Sample records for agency nuclear regulatory

  1. 44 CFR Appendix A to Part 353 - Memorandum of Understanding Between Federal Emergency Management Agency and Nuclear Regulatory...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Between Federal Emergency Management Agency and Nuclear Regulatory Commission A Appendix A to Part 353... Understanding Between Federal Emergency Management Agency and Nuclear Regulatory Commission The Federal Emergency Management Agency (FEMA) and the Nuclear Regulatory Commission (NRC) have entered into a new...

  2. 77 FR 8902 - Draft Regulatory Guide: Issuance, Availability Decommissioning of Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... Decommissioning of Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide... draft regulatory guide (DG) DG-1271 ``Decommissioning of Nuclear Power Reactors.'' This guide describes... Regulatory Guide 1.184, ``Decommissioning of Nuclear Power Reactors,'' dated July 2000. This proposed...

  3. 78 FR 45573 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-29

    ... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Nuclear Power Plant Fire Protection (CARMEN-FIRE), Draft Report for Comment.'' DATES: Comments on this... CONTACT: Felix Gonzalez, Fire Research Branch, Division of Risk Analysis, Office of Nuclear Regulatory...

  4. 75 FR 1088 - Notice of Availability of a Memorandum of Understanding Between the Nuclear Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-08

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0578] Notice of Availability of a Memorandum of Understanding Between the Nuclear Regulatory Commission and the Bureau of Land Management AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability. FOR FURTHER INFORMATION CONTACT: Mr. Alan Bjornsen, Project Manager, Environmental Review Branch,...

  5. 78 FR 55765 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Draft..., ``Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN-FIRE).'' In... integral part of NRC-approved fire protection programs. However, compensatory measures are not expected to...

  6. 76 FR 31997 - Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0118] Final Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the U.S. Department of Homeland Security on Chemical Facility Anti-Terrorism Standards AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. FOR FURTHER...

  7. Department of Transportation Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Department of Transportation Agency Semiannual Regulatory Agenda ] Part XIII Department of Transportation Semiannual Regulatory Agenda [[Page 79812

  8. The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

    As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  9. 75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

  10. 75 FR 20645 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0158] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make...

  11. 78 FR 13712 - U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Monitoring Activities for F-Area Tank Farm at the Savannah River Site, Revision 0 AGENCY: Nuclear Regulatory... carrying out its responsibilities for monitoring DOE's waste disposal activities at the F-Area Tank Farm at... the availability of ``U.S. Nuclear Regulatory Commission Plan for Monitoring Disposal Actions Taken by...

  12. 77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission... Activities at Nuclear Power Plants,'' published in May 2000. The document is redundant due to the inclusion... Risk Before Maintenance Activities at Nuclear Power Plants,'' published in May 2000. The requirements...

  13. 77 FR 45697 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0149] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending U.S. Nuclear... Budget and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

  14. 77 FR 29697 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0066] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending U.S. Nuclear... Budget and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

  15. 77 FR 6827 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0280] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC action to... public comment. SUMMARY: The Nuclear Regulatory Commission (NRC) invites public comment about our...

  16. 5 CFR 1320.15 - Independent regulatory agency override authority.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Independent regulatory agency override authority. 1320.15 Section 1320.15 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET OMB DIRECTIVES CONTROLLING PAPERWORK BURDENS ON THE PUBLIC § 1320.15 Independent regulatory agency override authority. (a) An...

  17. 76 FR 77855 - Criteria for Identifying Material Licensees for the U. S. Nuclear Regulatory Commission's Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-14

    ... Agencywide Documents Access and Management System (ADAMS) Accession Number: ML112280111) or in the... Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6272... ineffective in correcting their underlying issues. Discussion Criteria for Identifying Nuclear Material...

  18. Regulatory requirements for nuclear power plant site selection in Malaysia-a review.

    PubMed

    Basri, N A; Hashim, S; Ramli, A T; Bradley, D A; Hamzah, K

    2016-12-01

    Malaysia has initiated a range of pre-project activities in preparation for its planned nuclear power programme. Clearly one of the first steps is the selection of sites that are deemed suitable for the construction and operation of a nuclear power plant. Here we outline the Malaysian regulatory requirements for nuclear power plant site selection, emphasizing details of the selection procedures and site characteristics needed, with a clear focus on radiation safety and radiation protection in respect of the site surroundings. The Malaysia Atomic Energy Licensing Board (AELB) site selection guidelines are in accord with those provided in International Atomic Energy Agency (IAEA) and United Stated Nuclear Regulatory Commission (USNRC) documents. To enhance the suitability criteria during selection, as well as to assist in the final decision making process, possible assessments using the site selection characteristics and information are proposed.

  19. 77 FR 5279 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0009] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The Nuclear Regulatory Commission (NRC) invites public comment about...

  20. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  1. 75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  2. 77 FR 70192 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0263] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  3. 76 FR 72982 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0271] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  4. 77 FR 69661 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0230] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  5. 78 FR 70353 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0248] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  6. 77 FR 21813 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0058] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  7. 77 FR 58872 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0198] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  8. 78 FR 66078 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0238] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  9. 78 FR 42112 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0116] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  10. 77 FR 63893 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0228] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) invites...

  11. 78 FR 28244 - Agency Information Collection Activities; Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0085] Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  12. 77 FR 44289 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0150] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  13. 76 FR 72983 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0250] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  14. 77 FR 54617 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-05

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0184] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  15. 76 FR 33788 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-09

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0009] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... (OMB) and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites...

  16. 78 FR 79500 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0279] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  17. 77 FR 44290 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0155] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  18. 77 FR 48555 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0172] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC... solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) invites public comment...

  19. 75 FR 1830 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... review of applications for permits and licenses. RG 5.71, ``Cyber Security Programs for Nuclear... NUCLEAR REGULATORY COMMISSION [NRC-2010-0009] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

  20. 75 FR 12804 - Withdrawal of Regulatory Guide 8.6

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0103] Withdrawal of Regulatory Guide 8.6 AGENCY: Nuclear...[uuml]ller Counters.'' FOR FURTHER INFORMATION CONTACT: Harriet Karagiannis, U.S. Nuclear Regulatory... . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is withdrawing...

  1. 76 FR 41585 - Regulation and Independent Regulatory Agencies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ..., competitiveness, and job creation.'' Independent regulatory agencies, no less than executive agencies, should..., streamline, expand, or repeal them in accordance with what has been learned. Such retrospective analyses...

  2. 78 FR 19540 - Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Bureau of Land...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Regulatory Commission and the Bureau of Land Management AGENCY: Nuclear Regulatory Commission. ACTION: Notice... Review Branch, Division of Waste Management and Environmental Protection, Office of Federal and State... the Bureau of Land Management, United States Department of the Interior (BLM) entered into a...

  3. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content of License Termination Plans for Nuclear Power Reactors.'' FOR FURTHER INFORMATION CONTACT: James C....

  4. 76 FR 189 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-03

    .../reading-rm/doc-collections/ . In addition, regulatory guides are available for inspection at the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3...

  5. 75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Draft Regulatory Guide, DG-8035, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER...

  6. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

  7. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

  8. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

  9. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

  10. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...

  11. 76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

  12. Regulatory experience in applying a radiological environmental protection framework for existing and planned nuclear facilities.

    PubMed

    Mihok, S; Thompson, P

    2012-01-01

    Frameworks and methods for the radiological protection of non-human biota have been evolving rapidly at the International Commission on Radiological Protection and through various European initiatives. The International Atomic Energy Agency has incorporated a requirement for environmental protection in the latest revision of its Basic Safety Standards. In Canada, the Canadian Nuclear Safety Commission has been legally obligated to prevent unreasonable risk to the environment since 2000. Licensees have therefore been meeting generic legal requirements to demonstrate adequate control of releases of radioactive substances for the protection of both people and biota for many years. In the USA, in addition to the generic requirements of the Environmental Protection Agency and the Nuclear Regulatory Commission, Department of Energy facilities have also had to comply with specific dose limits after a standard assessment methodology was finalised in 2002. Canadian regulators developed a similar framework for biota dose assessment through a regulatory assessment under the Canadian Environmental Protection Act in the late 1990s. Since then, this framework has been applied extensively to satisfy legal requirements under the Canadian Environmental Assessment Act and the Nuclear Safety and Control Act. After approximately a decade of experience in applying these methods, it is clear that simple methods are fit for purpose, and can be used for making regulatory decisions for existing and planned nuclear facilities. Copyright © 2012. Published by Elsevier Ltd.

  13. 75 FR 9444 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-02

    ... applications for licenses and amendments thereto to construct and operate nuclear power plants, preliminary or... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0063] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...

  14. 76 FR 38212 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0275] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Revision 1 of Regulatory Guide (RG) 1.179, ``Standard Format [[Page 38213

  15. 76 FR 32379 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0114] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...: Applications for licenses are [[Page 32380

  16. 76 FR 6086 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [NRC-2011-0015] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability of Draft... comment Draft Regulatory Guide, DG-5020, ``Applying for Enhanced Weapons Authority, Applying for...

  17. 75 FR 63866 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... special nuclear material. The information in the applications, reports, and records is used by NRC to make... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0322] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...

  18. 76 FR 39906 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... collection is required: There is a one-time application for any licensee wishing to renew its nuclear power... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0130] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...

  19. 78 FR 67204 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... special nuclear material. The information in the applications, reports, and records is used by NRC to make... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0239] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC...

  20. 78 FR 52987 - Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit 3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-286; NRC-2013-0063] Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit 3 AGENCY: Nuclear Regulatory Commission. ACTION: Environmental assessment and finding of no significant impact; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission...

  1. 77 FR 70847 - Entergy Nuclear Indian Point 2, LLC; Entergy Nuclear Operations, Inc., Indian Point Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-247; NRC-2012-0284] Entergy Nuclear Indian Point 2, LLC; Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit No. 2, Request for Action AGENCY: Nuclear Regulatory Commission. ACTION: Request for Action; receipt. SUMMARY: The U.S. Nuclear...

  2. 76 FR 31382 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.2, Revision 1, ``Administrative Practices in Radiation Surveys and Monitoring.'' FOR FURTHER INFORMATION...

  3. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M....

  4. 76 FR 24539 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide (RG) 3.67, ``Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities.'' FOR FURTHER INFORMATION CONTACT: Kevin M. Ramse...

  5. 77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555... State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington...

  6. 44 CFR 351.21 - The Nuclear Regulatory Commission.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

  7. 44 CFR 351.21 - The Nuclear Regulatory Commission.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

  8. 44 CFR 351.21 - The Nuclear Regulatory Commission.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

  9. 44 CFR 351.21 - The Nuclear Regulatory Commission.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false The Nuclear Regulatory... Assignments § 351.21 The Nuclear Regulatory Commission. (a) Assess NRC nuclear facility (e.g., commercial... protect the health and safety of the public. (b) Verify that nuclear facility licensee emergency plans can...

  10. Environmental Protection Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Protection Agency (EPA) publishes the semiannual regulatory agenda online (the e-Agenda) at www.reginfo.gov... agenda'' all refer to the same comprehensive collection of information that until 2007 was published in... significant impact on a substantial number of small entities. It continues to be published in the Federal...

  11. 78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0230] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  12. 78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0263] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  13. 76 FR 77560 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0181] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  14. 77 FR 15398 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-15

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0271] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  15. 77 FR 12624 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0263] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  16. 77 FR 69662 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0172] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  17. 77 FR 69663 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0155] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  18. 77 FR 40091 - Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating, Units 2 and 3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2008-0672] Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating, Units 2 and 3 AGENCY: Nuclear Regulatory Commission... renewal of nuclear plants; availability. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the...

  19. 75 FR 44816 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0263] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC... individual monitoring for occupational radiation exposure during a monitoring (one calendar year) period to...

  20. 75 FR 39054 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0234] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC..., or wishing to participate in a license application review for the potential geologic repository. 5...

  1. 75 FR 17438 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0141] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of... new Agreement State applications. Annually for participation by Agreement States in the IMPEP reviews...

  2. 76 FR 23628 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-27

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0056] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending...: Applications for licenses are submitted once. Other reports are submitted annually or as other events require...

  3. Environmental Protection Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Protection Agency (EPA) publishes the semiannual regulatory agenda online (the e-Agenda) at www.reginfo.gov... agenda'' all refer to the same comprehensive collection of information that used to be published in the... impact on a substantial number of small entities. This continues to be published in the Federal Register...

  4. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC)...

  5. 76 FR 2726 - Withdrawal of Regulatory Guide 1.154

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0010] Withdrawal of Regulatory Guide 1.154 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.154, ``Format and Content of Plant-Specific Pressurized Thermal Shock Safety Analysis Reports for Pressurized Water Reactors.'' FOR FURTHER INFORMATION CONTACT: Mekonen M. Bayssie,...

  6. 76 FR 52698 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0181] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of pending... administration of the byproduct material or the radiation there from to human beings or animals. Possession of...

  7. 75 FR 45676 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0235] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...: Applications for new licenses and amendments may be submitted at any time. Applications for renewal are...

  8. 75 FR 37841 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0214] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of... the collection is required: Applications for new licenses and amendments may be submitted at any time...

  9. ASSESSMENT OF CAPABILITIES AND RESEARCH NEEDS IN THE AREA OF HEALTH EFFECTS OF LOW-LEVEL IONIZING RADIATION: A JOINT REPORT TO THE CONGRESS BY THE U.S. ENVIRONMENTAL PROTECTION AGENCY, AND THE U.S. NUCLEAR REGULATORY COMMISSION

    EPA Science Inventory

    The report summarizes the capabilities, research needs and on-going projects of the Environmental Protection Agency and the Nuclear Regulatory Commission related to the health effects of low-level ionizing radiation. The statutory authorities of both EPA and NRC related to radiat...

  10. 75 FR 39585 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0236] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of pending NRC... licensees to ascertain compliance with the provisions of the Atomic Energy Act of 1954, as amended, Title II...

  11. 78 FR 39018 - Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2008-0672] Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 2 and 3 AGENCY: Nuclear Regulatory Commission... Renewal of Nuclear Plants; issuance. SUMMARY: Notice is hereby given that the U.S. Nuclear Regulatory...

  12. KWOC (Key-Word-Out-of-Context) Index of US Nuclear Regulatory Commission Regulatory Guide Series

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Jennings, S.D.

    1990-04-01

    To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series.

  13. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... Analysis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... guide. Licensees should identify how chosen approaches and methods (whether they are quantitative or...

  14. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2008-01-01

    NASA's Agency-wide.resource for identifying and managing risks associated with changing environmental regulations Goals of the RRAC PC: 1) Proactively. detect, analyze and communicate environmental regulatory risks to NASA Programs and facilities; 2) Communicate with regulators and participate in the mitigation of such risks; and 3) Provide centralized support on emerging regulations to NASA HQ Environmental Management Division. When significant regulatory changes are identified, timely communication is essential. Communication of changing requirements to the regulatory stakeholders - NASA Programs and Facilities. Communication of potential issues to management and, when appropriate, back to the regulating agency.

  15. 77 FR 34379 - Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD06-6-000] Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold a joint meeting...

  16. Reformation of Regulatory Technical Standards for Nuclear Power Generation Equipments in Japan

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mikio Kurihara; Masahiro Aoki; Yu Maruyama

    2006-07-01

    Comprehensive reformation of the regulatory system has been introduced in Japan in order to apply recent technical progress in a timely manner. 'The Technical Standards for Nuclear Power Generation Equipments', known as the Ordinance No.622) of the Ministry of International Trade and Industry, which is used for detailed design, construction and operating stage of Nuclear Power Plants, was being modified to performance specifications with the consensus codes and standards being used as prescriptive specifications, in order to facilitate prompt review of the Ordinance with response to technological innovation. The activities on modification were performed by the Nuclear and Industrial Safetymore » Agency (NISA), the regulatory body in Japan, with support of the Japan Nuclear Energy Safety Organization (JNES), a technical support organization. The revised Ordinance No.62 was issued on July 1, 2005 and is enforced from January 1 2006. During the period from the issuance to the enforcement, JNES carried out to prepare enforceable regulatory guide which complies with each provisions of the Ordinance No.62, and also made technical assessment to endorse the applicability of consensus codes and standards, in response to NISA's request. Some consensus codes and standards were re-assessed since they were already used in regulatory review of the construction plan submitted by licensee. Other consensus codes and standards were newly assessed for endorsement. In case that proper consensus code or standards were not prepared, details of regulatory requirements were described in the regulatory guide as immediate measures. At the same time, appropriate standards developing bodies were requested to prepare those consensus code or standards. Supplementary note which provides background information on the modification, applicable examples etc. was prepared for convenience to the users of the Ordinance No. 62. This paper shows the activities on modification and the results, following

  17. 76 FR 60557 - Closure of the U.S. Nuclear Regulatory Commission's Two White Flint North Building Entrance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... Two White Flint North Building Entrance AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... through the recently renovated One White Flint North (OWFN) building entrance lobby. Only NRC badged employees and contractors shall be permitted to use the Two White Flint North (TWFN) building entrance. NRC...

  18. 75 FR 39056 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0113] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: U.S. Nuclear Regulatory... byproduct, source, or special nuclear material that are ceasing licensed activities and terminating the...

  19. OVERVIEW OF THE ACTIVITIES OF THE NUCLEAR ENERGY AGENCY WORKING GROUP ON EXTERNAL EVENTS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nakoski, John A.; Smith, Curtis L.; Kim, Min Kyu

    The Orgranisation for Economic Cooperation and Development (OECD) Nuclear Energy Agency (NEA) has established a Working Group on External Events (WGEV) that provides a forum for subject matter experts from the nuclear industry and regulators to improve the understanding and treatment of external hazards that would support the continued safety performance of nuclear installations, and improve the effectiveness of regulatory practices, in NEA member countries. This report provides a description of the ongoing work of the WGEV. The work of the WGEV includes the collection of information and conducting a workshop on severe weather and storm surge that brought togethermore » a diverse group of subject matter experts to identify commendable practices related to the treatment of severe weather and storm surge consideration in regulatory and operational decision-making. Other work of the WGEV includes looking at science-based screening of external events that are factored into decisions on the safe operation of nuclear facilities; and identification of commendable practices and knowledge gaps on riverine flooding.« less

  20. Progress in Norwegian-Russian Regulatory Cooperation in Management of the Nuclear Legacy

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sneve, M.K.; Shandala, N.K.; Smith, G.M.

    2008-07-01

    The Norwegian Radiation Protection Authority (NRPA) and the Federal Medical-Biological Agency (FMBA) of the Russian Federation have a collaboration programme which forms part of the Norwegian government's Plan of Action to improve radiation and nuclear safety in northwest Russia. The background to the NRPA-FMBA collaboration programme has been described in previous WM presentations. This paper presents the substantial progress made within that programme, describes ongoing progress within specific projects and sets out the value arising from wider involvement in the programme of other organisations such as NATO and the technical support derived from other national agencies such as the IAEA,more » and regulatory authorities from the USA, the UK and France. The main activities of the cooperation projects are concerned with the management of the nuclear legacy in northwest Russia, in particular the remediation of facilities, and related spent fuel and radioactive waste management, at the former Shore Technical Bases at Andreeva Bay and Gremikha Village. New regulatory guidance documents have been developed, necessary because of the special abnormal situation at these sites, now designated as Sites of Temporary Storage (STS), but also because of the transition from military to civilian regulatory supervision and the evolving regulatory system in the Russian Federation. The work has involved major technical inputs from the Russian Federation Institute of Biophysics, as well as review and advice on international recommendations and good practice in other countries provided by other technical support organisations. Projects on-going in 2007 are described which involve regulatory guidance on very Low-Level Waste management, specifically for the licensing and operation of new VLLW disposal facilities; optimisation of operational radiation protection, particularly in areas of high ambient radiation dose rate as are found in some parts of the STSs; determination of factors

  1. 78 FR 63249 - OMB Agency Information Collection Activities: Submission for the Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0116] OMB Agency Information Collection Activities: Submission for the Office of Management and Budget Review; Comment Request AGENCY: Nuclear... comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review...

  2. 77 FR 75451 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... upgraded licenses or license renewals to operate the controls at a nuclear reactor facility. This... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0184] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory...

  3. 78 FR 35646 - Byron Nuclear Station, Units 1 and 2, and Braidwood Nuclear Station, Units 1 and 2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-13

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos.: 50-454, 50-455, 50-456, 50-457; NRC-2013-0126] Byron Nuclear Station, Units 1 and 2, and Braidwood Nuclear Station, Units 1 and 2 AGENCY: Nuclear Regulatory.... Nuclear Regulatory Commission (NRC) has received an application, dated May 29, 2013, from Exelon...

  4. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kisner, Roger A; Wilgen, John B; Ewing, Paul D

    2006-01-01

    Abstract - Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance tomore » licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.« less

  5. Regulatory guidance for lightning protection in nuclear power plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kisner, R. A.; Wilgen, J. B.; Ewing, P. D.

    2006-07-01

    Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees andmore » applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects. (authors)« less

  6. 41 CFR 101-42.1102-4 - Nuclear Regulatory Commission-controlled materials.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 41 Public Contracts and Property Management 2 2014-07-01 2012-07-01 true Nuclear Regulatory...-Special Types of Hazardous Materials and Certain Categories of Property § 101-42.1102-4 Nuclear Regulatory Commission-controlled materials. (a) General. The Nuclear Regulatory Commission (NRC) has exclusive control...

  7. 41 CFR 101-42.1102-4 - Nuclear Regulatory Commission-controlled materials.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 41 Public Contracts and Property Management 2 2011-07-01 2007-07-01 true Nuclear Regulatory...-Special Types of Hazardous Materials and Certain Categories of Property § 101-42.1102-4 Nuclear Regulatory Commission-controlled materials. (a) General. The Nuclear Regulatory Commission (NRC) has exclusive control...

  8. 41 CFR 101-42.1102-4 - Nuclear Regulatory Commission-controlled materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 41 Public Contracts and Property Management 2 2012-07-01 2012-07-01 false Nuclear Regulatory...-Special Types of Hazardous Materials and Certain Categories of Property § 101-42.1102-4 Nuclear Regulatory Commission-controlled materials. (a) General. The Nuclear Regulatory Commission (NRC) has exclusive control...

  9. 41 CFR 101-42.1102-4 - Nuclear Regulatory Commission-controlled materials.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 41 Public Contracts and Property Management 2 2013-07-01 2012-07-01 true Nuclear Regulatory...-Special Types of Hazardous Materials and Certain Categories of Property § 101-42.1102-4 Nuclear Regulatory Commission-controlled materials. (a) General. The Nuclear Regulatory Commission (NRC) has exclusive control...

  10. 41 CFR 101-42.1102-4 - Nuclear Regulatory Commission-controlled materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 2 2010-07-01 2010-07-01 true Nuclear Regulatory...-Special Types of Hazardous Materials and Certain Categories of Property § 101-42.1102-4 Nuclear Regulatory Commission-controlled materials. (a) General. The Nuclear Regulatory Commission (NRC) has exclusive control...

  11. 78 FR 26662 - Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit No. 3 Extension of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-07

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-286; NRC-2013-0063] Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Unit No. 3 Extension of Public Comment Period AGENCY: Nuclear Regulatory... FURTHER INFORMATION CONTACT: Douglas V. Pickett, Senior Project Manager, Office of Nuclear Reactor...

  12. 76 FR 32878 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ...-0129] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1253, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors''. FOR FURTHER INFORMATION CONTACT: Mekonen M...

  13. 76 FR 65541 - Assuring the Availability of Funds for Decommissioning Nuclear Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0263] Assuring the Availability of Funds for Decommissioning Nuclear Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision to Regulatory...

  14. Meeting Regulatory Needs.

    PubMed

    Weber, Michael Fred

    2017-02-01

    The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

  15. 75 FR 66394 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0262] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory.... 10. Abstract: NRC Form 4 is used to record the summary of a radiation worker's cumulative...

  16. 77 FR 16278 - License Renewal Application for Indian Point Nuclear Generating Units 2 and 3; Entergy Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2008-0672] License Renewal Application for Indian Point Nuclear Generating Units 2 and 3; Entergy Nuclear Operations, Inc. AGENCY: Nuclear Regulatory Commission. ACTION: License renewal application; intent to prepare supplement to final...

  17. 10 CFR 70.11 - Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...

  18. 10 CFR 70.11 - Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...

  19. 10 CFR 70.11 - Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...

  20. 10 CFR 70.11 - Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...

  1. 10 CFR 70.11 - Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...

  2. 75 FR 63866 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0236] Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... compliance with the provisions of the Atomic Energy Act of 1954, as amended. Title II of the Energy...

  3. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents

    PubMed Central

    Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

    2014-01-01

    The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template. PMID:25538620

  4. 78 FR 22347 - GPU Nuclear Inc., Three Mile Island Nuclear Power Station, Unit 2, Exemption From Certain...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-320; NRC-2013-0065] GPU Nuclear Inc., Three Mile Island Nuclear Power Station, Unit 2, Exemption From Certain Security Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Exemption. FOR FURTHER INFORMATION CONTACT: John B. Hickman, Office of Federal and State Materials and Environmental...

  5. 77 FR 11164 - Agency Information Collection Activities: Emergency Clearance Submission for the Office of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... seven public meetings to gather stakeholder feedback. Further, the Nuclear Energy Institute provided... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0047] Agency Information Collection Activities...: Nuclear Regulatory Commission. ACTION: Notice of pending NRC action to submit an information collection...

  6. 78 FR 64028 - Decommissioning of Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0035] Decommissioning of Nuclear Power Reactors AGENCY... Commission (NRC) is issuing Revision 1 of regulatory guide (RG) 1.184 ``Decommissioning of Nuclear Power... the NRC's regulations relating to the decommissioning process for nuclear power reactors. The revision...

  7. 77 FR 76541 - Entergy Nuclear Operations, Inc.; Pilgrim Nuclear Power Station

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-28

    ....; Pilgrim Nuclear Power Station AGENCY: Nuclear Regulatory Commission. ACTION: Environmental assessment and... licensee), for operation of the Pilgrim Nuclear Power Station (Pilgrim), located in Plymouth, Massachusetts... Regarding Pilgrim Nuclear Power Station, Final Report- Appendices,'' published in July 2007 (ADAMS Accession...

  8. 77 FR 59994 - Nuclear Fuel Services, Inc., Erwin, TN; Issuance of License Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 70-143; NRC-2009-0435] Nuclear Fuel Services, Inc., Erwin, TN; Issuance of License Renewal AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of... Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001...

  9. 49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

  10. 49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

  11. 49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

  12. 49 CFR 173.471 - Requirements for U.S. Nuclear Regulatory Commission approved packages.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Requirements for U.S. Nuclear Regulatory...) Materials § 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. In addition to the applicable requirements of the U.S. Nuclear Regulatory Commission (NRC) and other requirements of...

  13. Federal guide for a radiological response: Supporting the Nuclear Regulatory Commission during the initial hours of a serious accident

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hogan, R.T.

    1993-11-01

    This document is a planning guide for those Federal agencies that work with the Nuclear Regulatory commission (NRC) during the initial hours of response to a serious radiological emergency in which the NRC is the Lead Federal Agency (LFA). These Federal agencies are: DOE, EPA, USDA, HHS, NOAA, and FEMA. This guide is intended to help these agencies prepare for a prompt response. Instructions are provided on receiving the initial notification, the type of person to send to the scene, the facility at which people are needed, how to get them to that facility, and what they should do whenmore » they arrive. Federal agencies not specifically mentioned in this guide may also be asked to support the NRC.« less

  14. The Environmental Protection Agency's Safety Standards for Disposal of Spent Nuclear Fuel: Potential Path Forward in Response to the Report of the Blue Ribbon Commission on America's Nuclear Future - 13388

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Forinash, Betsy; Schultheisz, Daniel; Peake, Tom

    2013-07-01

    Following the decision to withdraw the Yucca Mountain license application, the Department of Energy created a Blue Ribbon Commission (BRC) on America's Nuclear Future, tasked with recommending a national strategy to manage the back end of the nuclear fuel cycle. The BRC issued its final report in January 2012, with recommendations covering transportation, storage and disposal of spent nuclear fuel (SNF); potential reprocessing; and supporting institutional measures. The BRC recommendations on disposal of SNF and high-level waste (HLW) are relevant to the U.S. Environmental Protection Agency (EPA), which shares regulatory responsibility with the Nuclear Regulatory Commission (NRC): EPA issues 'generallymore » applicable' performance standards for disposal repositories, which are then implemented in licensing. For disposal, the BRC endorses developing one or more geological repositories, with siting based on an approach that is adaptive, staged and consent-based. The BRC recommends that EPA and NRC work cooperatively to issue generic disposal standards-applying equally to all sites-early in any siting process. EPA previously issued generic disposal standards that apply to all sites other than Yucca Mountain. However, the BRC concluded that the existing regulations should be revisited and revised. The BRC proposes a number of general principles to guide the development of future regulations. EPA continues to review the BRC report and to assess the implications for Agency action, including potential regulatory issues and considerations if EPA develops new or revised generic disposal standards. This review also involves preparatory activities to define potential process and public engagement approaches. (authors)« less

  15. The regulatory framework for safe decommissioning of nuclear power plants in Korea

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

    We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  16. 78 FR 75579 - License Renewal Application for Grand Gulf Nuclear Station, Unit 1

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-416; NRC-2011-0262] License Renewal Application for Grand Gulf Nuclear Station, Unit 1 AGENCY: Nuclear Regulatory Commission. ACTION: Draft supplemental....S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft, plant-specific...

  17. 48 CFR 2003.101-3 - Agency regulations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Agency regulations. 2003.101-3 Section 2003.101-3 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 2003.101-3 Agency regulations...

  18. 48 CFR 2003.101-3 - Agency regulations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Agency regulations. 2003.101-3 Section 2003.101-3 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 2003.101-3 Agency regulations...

  19. Regulatory cross-cutting topics for fuel cycle facilities.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott

    This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security,more » Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)« less

  20. 77 FR 12896 - Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... Act provides that in the event any self- regulatory organization is no longer in existence or has... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66458; File No. 600-9] Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency Registration February 24, 2012. I...

  1. 78 FR 50458 - Entergy Nuclear Operations, Inc., James A. Fitzpatrick Nuclear Power Plant, Vermont Yankee...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... Nuclear Operations, Inc., James A. Fitzpatrick Nuclear Power Plant, Vermont Yankee Nuclear Power Station, Pilgrim Nuclear Power Station, Request for Action AGENCY: Nuclear Regulatory Commission. ACTION: Request... that the NRC take action with regard to James A. Fitzpatrick Nuclear Power Plant, Vermont Yankee...

  2. 76 FR 63541 - Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-13

    ... Hurricane Missiles for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide... regulatory guide, (RG) 1.221, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants... missiles that a nuclear power plant should be designed to withstand to prevent undue risk to the health and...

  3. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

  4. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

  5. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

  6. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

  7. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices...

  8. 3 CFR 13579 - Executive Order 13579 of July 11, 2011. Regulation and Independent Regulatory Agencies

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., streamline, expand, or repeal them in accordance with what has been learned. Such retrospective analyses... agency's regulatory program more effective or less burdensome in achieving the regulatory objectives. Sec...

  9. Occupational exposure assessment: Practices in Malaysian nuclear agency

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sarowi, S. Muhd, E-mail: suzie@nuclearmalaysia.gov.my; Ramli, S. A.; Kontol, K. Mohamad

    Malaysian Nuclear Agency (Nuclear Malaysia) is the leading agency in introducing and promoting the application of nuclear science technology in Malaysia. The agency provides major nuclear facilities purposely for research and commercialisation such as reactor, irradiation plants and radioisotope production laboratory. When dealing with ionizing radiation, there is an obligatory requirement to monitor and assess the radiation exposure to the workers. The personal dose of radiation workers were monitored monthly by assessing their Thermoluminescence Dosimeter (TLD) dose reading. This paper will discuss the current practice in managing, assessing, record keeping and reporting of the occupational exposure in Nuclear Malaysia includingmore » the Health Physic Group roles and challenges. The statistics on occupational radiation exposure of monitored workers working in different fields in Nuclear Malaysia from 2011 - 2013 will also be presented. The results show that the null hypothesis (H{sub 0}) was accepted which the means of every populations are all equal or not differ significantly. This hypothesis states that the dose exposure received by the radiation workers in Nuclear Malaysia is similar and there were no significant changes from 2011 to 2013. The radiation monitoring programme correlate with the requirement of our national law, the Atomic Energy Licensing Act 1984 (Act 304)« less

  10. Occupational exposure assessment: Practices in Malaysian nuclear agency

    NASA Astrophysics Data System (ADS)

    Sarowi, S. Muhd; Ramli, S. A.; Kontol, K. Mohamad; Rahman, N. A. H. Abd.

    2016-01-01

    Malaysian Nuclear Agency (Nuclear Malaysia) is the leading agency in introducing and promoting the application of nuclear science technology in Malaysia. The agency provides major nuclear facilities purposely for research and commercialisation such as reactor, irradiation plants and radioisotope production laboratory. When dealing with ionizing radiation, there is an obligatory requirement to monitor and assess the radiation exposure to the workers. The personal dose of radiation workers were monitored monthly by assessing their Thermoluminescence Dosimeter (TLD) dose reading. This paper will discuss the current practice in managing, assessing, record keeping and reporting of the occupational exposure in Nuclear Malaysia including the Health Physic Group roles and challenges. The statistics on occupational radiation exposure of monitored workers working in different fields in Nuclear Malaysia from 2011 - 2013 will also be presented. The results show that the null hypothesis (H₀) was accepted which the means of every populations are all equal or not differ significantly. This hypothesis states that the dose exposure received by the radiation workers in Nuclear Malaysia is similar and there were no significant changes from 2011 to 2013. The radiation monitoring programme correlate with the requirement of our national law, the Atomic Energy Licensing Act 1984 (Act 304).

  11. 78 FR 66785 - Korea Hydro and Nuclear Power Co., Ltd., and Korea Electric Power Corporation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... NUCLEAR REGULATORY COMMISSION [Project No. 0782; NRC-2013-0244] Korea Hydro and Nuclear Power Co., Ltd., and Korea Electric Power Corporation AGENCY: Nuclear Regulatory Commission. ACTION: Notice of receipt; availability. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff acknowledges receipt of...

  12. 77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ...-Basis Hurricane and Hurricane Missiles AGENCY: Nuclear Regulatory Commission. ACTION: Proposed interim...-ISG-024, ``Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles....221, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants.'' DATES: Submit...

  13. 41 CFR 102-117.325 - May my agency appear on its own behalf before a transportation regulatory body proceeding?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... its own behalf before a transportation regulatory body proceeding? 102-117.325 Section 102-117.325... Regulatory Body Proceedings § 102-117.325 May my agency appear on its own behalf before a transportation regulatory body proceeding? Generally, no executive agency may appear on its own behalf in any proceeding...

  14. 41 CFR 102-117.325 - May my agency appear on its own behalf before a transportation regulatory body proceeding?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... its own behalf before a transportation regulatory body proceeding? 102-117.325 Section 102-117.325... Regulatory Body Proceedings § 102-117.325 May my agency appear on its own behalf before a transportation regulatory body proceeding? Generally, no executive agency may appear on its own behalf in any proceeding...

  15. 77 FR 12898 - Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... the event any self-regulatory organization is no longer in existence or has ceased to do business in... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66461; File No. 600-7] Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency Registration February 24, 2012...

  16. 10 CFR 76.53 - Consultation with Environmental Protection Agency.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

  17. 10 CFR 76.53 - Consultation with Environmental Protection Agency.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

  18. 10 CFR 76.53 - Consultation with Environmental Protection Agency.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

  19. 10 CFR 76.53 - Consultation with Environmental Protection Agency.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

  20. 10 CFR 76.53 - Consultation with Environmental Protection Agency.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Consultation with Environmental Protection Agency. 76.53 Section 76.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.53 Consultation with Environmental Protection Agency. In reviewing an application for a...

  1. Re-evaluation of Non-regulatory Asbestos Group Minerals for Regulatory Agencies

    NASA Astrophysics Data System (ADS)

    Dogan, M.; Dogan, A.

    2013-05-01

    Agencies should oversea "positive" identification guidelines followed closely for non-regulatory asbestos group minerals.

  2. 76 FR 46856 - Qualification of Connection Assemblies for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ... Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. SUMMARY: The U.S..., ``Qualification of Connection Assemblies for Nuclear Power Plants.'' This guide describes a method that the NRC... in nuclear power plants. The environmental qualification helps ensure that connection assemblies can...

  3. Joint US Geological Survey, US Nuclear Regulatory Commission workshop on research related to low-level radioactive waste disposal, May 4-6, 1993, National Center, Reston, Virginia; Proceedings

    USGS Publications Warehouse

    Stevens, Peter R.; Nicholson, Thomas J.

    1996-01-01

    This report contains papers presented at the "Joint U.S. Geological Survey (USGS) and U.S. Nuclear Regulatory Commission (NRC) Technical Workshop on Research Related to Low-Level Radioactive Waste (LLW) Disposal" that was held at the USGS National Center Auditorium, Reston, Virginia, May 4-6, 1993. The objective of the workshop was to provide a forum for exchange of information, ideas, and technology in the geosciences dealing with LLW disposal. This workshop was the first joint activity under the Memorandum of Understanding between the USGS and NRC's Office of Nuclear Regulatory Research signed in April 1992.Participants included invited speakers from the USGS, NRC technical contractors (U.S. Department of Energy (DOE) National Laboratories and universities) and NRC staff for presentation of research study results related to LLW disposal. Also in attendance were scientists from the DOE, DOE National Laboratories, the U.S. Environmental Protection Agency, State developmental and regulatory agencies involved in LLW disposal facility siting and licensing, Atomic Energy Canada Limited (AECL), private industry, Agricultural Research Service, universities, USGS and NRC.

  4. Use of Advanced Tsunami Hazard Assessment Techniques and Tsunami Source Characterizations in U.S. and International Nuclear Regulatory Activities

    NASA Astrophysics Data System (ADS)

    Kammerer, A. M.; Godoy, A. R.

    2009-12-01

    In response to the 2004 Indian Ocean Tsunami, as well as the anticipation of the submission of license applications for new nuclear facilities, the United States Nuclear Regulatory Commission (US NRC) initiated a long-term research program to improve understanding of tsunami hazard levels for nuclear power plants and other coastal facilities in the United States. To undertake this effort, the US NRC organized a collaborative research program jointly undertaken with researchers at the United States Geological Survey (USGS) and the National Oceanic and Atmospheric Administration (NOAA) for the purpose of assessing tsunami hazard on the Atlantic and Gulf Coasts of the United States. This study identified and modeled both seismic and landslide tsunamigenic sources in the near- and far-field. The results from this work are now being used directly as the basis for the review of tsunami hazard at potential nuclear plant sites. This application once again shows the importance that the earth sciences can play in addressing issues of importance to society. Because the Indian Ocean Tsunami was a global event, a number of cooperative international activities have also been initiated within the nuclear community. The results of US efforts are being incorporated into updated regulatory guidance for both the U.S. Nuclear Regulatory Commission and the United Nation’s International Atomic Energy Agency (IAEA). Coordinated efforts are underway to integrate state-of-the art tsunami warning tools developed by NOAA into NRC and IAEA activities. The goal of the warning systems project is to develop automated protocols that allow scientists at these agencies to have up-to-the minute user-specific information in hand shortly after a potential tsunami has been identified by the US Tsunami Warning System. Lastly, USGS and NOAA scientists are assisting the NRC and IAEA in a special Extra-Budgetary Program (IAEA EBP) on tsunami being coordinated by the IAEA’s International Seismic Safety

  5. IDNS: The Illinois Nuclear Safety Agency

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gallina, C.O.

    The Illinois Department of Nuclear Safety (IDNS) is one of only two cabinet-level state agencies in the United States devoted exclusively to nuclear and radiation safety. It was established in 1980 by then Gov. James Thompson in response to the 1979 accident at Three Mile Island-2, so the state would be prepared in case of a similar accident at an Illinois nuclear power facility. There are 13 commercial nuclear reactors at seven sites in Illinois, more than in any other state. If Illinois were a country, it would be seventh in the world in the amount of nuclear-generated electricity, andmore » second in the percentage of electricity produced by nuclear power. The state also has several major nonreactor nuclear facilities. 9 refs.« less

  6. Nuclear Forensic Science: Analysis of Nuclear Material Out of Regulatory Control

    NASA Astrophysics Data System (ADS)

    Kristo, Michael J.; Gaffney, Amy M.; Marks, Naomi; Knight, Kim; Cassata, William S.; Hutcheon, Ian D.

    2016-06-01

    Nuclear forensic science seeks to identify the origin of nuclear materials found outside regulatory control. It is increasingly recognized as an integral part of a robust nuclear security program. This review highlights areas of active, evolving research in nuclear forensics, with a focus on analytical techniques commonly employed in Earth and planetary sciences. Applications of nuclear forensics to uranium ore concentrates (UOCs) are discussed first. UOCs have become an attractive target for nuclear forensic researchers because of the richness in impurities compared to materials produced later in the fuel cycle. The development of chronometric methods for age dating nuclear materials is then discussed, with an emphasis on improvements in accuracy that have been gained from measurements of multiple radioisotopic systems. Finally, papers that report on casework are reviewed, to provide a window into current scientific practice.

  7. 76 FR 28192 - Petition for Rulemaking Submitted by the Nuclear Energy Institute

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-16

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 [Docket No. PRM-26-5; NRC-2010-0304] Petition for Rulemaking Submitted by the Nuclear Energy Institute AGENCY: Nuclear Regulatory Commission. ACTION: Petition... Anthony R. Pietrangelo, on behalf of the Nuclear Energy Institute (NEI), the petitioner, in the planned...

  8. 76 FR 74630 - Making Changes to Emergency Plans for Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Parts 50 and 52 RIN 3150-AI10 [NRC-2008-0122] Making Changes to Emergency Plans for Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION... guide (RG) 1.219, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors.'' This...

  9. 77 FR 13155 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of the OMB review of information collection and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  10. 78 FR 70353 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of the OMB review of information collection and solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the...

  11. 77 FR 34194 - Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Parts 71 and 73 RIN 3150-AG41 [NRC-1999-0005] Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is amending...

  12. The role of women in nuclear - attracting public participation in regulatory decision-making process

    NASA Astrophysics Data System (ADS)

    Mohamad Jais, Azlina; Hassan, Najwa

    2018-01-01

    Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

  13. 10 CFR 30.12 - Persons using byproduct material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...

  14. 10 CFR 30.12 - Persons using byproduct material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...

  15. 10 CFR 30.12 - Persons using byproduct material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...

  16. 10 CFR 30.12 - Persons using byproduct material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...

  17. 10 CFR 30.12 - Persons using byproduct material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...

  18. Regulatory Enforcement and Fiscal Impact in Local Health Agencies

    PubMed Central

    Rabarison, Kristina M.; Rabarison, Monika K.

    2015-01-01

    Objectives. We used a cross-sectional, retrospective study design to analyze the association between local health agency regulatory activities and revenues from nonclinical fees and fines (NFF). Methods. We extracted data from the 2010 National Association of County and City Health Officials (NACCHO) Profile Survey, the most recent report including NFF information, and used 2-part multivariable regression models to identify relationships between regulatory activities and revenue. We also interviewed LHD directors on access to revenue from fines. Results. NFFs generated substantial revenue for most LHDs, increasing in scope and amount with jurisdiction size for all but the largest municipalities. The greatest proportion of net revenue came from public pools, campgrounds and recreational vehicles, and solid waste disposal. For small and mid-sized LHDs, enforcement activities generated revenue in a dose–response pattern, with higher returns for increased activities. LHDs in decentralized governance states collected more NFF revenue than those in centralized states. States vary regarding LHD access to revenue from sanctions. Conclusions. The fiscal impact of changes in regulatory activity needs careful assessment to avoid unanticipated consequences of applicable law. PMID:25689178

  19. Nuclear Forensic Science: Analysis of Nuclear Material Out of Regulatory Control

    DOE PAGES

    Kristo, Michael J.; Gaffney, Amy M.; Marks, Naomi; ...

    2016-05-11

    Nuclear forensic science seeks to identify the origin of nuclear materials found outside regulatory control. It is increasingly recognized as an integral part of a robust nuclear security program. Our review highlights areas of active, evolving research in nuclear forensics, with a focus on analytical techniques commonly employed in Earth and planetary sciences. Applications of nuclear forensics to uranium ore concentrates (UOCs) are discussed first. UOCs have become an attractive target for nuclear forensic researchers because of the richness in impurities compared to materials produced later in the fuel cycle. Furthermore, the development of chronometric methods for age dating nuclearmore » materials is then discussed, with an emphasis on improvements in accuracy that have been gained from measurements of multiple radioisotopic systems. Finally, papers that report on casework are reviewed, to provide a window into current scientific practice.« less

  20. 75 FR 63725 - Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 70 [Docket No. PRM-70-8; NRC-2009-0184] Nuclear Energy Institute; Consideration of Petition in the Rulemaking Process AGENCY: Nuclear Regulatory Commission. ACTION... Commission (NRC) will consider five of the issues raised in a petition submitted by the Nuclear Energy...

  1. 10 CFR 40.11 - Persons using source material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...

  2. 10 CFR 40.11 - Persons using source material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...

  3. 10 CFR 40.11 - Persons using source material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...

  4. 10 CFR 40.11 - Persons using source material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...

  5. 10 CFR 40.11 - Persons using source material under certain Department of Energy and Nuclear Regulatory...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...

  6. 78 FR 1704 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... semiannual agenda on February 13, 2012 (77 FR 8078). Within each group, the rules are ordered according to... March 11, 2011, earthquake and tsunami. The NRC agenda lists all open rulemaking actions. Four rules... Regulatory Flexibility Analysis Required: Yes. Agency Contact: Solomon Sahle, Nuclear Regulatory Commission...

  7. Nuclear Regulatory Commission issuances, September 1995. Volume 42, Number 3

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    This book contains an issuance of the Atomic Safety and Licensing Board and a Director`s Decision, both of the US Nuclear Regulatory Commission. The issuance concerns the dismissal of a case by adopting a settlement reached by the Staff of the Nuclear Regulatory Commission and a Radiation Safety Officer of a hospital in which the safety officer pled guilty to deliberate misconduct. The Director`s Decision was to deny a petition to impose a fine on Tennessee Valley Authority concerning alleged harassment of the petitioner and to appoint an independent arbitration board to review all past complaints filed against TVA concerningmore » the Watts Bar Nuclear Plant.« less

  8. 44 CFR 352.21 - Participating Federal agencies.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) Department of Defense; (3) Department of Energy; (4) Department of Health and Human Services; (5) Department...; (8) Environmental Protection Agency; (9) Federal Communications Commission; (10) General Services Administration; (11) National Communications System; (12) Nuclear Regulatory Commission; (13) United States...

  9. 77 FR 24228 - Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-23

    ... Used in Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... guide, (RG) 1.218, ``Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants... of electric cables for nuclear power plants. RG 1.218 is not intended to be prescriptive, instead it...

  10. 77 FR 6131 - Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Department of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    .... Background Nuclear Regulatory Commission Pursuant to Section 103 of the Atomic Energy Act of 1954, as amended... NUCLEAR REGULATORY COMMISSION DEPARTMENT OF HOMELAND SECURITY [NRC-2012-0015] Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Department of Homeland Security Regarding...

  11. U.S. Nuclear Regulatory Commission natural analogue research program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kovach, L.A.; Ott, W.R.

    1995-09-01

    This article describes the natural analogue research program of the U.S. Nuclear Regulatory Commission (US NRC). It contains information on the regulatory context and organizational structure of the high-level radioactive waste research program plan. It also includes information on the conditions and processes constraining selection of natural analogues, describes initiatives of the US NRC, and describes the role of analogues in the licensing process.

  12. Regulatory Agencies and Food Safety

    PubMed Central

    Chapman, R. A.; Morrison, A. B.

    1966-01-01

    Prior to Confederation, food control legislation in Canada consisted of only a few simple laws governing the quality, grading, packing and inspection of certain staple foods. The Inland Revenue Act of 1875 provided the first real control in Canada over adulteration of liquor, foods and drugs. Since then, food legislation has evolved in scope and complexity as the industries involved have developed, as consumers have become better informed, and as scientific advances have provided a sound basis for regulations. Present regulations under the Food and Drugs Act are intended to give consumers broad protection against health hazards and fraud in the production, manufacture, labelling, packaging, advertising, and sale of foods. This principle is well illustrated by present requirements for the control of pesticide residues, chemical additives, and the addition of vitamins to foods. In today's era of rapid technological change, application of current scientific knowledge to the food industry obviously involves the possibility of hazards to health. Regulatory agencies with responsibility for food safety must, therefore, fully utilize scientific knowledge in order to reduce the risks involved to a minimum. PMID:5905951

  13. Controlling the atom. The beginnings of nuclear regulation 1946--1962

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mazuzan, G.T.; Walker, J.S.

    This book traces the early history of nuclear power regulation in the US. It focuses on the Atomic Energy Commission (AEC), the federal agency that until 1975 was primarily responsible for planning and carrying out programs to protect public health and safety from the hazards of the civilian use of nuclear energy. It also describes the role of other groups that figured significantly in the development of regulatory policies, including the congressional Joint Committee on Atomic Energy, federal agencies other than the AEC, state governments, the nuclear industry, and scientific organizations. And it considers changes in public perceptions of andmore » attitudes toward atomic energy and the dangers of radiation exposure. The context in which regulatory programs evolved is a rich and complex mixture of political, legislative, legal, technological, scientific, and administrative history. The basic purpose of this book is to provide the Nuclear Regulatory Commission (NRC), which inherited responsibility for nuclear safety after Congress disbanded the AEC, and the general public with information on the historical antecedents and background of regulatory issues.« less

  14. 76 FR 46330 - NUREG-1934, Nuclear Power Plant Fire Modeling Application Guide (NPP FIRE MAG); Second Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0568] NUREG-1934, Nuclear Power Plant Fire Modeling Application Guide (NPP FIRE MAG); Second Draft Report for Comment AGENCY: Nuclear Regulatory Commission... 1023259), ``Nuclear Power Plant Fire Modeling Application Guide (NPP FIRE MAG), Second Draft Report for...

  15. The Organization and Management of the Nuclear Weapons Program.

    DTIC Science & Technology

    1997-03-01

    over operations include the Defense Nuclear Facilities Safety Board, the Environmental Protection Agency, the Occupational Safety and Health...Safety, and Health. Still more guidance is received from the Defense Nuclear Facilities Safety Board and other external bodies such as the...state regulatory agencies, and the Defense Nuclear Facilities Safety Board. This chapter briefly reviews the most recent decade of this history, describes

  16. 78 FR 61401 - Entergy Nuclear Operations, Inc.; Big Rock Point; Independent Spent Fuel Storage Installation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-03

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-155; 72-43 and NRC-2013-0218] Entergy Nuclear Operations, Inc.; Big Rock Point; Independent Spent Fuel Storage Installation AGENCY: Nuclear Regulatory... the Big Rock Point (BRP) Independent Spent Fuel Storage Installation (ISFSI). ADDRESSES: Please refer...

  17. 10 CFR 9.62 - Records under control of another Government agency.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

  18. 10 CFR 9.62 - Records under control of another Government agency.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

  19. 10 CFR 9.62 - Records under control of another Government agency.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

  20. 10 CFR 9.62 - Records under control of another Government agency.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

  1. 10 CFR 9.62 - Records under control of another Government agency.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Records under control of another Government agency. 9.62 Section 9.62 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Privacy Act Regulations Nrc Procedures... requester with the name of the controlling Government agency, if known, within ten working days after...

  2. 76 FR 69120 - Regulatory Changes To Implement the United States/Australian Agreement for Peaceful Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... Government of the United States of America Concerning Peaceful Uses of Nuclear Energy'' (the Agreement). The... and the Government of the United States of America Concerning Peaceful Uses of Nuclear Energy, dated... NUCLEAR REGULATORY COMMISSION 10 CFR Part 40 RIN 3150-AI95 [NRC-2011-0072] Regulatory Changes To...

  3. 75 FR 76496 - Nuclear Fuel Services, Inc.; Environmental Assessment and Finding of No Significant Impact for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 70-143; NRC-2010-0379] Nuclear Fuel Services, Inc.; Environmental Assessment and Finding of No Significant Impact for Proposed Exemption From a Requirement To Measure the Uranium Element and Isotopic Content of Special Nuclear Material AGENCY: Nuclear Regulatory Commission. ACTION: Environmental...

  4. 75 FR 6070 - Notice of Public Meeting on the International Atomic Energy Agency Basic Safety Standards Version...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... Energy Agency Basic Safety Standards Version 3.0, Draft Safety Requirements DS379 AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Public Meeting on the International Atomic Energy Agency Basic... development of U.S. Government comments on this International Atomic Energy Agency (IAEA) draft General Safety...

  5. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory Commission...

  6. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory Commission...

  7. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory Commission...

  8. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory Commission...

  9. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory Commission...

  10. The Role of Regulatory Agencies and Intellectual Property: Part I

    PubMed Central

    Noonan, Kevin E.

    2015-01-01

    The patent and regulatory regimes of different agencies of the federal government are not always in agreement, and although the concept of the “unified executive” holds that the executive branch speaks with one voice, that is not always the case.1 Some agencies, like the Food and Drug Administration, tend toward cooperation with government patent policies, whereas others, notably the Federal Trade Commission, are often at odds with the Patent Office, the patent system, or both. These skirmishes, when they arise, eventually come before federal courts and ultimately the Supreme Court, where balancing the differing policy objectives, as well as the will of Congress as embodied in its statutes, is subject to the vagaries of the politics of how the issues are framed by the courts, and the judges’ and justices’ own predilections and prejudices. Examples of these situations were prevalent in 2013 and the circumstances surrounding them illustrative of the tensions inherent between the various federal agencies. PMID:25775921

  11. The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

    PubMed

    Dillon, Lindsey; Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

    2018-04-01

    We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

  12. 75 FR 2163 - Constellation Energy; Notice of Docketing of Special Nuclear Material License SNM-2505 Amendment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 72-8; NRC-2010-0011] Constellation Energy; Notice of... Independent Spent Fuel Storage Installation AGENCY: Nuclear Regulatory Commission. ACTION: Notice of license..., Division of Spent Fuel Storage and Transportation, Office of Nuclear Material Safety and Safeguards, U.S...

  13. 75 FR 25301 - Nuclear Fuel Services, Inc.; Environmental Assessment and Finding of No Significant Impact for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

    ... procedures for storing and handling radioactive materials. Thus, the impacts under the ``no action... of Special Nuclear Material AGENCY: Nuclear Regulatory Commission. ACTION: Environmental Assessment... Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Mail Stop EBB-2C40M, Rockville, MD...

  14. Protection of people and environment from radiation risk through good regulatory practice

    NASA Astrophysics Data System (ADS)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  15. 76 FR 35137 - Vulnerability and Threat Information for Facilities Storing Spent Nuclear Fuel and High-Level...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-16

    ... High-Level Radioactive Waste AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Public meeting... Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste,'' and 73... Spent Nuclear Fuel (SNF) and High-Level Radioactive Waste (HLW) storage facilities. The draft regulatory...

  16. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hughes, P. J.; Westwood, R.N; Mark, R. T.

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety casesmore » for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)« less

  17. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...

  18. NPP financial and regulatory risks-Importance of a balanced and comprehensive nuclear law for a newcomer country considering nuclear power programme

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Manan, J. A. N. Abd, E-mail: jamalan@tnb.com.my; Mostafa, N. A.; Salim, M. F.

    The nature of Nuclear Power Plant (NPP) projects are: long duration (10-15 years for new build), high capital investment, reasonable risks and highly regulated industries to meet national and international requirement on Safety, Security, Safeguards (3S) and Liabilities. It requires long term planning and commitment from siting to final disposal of waste/spent fuel. Potential financial and regulatory risks are common in massive NPP projects and will be magnified in the case of using unproven technology. If the risks are not properly managed, it can lead to high project and operation costs, and, fail to fulfil its objectives to provide compatiblemore » electricity prices and. energy security. To ensure successful, the government and investors need to ensure that the NPP project is bankable with low cost of project and funding, have fair treatment and proper risk mitigation, and able to complete on time with no cost overrun. One of the requirements as prerequisite for the development of NPP as stipulated by the International Atomic Energy Agency (IAEA) is the establishment of a Legal and Regulatory Framework. The main objective of nuclear law is to ensure that the activities and projects carried-out in the country are legal and compliant to national and international requirements. The law should also be able to provide fair treatment of risks on its activities that is acceptable to investors. The challenge for a newcomer country is to develop a balanced and comprehensive national nuclear law that meet these objectives while taking into consideration various stakeholders’ interest without compromising on safety, security, safeguard, liability requirements and other international obligations. This paper highlights the nature of NPP projects, its potential and associated financial and regulatory risks, and its major concerns and challenges. It proposes possible risks treatment and mitigation through the formulation of a balanced and comprehensive legislation by

  19. NPP financial and regulatory risks-Importance of a balanced and comprehensive nuclear law for a newcomer country considering nuclear power programme

    NASA Astrophysics Data System (ADS)

    Manan, J. A. N. Abd; Mostafa, N. A.; Salim, M. F.

    2015-04-01

    The nature of Nuclear Power Plant (NPP) projects are: long duration (10-15 years for new build), high capital investment, reasonable risks and highly regulated industries to meet national & international requirement on Safety, Security, Safeguards (3S) and Liabilities. It requires long term planning and commitment from siting to final disposal of waste/spent fuel. Potential financial and regulatory risks are common in massive NPP projects and will be magnified in the case of using unproven technology. If the risks are not properly managed, it can lead to high project and operation costs, and, fail to fulfil its objectives to provide compatible electricity prices and. energy security. To ensure successful, the government and investors need to ensure that the NPP project is bankable with low cost of project and funding, have fair treatment and proper risk mitigation, and able to complete on time with no cost overrun. One of the requirements as prerequisite for the development of NPP as stipulated by the International Atomic Energy Agency (IAEA) is the establishment of a Legal and Regulatory Framework. The main objective of nuclear law is to ensure that the activities and projects carried-out in the country are legal and compliant to national and international requirements. The law should also be able to provide fair treatment of risks on its activities that is acceptable to investors. The challenge for a newcomer country is to develop a balanced and comprehensive national nuclear law that meet these objectives while taking into consideration various stakeholders' interest without compromising on safety, security, safeguard, liability requirements and other international obligations. This paper highlights the nature of NPP projects, its potential and associated financial and regulatory risks, and its major concerns and challenges. It proposes possible risks treatment and mitigation through the formulation of a balanced and comprehensive legislation by clear

  20. Building Synergy between Regulatory and HTA Agencies beyond Processes and Procedures-Can We Effectively Align the Evidentiary Requirements? A Survey of Stakeholder Perceptions.

    PubMed

    Wang, Ting; McAuslane, Neil; Liberti, Lawrence; Leufkens, Hubert; Hövels, Anke

    2018-06-01

    To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  1. 78 FR 11904 - Zion Nuclear Power Station, Units 1 and 2; ZionSolutions, LLC; Consideration of Indirect Transfer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-295 and 50-304; NRC-2013-0034] Zion Nuclear Power Station, Units 1 and 2; ZionSolutions, LLC; Consideration of Indirect Transfer AGENCY: Nuclear Regulatory... the indirect transfer of Facility Operating License Nos. DPR-39 and DPR-48 for Zion Nuclear Power...

  2. 77 FR 12896 - Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66459; File No. 600-11] Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency Registration February 24, 2012. I..., 2006), 72 FR 814 (Jan. 8, 2007). Section 19(a)(3) of the Act \\14\\ provides that in the event any self...

  3. Regulatory decision with EPA/NRC/DOE/State Session (Panel)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    O`Donnell, E.

    1995-12-31

    This panel will cover the Nuclear Regulatory Commission`s (NRC) proposed radiation limits in the Branch Technical Position on Low-Level Radioactive Waste Performance Assessment and the Environmental Protection Agency`s (EPA) draft regulation in Part 193. Representatives from NRC and EPA will discuss the inconsistencies in these two regulations. DOE and state representatives will discuss their perspective on how these regulations will affect low-level radioactive waste performance assessments.

  4. The nuclear energy outlook--a new book from the OECD nuclear energy agency.

    PubMed

    Yoshimura, Uichiro

    2011-01-01

    This paper summarizes the key points of a report titled Nuclear Energy Outlook, published in 2008 by the Nuclear Energy Agency of the Organization for Economic Cooperation and Development, which has 30 member nations. The report discusses the commitment of many nations to increase nuclear power generating capacity and the potential rate of building new electricity-generating nuclear plants by 2030 to 2050. The resulting decrease in carbon dioxide emissions from fossil fuel combustion resulting from an increase in nuclear power sources is described. Other topics that are discussed include the need to develop non-proliferative nuclear fuels, the importance of developing geological disposal facilities or reprocessing capabilities for spent nuclear fuel and high-level radioactive waste materials, and the requirements for a larger nuclear workforce and greater cost competitiveness for nuclear power generation. Copyright © 2010 Health Physics Society

  5. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins, Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency

  6. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency

  7. Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Murphy, E.L.; Sullivan, E.J.

    1997-02-01

    In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule asmore » a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with.« less

  8. 78 FR 53173 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0112] Agency Information Collection Activities... for employment), contractors, and consultants of NRC licensees and contractors whose activities involve access to, or control over, special nuclear material at either fixed sites or for transportation...

  9. 75 FR 16645 - Increase in the Primary Nuclear Liability Insurance Premium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... Primary Nuclear Liability Insurance Premium AGENCY: Nuclear Regulatory Commission. ACTION: Final rule... impractical. The NRC is amending its regulations to increase the primary premium for liability insurance... protection requirements and indemnity agreements to increase the primary nuclear liability insurance layer...

  10. 78 FR 71675 - License Amendment Application for Vermont Yankee Nuclear Power Station

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-29

    ... Vermont Yankee Nuclear Power Station AGENCY: Nuclear Regulatory Commission. ACTION: License amendment... Vermont Yankee Nuclear Power Station, located in Windham County, VT. The proposed amendment would have... Vermont Yankee Nuclear Power Station, located in Windham County, VT. The proposed amendment would have...

  11. 78 FR 45984 - Yankee Atomic Electric Company, Yankee Nuclear Power Station

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... Electric Company, Yankee Nuclear Power Station AGENCY: Nuclear Regulatory Commission. ACTION: Environmental... (YAEC) is the holder of Possession-Only License DPR-3 for the Yankee Nuclear Power Station (YNPS... on the site of any nuclear power reactor. In its Statement of Considerations (SOC) for the Final Rule...

  12. Status of acute systemic toxicity testing requirements and data uses by U.S. regulatory agencies.

    PubMed

    Strickland, Judy; Clippinger, Amy J; Brown, Jeffrey; Allen, David; Jacobs, Abigail; Matheson, Joanna; Lowit, Anna; Reinke, Emily N; Johnson, Mark S; Quinn, Michael J; Mattie, David; Fitzpatrick, Suzanne C; Ahir, Surender; Kleinstreuer, Nicole; Casey, Warren

    2018-04-01

    Acute systemic toxicity data are used by a number of U.S. federal agencies, most commonly for hazard classification and labeling and/or risk assessment for acute chemical exposures. To identify opportunities for the implementation of non-animal approaches to produce these data, the regulatory needs and uses for acute systemic toxicity information must first be clarified. Thus, we reviewed acute systemic toxicity testing requirements for six U.S. agencies (Consumer Product Safety Commission, Department of Defense, Department of Transportation, Environmental Protection Agency, Food and Drug Administration, Occupational Safety and Health Administration) and noted whether there is flexibility in satisfying data needs with methods that replace or reduce animal use. Understanding the current regulatory use and acceptance of non-animal data is a necessary starting point for future method development, optimization, and validation efforts. The current review will inform the development of a national strategy and roadmap for implementing non-animal approaches to assess potential hazards associated with acute exposures to industrial chemicals and medical products. The Acute Toxicity Workgroup of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), U.S. agencies, non-governmental organizations, and other stakeholders will work to execute this strategy. Copyright © 2018 Elsevier Inc. All rights reserved.

  13. 77 FR 9273 - WORKSHOP Sponsored by the Nuclear Regulatory Commission and the Electric Power Research Institute...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-16

    ... Commission and the Electric Power Research Institute on the Treatment of Probabilistic Risk Assessment.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research (RES), in cooperation with the Electric Power Research Institute (EPRI), will hold a joint workshop on the Treatment of...

  14. Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC&A Program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy

    2009-10-07

    The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under theirmore » control. This regulatory development has been accomplished as part of the U.S.-Russian MPC&A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC&A regulations.« less

  15. 41 CFR 102-117.340 - What other types of assistance may GSA provide agencies in dealing with regulatory bodies?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...

  16. 41 CFR 102-117.340 - What other types of assistance may GSA provide agencies in dealing with regulatory bodies?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...

  17. 76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... waste. The draft Strategic Plan also describes the agency's Organizational Excellence Objectives of Openness, Regulatory Effectiveness, and Operational Excellence, which characterize the manner in which the...

  18. Audit Report Office of the Inspector General: Defense Nuclear Agency Activities at Johnston Atoll

    DTIC Science & Technology

    1989-12-15

    DEPARTMENT OF DEFENSE AUDIT REPORT DEFENSE NUCLEAR AGENCY ACTIVITIES AT JOHNSTON ATOLL NO. 90-020 December 15, 1989 A&piored tea ggabiic release...a 5330 Accession Number: 5320 Publication Date: Dec 15, 1989 Title: Audit Report Office Of The Inspector General: Defense Nuclear Agency...Descriptors, Keywords: DNA Johnston Atoll Audit Management Economy Efficiency BOS Administration Oversight DOE Nuclear Atmospheric Testing Safeguard

  19. Aflatoxin control--how a regulatory agency managed risk from an unavoidable natural toxicant in food and feed.

    PubMed

    Park, D L; Stoloff, L

    1989-04-01

    The control by the Food and Drug Administration (FDA) of aflatoxin, a relatively recently discovered, unavoidable natural contaminant produced by specific molds that invade a number of basic food and feedstuffs, provides an example of the varying forces that affect risk assessment and management by a regulatory Agency. This is the story of how the FDA responded to the initial discovery of a potential carcinogenic hazard to humans in a domestic commodity, to the developing information concerning the nature of the hazard, to the economic and political pressures that are created by the impact of natural forces on regulatory controls, and to the restraints of laws within which the Agency must work. This story covers four periods: the years of discovery and action decisions on the basis of meager knowledge and the fear of cancer; the years of tinkering on paper with the regulatory process, the years of digestion of the accumulating knowledge, and the application of that knowledge to actions forced by natural events; and an audit of the current status of knowledge about the hazard from aflatoxin, and proposals for regulatory control based on that knowledge.

  20. 76 FR 68792 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... Control and Accounting of Special Nuclear Material. 3. Current OMB approval number: 3150-0123. 4. The form... requirements for material control and accounting of SNM, and specific performance-based regulations for...

  1. 78 FR 35989 - Tennessee Valley Authority; Watts Bar Nuclear Plant, Unit 2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... Bar Nuclear Plant, Unit 2 AGENCY: Nuclear Regulatory Commission. ACTION: Final environmental statement... Operation of Watts Bar Nuclear Plant (WBN), Unit 2'' (SFES). ADDRESSES: Please refer to Docket ID NRC-2008... option of issuing the operating license for Watts Bar Nuclear Plant, Unit 2. This recommendation is based...

  2. Responsibilities of regulatory agencies in the marketing of antimicrobials.

    PubMed

    Grein, K

    2012-04-01

    The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

  3. 10 CFR 51.123 - Charges for environmental documents; distribution to public; distribution to governmental agencies.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Charges for environmental documents; distribution to public; distribution to governmental agencies. 51.123 Section 51.123 Energy NUCLEAR REGULATORY COMMISSION.... 10, 2003] Commenting ...

  4. Nuclear regulation: an evaluative study. [Monograph

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wood, W.C.

    This paper gives an overview of nuclear regulation, followed by an account of the legislative rationale and the economic rationale for safety regulation of nuclear technology. It goes on to review the structure and safety programs of the Nuclear Regulatory Commission (NRC) and to show how many of the NRC's problems are unlike those facing other regulatory agencies. In assessing the results of nuclear regulation, it examines whether regulation has produced an acceptable level of safety and the nature of the evidence on acceptability. It concludes that the existing level of safety achievement is not cost-effective, and identifies some sourcesmore » of regulatory failure as a failure to make hard decisions on risk, diffuse responsibility for safety, and economic dissincentives to cost-effective safety. Recommendations for reforming NRC are to separate technical issues from social ones and to correct the incentives for safety. 153 references, 6 figures, 4 tables.« less

  5. 41 CFR 102-117.335 - How does my agency ask for a delegation to represent itself in a regulatory body proceeding?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...

  6. 41 CFR 102-117.335 - How does my agency ask for a delegation to represent itself in a regulatory body proceeding?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...

  7. 77 FR 20437 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

    ... there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2012-0027] Agency Information Collection Activities... action to submit an information collection request to the Office of Management and Budget (OMB) and...

  8. Leak-Before-Break: Further developments in regulatory policies and supporting research

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Wilkowski, G.M.; Chao, K.-S.

    1990-02-01

    The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A papermore » by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately.« less

  9. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    PubMed

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  10. Nuclear regulatory legislation: 102d Congress. Volume 1, No. 2

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1993-10-01

    This document is a compilation of nuclear regulatory legislation and other relevant material through the 102d Congress, 2d Session. This compilation has been prepared for use as a resource document, which the NRC intends to update at the end of every Congress. The contents of NUREG-0980 include: The Atomic Energy Act of 1954, as amended; Energy Reorganization Act of 1974, as amended, Uranium Mill Tailings Radiation Control Act of 1978; Low-Level Radioactive Waste Policy Act; Nuclear Waste Policy Act of 1982; and NRC Authorization and Appropriations Acts. Other materials included are statutes and treaties on export licensing, nuclear non-proliferation, andmore » environmental protection.« less

  11. Nuclear regulatory legislation, 102d Congress. Volume 2, No. 2

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1993-10-01

    This document is a compilation of nuclear regulatory legislation and other relevant material through the 102d Congress, 2d Session. This compilation has been prepared for use as a resource document, which the NRC intends to update at the end of every Congress. The contents of NUREG-0980 include The Atomic Energy Act of 1954, as amended; Energy Reorganization Act of 1974, as amended, Uranium Mill Tailings Radiation Control Act of 1978; Low-Level Radioactive Waste Policy Act; Nuclear Waste Policy Act of 1982; and NRC Authorization and Appropriations Acts. Other materials included are statutes and treaties on export licensing, nuclear non-proliferation, andmore » environmental protection.« less

  12. Jaczko to resign as chair of Nuclear Regulatory Commission

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2012-05-01

    Gregory Jaczko, chair of the U.S. Nuclear Regulatory Commission (NRC), announced on 21 May that he will resign once his successor is appointed. His resignation will end a stormy 3-year chairmanship during which he was accused of bullying NRC staff, lying to Congress, and being too close to the political process. Jaczko formerly served as science advisor to Sen. Harry Reid (D-Nev.). As NRC chair, Jaczko halted the commission's license application review for storing nuclear waste at Nevada's Yucca Mountain. In addition, during his NRC tenure the commission focused on identifying and implementing lessons from Japan's Fukushima Daiichi reactors damaged by the 2011 tsunami.

  13. 78 FR 58570 - Environmental Assessment; Entergy Nuclear Operations, Inc., Big Rock Point

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... Assessment; Entergy Nuclear Operations, Inc., Big Rock Point AGENCY: Nuclear Regulatory Commission. ACTION... applicant or the licensee), for the Big Rock Point (BRP) Independent Spent Fuel Storage Installation (ISFSI... Rock Point (BRP) Independent Spent Fuel Storage Installation (ISFSI). II. Environmental Assessment (EA...

  14. 76 FR 52355 - NUREG-1482, Revision 2, “Guidelines for Inservice Testing at Nuclear Power Plants, Draft Report...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-22

    ... Testing at Nuclear Power Plants, Draft Report for Comment'' AGENCY: Nuclear Regulatory Commission. ACTION... Testing at Nuclear Power Plants, Draft Report for Comment,'' and subtitled ``Inservice Testing of Pumps and Valves, and Inservice Examination and Testing of Dynamic Restraints (Snubbers) at Nuclear Power...

  15. 78 FR 47014 - Configuration Management Plans for Digital Computer Software Used in Safety Systems of Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION... Computer Software Used in Safety Systems of Nuclear Power Plants.'' This RG endorses, with clarifications... Electrical and Electronic Engineers (IEEE) Standard 828-2005, ``IEEE Standard for Software Configuration...

  16. 78 FR 50455 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Changes to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Changes to the Chemical Volume Control System AGENCY: Nuclear Regulatory Commission. ACTION: Exemption and combined license amendment; issuance... Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, Municipal...

  17. Reducing carcinogens in public schools: A non-regulatory approach by a regulatory agency

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Roche, L.M.

    1995-05-01

    The New Jersey Public Employees` Occupational Safety and Health Program identified 318 public school districts that reported any of 10 selected carcinogens on their 1990 New Jersey Right to Know Survey of hazardous substances. After obtaining more information about the school districts` use of these carcinogens from a 10% random sample phone survey, a letter recommending substitution of less hazardous substances was sent to the 318 school districts. Individualized to reflect information provided by the schools in the 1990 survey, a form requesting additional information on the status of containers holding the carcinogens was also sent. There were 1,303 reportsmore » of the 10 carcinogens from the 272 (86%) school districts that completed the form. Most were disposed of (668, 51%), used completely (65, 5%), or were slated for disposal (287, 22%). This is an example of a successful project by a regulatory agency to reduce potential exposure to carcinogens in public schools. The 10 most reported carcinogens were arsenic, arsenic trioxide, asbestos, benzene, benzidine, lead chromate, sodium arsenate, sodium arsenite, sodium dichromate, and vinyl chloride.« less

  18. The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture

    PubMed Central

    Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

    2018-01-01

    We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt–led EPA and the extent to which these shifts steer the EPA away from its stated mission to “protect human and environmental health.” Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely—more so than at similar moments in the agency’s 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching. PMID:29698086

  19. 78 FR 23507 - Notice of Regulatory Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    .... 2013-N-06] Notice of Regulatory Review AGENCY: Federal Housing Finance Agency. ACTION: Request for comment. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of a regulatory review that will be conducted in accordance with the process set forth in the regulatory review plan published...

  20. 78 FR 55300 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... CFR Part 95-- Facility Security Clearance and Safeguarding of National Security Information and... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0088] Agency Information Collection Activities... Commission. ACTION: Notice of the OMB review of information collection and solicitation of public comment...

  1. 78 FR 47805 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-06

    ... Documents Access and Management System (ADAMS): You may access publicly available documents online in the... Management Plans for Digital Computer Software used in Safety Systems of Nuclear Power Plants,'' issued for... Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Revision...

  2. 76 FR 40150 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... Commission publishes its semiannual regulatory flexibility agenda. In addition, this document includes an...) requires each agency to publish twice each year a regulatory flexibility agenda containing a brief... 12866 requires each agency to publish twice each year a regulatory agenda of regulations under...

  3. 40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

  4. 40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

  5. 40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

  6. 40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

  7. 40 CFR 124.204 - What must I do as the Director of the regulatory agency to prepare a draft standardized permit?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... regulatory agency to prepare a draft standardized permit? 124.204 Section 124.204 Protection of Environment... agency to prepare a draft standardized permit? (a) You must review the Notice of Intent and supporting... protection of human health and the environment. (c) You must prepare your draft permit decision within 120...

  8. 10 CFR 51.123 - Charges for environmental documents; distribution to public; distribution to governmental agencies.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Charges for environmental documents; distribution to public; distribution to governmental agencies. 51.123 Section 51.123 Energy NUCLEAR REGULATORY COMMISSION... National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice of and Access to...

  9. 10 CFR 51.123 - Charges for environmental documents; distribution to public; distribution to governmental agencies.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Charges for environmental documents; distribution to public; distribution to governmental agencies. 51.123 Section 51.123 Energy NUCLEAR REGULATORY COMMISSION... National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice of and Access to...

  10. 10 CFR 51.123 - Charges for environmental documents; distribution to public; distribution to governmental agencies.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Charges for environmental documents; distribution to public; distribution to governmental agencies. 51.123 Section 51.123 Energy NUCLEAR REGULATORY COMMISSION... National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice of and Access to...

  11. 10 CFR 51.123 - Charges for environmental documents; distribution to public; distribution to governmental agencies.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Charges for environmental documents; distribution to public; distribution to governmental agencies. 51.123 Section 51.123 Energy NUCLEAR REGULATORY COMMISSION... National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice of and Access to...

  12. 76 FR 53156 - Agency Information Collection Activities: Submission for the Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-25

    ... for the Office of Management and Budget Review; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Office of Management and Budget review of information collection and solicitation of... Office of Management and Budget (OMB) for review the following proposal for the collection of information...

  13. 76 FR 78173 - Options for Developing the Regulatory Basis for Streamlining Non-Power Reactor License Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... Emergency Preparedness AGENCY: Nuclear Regulatory Commission. ACTION: Notice of public meeting. SUMMARY: The... non-power reactor license renewal and non-power reactor emergency preparedness. This meeting is a... potential enhancements to emergency preparedness requirements. This meeting is open to the public. DATES...

  14. 75 FR 39053 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    .... The title of the information collection: 10 CFR Part 95-- Facility Security Clearance and Safeguarding of National Security Information and Restricted Data. 3. Current OMB approval number: 3150-0047. 4... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0104] Agency Information Collection Activities...

  15. Cleaning up our Federal energy regulatory mess

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kennedy, R.T.

    1978-08-01

    The new Department of Energy is making much effort to cut back on overlaps of regulations in regard to energy. Several governmental agencies were absorbed into DOE, but many of the previous agencies' policies are still on the books. The Energy Reorganization Act of 1977 did not eliminate the problem of regulatory overlap and confusion, the author says. Also, our future national energy policy will have to rest on this very complex of laws and regulations, he says. The author, being a former deputy administrator of the FEA, uses the nuclear industry to discuss ''the confusion.'' He concludes that eachmore » of us ''has a responsibility to clean up the energy regulation situation. Broad national policy issues must be addressed by Congress and the President. The States must focus hard on ways to simplify and strengthen their processes; and Federal agencies must look to ways to improve their interface with the states and to reduce duplication both with the states and with each other. All regulatory agencies must, mindful of their role in the process, police themselves, and keep a close eye on how that process is working. Finally, each government official and citizen must do his part to bring problems and solutions to the attention of the appropriate officials. For you are the watchdogs in this process, the keystone upon which our system rests.'' (MCW)« less

  16. 76 FR 69296 - University of Utah, University of Utah TRIGA Nuclear Reactor, Notice of Issuance of Renewed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-407, NRC-2011-0153] University of Utah, University of Utah TRIGA Nuclear Reactor, Notice of Issuance of Renewed Facility Operating License No. R-126 AGENCY... University of Utah (UU, the licensee), which authorizes continued operation of the UU TRIGA Nuclear Reactor...

  17. 77 FR 3019 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass... 19b-4 thereunder,\\2\\ a proposed rule change related to post-trade transparency for agency pass-through...

  18. Government Performance and Results Act: Performance plan FY 1999, U.S. Nuclear Regulatory Commission. Volume 1

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Fuches, J.L.

    1998-02-01

    The Nuclear Regulatory Commission`s (NRC) strategic plan [NUREG-1614, Vol. 1, September 1997] establishes a strategic framework that will guide future decision-making and will help the NRC continue to meet its responsibility for protecting public health and safety, promoting the common defense and security, and protecting the environment. This performance plan complements the agency`s strategic plan by setting annual goals with measurable target levels of performance for FY 1999, as required by the Government Performance and Results Act. No significant contribution was made to the preparation of the performance plan by any non-Federal entity. However, a contractor was used to helpmore » facilitate discussions and resolution of issues. Within six months after the close of FY 1999, the NRC will submit to the President and the Congress a report on program performance for FY 1999. This performance report will review the success of the agency in achieving the performance goals established for FY 1999. Where those goals have been achieved, the underlying assumptions and strategies will be examined to ensure that continued applicability is warranted in the future. If any of the FY 1999 performance goals are not met, the agency will conduct a thorough analysis of why it did not meet the goal and the actions necessary to meet-the goal in the future. One result of this analysis will be the documentation of plans and schedules for achieving the established performance goal. If the analysis should indicate that the performance goal is impractical or infeasible, the performance report will document why that is the case and what action is recommended.« less

  19. Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

    PubMed Central

    Payne-Sturges, Devon; Kemp, Debra

    2008-01-01

    Background Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children. Objectives We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings. Discussion Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children. Conclusion The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health. PMID:19079726

  20. 77 FR 29701 - Impact of Construction (Under a Combined License) of New Nuclear Power Plant Units on Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ... New Nuclear Power Plant Units on Operating Units at Multi-Unit Sites AGENCY: Nuclear Regulatory... construct and operate new nuclear power plants (NPPs) on multi-unit sites to provide an evaluation of the... License) of New Nuclear Power Plants on Operating Units at Multi-Unit Sites (Package). ML112630039 Federal...

  1. Nuclear Regulatory Commission's inspection process: Hayward-Tyler Pump Company

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    A panel including Nunzio Palladino of the Nuclear Regulatory Commission (NRC) and members of the inspection and operations staff testified on the sworn affidavits filed by employees of the Hayward-Tyler Nuclear Pump Co., whose descriptions of shoddy workmanship, unacceptable working conditions, falsified paperwork, and the company's general disregard for manufacturing requirements prompted an inspection. NRC officials were asked to explain the lack of guidelines for plant inspections and to outline the corrective measures they will take. A panel of lawyers followed the NRC panel to describe their review of NRC inspection procedures and to support a move that would establishmore » an independent investigative arm that would report to the NRC. An appendix with additional statements and supporting material submitted for the record follows the testimony. (DCK)« less

  2. 77 FR 40385 - Withdrawal of Regulatory Guide 7.3; Procedures for Picking Up and Receiving Packages of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... Picking Up and Receiving Packages of Radioactive Material AGENCY: Nuclear Regulatory Commission. ACTION... Receiving Packages of Radioactive Material.'' The RG is being withdrawn because it is outdated and the..., ``Administrative Guide for Verifying Compliance with Packaging Requirements for Shipment and Receipt of Radioactive...

  3. 77 FR 36017 - Regulatory Guide 7.3, Procedures for Picking Up and Receiving Packages of Radioactive Material

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... Receiving Packages of Radioactive Material AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Guide (RG) 7.3, ``Procedures for Picking Up and Receiving Packages of Radioactive Material.'' The guide..., ``Administrative Guide for Verifying Compliance with Packaging Requirements for Shipment and Receipt of Radioactive...

  4. 76 FR 50767 - Southern Nuclear Operating Co., et al.; Combined Licenses for Vogtle Electric Generating Plant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Limited Work Authorizations AGENCY: Nuclear Regulatory Commission. ACTION: Notice of hearing. SUMMARY: The... Southern Nuclear Operating Company for two combined licenses (COLs) seeking approval to construct and...), as well as for two limited work authorizations (LWAs) to engage in selected construction activities...

  5. 75 FR 43208 - Withdrawal of Regulatory Guide 5.17

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide 5.17, ``Truck... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2010-18077 Filed...

  6. International Atomic Energy Agency Bulletin, volume 22, no. 5 and 6

    NASA Astrophysics Data System (ADS)

    1980-10-01

    The assessment of benefits and risks associated with various energy sources and systems is considered in relation to human needs. Particular emphasis is given to occupational hazards connected with coal mining, the handling of natural and liquified petroleum gases, and the use of nuclear energy for electric power generation. A method of energy risk comparison is examined as well as the approach of a regulatory agency to the concept of risk. Reports of international conferences on the management of alpha contaminated waste and on plasma physics and controlled nuclear fusion research are included.

  7. Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies

    PubMed Central

    Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis

    2017-01-01

    Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. PMID:28949463

  8. 78 FR 4878 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-23

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... the total number of hours needed annually to complete the requirement or request: 183.5. 10. Abstract... regulations and requirements, both technical and quality, in purchase documents. In order to ensure that...

  9. 76 FR 23629 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-27

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Notice of the OMB review of information collection and solicitation of public comment. SUMMARY: The NRC has recently submitted to OMB for review the following proposal for the...

  10. 76 FR 43731 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory...) the estimated number of individuals that will participate in the Generic Fundamentals Examination (GFE...-0131), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be e-mailed...

  11. 75 FR 81315 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: U. S. Nuclear Regulatory Commission (NRC). ACTION: Notice of the OMB review of information collection and solicitation of public comment. SUMMARY: The NRC has recently submitted to OMB for review the following proposal for the...

  12. Nuclear Regulatory Commission Issuances. Opinions and decisions of the Nuclear Regulatory Commission with selected orders: July 1, 1992--December 31, 1992, Volume 36, Pages 1--396

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-12-31

    This is the thirty-sixth volume of issuances (1-396) of the Nuclear Regulatory Commission and its Atomic Safety and Licensing Boards, Administrative Law Judges, and Office Directors. It covers the period from July 1, 1992-December 31, 1992. Atomic Safety and Licensing Boards are authorized by Section 191 of the Atomic Energy Act of 1954. These Boards, comprised of three members conduct adjudicatory hearings on applications to construct and operate nuclear power plants and related facilities and issue initial decisions which, subject to internal review and appellate procedures, become the final Commission action with respect to those applications. Boards are drawn frommore » the Atomic Safety and Licensing Board Panel, comprised of lawyers, nuclear physicists and engineers, environmentalists, chemists, and economists. The Atomic Energy Commission first established Licensing Boards in 1962 and the Panel in 1967.« less

  13. Role of regulatory subunits and protein kinase inhibitor (PKI) in determining nuclear localization and activity of the catalytic subunit of protein kinase A.

    PubMed

    Wiley, J C; Wailes, L A; Idzerda, R L; McKnight, G S

    1999-03-05

    Regulation of protein kinase A by subcellular localization may be critical to target catalytic subunits to specific substrates. We employed epitope-tagged catalytic subunit to correlate subcellular localization and gene-inducing activity in the presence of regulatory subunit or protein kinase inhibitor (PKI). Transiently expressed catalytic subunit distributed throughout the cell and induced gene expression. Co-expression of regulatory subunit or PKI blocked gene induction and prevented nuclear accumulation. A mutant PKI lacking the nuclear export signal blocked gene induction but not nuclear accumulation, demonstrating that nuclear export is not essential to inhibit gene induction. When the catalytic subunit was targeted to the nucleus with a nuclear localization signal, it was not sequestered in the cytoplasm by regulatory subunit, although its activity was completely inhibited. PKI redistributed the nuclear catalytic subunit to the cytoplasm and blocked gene induction, demonstrating that the nuclear export signal of PKI can override a strong nuclear localization signal. With increasing PKI, the export process appeared to saturate, resulting in the return of catalytic subunit to the nucleus. These results demonstrate that both the regulatory subunit and PKI are able to completely inhibit the gene-inducing activity of the catalytic subunit even when the catalytic subunit is forced to concentrate in the nuclear compartment.

  14. 76 FR 59448 - Agency Information Collection Activities; Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ...; Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... or employment clearance. Form 354 identifies the respondent, the marriage, and data on the spouse and... there is no increased risk to the common defense and security. The public may examine and have copied...

  15. 75 FR 59297 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of the OMB review of information collection and solicitation of public comment. SUMMARY: The NRC has recently submitted to OMB for review the following proposal for the...

  16. Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency

    PubMed Central

    Pelfrene, Eric; Pinheiro, Marie-Hélène; Cavaleri, Marco

    2015-01-01

    Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections. Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices. PMID:25855638

  17. 75 FR 79049 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ..., Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2010-31731 Filed...

  18. 77 FR 26321 - Reed College, Reed Research Nuclear Reactor, Renewed Facility Operating License No. R-112

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Nuclear Reactor, Renewed Facility Operating License No. R-112 AGENCY: Nuclear Regulatory Commission... Commission (NRC or the Commission) has issued renewed Facility Operating License No. R- 112, held by Reed... License No. R-112 will expire 20 years from its date of issuance. The renewed facility operating license...

  19. A nuclear nightmare

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1979-04-09

    The nuclear accident at the Three Mile Island power plant in Pennsylvania has dealt yet another setback to the beleaguered nuclear power industry. The plant accident, combined with a recent renewal of interest in the 1974 Karen Silkwood case, increased pressure from regulatory agencies concerning plant safety and waste disposal, and the release of the anti-nuclear film ''''The China Syndrome'' has made the nuclear power industry a source of public criticism and consternation. The fact that officials at the Three Mile Island facility were unsure of the causes and amounts of the radiation leaks further adds to the predicament ofmore » the nuclear industry. The situation was compounded by the formation of a hydrogen gas bubble with the potential to cause a massive explosion at the plant. The incident has sparked protest rallies by anti-nuclear groups. Possible radiation exposure danger levels are assessed. (2 diagrams, 1 map, 9 photos)« less

  20. 76 FR 59066 - Notice of Regulatory Review Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  1. Computer Security for Commercial Nuclear Power Plants - Literature Review for Korea Hydro Nuclear Power Central Research Institute

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Duran, Felicia Angelica; Waymire, Russell L.

    2013-10-01

    Sandia National Laboratories (SNL) is providing training and consultation activities on security planning and design for the Korea Hydro and Nuclear Power Central Research Institute (KHNPCRI). As part of this effort, SNL performed a literature review on computer security requirements, guidance and best practices that are applicable to an advanced nuclear power plant. This report documents the review of reports generated by SNL and other organizations [U.S. Nuclear Regulatory Commission, Nuclear Energy Institute, and International Atomic Energy Agency] related to protection of information technology resources, primarily digital controls and computer resources and their data networks. Copies of the key documentsmore » have also been provided to KHNP-CRI.« less

  2. Mitigating Community Impacts of Energy Development: Some Examples for Coal and Nuclear Generating Plants in the United States.

    ERIC Educational Resources Information Center

    Peelle, Elizabeth

    The Hartsville, Tennessee nuclear reactor site, the coal plant at Wheatland, Wyoming, and the nuclear plant at Skagit, Washington have mitigation plans developed in response to a federal, state, and local regulatory agency, respectively; the three mitigation plans aim at internalizing community-level social costs and benefits during the…

  3. Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency.

    PubMed

    Pelfrene, Eric; Pinheiro, Marie-Hélène; Cavaleri, Marco

    2015-07-01

    Malaria remains a major public health challenge with almost half of the world's population exposed to the risk of contracting the illness. Prompt, effective and well tolerated treatment remains one of the cornerstones in the disease management, with artemisinin-based combination therapy the recommended option for non-severe malaria in endemic areas with predominant Plasmodium falciparum infections.Recent experience has been obtained at the European Medicines Agency with regulatory approval of two such antimalarial fixed combination products. For these cases, two different regulatory pathways were applied. As such, the present contribution describes this experience, emphasising main differences and applicability offered by these regulatory choices. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

  4. Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments.

    PubMed

    1982-12-13

    In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.

  5. 75 FR 36715 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision..., Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory...

  6. Sabotage at Nuclear Power Plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Purvis, James W.

    1999-07-21

    Recently there has been a noted worldwide increase in violent actions including attempted sabotage at nuclear power plants. Several organizations, such as the International Atomic Energy Agency and the US Nuclear Regulatory Commission, have guidelines, recommendations, and formal threat- and risk-assessment processes for the protection of nuclear assets. Other examples are the former Defense Special Weapons Agency, which used a risk-assessment model to evaluate force-protection security requirements for terrorist incidents at DOD military bases. The US DOE uses a graded approach to protect its assets based on risk and vulnerability assessments. The Federal Aviation Administration and Federal Bureau of Investigationmore » conduct joint threat and vulnerability assessments on high-risk US airports. Several private companies under contract to government agencies use formal risk-assessment models and methods to identify security requirements. The purpose of this paper is to survey these methods and present an overview of all potential types of sabotage at nuclear power plants. The paper discusses emerging threats and current methods of choice for sabotage--especially vehicle bombs and chemical attacks. Potential consequences of sabotage acts, including economic and political; not just those that may result in unacceptable radiological exposure to the public, are also discussed. Applicability of risk-assessment methods and mitigation techniques are also presented.« less

  7. Nuclear medicine in the management of patients with heart failure: guidance from an expert panel of the International Atomic Energy Agency (IAEA).

    PubMed

    Peix, Amalia; Mesquita, Claudio Tinoco; Paez, Diana; Pereira, Carlos Cunha; Felix, Renata; Gutierrez, Claudia; Jaimovich, Rodrigo; Ianni, Barbara Maria; Soares, Jose; Olaya, Pastor; Rodriguez, Ma Victoria; Flotats, Albert; Giubbini, Raffaele; Travin, Mark; Garcia, Ernest V

    2014-08-01

    Heart failure is increasing worldwide at epidemic proportions, resulting in considerable disability, mortality, and increase in healthcare costs. Gated myocardial perfusion single photon emission computed tomography or PET imaging is the most prominent imaging modality capable of providing information on global and regional ventricular function, the presence of intraventricular synchronism, myocardial perfusion, and viability on the same test. In addition, I-mIBG scintigraphy is the only imaging technique approved by various regulatory agencies able to provide information regarding the adrenergic function of the heart. Therefore, both myocardial perfusion and adrenergic imaging are useful tools in the workup and management of heart failure patients. This guide is intended to reinforce the information on the use of nuclear cardiology techniques for the assessment of heart failure and associated myocardial disease.

  8. Nuclear medicine in the management of patients with heart failure: guidance from an expert panel of the International Atomic Energy Agency (IAEA)

    PubMed Central

    Peix, Amalia; Mesquita, Claudio Tinoco; Paez, Diana; Pereira, Carlos Cunha; Felix, Renata; Gutierrez, Claudia; Jaimovich, Rodrigo; Ianni, Barbara Maria; Soares, Jose; Olaya, Pastor; Rodriguez, Ma. Victoria; Flotats, Albert; Giubbini, Raffaele; Travin, Mark

    2014-01-01

    Heart failure is increasing worldwide at epidemic proportions, resulting in considerable disability, mortality, and increase in healthcare costs. Gated myocardial perfusion single photon emission computed tomography or PET imaging is the most prominent imaging modality capable of providing information on global and regional ventricular function, the presence of intraventricular synchronism, myocardial perfusion, and viability on the same test. In addition, 123I-mIBG scintigraphy is the only imaging technique approved by various regulatory agencies able to provide information regarding the adrenergic function of the heart. Therefore, both myocardial perfusion and adrenergic imaging are useful tools in the workup and management of heart failure patients. This guide is intended to reinforce the information on the use of nuclear cardiology techniques for the assessment of heart failure and associated myocardial disease. PMID:24781009

  9. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

  10. 78 FR 71675 - Update of the Office of Nuclear Reactor Regulation's Electronic Operating Reactor Correspondence

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-29

    ... correspondence to addressees and subscribers through a computer-based email distribution system. Since then, the... Electronic Operating Reactor Correspondence The U.S. Nuclear Regulatory Commission (NRC) is issuing this... available operating reactor licensing correspondence, effective December 9, 2013. Official agency records...

  11. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

  12. Proceedings of the seminar on Leak-Before-Break: Progress in regulatory policies and supporting research

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kashima, K.; Wilkowski, G.M.

    1988-03-01

    The third in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at TEPCO Hall in the Tokyo Electric Power Company's (TEPCO) Electric Power Museum on May 14 and 15, 1987. The seminar updated the international policies and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utility representatives, fabricators of nuclear power plants, research organizations, and university professors. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA), Dr. H. Schultz (GRS, W. Germany), Dr. P. Milella (ENEA-DISP, Italy), Dr. C. Faidy, P. Jamet,more » and S. Bhandari (EDF/Septen, CEA/CEN, and Framatome, France), and Mr. T. Fukuzawa (MITI, Japan). Dr. F. Nilsson presented revised nondestructive inspection requirements relative to LBB in Sweden. In addition, several papers on the supporting research programs discussed regulatory policy. Questions following the presentations of the papers focused on the impact of various LBB policies or the impact of research findings. Supporting research programs were reviewed on the first and second day by several participants from the US, Japan, Germany, Canada, Italy, Sweden, England, and France.« less

  13. Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies.

    PubMed

    Lehoux, Pascale; Miller, Fiona A; Daudelin, Geneviève; Denis, Jean-Louis

    2017-01-25

    New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec's (Canada) publicly funded healthcare system. Entrepreneurs have a direct influence over a new technology's value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology-as a health intervention and as an economic commodity-and provide economic worth to the venture that is bringing the technology to market. Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. © 2017 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

  14. Review of the Tri-Agency Space Nuclear Reactor Power System Technology Program

    NASA Technical Reports Server (NTRS)

    Ambrus, J. H.; Wright, W. E.; Bunch, D. F.

    1984-01-01

    The Space Nuclear Reactor Power System Technology Program designated SP-100 was created in 1983 by NASA, the U.S. Department of Defense, and the Defense Advanced Research Projects Agency. Attention is presently given to the development history of SP-100 over the course of its first year, in which it has been engaged in program objectives' definition, the analysis of civil and military missions, nuclear power system functional requirements' definition, concept definition studies, the selection of primary concepts for technology feasibility validation, and the acquisition of initial experimental and analytical results.

  15. 75 FR 20868 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ...: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.68.2... Water-Cooled Nuclear Power Plants.'' FOR FURTHER INFORMATION CONTACT: Mark P. Orr, Regulatory Guide... Shutdown Capability for Water-Cooled Nuclear Power Plants,'' was issued with a temporary identification as...

  16. Knowledge Management Initiatives Used to Maintain Regulatory Expertise in Transportation and Storage of Radioactive Materials - 12177

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lindsay, Haile; Garcia-Santos, Norma; Saverot, Pierre

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) was established in 1974 with the mission to license and regulate the civilian use of nuclear materials for commercial, industrial, academic, and medical uses in order to protect public health and safety, and the environment, and promote the common defense and security. Currently, approximately half (∼49%) of the workforce at the NRC has been with the Agency for less than six years. As part of the Agency's mission, the NRC has partial responsibility for the oversight of the transportation and storage of radioactive materials. The NRC has experienced a significant level of expertise leavingmore » the Agency due to staff attrition. Factors that contribute to this attrition include retirement of the experienced nuclear workforce and mobility of staff within or outside the Agency. Several knowledge management (KM) initiatives have been implemented within the Agency, with one of them including the formation of a Division of Spent Fuel Storage and Transportation (SFST) KM team. The team, which was formed in the fall of 2008, facilitates capturing, transferring, and documenting regulatory knowledge for staff to effectively perform their safety oversight of transportation and storage of radioactive materials, regulated under Title 10 of the Code of Federal Regulations (10 CFR) Part 71 and Part 72. In terms of KM, the SFST goal is to share critical information among the staff to reduce the impact from staff's mobility and attrition. KM strategies in place to achieve this goal are: (1) development of communities of practice (CoP) (SFST Qualification Journal and the Packaging and Storing Radioactive Material) in the on-line NRC Knowledge Center (NKC); (2) implementation of a SFST seminar program where the seminars are recorded and placed in the Agency's repository, Agency-wide Documents Access and Management System (ADAMS); (3) meeting of technical discipline group programs to share knowledge within specialty areas; (4

  17. 17 CFR 240.17a-22 - Supplemental material of registered clearing agencies.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a significant relationship, such as pledgees, transfer agents, or self-regulatory organizations, any... clearing agency for which the Commission is not the appropriate regulatory agency shall at the same time file one copy of such material with its appropriate regulatory agency. [45 FR 73914, Nov. 7, 1980] ...

  18. 77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

  19. Nuclear Terrorism - Dimensions, Options, and Perspectives in Moldova

    NASA Astrophysics Data System (ADS)

    Vaseashta, Ashok; Susmann, P.; Braman, Eric W.; Enaki, Nicolae A.

    Securing nuclear materials, controlling contraband and preventing proliferation is an international priority to resolve using technology, diplomacy, strategic alliances, and if necessary, targeted military exercises. Nuclear security consists of complementary programs involving international legal and regulatory structure, intelligence and law enforcement agencies, border and customs forces, point and stand-off radiation detectors, personal protection equipment, preparedness for emergency and disaster, and consequence management teams. The strategic goal of UNSCR 1540 and the GICNT is to prevent nuclear materials from finding their way into the hands of our adversaries. This multi-jurisdictional and multi-agency effort demands tremendous coordination, technology assessment, policy development and guidance from several sectors. The overall goal envisions creating a secured environment that controls and protects nuclear materials while maintaining the free flow of commerce and individual liberty on international basis. Integral to such efforts are technologies to sense/detect nuclear material, provide advance information of nuclear smuggling routes, and other advanced means to control nuclear contraband and prevent proliferation. We provide an overview of GICNT and several initiatives supporting such efforts. An overview is provided of technological advances in support of point and stand-off detection and receiving advance information of nuclear material movement from perspectives of the Republic of Moldova.

  20. ICH: an exclusive club of drug regulatory agencies and drug companies imposing its rules on the rest of the world.

    PubMed

    2010-08-01

    Under the pretext of harmonising regulatory requirements for marketing authorisation of new drugs, the drug regulatory agencies of the world's wealthiest countries and three pharmaceutical industry trade associations, joined together since 1990 in the ICH, are promoting their own interests by imposing their criteria for evaluating drugs on the whole world. The toxicity standards advocated by ICH sometimes promote faster, cheaper drug development over patient protection. The drug quality standards advocated by ICH sometimes increase manufacturing costs without providing any public health benefit. It would be preferable if the World Health Organization were in charge of setting standards for drug development, focusing on patients' interests.

  1. Human agency in social cognitive theory.

    PubMed

    Bandura, A

    1989-09-01

    The present article examines the nature and function of human agency within the conceptual model of triadic reciprocal causation. In analyzing the operation of human agency in this interactional causal structure, social cognitive theory accords a central role to cognitive, vicarious, self-reflective, and self-regulatory processes. The issues addressed concern the psychological mechanisms through which personal agency is exercised, the hierarchical structure of self-regulatory systems, eschewal of the dichotomous construal of self as agent and self as object, and the properties of a nondualistic but nonreductional conception of human agency. The relation of agent causality to the fundamental issues of freedom and determinism is also analyzed.

  2. 77 FR 7663 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ...The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http:// reginfo.gov. The fall 2011 Unified Agenda publication appearing in the Federal Register consists of agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

  3. Toxicogenomics and the Regulatory Framework

    EPA Science Inventory

    Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

  4. General Services Administration Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... regulatory plan. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch, at... Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat Branch, Office of...: 202 501-4755 Fax: 202 501-4067 Email: hada.flowers@gsa.gov RIN: 3090-AI32 276. GSAR CASE 2008-G517...

  5. 3 CFR - Regulatory Compliance

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 3 The President 1 2012-01-01 2012-01-01 false Regulatory Compliance Presidential Documents Other Presidential Documents Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to enhancing effectiveness and efficiency in Government. Pursuant to the...

  6. 76 FR 3825 - Regulatory Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to... regulatory compliance and enforcement activities, such as information with respect to administrative... compliance information fosters fair and consistent enforcement of important regulatory obligations. Such...

  7. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mladineo, Stephen V.; Frazar, Sarah L.; Kurzrok, Andrew J.

    This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation with either a newcomer State, or to a State with a fully developed SRA.

  8. 77 FR 8028 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and... Analysis Required: Yes. Agency Contact: Karlos Morgan, Procurement Analyst, DOD/GSA/NASA (FAR), 1275 First... 05/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Clark, Procurement...

  9. 78 FR 44399 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, and Transition Provisions. (Docket... Further Action........ 12/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Dena... Regulatory Capital Ratios, Capital Adequacy, and Transition Provisions. (Docket No. R-1442) Legal Authority...

  10. 77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...The Office of the Comptroller of the Currency (OCC), Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are seeking comment on three Notices of Proposed Rulemaking (NPR) that would revise and replace the agencies' current capital rules. In this NPR, the agencies are proposing to revise their risk-based and leverage capital requirements consistent with agreements reached by the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for More Resilient Banks and Banking Systems'' (Basel III). The proposed revisions would include implementation of a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for banking organizations subject to the advanced approaches capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator measure. Additionally, consistent with Basel III, the agencies are proposing to apply limits on a banking organization's capital distributions and certain discretionary bonus payments if the banking organization does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk- based capital requirements. This NPR also would establish more conservative standards for including an instrument in regulatory capital. As discussed in the proposal, the revisions set forth in this NPR are consistent with section 171 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), which requires the agencies to establish minimum risk-based and leverage capital requirements. In connection with the proposed changes to the agencies' capital rules in this NPR, the agencies are also seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related NPRs are discussed further in the SUPPLEMENTARY INFORMATION.

  11. An inventory of ambulance service regulatory programs in California.

    PubMed

    Narad, R A

    1998-01-01

    Ambulance regulation in California is the responsibility of numerous agencies on the state and local levels. By identifying and analyzing the variety of programs used in one state, this study establishes a framework for evaluation of state and local regulatory programs elsewhere. This study surveyed all California local EMS agencies (LEMSAs: California's equivalent of regional EMS organizations) to identify the types of regulatory programs used, the foci of these programs (e.g., equipment and personnel), and their application (e.g., public and private providers). All data acquired were analyzed using population parameters rather than inferential statistics. A response rate of 100% was obtained. Among the regulatory tools used are ordinances, contracts, and franchises. Regulatory standards vary widely as do their applications. Large counties and those that operate their own LEMSA have more extensive regulatory programs than do smaller counties and those who participate in multicounty agencies. Many of the enforcement mechanisms available are weak. This study suggests several policy implications for California and other states. The wide variation in the types of regulatory programs and the standards that are used suggest that the purpose and impact of regulatory programs should be studied further. The decentralization of the ambulance regulatory program and the lack of integration of ambulance regulations into EMS system planning also raise policy questions. In addition, the role of multicounty EMS agencies, as it relates to regulation of ambulance services, should be reviewed.

  12. 75 FR 37842 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... INFORMATION CONTACT: R. A. Jervey, Regulatory Guide Development Branch, Division of Engineering, Office of...) 251-7404 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc...

  13. 40 CFR 73.86 - State regulatory autonomy.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

  14. Bibliography of reports on research sponsored by the NRC Office of Nuclear Regulatory Research, July--December 1976

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Buchanan, J.R.

    A bibliography of 148 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period July through December 1976 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are sorted by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  15. Bibliography of reports on research sponsored by the NRC office of nuclear regulatory research, July--December 1977

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Buchanan, J.R.

    A bibliography of 198 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period July through December 1977 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are arranged first by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  16. Nuclear Regulatory Commission activities to prepare for reviewing license applications and issuing licenses

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Uleck, R.B.; DeFino, C.V.

    1991-12-31

    The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) assigned States the responsibility to provide for disposal of commercial low-level radioactive waste (LLRW) by 1993. The LLRWPAA also required the US Nuclear Regulatory Commission (NRC) to establish procedures and develop the technical review capability to process license applications for new LLRW disposal facilities. Under the LLRWPAA, NRC is required, to the extent practicable, to complete its review of an LLRW disposal facility license application within 15 months of its submittal by a State. This provision of the LLRWPAA helps ensure that NRC, in addition to protecting public health andmore » safety and the environment, facilitates States` achievement of LLRWPAA milestones for new facility development. A timely NRC review is needed for States to accomplish their objective of having new disposal facilities in operation on the dates prescribed in the LLRWPAA. To help assure NRC and States` compliance with the provisions of the LLRWPAA, NRC has developed a licensing review strategy that includes: (1) the further development of regulatory guidance, (2) enhancement of licensing review capability, and (3) prelicensing regulatory consultation with potential applicants.« less

  17. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    PubMed

    Hojo, Taisuke

    2017-01-01

    Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  18. 75 FR 54917 - Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... integral part of the evaluative process used by the agency to ensure the operational safety performance of... the AARM. The reason this additional criterion has been added is to allow NRC's senior management to..., Rockville, Maryland. NRC's Agencywide Documents Access and Management System (ADAMS): Publicly available...

  19. Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

    PubMed Central

    Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

    2013-01-01

    The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies’ ability to oversee their growing use and application in society. PMID:24244662

  20. 75 FR 34962 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-154-FOR; OSM 2010-0002] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control...

  1. 75 FR 43207 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing.... Jervey, Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear...

  2. Data Integrity-A Study of Current Regulatory Thinking and Action.

    PubMed

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  3. Regulatory T cells facilitate the nuclear accumulation of inducible cAMP early repressor (ICER) and suppress nuclear factor of activated T cell c1 (NFATc1)

    PubMed Central

    Vaeth, Martin; Gogishvili, Tea; Bopp, Tobias; Klein, Matthias; Berberich-Siebelt, Friederike; Gattenloehner, Stefan; Avots, Andris; Sparwasser, Tim; Grebe, Nadine; Schmitt, Edgar; Hünig, Thomas; Serfling, Edgar; Bodor, Josef

    2011-01-01

    Inducible cAMP early repressor (ICER) is a transcriptional repressor, which, because of alternate promoter use, is generated from the 3′ region of the cAMP response modulator (Crem) gene. Its expression and nuclear occurrence are elevated by high cAMP levels in naturally occurring regulatory T cells (nTregs). Using two mouse models, we demonstrate that nTregs control the cellular localization of ICER/CREM, and thereby inhibit IL-2 synthesis in conventional CD4+ T cells. Ablation of nTregs in depletion of regulatory T-cell (DEREG) mice resulted in cytosolic localization of ICER/CREM and increased IL-2 synthesis upon stimulation. Direct contacts between nTregs and conventional CD4+ T cells led to nuclear accumulation of ICER/CREM and suppression of IL-2 synthesis on administration of CD28 superagonistic (CD28SA) Ab. In a similar way, nTregs communicated with B cells and induced the cAMP-driven nuclear localization of ICER/CREM. High levels of ICER suppressed the induction of nuclear factor of activated T cell c1 (Nfatc1) gene in T cells whose inducible Nfatc1 P1 promoter bears two highly conserved cAMP-responsive elements to which ICER/CREM can bind. These findings suggest that nTregs suppress T-cell responses by the cAMP-dependent nuclear accumulation of ICER/CREM and inhibition of NFATc1 and IL-2 induction. PMID:21262800

  4. 78 FR 47426 - Virgil C. Summer Nuclear Station, Units 2 and 3; South Carolina Electric and Gas; Change to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-05

    ... Additional Electrical Penetration Assemblies AGENCY: Nuclear Regulatory Commission. ACTION: Exemption and... requested adding four electrical penetration assemblies to the containment vessel and shield building in... assemblies to containment and the shield building. As part of this request, the licensee needed to change...

  5. Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Levine, Aaron L

    Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

  6. 78 FR 49551 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Change to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... design and layout of the turbine building. As part of this request, the licensee needed to change the... information related to the design and layout of the Turbine Building detailed in the amendment request. These... Structures and Layout AGENCY: Nuclear Regulatory Commission. ACTION: Exemption and combined license amendment...

  7. 76 FR 16714 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-160-FOR; OSM 2010-0019] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation...

  8. 75 FR 21899 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ....regulations.gov. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch... Flexibility Analysis Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat, DOD/ GSA... Email: hada.flowers@gsa.gov RIN: 9000-AK92 301. FAR CASE 2006-005, HUBZONE PROGRAM REVISIONS Legal...

  9. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

    Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

  10. 76 FR 14107 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision... Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-5967 Filed 3-14-11...

  11. 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

    PubMed

    Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun Julia; Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Arienzo, Celia; Danan-Leon, Lieza; Donato, Lorella Di; Garofolo, Fabio; Haidar, Sam; Ishii-Watabe, Akiko; Jiang, Hao; Kadavil, John; Kassim, Sean; Kurki, Pekka; Blaye, Olivier Le; Liu, Kai; Mathews, Rod; Lima Santos, Gustavo Mendes; Niwa, Makoto; Pedras-Vasconcelos, João; Qian, Mark; Rago, Brian; Saad, Ola; Saito, Yoshiro; Savoie, Natasha; Su, Dian; Szapacs, Matthew; Tampal, Nilufer; Vinter, Stephen; Wang, Jian; Welink, Jan; Whale, Emma; Wilson, Amanda; Xue, Y-J

    2017-12-01

    The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches. This 2017 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for biotherapeutics, biomarkers and immunogenicity assays using hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (LCMS for small molecules, peptides and small molecule biomarkers) and Part 3 (LBA: immunogenicity, biomarkers and pharmacokinetic assays) are published in Volume 9 of Bioanalysis, issues 22 and 24 (2017), respectively.

  12. 77 FR 31486 - Virginia Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA-126-FOR; OSM-2008-0012] Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation... an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act...

  13. 75 FR 54918 - Draft Regulatory Guide, DG-1247, “Design-Basis Hurricane and Hurricane Missiles for Nuclear Power...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... that the staff uses in evaluating specific problems or postulated accidents, and data that the staff... turbine missiles. NUREG/CR 7004 is the technical basis for regulatory guidance on design-basis hurricane... hurricane wind speeds for new nuclear power plants. [[Page 54919

  14. Bibliography of reports on research sponsored by the NRC Office of Nuclear Regulatory Research, November 1975--June 1976

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Buchanan, J.R.

    1976-09-30

    A bibliography of 152 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period November 1975 through June 1976 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are sorted by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  15. Environmental Regulatory Update Table, October 1991

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  16. Environmental Regulatory Update Table, December 1991

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  17. Environmental Regulatory Update Table, September 1991

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-10-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  18. Environmental Regulatory Update Table, November 1991

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-12-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  19. 75 FR 53352 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Guide, DG-1247, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants.'' FOR FURTHER...'s ``Regulatory Guide'' series. This series was developed to describe and make available to the.... The draft regulatory guide (DG), entitled, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear...

  20. 75 FR 13801 - Firstenergy Nuclear Operating Company and Firstenergy Nuclear Generation Corp.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-346; NRC-2010-0121] Firstenergy Nuclear Operating Company and Firstenergy Nuclear Generation Corp.; Notice of Withdrawal of Application for Amendment to Facility Operating License The U.S. Nuclear Regulatory Commission (the Commission) has [[Page 13802

  1. Radiotherapy and Nuclear Medicine Project for an Integral Oncology Center at the Oaxaca High Specialization Regional Hospital

    NASA Astrophysics Data System (ADS)

    De Jesús, M.; Trujillo-Zamudio, F. E.

    2010-12-01

    A building project of Radiotherapy & Nuclear Medicine services (diagnostic and therapy), within an Integral Oncology Center (IOC), requires interdisciplinary participation of architects, biomedical engineers, radiation oncologists and medical physicists. This report focus on the medical physicist role in designing, building and commissioning stages, for the final clinical use of an IOC at the Oaxaca High Specialization Regional Hospital (HRAEO). As a first step, during design stage, the medical physicist participates in discussions about radiation safety and regulatory requirements for the National Regulatory Agency (called CNSNS in Mexico). Medical physicists propose solutions to clinical needs and take decisions about installing medical equipment, in order to fulfill technical and medical requirements. As a second step, during the construction stage, medical physicists keep an eye on building materials and structural specifications. Meanwhile, regulatory documentation must be sent to CNSNS. This documentation compiles information about medical equipment, radioactivity facility, radiation workers and nuclear material data, in order to obtain the license for the linear accelerator, brachytherapy and nuclear medicine facilities. As a final step, after equipment installation, the commissioning stage takes place. As the conclusion, we show that medical physicists are essentials in order to fulfill with Mexican regulatory requirements in medical facilities.

  2. International nuclear safety concerns. Hearing before the Subcommittee on Energy, Nuclear Proliferation, and Government Processes of the Committee on Governmental Affairs, United States Senate, Ninety-Ninth Congress, Second Session, May 8, 1986

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1986-01-01

    Allan I. Mendelowitz of the General Accounting Office (GAO) and James R. Shea of the Nuclear Regulatory Commission were the principal witnesses at a hearing on international concerns about reactor safety. The hearing focused on the Soviet accident at Chernobyl as a demonstration that safety matters are a legitimate area of international concern. Among the issues under discussion were safety standards and inspection procedures of the International Atomic Energy Agency (IAEA). Estimates developed by the GAO show that developing countries, which lack a strong technical base or nuclear background to handle emergencies, will have half the reactors in the worldmore » by the year 2000. Mendelowitz and Shea, together with supporting testimony from others in their agencies described international efforts to improve safeguards.« less

  3. 75 FR 60375 - Utah Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-047-FOR; Docket ID OSM-2010-0012] Utah Regulatory Program AGENCY: Office of Surface Mining... amendment to the Utah regulatory program (hereinafter, the ``Utah program'') under the Surface Mining...

  4. The Defense Threat Reduction Agency's Technical Nuclear Forensics Research and Development Program

    NASA Astrophysics Data System (ADS)

    Franks, J.

    2015-12-01

    The Defense Threat Reduction Agency (DTRA) Technical Nuclear Forensics (TNF) Research and Development (R&D) Program's overarching goal is to design, develop, demonstrate, and transition advanced technologies and methodologies that improve the interagency operational capability to provide forensics conclusions after the detonation of a nuclear device. This goal is attained through the execution of three focus areas covering the span of the TNF process to enable strategic decision-making (attribution): Nuclear Forensic Materials Exploitation - Development of targeted technologies, methodologies and tools enabling the timely collection, analysis and interpretation of detonation materials.Prompt Nuclear Effects Exploitation - Improve ground-based capabilities to collect prompt nuclear device outputs and effects data for rapid, complementary and corroborative information.Nuclear Forensics Device Characterization - Development of a validated and verified capability to reverse model a nuclear device with high confidence from observables (e.g., prompt diagnostics, sample analysis, etc.) seen after an attack. This presentation will outline DTRA's TNF R&D strategy and current investments, with efforts focusing on: (1) introducing new technical data collection capabilities (e.g., ground-based prompt diagnostics sensor systems; innovative debris collection and analysis); (2) developing new TNF process paradigms and concepts of operations to decrease timelines and uncertainties, and increase results confidence; (3) enhanced validation and verification (V&V) of capabilities through technology evaluations and demonstrations; and (4) updated weapon output predictions to account for the modern threat environment. A key challenge to expanding these efforts to a global capability is the need for increased post-detonation TNF international cooperation, collaboration and peer reviews.

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  8. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  9. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  10. Environmental Regulatory Update Table, August 1991

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

    1991-09-01

    This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  11. 77 FR 8185 - Ohio Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [SATS No. OH-252-FOR; Docket ID OSM 2011-0003] Ohio Regulatory Program AGENCY: Office of Surface Mining... amendment to the Ohio regulatory program (the ``Ohio program'') under the Surface Mining Control and...

  12. Environmental Regulatory Update Table, January/February 1995

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1995-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  13. ALARA at nuclear power plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Baum, J.W.

    1990-01-01

    Implementation of the As Low As Reasonably Achievable (ALARA) principle at nuclear power plants presents a continuing challenge for health physicists at utility corporate and plant levels, for plant designers, and for regulatory agencies. The relatively large collective doses at some plants are being addressed though a variety of dose reduction techniques. It is planned that this report will include material on historical aspects, management, valuation of dose reduction, quantitative and qualitative aspects of optimization, design, operational considerations, and training. The status of this work is summarized in this report. 30 refs., 1 fig., 6 tabs.

  14. 78 FR 63911 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926...; S2D2SSS08011000 SX066A00033 F13XS501520] Montana Regulatory Program AGENCY: Office of Surface Mining Reclamation... regulatory program (hereinafter, the ``Montana program'') under the Surface Mining Control and Reclamation...

  15. Radioactive Waste Management in Non-Nuclear Countries - 13070

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kubelka, Dragan; Trifunovic, Dejan

    2013-07-01

    This paper challenges internationally accepted concepts of dissemination of responsibilities between all stakeholders involved in national radioactive waste management infrastructure in the countries without nuclear power program. Mainly it concerns countries classified as class A and potentially B countries according to International Atomic Energy Agency. It will be shown that in such countries long term sustainability of national radioactive waste management infrastructure is very sensitive issue that can be addressed by involving regulatory body in more active way in the infrastructure. In that way countries can mitigate possible consequences on the very sensitive open market of radioactive waste management services,more » comprised mainly of radioactive waste generators, operators of end-life management facilities and regulatory body. (authors)« less

  16. Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

    PubMed

    Johnson, Branden B; Finkel, Adam M

    2016-06-01

    Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks. © 2016 Society for Risk Analysis.

  17. Technical support to the Nuclear Regulatory Commission for the boiling water reactor blowdown heat transfer program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rice, R.E.

    Results are presented of studies conducted by Aerojet Nuclear Company (ANC) in FY 1975 to support the Nuclear Regulatory Commission (NRC) on the boiling water reactor blowdown heat transfer (BWR-BDHT) program. The support provided by ANC is that of an independent assessor of the program to ensure that the data obtained are adequate for verification of analytical models used for predicting reactor response to a postulated loss-of-coolant accident. The support included reviews of program plans, objectives, measurements, and actual data. Additional activity included analysis of experimental system performance and evaluation of the RELAP4 computer code as applied to the experiments.

  18. 7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

  19. 7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program Accounting and Regulatory Analysis. RUS, through Program Accounting and Regulatory Analysis, monitors and...

  20. Drug Development for Pediatric Populations: Regulatory Aspects

    PubMed Central

    Zisowsky, Jochen; Krause, Andreas; Dingemanse, Jasper

    2010-01-01

    Pediatric aspects are nowadays integrated early in the development process of a new drug. The stronger enforcement to obtain pediatric information by the regulatory agencies in recent years resulted in an increased number of trials in children. Specific guidelines and requirements from, in particular, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) form the regulatory framework. This review summarizes the regulatory requirements and strategies for pediatric drug development from an industry perspective. It covers pediatric study planning and conduct, considerations for first dose in children, appropriate sampling strategies, and different methods for data generation and analysis to generate knowledge about the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug in children. The role of Modeling and Simulation (M&S) in pediatrics is highlighted—including the regulatory basis—and examples of the use of M&S are illustrated to support pediatric drug development. PMID:27721363

  1. 76 FR 31379 - Notice of Issuance of Bulletin 2011-01, Mitigating Strategies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ..., Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission. Telephone: 301-415-2963; e-mail... NUCLEAR REGULATORY COMMISSION [NRC-2011-0120] Notice of Issuance of Bulletin 2011-01, Mitigating Strategies AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of Issuance. SUMMARY: The U.S. Nuclear...

  2. 78 FR 59982 - Revisions to Radiation Protection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan section; issuance. SUMMARY: The U.S. Nuclear Regulatory... for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition'': Section 12.1...

  3. 48 CFR 41.402 - Rate changes and regulatory intervention.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

  4. 48 CFR 41.402 - Rate changes and regulatory intervention.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

  5. 48 CFR 41.402 - Rate changes and regulatory intervention.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

  6. 48 CFR 41.402 - Rate changes and regulatory intervention.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

  7. 48 CFR 41.402 - Rate changes and regulatory intervention.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...

  8. Environmental Regulatory Update Table, May--June 1994

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1994-07-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  9. Environmental Regulatory Update Table, January--February 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  10. Environmental regulatory update table, March--April 1994

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1994-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  11. Environmental regulatory update table, September--October 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

    1992-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  12. Environmental Regulatory Update Table, September/October 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  13. Environmental Regulatory Update Table, January--February 1994

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1994-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  14. Environmental regulatory update table November--December 1994

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1995-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  15. Environmental Regulatory Update Table, November--December 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

    1993-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  16. Environmental Regulatory Update Table, July--August 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

    1992-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  17. Environmental Regulatory Update Table July/August 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  18. Environmental Regulatory Update Table, March/April 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  19. Environmental regulatory update table, July/August 1994

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1994-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  20. Environmental Regulatory Update Table, November--December 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1994-01-01

    The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  1. Environmental Regulatory Update Table, May/June 1993

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-07-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  2. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

  3. 75 FR 45171 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555...-3040. This guide describes some engineering practices and methods generally considered by the NRC to be... they reflect the latest general engineering approaches that are acceptable to the NRC staff. If future...

  4. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kroger, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  5. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon; Duda, Kristen

    2008-01-01

    This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

  6. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    PubMed

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  7. Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

    PubMed

    Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

    2014-12-01

    The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  8. 76 FR 81994 - UniStar Nuclear Energy; Combined License Application for Calvert Cliffs Nuclear Power Plant, Unit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 52-016; NRC-2008-0250] UniStar Nuclear Energy; Combined License Application for Calvert Cliffs Nuclear Power Plant, Unit 3; Exemption 1.0 Background: UniStar Nuclear Energy (UNE) submitted to the U.S. Nuclear Regulatory Commission (NRC or the Commission ) a...

  9. 77 FR 28467 - Identifying and Reducing Regulatory Burdens

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

    ... online wherever practicable. Sec. 3. Setting Priorities. In implementing and improving their... regulatory priorities, to promote public participation in retrospective review, to modernize our regulatory..., agencies shall give priority, consistent with law, to those initiatives that will produce significant...

  10. 77 FR 53236 - Proposed International Isotopes Fluorine Extraction Process and Depleted Uranium Deconversion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-31

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0143] Proposed International Isotopes Fluorine Extraction Process and Depleted Uranium Deconversion Plant in Lea County, New Mexico AGENCY: Nuclear Regulatory... U.S. Nuclear Regulatory Commission (NRC or the Commission) has published the Final Environmental...

  11. 77 FR 4461 - New Mexico Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... [SATS No. NM-048-FOR; Docket ID OSM-2010-0014] New Mexico Regulatory Program AGENCY: Office of Surface... approving an amendment to the New Mexico regulatory program (the ``New Mexico program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). New Mexico proposed non...

  12. 75 FR 73135 - Southern Nuclear Operating Company, Inc. Joseph M. Farley Nuclear Plant, Environmental Assessment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-348 and 50-364; NRC-2009-0375] Southern Nuclear Operating Company, Inc. Joseph M. Farley Nuclear Plant, Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an Exemption, pursuant to Title 10 of the Code of Federal...

  13. 77 FR 66650 - Proposed Revisions to Radiation Protection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Proposed Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is revising the following sections...

  14. 76 FR 40755 - Impact of Reduced Dose Limits on NRC Licensed Activities; Solicitation of Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0279] Impact of Reduced Dose Limits on NRC Licensed Activities; Solicitation of Public Comment AGENCY: Nuclear Regulatory Commission. ACTION: Solicitation of public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or Commission) is seeking public...

  15. 75 FR 14212 - Proposed Generic Communications; Applicability of 10 CFR Part 21 Requirements to Applicants for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0122] Proposed Generic Communications; Applicability of 10 CFR Part 21 Requirements to Applicants for Standard Design Certifications AGENCY: Nuclear Regulatory Commission. ACTION: Notice of opportunity for public comment. SUMMARY: The U.S. Nuclear Regulatory Commission...

  16. 78 FR 47015 - Software Requirement Specifications for Digital Computer Software Used in Safety Systems of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Requirement Specifications for Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission... issuing a revised regulatory guide (RG), revision 1 of RG 1.172, ``Software Requirement Specifications for...

  17. 7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

  18. Applying and adapting the Swedish regulatory system for decommissioning to nuclear power reactors - The regulator's perspective.

    PubMed

    Amft, Martin; Leisvik, Mathias; Carroll, Simon

    2017-03-16

    Half of the original 13 Swedish nuclear power reactors will be shut down by 2020. The decommissioning of these reactors is a challenge for all parties involved, including the licensees, the waste management system, the financing system, and the Swedish Radiation Safety Authority (SSM). This paper presents an overview of the Swedish regulations for decommissioning of nuclear facilities. It describes some of the experiences that SSM has gained from the application of these regulations. The focus of the present paper is on administrative aspects of decommissioning, such as SSM's guidelines, the definition of fundamental concepts in the regulatory framework, and a proposed revision of the licensing process according to the Environmental Act. These improvements will help to streamline the administration of the commercial nuclear power plant decommissioning projects that are anticipated to commence in Sweden in the near future. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Development of automation software for neutron activation analysis process in Malaysian nuclear agency

    NASA Astrophysics Data System (ADS)

    Yussup, N.; Rahman, N. A. A.; Ibrahim, M. M.; Mokhtar, M.; Salim, N. A. A.; Soh@Shaari, S. C.; Azman, A.

    2017-01-01

    Neutron Activation Analysis (NAA) process has been established in Malaysian Nuclear Agency (Nuclear Malaysia) since 1980s. Most of the procedures established especially from sample registration to sample analysis are performed manually. These manual procedures carried out by the NAA laboratory personnel are time consuming and inefficient. Hence, a software to support the system automation is developed to provide an effective method to replace redundant manual data entries and produce faster sample analysis and calculation process. This paper describes the design and development of automation software for NAA process which consists of three sub-programs. The sub-programs are sample registration, hardware control and data acquisition; and sample analysis. The data flow and connection between the sub-programs will be explained. The software is developed by using National Instrument LabView development package.

  20. Determining Nuclear Fingerprints: Glove Boxes, Radiation Protection, and the International Atomic Energy Agency.

    PubMed

    Rentetzi, Maria

    2017-06-01

    In a nuclear laboratory, a glove box is a windowed, sealed container equipped with two flexible gloves that allow the user to manipulate nuclear materials from the outside in an ostensibly safe environment. As a routine laboratory device, it invites neglect from historians and storytellers of science. Yet, since especially the Gulf War, glove boxes have put the interdependence of science, diplomacy, and politics into clear relief. Standing at the intersection of history of science and international history, technological materials and devices such as the glove box can provide penetrating insight into the role of international diplomatic organizations to the global circulation and control of scientific knowledge. The focus here is on the International Atomic Energy Agency. Copyright © 2017 The Author. Published by Elsevier Ltd.. All rights reserved.

  1. 75 FR 39057 - Entergy Nuclear Operations, Inc.; Entergy Nuclear Vermont Yankee, LLC; Vermont Yankee Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-271; NRC-2010-0243; License No. DPR-28] Entergy Nuclear Operations, Inc.; Entergy Nuclear Vermont Yankee, LLC; Vermont Yankee Nuclear Power Station... action with regard to the Vermont Yankee Nuclear Power Station. Mr. Mulligan requested in his petition...

  2. 76 FR 19148 - Entergy Nuclear Operations, Inc., Entergy Nuclear Vermont Yankee, LLC, Vermont Yankee Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-271; License No. DPR-28; NRC-2011-0074] Entergy Nuclear Operations, Inc., Entergy Nuclear Vermont Yankee, LLC, Vermont Yankee Nuclear Power Station... regard to the Vermont Yankee Nuclear Power Station (VY). Mr. Saporito requested in his petition that the...

  3. 76 FR 40118 - Spring 2011 Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... Protection Agency (EPA) publishes the semiannual regulatory agenda online (the e-Agenda) at http://www... that, until 2007, was published in the Federal Register but that now is only available through an... publish it in the Federal Register because that is what is required by the Regulatory Flexibility Act of...

  4. 77 FR 15090 - Proposed Agency Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-14

    ... DEPARTMENT OF ENERGY Proposed Agency Information Collection AGENCY: U.S. Department of Energy, DOE... collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed...: Written comments should be sent to the: DOE Desk Officer, Office of Information and Regulatory Affairs...

  5. 78 FR 5438 - Proposed Agency Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... DEPARTMENT OF ENERGY National Nuclear Security Administration Proposed Agency Information Collection AGENCY: National Nuclear Security Administration, U.S. Department of Energy. ACTION: Notice and... techniques or other forms of information technology. DATES: Comments regarding this proposed information...

  6. MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Phillips, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  7. 75 FR 6063 - Availability of NRC Open Government Web Site

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0003] Availability of NRC Open Government Web Site AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability of Open Government Web site for Online... Register notice, informs the public that the Nuclear Regulatory Commission's (NRC) Open Government Web site...

  8. 76 FR 50500 - Request for Comments on the Draft Policy Statement on Volume Reduction and Low-Level Radioactive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0183] Request for Comments on the Draft Policy Statement on Volume Reduction and Low-Level Radioactive Waste Management AGENCY: Nuclear Regulatory Commission. ACTION: Request for public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is revising its...

  9. 44 CFR Appendix A to Part 353 - Memorandum of Understanding Between Federal Emergency Management Agency and Nuclear Regulatory...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY... responsibility to “* * * establish Federal policies for, and coordinate, all civil defense and civil emergency... report delineating milestones for preparation of the plan by the offsite authorities as well as FEMA's...

  10. 77 FR 41454 - Entergy Nuclear Indian Point Unit 2, LLC, Entergy Nuclear Indian Point Unit 3, LLC, Entergy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2012-0168] Entergy Nuclear Indian Point Unit 2, LLC, Entergy Nuclear Indian Point Unit 3, LLC, Entergy Nuclear Operations, Inc., Indian Point Nuclear Generating Units 2 and 3; Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC...

  11. US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

    PubMed

    McHughen, Alan; Smyth, Stuart

    2008-01-01

    This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

  12. 77 FR 1089 - Sunshine Act Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0002] Sunshine Act Meetings AGENCY: Agency Holding the Meetings: Nuclear Regulatory Commission DATES: Week of January 9, 2012. Place: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. Status: Public and Closed. Additional Items To Be Considered: Week of January 9, 2012 Wednesday,...

  13. 77 FR 19276 - Proposed Agency Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... DEPARTMENT OF ENERGY Proposed Agency Information Collection AGENCY: U.S. Department of Energy, DOE... and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the... should be sent to the DOE Desk Officer, Office of Information and Regulatory Affairs, Office of...

  14. 78 FR 24438 - Evaluations of Explosions Postulated To Occur at Nearby Facilities and on Transportation Routes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... Nearby Facilities and on Transportation Routes Near Nuclear Power Plants AGENCY: Nuclear Regulatory... Nearby Facilities and on Transportation Routes Near Nuclear Power Plants.'' This regulatory guide describes for applicants seeking nuclear power reactor licenses and licensees of nuclear power reactors...

  15. 78 FR 66785 - Luminant Generation Company, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 52-034 and 52-035; NRC-2008-0594] Luminant Generation Company, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Notice of receipt; availability. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is giving notice once each week for four consecutive weeks...

  16. 76 FR 76327 - Installation of Radiation Alarms for Rooms Housing Neutron Sources

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-07

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [Docket Nos. PRM-73-15; NRC-2011-0251] Installation of Radiation Alarms for Rooms Housing Neutron Sources AGENCY: Nuclear Regulatory Commission. ACTION: Petition for rulemaking; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the...

  17. 76 FR 12373 - Notice of Availability of Final Supplement to the Environmental Assessment for the Proposed Pa...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 30-36974; NRC-2010-0374] Notice of Availability of Final... AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. SUMMARY: Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) has published a Final Supplement to the Environmental...

  18. 78 FR 63501 - Request To Submit a Two-Part Application-Northwest Medical Isotopes, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... NUCLEAR REGULATORY COMMISSION [Project No. 0803; NRC-2013-0235] Request To Submit a Two-Part Application--Northwest Medical Isotopes, LLC AGENCY: Nuclear Regulatory Commission. ACTION: Exemption. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an August 9, 2013...

  19. 76 FR 24831 - Alternative to Minimum Days Off Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 RIN 3150-AI94 [NRC-2011-0058] Alternative to Minimum Days Off Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule; correction. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is correcting a proposed rule that appeared in the...

  20. 78 FR 69140 - CSMI, LLC; Request for Action

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0250] CSMI, LLC; Request for Action AGENCY: Nuclear Regulatory Commission. ACTION: Request for action; receipt. SUMMARY: The U.S. Nuclear Regulatory... petitioner) has requested that the NRC take action with regard to CSMI. The petitioner's requests are...

  1. 76 FR 23845 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... approach that the staff of the NRC considers acceptable for use in developing an appropriate surveillance... steel. The recommendations described in this draft regulatory guide are an approach acceptable to the...

  2. Regulatory requirements and tools for environmental assessment of hazardous wastes: Understanding tribal and stakeholder concerns using Department of Energy sites

    PubMed Central

    Burger, Joanna; Powers, Charles; Gochfeld, Michael

    2014-01-01

    Many US governmental and Tribal Nation agencies, as well as state and local entities, deal with hazardous wastes within regulatory frameworks that require specific environmental assessments. In this paper we use Department of Energy (DOE) sites as examples to examine the relationship between regulatory requirements and environmental assessments for hazardous waste sites and give special attention to how assessment tools differ. We consider federal laws associated with environmental protection include the National Environmental Policy Act (NEPA), the Resource Conservation and Recovery Act (RCRA), the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), as well as regulations promulgated by the Nuclear Regulatory Commission, Tribal Nations and state agencies. These regulatory regimes require different types of environmental assessments and remedial investigations, dose assessments and contaminant pathways. The DOE case studies illustrate the following points: 1) there is often understandable confusion about what regulatory requirements apply to the site resources, and what environmental assessments are required by each, 2) the messages sent on site safety issued by different regulatory agencies are sometimes contradictory or confusing (e.g. Oak Ridge Reservation), 3) the regulatory frameworks being used to examine the same question can be different, leading to different conclusions (e.g. Brookhaven National Laboratory), 4) computer models used in support of groundwater models or risk assessments are not necessarily successful in convincing Native Americans and others that there is no possibility of risk from contaminants (e.g. Amchitka Island), 5) when given the opportunity to choose between relying on a screening risk assessments or waiting for a full site-specific analysis of contaminants in biota, the screening risk assessment option is rarely selected (e.g. Amchitka, Hanford Site), and finally, 6) there needs to be agreement on whether

  3. 76 FR 39991 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... Deregulatory Actions. SUMMARY: The Regulatory Flexibility Act requires that agencies publish semiannual... agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the... Published? III. How Is the Unified Agenda Organized? IV. What Information Appears for Each Entry? V...

  4. 77 FR 21785 - Medical Countermeasures Initiative Regulatory Science Symposium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Medical Countermeasures Initiative Regulatory Science Symposium AGENCY: Food and Drug Administration, HHS...: Medical Countermeasures Initiative Regulatory Science Symposium. The symposium is intended to provide a...

  5. Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

    PubMed Central

    Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

    2015-01-01

    While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

  6. 77 FR 33253 - Regulatory Guide 8.33, Quality Management Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0126] Regulatory Guide 8.33, Quality Management Program... Regulatory Commission (NRC or Commission) is withdrawing Regulatory Guide (RG) 8.33, ``Quality Management... Quality Management Program was deleted from the regulations as part of an overall revision in 2002 of the...

  7. 78 FR 51753 - AUC, LLC Reno Creek, In Situ Project, New Source Material License Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 040-09092; [NRC-2013-0164] AUC, LLC Reno Creek, In Situ Project, New Source Material License Application AGENCY: Nuclear Regulatory Commission. ACTION: Notice of..., AUC, LLC (AUC) submitted to the U.S. Nuclear Regulatory Commission (NRC) an application for a new...

  8. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

  9. Cyclosporin A and FK-506 both affect DNA binding of regulatory nuclear proteins to the human interleukin-2 promoter.

    PubMed

    Baumann, G; Geisse, S; Sullivan, M

    1991-03-01

    The structurally unrelated immunosuppressive drugs cyclosporin A (Sandimmun) and FK-506 both interfere with the process of T-cell proliferation by blocking the transcription of the T-cell growth factor interleukin-2 (IL-2). Here we demonstrate that the transcriptional activation of this gene requires the binding of regulatory nuclear proteins to a promoter element with sequence similarity to the consensus binding site for NF-kappa B-related transcription factors. We present evidence that the binding by regulatory nuclear proteins to the kappa B element of the IL-2 promoter is affected negatively by cyclosporin A and FK-506 at concentrations paralleling their immunosuppressive activity in vivo. The decrease in DNA-protein complex formation induced by the immunosuppressive drugs correlates with a decrease in IL-2 production. FK-506 is 10 to 100 times more potent than cyclosporin A in its ability to inhibit sequence-specific DNA binding and IL-2 production. Our findings suggest that the actions of both drugs converge at the level of DNA-protein interaction.

  10. 75 FR 14639 - Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 1, 2, and 3...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-003, 50-247, and 50-286; NRC-2010-0137] Entergy Nuclear Operations, Inc.; Indian Point Nuclear Generating Unit Nos. 1, 2, and 3; Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an exemption, pursuant to Title 10 of...

  11. 75 FR 69137 - Southern Nuclear Operating Company Inc. Edwin I. Hatch Nuclear Plant, Unit No. 2 Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-366; NRC-2010-0345] Southern Nuclear Operating Company Inc. Edwin I. Hatch Nuclear Plant, Unit No. 2 Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of an exemption from Title 10 of the Code of Federal Regulations, ...

  12. 77 FR 59702 - Promoting U.S. EC Regulatory Compatibility

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ... TRADE REPRESENTATIVE Promoting U.S. EC Regulatory Compatibility AGENCY: Office of the United... and European Commission (EC) share the goal of reducing excessive regulatory costs, unjustified..., safety, welfare, and the environment. Promoting this goal will help businesses to grow, create jobs, and...

  13. 75 FR 21885 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... regulatory plan. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch, at... Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat Branch, Office of...: 202 501-4755 Fax: 202 501-4067 Email: hada.flowers@gsa.gov RIN: 3090-AI32 276. GSAR CASE 2008-G517...

  14. 75 FR 8150 - STP Nuclear Operating Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-498 and 50-499; NRC-2010-060] STP Nuclear Operating... The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an exemption, pursuant to...,'' for Facility Operating [[Page 8151

  15. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

    PubMed

    Sneve, M K; Kiselev, M; Shandala, N K

    2014-05-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  16. 77 FR 48177 - Fuel Oil Systems for Emergency Power Supplies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0159] Fuel Oil Systems for Emergency Power Supplies AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; extension of comment period. SUMMARY: On... Regulatory Guide, DG- 1282, ``Fuel Oil Systems for Emergency Power Supplies,'' in the Federal Register for a...

  17. 77 FR 62538 - Advisory Committee on the Medical Uses of Isotopes: Call for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ...) nuclear medicine physicist; (d) therapy medical physicist; (e) radiation safety officer; (f) nuclear... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Call for Nominations AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Call for nominations. SUMMARY: The U.S...

  18. 77 FR 29697 - Honeywell Metropolis Works; Grant of Exemption for Honeywell Metropolis Works License

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-18

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 40-3392; NRC-2012-0111] Honeywell Metropolis Works; Grant of Exemption for Honeywell Metropolis Works License AGENCY: Nuclear Regulatory Commission. ACTION...

  19. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

  20. 75 FR 3761 - Southern Nuclear Operating Company, Inc., Edwin I. Hatch Nuclear Plant, Units 1 and 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-321 and 50-366; NRC-2010-0024] Southern Nuclear Operating Company, Inc., Edwin I. Hatch Nuclear Plant, Units 1 and 2; Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an Exemption, pursuant to Title 10 of the Code of...

  1. 76 FR 40208 - Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    .... ACTION: Semiannual regulatory agenda. SUMMARY: The Securities and Exchange Commission is publishing an... INFORMATION: The RFA requires each Federal agency, during April and October of each year, to publish in the...

  2. FEDERAL RULEMAKING: Procedural and Analytical Requirements at OSHA and Other Agencies

    DTIC Science & Technology

    2001-06-14

    informal rulemaking. Formal rulemaking is used in ratemaking proceedings and in certain other cases when rules are required by statute to be made “on...crosscutting statutory requirements that I have just listed are by no means the only statutory requirements that guide agency rulemaking. Regulations generally...directives designed to guide the federal rulemaking process, often with the goal of reducing regulatory burden. Although independent regulatory agencies are

  3. Environmental Regulatory Update Table, March/April 1993. Revision 1

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1993-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  4. 78 FR 20664 - 2013 Medical Countermeasures Initiative Regulatory Science Symposium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] 2013 Medical Countermeasures Initiative Regulatory Science Symposium AGENCY: Food and Drug... following meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The...

  5. 75 FR 6223 - PSEG Nuclear LLC; Hope Creek Generating Station and Salem Nuclear Generating Station, Unit Nos. 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-272, 50-311 and 50-354; NRC-2010-0043] PSEG Nuclear LLC; Hope Creek Generating Station and Salem Nuclear Generating Station, Unit Nos. 1 and 2; Environmental Assessment and Finding of No Significant Impact The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an Exemption, pursuant...

  6. 78 FR 54517 - Water Quality Standards Regulatory Clarifications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

    ... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

  7. 75 FR 39057 - Sunshine Federal Register Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Federal Register Notice Agency Holding the Meetings: Nuclear Regulatory Commission. Date: Weeks of July 5, 12, 19, 26, August 2, 9, 2010. Place... Licensing Board Initial Decision (Tentative). b. Entergy Nuclear Operations, Inc. (Indian Point Nuclear...

  8. 77 FR 17102 - Sunshine Federal Register Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-23

    ...) (Tentative). a. FirstEnergy Nuclear Operating Co. (Davis-Besse Nuclear Power Station, Unit 1), Appeal of LBP... NUCLEAR REGULATORY COMMISSION Sunshine Federal Register Notice AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission, [NRC-2012- 0002]. DATE: Week of March 26, 2012. PLACE: Commissioners...

  9. 77 FR 17529 - Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... scientific and non-scientific disciplines including nuclear medicine; nuclear cardiology; radiation therapy... NUCLEAR REGULATORY COMMISSION Notice of Charter Renewal: Advisory Committee on the Medical Uses of Isotopes AGENCY: U.S. Nuclear Regulatory Commission. ACTION: This notice is to announce the renewal of the...

  10. The Architectural Organization of Human Stem Cell Cycle Regulatory Machinery

    PubMed Central

    Stein, Gary S.; Stein, Janet L.; Wijnen, Andre van J; Lian, Jane B.; Montecino, Martin; Medina, Ricardo; Kapinas, Kristie; Ghule, Prachi; Grandy, Rodrigo; Zaidi, Sayyed K.; Becker, Klaus A.

    2013-01-01

    Two striking features of human embryonic stem cells that support biological activity are an abbreviated cell cycle and reduced complexity to nuclear organization. The potential implications for rapid proliferation of human embryonic stem cells within the context of sustaining pluripotency, suppressing phenotypic gene expression and linkage to simplicity in the architectural compartmentalization of regulatory machinery in nuclear microenvironments is explored. Characterization of the molecular and architectural commitment steps that license human embryonic stem cells to initiate histone gene expression is providing understanding of the principal regulatory mechanisms that control the G1/S phase transition in primitive pluripotent cells. From both fundamental regulatory and clinical perspectives, further understanding of the pluripotent cell cycle in relation to compartmentalization of regulatory machinery in nuclear microenvironments is relevant to applications of stem cells for regenerative medicine and new dimensions to therapy where traditional drug discovery strategies have been minimally effective. PMID:22394165

  11. 78 FR 70905 - Extension of Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... Comment Period for the Water Quality Standards Regulatory Clarifications Proposed Rule AGENCY... Environmental Protection Agency (EPA) is extending the comment period for the proposed rule ``Water Quality... published the proposed rule ``Water Quality Standards Regulatory Clarifications'' in the Federal Register...

  12. 75 FR 3497 - Entergy Nuclear Operations, Inc., Entergy Nuclear Indian Point 2, LLC, Entergy Nuclear Indian...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-21

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-247 and 50-286; NRC-2010-0006] Entergy Nuclear Operations, Inc., Entergy Nuclear Indian Point 2, LLC, Entergy Nuclear Indian Point 3, LLC,: Indian Point Nuclear Generating Unit Nos. 2 and 3; Notice of Consideration of Issuance of Amendment to Facility Operating License and Opportunity To Request a...

  13. 75 FR 33361 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... staff needs in its review of applications for permits and licenses. Revision 4 of Regulatory Guide 1.28... (Design and Construction).'' Proposed RG 1.28, Revision 4, extends the scope of the NRC's endorsement to...: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.28...

  14. 76 FR 32379 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... asked to report: NRC contractors, licensees, applicants, and other (e.g. intervenor's) who marry or.... Mail comments to NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission... Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001...

  15. 75 FR 21773 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Register is mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U... the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because... Flexibility Act. Printing of these entries is limited to fields that contain information required by the...

  16. 77 FR 62539 - Sunshine Federal Register Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... NUCLEAR REGULATORY COMMISSION Sunshine Federal Register Notice AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission [NRC-2012- 0002]. DATE: Weeks of October 8, 15, 22, 29, November 5, 12, 19... Meeting) (Tentative) a. Entergy Nuclear Operations, Inc. (Indian Point Nuclear Generating Units 2 and 3...

  17. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    ... nuclear power plants. In response to a request from the Nuclear Energy Institute (NEI), the NRC is... NUCLEAR REGULATORY COMMISSION [NRC-2011-0191] Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience AGENCY: Nuclear Regulatory Commission. ACTION: Draft...

  18. 76 FR 81996 - Entergy Operations, Inc.; Notice of Intent To Prepare an Environmental Impact Statement and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-416; NRC-2011-0262] Entergy Operations, Inc.; Notice... Nuclear Station, Unit 1 AGENCY: Nuclear Regulatory Commission. ACTION: Intent to prepare environmental... years of operation at Grand Gulf Nuclear Station, Unit 1 (GGNS). GGNS is located in Claiborne County...

  19. 75 FR 6064 - Draft Emergency Action Level Frequently Asked Questions; Request for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-05

    ... provide clarification of endorsed Nuclear Energy Institute (NEI) guidance related to the development of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0034] Draft Emergency Action Level Frequently Asked Questions; Request for Comment AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability and...

  20. 77 FR 13155 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... form of surveys, e.g., telephonic and electronic surveys/polls and facsimiles. Submit, by May 4, 2012..., Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about... (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415...

  1. Characterization of the evolution of the pharmaceutical regulatory environment.

    PubMed

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  2. 77 FR 61596 - Illinois Electric Agency; Notice of Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-2-000] Illinois Electric Agency; Notice of Filing Take notice that on October 1, 2012, Illinois Electric Agency filed its Revised and Superseding Proposed Revenue Requirement for reactive supply service under Midwest Independent...

  3. 78 FR 28652 - Advisory Committee on the Medical Uses of Isotopes: Call for Nominations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-15

    ...; (d) therapy physicist; (e) radiation safety officer; (f) nuclear pharmacist; (g) two radiation... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Call for Nominations AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Call for Nominations. SUMMARY: The U.S...

  4. 75 FR 36717 - Washington State University; Notice of Acceptance for Docketing and Opportunity for Hearing on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... University (the licensee, WSU) to operate the Washington State University Modified TRIGA Nuclear Radiation... NUCLEAR REGULATORY COMMISSION [Docket No. 50-27; Facility Operating License No. R-76; NRC-2010... Safeguards Information and Sensitive Unclassified Non-Safeguards Information AGENCY: Nuclear Regulatory...

  5. 78 FR 59073 - Pacific Gas and Electric Company; Humboldt Bay Independent Spent Fuel Storage Installation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... AGENCY: Nuclear Regulatory Commission. ACTION: License amendment application; issuance. SUMMARY: The U.S...: 301-287- 3422; email: [email protected] . For technical questions, contact the individual(s...: Chris Allen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission...

  6. 76 FR 76192 - NRC Enforcement Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0273] NRC Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Proposed enforcement policy revision; request for comment. SUMMARY: The U.S. Nuclear... licensees, vendors, and contractors), on proposed revisions to the NRC's Enforcement Policy (the Policy) and...

  7. 75 FR 47856 - Draft Emergency Action Level Frequently Asked Questions; Request for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... provide clarification of guidance submitted by the Nuclear Energy Institute (NEI) and endorsed by the NRC... NUCLEAR REGULATORY COMMISSION [NRC-2010-0273] Draft Emergency Action Level Frequently Asked Questions; Request for Comment AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability and...

  8. 76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... NRC staff's evaluation of the suitability of using Revision 3 of the Nuclear Energy Institute's (NEI... NUCLEAR REGULATORY COMMISSION [NRC-2011-0228] Interim Staff Guidance on Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance...

  9. 78 FR 69139 - Physical Security-Design Certification and Operating Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... scheduled to close on October 30, 2013. The Nuclear Energy Institute (NEI) submitted a letter on October 9... NUCLEAR REGULATORY COMMISSION [NRC-2013-0225] Physical Security--Design Certification and Operating Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan--draft section...

  10. 78 FR 29390 - Applications; SHINE Medical Technologies, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-20

    ... NUCLEAR REGULATORY COMMISSION [Proj-0792; NRC-2013-0053] Applications; SHINE Medical Technologies, Inc. AGENCY: Nuclear Regulatory Commission. ACTION: Notice; receipt and availability. FOR FURTHER... (ADAMS) Accession No. ML13088A192), SHINE Medical Technologies (SHINE) filed with the U.S. Nuclear...

  11. 78 FR 73897 - SHINE Medical Technologies, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 50-608; NRC-2013-0053] SHINE Medical Technologies, Inc. AGENCY: Nuclear Regulatory Commission. ACTION: License application; docketing. SUMMARY: The U.S. Nuclear... construction permit, submitted by SHINE Medical Technologies, Inc. (SHINE) is acceptable for docketing...

  12. Human Factors Research and Nuclear Safety.

    ERIC Educational Resources Information Center

    Moray, Neville P., Ed.; Huey, Beverly M., Ed.

    The Panel on Human Factors Research Needs in Nuclear Regulatory Research was formed by the National Research Council in response to a request from the Nuclear Regulatory Commission (NRC). The NRC asked the research council to conduct an 18-month study of human factors research needs for the safe operation of nuclear power plants. This report…

  13. 77 FR 66492 - Entergy Nuclear Operations, Inc., Entergy Nuclear Indian Point 2, LLC, and Entergy Nuclear Indian...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-05

    ... NUCLEAR REGULATORY COMMISSION [Docket Nos.: 50-003, 50-247, 50-286; NRC-2012-0265: License Nos.: DPR- 5, DPR-26, and DPR-64] Entergy Nuclear Operations, Inc., Entergy Nuclear Indian Point 2, LLC, and Entergy Nuclear Indian Point 3, LLC; Issuance of Director's Decision Notice is hereby given that the Director, Office of Nuclear Reactor Regulation...

  14. 78 FR 77606 - Security Requirements for Facilities Storing Spent Nuclear Fuel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... regulatory basis; availability of responses to public comments. SUMMARY: The U.S. Nuclear Regulatory... to Carol Gallagher; telephone: 301-287- 3422; email: [email protected] . For technical... Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001...

  15. 75 FR 79751 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries include only: (1) Rules that are in the Agency's regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely to have a significant...

  16. How health technology assessment agencies address the issue of unpublished data.

    PubMed

    Kreis, Julia; Panteli, Dimitra; Busse, Reinhard

    2014-01-01

    Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

  17. 75 FR 44781 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on August 11, 2010, from 9 a.m...

  18. 75 FR 66362 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting on November 5, 2010, from 9 a.m...

  19. 78 FR 9743 - Event Reporting Guidelines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0237] Event Reporting Guidelines AGENCY: Nuclear... Regulatory Commission (NRC) has issued NUREG- 1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73.'' [[Page 9744

  20. The Projected Impacts to Clark County and Local Governmental Public Safety Agencies Resulting from the Transportation of High-Level Nuclear Waste to Yucca Mountain

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mushkatel, A.H.; Conway, S.; Navis, I.

    2006-07-01

    This paper focuses on the difficulties of projecting fiscal impacts to public safety agencies from the proposed high-level nuclear waste repository at Yucca Mountain, Nevada. The efforts made by Clark County Nevada, to develop a fiscal model of impacts for public safety agencies are described in this paper. Some of the difficulties in constructing a fiscal model of impacts for the entire 24 year high-level nuclear waste transportation shipping campaign are identified, and a refined methodology is provided to accomplish this task. Finally, a comparison of the fiscal impact projections for public safety agencies that Clark County developed in 2001,more » with those done in 2005 is discussed, and the fiscal impact cost projections for the entire 24 year transportation campaign are provided. (authors)« less