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Sample records for 95-4 regulatory status

  1. 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)...

  2. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 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)...

  3. 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...

  4. 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...

  5. 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...

  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 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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

  12. Current status of herbal product: Regulatory overview.

    PubMed

    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.

  13. 40 CFR 97.187 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status. 97.187... § 97.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit becomes a CAIR NOX... authority and the Administrator of such change in the CAIR NOX opt-in unit's regulatory status, within...

  14. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status. 97.287... § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within...

  15. 40 CFR 97.187 - 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. 97.187... § 97.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit becomes a CAIR NOX... authority and the Administrator of such change in the CAIR NOX opt-in unit's regulatory status, within...

  16. 40 CFR 97.187 - 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. 97.187... § 97.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit becomes a CAIR NOX... authority and the Administrator of such change in the CAIR NOX opt-in unit's regulatory status, within...

  17. 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... CAIR SO 2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in... regulatory status, within 30 days of such change. (b) Permitting authority's and Administrator's actions....

  18. 40 CFR 97.187 - 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. 97.187... § 97.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit becomes a CAIR NOX... authority and the Administrator of such change in the CAIR NOX opt-in unit's regulatory status, within...

  19. 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... CAIR SO 2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in... regulatory status, within 30 days of such change. (b) Permitting authority's and Administrator's actions....

  20. 40 CFR 97.87 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status. 97.87... § 97.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in unit becomes a NOX... permitting authority and the Administrator of such change in the NOX Budget opt-in unit's regulatory...

  1. 40 CFR 97.87 - 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. 97.87.... § 97.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in unit becomes a NOX... permitting authority and the Administrator of such change in the NOX Budget opt-in unit's regulatory...

  2. 40 CFR 97.87 - 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. 97.87... § 97.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in unit becomes a NOX... permitting authority and the Administrator of such change in the NOX Budget opt-in unit's regulatory...

  3. 40 CFR 97.87 - 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. 97.87... § 97.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in unit becomes a NOX... permitting authority and the Administrator of such change in the NOX Budget opt-in unit's regulatory...

  4. 40 CFR 96.187 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status. 96.187... CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit... status, within 30 days of such change. (b) Permitting authority's and Administrator's actions. (1) If...

  5. 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... CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit... status, within 30 days of such change. (b) Permitting authority's and Administrator's actions. (1) If...

  6. 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... CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit... status, within 30 days of such change. (b) Permitting authority's and Administrator's actions. (1) If...

  7. 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... CAIR NOX Opt-in Units § 96.187 Change in regulatory status. (a) Notification. If a CAIR NOX opt-in unit... status, within 30 days of such change. (b) Permitting authority's and Administrator's actions. (1) If...

  8. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within...

  9. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within...

  10. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within...

  11. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within...

  12. 40 CFR 97.187 - 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. 97.187 Section 97.187 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR NOX Opt-In Units § 97.187 Change in regulatory status....

  13. 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... Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  14. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 22 2012-07-01 2012-07-01 false Change in regulatory status. 96.87... Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  15. 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... Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  16. 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... Individual Unit Opt-ins § 96.87 Change in regulatory status. (a) Notification. When a NOX Budget opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  17. 40 CFR 97.87 - 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. 97.87 Section 97.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS Individual Unit Opt-ins. § 97.87 Change in regulatory status....

  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. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (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 unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in...

  9. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (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 unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in...

  10. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (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 unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in...

  11. 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...

  12. 40 CFR 96.87 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (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 opt-in source becomes a NOX Budget unit under § 96.4, the NOX authorized account representative shall notify...

  13. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... of days, in the control period, starting with the date on which the CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304 divided by the total number of days in the...

  14. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... of days, in the control period, starting with the date on which the CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304 divided by the total number of days in the...

  15. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... CAIR NOX Ozone Season unit under § 97.304, multiplied by the ratio of the number of days, in the... Ozone Season unit under § 97.304 divided by the total number of days in the control period and...

  16. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... CAIR NOX Ozone Season unit under § 97.304, multiplied by the ratio of the number of days, in the... Ozone Season unit under § 97.304 divided by the total number of days in the control period and...

  17. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... of days, in the control period, starting with the date on which the CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304 divided by the total number of days in the...

  18. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... CAIR NOX Ozone Season unit under § 97.304, multiplied by the ratio of the number of days, in the... Ozone Season unit under § 97.304 divided by the total number of days in the control period and...

  19. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... CAIR NOX Ozone Season unit under § 97.304, multiplied by the ratio of the number of days, in the... Ozone Season unit under § 97.304 divided by the total number of days in the control period and...

  20. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... of days, in the control period, starting with the date on which the CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304 divided by the total number of days in the...

  1. 40 CFR 96.387 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... change in the CAIR NOX Ozone Season opt-in unit's regulatory status, within 30 days of such change. (b... of days, in the control period, starting with the date on which the CAIR NOX Ozone Season opt-in unit becomes a CAIR NOX Ozone Season unit under § 96.304 divided by the total number of days in the...

  2. 40 CFR 97.387 - Change in regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Season opt-in unit's regulatory status, within 30 days of such change. (b) Permitting authority's and... CAIR NOX Ozone Season unit under § 97.304, multiplied by the ratio of the number of days, in the... Ozone Season unit under § 97.304 divided by the total number of days in the control period and...

  3. 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 Section 96.187 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR NOX Opt-in Units § 96.187 Change...

  4. 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

  5. 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.

  6. 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

  7. MT95-4, a fully humanized antibody raised against aminopeptidase N, reduces tumor progression in a mouse model

    PubMed Central

    Akita, Shin; Hattori, Noboru; Masuda, Takeshi; Horimasu, Yasushi; Nakashima, Taku; Iwamoto, Hiroshi; Fujitaka, Kazunori; Miyake, Masayuki; Kohno, Nobuoki

    2015-01-01

    Aminopeptidase N (APN/CD13) is involved in tumor cell invasion and tumor angiogenesis and is considered a promising therapeutic target in the treatment of cancer. To develop a novel monoclonal antibody-based cancer therapy targeting APN/CD13, we established a fully humanized anti-APN/CD13 monoclonal antibody, MT95-4. In vitro, MT95-4 inhibited APN/CD13 enzymatic activity on the tumor cell surface and blocked tumor cell invasion. B16 mouse melanoma cells stably expressing human APN/CD13 were also established and were inoculated s.c. or injected i.v. into nude mice. We found that expression of human APN/CD13 in murine melanoma cells increased the size of subcutaneous tumors, extent of lung metastasis and degree of angiogenesis in the subcutaneous tumors; these tumor-promoting and angiogenesis-promoting characteristics were reduced by the i.p. administration of MT95-4. To further verify the specificity of MT95-4 for neutralization of APN/CD13 activity, MT95-4 was administered into NOD/SCID mice inoculated s.c. with H1299 or PC14 cells, which exhibit high expression of APN/CD13, or with A549 cells, which exhibit weak expression of APN/CD13. MT95-4 reduced tumor growth and angiogenesis in mice bearing H1299-derived and PC14-derived tumors, but not in mice bearing A549-derived tumors. These results suggested that the antitumor and anti-angiogenic effects of MT95-4 were dependent on APN/CD13 expression in tumor cells. Given that MT95-4 is the first fully humanized monoclonal antibody against APN/CD13, MT95-4 should be recognized as a promising candidate for monoclonal antibody therapy against tumors expressing APN/CD13. PMID:25950387

  8. 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

  9. [EVALUATION OF THE REGULATORY-ADAPTIVE STATUS FOR PROGNOSTICATION IN SYSTOLIC CHRONIC HEART FAILURE].

    PubMed

    Tregubov, V G; Kanorsky, S G; Pokrovsky, V M

    2015-01-01

    We studied a new approach to prognostication in systolic chronic heart failure (CHF) based on the quantitative evaluation of the regulatory-adaptive status (RAS) in 100 patients with FC III CHF and compromised LV systolic function associated with hypertensive disease and/or ischemic heart disease. The patients managed by combined therapy (quinapril, torasemid, spironolactone) were randomized into 2 groups. Group 1 included 56 patients (57.5 ± 21.7 yr) treated with metoprolol succinate (59.1 ± 12.1 mg/d), group 2 contained 44 patients (57.5 ± 21.4 yr) treated with ivabradine (12.1 ± 4.6 mg/d). A test of cardio-respiratory synchronism for quantitative RAS evaluation, echocardiography, treadmill exercise, determination of N-terminal precursor of brain natriuretic peptide in blood plasma, and 6 min walk test were performed before and 6 months after the onset of the study. A 12 month follow up study with controlled pharmacotherapy was carried out to analyse cardiovascular complications. The clinical efficiency of pharmacotherapy was found to be identical in both groups. The frequency of hospitalization for the treatment of CHF, ischemic stroke, and myocardial infarction as well as the number of deaths from cardiovascular disorders were not significantly different. Cardiovascular complications occurred more frequently in patients with initially low or inadequate RAS associated with an enhanced risk of sudden cardiac death. These data are comparable with results of conventional diagnostic tests and reflect independent significance of RAS evaluation for prognostication of the outcome of systolic CHE PMID:26987135

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  16. 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

  17. 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...

  18. 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).

  19. 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…

  20. 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

  1. 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

  2. Reciprocal control between a bacterium's regulatory system and the modification status of its lipopolysaccharide.

    PubMed

    Kato, Akinori; Chen, H Deborah; Latifi, Tammy; Groisman, Eduardo A

    2012-09-28

    Gram-negative bacteria often modify their lipopolysaccharide (LPS), thereby increasing resistance to antimicrobial agents and avoidance of the host immune system. However, it is unclear how bacteria adjust the levels and activities of LPS-modifying enzymes in response to the modification status of their LPS. We now address this question by investigating the major regulator of LPS modifications in Salmonella enterica. We report that the PmrA/PmrB system controls expression of a membrane peptide that inhibits the activity of LpxT, an enzyme responsible for increasing the LPS negative charge. LpxT's inhibition and the PmrA-dependent incorporation of positively charged L-4-aminoarabinose into the LPS decrease Fe(3+) binding to the bacterial cell. Because Fe(3+) is an activating ligand for the sensor PmrB, transcription of PmrA-dependent LPS-modifying genes is reduced. This mechanism enables bacteria to sense their cell surface by its effect on the availability of an inducing signal for the system regulating cell-surface modifications.

  3. Antimicrobials in shrimp aquaculture in the United States: regulatory status and safety concerns.

    PubMed

    Park, E D; Lightner, D V; Park, D L

    1994-01-01

    The consumption of seafood, especially shrimp, increases yearly in the U.S. The U.S. is the second largest importer of shrimp in the world, consuming more than 11% of the total world production. Aquaculture is becoming an increasingly important source of the world's shrimp, currently accounting for approximately 30% of the world's supply. Unfortunately, in this era of international trade deficits, U.S. production of aquacultured shrimp is insignificant (< 0.1%) compared with world production. As shrimp aquaculture expands in the U.S., so does the use of intensive farming techniques. Shrimp aquaculture is like any other animal husbandry industry in that shrimp are subject to disease, especially under intensive farming methods. In penaeid shrimp, the primary diseases associated with mortalities are usually viral or bacterial. The majority of bacterial infections in penaeid shrimp are attributable to Vibrio species, with mortalities ranging from insignificant to 100%. However, the rapid growth of this industry has outpaced efforts by researchers, pharmaceutical companies, and federal regulatory agencies to provide approved therapeutants for shrimp disease management. Approval of drugs and their surveillance for compliance with regulations applicable to seafoods, including aquacultured goods, is the responsibility of the FDA. There are three general areas of concern regarding human health when chemotherapeutants are used in aquaculture: (1) residues of drugs in fish destined for human consumption; (2) development of drug resistance in human pathogenic bacteria; and (3) direct toxic effects to humans from handling of drugs. Currently, there are no antibacterials approved for shrimp aquaculture in the U.S. One of the major obstacles in the development and approval of new drugs for aquaculture is the cost of conducting the required studies. The high cost to pharmaceutical companies discourages investment in shrimp chemotherapeutant research, since the current U.S. market

  4. 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

  5. Hepatic PCSK9 expression is regulated by nutritional status via insulin and sterol regulatory element-binding protein 1c.

    PubMed

    Costet, Philippe; Cariou, Bertrand; Lambert, Gilles; Lalanne, Florent; Lardeux, Bernard; Jarnoux, Anne-Laure; Grefhorst, Aldo; Staels, Bart; Krempf, Michel

    2006-03-10

    Familial autosomal dominant hypercholesterolemia is associated with high risk for cardiovascular accidents and is related to mutations in the low density lipoprotein receptor or its ligand apolipoprotein B (apoB). Mutations in a third gene, proprotein convertase subtilisin kexin 9 (PCSK9), were recently associated to this disease. PCSK9 acts as a natural inhibitor of the low density lipoprotein receptor pathway, and both genes are regulated by depletion of cholesterol cell content and statins, via sterol regulatory element-binding protein (SREBP). Here we investigated the regulation of PCSK9 gene expression during nutritional changes. We showed that PCSK9 mRNA quantity is decreased by 73% in mice after 24 h of fasting, leading to a 2-fold decrease in protein level. In contrast PCSK9 expression was restored upon high carbohydrate refeeding. PCSK9 mRNA increased by 4-5-fold in presence of insulin in rodent primary hepatocytes, whereas glucose had no effect. Moreover, insulin up-regulated hepatic PCSK9 expression in vivo during a hyperinsulinemic-euglycemic clamp in mice. Adenoviral mediated overexpression of a dominant or negative form of SREBP-1c confirmed the implication of this transcription factor in insulin-mediated stimulation of PCSK9 expression. Liver X receptor agonist T0901317 also regulated PCSK9 expression via this same pathway (a 2-fold increase in PCSK9 mRNA of primary hepatocytes cultured for 24 h in presence of 1 microm T0901317). As our last investigation, we isolated PCSK9 proximal promoter and verified the functionality of a SREBP-1c responsive element located from 335 bp to 355 bp upstream of the ATG. Together, these results show that PCSK9 expression is regulated by nutritional status and insulinemia. PMID:16407292

  6. Copper toxicity in Chinese cabbage is not influenced by plant sulphur status, but affects sulphur metabolism-related gene expression and the suggested regulatory metabolites.

    PubMed

    Shahbaz, M; Stuiver, C E E; Posthumus, F S; Parmar, S; Hawkesford, M J; De Kok, L J

    2014-01-01

    The toxicity of high copper (Cu) concentrations in the root environment of Chinese cabbage (Brassica pekinensis) was little influenced by the sulphur nutritional status of the plant. However, Cu toxicity removed the correlation between sulphur metabolism-related gene expression and the suggested regulatory metabolites. At high tissue Cu levels, there was no relation between sulphur metabolite levels viz. total sulphur, sulphate and water-soluble non-protein thiols, and the expression and activity of sulphate transporters and expression of APS reductase under sulphate-sufficient or-deprived conditions, in the presence or absence of H2 S. This indicated that the regulatory signal transduction pathway of sulphate transporters was overruled or by-passed upon exposure to elevated Cu concentrations.

  7. 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

  8. 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

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

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-03-18

    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.

  10. 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

  11. 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

  12. Evaluating the effect of regulatory prohibitions against risk selection by health status on supplemental insurance ownership in Israel.

    PubMed

    Gross, Revital; Brammli-Greenberg, Shuli

    2004-05-01

    In Israel, supplemental insurance, which covers services not included in the mandatory basic benefits package, is offered by sick funds and regulated by the Ministry of Health. In 1998, policy regulations were set to eliminate barriers that prevented the ill from purchasing supplemental insurance, thereby increasing equality and risk solidarity. In this paper, we examine whether these regulations have indeed changed the extent of ownership and characteristics of policyholders, using data from surveys conducted in 1995, 1997, 1999, and 2001. The findings indicate that while there were no significant changes between 1995 and 1997, there was a significant increase in ownership among those with poor health status after the new regulations came into effect. We conclude that administrative regulations can influence the structure of supplemental insurance to achieve desired social values, and discuss additional policy options that are currently under debate in Israel to further promote equality and solidarity in this market by increasing accessibility to low income and other underserved populations.

  13. Interactions between Copper-binding Sites Determine the Redox Status and Conformation of the Regulatory N-terminal Domain of ATP7B*

    PubMed Central

    LeShane, Erik S.; Shinde, Ujwal; Walker, Joel M.; Barry, Amanda N.; Blackburn, Ninian J.; Ralle, Martina; Lutsenko, Svetlana

    2010-01-01

    Copper-transporting ATPase ATP7B is essential for human copper homeostasis and normal liver function. ATP7B has six N-terminal metal-binding domains (MBDs) that sense cytosolic copper levels and regulate ATP7B. The mechanism of copper sensing and signal integration from multiple MBDs is poorly understood. We show that MBDs communicate and that this communication determines the oxidation state and conformation of the entire N-terminal domain of ATP7B (N-ATP7B). Mutations of copper-coordinating Cys to Ala in any MBD (2, 3, 4, or 6) change the N-ATP7B conformation and have distinct functional consequences. Mutating MBD2 or MBD3 causes Cys oxidation in other MBDs and loss of copper binding. In contrast, mutation of MBD4 and MBD6 does not alter the redox status and function of other sites. Our results suggest that MBD2 and MBD3 work together to regulate access to other metal-binding sites, whereas MBD4 and MBD6 receive copper independently, downstream of MBD2 and MBD3. Unlike Ala substitutions, the Cys-to-Ser mutation in MBD2 preserves the conformation and reduced state of N-ATP7B, suggesting that hydrogen bonds contribute to interdomain communications. Tight coupling between MBDs suggests a mechanism by which small changes in individual sites (induced by copper binding or mutation) result in stabilization of distinct conformations of the entire N-ATP7B and altered exposure of sites for interactions with regulatory proteins. PMID:20032459

  14. NRC regulatory initiatives

    SciTech Connect

    Johnson, T.C.

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  15. State regulatory authorities and nonregulated utilities: purposes of Title I and III of the Public Utility Regulatory Policies Act (PURPA) of 1978. Quarterly project status report, July-September 1982

    SciTech Connect

    Not Available

    1982-09-01

    The Department of Energy's (DOE) Economic Regulation Administration (ERA) had a requirement to report to Congress on determinations made by State regulatory authorities and nonregulated utilities regarding their purposes of Title I and III of the Public Utility Regulatory Policies Act, (PURPA) of 1978. The purposes stated in PURPA are to promote conservation of energy supplied by utilities, efficiency in use of utilities, and equitable rates for utility consumers. In addition, ERA is required to assist State regulatory authorities and nonregulated utilities in carrying out their PURPA responsibilities by implementing information dissemination activities. The technical and administrative support for implementing ERA's information data base to their clientele is discussed. The following segments are discussed as they relate to ERA's information dissemination system: information acquisition dissemination; information analysis and retrieval; information storage; and information maintenance.

  16. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... virtue of an audit. Claim means a request for Federal financial participation in the manner and format... financial participation means the Federal government's share of an expenditure made by a State agency under... definitions in the appropriate program's regulations. The Act means the Social Security Act, as amended....

  17. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... under title IV-A and for support enforcement services under title IV-D means any agency or organization... definitions in the appropriate program's regulations. The Act means the Social Security Act, as amended....

  18. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 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 File... State Child Health Agency, its fiscal agents, a State health agency, or any other State or...

  19. 45 CFR 95.4 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 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 File... State Child Health Agency, its fiscal agents, a State health agency, or any other State or...

  20. Status of Legislation and Regulatory Control of Public Health Pesticides in Countries Endemic with or at Risk of Major Vector-Borne Diseases

    PubMed Central

    Matthews, Graham; Zaim, Morteza; Soares, Agnes; Hii, Jeffrey; Ameneshewa, Birkinesh; Mnzava, Abraham; Dash, Aditya Prasad; Ejov, Mikhail; Tan, Soo Hian; van den Berg, Henk

    2011-01-01

    Background: Legislation and regulation of pesticides used in public health are essential for reducing risks to human health and the environment. Objective: We assessed the global situation on legislation and regulatory control of public health pesticides. Methods: A peer-reviewed and field-tested questionnaire was distributed to 142 member states of the World Health Organization (WHO); 113 states completed the questionnaire. Results: Legislation on public health pesticides was absent in 25% of the countries. Where present, legislation often lacked comprehensiveness, for example, on basic aspects such as labeling, storage, transport, and disposal of public health pesticides. Guidelines or essential requirements for the process of pesticide registration were lacking in many countries. The capacity to enforce regulations was considered to be weak across WHO regions. Half of all countries lacked pesticide quality control laboratories, and two-thirds reported high concern over quality of products on the market. National statistics on production and trade of pesticides and poisoning incidents were lacking in many countries. Despite the shortcomings, WHO recommendations were considered to constitute a supportive or sole basis in national registration. Also, some regions showed high participation of countries in regional schemes to harmonize pesticide registration requirements. Conclusions: Critical deficiencies are evident in the legislative and regulatory framework for public health pesticides across regions, posing risks to human health and the environment. Recent experience in some countries with situational analysis, needs assessment, action planning, and regional collaboration has signaled a promising way forward. PMID:21742577

  1. 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.

  2. 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...

  3. Parabens can enable hallmarks and characteristics of cancer in human breast epithelial cells: a review of the literature with reference to new exposure data and regulatory status.

    PubMed

    Darbre, Philippa D; Harvey, Philip W

    2014-09-01

    A framework for understanding the complexity of cancer development was established by Hanahan and Weinberg in their definition of the hallmarks of cancer. In this review, we consider the evidence that parabens can enable development in human breast epithelial cells of four of six of the basic hallmarks, one of two of the emerging hallmarks and one of two of the enabling characteristics. In Hallmark 1, parabens have been measured as present in 99% of human breast tissue samples, possess oestrogenic activity and can stimulate sustained proliferation of human breast cancer cells at concentrations measurable in the breast. In Hallmark 2, parabens can inhibit the suppression of breast cancer cell growth by hydroxytamoxifen, and through binding to the oestrogen-related receptor gamma may prevent its deactivation by growth inhibitors. In Hallmark 3, in the 10 nm-1 μm range, parabens give a dose-dependent evasion of apoptosis in high-risk donor breast epithelial cells. In Hallmark 4, long-term exposure (>20 weeks) to parabens leads to increased migratory and invasive activity in human breast cancer cells, properties that are linked to the metastatic process. As an emerging hallmark methylparaben has been shown in human breast epithelial cells to increase mTOR, a key regulator of energy metabolism. As an enabling characteristic parabens can cause DNA damage at high concentrations in the short term but more work is needed to investigate long-term, low-dose mixtures. The ability of parabens to enable multiple cancer hallmarks in human breast epithelial cells provides grounds for regulatory review of the implications of the presence of parabens in human breast tissue.

  4. 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:

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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:

  11. The effect of nutritional status and myogenic satellite cell age on turkey satellite cell proliferation, differentiation, and expression of myogenic transcriptional regulatory factors and heparan sulfate proteoglycans syndecan-4 and glypican-1.

    PubMed

    Harthan, Laura B; McFarland, Douglas C; Velleman, Sandra G

    2014-01-01

    Posthatch satellite cell mitotic activity is a critical component of muscle development and growth. Satellite cells are myogenic stem cells that can be induced by nutrition to follow other cellular developmental pathways, and whose mitotic activity declines with age. The objective of the current study was to determine the effect of restricting protein synthesis on the proliferation and differentiation, expression of myogenic transcriptional regulatory factors myogenic determination factor 1, myogenin, and myogenic regulatory factor 4, and expression of the heparan sulfate proteoglycans syndecan-4 and glypican-1 in satellite cells isolated from 1-d-, 7-wk-, and 16-wk-old turkey pectoralis major muscle (1 d, 7 wk, and 16 wk cells, respectively) by using variable concentrations of Met and Cys. Four Met concentrations-30 (control), 7.5, 3, or 0 mg/L with 3.2 mg/L of Cys per 1 mg/L of Met-were used for culture of satellite cells to determine the effect of nutrition and age on satellite cell behavior during proliferation and differentiation. Proliferation was reduced by lower Met and Cys concentrations in all ages at 96 h of proliferation. Differentiation was increased in the 1 d Met-restricted cells, whereas the 7 wk cells treated with 3 mg/L of Met had decreased differentiation. Reduced Met and Cys levels from the control did not significantly affect the 16 wk cells at 72 h of differentiation. However, medium with no Met or Cys suppressed differentiation at all ages. The expression of myogenic determination factor 1, myogenin, myogenic regulatory factor 4, syndecan-4, and glypican-1 was differentially affected by age and Met or Cys treatment. These data demonstrate the age-specific manner in which turkey pectoralis major muscle satellite cells respond to nutritional availability and the importance of defining optimal nutrition to maximize satellite cell proliferation and differentiation for subsequent muscle mass accretion.

  12. Environmental regulatory update table

    SciTech Connect

    Brown, K.J.; Langston, M.E.; Tucker, C.S.; Reed, R.M.

    1987-06-01

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

  13. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... 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 rules... regulations to improve the control over the distribution of source material to exempt persons and to...

  14. Regulatory organizations for physicians' status and administrative sanctions on physicians: - examining the framework of government administrative systems for physicians in Japan based on a questionnaire survey conducted on 13 national medical associations.

    PubMed

    Morioka, Yasuhiko; Higuchi, Norio; Kuroyanagi, Tatsuo; Nudeshima, Jiro

    2014-05-01

    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.

  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. Regulatory sequence analysis tools.

    PubMed

    van Helden, Jacques

    2003-07-01

    The web resource Regulatory Sequence Analysis Tools (RSAT) (http://rsat.ulb.ac.be/rsat) offers a collection of software tools dedicated to the prediction of regulatory sites in non-coding DNA sequences. These tools include sequence retrieval, pattern discovery, pattern matching, genome-scale pattern matching, feature-map drawing, random sequence generation and other utilities. Alternative formats are supported for the representation of regulatory motifs (strings or position-specific scoring matrices) and several algorithms are proposed for pattern discovery. RSAT currently holds >100 fully sequenced genomes and these data are regularly updated from GenBank.

  17. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... been learned since that time. Far more is now known about regulation—not only about when it is... interests of future generations; identify methods of ensuring that regulatory review does not produce...

  18. Assessing the regulatory picture

    SciTech Connect

    Not Available

    1994-02-01

    This article addresses the safety of the nation's drinking water supply and discusses compliance of the Clean Water Act. Right now, the shape of the regulatory future is uncertain. The results of the D-DBP regulatory negotiation are imminent. Congress is ready to begin debating reauthorization of the Safe Drinking Water Act, and utilities are trying to comply with the regulations while trying not to price water out of the reach of some of their customers.

  19. 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:

  20. 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:

  1. 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:

  2. 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)

  3. 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.

  4. Viral complement regulatory proteins.

    PubMed

    Rosengard, A M; Ahearn, J M

    1999-05-01

    The inactivation of complement provides cells and tissues critical protection from complement-mediated attack and decreases the associated recruitment of other inflammatory mediators. In an attempt to evade the host immune response, viruses have evolved two mechanisms to acquire complement regulatory proteins. They can directly seize the host cell complement regulators onto their outer envelope and/or they can produce their own proteins which are either secreted into the neighboring intercellular space or expressed as membrane-bound proteins on the infected host cell. The following review will concentrate on the viral homologues of the mammalian complement regulatory proteins, specifically those containing complement control protein (CCP) repeats. PMID:10408371

  5. 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.

  6. 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.

  7. 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…

  8. 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...

  9. 75 FR 11962 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-12

    ... COMMISSION Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating To Temporary Membership Status and Interim Trading... from interested parties. \\1\\ 15 U.S.C. 78s(b)(1). I. Self-Regulatory Organization's Statement of...

  10. 75 FR 3951 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-25

    ... COMMISSION Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Temporary Membership Status and Interim Trading... interested parties. \\1\\ 15 U.S.C. 78s(b)(1). I. Self-Regulatory Organization's Statement of the Terms...

  11. 75 FR 7301 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ... COMMISSION Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Temporary Membership Status and Interim Trading... from interested parties. \\1\\ 15 U.S.C. 78s(b)(1). I. Self-Regulatory Organization's Statement of...

  12. 75 FR 18934 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... COMMISSION Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Temporary Membership Status and Interim Trading... from interested parties. \\1\\ 15 U.S.C. 78s(b)(1). I. Self-Regulatory Organization's Statement of...

  13. 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).

  14. 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.

  15. Orphan drugs: the regulatory environment.

    PubMed

    Franco, Pedro

    2013-02-01

    The definition of a rare disease is not universal and depends on the legislation and policies adopted by each region or country. The main objective of this article is to describe and discuss the legal framework and the regulatory environment of orphan drugs worldwide. Some reflections and discussions on the need for specific orphan drug legislation or policies are described at length. Furthermore, some aspects of the history of each region in respect of the orphan drug legislation evolution are outlined. This article describes and compares the orphan drug legislation or policies of the following countries or regions: United Sates of America (US), European Union (EU), Japan, Australia, Singapore, Taiwan and Canada. The incentives described in the orphan drug legislations or policies, the criteria for designation of orphan status and the authorisation process of an orphan drug are also described and compared. The legislations and policies are to some extent similar but not the same. It is important to understand the main differences among all available legislative systems to improve the international collaboration in the field of orphan drugs and rare diseases.

  16. 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...

  17. 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.

  18. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of the special supervisory, regulatory, and economic policy needs served by such reports. Regulatory... reflects the underlying economic substance of the transaction at issue. Regulatory reporting...

  19. 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...

  20. 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...

  1. 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... Administration (NASA). ACTION: Semiannual regulatory agenda. SUMMARY: NASA's regulatory agenda describes those regulations being considered for development or amendment by NASA, the need and legal basis for the...

  2. 75 FR 79759 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Action 04/16/10 75 FR 2012 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mohammed Khan... ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et seq... use throughout the rulemaking process. Timetable: Action Date FR Cite Notice: Public Meeting...

  3. Establishing regulatory priorities

    SciTech Connect

    Pontius, F.W.

    1995-12-01

    Statutory deadlines for setting regulations under the 1986 Safe Drinking Water Act (SDWA) have not been met. Faced with limited resources, the US Environmental Protection Agency (USEPA) has historically set regulatory priorities based on perceived need, politics, and legal deadlines. This has resulted in a fragmented regulatory program and confusion on the part of the regulated community and on the part of other stakeholders. Even though the agency has been subject to court-imposed deadlines for most new regulations, resource limitations have caused these deadlines to be missed, resulting in new court-imposed deadlines. In 1994, the agency began considering a new approach for determining how many regulations can be developed and in what order. A draft strategic plan was prepared in December 1994. Based on discussion of this plan, USEPA requested the US District Court for Oregon to extend certain regulatory deadlines so that new priorities could be set for the highest-risk substances. An extension was granted until Aug. 1, 1995, and was subsequently extended to Dec. 15, 1995.

  4. 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.

  5. 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.

  6. Status Epilepticus

    PubMed Central

    Manno, Edward M.

    2011-01-01

    Status epilepticus is a neurological emergency that is commonly encountered by the neurohospitalist. Successful treatment depends upon the recognition of prolonged seizure activity and the acute mobilization of available resources. Pharmacologic treatment regimens have been shown to decrease the time needed for successful control of seizures and have provided for the rapid administration of anticonvulsant medications. Treatment strategies have evolved so that clinicians can administer effective doses of medication by whatever routes of administration are immediately available. Traditional algorithms for the treatment of status epilepticus have used a stepwise approach to the administration of first-, second-, and third-order medications. More recent options have included aggressive anesthetic doses of medications while second-line medications are being titrated. PMID:23983834

  7. 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.

  8. 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.

  9. Regulatory Considerations for Biosimilars

    PubMed Central

    Nellore, Ranjani

    2010-01-01

    Currently there is considerable interest in the legislative debate around generic biological drugs or “biosimilars” in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved “similar” biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products. PMID:21829775

  10. 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

  11. Role of modelling and simulation: a European regulatory perspective.

    PubMed

    Jönsson, Siv; Henningsson, Anja; Edholm, Monica; Salmonson, Tomas

    2012-02-01

    Modelling and simulation (M&S) of clinical data, e.g. pharmacokinetic, pharmacodynamic and clinical endpoints, is a useful approach for more efficient interpretation of collected data and for extrapolation of knowledge to the entire target population. This type of documentation is included in the majority of marketing authorization applications for new medicinal products. This article summarizes the current status of regulatory review with respect to the role of M&S in Europe from the perspective of the Swedish Medical Products Agency. At present, regulatory bodies in Europe encourage the application of the M&S approach during drug development. However, there is a lack of consensus and transparent guidance documents. The main regulatory usage is in the evaluation of dose choices in sub-populations and as support for the dosing regimen in general. The regulatory review of conestat alfa illustrates how the dose recommendation was revised during the approval procedure based on M&S information. A survey of marketing authorization applications for new medicinal products approved in 2010 revealed that the use of the information gained from M&S documentation varies with respect to both regulatory review and the applicants' presentation of the data in the submitted dossier. Increased utilization and broadened application of M&S is anticipated in pharmaceutical development, where one area of focus is medicines for paediatric patients. Accordingly, the regulatory agencies will need to increase their capability to assess and utilize this type of information, and an interactive process among regulatory agencies is warranted to provide more unified regulatory assessment and guidance. Moreover, applicants are encouraged to expand on the usage of exposure-response models to map the systemic exposure range that yields safe and efficacious treatment and to improve the presentation of the gained knowledge in summary documents of the marketing authorization applications. PMID

  12. 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...

  13. 78 FR 1634 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Administration (NASA). ACTION: Semiannual regulatory agenda. SUMMARY: NASA's regulatory agenda describes those regulations being considered for development or amendment by NASA, the need and legal basis for the actions... Controls and Management Systems, Office of Management Systems Division, NASA Headquarters, Washington,...

  14. 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...

  15. 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…

  16. 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.

  17. 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:

  18. Regulatory T cells and transplantation tolerance.

    PubMed

    Cobbold, S P

    2008-01-01

    Rodent models of transplantation have demonstrated that it is possible to induce specific immunological tolerance of donor antigens and indefinite graft survival in the absence of any continued immunosuppression. If this situation could be achieved clinically it would avoid many of the longer term complications of organ grafting, such as the increased risk of infection and cancer and the nephrotoxicity of many immunosuppressive agents. In this review we shall consider the interplay between regulatory T cells, dendritic cells and the graft itself and the resulting local protective mechanisms that are coordinated to maintain the tolerant state. We will discuss how both anti-inflammatory cytokines and negative costimulatory interactions can elicit a number of interrelated mechanisms to regulate both T cell and antigen-presenting cell activity. The induction and maintenance of tolerance via acquired local immune privilege has implications for the design of therapeutic regimens and the monitoring of the tolerant status of patients being weaned off immunosuppression. PMID:18651537

  19. 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.

  20. Internationalization of regulatory requirements.

    PubMed

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  1. Regulatory Dendritic Cells for Immunotherapy in Immunologic Diseases

    PubMed Central

    Gordon, John R.; Ma, Yanna; Churchman, Laura; Gordon, Sara A.; Dawicki, Wojciech

    2013-01-01

    We recognize well the abilities of dendritic cells to activate effector T cell (Teff cell) responses to an array of antigens and think of these cells in this context as pre-eminent antigen-presenting cells, but dendritic cells are also critical to the induction of immunologic tolerance. Herein, we review our knowledge on the different kinds of tolerogenic or regulatory dendritic cells that are present or can be induced in experimental settings and humans, how they operate, and the diseases in which they are effective, from allergic to autoimmune diseases and transplant tolerance. The primary conclusions that arise from these cumulative studies clearly indicate that the agent(s) used to induce the tolerogenic phenotype and the status of the dendritic cell at the time of induction influence not only the phenotype of the dendritic cell, but also that of the regulatory T cell responses that they in turn mobilize. For example, while many, if not most, types of induced regulatory dendritic cells lead CD4+ naïve or Teff cells to adopt a CD25+Foxp3+ Treg phenotype, exposure of Langerhans cells or dermal dendritic cells to vitamin D leads in one case to the downstream induction of CD25+Foxp3+ regulatory T cell responses, while in the other to Foxp3− type 1 regulatory T cells (Tr1) responses. Similarly, exposure of human immature versus semi-mature dendritic cells to IL-10 leads to distinct regulatory T cell outcomes. Thus, it should be possible to shape our dendritic cell immunotherapy approaches for selective induction of different types of T cell tolerance or to simultaneously induce multiple types of regulatory T cell responses. This may prove to be an important option as we target diseases in different anatomic compartments or with divergent pathologies in the clinic. Finally, we provide an overview of the use and potential use of these cells clinically, highlighting their potential as tools in an array of settings. PMID:24550907

  2. Healthcare regulatory concepts in Brazil.

    PubMed

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

  3. 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

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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....

  9. AN OVERVIEW OF THE DEVELOPMENT, STATUS, AND APPLICATION OF EQUILIBRIUM PARTITIONING SEDIMENT BENCHMARKS FOR PAH MIXTURES

    EPA Science Inventory

    This article provides an overview of the development, theoretical basis, regulatory status, and application of the U.S. Environmental Protection Agency's (USEPA's)< Equilibrium Partitioning Sediment Benchmarks (ESBs) for PAH mixtures. ESBs are compared to other sediment quality g...

  10. 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

  11. 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.

  12. Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.

    PubMed

    Tralau, Tewes; Oelgeschläger, Michael; Gürtler, Rainer; Heinemeyer, Gerhard; Herzler, Matthias; Höfer, Thomas; Itter, Heike; Kuhl, Thomas; Lange, Nikola; Lorenz, Nicole; Müller-Graf, Christine; Pabel, Ulrike; Pirow, Ralph; Ritz, Vera; Schafft, Helmut; Schneider, Heiko; Schulz, Thomas; Schumacher, David; Zellmer, Sebastian; Fleur-Böl, Gaby; Greiner, Matthias; Lahrssen-Wiederholt, Monika; Lampen, Alfonso; Luch, Andreas; Schönfelder, Gilbert; Solecki, Roland; Wittkowski, Reiner; Hensel, Andreas

    2015-06-01

    The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.

  13. 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.

  14. 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

  15. 75 FR 79929 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Commission ###Semiannual Regulatory Agenda### ] FEDERAL TRADE COMMISSION (FTC) FEDERAL TRADE COMMISSION 16 CFR Ch. I Semiannual Regulatory Agenda AGENCY: Federal Trade Commission. ACTION: Semiannual regulatory... 22(d)(1) of the Federal Trade Commission Act, 15 U.S.C. 57b-3(d)(1), and the Regulatory......

  16. Department of Energy Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Semiannual Regulatory Agenda 10 CFR Chs. II, III, and X 48 CFR Ch. 9 Regulatory Agenda AGENCY: Department of... ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et seq... use throughout the rulemaking process. Timetable: Action Date FR Cite Notice: Public Meeting...

  17. 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:

  18. 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:

  19. 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:

  20. 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:

  1. 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:

  2. 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.

  3. 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.

  4. 10 CFR 72.76 - 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. 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...

  5. 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...

  6. 10 CFR 72.168 - Inspection, test, and operating status.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....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... licensee shall establish measures to identify the operating status of structures, systems, and...

  7. 10 CFR 72.76 - Material status reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 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...

  8. Finding regulatory elements and regulatory motifs: a general probabilistic framework

    PubMed Central

    van Nimwegen, Erik

    2007-01-01

    Over the last two decades a large number of algorithms has been developed for regulatory motif finding. Here we show how many of these algorithms, especially those that model binding specificities of regulatory factors with position specific weight matrices (WMs), naturally arise within a general Bayesian probabilistic framework. We discuss how WMs are constructed from sets of regulatory sites, how sites for a given WM can be discovered by scanning of large sequences, how to cluster WMs, and more generally how to cluster large sets of sites from different WMs into clusters. We discuss how 'regulatory modules', clusters of sites for subsets of WMs, can be found in large intergenic sequences, and we discuss different methods for ab initio motif finding, including expectation maximization (EM) algorithms, and motif sampling algorithms. Finally, we extensively discuss how module finding methods and ab initio motif finding methods can be extended to take phylogenetic relations between the input sequences into account, i.e. we show how motif finding and phylogenetic footprinting can be integrated in a rigorous probabilistic framework. The article is intended for readers with a solid background in applied mathematics, and preferably with some knowledge of general Bayesian probabilistic methods. The main purpose of the article is to elucidate that all these methods are not a disconnected set of individual algorithmic recipes, but that they are just different facets of a single integrated probabilistic theory. PMID:17903285

  9. 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

  10. Below Regulatory Concern Owners Group:

    SciTech Connect

    Smith, C.F.; Phillips, L.B.; Williams, W.J.

    1988-03-01

    The US Nuclear Regulatory Commission has indicated that Below Regulatory Concern (BRC) exemption of waste streams from the disposal requirements for low level radioactive waste should be based on actual expected nuclide concentration and variability. Because of variations in the importance and relative abundance of nuclides in waste, one or a small number of nuclides may control the detemination of a waste steam as BRC. This study wasconducted to evaluate the relative importance of the major radionucldies in dose assessments for the disposal options and geographic regions under consideration for BRC waste. 6 refs., 25 tabs.

  11. Glycoconjugate Vaccines: The Regulatory Framework.

    PubMed

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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....

  18. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 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....

  19. 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....

  20. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 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....

  1. 10 CFR 150.17 - Submission to Commission of nuclear material status reports.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 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....

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 78 FR 52224 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... the different Continuing Education ] (``CE'') requirements for registered persons based upon their... status of persons subject to this IM-2040-5''. The Regulatory Element is a computer-based education... firm. The Proprietary Trader Continuing Education Program (S501) is a computer-based education...

  8. 75 FR 79799 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Hinchman, Senior Counsel, Office of Legal Policy, Department of Justice, Room 4252, 950 Pennsylvania Avenue... Department of Justice and the Access Board have each gathered a great deal of information regarding the... Justice ###Semiannual Regulatory Agenda### ] DEPARTMENT OF JUSTICE (DOJ) DEPARTMENT OF JUSTICE 8 CFR Ch....

  9. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... agenda pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735, and the... destruction of controlled substances consistent with the Controlled Substances Act. Timetable: Action Date FR Cite ANPRM 01/21/09 74 FR 3480 ANPRM Comment Period End 03/23/09 Notice of Public Meeting 12/22/10...

  10. 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.

  11. Mental status testing

    MedlinePlus

    Mental status exam; Neurocognitive testing; Dementia-mental status testing ... A health care provider will ask a number of questions. The test can be ... cognitive assessment (MoCA). The following may be tested: ...

  12. 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.

  13. Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy.

    PubMed

    Sinha, V; Zhao, P; Huang, S M; Zineh, I

    2014-05-01

    Assessment of controllable sources of intra- and interpatient variability in drug response is of critical importance in the regulatory evaluation of new drugs.(1) Although determinants of response variability would ideally be understood and accounted for before approval of a new pharmaceutical product, this is rarely the case for all; clinical trials in specific populations that definitively test optimal dosing in patient management strategies are not routinely performed prior to drug approval.

  14. Regulatory applications of sediment criteria. Final report

    SciTech Connect

    Not Available

    1987-06-23

    The report briefly describes the development of sediment criteria, discusses their utility and appropriate regulatory applications, and recommends steps to enhance the acceptance of sediment criteria by the regulatory and regulated communities.

  15. 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

  16. Small Business Administration Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... businesses. Timetable: Action Date FR Cite NPRM 08/00/10 Regulatory Flexibility Analysis Required: Yes Agency... Manufacturing Assistance Act of 2004 (Reauthorization Act) to regulate Small Business Lending Companies (SBLCs... Part XVI Small Business Administration Semiannual Regulatory Agenda ] SMALL...

  17. 75 FR 61531 - Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... E. Norris, Component Integrity Branch, Division of Engineering, Office of Nuclear Regulatory... acceptable alternatives to requirements in the American Society of Mechanical Engineers (ASME) Boiler and.... Harriet Karagiannis, Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office...

  18. 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.

  19. 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.

  20. Genetic flexibility of regulatory networks.

    PubMed

    Hunziker, Alexander; Tuboly, Csaba; Horváth, Péter; Krishna, Sandeep; Semsey, Szabolcs

    2010-07-20

    Gene regulatory networks are based on simple building blocks such as promoters, transcription factors (TFs) and their binding sites on DNA. But how diverse are the functions that can be obtained by different arrangements of promoters and TF binding sites? In this work we constructed synthetic regulatory regions using promoter elements and binding sites of two noninteracting TFs, each sensing a single environmental input signal. We show that simply by combining these three kinds of elements, we can obtain 11 of the 16 Boolean logic gates that integrate two environmental signals in vivo. Further, we demonstrate how combination of logic gates can result in new logic functions. Our results suggest that simple elements of transcription regulation form a highly flexible toolbox that can generate diverse functions under natural selection.

  1. Regulatory cells and transplantation tolerance.

    PubMed

    Cobbold, Stephen P; Waldmann, Herman

    2013-06-01

    Transplantation tolerance is a continuing therapeutic goal, and it is now clear that a subpopulation of T cells with regulatory activity (Treg) that express the transcription factor foxp3 are crucial to this aspiration. Although reprogramming of the immune system to donor-specific transplantation tolerance can be readily achieved in adult mouse models, it has yet to be successfully translated in human clinical practice. This requires that we understand the fundamental mechanisms by which donor antigen-specific Treg are induced and function to maintain tolerance, so that we can target therapies to enhance rather than impede these regulatory processes. Our current understanding is that Treg act via numerous molecular mechanisms, and critical underlying components such as mTOR inhibition, are only now emerging. PMID:23732858

  2. 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)...

  3. 78 FR 44399 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, and Transition... leverage capital requirements. Timetable: Action Date FR Cite Board Requested Comment 08/30/12 77 FR 53059... Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios,......

  4. Department of Energy Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... OF ENERGY Semiannual Regulatory Agenda 10 CFR Chs. II, III, and X 48 CFR Ch. 9 Regulatory Agenda... Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. SUPPLEMENTARY INFORMATION... and direct heating equipment. This is the second review for water heaters. Timetable: Action Date...

  5. 78 FR 1624 - Fall 2012 Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... and not to existing residential wood-heating appliances. Timetable: Action Date FR Cite NPRM 06/00/13... that start up after the regulatory agenda is signed? H. What tools are available for mining regulatory..., ``Regulatory Planning and Review'' (58 FR 51735, Oct. 4, 1993), as supplemented by Executive Order (EO)...

  6. 78 FR 1594 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    .... Timetable: Action Date FR Cite ANPRM 01/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact...: Action Date FR Cite Final Action 12/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact... idle facilities. Completed: Reason Date FR Cite Withdrawn 10/18/12 Regulatory Flexibility...

  7. 78 FR 23507 - Notice of Regulatory Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... regulations may be made more effective and less burdensome. \\1\\ Regulatory Review Plan, 77 FR 10351 (Feb. 22...'s Director. \\2\\ Notice of Regulatory Review Plan, 76 FR 59066 (Sept. 23, 2011). \\3\\ Regulatory Review Plan, 77 FR 10351 (Feb. 22, 2012). This Notice initiates the first such review. II. Request...

  8. 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)...

  9. Securities and Exchange Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    .... Timetable: Action Date FR Cite NPRM 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact...: Action Date FR Cite NPRM 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Jennifer... Date FR Cite NPRM 09/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Anthony...

  10. Summation from a regulatory perspective

    SciTech Connect

    Ohanian, E.V.; Cotruvo, J.A.

    1986-11-01

    There is an urgent need to discuss the Office of Drinking Water's standard-setting or rule making process since most of the researchers whose papers are presented here directly or indirectly play a crucial role in this complex undertaking. Therefore, this paper will address the research data required to support policy making and regulatory decisions pertaining to health effects of disinfectants and disinfection by-products.

  11. Regulatory motifs in Chk1

    PubMed Central

    Caparelli, Michael L.; O’Connell, Matthew J.

    2013-01-01

    Chk1 is the effector kinase of the G2 DNA damage checkpoint. Chk1 homologs possess a highly conserved N-terminal kinase domain and a less conserved C-terminal regulatory domain. In response to DNA damage, Chk1 is recruited to mediator proteins assembled at lesions on replication protein A (RPA)-coated single-stranded DNA (ssDNA). Chk1 is then activated by phosphorylation on S345 in the C-terminal regulatory domain by the PI3 kinase-related kinases ATM and ATR to enforce a G2 cell cycle arrest to allow time for DNA repair. Models have emerged in which this C-terminal phosphorylation relieves auto-inhibitory regulation of the kinase domain by the regulatory domain. However, experiments in fission yeast have shown that deletion of this putative auto-inhibitory domain actually inactivates Chk1 function. We show here that Chk1 homologs possess a kinase-associated 1 (KA1) domain that possesses residues previously implicated in Chk1 auto-inhibition. In addition, all Chk1 homologs have a small and highly conserved C-terminal extension (CTE domain). In fission yeast, both of these motifs are essential for Chk1 activation through interaction with the mediator protein Crb2, the homolog of human 53BP1. Thus, through different intra- and intermolecular interactions, these motifs explain why the regulatory domain exerts both positive and negative control over Chk1 activation. Such motifs may provide alternative targets to the ATP-binding pocket on which to dock Chk1 inhibitors as anticancer therapeutics. PMID:23422000

  12. 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.

  13. 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.

  14. 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...

  15. 77 FR 56686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

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

  16. 78 FR 70602 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule... of the rules in accordance with the requirements of Form 19b-4. II. Self-Regulatory...

  17. Regulatory pathways for vaccines for developing countries.

    PubMed

    Milstien, Julie; Belgharbi, Lahouari

    2004-02-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  18. Regulatory pathways for vaccines for developing countries.

    PubMed Central

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  19. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content...

  20. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content...

  1. 78 FR 44165 - Nuclear Regulatory Commission Enforcement Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Nuclear Regulatory Commission Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Enforcement policy; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is...

  2. 75 FR 16525 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear...

  3. 75 FR 36715 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION.... Sturzebecher, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: (301) 251- 7494 or...

  4. A global regulatory science agenda for vaccines.

    PubMed

    Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

    2013-04-18

    The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

  5. Wetlands: The changing regulatory landscape

    SciTech Connect

    Glick, R.M. )

    1993-05-01

    Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his [open quotes]environmental presidency.[close quotes] As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is [open quotes]buildable[close quotes] from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands.

  6. Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina.

    PubMed

    Whelan, Agustina I; Lema, Martin A

    2015-01-01

    "New Breeding Techniques" (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government. PMID:26552666

  7. Regulatory framework for gene editing and other new breeding techniques (NBTs) in Argentina.

    PubMed

    Whelan, Agustina I; Lema, Martin A

    2015-01-01

    "New Breeding Techniques" (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government.

  8. 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.

  9. Human System Integration: Regulatory Analysis

    NASA Technical Reports Server (NTRS)

    2005-01-01

    This document was intended as an input to the Access 5 Policy Integrated Product team. Using a Human System Integration (HIS) perspective, a regulatory analyses of the FARS (specifically Part 91), the Airman s Information Manual (AIM) and the FAA Controllers Handbook (7110.65) was conducted as part of a front-end approach needed to derive HSI requirements for Unmanned Aircraft Systems (UAS) operations in the National Airspace System above FL430. The review of the above aviation reference materials yielded eighty-four functions determined to be necessary or highly desirable for flight within the Air Traffic Management System. They include categories for Flight, Communications, Navigation, Surveillance, and Hazard Avoidance.

  10. Dynamic chromatin: the regulatory domain organization of eukaryotic gene loci.

    PubMed

    Bonifer, C; Hecht, A; Saueressig, H; Winter, D M; Sippel, A E

    1991-10-01

    It is hypothesized that nuclear DNA is organized in topologically constrained loop domains defining basic units of higher order chromatin structure. Our studies are performed in order to investigate the functional relevance of this structural subdivision of eukaryotic chromatin for the control of gene expression. We used the chicken lysozyme gene locus as a model to examine the relation between chromatin structure and gene function. Several structural features of the lysozyme locus are known: the extension of the region of general DNAasel sensitivity of the active gene, the location of DNA-sequences with high affinity for the nuclear matrix in vitro, and the position of DNAasel hypersensitive chromatin sites (DHSs). The pattern of DHSs changes depending on the transcriptional status of the gene. Functional studies demonstrated that DHSs mark the position of cis-acting regulatory elements. Additionally, we discovered a novel cis-activity of the border regions of the DNAasel sensitive domain (A-elements). By eliminating the position effect on gene expression usually observed when genes are randomly integrated into the genome after transfection, A-elements possibly serve as punctuation marks for a regulatory chromatin domain. Experiments using transgenic mice confirmed that the complete structurally defined lysozyme gene domain behaves as an independent regulatory unit, expressing the gene in a tissue specific and position independent manner. These expression features were lost in transgenic mice carrying a construct, in which the A-elements as well as an upstream enhancer region were deleted, indicating the lack of a locus activation function on this construct. Experiments are designed in order to uncover possible hierarchical relationships between the different cis-acting regulatory elements for stepwise gene activation during cell differentiation. We are aiming at the definition of the basic structural and functional requirements for position independent and high

  11. Dynamic chromatin: the regulatory domain organization of eukaryotic gene loci.

    PubMed

    Bonifer, C; Hecht, A; Saueressig, H; Winter, D M; Sippel, A E

    1991-10-01

    It is hypothesized that nuclear DNA is organized in topologically constrained loop domains defining basic units of higher order chromatin structure. Our studies are performed in order to investigate the functional relevance of this structural subdivision of eukaryotic chromatin for the control of gene expression. We used the chicken lysozyme gene locus as a model to examine the relation between chromatin structure and gene function. Several structural features of the lysozyme locus are known: the extension of the region of general DNAasel sensitivity of the active gene, the location of DNA-sequences with high affinity for the nuclear matrix in vitro, and the position of DNAasel hypersensitive chromatin sites (DHSs). The pattern of DHSs changes depending on the transcriptional status of the gene. Functional studies demonstrated that DHSs mark the position of cis-acting regulatory elements. Additionally, we discovered a novel cis-activity of the border regions of the DNAasel sensitive domain (A-elements). By eliminating the position effect on gene expression usually observed when genes are randomly integrated into the genome after transfection, A-elements possibly serve as punctuation marks for a regulatory chromatin domain. Experiments using transgenic mice confirmed that the complete structurally defined lysozyme gene domain behaves as an independent regulatory unit, expressing the gene in a tissue specific and position independent manner. These expression features were lost in transgenic mice carrying a construct, in which the A-elements as well as an upstream enhancer region were deleted, indicating the lack of a locus activation function on this construct. Experiments are designed in order to uncover possible hierarchical relationships between the different cis-acting regulatory elements for stepwise gene activation during cell differentiation. We are aiming at the definition of the basic structural and functional requirements for position independent and high

  12. 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.

  13. Regulatory RNAs in photosynthetic cyanobacteria.

    PubMed

    Kopf, Matthias; Hess, Wolfgang R

    2015-05-01

    Regulatory RNAs play versatile roles in bacteria in the coordination of gene expression during various physiological processes, especially during stress adaptation. Photosynthetic bacteria use sunlight as their major energy source. Therefore, they are particularly vulnerable to the damaging effects of excess light or UV irradiation. In addition, like all bacteria, photosynthetic bacteria must adapt to limiting nutrient concentrations and abiotic and biotic stress factors. Transcriptome analyses have identified hundreds of potential regulatory small RNAs (sRNAs) in model cyanobacteria such as Synechocystis sp. PCC 6803 or Anabaena sp. PCC 7120, and in environmentally relevant genera such as Trichodesmium, Synechococcus and Prochlorococcus. Some sRNAs have been shown to actually contain μORFs and encode short proteins. Examples include the 40-amino-acid product of the sml0013 gene, which encodes the NdhP subunit of the NDH1 complex. In contrast, the functional characterization of the non-coding sRNA PsrR1 revealed that the 131 nt long sRNA controls photosynthetic functions by targeting multiple mRNAs, providing a paradigm for sRNA functions in photosynthetic bacteria. We suggest that actuatons comprise a new class of genetic elements in which an sRNA gene is inserted upstream of a coding region to modify or enable transcription of that region.

  14. RSAT: regulatory sequence analysis tools.

    PubMed

    Thomas-Chollier, Morgane; Sand, Olivier; Turatsinze, Jean-Valéry; Janky, Rekin's; Defrance, Matthieu; Vervisch, Eric; Brohée, Sylvain; van Helden, Jacques

    2008-07-01

    The regulatory sequence analysis tools (RSAT, http://rsat.ulb.ac.be/rsat/) is a software suite that integrates a wide collection of modular tools for the detection of cis-regulatory elements in genome sequences. The suite includes programs for sequence retrieval, pattern discovery, phylogenetic footprint detection, pattern matching, genome scanning and feature map drawing. Random controls can be performed with random gene selections or by generating random sequences according to a variety of background models (Bernoulli, Markov). Beyond the original word-based pattern-discovery tools (oligo-analysis and dyad-analysis), we recently added a battery of tools for matrix-based detection of cis-acting elements, with some original features (adaptive background models, Markov-chain estimation of P-values) that do not exist in other matrix-based scanning tools. The web server offers an intuitive interface, where each program can be accessed either separately or connected to the other tools. In addition, the tools are now available as web services, enabling their integration in programmatic workflows. Genomes are regularly updated from various genome repositories (NCBI and EnsEMBL) and 682 organisms are currently supported. Since 1998, the tools have been used by several hundreds of researchers from all over the world. Several predictions made with RSAT were validated experimentally and published.

  15. 76 FR 50663 - Revisions to Form, Procedures and Criteria for Certification of Qualifying Facility Status for a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... facilities. List of Subjects in 18 CFR Part 292 Electric power, Electric power plants, Electric utilities... Facility Status for a Small Power Production or Cogeneration Facility AGENCY: Federal Energy Regulatory... facility status for a small power production or cogeneration facility. DATES: August 16, 2011. FOR...

  16. [Advanced therapy: from European regulatory framework to national regulatory framework].

    PubMed

    Lucas-Samuel, S

    2013-05-01

    The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012.

  17. Global Summit on Regulatory Science 2013.

    PubMed

    Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

    2014-12-01

    Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed.

  18. Nuclear proliferation status report. Status report

    SciTech Connect

    1992-07-01

    This report contains information concerning the nuclear proliferation status of the following countries: (1) Russia, (2) Ukraine, (3) Belarus, (4) Kazakhstan, (5) Israel, (6) India, (7) Pakistan, (8) South Africa, (9) North Korea, (10) Iraq, (11) Iran, (12) Lybia, (13) Algeria, (14) Syria, (15) Brazil, (16) Argentina, and (17) Taiwan.

  19. X-33 Program Status

    NASA Technical Reports Server (NTRS)

    Dill, Charlie C.; Austin, Robert E. (Technical Monitor)

    2000-01-01

    The presentation briefly presents the current status of the program. The program's objectives and near term plans are stated. A brief description of the vehicle configuration, the technologies to be demonstrated and the missions to be flown are presented. Finally, a status of the vehicle assembly, the launch control center development and the significant test programs' accomplishments are presented.

  20. Environmental Regulatory Update Table, January 1991

    SciTech Connect

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

    1991-02-01

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

  1. Environmental regulatory update table, March 1989

    SciTech Connect

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-04-01

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

  2. Environmental regulatory update table, July 1991

    SciTech Connect

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

    1991-08-01

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

  3. Environmental Regulatory Update Table, December 1990

    SciTech Connect

    Hawkins, G.T.; Houlberg, L.M.; Noghrei-Nikbakht, P.A.; Salk, M.S.

    1991-01-01

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

  4. Environmental Regulatory Update Table, November 1990

    SciTech Connect

    Hawkins, G.T.; Houlberg, L.M.; Noghrei-Nikbakht, P.A.; Salk, M.S.

    1990-12-01

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

  5. Environmental Regulatory Update Table, September 1990

    SciTech Connect

    Houlberg, L.M.; Nikbakht, A.; Salk, M.S.

    1990-10-01

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

  6. Environmental Regulatory Update Table, October 1991

    SciTech Connect

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

    1991-11-01

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

  7. Environmental Regulatory Update Table, October 1990

    SciTech Connect

    Houlberg, L.M.; Noghrei-Nikbakht, P.A.; Salk, M.S.

    1990-11-01

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

  8. Environmental Regulatory Update Table, April 1989

    SciTech Connect

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-05-01

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

  9. Environmental Regulatory Update Table, December 1989

    SciTech Connect

    Houlbert, L.M.; Langston, M.E. ); Nikbakht, A.; Salk, M.S. )

    1990-01-01

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

  10. Environmental Regulatory Update Table, August 1991

    SciTech Connect

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

    1991-09-01

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

  11. Environmental Regulatory Update Table, December 1991

    SciTech Connect

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

    1992-01-01

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

  12. Environmental Regulatory Update Table, November 1991

    SciTech Connect

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

    1991-12-01

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

  13. Environmental Regulatory Update Table, September 1991

    SciTech Connect

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

    1991-10-01

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

  14. Status epilepticus in adults.

    PubMed

    Betjemann, John P; Lowenstein, Daniel H

    2015-06-01

    Status epilepticus is a common neurological emergency with considerable associated health-care costs, morbidity, and mortality. The definition of status epilepticus as a prolonged seizure or a series of seizures with incomplete return to baseline is under reconsideration in an effort to establish a more practical definition to guide management. Clinical research has focused on early seizure termination in the prehospital setting. The approach of early escalation to anaesthetic agents for refractory generalised convulsive status epilepticus, rather than additional trials of second-line anti-epileptic drugs, to avoid neuronal injury and pharmaco-resistance associated with prolonged seizures is gaining momentum. Status epilepticus is also increasingly identified in the inpatient setting as the use of extended electroencephalography monitoring becomes more commonplace. Substantial further research to enable early identification of status epilepticus and efficacy of anti-epileptic drugs will be important to improve outcomes.

  15. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory...

  16. A genomic regulatory network for development

    NASA Technical Reports Server (NTRS)

    Davidson, Eric H.; Rast, Jonathan P.; Oliveri, Paola; Ransick, Andrew; Calestani, Cristina; Yuh, Chiou-Hwa; Minokawa, Takuya; Amore, Gabriele; Hinman, Veronica; Arenas-Mena, Cesar; Otim, Ochan; Brown, C. Titus; Livi, Carolina B.; Lee, Pei Yun; Revilla, Roger; Rust, Alistair G.; Pan, Zheng jun; Schilstra, Maria J.; Clarke, Peter J C.; Arnone, Maria I.; Rowen, Lee; Cameron, R. Andrew; McClay, David R.; Hood, Leroy; Bolouri, Hamid

    2002-01-01

    Development of the body plan is controlled by large networks of regulatory genes. A gene regulatory network that controls the specification of endoderm and mesoderm in the sea urchin embryo is summarized here. The network was derived from large-scale perturbation analyses, in combination with computational methodologies, genomic data, cis-regulatory analysis, and molecular embryology. The network contains over 40 genes at present, and each node can be directly verified at the DNA sequence level by cis-regulatory analysis. Its architecture reveals specific and general aspects of development, such as how given cells generate their ordained fates in the embryo and why the process moves inexorably forward in developmental time.

  17. Immunometabolism of regulatory T cells

    PubMed Central

    Newton, Ryan; Priyadharshini, Bhavana; Turka, Laurence A

    2016-01-01

    The bidirectional interaction between the immune system and whole-body metabolism has been well recognized for many years. Via effects on adipocytes and hepatocytes, immune cells can modulate whole-body metabolism (in metabolic syndromes such as type 2 diabetes and obesity) and, reciprocally, host nutrition and commensal-microbiota-derived metabolites modulate immunological homeostasis. Studies demonstrating the metabolic similarities of proliferating immune cells and cancer cells have helped give birth to the new field of immunometabolism, which focuses on how the cell-intrinsic metabolic properties of lymphocytes and macrophages can themselves dictate the fate and function of the cells and eventually shape an immune response. We focus on this aspect here, particularly as it relates to regulatory T cells. PMID:27196520

  18. Regulatory Analysis of Reactivity Transients

    SciTech Connect

    Beyer, Carl E.; Clifford, Paul M.; Geelhood, Kenneth J.; Voglewede, John C.

    2009-08-01

    This paper will describe modifications made to the FRAPCON-3 and FRAPTRAN fuel performance codes and models that impact reactivity initiated accident (RIA) analyses. The modified models include an upper bound empirical and best estimate release models for fast transients, and a revised fuel failure model that accounts for ductile and brittle failure. Because experimental data exists for discrete test conditions, the codes and models are used to interpolate and to some extent, to extrapolate these test conditions. An upper bound empirical model for release is used to establish new recommended release fractions for long-lived and short lived (radioactive) isotopes for RIA events in Regulatory Guide 1.183. A best estimate release model is used in FRAPTRAN 1.4 based on grain boundary gas concentrations from FRAPCON-3.4 to predict release for RIA events. Code and model predictions will be compared to failure and release data from RIA tests to demonstrate accuracy.

  19. Small regulatory RNAs in Archaea.

    PubMed

    Babski, Julia; Maier, Lisa-Katharina; Heyer, Ruth; Jaschinski, Katharina; Prasse, Daniela; Jäger, Dominik; Randau, Lennart; Schmitz, Ruth A; Marchfelder, Anita; Soppa, Jörg

    2014-01-01

    Small regulatory RNAs (sRNAs) are universally distributed in all three domains of life, Archaea, Bacteria, and Eukaryotes. In bacteria, sRNAs typically function by binding near the translation start site of their target mRNAs and thereby inhibit or activate translation. In eukaryotes, miRNAs and siRNAs typically bind to the 3'-untranslated region (3'-UTR) of their target mRNAs and influence translation efficiency and/or mRNA stability. In archaea, sRNAs have been identified in all species investigated using bioinformatic approaches, RNomics, and RNA-Seq. Their size can vary significantly between less than 50 to more than 500 nucleotides. Differential expression of sRNA genes has been studied using northern blot analysis, microarrays, and RNA-Seq. In addition, biological functions have been unraveled by genetic approaches, i.e., by characterization of designed mutants. As in bacteria, it was revealed that archaeal sRNAs are involved in many biological processes, including metabolic regulation, adaptation to extreme conditions, stress responses, and even in regulation of morphology and cellular behavior. Recently, the first target mRNAs were identified in archaea, including one sRNA that binds to the 5'-region of two mRNAs in Methanosarcina mazei Gö1 and a few sRNAs that bind to 3'-UTRs in Sulfolobus solfataricus, three Pyrobaculum species, and Haloferax volcanii, indicating that archaeal sRNAs appear to be able to target both the 5'-UTR or the 3'-UTRs of their respective target mRNAs. In addition, archaea contain tRNA-derived fragments (tRFs), and one tRF has been identified as a major ribosome-binding sRNA in H. volcanii, which downregulates translation in response to stress. Besides regulatory sRNAs, archaea contain further classes of sRNAs, e.g., CRISPR RNAs (crRNAs) and snoRNAs.

  20. 76 FR 59476 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... COMMISSION Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing of Proposed Rule Change To Change the Status of Exchange-Registered Institutional Broker Firms September 19, 2011... rule change as described in Items I and II below, which Items have been prepared by the Exchange....

  1. Regulatory fit messages and physical activity motivation.

    PubMed

    Pfeffer, Ines

    2013-04-01

    Targeted communication about health behaviors seems to be more effective than mass communication in which undifferentiated audiences receive identical messages. Regulatory focus is psychological variable that can be used to build two target groups: promotion-focused or prevention-focused people. It is hypothesized that targeting messages to an individual's regulatory focus creates regulatory fit and is more successful to promote a physically active lifestyle than nonfit messages. Two different print messages promoting a physically active lifestyle derived from regulatory focus theory (promotion message vs. prevention message) were randomly assigned to N = 98 participants after measuring their regulatory focus. It was examined whether regulatory fit between the regulatory focus and the assigned print message would lead to more positive evaluations in the dependent variables inclination toward the message (preference for the message), intention to perform the behavior, prospective and retrospective feelings associated with the behavior (positive and negative), and perceived value of the behavior directly after reading the message. Hierarchical linear regression analyses revealed that regulatory fit led to stronger intentions in the prevention-message condition and more prospective positive and retrospective positive feelings associated with the behavior in the promotion-message condition in contrast to the nonfit conditions. Prospective positive feelings associated with the behavior mediated the effect of regulatory fit on intention. The results partly provided support for the regulatory fit concept. Matching print messages to the regulatory focus of individuals seems to be a useful approach to enhance physical activity motivation. Future studies should include an objective measure of physical activity behavior.

  2. Actual operation and regulatory activities on steam generator replacement in Japan

    SciTech Connect

    Saeki, Hitoshi

    1997-02-01

    This paper summarizes the operating reactors in Japan, and the status of the steam generators in these plants. It reviews plans for replacement of existing steam generators, and then goes into more detail on the planning and regulatory steps which must be addressed in the process of accomplishing this maintenance. The paper also reviews the typical steps involved in the process of removal and replacement of steam generators.

  3. 76 FR 59751 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... thereunder,\\2\\ notice is hereby given that on September 7, 2011, Financial Industry Regulatory Authority, Inc...), or are subject to a separate registration and qualification requirement, Investment...

  4. 77 FR 61647 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... turn transactions in security futures. \\12\\ 15 U.S.C. 78o-3(b)(5). B. Self-Regulatory Organization's... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... in Security Futures October 3, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange Act...

  5. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of...

  6. 76 FR 37384 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Exemptions from the Order Audit Trail System..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...

  7. 76 FR 60567 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Reporting Rules for Certain Alternative Trading Systems September 23, 2011. Pursuant to Section 19(b)(1) of... that on September 16, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed...

  8. 76 FR 71404 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-17

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Order Audit Trail System Definitions of... November 4, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities...

  9. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open meeting of the Regional (Region X) Small... requested. Anyone wishing to attend and/or make a presentation to the Region X Regulatory Fairness...

  10. 77 FR 14052 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Change in Ownership, Control, or Business Operations) To Adopt New Standardized Electronic Form CMA March.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of...

  11. 75 FR 39603 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Exchange Act Release No. 61189 (December 17, 2009), 74 FR 68648 (``Notice''). \\4\\ See Letter to Elizabeth M... obligations, if applicable, to the Commission or other regulatory authority; (3) FINRA has actual...

  12. 75 FR 49542 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... 19b-4 thereunder,\\2\\ notice is hereby given that on July 27, 2010, Financial Industry Regulatory... members in a timely fashion to facilitate its Regulation M compliance program. Rule 5190(d) sets forth...

  13. 75 FR 74766 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...\\ See Exchange Act Release No. 62434 (July 1, 2010; 75 FR 39603 (July 9, 2010); SR-FINRA-2009-089...

  14. Status Epilepticus and Refractory Status Epilepticus Management

    PubMed Central

    Abend, Nicholas S.; Bearden, David; Helbig, Ingo; McGuire, Jennifer; Narula, Sona; Panzer, Jessica A.; Topjian, Alexis; Dlugos, Dennis J.

    2014-01-01

    Status epilepticus (SE) describes persistent or recurring seizures without a return to baseline mental status, and is a common neurologic emergency. SE can occur in the context of epilepsy or may be symptomatic of a wide range of underlying etiologies. The clinician’s aim is to rapidly institute care that simultaneously stabilizes the patient medically, identifies and manages any precipitant conditions, and terminates seizures. Seizure management involves “emergent” treatment with benzodiazepines followed by “urgent” therapy with other anti-seizure medications. If seizures persist then refractory SE is diagnosed and management options include additional anti-seizure medications or infusions of midazolam or pentobarbital. This paper reviews the management of pediatric SE and RSE. PMID:25727508

  15. Department of Labor Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Date FR Cite ANPRM 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Government Levels...: Action Date FR Cite NPRM 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Government..., 202, 205, 211, 301, 302, and 303 of EO 11246, as amended; 30 FR 12319; 32 FR 14303, as amended by...

  16. Department of Transportation Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... continues to have a SEIOSNOSE. Amendment No. 125-10 Amendment No. 125-10 required digital flight data... with Executive Order 12866 ``Regulatory Planning and Review'' (58 FR 51735; October 4, 1993) and the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979), the Department prepares...

  17. Federal Trade Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... and Review'' of September 30, 1993, 58 FR 51735 (Oct. 4, 1993). This edition of the Unified Agenda of..., ``Federalism,'' of August 4, 1999, 64 FR 43255 (Aug. 10, 1999), which does not apply to independent regulatory...'s Telemarketing Sales Rule (TSR or Rule) to address the sale of debt relief services (74 FR...

  18. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  19. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  20. Department of Defense Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... American Act. Timetable: Action Date FR Cite NPRM 06/00/10 Regulatory Flexibility Analysis Required: Yes... DoD oversight of contractor business systems. Timetable: Action Date FR Cite NPRM 01/15/10 75 FR 2457... Part V Department of Defense Semiannual Regulatory Agenda ] DEPARTMENT OF DEFENSE (DOD)...

  1. Environmental Protection Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ...:// Not in FR www.epa.gov/lawsregs/search/regagenda.html Semiannual Regulatory Flexibility Agenda www....html issue ] Monthly Action Initiation List http://www.regulations.gov/fdmspublic/component/ Not in FR... Rulemaking Gateway www.epa.gov/rulemaking/ Not in FR B. What Are EPA's Regulatory Goals, and What...

  2. 75 FR 79843 - Fall 2010 Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Locations Location Semiannual Regulatory Agenda www.reginfo.gov/, www.regulations.gov, and http:// Not in FR.../component/ Not in FR main?main=DocketDetail& d=EPA-HQ-OA-2008-0265 and http:// www.epa.gov/lawsregs/ search/ail.html Rulemaking Gateway www.epa.gov/rulemaking/ Not in FR B. What Are EPA's Regulatory...

  3. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  4. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... and locomotive engines for which the regulations of this part (i.e., 40 CFR part 92) apply are... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Regulatory structure. 92.6 Section 92.6... Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides an overview of...

  5. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  6. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... locomotives and locomotive engines for which the regulations of this part (i.e., 40 CFR part 92) apply are... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides...

  7. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  8. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  9. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... emissions from in-use marine engines. (b) The engines for which the regulations of this part (i.e., 40 CFR... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an...

  10. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  11. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... emissions from in-use marine engines. (b) The engines for which the regulations of this part (i.e., 40 CFR... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an...

  12. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  13. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... emissions from in-use marine engines. (b) The engines for which the regulations of this part (i.e., 40 CFR... 40 Protection of Environment 21 2013-07-01 2013-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an...

  14. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  15. 5 CFR 847.102 - Regulatory structure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Regulatory structure. 847.102 Section 847.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... INSTRUMENTALITIES General Provisions § 847.102 Regulatory structure. (a)(1) Subpart A of this part...

  16. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... emissions from in-use marine engines. (b) The engines for which the regulations of this part (i.e., 40 CFR... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Regulatory structure. 94.6 Section 94... for Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an...

  17. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  18. 40 CFR 94.6 - Regulatory structure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... in-use marine engines. (b) The engines for which the regulations of this part (i.e., 40 CFR part 94... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Regulatory structure. 94.6 Section 94.6... Compression-Ignition Marine Engines § 94.6 Regulatory structure. This section provides an overview of...

  19. 5 CFR 880.102 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Regulatory structure. 880.102 Section 880.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... Regulatory structure. (a) This part contains the following subparts: (1) Subpart A contains...

  20. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... locomotives and locomotive engines for which the regulations of this part (i.e., 40 CFR part 92) apply are... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides...

  1. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... locomotives and locomotive engines for which the regulations of this part (i.e., 40 CFR part 92) apply are... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides...

  2. 40 CFR 92.6 - Regulatory structure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... locomotives and locomotive engines for which the regulations of this part (i.e., 40 CFR part 92) apply are... 40 Protection of Environment 21 2013-07-01 2013-07-01 false Regulatory structure. 92.6 Section 92... Regulations for Locomotives and Locomotive Engines § 92.6 Regulatory structure. This section provides...

  3. 78 FR 1698 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ..., Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, and Transition Provisions..., Capital Adequacy, and Transition Provisions (Docket No. R-1442) Legal Authority: 12 U.S.C. 24; 12 U.S.C... disclosures related to regulatory capital instruments. Timetable: Action Date FR Cite Merged With 7100 AD87...

  4. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  5. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  6. 5 CFR 340.201 - Regulatory requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 340.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS OTHER THAN FULL-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part-Time Employment § 340.201 Regulatory requirements. This subpart contains the regulations of...

  7. 12 CFR 1010.14 - Regulatory exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 8 2014-01-01 2014-01-01 false Regulatory exemptions. 1010.14 Section 1010.14 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION LAND REGISTRATION (REGULATION J) General Requirements § 1010.14 Regulatory exemptions. (a) Eligibility requirements. The following transactions...

  8. 12 CFR 233.7 - Regulatory enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory enforcement....

  9. 31 CFR 132.7 - Regulatory enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory enforcement. The requirements under this part are subject...

  10. 12 CFR 233.7 - Regulatory enforcement.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory enforcement....

  11. 47 CFR 69.727 - Regulatory relief.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 3 2013-10-01 2013-10-01 false Regulatory relief. 69.727 Section 69.727 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase...

  12. 47 CFR 69.727 - Regulatory relief.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 3 2011-10-01 2011-10-01 false Regulatory relief. 69.727 Section 69.727 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase...

  13. 47 CFR 69.727 - Regulatory relief.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 3 2012-10-01 2012-10-01 false Regulatory relief. 69.727 Section 69.727 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase...

  14. 47 CFR 69.727 - Regulatory relief.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 3 2014-10-01 2014-10-01 false Regulatory relief. 69.727 Section 69.727 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase...

  15. 47 CFR 69.727 - Regulatory relief.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Regulatory relief. 69.727 Section 69.727 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) ACCESS CHARGES Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase...

  16. 77 FR 58025 - Texas Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY... the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding annual permit...

  17. Federal Trade Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Part XX Federal Trade Commission Semiannual Regulatory Agenda ] FEDERAL TRADE COMMISSION (FTC) FEDERAL TRADE COMMISSION 16 CFR Ch. I Semiannual Regulatory Agenda AGENCY: Federal Trade Commission... published in accordance with section 22(d)(1) of the Federal Trade Commission Act, 15 U.S.C.......

  18. 75 FR 61530 - Issuance of Regulatory Guides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Guides 1.84, Rev. 35, ``Design, Fabrication, and Materials Code Case Acceptability, ASME Section III... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555..., Revision 16, on June 2, 2009, 74 FR 26303. On the same date, the NRC published a parallel notice...

  19. Department of Interior Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ...: Action Date FR Cite Final Action 04/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact... idle facilities. Timetable: Action Date FR Cite NPRM 12/00/10 NPRM Comment Period End 02/00/11... Part IX Department of the Interior Semiannual Regulatory Agenda ] DEPARTMENT OF THE INTERIOR...

  20. Genomics in the land of regulatory science.

    PubMed

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.

  1. Environmental regulatory update table, November 1987

    SciTech Connect

    Langston, M.E.; Sharples, F.E.; Tucker, C.S.

    1987-11-01

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

  2. Environmental regulatory update table, September 1987

    SciTech Connect

    Langston, M.E.; Sharples, F.E.; Tucker, C.S.

    1987-10-01

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

  3. Environmental Regulatory Update Table, May 1987

    SciTech Connect

    Brown, K.J.; Tucker, C.S.; Reed, R.M.

    1987-06-01

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

  4. Meditation and its regulatory role on sleep.

    PubMed

    Nagendra, Ravindra P; Maruthai, Nirmala; Kutty, Bindu M

    2012-01-01

    Intense meditation practices help to achieve a harmony between body and mind. Meditation practices influence brain functions, induce various intrinsic neural plasticity events, modulate autonomic, metabolic, endocrine, and immune functions and thus mediate global regulatory changes in various behavioral states including sleep. This brief review focuses on the effect of meditation as a self regulatory phenomenon on sleep.

  5. 78 FR 44315 - Spring 2013 Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Agenda and the E-Agenda? G. How can you find out about rulemakings that start up after the Regulatory... requirements contained in numerous executive orders: 12866, ``Regulatory Planning and Review'' (58 FR 51735...'' (76 FR 3821, Jan. 21, 2011); 12898, ``Environmental Justice'' (59 FR 7629, Feb. 16, 1994);...

  6. 78 FR 1708 - Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... section 4(6) of the Securities Act. Timetable: Action Date FR Cite NPRM 12/00/12 Regulatory Flexibility... Expansion) of the JOBS Act. Timetable: Action Date FR Cite NPRM 01/00/13 Regulatory Flexibility Analysis... on existing exemptions under the Securities Act. Timetable: Action Date FR Cite Interim Final Rule...

  7. [Regulatory B cells in human autoimmune diseases].

    PubMed

    Miyagaki, Tomomitsu

    2015-01-01

    B cells have been generally considered to be positive regulators of immune responses because of their ability to produce antigen-specific antibodies and to activate T cells through antigen presentation. Impairment of B cell development and function may cause autoimmune diseases. Recently, specific B cell subsets that can negatively regulate immune responses have been described in mouse models of a wide variety of autoimmune diseases. The concept of those B cells, termed regulatory B cells, is now recognized as important in the murine immune system. Among several regulatory B cell subsets, IL-10-producing regulatory B cells are the most widely investigated. On the basis of discoveries from studies of such mice, human regulatory B cells that produce IL-10 in most cases are becoming an active area of research. There have been emerging data suggesting the importance of human regulatory B cells in various diseases. Revealing the immune regulation mechanisms of human regulatory B cells in human autoimmune diseases could lead to the development of novel B cell targeted therapies. This review highlights the current knowledge on regulatory B cells, mainly IL-10-producing regulatory B cells, in clinical research using human samples. PMID:26725860

  8. Weight of evidence: regulatory toxicology in Canada

    SciTech Connect

    Somers, E.

    1986-12-01

    The legislative application of regulatory toxicology in Canada is reviewed, together with the sources of experimental evidence used for action. Examples are given of the critical toxicological information that led to a regulatory decision. Risk numbers have only been used to a limited extent in Canada. Some possibilities for future research are offered.

  9. 76 FR 40208 - Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... Date FR Cite NPRM 03/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Sean Harrison... Rule 506 of Regulation D. Timetable: Action Date FR Cite NPRM 06/01/11 76 FR 31518 NPRM Comment Period... by registrants. Timetable: Action Date FR Cite NPRM 03/00/12 Regulatory Flexibility Analysis...

  10. 76 FR 40050 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... July 7, 2011 Part VII Department of Energy Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 76 , No. 130 / Thursday, July 7, 2011 / Unified Agenda#0;#0; ] DEPARTMENT OF ENERGY 10 CFR Chs. II, III, and X 48 CFR Ch. 9 Semiannual Regulatory Agenda AGENCY: Department of Energy. ACTION: Notice...

  11. 78 FR 1570 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... January 8, 2013 Part VII Department of Energy Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 78 , No. 5 / Tuesday, January 8, 2013 / Unified Agenda#0;#0; ] DEPARTMENT OF ENERGY 10 CFR Chs. II, III, and X 48 CFR Ch. 9 Semiannual Regulatory Agenda AGENCY: Department of Energy. ACTION: Notice...

  12. Regulatory Reform: Low Risk, High Promise.

    ERIC Educational Resources Information Center

    Tanenbaum, Morris

    The press of telecommunication technologies and their progeny have undermined the natural monopoly basis for long distance telecommunications and customer premise products, forced open regulatory doors, toppled barriers to market entry, and led to the reshaping of regulatory philosophy as regulators have seen new, wider horizons for the industry.…

  13. Department of Transportation Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... accordance with Executive Order 12866 ``Regulatory Planning and Review'' (58 FR 51735; October 4, 1993) and the Department's Regulatory Policies and Procedures (44 FR 11034; February 26, 1979), the Department... last agenda was published in the Federal Register on April 26, 2010 (75 FR 21840). The next one...

  14. 76 FR 33181 - Regulatory Review Schedule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... processes. (76 FR 18457, April 4, 2011). The Commission's regulatory review process establishes a detailed... National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule AGENCY: National Indian... Notice of Consultation advising the public that the NIGC was conducting a comprehensive review of all...

  15. 49 CFR 355.21 - Regulatory review.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Regulatory review. 355.21 Section 355.21... AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS Requirements § 355.21 Regulatory review... review are provided in the appendix to this part. (b) Responsibility. The State agency designated as...

  16. 76 FR 54408 - Regulatory Review Schedule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    .... (76 FR 18457, April 4, 2011). The Commission's regulatory review process established a tribal... National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule AGENCY: National Indian..., 1441 L Street, NW., Suite 9100, Washington, DC 20005. Telephone: 202-632-7003; e-mail:...

  17. 77 FR 10351 - Regulatory Review Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... plan and requested comments on the plan. 76 FR 59066 (September 23, 2011). FHFA received no comments... XII Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION: Notice of final regulatory review plan. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of the final...

  18. 76 FR 26967 - Regulatory Review Schedule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule AGENCY: National Indian... advising the public that the NIGC was conducting a comprehensive review of its regulations and requesting public comment on the process for conducting the regulatory review. On April 4, 2011, after holding...

  19. 49 CFR 355.21 - Regulatory review.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory review. 355.21 Section 355.21... AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS Requirements § 355.21 Regulatory review... review are provided in the appendix to this part. (b) Responsibility. The State agency designated as...

  20. 75 FR 79925 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... FR Cite Board Issued Final Rule on 02/22/10 75 FR 7658 Regulatory Flexibility Analysis Required: Yes... FR 37526 Regulatory Flexibility Analysis Required: Yes Agency Contact: Amy Henderson, Senior Attorney... similar to the proposed rule. Timetable: Action Date FR Cite Board Requested Comment 08/26/09 74 FR...

  1. Closing Regulatory Loopholes Act of 2011

    THOMAS, 112th Congress

    Sen. Johanns, Mike [R-NE

    2011-09-08

    09/08/2011 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:

  2. Closing Regulatory Loopholes Act of 2013

    THOMAS, 113th Congress

    Sen. Johanns, Mike [R-NE

    2013-02-13

    02/13/2013 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. EPA Regulatory Relief Act of 2011

    THOMAS, 112th Congress

    Rep. Griffith, H. Morgan [R-VA-9

    2011-06-21

    10/18/2011 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 201. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  4. Cement Sector Regulatory Relief Act of 2011

    THOMAS, 112th Congress

    Rep. Sullivan, John [R-OK-1

    2011-07-28

    10/12/2011 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 192. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  5. Regulatory Information Reporting Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. Regulatory Time-Out Act of 2011

    THOMAS, 112th Congress

    Sen. Collins, Susan M. [R-ME

    2011-09-12

    09/12/2011 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:

  7. Regulatory Capture Prevention Act of 2011

    THOMAS, 112th Congress

    Sen. Whitehouse, Sheldon [D-RI

    2011-07-07

    07/20/2011 Committee on Homeland Security and Governmental Affairs. Hearings held. Hearings printed: S.Hrg. 112-220. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. National Regulatory Budget Act of 2014

    THOMAS, 113th Congress

    Sen. Rubio, Marco [R-FL

    2014-03-25

    03/25/2014 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:

  9. Small Business Regulatory Sunset Act of 2014

    THOMAS, 113th Congress

    Sen. Kirk, Mark Steven [R-IL

    2014-07-31

    07/31/2014 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:

  10. Independent Agency Regulatory Analysis Act of 2012

    THOMAS, 112th Congress

    Sen. Portman, Rob [R-OH

    2012-08-01

    08/01/2012 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:

  11. Independent Agency Regulatory Analysis Act of 2013

    THOMAS, 113th Congress

    Sen. Portman, Rob [R-OH

    2013-06-18

    06/18/2013 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:

  12. Regulatory Cost Assessment Act of 2014

    THOMAS, 113th Congress

    Sen. Lee, Mike [R-UT

    2014-12-08

    12/08/2014 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:

  13. Reducing Regulatory Burdens Act of 2014

    THOMAS, 113th Congress

    Rep. Gibbs, Bob [R-OH-7

    2013-03-04

    08/01/2014 Received in the Senate and Read twice and referred to the Committee on Environment and Public Works. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  14. Hydropower Regulatory Efficiency Act of 2012

    THOMAS, 112th Congress

    Rep. McMorris Rodgers, Cathy [R-WA-5

    2012-06-05

    07/10/2012 Received in the Senate and Read twice and referred to the Committee on Energy and Natural Resources. (All Actions) Tracker: This bill has the status Passed HouseHere are the steps for Status of Legislation:

  15. Mediation: Sanity in the regulatory process

    SciTech Connect

    Cohen, D.S.

    1993-01-15

    The regulatory process is in need of change. The adversarial model used by most regulatory agencies is an inefficient, expensive, and conflict-producing procedure. Ill-adapted to resolving issues of great public policy concern, regulation calls out for non-adversarial alternative processes to address the resolution of public policy disputes between the players in the regulatory process. The adversarial model of regulation mimics traditional courtroom procedures. It is designed to determine issues of fact, not issues of public policy with legal maneuvering used to shroud the development of facts. Conflict maintenance and not conflict resolution has become the hallmark of the adversarial process in the regulatory arena. Unlike the courtroom process which provides a certain finality to conflicts, the adversarial process in the regulatory process is perpetual.

  16. Redox control of iron regulatory protein 2 stability.

    PubMed

    Hausmann, Anja; Lee, Julie; Pantopoulos, Kostas

    2011-02-18

    Iron regulatory protein 2 (IRP2) is a critical switch for cellular and systemic iron homeostasis. In iron-deficient or hypoxic cells, IRP2 binds to mRNAs containing iron responsive elements (IREs) and regulates their expression. Iron promotes proteasomal degradation of IRP2 via the F-box protein FBXL5. Here, we explored the effects of oxygen and cellular redox status on IRP2 stability. We show that iron-dependent decay of tetracycline-inducible IRP2 proceeds efficiently under mild hypoxic conditions (3% oxygen) but is compromised in severe hypoxia (0.1% oxygen). A treatment of cells with exogenous H(2)O(2) protects IRP2 against iron and increases its IRE-binding activity. IRP2 is also stabilized during menadione-induced oxidative stress. These data demonstrate that the degradation of IRP2 in iron-replete cells is not only oxygen-dependent but also sensitive to redox perturbations.

  17. Risk Analysis as Regulatory Science: Toward The Establishment of Standards.

    PubMed

    Murakami, Michio

    2016-09-01

    Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional 'Standard I', which has a paternalistic orientation, and 'Standard II', established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being.

  18. Risk Analysis as Regulatory Science: Toward The Establishment of Standards.

    PubMed

    Murakami, Michio

    2016-09-01

    Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional 'Standard I', which has a paternalistic orientation, and 'Standard II', established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. PMID:27475751

  19. Risk Analysis as Regulatory Science: Toward The Establishment of Standards

    PubMed Central

    Murakami, Michio

    2016-01-01

    Understanding how to establish standards is essential for risk communication and also provides perspectives for further study. In this paper, the concept of risk analysis as regulatory science for the establishment of standards is demonstrated through examples of standards for evacuation and provisional regulation values in foods and drinking water. Moreover, academic needs for further studies related to standards are extracted. The concepts of the traditional ‘Standard I’, which has a paternalistic orientation, and ‘Standard II’, established through stakeholder consensus, are then systemized by introducing the current status of the new standards-related movement that developed after the Fukushima nuclear power plant accident, and the perspectives of the standards are discussed. Preparation of standards on the basis of stakeholder consensus through intensive risk dialogue before a potential nuclear power plant accident is suggested to be a promising approach to ensure a safe society and enhance subjective well-being. PMID:27475751

  20. Interagency Depainting Study Status

    NASA Technical Reports Server (NTRS)

    Clark-Ingram, Marceia; Cook, Beth

    1999-01-01

    This document discusses coating removal in general. Sections of this presentation include: regulatory background, the initial parameters of the study, the current parameters of the study, stages in each sequence, preparation of the test specimen, material evaluation testing, chemical stripping, CO2 blasting, Flashjet coating removal, plastic media blasting, sodium bicarbonate wet stripping, water stripping, and wheat starch stripping.

  1. Boolean Modelingof Genetic Regulatory Networks

    NASA Astrophysics Data System (ADS)

    Albert, Réka

    Biological systems form complex networks of interaction on several scales, ranging from the molecular to the ecosystem level. On the subcellular scale, interaction between genes and gene products (mRNAs, proteins) forms the basis of essential processes like signal transduction, cell metabolism or embryonic development. Recent experimental advances helped uncover the qualitative structure of many gene control networks, creating a surge of interest in the quantitative description of gene regulation. We give a brief description of the main frameworks and methods used in modeling gene regulatory networks, then focus on a recent model of the segment polarity genes of the fruit fly Drosophila melanogaster. The basis of this model is the known interactions between the products of the segment polarity genes, and the network topology these interactions form. The interactions between mRNAs and proteins are described as logical (Boolean) functions. The success in reproducing both wild type and mutant gene expression patterns suggests that the kinetic details of the interactions are not essential as long as the network of interactions is unperturbed. The model predicts the gene patterns for cases that were not yet studied experimentally, and implies a remarkable robustness toward changes in internal parameters, initial conditions and even some mutations.

  2. Evolving Robust Gene Regulatory Networks

    PubMed Central

    Noman, Nasimul; Monjo, Taku; Moscato, Pablo; Iba, Hitoshi

    2015-01-01

    Design and implementation of robust network modules is essential for construction of complex biological systems through hierarchical assembly of ‘parts’ and ‘devices’. The robustness of gene regulatory networks (GRNs) is ascribed chiefly to the underlying topology. The automatic designing capability of GRN topology that can exhibit robust behavior can dramatically change the current practice in synthetic biology. A recent study shows that Darwinian evolution can gradually develop higher topological robustness. Subsequently, this work presents an evolutionary algorithm that simulates natural evolution in silico, for identifying network topologies that are robust to perturbations. We present a Monte Carlo based method for quantifying topological robustness and designed a fitness approximation approach for efficient calculation of topological robustness which is computationally very intensive. The proposed framework was verified using two classic GRN behaviors: oscillation and bistability, although the framework is generalized for evolving other types of responses. The algorithm identified robust GRN architectures which were verified using different analysis and comparison. Analysis of the results also shed light on the relationship among robustness, cooperativity and complexity. This study also shows that nature has already evolved very robust architectures for its crucial systems; hence simulation of this natural process can be very valuable for designing robust biological systems. PMID:25616055

  3. Web Operational Status Boards

    2004-04-16

    Web Operational Status Boards (WebOSB)is a web-based application designed to acquire, display, and update highly dynamic status information between multiple users and jurisdictions. WebOSB is able to disseminate real-time status information—support the timely sharing of information—with constant, dynamic updates via personal computers and the Internet between emergency operations centers (EOCs), incident command centers, and to users outside the EOC who need to know the information (hospitals, shelters, schools). The WebOSB application far exceeds outdated information-sharingmore » methods used by emergency workers: whiteboards, Word and Excel documents, or even locality-specific Web sites. WebOSB’s capabilities include the following elements: - Secure access. Multiple users can access information on WebOSB from any personal computer with Internet access and a secure ID. Privileges are use to control access and distribution of status information and to identify users who are authorized to add or edit information. - Simultaneous update. WebOSB provides options for users to add, display, and update dynamic information simultaneously at all locations involved in the emergency management effort, A single status board can be updated from multiple locations enabling shelters and hospitals to post bed availability or list decontamination capability. - On-the-fly modification. Allowing the definition of an existing status board to be modified on-the-fly can be an asset during an emergency, where information requirements can change quickly. The status board designer feature allows an administrator to quickly define, modi,, add to, and implement new status boards in minutes without needing the help of Web designers and computer programmers. - Publisher/subscriber notification. As a subscriber, each user automatically receives notification of any new information relating to specific status boards. The publisher/subscriber feature automatically notified each user of any

  4. Regulatory analysis technical evaluation handbook. Final report

    SciTech Connect

    1997-01-01

    The purpose of this Handbook is to provide guidance to the regulatory analyst to promote preparation of quality regulatory analysis documents and to implement the policies of the Regulatory Analysis Guidelines of the US Nuclear Regulatory Commission (NUREG/BR-0058 Rev. 2). This Handbook expands upon policy concepts included in the NRC Guidelines and translates the six steps in preparing regulatory analyses into implementable methodologies for the analyst. It provides standardized methods of preparation and presentation of regulatory analyses, with the inclusion of input that will satisfy all backfit requirements and requirements of NRC`s Committee to Review Generic Requirements. Information on the objectives of the safety goal evaluation process and potential data sources for preparing a safety goal evaluation is also included. Consistent application of the methods provided here will result in more directly comparable analyses, thus aiding decision-makers in evaluating and comparing various regulatory actions. The handbook is being issued in loose-leaf format to facilitate revisions. NRC intends to periodically revise the handbook as new and improved guidance, data, and methods become available.

  5. Regulatory bioinformatics for food and drug safety.

    PubMed

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  6. Regulatory bioinformatics for food and drug safety.

    PubMed

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  7. 75 FR 62436 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Coatings Applied to Nuclear Power Plants.'' FOR FURTHER INFORMATION CONTACT: Bruce P. Lin, Division...

  8. 76 FR 31382 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Surveys and Monitoring.'' FOR FURTHER INFORMATION CONTACT: Harriet Karagiannis, U.S. Nuclear...

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

    SciTech Connect

    Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo; Kim, Juyoul; Kim, Juyub

    2013-07-01

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

  10. Regulatory T cells: balancing protection versus pathology.

    PubMed

    Rakebrandt, Nikolas; Littringer, Katharina; Joller, Nicole

    2016-01-01

    Foxp3+ regulatory T cells (Tregs) maintain immune tolerance, prevent autoimmunity and modulate immune responses during infection and cancer. Recent studies have revealed considerable heterogeneity and plasticity within the Treg compartment, depending on the immunological context, which may result in Tregs losing their suppressive function in inflammatory environments. We review how dysfunctional Tregs contribute to disease pathogenesis in inflammatory conditions and how inappropriate regulatory responses may hamper protective immunity in the context of infection and cancer. We also discuss how Tregs might be targeted therapeutically to re-establish a proper balance between regulatory and effector responses in autoimmunity, infections, and cancer. PMID:27497235

  11. REGULATORY T CELLS AND VASECTOMY

    PubMed Central

    Rival, Claudia; Wheeler, Karen; Jeffrey, Sarah; Qiao, Hui; Luu, Brian; Tewalt, Eric F; Engelhard, Victor H; Tardif, Stephen; Hardy, Daniel; del Rio, Roxana; Teuscher, Cory; Tung, Kenneth

    2013-01-01

    CD4+CD25+ regulatory T cells (Tregs) strongly influence the early and late autoimmune responses to meiotic germ cell antigens (MGCA) and the gonadal immunopathology in vasectomized mice. This is supported by the published and recently acquired information presented here. Within 24 hours of unilateral vasectomy (uni-vx) the ipsilateral epididymis undergoes epithelial cell apoptosis followed by necrosis, severe inflammation, and granuloma formation. Unexpectedly, vasectomy alone induced MGCA-specific tolerance. In contrast, uni-vx plus simultaneous Treg depletion resulted in MGCA-specific autoimmune response and bilateral autoimmune orchitis. Both tolerance and autoimmunity were strictly linked to the early epididymal injury. We now discovered that testicular autoimmunity in uni-vx mice did not occur when Treg depletion was delayed by one week. Remarkably, this delayed Treg depletion also prevented tolerance induction. Therefore, tolerance depends on a rapid de novo Treg response to MGCA exposed after vasectomy. Moreover, tolerance was blunted in mice genetically deficient in PD-1 ligand, suggesting the involvement of induced Treg. We conclude that pre-existing natural Treg prevents post-vasectomy autoimmunity, whereas vasectomy-induced Treg maintains post-vasectomy tolerance. We further discovered that vasectomized mice were still resistant to autoimmune orchitis induction for at least 12–16 months; thus, tolerance is long-lasting. Although significant sperm autoantibodies of low titers became detectable in uni-vx mice at seven months, the antibody titers fluctuated over time, suggesting a dynamic “balance” between the autoimmune and tolerance states. Finally, we observed severe epididymal fibrosis and hypo-spermatogenesis at 12 months after uni-vx: findings of highly critical clinical significance. PMID:24080233

  12. Refractory status epilepticus

    PubMed Central

    Singh, Sanjay P; Agarwal, Shubhi; Faulkner, M

    2014-01-01

    Refractory status epilepticus is a potentially life-threatening medical emergency. It requires early diagnosis and treatment. There is a lack of consensus upon its semantic definition of whether it is status epilepticus that continues despite treatment with benzodiazepine and one antiepileptic medication (AED), i.e., Lorazepam + phenytoin. Others regard refractory status epilepticus as failure of benzodiazepine and 2 antiepileptic medications, i.e., Lorazepam + phenytoin + phenobarb. Up to 30% patients in SE fail to respond to two antiepileptic drugs (AEDs) and 15% continue to have seizure activity despite use of three drugs. Mechanisms that have made the treatment even more challenging are GABA-R that is internalized during status epilepticus and upregulation of multidrug transporter proteins. All patients of refractory status epilepticus require continuous EEG monitoring. There are three main agents used in the treatment of RSE. These include pentobarbital or thiopental, midazolam and propofol. RSE was shown to result in mortality in 35% cases, 39.13% of patients were left with severe neurological deficits, while another 13% had mild neurological deficits. PMID:24791086

  13. Communication about social status.

    PubMed

    Fernald, Russell D

    2014-10-01

    Dominance hierarchies are ubiquitous in social species and serve to organize social systems. Social and sexual status is communicated directly among animals via sensory systems evolved in the particular species. Such signals may be chemical, visual, auditory, postural or a combination of signals. In most species, status is initially established through physical conflict between individuals that leads to ritualized conflict or threats, reducing possibly dangerous results of fighting. Many of the status signals contain other information, as in some bird species that communicate both the size of their group and their individual rank vocally. Recent studies have shown that scent signaling among hyenas of east Africa is unique, being produced by fermentative, odor producing bacteria residing in the scent glands. PMID:24793315

  14. System status display evaluation

    NASA Technical Reports Server (NTRS)

    Summers, Leland G.

    1988-01-01

    The System Status Display is an electronic display system which provides the crew with an enhanced capability for monitoring and managing the aircraft systems. A flight simulation in a fixed base cockpit simulator was used to evaluate alternative design concepts for this display system. The alternative concepts included pictorial versus alphanumeric text formats, multifunction versus dedicated controls, and integration of the procedures with the system status information versus paper checklists. Twelve pilots manually flew approach patterns with the different concepts. System malfunctions occurred which required the pilots to respond to the alert by reconfiguring the system. The pictorial display, the multifunction control interfaces collocated with the system display, and the procedures integrated with the status information all had shorter event processing times and lower subjective workloads.

  15. COMMUNICATION ABOUT SOCIAL STATUS

    PubMed Central

    Fernald, Russell D.

    2014-01-01

    Dominance hierarchies are ubiquitous in social species and serve to organize social systems. Social and sexual status is communicated directly among animals via sensory systems evolved in the particular species. Such signals may be chemical, visual, auditory, postural or a combination of signals. In most species, status is initially established through physical conflict between individuals that leads to ritualized conflict or threats, reducing possibly dangerous results of fighting. Many of the status signals contain other information, as in some bird species that communicate both the size of their group and their individual rank vocally. Recent studies have shown that scent signaling among hyenas of east Africa is unique, being produced by fermentative, odor producing bacteria residing in the scent glands. PMID:24793315

  16. BIOSENSORS FOR ENVIRONMENTAL MONITORING: A REGULATORY PERSPECTIVE

    EPA Science Inventory

    Biosensors show the potential to complement laboratory-based analytical methods for environmental applications. Although biosensors for potential environmental-monitoring applications have been reported for a wide range of environmental pollutants, from a regulatory perspective, ...

  17. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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 Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory...

  18. Electricity distribution networks: Changing regulatory approaches

    NASA Astrophysics Data System (ADS)

    Cambini, Carlo

    2016-09-01

    Increasing the penetration of distributed generation and smart grid technologies requires substantial investments. A study proposes an innovative approach that combines four regulatory tools to provide economic incentives for distribution system operators to facilitate these innovative practices.

  19. 21 CFR 26.18 - Regulatory collaboration.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory...

  20. EVOLUTIONARY BIOSCIENCE AS REGULATORY SYSTEMS BIOLOGY

    PubMed Central

    Davidson, Eric H.

    2011-01-01

    At present several entirely different explanatory approaches compete to illuminate the mechanisms by which animal body plans have evolved. Their respective relevance is briefly considered here in the light of modern knowledge of genomes and the regulatory processes by which development is controlled. Just as development is a system property of the regulatory genome, so causal explanation of evolutionary change in developmental process must be considered at a system level. Here I enumerate some mechanistic consequences that follow from the conclusion that evolution of the body plan has occurred by alteration of the structure of developmental gene regulatory networks. The hierarchy and multiple additional design features of these networks act to produce Boolean regulatory state specification functions at upstream phases of development of the body plan. These are created by the logic outputs of network subcircuits, and in modern animals these outputs are impervious to continuous adaptive variation unlike genes operating more peripherally in the network. PMID:21320483

  1. REGULATORY APPLICATIONS OF POREWATER TOXICITY TESTING

    EPA Science Inventory

    The purpose of this chapter is to evaluate the use of porewater toxicity tests in regulatory applications, including their potential use in the development of sediment quality guideline (SQG) values. Specifically, the following discussion focuses on the appropriateness and readin...

  2. 77 FR 26413 - Promoting International Regulatory Cooperation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U... HOUSE, May 1, 2012. [FR Doc. 2012-10968 Filed 5-3-12; 8:45 am] Billing code 3295-F2-P...

  3. 21 CFR 26.34 - Regulatory authorities.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... and monitoring of conformity assessment bodies (CAB's). Regulatory authorities will be specified...

  4. 21 CFR 26.34 - Regulatory authorities.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... and monitoring of conformity assessment bodies (CAB's). Regulatory authorities will be specified...

  5. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... regulatory method must be able to confirm the identity of the marker residue in the target tissue at a... ascertaining the marker residue in the target tissue in accordance with the provisions of sections...

  6. Regulatory focus in predictions about others.

    PubMed

    Woltin, Karl-Andrew; Yzerbyt, Vincent

    2015-03-01

    Based on social projection research, four studies investigated whether people rely on their own regulatory focus when making predictions about others. Chronic (Study 1) and induced (Study 2) regulatory focus shaped estimations of others' strategic promotion or prevention inclinations and choices between enriched (fitting promotion) and impoverished options (fitting prevention). Providing indirect process evidence via boundary conditions, participants only relied on their induced regulatory focus in predictions of others' inclinations to seek romantic alternatives to the extent that this did not run counter to stereotypic gender beliefs (Study 3). In addition, participants only relied on their induced regulatory focus in preference predictions concerning promotion and prevention products when they lacked idiosyncratic target knowledge (Study 4). These effects were not mediated by mood, judgment-certainty, perceived task-enjoyment, or task-difficulty. Implications of these findings for social projection research as well as possible interpersonal consequences are delineated.

  7. Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

    PubMed

    Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

    2012-03-01

    We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics. PMID:22181678

  8. Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

    PubMed

    Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

    2012-03-01

    We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.

  9. Advancing a Vision for Regulatory Science Training.

    PubMed

    Adamo, Joan E; Wilhelm, Erin E; Steele, Scott J

    2015-10-01

    Regulatory science, a complex field which draws on science, law, and policy, is a growing discipline in medical-related applications. Competencies help define both a discipline and the criteria to measure high-quality learning experiences. This paper identifies competencies for regulatory science, how they were developed, and broader recommendations to enhance education and training in this burgeoning field, including a multifaceted training approach.

  10. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    PubMed

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  11. Mission Risk Reduction Regulatory Change Management

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2007-01-01

    NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated

  12. Regulatory changes for international satellite systems

    NASA Astrophysics Data System (ADS)

    Roseman, Walda W.

    Proposals for mobile and broadcast satellite systems and advances in fixed satellite systems and applications are placing new demands on governments to find efficient means of access to spectrum and create regulatory policies that facilitate the cross-border harmonization of satellite services. In an environment where liberalization is proceeding, but doing so unevenly, special responsibilities devolve to consumers and to the satellite enterprises themselves to ensure that an appropriate international regulatory framework is adopted.

  13. Regulatory frameworks for mobile medical applications.

    PubMed

    Censi, Federica; Mattei, Eugenio; Triventi, Michele; Calcagnini, Giovanni

    2015-05-01

    A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

  14. FRIB Cryogenic Plant Status

    NASA Astrophysics Data System (ADS)

    Dixon, K.; Ganni, V.; Knudsen, P.; Casagrande, F.

    2015-12-01

    After practical changes were approved to the initial conceptual design of the cryogenic system for MSU FRIB and an agreement was made with JLab in 2012 to lead the design effort of the cryogenic plant, many activities are in place leading toward a cool-down of the linacs prior to 2018. This is mostly due to using similar equipment used at CHLII for the 12 GeV upgrade at JLab and an aggressive schedule maintained by the MSU Conventional Facilities department. Reported here is an updated status of the cryogenic plant, including the equipment procurement status, plant layout, facility equipment and project schedule.

  15. Nutritional Status Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Scott M.

    2008-01-01

    Nutritional Status Assessment (Nutrition) is the most comprehensive inflight study done by NASA to date of human physiologic changes during long-duration space flight; this includes measures of bone metabolism, oxidative damage, nutritional assessments, and hormonal changes. This study will impact both the definition of nutritional requirements and development of food systems for future space exploration missions to the Moon and Mars. This experiment will also help to understand the impact of countermeasures (exercise and pharmaceuticals) on nutritional status and nutrient requirements for astronauts.

  16. Iron status of vegetarians.

    PubMed

    Craig, W J

    1994-05-01

    An appropriately planned well-balanced vegetarian diet is compatible with an adequate iron status. Although the iron stores of vegetarians may be reduced, the incidence of iron-deficiency anemia in vegetarians is not significantly different from that in omnivores. Restrictive vegetarian diets (eg, macrobiotic) are associated with more widespread iron-deficiency anemia. Western vegetarians who consume a variety of foods have a better iron status than do those in developing countries who consume a limited diet based on unleavened, unrefined cereals. Whereas phytates, polyphenolics, and other plant constituents found in vegetarian diets inhibit nonheme-iron absorption, vitamin C, citric acid, and other organic acids facilitate nonheme-iron absorption.

  17. 10 CFR 50.76 - Licensee's change of status; financial qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... license) for a nuclear power reactor, no later than seventy-five (75) days prior to ceasing to be an... 10 Energy 1 2010-01-01 2010-01-01 false Licensee's change of status; financial qualifications. 50.76 Section 50.76 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION...

  18. 10 CFR 50.76 - Licensee's change of status; financial qualifications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... license) for a nuclear power reactor, no later than seventy-five (75) days prior to ceasing to be an... 10 Energy 1 2012-01-01 2012-01-01 false Licensee's change of status; financial qualifications. 50.76 Section 50.76 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION...

  19. 10 CFR 50.76 - Licensee's change of status; financial qualifications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... license) for a nuclear power reactor, no later than seventy-five (75) days prior to ceasing to be an... 10 Energy 1 2011-01-01 2011-01-01 false Licensee's change of status; financial qualifications. 50.76 Section 50.76 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION...

  20. 10 CFR 50.76 - Licensee's change of status; financial qualifications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... license) for a nuclear power reactor, no later than seventy-five (75) days prior to ceasing to be an... 10 Energy 1 2014-01-01 2014-01-01 false Licensee's change of status; financial qualifications. 50.76 Section 50.76 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION...

  1. 10 CFR 50.76 - Licensee's change of status; financial qualifications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... license) for a nuclear power reactor, no later than seventy-five (75) days prior to ceasing to be an... 10 Energy 1 2013-01-01 2013-01-01 false Licensee's change of status; financial qualifications. 50.76 Section 50.76 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION...

  2. Soils and groundwater cleanup at Fernald: A status update on Operable Unit No. 5

    SciTech Connect

    Yerace, P.J.; Bomberger, A.K.; Brettschneider, D.J.

    1993-11-01

    This report discusses a status update on the cleanup operations at FERNALD. Discussed is the regulatory framework for FERNALD cleanup; overview of the FERNALD site; description of operable unit 5;remedial investigation; pattern of contamination; feasibility studies; and tangible progress to date.

  3. 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. Dominion Bridgeport Fuel Cell, LLC EG13-31-000 Arlington Valley Solar Energy II, LLC EG13-32-000 Solar...

  4. 78 FR 16494 - Notice of Effectiveness of Foreign Utility Company Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-15

    ... Energy Regulatory Commission Notice of Effectiveness of Foreign Utility Company Status Docket Nos. Pacific Northern Gas Ltd FC13-1-000 AtlaGas Utilities Inc FC13-2-000 Heritage Gas Ltd FC13-3-000 McNair...-captioned entities as Foreign Utility Companies became effective by operation of the...

  5. 75 FR 57013 - Notice of Effectiveness of Exempt Wholesale Generator Status; Taloga Wind, LLC, Stephentown...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... 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; Taloga Wind... above-captioned entities as Exempt Wholesale Generators became effective by operation of the...

  6. 76 FR 22094 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ... 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. LSP... entities as Exempt Wholesale Generators or Foreign Utility Companies became effective by operation of...

  7. 75 FR 32458 - Notice of Effectiveness of Exempt Wholesale Generator or Foreign Utility Company Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Effectiveness of Exempt Wholesale Generator or Foreign Utility... 2010, the status of the above-captioned entities as Exempt Wholesale Generators or Foreign...

  8. 76 FR 27312 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... 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... Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a)....

  9. 78 FR 46939 - Notice of Effectiveness of Exempt Wholesale Generator Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... 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 Ivanpah Master...-captioned entities as Exempt Wholesale Generators Companies became effective by operation of the...

  10. Apprehending multicellularity: regulatory networks, genomics and evolution

    PubMed Central

    Aravind, L.; Anantharaman, Vivek; Venancio, Thiago M.

    2009-01-01

    The genomic revolution has provided the first glimpses of the architecture of regulatory networks. Combined with evolutionary information, the “network view” of life processes leads to remarkable insights into how biological systems have been shaped by various forces. This understanding is critical because biological systems, including regulatory networks, are not products of engineering but of historical contingencies. In this light, we attempt a synthetic overview of the natural history of regulatory networks operating in the development and differentiation of multicellular organisms. We first introduce regulatory networks and their organizational principles as can be deduced using ideas from the graph theory. We then discuss findings from comparative genomics to illustrate the effects of lineage-specific expansions, gene-loss, and non-protein-coding DNA on the architecture of networks. We consider the interaction between expansions of transcription factors, and cis regulatory and more general chromatin state stabilizing elements in the emergence of morphological complexity. Finally, we consider a case study of the Notch sub-network, which is present throughout Metazoa, to examine how such a regulatory system has been pieced together in evolution from new innovations and pre-existing components that were originally functionally distinct. PMID:19530132

  11. Cis-regulatory mutations in human disease

    PubMed Central

    2009-01-01

    Cis-acting regulatory sequences are required for the proper temporal and spatial control of gene expression. Variation in gene expression is highly heritable and a significant determinant of human disease susceptibility. The diversity of human genetic diseases attributed, in whole or in part, to mutations in non-coding regulatory sequences is on the rise. Improvements in genome-wide methods of associating genetic variation with human disease and predicting DNA with cis-regulatory potential are two of the major reasons for these recent advances. This review will highlight select examples from the literature that have successfully integrated genetic and genomic approaches to uncover the molecular basis by which cis-regulatory mutations alter gene expression and contribute to human disease. The fine mapping of disease-causing variants has led to the discovery of novel cis-acting regulatory elements that, in some instances, are located as far away as 1.5 Mb from the target gene. In other cases, the prior knowledge of the regulatory landscape surrounding the gene of interest aided in the selection of enhancers for mutation screening. The success of these studies should provide a framework for following up on the large number of genome-wide association studies that have identified common variants in non-coding regions of the genome that associate with increased risk of human diseases including, diabetes, autism, Crohn's, colorectal cancer, and asthma, to name a few. PMID:19641089

  12. Mexico: Country Status Report.

    ERIC Educational Resources Information Center

    McFerren, Margaret

    A survey of the status of language usage in Mexico begins with an overview of language distribution among the population, mono- and multilingualism, changes in patterns of usage between the 1970 and 1980 censuses, and linguistic issues related to assimilation of the Indian population and the role and philosophy of the Instituto Nacional…

  13. Glueballs: a status report

    SciTech Connect

    Scharre, D.L.

    1982-01-01

    It is expected from quantum chromodynamics (QCD) that glueballs, bound states which contain gluons but no valence quarks, should exist. To date, no conclusive evidence for glueballs has been presented. After a brief review of the expected properties and experimental signatures of glueballs the status of some glueball candidate states are discussed.

  14. Status of TRISTAN

    NASA Astrophysics Data System (ADS)

    Nagashima, Yorikiyo

    1988-02-01

    Present status of the TRISTAN accelerator1) and its three major detectors2), TOPAZ, AMY and VENUS is described. The colliding e+e- beam started operation in November 1986. During the period from Jan. 28-Feb. 19. VENUS and AMY have accumulated integrated lumunosity of 93 nb-1 and 52 nb-1 respectively. Some of their analysis results are given.

  15. Status of HRD Research.

    ERIC Educational Resources Information Center

    1996

    This document contains four papers presented at a symposium on the status of human resource development (HRD) research moderated by Barry Johansen at the 1996 conference of the Academy of Human Resource Development. "An Exploration of the Type of Research Appearing in the AHRD Conference Proceedings" (David E. Arnold) reviews and classifies the…

  16. Angola: Country Status Report.

    ERIC Educational Resources Information Center

    Bruhn, Thea C.

    A survey of the status of language usage in Angola begins with an overview of the usage and distribution of Portuguese as the official language, and the four most significant native languages and dialects spoken there: Umbundu, Kimbundu, Kikongo, and Lunda-Chokwe. The introduction of Spanish through Cuban trainers, teachers, and military advisors…

  17. Status, Numbers and Influence

    ERIC Educational Resources Information Center

    Melamed, David; Savage, Scott V.

    2013-01-01

    We develop a theoretical model of social influence in n-person groups. We argue that disagreement between group members introduces uncertainty into the social situation, and this uncertainty motivates people to use status characteristics to evaluate the merits of a particular opinion. Our model takes the numerical distribution of opinions and the…

  18. Chad: Country Status Report.

    ERIC Educational Resources Information Center

    McFerren, Margaret

    A survey of the status of language usage in Chad begins with an overview of the usage patterns of four languages. They include: French, designated the official language as a practical necessity; Chadian Arabic and Sara, important popularly spoken languages in their respective regions; and Toubou, a less prevalent language but one that is spoken by…

  19. Behavior, Expectations and Status

    ERIC Educational Resources Information Center

    Webster, Jr, Murray; Rashotte, Lisa Slattery

    2010-01-01

    We predict effects of behavior patterns and status on performance expectations and group inequality using an integrated theory developed by Fisek, Berger and Norman (1991). We next test those predictions using new experimental techniques we developed to control behavior patterns as independent variables. In a 10-condition experiment, predictions…

  20. TRU relocation status report

    SciTech Connect

    Irwin, R.M.

    1997-01-20

    To meet an internal milestone, 257 containers identified as contact- handled transuranic waste are being relocated from uncovered drum modules in the Low-Level Burial Grounds into covered facilities. The project is not yet complete. This report discusses the project and its status as of December 31, 1996.

  1. Somalia: Country Status Report.

    ERIC Educational Resources Information Center

    McFerren, Margaret

    A survey of the status of language usage in Somalia begins with an overview of the usage patterns of Somali, the official language, and three languages previously used officially: English, Italian, and Arabic. The cultural context that for many years has supported the usage of a single native language for communication and administration is also…

  2. NASA Armstrong Status

    NASA Technical Reports Server (NTRS)

    Jacobson, Steven R.

    2014-01-01

    Armstrong (formerly Dryden) Flight Research Center continues it's legacy of exciting work in the area of dynamics and control of advanced vehicle concepts. This status presentation highlights the research and technology development that Armstrong's Control and Dynamics branch is performing in the areas of Control of Flexible Structures and Automated Cooperative Trajectories.

  3. Health Is a Status.

    ERIC Educational Resources Information Center

    Carter, George F.

    1984-01-01

    Although the terms "personal health" and "medical care" are used interchangeably, they have different meanings. Health is a personal responsibility, medicine is a drug given as a form of treatment. A new definition of health is suggested that treats health as a dynamic status. (DF)

  4. Somali. Materials Status Report.

    ERIC Educational Resources Information Center

    Center for Applied Linguistics, Washington, DC. Language/Area Reference Center.

    The materials status report for Somali, the official language of Somalia, is one of a series intended to provide the nonspecialist with a picture of the availability and quality of texts for teaching various languages to English speakers. The report consists of: (1) a brief narrative description of Somali, the areas where it is spoken, its major…

  5. NASA Dryden Status

    NASA Technical Reports Server (NTRS)

    Cox, Timothy H.

    2008-01-01

    This viewgraph document reviews the status of several Dryden projects. They are: the Ikhana Project, development of the F-15 Intelligent Flight Control System, the development of a C-20A Precision Autopilot for use in Unmanned Aerial Vehicle Synthetic Aperture Radar (UAVSAR), the development of the X-48B Blended Wing Body aircraft, and development of Stratospheric Observatory for Infrared Astronomy (SOFIA).

  6. Malawi: Country Status Report.

    ERIC Educational Resources Information Center

    Robson, Barbara

    A survey of the status of language usage in Malawi begins with an overview of the distribution and usage of English (the official language) and the native Bantu languages: Chichewa or Nyanja (Chinyanja), the language used by half the population; and three other Bantu languages also used there--Lomwe, Yao, and Tumbuka. The social situation favoring…

  7. VERITAS: status c.2005

    SciTech Connect

    Weekes, T. C.; Atkins, R. W.; Badran, H. M.; Blaylock, G.; Bond, I. H.; Boyle, P. J.; Bradbury, S. M.; Buckley, J. H.; Bryum, K. L.; Carter-Lewis, D. A.; Celik, O.; Chow, Y. C. K.; Cogan, P.; Cui, W.; Daniel, M. K.; Calle Perez, I. de la; Dowdall, C.; Dowkontt, P.; Duke, C.; Ergin, T.

    2006-07-11

    VERITAS (Very Energetic Radiation Imaging Telescope Array System), is one of a new generation of TeV gamma-ray observatories. The current status of its construction is described here. The first two telescopes and cameras have been completed and meet the design specifications; the full array of four telescopes could be operational by the end of 2006.

  8. The Status of Teachers

    ERIC Educational Resources Information Center

    Banerji, R. C.

    1976-01-01

    Various factors related to the decline in social status by teachers are examined, with special consideration given to reasons for this decline in India. It is suggested that the community, government, and educational administrators must bring about changes in attitudes and relationships that affect public opinion of teachers. (LBH)

  9. Tanzania: Country Status Report.

    ERIC Educational Resources Information Center

    Robson, Barbara

    A survey of the status of language usage in Tanzania begins with an overview of the three levels of language use: (1) Swahili, the national and official language, used in public life; (2) English, used in international affairs and in technical and intellectual matters; and (3) the over 120 vernacular languages used in family and religious life,…

  10. The status of GALLEX

    SciTech Connect

    Wink, R.; The GALLEX Collaboration

    1991-12-31

    We describe the status of G A L L E X solar neutrino experiment until the end of June 1991. Since June 1990 31 desorptions with the full equipment have been done. The results of the first 27 desorptions are presented. We also describe our low level proportional counters including the counting system.

  11. The status of GALLEX

    SciTech Connect

    Wink, R. )

    1991-01-01

    We describe the status of G A L L E X solar neutrino experiment until the end of June 1991. Since June 1990 31 desorptions with the full equipment have been done. The results of the first 27 desorptions are presented. We also describe our low level proportional counters including the counting system.

  12. Status and the Brain

    PubMed Central

    Utevsky, Amanda V.; Platt, Michael L.

    2014-01-01

    Social hierarchy is a fact of life for many animals. Navigating social hierarchy requires understanding one's own status relative to others and behaving accordingly, while achieving higher status may call upon cunning and strategic thinking. The neural mechanisms mediating social status have become increasingly well understood in invertebrates and model organisms like fish and mice but until recently have remained more opaque in humans and other primates. In a new study in this issue, Noonan and colleagues explore the neural correlates of social rank in macaques. Using both structural and functional brain imaging, they found neural changes associated with individual monkeys' social status, including alterations in the amygdala, hypothalamus, and brainstem—areas previously implicated in dominance-related behavior in other vertebrates. A separate but related network in the temporal and prefrontal cortex appears to mediate more cognitive aspects of strategic social behavior. These findings begin to delineate the neural circuits that enable us to navigate our own social worlds. A major remaining challenge is identifying how these networks contribute functionally to our social lives, which may open new avenues for developing innovative treatments for social disorders. PMID:25181006

  13. Evolution of splicing regulatory networks in Drosophila

    PubMed Central

    McManus, C. Joel; Coolon, Joseph D.; Eipper-Mains, Jodi; Wittkopp, Patricia J.; Graveley, Brenton R.

    2014-01-01

    The proteome expanding effects of alternative pre-mRNA splicing have had a profound impact on eukaryotic evolution. The events that create this diversity can be placed into four major classes: exon skipping, intron retention, alternative 5′ splice sites, and alternative 3′ splice sites. Although the regulatory mechanisms and evolutionary pressures among alternative splicing classes clearly differ, how these differences affect the evolution of splicing regulation remains poorly characterized. We used RNA-seq to investigate splicing differences in D. simulans, D. sechellia, and three strains of D. melanogaster. Regulation of exon skipping and tandem alternative 3′ splice sites (NAGNAGs) were more divergent than other splicing classes. Splicing regulation was most divergent in frame-preserving events and events in noncoding regions. We further determined the contributions of cis- and trans-acting changes in splicing regulatory networks by comparing allele-specific splicing in F1 interspecific hybrids, because differences in allele-specific splicing reflect changes in cis-regulatory element activity. We find that species-specific differences in intron retention and alternative splice site usage are primarily attributable to changes in cis-regulatory elements (median ∼80% cis), whereas species-specific exon skipping differences are driven by both cis- and trans-regulatory divergence (median ∼50% cis). These results help define the mechanisms and constraints that influence splicing regulatory evolution and show that networks regulating the four major classes of alternative splicing diverge through different genetic mechanisms. We propose a model in which differences in regulatory network architecture among classes of alternative splicing affect the evolution of splicing regulation. PMID:24515119

  14. Consequences of Schistosoma haematobium infection on the iron status of schoolchildren in Niger.

    PubMed

    Prual, A; Daouda, H; Develoux, M; Sellin, B; Galan, P; Hercberg, S

    1992-09-01

    The relationship between iron status and degree of infection by Schistosoma haematobium was studied in 174 schoolchildren from Niger in an area endemic for urinary schistosomiasis. Iron deficiency was defined by a combination of three reliable indicators: a low serum ferritin level combined with a low transferrin saturation, a high erythrocyte protoporphyrin level, or both. Hematuria and proteinuria were found in 76.4% and 79.9% of the children, respectively, while 95.4% excreted eggs (geometric mean egg count of 31.5 eggs per 10 ml of urine). Anemia was observed in 59.7% of the subjects. The prevalence of iron deficiency was 47.1%. Anemia was associated with iron deficiency in 57.7% of the cases. The hemoglobin level and transferrin saturation decreased significantly when the degree of hematuria increased, while prevalence of anemia and prevalence of iron deficiency increased significantly. The hemoglobin level and the hematocrit were negatively correlated with egg count, while prevalence of anemia increased with increasing egg count. This inverse relationship between degree of infection by S. haematobium and iron status shows a deleterious consequence of urinary schistosomiasis on nutrition and hematopoietic status, which should be considered in the design of nutrition intervention programs.

  15. 12 CFR 742.1 - Regulatory Flexibility Program.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 7 2012-01-01 2012-01-01 false Regulatory Flexibility Program. 742.1 Section 742.1 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS REGULATORY FLEXIBILITY PROGRAM § 742.1 Regulatory Flexibility Program. NCUA's Regulatory Flexibility...

  16. 12 CFR 742.1 - Regulatory Flexibility Program.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 6 2011-01-01 2011-01-01 false Regulatory Flexibility Program. 742.1 Section 742.1 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS REGULATORY FLEXIBILITY PROGRAM § 742.1 Regulatory Flexibility Program. NCUA's Regulatory Flexibility...

  17. 12 CFR 742.1 - Regulatory Flexibility Program.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Regulatory Flexibility Program. 742.1 Section 742.1 Banks and Banking NATIONAL CREDIT UNION ADMINISTRATION REGULATIONS AFFECTING CREDIT UNIONS REGULATORY FLEXIBILITY PROGRAM § 742.1 Regulatory Flexibility Program. NCUA's Regulatory Flexibility...

  18. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  19. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  20. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  1. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  2. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  3. Hydropower Regulatory Efficiency Act of 2013

    THOMAS, 113th Congress

    Sen. Murkowski, Lisa [R-AK

    2013-03-13

    06/03/2013 By Senator Wyden from Committee on Energy and Natural Resources filed written report. Report No. 113-36. (All Actions) Notes: For further action, see H.R.267, which became Public Law 113-23 on 8/9/2013. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  4. Nanotechnology Regulatory Science Act of 2011

    THOMAS, 112th Congress

    Sen. Pryor, Mark L. [D-AR

    2011-10-06

    10/06/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S6333-6334) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  5. Regulatory Flexibility Improvements Act of 2011

    THOMAS, 112th Congress

    Sen. Snowe, Olympia J. [R-ME

    2011-12-01

    12/01/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (text of measure as introduced: CR S8152-8155) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  6. Regulatory Flexibility Improvements Act of 2011

    THOMAS, 112th Congress

    Rep. Smith, Lamar [R-TX-21

    2011-02-08

    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:

  7. Small Business Regulatory Freedom Act of 2011

    THOMAS, 112th Congress

    Sen. Snowe, Olympia J. [R-ME

    2011-03-03

    03/03/2011 Read twice and referred to the Committee on Homeland Security and Governmental Affairs. (text of measure as introduced: CR S1225-1228) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. The NRC's SPAR Models: Current Status, Future Development, and Modeling Issues

    SciTech Connect

    Robert F. Buell

    2008-09-01

    Probabilistic risk assessments (PRAs) play an increasingly important role in the regulatory framework of the U.S. nuclear power industry. The Nuclear Regulatory Commission (NRC) relies on a set of plant-specific Standardized Plant Analysis Risk (SPAR) models to provide critical risk-based input to the regulatory process. The Significance Determination Process (SDP), Management Directive 8.3 - NRC Incident Investigation Program, Accident Sequence Precursor (ASP) and Mitigating Systems Performance Index (MSPI) programs are among the regulatory initiatives that receive significant input from the SPAR models. Other uses of the SPAR models include: Screening & Resolution of Generic Safety Issues, License Amendment reviews and Notice of Enforcement Discretion (NOEDs). This paper presents the current status of SPAR model development activities, future development objectives, and issues related to the development, verification and maintenance of the SPAR models.

  9. 76 FR 41537 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Implement Revolving Door Restrictions on Former Officers of FINRA July 8, 2011. Pursuant...

  10. 76 FR 72463 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change Relating to FINRA's Code of Procedure November 18, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of...

  11. 76 FR 82014 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... Analysis Tools), 2215 (Communications With the Public Regarding Security Futures), and 2216 (Communications...), 76 FR 46870 (August 3, 2011). \\4\\ Comment letters are available at www.sec.gov . \\5\\ See letter...

  12. 76 FR 46340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... Securities Exchange Act Release No. 59921 (May 14, 2009), 74 FR 23912 (May 21, 2009) (``Notice''). I. Self... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of... (October 21, 2010); 75 FR 66173 (October 27, 2010) (Order Granting Accelerated Approval of Proposed...

  13. 78 FR 72946 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of....19b-4. \\3\\ See Securities Exchange Act Release No. 70312 (Sept. 4, 2013), 78 FR 55322 (Sept. 10, 2013... the identity of the beneficial owners of the fund of funds invested in the account. Thus, in...

  14. 75 FR 51147 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving the Proposed Rule Change To Adopt FINRA Rule 5121 (Public Offerings of Securities With Conflicts of Interest... proposal to adopt FINRA Rule 5121 (Public Offerings of Securities With Conflicts of Interest) (``Rule'')...

  15. 75 FR 31825 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Adopt FINRA Rule 5121 (Public Offerings of Securities With Conflicts of Interest... Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing to adopt...

  16. 76 FR 67236 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Securities Positions in Connection With Certain Corporate Control Transactions October 25, 2011. Pursuant to... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. \\3\\ 17 CFR 240.19b-4(f)(6). I....

  17. 76 FR 77034 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-09

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Order Granting Accelerated Approval of Proposed Rule Change To Amend FINRA Rule 4512 (Customer Account Information) December 5, 2011....

  18. 75 FR 80556 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update a Cross-Reference in FINRA Rule 2232 (Customer Confirmations) December 16,...

  19. 75 FR 62904 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Reconcile Certain Amendments Approved Pursuant to SR-FINRA-2009-061 and...

  20. 75 FR 34183 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Market Volatility) To Permit FINRA To Halt Trading by FINRA Members Otherwise Than on an Exchange Where a Primary Listing Market Has Issued a Trading Pause Due to Extraordinary Market Conditions June 10, 2010....

  1. 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 Proposed Rule Change Relating to FINRA Rule 6121 (Trading Halts Due to Extraordinary Market Volatility... Rule 19b-4 thereunder,\\2\\ notice is hereby given that on June 30, 2010, Financial Industry...

  2. Special regulatory T cell review: How I became a T suppressor/regulatory cell maven

    PubMed Central

    Shevach, Ethan M

    2008-01-01

    I have briefly reviewed the factors that motivated me to change my views about the existence and importance of suppressor/regulatory T cells and to devote the majority of my laboratory efforts to this newly revitalized area of immunologic research. I am optimistic that manipulation of regulatory T-cell function will shortly be applicable to the clinic. PMID:18154610

  3. 77 FR 74249 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change To Establish Optional TRACE Data Delivery Services and Related Fees December 7, 2012. Pursuant to Section 19(b)(1) of...

  4. Team Structure and Regulatory Focus: The Impact of Regulatory Fit on Team Dynamic

    ERIC Educational Resources Information Center

    Dimotakis, Nikolaos; Davison, Robert B.; Hollenbeck, John R.

    2012-01-01

    We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus…

  5. 76 FR 25385 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a Proposed Rule Change Relating to TRACE Reporting of Asset-Backed Securities April 28, 2011. I. Introduction On March 3, 2011,...

  6. Negative feedback buffers effects of regulatory variants

    PubMed Central

    Bader, Daniel M; Wilkening, Stefan; Lin, Gen; Tekkedil, Manu M; Dietrich, Kim; Steinmetz, Lars M; Gagneur, Julien

    2015-01-01

    Mechanisms conferring robustness against regulatory variants have been controversial. Previous studies suggested widespread buffering of RNA misexpression on protein levels during translation. We do not find evidence that translational buffering is common. Instead, we find extensive buffering at the level of RNA expression, exerted through negative feedback regulation acting in trans, which reduces the effect of regulatory variants on gene expression. Our approach is based on a novel experimental design in which allelic differential expression in a yeast hybrid strain is compared to allelic differential expression in a pool of its spores. Allelic differential expression in the hybrid is due to cis-regulatory differences only. Instead, in the pool of spores allelic differential expression is not only due to cis-regulatory differences but also due to local trans effects that include negative feedback. We found that buffering through such local trans regulation is widespread, typically compensating for about 15% of cis-regulatory effects on individual genes. Negative feedback is stronger not only for essential genes, indicating its functional relevance, but also for genes with low to middle levels of expression, for which tight regulation matters most. We suggest that negative feedback is one mechanism of Waddington's canalization, facilitating the accumulation of genetic variants that might give selective advantage in different environments. PMID:25634765

  7. Regulatory Fit Effects on Stimulus Identification

    PubMed Central

    Glass, Brian D.; Maddox, W. Todd; Markmana, Arthur B.

    2010-01-01

    This article examines the effects of a fit between a person's global regulatory focus and the local task reward structure on perceptual processing and judgment. On each trial, participants were presented with one of two briefly presented stimuli and were asked to identify it. Participants were placed in a promotion focus (a situationally induced sensitivity to gains) or a prevention focus (a situationally induced sensitivity to losses) and were asked to maximize gains or minimize losses. An asymmetric payoff ratio biased the overall reward toward one identification response over the other. Two experiments tested the role of regulatory fit when internal familiarity and perceptual sensitivity was low or high. When familiarity and sensitivity were low, participants in a regulatory fit (promotion focus with gains or a prevention focus with losses) showed greater perceptual sensitivity, but no response bias differences relative to participants in a regulatory mismatch. When familiarity and sensitivity were high, participants in a regulatory fit showed a response bias toward the high payoff stimulus, but no differences in perceptual sensitivity. Speculation on the neurobiological basis of this effect, as well as implications of this work for clinical disorders, such as depression, is offered. PMID:21264696

  8. Regulatory principles governing Salmonella and Yersinia virulence

    PubMed Central

    Erhardt, Marc; Dersch, Petra

    2015-01-01

    Enteric pathogens such as Salmonella and Yersinia evolved numerous strategies to survive and proliferate in different environmental reservoirs and mammalian hosts. Deciphering common and pathogen-specific principles for how these bacteria adjust and coordinate spatiotemporal expression of virulence determinants, stress adaptation, and metabolic functions is fundamental to understand microbial pathogenesis. In order to manage sudden environmental changes, attacks by the host immune systems and microbial competition, the pathogens employ a plethora of transcriptional and post-transcriptional control elements, including transcription factors, sensory and regulatory RNAs, RNAses, and proteases, to fine-tune and control complex gene regulatory networks. Many of the contributing global regulators and the molecular mechanisms of regulation are frequently conserved between Yersinia and Salmonella. However, the interplay, arrangement, and composition of the control elements vary between these closely related enteric pathogens, which generate phenotypic differences leading to distinct pathogenic properties. In this overview we present common and different regulatory networks used by Salmonella and Yersinia to coordinate the expression of crucial motility, cell adhesion and invasion determinants, immune defense strategies, and metabolic adaptation processes. We highlight evolutionary changes of the gene regulatory circuits that result in different properties of the regulatory elements and how this influences the overall outcome of the infection process. PMID:26441883

  9. Regulatory focus affects physician risk tolerance.

    PubMed

    Veazie, Peter J; McIntosh, Scott; Chapman, Benjamin P; Dolan, James G

    2014-01-01

    Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention-regulatory focus theory suggests such a factor. This study tested whether regulatory focus affects risk tolerance among primary care physicians. Twenty-seven primary care physicians were assigned to promotion-focused or prevention-focused manipulations and compared on the Risk Taking Attitudes in Medical Decision Making scale using a randomization test. Results provide evidence that physicians assigned to the promotion-focus manipulation adopted an attitude of greater risk tolerance than the physicians assigned to the prevention-focused manipulation (p = 0.01). The Cohen's d statistic was conventionally large at 0.92. Results imply that situational regulatory focus in primary care physicians affects risk tolerance and may thereby be a nonclinical source of practice variation. Results also provide marginal evidence that chronic regulatory focus is associated with risk tolerance (p = 0.05), but the mechanism remains unclear. Research and intervention targeting physician risk tolerance may benefit by considering situational regulatory focus as an explanatory factor.

  10. cis-regulatory region analysis using BEARR.

    PubMed

    Vega, Vinsensius Berlian

    2006-01-01

    Genome-wide studies are fast becoming the norm, partly fueled by the availability of genome sequences and the feasibility of high-throughput experimental platforms, e.g., microarrays. An important aspect in any genome-wide studies is determination of regulatory relationships, believed to be primarily transacted through transcription factor binding to DNA. Identification of specific transcription factor binding sites in the cis-regulatory regions of genes makes it possible to list direct targets of transcription factors, model transcriptional regulatory networks, and mine other associated datasets for relevant targets for experimental and clinical manipulation. We have developed a web-based tool to assist biologists in efficiently carrying out the analysis of genes from studies of specific transcription factors or otherwise. The batch extraction and analysis of cis-regulatory regions (BEARR) facilitates identification, extraction, and analysis of regulatory regions from the large amount of data that is typically generated in genome-wide studies. This chapter highlights features and serves as a tutorial for using this publicly available software. The URL is http://giscompute.gis.a-star.edu.sg/~vega/BEARR1.0/. PMID:16888354

  11. Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

    PubMed

    Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G

    2015-10-01

    The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them.

  12. Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

    PubMed

    Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G

    2015-10-01

    The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. PMID:26188116

  13. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised...

  14. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders? 120.463 Section 120.463 Business....463 Regulatory accounting—What are SBA's regulatory accounting requirements for SBA Supervised...

  15. Health status of newcomers.

    PubMed

    Matuk, L C

    1996-01-01

    This article presents and discusses findings on the health status of newcomers residing in Windsor, Ontario. The data are part of a larger study, which was based on the Ontario Health Survey's questionnaire. Data were collected from 548 newcomers through home visits, focus groups, mail surveys, and telephone interviews. Descriptive multivariate analyses focused on main areas in newcomers' physical and mental health status and their access to health services. The findings identified that most newcomers do not have acute, life-threatening physical problems or chronic illness. They do not experience major problems with access to health care or activity limitations. Men are happier, more satisfied with their health, and less stressed than women. This study has implications for adoption of sensitive transcultural approaches to promote newcomers' health. Special challenges lie in women's health and mental health.

  16. Final environmental and regulatory assessment of using asphalt as a sealant in mine shafts

    SciTech Connect

    Not Available

    1987-01-01

    This report discusses the properties of asphalt, the current regulatory status governing asphalt and future regulatory implications which may be pertinent in using asphalt as a waterproof shaft sealant. An understanding of the inherent organic composition of asphalt, an increase in the number of health and environmental research publications conducted on asphalt and an examination of the apparent trend of regulatory agencies toward more stringent environmental regulation governing the use of organic materials suggests asphalt could become regulated at a future time. This would only occur, however, if asphalt was found to conform to the present regulatory definitions of pollutants, contaminants or hazardous substances or if asphalt was included on a regulated substance list. In this regard, the study points out that asphalt contains very low levels of hazardous poly-nuclear aromatics (PNA's). These levels are significantly lower than the levels present in coal tars, a substance known to contain high levels of hazardous PNA's. Asphalt, however, has the inherent potential of producing higher concentrations of PNA's if the adverse condition of cracking should occur during the refinery production stage or on-site preparation of the asphalt. Also, unless existing control technology is applied, emission levels of sulfur dioxide, carbon monoxide, particulates and volatile organic carbons from the on-site preparation facilities could approach the permissible health standard levels of EPA. The study indicates, however, that available literature is limited on these issues.

  17. A Functional and Regulatory Network Associated with PIP Expression in Human Breast Cancer

    PubMed Central

    Debily, Marie-Anne; Marhomy, Sandrine El; Boulanger, Virginie; Eveno, Eric; Mariage-Samson, Régine; Camarca, Alessandra; Auffray, Charles; Piatier-Tonneau, Dominique; Imbeaud, Sandrine

    2009-01-01

    Background The PIP (prolactin-inducible protein) gene has been shown to be expressed in breast cancers, with contradictory results concerning its implication. As both the physiological role and the molecular pathways in which PIP is involved are poorly understood, we conducted combined gene expression profiling and network analysis studies on selected breast cancer cell lines presenting distinct PIP expression levels and hormonal receptor status, to explore the functional and regulatory network of PIP co-modulated genes. Principal Findings Microarray analysis allowed identification of genes co-modulated with PIP independently of modulations resulting from hormonal treatment or cell line heterogeneity. Relevant clusters of genes that can discriminate between [PIP+] and [PIP−] cells were identified. Functional and regulatory network analyses based on a knowledge database revealed a master network of PIP co-modulated genes, including many interconnecting oncogenes and tumor suppressor genes, half of which were detected as differentially expressed through high-precision measurements. The network identified appears associated with an inhibition of proliferation coupled with an increase of apoptosis and an enhancement of cell adhesion in breast cancer cell lines, and contains many genes with a STAT5 regulatory motif in their promoters. Conclusions Our global exploratory approach identified biological pathways modulated along with PIP expression, providing further support for its good prognostic value of disease-free survival in breast cancer. Moreover, our data pointed to the importance of a regulatory subnetwork associated with PIP expression in which STAT5 appears as a potential transcriptional regulator. PMID:19262752

  18. MARS Flight Engineering Status

    SciTech Connect

    Fast, James E.; Dorow, Kevin E.; Morris, Scott J.; Thompson, Robert C.; Willett, Jesse A.

    2010-04-06

    The Multi-sensor Airborne Radiation Survey Flight Engineering project (MARS FE) has designed a high purity germanium (HPGe) crystal array for conducting a wide range of field measurements. In addition to the HPGe detector system, a platform-specific shock and vibration isolation system and environmental housing have been designed to support demonstration activities in a maritime environment on an Unmanned Surface Vehicle (USV). This report describes the status of the equipment as of the end of FY09.

  19. Present Status of Venusvenus

    NASA Astrophysics Data System (ADS)

    Sugimoto, Shojiro

    The TRISTAN e+e- collider came into operation in the last October. The first beam collision was confirmed with the VENUS detector on November 19, '86. Then we have observed 56 Bhabha events and 16 hadronic events for the integrated luminosity of 93 nb-1 at √ {s} = 50 GeV. R-value obtained by a preliminary quick analysis is 5.7±1.6. Here we report the present status and the results of the VENUS experiment.

  20. Automated Status Notification System

    NASA Technical Reports Server (NTRS)

    2005-01-01

    NASA Lewis Research Center's Automated Status Notification System (ASNS) was born out of need. To prevent "hacker attacks," Lewis' telephone system needed to monitor communications activities 24 hr a day, 7 days a week. With decreasing staff resources, this continuous monitoring had to be automated. By utilizing existing communications hardware, a UNIX workstation, and NAWK (a pattern scanning and processing language), we implemented a continuous monitoring system.