Science.gov

Sample records for 95-4 regulatory status

  1. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 2 2012-10-01 2012-10-01 false Regulatory status. 27.10 Section 27.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Applications and Licenses § 27.10 Regulatory status. The following rules apply...

  2. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 2 2014-10-01 2014-10-01 false Regulatory status. 27.10 Section 27.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Applications and Licenses § 27.10 Regulatory status. The following rules apply...

  3. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 2 2013-10-01 2013-10-01 false Regulatory status. 27.10 Section 27.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Applications and Licenses § 27.10 Regulatory status. The following rules apply...

  4. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a)...

  5. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 2 2011-10-01 2011-10-01 false Regulatory status. 27.10 Section 27.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Applications and Licenses § 27.10 Regulatory status. The following rules apply...

  6. 47 CFR 27.10 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 2 2010-10-01 2010-10-01 false Regulatory status. 27.10 Section 27.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES MISCELLANEOUS WIRELESS COMMUNICATIONS SERVICES Applications and Licenses § 27.10 Regulatory status. The following rules apply...

  7. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  8. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  9. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory...

  10. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory...

  11. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory...

  12. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory...

  13. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory...

  14. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Definitions. 95.4 Section 95.4 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION GENERAL ADMINISTRATION-GRANT PROGRAMS (PUBLIC ASSISTANCE, MEDICAL ASSISTANCE AND STATE CHILDREN'S HEALTH INSURANCE PROGRAMS) Time Limits for States To...

  15. Current status of herbal product: Regulatory overview

    PubMed Central

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

  16. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Change in regulatory status....

  17. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status....

  18. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Opt-in Units § 97.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status....

  19. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Change in regulatory status....

  20. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Opt-in Units § 97.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Change in regulatory status....

  1. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Opt-in Units § 97.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status....

  2. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Opt-in Units § 97.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Change in regulatory status....

  3. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Opt-in Units § 97.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Change in regulatory status....

  4. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Change in regulatory status. 96.87... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget...

  5. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Change in regulatory status. 96.187... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO 2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in...

  6. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Change in regulatory status. 96.287... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO 2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2...

  7. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Change in regulatory status. 96.287... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO 2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO 2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2...

  8. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 21 2014-07-01 2014-07-01 false Change in regulatory status. 96.187... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in...

  9. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 22 2013-07-01 2013-07-01 false Change in regulatory status. 96.87... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO 2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget...

  10. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304, then the CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change....

  11. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CAIR NOX Ozone Season Opt-in Units § 96.387 Change in regulatory status. (a) Notification. If a CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304, then the CAIR... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change....

  12. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Change in regulatory status. 96.87... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget...

  13. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Change in regulatory status. 96.287... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in...

  14. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 96.187... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in...

  15. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 96.87... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget...

  16. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 21 2011-07-01 2011-07-01 false Change in regulatory status. 96.187... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in...

  17. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 96.287... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in...

  18. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Review and construction. 95.4 Section 95.4 Foreign Relations DEPARTMENT OF STATE LEGAL AND RELATED SERVICES IMPLEMENTATION OF TORTURE CONVENTION IN EXTRADITION CASES § 95.4 Review and construction. Decisions of the Secretary concerning surrender of...

  19. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Review and construction. 95.4 Section 95.4 Foreign Relations DEPARTMENT OF STATE LEGAL AND RELATED SERVICES IMPLEMENTATION OF TORTURE CONVENTION IN EXTRADITION CASES § 95.4 Review and construction. Decisions of the Secretary concerning surrender of...

  20. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Review and construction. 95.4 Section 95.4 Foreign Relations DEPARTMENT OF STATE LEGAL AND RELATED SERVICES IMPLEMENTATION OF TORTURE CONVENTION IN EXTRADITION CASES § 95.4 Review and construction. Decisions of the Secretary concerning surrender of...

  1. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Review and construction. 95.4 Section 95.4 Foreign Relations DEPARTMENT OF STATE LEGAL AND RELATED SERVICES IMPLEMENTATION OF TORTURE CONVENTION IN EXTRADITION CASES § 95.4 Review and construction. Decisions of the Secretary concerning surrender of...

  2. 22 CFR 95.4 - Review and construction.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Review and construction. 95.4 Section 95.4 Foreign Relations DEPARTMENT OF STATE LEGAL AND RELATED SERVICES IMPLEMENTATION OF TORTURE CONVENTION IN EXTRADITION CASES § 95.4 Review and construction. Decisions of the Secretary concerning surrender of...

  3. 77 FR 65840 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-31

    ... FR 46339-46340, Docket No. APHIS-2012-0001), an advance notice of proposed rulemaking (ANPR) to... Chrysanthemum White Rust Regulatory Status and Restrictions AGENCY: Animal and Plant Health Inspection Service... whether and how we should amend our process for responding to domestic chrysanthemum white rust...

  4. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  5. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  6. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  7. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  8. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting...

  9. 40 CFR 95.4 - Limitations on mandatory licenses

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the following limitations:...

  10. 40 CFR 95.4 - Limitations on mandatory licenses

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the following limitations:...

  11. 40 CFR 95.4 - Limitations on mandatory licenses.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses. (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the...

  12. 40 CFR 95.4 - Limitations on mandatory licenses

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the following limitations:...

  13. 40 CFR 95.4 - Limitations on mandatory licenses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) MANDATORY PATENT LICENSES § 95.4 Limitations on mandatory licenses. (a) If the Administrator, or the Administrator's designee, decides to apply to the Attorney General for a mandatory patent license in accordance with § 95.3, the application shall include a proposed patent license with the following limitations:...

  14. The Regulatory Status of Genome-edited Crops.

    PubMed

    Wolt, Jeffrey D; Wang, Kan; Yang, Bing

    2016-02-01

    Genome editing with engineered nucleases (GEEN) represents a highly specific and efficient tool for crop improvement with the potential to rapidly generate useful novel phenotypes/traits. Genome editing techniques initiate specifically targeted double strand breaks facilitating DNA-repair pathways that lead to base additions or deletions by non-homologous end joining as well as targeted gene replacements or transgene insertions involving homology-directed repair mechanisms. Many of these techniques and the ancillary processes they employ generate phenotypic variation that is indistinguishable from that obtained through natural means or conventional mutagenesis; and therefore, they do not readily fit current definitions of genetically engineered or genetically modified used within most regulatory regimes. Addressing ambiguities regarding the regulatory status of genome editing techniques is critical to their application for development of economically useful crop traits. Continued regulatory focus on the process used, rather than the nature of the novel phenotype developed, results in confusion on the part of regulators, product developers, and the public alike and creates uncertainty as of the use of genome engineering tools for crop improvement. PMID:26251102

  15. Regulatory ozone modeling: status, directions, and research needs.

    PubMed Central

    Georgopoulos, P G

    1995-01-01

    The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAQSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAQSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model's performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. Selected interim results from diagnostic analyses, which are performed as a component of the regulatory ozone modeling process for the Philadelphia-New Jersey region, are also presented to provide some specific examples related to the general issues discussed in this work. Finally, research needs related to a) the evaluation and refinement of regulatory ozone modeling, b) the characterization of uncertainty in photochemical modeling, and c

  16. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    SciTech Connect

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed.

  17. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Samples § 761.257 Determining the regulatory status of sampled pipe. (a) For purposes of removal for disposal of a pipe segment that has been sampled, the sample results for that segment determines its...

  18. Regulatory Organizations for Physicians’ Status and Administrative Sanctions on Physicians

    PubMed Central

    MORIOKA, Yasuhiko; HIGUCHI, Norio; KUROYANAGI, Tatsuo; NUDESHIMA, Jiro

    2014-01-01

    Society bestows professional privilege on physicians. At the same time, it expects physicians to strive constantly to improve their ethics and quality in medical expertise. In every nation, some level of government is responsible for certifying or licensing physicians and imposes strict management, including revoking licenses from inappropriate physicians or providing severe sanctions for misconduct or conduct unbecoming of a physician. In reality, however, it is difficult to reduce the number of inappropriate or indiscreet physicians, and each nation faces its own challenges. We conducted a questionnaire survey of 13 national medical associations, including some major Western countries, regarding the licensing of physicians, the organizations managing their medical practice status, and the data and grounds for administrative sanctioning of physicians. We then examined the circumstances in Japan based on the survey results and pointed out the domestic issues. PMID:25784827

  19. Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics.

    PubMed

    Kim, Mi-Gyeong; Kim, Dongyoon; Suh, Soo-Kyung; Park, Zewon; Choi, Min Joung; Oh, Yu-Kyoung

    2016-04-01

    Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody-drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy. PMID:26895243

  20. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs) in Taiwan

    PubMed Central

    Tsai, Wen-Tien

    2010-01-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years. PMID:21139852

  1. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    PubMed

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users. PMID:18994682

  2. Technical Status Report of the Regulatory Assistance Project: October 2001-February 2003

    SciTech Connect

    Not Available

    2003-08-01

    This report details the work undertaken from October 2001 to February 2003 by the Regulatory Assistance Project under subcontract to the National Renewable Energy Laboratory. The objectives of this work were to develop regulatory policy options that would reduce the institutional and infrastructure barriers to full-value deployment of distributed power systems. Specific tasks included leading technical workshops on removing or overcoming regulatory barriers to distributed resources for state utility regulators and developing a draft model rule on emission performance standards for distributed generation.

  3. Harmonization of regulatory guidelines on efficacy of ectoparasiticides for companion animals: status and missing points.

    PubMed

    Curet Bobey, Marianne

    2015-02-28

    Ectoparasites of major clinical significance in companion animals include fleas, ticks, lice, mange, mite, mosquitoes and sandflies, as well as biting flies. Obtaining a marketing authorization (or licence) for an ectoparasiticide relies on the assessment by regulatory agencies of a comprehensive data package to confirm the quality, safety and efficacy of the product when used in the target animal species for the proposed claims. Such approval is done under a highly regulated system. However, the global regulatory framework for pet ectoparasiticides is complex, since these products may be classified either as pesticides or as pharmaceuticals depending on the country or even within a given country, based on the presentation or mode of action. Within each jurisdiction, regulatory guidelines provide standards relating to study designs, relevant parasite species, efficacy calculation and acceptable thresholds, and define the corresponding acceptable label claims. Despite some similarities, there is no formal international harmonization for development requirements. In some areas, gaps and/or inconsistencies are more marked than others. Published recommendations from scientific expert groups (e.g. W.A.A.V.P. guidelines) are therefore a useful tool for regulatory bodies, researchers, developers and animal health companies. These expert recommendations reflect the current position of the scientific community and potentially address aspects not covered satisfactorily by regulatory texts while taking into account the latest advancements in experimental methodologies. Since the changes to official regulatory texts generally occur at a slower pace than the scientific state-of-the-art, and because of the lack of a harmonized approach, both scientific and regulatory guidance documents are necessary. The main objective of this review is to explore the complexity of the international regulatory framework for pet ectoparasiticides and to highlight some areas that are

  4. Classical Hodgkin Lymphoma with Positive Epstein-Barr Virus Status is Associated with More FOXP3 Regulatory T Cells.

    PubMed

    Pavlovic, Antonia; Glavina Durdov, Merica; Capkun, Vesna; Jakelic Pitesa, Jasminka; Bozic Sakic, Maja

    2016-01-01

    BACKGROUND Classical Hodgkin lymphoma (cHL) is characterized by sparse malignant Hodgkin and Reed-Sternberg cells dispersed in an inflammatory microenvironment. Immune evasion of malignant cells is partially due to the existence of a subpopulation of immunosuppressive regulatory T cells (Treg). The aim of this study was to analyze T cell composition in cHL with special emphasis on Treg in regard to Epstein-Barr virus (EBV) status, subtype, and patient age. MATERIAL AND METHODS The study included 102 patients with cHL diagnosed during a 12-year period. EBV status of cHL was assessed immunohistochemically using antibodies directed to the EBV- encoded LMP1. To define T lymphocyte populations, slides were double-stained with FOXP3 for Treg, and CD4 or CD8 for T cells. In each case the number of single- and/or double-positive cells was counted on an image analyzer in 10 high-power fields. Statistical analysis was performed and differences were considered significant at P<0.05. RESULTS EBV-positive status of cHL was confirmed in 30 (29%) cases, mainly in patients older than 54 years and in mixed cellularity subtype. In EBV-positive cHL, higher numbers of CD8+ cells were found. In cHL with positive EBV status, more FOXP3+ Treg were found, as well as higher numbers of FOXP3+CD4+ Treg compared with EBV-negative cHL. The number of CD4+ cells decreased with age. The frequency of FOXP3+CD8+ Treg was variable, without a statistically significant association with age or EBV status. CONCLUSIONS EBV status has an impact on composition of T cell populations in the cHL microenvironment. PMID:27377121

  5. Classical Hodgkin Lymphoma with Positive Epstein-Barr Virus Status is Associated with More FOXP3 Regulatory T Cells

    PubMed Central

    Pavlovic, Antonia; Durdov, Merica Glavina; Capkun, Vesna; Pitesa, Jasminka Jakelic; Sakic, Maja Bozic

    2016-01-01

    Background Classical Hodgkin lymphoma (cHL) is characterized by sparse malignant Hodgkin and Reed-Sternberg cells dispersed in an inflammatory microenvironment. Immune evasion of malignant cells is partially due to the existence of a subpopulation of immunosuppressive regulatory T cells (Treg). The aim of this study was to analyze T cell composition in cHL with special emphasis on Treg in regard to Epstein-Barr virus (EBV) status, subtype, and patient age. Material/Methods The study included 102 patients with cHL diagnosed during a 12-year period. EBV status of cHL was assessed immunohistochemically using antibodies directed to the EBV- encoded LMP1. To define T lymphocyte populations, slides were double-stained with FOXP3 for Treg, and CD4 or CD8 for T cells. In each case the number of single- and/or double-positive cells was counted on an image analyzer in 10 high-power fields. Statistical analysis was performed and differences were considered significant at P<0.05. Results EBV-positive status of cHL was confirmed in 30 (29%) cases, mainly in patients older than 54 years and in mixed cellularity subtype. In EBV-positive cHL, higher numbers of CD8+ cells were found. In cHL with positive EBV status, more FOXP3+ Treg were found, as well as higher numbers of FOXP3+CD4+ Treg compared with EBV-negative cHL. The number of CD4+ cells decreased with age. The frequency of FOXP3+CD8+ Treg was variable, without a statistically significant association with age or EBV status. Conclusions EBV status has an impact on composition of T cell populations in the cHL microenvironment. PMID:27377121

  6. Current regulatory and licensing status for byproduct sources, facilities and applications

    SciTech Connect

    Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

    1985-02-01

    Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig.

  7. Current regulatory and licensing status for byproduct sources, facilities and applications

    NASA Astrophysics Data System (ADS)

    Tingey, G. L.; Jensen, G. A.; Hazelton, R. F.

    1985-02-01

    Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights.

  8. 75 FR 32860 - Regulatory Guidance Concerning the Preparation of Drivers' Record of Duty Status To Document...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ..., 1997 (62 FR 16370, 16408), FMCSA published ``Regulatory Guidance for the Federal Motor Carrier Safety... original handwritten record, and subsequent electronic submission to the motor carrier of a scanned image... electronic scanned electronic image along with any supporting documents. ] The guidance is applicable to...

  9. Annual Technical Status Report of the Regulatory Assistance Project: September 2000--September 2001

    SciTech Connect

    Not Available

    2002-10-01

    This report summarizes the work in 2001 by the Regulatory Assistance Project (RAP), under contract to the National Renewable Energy Laboratory. This work focused on identifying and removing the regulatory and institutional barriers that keep the full economic value of distributed resources from being realized. The following five reports present the work details: (1) Accommodating Distributed Resources in Wholesale Markets, NREL/SR-560-32497; (2) Distributed Resource Distribution Credit Pilot Programs - Revealing the Value to Consumers and Vendors, NREL/SR-560-32499; (3) Distributed Resources and Electric System Reliability, NREL/SR-560-32498; (4) Distribution System Cost Methodologies for Distributed Generation, NREL/SR-560-32500; (5) Distribution System Cost Methodologies for Distributed Generation Appendices, NREL/SR. Visit www.eren.doe.gov/distributedpower for more information about RAP contract activity to establish environmental output air emissions standards for small-scale electricity generation (to be published as a future NREL subcontract report).

  10. Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals.

    PubMed

    Brownawell, Amy M; Caers, Wim; Gibson, Glenn R; Kendall, Cyril W C; Lewis, Kara D; Ringel, Yehuda; Slavin, Joanne L

    2012-05-01

    First defined in the mid-1990s, prebiotics, which alter the composition and activity of gastrointestinal (GI) microbiota to improve health and well-being, have generated scientific and consumer interest and regulatory debate. The Life Sciences Research Organization, Inc. (LSRO) held a workshop, Prebiotics and the Health Benefits of Fiber: Future Research and Goals, in February 2011 to assess the current state of the science and the international regulatory environment for prebiotics, identify research gaps, and create a strategy for future research. A developing body of evidence supports a role for prebiotics in reducing the risk and severity of GI infection and inflammation, including diarrhea, inflammatory bowel disease, and ulcerative colitis as well as bowel function disorders, including irritable bowel syndrome. Prebiotics also increase the bioavailability and uptake of minerals and data suggest that they reduce the risk of obesity by promoting satiety and weight loss. Additional research is needed to define the relationship between the consumption of different prebiotics and improvement of human health. New information derived from the characterization of the composition and function of different prebiotics as well as the interactions among and between gut microbiota and the human host would improve our understanding of the effects of prebiotics on health and disease and could assist in surmounting regulatory issues related to prebiotic use. PMID:22457389

  11. The Counselling and Psychotherapy Profession in Canada: Regulatory Processes and Current Status

    ERIC Educational Resources Information Center

    Martin, Lorna; Turcotte, Michel; Matte, Laurent; Shepard, Blythe

    2013-01-01

    Like the Canadian landscape and culture, the status of professional regulation for counselling and psychotherapy is a mosaic reflecting the unique cultural, linguistic and contextual realities of Canada. Statutory regulation in Canada is constitutionally a provincial/territorial matter. In the past five years, a major movement towards professional…

  12. Replacement of in vivo acute oral toxicity studies by in vitro cytotoxicity methods: opportunities, limits and regulatory status.

    PubMed

    Ukelis, Ute; Kramer, Peter-Jürgen; Olejniczak, Klaus; Mueller, Stefan O

    2008-06-01

    The development of a new medicinal product is a long and costly process in particular due to the regulatory requirements for quality, safety and efficacy. There is a common interest to increase the efficiency of drug development and to provide new, better quality medicinal products much faster to the public. One possible way to economize time and costs, as well as to consider animal protection issues, is to introduce new alternative methods into non-clinical toxicity testing. Currently, animal tests are mandatory for the evaluation of acute toxicity of chemicals and new drugs. The replacement of the in vivo tests by alternative in vitro assays would offer the opportunity to screen and assess numerous compounds at the same time, to predict acute oral toxicity and thus accelerate drug development. Moreover, the substitution of in vivo tests by in vitro methods shows a proactive pursuit of ethical and animal welfare issues. Importantly, the implementation of in vitro assays for acute oral toxicity would require the establishment of common test guidelines across the EU, USA and Japan, i.e., the regions of ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). Presently, alternative in vitro tests are being investigated internationally. Yet, in order to achieve regulatory acceptance and implementation of in vitro assays, convincing results from validation studies are required. In this review, we discuss the current regulatory status of acute oral toxicity testing and point out achievements of alternative methods. We describe the application of in vitro tests, correlating in vitro with in vivo data. The use of in vitro data to predict in vivo acute oral toxicity is analyzed using the Registry of Cytotoxicity, an official independent database. We have then analyzed opportunities and drawbacks for future implementation of in vitro test methods, with particular focus on industrial use. PMID:18362045

  13. Current status of IL-10 and regulatory T-cells in cancer

    PubMed Central

    Dennis, Kristen L.; Blatner, Nichole R.; Gounari, Fotini; Khazaie, Khashayarsha

    2014-01-01

    Purpose of review Tumor growth elicits antigen-specific cytotoxic as well as immune suppressive responses. Interleukin-10 (IL-10) is a key immune-suppressive cytokine produced by regulatory T-cells (Tregs) and by helper T-cells (TH). Here we review pleiotropic functions of IL-10 that impact the immune pathology of cancer. Recent findings The role of IL-10 in cancer has become less certain with knowledge of its immune stimulatory functions. IL-10 is needed for T-helper cell functions, T-cell immune surveillance, and suppression of cancer-associated inflammation. By promoting tumor specific immune surveillance and hindering pathogenic inflammation IL-10 is emerging as a key cytokine in the battle of the host against cancer. Summary IL-10 functions at the cross roads of immune stimulation and immune suppression in cancer. Immunological mechanisms of action of IL-10 can be ultimately exploited to develop novel and effective cancer therapies. PMID:24076584

  14. A regulatory role of NAD redox status on flavin cofactor homeostasis in S. cerevisiae mitochondria.

    PubMed

    Giancaspero, Teresa Anna; Locato, Vittoria; Barile, Maria

    2013-01-01

    Flavin adenine dinucleotide (FAD) and nicotinamide adenine dinucleotide (NAD) are two redox cofactors of pivotal importance for mitochondrial functionality and cellular redox balance. Despite their relevance, the mechanism by which intramitochondrial NAD(H) and FAD levels are maintained remains quite unclear in Saccharomyces cerevisiae. We investigated here the ability of isolated mitochondria to degrade externally added FAD and NAD (in both its reduced and oxidized forms). A set of kinetic experiments demonstrated that mitochondrial FAD and NAD(H) destroying enzymes are different from each other and from the already characterized NUDIX hydrolases. We studied here, in some detail, FAD pyrophosphatase (EC 3.6.1.18), which is inhibited by NAD(+) and NADH according to a noncompetitive inhibition, with Ki values that differ from each other by an order of magnitude. These findings, together with the ability of mitochondrial FAD pyrophosphatase to metabolize endogenous FAD, presumably deriving from mitochondrial holoflavoproteins destined to degradation, allow for proposing a novel possible role of mitochondrial NAD redox status in regulating FAD homeostasis and/or flavoprotein degradation in S. cerevisiae. PMID:24078860

  15. A Regulatory Role of NAD Redox Status on Flavin Cofactor Homeostasis in S. cerevisiae Mitochondria

    PubMed Central

    Giancaspero, Teresa Anna; Barile, Maria

    2013-01-01

    Flavin adenine dinucleotide (FAD) and nicotinamide adenine dinucleotide (NAD) are two redox cofactors of pivotal importance for mitochondrial functionality and cellular redox balance. Despite their relevance, the mechanism by which intramitochondrial NAD(H) and FAD levels are maintained remains quite unclear in Saccharomyces cerevisiae. We investigated here the ability of isolated mitochondria to degrade externally added FAD and NAD (in both its reduced and oxidized forms). A set of kinetic experiments demonstrated that mitochondrial FAD and NAD(H) destroying enzymes are different from each other and from the already characterized NUDIX hydrolases. We studied here, in some detail, FAD pyrophosphatase (EC 3.6.1.18), which is inhibited by NAD+ and NADH according to a noncompetitive inhibition, with Ki values that differ from each other by an order of magnitude. These findings, together with the ability of mitochondrial FAD pyrophosphatase to metabolize endogenous FAD, presumably deriving from mitochondrial holoflavoproteins destined to degradation, allow for proposing a novel possible role of mitochondrial NAD redox status in regulating FAD homeostasis and/or flavoprotein degradation in S. cerevisiae. PMID:24078860

  16. Regulatory Control or Oxidative Damage? Proteomic Approaches to Interrogate the Role of Cysteine Oxidation Status in Biological Processes*

    PubMed Central

    Held, Jason M.; Gibson, Bradford W.

    2012-01-01

    Oxidation is a double-edged sword for cellular processes and its role in normal physiology, cancer and aging remains only partially understood. Although oxidative stress may disrupt biological function, oxidation-reduction (redox) reactions in a cell are often tightly regulated and play essential physiological roles. Cysteines lie at the interface between these extremes since the chemical properties that make specific thiols exquisitely redox-sensitive also predispose them to oxidative damage by reactive oxygen or nitrogen species during stress. Thus, these modifications can be either under reversible redox regulatory control or, alternatively, a result of reversible or irreversible oxidative damage. In either case, it has become increasingly important to assess the redox status of protein thiols since these modifications often impact such processes as catalytic activity, conformational alterations, or metal binding. To better understand the redox changes that accompany protein cysteine residues in complex biological systems, new experimental approaches have been developed to identify and characterize specific thiol modifications and/or changes in their overall redox status. In this review, we describe the recent technologies in redox proteomics that have pushed the boundaries for detecting and quantifying redox cysteine modifications in a cellular context. While there is no one-size-fits-all analytical solution, we highlight the rationale, strengths, and limitations of each technology in order to effectively apply them to specific biological questions. Several technological limitations still remain unsolved, however these approaches and future developments play an important role toward understanding the interplay between oxidative stress and redox signaling in health and disease. PMID:22159599

  17. How numbers, nature, and immune status of foxp3(+) regulatory T-cells shape the early immunological events in tumor development.

    PubMed

    Darrasse-Jèze, Guillaume; Podsypanina, Katrina

    2013-01-01

    The influence of CD4(+)CD25(+)Foxp3(+) regulatory T-cells (Tregs) on cancer progression has been demonstrated in a large number of preclinical models and confirmed in several types of malignancies. Neoplastic processes trigger an increase of Treg numbers in draining lymph nodes, spleen, blood, and tumors, leading to the suppression of anti-tumor responses. Treg-depletion before or early in tumor development may lead to complete tumor eradication and extends survival of mice and humans. However this strategy is ineffective in established tumors, highlighting the critical role of the early Treg-tumor encounters. In this review, after discussing old and new concepts of immunological tumor tolerance, we focus on the nature (thymus-derived vs. peripherally derived) and status (naïve or activated/memory) of the regulatory T-cells at tumor emergence. The recent discoveries in this field suggest that the activation status of Tregs and effector T-cells (Teffs) at the first encounter with the tumor are essential to shape the fate and speed of the immune response across a variety of tumor models. The relative timing of activation/recruitment of anti-tumor cells vs. tolerogenic cells at tumor emergence appears to be crucial in the identification of tumor cells as friend or foe, which has broad implications for the design of cancer immunotherapies. PMID:24133490

  18. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. PMID:26344953

  19. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

    PubMed Central

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. PMID:26344953

  20. Effect of cognitive status on self-regulatory driving behavior in older adults: an assessment of naturalistic driving using in-car video recordings.

    PubMed

    Festa, Elena K; Ott, Brian R; Manning, Kevin J; Davis, Jennifer D; Heindel, William C

    2013-03-01

    Previous findings that older drivers engage in strategic self-regulatory behaviors to minimize perceived safety risks are primarily based on survey reports rather than actual behavior. This study analyzed in-car video recording of naturalistic driving of 18 patients with Alzheimer disease (AD) and 20 age-matched controls in order to (1) characterize self-regulatory behaviors engaged by older drivers and (2) assess how behaviors change with cognitive impairment. Only participants who were rated "safe" on a prior standardized road test were selected for this study. Both groups drove primarily in environments that minimized the demands on driving skill and that incurred the least risk for involvement in major crashes. Patients with AD displayed further restrictions of driving behavior beyond those of healthy elderly individuals, suggesting additional regulation on the basis of cognitive status. These data provide critical empirical support for findings from previous survey studies indicating an overall reduction in driving mobility among older drivers with cognitive impairment. PMID:23385363

  1. A regulatory approach on low temperature induced enzymatic and anti oxidative status in leaf of Pui vegetable (Basella alba).

    PubMed

    Shahidul Haque, Md; Monirul Islam, Md; Abdur Rakib, Md; Asraful Haque, Md

    2014-09-01

    Basella alba is a soft green vegetable, survives in adverse environmental circumstances, for example, very cold temperature although the mechanism and the temperature sensitivity in this species are not clarified. Pot experiment for cultivation of B. alba was carried out to examine the effects of low temperature on the synthesis of two enzymes, polyphenol oxidase (PPO) and peroxidase (POD) in leaf of this plant. They were exposed to 8 °C for 24 h, 48 h and 72 h periods and the respective controls were kept in ambient room temperature for the above mentioned time. Low temperature causes the higher activity of PPO and the threshold level was found after 48 h period when compared to the respective controls. The activity was higher at 10 mM catechol, substrate for this enzyme, than 100 mM and 200 mM concentration, however, the three doses yielded the gradual increase in activity. Similar stimulatory effects on peroxidase (POD) activity in leaf were observed whenever the plants were exposed to cold for 24 h, 48 h and 72 h periods and maximal after 48 h period. Our findings demonstrate that the higher activity of these enzymes in leaf might be an index for the regulatory mechanism of the survival of these species in such adverse environment. PMID:25183947

  2. A regulatory approach on low temperature induced enzymatic and anti oxidative status in leaf of Pui vegetable (Basella alba)

    PubMed Central

    Shahidul Haque, Md.; Monirul Islam, Md.; Abdur Rakib, Md.; Asraful Haque, Md.

    2013-01-01

    Basella alba is a soft green vegetable, survives in adverse environmental circumstances, for example, very cold temperature although the mechanism and the temperature sensitivity in this species are not clarified. Pot experiment for cultivation of B. alba was carried out to examine the effects of low temperature on the synthesis of two enzymes, polyphenol oxidase (PPO) and peroxidase (POD) in leaf of this plant. They were exposed to 8 °C for 24 h, 48 h and 72 h periods and the respective controls were kept in ambient room temperature for the above mentioned time. Low temperature causes the higher activity of PPO and the threshold level was found after 48 h period when compared to the respective controls. The activity was higher at 10 mM catechol, substrate for this enzyme, than 100 mM and 200 mM concentration, however, the three doses yielded the gradual increase in activity. Similar stimulatory effects on peroxidase (POD) activity in leaf were observed whenever the plants were exposed to cold for 24 h, 48 h and 72 h periods and maximal after 48 h period. Our findings demonstrate that the higher activity of these enzymes in leaf might be an index for the regulatory mechanism of the survival of these species in such adverse environment. PMID:25183947

  3. Exposure to 3,3',5-triiodothyronine affects histone and RNA polymerase II modifications, but not DNA methylation status, in the regulatory region of the Xenopus laevis thyroid hormone receptor βΑ gene.

    PubMed

    Kasai, Kentaro; Nishiyama, Norihito; Izumi, Yushi; Otsuka, Shunsuke; Ishihara, Akinori; Yamauchi, Kiyoshi

    2015-11-01

    Thyroid hormones (THs) play a critical role in amphibian metamorphosis, during which the TH receptor (TR) gene, thrb, is upregulated in a tissue-specific manner. The Xenopus laevis thrb gene has 3 TH response elements (TREs) in the 5' flanking regulatory region and 1 TRE in the exon b region, around which CpG sites are highly distributed. To clarify whether exposure to 3,3',5-triiodothyronine (T3) affects histone and RNA polymerase II (RNAPII) modifications and the level of DNA methylation in the 5' regulatory region, we conducted reverse transcription-quantitative polymerase chain reaction, bisulfite sequencing and chromatin immunoprecipitation assay using X. laevis cultured cells and premetamorphic tadpoles treated with or without 2 nM T3. Exposure to T3 increased the amount of the thrb transcript, in parallel with enhanced histone H4 acetylation and RNAPII recruitment, and probably phosphorylation of RNAPII at serine 5, in the 5' regulatory and exon b regions. However, the 5' regulatory region remained hypermethylated even with exposure to T3, and there was no significant difference in the methylation status between DNAs from T3-untreated and -treated cultured cells or tadpole tissues. Our results demonstrate that exposure to T3 induced euchromatin-associated epigenetic marks by enhancing histone acetylation and RNAPII recruitment, but not by decreasing the level of DNA methylation, in the 5' regulatory region of the X. laevis thrb gene. PMID:26417689

  4. Safety system status monitoring

    SciTech Connect

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  5. The frequency of T regulatory cells modulates the survival of multiple myeloma patients: detailed characterisation of immune status in multiple myeloma

    PubMed Central

    Giannopoulos, K; Kaminska, W; Hus, I; Dmoszynska, A

    2012-01-01

    Background: Multiple myeloma (MM) is an immunoproliferative disease characterised by the uncontrolled proliferation of plasma cells, which is accompanied by defects in the immune system. Methods: This study aimed to characterise the frequency of T regulatory cells (Tregs), dendritic cells (DCs) as well as sub-populations of T cells bearing regulatory properties like CD4+GITR+, CD4+CD62L+, CD3+TCRγδ+ along with the concentrations of IL-10, TGFβ, IL-6 in 66 patients with MM. Subsequently, the influence of therapy on those components of immune system was assessed. Results: The percentage of both myeloid and plasmacytoid DC was lower in MM compared with control group while Treg (CD4+CD25highFOXP3+) frequencies were significantly higher in MM patients compared with healthy control (6.16% vs 0.05%, respectively). Also, the percentages of CD4+GITR+, CD4+CD62L+ were increased compared with healthy volunteers. We found that patients with higher percentages of Treg live shorter (median overall survival 21 months vs not-reached, P=0.013). Conclusion: This study identifies several abnormalities of immune system in MM, which only partly could be normalised after successful therapy. The dysfunction of immune system such as decreased antigen presentation along with increased frequencies of suppressive cells and cytokines might facilitate progression of the disease and infectious complications limiting survival of MM patients. PMID:22223085

  6. 75 FR 71166 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... thereunder,\\2\\ notice is hereby given that on November 1, 2010, Financial Industry Regulatory Authority, Inc... similar status or performing similar functions, or a natural person engaged in the investment banking...

  7. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... amount of a particular cost item that was previously claimed under an interim rate concept and for which... Enforcement, Office of Human Development Services, or the Social Security Administration, depending on...

  8. 75 FR 9626 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    ... COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Regulatory Guide 1.47, Revision 1, ``Bypassed and Inoperable Status Indication... an existing guide in the agency's ``Regulatory Guide'' series. This series was developed to...

  9. Job Creation and Regulatory Freeze Act of 2011

    THOMAS, 112th Congress

    Rep. Griffin, Tim [R-AR-2

    2011-10-13

    11/02/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  10. 78 FR 44329 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ....nasa.gov/open . Timetable: Action Date FR Cite NPRM 10/00/13 Regulatory Flexibility Analysis Required... analysis is required, and the status of regulations previously reported. ADDRESSES: Acting Assistant... the new accessibility standards. Other amendments include updates to organizational information,...

  11. 78 FR 1634 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Date FR Cite NPRM 02/00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W... analysis is required, and the status of regulations previously reported. ADDRESSES: Director, for Internal... accessibility standards. Other amendments include updates to organizational information, use of the...

  12. Regulatory factors of induced pluripotency: current status

    PubMed Central

    Ning, Bo; Qian, Chen

    2014-01-01

    Somatic cells can be reprogrammed to induced pluripotent stem cells (iPSCs) through enforced expression of four transcription factors [Oct4, Sox2, Klf4, and c-Myc (OSKM)]; however, the reprogramming efficiency is extremely low. This finding raises fundamental questions about the regulators that influence the change in epigenetic stability and endowment of dedifferentiation potential during reprogramming. Identification of such regulators is critical to removing the roadblocks impeding the efficient generation of safe iPSCs and their successful translation into clinical therapies. In this review, we summarize the current progress that has been made in understanding cellular reprogramming, with an emphasis on the molecular mechanisms of epigenetic regulators in induced pluripotency.

  13. Regulatory Physiology

    NASA Technical Reports Server (NTRS)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  14. Regulatory Anatomy

    PubMed Central

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. PMID:26139952

  15. Regulatory RNAs

    PubMed Central

    Vazquez-Anderson, Jorge; Contreras, Lydia M

    2013-01-01

    RNAs have many important functional properties, including that they are independently controllable and highly tunable. As a result of these advantageous properties, their use in a myriad of sophisticated devices has been widely explored. Yet, the exploitation of RNAs for synthetic applications is highly dependent on the ability to characterize the many new molecules that continue to be discovered by large-scale sequencing and high-throughput screening techniques. In this review, we present an exhaustive survey of the most recent synthetic bacterial riboswitches and small RNAs while emphasizing their virtues in gene expression management. We also explore the use of these RNA components as building blocks in the RNA synthetic biology toolbox and discuss examples of synthetic RNA components used to rewire bacterial regulatory circuitry. We anticipate that this field will expand its catalog of smart devices by mimicking and manipulating natural RNA mechanisms and functions. PMID:24356572

  16. Environment, safety, and health regulatory implementation plan

    SciTech Connect

    Not Available

    1993-10-21

    To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project`s environment, safety, and health (ES&H) regulatory requirements, the US Department of Energy (DOE) UMTRA Project Office tasked the Technical Assistance Contractor (TAC) to develop a regulatory operating envelope for the UMTRA Project. The system selected for managing the UMTRA regulatory operating envelope data bass is based on the Integrated Project Control/Regulatory Compliance System (IPC/RCS) developed by WASTREN, Inc. (WASTREN, 1993). The IPC/RCS is a tool used for identifying regulatory and institutional requirements and indexing them to hardware, personnel, and program systems on a project. The IPC/RCS will be customized for the UMTRA Project surface remedial action and groundwater restoration programs. The purpose of this plan is to establish the process for implementing and maintaining the UMTRA Project`s regulatory operating envelope, which involves identifying all applicable regulatory and institutional requirements and determining compliance status. The plan describes how the Project will identify ES&H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status.

  17. Toxicogenomics in regulatory ecotoxicology

    USGS Publications Warehouse

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  18. Regulatory physiology discipline science plan

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

  19. Congressional Office of Regulatory Analysis Creation and Sunset and Review Act of 2011

    THOMAS, 112th Congress

    Rep. Young, Don [R-AK-At Large

    2011-01-07

    02/08/2011 Referred to the Subcommittee on Regulatory Affairs, Stimulus Oversight and Government Spending . (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. Small Business Administration Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... of small business size and status fraud. Timetable: Action Date FR Cite NPRM 01/00/11 Regulatory... assistance projects conducted by Women's Business Center program grantees. Timetable: Action Date FR Cite... published on April 26, 2010, at 75 FR 21890. Beginning in fall 2007, the Internet became the basic means...

  1. Standards development status. Summary report

    SciTech Connect

    Not Available

    1981-12-01

    The Standards Development Status Summary Report is designed for scheduling, monitoring, and controlling the process by which Regulatory Standards, Guides, Reports, Petitions, and Environmental Statements are written. It is a summary of the current schedule plans for development of the above products.

  2. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Regulatory Review Presidential Documents Other Presidential Documents Memorandum of January 30, 2009 Regulatory Review Memorandum for the Heads of Executive Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at the Office of Management...

  3. Regulatory affairs administration as regulatory policy determinant

    SciTech Connect

    Forcier, J.R.

    1984-05-10

    It is the thesis of this article that the processing of a utility company's regulation-related work, the supporting tasks and the manner in which they are completed, can and does have a significant impact on the final results or work product of the regulatory affairs function, including even, potentially, the action of the regulatory agency. The article is therefore full of practical pointers on how the interface with the regulatory authority can best be organized, managed, and carried through to the attainment of optimum results for the utility. 2 references.

  4. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for each physical inventory which is taken as part of...

  5. 10 CFR 75.35 - Material status reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Material status reports. 75.35 Section 75.35 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) SAFEGUARDS ON NUCLEAR MATERIAL-IMPLEMENTATION OF US/IAEA AGREEMENT Reports § 75.35 Material status reports. (a) A material status report must be submitted for each physical inventory which is taken as part of...

  6. Waterborne cryptosporidiosis: current status.

    PubMed

    Smith, H V; Rose, J B

    1998-01-01

    In the past ten years Cryptosporidium oocysts have been shown to be common contaminants of water, causing at least 19 waterborne outbreaks of cryptosporidiosis which have affected more than 427 000 individuals. Recommended methods for oocyst isolation and enumeration are time-consuming and inefficient and experts state that the absence of Cryptosporidium oocysts in drinking water can never be guaranteed. In the UK alone, a National Research Programme costing pound3 million has been undertaken. Here, Huw Smith and Joan Rose review the current status of knowledge and identify approaches taken by UK and USA Government regulatory bodies in order to reduce the likelihood of waterborne transmission. PMID:17040684

  7. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ...) 2010, less the amounts appropriated from the Nuclear Waste Fund, amounts appropriated for Waste... agenda on April 26, 2010 (75 FR 21960). For this edition of the NRC's regulatory agenda, the most... publication of the last NRC semiannual agenda on April 26, 2010 (75 FR 21960). Within each group, the...

  8. NRC regulatory agenda

    SciTech Connect

    Not Available

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  9. NRC regulatory agenda

    SciTech Connect

    Not Available

    1992-05-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  10. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  11. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  12. NRC regulatory agenda

    SciTech Connect

    Not Available

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  13. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-07-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  14. Plant Regulatory Organizations

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The chapter on Plant Regulatory Organizations is part of a book titled Pest Management and Phytosanitary Trade Barriers authored by Neil Heather (Australia) and Guy Hallman. It covers the role of plant regulatory organizations from the international to state level in protecting plant health. At on...

  15. Regulatory guidance document

    SciTech Connect

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

  16. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ...The Department of Justice is publishing its spring 2013 regulatory agenda pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. sections 601 to 612...

  17. The ensembl regulatory build.

    PubMed

    Zerbino, Daniel R; Wilder, Steven P; Johnson, Nathan; Juettemann, Thomas; Flicek, Paul R

    2015-01-01

    Most genomic variants associated with phenotypic traits or disease do not fall within gene coding regions, but in regulatory regions, rendering their interpretation difficult. We collected public data on epigenetic marks and transcription factor binding in human cell types and used it to construct an intuitive summary of regulatory regions in the human genome. We verified it against independent assays for sensitivity. The Ensembl Regulatory Build will be progressively enriched when more data is made available. It is freely available on the Ensembl browser, from the Ensembl Regulation MySQL database server and in a dedicated track hub. PMID:25887522

  18. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  19. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1989-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  20. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  1. Current Status of On-Site Wastewater Management

    ERIC Educational Resources Information Center

    Senn, Charles L.

    1978-01-01

    Wastewater management is becoming an important environmental issue nationally. This article reports the history and current status of wastewater management. Regulatory programs are discussed with specific state examples. Needs assessment is also included. (MA)

  2. Canadian drug regulatory framework.

    PubMed

    Kelly, L; Lazzaro, M; Petersen, C

    2007-03-01

    The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues. PMID:17469674

  3. SEC Regulatory Accountability Act

    THOMAS, 113th Congress

    Rep. Garrett, Scott [R-NJ-5

    2013-03-12

    05/20/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  4. Swaps Regulatory Improvement Act

    THOMAS, 113th Congress

    Rep. Hultgren, Randy [R-IL-14

    2013-03-06

    10/31/2013 Received in the Senate and Read twice and referred to the Committee on Banking, Housing, and Urban Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  5. Silviculture Regulatory Consistency Act

    THOMAS, 113th Congress

    Sen. Wyden, Ron [D-OR

    2013-05-16

    05/16/2013 Read twice and referred to the Committee on Environment and Public Works. (text of measure as introduced: CR S3573) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. 75 FR 72737 - Proposed Generic Communications Reporting for Decommissioning Funding Status Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... Funding Status Reports AGENCY: Nuclear Regulatory Commission. ACTION: Notice of opportunity for public... present to the NRC in the Decommissioning Funding Status (DFS) reports to ensure that the NRC staff... INFORMATION: NRC Regulatory Issue Summary 2010-XXX 10 CFR 50.75 Reporting for Decommissioning Funding...

  7. Regulatory aspects of clinical xenotransplantation.

    PubMed

    Schuurman, Henk-Jan

    2015-11-01

    Xenotransplantation attracted interest from regulatory authorities, particularly after the demonstration of pig-to-human transmission of porcine endogenous retrovirus (1996). This added to the risk of a product, resulting in a Guidance of the US Food and Drug Administration (2003). This addresses the full flow chart in product manufacturing, starting with the designated pathogen-free status of the source animal; and special aspects regarding the recipient like informed consent and monitoring for infectious pathogens. Also archiving of records from the donor and recipient, as well as storage of samples is described. The European Medicines Agency issued a Guideline on xenogeneic cell therapy products (2009). Cell-based medicinal products are subject to specific regulations and directives, which apply also to xenogeneic products: the xenotransplant guidances/guidelines are an addition to these regulations. Noteworthy, acellular products like heart valves and decellularized cornea are not considered a cell therapy product, but rather a medical device with its own regulation. WHO issued relevant documents, especially about safety, and the International Xenotransplantation Association published consensus documents, a.o., addressing preclinical efficacy requirements before entering clinical trials. This manuscript presents an overview of the regulatory framework, with special focus on cell therapy products necause these are expected to reach the market first (i.e., pancreatic islets, hepatocytes and cellularized cornea); major illustrations are from the European situation. Albeit being complex, the regulation of xenotransplant products does not form a block in product development, but rather supports the introduction of efficacious and safe products to meet the medical need. PMID:26408947

  8. Steam generators regulatory practices and issues in Spain

    SciTech Connect

    Mendoza, C.; Castelao, C.; Ruiz-Colino, J.; Figueras, J.M.

    1997-02-01

    This paper presents the actual status of Spanish Steam Generator tubes, actions developed by PWR plant owners and submitted to CSN, and regulatory activities related to tube degradation mechanisms analysis; NDT tube inspection techniques; tube, tubesheet and TSPs integrity studies; tube plugging/repair criteria; preventive and corrective measures including whole SGs replacement; tube leak measurement methods and other operational aspects.

  9. Regulatory Enhancements, Infrastructure Modernization, and Connecticut's Interactive, Distance Learning Network.

    ERIC Educational Resources Information Center

    Pietras, Jesse John

    This paper presents an overview of the regulatory, technological, and economic status of interactive distance learning in Connecticut as it relates to the current and future provisioning of services by the telecommunications and cable television industries. The review is predicated upon the following questions: (1) What obligations should the…

  10. Rationales for regulatory activity

    SciTech Connect

    Perhac, R.M.

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  11. Biosimilar drugs: Current status.

    PubMed

    Kumar, Rajiv; Singh, Jagjit

    2014-07-01

    Biologic products are being developed over the past three decades. The expiry of patent protection for many biological medicines has led to the development of biosimilars in UK or follow on biologics in USA. This article reviews the literature on biosimilar drugs that covers the therapeutic status and regulatory guidelines. Appraisal of published articles from peer reviewed journals for English language publications, search from PubMed, and guidelines from European Medicines Agency, US Food Drug Administration (FDA) and India were used to identify data for review. Literature suggest that biosimilars are similar biological products, i.e., comparable but not identical to the reference product, are not generic version of innovator product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and marketing approval is also more complicated. To improve access, US Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed "abbreviated pathway" for their approval. U.S law has defined new standards and terms and EMA scientific guidelines have also set detailed approval standards. India being one of the most preferred manufacturing destinations of biosimilars, there is a need for stringent safety and regulatory guidelines. The New India Guidelines "Draft Guidelines on Similar Biologics were announced in June 2012, by Department of Biotechnology at Boston bio and available online. PMID:25143877

  12. Compliance status

    SciTech Connect

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford`s compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute.

  13. GMI Status

    NASA Technical Reports Server (NTRS)

    Krimchansky, Sergey; Newell, David

    2008-01-01

    This viewgraph presentation is concerned with the status of the Global Precipitation Measurement-Microwave Imager (GMI). Included in the presentation is an overview that shows a diagram of the craft, the improvements over other precipitation measurement satellites, and information about the calibration approach.

  14. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Inspection, test, and operating status. 72.168 Section 72.168 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT... WASTE Quality Assurance § 72.168 Inspection, test, and operating status. (a) The licensee, applicant...

  15. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Inspection, test, and operating status. 72.168 Section 72.168 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT... WASTE Quality Assurance § 72.168 Inspection, test, and operating status. (a) The licensee, applicant...

  16. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Inspection, test, and operating status. 72.168 Section 72.168 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT... WASTE Quality Assurance § 72.168 Inspection, test, and operating status. (a) The licensee, applicant...

  17. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Inspection, test, and operating status. 72.168 Section 72.168 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT... WASTE Quality Assurance § 72.168 Inspection, test, and operating status. (a) The licensee, applicant...

  18. 10 CFR 71.129 - Inspection, test, and operating status.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Inspection, test, and operating status. 71.129 Section 71.129 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71.129 Inspection, test, and operating status. (a) The licensee,...

  19. 39 CFR 3060.22 - Financial status report.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Financial status report. 3060.22 Section 3060.22 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL ACCOUNTING PRACTICES AND TAX RULES FOR THE THEORETICAL COMPETITIVE PRODUCTS ENTERPRISE § 3060.22 Financial status report. The Postal Service shall file...

  20. EPAct Transportation Regulatory Activities

    SciTech Connect

    2011-11-21

    The U.S. Department of Energy's (DOE) Vehicle Technologies Program manages several transportation regulatory activities established by the Energy Policy Act of 1992 (EPAct), as amended by the Energy Conservation Reauthorization Act of 1998, EPAct 2005, and the Energy Independence and Security Act of 2007 (EISA).

  1. REFINE WETLAND REGULATORY PROGRAM

    EPA Science Inventory

    The Tribes will work toward refining a regulatory program by taking a draft wetland conservation code with permitting incorporated to TEB for review. Progress will then proceed in developing a permit tracking system that will track both Tribal and fee land sites within reservati...

  2. Toxicogenomics in Regulatory Ecotoxicology

    EPA Science Inventory

    The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions, and as with any new technology, there is a wide range of opinion. The purpose of this feature article is to consider roles of toxicogenomic...

  3. The regulatory horizon

    NASA Technical Reports Server (NTRS)

    Cook, ED

    1987-01-01

    The author briefly discusses the FAA's position as it relates to cockpit resource management. For example, if Cockpit Resource Management (CRM) is a positive concept, why isn't everyone required to implement it? The regulatory practice of the FAA is discussed and questions and answers are presented.

  4. REGULATORY AIR QUALITY MODELS

    EPA Science Inventory

    Appendix W to 40CFR Part 51 (Guideline on Air Quality Models) specifies the models to be used for purposes of permitting, PSD, and SIPs. Through a formal regulatory process this modeling guidance is periodically updated to reflect current science. In the most recent action, thr...

  5. NRC regulatory agenda

    SciTech Connect

    Not Available

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  6. NRC regulatory agenda

    SciTech Connect

    Not Available

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  7. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  8. 77 FR 46339 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ... to prevent the introduction of CWR into the United States. In addition, importation of cut flowers of... flower production. APHIS considers P. horiana a quarantine pest. Reports of CWR occurrences within the... regulations in 7 CFR 319.74 restrict the entry into the United States of cut flowers of CWR host plants...

  9. 47 CFR 101.1411 - Regulatory status and eligibility.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... one-way video programming and data services on a non-common carrier and/or on a common carrier basis... voice and data services through the public switched network. (b) MVDDS licensees in the 12.2-12.7...

  10. 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...

  11. Nuclear Regulatory Commission information digest

    SciTech Connect

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  12. Regulatory aspects on nanomedicines.

    PubMed

    Sainz, Vanessa; Conniot, João; Matos, Ana I; Peres, Carina; Zupancic, Eva; Moura, Liane; Silva, Liana C; Florindo, Helena F; Gaspar, Rogério S

    2015-12-18

    Nanomedicines have been in the forefront of pharmaceutical research in the last decades, creating new challenges for research community, industry, and regulators. There is a strong demand for the fast development of scientific and technological tools to address unmet medical needs, thus improving human health care and life quality. Tremendous advances in the biomaterials and nanotechnology fields have prompted their use as promising tools to overcome important drawbacks, mostly associated to the non-specific effects of conventional therapeutic approaches. However, the wide range of application of nanomedicines demands a profound knowledge and characterization of these complex products. Their properties need to be extensively understood to avoid unpredicted effects on patients, such as potential immune reactivity. Research policy and alliances have been bringing together scientists, regulators, industry, and, more frequently in recent years, patient representatives and patient advocacy institutions. In order to successfully enhance the development of new technologies, improved strategies for research-based corporate organizations, more integrated research tools dealing with appropriate translational requirements aiming at clinical development, and proactive regulatory policies are essential in the near future. This review focuses on the most important aspects currently recognized as key factors for the regulation of nanomedicines, discussing the efforts under development by industry and regulatory agencies to promote their translation into the market. Regulatory Science aspects driving a faster and safer development of nanomedicines will be a central issue for the next years. PMID:26260323

  13. RHIC Status

    NASA Astrophysics Data System (ADS)

    Peggs, Steve

    1997-05-01

    The design and construction status of the Relativistic Heavy Ion Collider, RHIC, is discussed. Those novel performance features of a heavy ion collider that are distinct from hadron colliders in general are noted. These features are derived from the experimental requirements of operation with a variety of ion species over a wide energy range, including collisions between protons and ions, and between ions of unequal energies. The project is in the fifth year of a seven year construction cycle. A brief review of the recent Sextant Test is given, together with progress to date on machine construction.

  14. Tevatron status

    SciTech Connect

    Dugan, G.

    1989-03-01

    The Fermilab Tevatron is both the world's highest energy accelerator system and first large-scale superconducting synchrotron. Since Tevatron commissioning in July 1983, the accelerator has operated in 1984, 1985 and 1987 with extracted beams of 800 GeV for three runs of fixed target physics, and in 1987, and 1988, with proton-antiproton colliding beams at 900 /times/ 900 GeV. This paper will focus on the collider operation of the Tevatron: its present status and the outlook for its longer-term future evolution. 18 refs., 3 figs., 2 tabs.

  15. Automated Identification of Core Regulatory Genes in Human Gene Regulatory Networks

    PubMed Central

    Singhal, Amit; Kumar, Pavanish; de Libero, Gennaro; Poidinger, Michael; Monterola, Christopher

    2015-01-01

    Human gene regulatory networks (GRN) can be difficult to interpret due to a tangle of edges interconnecting thousands of genes. We constructed a general human GRN from extensive transcription factor and microRNA target data obtained from public databases. In a subnetwork of this GRN that is active during estrogen stimulation of MCF-7 breast cancer cells, we benchmarked automated algorithms for identifying core regulatory genes (transcription factors and microRNAs). Among these algorithms, we identified K-core decomposition, pagerank and betweenness centrality algorithms as the most effective for discovering core regulatory genes in the network evaluated based on previously known roles of these genes in MCF-7 biology as well as in their ability to explain the up or down expression status of up to 70% of the remaining genes. Finally, we validated the use of K-core algorithm for organizing the GRN in an easier to interpret layered hierarchy where more influential regulatory genes percolate towards the inner layers. The integrated human gene and miRNA network and software used in this study are provided as supplementary materials (S1 Data) accompanying this manuscript. PMID:26393364

  16. Securities and Exchange Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... [Securities and Exchange Commission Semiannual Regulatory Agenda ] Part XXIII Securities and Exchange Commission Semiannual Regulatory Agenda ] SECURITIES AND EXCHANGE COMMISSION (SEC) SECURITIES AND EXCHANGE COMMISSION 17 CFR Ch. II Regulatory Flexibility Agenda AGENCY: Securities and Exchange Commission. ACTION: Semiannual regulatory...

  17. The core to regulatory reform

    SciTech Connect

    Partridge, J.W. Jr.

    1993-06-15

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges.

  18. RHIC status

    SciTech Connect

    Peggs, S.

    1997-08-01

    The design and construction status of the Relativistic Heavy Ion Collider, RHIC, which is in the seventh year of a nine year construction cycle, is discussed. Those novel performance features of a heavy ion collider that are distinct from hadron colliders in general are noted. These features are derived from the experimental requirements of operation with a variety of ion species over a wide energy range, including collisions between protons and ions, and between ions of unequal energies. Section 1 gives a brief introduction to the major parameters and overall layout of RHIC. A review of the superconducting magnet program is given in Section 2. Activities during the recent Sextant Test are briefly reviewed in Section 3. Finally, Section 4 presents the plans for RHIC commissioning in 1999.

  19. Japanese pharmaceutical and regulatory environment.

    PubMed

    Nagata, Ryoichi; Rafizadeh-Kabe, Jean-David

    2002-12-01

    Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities. PMID:22034129

  20. The Effect of Self-Regulatory and Metacognitive Strategy Instruction on Impoverished Students' Assessment Achievement in Physics

    ERIC Educational Resources Information Center

    Fouche, Jaunine

    2013-01-01

    The purpose of this nonequivalent control group design study was to evaluate the effectiveness of metacognitive and self-regulatory strategy use on the assessment achievement of 215 9th-grade, residential physics students from low socioeconomic status (low-SES) backgrounds. Students from low-SES backgrounds often lack the self-regulatory habits…

  1. Regulatory Streamlining and Improvement

    SciTech Connect

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and Development: This area

  2. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2011-09-22

    09/22/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. Regulatory Foci and Organizational Commitment

    ERIC Educational Resources Information Center

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  4. 75 FR 79759 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... use throughout the rulemaking process. Timetable: Action Date FR Cite Notice: Public Meeting Framework... heating equipment. This is the second review for water heaters. Completed: Reason Date FR Cite Final... ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et...

  5. Building Developmental Gene Regulatory Networks

    PubMed Central

    Li, Enhu; Davidson, Eric H.

    2009-01-01

    Animal development is an elaborate process programmed by genomic regulatory instructions. Regulatory genes encode transcription factors and signal molecules, and their expression is under the control of cis-regulatory modules that define the logic of transcriptional responses to the inputs of other regulatory genes. The functional linkages amongst regulatory genes constitute the gene regulatory networks (GRNs) that govern cell specification and patterning in development. Constructing such networks requires identification of the regulatory genes involved and characterization of their temporal and spatial expression patterns. Interactions (activation/repression) among transcription factors or signals can be investigated by large-scale perturbation analysis, in which the function of each gene is specifically blocked. Resultant expression changes are then integrated to identify direct linkages, and to reveal the structure of the GRN. Predicted GRN linkages can be tested and verified by cis-regulatory analysis. The explanatory power of the GRN was shown in the lineage specification of sea urchin endomesoderm. Acquiring such networks is essential for a systematic and mechanistic understanding of the developmental process. PMID:19530131

  6. 77 FR 7972 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... agenda pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735, and the... Identifier No. 396 National Standards to 1105-AB34 Prevent, Detect, and Respond to Prison Rape (Reg Plan Seq... Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is Seq. No. 85 in part II of...

  7. Citizen participation on regulatory boards.

    PubMed

    Chesney, J D

    1984-01-01

    This article examines the relationship between regulatory board function and citizen participation. The research indicates that public members generally prefer advisory boards, while provider members prefer quasi-judicial bodies. Implications of these findings for structuring citizen participation in the regulatory process are examined. PMID:6736596

  8. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... and stability to receive opioid addiction treatment medication. Timetable: Action Date FR Cite NPRM 06/19/09 74 FR 29153 NPRM Comment Period End 08/18/09 Final Action 12/06/12 77 FR 72752 Regulatory... FR Cite NPRM 03/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Charles...

  9. 76 FR 3825 - Regulatory Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ..., Washington, January 18, 2011 [FR Doc. 2011-1386 Filed 1-20-11; 8:45 am] Billing code 3110-01-P ... Documents#0;#0; ] Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive... accessible to the public, information concerning their regulatory compliance and enforcement activities,...

  10. 78 FR 3892 - Turlock Irrigation District and Modesto Irrigation District; Notice Clarifying Party Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Turlock Irrigation District and Modesto Irrigation District; Notice Clarifying Party Status On January 9, 2013, the Modesto Irrigation District (Modesto) filed a motion...

  11. 78 FR 59922 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos...-captioned entities as Exempt Wholesale Generators became effective by operation of the...

  12. 77 FR 3759 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR...

  13. 78 FR 52523 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... the above-captioned entities as Exempt Wholesale Generators or Foreign Utility Companies...

  14. 76 FR 47573 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of the...

  15. 76 FR 44900 - Notice of Effectiveness of Exempt Wholesale; Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale; Generator Status July 13, 2011...-captioned entities as Exempt Wholesale Generators became effective by operation of the...

  16. 77 FR 21761 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations....

  17. 75 FR 4373 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status January 20... Exempt Wholesale Generators became effective by operation of the Commission's regulations 18 CFR...

  18. Understanding genetic regulatory networks

    NASA Astrophysics Data System (ADS)

    Kauffman, Stuart

    2003-04-01

    Random Boolean networks (RBM) were introduced about 35 years ago as first crude models of genetic regulatory networks. RBNs are comprised of N on-off genes, connected by a randomly assigned regulatory wiring diagram where each gene has K inputs, and each gene is controlled by a randomly assigned Boolean function. This procedure samples at random from the ensemble of all possible NK Boolean networks. The central ideas are to study the typical, or generic properties of this ensemble, and see 1) whether characteristic differences appear as K and biases in Boolean functions are introducted, and 2) whether a subclass of this ensemble has properties matching real cells. Such networks behave in an ordered or a chaotic regime, with a phase transition, "the edge of chaos" between the two regimes. Networks with continuous variables exhibit the same two regimes. Substantial evidence suggests that real cells are in the ordered regime. A key concept is that of an attractor. This is a reentrant trajectory of states of the network, called a state cycle. The central biological interpretation is that cell types are attractors. A number of properties differentiate the ordered and chaotic regimes. These include the size and number of attractors, the existence in the ordered regime of a percolating "sea" of genes frozen in the on or off state, with a remainder of isolated twinkling islands of genes, a power law distribution of avalanches of gene activity changes following perturbation to a single gene in the ordered regime versus a similar power law distribution plus a spike of enormous avalanches of gene changes in the chaotic regime, and the existence of branching pathway of "differentiation" between attractors induced by perturbations in the ordered regime. Noise is serious issue, since noise disrupts attractors. But numerical evidence suggests that attractors can be made very stable to noise, and meanwhile, metaplasias may be a biological manifestation of noise. As we learn more

  19. 78 FR 1636 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ...This Regulatory Agenda is a semiannual summary of all current and projected rulemakings, existing regulations, and completed actions of the Small Business Administration (SBA). For this fall edition of the SBA's Regulatory Agenda, a Regulatory Plan that contains a list of the Agency's most important and significant regulatory actions and a Statement of Regulatory Priorities is also included.......

  20. Department of Justice 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] Part XI Department of Justice Semiannual Regulatory Agenda ] DEPARTMENT OF JUSTICE (DOJ) DEPARTMENT OF JUSTICE 8 CFR Ch. V 21 CFR Ch. I 27 CFR Ch. II 28 CFR Ch. I, V Regulatory Agenda AGENCY: Department of Justice. ACTION: Semiannual regulatory agenda....

  1. T follicular regulatory cells.

    PubMed

    Sage, Peter T; Sharpe, Arlene H

    2016-05-01

    Pathogen exposure elicits production of high-affinity antibodies stimulated by T follicular helper (Tfh) cells in the germinal center reaction. Tfh cells provide both costimulation and stimulatory cytokines to B cells to facilitate affinity maturation, class switch recombination, and plasma cell differentiation within the germinal center. Under normal circumstances, the germinal center reaction results in antibodies that precisely target foreign pathogens while limiting autoimmunity and excessive inflammation. In order to have this degree of control, the immune system ensures Tfh-mediated B-cell help is regulated locally in the germinal center. The recently identified T follicular regulatory (Tfr) cell subset can migrate to the germinal center and inhibit Tfh-mediated B-cell activation and antibody production. Although many aspects of Tfr cell biology are still unclear, recent data have begun to delineate the specialized roles of Tfr cells in controlling the germinal center reaction. Here we discuss the current understanding of Tfr-cell differentiation and function and how this knowledge is providing new insights into the dynamic regulation of germinal centers, and suggesting more efficacious vaccine strategies and ways to treat antibody-mediated diseases. PMID:27088919

  2. Overview of Botanical Status in EU, USA, and Thailand

    PubMed Central

    Mahady, Gail B.

    2013-01-01

    The botanical status in EU, USA, and Thailand is different owing to the regulatory status, the progress of science, and the influence of culture and society. In the EU, botanicals are positioned as herbal medicinal products and food supplements, in the US they are regulated as dietary supplements but often used as traditional medicines, and in Thailand, they are regulated and used as traditional medicines. Information for some of the most popular botanicals from each country is included in this review. PMID:24228061

  3. Nitrogen fixation: key genetic regulatory mechanisms.

    PubMed

    Martinez-Argudo, I; Little, R; Shearer, N; Johnson, P; Dixon, R

    2005-02-01

    The necessity to respond to the level of fixed nitrogen and external oxygen concentrations and to provide sufficient energy for nitrogen fixation imposes common regulatory principles amongst diazotrophs. The NifL-NifA system in Azotobacter vinelandii integrates the signals of redox, fixed-nitrogen and carbon status to regulate nif transcription. Multidomain signalling interactions between NifL and NifA are modulated by redox changes, ligand binding and interaction with the signal-transduction protein GlnK. Under adverse redox conditions (excess oxygen) or when fixed nitrogen is in excess, NifL forms a complex with NifA in which transcriptional activation is prevented. Oxidized NifL forms a binary complex with NifA to inhibit NifA activity. When fixed nitrogen is in excess, the non-covalently modified form of GlnK interacts with NifL to promote the formation of a GlnK-NifL-NifA ternary complex. When the cell re-encounters favourable conditions for nitrogen fixation, it is necessary to deactivate the signals to ensure that the NifL-NifA complex is dissociated so that NifA is free to activate transcription. This is achieved through interactions with 2-oxoglutarate, a key metabolic signal of the carbon status, which binds to the N-terminal GAF (cGMP-specific and stimulated phosphodiesterases, Anabaena adenylate cyclases and Escherichia coli FhlA) domain of NifA. PMID:15667291

  4. Regulatory approaches to reproductive genetic testing.

    PubMed

    Knoppers, Bartha M; Isasi, Rosario M

    2004-12-01

    This report analyses the ethical and legal aspects of reproductive genetic testing in 11 countries (Australia, Austria, Canada, France, Germany, India, Israel, Japan, The Netherlands, Switzerland and the UK). The legal status of reproductive genetic testing in the countries under analysis is difficult to generalize due to the different regulatory systems adopted. These approaches are a reflection of the legal traditions and cultural and socio-religious beliefs which inform and shape public policy on assisted reproductive technologies and genetic testing. We divide approaches into two groups: public ordering (legislative, top-down approach) and private ordering (non-legislative, bottom-up approach). Even limiting our analysis to a number of countries that span the range from restrictive to pragmatic approaches, there is remarkable symmetry in both the (i) substantive requirements (i.e. gravity, health indications generally) and (ii) procedural safeguards (i.e. informed consent, counselling, confidentiality, civil status, oversight and accreditation) surrounding reproductive genetic testing. Indeed, irrespective of whether a country adopts a prohibitive or a permissive approach through legislation or self-regulation or a mix of both, the ultimate decision is--and should continue to be--a medical one. Nowhere is this more evident than in the substantive requirements. PMID:15388677

  5. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    PubMed

    Gonçalves, Joana P; Aires, Ricardo S; Francisco, Alexandre P; Madeira, Sara C

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  6. Homotypic Regulatory Clusters in Drosophila

    PubMed Central

    Lifanov, Alexander P.; Makeev, Vsevolod J.; Nazina, Anna G.; Papatsenko, Dmitri A.

    2003-01-01

    Cis-regulatory modules (CRMs) are transcription regulatory DNA segments (∼1 Kb range) that control the expression of developmental genes in higher eukaryotes. We analyzed clustering of known binding motifs for transcription factors (TFs) in over 60 known CRMs from 20 Drosophila developmental genes, and we present evidence that each type of recognition motif forms significant clusters within the regulatory regions regulated by the corresponding TF. We demonstrate how a search with a single binding motif can be applied to explore gene regulatory networks and to discover coregulated genes in the genome. We also discuss the potential of the clustering method in interpreting the differential response of genes to various levels of transcriptional regulators. PMID:12670999

  7. Regulatory facility guide for Ohio

    SciTech Connect

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O.; Rymer, A.C.

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  8. The limits of regulatory toxicology

    SciTech Connect

    Carrington, Clark D.; Bolger, P. Michael

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standards are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.

  9. 18 CFR 35.42 - Change in status reporting requirement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Change in status reporting requirement. 35.42 Section 35.42 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT FILING OF RATE SCHEDULES AND TARIFFS Wholesale Sales of Electric...

  10. 10 CFR 72.76 - Material status reports.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Material status reports. 72.76 Section 72.76 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Records, Reports, Inspections, and Enforcement § 72.76...

  11. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Inspection, test, and operating status. 72.168 Section 72.168 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.168 Inspection,...

  12. 75 FR 53295 - Hatchet Ridge Wind, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Hatchet Ridge Wind, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status August 23, 2010. Take notice that during the month of July 2010, the status of the...

  13. 39 CFR 3007.30 - Termination of non-public status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 39 Postal Service 1 2012-07-01 2012-07-01 false Termination of non-public status. 3007.30 Section 3007.30 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL TREATMENT OF NON-PUBLIC MATERIALS PROVIDED BY THE POSTAL SERVICE § 3007.30 Termination of non-public status. Ten years after the date...

  14. 39 CFR 3007.30 - Termination of non-public status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 39 Postal Service 1 2011-07-01 2011-07-01 false Termination of non-public status. 3007.30 Section 3007.30 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL TREATMENT OF NON-PUBLIC MATERIALS PROVIDED BY THE POSTAL SERVICE § 3007.30 Termination of non-public status. Ten years after the date...

  15. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports....

  16. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Submission to Commission of nuclear material status reports. 150.17 Section 150.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED... Authority in Agreement States § 150.17 Submission to Commission of nuclear material status reports....

  17. 75 FR 19959 - Uilk Wind Farm, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Uilk Wind Farm, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status April 9, 2010. Take notice that during the month March, 2010, the status of the...

  18. 76 FR 3540 - Proposed Generic Communications Reporting for Decommissioning Funding Status Reports

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... FR 72737). The purpose of the RIS is to clarify for licensees and external stakeholders the information that they should use and present to the NRC in the Decommissioning Funding Status reports to... Funding Status Reports AGENCY: Nuclear Regulatory Commission. ACTION: Proposed generic...

  19. 76 FR 65716 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket No..., the status of the above-captioned entities as Exempt Wholesale Generators became effective...

  20. 76 FR 13610 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Windstar Energy... 2011, the status of the above-captioned entities as Exempt Wholesale Generators became effective...

  1. 76 FR 81926 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos... status of the above-captioned entities as Exempt Wholesale Generators became effective by operation...

  2. 78 FR 69847 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Buffalo Dunes... status of the above-captioned entities as Exempt Wholesale Generators became effective by operation...

  3. 76 FR 2365 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status January 6, 2011..., the status of the above-captioned entities as Exempt Wholesale Generators became effective...

  4. 78 FR 35622 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator Status Docket Nos. CPV... status of the above-captioned entities as Exempt Wholesale Generators Companies became effective...

  5. Regulatory Improvement Act of 2013

    THOMAS, 113th Congress

    Sen. King, Angus S. Jr. [I-ME

    2013-07-30

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. Regulatory Accountability Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-05-23

    03/11/2014 Committee on Homeland Security and Governmental Affairs Subcommittee on the Efficiency and Effectiveness of Federal Programs and the Federal Workforce. Hearings held. With printed Hearing: S.Hrg. 113-371. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  7. Regulatory Integrity Act of 2016

    THOMAS, 112th Congress

    Rep. Walberg, Tim [R-MI-7

    2016-05-13

    09/13/2016 Rules Committee Resolution H. Res. 863 Reported to House. Rule provides for consideration of H.R. 5351 and H.R. 5226. Rule provides for one hour of debate on both H.R. 5351 and H.R. 5226. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. Regulatory Integrity Act of 2016

    THOMAS, 112th Congress

    Rep. Walberg, Tim [R-MI-7

    2016-05-13

    09/15/2016 Received in the Senate and Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  9. Regulatory Accountability Act of 2011

    THOMAS, 112th Congress

    Rep. Smith, Lamar [R-TX-21

    2011-09-22

    12/05/2011 Received in the Senate and Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  10. 7 CFR 1773.40 - Regulatory assets.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 12 2010-01-01 2010-01-01 false Regulatory assets. 1773.40 Section 1773.40... § 1773.40 Regulatory assets. The CPA's workpapers must document whether all regulatory assets comply with... whether all regulatory assets have received RUS approval....

  11. Securities and Exchange Commission 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] Part XXIV Securities and Exchange Commission Semiannual Regulatory Agenda ] SECURITIES AND EXCHANGE COMMISSION (SEC) SECURITIES AND EXCHANGE COMMISSION 17 CFR Ch. II Regulatory Flexibility Agenda AGENCY: Securities and Exchange Commission. ACTION:...

  12. Approach for Czech regulatory body to LBB

    SciTech Connect

    Tendera, P.

    1997-04-01

    At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany NPP is about ten years in operation (four units 440 MW - WWER model 213) and Temelin NPP is under construction (two units 1000 MW-WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufactures. The objective for the Czech LBB programme is to prove the LBB status of the primary piping systems of these NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety facilities, too. For both Dukovany and Temolin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASME, CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No. 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quotes} and consists of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

  13. Approach of Czech regulatory body to LBB

    SciTech Connect

    Tendera, P.

    1997-04-01

    At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany, NPP is about ten years in operation (four units 440 MW - WWBFL model 213) and Tomelin NPP is under construction (two units 1000 MW - WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufacturers. The objective of the Czech LBB program is to prove the LBB status of the primary piping systems of there NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety Facilities too. For both Dukovany and Tomelin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement, {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASMF CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quote} and consist of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

  14. The Tortoise and the Hare: Evolving Regulatory Landscapes for Biosimilars.

    PubMed

    Konara, Chamindika S; Barnard, Ross T; Hine, Damian; Siegel, Evan; Ferro, Vito

    2016-01-01

    Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution of regulations governing biosimilars, have meant that the development of the biosimilars industry has not been, and will not be, a carbon copy of the generics industry. Complexity in the development process reduces the cost advantages for biosimilars that generics offer over originators. There has been a marked difference in the number of biosimilars approved by the European Medicines Agency (EMA) and US FDA due to a lack of consensus and the different rates of progress in establishing both law and stable evidence-based regulatory guidelines for biosimilars. In this review, we provide a précis of the history and status of the regulatory regimes in the USA and Europe. Included is an assessment of market and nonmarket factors that may continue to influence the development of the biosimilars industry. PMID:26620970

  15. 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

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 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,...

  16. [Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial].

    PubMed

    Guo Xiaolei

    2015-07-01

    Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome. PMID:26665950

  17. 78 FR 36616 - Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ...\\ 17 CFR 240.19b-4. \\3\\ Securities Exchange Act Release No. 69494 (May 2, 2013), 78 FR 26823 (May 8... being asked to identify their expected FATCA status as a condition of continuing to do business... COMMISSION Self-Regulatory Organizations; The Depository Trust Company; Order Approving Proposed Rule...

  18. 77 FR 66211 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... From the Federal Register Online via the Government Publishing Office ] SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing of Proposed Rule Change To Amend Rules in Connection With Status as a ``Deemed Registered'' Clearing Agency October 29, 2012. Pursuant to Section 19(b)(1)...

  19. 76 FR 40074 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ...' last semiannual regulatory agenda was published on December 20, 2010, at 75 FR 79788. Beginning in the... these H-1B petitions. Timetable: Action Date FR Cite NPRM 03/03/11 76 FR 11686 NPRM Comment Period End... incident to CW status. Timetable: Action Date FR Cite Interim Final Rule 10/27/09 74 FR 55094 Interim...

  20. Noncoding Regulatory RNAs in Hematopoiesis.

    PubMed

    Jeong, M; Goodell, M A

    2016-01-01

    Hematopoiesis is a dynamic process in which blood cells are continuously generated from hematopoietic stem cells (HSCs). The regulatory mechanisms controlling HSC fate have been studied extensively over the past several decades. Although many protein-coding genes have been shown to regulate hematopoietic differentiation, additional levels of HSC regulation are not well studied. Advances in deep sequencing have revealed many new classes of regulatory noncoding RNAs (ncRNAs), such as enhancer RNAs and antisense ncRNAs. Functional analysis of some of these ncRNAs has provided insights into the molecular mechanisms that regulate hematopoietic development and disease. In this review, we summarize recent advances in our understanding of functional regulatory ncRNAs associated with hematopoietic self-renewal and differentiation, as well as those dysregulated ncRNAs involved in hematologic malignancies. PMID:27137659

  1. Negative cooperativity in regulatory enzymes.

    PubMed

    Levitzki, A; Koshland, D E

    1969-04-01

    Negative cooperativity has been observed in CTP synthetase, an allosteric enzyme which contains a regulatory site. Thus, the same enzyme exhibits negative cooperativity for GTP (an effector) and glutamine (a substrate) and positive cooperativity for ATP and UTP (both substrates). In the process of the delineation of these phenomena, diagnostic procedures for negative cooperativity were developed. Application of these procedures to other enzymes indicates that negative cooperativity is a characteristic of many of them. These findings add strong support for the sequential model of subunit interactions which postulates that ligand-induced conformational changes are responsible for regulatory and cooperative phenomena in enzymes. PMID:5256410

  2. The rise of regulatory RNA

    PubMed Central

    Morris, K.V.; Mattick, J.S.

    2015-01-01

    Discoveries over the last decade portend a paradigm shift in molecular biology. Evidence suggests that RNA is not only functional as a messenger between DNA and protein but also in the regulation of genome organization and gene expression, which is increasingly elaborated in complex organisms. Regulatory RNAs appear to operate at many levels, but in particular to play an important role in the epigenetic processes that control differentiation and development. These discoveries suggest a central role for RNA in human evolution and ontogeny. Here we survey the emergence of the previously unsuspected world of regulatory RNAs from an historical perspective. PMID:24776770

  3. Heuristic status polling

    DOEpatents

    Archer, Charles J.; Blocksome, Michael A.; Heidelberger, Philip; Kumar, Sameer; Parker, Jeffrey J.; Ratterman, Joseph D.

    2011-06-07

    Methods, compute nodes, and computer program products are provided for heuristic status polling of a component in a computing system. Embodiments include receiving, by a polling module from a requesting application, a status request requesting status of a component; determining, by the polling module, whether an activity history for the component satisfies heuristic polling criteria; polling, by the polling module, the component for status if the activity history for the component satisfies the heuristic polling criteria; and not polling, by the polling module, the component for status if the activity history for the component does not satisfy the heuristic criteria.

  4. Report of the Committee on Legislation and Regulatory Reform

    SciTech Connect

    Not Available

    1985-01-01

    The report covers the last eight months of the Second Session of the 98th Congress and the opening days of the 99th Congress. The report limits its coverage because of the large number of legislative proposals. Natural gas pricing and regulation, taxes to reduce the federal deficit, and regulatory reform received major legislative attention. Other proposals addressed energy preparedness, oil pipeline deregulation, petroleum overcharge restitution funds, low-income home energy assistance, a moratorium on offshore leasing, Superfund, involuntary utility terminations, and conservation. The report indicates the purpose and the status or outcome of the proposals.

  5. 77 FR 74712 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change To Amend the Customer and Industry Codes of Arbitration Procedure Relating to... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  6. 75 FR 18245 - Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... From the Federal Register Online via the Government Publishing Office SMALL BUSINESS ADMINISTRATION Public Federal Regulatory Enforcement Fairness Hearing Region IX Regulatory Fairness Board.... Small Business Administration (SBA) Region IX Regulatory Fairness Board and the SBA Office of...

  7. Uncovering Transcriptional Regulatory Networks by Sparse Bayesian Factor Model

    NASA Astrophysics Data System (ADS)

    Meng, Jia; Zhang, Jianqiu(Michelle); Qi, Yuan(Alan); Chen, Yidong; Huang, Yufei

    2010-12-01

    The problem of uncovering transcriptional regulation by transcription factors (TFs) based on microarray data is considered. A novel Bayesian sparse correlated rectified factor model (BSCRFM) is proposed that models the unknown TF protein level activity, the correlated regulations between TFs, and the sparse nature of TF-regulated genes. The model admits prior knowledge from existing database regarding TF-regulated target genes based on a sparse prior and through a developed Gibbs sampling algorithm, a context-specific transcriptional regulatory network specific to the experimental condition of the microarray data can be obtained. The proposed model and the Gibbs sampling algorithm were evaluated on the simulated systems, and results demonstrated the validity and effectiveness of the proposed approach. The proposed model was then applied to the breast cancer microarray data of patients with Estrogen Receptor positive ([InlineEquation not available: see fulltext.]) status and Estrogen Receptor negative ([InlineEquation not available: see fulltext.]) status, respectively.

  8. 75 FR 79799 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... agenda pursuant to Executive Order 12866 ``Regulatory Planning and Review,'' 58 FR 51735, and the... rulemaking that was published in the Federal Register on September 30, 2004, at 69 FR 58768, issued under... Enforcement Fairness Act of 1996 (SBREFA). Completed: Reason Date FR Cite Final Action 09/15/10 75 FR...

  9. 75 FR 79763 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... e mail communications. Timetable: Action Date FR Cite NPRM 04/00/11 NPRM Comment Period End 06/00/11... Medicaid EHR Incentive Programs. Timetable: Action Date FR Cite Interim Final Rule 01/13/10 75 FR 2014... 75 FR 44590 Regulatory Flexibility Analysis Required: No Agency Contact: Steven Posnack,...

  10. Food irradiation—US regulatory considerations

    NASA Astrophysics Data System (ADS)

    Morehouse, Kim M.

    2002-03-01

    The use of ionizing radiation in food processing has received increased interest as a means of reducing the level of foodborne pathogens. This overview discusses the regulatory issues connected with the use of this technology in the United States. Several recent changes in the FDA's review process are discussed. These include the current policy that utilizes an expedited review process for petitions seeking approval of additives and technologies intended to reduce pathogen levels in food, and the recent USDA rule that eliminates the need for a separate rulemaking process by USDA for irradiation of meat and poultry. Recently promulgated rules and pending petitions before the FDA associated with the use of ionizing radiation for the treatment of foods are also discussed along with the current FDA labeling requirements for irradiated foods and the 1999 advanced notice of proposed rule on labeling. Another issue that is presented is the current status of the approval of packaging materials intended for food contact during irradiation treatment of foods.

  11. 18 CFR 131.80 - FERC Form No. 556, Certification of qualifying facility (QF) status for a small power production...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., Certification of qualifying facility (QF) status for a small power production or cogeneration facility. 131.80 Section 131.80 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY APPROVED FORMS, FEDERAL POWER ACT AND PUBLIC UTILITY REGULATORY POLICIES ACT OF 1978...

  12. 77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... approaches capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the... regulatory capital buffer. B. Leverage Ratio 1. Minimum Tier 1 Leverage Ratio. A description of the minimum tier 1 leverage ratio, including the calculation of the numerator and the denominator. 2....

  13. 21 CFR 26.34 - Regulatory authorities.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.34 Regulatory authorities. The regulatory...

  14. 21 CFR 26.34 - Regulatory authorities.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.34 Regulatory authorities. The regulatory...

  15. 21 CFR 26.34 - Regulatory authorities.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY Specific Sector Provisions for Medical Devices § 26.34 Regulatory authorities. The regulatory...

  16. 76 FR 6123 - Reducing Regulatory Burden

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... achieving its regulatory objectives. DATES: Written comments and information are requested on or before... the least burden on society, consistent with obtaining the regulatory objectives, taking into account... approaches that reduce burdens and maintain flexibility. Regulations be guided by objective...

  17. Plant Evolution: Evolving Antagonistic Gene Regulatory Networks.

    PubMed

    Cooper, Endymion D

    2016-06-20

    Developing a structurally complex phenotype requires a complex regulatory network. A new study shows how gene duplication provides a potential source of antagonistic interactions, an important component of gene regulatory networks. PMID:27326708

  18. Nuclear Regulatory Commission 1989 Information Digest

    SciTech Connect

    None,

    1989-03-01

    The Nuclear Regulatory Commission 1989 Information Digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the Commission. This is the first of an annual publication for the general use of the NRC staff and is available to the public. The Digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  19. STATUS OF THE NRC'S DECOMMISSIONING PROGRAM

    SciTech Connect

    Orlando, D. A.; Camper, L. W.; Buckley, J.

    2002-02-25

    On July 21, 1997, the U.S. Nuclear Regulatory Commission published the final rule on Radiological Criteria for License Termination (the License Termination Rule) as Subpart E to 10 CFR Part 20. NRC regulations require that materials licensees submit Decommissioning Plans to support the decommissioning of its facility if it is required by license condition, or if the procedures and activities necessary to carry out the decommissioning have not been approved by NRC and these procedures could increase the potential health and safety impacts to the workers or the public. NRC regulations also require that reactor licensees submit Post-shutdown Decommissioning Activities Reports and License Termination Plans to support the decommissioning of nuclear power facilities. This paper provides an update on the status of the NRC's decommissioning program. It discusses the status of permanently shut-down commercial power reactors, complex decommissioning sites, and sites listed in the Site Decommissioning Management Plan. The paper provides the status of various tools and guidance the NRC is developing to assist licensees during decommissioning, including a Standard Review Plan for evaluating plans and information submitted by licensees to support the decommissioning of nuclear facilities and the D and D Screen software for determining the potential doses from residual radioactivity. Finally, it discusses the status of the staff's current efforts to streamline the decommissioning process.

  20. CALIPSO Mission Status Update: Payload Status

    NASA Technical Reports Server (NTRS)

    Verhappen, Ron; Borchardt, Robert; MacDonnell, David; Cisewski, Mike

    2007-01-01

    The CALIPSO mission payload status update is presented. The contents include: 1) Wide Field Camera Overview; 2) WFC Temperatures; 3) WFC Voltages; 4) Imaging Infrared Radiometer (IIR) Health; 5) IIR Voltages; 6) Payload Control (PLC) Voltages; 7) PLC Temperatures; 8) Low Voltage Power Supply (LVPS) (CALOPS0025N); 9) PLC Radiation Effects; 10) SDS Status (CALOPS0020N); 11) CALIOP LIDAR; 12) Laser Energy Trends; 13) Laser Energy Zoom; 14) Laser Management Approach; 15) Green / Red Ratio; 16) Pedestal @ SHG Temperature Trends; 17) LOM Heater Duty Cycle Trends; 18) LOM Pressure Trends; 19) Boresight Trend; 20) 1064 Dark Noise Trend; 21) 532 SNR Trend; 22) Spike Trends; 23) LIDAR Highlights; 24) Backup Laser Status; and 25) Future Plans.

  1. [Regulatory requirements for topical preparations].

    PubMed

    Wohlrab, J; Klauck, D; Savtcheva, E

    2014-03-01

    Professional use of topical treatment in dermatological practice requires not only knowledge about the pharmacological properties, efficacy, safety and pharmaceutical quality of a preparation, but also about its regulatory classification. The latter essentially determines the physician's prescription practice and therapeutic freedom. The regulatory framework with which one is confronted unfortunately lacks transparency. It regulates not only the prescribability and reimbursability of proprietary medicinal products and extemporaneous preparations, but also the obligation to give information as well as the details of liability of both the prescriber (physician) and the manufacturer (pharmaceutical company or pharmacist). The prescriber needs to be aware of to what extent the pharmacist has the possibility and even obligation to change the prescribed preparation. In some cases this can directly affect the therapeutic concept of the physician and even impair the effectiveness and safety of the chosen therapy. PMID:24622851

  2. 75 FR 61531 - Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... COMMISSION Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY: The... Guide 1.193, Rev. 3, ``ASME Code Cases Not Approved for Use.'' FOR FURTHER INFORMATION CONTACT: Wallace... Wallace.Norris@nrc.gov . SUPPLEMENTARY INFORMATION: I. Introduction The NRC is issuing Regulatory...

  3. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  4. Department of Commerce 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] Part IV Department of Commerce Semiannual Regulatory Agenda ] DEPARTMENT OF COMMERCE (DOC) DEPARTMENT OF COMMERCE Office of the Secretary 13 CFR Ch. III 15 CFR Subtitle A; Subtitle B, Chs. I, II, III, VII, VIII, IX, and XI 19 CFR Ch. III 37 CFR Chs. I, IV,...

  5. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  6. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  7. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  8. Regulatory aspects of neutron radiography

    NASA Astrophysics Data System (ADS)

    Hammer, J.

    1999-11-01

    While full legislation for industrial radiography with gamma and X-rays already exists in many countries, the situation is different for neutron radiography. Therefore, the licensing for equipment and procedures in this field has to be based on basic principles of national and international rules. This contribution will explain how the regulatory body in Switzerland deals with neutron radiography installations in order to maintain national standards of health and safety.

  9. Regulatory strategies and market entry

    SciTech Connect

    Russo, M.V.

    1988-01-01

    This paper discusses the intertwining influence of regulation, the pursuit of social goals, and market entry. The authors focus on the California natural gas distribution system, showing how the California Public Utilies Commission increasingly exercised its authority to set rates so as to meet social goals. Among these goals were lower fuel oil use, lower residential rates, and greater small power production. However, by calling on large users to pay substantially above their costs to subsidize these programs, the system was left open to cream-skimming entry. When a major new market for natural gas in the Kern County oil fields arose, several groups applied to the Federanl Energy Regulatory Commission to build an interstate gas pipeline - Califronia's first- dedicated to serving those customers. The proposals are being considered because of past pricing trends, because of the desire to avoid state regulatory oversight of their operations, and because they can be used to evade federal price regulations on natural gas. However, from a societal economic standpoint, all of the pipelines would be exceedingly expensive. The case demonstrates the unexpected and often the perverse consequences of pursuing social goals within a regulatory framework.

  10. 75 FR 39069 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the... FINRA and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of...