides greater assurance of quality of the testing process.
• Sixth, specific statements regarding the probability of test failure and a description of scenarios in which a test can fail are prescribed in the special controls.
• Lastly, the special controls require warnings in the labeling to help ensure that persons for whom the tests are conducted and users are able to understand the testing prior to the test being performed, as well as provide context, including limitations, regarding the analytical validity of the variants reported.
Taken together, these special controls mitigate the risks through lowering the probability of inaccurate test results and increasing the likelihood of user understanding regarding test limitations and performance. FDA believes that given the unique characteristics of an autosomal recessive carrier screening gene mutation detection system, including that both a mother and father must be carriers in order to have a 25 percent chance that their child would have the disorder, these special controls reasonably assure that a legally marketed device of this type will have the characteristics necessary for its safe and effective performance without the need for premarket notification.
The special controls, in combination with the general controls, assure that anticipated changes in the device that could affect safety and effectiveness will either be readily detectable by users or not materially increase risk.
As discussed previously, the special controls include a detailed outline of clinical and analytical performance information that must be generated or obtained and posted on the manufacturer's Web site. Such special controls provide details on how analytical testing must be performed and provide certain performance criteria that the analytical testing must demonstrate have been met. Any changes to the device that could significantly affect safety or effectiveness would require new data or information in support of such changes, which would also have to be posted on
Subject to the applicable requirements under the special controls, in combination with general controls, changes to a device of this type would not be likely to result in a change in the device's classification. FDA also considered, in proposing to exempt these devices, that these devices would be subject to the limitations described in section IV.
FDA's proposal to grant an exemption from the premarket notification for an autosomal recessive carrier screening gene mutation detection system applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA proposes that a manufacturer of an autosomal recessive carrier screening gene mutation detection system would still be required to submit a premarket notification to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in § 866.9, except § 866.9(c)(2) to the extent it may include an autosomal recessive carrier screening gene mutation detection system.
FDA added the limitation of exemption from section 510(k) of the FD&C Act for in vitro devices intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism (codified at § 866.9(c)(2)) by notice in the
First, autosomal recessive carrier screening gene mutation detection present very different risks from other tests covered by § 866.9(c)(2), such as tests for screening or diagnosis of genetic disorders in the individuals being tested, as opposed to their offspring. As discussed in detail previously, because carrier screening is only intended to detect heterozygotes (carriers), false positive results would suggest that a person was a carrier of a mutation, but would not contain information that could lead to conclusions of disease for the tested person. Further, no conclusion about an individual's future children could be made given that the carrier status of the child's second parent would need to be known to reach such a conclusion, and even where both parents are truly positive the only conclusion that may be drawn is that the child has a 25 percent likelihood of manifesting the disease. The probability of a both parents receiving false positive carrier results from using a device of this type is vastly smaller than for a single false positive result.
Second, based on FDA's increased understanding of genetic testing and the risks posed by devices of this type, FDA was able to develop special controls to mitigate the risks of false positive and false negative results, as detailed in section III. For example, the special controls requiring demonstration of both analytical and clinical validity, posting of this information on the manufacturer's Web site, consumer comprehension studies, information regarding genetic counseling, and warnings regarding the meaning, context, and limitations of results all reduce the likelihood of false results and of the harms that such may cause. As a result, the risk of false results, as mitigated by the special controls, in combination with general controls, for such device would not be associated with high morbidity or mortality, and FDA is proposing that the limitation of exemption in § 866.9(c)(2) not apply to devices of this type to the extent the limitation includes autosomal recessive carrier screening gene mutation detection.
FDA proposes that an autosomal recessive carrier screening gene mutation detection system is not exempt from the premarket notification requirement if such device: (1) Has an intended use that is different from the intended use of a legally marketed device in that generic type;
When a device falls within or “trips” any of these limitations, 510(k) clearance is required prior to marketing. Following a determination by FDA, through the premarket notification process, that such a device is substantially equivalent to a legally marketed device in the 510(k)-exempt generic type under 21 CFR 866.5940, and compliance with the special controls, future devices with the same indications and technological characteristics would be exempt from premarket notification. If you have questions regarding whether your device's indication for use constitutes a different intended use requiring 510(k) submission, you may contact the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics and Radiological Health to request a review of your indication for use and any relevant literature.
Based on FDA's review of current scientific literature, FDA would not consider the determination of carrier status by detection of clinically relevant gene mutations associated with the diseases and conditions listed in Table 1 to constitute a different intended use from that of a legally marketed device in the generic type 21 CFR 866.5940 for purposes of § 866.9(a). Thus such uses would be 510(k)-exempt once there is compliance with special controls. A gene mutation detection system indicated for the determination of carrier status by detection of clinically relevant gene mutations associated with Cystic Fibrosis is not 510(k)-exempt since it is a class II device subject to premarket notification and special controls under 21 CFR 866.5900—
Exemption from the requirement of premarket notification does not exempt a device from other applicable regulatory controls under the FD&C Act, including the applicable general and special controls. Indeed, FDA's decision to propose 510(k) exemption for these devices is based, in part, on the special controls, in combination with general controls, providing sufficiently rigorous mitigations for the risks identified for this generic type.
Subject to the limitations described previously, FDA has determined that the requirement of premarket notification is not necessary to assure the safety and effectiveness of an autosomal recessive carrier screening gene mutation detection system. Accordingly, FDA is announcing its intent to exempt from the premarket notification requirements autosomal recessive carrier screening gene mutation detection systems, subject to the limitations described previously. FDA is publishing this notice in order to obtain comments regarding the proposed exemption.
This notice refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart, E have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485.
The following reference is on display in the Division of Dockets Management (see
1. “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 1998, available at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by December 28, 2015.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners and operators are required to electronically submit establishment registration and device listing information.
Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: (1) Identification of establishments producing marketed medical devices, (2) identification of establishments producing a specific device when that device is in short supply or is needed for national emergency, (3) facilitation of recalls for devices marketed by owners and operators of device establishments, (4) identification and cataloguing of marketed devices, (5) administering postmarketing surveillance programs for devices, (6) identification of devices marketed in violation of the law, (7) identification and control of devices imported into the country from foreign establishments, (8) and scheduling and planning inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374)
Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices, who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements. The number of respondents is based on data from the FDA Unified Registration and Listing System.
Burden estimates are based on recent experience with the existing medical device registration and listing program, electronic system operating experience, and the economic analysis for the final
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” The draft guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of this 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-796-3110.
FDA is announcing the availability of a draft guidance entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Sections 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act: Section 505 (concerning the approval of drugs under new drug applications or abbreviated new drug applications); section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); and section 501(a)(2)(B) (concerning current good manufacturing practice requirements).
One of the conditions that must be met for a compounded drug product to qualify for these exemptions is that a licensed pharmacist or licensed physician compounds the drug product using bulk drug substances that: (1) Comply with the standards of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if a monograph exists, and the USP chapter on pharmacy compounding; (2) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or (3) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, appears on a list developed by the Secretary through regulations issued by the Secretary under subsection (c) of section 503A. (See section 503A(b)(1)(A)(i) of the FD&C Act).
This guidance describes the conditions under which FDA does not intend to take action against a licensed pharmacist or licensed physician for compounding a drug product from a bulk drug substance that is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved drug, or does not appear on the list of bulk drug substances that can be used in compounding under section 503A(b)(1)(A)(i)(III) of the FD&C Act by a licensed pharmacist or licensed physician while FDA is developing the list.
Elsewhere in this issue of the
The final guidance “Pharmacy Compounding of Human Drug Products Under Section 503A of the FD&C Act,” (503A Final Guidance) published in 2014 (79 FR 37742; July 2, 2014), states, “Until a bulk drug substances list is published in the
Persons with access to the Internet may obtain the guidance at either
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice amends
Webinars: November 4, 2015; December 3, 2015; and January 6, 2016; at 11:00 a.m. EST.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2), notice is hereby given of the joint meeting of the National Cancer Advisory Board (NCAB) and NCI Board of Scientific Advisors (BSA).
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (
A portion of the National Cancer Advisory Board meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended, for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Cancer Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page: NCAB:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sleep Disorders Research Advisory Board.
The meeting will be open to the public and conducted electronically. The public is encouraged to observe the meeting, and should request instructions from the Contact Person listed below in advance.
Information is also available on the Institute's/Center's home page:
Federal Emergency Management Agency, DHS.
Final Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of November 18, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before January 25, 2016.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1539, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with title 44, part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Science and Technology Directorate, DHS
Notice; correction.
The Department of Homeland Security (DHS) Homeland Security Science and Technology Advisory Committee (HSSTAC) published a document in the
Bishop Garrison,
In the
Written comments must be received by October 29, 2015.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
12 U.S.C. 1701z-1 Research and Demonstrations.
Fish and Wildlife Service, Interior.
Notice of availability; request for comment.
We, the Fish and Wildlife Service (Service), announce the availability of our draft recovery plan for the Gila chub, which is listed as endangered under the Endangered Species Act of 1973, as amended (Act). This fish species is currently found in Arizona and New Mexico in the United States, and in northern Mexico. The draft recovery plan includes specific recovery objectives and criteria to be met in order to enable us to remove this species from the list of endangered and threatened wildlife and plants. We request review and comment on this plan from local, State, and Federal agencies; Tribes; and the public. We will also accept any new information on the status of the Gila chub throughout its range to assist in finalizing the recovery plan.
To ensure consideration, we must receive written comments on or before December 28, 2015. However, we will accept information about any species at any time.
If you wish to review the draft recovery plan, you may obtain a copy by any one of the following methods:
If you wish to comment on the draft recovery plan, you may submit your comments in writing by any one of the following methods:
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For additional information about submitting comments, see the “Request for Public Comments” section below.
Steve Spangle, Field Supervisor, Arizona Ecological Services Field Office, at the above address and phone number, or by email at
Recovery of endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program and the Act (16 U.S.C. 1531
Gila chub was listed as endangered throughout its range with critical habitat on November 2, 2005 (effective date December 2, 2005). The species has a recovery priority number of 2C, which is based on a high degree of threat, high potential for recovery, taxonomic classification as a species, and potential for conflict over resources (primarily water) and economic development. Gila chub is included on the Arizona Game and Fish Departments' draft species of concern (1996), and possession of Gila chub in Arizona is prohibited except where such collection is authorized by special permit. The species was listed by the New Mexico Department of Game and Fish as endangered in 1988. Gila chub is listed as endangered by The Republic of Mexico; a recovery plan, or Program de Acción para la Conservación de las Especies (PACE), has not been developed for this species in Mexico.
Gila chub is a member of the roundtail chub (
Gila chub is considered a habitat generalist (Schultz and Bonar 2006), and commonly inhabits pools in smaller (higher order) streams and cienegas throughout its range in the Gila River basin, at elevations between 609 and 1,676 meters (m) (2,000-5,500 feet [ft]) (Miller 1946, Minckley 1973, Rinne 1976, Weedman et al. 1996). Gila chub is a highly secretive species, remaining near cover, including undercut banks, terrestrial vegetation, boulders, root wads, fallen logs, and thick overhanging or aquatic vegetation in deeper waters, especially pools (Minckley and Rinne 1991, Nelson 1993, Weedman et al. 1996).
Historically, Gila chub was recorded from nearly 50 higher order streams throughout the Gila River basin in southwestern New Mexico, central and southeastern Arizona, and northern Sonora, Mexico (Miller and Lowe 1967, Rinne and Minckley 1970, Minckley 1973, Rinne 1976, DeMarais 1986, Sublette et al. 1990, Weedman et al. 1996). Recent literature indicates that approximately 25 of these localities are considered occupied, and most are small and isolated, and face one or more threats (Weedman et al. 1996, USFWS 2005, Clarkson et al. 2012).
It was also estimated that 90 percent of the currently occupied habitat is degraded, due to the presence of nonnative fishes and land management actions. The few remaining small, isolated populations are vulnerable to environmental conditions such as drought, flood events, and wildfire. Primary threats to Gila chub, such as nonnative fish predation and competition, and secondary threats identified as habitat alteration, destruction, and fragmentation, are all factors identified in the final rule that contribute to the consideration that Gila chub is likely to become extinct throughout all or a significant portion of its range (USFWS 2005).
The recovery strategy for Gila chub is to ensure that existing habitat integrity and genetic diversity of the species are adequately protected, represented, and replicated within each of the major subbasins in the greater Gila River watershed, in which the species still resides. This involves protection of remnant populations, through management and regulatory agreements with agencies and partners; captive rearing with appropriate genetic, demographic, and health management for population establishment and supplementation; control of threats of nonnative fish predation and competition, as well as potential hybridization with other chub species; establishment of replicated populations in refuges and selected streams; monitoring of populations under a scientifically based, standardized protocol; and cooperation and education with agencies, partners, Tribes, and Mexico to ensure habitat quantity and quality are maintained and adaptively managed into the future.
The draft recovery plan proposes the delineation of five recovery units (RUs) that represent the major subbasins of the Gila River basin. These RUs cover much of the historical and current habitat for the species in Arizona, New Mexico, and Mexico, and provide a diversity of habitats and represent groupings of Gila chub populations, within which gene flow may have been common historically. Designation of RUs is intended to ensure that the species remains distributed across its historical range in representative ecological settings, and will sustain the remaining genetic, demographic, morphological, behavioral, and other life history elements of the species necessary for the long-term conservation of the entire listed taxon. The strategy to recover Gila chub further relies upon identifying, preserving, and replicating 17 genetic Management Units (MUs) that are distributed among the RUs.
The objective of an agency recovery plan is to provide a framework for the recovery of a species so that protection under the Act is no longer necessary. A recovery plan includes scientific information about the species and provides criteria and actions necessary for us to be able to reclassify the species to threatened status or remove it from the List. Recovery plans help guide our recovery efforts by describing actions we consider necessary for the species' conservation, and by estimating time and costs for implementing needed recovery measures. To achieve its goals, this draft recovery plan identifies the following objectives:
1. Maintain and protect all remnant populations in the wild.
2. Ensure representation, resiliency, and redundancy by maintaining genetic diversity and expanding the size and number of populations within Gila chub historical range via replication of remnant populations within each RU.
3. Manage or eliminate nonnative fish predation and competition and associated habitat-related modifications or loss.
4. Improve or develop new State regulations or firm agreements that
5. Work with stakeholders to improve and conserve existing and newly established Gila chub populations and their habitats and ensure that appropriate management plans and agreements are in place post-delisting.
6. Promote conservation of Gila chub in Mexico and on Tribal lands by forming partnerships and supporting research, outreach, and conservation management.
7. Monitor remnant, repatriated, and refuge populations to inform adaptive management strategies.
The draft recovery plan contains recovery criteria based on protecting all available remnant populations and replicating each MU in at least two streams. To achieve recovery criteria, threats of nonnative fish predation and competition, habitat alteration and fragmentation, and decreasing water availability should be controlled to manageable levels in streams occupied by Gila chub such that these threats do not pose imminent or chronic downward pressures on population sizes. When the status of Gila chub meets these criteria, the species will no longer meet the conditions of being endangered throughout a significant portion of its range and will no longer warrant listing.
Section 4(f) of the Act requires us to provide public notice and an opportunity for public review and comment during recovery plan development. It is also our policy to request peer review of recovery plans (July 1, 1994; 59 FR 34270). We will summarize and respond to the issues raised by the public and peer reviewers and post our responses on our Web site. Substantive comments may or may not result in changes to the recovery plan; comments regarding recovery plan implementation will be forwarded as appropriate to Federal or other entities so that they can be taken into account during the course of implementing recovery actions. Responses to individual commenters will not be provided, but we will provide a summary of how we addressed substantive comments in an appendix to the approved recovery plan.
We invite written comments on the draft recovery plan. In particular, we are interested in additional information regarding the current threats to the species and the costs associated with implementing the recommended recovery actions. Suggestions of how to craft recovery criteria addressing threats that are objective and measureable are welcome.
Before we approve our final recovery plan, we will consider all comments we receive by the date specified in
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.
Comments and materials we receive will be available, by appointment, for public inspection during normal business hours at our office (see
A complete list of all references cited herein is available upon request from the Arizona Ecological Services Field Office (see
We developed our draft recovery plan under the authority of section 4(f) of the Act, 16 U.S.C. 1533(f). We publish this notice under section 4(f) Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Reopening of the public comment period.
We, the U.S. Fish and Wildlife Service (USFWS), in coordination with the California State Coastal Conservancy, announce the reopening of the public comment period for the Draft Environmental Impact Statement/Environmental Impact Report (DEIS/EIR) for Phase 2 of the South Bay Salt Pond (SBSP) Restoration Project at the Don Edwards San Francisco Bay National Wildlife Refuge (Refuge) in Alameda, Santa Clara, and San Mateo Counties, California. The DEIS/EIR, which we prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), describes and analyzes the alternatives identified for Phase 2 of the South Bay Salt Pond Restoration Project.
We will accept comments received or postmarked on or before October 30, 2015.
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○ San Francisco Bay National Wildlife Refuge Complex Headquarters, 1 Marshlands Road, Fremont, CA 94555.
○ The following libraries:
Alviso Branch Library, 5050 N. First St., San Jose, CA 95002.
Biblioteca Latino America, 921 South First St., San Jose, CA 95110.
California State University Library, 25800 Carlos Bee Blvd., Hayward, CA 94542.
Fremont Main Library, 2400 Stevenson Blvd., Fremont, CA 94538.
Menlo Park Library, 800 Alma St., Menlo Park, CA 94025.
Mountain View Library, 585 Franklin St., Mountain View, CA 94041.
Rinconada Library, 1213 Newell Rd., Palo Alto, CA 94303.
King Library, 150 E San Fernando St., San Jose, CA 95112.
Redwood City Main Library, 1044 Middlefield Road, Redwood City, CA 94063.
San Mateo County East Palo Alto Library, 2415 University Ave., East Palo Alto, CA 94303.
Santa Clara County Milpitas Library, 160 N Main St., Milpitas, CA 95035.
Santa Clara Public Library, 2635 Homestead Rd., Santa Clara, CA 95051.
Sunnyvale Public Library, 665 W Olive Ave., Sunnyvale, CA 94086.
Natural Resources Library, U.S. Department of the Interior, 1849 C Street NW., Washington, DC 20240-0001.
For how to view comments on the draft EIS from the Environmental Protection Agency (EPA), or for information on EPA's role in the EIS
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To have your name added to our mailing list, contact Ariel Ambruster (see
Anne Morkill, Project Leader, USFWS, 510-792-0222.
In coordination with the California State Coastal Conservancy, we publish this notice to announce the reopening of the comment period for the DEIS/EIR for Phase 2 of the SBSP Restoration Project at the Don Edwards San Francisco Bay Refuge which originally ran from July 22, 2015, to September 22, 2015 (80 FR 43456). The DEIS/EIR, which we prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), describes and analyzes the alternatives identified for Phase 2 of the SBSP Restoration Project.
The EPA is charged under section 309 of the CAA (42 U.S.C. 7401
EPA also serves as the repository (EIS database) for EISs prepared by Federal agencies and provides notice of their availability in the
We are conducting environmental review in accordance with the requirements of NEPA, as amended (42 U.S.C. 4321
We request that you send comments only by one of the methods described in
We provide this notice in accordance with the requirements of NEPA (42 U.S.C. 4321
Fish and Wildlife Service, Interior.
Notice of availability; request for comments; correction.
On October 21, 2015, we, the U.S. Fish and Wildlife Service (Service), announced receipt of an application from Kaufman Real Estate LLC, Kaufman Holdings Inc., and Liberty Leasing & Construction, Inc. (applicants), for an incidental take permit (ITP) pursuant to the Endangered Species Act of 1973, as amended (ESA). The notice contained an incorrect comment-period end date. The correct date is December 21, 2015. With this notice, we correct that error. If you sent a comment previously, you need not re-send the comment.
Tim Romanski, 360-753-5823. If you use a telecommunications device for the deaf, please call the Federal Information Relay Service at 800-877-8339.
In the
Bureau of Indian Affairs, Interior.
Notice of request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Bureau of Indian Affairs is seeking comments on the renewal of Office of Management and Budget (OMB) approval for the collection of information for Tribal Self-Governance Program authorized by OMB Control Number 1076-0143. This information collection expires January 31, 2016.
Submit comments on or before December 28, 2015.
You may submit comments on the information collection to Sharee M. Freeman, Director, Office of Self-Governance, 1951 Constitution Avenue NW., Mail Stop 355-G SIB, Washington, DC 20240; telephone: (202) 219-0240, email:
Sharee Freeman, (202) 219-0240.
The Office of Self-Governance is seeking comments on the information collection entitled “Tribal Self-Governance Program, 25 CFR 1000,” as we prepare to renew these collections that are required by the Paperwork Reduction Act of 1995. The information collected will be used to establish requirements for entry into the pool of qualified applicants for Self-Governance and to meet reporting requirements of the Tribal Self-Governance Act.
The BIA requests your comments on this collection concerning: (a) The necessity of this information collection for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) The accuracy of the agency's estimate of the burden (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.
Please note that an agency may not conduct or sponsor, and an individual may not respond to, a collection of information unless it has a valid OMB Control Number.
It is our policy to make all comments available to the public for review at the location listed in the
Bureau of Reclamation, Interior.
Notice.
Notice is hereby given of contractual actions that have been proposed to the Bureau of Reclamation (Reclamation) and are new, discontinued, or completed since the last publication of this notice. This notice is one of a variety of means used to inform the public about proposed contractual actions for capital recovery and management of project resources and facilities consistent with section 9(f) of the Reclamation Project Act of 1939. Additional announcements of individual contract actions may be published in the
The identity of the approving officer and other information pertaining to a specific contract proposal may be obtained by calling or writing the appropriate regional office at the address and telephone number given for each region in the
Michelle Kelly, Reclamation Law Administration Division, Bureau of Reclamation, P.O. Box 25007, Denver, Colorado 80225-0007; telephone 303-445-2888.
Consistent with section 9(f) of the Reclamation Project Act of 1939, and the rules and regulations published in 52 FR 11954, April 13, 1987 (43 CFR 426.22), Reclamation will publish notice of proposed or amendatory contract actions for any contract for the delivery of project water for authorized uses in newspapers of general circulation in the affected area at least 60 days prior to contract execution. Announcement may be in the form of news releases, legal notices, official letters, memorandums, or other forms of written material. Meetings, workshops, and/or hearings may also be used, as appropriate, to provide local publicity. The public participation procedures do not apply to proposed contracts for the sale of surplus or interim irrigation water for a term of 1 year or less. Either of the contracting parties may invite the public to observe contract proceedings. All public participation procedures will be coordinated with those involved in complying with the National Environmental Policy Act. Pursuant to the “Final Revised Public Participation Procedures” for water resource-related contract negotiations, published in 47 FR 7763, February 22, 1982, a tabulation is provided of all proposed contractual actions in each of the five Reclamation regions. When contract negotiations are completed, and prior to execution, each proposed contract form must be approved by the Secretary of the Interior, or pursuant to delegated or redelegated authority, the Commissioner of Reclamation or one of the regional directors. In some instances, congressional review and approval of a report, water rate, or other terms and conditions of the contract may be involved.
Public participation in and receipt of comments on contract proposals will be facilitated by adherence to the following procedures:
1. Only persons authorized to act on behalf of the contracting entities may negotiate the terms and conditions of a specific contract proposal.
2. Advance notice of meetings or hearings will be furnished to those parties that have made a timely written request for such notice to the appropriate regional or project office of Reclamation.
3. Written correspondence regarding proposed contracts may be made available to the general public pursuant to the terms and procedures of the Freedom of Information Act, as amended.
4. Written comments on a proposed contract or contract action must be submitted to the appropriate regional officials at the locations and within the time limits set forth in the advance public notices.
5. All written comments received and testimony presented at any public hearings will be reviewed and summarized by the appropriate regional office for use by the contract approving authority.
6. Copies of specific proposed contracts may be obtained from the appropriate regional director or his or her designated public contact as they become available for review and comment.
7. In the event modifications are made in the form of a proposed contract, the appropriate regional director shall determine whether republication of the notice and/or extension of the comment period is necessary.
Factors considered in making such a determination shall include, but are not limited to, (i) the significance of the modification, and (ii) the degree of public interest which has been expressed over the course of the negotiations. At a minimum, the regional director will furnish revised contracts to all parties who requested the contract in response to the initial public notice.
11. City of Prineville and Ochoco ID, Crooked River Project, Oregon: Long-term contract to provide the city of Prineville with a mitigation water supply from Prineville Reservoir; with the Ochoco ID being a party to the contract, as they are responsible for O&M of the dam and reservoir.
12. Burley and Minidoka IDs, Minidoka Project, Idaho: Supplemental and amendatory contracts to transfer the O&M of the Main South Side Canal Headworks to Burley ID and transfer the O&M of the Main North Side Canal Headworks to the Minidoka ID.
The Mid-Pacific Region has no updates to report for this quarter.
25. La Paz County and Ehrenberg Improvement Association (EIA), BCP, Arizona: Review and approve a proposed partial assignment to the Association of 150 acre-feet per year of La Paz County's Arizona fourth priority water entitlement amount of 500 acre-feet per year and execute the associated amendments to La Paz County's contract and the Association's contract.
11. Flowing Wells ID and the City of Tucson, CAP, Arizona: Execute a proposed partial assignment to the City of 19 acre-feet per year from the District's CAP water entitlement amount of 4,354 acre-feet per year. Contract executed July 20, 2015.
32. Uintah Water Conservancy District; Flaming Gorge Unit, CRSP; Utah: The District has requested a long-term water service contract to remove up to 5,500 acre-feet of water annually from the Green River for irrigation purposes under the authority of Section 9(e) of the Reclamation Project Act of 1939. A short-term contract may be executed until a long-term contract can be completed.
33. Salem Canal and Irrigation Company, Strawberry Valley Project, Utah: The United States intends to enter into an amendatory contract regarding possible lost generation of power revenues generated at the Spanish Fork Power Plant on the Strawberry Valley Project.
34. Weber Basin Water Conservancy District, A.V. Watkins Dam, Utah: The United States intends to enter into an implementation agreement with the District giving the District the authority to modify Federal facilities to raise the crest of AV Watkins Dam.
16. Azalea Oil Company; Flaming Gorge Unit, CRSP; Wyoming: The Company has requested a contract for 1 acre-foot of water for drilling, dust suppression, and other uses for a well. The Company plans on drilling in Southwest Wyoming. Contract executed March 24, 2015.
26. La Plata Water Conservancy District, Animas-La Plata Project, Colorado: The District has requested a 1-year temporary water service contract for the use of Reclamation shares in the Pine Ridge Ditch for the temporary use of up to 262 acre-feet. A contract is currently being drafted which will determine point(s) of delivery and rate and method of water payments. Contract executed June 22, 2015.
64. Glen Elder ID No. 8; Glen Elder Unit, P-SMBP; Kansas: Consideration to renew long-term water service contract No. 2-07-60-W0855.
65. Mitchell County Rural Water District No. 2; Glen Elder Unit, P-SMBP; Kansas: Consideration to renew long-term water delivery contract No. 7-07-70-W0108.
30. Helena Valley ID; Helena Valley Unit, P-SMBP; Montana: Consideration of a contract to allow for delivery of up to 500 acre-feet of water for M&I purposes within the District boundaries.
40. William Rau; Canyon Ferry Unit, P-SMBP; Montana: Renewal of a long-term water service contract.
52. Jeffrey N. Edwards Revocable Trust; Bostwick Division, P-SMBP; Nebraska: Excess capacity contract for the conveyance of nonproject water.
54. Fort Cobb Reservoir Master Conservancy District, Fort Cobb Division, Washita River Basin Project: Reclamation intends to enter into an amendment to contract No. 14-06-500-295 to recognize the previously uncommitted irrigation water allocation as available for M&I use.
58. Sunny Brooks Colony, Inc.; Lower Marias Unit, P-SMBP; Montana: Consideration to enter into a long-term contract for up to 59 acre-feet of M&I water from Lake Elwell. Contract executed June 24, 2015.
59. Devon Water Inc.; Lower Marias Unit, P-SMBP; Montana: Proposed 40-year contract for M&I water. Contract executed July 16, 2015.
60. Tiber County WD; Lower Marias Unit, P-SMBP; Montana: Proposed 40-year contract for M&I water. Contract executed July 31, 2015.
61. Dugout Water Association; Lower Marias Unit, P-SMBP; Montana: Proposed renewal of 40-year contract for M&I water. Contract executed September 10, 2015.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to terminate the investigation as to the remaining respondents, LaRose Industries, LLC d/b/a Cra-Z-Art (“LaRose”) and MEGA Brands, Inc. (“MEGA”), based upon consent order stipulations and settlement agreements. The Commission has entered consent orders with respect to LaRose and MEGA.
Cathy Chen, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on March 16, 2015, based on a complaint filed by LEGO A/S of Billund, Denmark; LEGO System A/S of Billund, Denmark; and LEGO Systems, Inc. of Enfield, Connecticut. 80 FR 13629-30 (March 16, 2015). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain toy figurines and toy sets containing the same by reason of infringement of four U.S. design patents and four registered U.S. copyrights. The notice of investigation named as respondents LaRose; MEGA; and Best-Lock Construction Toys, Inc., of Miami, Florida (“Best-Lock”). Best-Lock has been terminated from the investigation based on a consent order.
On July 9, 2015, Complainants and LaRose filed a joint motion to terminate LaRose based on a consent order stipulation, a proposed consent order, and a settlement agreement. On July 22, 2015, the investigative attorney filed a response in conditional support of the motion provided that the movants submit a revised version of the public settlement agreement that contained fewer redactions. On July 31, 2015, the ALJ ordered the movants to file a revised version of the public settlement agreement, which the movants complied with on August 24, 2015.
On July 28, 2015, Complainants and MEGA filed a renewed joint motion to terminate the investigation as to MEGA based on a consent order stipulation, a proposed consent order, and a settlement agreement. On August 21, 2015, complainants and MEGA jointly submitted a revised consent order stipulation and proposed consent order. The Investigative Attorney did not oppose the renewed motion to terminate based in part on the August 21, 2015, revised consent order stipulation and proposed consent order. On August 26, 2015, the ALJ ordered the movants to file a revised version of the public settlement agreement, which the movants complied with on August 31, 2015.
The Commission determined to review the IDs on September 18, 2015, and October 1, 2015, respectively, because the consent order stipulations and the proposed consent orders did not comply with Commission Rule 210.21(c). The moving parties were requested to file with the Commission revised versions of the consent order stipulations and proposed consent orders in compliance with that Rule. On October 7, 2015, LaRose and MEGA submitted revised consent order stipulations and revised proposed consent orders in compliance with Rule 210.21(c).
The Commission has determined to terminate the investigation in its entirety, and to issue consent orders with respect to LaRose and MEGA.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Federal Bureau of Investigation (FBI), Department of Justice.
60-Day notice.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with established review procedures of the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until December 28, 2015.
Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to John E. Strovers, Global Operations Section, CJIS Division Intelligence Group, Federal Bureau of Investigation, Criminal Justice Information Services Division, (CJIS), Module D-3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; facsimile (304) 625-2198.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques of other forms of information technology,
Overview of this information collection:
(1) Type of information collection: Extension of current collection.
(2) The title of the form/collection: Federal Bureau of Investigation Bioterrorism Preparedness Act: Entity/Individual Information.
(3) The agency form number, if any, and the applicable component of the department sponsoring the collection: Forms FD-961; Criminal Justice Information Services Division, Federal Bureau of Investigation, Department of Justice.
(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: City, county, state, federal, individuals, business or other for profit, and not-for-profit institute. This collection is needed to receive names and other identifying information submitted by individuals requesting access to specific agents or toxins, and consult with appropriate officials of the Department of Health and Human Services and the Department of Agriculture as to whether certain individuals specified in the provisions should be denied access to or granted limited access to specific agents.
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: There are approximately 4,635 (FY 2015) respondents at 45 minutes for the FD-961 Form.
(6) An estimate of the total public burden (in hours) associated with this collection: There are approximately 3,476 hours, annual burden, associated with this information collection.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice
30-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 27, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Christopher Reeves
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• 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;
• Evaluate whether and if so how the quality, utility, and clarity of the
• 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,
Overview of this information collection 1140-0074:
1
2
3
Form number: None.
Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.
4
Primary: Individuals or households.
Other: Business or other for-profit.
Abstract: All persons holding ATF explosives licenses or permits must report any change in responsible persons or employees authorized to possess explosive materials to ATF. Such report must be submitted within 30 days of the change and must include appropriate identifying information for each responsible person.
5
6
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 27, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Jacqueline Pitts
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• 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;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; 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,
1.
2.
3.
Form number: None.
Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.
4.
Primary: Business or other for-profit.
Other: Not-for-profit institutions, Federal Government, State, Local, or Tribal Government.
Abstract: The Office of Strategic Management at ATF will use the information to help identify and validate the agency's internal strengths and weaknesses.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 27, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Christopher Reeves,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
Form number: ATF Form 5000.30.
Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.
4.
Primary: Business or other for-profit.
Other: None.
Abstract: ATF collects this data for the purpose of identifying waste product(s) generated as a result of explosives operations, the disposal of the products into navigable waters, and if there is any adverse impact on the environment. The information may be disclosed to other Federal, State, and local law enforcement and regulatory personnel to verify information on the form and to aid in the enforcement of environmental laws.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Office on Violence Against Women, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Office on Violence Against Women, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until November 27, 2015.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Attorney Advisor, Office on Violence Against Women, 145 N Street NE., Washington, DC 20530 (phone: 202-514-5430). Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
The Consolidated Youth Program supports projects designed to provide coordinated community responses that support child, youth and young adult victims through direct services, training, coordination and collaboration, effective intervention, treatment, response, and prevention strategies. The Consolidated Youth Program creates a unique opportunity for communities to increase collaboration among non-profit victim service providers; violence prevention, and children (0-10), youth (11-18), young adult (19-24) and men-serving organizations; tribes and tribal governments; local government agencies; schools; and programs that support men's role in combating sexual assault, domestic violence, dating violence and stalking.
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E.405B, Washington, DC 20530.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until November 27, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact James Scott
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• 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;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; 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,
Overview of this information collection 1140-0095:
1.
2.
3.
Form number: None.
Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.
4.
Primary: State, Local, or Tribal Government.
Other: Federal Government.
Abstract: Collection of this information will help ATF determine whether the training program is consistently meeting objectives and impacting the performance of the individuals in their work place.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E-405B, Washington, DC 20530.
Office on Violence Against Women, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Office on Violence Against Women, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until November 27, 2015.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Attorney Advisor, Office on Violence Against Women, 145 N Street NE., Washington, DC 20530 (phone: 202-514-5430). Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department, Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E.405B, Washington, DC 20530.
The Bureau of International Labor Affairs, United States Department of Labor.
Notice: Request for information and invitation to comment.
This notice is a request for information and/or comment on three reports issued by the Bureau of International Labor Affairs (ILAB) in 2014 and 2015 regarding child labor and forced labor in certain foreign countries. Relevant information submitted by the public will be used by the Department of Labor (DOL) in preparation of its ongoing reporting under Congressional mandates and Presidential directive. The 2014 Findings on the Worst Forms of Child Labor report (TDA report), published on September 30, 2015, assessed efforts by 140 countries to reduce the worst forms of child labor and reported whether countries made significant, moderate, minimal, or no advancement. It also suggested actions foreign countries can take to eliminate the worst forms of child labor through legislation, enforcement, coordination, policies and social programs. The 2014 edition of the List of Goods Produced by Child Labor or Forced Labor (TVPRA List), published on December 1, 2014, made available to the public a list of goods from countries that ILAB has reason to believe are produced by child labor or forced labor in violation of international standards. The List of Products Produced by Forced or Indentured Child Labor (EO List), most recently published on December 1, 2014, provides a list of products, identified by country of origin, that the Department, in consultation and cooperation with the Departments of State (DOS) and Homeland Security (DHS), have a reasonable basis to believe might have been mined, produced or manufactured with forced or indentured child labor. Relevant information submitted by the public will be used by DOL in preparation of the next editions of all three reports, to be published in 2016.
Submitters of information are requested to provide their submission to the Office of Child Labor, Forced Labor, and Human Trafficking (OCFT) at the email or physical address below by 5 p.m. January 04, 2016.
The portal includes instructions for submitting comments. Parties submitting responses electronically are encouraged not to submit paper copies.
Chanda Uluca and Rachel Rigby. Please see contact information above).
I. Section 105(b)(1) of the Trafficking Victims Protection Reauthorization Act of 2005 (“TVPRA of 2005”), Public Law 109-164 (2006), directed the Secretary of Labor, acting through ILAB, to “develop and make available to the public a list of goods from countries that the Bureau of International Labor Affairs has reason to believe are produced by forced labor or child labor in violation of international standards” (TVPRA List).
Pursuant to this mandate, in December 2007 DOL published in the
ILAB published its first TVPRA List on September 30, 2009, and has issued updates in 2010, 2011, 2012, 2013 and 2014. In 2014, ILAB began publishing the TVPRA List every other year, pursuant to changes in the law. See 22 U.S.C. 7112(b). The next TVPRA List will be published in 2016. For a copy of the 2014 TVPRA List, Frequently Asked Questions, and other materials relating to the TVPRA List, see ILAB's TVPRA Web page at
II. Executive Order No. 13126 (E.O. 13126) declared that it was “the policy of the United States Government . . . that the executive agencies shall take appropriate actions to enforce the laws prohibiting the manufacture or importation of goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part by forced or indentured child labor.” Pursuant to E.O. 13126, and following public notice and comment, the Department of Labor published in the January 18, 2001
Pursuant to Sections D through G of the Procedural Guidelines, the EO List may be updated through consideration of submissions by individuals or through OCFT's own initiative.
DOL has officially revised the EO List four times, most recently on July 23, 2013, each time after public notice and comment as well as consultation with DOS and DHS.
The current EO List, Procedural Guidelines, and related information can be accessed on the Internet at
III. The Trade and Development Act of 2000 (TDA), Public Law 106-200 (2000), established a new eligibility criterion for receipt of trade benefits under the Generalized System of Preferences (GSP), Caribbean Basin Trade and Partnership Act (CBTPA), and Africa Growth and Opportunity Act (AGOA) and the (now-expired) Andean Trade Preference Act/Andean Trade Promotion and Drug Eradication Act (ATPA/ATPDEA).
The TDA amended the GSP reporting requirements of Section 504 of the Trade Act of 1974, 19 U.S.C. 2464, to require that the President's annual report on the status of internationally recognized worker rights include “findings by the Secretary of Labor with respect to the beneficiary country's
DOL fulfills these reporting mandates through annual publication of the U.S. Department of Labor's Findings on the Worst Forms of Child Labor with respect to countries eligible for the aforementioned programs. The 2014 report and additional background information are available on the Internet at
Information Requested and Invitation to Comment: Interested parties are invited to comment and provide information regarding DOL's TVPRA List which may be found on the Internet at
This notice is a general solicitation of comments from the public.
Notice.
The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, “Definition of Plan Assets—Participant Contributions,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
The OMB will consider all written comments that agency receives on or before November 27, 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-EBSA, 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 by email at
44 U.S.C. 3507(a)(1)(D).
This ICR seeks to extend PRA authority for the Definition of Plan Assets—Participant Contributions information collection codified in regulations 29 CFR 2520.3-102(d). The regulation concerning plan assets and participant contributions provides guidance for a fiduciary, participant, or beneficiary of an employee benefit plan regarding how a participant contribution to a pension plan must be handled when the contribution is either paid to the employer by the participant or directly withheld by the employer from the employee's wages for transmission to the pension plan. In particular, the regulation sets standards for the timely delivery of such participant contributions, including an outside time limit for the employer's holding of participant contributions. In addition, for an employer who may have difficulty meeting the regulation's outside deadlines for transmitting participant contribution, the regulation provides the opportunity for the employer to obtain an extension of the time limit by providing participants and the Department with a notice that contains specified information. Employee Retirement Income Security Act of 1974 section 404 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
OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2015. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the
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,
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from September 29 to October 9, 2015. The last biweekly notice was published on October 13, 2015.
Comments must be filed by November 27, 2015. A request for a hearing must be filed by December 28, 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):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Paula Blechman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2242, email:
Please refer to Docket ID NRC-2015-0242 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0242, facility name, unit number(s), application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and to submit a cross-examination plan for cross-examination of witnesses, consistent with NRC regulations, policies and procedures.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it
A State, local governmental body, federally-recognized Indian tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by December 28, 2015. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions for leave to intervene set forth in this section, except that under § 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. A State, local governmental body, Federally-recognized Indian tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Persons desiring to make a limited appearance are requested to inform the Secretary of the Commission by December 28, 2015.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North,
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)-(iii).
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The ECCS provides a mitigating function, and as such, it does not impact the probability of an accident. The consequences of an accident requiring the ECCS function will continue to be mitigated by the operable 1B RHR system train during the extended period in which the 1A RHR system train is considered inoperable. Each of the two RHR trains are redundant, so the 1B RHR pump is capable of performing the necessary mitigating function.
Additionally, engineering evaluations, as documented in the [Engineering Change (EC)] process, demonstrate that the 1A RHR pump will continue to be capable of performing its mitigating ECCS function using a defense-in-depth measure that establishes alternate forced cooling to the room.
As such, the proposed amendment does not result in an increase in consequences of an accident.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
No new accident causal mechanisms are created as a result of this proposed license amendment request (LAR). No changes are being made to any SSC [structure, system, or component] that will introduce any new accident causal mechanisms. The defense-in-depth measure to install alternate forced cooling to the 1A RHR pump motor during the repair evolution has been analyzed and evaluated using the Duke Energy EC process.
The EC concludes that the installation of alternate forced cooling equipment would not adversely impact other components such that a new or different accident scenario is created.
3. Does the proposed amendment involve a significant reduction in the margin of safety?
Response: No.
Margin of safety is related to the confidence in the ability of the fission product barriers to perform their design functions during and following an accident situation. These barriers include the fuel cladding, the reactor coolant system, and the containment system. The performance of the fuel cladding, reactor coolant and containment systems will not be impacted by the proposed LAR.
The proposed activity only impacts the amount of time that the 1A RHR system can be considered inoperable. The amount of inoperable time still remains small relative to the total operating time, and the 1A RHR train would still be considered available (
Therefore, it is concluded that the proposed changes do not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment adds a high flux trip for three (3) Reactor Coolant Pump (RCP) Operation by modifying the existing Nuclear Overpower-High Setpoint function in Technical Specification (TS) Table 3.3.1-1 to delineate between a setpoint valid for four (4) RCP operation and three (3) RCP operation. TS 3.4.4 is modified to require the Nuclear Overpower—High Setpoint to be reset to less than or equal to the Allowable Value of Table 3.3.1-1 for three (3) RCPs operating. The proposed change provides automatic overpower protection when the plant is operating with three (3) RCPs. The existing overpower protection for three (3) RCP operation is the Nuclear Overpower Flux/Flow/Imbalance trip function. Providing a Nuclear Overpower flux setpoint provides an absolute setpoint that can be actuated regardless of the transient or RCS flow conditions. The proposed TS change does not modify the reactor coolant system pressure boundary, nor make any physical changes to the facility design, material, or construction standards. The probability of any design basis accident (DBA) is not affected by this change, nor are the consequences of any DBA significantly affected by this change. The proposed change does not involve changes to any structures, systems, or components (SSCs) that can alter the probability for initiating a LOCA [loss-of-coolant accident] event. This amendment request includes the adoption of Option A of Technical Specification Task Force (TSTF) TSTF-493-A, Revision 4, “Clarify Application of Setpoint Methodology for LSSS [Limiting Safety System Setting] Functions,” for the Nuclear Overpower—High Setpoint trip function of TS Table 3.3.1-1. The TS changes associated with the implementation of TSTF-493-A will provide additional assurance that the instrumentation setpoints for the Nuclear Overpower—High Setpoint trip function are maintained consistent with the setpoint methodology to ensure the required automatic trips and safety feature actuations occur such that the safety limits are not exceeded.
Therefore, the proposed TS changes do not significantly increase the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed amendment adds a high flux trip for three (3) Reactor Coolant Pump Operation by modifying the existing Nuclear Overpower-High Setpoint function in TS Table 3.3.1-1 to delineate between a setpoint valid for four (4) RCP operation and three (3) RCP operation. This proposed change and the implementation of TSTF-493-A do not alter the plant configuration (no new or different type of equipment will be installed) or make changes in methods governing normal plant operation. No new failure modes are identified, nor are any SSCs required to be operated outside the design bases.
Therefore, the possibility of a new or different kind of accident from any kind of accident previously evaluated is not created.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed amendment adds a high flux trip for three (3) Reactor Coolant Pump Operation by modifying the existing Nuclear Overpower-High Setpoint function in TS Table 3.3.1-1 to delineate between a setpoint valid for four (4) RCP operation and three (3) RCP operation. This proposed TS change and the implementation of TSTF-493-A do not involve: (1) A physical alteration of the Oconee Units; (2) the installation of new or different equipment; or (3) any impact on the fission product barriers or safety limits. The proposed change adds a new setpoint, which is more conservative than the existing high flux setpoint that initiates a protective action to provide protection for power excursion events initiated from three (3) RCP operation equivalent to that provided for four (4) RCP operation.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The proposed changes to the TS are consistent with the NRC-approved Technical Specification Task Force (TSTF) Standard Technical Specification change traveler TSTF-427, “Allowance for Non-Technical Specification Barrier Degradation on Supported System OPERABILITY,” Revision 2 (ADAMS Accession No. ML061240055). The availability of the TS improvement and the model application was published in the
The proposed change allows a delay time for entering a supported system technical specification (TS) when the inoperability is due solely to an unavailable barrier if risk is assessed and managed. The postulated initiating events which may require a functional barrier are limited to those with low frequencies of occurrence, and the overall TS system safety function would still be available for the majority of anticipated challenges. Therefore, the probability of an accident previously evaluated is not significantly increased, if at all. The consequences of an accident while relying on the allowance provided by proposed LCO 3.0.9 are no different than the consequences of an accident while relying on the TS required actions in effect without the allowance provided by proposed LCO 3.0.9. Therefore, the consequences of an accident previously evaluated are not significantly affected by this change. The addition of a requirement to assess and manage the risk introduced by this change will further minimize possible concerns.
Therefore, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Allowing delay times for entering supported
Thus, this change does not create the possibility of a new or different kind of accident from an accident previously evaluated.
The proposed change allows a delay time for entering a supported system TS when the inoperability is due solely to an unavailable barrier, if risk is assessed and managed. The postulated initiating events which may require a functional barrier are limited to those with low frequencies of occurrence, and the overall TS system safety function would still be available for the majority of anticipated challenges. The risk impact of the proposed TS changes was assessed following the three-tiered approach recommended in [NRC Regulatory Guide 1.177, “An Approach for Plant-Specific Risk-Informed Decisionmaking: Technical Specifications,” August 1998 (ADAMS Accession No. ML003740176)]. A bounding risk assessment was performed to justify the proposed TS changes. This application of LCO 3.0.9 is predicated upon the licensee's performance of a risk assessment and the management of plant risk. The net change to the margin of safety is insignificant as indicated by the anticipated low levels of associated risk (ICCDP [incremental conditional core damage probability] and ICLERP [incremental large early release probability]) as shown in Table 1 of Section 3.1.1 in the Safety Evaluation [published in the
Therefore, this change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the above analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change to the CSP Implementation Schedule is administrative in nature. This change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and have no impact on the probability or consequences of an accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change to the CSP Implementation Schedule is administrative in nature. This proposed change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and do not create the possibility of a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
Plant safety margins are established through limiting conditions for operation, limiting safety system settings, and safety limits specified in the technical specifications. The proposed change to the CSP Implementation Schedule is administrative in nature. In addition, the milestone date delay for full implementation of the CSP has no substantive impact because other measures have been taken which provide adequate protection during this period of time. Because there is no change to established safety margins as a result of this change, the proposed change does not involve a significant reduction in a margin of safety.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change to the reactor steam dome pressure in the CPS [Clinton Power Station, Unit 1], DNPS [Dresdent Nuclear Power Station, Units 2 and 3], and QCNPS [Quad Cities Nuclear Power Station, Units 1 and 2] Reactor Core Safety Limits TS 2.1.1.1 and 2.1.1.2 does not alter the use of the analytical methods used to determine the safety limits that have been previously reviewed and approved by the NRC. The proposed change is in accordance with an NRC approved critical power correlation
The proposed change does not alter or prevent the ability of structures, systems, and components (SSCs) from performing their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed change does not require any physical change to any plant SSCs nor does it require any change in systems or plant operations. The proposed change is consistent with the safety analysis assumptions and resultant consequences.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed reduction in the reactor dome pressure safety limit from 785 psig [pounds per square inch gauge] to 685 psig is a change based upon previously approved documents and does not involve changes to the plant hardware or its operating characteristics. As a result, no new failure modes are being introduced. There are no hardware changes nor are there any changes in the method by which any plant systems perform a safety function. No new accident scenarios, failure mechanisms, or limiting single failures are introduced as a result of the proposed change.
The proposed change does not introduce any new accident precursors, nor does it involve any physical plant alterations or changes in the methods governing normal plant operation. Also, the change does not impose any new or different requirements or eliminate any existing requirements. The change does not alter assumptions made in the safety analysis.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The margin of safety is established through the design of the plant structures, systems, and components, and through the parameters for safe operation and setpoints for the actuation of equipment relied upon to respond to transients and design basis accidents. Evaluation of the 10 CFR part 21 condition by General Electric determined that since the Minimum Critical Power Ratio improves during the PRFO [pressure regulator failure maximum demand (open)] transient, there is no decrease in the safety margin and therefore there is not a threat to fuel cladding integrity. The proposed change in reactor dome pressure supports the current safety margin, which protects the fuel cladding integrity during a depressurization transient, but does not change the requirements governing operation or availability of safety equipment assumed to operate to preserve the margin of safety. The change does not alter the behavior of plant equipment, which remains unchanged.
The proposed change to Reactor Core Safety Limits 2.1.1.1 and 2.1.1.2 is consistent with and within the capabilities of the applicable NRC approved critical power correlation for the fuel designs in use at CPS, DNPS, and QCNPS. No setpoints at which protective actions are initiated are altered by the proposed change. The proposed change does not alter the manner in which the safety limits are determined. This change is consistent with plant design and does not change the TS operability requirements; thus, previously evaluated accidents are not affected by this proposed change.
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the requested amendments involve no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes remove [from the TSs] the current necessity of establishing and maintaining communications between the control room and the refueling station and the minimum load capacities and load limit controls required for the manipulator crane limits and relocate the requirements to the UFSAR and related procedures, which will have no impact on any safety related structures, systems or components. Once relocated to the UFSAR and related procedures, changes to establishing and maintaining communications between the control room and the refueling station and the minimum load capacities and load limit controls required for the manipulator crane limits will be controlled in accordance with 10 CFR 50.59.
The probability of occurrence of a previously evaluated accident is not increased because these changes do not introduce any new potential accident initiating conditions. The consequences of accidents previously evaluated in the UFSAR are not affected because the ability of the components to perform their required functions is not affected.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes remove [from the TSs] the current necessity of establishing and maintaining communications between the control room and the refueling station and the minimum load capacities and load limit controls required for the manipulator crane limits and relocate the requirements to the UFSAR and related procedures, which will have no impact on any safety related structures, systems or components. Once relocated to the UFSAR and related procedures, changes to establishing and maintaining communications between the control room and the refueling station and the minimum load capacities and load limit controls required for the manipulator crane limits will be controlled in accordance with 10 CFR 50.59.
The proposed changes do not introduce new modes of plant operation and do not involve physical modifications to the plant (no new or different type of equipment will be installed). There are no changes in the method by which any safety related plant structure, system, or component (SSC) performs its specified safety function. As such, the plant conditions for which the design basis accident analyses were performed remain valid.
No new accident scenarios, transient precursors, failure mechanisms, or limiting single failures will be introduced as a result of the proposed change. There will be no adverse effect or challenges imposed on any SSC as a result of the proposed changes.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
Margin of safety is related to confidence in the ability of the fission product barriers to
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.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment adopts the NRC-accepted guidelines of NEI 94-01, Revision 3-A, “Industry Guideline for Implementing Performance-Based Option of 10 CFR part 50, Appendix J,” for development of the DAEC performance-based containment testing program. NEI 94-01 allows, based on risk and performance, an extension of Type A and Type C containment leak test intervals. Implementation of these guidelines continues to provide adequate assurance that during design basis accidents, the primary containment and its components will limit leakage rates to less than the values assumed in the plant safety analyses.
The findings of the DAEC risk assessment confirm the general findings of previous studies that the risk impact with extending the containment leak rate is small. Per the guidance provided in Regulatory Guide 1.174, an extension of the leak test interval in accordance with NEI 94-01, Revision 3-A results in an estimated change within the very small change region.
Since the change is implementing a performance-based containment testing program, the proposed amendment does not involve either a physical change to the plant or a change in the manner in which the plant is operated or controlled. The requirement for containment leakage rate acceptance will not be changed by this amendment. Therefore, the containment will continue to perform its design function as a barrier to fission product releases.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change to implement a performance-based containment testing program, associated with integrated leakage rate test frequency, does not change the design or operation of structures, systems, or components of the plant.
The proposed changes would continue to ensure containment integrity and would ensure operation within the bounds of existing accident analyses. There are no accident initiators created or affected by these changes. Therefore, the proposed changes will not create the possibility of a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
Margin of safety is related to confidence in the ability of the fission product barriers (fuel cladding, reactor coolant system, and primary containment) to perform their design functions during and following postulated accidents. The proposed change to implement a performance-based containment testing program, associated with integrated leakage rate test frequency, does not affect plant operations, design functions, or any analysis that verifies the capability of a structure, system, or component of the plant to perform a design function. In addition, this change does not affect safety limits, limiting safety system setpoints, or limiting conditions for operation.
The specific requirements and conditions of the TS Primary Containment Leakage Rate Testing Program exist to ensure that the degree of containment structural integrity and leak-tightness that is considered in the plant safety analysis is maintained. The overall containment leak rate limit specified by TS is maintained. This ensures that the margin of safety in the plant safety analysis is maintained. The design, operation, testing methods and acceptance criteria for Type A, B, and C containment leakage tests specified in applicable codes and standards would continue to be met, with the acceptance of this proposed change, since these are not affected by implementation of a performance-based containment testing program.
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.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment would reclassify Fire Area Figures Tier 2* information. The proposed amendment does not modify the design, construction, or operation of any plant structures, systems, or components (SSCs), nor does it change any procedures or method of control for any SSCs. Because the proposed amendment does not change the design, construction, or operation of any SSCs, it does not adversely affect any design function as described in the Updated Final Safety Analysis Report.
Therefore, the proposed amendment does not affect the probability of an accident previously evaluated. Similarly, because the proposed amendment does not alter the design or operation of the nuclear plant or any plant SSCs, the proposed amendment does not represent a change to the radiological effects of an accident, and therefore, does not involve an increase in the consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed amendment would reclassify Fire Area Figures Tier 2* information. The proposed amendment is not a modification, addition to, or removal of any plant SSCs. Furthermore, the proposed amendment is not a change to procedures or method of control of the nuclear plant or any plant SSCs. The only impact of this activity is the reclassification of information in the Updated Final Safety Analysis Report.
Because the proposed amendment only reclassifies information and does not change the design, construction, or operation of the nuclear plant or any plant operations, the amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The proposed amendment would reclassify Fire Area Figures Tier 2* information. The proposed amendment is not a modification, addition to, or removal of any plant SSCs. Furthermore, the proposed amendment is not a change to procedures or method of control of the nuclear plant or any plant SSCs. The only impact of this activity is the reclassification of information in the Updated Final Safety Analysis Report.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The two motor-operated gate valves located in each RHR System suction line are normally-closed to maintain the low pressure RHR System (design pressure of 600 psig) isolated from the high pressure [reactor coolant system] RCS (normal operating pressure of 2235 psig). An [autoclosure interlock] ACI was provided to isolate the low pressure RHR System from the RCS when the pressure increases above the ACI setpoint. However, spurious ACI actuation has resulted in RHR System isolation and subsequent loss of decay heat removal capability. The removal of the ACI feature will preclude this inadvertent isolation, thus increasing the likelihood that RHR will be available to remove decay heat. The addition of a control room alarm to alert the operator that a suction/isolation valve(s) is not fully closed when the RCS pressure is above the alarm setpoint and administrative procedures will ensure that the RHR System will be isolated from the RCS, if the RCS pressure increases above the alarm setpoint, which will decrease the likelihood of an interfacing system [Loss-of-Coolant Accident] LOCA. Therefore, the performance of the RHR System would not be adversely affected by the ACI deletion and the RHR suction isolation valve alarm installation.
The RHR ACI provides automatic closure to the RHR System suction isolation valves on high RCS pressure; however, rapid overpressure protection of the RHR System is provided by the RHR relief valves and not by the slow acting suction isolation valves. This RHR System overpressure protection is not affected by the removal of the ACI, this feature also serves to decrease the likelihood of an interfacing system LOCA. Thus, the RHR System integrity will not be affected by the removal of the ACI feature. In addition, the removal of the ACI feature does not adversely affect any fission barrier, alter any assumptions made in the radiological consequences evaluations, or affect the mitigation of radiological consequences.
The impact of ACI removal on RHR shutdown cooling, low temperature overpressure protection, and interfacing system LOCA initiating event frequency was assessed. For each of these areas that were assessed, it was concluded that the removal of ACI and the accompanying plant changes provides a benefit to plant safety.
With the deletion of the ACI, there is no longer any potential for spurious automatic closure of a RHR System suction isolation valve resulting in inadvertent RHR System isolation and loss of shutdown cooling.
Therefore, it is concluded that the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The removal of the RHR System ACI, and corresponding TS requirements, does not result in the initiation of any accident nor create any new credible limiting single failures.
The removal of the ACI eliminates the potential for spurious circuitry actuation causing isolation of the RHR system. Furthermore, the addition of an alarm to alert the operator that a suction valve is not fully closed when RCS pressure is above the alarm setpoint reduces the likelihood that the RHR system will be exposed to high pressure conditions. These modifications and the resulting elimination of the ACI TS Surveillance Requirement will not result in the RHR system being operated in any unanalyzed modes, either during normal or accident conditions. Also, the AHA system will continue to be maintained and surveilled as it is currently.
No new accident scenarios, failure mechanisms, or limiting single failures are introduced as a result of the proposed changes. The proposed change does not
Therefore, it is concluded that the proposed changes do not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
Removal of the ACI interlock, and its corresponding TS Surveillance Requirement, does not alter or prevent any plant response such that the margin of safety to any applicable acceptance criteria is significantly decreased. In fact, the addition of a control room alarm that identifies that the suction valve is not fully open, together with the existing overpressure alarm, ensures that the margin of safety to an AHA overpressure condition is not significantly reduced.
Furthermore, the actuation of safety-related components and the response of plant systems to accident scenarios are not affected, and thus will remain as assumed in the safety analysis.
Therefore, the proposed change will not adversely affect the operation or safety function of equipment assumed in the safety analysis.
For the reasons noted above, it is concluded that the proposed change does not involves a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The VEGP [Units] 3 and 4 emergency planning inspections, tests, analyses, and acceptance criteria (ITAAC) provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The proposed change to remove the copy of UFSAR Table 7.5-1 from Appendix C of the VEGP [Units 3 and 4] COLs does not affect the design of a system, structure, or component (SSC) used to meet the design bases of the nuclear plant. Nor do the changes affect the construction or operation of the nuclear plant itself, so there is no change to the probability or consequences of an accident previously evaluated. Removing the copy of UFSAR Table 7.5-1 from Appendix C of the COLs does not affect prevention and mitigation of abnormal events,
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The VEGP [Units] 3 and 4 emergency planning ITAAC provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The changes do not affect the design of an SSC used to meet the design bases of the nuclear plant, nor do the changes affect the construction or operation of the nuclear plant. Consequently, there is no new or different kind of accident from any accident previously evaluated. The changes do not affect safety-related equipment, nor do they affect equipment which, if it failed, could initiate an accident or a failure of a fission product barrier. In addition, the changes do not result in a new failure mode, malfunction or sequence of events that could affect safety or safety-related equipment.
No analysis is adversely affected. No system or design function or equipment qualification is adversely affected by the changes. This activity will not allow for a new fission product release path, result in a new fission product barrier failure mode, nor create a new sequence of events that would result in significant fuel cladding failures.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Response: No.
The VEGP [Units] 3 and 4 emergency planning ITAAC provide assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations. The changes do not affect the assessments or the plant itself. The changes do not adversely interface with safety-related equipment or fission product barriers. No safety analysis, design basis limit or acceptance criterion are challenged or exceeded by the proposed change.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed changes have no effect on normal plant operation or on any accident initiator or precursors, and do not impact the function of plant structures, systems, or components (SSCs). The proposed changes do not alter or prevent the ability of the emergency response organization to perform its intended functions to mitigate the consequences of an accident or event. The ability of the emergency response organization to respond adequately to radiological emergencies has been demonstrated as acceptable through a staffing analysis as required by 10 CFR 50 Appendix E.IV.A.9.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes will not change the design function or operation of SSCs. The changes do not impact the accident analysis. The changes do not involve a physical alteration of the plant, a change in the method of plant operation, or new operator actions. The proposed changes do not introduce failure modes that could result in a new accident, and the changes do not alter assumptions made in the safety analysis. As demonstrated by the SNC staffing analysis performed in accordance with 10 CFR 50 Appendix E.IV.A.9, the proposed changes do not alter or prevent the ability of the emergency response organization to perform its intended functions to mitigate the consequences of an accident or event.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed changes involve a significant reduction in a margin of safety?
Response: No.
Margin of safety is associated with confidence in the ability of the fission product barriers (
Therefore, the proposed changes do not involve a significant reduction in the 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 following notices were previously published as separate individual notices. The notice content was the same as above. They were published as individual notices either because time did not allow the Commission to wait for this biweekly notice or because the action involved exigent circumstances. They are repeated here because the biweekly notice lists all amendments issued or proposed to be issued involving no significant hazards consideration.
For details, see the individual notice in the
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commissions related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 29, 2015.
The Commission's related evaluation of the amendment is contained in an SE dated August 14, 2015.
The Commission's related evaluation of this amendment is contained in a Safety Evaluation dated October 7, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 1, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 5, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 28, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 6, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 30, 2015.
The Commission's related evaluation of the amendment is contained in the Safety Evaluation dated September 1, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 1, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated August 31, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 5, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 30, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 29, 2015.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated September 30, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated September 29, 2015.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 7, 2015.
No significant hazards consideration comments received: No.
For the Nuclear Regulatory Commission.
October 26, November 2, 9, 16, 23, 30, 2015.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of October 26, 2015.
There are no meetings scheduled for the week of November 2, 2015.
There are no meetings scheduled for the week of November 9, 2015.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of November 23, 2015.
This meeting will be webcast live at the Web address—
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
Appointments.
The U.S. Nuclear Regulatory Commission (NRC) has announced appointments to the NRC Performance Review Board (PRB) responsible for making recommendations on performance appraisal ratings and performance awards for NRC Senior Executives and Senior Level System employees and appointments to the NRC PRB Panel responsible for making recommendations to the appointing and awarding authorities for NRC PRB members.
October 27, 2015.
Please refer to Docket ID NRC-2015-0245 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:
•
•
•
Miriam L. Cohen, Secretary, Executive Resources Board, U.S. Nuclear Regulatory Commission, Washington, DC 20555; telephone: 301-287-0747, email:
The following individuals appointed as members of the NRC PRB are responsible for making recommendations to the appointing and awarding authorities on performance appraisal ratings and performance awards for Senior Executives and Senior Level System employees:
The following individuals will serve as members of the NRC PRB Panel that was established to review appraisals and make recommendations to the appointing and awarding authorities for NRC PRB members:
All appointments are made pursuant to Section 4314 of Chapter 43 of Title 5 of the United States Code.
For the U.S. Nuclear Regulatory Commission.
On September 3, 2015, EDGX Exchange, Inc. (the “Exchange” or “EDGX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 1, 2015, BATS Y-Exchange, Inc. (the “Exchange” or “BYX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend Rule 11.24, which governs the Exchange's Retail Price Improvement Program (“Retail Program”), to distinguish between retail orders routed on behalf of other broker-dealers and retail orders that are routed on behalf of introduced retail accounts that are carried on a fully disclosed basis, as further described below.
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange 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 Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 11.24, which governs the Exchange's Retail Program,
The Exchange established the Retail Program in an attempt to attract retail order flow to the Exchange by potentially providing price improvement to such order flow. Under the Retail Program, Retail Member Organizations
Exchange Rule 11.24(b)(1) currently states that “[t]o qualify as a Retail Member Organization, a Member must conduct a retail business or
As background with respect to the proposed change, the Exchange first would like to describe the terms “introducing broker”, “carrying firm” or “carrying broker-dealer”, and “fully disclosed,” as such terms are commonly used in the securities industry. An “introducing” broker-dealer is “one that has a contractual arrangement with another firm, known as the carrying or clearing firm, under which the carrying firm agrees to perform certain services for the introducing firm. Usually, the introducing firm submits its customer accounts and customer orders to the carrying firm, which executes the orders and carries the account. The carrying firm's duties include the proper disposition of the customer funds and securities after the trade date, the custody of customer securities and funds, and the recordkeeping associated with carrying customer accounts.”
Further, a “fully disclosed” introducing arrangement is “distinguished from an omnibus clearing arrangement where the clearing firm maintains one account for all the customer transactions of the introducing firm. In an omnibus relationship, the clearing firm does not know the identity of the customers of the introducing firm. In a fully disclosed clearing arrangement, the clearing firm knows the names, addresses, securities positions and other relevant data as to each customer.”
With respect to a broker-dealer that is routing on behalf of another broker-dealer, the Exchange does not believe that the routing broker-dealer has sufficient information to assess whether orders are truly retail in nature, and thus, requires an RMO routing on behalf of other broker-dealers to maintain additional supervisory procedures and obtain annual attestations, as described below, in order to submit Retail Orders to the Exchange. In contrast, however, if a broker-dealer is carrying a customer account on a fully disclosed basis, then such carrying broker-dealer is required to perform certain diligence regarding such account that the Exchange believes is sufficient to assess whether a customer is a retail customer in order to submit orders on behalf of such a customer to the Exchange as a Retail Order. The carrying broker of an account typically handles orders from its retail customers that are “introduced” by an introducing broker. However, as noted above, in contrast to a typical routing relationship on behalf of another broker-dealer, a carrying broker does obtain a significant level of information regarding each customer introduced by the introducing broker. Accordingly, the Exchange proposes to state in Rule 11.24(b)(1) that for purposes of Rule 11.24, “conducting a retail business shall include carrying retail customer accounts on a fully disclosed basis.”
Rule 11.24(b)(6) currently states, in part, that “[i]f a Retail Member Organization represents Retail Orders from another broker-dealer customer, the Retail Member Organization's supervisory procedures must be reasonably designed to assure that the orders it receives from such broker-dealer customer that it designates as Retail Orders meet the definition of a Retail Order.” This includes obtaining attestations from the other broker-dealers for whom the RMO routes. In addition to the proposed changes to Rule 11.24(b)(1) described above, the Exchange proposes to modify the language of Rule 11.24(b)(6) to again distinguish between an RMO that conducts a retail business because it carries accounts on a fully disclosed basis from an RMO that routes orders on behalf of another broker-dealer. As proposed, the additional attestation requirements of Rule 11.24(b)(6) would apply to an RMO that does not itself conduct a retail business but routes Retail Orders on behalf of other broker-dealers. In turn, such attestation requirements would not apply to an RMO that carries retail customer accounts on a fully disclosed basis. In connection with this change, the Exchange is proposing various edits to the existing rule text so that the reference is consistently to “other broker-dealers” rather than “broker-dealer customers.”
The Exchange believes that allowing an RMO that carries retail customer accounts on a fully disclosed basis to submit Retail Orders to the Exchange without obtaining attestations from broker-dealers that might introduce such accounts will encourage participation in the Retail Program. As noted above, the Exchange believes that the carrying broker has sufficient information to itself confirm that orders are Retail Orders without such attestations. The Exchange still believes it is necessary to require the attestation by broker-dealers that route Retail Orders on behalf of other broker-dealers, because, in contrast, such broker-dealers typically do not have a relationship with the retail customer and would not be in position to confirm that such customers are in fact retail customers.
The Exchange believes the rule change proposed in this submission is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices because it highlights the parties for whom additional procedures are required because they do not maintain relationships with the end customer (
The Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system because it will allow RMOs that carry retail customer accounts to participate in the Program without imposing additional attestation requirements that the Exchange did not initially intend to impose upon them. By removing impediments to participation in the Program, the proposed change would permit expanded access of retail customers to the Program.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the NYSE Amex Options Fee Schedule. The Exchange proposes to implement the fee change effective October 15, 2015. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below,
The purpose of this filing is to change the Section I.C.—NYSE Amex Options Market Maker Sliding Scale—Electronic (“Market Maker Sliding Scale”) to reduce the per contract rate for each tier by $0.03 if volume from posted liquidity exceeds a threshold, effective on October 15, 2015.
Section I.C. of the Fee Schedule currently provides a discount to NYSE Amex Options Market Maker transaction fees based on a sliding volume scale.
The Exchange is proposing to offer Market Makers the ability to reduce the per contract rate charged per Tier of the Market Maker Sliding Scale—Electronic by $0.03. Specifically, a Market Maker would receive the additional $0.03 discount if its monthly volume includes contracts traded as a result of posted trading interest that is in excess of 0.85% of Industry Customer Equity and ETF Option Volume.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposal to offer an additional rebate to Market Makers eligible for the Sliding Scale is reasonable, equitable and not unfairly discriminatory because it would incentivize Market Makers to increase posted liquidity on the Exchange, which would benefit all Exchange participants, including ATP Holders, through increased opportunities to trade as well as enhancing price discovery. In addition, the proposed changes are equitable and not unfairly discriminatory because the credits offered would be based on the amount of business transacted on the Exchange.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend Rule 11.25, which governs the Exchange's Retail Order Attribution Program (“Retail Program”), to distinguish between retail orders routed on behalf of other broker-dealers and retail orders that are routed on behalf of introduced retail accounts that are carried on a fully disclosed basis, as further described below.
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange 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 Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 11.25, which governs the Exchange's Retail Program,
The Exchange established the Retail Program in an attempt to attract retail order flow to the Exchange, primarily by offering pricing incentives. Under the Retail Program, Retail Member Organizations
Exchange Rule 11.25(b)(1) currently states that “[t]o qualify as a Retail Member Organization, a Member must conduct a retail business or
As background with respect to the proposed change, the Exchange first would like to describe the terms “introducing broker”, “carrying firm” or “carrying broker-dealer”, and “fully disclosed,” as such terms are commonly used in the securities industry. An “introducing” broker-dealer is “one that
Further, a “fully disclosed” introducing arrangement is “distinguished from an omnibus clearing arrangement where the clearing firm maintains one account for all the customer transactions of the introducing firm. In an omnibus relationship, the clearing firm does not know the identity of the customers of the introducing firm. In a fully disclosed clearing arrangement, the clearing firm knows the names, addresses, securities positions and other relevant data as to each customer.”
With respect to a broker-dealer that is routing on behalf of another broker-dealer, the Exchange does not believe that the routing broker-dealer has sufficient information to assess whether orders are truly retail in nature, and thus, requires an RMO routing on behalf of other broker-dealers to maintain additional supervisory procedures and obtain annual attestations, as described below, in order to submit Retail Orders to the Exchange. In contrast, however, if a broker-dealer is carrying a customer account on a fully disclosed basis, then such carrying broker-dealer is required to perform certain diligence regarding such account that the Exchange believes is sufficient to assess whether a customer is a retail customer in order to submit orders on behalf of such a customer to the Exchange as a Retail Order. The carrying broker of an account typically handles orders from its retail customers that are “introduced” by an introducing broker. However, as noted above, in contrast to a typical routing relationship on behalf of another broker-dealer, a carrying broker does obtain a significant level of information regarding each customer introduced by the introducing broker. Accordingly, the Exchange proposes to state in Rule 11.25(b)(1) that for purposes of Rule 11.25, “conducting a retail business shall include carrying retail customer accounts on a fully disclosed basis.”
Rule 11.25(b)(6) currently states, in part, that “[i]f a Retail Member Organization represents Retail Orders from another broker-dealer customer, the Retail Member Organization's supervisory procedures must be reasonably designed to assure that the orders it receives from such broker-dealer customer that it designates as Retail Orders meet the definition of a Retail Order.” This includes obtaining attestations from the other broker-dealers for whom the RMO routes. In addition to the proposed changes to Rule 11.25(b)(1) described above, the Exchange proposes to modify the language of Rule 11.25(b)(6) to again distinguish between an RMO that conducts a retail business because it carries accounts on a fully disclosed basis from an RMO that routes orders on behalf of another broker-dealer. As proposed, the additional attestation requirements of Rule 11.25(b)(6) would apply to an RMO that does not itself conduct a retail business but routes Retail Orders on behalf of other broker-dealers. In turn, such attestation requirements would not apply to an RMO that carries retail customer accounts on a fully disclosed basis. In connection with this change, the Exchange is proposing various edits to the existing rule text so that the reference is consistently to “other broker-dealers” rather than “broker-dealer customers.”
The Exchange believes that allowing an RMO that carries retail customer accounts on a fully disclosed basis to submit Retail Orders to the Exchange without obtaining attestations from broker-dealers that might introduce such accounts will encourage participation in the Retail Program. As noted above, the Exchange believes that the carrying broker has sufficient information to itself confirm that orders are Retail Orders without such attestations. The Exchange still believes it is necessary to require the attestation by broker-dealers that route Retail Orders on behalf of other broker-dealers, because, in contrast, such broker-dealers typically do not have a relationship with the retail customer and would not be in position to confirm that such customers are in fact retail customers.
The Exchange believes the rule change proposed in this submission is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices because it highlights the parties for whom additional procedures are required because they do not maintain relationships with the end customer (
The Exchange believes that the proposed rule change will remove impediments to and perfect the mechanism of a free and open market and a national market system because it will allow RMOs that carry retail customer accounts to participate in the Program without imposing additional attestation requirements that the Exchange did not initially intend to impose upon them. By removing impediments to participation in the Program, the proposed change would permit expanded access of retail customers to the Program.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the amendment, by increasing the level of participation in the Program, will increase the level of competition around retail executions. The Exchange believes that the transparency and competitiveness of operating a program such as the Program on an exchange market would result in better prices for retail investors and benefits retail investors by expanding the capabilities of Exchanges to encompass practices currently allowed on non-exchange venues.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
ISE Gemini proposes to amend the Schedule of Fees to adjust the maker rebates provided to Non-ISE Gemini Market Maker, Firm Proprietary/Broker-Dealer, and Professional Customer orders by adopting a new Performance Routing Program as described in more detail below. The text of the proposed rule change is available on the Exchange's Internet Web site at
In its filing with the Commission, the Exchange 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 self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
Currently, the Exchange provides maker rebates to Firm Proprietary
The proposed rebates under the PRP will be based on each member's maker ADV in Non-ISE Gemini Market Maker,
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes that it is reasonable and equitable to eliminate the current standalone tiers for Firm Proprietary/Broker-Dealer and Professional Customer orders as this rebate program being replaced with a new rebate program that is designed to be more attractive to members. The PRP is similar to a program offered on the BATS Options Exchange (“BATS”),
The Exchange further believes that the proposed fee change is not unfairly discriminatory as it provides equal rebates to Non-ISE Gemini Market Maker, Firm Proprietary/Broker-Dealer, and Professional Customer orders. The Exchange notes that, with the proposed fee change, Non-ISE Gemini Market Makers will now be entitled to tiered rebates similar to other market participants. Priority Customer
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 1, 2015, BATS Exchange, Inc. (the “Exchange” or “BATS”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the NYSE Amex Options Fee Schedule (“Fee Schedule”) related to the Amex Customer Engagement (“ACE”) Program. The Exchange proposes to implement the fee change effective October 15, 2015. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The purpose of this filing is to increase the credits available to participants that achieve Tier 2 of the ACE Program as described below.
Section I.E. of the Fee Schedule describes the ACE Program,
1. By calculating, on a monthly basis, the average daily Customer contract volume an OFP executes Electronically on the Exchange as a percentage of total average daily industry Customer equity and ETF options volume;
2. By calculating, on a monthly basis, the average daily contract volume an OFP executes Electronically in all participant types (
Upon reaching a higher tier, an OFP would receive for all eligible Customer
The Exchange proposes to modify the ACE Program by increasing the credits available for Tier 2 as illustrated in the table below, with proposed additions appearing italicized and proposed deletions appearing in brackets:
The proposed amendments to the ACE Program are designed to enhance the rebates, which the Exchange believes would attract more volume and liquidity to the Exchange to the benefit of Exchange participants through increased opportunities to trade as well as enhancing price discovery.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed changes to the ACE Program are reasonable, equitable and not unfairly discriminatory because the credits offered are based on the amount of business transacted on the Exchange. In addition, the Exchange believes that the proposed amendments to the ACE Program are reasonable, equitable and not unfairly discriminatory because they would enhance the incentives to OFPs to transact Customer orders on the Exchange, which would benefit all market participants by providing more trading opportunities and tighter spreads, even to those market participants that do not participate in the ACE Program. Additionally, the Exchange believes the proposed changes to the ACE Program are consistent with the Act because they may attract greater volume and liquidity to the Exchange, which would benefit all market participants by providing tighter quoting and better prices, all of which perfects the mechanism for a free and open market and national market system.
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
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 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, October 29, 2015 at 12:00 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Stein, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Adjudicatory matters;
Opinion;
Post argument discussion; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
On September 3, 2015, EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange filed a proposal to amend Rule 11.11, Routing to Away Trading Centers, to: (i) Enable Users
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange 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 Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend Rule 11.11, Routing to Away Trading Centers, to: (i) Enable Users
The proposed optionality would operate like the current ROOC routing option, but for routing to the primary listing market's opening or closing process. Lastly, like the ROOC routing option, any remaining shares will either be posted to the EDGX Book, executed, or routed to destinations on the System routing table.
In addition, the Exchange proposes to amend the ROOC routing option to remove a provision regarding not routing orders in BATS listed securities designated for participation in the re-opening process on BATS following a halt, suspension, or pause. Previously, due to system limitations, the Exchange was unable to route orders in BATS listed securities to participate in the re-opening process on BATS following a halt, suspension or pause. In such case, the orders remained on the EDGX Book
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange also believes its proposal to remove a provision from the description of the ROOC routing option regarding not routing orders in BATS listed securities designated for participation in the re-opening process on BATS following a halt, suspension, or pause is consistent with Section 6(b)(5) of the Act
The Exchange does not believe that the proposal will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that its proposal would increase competition because it offers Users an alternative means to route orders to the primary listing market to participate in the re-opening following a halt, suspension, or pause as if they entered orders on that market directly. In addition, the proposed rule change amendment to the ROOC routing option is not designed to address any competitive issues but rather avoid investor confusion by updating the rule text to reflect current system functionality.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange stated that waiver of the operative delay will allow the ROOC routing option to be used to route orders in BATS listed securities to BATS to participate in the re-opening process on BATS. The Exchange also stated that the proposal would enable orders in BATS listed securities to be treated like orders in NYSE and Nasdaq listed securities when using the ROOC routing option. Moreover, the Exchange stated that the proposed new routing functionality would operate like its current ROOC routing option and would provide Users with additional flexibility to have their orders routed only to the primary market's re-opening process. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Therefore, the Commission hereby waives the operative delay and designates the proposed rule change operative upon filing.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to adopt Rule 6184 (Transactions in Exchange-Traded Managed Fund Shares (“NextShares”)) relating to the reporting of over-the-counter (“OTC”) transactions in exchange-traded managed fund shares, which have been approved by the SEC for listing and trading on the Nasdaq Stock Market LLC (“Nasdaq”). Exchange-traded managed fund shares are referred to under Nasdaq rules and herein as “NextShares.”
The text of the proposed rule change is available on FINRA's Web site at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In November 2014, the SEC approved a proposed rule change filed by Nasdaq to adopt Nasdaq Rule 5745 governing the listing and trading of NextShares.
In its filing with the SEC, Nasdaq explained that, because existing order transmission and processing systems commonly used by exchanges and firms are generally not designed to accommodate pricing arrangements such as NAV-Based Trading, the prices of NextShares trades and quotes will be represented intraday using a “proxy price” format. In proxy price format, a NextShares Fund's next-determined NAV will be represented as 100.00. A premium or discount of a stated amount to the next-determined NAV will be represented by the same increment or decrement from 100,
Under Nasdaq Rule 5745, the Intraday Indicative Value (“IIV”) of a NextShares Fund is the estimated intraday value of a fund share based on current information regarding the value of the securities and other assets held by the fund. Nasdaq's rule requires that IIVs for each NextShares Fund be widely disseminated by one or more major market data vendors at intervals of not more than 15 minutes throughout Nasdaq's Regular Market Session.
On July 21, 2015, the SEC approved Nasdaq's filing proposing to list and trade the shares of 18 NextShares Funds, each of which is registered as an open-end investment company.
Because NextShares are NMS stocks, FINRA, as the self-regulatory organization (“SRO”) with responsibility for the OTC market, must support OTC trading in NextShares, and FINRA members that trade NextShares OTC will be required to report such transactions to FINRA. Thus, existing trade reporting requirements applicable to OTC transactions in NMS stocks will apply to OTC transactions in NextShares, including, for example, the requirement to report the trade as soon as practicable, but no later than 10 seconds, following execution.
Pursuant to paragraph (a) of proposed Rule 6184, members that execute secondary market transactions in NextShares OTC must report such transactions for public dissemination or regulatory purposes to the FINRA/Nasdaq Trade Reporting Facility (“FINRA/Nasdaq TRF”) or the Alternative Display Facility (“ADF”) in accordance with the proposed Rule and the rules applicable to the trade reporting facility used by the reporting member.
Given the unique nature of NAV-Based Trading, FINRA is proposing the following specific requirements for reporting OTC transactions in NextShares to FINRA under proposed Rule 6184. First, as noted above, Nasdaq Rule 5745 limits trading in NextShares to Nasdaq's Regular Market Session. Accordingly, pursuant to paragraph (b) of proposed Rule 6184, trades in NextShares reported with an execution time outside of Regular Market Session hours will be rejected by the FINRA trade reporting facility.
Second, pursuant to paragraph (c) of the proposed Rule, except as otherwise expressly provided, members must use the above-described proxy price format on all reports of transactions in NextShares submitted to FINRA, including all tape and non-tape reports, intraday clearing reports, as/of reports and reports of reversals.
Third, pursuant to paragraph (d)(2)(A) of the proposed Rule, members that report transactions in NextShares for submission by the FINRA/Nasdaq TRF to NSCC for clearance and settlement must submit two clearing reports: (1) The member must submit a clearing report intraday in the proxy price format in accordance with paragraph (c);
First, the Clearing Copy report must be submitted before the close of the FINRA/Nasdaq TRF on the same day as submission of the transaction in the proxy price format to ensure that the transaction is included in NSCC's end of day processing. Second, consistent with current FINRA rules,
Finally, pursuant to paragraph (d)(2)(C) of the proposed Rule, clearing reports for the purpose of transferring a position related to a previously executed trade, such as step-outs,
The proposed Supplementary Material provides additional guidance for members on reporting in the proxy price format, as well as the process for the submission of OTC transactions in NextShares to NSCC intraday before the final trade price is known. Specifically, in accordance with NSCC requirements, the FINRA/Nasdaq TRF will calculate
The proposed Supplementary Material also clarifies that members that clear directly at NSCC (and do not elect to have the FINRA/Nasdaq TRF submit trades on their behalf for clearance and settlement) must provide final pricing information for their executed trades to NSCC after the NAV is published, in accordance with NSCC requirements. FINRA will not do so on behalf of the member.
FINRA notes that the staff discussed the proposed trade reporting requirements with two of its industry advisory committees, which generally indicated that the proposed approach to OTC trade reporting was reasonable. Committee members also acknowledged that firms would be required to make some systems changes for both trading and trade reporting purposes due to the unique nature of the NAV-Based Trading protocol. While some committee members indicated that they may not accept customer orders in NextShares due to the complexity of the product, other members felt that if there was customer demand, they would have to support trading in NextShares. However, FINRA notes that firms would not necessarily have to execute trades OTC, but could route to an exchange or another FINRA member for execution, and in that instance, would not be responsible for reporting the trade to FINRA.
As noted in Item 2 of this filing, FINRA has filed the proposed rule change for immediate effectiveness and proposes that the operative date will be the date announced by Nasdaq for commencement of listing and trading of NextShares on the Nasdaq exchange under Nasdaq rules, which is currently anticipated to be on or about February 1, 2016. FINRA believes that the FINRA/Nasdaq TRF and members alike will have sufficient time to make and test the necessary systems changes to ensure systems readiness by the operative date.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The proposed rule change proposes specific trade reporting requirements for OTC transactions in NextShares, which are NMS stocks that have been approved and determined by the Commission to be consistent with the requirements of the Exchange Act.
Nonetheless, members that choose to execute OTC transactions in NextShares will need to make systems changes to comply with the proposed amendments, including coding changes to accommodate the submission of Clearing Copy reports for firms that elect to clear through the FINRA/Nasdaq TRF. In addition, firms will need to adopt policies and procedures relating to the trading and reporting of such transactions. Firms will incur costs to implement and test these changes. While these costs may vary by firm (depending, for example, on the level of sophistication of a firm's technology and trading and reporting platforms), as noted above, firms will not be required to trade in NextShares. Therefore, each firm can determine for itself whether the costs of implementing the changes necessary to support OTC trading in NextShares are warranted. Additionally, as noted above, two of FINRA's industry advisory committees indicated that they believe the proposed trade reporting requirements are reasonable. As such, FINRA does not believe that the proposed rule change would impose significant or differential costs on similarly situated firms.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
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 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Fees Schedule. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend its Fees Schedule
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, the Exchange believes it is reasonable to provide a waiver of FBW2 fees for each FBW login a TPH has through December 2015 because it encourages users to use and become familiar with the updated FBW2 login IDs while waiting for certain features to be implemented on FBW2. Additionally, the Exchange notes the proposed rule change provides users additional time to become familiar with and fully acclimated to the new FBW functionality. The Exchange believes the proposed changes are equitable and not unfairly discriminatory because it applies to all users of FBW2.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, because it applies to all users of FBW2 and because the Exchange wants to encourage the use of FBW2 login IDs while users wait for new features to be added. The Exchange believes this proposal will not cause an unnecessary burden on intermarket competition because the proposal only affects trading on CBOE. To the extent that the proposed changes make CBOE a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become CBOE market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing 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 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549-1090, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing will also be available for inspection and copying at the principal offices of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CBOE-2015-090 and should be submitted on or before November 17, 2015.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice of new Privacy Act system of records.
The Small Business Administration (SBA) proposes to add a new system of records titled, Veteran Programs Training and Counseling Records, to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. Publication of this notice complies with the Privacy Act and the Office of Management and Budget (OMB) Circular A-130 requirement for agencies to publish a notice in the
This action will be effective without further notice on December 11, 2015 unless comments are received that would result in a contrary determination.
Submit written comments to Linda Di Giandomenico, Acting Chief, Freedom of Information/Privacy Acts Office, U.S. Small Business Administration, 409 3rd Street SW., 8th Floor, Washington, DC 20416.
Linda Di Giandomenico, Acting Chief, Freedom of Information/Privacy Acts Office, (202) 401-8203.
A system of records is a group of any records under the control of a Federal agency from which information is retrieved by the name of an individual or by a number, symbol or other identifier assigned to the individual. The Privacy Act, 5 U.S.C. 552a, requires each Federal agency to publish in the
The SBA's Office of Veterans Business Development (OVBD) provides counseling and training services to veterans, transitioning service members and their dependents. These services include the Boots to Business program, an entrepreneurial education initiative offered as a two part program and the Veterans Business Outreach Center program designed to provide entrepreneurial development services nationwide. VBOCs and other resource partners, established through cooperative agreements, implement SBA's veterans programs and initiatives as authorized by section 32 of the Small Business Act (15 U.S.C. 657b). In order to measure program performance, implement standardized outreach efforts and register participants for training/counseling, information is collected through various methods. These methods include registration forms, participant/client surveys, interviews, resource partner surveys, and data obtained through data sharing agreements with other Federal agencies. Collected information is used to analyze the population of veterans who are seeking entrepreneurial training, identify trends among participants, facilitate communication between the Office of Veterans Business Development and training/counseling participants and to evaluate the performance of the OVBD programs.
Veteran Programs Training and Counseling Records
SBA headquarters (HQ) and all SBA field offices
Eligible service members, veterans and dependents who participate in the veteran training and counseling services provided by the Small Business Administration including services provided in conjunction with other agencies such as the Department of Defense.
There records in this system include:
1. Course data
2. Personal Data (
3. Military service data
4. Demographics
5. Previous business ownership experience data
6. Transition Assistance Program data
7. Course/counseling/training survey data
1. 15 U.S.C. 657b
2. 44 U.S.C. 3101
3. E.O. 9397
These records are used by program personnel for the following reasons:
a. To determine basic program eligibility and to register individuals for veteran counseling and training programs.
b. For program evaluation functions to determine the effectiveness of the program and to improve program operations.
c. To facilitate interaction and communication regarding the effectiveness of the SBA veteran and training programs between the Office of Veterans Business Development and veteran training and counseling participants.
d. To schedule and track participation in veteran counseling and training programs.
e. To maintain contact information of individuals who complete veteran training and counseling programs for continued follow-up services.
f. To disseminate program information to resource partner instructors.
g. To reduce duplication of collections of information through approved data sharing agreements with other agencies.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed to authorized entities, as is determined to be relevant and necessary, outside SBA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. For Congressional Inquiry—To provide information to a Congressional office from the record of an individual in response to an inquiry from that Congressional office made at the request of that individual.
2. For National Archives and Records Administration—To provide information to the National Archives and Records Administration for use in records management inspections.
3. For Non-Federal Personnel—To provide information to SBA volunteers, contractors, interns, grantees, experts and others who have been engaged by SBA to perform or assist in the performance of a service related to this system of records and who need access to the records in order to perform such service. Recipients of these records shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
4. To the Department of Justice (DOJ) when any of the following is a party to litigation or has an interest in such litigation, and the use of such records by DOJ is deemed by SBA to be relevant and necessary to the litigation, provided, however, that in each case,
5. In a proceeding before a court, or adjudicative body, or a dispute resolution body before which SBA is authorized to appear or before which any of the following is a party to litigation or has an interest in litigation, provided, however, that SBA determines that the use of such records is relevant and necessary to the litigation, and that, in each case, SBA determines that disclosure of the records to a court or other adjudicative body is a use of the information contained in the records that is a compatible purpose for which the records were collected: SBA, or any SBA component; any SBA employee in their official capacity; any SBA employee in their individual capacity where DOJ has agreed to represent the employee; or the United States Government, where SBA determines that litigation is likely to affect SBA or any of its components.
6. To appropriate agencies, entities, and persons when: SBA suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; SBA has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identify theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Agency or entity) that rely upon the compromised information; and the disclosure made to such agencies, entities and persons as reasonably necessary to assist in connection with SBA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper and electronic files.
Data initially stored outside the SBA network due to contract requirements will be stored on secure servers and transferred to SBA upon completion of the contract. Transfers will be conducted in accordance with established security agreements.
Data sharing files are retrieved by:
1. Service, race, level of education, gender; or
2. Pay grade, civilian address city, civilian address state code, civilian address zip code, Guard/Reserve status.
SBA files are retrieved by:
1. Name
2. Gender
3. Race
4. Ethnicity
5. Service
6. Pay grade
Access and use is limited to persons with official need to know; computers are protected by password and user identification codes. Users are evaluated on a recurring basis to ensure need-to-know still exists.
Records are maintained in accordance with SBA SOP 00 41 2, schedules 65:02 through 65:06. Records maintained as part of the General Records Schedules (GRS) are disposed of accordingly.
Associate Administrators for SBA program offices carrying out Veteran Programs Training and Counseling, and Privacy Act Officer, 409 Third Street SW., Washington, DC 20416.
Individuals may make record inquiries in person or in writing to the Systems Manager or SBA Privacy Act Officer.
Systems Manager or Privacy Act Officer will determine procedures.
Notify officials listed above and state reason(s) for contesting any information and provide proposed amendment(s) sought.
Information contained within this system is obtained from:
1. Individuals covered by this system of records (
2. SBA Resource Partners
3. DOD/DMDC
Bureau of International Security and Nonproliferation, Department of State.
Notice; correction.
The Department of State published a
On general issues: Pam Durham, Office of Missile, Biological, and Chemical Nonproliferation, Bureau of International Security and Nonproliferation, Department of State, Telephone (202) 647-4930. For U.S. Government procurement ban issues: Eric Moore, Office of the Procurement Executive, Department of State, Telephone: (703) 875-4079.
Section 3 of the Iran, North Korea, and Syria Nonproliferation Act (Public Law 106-178, as amended by Public Laws 109-112 and 109-353) (the Act), provides that the application of measures to a foreign person pursuant to subsection 3(a) of the Act shall be announced by notice published in the
In the
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to December 28, 2015.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number (if any) in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Andrej Kolaja who may be reached on (202) 632-6412 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
This collection of information is under the provisions of the Mutual Educational and Cultural Exchange Act, as amended, and the Exchange Visitor Program regulations (22 CFR part 62), as applicable. The information collected will be used by the Department to ascertain whether there are any issues that would affect the safety and well-being of exchange program participants.
The survey will be sent electronically via the Survey Monkey tool and responses collected electronically. If a respondent requests a paper version of the survey it will be provided.
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to December 28, 2015.
Direct any comments on this request to Sumitra Siram, Program Officer, Department of State, Bureau of Population, Refugees and Migration, Office of Admissions, 2025 E Street NW., Washington, DC 20522.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Sumitra Siram, Program Officer,
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Form DS-234 is being added to this collection to elicit information used to determine the eligibility of Iraqis and Afghan nationals applying for special immigrant visas.
The SIV Biodata information form (DS-234) is submitted electronically by the applicant to the National Visa Center, which will forward the forms to the Refugee Processing Center of the Bureau of Population, Refugees and Migration.
In accordance with section 4314(c)(4) of 5 United States Code, the Department of State has appointed the following individuals to the Department of State Performance Review Board for Senior Executive Service members:
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to November 27, 2015.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Taylor Mauck, who may be reached on 202-485-7635 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
DS-1884 solicits information from petitioners claiming employment-based immigrant visa preference under section 203(b)(4) of the Immigration and Nationality Act on the basis of qualification as a special immigrant described in INA section 101(a)(27)(D). A petitioner may file the DS-1884 petition within one year of notification by the Department of State that the Secretary has approved a recommendation that such special immigrant status be accorded to the alien. DS-1884 solicits information that will assist the consular officer in ensuring that the petitioner is statutorily qualified to receive such status, including meeting the years of service and exceptional service requirements.
The form can be obtained from posts abroad or through the Department's eForms intranet site. The application available through eForms allows the applicant to complete the application online and then print the application. Most applicants are current federal government employees abroad and have access to the internet system. Once the form is printed, it is submitted to post.
In accordance with the Federal Advisory Committee Act, 5 U.S.C. App., the Department of State announces a meeting of the Foreign Affairs Policy Board to take place on October 28, 2015, at the Department of State, Washington, DC.
The Foreign Affairs Policy Board reviews and assesses: (1) Global threats and opportunities; (2) trends that implicate core national security interests; (3) tools and capacities of the civilian foreign affairs agencies; and (4) priorities and strategic frameworks for U.S. foreign policy. Pursuant to section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. App § 10(d), and 5 U.S.C. 552b(c)(1), it has been determined that this meeting will be closed to the public as the Board will be reviewing and discussing matters properly classified in accordance with Executive Order 13526.
This Notice will publish with less than 15 calendar days' notice. The Department of State finds exceptional circumstances, in that the Secretary of State must address this meeting of the Foreign Affairs Policy Board and his schedule, including his travel schedule, does not permit rescheduling this meeting to a later date.
For more information, contact Gloria Lee at (202) 647-1965.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. The collection involves an extension to a currently-approved ICR, and includes the assessment of FMCSA's strategic decision to integrate its Information Technology (IT) with its business processes using portal technology to consolidate its systems and databases through the FMCSA Information Technology Services Survey modernization initiative. The information to be collected will be used to assess the satisfaction of Federal, State, and industry customers with the FMCSA Information Technology Services Survey Portal. The name of the “COMPASS Portal Customer Satisfaction Assessment,” ICR was previously changed to “Information Technology Services Survey Portal Customer Satisfaction Assessment,” to reflect the need for a broader term than “COMPASS” for the portal.
We must receive your comments on or before December 28, 2015.
You may submit comments identified by Federal Docket Management System (FDMS) Docket Number FMCSA-2015-0332 using any of the following methods:
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Ms. Katherine Cooper, Department of Transportation, Federal Motor Carrier Safety Administration, West Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: 202-366-3843 email:
Title II, section 207 of the E-Government Act of 2002 requires Government agencies to improve the methods by which government information, including information on the Internet, is organized, preserved, and made accessible to the public. To meet this goal, FMCSA plans to provide a survey on the FMCSA Portal, allowing users to assess its functionality. This functionality includes the capability for Federal, State, and industry users to access the Agency's existing safety IT systems with a single set of credentials and have easy access to safety data about the companies that do business with FMCSA. The Information Technology program will also focus on improving the accuracy of data to help ensure information, such as carrier name and address, is valid and reliable.
FMCSA's legacy information systems are currently operational. However, having this many stand-alone systems has led to data quality concerns, a need for excessive IDs and passwords, and significant operational and maintenance costs. Integrating our information technologies with our business processes will, in turn, improve our operations considerably, particularly in terms of data quality, ease of use, and reduction of maintenance costs.
In early 2007, FMCSA's Information Technology program launched a series of releases of a new FMCSA Portal to its Federal, State and industry customers. Over the coming years, more than 15 releases are planned. These releases will use portal technology to fuse and provide numerous services and functions via a single user interface and provide tailored services that seek to meet the needs of specific constituencies within our customer universe.
The FMCSA Information Technology Services Survey Portal will entail considerable expenditure of Federal Government dollars over the years and will fundamentally impact the nature of the relationship between the Agency and its Federal, State, and industry customers. Consequently, the Agency intends to conduct regular and ongoing assessments of customer satisfaction with the Information Technology Services Survey.
The primary purposes of this assessment are to:
• Determine the extent to which the FMCSA Portal functionality continues to meet the needs of Agency customers;
• Identify and prioritize additional modifications; and
• Determine the extent that the FMCSA Portal has impacted FMCSA's relationships with its main customer groups.
The assessment will address:
• Overall customer satisfaction;
• Customer satisfaction against specific items;
• Performance of systems integrator against agreed objectives;
• Desired adjustments and modifications to systems;
• Demonstrated value of investment to FMCSA and DOT;
• Items about the FMCSA Portal that customers like best; and
• Customer ideas for making the FMCSA Portal better.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the renewal Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected burden. The
Comments must be submitted on or before November 27, 2015.
Mr. Robert Brogan, Safety Regulatory Analysis Division, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 25, Washington, DC 20590 (Telephone: (202) 493-6292), or Ms. Kimberly Toone, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop 35, Washington, DC 20590 (Telephone: (202) 493-6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, sec. 2, 109
The Association of American Railroads submitted a comment on October 5 on behalf of its member railroads and itself. In its letter, AAR recommended four changes to the PTC Implementation Status Update Questionnaire. First, AAR recommended that FRA adjust its estimate of the amount of time required to fill out each questionnaire/form (Form FRA F 6180.162).
Second, AAR/its members recommended that FRA “clarify the second survey question,” which relates to the “current number of full mission capable PTC equipped locomotives completely implemented under the regulation.” In particular, “the railroads recommend that FRA specify that this question pertains to the locomotives which have been fully equipped with PTC hardware.”
Third, AAR/its members recommended that “FRA clarify the fourth survey question,” which relates to the “. . . current number of fully mission capable PTC equipped track segments completely implemented under the regulations. The railroads recommend that FRA refer to track miles instead of the unclear reference to ‘track segment.’ ”
Last, AAR stated “the railroads request that FRA ensures that the comment box for the fourteenth question be large enough to accept substantial comments regarding the status of each individual railroad's PTC implementation status.”
Regarding AAR's first recommendation, FRA based its estimate on the average amount of time that it would take all railroads—Class Is, Class IIs, Class IIIs, and passenger railroads—to complete the questionnaire each month on an ongoing basis. FRA realizes that it might take some railroads longer than the estimated average amount of time to complete the questionnaire. However, FRA does not agree with AAR's comment that it will take all affected railroads an average of three hours each month to complete the questionnaire. FRA believes that 30 minutes is a more accurate estimate of the average amount of time that it will take railroads to complete the questionnaire on a recurring monthly basis. Accordingly, FRA is modifying its estimate to reflect this higher number.
Regarding AAR's second recommendation relating to the second survey question, FRA is modifying footnote number 2 of the questionnaire to make clear that this question pertains to locomotives fully equipped with PTC hardware and software.
Regarding AAR's third recommendation, FRA is taking a flexible approach and is modifying footnote number 3 of the questionnaire to state that railroads use a uniform unit of measurement that is consistent for the fourth survey question. Thus, track miles would be fine as a uniform unit of measurement.
Last, regarding AAR's recommendation about enlarging the comment box for the fourteenth question, FRA is expanding the comment box to the maximum number of characters permitted on the electronic version of the questionnaire/form.
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30 day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d);
The summary below describes the nature of the information collection request (ICR) and the expected burden. The revised request is being submitted for clearance by OMB as required by the PRA.
On July 24, 2015, OMB granted Emergency Processing approval for the PTC Implementation Status Update Questionnaire information collection for a period of 180 days. This approval currently expires on January 31, 2016. FRA is now seeking a three-year approval under Regular Clearance Procedures from the Office of Management and Budget (OMB).
A comment to OMB is best assured of having its full effect if OMB receives it
44 U.S.C. 3501-3520.
On October 7, 2015, New York & Atlantic Railway Company (NYA) filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the provisions of 49 U.S.C. 10903 to discontinue freight operations over the following two segments of rail line: (1) An approximately 0.69-mile segment located between milepost 0.0 and milepost 0.69, in Long Island City, N.Y., and traversing through United States Postal Service Zip Code 11101 and (2) an approximately 0.38-mile segment located between milepost 0.82 and milepost 1.2, in Long Island City, N.Y., and traversing through United States Postal Service Zip Code 11101 (collectively, the Subject Segments).
NYA is not the owner of the Subject Segments. Long Island Railroad Company (LIRR), is the owner of the Subject Segments, and has advised NYA that, based on information in LIRR's possession, the Subject Segments do not contain federally granted rights-of-way. Any documentation in NYA's possession will be made available promptly to those requesting it.
The interest of railroad employees will be protected by the conditions set forth in
Because this is a discontinuance proceeding and not an abandonment proceeding, trail use/rail banking and public use conditions are not appropriate.
By issuance of this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by January 25, 2016.
Any offer of financial assistance (OFA) under 49 CFR 1152.27(b)(2) to subsidize continued rail service will be due no later than February 4, 2016, or 10 days after service of a decision granting the petition for exemption, whichever occurs first. Each OFA must be accompanied by a $1,600 filing fee.
All filings in response to this notice must refer to Docket No. AB 1236X and must be sent to: (1) Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001; and (2) Rose-Michele Nardi, Transport Counsel, PC, 1701 Pennsylvania Ave. NW., Suite 300, Washington, DC 20006. Replies to the petition are due on or before November 16, 2015.
Persons seeking further information concerning discontinuance procedures may contact the Board's Office of Public Assistance, Governmental Affairs, and Compliance at (202) 245-0238 or refer to the full abandonment or discontinuance regulations at 49 CFR part 1152. Questions concerning environmental issues may be directed to the Board's Office of Environmental Analysis (OEA) at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Board decisions and notices are available on our Web site at “
Decided: October 22, 2015.
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Wisconsin Central Ltd. (WCL), a wholly owned subsidiary of Canadian National Railway Company has filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—
WCL has certified that: (1) No local traffic has moved over the Line for at least two years; (2) there is no overhead traffic on the Line that would have to be rerouted over other lines; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the Line either is pending with the Surface Transportation Board (Board) or with any U.S. District Court or has been decided in favor of complainant within the two-year period; and (4) the requirements at 49 CFR 1105.7(c) (environmental report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will become effective on November 26, 2015, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to WCL's representative: Audrey L. Brodrick, Fletcher & Sippel LLC, 29 N. Wacker Dr., Suite 920, Chicago, IL 60606.
If the verified notice contains false or misleading information, the exemption is void ab initio.
WCL has filed a combined environmental and historic report that addresses the effects, if any, of the
Environmental, historic preservation, public use, or interim trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), WCL shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by WCL's filing of a notice of consummation by October 27, 2016, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at “
Decided: October 22, 2015.
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Internal Revenue Service (IRS), Treasury.
Notice.
This notice is provided in accordance with IRC section 6039G of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, as amended. This listing contains the name of each individual losing United States citizenship (within the meaning of section 877(a) or 877A) with respect to whom the Secretary received information during the quarter ending September 30, 2015. For purposes of this listing, long-term residents, as defined in section 877(e)(2), are treated as if they were citizens of the United States who lost citizenship.
United States Mint, Department of the Treasury.
Notice of Proposed New Privacy Act of 1974 system of records.
In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the United States Mint proposes to establish a new Privacy Act system of records entitled, “Treasury/United States Mint .014—Denver Public Tour and Outreach Reservation System.”
Comments must be received no later than November 27, 2015. The proposed new system of records will be effective December 7, 2015 unless comments are received that would result in a contrary determination.
Comments should be sent to Kathleen Saunders-Mitchell, Disclosure Officer, United States Mint, 801 9th Street NW., Washington, DC 20220. Comments can be faxed to (202) 756-6153 or emailed to
For general questions and privacy issues, please contact Kathleen Saunders-Mitchell, Disclosure Officer, United States Mint, 801 9th Street NW., Washington, DC 20220. Telephone number: (202) 354-6788. Email:
In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Department of the Treasury and the United States Mint are proposing to establish a new system of records entitled, “Treasury/United States Mint .014—Denver Public Tour and Outreach Reservation System.”
The United States Mint is establishing the United States Mint Denver Public Tour and Outreach Reservation System of Records to allow individual members of the public and federal employees to contact the United States Mint to request guided public tours of the United States Mint at Denver facility for themselves or on behalf of a group (Tour(s)), and to request a visit and presentation by United States Mint staff on the Bureau's history, mission, and coin-making process on behalf of a group in the extended Denver metropolitan area (Outreach Program(s)).
System features are intended to enhance the process of registration and communication between the United States Mint and the individual requesting a Tour or Outreach Program (Requester), and to allow the United States Mint to schedule and manage the arrangements including any necessary cancellations.
All Requesters must provide scheduling and contact information. For Outreach Programs and larger Tours, Requesters must also provide the name of the participant group or school (if any), group size, age range, and grade. Outreach Program Requesters are additionally required to provide site location and information on how they learned of the program, and may request topics to be covered by the presenter. All Requesters may provide information on special requirements (such as a participant needing a reasonable accommodation) for themselves or their groups, and may (but are not required to) name or otherwise identify any individual participants having special requirements.
Authority for this system derives from 31 U.S.C. 5131 and 31 U.S.C. 5136. In accordance with 5 U.S.C. 552a(r), a report of this proposed new system of records has been provided to the Office of Management and Budget and to Congress.
Treasury/United States Mint .014.
United States Mint, Denver facility, 320 West Colfax Avenue, Denver, Colorado 80204.
• Tour Requesters: Individual members of the public or federal employees who contact the United States Mint and request public tours of the United States Mint at Denver facility.
• Outreach Program Requesters: Individual members of the public or federal employees who contact the United States Mint and request Outreach Programs presentations by United States Mint staff on the Bureau's history, mission and coin-making process on behalf of a group meeting applicable size and location criteria in the extended Denver metropolitan area.
• Individual members of the public or federal employees other than Requesters, whose name and other personal information a Requester voluntarily provides to identify a participant in the Tour or Outreach Program the Requester arranges.
• Name of Requester;
• Information about a Requester's special requirements, including information to allow the United States Mint to provide a reasonable accommodation for Requester's disability;
• Names of other Tour or Outreach Program participants volunteered by a Requester;
• Information about participants' special requirements, including information to allow the United States Mint to provide a reasonable accommodation for a participant with a disability;
• Requester's email address, telephone, fax number, and postal address;
• Outreach Program site address, if applicable;
• Participant group name, and school name, if applicable;
• Source of Outreach Requester's awareness of the Outreach Program;
• Outreach Program topics requested.
31 U.S.C. 5131; 31 U.S.C. 5136.
The purpose of this system is to allow the United States Mint the ability to work with Requesters to schedule, confirm, plan and manage arrangements for Tours and Outreach Programs, understand the needs of participants, and allow the Bureau to manage its Denver facility visitor volume, interests, and safety. It also provides the United States Mint with contact information to notify Requesters of schedule changes, and to send an optional customer satisfaction survey invitation containing a link to the survey, allowing the participating public to provide feedback that enables the Bureau to continually improve its Tour and Outreach Program services. Surveys do not solicit personal information and results are not stored in the system.
The United States Mint at Denver offers guided public Tours of its facility to members of the public, including federal employees. For groups (such as schools, clubs, civic groups, and other organizations whose members may be unable to travel to the facility), the United States Mint provides the opportunity to request an Outreach Program visit and presentation, provided these groups meet certain size and location criteria. Both Tours and Outreach Programs require advance reservations. The system will provide an enhanced process by which individuals can request, schedule, and manage Tour and Outreach Program arrangements, and the Bureau can contact Requesters to confirm, reschedule, or cancel Tours or Outreach Programs. The system will also allow Requesters to note any special requirements (including requests for reasonable accommodations for persons with disabilities).
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside Treasury as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. To medical personnel to meet a bona fide medical emergency;
2. To appropriate federal, state, local or foreign agencies responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order or license, when the disclosing agency becomes aware of a potential violation of civil or criminal law or regulation and that misconduct is
3. To a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations, in response to a court-ordered subpoena, or in connection with criminal law proceedings;
4. To a congressional office in response to an inquiry made at the request of the individual to whom the record pertains;
5. To the news media in accordance with guidelines contained in 28 CFR 50.02, which pertains to an agency's functions relating to civil and criminal proceedings;
6. To representatives of the National Archives and Records Administration (NARA) who are conducting records management inspections under authority of 44 U.S.C. 2904 and 2906;
7. To contractors, grantees, experts, consultants, interns, volunteers, and others (including agents of the foregoing) performing or working on a contract, service, grant, cooperative agreement, or other assignment for the federal government, when necessary to accomplish such function;
8. To appropriate agencies, entities, and persons when (a) it is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the United States Mint has determined that, as a result of the suspected or confirmed compromise, there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the United States Mint or another agency or entity) that rely on the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the United States Mint's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm; and
9. To the news media and the public, with the approval of the Treasury Department's Senior Agency Official for Privacy, or her designee, in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information or when disclosure is necessary to preserve confidence in the integrity of Treasury or is necessary to demonstrate the accountability of Treasury's officers, employees, or individuals covered by the system, except to the extent it is determined that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
Paper documents and electronic records.
Records are retrieved by:
• Name of Requester;
• Name of Participant Group (if any);
• Event category (Tour or Outreach Program);
• Requested event dates;
• Final event date;
• Name of participants provided by Requester (if any);
• Request for reasonable accommodation or other special requirement for the event (if any);
• Name of individual participant indicated by Requester as requesting reasonable accommodation for disability, or having other special requirement for event (if any);
• Confirmation Number;
• Size of Tour;
• Requester telephone number, email address, postal address, and fax number (if any);
• Address of Outreach Program site (if any).
Paper records are stored in secured filing cabinets with access only by authorized personnel. Electronic records are stored in secured systems subject to access controls in accordance with Department of the Treasury and United States Mint policies and procedures. Access to electronic records is restricted to authorized personnel, and is subject to multiple controls including an access approval process, unique user identifier, user authentication and account management, and password management.
Data is retained and preserved or destroyed in accordance with National Archives and Records Administration (NARA) schedules for the categories of data in the system and for system security backup data.
Jennifer DeBroekert, Supervisory Public Affairs Specialist, Office of Corporate Communications, United States Mint at Denver, 320 West Colfax Avenue, Denver, Colorado 80204-269.
Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to Kathleen Saunders-Mitchell, Disclosure Officer, United States Mint, 801 9th Street NW., Washington, DC 20220.
Refer to “Notification Procedure” above for address to which requests may be sent for gaining access to records.
Refer to “Notification Procedure” above for address to which requests may be sent for gaining access to records.
Information in the system, including individually-identifying information submitted to the United States Mint, is obtained from Requesters, or from persons responding to United States Mint communications in connection with scheduling made to email addresses or numbers provided by Requesters.
None.
Department of Veterans Affairs.
Notice.
The Department of Veterans Affairs (VA) provides notice that it intends to conduct a recurring computer-matching program matching Internal Revenue Service (IRS) Federal tax information with VA pension and parents' dependency and indemnity compensation records. The purpose of this match is to identify applicants and beneficiaries who have applied for or who are receiving VA benefits and received unearned income, and to adjust or terminate VA benefits, if appropriate.
The match will start no sooner than 30 days after publication of this notice in the
Written comments may be submitted through
David Klusman, Pension Analyst, Pension and Fiduciary Service (21PF), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-8863.
VA plans to match records of applicants and beneficiaries who have applied for or who are receiving needs-based VA benefits, with unearned income information maintained by IRS. VA will use this information to verify income information submitted by applicants and beneficiaries and deny or adjust VA benefit payments as prescribed by law. The matching program will enable VA to ensure accurate reporting of income.
The legal authority to conduct this match is 38 U.S.C. 5106, which requires any Federal department or agency to provide VA information upon request for the purposes of determining eligibility for benefits or verifying other information that affects payment of benefits. In addition, 26 U.S.C. 6103(l)(7) authorizes IRS to disclose Federal tax information to VA.
VA records involved in the match are in “Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records—VA (58VA21/22/28),” a system of records that was first published at 41 FR 9294 (March 3, 1976), amended and republished in its entirety at 77 FR 42593 (July 19, 2012). The IRS records are from the system of records identified as the Information Return Master File (IRMF)/IRS 22.061, as published at 73 FR 13302 (March 12, 2008), amended and republished in its entirety at 77 FR 47946-947 (August 10, 2012), through the Disclosure of Information to Federal, State and Local Agencies (DIFSLA) program.
In accordance with the Privacy Act, 5 U.S.C. 552a(o)(2) and (r), VA is providing copies of the agreement to both Houses of Congress and to OMB. VA is publishing this
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, approved this document on October 8, 2015, for publication.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act 5 U.S.C. App. 2 that the subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board (JBL/CS SMRB) will meet from 8 a.m. to 5 p.m. on the dates indicated below (unless otherwise listed):
The purpose of the subcommittees is to provide advice on the scientific quality, budget, safety and mission relevance of investigator-initiated research proposals submitted for VA merit review evaluation. Proposals submitted for review include diverse medical specialties within the general areas of biomedical, behavioral, and clinical science research.
The subcommittee meetings will be closed to the public for the review, discussion, and evaluation of initial and renewal research proposals. However, the JBL/CS SMRB teleconference meeting will be open to the public; date, time and location will be announced later.
The closed subcommittee meetings involve discussion, examination, and reference to staff and consultant critiques of research proposals. Discussions will deal with scientific merit of each proposal and qualifications of personnel conducting the studies, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Additionally, premature disclosure of research information could significantly frustrate implementation of proposed agency action regarding the research
Those who would like to obtain a copy of the minutes from the closed subcommittee meetings and rosters of the subcommittee members should contact Alex Chiu, Ph.D., Manager, Merit Review Program (10P9B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, at (202) 443-5672 or email at
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2 that a meeting of the Advisory Committee on the Readjustment of Veterans will be held Thursday and Friday, November 5-6, 2015. The meeting on both days will be conducted at the Readjustment Counseling Service (RCS) Headquarters Offices, located at 1717 H Street NW., Washington, DC 20006, in Conference Room 430C. The agenda for these two days will begin at 8:00 a.m. and end at 4:30 p.m. The meeting on both days is open to the public.
The purpose of the Committee is to review the post-war readjustment needs of combat Veterans and to evaluate the availability, effectiveness and coordination of VA programs required to meet Veterans' readjustment service needs.
On November 5, the Committee will conduct a round table discussion with a panel of VSO national leaders. The focus of the discussion will be to explore common areas of interest and potential partnership regarding the full scope of Veterans' post-war readjustment.
The November 5 agenda will also include briefings on the current activities of the Readjustment Counseling Service (RCS) Vet Center program to include the full scope of outreach and readjustment counseling services provided to combat Veterans, Service members and families. The briefing will focus on the coordination of Vet Center services with VHA health care, mental health, and social work services. The Committee will also receive a briefing from VHA Care Management and Social Work Services program officials focusing on the key role of social work services for the psychological, social, and economic readjustment of combat Veterans. Program officials from VHA's Office of Academic Affiliations will meet with the Committee to discuss avenues for increasing the use of the Vet Centers as student rotation sites of value for the educational readjustment of combat Veterans.
On November 6, Committee members will conduct a roundtable discussion with staff members from the Senate and House Committees on Veterans Affairs. The Committee's purpose is to engage the staffers in discussion to explore the full scope of combat Veterans' readjustment and to ensure the Committee's deliberations are synchronized with the priorities of Congress. The Committee will also receive briefings from VHA mental health program officials focusing on the key role of mental health services for the psychological, social, and economic readjustment of combat Veterans.
The agenda for November 6 will conclude with a Committee strategic planning session for developing the observations and conclusions for inclusion in the Committee's 2016 report.
No time will be allocated at this meeting for receiving oral presentations from the public. However, members of the public may direct written questions or submit prepared statements for review by the Committee before the meeting to Mr. Charles M. Flora, M.S.W., Designated Federal Officer, Readjustment Counseling Service, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420. Because the meeting will be in a Government building, please provide valid photo identification for check-in. Please allow 15 minutes before the meeting for the check-in process. If you plan to attend or have questions concerning the meeting, please contact Mr. Flora at (202) 461-6525 or by email at
Department of Veterans Affairs.
Notice of Computer Match Program.
Pursuant to 5 U.S.C. 552a, the Privacy Act of 1974, as amended, and the Office of Management and Budget (OMB) Guidelines on the Conduct of Matching Programs, notice is hereby given that the Department of Veterans Affairs (VA) intends to conduct a computer matching program with the Social Security Administration (SSA). Data from the proposed match will be used to verify the earned income of nonservice-connected veterans, and those veterans who are zero percent service-connected (noncompensable), whose eligibility for VA medical care is based on their inability to defray the cost of medical care. These veterans supply household income information that includes their spouses and dependents at the time of application for VA health care benefits.
Written comments may be submitted by mail or hand-delivery to Director, Regulations Policy and Management (02REG), Department of Veterans Affairs, 810 Vermont Ave. NW., Room 1068, Washington, DC 20420; fax to (202) 273-9026; or email through
Benita K. Miller, MHA, FACHE, Director, Health Eligibility Center, (404) 848-5300 (this is not a toll free number).
The Department of Veterans Affairs has statutory authorization under 38 U.S.C. 5317, 38 U.S.C. 5106, 26 U.S.C. 6103(l)(7)(D)(viii) and 5 U.S.C. 552a to establish matching agreements and request and use income information from other agencies for purposes of verification of income for determining eligibility for benefits. 38 U.S.C. 1710(a)
This matching agreement expires 18 months after its effective date. This match will not continue past the legislative authorized date to obtain this information.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Nabors II, Chief of Staff, approved this document on October 8, 2015, for publication.
National Cemetery Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before November 27, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that a meeting of the Federal Advisory Committee on Prosthetics and Special-Disabilities Programs will be held on November 17-18, 2015, in Room 530 at VA Central Office, 810 Vermont Avenue NW., Washington, DC 20420. The meeting will convene at 8:30 a.m. on both days, and will adjourn at 4:30 p.m. on November 17 and at 12 noon on November 18. This meeting is open to the public.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on VA's prosthetics programs designed to provide state-of-the-art prosthetics and the associated rehabilitation research, development, and evaluation of such technology. The Committee also provides advice to the Secretary on special-disabilities programs, which are defined as any program administered by the Secretary to serve Veterans with spinal cord injuries, blindness or visual impairments, loss of extremities or loss of function, deafness or hearing impairment, and other serious incapacities in terms of daily life functions.
On November 17, the Committee will receive briefings on Advisory Committee Management, Physical Medicine and Rehabilitation, Polytrauma System of Care, Clinical Orthotists and Prosthetists, Spinal Cord Injury and Disorders, Eye Care (Optometry and Ophthalmology), and VA Library Orientation. On November 18, the Committee will receive a briefing on Workforce Planning.
No time will be allocated for receiving oral presentations from the public; however, members of the public may direct questions or submit written statements for review by the Committee in advance of the meeting to Mr. Larry N. Long, Designated Federal Officer, Veterans Health Administration, Patient Care Services, Rehabilitation and Prosthetic Services (10P4RR), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, or by email 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 |