Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-16
...: (404) 562-9019. 4. Mail: ``EPA-R04-OAR-2011-0867,'' Regulatory Development Section, Air Planning Branch..., Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S....regulations.gov or in hard copy at the Regulatory Development Section, [[Page 78163
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
... Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental...: Lynorae Benjamin, Chief, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics... Bradley, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
Section 210 of the Public Utility Regulatory Policies Act of 1978 (PURPA) (16 U.S.C. Section 824a-3) (Attachment 1) was enacted to overcome certain institutional barriers and to provide a favorable, non-discriminatory regulatory environment for the integration of electricity-producing solar thermal and other qualifying technologies into the electric utility network. PURPA Section 210 is designed to reduce these institutional barriers for qualifying cogeneration and small power production facilities (QF's) - terminology which includes solar thermal facilities producing electricity for sale, if other prerequisites are met - by exempting certain QF's from economically burdensome legal requirements applicable to electric utilities, and bymore » requiring utilities to offer to purchase electricity from, and sell electricity to, QF's at reasonable and non-discriminatory rates. The present and future PURPA Section 210 regulatory implications for solar thermal QF's are explored. The current PURPA Section 210 regulatory environment and its consequences for solar thermal energy development are outlined. Legislation pending before Congress to amend PURPA Section 210 is described. Possible amendments to PURPA Section 210 that might further stimulate construction and operation of economically sound solar thermal facilities are explored.« less
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-21
...-2010-0150,'' Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management... Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency... at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management...
24 CFR 241.635 - Regulatory agreement.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 24 Housing and Urban Development 2 2014-04-01 2014-04-01 false Regulatory agreement. 241.635 Section 241.635 Housing and Urban Development Regulations Relating to Housing and Urban Development... Regulatory agreement. Any borrower obligated on the note for any loan insured under this subpart shall be...
24 CFR 241.635 - Regulatory agreement.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 24 Housing and Urban Development 2 2012-04-01 2012-04-01 false Regulatory agreement. 241.635 Section 241.635 Housing and Urban Development Regulations Relating to Housing and Urban Development... Regulatory agreement. Any borrower obligated on the note for any loan insured under this subpart shall be...
24 CFR 241.635 - Regulatory agreement.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Regulatory agreement. 241.635 Section 241.635 Housing and Urban Development Regulations Relating to Housing and Urban Development... Regulatory agreement. Any borrower obligated on the note for any loan insured under this subpart shall be...
24 CFR 241.635 - Regulatory agreement.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 24 Housing and Urban Development 2 2013-04-01 2013-04-01 false Regulatory agreement. 241.635 Section 241.635 Housing and Urban Development Regulations Relating to Housing and Urban Development... Regulatory agreement. Any borrower obligated on the note for any loan insured under this subpart shall be...
21 CFR 500.88 - Regulatory method.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...
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) The...
21 CFR 500.88 - Regulatory method.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...
21 CFR 500.88 - Regulatory method.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 6 2014-04-01 2014-04-01 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) The...
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) The...
24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.
Code of Federal Regulations, 2011 CFR
2011-04-01
.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2011-04-01 2011-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...
24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.
Code of Federal Regulations, 2014 CFR
2014-04-01
.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...
24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.
Code of Federal Regulations, 2013 CFR
2013-04-01
.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...
24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.
Code of Federal Regulations, 2012 CFR
2012-04-01
.... Any development will likely have some impact on the surrounding environment. Development which... 24 Housing and Urban Development 5 2012-04-01 2012-04-01 false Regulatory exemption-multiple site subdivision-determination required. 1710.15 Section 1710.15 Housing and Urban Development Regulations Relating...
40 CFR 256.62 - Requirements for public participation in State regulatory development.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...
40 CFR 256.62 - Requirements for public participation in State regulatory development.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...
40 CFR 256.62 - Requirements for public participation in State regulatory development.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...
40 CFR 256.62 - Requirements for public participation in State regulatory development.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...
40 CFR 256.62 - Requirements for public participation in State regulatory development.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Requirements for public participation in State regulatory development. 256.62 Section 256.62 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-27
... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5529-N-02] Notice of Regulatory Waiver.... ACTION: Notice. SUMMARY: Section 106 of the Department of Housing and Urban Development Reform Act of..., Department of Housing and Urban Development, 451 7th Street, SW., Room 10282, Washington, DC 20410- 0500...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-31
...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on October 1, 2010, and ending on December 31, 2010.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-27
...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on July 1, 2010, and ending on September 30, 2010.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-13
...Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on October 1, 2011, and ending on December 31, 2011.
NRC ARDC Guidance Support Status Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Holbrook, Mark R.
This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) andmore » modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”« less
75 FR 21889 - Semiannual Regulatory Agenda
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...--Resetting Fixed Interest Rate 3245-AG03 286 504 Program Governance Regulations 3245-AG04 287 Small Business...). It also conforms SBA rules for the section 7(a) Business Loan Program and the Certified Development... Part XVI Small Business Administration ###Semiannual Regulatory Agenda### [[Page 21890
75 FR 79863 - Semiannual Regulatory Agenda
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-20
... represent that it will make good faith efforts to award subcontracts to small businesses at the same...). It also conforms SBA rules for the section 7(a) Business Loan Program and the Certified Development... Part XVII Small Business Administration ###Semiannual Regulatory Agenda### [[Page 79864
Small Business Administration Semiannual Regulatory Agenda
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-20
... represent that it will make good faith efforts to award subcontracts to small businesses at the same...). It also conforms SBA rules for the section 7(a) Business Loan Program and the Certified Development... Business Administration Semiannual Regulatory Agenda] Part XVII Small Business Administration Semiannual...
40 CFR 256.22 - Recommendations for State regulatory powers.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
40 CFR 256.22 - Recommendations for State regulatory powers.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
40 CFR 256.21 - Requirements for State regulatory powers.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 26 2013-07-01 2013-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
40 CFR 256.21 - Requirements for State regulatory powers.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
40 CFR 256.21 - Requirements for State regulatory powers.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 25 2014-07-01 2014-07-01 false Requirements for State regulatory powers. 256.21 Section 256.21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
40 CFR 256.22 - Recommendations for State regulatory powers.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Recommendations for State regulatory powers. 256.22 Section 256.22 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR DEVELOPMENT AND IMPLEMENTATION OF STATE SOLID WASTE MANAGEMENT PLANS Solid Waste...
20 CFR 668.900 - Does WIA provide regulatory and/or statutory waiver authority?
Code of Federal Regulations, 2010 CFR
2010-04-01
... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Does WIA provide regulatory and/or statutory waiver authority? 668.900 Section 668.900 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION... WIA support of long term community development goals. ...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-20
... developed to allow eligible businesses to self-certify that they meet the regulatory definition of a Section... definition of a Section 3 Business. The information collected from the Section 3 Business Self-Certification... Collection; Comment Request; Section 3 Business Self-Certification Application AGENCY: Office of the...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-11
... Community Development and Regulatory Improvement Act of 1994 was signed into law. Section 303 (a) of this... requirement for federally regulated lending institutions to determine whether a building or mobile home... Regulatory Improvement Act of 1994. The establishment of the Standard Flood Hazard Determination form has...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-14
... Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency..., Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S... Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... Change Relating to Amendments to the Order Audit Trail System Rules November 4, 2011. Pursuant to Section... members report to the Order Audit Trail System (``OATS'') information barriers put into place by the... the Commission, FINRA noted: Based on further development of the Order Audit System and determinations...
77 FR 7663 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-13
...The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 ``Regulatory Planning and Review,'' signed September 30, 1993 (58 FR 51735), and Office of Management and Budget memoranda implementing section 4 of that Order establish minimum standards for agencies' agendas, including specific types of information for each entry. The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda. Editions of the Unified Agenda prior to fall 2007 were printed in their entirety in the Federal Register. Beginning with the fall 2007 edition, the Internet is the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda for fall 2011, which contains the regulatory agendas for 59 Federal agencies, is available to the public at http:// reginfo.gov. The fall 2011 Unified Agenda publication appearing in the Federal Register consists of agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.
75 FR 3907 - Agency Information Collection Activities: Proposed Collection; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-25
... implementing Section 6087 of the Deficit Reduction Act: Optional Self-Direction Personal Assistance Services... State's proposal to implement Section 6087 of the Deficit Reduction Act (DRA). State Medicaid Agencies... Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document...
Issues in Peer Review of the Scientific Basis for Regulatory Decisions.
ERIC Educational Resources Information Center
American Chemical Society, Washington, DC.
This document is intended to provide a discussion of the issues that need to be addressed in the development of peer review guidelines, the options for addressing the issues, and a range of views about such options. The document focuses on peer review with regard to regulatory decisions and contains major sections which deal with: (1) what should…
Code of Federal Regulations, 2012 CFR
2012-04-01
... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...
Code of Federal Regulations, 2013 CFR
2013-04-01
... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...
Code of Federal Regulations, 2011 CFR
2011-04-01
... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...
Code of Federal Regulations, 2010 CFR
2010-04-01
... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...
Code of Federal Regulations, 2014 CFR
2014-04-01
... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...
A High-Resolution Enhancer Atlas of the Developing Telencephalon
Visel, Axel; Taher, Leila; Girgis, Hani; May, Dalit; Golonzhka, Olga; Hoch, Renee; McKinsey, Gabriel L.; Pattabiraman, Kartik; Silberberg, Shanni N.; Blow, Matthew J.; Hansen, David V.; Nord, Alex S.; Akiyama, Jennifer A.; Holt, Amy; Hosseini, Roya; Phouanenavong, Sengthavy; Plajzer-Frick, Ingrid; Shoukry, Malak; Afzal, Veena; Kaplan, Tommy; Kriegstein, Arnold R.; Rubin, Edward M.; Ovcharenko, Ivan; Pennacchio, Len A.; Rubenstein, John L. R.
2013-01-01
Summary The mammalian telencephalon plays critical roles in cognition, motor function, and emotion. While many of the genes required for its development have been identified, the distant-acting regulatory sequences orchestrating their in vivo expression are mostly unknown. Here we describe a digital atlas of in vivo enhancers active in subregions of the developing telencephalon. We identified over 4,600 candidate embryonic forebrain enhancers and studied the in vivo activity of 329 of these sequences in transgenic mouse embryos. We generated serial sets of histological brain sections for 145 reproducible forebrain enhancers, resulting in a publicly accessible web-based data collection comprising over 32,000 sections. We also used epigenomic analysis of human and mouse cortex tissue to directly compare the genome-wide enhancer architecture in these species. These data provide a primary resource for investigating gene regulatory mechanisms of telencephalon development and enable studies of the role of distant-acting enhancers in neurodevelopmental disorders. PMID:23375746
78 FR 78968 - Agency Information Collection Activities: Proposed Collection; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention... Disclosure and Review Reporting Requirements CMS-724 Medicare/Medicaid Psychiatric Hospital Survey Data Under... Reporting Requirements; Use: Section 1003 of the Affordable Care Act adds a new section 2794 of the PHS Act...
40 CFR 92.6 - Regulatory structure.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 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 an overview of the regulatory structure of this part. (a) The regulations of this part 92 are intended to...
40 CFR 94.6 - Regulatory structure.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 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 overview of the regulatory structure of this part. (a) The regulations of this Part 94 are intended to control...
Code of Federal Regulations, 2013 CFR
2013-04-01
..., registered futures association or self-regulatory organization. 140.72 Section 140.72 Commodity and... futures association, or self-regulatory organization as defined in section 3(a)(26) of the Securities... futures association or self-regulatory organization. (b) Disclosure under this section shall only be made...
78 FR 59982 - Revisions to Radiation Protection
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-30
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan section; issuance. SUMMARY: The U.S. Nuclear Regulatory... for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition'': Section 12.1...
77 FR 66650 - Proposed Revisions to Radiation Protection
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-06
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0268] Proposed Revisions to Radiation Protection AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section revision; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is revising the following sections...
Code of Federal Regulations, 2012 CFR
2012-04-01
... filing with respect to proposed rule changes by all self-regulatory organizations. 249.819 Section 249..., SECURITIES EXCHANGE ACT OF 1934 Forms for Self-Regulatory Organization Rule Changes and Forms for... organizations. This form shall be used by all self-regulatory organizations, as defined in section 3(a)(26) of...
Code of Federal Regulations, 2011 CFR
2011-04-01
... filing with respect to proposed rule changes by all self-regulatory organizations. 249.819 Section 249..., SECURITIES EXCHANGE ACT OF 1934 Forms for Self-Regulatory Organization Rule Changes and Forms for... organizations. This form shall be used by all self-regulatory organizations, as defined in section 3(a)(26) of...
Code of Federal Regulations, 2010 CFR
2010-04-01
... filing with respect to proposed rule changes by all self-regulatory organizations. 249.819 Section 249..., SECURITIES EXCHANGE ACT OF 1934 Forms for Self-Regulatory Organization Rule Changes and Forms for... organizations. This form shall be used by all self-regulatory organizations, as defined in section 3(a)(26) of...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 24 Housing and Urban Development 5 2010-04-01 2010-04-01 false Settlements. 3800.60 Section 3800... DEVELOPMENT INVESTIGATIONS IN CONSUMER REGULATORY PROGRAMS § 3800.60 Settlements. (a) At any time during an investigation, the Department and the parties subject to an investigation may conduct settlement negotiations...
A high-resolution enhancer atlas of the developing telencephalon.
Visel, Axel; Taher, Leila; Girgis, Hani; May, Dalit; Golonzhka, Olga; Hoch, Renee V; McKinsey, Gabriel L; Pattabiraman, Kartik; Silberberg, Shanni N; Blow, Matthew J; Hansen, David V; Nord, Alex S; Akiyama, Jennifer A; Holt, Amy; Hosseini, Roya; Phouanenavong, Sengthavy; Plajzer-Frick, Ingrid; Shoukry, Malak; Afzal, Veena; Kaplan, Tommy; Kriegstein, Arnold R; Rubin, Edward M; Ovcharenko, Ivan; Pennacchio, Len A; Rubenstein, John L R
2013-02-14
The mammalian telencephalon plays critical roles in cognition, motor function, and emotion. Though many of the genes required for its development have been identified, the distant-acting regulatory sequences orchestrating their in vivo expression are mostly unknown. Here, we describe a digital atlas of in vivo enhancers active in subregions of the developing telencephalon. We identified more than 4,600 candidate embryonic forebrain enhancers and studied the in vivo activity of 329 of these sequences in transgenic mouse embryos. We generated serial sets of histological brain sections for 145 reproducible forebrain enhancers, resulting in a publicly accessible web-based data collection comprising more than 32,000 sections. We also used epigenomic analysis of human and mouse cortex tissue to directly compare the genome-wide enhancer architecture in these species. These data provide a primary resource for investigating gene regulatory mechanisms of telencephalon development and enable studies of the role of distant-acting enhancers in neurodevelopmental disorders. Copyright © 2013 Elsevier Inc. All rights reserved.
Hussain, Nasir
2016-11-30
This article reviews the field of oral uptake of nanoparticles across the gastrointestinal epithelium for the period 2006-2016. Analysis is conducted from the viewpoint of i) M-cell genetics and model development, ii) drug targeting to Peyer's patches and M-cells, and iii) physicochemical interactions of nanoparticles in the intestinal milieu. In light of these recent developments, regulatory considerations in the development of orally-absorbable nanoparticle drug products are discussed and focused on Module 3.2.P sub-sections of the Common Technical Document. Particular attention is paid to novel excipients, ligands and the non-standard method of manufacture. The novelty of this drug delivery system demands not only a multi-disciplinary scientific and regulatory approach but also a risk-adjusted consideration for a system defined by both processes and specifications. Given the current state of scientific development in the field it is suggested (in the author's personal opinion) that the design of nanoparticulate drug delivery systems should be kept as simple as possible (from a regulatory and manufacturing perspective) and to target the entire gastrointestinal epithelium. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.
Detailed costing document for the centralized waste treatment industry
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1998-12-01
In this document, EPA presents the costs estimated for compliance with the proposed CWT effluent limitations guidelines and standards. Section 1 provides a general description of how the individual treatment technology and regulatory option costs were developed. In Sections 2 through 4, EPA describes the development of costs for each of the wastewater and sludge treatment technologies. In Section 5, EPA presents additional compliance costs to be incurred by facilities, which are not technology specific. These additional items are retrofit costs, monitoring costs, RCRA permit modification costs, and land costs.
75 FR 76455 - Coso Energy Developers; Coso Finance Partners; Coso Power Developers; Notice Of Filing
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-08
... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL11-4-000] Coso Energy Developers; Coso Finance Partners; Coso Power Developers; Notice Of Filing December 1, 2010. Take notice that on November 18, 2010, Coso Energy Developers, Coso Finance Partners, and Coso Power Developers, pursuant to section 207 of the Federal Energy...
Code of Federal Regulations, 2012 CFR
2012-04-01
... membership in a contract market, a registered futures association, any other self-regulatory organization or... contract market, association, self-regulatory organization, or foreign regulatory body. The Commission interprets the term “self-regulatory organization” to include, in addition to a contract market and a...
Code of Federal Regulations, 2014 CFR
2014-04-01
... membership in a contract market, a registered futures association, any other self-regulatory organization or... contract market, association, self-regulatory organization, or foreign regulatory body. The Commission interprets the term “self-regulatory organization” to include, in addition to a contract market and a...
Code of Federal Regulations, 2013 CFR
2013-04-01
... membership in a contract market, a registered futures association, any other self-regulatory organization or... contract market, association, self-regulatory organization, or foreign regulatory body. The Commission interprets the term “self-regulatory organization” to include, in addition to a contract market and a...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-07
... By-Laws, Article VIII, Section 8.1 (Establishment of Districts) and Section 8.2 (Composition of..., Article VIII, Section 2(c) (District Committees and District Business Conduct Committees), amended...\\ See FINRA Regulation By-Laws, Article VIII, Section 8.1 (Establishment of Districts) and Section 8.2...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-15
... CONTACT: Richard Wong, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics... organic compounds. Dated: April 3, 2013. A. Stanley Meiburg, Acting Regional Administrator, Region 4. 0...
10 CFR 1040.124 - Responsibility of the Federal Energy Regulatory Commission.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 4 2011-01-01 2011-01-01 false Responsibility of the Federal Energy Regulatory Commission. 1040.124 Section 1040.124 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN... the Federal Energy Regulatory Commission. The FERC has authority under section 402(b) of the DOE...
10 CFR 1040.124 - Responsibility of the Federal Energy Regulatory Commission.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 4 2010-01-01 2010-01-01 false Responsibility of the Federal Energy Regulatory Commission. 1040.124 Section 1040.124 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN... the Federal Energy Regulatory Commission. The FERC has authority under section 402(b) of the DOE...
10 CFR 1040.124 - Responsibility of the Federal Energy Regulatory Commission.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 4 2013-01-01 2013-01-01 false Responsibility of the Federal Energy Regulatory Commission. 1040.124 Section 1040.124 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NONDISCRIMINATION IN... the Federal Energy Regulatory Commission. The FERC has authority under section 402(b) of the DOE...
44 CFR 350.6 - Assistance in development of State and local plans.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Assistance in development of State and local plans. 350.6 Section 350.6 Emergency Management and Assistance FEDERAL EMERGENCY... Nuclear Regulatory Commission, Department of Health and Human Services, Department of Energy, Department...
44 CFR 350.6 - Assistance in development of State and local plans.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Assistance in development of State and local plans. 350.6 Section 350.6 Emergency Management and Assistance FEDERAL EMERGENCY... Nuclear Regulatory Commission, Department of Health and Human Services, Department of Energy, Department...
12 CFR 562.2 - Regulatory reports.
Code of Federal Regulations, 2010 CFR
2010-01-01
... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...
Code of Federal Regulations, 2014 CFR
2014-04-01
..., registered futures association or self-regulatory organization. 140.72 Section 140.72 Commodity and... or self-regulatory organization. (a) Pursuant to the authority granted under sections 2(a)(11), 8a(5... execution facility, swap data repository, registered futures association, or self-regulatory organization as...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1991-10-01
According to {section} 35.32, Quality Management Program,'' of 10 CFR Part 35, Medical Use of Byproduct Material,'' applicants or licensees, as applicable, are required to establish a quality management (QM) program. This regulatory guide provides guidance to licensees and applicants for developing policies and procedures for the QM program. This guide does not restrict or limit the licensee from using other guidance that may be equally useful in developing a QM program, e.g., information available from the Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology. Any information collection activities mentioned in this regulatory guide aremore » contained as requirements in 10 CFR Part 35, which provides the regulatory basis for this guide. This information collection requirements in 10 CFR Part 35 have been cleared under OMB Clearance No. 3150-0010.« less
5 CFR 470.201 - Purposes of research programs.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Section 470.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to... under this subpart are to stimulate and conduct personnel management research which: (a) Develops new...
Code of Federal Regulations, 2013 CFR
2013-04-01
... self-regulatory organizations. 249.819 Section 249.819 Commodity and Securities Exchanges SECURITIES... changes, advance notices and security-based swap submissions by all self-regulatory organizations. This form shall be used by all self-regulatory organizations, as defined in Section 3(a)(26) of the...
Code of Federal Regulations, 2014 CFR
2014-04-01
... self-regulatory organizations. 249.819 Section 249.819 Commodity and Securities Exchanges SECURITIES... changes, advance notices and security-based swap submissions by all self-regulatory organizations. This form shall be used by all self-regulatory organizations, as defined in Section 3(a)(26) of the...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-09
... Trading Activity Fee (``TAF''). Certain transactions and transfers of securities are not required to be... transaction fees under Section 3 or the TAF.\\6\\ \\6\\ FINRA explained that this exception was adopted to align... regulatory transaction fees under Section 3 or the TAF. \\9\\ Rule 5190 imposes certain notice requirements on...
ACHP | Alternatives for Implementing Section 106 of NHPA: An Assessment
Historic Preservation Act: An Assessment: examines possible statutory, regulatory, and non-regulatory Preservation Act; considers the extent to which regulatory reforms already underway and new non-regulatory
Code of Federal Regulations, 2013 CFR
2013-01-01
... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 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 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 Lenders...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 13 Business Credit and Assistance 1 2014-01-01 2014-01-01 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 Lenders...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 13 Business Credit and Assistance 1 2011-01-01 2011-01-01 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 Lenders...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-28
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Indian Gaming AGENCY: Bureau of Indian Affairs... Indian Gaming, Office of the Deputy Assistant Secretary--Policy and Economic Development, Washington, DC 20240, (202) 219-4066. SUPPLEMENTARY INFORMATION: Under section 11 of the Indian Gaming Regulatory Act...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hasanbeigi, Ali; Lu, Hongyou; Williams, Christopher
The purpose of this report is to describe international best practices for pre-processing and coprocessing of MSW and sewage sludge in cement plants, for the benefit of countries that wish to develop co-processing capacity. The report is divided into three main sections. Section 2 describes the fundamentals of co-processing, Section 3 describes exemplary international regulatory and institutional frameworks for co-processing, and Section 4 describes international best practices related to the technological aspects of co-processing.
Code of Federal Regulations, 2013 CFR
2013-04-01
... submitted pursuant to Section 19(b)(7) of the Act. Preliminary Note: A self-regulatory organization also... proposed rule changes. (a) Filings with respect to proposed rule changes by a self-regulatory organization... organization on the proposed rule change. (c) Self-regulatory organizations shall retain at their principle...
Code of Federal Regulations, 2014 CFR
2014-04-01
... submitted pursuant to Section 19(b)(7) of the Act. Preliminary Note: A self-regulatory organization also... proposed rule changes. (a) Filings with respect to proposed rule changes by a self-regulatory organization... organization on the proposed rule change. (c) Self-regulatory organizations shall retain at their principle...
Code of Federal Regulations, 2011 CFR
2011-04-01
... submitted pursuant to Section 19(b)(7) of the Act. Preliminary Note: A self-regulatory organization also... proposed rule changes. (a) Filings with respect to proposed rule changes by a self-regulatory organization... organization on the proposed rule change. (c) Self-regulatory organizations shall retain at their principle...
Code of Federal Regulations, 2012 CFR
2012-04-01
... submitted pursuant to Section 19(b)(7) of the Act. Preliminary Note: A self-regulatory organization also... proposed rule changes. (a) Filings with respect to proposed rule changes by a self-regulatory organization... organization on the proposed rule change. (c) Self-regulatory organizations shall retain at their principle...
Code of Federal Regulations, 2010 CFR
2010-04-01
... submitted pursuant to Section 19(b)(7) of the Act. Preliminary Note: A self-regulatory organization also... proposed rule changes. (a) Filings with respect to proposed rule changes by a self-regulatory organization... organization on the proposed rule change. (c) Self-regulatory organizations shall retain at their principle...
2002 Mitigation Regulatory Guidance Letter (RGL) 02-2
Guidance on Compensatory Mitigation Projects for Aquatic Resource Impacts Under the Corps Regulatory Program Pursuant to Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbors Act of 1899
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-06
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Amend Certain Trade Reporting and Compliance Rules September 30, 2011. Pursuant to Section 19(b... hereby given that on September 22, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-11
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Reporting Facility and OTC Reporting Facility Fees March 4, 2010. Pursuant to Section 19(b)(1) of the... March 1, 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-01
...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...
41 CFR 102-117.320 - What is a transportation regulatory body proceeding?
Code of Federal Regulations, 2011 CFR
2011-01-01
... regulatory body proceeding? 102-117.320 Section 102-117.320 Public Contracts and Property Management Federal...-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body Proceedings § 102-117.320 What is a transportation regulatory body proceeding? A transportation regulatory body proceeding is a hearing before a...
10 CFR 1.45 - Office of Nuclear Regulatory Research.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...
10 CFR 1.45 - Office of Nuclear Regulatory Research.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...
10 CFR 1.45 - Office of Nuclear Regulatory Research.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...
10 CFR 1.45 - Office of Nuclear Regulatory Research.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...
10 CFR 1.45 - Office of Nuclear Regulatory Research.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Office of Nuclear Regulatory Research. 1.45 Section 1.45 Energy NUCLEAR REGULATORY COMMISSION STATEMENT OF ORGANIZATION AND GENERAL INFORMATION Headquarters Program Offices § 1.45 Office of Nuclear Regulatory Research. The Office of Nuclear Regulatory Research...
41 CFR 102-117.320 - What is a transportation regulatory body proceeding?
Code of Federal Regulations, 2010 CFR
2010-07-01
... regulatory body proceeding? 102-117.320 Section 102-117.320 Public Contracts and Property Management Federal...-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body Proceedings § 102-117.320 What is a transportation regulatory body proceeding? A transportation regulatory body proceeding is a hearing before a...
10 CFR 20.1101 - Radiation protection programs.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Radiation protection programs. 20.1101 Section 20.1101 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Protection Programs § 20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement...
10 CFR 20.1101 - Radiation protection programs.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Radiation protection programs. 20.1101 Section 20.1101 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Protection Programs § 20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement...
10 CFR 20.1101 - Radiation protection programs.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Radiation protection programs. 20.1101 Section 20.1101 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Protection Programs § 20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement...
10 CFR 20.1101 - Radiation protection programs.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Radiation protection programs. 20.1101 Section 20.1101 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Protection Programs § 20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement...
10 CFR 20.1101 - Radiation protection programs.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Radiation protection programs. 20.1101 Section 20.1101 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Protection Programs § 20.1101 Radiation protection programs. (a) Each licensee shall develop, document, and implement...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Procedures. 26.127 Section 26.127 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.127 Procedures. (a) Licensee testing facilities shall develop, implement, and maintain clear and well-documented procedures for...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Procedures. 26.127 Section 26.127 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Licensee Testing Facilities § 26.127 Procedures. (a) Licensee testing facilities shall develop, implement, and maintain clear and well-documented procedures for...
47 CFR 1.1160 - Refunds of regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 1 2010-10-01 2010-10-01 false Refunds of regulatory fees. 1.1160 Section 1... Statutory Charges and Procedures for Payment § 1.1160 Refunds of regulatory fees. (a) Regulatory fees will be refunded, upon request, only in the following instances: (1) When no regulatory fee is required or...
10 CFR 51.30 - Environmental assessment.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Environmental assessment. 51.30 Section 51.30 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false [Reserved] 51.99 Section 51.99 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Final Environmental...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false [Reserved] 51.99 Section 51.99 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Final Environmental...
10 CFR 51.16 - Proprietary information.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Proprietary information. 51.16 Section 51.16 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
10 CFR 51.16 - Proprietary information.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Proprietary information. 51.16 Section 51.16 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
47 CFR 101.1309 - Regulatory status.
Code of Federal Regulations, 2010 CFR
2010-10-01
... party may challenge the regulatory status granted an MAS licensee. System License Requirements ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.1309 Section 101.1309... SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission will...
40 CFR 73.86 - State regulatory autonomy.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...
41 CFR 109-40.102 - Representation before regulatory bodies.
Code of Federal Regulations, 2011 CFR
2011-01-01
... regulatory bodies. 109-40.102 Section 109-40.102 Public Contracts and Property Management Federal Property... Representation before regulatory bodies. Participation in proceedings related to carrier applications to regulatory bodies for temporary or permanent authority to operate in specified geographical locations shall...
41 CFR 109-40.102 - Representation before regulatory bodies.
Code of Federal Regulations, 2010 CFR
2010-07-01
... regulatory bodies. 109-40.102 Section 109-40.102 Public Contracts and Property Management Federal Property... Representation before regulatory bodies. Participation in proceedings related to carrier applications to regulatory bodies for temporary or permanent authority to operate in specified geographical locations shall...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-01
... closely the governance structure of the FINRA Board. Section 4.3--Qualifications The proposed rule change would amend Article IV, section 4.3(a) to reflect FINRA's current governance structure by establishing... to Article IV, section 4.3 as follows: Re-structure the Board to remove the President of NASD Dispute...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-07
... the proposed Revision 4 to Standard Review Plan Section 8.1 on ``Electric Power-- Introduction.'' The... NUCLEAR REGULATORY COMMISSION [NRC-2011-0119] Office of New Reactors; Proposed Revision 4 to Standard Review Plan Section 8.1 on Electric Power--Introduction, Correction AGENCY: Nuclear Regulatory...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-26
... NUCLEAR REGULATORY COMMISSION [NRC-2010-0184] Office of New Reactors: Proposed NUREG-0800; Standard Review Plan Section 13.6.6, Draft Revision 0 on Cyber Security Plan AGENCY: Nuclear Regulatory... Plants,'' on a proposed Standard Review Plan (SRP) Section 13.6.6 on ``Cyber Security Plan'' (Agencywide...
Technical approach to groundwater restoration. Final report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1993-11-01
The Technical Approach to Groundwater Restoration (TAGR) provides general technical guidance to implement the groundwater restoration phase of the Uranium Mill Tailings Remedial Action (UMTRA) Project. The TAGR includes a brief overview of the surface remediation and groundwater restoration phases of the UMTRA Project and describes the regulatory requirements, the National Environmental Policy Act (NEPA) process, and regulatory compliance. A section on program strategy discusses program optimization, the role of risk assessment, the observational approach, strategies for meeting groundwater cleanup standards, and remedial action decision-making. A section on data requirements for groundwater restoration evaluates the data quality objectives (DQO) andmore » minimum data required to implement the options and comply with the standards. A section on sits implementation explores the development of a conceptual site model, approaches to site characterization, development of remedial action alternatives, selection of the groundwater restoration method, and remedial design and implementation in the context of site-specific documentation in the site observational work plan (SOWP) and the remedial action plan (RAP). Finally, the TAGR elaborates on groundwater monitoring necessary to evaluate compliance with the groundwater cleanup standards and protection of human health and the environment, and outlines licensing procedures.« less
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false [Reserved] 51.110 Section 51.110 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Rulemaking § 51.110...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Emergencies. 51.13 Section 51.13 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) § 51.13 Emergencies...
10 CFR 51.88 - Proposals for legislation.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Proposals for legislation. 51.88 Section 51.88 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
10 CFR 51.125 - Responsible official.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Responsible official. 51.125 Section 51.125 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Responsible...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Emergencies. 51.13 Section 51.13 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) § 51.13 Emergencies...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false [Reserved] 51.110 Section 51.110 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Rulemaking § 51.110...
10 CFR 51.125 - Responsible official.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Responsible official. 51.125 Section 51.125 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Responsible...
Martínez, A; Buchan, A M; López, J; Sesma, P
2000-05-01
The colocalization of regulatory peptide immunoreactivities in endocrine cells of the chicken proventriculus at hatching has been investigated using the avidin-biotin technique in serial sections and double immunofluorescence in the same section for light microscopy, and double immunogold staining for electron microscopy. In addition to the eight immunoreactivities previously described in this organ, cells immunoreactive for peptide histidine isoleucine (PHI), peptide gene product 9.5 (PGP), and the amidating enzyme, peptidylglycine alpha-amidating monooxygenase (PAM) were observed. All the cells immunoreactive to glucagon were also immunostained by the PHI antiserum. In addition, all the glucagon-like peptide 1, avian pancreatic polypeptide, and some of the neurotensin-like cells costored also glucagon- and PHI-immunoreactive substances. PGP- and PAM-immunoreactivities were also found in the glucagon-positive cells. A small proportion of the somatostatin-containing cells were positive for PHI but not for other regulatory peptides. These results could suggest either the existence of a very complex regulatory system or that the endocrine system of the newborn chickens is not yet fully developed.
76 FR 3909 - Agency Information Collection Activities: Proposed Collection; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-21
... Annual Reporting; Use: Section 1923(j)(i) of the Social Security Act requires States to submit an annual...); Frequency: Yearly; Affected Public: Business or other for-profit, not-for-profit institutions; Number of... Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document...
18 CFR 154.401 - RD&D expenditures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false RD&D expenditures. 154.401 Section 154.401 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION... file to recover research, development, and demonstration (RD&D) expenditures in its rates under this...
10 CFR 51.116 - Notice of intent.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Notice of intent. 51.116 Section 51.116 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice...
10 CFR 51.27 - Notice of intent.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Notice of intent. 51.27 Section 51.27 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Determinations...
10 CFR 51.124 - Commission duty to comment.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Commission duty to comment. 51.124 Section 51.124 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
10 CFR 51.28 - Scoping-participants.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Scoping-participants. 51.28 Section 51.28 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Scoping § 51...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Definitions. 51.14 Section 51.14 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) § 51.14 Definitions. (a...
10 CFR 51.27 - Notice of intent.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Notice of intent. 51.27 Section 51.27 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Determinations...
10 CFR 51.28 - Scoping-participants.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Scoping-participants. 51.28 Section 51.28 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Scoping § 51...
10 CFR 51.100 - Timing of Commission action.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Timing of Commission action. 51.100 Section 51.100 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
10 CFR 51.116 - Notice of intent.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Notice of intent. 51.116 Section 51.116 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2) Public Notice...
10 CFR 51.100 - Timing of Commission action.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Timing of Commission action. 51.100 Section 51.100 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2...
48 CFR 41.402 - Rate changes and regulatory intervention.
Code of Federal Regulations, 2014 CFR
2014-10-01
... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...
48 CFR 41.402 - Rate changes and regulatory intervention.
Code of Federal Regulations, 2010 CFR
2010-10-01
... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...
48 CFR 41.402 - Rate changes and regulatory intervention.
Code of Federal Regulations, 2013 CFR
2013-10-01
... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...
48 CFR 41.402 - Rate changes and regulatory intervention.
Code of Federal Regulations, 2012 CFR
2012-10-01
... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...
48 CFR 41.402 - Rate changes and regulatory intervention.
Code of Federal Regulations, 2011 CFR
2011-10-01
... regulatory intervention. 41.402 Section 41.402 Federal Acquisition Regulations System FEDERAL ACQUISITION... changes and regulatory intervention. (a) When a change is proposed to rates or terms and conditions of... that may be of interest to other Federal agencies, and intervention before a regulatory body is...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-28
... incorporate Revision 4 of SRP Section 8.1 into the next revisions of the Regulatory Guide 1.206, ``Combined..., 2011 (76 FR 31381), the NRC published for public comment the proposed Revision 4 on Section 8.1 on... NUCLEAR REGULATORY COMMISSION [NRC-2011-0119] Final Staff Guidance, Revision 4 to Standard Review...
Code of Federal Regulations, 2010 CFR
2010-04-01
... and Regulatory Waiver Authority provided at section 189(i)(4) of the Workforce Investment Act? 661.400... AND LOCAL GOVERNANCE OF THE WORKFORCE INVESTMENT SYSTEM UNDER TITLE I OF THE WORKFORCE INVESTMENT ACT... Authority provided at section 189(i)(4) of the Workforce Investment Act? (a) The purpose of the general...
21 CFR 312.86 - Focused FDA regulatory research.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...
21 CFR 312.86 - Focused FDA regulatory research.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...
21 CFR 312.86 - Focused FDA regulatory research.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...
21 CFR 312.86 - Focused FDA regulatory research.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...
17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.
Code of Federal Regulations, 2012 CFR
2012-04-01
... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...
17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...
17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.
Code of Federal Regulations, 2014 CFR
2014-04-01
... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...
17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.
Code of Federal Regulations, 2014 CFR
2014-04-01
... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...
17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.
Code of Federal Regulations, 2013 CFR
2013-04-01
... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...
17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...
17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.
Code of Federal Regulations, 2010 CFR
2010-04-01
... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...
17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.
Code of Federal Regulations, 2010 CFR
2010-04-01
... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...
17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.
Code of Federal Regulations, 2012 CFR
2012-04-01
... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...
17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.
Code of Federal Regulations, 2013 CFR
2013-04-01
... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...
12 CFR 914.2 - Filing Regulatory Reports.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Filing Regulatory Reports. 914.2 Section 914.2 Banks and Banking FEDERAL HOUSING FINANCE BOARD GOVERNANCE AND MANAGEMENT OF THE FEDERAL HOME LOAN BANKS DATA AVAILABILITY AND REPORTING § 914.2 Filing Regulatory Reports. Each Bank shall file Regulatory...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Criteria for and identification of licensing and regulatory actions requiring environmental assessments. 51.21 Section 51.21 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Criteria for and identification of licensing and regulatory actions requiring environmental assessments. 51.21 Section 51.21 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY...
13 CFR 108.585 - Voluntary decrease in NMVC Company's Regulatory Capital.
Code of Federal Regulations, 2010 CFR
2010-01-01
...'s Regulatory Capital. 108.585 Section 108.585 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Managing the Operations of a NMVC Company Voluntary Decrease in Regulatory Capital § 108.585 Voluntary decrease in NMVC Company's Regulatory Capital. You must...
21 CFR 312.86 - Focused FDA regulatory research.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...
Hamilton, Samina; Bernstein, Aaron B; Blakey, Graham; Fagan, Vivien; Farrow, Tracy; Jordan, Debbie; Seiler, Walther; Shannon, Anna; Gertel, Art
2016-01-01
Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today's studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into 'regulatory' and 'public disclosure' categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes.A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided.Together, CORE Reference and the mapping tool constitute the user manual. This publication is intended to enhance the use, understanding and dissemination of CORE Reference.The CORE Reference user manual and the associated website (http://www.core-reference.org) should improve the reporting of interventional clinical studies.Periodic updates of CORE Reference are planned to maintain its relevance. CORE Reference was registered with http://www.equator-network.org on 23 March 2015.
Federal Reserve System Semiannual Regulatory Agenda
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
... Rulemaking Procedures. The Board anticipates having under consideration regulatory matters as indicated below... sections. The first, Proposed Rule Stage, reports on matters the Board may consider for public comment during the next 6 months. The second section, Final Rule Stage, reports on matters that have been...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-22
.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance..., and at the Commission's Public Reference Room. II. Self-Regulatory Organization's Statement of the... in sections A, B, and C below, of the most significant aspects of such statements. A. Self-Regulatory...
76 FR 54426 - Effects of Foreign Policy-Based Export Controls
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-01
... [email protected] or on paper to Regulatory Policy Division, Bureau of Industry and Security, Department... comments on paper. All comments must be in writing (either e-mail or on paper). All comments, including... ``military end-users'' (Sec. 744.17); Significant items (SI): Hot section technology for the development...
18 CFR 5.19 - Tendering notice and schedule.
Code of Federal Regulations, 2013 CFR
2013-04-01
... application for a license developed pursuant to this part, the Director of the Office of Energy Projects will... schedule. 5.19 Section 5.19 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS § 5.19...
18 CFR 5.19 - Tendering notice and schedule.
Code of Federal Regulations, 2014 CFR
2014-04-01
... application for a license developed pursuant to this part, the Director of the Office of Energy Projects will... schedule. 5.19 Section 5.19 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS § 5.19...
18 CFR 5.19 - Tendering notice and schedule.
Code of Federal Regulations, 2012 CFR
2012-04-01
... application for a license developed pursuant to this part, the Director of the Office of Energy Projects will... schedule. 5.19 Section 5.19 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS § 5.19...
40 CFR 123.63 - Criteria for withdrawal of State programs.
Code of Federal Regulations, 2014 CFR
2014-07-01
... programs. 123.63 Section 123.63 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER... requirements of this part, including: (i) Failure to exercise control over activities required to be regulated... regulatory program for developing water quality-based effluent limits in NPDES permits. (6) Where a Great...
40 CFR 123.63 - Criteria for withdrawal of State programs.
Code of Federal Regulations, 2012 CFR
2012-07-01
... programs. 123.63 Section 123.63 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER... requirements of this part, including: (i) Failure to exercise control over activities required to be regulated... regulatory program for developing water quality-based effluent limits in NPDES permits. (6) Where a Great...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-15
... Promulgation of Implementation Plans for Tennessee: Revisions to Volatile Organic Compound Definition AGENCY... total of 17 compounds to the list of compounds excluded from the definition of ``Volatile Organic...: Sean Lakeman, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Subparts. 51.2 Section 51.2 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.2 Subparts. (a) The regulations in subpart A of this part implement section 102(2) of the...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Subparts. 51.2 Section 51.2 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.2 Subparts. (a) The regulations in subpart A of this part implement section 102(2) of the...
10 CFR 150.10 - Persons exempt.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Persons exempt. 150.10 Section 150.10 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Exemptions in Agreement States § 150.10 Persons exempt. Except as...
10 CFR 150.10 - Persons exempt.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Persons exempt. 150.10 Section 150.10 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Exemptions in Agreement States § 150.10 Persons exempt. Except as...
10 CFR 150.10 - Persons exempt.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Persons exempt. 150.10 Section 150.10 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Exemptions in Agreement States § 150.10 Persons exempt. Except as...
10 CFR 150.10 - Persons exempt.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Persons exempt. 150.10 Section 150.10 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Exemptions in Agreement States § 150.10 Persons exempt. Except as...
Medical Writing Competency Model - Section 1: Functions, Tasks, and Activities.
Clemow, David B; Wagner, Bertil; Marshallsay, Christopher; Benau, Dan; L'Heureux, Darryl; Brown, David H; Dasgupta, Devjani Ghosh; Girten, Eileen; Hubbard, Frank; Gawrylewski, Helle-Mai; Ebina, Hiroko; Stoltenborg, Janet; York, J P; Green, Kim; Wood, Linda Fossati; Toth, Lisa; Mihm, Michael; Katz, Nancy R; Vasconcelos, Nina-Maria; Sakiyama, Norihisa; Whitsell, Robin; Gopalakrishnan, Shobha; Bairnsfather, Susan; Wanderer, Tatyana; Schindler, Thomas M; Mikyas, Yeshi; Aoyama, Yumiko
2018-01-01
This article provides Section 1 of the 2017 Edition 2 Medical Writing Competency Model that describes the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry. The functions in the Model are scientific communication strategy; document preparation, development, and finalization; document project management; document template, standard, format, and style development and maintenance; outsourcing, alliance partner, and client management; knowledge, skill, ability, and behavior development and sharing; and process improvement. The full Model also includes Section 2, which covers the knowledge, skills, abilities, and behaviors needed for medical writers to be effective in their roles; Section 2 is presented in a companion article. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.
Code of Federal Regulations, 2012 CFR
2012-04-01
... of self-regulatory organization governing boards and various committees. 1.69 Section 1.69 Commodity... EXCHANGE ACT Miscellaneous § 1.69 Voting by interested members of self-regulatory organization governing... violation of the rules of the self-regulatory organization except those cases where the person or committee...
Code of Federal Regulations, 2013 CFR
2013-04-01
... of self-regulatory organization governing boards and various committees. 1.69 Section 1.69 Commodity... EXCHANGE ACT Miscellaneous § 1.69 Voting by interested members of self-regulatory organization governing... violation of the rules of the self-regulatory organization except those cases where the person or committee...
Code of Federal Regulations, 2014 CFR
2014-04-01
... of self-regulatory organization governing boards and various committees. 1.69 Section 1.69 Commodity... EXCHANGE ACT Miscellaneous § 1.69 Voting by interested members of self-regulatory organization governing... violation of the rules of the self-regulatory organization except those cases where the person or committee...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-05
... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and... those listed in Section I of the Fee Schedule. B. Self-Regulatory Organization's Statement on Burden on...
Code of Federal Regulations, 2011 CFR
2011-04-01
... of self-regulatory organization governing boards and various committees. 1.69 Section 1.69 Commodity... EXCHANGE ACT Miscellaneous § 1.69 Voting by interested members of self-regulatory organization governing... violation of the rules of the self-regulatory organization except those cases where the person or committee...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-07
.... Background Nuclear Regulatory Commission Pursuant to Section 103 of the Atomic Energy Act of 1954, as amended... NUCLEAR REGULATORY COMMISSION DEPARTMENT OF HOMELAND SECURITY [NRC-2012-0015] Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Department of Homeland Security Regarding...
47 CFR 1.1163 - Adjustments to regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 1 2010-10-01 2010-10-01 false Adjustments to regulatory fees. 1.1163 Section... of Statutory Charges and Procedures for Payment § 1.1163 Adjustments to regulatory fees. (a) For Fiscal Year 1995, the amounts assessed for regulatory fees are set forth in §§ 1.1152 through 1.1156. (b...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Persons using source material under certain Department of Energy and Nuclear Regulatory Commission contracts. 40.11 Section 40.11 Energy NUCLEAR REGULATORY... certain Department of Energy and Nuclear Regulatory Commission contracts. Except to the extent that...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission contracts. 30.12 Section 30.12 Energy NUCLEAR REGULATORY... Persons using byproduct material under certain Department of Energy and Nuclear Regulatory Commission...
47 CFR 1.1151 - Authority to prescribe and collect regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... regulatory activities in the private radio, mass media, common carrier, and cable television services. [59 FR... fees. 1.1151 Section 1.1151 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... section 9 of the Communications Act, 47 U.S.C. 159, which directs the Commission to prescribe and collect...
75 FR 24641 - Order Finding That the HSC1
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... commercial market (``ECM'') under sections 2(h)(3)--(5) of the Commodity Exchange Act (``CEA'' or the ``Act... (``Reauthorization Act'') \\4\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-25
...: This document announces the Agricultural Marketing Service's (AMS) plans to review the National Organic... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-11-0005; NOP-11-01] Regulatory Flexibility Act: Section 610 Review of National Organic Program...
18 CFR 292.305 - Rates for sales.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Rates for sales. 292.305 Section 292.305 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION... SECTIONS 201 AND 210 OF THE PUBLIC UTILITY REGULATORY POLICIES ACT OF 1978 WITH REGARD TO SMALL POWER...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Definitions. 9.3 Section 9.3 Energy NUCLEAR REGULATORY... the Nuclear Regulatory Commission, established by the Energy Reorganization Act of 1974. NRC personnel... members or a quorum thereof sitting as a body, as provided by section 201 of the Energy Reorganization Act...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Definitions. 9.3 Section 9.3 Energy NUCLEAR REGULATORY... the Nuclear Regulatory Commission, established by the Energy Reorganization Act of 1974. NRC personnel... members or a quorum thereof sitting as a body, as provided by section 201 of the Energy Reorganization Act...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Definitions. 9.3 Section 9.3 Energy NUCLEAR REGULATORY... the Nuclear Regulatory Commission, established by the Energy Reorganization Act of 1974. NRC personnel... members or a quorum thereof sitting as a body, as provided by section 201 of the Energy Reorganization Act...
12 CFR 217.22 - Regulatory capital adjustments and deductions.
Code of Federal Regulations, 2014 CFR
2014-01-01
.... 217.22 Section 217.22 Banks and Banking FEDERAL RESERVE SYSTEM BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM CAPITAL ADEQUACY OF BOARD-REGULATED INSTITUTIONS Definition of Capital § 217.22 Regulatory...) in accordance with paragraph (e) of this section, including goodwill that is embedded in the...
47 CFR 1.1166 - Waivers, reductions and deferrals of regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... fees. 1.1166 Section 1.1166 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... deferrals of regulatory fees. The fees established by sections 1.1152 through 1.1156 may be waived, reduced... waiver, reduction or deferral of the fee would promote the public interest. Requests for waivers...
18 CFR 294.101 - Shortages of electric energy and capacity.
Code of Federal Regulations, 2011 CFR
2011-04-01
... energy and capacity. 294.101 Section 294.101 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE PUBLIC UTILITY REGULATORY POLICIES ACT OF 1978 PROCEDURES FOR SHORTAGES OF ELECTRIC ENERGY AND CAPACITY UNDER SECTION 206 OF THE PUBLIC UTILITY...
18 CFR 294.101 - Shortages of electric energy and capacity.
Code of Federal Regulations, 2013 CFR
2013-04-01
... energy and capacity. 294.101 Section 294.101 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE PUBLIC UTILITY REGULATORY POLICIES ACT OF 1978 PROCEDURES FOR SHORTAGES OF ELECTRIC ENERGY AND CAPACITY UNDER SECTION 206 OF THE PUBLIC UTILITY...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Definitions. 9.3 Section 9.3 Energy NUCLEAR REGULATORY... the Nuclear Regulatory Commission, established by the Energy Reorganization Act of 1974. NRC personnel... members or a quorum thereof sitting as a body, as provided by section 201 of the Energy Reorganization Act...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Definitions. 9.3 Section 9.3 Energy NUCLEAR REGULATORY... the Nuclear Regulatory Commission, established by the Energy Reorganization Act of 1974. NRC personnel... members or a quorum thereof sitting as a body, as provided by section 201 of the Energy Reorganization Act...
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 regulatory...
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 regulatory...
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 regulatory...
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 regulatory...
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 regulatory...
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 concerning...
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 concerning...
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 general...
17 CFR 240.19b-4 - Filings with respect to proposed rule changes by self-regulatory organizations.
Code of Federal Regulations, 2014 CFR
2014-04-01
... proposed rule changes by self-regulatory organizations. 240.19b-4 Section 240.19b-4 Commodity and...) Any material aspect of the operation of the facilities of the self-regulatory organization; or (ii... securities associations, through a member) to facilities of, the self-regulatory organization (“specified...
Code of Federal Regulations, 2012 CFR
2012-04-01
... Expulsion of Exchange Members § 240.19d-1 Notices by self-regulatory organizations of final disciplinary... services, and summary suspensions. (a) General. If any self-regulatory organization for which the...) of the Act, concerning an action subject to such section taken by a self-regulatory organization for...
Code of Federal Regulations, 2010 CFR
2010-04-01
... Expulsion of Exchange Members § 240.19d-1 Notices by self-regulatory organizations of final disciplinary... services, and summary suspensions. (a) General. If any self-regulatory organization for which the...) of the Act, concerning an action subject to such section taken by a self-regulatory organization for...
Code of Federal Regulations, 2011 CFR
2011-04-01
... Expulsion of Exchange Members § 240.19d-1 Notices by self-regulatory organizations of final disciplinary... services, and summary suspensions. (a) General. If any self-regulatory organization for which the...) of the Act, concerning an action subject to such section taken by a self-regulatory organization for...
17 CFR 240.19b-4 - Filings with respect to proposed rule changes by self-regulatory organizations.
Code of Federal Regulations, 2013 CFR
2013-04-01
... proposed rule changes by self-regulatory organizations. 240.19b-4 Section 240.19b-4 Commodity and...) Any material aspect of the operation of the facilities of the self-regulatory organization; or (ii... securities associations, through a member) to facilities of, the self-regulatory organization (“specified...
Code of Federal Regulations, 2013 CFR
2013-04-01
... Expulsion of Exchange Members § 240.19d-1 Notices by self-regulatory organizations of final disciplinary... services, and summary suspensions. (a) General. If any self-regulatory organization for which the...) of the Act, concerning an action subject to such section taken by a self-regulatory organization for...
Code of Federal Regulations, 2014 CFR
2014-04-01
... Expulsion of Exchange Members § 240.19d-1 Notices by self-regulatory organizations of final disciplinary... services, and summary suspensions. (a) General. If any self-regulatory organization for which the...) of the Act, concerning an action subject to such section taken by a self-regulatory organization for...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64841; File No. SR-FINRA-2011-032] Self... self-regulatory organization under Section 19(b)(3)(A)(iii) of the Act \\3\\ and Rule 19b-4(f)(3...(f)(3). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule...
75 FR 8489 - Security Zone; Freeport Channel Entrance, Freeport, TX
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-25
... rulemaking (33 FR 19923). Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or... of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-09
... revisions include multiple modifications to Georgia's Air Quality Rules found at Chapter 391-3-1. These...: Ms. Lynorae Benjamin, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics...-8960. The telephone number is (404) 562-9042. Ms. Harder can also be reached via electronic mail at...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-07
... Cabell and Wayne Counties in their entireties and a portion of Mason County (Graham Tax District) in West... reasonable further progress (RFP) plan, contingency measures, and other planning State Implementation Plan... Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S...
The U.S. Environmental Protection Agency's (EPA) authority for enhanced monitoring activities is provided for in Title I, Section 182 of the Clean Air Act Amendment of 1990. or example, the Photochemical Assessment Monitoring Station (PAMS) network is one such program which requi...
Advancing Vocational Education Through Research and Development.
ERIC Educational Resources Information Center
Bureau of Occupational and Adult Education (DHEW/OE), Washington, DC. Div. of Research and Demonstration.
This report contains information about the legislative and regulatory framework for Section 131 (a) of part C of the U.S. Commissioner of Education's Vocational Education Research Programs; the planning and its procedures leading to the determination of the program priority areas for fiscal year 1976 and the transition quarter; the processes used…
Transcriptional regulatory elements in the noncoding region of human papillomavirus type 6
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wu, Tzyy-Choou.
1989-01-01
The structure and function of the transcriptional regulatory region of human papillomavirus type 6 (HPV-6) has been investigated. To investigate tissue specific gene expression, a sensitive method to detect and localize HPV-6 viral DNA, mRNA and protein in plastic-embedded tissue sections of genital and respiratory tract papillomata by using in situ hybridization and immunoperoxidase assays has been developed. This method, using ultrathin sections and strand-specific {sup 3}H labeled riboprobes, offers the advantages of superior morphological preservation and detection of viral genomes at low copy number with good resolution, and the modified immunocytochemistry provides better sensitivity. The results suggest that genitalmore » tract epithelium is more permissive for HPV-6 replication than respiratory tract epithelium. To study the tissue tropism of HPV-6 at the level of regulation of viral gene expression, the polymerase chain reaction was used to isolate the noncoding region (NCR) of HPV-6 in independent isolates. Nucleotide sequence analysis of molecularly cloned DNA identified base substitutions, deletions/insertions and tandem duplications. Transcriptional regulatory elements in the NCR were assayed in recombinant plasmids containing the bacterial gene for chloramphenicol acetyl transferase.« less
Common Carrier Access to Cable Communications: Regulatory and Economic Issues.
ERIC Educational Resources Information Center
Kestenbaum, Lionel
The implications of cable television (CATV) common carrier access and economic and regulatory issues associated with it are examined in this paper. The first section provides a discussion of the feasibility and legal basis of common carrier access; the next section contrasts common carrier access with existing over-the-air television broadcasting…
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Definitions. 7.2 Section 7.2 Energy NUCLEAR REGULATORY...). Commission means the Nuclear Regulatory Commission of five members, or a quorum thereof, sitting as a body, as provided by section 201 of the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Definitions. 13.2 Section 13.2 Energy NUCLEAR REGULATORY... to 5 U.S.C. 3344. Authority means the Nuclear Regulatory Commission. Authority head means the Commission of five members or a quorum thereof sitting as a body, as provided by section 201 of the Energy...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Definitions. 7.2 Section 7.2 Energy NUCLEAR REGULATORY...). Commission means the Nuclear Regulatory Commission of five members, or a quorum thereof, sitting as a body, as provided by section 201 of the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Definitions. 7.2 Section 7.2 Energy NUCLEAR REGULATORY...). Commission means the Nuclear Regulatory Commission of five members, or a quorum thereof, sitting as a body, as provided by section 201 of the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242...
75 FR 41931 - Assessment and Collection of Regulatory Fees for Fiscal Year 2010
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-19
... Communications Act of 1934, as amended (the Act). These fees are mandated by Congress and are collected to... 2010, pursuant to section 9 of the Communications Act of 1934, as amended (the ``Act''). Section 9... allocation between submarine cable and satellite/ terrestrial for the bearer circuit regulatory fees for 2010...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-08
... eliminate references in Sections E.1 and E.8 to ``Derivative Securities Products'' (``DSPs'') and ``Non-Derivative Securities Products'' (``Non-DSPs'') and to eliminate references in Section E.1 to ``Regular... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69903; File No. SR-CHX-2013-12] Self-Regulatory...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Definitions. 7.2 Section 7.2 Energy NUCLEAR REGULATORY...). Commission means the Nuclear Regulatory Commission of five members, or a quorum thereof, sitting as a body, as provided by section 201 of the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Definitions. 7.2 Section 7.2 Energy NUCLEAR REGULATORY...). Commission means the Nuclear Regulatory Commission of five members, or a quorum thereof, sitting as a body, as provided by section 201 of the Energy Reorganization Act of 1974, 42 U.S.C. 5841, (88 Stat. 1242...
Drug-device combination products: regulatory landscape and market growth.
Bayarri, L
2015-08-01
Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.
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 contains...
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 will...
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) Initial...
A broad-group cross-section library based on ENDF/B-VII.0 for fast neutron dosimetry Applications
DOE Office of Scientific and Technical Information (OSTI.GOV)
Alpan, F.A.
2011-07-01
A new ENDF/B-VII.0-based coupled 44-neutron, 20-gamma-ray-group cross-section library was developed to investigate the latest evaluated nuclear data file (ENDF) ,in comparison to ENDF/B-VI.3 used in BUGLE-96, as well as to generate an objective-specific library. The objectives selected for this work consisted of dosimetry calculations for in-vessel and ex-vessel reactor locations, iron atom displacement calculations for reactor internals and pressure vessel, and {sup 58}Ni(n,{gamma}) calculation that is important for gas generation in the baffle plate. The new library was generated based on the contribution and point-wise cross-section-driven (CPXSD) methodology and was applied to one of the most widely used benchmarks, themore » Oak Ridge National Laboratory Pool Critical Assembly benchmark problem. In addition to the new library, BUGLE-96 and an ENDF/B-VII.0-based coupled 47-neutron, 20-gamma-ray-group cross-section library was generated and used with both SNLRML and IRDF dosimetry cross sections to compute reaction rates. All reaction rates computed by the multigroup libraries are within {+-} 20 % of measurement data and meet the U. S. Nuclear Regulatory Commission acceptance criterion for reactor vessel neutron exposure evaluations specified in Regulatory Guide 1.190. (authors)« less
Code of Federal Regulations, 2013 CFR
2013-04-01
... 17 Commodity and Securities Exchanges 3 2013-04-01 2013-04-01 false Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any...
17 CFR 240.19b-4 - Filings with respect to proposed rule changes by self-regulatory organizations.
Code of Federal Regulations, 2010 CFR
2010-04-01
... proposed rule changes by self-regulatory organizations. 240.19b-4 Section 240.19b-4 Commodity and... organizations. Preliminary Note: A self-regulatory organization also must refer to Form 19b-4 (17 CFR 249.819... to proposed rule changes by a self-regulatory organization, except filings with respect to proposed...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-04
... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 17 Commodity and Securities Exchanges 3 2012-04-01 2012-04-01 false Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any...
17 CFR 240.19b-4 - Filings with respect to proposed rule changes by self-regulatory organizations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... proposed rule changes by self-regulatory organizations. 240.19b-4 Section 240.19b-4 Commodity and... organizations. Preliminary Note: A self-regulatory organization also must refer to Form 19b-4 (17 CFR 249.819... to proposed rule changes by a self-regulatory organization, except filings with respect to proposed...
17 CFR 240.19b-4 - Filings with respect to proposed rule changes by self-regulatory organizations.
Code of Federal Regulations, 2012 CFR
2012-04-01
... proposed rule changes by self-regulatory organizations. 240.19b-4 Section 240.19b-4 Commodity and... organizations. Preliminary Note: A self-regulatory organization also must refer to Form 19b-4 (17 CFR 249.819... respect to proposed rule changes by a self-regulatory organization, except filings with respect to...
Code of Federal Regulations, 2011 CFR
2011-01-01
... its own behalf before a transportation regulatory body proceeding? 102-117.325 Section 102-117.325... Regulatory Body Proceedings § 102-117.325 May my agency appear on its own behalf before a transportation regulatory body proceeding? Generally, no executive agency may appear on its own behalf in any proceeding...
Code of Federal Regulations, 2010 CFR
2010-07-01
... its own behalf before a transportation regulatory body proceeding? 102-117.325 Section 102-117.325... Regulatory Body Proceedings § 102-117.325 May my agency appear on its own behalf before a transportation regulatory body proceeding? Generally, no executive agency may appear on its own behalf in any proceeding...
47 CFR 101.1411 - Regulatory status and eligibility.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status and eligibility. 101.1411 Section 101.1411 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... GHz Band § 101.1411 Regulatory status and eligibility. (a) MVDDS licensees are permitted to provide...
47 CFR 101.1411 - Regulatory status and eligibility.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 5 2011-10-01 2011-10-01 false Regulatory status and eligibility. 101.1411 Section 101.1411 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO... GHz Band § 101.1411 Regulatory status and eligibility. (a) MVDDS licensees are permitted to provide...
12 CFR 1263.15 - Recent merger or acquisition applicants.
Code of Federal Regulations, 2014 CFR
2014-01-01
... section. (a) Financial condition requirement—(1) Regulatory financial reports. For purposes of § 1263.11(a... its application for membership, has not yet filed regulatory financial reports with its appropriate... regulatory financial reports that the applicant has filed with its appropriate regulator. (2) Performance...
12 CFR 1263.15 - Recent merger or acquisition applicants.
Code of Federal Regulations, 2013 CFR
2013-01-01
... section. (a) Financial condition requirement—(1) Regulatory financial reports. For purposes of § 1263.11(a... its application for membership, has not yet filed regulatory financial reports with its appropriate... regulatory financial reports that the applicant has filed with its appropriate regulator. (2) Performance...
12 CFR 1263.15 - Recent merger or acquisition applicants.
Code of Federal Regulations, 2011 CFR
2011-01-01
... section. (a) Financial condition requirement—(1) Regulatory financial reports. For purposes of § 1263.11(a... its application for membership, has not yet filed regulatory financial reports with its appropriate... regulatory financial reports that the applicant has filed with its appropriate regulator. (2) Performance...
12 CFR 1263.15 - Recent merger or acquisition applicants.
Code of Federal Regulations, 2012 CFR
2012-01-01
... section. (a) Financial condition requirement—(1) Regulatory financial reports. For purposes of § 1263.11(a... its application for membership, has not yet filed regulatory financial reports with its appropriate... regulatory financial reports that the applicant has filed with its appropriate regulator. (2) Performance...
31 CFR 132.7 - Regulatory enforcement.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 31 Money and Finance: Treasury 1 2014-07-01 2014-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance MONETARY OFFICES, DEPARTMENT OF THE TREASURY PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory...
31 CFR 132.7 - Regulatory enforcement.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 31 Money and Finance: Treasury 1 2013-07-01 2013-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance MONETARY OFFICES, DEPARTMENT OF THE TREASURY PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory...
31 CFR 132.7 - Regulatory enforcement.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 31 Money and Finance: Treasury 1 2012-07-01 2012-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance MONETARY OFFICES, DEPARTMENT OF THE TREASURY PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory...
76 FR 31507 - Domestic Licensing of Source Material-Amendments/Integrated Safety Analysis
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-01
... Licensing of Source Material--Amendments/Integrated Safety Analysis AGENCY: Nuclear Regulatory Commission... rule announced the availability of a draft regulatory analysis for public comment. This document... in Section XI, ``Regulatory Analysis.'' The correct ADAMS accession number is ML102380243. DATES: The...
47 CFR 90.1309 - Regulatory status.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 5 2011-10-01 2011-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory status...
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 status...
21 CFR 26.18 - Regulatory collaboration.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...
31 CFR 132.7 - Regulatory enforcement.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 31 Money and Finance: Treasury 1 2011-07-01 2011-07-01 false Regulatory enforcement. 132.7 Section 132.7 Money and Finance: Treasury Regulations Relating to Money and Finance MONETARY OFFICES, DEPARTMENT OF THE TREASURY PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING § 132.7 Regulatory...
10 CFR 76.60 - Regulatory requirements which apply.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Regulatory requirements which apply. 76.60 Section 76.60 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification... requirements for certification of the Corporation for operation of the gaseous diffusion plants: (a) The...
10 CFR 76.60 - Regulatory requirements which apply.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Regulatory requirements which apply. 76.60 Section 76.60 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification... requirements for certification of the Corporation for operation of the gaseous diffusion plants: (a) The...
10 CFR 76.60 - Regulatory requirements which apply.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Regulatory requirements which apply. 76.60 Section 76.60 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification... requirements for certification of the Corporation for operation of the gaseous diffusion plants: (a) The...
10 CFR 76.60 - Regulatory requirements which apply.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Regulatory requirements which apply. 76.60 Section 76.60 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification... requirements for certification of the Corporation for operation of the gaseous diffusion plants: (a) The...
10 CFR 76.60 - Regulatory requirements which apply.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Regulatory requirements which apply. 76.60 Section 76.60 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification... requirements for certification of the Corporation for operation of the gaseous diffusion plants: (a) The...
49 CFR 389.5 - Regulatory docket.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Regulatory docket. 389.5 Section 389.5...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS General § 389.5 Regulatory docket. (a) Information and data... § 389.25; and final rules are maintained at headquarters, Federal Motor Carrier Safety Administration...
49 CFR 389.5 - Regulatory docket.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory docket. 389.5 Section 389.5...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS General § 389.5 Regulatory docket. (a) Information and data... § 389.25; and final rules are maintained at headquarters, Federal Motor Carrier Safety Administration...
76 FR 46652 - Retail Foreign Exchange Transactions (Regulation NN)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-03
... Federal regulatory agency shall prescribe \\6\\ (a ``retail forex rule''). Section 2(c)(2)(B)(i)(I) includes... Exchange Act of 1934 (15 U.S.C. 78f(a)).'' \\7\\ A Federal regulatory agency's retail forex rule must treat... retail forex statutory provisions will be the section where the provisions will be codified in the...
18 CFR 284.263 - Exemption from section 7 of Natural Gas Act and certain regulatory conditions.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 7 of Natural Gas Act and certain regulatory conditions. 284.263 Section 284.263 Conservation of... UNDER THE NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES CERTAIN SALES AND TRANSPORTATION OF NATURAL GAS UNDER THE NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES Emergency Natural Gas Sale...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-04
... commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act...\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price discovery contracts (``SPDCs...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act''), performs a...\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price discovery contracts (``SPDCs...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-04
... commercial market (``ECM'') under Section 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act... (``Reauthorization Act'') \\2\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
18 CFR 284.263 - Exemption from section 7 of Natural Gas Act and certain regulatory conditions.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 7 of Natural Gas Act and certain regulatory conditions. 284.263 Section 284.263 Conservation of... UNDER THE NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES CERTAIN SALES AND TRANSPORTATION OF NATURAL GAS UNDER THE NATURAL GAS POLICY ACT OF 1978 AND RELATED AUTHORITIES Emergency Natural Gas Sale...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-21
... Extend the Penny Pilot Program December 15, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange... Chapter V, Section 33 (Penny Pilot Program) of the Rules of the Boston Options Exchange Group, LLC (``BOX... penny increments on BOX (``Penny Pilot Program''). II. Self-Regulatory Organization's Statement of the...
12 CFR 233.7 - Regulatory enforcement.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory...
12 CFR 233.7 - Regulatory enforcement.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory...
12 CFR 233.7 - Regulatory enforcement.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Regulatory enforcement. 233.7 Section 233.7 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) PROHIBITION ON FUNDING OF UNLAWFUL INTERNET GAMBLING (REGULATION GG) § 233.7 Regulatory...
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. The...
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. The...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Communications. 9.6 Section 9.6 Energy NUCLEAR REGULATORY... the NRC by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by.... Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Communications. 9.6 Section 9.6 Energy NUCLEAR REGULATORY... the NRC by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by.... Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Communications. 9.6 Section 9.6 Energy NUCLEAR REGULATORY... the NRC by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by.... Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the...
5 CFR 1320.15 - Independent regulatory agency override authority.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Independent regulatory agency override authority. 1320.15 Section 1320.15 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET OMB DIRECTIVES CONTROLLING PAPERWORK BURDENS ON THE PUBLIC § 1320.15 Independent regulatory agency override authority. (a) An...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Communications. 9.6 Section 9.6 Energy NUCLEAR REGULATORY... the NRC by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by.... Nuclear Regulatory Commission, Washington, DC 20555-0001.The guidance discusses, among other topics, the...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Communications. 9.6 Section 9.6 Energy NUCLEAR REGULATORY... the NRC by mail addressed to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by.... Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the...
Leak-Before-Break: Further developments in regulatory policies and supporting research
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wilkowski, G.M.; Chao, K.-S.
1990-02-01
The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A papermore » by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately.« less
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-16
... at non-powered dams and closed-loop pumped storage projects in compliance with section 6 of the... process for licensing hydropower development at non-powered dams and closed-loop pumped storage projects...-powered dam versus closed- loop pumped storage) affect the steps included in a two-year process? 3.9...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-17
... all operations conducted under a lease. Operations in the OCS must preserve, protect, and develop oil.... Section 1332(6) states that ``operations in the [O]uter Continental Shelf should be conducted in a safe... deal with regulatory requirements of oil, gas, and sulphur operations on the OCS. This request also...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Woods, T.W.
1991-09-01
This report is volume 3, part B, of the program to satisfy the allocated requirements of the Office of Civilian Radioactive Waste Management Program, in the development of the nuclear waste management system. The report is divided into the following sections: regulatory compliance; external relations; international programs; strategic and contingency planning; contract business management; and administrative services. (CS)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-14
.... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...). II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed... self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the...
Code of Federal Regulations, 2011 CFR
2011-01-01
... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...
Code of Federal Regulations, 2010 CFR
2010-07-01
... for a delegation to represent itself in a regulatory body proceeding? 102-117.335 Section 102-117.335... Regulatory Body Proceedings § 102-117.335 How does my agency ask for a delegation to represent itself in a regulatory body proceeding? You must send your request for delegation with enough detail to explain the...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Rosengrant, L.; Craig, R.
1989-11-01
The background document presents the technical support and rationale for developing regulatory standards for K031, K084, K101, K102, D004, D010 and P and U wastes. Section 1 presents available data regarding the industries affected by the land disposal restriction, brief descriptions of the waste-generating processes, and waste characterization data. Section 2 discusses the technologies used to treat the wastes; Section 3 presents available treatment performance data; Section explains EPA's determination of BDAT; Section 5 discusses the selection of constituents to be regulated; and Section 6 determines the proposed treatment standards.
Thudium, Karen; Bilic, Sanela; Leipold, Douglas; Mallet, William; Kaur, Surinder; Meibohm, Bernd; Erickson, Hans; Tibbitts, Jay; Zhao, Hong; Gupta, Manish
2013-01-01
The American Association of Pharmaceutical Scientists (AAPS) National Biotechnology Conference Short Course "Translational Challenges in Developing Antibody-Drug Conjugates (ADCs)," held May 24, 2012 in San Diego, CA, was organized by members of the Pharmacokinetics, Pharmacodynamics and Drug Metabolism section of AAPS. Representatives from the pharmaceutical industry, regulatory authorities, and academia in the US and Europe attended this short course to discuss the translational challenges in ADC development and the importance of characterizing these molecules early in development to achieve therapeutic utility in patients. Other areas of discussion included selection of target antigens; characterization of absorption, distribution, metabolism, and excretion; assay development and hot topics like regulatory perspectives and the role of pharmacometrics in ADC development. MUC16-targeted ADCs were discussed to illustrate challenges in preclinical development; experiences with trastuzumab emtansine (T-DM1; Genentech) and the recently approved brentuximab vedotin (Adcetris; Seattle Genetics) were presented in depth to demonstrate considerations in clinical development. The views expressed in this report are those of the participants and do not necessarily represent those of their affiliations.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-10
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Options Regulatory Fee March 3, 2010. Pursuant to Section... 23, 2010, Chicago Board Options Exchange, Incorporated (``CBOE'' or the ``Exchange'') filed with the...
30 CFR 917.13 - State statutory and regulatory provisions set aside.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 3 2011-07-01 2011-07-01 false State statutory and regulatory provisions set aside. 917.13 Section 917.13 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT... § 917.13 State statutory and regulatory provisions set aside. (a) The following provision of Kentucky...
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 to...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-18
...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... part of the SUPPLEMENTARY INFORMATION section below. Write ``kidSAFE Application for Safe Harbor...
47 CFR 1.1165 - Payment by cashier's check for regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 1 2010-10-01 2010-10-01 false Payment by cashier's check for regulatory fees. 1.1165 Section 1.1165 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... regulatory fees. Payment by cashier's check may be required when a person or organization makes payment, on...
77 FR 21866 - Safety Zone; Sunken Vessel, Puget Sound, Everett, WA
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-12
... significant regulatory action due to being limited in size and duration. Small Entities Under the Regulatory... impact on a substantial number of small entities. The term ``small entities'' comprises small businesses... duration. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-13
... the Regulatory Flexibility Act (5 U.S.C. 602), the Department of Defense's printed agenda entries... section 610 of the Regulatory Flexibility Act. Printing of these entries is limited to fields that contain...D Intelligence Interrogations, Detainee Debriefings, and Tactical Questioning. This rule only...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act''), performs a...\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price discovery contracts (``SPDCs...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-02
... exempt commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or... (``Reauthorization Act'') \\4\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act''), performs a... (``Reauthorization Act'') \\2\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act''), performs a... (``Reauthorization Act'') \\2\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-21
...''), an exempt commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA... (``Reauthorization Act'') \\5\\ significantly broadened the CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-02
... market (``ECM'') under sections 2(h)(3)-(5) of the Commodity Exchange Act (``CEA'' or the ``Act... CFTC's regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price discovery contracts (``SPDCs'') are traded--and treating...
17 CFR 41.3 - Application for an exemptive order pursuant to section 4f(a)(4)(B) of the Act.
Code of Federal Regulations, 2010 CFR
2010-04-01
... member of the National Association of Securities Dealers, Inc.) or equivalent self-regulatory... self-regulatory organization may submit an application for an order pursuant to this section on behalf... exemption; (4) Any provision(s) of the securities laws or rules, or of the rules of a securities self...
The Regulatory Evaluation of Vaccines for Human Use.
Baylor, Norman W
2016-01-01
A vaccine is an immunogen, the administration of which is intended to stimulate the immune system to result in the prevention, amelioration, or therapy of any disease or infection (US Food and Drug Administration. Guidance for Industry: content and format of chemistry, manufacturing, and controls information and establishment description information for a vaccine or related product). A vaccine may be a live attenuated preparation of microorganisms, inactivated (killed) whole organisms, living irradiated cells, crude fractions, or purified immunogens, including those derived from recombinant DNA in a host cell, conjugates formed by covalent linkage of components, synthetic antigens, polynucleotides (such as the plasmid DNA vaccines), living vectored cells expressing specific heterologous immunogens, or cells pulsed with immunogen. Vaccines are highly complex products that differ from small molecule drugs because of the biological nature of the source materials such as those derived from microorganisms as well as the various cell substrates from which some are derived. Regardless of the technology used, because of their complexities, vaccines must undergo extensive characterization and testing. Special expertise and procedures are needed for their manufacture, control, and regulation. The Food and Drug Administration (FDA) is the National Regulatory Authority (NRA) in the United States responsible for assuring quality, safety, and effectiveness of all human medical products, including vaccines for human use.The Center for Biologics Evaluation and Research (CBER) within the US FDA is responsible for overseeing the regulation of therapeutic and preventative vaccines against infectious diseases. Authority for the regulation of vaccines resides in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug, and Cosmetic Act (FD&C). Vaccines are regulated as biologics and licensed based on the demonstration of safety and effectiveness. The vaccine development process can be divided into two major categories: those events that are not under the regulatory authority of the FDA and are exploratory in nature and those events that are subject to regulatory authority by the FDA. Exploratory events or research and development cover basic research drug discovery processes that occur before the sponsor submits an investigational new drug application (IND) to the FDA. There are four main stages of vaccine development under the purview of regulatory authorities: preclinical, clinical (IND), licensing, and post-licensure. Throughout their life cycle from preclinical evaluation to post-licensure lot release testing, vaccines are subject to rigorous testing and oversight by manufacturers and NRAs. In this chapter an overview of the regulatory evaluation and testing requirements for vaccines is presented.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Criteria for and identification of licensing and regulatory actions requiring environmental impact statements. 51.20 Section 51.20 Energy NUCLEAR REGULATORY... the Commission, in the exercise of its discretion, has determined should be covered by an...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-18
... Schedule of Timeframes, and Fee Structure in the GSD Rules. II. Self-Regulatory Organization's Statement of...-Regulatory Organizations; The Fixed Income Clearing Corporation; Notice of Filing and Immediate Effectiveness... Timeframes, and Fee Structure in the GSD Rules October 12, 2011. Pursuant to Section 19(b)(1) of the...
17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.
Code of Federal Regulations, 2010 CFR
2010-04-01
... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...
17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.
Code of Federal Regulations, 2012 CFR
2012-04-01
... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...
17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.
Code of Federal Regulations, 2014 CFR
2014-04-01
... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...
17 CFR 240.19b-5 - Temporary exemption from the filing requirements of Section 19(b) of the Act.
Code of Federal Regulations, 2013 CFR
2013-04-01
... filing requirement for self-regulatory organizations that file proposed rule changes concerning the... other requirements under the Act that are applicable to self-regulatory organizations continue to apply... term specialist means any member subject to a requirement of a self-regulatory organization that such...
17 CFR 240.19b-5 - Temporary exemption from the filing requirements of Section 19(b) of the Act.
Code of Federal Regulations, 2010 CFR
2010-04-01
... filing requirement for self-regulatory organizations that file proposed rule changes concerning the... other requirements under the Act that are applicable to self-regulatory organizations continue to apply... term specialist means any member subject to a requirement of a self-regulatory organization that such...
17 CFR 240.19b-5 - Temporary exemption from the filing requirements of Section 19(b) of the Act.
Code of Federal Regulations, 2014 CFR
2014-04-01
... filing requirement for self-regulatory organizations that file proposed rule changes concerning the... other requirements under the Act that are applicable to self-regulatory organizations continue to apply... term specialist means any member subject to a requirement of a self-regulatory organization that such...
17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...
17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.
Code of Federal Regulations, 2013 CFR
2013-04-01
... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...
17 CFR 240.19b-5 - Temporary exemption from the filing requirements of Section 19(b) of the Act.
Code of Federal Regulations, 2012 CFR
2012-04-01
... filing requirement for self-regulatory organizations that file proposed rule changes concerning the... other requirements under the Act that are applicable to self-regulatory organizations continue to apply... term specialist means any member subject to a requirement of a self-regulatory organization that such...
17 CFR 240.19b-5 - Temporary exemption from the filing requirements of Section 19(b) of the Act.
Code of Federal Regulations, 2011 CFR
2011-04-01
... filing requirement for self-regulatory organizations that file proposed rule changes concerning the... other requirements under the Act that are applicable to self-regulatory organizations continue to apply... term specialist means any member subject to a requirement of a self-regulatory organization that such...
17 CFR 240.15b2-2 - Inspection of newly registered brokers and dealers.
Code of Federal Regulations, 2010 CFR
2010-04-01
... section 15C(b)(1) of the Act. (b) Each self-regulatory organization that has responsibility for examining... conformity with applicable financial responsibility rules. (c) The examining self-regulatory organization is... examining self-regulatory organization determines that a broker or dealer member has not commenced actual...
21 CFR 60.28 - Time frame for determining regulatory review periods.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Time frame for determining regulatory review periods. 60.28 Section 60.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Regulatory Review Period Determinations § 60.28 Time frame for...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-14
...-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change In...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify the CBOE Fees Schedule March 8, 2011. Pursuant to Section 19(b...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-13
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66528; File No. SR-FINRA-2012-014] Self... Requirements for Credit Default Swaps) March 7, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange..., 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-22
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63319; File No. SR-FINRA-2010-060] Self... Changes to Certain FINRA Rules November 16, 2010. Pursuant to Section 19(b)(1) of the Securities Exchange..., 2010, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange...
Code of Federal Regulations, 2011 CFR
2011-01-01
... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-08
...-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate... Fee to a Flat Fee June 3, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934.... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The...
9 CFR 124.22 - Revision of regulatory review period determination.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...
9 CFR 124.22 - Revision of regulatory review period determination.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...
9 CFR 124.22 - Revision of regulatory review period determination.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...
9 CFR 124.22 - Revision of regulatory review period determination.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PATENT TERM RESTORATION Regulatory Review...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Criteria for and identification of licensing and regulatory actions requiring environmental impact statements. 51.20 Section 51.20 Energy NUCLEAR REGULATORY... radioactive waste in a monitored retrievable storage installation (MRS). (10) Issuance of a license for a...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...
5 CFR 1315.19 - Regulatory references to OMB Circular A-125.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Regulatory references to OMB Circular A-125. 1315.19 Section 1315.19 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET OMB DIRECTIVES PROMPT PAYMENT § 1315.19 Regulatory references to OMB Circular A-125. This part supercedes OMB Circular A...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-27
... Activity Fee (``TAF'').\\4\\ Under FINRA trade reporting rules, certain transactions and transfers are not... from its membership in accordance with Section 3. \\4\\ The TAF is one of the member regulatory fees... and policymaking, rulemaking and enforcement activities. Among others, the TAF is assessed for the...
47 CFR 1.1155 - Schedule of regulatory fees and filing locations for cable television services.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 1 2010-10-01 2010-10-01 false Schedule of regulatory fees and filing locations for cable television services. 1.1155 Section 1.1155 Telecommunication FEDERAL COMMUNICATIONS... Schedule of regulatory fees and filing locations for cable television services. Fee amount Address 1. Cable...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Persons using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission contracts. 70.11 Section 70.11 Energy NUCLEAR... using special nuclear material under certain Department of Energy and Nuclear Regulatory Commission...
Code of Federal Regulations, 2010 CFR
2010-07-01
... assistance may GSA provide agencies in dealing with regulatory bodies? 102-117.340 Section 102-117.340 Public... MANAGEMENT REGULATION TRANSPORTATION 117-TRANSPORTATION MANAGEMENT Representation Before Regulatory Body... bodies? (a) GSA has oversight of all public utilities used by the Federal Government including...
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-11-01
The module explains the statutory and regulatory definitions of solid waste, including the standards governing the recycling and management of specific types of wastes. It lists and cites three use/reuse scenarios where the materials are not solid wastes and states the requirements for documentation. It lists examples of sham recycling and describes the conditions under which hazardous waste-derived products may be excluded from regulation. It cites the provisions for precious metal recovery and discusses potential regulatory developments affecting the definition of solid waste and hazardous waste recycling.
18 CFR 2.76 - Regulatory treatment of payments made in lieu of take-or-pay obligations.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Regulatory treatment of payments made in lieu of take-or-pay obligations. 2.76 Section 2.76 Conservation of Power and Water... violation of section 504(a) of the NGPA. (b) Recovery in rates. A pipeline that makes any payments referred...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-13
...-Regulatory Organizations; the NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change To Adopt... Proposed Rule Change The Exchange proposes to adopt a new Chapter V, Section 3(d)(iii) to provide for how... 1. Purpose The Exchange proposes to adopt Chapter V, Section 3(d)(iii) \\3\\ to provide for how the...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-21
...Exchange, Inc. (``ICE''), an exempt commercial market (``ECM'') under sections 2(h)(3)-(5) of the Commodity... regulatory authority with respect to ECMs by creating, in section 2(h)(7) of the CEA, a new regulatory category--ECMs on which significant price discovery contracts (``SPDCs'') are traded--and treating ECMs in...
Pharmaceutical product development: A quality by design approach
Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed
2016-01-01
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256
Pharmaceutical product development: A quality by design approach.
Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed
2016-01-01
The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development.
Public Utility Commission manual for Section 210 of PURPA for Vermont
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981, and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations, analysis of the relationship between federal and state laws, analysis of Vermont's implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less
Public Utility Commission manual for Section 210 of PURPA for Montana
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981; and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations analysis of the relationship between federal and state laws, analysis of Montana's implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less
Public Utility Commission manual for Section 210 of PURPA for Arkansas
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Public Utility Regulatory Policies Act of 1978 (PURPA) places obligations on both electric utilities and state regulatory commissions. PURPA requires every electric utility to purchase all energy and capacity made available to it, by a qualifying facility, and to sell energy and capacity to a qualifying facility upon the qualifying facility's request. State regulatory commissions must implement and administer these utility obligations and other requirements that were implemented by the Federal Energy Regulatory Commission's (FERC) final rules, which became effective March 20, 1981; and must set fair rates for electric power purchases and sales between utilities and small powermore » producers. This manual provides a concise, annotated explanation of the final FERC rules, a description of federal and state statutory authorizations, court challenges to these authorizations, analysis of the relationship between federal and state laws, analysis of Arkansas' implementation of section 210 of PURPA and for comparison, annotations of selected state regulatory authority decisions.« less
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-11
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61647; File No. SR-MSRB-2010-01] Self... of the self- regulatory organization pursuant to Section 19(b)(3)(A)(i) of the Act,\\3\\ and Rule 19b-4...)(1). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-15
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63499; File No. SR-BX-2010-087] Self-Regulatory... Quote Management Procedures December 9, 2010. Pursuant to Section 19(b)(1) of the Securities Exchange...-4(f)(6). I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of... Information Outside of Nasdaq Market Hours February 16, 2010. Pursuant to Section 19(b)(1) of the Securities...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change Nasdaq proposes to...
47 CFR 1.1153 - Schedule of annual regulatory fees and filing locations for mass media services.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 47 Telecommunication 1 2012-10-01 2012-10-01 false Schedule of annual regulatory fees and filing locations for mass media services. 1.1153 Section 1.1153 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Payment § 1.1153 Schedule of annual regulatory fees and filing locations for mass media services. Fee...
47 CFR 1.1153 - Schedule of annual regulatory fees and filing locations for mass media services.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 47 Telecommunication 1 2014-10-01 2014-10-01 false Schedule of annual regulatory fees and filing locations for mass media services. 1.1153 Section 1.1153 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Payment § 1.1153 Schedule of annual regulatory fees and filing locations for mass media services. Radio...
47 CFR 1.1153 - Schedule of annual regulatory fees and filing locations for mass media services.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 1 2011-10-01 2011-10-01 false Schedule of annual regulatory fees and filing locations for mass media services. 1.1153 Section 1.1153 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... of annual regulatory fees and filing locations for mass media services. Radio [AM and FM] (47 CFR...
47 CFR 1.1153 - Schedule of annual regulatory fees and filing locations for mass media services.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 47 Telecommunication 1 2013-10-01 2013-10-01 false Schedule of annual regulatory fees and filing locations for mass media services. 1.1153 Section 1.1153 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... Payment § 1.1153 Schedule of annual regulatory fees and filing locations for mass media services. Radio...
47 CFR 1.1153 - Schedule of annual regulatory fees and filing locations for mass media services.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 1 2010-10-01 2010-10-01 false Schedule of annual regulatory fees and filing locations for mass media services. 1.1153 Section 1.1153 Telecommunication FEDERAL COMMUNICATIONS COMMISSION... of annual regulatory fees and filing locations for mass media services. Radio [AM and FM] (47 CFR...
Code of Federal Regulations, 2011 CFR
2011-04-01
... association, or self-regulatory organization as defined in section 3(a)(26) of the Securities Exchange Act of... by an official of a contract market, registered futures association or self-regulatory organization... association or self-regulatory organization official who is named in a list filed with the Commission by the...
Code of Federal Regulations, 2012 CFR
2012-04-01
... association, or self-regulatory organization as defined in section 3(a)(26) of the Securities Exchange Act of... by an official of a contract market, registered futures association or self-regulatory organization... association or self-regulatory organization official who is named in a list filed with the Commission by the...
Code of Federal Regulations, 2010 CFR
2010-04-01
... association, or self-regulatory organization as defined in section 3(a)(26) of the Securities Exchange Act of... by an official of a contract market, registered futures association or self-regulatory organization... association or self-regulatory organization official who is named in a list filed with the Commission by the...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-03
... Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule Change by NASDAQ OMX BX, Inc. To...-regulatory organization. The Exchange filed the proposed rule change pursuant to Section 19(b)(3)(A)(ii) of... purposes of the Act. C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change...
40 CFR 142.304 - For which of the regulatory requirements is a small system variance available?
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 23 2011-07-01 2011-07-01 false For which of the regulatory requirements is a small system variance available? 142.304 Section 142.304 Protection of Environment... REGULATIONS IMPLEMENTATION Variances for Small System General Provisions § 142.304 For which of the regulatory...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-17
... opportunities for price improvement. B. Self-Regulatory Organization's Statement on Burden on Competition C2... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66384; File No. SR-C2-2012-006] Self-Regulatory... Automated Improvement Mechanism February 13, 2012. Pursuant to Section 19(b)(1) of the Securities Exchange...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-01
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69853; File No. SR-ISE-2013-41] Self-Regulatory... Rule Change To Extend the Price Improvement Mechanism Pilot Program June 25, 2013. Pursuant to Section... described in Items I and II below, which items have been prepared by the self-regulatory organization. The...
77 FR 60420 - Notice of Petition for Enforcement
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-03
...)(2) of the Public Utility Regulatory Policies Act of 1978 (PURPA),\\1\\ Murphy Flat Energy LLC, Murphy... Federal Energy Regulatory Commission take enforcement action under section 210(h) of PURPA against the...
DOE Office of Scientific and Technical Information (OSTI.GOV)
O'Farrell, T.; Hund, F.
1986-12-01
The document presents the technical rationale for best conventional technology (BCI) effluent limitations guidelines for the pharmaceutical manufacturing point-source category as required by the Clean Water Act of 1977 (P.L. 95-217, the Act). The document describes the technologies considered as the bases for BCT limitations. Section II of this document summarizes the rulemaking process. Sections III through V describe the technical data and engineering analyses used to develop the regulatory technology options. The costs and removals associated with each technology option for each plant and the application of the BCT cost test methodology are presented in Section VI. BCI limitationsmore » bases on the best conventional pollutant control technology are to be achieved by existing direct-discharging facilities.« less
Biosimilars: a regulatory perspective from America
2011-01-01
Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US. PMID:21586106
Biosimilars: a regulatory perspective from America.
Kay, Jonathan
2011-05-12
Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Risner, J.M.; Wiarda, D.; Miller, T.M.
2011-07-01
The U.S. Nuclear Regulatory Commission's Regulatory Guide 1.190 states that calculational methods used to estimate reactor pressure vessel (RPV) fluence should use the latest version of the evaluated nuclear data file (ENDF). The VITAMIN-B6 fine-group library and BUGLE-96 broad-group library, which are widely used for RPV fluence calculations, were generated using ENDF/B-VI.3 data, which was the most current data when Regulatory Guide 1.190 was issued. We have developed new fine-group (VITAMIN-B7) and broad-group (BUGLE-B7) libraries based on ENDF/B-VII.0. These new libraries, which were processed using the AMPX code system, maintain the same group structures as the VITAMIN-B6 and BUGLE-96 libraries.more » Verification and validation of the new libraries were accomplished using diagnostic checks in AMPX, 'unit tests' for each element in VITAMIN-B7, and a diverse set of benchmark experiments including critical evaluations for fast and thermal systems, a set of experimental benchmarks that are used for SCALE regression tests, and three RPV fluence benchmarks. The benchmark evaluation results demonstrate that VITAMIN-B7 and BUGLE-B7 are appropriate for use in RPV fluence calculations and meet the calculational uncertainty criterion in Regulatory Guide 1.190. (authors)« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Risner, Joel M; Wiarda, Dorothea; Miller, Thomas Martin
2011-01-01
The U.S. Nuclear Regulatory Commission s Regulatory Guide 1.190 states that calculational methods used to estimate reactor pressure vessel (RPV) fluence should use the latest version of the Evaluated Nuclear Data File (ENDF). The VITAMIN-B6 fine-group library and BUGLE-96 broad-group library, which are widely used for RPV fluence calculations, were generated using ENDF/B-VI data, which was the most current data when Regulatory Guide 1.190 was issued. We have developed new fine-group (VITAMIN-B7) and broad-group (BUGLE-B7) libraries based on ENDF/B-VII. These new libraries, which were processed using the AMPX code system, maintain the same group structures as the VITAMIN-B6 and BUGLE-96more » libraries. Verification and validation of the new libraries was accomplished using diagnostic checks in AMPX, unit tests for each element in VITAMIN-B7, and a diverse set of benchmark experiments including critical evaluations for fast and thermal systems, a set of experimental benchmarks that are used for SCALE regression tests, and three RPV fluence benchmarks. The benchmark evaluation results demonstrate that VITAMIN-B7 and BUGLE-B7 are appropriate for use in LWR shielding applications, and meet the calculational uncertainty criterion in Regulatory Guide 1.190.« less
Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S
2015-01-01
Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713
Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S
2015-10-01
Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.
Regulatory scientific advice in drug development: does company size make a difference?
Putzeist, Michelle; Gispen-De Wied, Christine C.; Hoes, Arno W.; Leufkens, Hubert G.
2010-01-01
Purpose To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. Methodology A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006–2008. Definition of company size was based on ranking by total revenues (Scrip’s Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). Results In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P < 0.001) and clinical questions less frequently than large companies (P = 0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P < 0.001). Conclusion The array of topics addressed in SA provides an interesting outlook on what industry considers to be still unresolved in drug development and worthwhile to discuss with regulators. Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development. PMID:21049297
Regulatory scientific advice in drug development: does company size make a difference?
Putzeist, Michelle; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G
2011-02-01
To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006-2008. Definition of company size was based on ranking by total revenues (Scrip's Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P < 0.001) and clinical questions less frequently than large companies (P = 0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P < 0.001). The array of topics addressed in SA provides an interesting outlook on what industry considers to be still unresolved in drug development and worthwhile to discuss with regulators. Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-14
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69071; File No. SR-BX-2013-020] Self-Regulatory... Amend Chapter V, Regulation of Trading on BX Options, Section 6, Obvious Errors March 7, 2013. Pursuant.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-03
... advance notice of the new Verification of Assets rule. \\8\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63383; File No. SR-FINRA-2010-062] Self... in SR-FINRA-2010-042 (Verification of Assets) November 29, 2010. Pursuant to Section 19(b)(1) of the...
Code of Federal Regulations, 2012 CFR
2012-04-01
... limitations of access to services imposed by self-regulatory organizations. 240.19d-3 Section 240.19d-3... services imposed by self-regulatory organizations. Applications to the Commission for review of any final... prohibition or limitation with respect to access to services offered by a self-regulatory organization or a...
Code of Federal Regulations, 2010 CFR
2010-04-01
... limitations of access to services imposed by self-regulatory organizations. 240.19d-3 Section 240.19d-3... services imposed by self-regulatory organizations. Applications to the Commission for review of any final... prohibition or limitation with respect to access to services offered by a self-regulatory organization or a...
Code of Federal Regulations, 2011 CFR
2011-04-01
... limitations of access to services imposed by self-regulatory organizations. 240.19d-3 Section 240.19d-3... services imposed by self-regulatory organizations. Applications to the Commission for review of any final... prohibition or limitation with respect to access to services offered by a self-regulatory organization or a...
Code of Federal Regulations, 2013 CFR
2013-04-01
... limitations of access to services imposed by self-regulatory organizations. 240.19d-3 Section 240.19d-3... services imposed by self-regulatory organizations. Applications to the Commission for review of any final... prohibition or limitation with respect to access to services offered by a self-regulatory organization or a...
Code of Federal Regulations, 2014 CFR
2014-04-01
... limitations of access to services imposed by self-regulatory organizations. 240.19d-3 Section 240.19d-3... services imposed by self-regulatory organizations. Applications to the Commission for review of any final... prohibition or limitation with respect to access to services offered by a self-regulatory organization or a...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-15
... To Increase the Options Regulatory Fee and To Revise the Circumstances Under Which NYSE Amex Options LLC Will Collect the Options Regulatory Fee November 8, 2012. Pursuant to Section 19(b)(1) \\1\\ of the... Terms of the Substance of the Proposed Rule Change The Exchange proposes to amend the NYSE Amex Options...
Code of Federal Regulations, 2014 CFR
2014-10-01
... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Policy. 2001.301 Section 2001.301 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Agency Acquisition Regulations 2001.301 Policy. Policy...
Code of Federal Regulations, 2012 CFR
2012-10-01
... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Policy. 2001.301 Section 2001.301 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Agency Acquisition Regulations 2001.301 Policy. Policy...
Code of Federal Regulations, 2010 CFR
2010-10-01
... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Policy. 2001.301 Section 2001.301 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Agency Acquisition Regulations 2001.301 Policy. Policy...
26 CFR 1.611-0 - Regulatory authority.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) INCOME TAXES (CONTINUED) Natural Resources § 1.611-0 Regulatory authority. Sections 1.611-1 through 1.614... of mines, oil and gas wells, other natural deposits and timber. [T.D. 6965, 33 FR 10692, July 26...
26 CFR 1.611-0 - Regulatory authority.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) INCOME TAXES (CONTINUED) Natural Resources § 1.611-0 Regulatory authority. Sections 1.611-1 through 1.614... of mines, oil and gas wells, other natural deposits and timber. [T.D. 6965, 33 FR 10692, July 26...
Applications of pharmacogenomics in regulatory science: a product life cycle review.
Tan-Koi, W C; Leow, P C; Teo, Y Y
2018-05-22
With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-15
... (Front Running of Block Transactions) May 9, 2013. Pursuant to Section 19(b)(1) of the Securities... of FINRA Rule 5270 (Front Running of Block Transactions) that the Commission approved on September 4...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-25
... duplicates the requirement in Section 22(d) of the Investment Company Act to sell mutual fund shares to... requiring the deposit of sufficient funds within the specified payment period. FINRA also stated that the...
Medical Writing Competency Model - Section 2: Knowledge, Skills, Abilities, and Behaviors.
Clemow, David B; Wagner, Bertil; Marshallsay, Christopher; Benau, Dan; L'Heureux, Darryl; Brown, David H; Dasgupta, Devjani Ghosh; Girten, Eileen; Hubbard, Frank; Gawrylewski, Helle-Mai; Ebina, Hiroko; Stoltenborg, Janet; York, J P; Green, Kim; Wood, Linda Fossati; Toth, Lisa; Mihm, Michael; Katz, Nancy R; Vasconcelos, Nina-Maria; Sakiyama, Norihisa; Whitsell, Robin; Gopalakrishnan, Shobha; Bairnsfather, Susan; Wanderer, Tatyana; Schindler, Thomas M; Mikyas, Yeshi; Aoyama, Yumiko
2018-01-01
This article provides Section 2 of the 2017 Edition 2 Medical Writing Competency Model that describes the knowledge, skills, abilities, and behaviors that professional medical writers need in order to perform effectively within the life sciences industry. What a medical writer should know, what they should be able to do, and how they should use this knowledge and these skills to facilitate their primary work function is a focus. Regulatory, publication, and other scientific writing as well as management of writing activities are covered. The full Model also includes Section 1, which covers the core work functions and associated tasks and activities related to professional medical writing within the life sciences industry; Section 1 is included in a companion article. The Model was developed to aid medical writers and managers within the life sciences industry regarding medical writing hiring, training, expectation and goal setting, performance evaluation, career development, retention, and role value sharing to cross-functional partners.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-09
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66081; File No. SR-OCC-2011-18] Self-Regulatory... Proposed Rule Change Relating to DCO 60 Day Regulations January 3, 2012. Pursuant to Section 19(b)(1) of... accelerated basis. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-11
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62655; File No. SR-FINRA-2010-042] Self... Change To Adopt FINRA Rule 4160 (Verification of Assets) August 5, 2010. Pursuant to Section 19(b)(1) of... rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...
Code of Federal Regulations, 2010 CFR
2010-04-01
... CLASS II GAMES § 547.17 How does a tribal gaming regulatory authority apply for a variance from these... 25 Indians 2 2010-04-01 2010-04-01 false How does a tribal gaming regulatory authority apply for a variance from these standards? 547.17 Section 547.17 Indians NATIONAL INDIAN GAMING COMMISSION, DEPARTMENT...
41 CFR 102-2.115 - What kinds of non-regulatory material does GSA publish outside of the FMR?
Code of Federal Regulations, 2010 CFR
2010-07-01
... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What kinds of non-regulatory material does GSA publish outside of the FMR? 102-2.115 Section 102-2.115 Public Contracts and....115 What kinds of non-regulatory material does GSA publish outside of the FMR? As GSA converts the...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-06
... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61805; File No. SR-BX-2010-022] Self-Regulatory... Relating to the Price Improvement Period March 31, 2010. Pursuant to Section 19(b)(1) of the Securities... change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...
A Default Temporal Logic for Regulatory Conformance Checking
2008-04-01
proofs. In Section 4.3, we provide an axiomatization using Fitting’s sequent calculus [25]. Completeness is proved in Section 4.4. We conclude, in...axiomatize RefL. 4.3 Sequent Calculus We use Fitting’s sequent calculus [25]. A sequent is a statement of the form Γ → ∆, where Γ and ∆ are finite sets of...T.D., Vail, M.W., Anton , A.I.: Towards regulatory compliance: Extracting rights and obligations to align requirements with regulations. In
DOE Office of Scientific and Technical Information (OSTI.GOV)
Danziger, R.N.; Caples, P.W.; Huning, J.R.
1980-09-15
An analysis is made of the rules implementing Sections 201 and 210 of the Public Utility Regulatory Policies Act of 1978 (PURPA). The act provides that utilities must purchase power from qualifying producers of electricity at nondiscriminatory rates, and it exempts private generators from virtually all state and Federal utility regulations. Most of the analysis presented is taken from the perspective of photovoltaics (PV) and solar thermal electric point-focusing distributed receivers (pfdr). It is felt, however, that the analysis is applicable both to cogeneration and other emerging technologies. Chapters presented are: The FERC Response to Oral Comments on the Proposedmore » Rules Implementing Sections 201 and 210 of PURPA; Additional Changes Made or Not Made That Were Addressed in Other Than Oral Testimony; View on the Proposed Rules Implementing Sections 201 and 210 of PURPA; Response to Comments on the Proposed 201 and 210 Rules; and Summary Analysis of the Environmental Assessment of the Rules. Pertinent reference material is provided in the Appendices, including the text of the rules. (MCW)« less
March Assumable Waters Subcommittee Presentations
Presentations covering the legislative and regulatory history of Clean Water Act Section 404(g), meaning of adjacent in Section 404(g)(1) , Rivers and Harbors Act Section 10 Case Law, recommendations of the Water Workgroup, among other subjects.
18 CFR 4.201 - Contents of application.
Code of Federal Regulations, 2011 CFR
2011-04-01
.... 4.201 Section 4.201 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT LICENSES, PERMITS, EXEMPTIONS, AND DETERMINATION... form specified. (a) Initial statement. Before the Federal Energy Regulatory Commission Application for...
18 CFR 4.201 - Contents of application.
Code of Federal Regulations, 2014 CFR
2014-04-01
.... 4.201 Section 4.201 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT LICENSES, PERMITS, EXEMPTIONS, AND DETERMINATION... form specified. (a) Initial statement. Before the Federal Energy Regulatory Commission Application for...
18 CFR 4.201 - Contents of application.
Code of Federal Regulations, 2013 CFR
2013-04-01
.... 4.201 Section 4.201 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT LICENSES, PERMITS, EXEMPTIONS, AND DETERMINATION... form specified. (a) Initial statement. Before the Federal Energy Regulatory Commission Application for...
18 CFR 4.201 - Contents of application.
Code of Federal Regulations, 2012 CFR
2012-04-01
.... 4.201 Section 4.201 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT LICENSES, PERMITS, EXEMPTIONS, AND DETERMINATION... form specified. (a) Initial statement. Before the Federal Energy Regulatory Commission Application for...
18 CFR 4.201 - Contents of application.
Code of Federal Regulations, 2010 CFR
2010-04-01
.... 4.201 Section 4.201 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT LICENSES, PERMITS, EXEMPTIONS, AND DETERMINATION... form specified. (a) Initial statement. Before the Federal Energy Regulatory Commission Application for...
75 FR 9400 - Submission for OMB Review; Comment Request
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-02
.... SUMMARY: The Acting Director, Information Collection Clearance Division, Regulatory Information Management... 1, 2010. ADDRESSES: Written comments should be addressed to the Office of Information and Regulatory... [email protected] with a cc: to [email protected] . SUPPLEMENTARY INFORMATION: Section 3506...
10 CFR 51.71 - Draft environmental impact statement-contents.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-contents. 51.71 Section 51.71 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
Code of Federal Regulations, 2010 CFR
2010-10-01
... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Policy. 2001.402 Section 2001.402 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.402 Policy. (a...
Code of Federal Regulations, 2012 CFR
2012-10-01
... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Policy. 2001.402 Section 2001.402 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.402 Policy. (a...
Code of Federal Regulations, 2014 CFR
2014-10-01
... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Policy. 2001.402 Section 2001.402 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION GENERAL NUCLEAR REGULATORY COMMISSION ACQUISITION REGULATION SYSTEM Deviations From the FAR and the NRCAR 2001.402 Policy. (a...
10 CFR 51.11 - Relationship to other subparts. [Reserved
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Relationship to other subparts. [Reserved] 51.11 Section 51.11 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
Code of Federal Regulations, 2010 CFR
2010-04-01
... ADMINISTRATION, DEPARTMENT OF LABOR NATIONAL FARMWORKER JOBS PROGRAM UNDER TITLE I OF THE WORKFORCE INVESTMENT ACT Performance Accountability, Planning and Waiver Provision § 669.560 Are there regulatory and/or...
10 CFR 51.41 - Requirement to submit environmental information.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Requirement to submit environmental information. 51.41 Section 51.41 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.31 - Determinations based on environmental assessment.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Determinations based on environmental assessment. 51.31 Section 51.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.31 - Determinations based on environmental assessment.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Determinations based on environmental assessment. 51.31 Section 51.31 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.5 - Interpretations.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Interpretations. 51.5 Section 51.5 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.5 Interpretations. Except as specifically authorized by the Commission in writing...
10 CFR 51.5 - Interpretations.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Interpretations. 51.5 Section 51.5 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.5 Interpretations. Except as specifically authorized by the Commission in writing...
10 CFR 51.17 - Information collection requirements; OMB approval.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Information collection requirements; OMB approval. 51.17 Section 51.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.67 - Environmental information concerning geologic repositories.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Environmental information concerning geologic repositories. 51.67 Section 51.67 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act...
10 CFR 51.41 - Requirement to submit environmental information.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Requirement to submit environmental information. 51.41 Section 51.41 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.90 - Final environmental impact statement-general.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Final environmental impact statement-general. 51.90 Section 51.90 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.17 - Information collection requirements; OMB approval.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Information collection requirements; OMB approval. 51.17 Section 51.17 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.55 - Environmental report-standard design certification.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Environmental report-standard design certification. 51.55 Section 51.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.91 - Final environmental impact statement-contents.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Final environmental impact statement-contents. 51.91 Section 51.91 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.11 - Relationship to other subparts. [Reserved
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Relationship to other subparts. [Reserved] 51.11 Section 51.11 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.66 - Environmental report-number of copies; distribution.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Section 51.66 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations... submit to the Director of Nuclear Material Safety and Safeguards an environmental report or any...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-13
... memberships in more than one SRO (``common members''). Such regulatory duplication would add unnecessary expenses for common members and their SROs. \\3\\ 15 U.S.C. 78s(g)(1). \\4\\ 15 U.S.C. 78q(d). \\5\\ 15 U.S.C... examinations and regulatory duplication.\\7\\ With respect to a common member, Section 17(d)(1) authorizes the...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-01
... memberships in more than one SRO (``common members''). Such regulatory duplication would add unnecessary expenses for common members and their SROs. \\3\\ 15 U.S.C. 78s(g)(1). \\4\\ 15 U.S.C. 78q(d). \\5\\ 15 U.S.C... examinations and regulatory duplication.\\7\\ With respect to a common member, Section 17(d)(1) authorizes the...
10 CFR 100.4 - Communications.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Communications. 100.4 Section 100.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.4 Communications. Except where otherwise... Reactor Regulation or Director, Office of New Reactors, as appropriate, U.S. Nuclear Regulatory Commission...
10 CFR 100.4 - Communications.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Communications. 100.4 Section 100.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.4 Communications. Except where otherwise... Reactor Regulation or Director, Office of New Reactors, as appropriate, U.S. Nuclear Regulatory Commission...
7 CFR 636.17 - Compliance with regulatory measures.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 6 2011-01-01 2011-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...
7 CFR 636.17 - Compliance with regulatory measures.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 6 2013-01-01 2013-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...
7 CFR 636.17 - Compliance with regulatory measures.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 6 2014-01-01 2014-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...
7 CFR 636.17 - Compliance with regulatory measures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 6 2012-01-01 2012-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...
7 CFR 636.17 - Compliance with regulatory measures.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 6 2010-01-01 2010-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVES PROGRAM § 636...
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Examination. 850.14 Section 850.14 Mineral..., EXAMINATION, AND CERTIFICATION OF BLASTERS PERMANENT REGULATORY PROGRAM REQUIREMENTS-STANDARDS FOR CERTIFICATION OF BLASTERS § 850.14 Examination. (a) The regulatory authority shall ensure that candidates for...
75 FR 49918 - Notice of Baseline Filings
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-16
... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Baseline Filings August 6... submitted their baseline filing of its Statement of Operating Conditions for services provided under section... an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission...
10 CFR 71.1 - Communications and records.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Communications and records. 71.1 Section 71.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL General... of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555...
10 CFR 52.3 - Written communications.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Written communications. 52.3 Section 52.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General... to the Nuclear Regulatory Commission concerning the regulations in this part, individual license...
10 CFR 71.1 - Communications and records.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Communications and records. 71.1 Section 71.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL General... of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555...
10 CFR 51.66 - Environmental report-number of copies; distribution.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Environmental report-number of copies; distribution. 51.66 Section 51.66 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.6 - Specific exemptions.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Specific exemptions. 51.6 Section 51.6 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.6 Specific exemptions. The Commission may, upon application of any interested...
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Scope. 51.1 Section 51.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.1 Scope. This part contains environmental protection regulations applicable to NRC's domestic...
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Scope. 51.1 Section 51.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.1 Scope. This part contains environmental protection regulations applicable to NRC's domestic...
10 CFR 51.6 - Specific exemptions.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Specific exemptions. 51.6 Section 51.6 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS § 51.6 Specific exemptions. The Commission may, upon application of any interested...
10 CFR 51.32 - Finding of no significant impact.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Finding of no significant impact. 51.32 Section 51.32 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing...
10 CFR 51.122 - List of interested organizations and groups.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false List of interested organizations and groups. 51.122 Section 51.122 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Certification. 55.23 Section 55.23 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) OPERATORS' LICENSES Medical Requirements § 55.23 Certification. To certify... obtained by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC...
10 CFR 52.3 - Written communications.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Written communications. 52.3 Section 52.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General... to the Nuclear Regulatory Commission concerning the regulations in this part, individual license...
10 CFR 52.3 - Written communications.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Written communications. 52.3 Section 52.3 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS General... to the Nuclear Regulatory Commission concerning the regulations in this part, individual license...
10 CFR 71.1 - Communications and records.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Communications and records. 71.1 Section 71.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL General... of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555...
10 CFR 71.1 - Communications and records.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Communications and records. 71.1 Section 71.1 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL General... of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555...
78 FR 69139 - Physical Security-Design Certification and Operating Reactors
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-18
... scheduled to close on October 30, 2013. The Nuclear Energy Institute (NEI) submitted a letter on October 9... NUCLEAR REGULATORY COMMISSION [NRC-2013-0225] Physical Security--Design Certification and Operating Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan--draft section...
10 CFR 100.4 - Communications.
Code of Federal Regulations, 2012 CFR
2012-01-01
... Reactor Regulation or Director, Office of New Reactors, as appropriate, U.S. Nuclear Regulatory Commission... 10 Energy 2 2012-01-01 2012-01-01 false Communications. 100.4 Section 100.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) REACTOR SITE CRITERIA § 100.4 Communications. Except where otherwise...
10 CFR 51.122 - List of interested organizations and groups.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false List of interested organizations and groups. 51.122 Section 51.122 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations...
10 CFR 51.88 - Proposals for legislation.
Code of Federal Regulations, 2010 CFR
2010-01-01
... NUCLEAR REGULATORY COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY FUNCTIONS National Environmental Policy Act-Regulations Implementing Section 102(2... Commission will, as a matter of policy, follow the provisions of 40 CFR 1506.8 regarding the NEPA process for...
Regulatory focus and adherence to self-care behaviors among adults with type 2 diabetes.
Avraham, Rinat; Van Dijk, Dina; Simon-Tuval, Tzahit
2016-09-01
The aims of this study were, first, to test the association between regulatory focus of adults with type 2 diabetes and their adherence to two types of self-care behaviors - lifestyle change (e.g. physical activity and diet) and medical care regimens (blood-glucose monitoring, foot care and medication usage). Second, to explore whether a fit between the message framing and patients' regulatory focus would improve their intentions to adhere specifically when the type of behavior fits the patients' regulatory focus as well. A cross-sectional study was conducted among 130 adults with type 2 diabetes who were hospitalized in an academic medical center. The patients completed a set of questionnaires that included their diabetes self-care activities, regulatory focus, self-esteem and demographic, socioeconomic and clinical data. In addition, participants were exposed to either a gain-framed or a loss-framed message, and were then asked to indicate their intention to improve adherence to self-care behaviors. A multivariable linear regression model revealed that promoters reported higher adherence to lifestyle change behaviors than preventers did (B = .60, p = .028). However, no effect of regulatory focus on adherence to medical care regimens was found (B = .46, p = .114). In addition, preventers reported higher intentions to adhere to medical care behaviors when the message framing was congruent with prevention focus (B = 1.16, p = .023). However, promoters did not report higher intentions to adhere to lifestyle behaviors when the message framing was congruent with promotion focus (B = -.16, p = .765). These findings justify the need to develop tailor-made interventions that are adjusted to both patients' regulatory focus and type of health behavior.
Elliott, Michael R; Keindorfer, Paul R; Lowe, Robert A
2003-10-01
This article presents the results of an analysis of the accident history data reported under section 112(r) of the Clean Air Act Amendments. These data provide a fairly complete record of the consequences of reportable accidental releases occurring during the time frame 1995-1999 in the U.S. chemical industry and covering 77 toxic and 63 flammable substances subject to the provisions of section 112(r). As such, these results are of fundamental interest to the affected communities, regulators, and insurers, as well as to owners and managers in the chemical industry. The results show the statistical associations between accident frequency and severity and a number of characteristics of reporting facilities, including their size, the hazardousness of the processes and chemicals inventoried, and the regulatory programs (in addition to section 112(r)) to which these facilities are subject. The results are interpreted in light of economic drivers of protective activity and regulatory priorities for monitoring and enforcement.
10 CFR 170.5 - Communications.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Communications. 170.5 Section 170.5 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.5 Communications...
10 CFR 170.4 - Interpretations.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Interpretations. 170.4 Section 170.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.4...
10 CFR 170.4 - Interpretations.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Interpretations. 170.4 Section 170.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.4...
10 CFR 170.5 - Communications.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Communications. 170.5 Section 170.5 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.5 Communications...
10 CFR 170.4 - Interpretations.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Interpretations. 170.4 Section 170.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.4...
10 CFR 170.4 - Interpretations.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Interpretations. 170.4 Section 170.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.4...
10 CFR 170.4 - Interpretations.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Interpretations. 170.4 Section 170.4 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT OF 1954, AS AMENDED General Provisions § 170.4...
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Permits. 740.13 Section 740.13 Mineral... regulations. (3) Surface coal mining operations authorized under the initial regulatory program or 43 CFR... package shall be filed with the regulatory authority. (3) Each permit application package shall include...
This action presents the Agency's final regulatory determination required by section 3001(b)(3)(C) of the Resource Conservation and Recovery Act (RCRA) for 20 special wastes from the processing of ores and minerals.
47 CFR 1.1162 - General exemptions from regulatory fees.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Commission authorization in any other mass media radio service (except the international broadcast (HF... 47 Telecommunication 1 2010-10-01 2010-10-01 false General exemptions from regulatory fees. 1.1162 Section 1.1162 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Schedule...
21 CFR 26.49 - Regulatory cooperation.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory cooperation. 26.49 Section 26.49 Food 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...
21 CFR 26.18 - Regulatory collaboration.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food 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...
21 CFR 26.34 - Regulatory authorities.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory authorities. 26.34 Section 26.34 Food 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...
10 CFR 150.20 - Recognition of Agreement State licenses.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 150.20 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Reciprocity § 150.20 Recognition of... office for directing the licensed activity and retaining radiation safety records, is granted a general...
10 CFR 150.20 - Recognition of Agreement State licenses.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 150.20 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274 Reciprocity § 150.20 Recognition of... office for directing the licensed activity and retaining radiation safety records, is granted a general...
77 FR 74063 - Amendments to the Abandoned Plan Regulations
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-12
... forth below in Section G of this preamble, entitled ``Regulatory Impact Analysis.'' B. Background On... detailed Regulatory Impact Analysis. For purposes of readability, the proposed rulemaking republishes the... sponsor's delinquent contribution debts to the plan and to collect these delinquencies (or to notify the...
10 CFR 32.8 - Information collection requirements: OMB approval.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...
10 CFR 32.8 - Information collection requirements: OMB approval.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Information collection requirements: OMB approval. 32.8 Section 32.8 Energy NUCLEAR REGULATORY COMMISSION SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER...) The Nuclear Regulatory Commission has submitted the information collection requirements contained in...