Sample records for usnrc regulatory guide

  1. Application of USNRC NUREG/CR-6661 and draft DG-1108 to evolutionary and advanced reactor designs

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

    Chang 'Apollo', Chen

    2006-07-01

    For the seismic design of evolutionary and advanced nuclear reactor power plants, there are definite financial advantages in the application of USNRC NUREG/CR-6661 and draft Regulatory Guide DG-1108. NUREG/CR-6661, 'Benchmark Program for the Evaluation of Methods to Analyze Non-Classically Damped Coupled Systems', was by Brookhaven National Laboratory (BNL) for the USNRC, and Draft Regulatory Guide DG-1108 is the proposed revision to the current Regulatory Guide (RG) 1.92, Revision 1, 'Combining Modal Responses and Spatial Components in Seismic Response Analysis'. The draft Regulatory Guide DG-1108 is available at http://members.cox.net/apolloconsulting, which also provides a link to the USNRC ADAMS site to searchmore » for NUREG/CR-6661 in text file or image file. The draft Regulatory Guide DG-1108 removes unnecessary conservatism in the modal combinations for closely spaced modes in seismic response spectrum analysis. Its application will be very helpful in coupled seismic analysis for structures and heavy equipment to reduce seismic responses and in piping system seismic design. In the NUREG/CR-6661 benchmark program, which investigated coupled seismic analysis of structures and equipment or piping systems with different damping values, three of the four participants applied the complex mode solution method to handle different damping values for structures, equipment, and piping systems. The fourth participant applied the classical normal mode method with equivalent weighted damping values to handle differences in structural, equipment, and piping system damping values. Coupled analysis will reduce the equipment responses when equipment, or piping system and structure are in or close to resonance. However, this reduction in responses occurs only if the realistic DG-1108 modal response combination method is applied, because closely spaced modes will be produced when structure and equipment or piping systems are in or close to resonance. Otherwise, the conservatism in the current Regulatory Guide 1.92, Revision 1, will overshadow the advantage of coupled analysis. All four participants applied the realistic modal combination method of DG-1108. Consequently, more realistic and reduced responses were obtained. (authors)« less

  2. Eleventh international CODATA conference, scientific and technical data in a new era, Karlsruhe, Federal Republic of Germany, 26--29 September 1988: Foreign trip report

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

    Tichler, J.L.

    Information on release of radioactive materials in airborne and liquid effluents, solid waste shipments and selected operating information from commercial nuclear power plants in the United States is maintained in a computer data base at Brookhaven National Laboratory (BNL) for the United States Nuclear Regulatory Commission (USNRC). The information entered into the data base is obtained from semiannual reports submitted by the operators of the plants to the USNRC in compliance with the USNRC Regulatory Guide 1.21, ''Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants.''more » The data on releases in the calendar year 1986 include information from 69 plants representing 87 reactors and contain approximately 19,000 entries. Since all the information is contained in a computer data base management system, entry and rapidly respond to inquiries about the data set and to generate computer readable subsets of the data. Such a subset is used as input to the computer program which generates the annual report, ''Population Dose Commitments Due to Radioactive Releases from Nuclear Power Plant Sites,'' prepared by Pacific Northwest Laboratory for the USNRC. BNL began maintaining this data base for the USNRC with the 1978 information and has added information to the data base for each succeeding year. An annual report summarizing the information for each year, prepared by BNL, and published by the USNRC, is available to the general public. Prior to 1978, annual reports were prepared by the USNRC and are available for the years 1972--1977; however, the information for these years is not in a computer accessible data base.« less

  3. Maxdose-SR and popdose-SR routine release atmospheric dose models used at SRS

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

    Jannik, G. T.; Trimor, P. P.

    MAXDOSE-SR and POPDOSE-SR are used to calculate dose to the offsite Reference Person and to the surrounding Savannah River Site (SRS) population respectively following routine releases of atmospheric radioactivity. These models are currently accessed through the Dose Model Version 2014 graphical user interface (GUI). MAXDOSE-SR and POPDOSE-SR are personal computer (PC) versions of MAXIGASP and POPGASP, which both resided on the SRS IBM Mainframe. These two codes follow U.S. Nuclear Regulatory Commission (USNRC) Regulatory Guides 1.109 and 1.111 (1977a, 1977b). The basis for MAXDOSE-SR and POPDOSE-SR are USNRC developed codes XOQDOQ (Sagendorf et. al 1982) and GASPAR (Eckerman et. almore » 1980). Both of these codes have previously been verified for use at SRS (Simpkins 1999 and 2000). The revisions incorporated into MAXDOSE-SR and POPDOSE-SR Version 2014 (hereafter referred to as MAXDOSE-SR and POPDOSE-SR unless otherwise noted) were made per Computer Program Modification Tracker (CPMT) number Q-CMT-A-00016 (Appendix D). Version 2014 was verified for use at SRS in Dixon (2014).« less

  4. Final Report Inspection of Aged/Degraded Containments Program.

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

    Naus, Dan J; Ellingwood, B R; Oland, C Barry

    2005-09-01

    The Inspection of Aged/Degraded Containments Program had primary objectives of (1) understanding the significant factors relating corrosion occurrence, efficacy of inspection, and structural capacity reduction of steel containments and liners of reinforced concrete containments; (2) providing the United States Nuclear Regulatory Commission (USNRC) reviewers a means of establishing current structural capacity margins or estimating future residual structural capacity margins for steel containments, and concrete containments as limited by liner integrity; (3) providing recommendations, as appropriate, on information to be requested of licensees for guidance that could be utilized by USNRC reviewers in assessing the seriousness of reported incidences of containmentmore » degradation; and (4) providing technical assistance to the USNRC (as requested) related to concrete technology. Primary program accomplishments have included development of a degradation assessment methodology; reviews of techniques and methods for inspection and repair of containment metallic pressure boundaries; evaluation of high-frequency acoustic imaging, magnetostrictive sensor, electromagnetic acoustic transducer, and multimode guided plate wave technologies for inspection of inaccessible regions of containment metallic pressure boundaries; development of a continuum damage mechanics-based approach for structural deterioration; establishment of a methodology for reliability-based condition assessments of steel containments and liners; and fragility assessments of steel containments with localized corrosion. In addition, data and information assembled under this program has been transferred to the technical community through review meetings and briefings, national and international conference participation, technical committee involvement, and publications of reports and journal articles. Appendix A provides a listing of program reports, papers, and publications; and Appendix B contains a listing of program-related presentations.« less

  5. An update of preliminary perspectives gained from Individual Plant Examination of External Events (IPEEE) submittal reviews

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

    Rubin, A.M.; Chen, J.T.; Chokshi, N.

    1998-03-01

    As a result of the US Nuclear Regulatory Commission (USNRC) initiated Individual Plant Examination of External Events (IPEEE) program, virtually every operating commercial nuclear power reactor in the US has performed an assessment of severe accident risk due to external events. To date, the USNRC staff has received 63 IPEEE submittals and will receive an additional 11 by mid 1998. Currently, 49 IPEEE submittals are under various stages ore view. This paper is based on the information available for those 41 plants for which at least preliminary Technical Evaluation Reports have been prepared by the review teams. The goal ofmore » the review is to ascertain whether the licensee`s IPEEE process is capable of identifying external events-induced severe accident vulnerabilities and cost-effective safety improvements to either eliminate or reduce the impact of these vulnerabilities. The review does not, however, attempt to validate or verify the results of the licensee`s IPEEE. The primary objective of this paper is to provide an update on the preliminary perspectives and insights gained from the IPEEE process.« less

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

    PubMed

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

    2016-12-01

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

  7. Thermal-hydraulic modeling needs for passive reactors

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

    Kelly, J.M.

    1997-07-01

    The U.S. Nuclear Regulatory Commission has received an application for design certification from the Westinghouse Electric Corporation for an Advanced Light Water Reactor design known as the AP600. As part of the design certification process, the USNRC uses its thermal-hydraulic system analysis codes to independently audit the vendor calculations. The focus of this effort has been the small break LOCA transients that rely upon the passive safety features of the design to depressurize the primary system sufficiently so that gravity driven injection can provide a stable source for long term cooling. Of course, large break LOCAs have also been considered,more » but as the involved phenomena do not appear to be appreciably different from those of current plants, they were not discussed in this paper. Although the SBLOCA scenario does not appear to threaten core coolability - indeed, heatup is not even expected to occur - there have been concerns as to the performance of the passive safety systems. For example, the passive systems drive flows with small heads, consequently requiring more precision in the analysis compared to active systems methods for passive plants as compared to current plants with active systems. For the analysis of SBLOCAs and operating transients, the USNRC uses the RELAP5 thermal-hydraulic system analysis code. To assure the applicability of RELAP5 to the analysis of these transients for the AP600 design, a four year long program of code development and assessment has been undertaken.« less

  8. Assessment of the point-source method for estimating dose rates to members of the public from exposure to patients with 131I thyroid treatment

    DOE PAGES

    Dewji, Shaheen Azim; Bellamy, Michael B.; Hertel, Nolan E.; ...

    2015-09-01

    The U.S. Nuclear Regulatory Commission (USNRC) initiated a contract with Oak Ridge National Laboratory (ORNL) to calculate radiation dose rates to members of the public that may result from exposure to patients recently administered iodine-131 ( 131I) as part of medical therapy. The main purpose was to compare dose rate estimates based on a point source and target with values derived from more realistic simulations that considered the time-dependent distribution of 131I in the patient and attenuation of emitted photons by the patient’s tissues. The external dose rate estimates were derived using Monte Carlo methods and two representations of themore » Phantom with Movable Arms and Legs, previously developed by ORNL and the USNRC, to model the patient and a nearby member of the public. Dose rates to tissues and effective dose rates were calculated for distances ranging from 10 to 300 cm between the phantoms and compared to estimates based on the point-source method, as well as to results of previous studies that estimated exposure from 131I patients. The point-source method overestimates dose rates to members of the public in very close proximity to an 131I patient but is a broadly accurate method of dose rate estimation at separation distances of 300 cm or more at times closer to administration.« less

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

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

  11. 76 FR 189 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-03

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

  12. 77 FR 8902 - Draft Regulatory Guide: Issuance, Availability Decommissioning of Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  13. 76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

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

  14. Heavy-section steel technology and irradiation programs-retrospective and prospective views

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

    Nanstad, Randy K; Bass, Bennett Richard; Rosseel, Thomas M

    In 1965, the Atomic Energy Commission (AEC), at the advice of the Advisory Committee on Reactor Safeguards (ACRS), initiated the process that resulted in the establishment of the Heavy Section Steel Technology (HSST) Program at Oak Ridge National Laboratory (ORNL). Dr. Spencer H. Bush of Battelle Northwest Laboratory, the man being honored by this symposium, representing the ACRS, was one of the Staff Advisors for the program and helped to guide its technical direction. In 1989, the Heavy-Section Steel Irradiation (HSSI) Program, formerly the HSST task on irradiation effects, was formed as a separate program, and this year the HSST/HSSImore » Programs, sponsored by the U.S. Nuclear Regulatory Commission (USNRC), celebrate 40 years of continuous research oriented toward the safety of light-water nuclear reactor pressure vessels. This paper presents a summary of results from those programs with a view to future activities. The HSST Program was established in 1967 and initially included extensive investigations of heavy-section low-alloy steel plates, forgings, and welds, including metallurgical studies, mechanical properties, fracture toughness (quasi-static and dynamic), fatigue crack-growth, and crack arrest toughness. Also included were irradiation effects studies, thermal shock analyses, testing of thick-section tensile and fracture specimens, and non-destructive testing. In the subsequent decades, the HSST Program conducted extensive large-scale experiments with intermediate-size vessels (with varying size flaws) pressurized to failure, similar experiments under conditions of thermal shock and even pressurized thermal shock (PTS), wide-plate crack arrest tests, and biaxial tests with cruciform-shaped specimens. Extensive analytical and numerical studies accompanied these experiments, including the development of computer codes such as the recent Fracture Analysis of Vessels Oak Ridge (FAVOR) code currently being used for PTS evaluations. In the absence of radiation damage to the RPV, fracture of the vessel is improbable. However, exposure to high energy neutrons can result in embrittlement of radiation-sensitive RPV materials. The HSSI Program has conducted a series of experiments to assess the effects of neutron irradiation on RPV material behavior, especially fracture toughness. These studies have included RPV plates and welds, varying chemical compositions, and fracture toughness specimens up to 4 in. thickness. The results of these investigations, in conjunction with results from commercial reactor surveillance programs, are used to develop a methodology for the prediction of radiation effects on RPV materials. Results from the HSST and HSSI Program are used by the USNRC in the evaluation of RPV integrity and regulation of overall nuclear plant safety.« less

  15. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

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

  16. 75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

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

  17. 75 FR 52996 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

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

  18. 76 FR 38212 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

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

  20. 76 FR 31382 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

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

  1. 76 FR 6086 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

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

  2. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

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

  3. 77 FR 33253 - Regulatory Guide 8.33, Quality Management Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0126] Regulatory Guide 8.33, Quality Management Program... Regulatory Commission (NRC or Commission) is withdrawing Regulatory Guide (RG) 8.33, ``Quality Management... Quality Management Program was deleted from the regulations as part of an overall revision in 2002 of the...

  4. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

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

  5. 76 FR 2726 - Withdrawal of Regulatory Guide 1.154

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

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

  6. 76 FR 24539 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

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

  7. 76 FR 32878 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

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

  8. A mid-layer model for human reliability analysis : understanding the cognitive causes of human failure events.

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

    Shen, Song-Hua; Chang, James Y. H.; Boring,Ronald L.

    2010-03-01

    The Office of Nuclear Regulatory Research (RES) at the US Nuclear Regulatory Commission (USNRC) is sponsoring work in response to a Staff Requirements Memorandum (SRM) directing an effort to establish a single human reliability analysis (HRA) method for the agency or guidance for the use of multiple methods. As part of this effort an attempt to develop a comprehensive HRA qualitative approach is being pursued. This paper presents a draft of the method's middle layer, a part of the qualitative analysis phase that links failure mechanisms to performance shaping factors. Starting with a Crew Response Tree (CRT) that has identifiedmore » human failure events, analysts identify potential failure mechanisms using the mid-layer model. The mid-layer model presented in this paper traces the identification of the failure mechanisms using the Information-Diagnosis/Decision-Action (IDA) model and cognitive models from the psychological literature. Each failure mechanism is grouped according to a phase of IDA. Under each phase of IDA, the cognitive models help identify the relevant performance shaping factors for the failure mechanism. The use of IDA and cognitive models can be traced through fault trees, which provide a detailed complement to the CRT.« less

  9. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

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

  10. 75 FR 20868 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

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

  11. 75 FR 37842 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

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

  12. 75 FR 53352 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

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

  13. 76 FR 23845 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... approach that the staff of the NRC considers acceptable for use in developing an appropriate surveillance... steel. The recommendations described in this draft regulatory guide are an approach acceptable to the...

  14. 75 FR 33361 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... staff needs in its review of applications for permits and licenses. Revision 4 of Regulatory Guide 1.28... (Design and Construction).'' Proposed RG 1.28, Revision 4, extends the scope of the NRC's endorsement to...: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.28...

  15. 75 FR 45677 - Draft Regulatory Guide, DG-1216,”Plant-Specific Applicability of Transition Break Size Specified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0229] Draft Regulatory Guide, DG-1216,''Plant-Specific... Commission (NRC) is extending the public comment period for DG-1216 from August 25, 2010 to November 8, 2010... [email protected] . The Draft Regulatory Guide, DG-1216, ``Plant- Specific Applicability of...

  16. 75 FR 36715 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

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

  17. 75 FR 43208 - Withdrawal of Regulatory Guide 5.17

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

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

  18. 75 FR 70044 - Withdrawal of Regulatory Guide 1.39

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ...: Hector L. Rodriguez-Luccioni, Regulatory Guide Development Branch, Division of Engineering, Office of...-251-7685 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The... N. Ridgely, Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office of...

  19. 75 FR 12804 - Withdrawal of Regulatory Guide 8.6

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-17

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

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

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

    Jennings, S.D.

    1990-04-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

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

  2. 75 FR 9002 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... Guide, DG-3040, ``Design, Construction, and Inspection of Embankment Retention Systems at Fuel Cycle... guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... to be satisfactory for the design, construction, and inspection of embankment retention systems used...

  3. 77 FR 48177 - Fuel Oil Systems for Emergency Power Supplies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0159] Fuel Oil Systems for Emergency Power Supplies AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; extension of comment period. SUMMARY: On... Regulatory Guide, DG- 1282, ``Fuel Oil Systems for Emergency Power Supplies,'' in the Federal Register for a...

  4. 78 FR 58574 - Maintenance, Testing, and Replacement of Vented Lead-Acid Storage Batteries for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... time that a document is referenced. Revision 3 of Regulatory Guide 1.129 is available in ADAMS under...-251-7455; email: [email protected] . Both of the Office of Nuclear Regulatory Research, U.S... NRC is issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series...

  5. 76 FR 26320 - Draft Regulatory Guide: Reissuance and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Guide, DG-1217 ``Protection Against Turbine Missiles.'' SUMMARY: On November 2, 2009 (74 FR 56672), the... availability of Draft Regulatory Guide (DG)--1217, ``Protection Against Turbine Missiles.'' The guide is being... appropriately protected against the effects of missiles that might result from equipment failures. Failures that...

  6. 78 FR 57916 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... Relating to Amendments to the Discovery Guide Used in Customer Arbitration Proceedings, as Modified by... update the Discovery Guide (``Guide'') used in customer arbitration proceedings.\\1\\ According to FINRA, the Guide supplements the discovery rules contained in the FINRA Code of Arbitration Procedure for...

  7. 77 FR 36017 - Regulatory Guide 7.3, Procedures for Picking Up and Receiving Packages of Radioactive Material

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

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

  8. 78 FR 73566 - Standard Format and Content for a License Application for an Independent Spent Fuel Storage...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-06

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-3042, ``Standard Format and Content for a License Application for an Independent Spent Fuel Storage Installation or a Monitored Retrievable Storage Facility.'' This draft regulatory guide is proposed revision 2 of Regulatory Guide 3.50, which provides a format that the NRC considers acceptable for submitting the information for license applications to store spent nuclear fuel, high-level radioactive waste, and/or reactor-related Greater than Class C waste.

  9. 76 FR 11288 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

    ... Guide, DG-7008, ``Leakage Tests on Packages for Shipment of Radioactive Materials.'' FOR FURTHER... regulatory guide (DG), entitled, ``Leakage Tests on Packages for Shipment of Radioactive Materials'' is... Radioactive and Nonnuclear Hazardous Materials, N14, Subcommittee of the American National Standards Institute...

  10. 75 FR 9626 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    ... maintain variables and systems that can affect the fission process, the integrity of the reactor core, the... on some other defined basis. GDC 24 requires that interconnection of the protection and control..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc...

  11. 75 FR 45171 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555...-3040. This guide describes some engineering practices and methods generally considered by the NRC to be... they reflect the latest general engineering approaches that are acceptable to the NRC staff. If future...

  12. 76 FR 14108 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ..., Revision 1, ``Control of Preheat Temperature for Welding of Low-Alloy Steel.'' FOR FURTHER INFORMATION... for Welding of Low-Alloy Steel,'' was issued with a temporary identification as Draft Regulatory Guide... implementing regulatory requirements related to the control of welding for low-alloy steel components during...

  13. 77 FR 55877 - Initial Test Program of Condensate and Feedwater Systems for Light-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ...-492- 3668; email: [email protected] . NRC's Agencywide Documents Access and Management System... Systems for Light-Water Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance... Systems for Boiling Water Reactor Power Plants.'' This regulatory guide is being revised to: (1) Expand...

  14. 77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

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

  15. 78 FR 36278 - Fuel Oil Systems for Emergency Power Supplies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... this notice (if that document is available in ADAMS) is provided the first time that a document is..., Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001... issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series was...

  16. 75 FR 16525 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... CONTACT: Mekonen M. Bayssie, Regulatory Guide Development Branch, Division of Engineering, Office of...) 251-7489 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U.S..., Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2010-7391 Filed 3-31-10; 8:45 am...

  17. Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct.

    PubMed

    Lim, Robyn R

    2007-08-01

    This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP). Background information is provided on the Therapeutic Products Directorate (TPD) and its regulatory activities regarding drug and medical device assessment in both the pre- and post-market setting. The TPD Good Review Guiding Principles (GRGP) are described which include a Definition of a Good Therapeutic Product Regulatory Review, Ten Hallmarks of a Good Therapeutic Product Regulatory Review and Ten Precepts. Analysis of the guiding principles discusses possible linkages between the guiding principles and intellectual virtues. Through this analysis an hypothesis is developed that the guiding principles outline a code of intellectual conduct for Health Canada's reviewers of evidence for efficacy, safety, manufacturing quality and benefit-risk regarding therapeutic products. Opportunities to advance therapeutic product regulatory review as a scientific discipline in its own right and to acknowledge that these reviewers constitute a specific community of practice are discussed. Integration of intellectual and ethical approaches across therapeutic product review sectors is also suggested.

  18. 78 FR 37261 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... Change Relating to Amendments to the Discovery Guide Used in Customer Arbitration Proceedings June 13... Discovery Guide (``Guide'') used in customer arbitration proceedings to provide general guidance on electronic discovery (``e-discovery'') issues and product cases and to clarify the existing provision...

  19. 77 FR 18872 - Availability of Electric Power Sources

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... the first time that document is referenced. Revision 1 of Regulatory Guide 1.93 is available.... Introduction The NRC is issuing a revision to an existing guide in the NRC's ``Regulatory Guide'' series. This series was developed to describe and make available to the public information such as methods that are...

  20. 76 FR 46330 - NUREG-1934, Nuclear Power Plant Fire Modeling Application Guide (NPP FIRE MAG); Second Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

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

  1. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., Revision 2, ``An Acceptable Model and Related Statistical Methods for the Analysis of Fuel Densification.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing guide in the... nuclear power reactors. To meet these objectives, the guide describes statistical methods related to...

  2. Automated Non-Destructive Testing Array Evaluation System

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

    Wei, T; Zavaljevski, N; Bakhtiari, S

    2004-12-24

    Automated Non-Destructive Testing Array Evaluation System (ANTARES) sofeware alogrithms were developed for use on X-probe(tm) data. Data used for algorithm development and preliminary perfomance determination was obtained for USNRC mock-up at Argone and data from EPRI.

  3. 77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0115] Regulatory Guide 8.24, Revision 2, Health Physics..., ``Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication'' was issued with a... specifically with the following aspects of an acceptable occupational health physics program that are closely...

  4. 78 FR 35330 - Initial Test Programs for Water-Cooled Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... this notice is provided the first time that a document is referenced. Revision 4 of Regulatory Guide 1... FURTHER INFORMATION CONTACT: Mark Orr, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory... Guide'' series. This series was developed to describe and make available to the public information such...

  5. 78 FR 37848 - ASME Code Cases Not Approved for Use

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1233, ``ASME Code Cases not Approved for Use.'' This regulatory guide lists the American Society of Mechanical Engineers (ASME) Code Cases that the NRC has determined not to be acceptable for use on a generic basis.

  6. 76 FR 63541 - Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-13

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

  7. 75 FR 45172 - Withdrawal of Regulatory Guides 3.44 and 3.49

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Format and Content for the Safety Analysis Report for an Independent Spent Fuel Storage Installation... on the format and content of the safety analysis report that is required as part of an application to...: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 3.44, ``Standard Format and Content...

  8. Thermal overload protection for electric motors on safety-related motor-operated valves: Generic Issue II. E. 6. 1

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

    Rothberg, O.

    1988-06-01

    NRC regulatory positions, as stated in Regulatory Guide 1.106, Revision 1, have been identified by the Office for Analysis and Evaluation of Operational Data (AEOD) as potential contributors to valve motor burnout. AEOD is particularly concerned about the allowed policy of bypassing thermal overload devices during normal or accident conditions. Regulatory Guide 1.106 favors compromising the function of thermal overload devices in favor of completing the safety-related action of valves. The purpose of this study was to determine if the guidance contained in Regulatory Guide 1.106 is appropriate and, if not, to recommend the necessary changes. This report describes thermalmore » overload devices commonly used to protect safety-related valve operator motors. The regulatory guidelines stated in Regulatory Guide 1.106 along with the limitations of thermal overload protection are discussed. Supplements and alternatives to thermal overload protection are also described. Findings and conclusions of several AEOD reports are discussed. Information obtained from the standard review plan, standard technical specifications, technical specifications from representative plants, and several papers are cited.« less

  9. Analytical Prediction of the Seismic Response of a Reinforced Concrete Containment Vessel

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

    James, R.J.; Rashid, Y.R.; Cherry, J.L.

    Under the sponsorship of the Ministry of International Trade and Industry (MITI) of Japan, the Nuclear Power Engineering Corporation (NUPEC) is investigating the seismic behavior of a Reinforced Concrete Containment Vessel (RCCV) through scale-model testing using the high-performance shaking table at the Tadotsu Engineering Laboratory. A series of tests representing design-level seismic ground motions was initially conducted to gather valuable experimental measurements for use in design verification. Additional tests will be conducted with increasing amplifications of the seismic input until a structural failure of the test model occurs. In a cooperative program with NUPEC, the US Nuclear Regulatory Commission (USNRC),more » through Sandia National Laboratories (SNL), is conducting analytical research on the seismic behavior of RCCV structures. As part of this program, pretest analytical predictions of the model tests are being performed. The dynamic time-history analysis utilizes a highly detailed concrete constitutive model applied to a three-dimensional finite element representation of the test structure. This paper describes the details of the analysis model and provides analysis results.« less

  10. Establishment and assessment of code scaling capability

    NASA Astrophysics Data System (ADS)

    Lim, Jaehyok

    In this thesis, a method for using RELAP5/MOD3.3 (Patch03) code models is described to establish and assess the code scaling capability and to corroborate the scaling methodology that has been used in the design of the Purdue University Multi-Dimensional Integral Test Assembly for ESBWR applications (PUMA-E) facility. It was sponsored by the United States Nuclear Regulatory Commission (USNRC) under the program "PUMA ESBWR Tests". PUMA-E facility was built for the USNRC to obtain data on the performance of the passive safety systems of the General Electric (GE) Nuclear Energy Economic Simplified Boiling Water Reactor (ESBWR). Similarities between the prototype plant and the scaled-down test facility were investigated for a Gravity-Driven Cooling System (GDCS) Drain Line Break (GDLB). This thesis presents the results of the GDLB test, i.e., the GDLB test with one Isolation Condenser System (ICS) unit disabled. The test is a hypothetical multi-failure small break loss of coolant (SB LOCA) accident scenario in the ESBWR. The test results indicated that the blow-down phase, Automatic Depressurization System (ADS) actuation, and GDCS injection processes occurred as expected. The GDCS as an emergency core cooling system provided adequate supply of water to keep the Reactor Pressure Vessel (RPV) coolant level well above the Top of Active Fuel (TAF) during the entire GDLB transient. The long-term cooling phase, which is governed by the Passive Containment Cooling System (PCCS) condensation, kept the reactor containment system that is composed of Drywell (DW) and Wetwell (WW) below the design pressure of 414 kPa (60 psia). In addition, the ICS continued participating in heat removal during the long-term cooling phase. A general Code Scaling, Applicability, and Uncertainty (CSAU) evaluation approach was discussed in detail relative to safety analyses of Light Water Reactor (LWR). The major components of the CSAU methodology that were highlighted particularly focused on the scaling issues of experiments and models and their applicability to the nuclear power plant transient and accidents. The major thermal-hydraulic phenomena to be analyzed were identified and the predictive models adopted in RELAP5/MOD3.3 (Patch03) code were briefly reviewed.

  11. Guiding College Students to Develop Academic Self-Regulatory Skills

    ERIC Educational Resources Information Center

    Chen, Pin-Hwa

    2011-01-01

    This study aimed to explore the efficaciousness of a guiding model for Taiwanese college students employed to develop their academic self-regulatory skills. Twenty-eight undergraduates in a university in southern Taiwan were recruited as participants. The participants received training on the proposed guiding model and were asked to take their own…

  12. 76 FR 14108 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ..., telephone (301) 251-7569 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U.S.... Thomas H. Boyce, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear...

  13. 76 FR 35922 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... CONTACT: Harriet Karagiannis, Regulatory Guide Development Branch, Division of Engineering, Office of... direct the use of individual monitoring devices. In addition, 10 CFR part 34, ``Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations,'' includes a specific...

  14. 77 FR 40921 - Communication With Transport Vehicles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0163] Communication With Transport Vehicles AGENCY... Transport Vehicles,'' published in May 1975. The guide is being withdrawn because it is outdated due to... withdrawing Regulatory Guide 5.32, revision 1, ``Communication with Transport Vehicles,'' published in May...

  15. 76 FR 24538 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... Guide, DG-1264, ``Thermal Overload Protection for Electric Motors On Motor- Operated Valves.'' FOR FURTHER INFORMATION CONTACT: Darrell Murdock, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-251- 7629 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I...

  16. 78 FR 663 - Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-04

    ...] Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide..., ``Decommissioning Planning During Operations.'' The guide describes a method that the NRC staff considers acceptable for use by holders of licenses in complying with the NRC's Decommissioning Planning Rule (DPR) (76 FR...

  17. 75 FR 81675 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... Fuel Cycle Facilities.'' FOR FURTHER INFORMATION CONTACT: Mekonen M. Bayssie, Regulatory Guide... Materials in Liquid and Gaseous Effluents from Nuclear Fuel Cycle Facilities,'' was published as Draft... guidance is applicable to nuclear fuel cycle facilities, with the exception of uranium milling facilities...

  18. 76 FR 2725 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    .... The draft regulatory guide, entitled, ``Inspection of Water-Control Structures Associated with Nuclear... and surveillance program for dams, slopes, canals, and other water-control structures associated with emergency cooling water systems or flood protection of nuclear power plants. II. Further Information The NRC...

  19. 75 FR 35508 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... Systems and Networks,'' requires licensees to develop cyber-security plans and programs to protect critical digital assets, including digital safety systems, from malicious cyber attacks. Regulatory Guide 5.71, ``Cyber Security Programs for Nuclear Facilities,'' provides guidance to meet the requirements of...

  20. 75 FR 79049 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ... (RG) 5.80, ``Pressure-Sensitive and Tamper-Indicating Device Seals for Material Control and Accounting... and licenses. Regulatory Guide 5.80, ``Pressure-Sensitive and Tamper-Indicating Device Seals for... and Use of Pressure-Sensitive Seals on Containers for Onsite Storage of Special Nuclear Material...

  1. 75 FR 62436 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ... Power Plants,'' includes in its scope safety- related structures, systems, and components (SSCs) that... monitor the effectiveness of maintenance for protective coatings within its scope (as discrete systems or... and Management System (ADAMS) under Accession No. ML102230359. Electronic copies of Regulatory Guide 1...

  2. 75 FR 54921 - Withdrawal of Regulatory Guides 1.38, 1.94, and 1.116

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ....116, ``Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical....116, ``Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems,'' dated May 1977. Regulatory Guide 1.38 endorses the American Society of Mechanical...

  3. 75 FR 11574 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... protection during plant operation and maintenance activities. For plants that have a design basis that... coatings be qualified and capable of surviving a design-basis accident without adversely affecting safety...

  4. 77 FR 18871 - Administrative Guide for Verifying Compliance With Packaging Requirements for Shipment and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Packaging Requirements for Shipment and Receipt of Radioactive Material AGENCY: Nuclear Regulatory... with Packaging Requirements for Shipment and Receipt of Radioactive Material.'' This regulatory guide... for transporting licensed material under 10 CFR part 71, ``Packaging and Transportation of Radioactive...

  5. 78 FR 64030 - Monitoring Criteria and Methods To Calculate Occupational Radiation Doses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0234] Monitoring Criteria and Methods To Calculate... regulatory guide (DG), DG-8031, ``Monitoring Criteria and Methods to Calculate Occupational Radiation Doses.'' This guide describes methods that the NRC staff considers acceptable for licensees to use to determine...

  6. 76 FR 55137 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at... comment draft regulatory guide (DG) DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide endorses Revision 4A to Nuclear Management and Resources Council (NUMARC) 93...

  7. 76 FR 10917 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... in the agency's ``Regulatory Guide'' series. This series was developed to describe and make available... connection assemblies can perform their safety functions during and after a design-basis event. Title 10 of... Reprocessing Plants,'' Criterion III, ``Design Control,'' requires, in part, that test programs used to verify...

  8. 76 FR 46856 - Qualification of Connection Assemblies for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

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

  9. 76 FR 65541 - Assuring the Availability of Funds for Decommissioning Nuclear Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

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

  10. 78 FR 63517 - Control of Ferrite Content in Stainless Steel Weld Metal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to Regulatory Guide (RG) 1.31, ``Control of Ferrite Content in Stainless Steel Weld Metal.'' This guide (Revision 4) describes a method that the NRC staff considers acceptable for controlling ferrite content in stainless steel weld metal. It updates the guide to remove references to outdated standards and to remove an appendix that has been incorporated into relevant specifications.

  11. 75 FR 16516 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...: R.A. Jervey, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: (301) 251...'' series. This series was developed to describe and make available to the public such information as.... Although a time limit is given, comments and suggestions in connection with items for inclusion in guides...

  12. 76 FR 82323 - Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0296] Design, Inspection, and Testing Criteria for Air... for public comment draft regulatory guide (DG), DG-1274, ``Design, Inspection, and Testing Criteria... Systems in Light-Water-Cooled Nuclear Power Plants.'' This guide applies to the design, inspection, and...

  13. Regulatory facility guide for Ohio

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

    Anderson, S.S.; Bock, R.E.; Francis, M.W.

    1994-02-28

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

  14. Quality Management Program

    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

  15. 75 FR 79049 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

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

  16. Inspection of Nuclear Power Plant Containment Structures

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

    Graves, H.L.; Naus, D.J.; Norris, W.E.

    1998-12-01

    Safety-related nuclear power plant (NPP) structures are designed to withstand loadings from a number of low-probability external and interval events, such as earthquakes, tornadoes, and loss-of-coolant accidents. Loadings incurred during normal plant operation therefore generally are not significant enough to cause appreciable degradation. However, these structures are susceptible to aging by various processes depending on the operating environment and service conditions. The effects of these processes may accumulate within these structures over time to cause failure under design conditions, or lead to costly repair. In the late 1980s and early 1990s several occurrences of degradation of NPP structures were discoveredmore » at various facilities (e.g., corrosion of pressure boundary components, freeze- thaw damage of concrete, and larger than anticipated loss of prestressing force). Despite these degradation occurrences and a trend for an increasing rate of occurrence, in-service inspection of the safety-related structures continued to be performed in a somewhat cursory manner. Starting in 1991, the U.S. Nuclear Regulatory Commission (USNRC) published the first of several new requirements to help ensure that adequate in-service inspection of these structures is performed. Current regulatory in-service inspection requirements are reviewed and a summary of degradation experience presented. Nondestructive examination techniques commonly used to inspect the NPP steel and concrete structures to identify and quantify the amount of damage present are reviewed. Finally, areas where nondestructive evaluation techniques require development (i.e., inaccessible portions of the containment pressure boundary, and thick heavily reinforced concrete sections are discussed.« less

  17. 77 FR 60478 - Control of Ferrite Content in Stainless Steel Weld Metal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ...The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing for public comment draft regulatory guide (DG), DG-1279, ``Control of Ferrite Content in Stainless Steel Weld Metal.'' This guide describes a method that the NRC staff considers acceptable for controlling ferrite content in stainless steel weld metal. Revision 4 updates the guide to remove references to outdated standards and to remove an appendix that has been incorporated into relevant specifications.

  18. 77 FR 24228 - Condition Monitoring Techniques for Electric Cables Used in Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-23

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

  19. 77 FR 40385 - Withdrawal of Regulatory Guide 7.3; Procedures for Picking Up and Receiving Packages of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

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

  20. 75 FR 36445 - Draft Regulatory Guide, DG-4018, “Constraint on Releases of Airborne Radioactive Materials To the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... Releases of Airborne Radioactive Materials To the Environment for Licensees Other Than Power Reactors... Regulatory Guide (DG)-4018, ``Constraint on Releases of Airborne Radioactive Materials to the Environment for..., ``Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees Other than Power...

  1. 78 FR 40776 - Issuance of Regulatory Guide 1.124 and Regulatory Guide 1.130

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-08

    ... Limits and Loading Combinations for Class 1 Plate-and- Shell-Type Supports.'' There are no substantive... 1 linear-type component and piping supports, and Class 1 plate-and-shell-type component and piping... Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0141. Address...

  2. 76 FR 14107 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

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

  3. 78 FR 38739 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 of Regulatory Guide (RG) 1.185, ``Standard Format and Content for Post-shutdown Decommissioning Activities Report.'' This guide describes a method that the NRC staff considers acceptable for use in complying with the Commission's requirements regarding the submission of a post-shutdown decommissioning activities report (PSDAR).

  4. 77 FR 75198 - Standard Format and Content for Post-Shutdown Decommissioning Activities Report

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1272, ``Standard Format and Content for Post-shutdown Decommissioning Activities Report.'' This guide describes a method that the NRC staff considers acceptable for use in complying with the Commission's requirements regarding the submission of a post-shutdown decommissioning activities report (PSDAR).

  5. Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

    PubMed

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

    Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

  6. A guide to federal-aid programs and projects

    DOT National Transportation Integrated Search

    1999-05-01

    This guide provides basic information about Federal-aid programs, projects, and other program characteristics. The information sheets contained in the guide provide fiscal information, statutory and regulatory references, general eligibility and back...

  7. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

  8. 78 FR 37850 - Quality Assurance Program Requirements (Operations)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0021] Quality Assurance Program Requirements (Operations... Regulatory Commission (NRC) is issuing a revision to Regulatory Guide (RG) 1.33, ``Quality Assurance Program... managerial and administrative Quality Assurance (QA) controls for nuclear power plants during operations...

  9. VICTORIA-92 pretest analyses of PHEBUS-FPT0

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

    Bixler, N.E.; Erickson, C.M.

    FPT0 is the first of six tests that are scheduled to be conducted in an experimental reactor in Cadarache, France. The test apparatus consists of an in-pile fuel bundle, an upper plenum, a hot leg, a steam generator, a cold leg, and a small containment. Thus, the test is integral in the sense that it attempts to simulate all of the processes that would be operative in a severe nuclear accident. In FPT0, the fuel will be trace irradiated; in subsequent tests high burn-up fuel will be used. This report discusses separate pretest analyses of the FPT0 fuel bundle andmore » primary circuit have been conducted using the USNRC`s source term code, VICTORIA-92. Predictions for release of fission product, control rod, and structural elements from the test section are compared with those given by CORSOR-M. In general, the releases predicted by VICTORIA-92 occur earlier than those predicted by CORSOR-M. The other notable difference is that U release is predicted to be on a par with that of the control rod elements; CORSOR-M predicts U release to be about 2 orders of magnitude greater.« less

  10. 77 FR 75462 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... Amending Section 102(a) of the NYSE MKT Company Guide To Eliminate an Erroneous Reference December 14, 2012... MKT Company Guide (the ``Company Guide'') to eliminate an erroneous reference. The text of the... Company Guide (to eliminate an erroneous reference. Section 102(a) of the Company Guide provides that a...

  11. FEDERAL RULEMAKING: Procedural and Analytical Requirements at OSHA and Other Agencies

    DTIC Science & Technology

    2001-06-14

    informal rulemaking. Formal rulemaking is used in ratemaking proceedings and in certain other cases when rules are required by statute to be made “on...crosscutting statutory requirements that I have just listed are by no means the only statutory requirements that guide agency rulemaking. Regulations generally...directives designed to guide the federal rulemaking process, often with the goal of reducing regulatory burden. Although independent regulatory agencies are

  12. Assessment of Individual Differences in Regulatory Focus among Cigarette Smokers

    PubMed Central

    Haaga, David A. F.; Friedman-Wheeler, Dara G.; McIntosh, Elizabeth; Ahrens, Anthony H.

    2008-01-01

    Smoking cessation programs might benefit from tailoring messages to individual differences in regulatory focus (see Higgins, 1997), but there is little evidence on the stability or convergent validity of regulatory focus measures. In two studies, smokers completed four measures of regulatory focus: (a) Regulatory Focus Questionnaire (RFQ); (b) actual-ideal and actual-ought self-discrepancies; (c) response duration in naming name ideal or ought self-guides; and (d) reaction time for lexical decisions about one’s ideal or ought self-guides. Study 1 included a one-month retest. Retest reliability was adequate, but convergent validity was poor. Questionnaire and self-discrepancy measures were unrelated to each other or to the reaction time measures. To facilitate future studies of tailored health behavior change interventions, research is needed to determine whether weak convergent validity resulted from (a) invalidity of some or all of the regulatory focus measures or (b) validity of each for measuring a different aspect of the construct. PMID:18958291

  13. 76 FR 54739 - Pacific Halibut Fishery; Guideline Harvest Levels for the Guided Sport Fishery for Pacific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-02

    ... Halibut Fishery; Guideline Harvest Levels for the Guided Sport Fishery for Pacific Halibut in...) for the guided sport fishery in International Pacific Halibut Commission (IPHC) Regulatory Areas 2C... sport fishery for halibut. The GHLs are benchmark harvest levels for participants in the guided sport...

  14. 78 FR 18323 - Pacific Halibut Fishery; Guideline Harvest Levels for the Guided Sport Fishery for Pacific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Halibut Fishery; Guideline Harvest Levels for the Guided Sport Fishery for Pacific Halibut in...) for the guided sport fishery in International Pacific Halibut Commission (IPHC) Regulatory Areas 2C... the guided sport fishery for halibut. The GHLs are benchmark harvest levels for participants in the...

  15. 78 FR 47015 - Software Requirement Specifications for Digital Computer Software Used in Safety Systems of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Requirement Specifications for Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory Commission... issuing a revised regulatory guide (RG), revision 1 of RG 1.172, ``Software Requirement Specifications for...

  16. 78 FR 25488 - Qualification Tests for Safety-Related Actuators in Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-01

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0079] Qualification Tests for Safety-Related Actuators in... regulatory guide (DG), DG-1235, ``Qualification Tests for Safety-Related Actuators in Nuclear Power Plants...-251- 7495, email: [email protected] . Both of the Office of Nuclear Regulatory Research, U.S. Nuclear...

  17. Regulatory Facility Guide for Tennessee

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

    Anderson, S.S.; Bock, R.E.; Francis, M.W.

    1994-02-28

    This guide provides detailed compilations of international, federal, and state transportation related regulations applicable to shipments originating at or destined to Tennessee facilities. Information on preferred routes is also given.

  18. Impact of guided exploration and enactive exploration on self-regulatory mechanisms and information acquisition through electronic search.

    PubMed

    Debowski, S; Wood, R E; Bandura, A

    2001-12-01

    Following instruction in basic skills for electronic search, participants who practiced in a guided exploration mode developed stronger self-efficacy and greater satisfaction than those who practiced in a self-guided exploratory mode. Intrinsic motivation was not affected by exploration mode. On 2 post-training tasks, guided exploration participants produced more effective search strategies. expended less effort, made fewer errors, rejected fewer lines of search, and achieved higher performance. Relative lack of support for self-regulatory factors as mediators of exploration mode impacts was attributed to the uninformative feedback from electronic search, which causes most people to remain at a novice level and to require external guidance for development of self-efficacy and skills. Self-guided learning will be more effective on structured tasks with more informative feedback and for individuals with greater expertise on dynamic tasks.

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

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

    Hogan, R.T.

    1993-11-01

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

  20. 76 FR 16017 - Withdrawal of Regulatory Guide 8.5

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ...) Standard N2.3-1979 ``Immediate Evacuation Signal for Use in Industrial Installations,'' published September... Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-6665 Filed 3-21-11...

  1. 76 FR 52715 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... review Draft Final Regulatory Guide (RG) 1.93, ``Availability of Electric Power Sources,'' Revision 1 and new Draft Final RG 1.218, ``Condition Monitoring Techniques for Electric Cables Used in Nuclear Power... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...

  2. 77 FR 60481 - Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Post-Accident...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ...The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing a revision to Regulatory Guide (RG) 1.52, ``Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Post-accident Engineered-Safety-Feature Atmosphere Cleanup Systems in Light-Water-Cooled Nuclear Power Plants.'' This guide applies to the design, inspection, and testing of air filtration and iodine adsorption units of engineered-safety-feature (ESF) atmosphere cleanup systems in light-water-cooled nuclear power plants.

  3. 1 CFR 6.5 - Indexes, digests, and guides.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ANCILLARIES § 6.5 Indexes, digests, and guides. (a) The Director of the Federal Register may order the..., regulatory documents, and notice materials published by the Office, which will serve users of the Federal Register. Indexes, digests, and similar guides will be published yearly or at other intervals as necessary...

  4. 76 FR 18262 - Notice of issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... application and processing of stainless steel to avoid severe sensitization that could lead to stress-corrosion cracking. This guide applies to light-water-cooled reactors. II. Further Information In June 2009...

  5. 76 FR 59173 - Standard Format and Content of License Applications for Conventional Uranium Mills

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ...On May 30, 2008 (73 FR 31152), the U.S. Nuclear Regulatory Commission (NRC) published for public comment a notice of issuance and availability of Draft Regulatory Guide (DG)-3024, ``Standard Format and Content of License Applications for Conventional Uranium Mills.'' DG- 3024 was a proposed Revision 2 of Regulatory Guide (RG) 3.5. However, upon further consideration the NRC has decided not to revise RG 3.5 at this time. For this reason, DG-3024 will be withdrawn. The comment period closed on August 4, 2008, and 6 comments were received. The comments received will be considered and incorporated as appropriate if the NRC decides to revise RG 3.5 in the future.

  6. 76 FR 65544 - Standard Format and Content of License Applications for Mixed Oxide Fuel Fabrication Facilities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ...The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision to regulatory guide (RG) 3.39, ``Standard Format and Content of License Applications for Mixed Oxide Fuel Fabrication Facilities.'' This guide endorses the standard format and content for license applications and integrated safety analysis (ISA) summaries described in the current version of NUREG-1718, ``Standard Review Plan for the Review of an Application for a Mixed Oxide (MOX) Fuel Fabrication Facility,'' as a method that the NRC staff finds acceptable for meeting the regulatory requirements of Title 10 of the Code of Federal Regulations (10 CFR) part 70, ``Domestic Licensing of Special Nuclear Material'' for mixed oxide fuel fabrication facilities.

  7. Carpet Specifiers Guide. Ultron, Advanced Generation Nylon Carpet Fiber.

    ERIC Educational Resources Information Center

    Monsanto Textiles Co., Atlanta, GA.

    The purpose of this guide is to assist specifiers in properly specifying carpet made of Monsanto Ultron advanced generation nylon fiber. The guide describes a variety of conditions that should be considered in arriving at the proper selection and provides reference information and data, ranging from varying regulatory requirements, performance and…

  8. 77 FR 3514 - Protection Against Turbine Missiles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0481] Protection Against Turbine Missiles AGENCY: Nuclear... (NRC or Commission) is issuing a revision to Regulatory Guide 1.115, ``Protection Against Turbine... structures, systems, and components against missiles resulting from turbine failure by the appropriate...

  9. 77 FR 56239 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-12

    ... Draft Final Revision 1 to Regulatory Guide 1.163, ``Performance-Based Containment Leak-Test Program... inconvenience. If attending this meeting, please enter through the One White Flint North building, 11555...

  10. 77 FR 68162 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

    ... Water Reactors,'' Revision 2, and Regulatory Guide 1.79.1, ``Initial Test Program of Emergency Core... White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please...

  11. 77 FR 64148 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-18

    ... Regulatory Guides (RG) RG 1.79, ````Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors,'' Revision 2 and RG 1.79.1, ``Initial Test Program of Emergency Core Cooling Systems for...

  12. 76 FR 50274 - Terrestrial Environmental Studies for Nuclear Power Stations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0182] Terrestrial Environmental Studies for Nuclear Power... draft regulatory guide (DG), DG-4016, ``Terrestrial Environmental Studies for Nuclear Power Stations... environmental studies and analyses supporting licensing decisions for nuclear power reactors. DATES: Submit...

  13. 77 FR 15812 - Initial Test Program of Condensate and Feedwater Systems for Light-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ... comments received on or before this date. Although a time limit is given, comments and suggestions in... guides are encouraged at any time. ADDRESSES: You may access information and comment submissions related... Information The NRC is issuing for public comment a draft guide in the NRC's ``Regulatory Guide'' series. This...

  14. 10 CFR 2.1001 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., magnetic, graphic matter, or other documentary material, regardless of form or characteristic. Documentary... documentary material shall be guided by the topical guidelines in the applicable NRC Regulatory Guide. DOE... Network means the combined system that makes documentary material available electronically to parties...

  15. 75 FR 22868 - Withdrawal of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... Characterization of Seismic Sources and Determination of Safe Shutdown Earthquake Ground Motion.'' FOR FURTHER.... Nuclear Regulatory Commission (NRC) is withdrawing RG 1.165, ``Identification and Characterization of... alter the licensing basis of any currently operating reactor or any of the currently issued early site...

  16. 78 FR 64028 - Decommissioning of Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

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

  17. Transcriptional Regulatory Network Analysis of MYB Transcription Factor Family Genes in Rice.

    PubMed

    Smita, Shuchi; Katiyar, Amit; Chinnusamy, Viswanathan; Pandey, Dev M; Bansal, Kailash C

    2015-01-01

    MYB transcription factor (TF) is one of the largest TF families and regulates defense responses to various stresses, hormone signaling as well as many metabolic and developmental processes in plants. Understanding these regulatory hierarchies of gene expression networks in response to developmental and environmental cues is a major challenge due to the complex interactions between the genetic elements. Correlation analyses are useful to unravel co-regulated gene pairs governing biological process as well as identification of new candidate hub genes in response to these complex processes. High throughput expression profiling data are highly useful for construction of co-expression networks. In the present study, we utilized transcriptome data for comprehensive regulatory network studies of MYB TFs by "top-down" and "guide-gene" approaches. More than 50% of OsMYBs were strongly correlated under 50 experimental conditions with 51 hub genes via "top-down" approach. Further, clusters were identified using Markov Clustering (MCL). To maximize the clustering performance, parameter evaluation of the MCL inflation score (I) was performed in terms of enriched GO categories by measuring F-score. Comparison of co-expressed cluster and clads analyzed from phylogenetic analysis signifies their evolutionarily conserved co-regulatory role. We utilized compendium of known interaction and biological role with Gene Ontology enrichment analysis to hypothesize function of coexpressed OsMYBs. In the other part, the transcriptional regulatory network analysis by "guide-gene" approach revealed 40 putative targets of 26 OsMYB TF hubs with high correlation value utilizing 815 microarray data. The putative targets with MYB-binding cis-elements enrichment in their promoter region, functional co-occurrence as well as nuclear localization supports our finding. Specially, enrichment of MYB binding regions involved in drought-inducibility implying their regulatory role in drought response in rice. Thus, the co-regulatory network analysis facilitated the identification of complex OsMYB regulatory networks, and candidate target regulon genes of selected guide MYB genes. The results contribute to the candidate gene screening, and experimentally testable hypotheses for potential regulatory MYB TFs, and their targets under stress conditions.

  18. Guide for the preparation of applications for Nuclear Pharmacy Licenses

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

    Not Available

    1985-08-01

    The purpose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals for the possession, use, and distribution of by-product material in nuclear pharmacy operations.

  19. Documentation of probabilistic fracture mechanics codes used for reactor pressure vessels subjected to pressurized thermal shock loading: Parts 1 and 2. Final report

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

    Balkey, K.; Witt, F.J.; Bishop, B.A.

    1995-06-01

    Significant attention has been focused on the issue of reactor vessel pressurized thermal shock (PTS) for many years. Pressurized thermal shock transient events are characterized by a rapid cooldown at potentially high pressure levels that could lead to a reactor vessel integrity concern for some pressurized water reactors. As a result of regulatory and industry efforts in the early 1980`s, a probabilistic risk assessment methodology has been established to address this concern. Probabilistic fracture mechanics analyses are performed as part of this methodology to determine conditional probability of significant flaw extension for given pressurized thermal shock events. While recent industrymore » efforts are underway to benchmark probabilistic fracture mechanics computer codes that are currently used by the nuclear industry, Part I of this report describes the comparison of two independent computer codes used at the time of the development of the original U.S. Nuclear Regulatory Commission (NRC) pressurized thermal shock rule. The work that was originally performed in 1982 and 1983 to compare the U.S. NRC - VISA and Westinghouse (W) - PFM computer codes has been documented and is provided in Part I of this report. Part II of this report describes the results of more recent industry efforts to benchmark PFM computer codes used by the nuclear industry. This study was conducted as part of the USNRC-EPRI Coordinated Research Program for reviewing the technical basis for pressurized thermal shock (PTS) analyses of the reactor pressure vessel. The work focused on the probabilistic fracture mechanics (PFM) analysis codes and methods used to perform the PTS calculations. An in-depth review of the methodologies was performed to verify the accuracy and adequacy of the various different codes. The review was structured around a series of benchmark sample problems to provide a specific context for discussion and examination of the fracture mechanics methodology.« less

  20. 78 FR 58575 - Review of Experiments for Research Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0219] Review of Experiments for Research Reactors AGENCY... Commission (NRC) is withdrawing Regulatory Guide (RG) 2.4, ``Review of Experiments for Research Reactors... withdrawing RG 2.4, ``Review of Experiments for Research Reactors,'' (ADAMS Accession No. ML003740131) because...

  1. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ..., Probabilistic Risk Assessment Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research, U.S... approaches and methods (whether quantitative or qualitative, deterministic or probabilistic), data, and... uses in evaluating specific problems or postulated accidents, and data that the staff needs in its...

  2. 76 FR 2425 - Draft Regulatory Guide: Reissuance and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... posted on the NRC website and on the Federal rulemaking website Regulations.gov . Because your comments... publicly disclosed. Federal Rulemaking Website: Go to http://www.regulations.gov and search for [email protected] . The Regulatory Analysis is available electronically under ADAMS Accession Number...

  3. 76 FR 20052 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... Guide 1.149, ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License..., ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License Examinations, and... simulation facility for use in operator and senior operator training, license examination operating tests...

  4. 75 FR 29785 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... Guide, DG-1248, ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License..., ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License Examinations, and... or acceptance of a nuclear power plant simulation facility for use in operator and senior operator...

  5. 76 FR 77431 - Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... (DG) DG-4014, ``Decommissioning Planning During Operations.'' This guide describes a method that the.... The draft regulatory guide entitled, ``Decommissioning Planning During Operations,'' is temporarily..., 40, 50, 70, and 72 RIN 3150-AI55 [NRC-2011-0286; NRC-2008-0030] Decommissioning Planning During...

  6. Air Force Third Party Financing Management Guide.

    DTIC Science & Technology

    1984-05-01

    lhe Public Utility Regulatory Policies Act of 1978 ( PURPA ) a l,s qualifying cogenerators to sell their power back to the utilities al the utilities...Conditions favorable to the sale of cogenerated or independrt~y produced power created by the Public Utility Regulatory Policies Act ( PURPA ) of 1978; o...electrical energy. The Public Utility Regulatory Policies Act of 1978 ( PURPA ) allows qualifying cogenerators to sell their powcr back to the

  7. 76 FR 65753 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at...) re-issued Draft Regulatory Guide, DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear... Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for Monitoring...

  8. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Quality assurance program change. 63.144 Section 63.144 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC... assurance program information that duplicates language in quality assurance regulatory guides and quality...

  9. 77 FR 823 - Guidance for Fuel Cycle Facility Change Processes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-06

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes... Fuel Cycle Facility Change Processes.'' This regulatory guide describes the types of changes for which fuel cycle facility licensees should seek prior approval from the NRC and discusses how licensees can...

  10. Development and testing of the VITAMIN-B7/BUGLE-B7 coupled neutron-gamma multigroup cross-section libraries

    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

  11. Development and Testing of the VITAMIN-B7/BUGLE-B7 Coupled Neutron-Gamma Multigroup Cross-Section Libraries

    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

  12. 75 FR 13599 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... Guide, DG-8040, ``Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication... it deal specifically with the following aspects of an acceptable occupational health physics program that are closely related to surveys: (1) The number and qualification of the health physics staff, (2...

  13. 75 FR 58444 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... Guide, DG-1244, ``Availability of Electric Power Sources.'' FOR FURTHER INFORMATION CONTACT: Satish..., ``Availability of Electric Power Sources'' temporarily identified by its task number, DG- 1244, which should be... Commission (NRC) considers acceptable when the available electric power sources are less than the number of...

  14. 75 FR 62610 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Plant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ...: Draft Regulatory Guide DG-1237, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors,'' Interim Staff Guidance (ISG) NSIR/DPR-ISG-01, ``Emergency Planning for Nuclear Power Plants... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...

  15. 78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ... environmental justice assessments of its regulatory actions for years. This experience and body of work... set of questions to guide analysts in evaluating potential environmental justice concerns in EPA rules.... This guidance takes into account EPA's past experience in integrating EJ into the rulemaking process...

  16. 77 FR 59023 - Preoperational Testing of Instrument and Control Air Systems

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0065] Preoperational Testing of Instrument and Control Air..., ``Preoperational Testing of Instrument and Control Air Systems.'' This regulatory guide is being revised to address... instrument and control air systems (ICAS) to meet seismic requirement, ICAS air- dryer testing to meet dew...

  17. 77 FR 50720 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Test Documentation for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1207, ``Test Documentation for Digital... practices for test documentation for software and computer systems as described in the Institute of...

  18. 78 FR 28896 - Design Limits and Loading Combinations for Metal Primary Reactor Containment System Components

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0095] Design Limits and Loading Combinations for Metal... Regulatory Guide (RG) 1.57, ``Design Limits and Loading Combinations for Metal Primary Reactor Containment... the NRC staff considers acceptable for design limits and loading combinations for metal primary...

  19. 76 FR 74630 - Making Changes to Emergency Plans for Nuclear Power Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

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

  20. 78 FR 24438 - Evaluations of Explosions Postulated To Occur at Nearby Facilities and on Transportation Routes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... Nearby Facilities and on Transportation Routes Near Nuclear Power Plants AGENCY: Nuclear Regulatory... Nearby Facilities and on Transportation Routes Near Nuclear Power Plants.'' This regulatory guide describes for applicants seeking nuclear power reactor licenses and licensees of nuclear power reactors...

  1. 76 FR 50275 - Guidance for the Assessment of Beyond-Design-Basis Aircraft Impacts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ...: Mekonen M. Bayssie, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear... e-mail to [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The Nuclear..., Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-20513 Filed 8-11-11; 8:45 am...

  2. 76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes...-issued Draft Regulatory Guide, DG- 3037, ``Guidance for Fuel Cycle Facility Change Processes'' in the...-3037 from August 12, 2011 to September 16, 2011. DG-3037 describes the types of changes for fuel cycle...

  3. 77 FR 36014 - Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0134] Initial Test Program of Emergency Core Cooling... for public comment draft regulatory guide (DG), DG-1277, ``Initial Test Program of Emergency Core... acceptable to implement with regard to initial testing features of emergency core cooling systems (ECCSs) for...

  4. 76 FR 31467 - Guide Concerning Fuel Economy Advertising for New Automobiles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ...The Federal Trade Commission (``FTC'' or ``Commission'') gives notice that it is postponing any amendments to its Guide Concerning Fuel Economy Advertising for New Automobiles (``Fuel Economy Guide'' or ``Guide'') pending completion of ongoing review by the Environmental Protection Agency (``EPA'') and the National Highway Traffic Safety Administration (``NHTSA'') of current fuel economy labeling requirements and the Commission's accelerated regulatory review of its own Labeling Requirements for Alternative Fuels and Alternative Fueled Vehicles Rule (``Alternative Fuels Rule'').

  5. Advanced Tools Webinar Series Presents: Regulatory Issues and Case Studies of Advanced Tools

    EPA Science Inventory

    U.S. EPA has released A Guide for Assessing Biodegradation and Source Identification of Organic Ground Water Contaminants using Compound Specific Isotope Analysis (CSIA) [EPA 600/R-08/148 | December 2008 | www.epa.gov/ada]. The Guide provides recommendations for sample collecti...

  6. ASME Nuclear Crane Standards for Enhanced Crane Safety and Increased Profit

    NASA Astrophysics Data System (ADS)

    Parkhurst, Stephen N.

    2000-01-01

    The ASME NOG-1 standard, 'Rules for Construction of Overhead and Gantry Cranes', covers top running cranes for nuclear facilities; with the ASME NUM-1 standard, 'Rules for Construction of Cranes, Monorails, and Hoists', covering the single girder, underhung, wall and jib cranes, as well as the monorails and hoists. These two ASME nuclear crane standards provide criteria for designing, inspecting and testing overhead handling equipment with enhanced safety to meet the 'defense-in-depth' approach of the United States Nuclear Regulatory Commission (USNRC) documents NUREG 0554 and NUREG 0612. In addition to providing designs for enhanced safety, the ASME nuclear crane standards provide a basis for purchasing overhead handling equipment with standard safety features, based upon accepted engineering principles, and including performance and environmental parameters specific to nuclear facilities. The ASME NOG-1 and ASME NUM-1 standards not only provide enhanced safety for handling a critical load, but also increase profit by minimizing the possibility of load drops, by reducing cumbersome operating restrictions, and by providing the foundation for a sound licensing position. The ASME nuclear crane standards can also increase profit by providing the designs and information to help ensure that the right standard equipment is purchased. Additionally, the ASME nuclear crane standards can increase profit by providing designs and information to help address current issues, such as the qualification of nuclear plant cranes for making 'planned engineered lifts' for steam generator replacement and decommissioning.

  7. Expert opinion vs. empirical evidence

    PubMed Central

    Herman, Rod A; Raybould, Alan

    2014-01-01

    Expert opinion is often sought by government regulatory agencies when there is insufficient empirical evidence to judge the safety implications of a course of action. However, it can be reckless to continue following expert opinion when a preponderance of evidence is amassed that conflicts with this opinion. Factual evidence should always trump opinion in prioritizing the information that is used to guide regulatory policy. Evidence-based medicine has seen a dramatic upturn in recent years spurred by examples where evidence indicated that certain treatments recommended by expert opinions increased death rates. We suggest that scientific evidence should also take priority over expert opinion in the regulation of genetically modified crops (GM). Examples of regulatory data requirements that are not justified based on the mass of evidence are described, and it is suggested that expertise in risk assessment should guide evidence-based regulation of GM crops. PMID:24637724

  8. Expert opinion vs. empirical evidence: the precautionary principle applied to GM crops.

    PubMed

    Herman, Rod A; Raybould, Alan

    2014-01-01

    Expert opinion is often sought by government regulatory agencies when there is insufficient empirical evidence to judge the safety implications of a course of action. However, it can be reckless to continue following expert opinion when a preponderance of evidence is amassed that conflicts with this opinion. Factual evidence should always trump opinion in prioritizing the information that is used to guide regulatory policy. Evidence-based medicine has seen a dramatic upturn in recent years spurred by examples where evidence indicated that certain treatments recommended by expert opinions increased death rates. We suggest that scientific evidence should also take priority over expert opinion in the regulation of genetically modified crops (GM). Examples of regulatory data requirements that are not justified based on the mass of evidence are described, and it is suggested that expertise in risk assessment should guide evidence-based regulation of GM crops.

  9. Acrilan Contract Carpet Specification Guide.

    ERIC Educational Resources Information Center

    Monsanto Textiles Co., Atlanta, GA.

    The purpose of this guide is to assist specifiers in properly specifying carpet made of Monsanto Acrilan acrylic fiber. As carpet is used in an expanding range of applications, it must meet increasing and varying regulatory requirements. Performance needs vary with the type of environment in which the carpet is installed. Carpet construction must…

  10. 76 FR 59448 - Draft Regulatory Guide; Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-26

    ... consideration only for comments received on or before this date. Although a time limit is given, comments and... published guides are encouraged at any time. ADDRESSES: Please include Docket ID NRC-2011-0224 in the... document using the following methods: NRC's Public Document Room (PDR): The public may examine and have...

  11. 78 FR 38739 - Special Nuclear Material Control and Accounting Systems for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0109] Special Nuclear Material Control and Accounting... Guide (RG) 5.29, ``Special Nuclear Material Control and Accounting Systems for Nuclear Power Plants... material control and accounting. This guide applies to all nuclear power plants. ADDRESSES: Please refer to...

  12. 78 FR 47012 - Developing Software Life Cycle Processes Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Developing Software Life Cycle Processes Used in... revised regulatory guide (RG), revision 1 of RG 1.173, ``Developing Software Life Cycle Processes for... Developing a Software Project Life Cycle Process,'' issued 2006, with the clarifications and exceptions as...

  13. 77 FR 19740 - Water Sources for Long-Term Recirculation Cooling Following a Loss-of-Coolant Accident

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0249] Water Sources for Long-Term Recirculation Cooling... Regulatory Guide (RG) 1.82, ``Water Sources for Long-Term Recirculation Cooling Following a Loss-of-Coolant... regarding the sumps and suppression pools that provide water sources for emergency core cooling, containment...

  14. 75 FR 54918 - Draft Regulatory Guide, DG-1247, “Design-Basis Hurricane and Hurricane Missiles for Nuclear Power...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

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

  15. Evaluation of Modified Risk Claim Advertising Formats for Camel Snus

    ERIC Educational Resources Information Center

    Fix, Brian V.; Adkison, Sarah E.; O'Connor, Richard J.; Bansal-Travers, Maansi; Cummings, K. Michael; Rees, Vaughan W.; Hatsukami, Dorothy K.

    2017-01-01

    Objectives: The US Food and Drug Administration (FDA) has regulatory authority for modified risk tobacco product advertising claims. To guide future regulatory efforts, we investigated how variations in modified risk claim advertisements influence consumer perceptions of product risk claims for Camel Snus. Methods: Young people and adults (15-65),…

  16. 77 FR 50722 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1208, ``Software Unit Testing for Digital Computer Software used in Safety Systems of Nuclear Power Plants.'' The DG-1208 is proposed...

  17. 78 FR 47011 - Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Software Unit Testing for Digital Computer Software... revised regulatory guide (RG), revision 1 of RG 1.171, ``Software Unit Testing for Digital Computer Software Used in Safety Systems of Nuclear Power Plants.'' This RG endorses American National Standards...

  18. Social Possible Selves, Self-Regulation, and Social Goal Progress in Older Adulthood

    ERIC Educational Resources Information Center

    Ko, Han-Jung; Mejía, Shannon; Hooker, Karen

    2014-01-01

    Lifespan development involves setting and pursuing self-guided goals. This study examines how in the social domain, possible selves, a future-oriented self-concept, and self-regulation, including self-regulatory beliefs and intraindividual variability in self-regulatory behavior, relate to differences in overall daily social goal progress. An…

  19. 77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

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

  20. Voices from the Other Side of the Fence: Early Childhood Teachers' Experiences with Mandatory Regulatory Requirements

    ERIC Educational Resources Information Center

    Bown, Kathryn; Sumsion, Jennifer

    2007-01-01

    Guided by feminist research principles, the study reported in this article contributes to the growing research dialogue on early childhood teachers' experiences with, and perceptions of, the impact of regulatory requirements on their teaching and on their perceptions of themselves as professionals. Specifically, three teachers from metropolitan…

  1. 78 FR 64027 - Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to regulatory guide (RG), 1.79, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors.'' This RG is being revised to incorporate guidance for preoperational testing of new pressurized water reactor (PWR) designs.

  2. 76 FR 53979 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Thermal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Thermal Hydraulics Phenomena; Notice of Meeting The ACRS Subcommittee on Thermal Hydraulics... Revision 4 to Regulatory Guide 1.82, ``Water Sources for Long-Term Recirculation Cooling Following a Loss...

  3. 76 FR 43356 - Evaluations of Explosions Postulated To Occur at Nearby Facilities and on Transportation Routes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... the ``Regulatory Guides'' collection of the NRC's Library at http://www.nrc.gov/reading-rm/doc... NUCLEAR REGULATORY COMMISSION [NRC-2011-0152] Evaluations of Explosions Postulated To Occur at..., ``Evaluations of Explosions Postulated to Occur at Nearby Facilities and on Transportation Routes Near Nuclear...

  4. 77 FR 38856 - An Approach for Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ... discussion on defense-in-depth. Specifically, the SRM stated, Because the statements in Regulatory Guide 1... language to assure that the defense-in-depth philosophy is interpreted and implemented consistently. To the extent that other regulatory guidance refers to defense in depth, the relevant documents should be...

  5. [Sporulation or competence development? A genetic regulatory network model of cell-fate determination in Bacillus subtilis].

    PubMed

    Lu, Zhenghui; Zhou, Yuling; Zhang, Xiaozhou; Zhang, Guimin

    2015-11-01

    Bacillus subtilis is a generally recognized as safe (GRAS) strain that has been widely used in industries including fodder, food, and biological control. In addition, B. subtilis expression system also plays a significant role in the production of industrial enzymes. However, its application is limited by its low sporulation frequency and transformation efficiency. Immense studies have been done on interpreting the molecular mechanisms of sporulation and competence development, whereas only few of them were focused on improving sporulation frequency and transformation efficiency of B. subtilis by genetic modification. The main challenge is that sporulation and competence development, as the two major developmental events in the stationary phase of B. subtilis, are regulated by the complicated intracellular genetic regulatory systems. In addition, mutual regulatory mechanisms also exist in these two developmental events. With the development of genetic and metabolic engineering, constructing genetic regulatory networks is currently one of the most attractive research fields, together with the genetic information of cell growth, metabolism, and development, to guide the industrial application. In this review, the mechanisms of sporulation and competence development of B. subtilis, their interactions, and the genetic regulation of cell growth were interpreted. In addition, the roles of these regulatory networks in guiding basic and applied research of B. subtilis and its related species were discussed.

  6. Molecular mechanisms of system responses to novel stimuli are predictable from public data

    PubMed Central

    Danziger, Samuel A.; Ratushny, Alexander V.; Smith, Jennifer J.; Saleem, Ramsey A.; Wan, Yakun; Arens, Christina E.; Armstrong, Abraham M.; Sitko, Katherine; Chen, Wei-Ming; Chiang, Jung-Hsien; Reiss, David J.; Baliga, Nitin S.; Aitchison, John D.

    2014-01-01

    Systems scale models provide the foundation for an effective iterative cycle between hypothesis generation, experiment and model refinement. Such models also enable predictions facilitating the understanding of biological complexity and the control of biological systems. Here, we demonstrate the reconstruction of a globally predictive gene regulatory model from public data: a model that can drive rational experiment design and reveal new regulatory mechanisms underlying responses to novel environments. Specifically, using ∼1500 publically available genome-wide transcriptome data sets from Saccharomyces cerevisiae, we have reconstructed an environment and gene regulatory influence network that accurately predicts regulatory mechanisms and gene expression changes on exposure of cells to completely novel environments. Focusing on transcriptional networks that induce peroxisomes biogenesis, the model-guided experiments allow us to expand a core regulatory network to include novel transcriptional influences and linkage across signaling and transcription. Thus, the approach and model provides a multi-scalar picture of gene dynamics and are powerful resources for exploiting extant data to rationally guide experimentation. The techniques outlined here are generally applicable to any biological system, which is especially important when experimental systems are challenging and samples are difficult and expensive to obtain—a common problem in laboratory animal and human studies. PMID:24185701

  7. Rationales for regulatory activity

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

    Perhac, R.M.

    1997-02-01

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

  8. Increasing Student Achievement: Educators' Guide to Secondary Career & Technical Education Assessment

    ERIC Educational Resources Information Center

    National Occupational Competency Testing Institute, 2012

    2012-01-01

    This guide attempts to address an aspect of secondary CTE (Career and Technical Education) that has received little attention; the assessment literacy of educators. School leaders need to go beyond ensuring routine compliance with external and internal regulatory forces to identify ways in which CTE program teachers might better understand…

  9. 76 FR 51308 - Retail Food Store Advertising and Marketing Practices Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... FTC rules and guides, the Commission requests public comment on the overall costs, benefits, necessity..., after a comment period and public hearings, the Commission concluded that the costs of complying with... about the costs and benefits of the rules and guides as well as their regulatory and economic impact...

  10. 75 FR 66411 - Small Entity Compliance Guide: Women-Owned Small Business Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ...-Owned Small Business (WOSB) Program. This guide sets forth in plain language the requirements for... effective February 4, 2011 because the agency is in the process of working with the Federal Acquisition Regulatory Council to implement this program in the Federal Acquisition Regulations. In addition, the SBA is...

  11. 78 FR 70482 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-71; Small Entity Compliance Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ...: Small Entity Compliance Guide. SUMMARY: This document is issued under the joint authority of DOD, GSA... the FAR case number. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202- 501-4755. Rules Listed in FAC 2005-71 Item Subject FAR Case Analyst *I...

  12. 76 FR 41150 - Notice Announcing Ten-Year Regulatory Review Schedule and Request for Public Comment on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... in the face of changing marketplace conditions, evolving consumer behavior, and technological...) 326-2984, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission... continuing need for the rule or guide as well as the rule's or guide's costs and benefits to consumers and...

  13. 76 FR 72738 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ...-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Correcting an Error by Renumbering the Subsections of Section 101 of the Company Guide November 18, 2011... thereunder,\\3\\ notice is hereby given that on November 16, 2011, NYSE Amex LLC (the ``Exchange'' or...

  14. Regulatory Services and Records. A Major Occupational Group in the Public Service Cluster. Teacher's Manual.

    ERIC Educational Resources Information Center

    Gwinnett County Schools, GA.

    Part of a course designed to acquaint high school students with basic information concerning careers in public service, this teacher's manual is one of nine (each with accompanying student guide) which constitute a course entitled "Orientation to Public Service." Focus in the units covered by the manual is on regulatory services and…

  15. 76 FR 19155 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... stated that it would offer training on the revised Discovery Guide in a workshop that FINRA would post as... Procedure for Customer Disputes April 1, 2011. I. Introduction On July 12, 2010, the Financial Industry... Arbitration Procedure for Customer Disputes (``Customer Code''). The proposed rule change was published for...

  16. 77 FR 75453 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 68443; File No. SR-DTC-2012-09] Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Make Ministerial Changes to the Existing Reorganization Service Guide December 14, 2012. Pursuant to Section 19(b)(1) of the Securitie...

  17. 76 FR 52596 - Request for Comment Concerning Interpretations of the Magnuson-Moss Warranty Act; Rule Governing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... requests public comment on the overall costs, benefits, necessity and regulatory and economic impact of... of the Interpretations, Rules and Guides? Why or why not? 2. What benefits and costs have the... benefits and costs have the Interpretations, Rules and Guides had on consumers who purchase the warranted...

  18. Urban Stormwater Runoff. Instructor Guide. Working for Clean Water: An Information Program for Advisory Groups.

    ERIC Educational Resources Information Center

    Simko, Robert A.

    Urban stormwater runoff collects pollutants from many parts of a city and is an important consideration in water quality planning. Presented is an instructor's guide for a learning session covering various aspects of urban runoff including pollutant sources, management practices, and regulatory programs. Intended for citizen advisory groups, this…

  19. 78 FR 55117 - Ultimate Heat Sink for Nuclear Power Plants; Draft Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... applicants may use to implement general design criteria (GDC) that are applicable to the ultimate heat sink... only for comments received on or before this date. Although a time limit is given, comments and... published guides are encouraged at any time. ADDRESSES: You may submit comment by any of the following...

  20. 78 FR 15753 - Maintenance, Testing, and Replacement of Vented Lead-Acid Storage Batteries for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    .... Although a time limit is given, comments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time. ADDRESSES: You...: 301-251-7455, or by email: [email protected] . Both of the Office of Nuclear Regulatory Research...

  1. Occupational Safety and Health in Vocational Education: A Guide for Administrators, Faculty, and Staff.

    ERIC Educational Resources Information Center

    Godbey, Frank W.

    This guide is intended to help administrators at schools having vocational education programs assess their occupational safety and health needs and establish a program to ensure a safer and more healthful work environment. It consists of three sections: (1) administrative guidelines, (2) technical-regulatory guidelines, and (3) a self-evaluation…

  2. The VTAC Committee: developing guidance for an alternative regulatory pathway to the anadromous salmonid protection rules

    Treesearch

    Michael Liquori; Peter Cafferata; Kevin Boston; Richard Gienger; David Hope

    2012-01-01

    In recent decades, riparian protection standards have been guided by generalized prescriptive rules. With the passage of the Anadromous Salmonid Protection rules in 2009, the Board of Forestry and Fire Protection (Board) established a regulatory pathway that provides an alternative approach for riparian protection based on site-specific criteria (14 CCR § 916....

  3. 77 FR 12086 - Final Staff Guidance, Revision 4 to Standard Review Plan; Section 8.1 on Electric Power-Introduction

    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...

  4. Clinical and regulatory considerations in pharmacogenetic testing.

    PubMed

    Schuck, Robert N; Marek, Elizabeth; Rogers, Hobart; Pacanowski, Michael

    2016-12-01

    Both regulatory science and clinical practice rely on best available scientific data to guide decision-making. However, changes in clinical practice may be driven by numerous other factors such as cost. In this review, we reexamine noteworthy examples where pharmacogenetic testing information was added to drug labeling to explore how the available evidence, potential public health impact, and predictive utility of each pharmacogenetic biomarker impacts clinical uptake. Advances in the field of pharmacogenetics have led to new discoveries about the genetic basis for variability in drug response. The Food and Drug Administration recognizes the value of pharmacogenetic testing strategies and has been proactive about incorporating pharmacogenetic information into the labeling of both new drugs and drugs already on the market. Although some examples have readily translated to routine clinical practice, clinical uptake of genetic testing for many drugs has been limited. Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmacogenetic testing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  5. Verification and Validation Strategy for LWRS Tools

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

    Carl M. Stoots; Richard R. Schultz; Hans D. Gougar

    2012-09-01

    One intension of the Department of Energy (DOE) Light Water Reactor Sustainability (LWRS) program is to create advanced computational tools for safety assessment that enable more accurate representation of a nuclear power plant safety margin. These tools are to be used to study the unique issues posed by lifetime extension and relicensing of the existing operating fleet of nuclear power plants well beyond their first license extension period. The extent to which new computational models / codes such as RELAP-7 can be used for reactor licensing / relicensing activities depends mainly upon the thoroughness with which they have been verifiedmore » and validated (V&V). This document outlines the LWRS program strategy by which RELAP-7 code V&V planning is to be accomplished. From the perspective of developing and applying thermal-hydraulic and reactivity-specific models to reactor systems, the US Nuclear Regulatory Commission (NRC) Regulatory Guide 1.203 gives key guidance to numeric model developers and those tasked with the validation of numeric models. By creating Regulatory Guide 1.203 the NRC defined a framework for development, assessment, and approval of transient and accident analysis methods. As a result, this methodology is very relevant and is recommended as the path forward for RELAP-7 V&V. However, the unique issues posed by lifetime extension will require considerations in addition to those addressed in Regulatory Guide 1.203. Some of these include prioritization of which plants / designs should be studied first, coupling modern supporting experiments to the stringent needs of new high fidelity models / codes, and scaling of aging effects.« less

  6. 75 FR 16216 - Self-Regulatory Organizations; the Depository Trust Company; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... Change To Update Its Settlement Service Guide as It Relates to the ID Net Service March 25, 2010... change amends DTC's rules in order to update its Settlement Service Guide as it relates to the ID Net... the purpose of and basis for the proposed rule change and discussed any comments it received on the...

  7. An Exploration of the Legal and Regulatory Environment of Privacy and Security through Active Research, Guided Study, Blog Creation, and Discussion

    ERIC Educational Resources Information Center

    Peslak, Alan R.

    2010-01-01

    One of the most important topics for today's information technology professional is the study of legal and regulatory issues as they relate to privacy and security of personal and business data and identification. This manuscript describes the topics and approach taken by the instructors that focuses on independent research of source documents and…

  8. Phase 1 environmental report for the Advanced Neutron Source at Oak Ridge National Laboratory

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

    Blasing, T.J.; Brown, R.A.; Cada, G.F.

    1992-02-01

    The US Department of Energy (DOE) has proposed the construction and operation of the Advanced Neutron Source (ANS), a 330-MW(f) reactor, at Oak Ridge National Laboratory (ORNL) to support neutron scattering and nuclear physics experiments. ANS would provide a steady-state source of neutrons that are thermalized to produce sources of hot, cold, and very coal neutrons. The use of these neutrons in ANS experiment facilities would be an essential component of national research efforts in basic materials science. Additionally, ANS capabilities would include production of transplutonium isotopes, irradiation of potential fusion and fission reactor materials, activation analysis, and production ofmore » medical and industrial isotopes such as {sup 252}Cf. Although ANS would not require licensing by the US Nuclear Regulatory Commission (NRC), DOE regards the design, construction, and operation of ANS as activities that would produce a licensable facility; that is, DOE is following the regulatory guidelines that NRC would apply if NRC were licensing the facility. Those guidelines include instructions for the preparation of an environmental report (ER), a compilation of available data and preliminary analyses regarding the environmental impacts of nuclear facility construction and operation. The ER, described and outlined in NRC Regulatory Guide 4.2, serves as a background document to facilitate the preparation of environmental impact statements (EISs). Using Regulatory Guide 4.2 as a model, this ANS ER provides analyses and information specific to the ANS site and area that can be adopted (and modified, if necessary) for the ANS EIS. The ER is being prepared in two phases. Phase 1 ER includes many of the data and analyses needed to prepare the EIS but does not include data or analyses of alternate sites or alternate technologies. Phase 2 ER will include the additional data and analyses stipulated by Regulatory Guide 4.2.« less

  9. NRC safety research in support of regulation - FY 1994. Volume 9

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

    NONE

    This report, the tenth in a series of annual reports, was prepared in response to congressional inquiries concerning how nuclear regulatory research is used. It summarizes the accomplishments of the Office of Nuclear Regulatory Research during FY 1994. The goal of the Office of Nuclear Regulatory Research (RES) is to ensure the availability of sound technical bases for timely rulemaking and related decisions in support of NRC regulatory/licensing/inspection activities. RES also has responsibilities related to the resolution of generic safety issues and to the review of licensee submittals regarding individual plant examinations. It is the responsibility of RES to conductmore » the NRC`s rulemaking process, including the issuance of regulatory guides and rules that govern NRC licensed activities.« less

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

    Eperin, A.P.; Zakharzhevsky, Yu.O.; Arzhaev, A.I.

    A two-year Finnish-Russian cooperation program has been initiated in 1995 to demonstrate the applicability of the leak-before-break concept (LBB) to the primary circuit piping of the Leningrad NPP. The program includes J-R curve testing of authentic pipe materials at full operating temperature, screening and computational LBB analyses complying with the USNRC Standard Review Plan 3.6.3, and exchange of LBB-related information with emphasis on NDE. Domestic computer codes are mainly used, and all tests and analyses are independently carried out by each party. The results are believed to apply generally to RBMK type plants of the first generation.

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

    Bozoki, G.E.; Fitzpatrick, R.G.; Bohn, M.P.

    This report details the review of the Diablo Canyon Probabilistic Risk Assessment (DCPRA). The study was performed under contract from the Probabilistic Risk Analysis Branch, Office of Nuclear Reactor Research, USNRC by Brookhaven National Laboratory. The DCPRA is a full scope Level I effort and although the review touched on all aspects of the PRA, the internal events and seismic events received the vast majority of the review effort. The report includes a number of independent systems analyses sensitivity studies, importance analyses as well as conclusions on the adequacy of the DCPRA for use in the Diablo Canyon Long Termmore » Seismic Program.« less

  12. 75 FR 19665 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ... processes, including welding, heat treating, and nondestructive testing, are controlled and accomplished by... that when stressed under operating, maintenance, testing, and postulated accident conditions (1) the...

  13. 75 FR 48381 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ..., (2) demonstrating containment structural integrity related to combustible gas control, and (3... pertain to the containment structural capacity above design-basis pressures, to combustible gas control...

  14. Acid-base homeostasis in the human system

    NASA Technical Reports Server (NTRS)

    White, R. J.

    1974-01-01

    Acid-base regulation is a cooperative phenomena in vivo with body fluids, extracellular and intracellular buffers, lungs, and kidneys all playing important roles. The present account is much too brief to be considered a review of present knowledge of these regulatory systems, and should be viewed, instead, as a guide to the elements necessary to construct a simple model of the mutual interactions of the acid-base regulatory systems of the body.

  15. Metabolic engineering of Bacillus subtilis fueled by systems biology: Recent advances and future directions.

    PubMed

    Liu, Yanfeng; Li, Jianghua; Du, Guocheng; Chen, Jian; Liu, Long

    By combining advanced omics technology and computational modeling, systems biologists have identified and inferred thousands of regulatory events and system-wide interactions of the bacterium Bacillus subtilis, which is commonly used both in the laboratory and in industry. This dissection of the multiple layers of regulatory networks and their interactions has provided invaluable information for unraveling regulatory mechanisms and guiding metabolic engineering. In this review, we discuss recent advances in the systems biology and metabolic engineering of B. subtilis and highlight current gaps in our understanding of global metabolism and global pathway engineering in this organism. We also propose future perspectives in the systems biology of B. subtilis and suggest ways that this approach can be used to guide metabolic engineering. Specifically, although hundreds of regulatory events have been identified or inferred via systems biology approaches, systematic investigation of the functionality of these events in vivo has lagged, thereby preventing the elucidation of regulatory mechanisms and further rational pathway engineering. In metabolic engineering, ignoring the engineering of multilayer regulation hinders metabolic flux redistribution. Post-translational engineering, allosteric engineering, and dynamic pathway analyses and control will also contribute to the modulation and control of the metabolism of engineered B. subtilis, ultimately producing the desired cellular traits. We hope this review will aid metabolic engineers in making full use of available systems biology datasets and approaches for the design and perfection of microbial cell factories through global metabolism optimization. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. A Field Experiment Testing the Utility of Regulatory Fit Messages for Promoting Physical Activity.

    PubMed

    Latimer, Amy E; Rivers, Susan E; Rench, Tara A; Katulak, Nicole A; Hicks, Althea; Hodorowski, Julie Keany; Higgins, E Tory; Salovey, Peter

    2008-05-01

    Guided by regulatory focus theory, we examined whether messages tailored to individuals' promotion- or prevention-goal orientation (regulatory focus) elicit positive thoughts and feelings about physical activity and increase participation in physical activity. Inactive participants (N = 206) were assigned randomly to receive either promotion-focused or prevention-focused messages encouraging physical activity. Two weeks after message exposure, we assessed participants' thoughts and feelings about physical activity and physical activity behavior. Tailored messages that fit individuals' regulatory focus led to greater physical activity participation and more positive feelings than non-fit messages, particularly in the promotion-focused condition. Furthermore, positive retrospective feelings about physical activity mediated the effects of the tailored messages on behavior. These findings provide support for regulatory focus theory and direction for enhancing the effectiveness of messages encouraging physical activity and other health behaviors.

  17. The role of the PIRT process in identifying code improvements and executing code development

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

    Wilson, G.E.; Boyack, B.E.

    1997-07-01

    In September 1988, the USNRC issued a revised ECCS rule for light water reactors that allows, as an option, the use of best estimate (BE) plus uncertainty methods in safety analysis. The key feature of this licensing option relates to quantification of the uncertainty in the determination that an NPP has a {open_quotes}low{close_quotes} probability of violating the safety criteria specified in 10 CFR 50. To support the 1988 licensing revision, the USNRC and its contractors developed the CSAU evaluation methodology to demonstrate the feasibility of the BE plus uncertainty approach. The PIRT process, Step 3 in the CSAU methodology, wasmore » originally formulated to support the BE plus uncertainty licensing option as executed in the CSAU approach to safety analysis. Subsequent work has shown the PIRT process to be a much more powerful tool than conceived in its original form. Through further development and application, the PIRT process has shown itself to be a robust means to establish safety analysis computer code phenomenological requirements in their order of importance to such analyses. Used early in research directed toward these objectives, PIRT results also provide the technical basis and cost effective organization for new experimental programs needed to improve the safety analysis codes for new applications. The primary purpose of this paper is to describe the generic PIRT process, including typical and common illustrations from prior applications. The secondary objective is to provide guidance to future applications of the process to help them focus, in a graded approach, on systems, components, processes and phenomena that have been common in several prior applications.« less

  18. Communication Regulatory Science: Mapping a New Field.

    PubMed

    Noar, Seth M; Cappella, Joseph N; Price, Simani

    2017-12-13

    Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

  19. Towards a successful clinical implementation of fluorescence-guided surgery.

    PubMed

    Snoeks, T J A; van Driel, P B A A; Keereweer, S; Aime, S; Brindle, K M; van Dam, G M; Löwik, C W G M; Ntziachristos, V; Vahrmeijer, A L

    2014-04-01

    During the European Molecular Imaging Meeting (EMIM) 2013, the fluorescence-guided surgery study group held its inaugural session to discuss the clinical implementation of fluorescence-guided surgery. The general aim of this study group is to discuss and identify the steps required to successfully and safely bring intraoperative fluorescence imaging to the clinics. The focus group intends to use synergies between interested groups as a tool to address regulatory and implementation hurdles in Europe and operates within the intraoperative focus group of the World Molecular Imaging Society (WMIS) that promotes the same interests at the WMIS level. The major topics on the critical path of implementation identified within the study group were quality controls and standards for ensuring accurate imaging and the ability to compare results from different studies, regulatory affairs, and strategies to increase awareness among physicians, regulators, insurance companies, and a broader audience. These hurdles, and the possible actions discussed to overcome them, are summarized in this report. Furthermore, a number of recommendations for the future shape of the fluorescence-guided study group are discussed. A main driving conclusion remains that intraoperative imaging has great clinical potential and that many of the solutions required are best addressed with the community working together to optimally promote and accelerate the clinical implementation of fluorescence imaging towards improving surgical procedures.

  20. Printing and Related Support Activities Sector (NAICS 323)

    EPA Pesticide Factsheets

    Find environmental regulatory and compliance information for the printing sector, including NESHAPs for paper surface coating, RCRA hazardous waste guide for small business, and a pollution prevention guidance for lithographic and screen printing

  1. 75 FR 42170 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ..., techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the... (EDEX) radiation exposures. These methods provide a conservative estimate of the EDEX and may be used to...

  2. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

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

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

    2006-01-01

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

  3. Regulatory guidance for lightning protection in nuclear power plants

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

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

    2006-07-01

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

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

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

    Mikio Kurihara; Masahiro Aoki; Yu Maruyama

    2006-07-01

    Comprehensive reformation of the regulatory system has been introduced in Japan in order to apply recent technical progress in a timely manner. 'The Technical Standards for Nuclear Power Generation Equipments', known as the Ordinance No.622) of the Ministry of International Trade and Industry, which is used for detailed design, construction and operating stage of Nuclear Power Plants, was being modified to performance specifications with the consensus codes and standards being used as prescriptive specifications, in order to facilitate prompt review of the Ordinance with response to technological innovation. The activities on modification were performed by the Nuclear and Industrial Safetymore » Agency (NISA), the regulatory body in Japan, with support of the Japan Nuclear Energy Safety Organization (JNES), a technical support organization. The revised Ordinance No.62 was issued on July 1, 2005 and is enforced from January 1 2006. During the period from the issuance to the enforcement, JNES carried out to prepare enforceable regulatory guide which complies with each provisions of the Ordinance No.62, and also made technical assessment to endorse the applicability of consensus codes and standards, in response to NISA's request. Some consensus codes and standards were re-assessed since they were already used in regulatory review of the construction plan submitted by licensee. Other consensus codes and standards were newly assessed for endorsement. In case that proper consensus code or standards were not prepared, details of regulatory requirements were described in the regulatory guide as immediate measures. At the same time, appropriate standards developing bodies were requested to prepare those consensus code or standards. Supplementary note which provides background information on the modification, applicable examples etc. was prepared for convenience to the users of the Ordinance No. 62. This paper shows the activities on modification and the results, following the NISA's presentation at ICONE-13 that introduced the framework of the performance specifications and the modification process of the Ordinance NO. 62. (authors)« less

  5. Land and Water Use Characteristics and Human Health Input Parameters for use in Environmental Dosimetry and Risk Assessments at the Savannah River Site. 2016 Update

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

    Jannik, G. Tim; Hartman, Larry; Stagich, Brooke

    Operations at the Savannah River Site (SRS) result in releases of small amounts of radioactive materials to the atmosphere and to the Savannah River. For regulatory compliance purposes, potential offsite radiological doses are estimated annually using computer models that follow U.S. Nuclear Regulatory Commission (NRC) regulatory guides. Within the regulatory guides, default values are provided for many of the dose model parameters, but the use of applicant site-specific values is encouraged. Detailed surveys of land-use and water-use parameters were conducted in 1991 and 2010. They are being updated in this report. These parameters include local characteristics of meat, milk andmore » vegetable production; river recreational activities; and meat, milk and vegetable consumption rates, as well as other human usage parameters required in the SRS dosimetry models. In addition, the preferred elemental bioaccumulation factors and transfer factors (to be used in human health exposure calculations at SRS) are documented. The intent of this report is to establish a standardized source for these parameters that is up to date with existing data, and that is maintained via review of future-issued national references (to evaluate the need for changes as new information is released). These reviews will continue to be added to this document by revision.« less

  6. Land and Water Use Characteristics and Human Health Input Parameters for use in Environmental Dosimetry and Risk Assessments at the Savannah River Site 2017 Update

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

    Jannik, T.; Stagich, B.

    Operations at the Savannah River Site (SRS) result in releases of relatively small amounts of radioactive materials to the atmosphere and to the Savannah River. For regulatory compliance purposes, potential offsite radiological doses are estimated annually using computer models that follow U.S. Nuclear Regulatory Commission (NRC) regulatory guides. Within the regulatory guides, default values are provided for many of the dose model parameters, but the use of site-specific values is encouraged. Detailed surveys of land-use and water-use parameters were conducted in 1991, 2008, 2010, and 2016 and are being concurred with or updated in this report. These parameters include localmore » characteristics of meat, milk, and vegetable production; river recreational activities; and meat, milk, and vegetable consumption rates, as well as other human usage parameters required in the SRS dosimetry models. In addition, the preferred elemental bioaccumulation factors and transfer factors (to be used in human health exposure calculations at SRS) are documented. The intent of this report is to establish a standardized source for these parameters that is up to date with existing data, and that is maintained via review of future-issued national references (to evaluate the need for changes as new information is released). These reviews will continue to be added to this document by revision.« less

  7. Effects on fatigue life of gate valves due to higher torque switch settings during operability testing

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

    Richins, W.D.; Snow, S.D.; Miller, G.K.

    1995-12-01

    Some motor operated valves now have higher torque switch settings due to regulatory requirements to ensure valve operability with appropriate margins at design basis conditions. Verifying operability with these settings imposes higher stem loads during periodic inservice testing. These higher test loads increase stresses in the various valve internal parts which may in turn increase the fatigue usage factors. This increased fatigue is judged to be a concern primarily in the valve disks, seats, yokes, stems, and stem nuts. Although the motor operators may also have significantly increased loading, they are being evaluated by the manufacturers and are beyond themore » scope of this study. Two gate valves representative of both relatively weak and strong valves commonly used in commercial nuclear applications were selected for fatigue analyses. Detailed dimensional and test data were available for both valves from previous studies at the Idaho National Engineering Laboratory. Finite element models were developed to estimate maximum stresses in the internal parts of the valves and to identity the critical areas within the valves where fatigue may be a concern. Loads were estimated using industry standard equations for calculating torque switch settings prior and subsequent to the testing requirements of USNRC Generic Letter 89--10. Test data were used to determine both; (1) the overshoot load between torque switch trip and final seating of the disk during valve closing and (2) the stem thrust required to open the valves. The ranges of peak stresses thus determined were then used to estimate the increase in the fatigue usage factors due to the higher stem thrust loads. The usages that would be accumulated by 100 base cycles plus one or eight test cycles per year over 40 and 60 years of operation were calculated.« less

  8. Finite element analyses for seismic shear wall international standard problem

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

    Park, Y.J.; Hofmayer, C.H.

    Two identical reinforced concrete (RC) shear walls, which consist of web, flanges and massive top and bottom slabs, were tested up to ultimate failure under earthquake motions at the Nuclear Power Engineering Corporation`s (NUPEC) Tadotsu Engineering Laboratory, Japan. NUPEC provided the dynamic test results to the OECD (Organization for Economic Cooperation and Development), Nuclear Energy Agency (NEA) for use as an International Standard Problem (ISP). The shear walls were intended to be part of a typical reactor building. One of the major objectives of the Seismic Shear Wall ISP (SSWISP) was to evaluate various seismic analysis methods for concrete structuresmore » used for design and seismic margin assessment. It also offered a unique opportunity to assess the state-of-the-art in nonlinear dynamic analysis of reinforced concrete shear wall structures under severe earthquake loadings. As a participant of the SSWISP workshops, Brookhaven National Laboratory (BNL) performed finite element analyses under the sponsorship of the U.S. Nuclear Regulatory Commission (USNRC). Three types of analysis were performed, i.e., monotonic static (push-over), cyclic static and dynamic analyses. Additional monotonic static analyses were performed by two consultants, F. Vecchio of the University of Toronto (UT) and F. Filippou of the University of California at Berkeley (UCB). The analysis results by BNL and the consultants were presented during the second workshop in Yokohama, Japan in 1996. A total of 55 analyses were presented during the workshop by 30 participants from 11 different countries. The major findings on the presented analysis methods, as well as engineering insights regarding the applicability and reliability of the FEM codes are described in detail in this report. 16 refs., 60 figs., 16 tabs.« less

  9. An Application of the SSHAC Level 3 Process to the Probabilistic Seismic Hazard Analysis for Nuclear Facilities at the Hanford Site, Eastern Washington, USA

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

    Coppersmith , Kevin J.; Bommer, Julian J.; Bryce, Robert W.

    Under the sponsorship of the US Department of Energy (DOE) and the electric utility Energy Northwest, the Pacific Northwest National Laboratory (PNNL) is conducting a probabilistic seismic hazard analysis (PSHA) within the framework of a SSHAC Level 3 procedure (Senior Seismic Hazard Analysis Committee; Budnitz et al., 1997). Specifically, the project is being conducted following the guidelines and requirements specified in NUREG-2117 (USNRC, 2012b) and consistent with approach given in the American Nuclear Standard ANSI/ANS-2.29-2008 Probabilistic Seismic Hazard Analysis. The collaboration between DOE and Energy Northwest is spawned by the needs of both organizations for an accepted PSHA with highmore » levels of regulatory assurance that can be used for the design and safety evaluation of nuclear facilities. DOE committed to this study after performing a ten-year review of the existing PSHA, as required by DOE Order 420.1C. The study will also be used by Energy Northwest as a basis for fulfilling the NRC’s 10CFR50.54(f) requirement that the western US nuclear power plants conduct PSHAs in conformance with SSHAC Level 3 procedures. The study was planned and is being carried out in conjunction with a project Work Plan, which identifies the purpose of the study, the roles and responsibilities of all participants, tasks and their associated schedules, Quality Assurance (QA) requirements, and project deliverables. New data collection and analysis activities are being conducted as a means of reducing the uncertainties in key inputs to the PSHA. It is anticipated that the results of the study will provide inputs to the site response analyses at multiple nuclear facility sites within the Hanford Site and at the Columbia Generating Station.« less

  10. 76 FR 66090 - Facility Operating License Amendment From Virginia Electric and Power Company, Surry Power...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... operating pressures, leakage from primary water stress corrosion cracking below the proposed limited... discussed in Regulatory Guide (RG) 1.121, ``Bases for Plugging Degraded PWR [Pressurized-Water Reactor...

  11. Guide for FOIA Requests for Pesticide Information

    EPA Pesticide Factsheets

    Much scientific and regulatory information concerning pesticides is available to the public without submitting a FOIA request. Review pesticide information resources that may include the information you are seeking. Learn how to submit a FOIA request.

  12. 75 FR 9627 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-03

    ... staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its... qualification testing of a prototype unit under the most adverse design conditions. II. Further Information In...

  13. Frameworks for Assessing the Quality of Modeling and Simulation Capabilities

    NASA Astrophysics Data System (ADS)

    Rider, W. J.

    2012-12-01

    The importance of assuring quality in modeling and simulation has spawned several frameworks for structuring the examination of quality. The format and content of these frameworks provides an emphasis, completeness and flow to assessment activities. I will examine four frameworks that have been developed and describe how they can be improved and applied to a broader set of high consequence applications. Perhaps the first of these frameworks was known as CSAU [Boyack] (code scaling, applicability and uncertainty) used for nuclear reactor safety and endorsed the United States' Nuclear Regulatory Commission (USNRC). This framework was shaped by nuclear safety practice, and the practical structure needed after the Three Mile Island accident. It incorporated the dominant experimental program, the dominant analysis approach, and concerns about the quality of modeling. The USNRC gave it the force of law that made the nuclear industry take it seriously. After the cessation of nuclear weapons' testing the United States began a program of examining the reliability of these weapons without testing. This program utilizes science including theory, modeling, simulation and experimentation to replace the underground testing. The emphasis on modeling and simulation necessitated attention on the quality of these simulations. Sandia developed the PCMM (predictive capability maturity model) to structure this attention [Oberkampf]. PCMM divides simulation into six core activities to be examined and graded relative to the needs of the modeling activity. NASA [NASA] has built yet another framework in response to the tragedy of the space shuttle accidents. Finally, Ben-Haim and Hemez focus upon modeling robustness and predictive fidelity in another approach. These frameworks are similar, and applied in a similar fashion. The adoption of these frameworks at Sandia and NASA has been slow and arduous because the force of law has not assisted acceptance. All existing frameworks are incomplete and need to be extended incorporating elements from the other as well as new elements related to how models are solved, and how the model will be applied. I will describe this merger of approach and how it should be applied. The problems in adoption are related to basic human nature in that no one likes to be graded, or told they are not sufficiently quality oriented. Rather than engage in an adversarial role, I suggest that the frameworks be viewed as a collaborative tool. Instead these frameworks should be used to structure collaborations that can be used to assist the modeling and simulation efforts to be high quality. The framework provides a comprehensive setting of modeling and simulation themes that should be explored in providing high quality. W. Oberkampf, M. Pilch, and T. Trucano, Predictive Capability Maturity Model for Computational Modeling and Simulation, SAND2007-5948, 2007. B. Boyack, Quantifying Reactor Safety Margins Part 1: An Overview of the Code Scaling, Applicability, and Uncertainty Evaluation Methodology, Nuc. Eng. Design, 119, pp. 1-15, 1990. National Aeronautics and Space Administration, STANDARD FOR MODELS AND SIMULATIONS, NASA-STD-7009, 2008. Y. Ben-Haim and F. Hemez, Robustness, fidelity and prediction-looseness of models, Proc. R. Soc. A (2012) 468, 227-244.

  14. Drug interactions evaluation: An integrated part of risk assessment of therapeutics

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

    Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping

    2010-03-01

    Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industrymore » and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.« less

  15. 76 FR 44155 - Pacific Halibut Fisheries; Catch Sharing Plan for Guided Sport and Commercial Fisheries in Alaska

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ...NMFS proposes regulations that would implement a catch sharing plan for the guided sport and commercial fisheries for Pacific halibut in waters of International Pacific Halibut Commission (IPHC) Regulatory Areas 2C (Southeast Alaska) and 3A (Central Gulf of Alaska). If approved, this catch sharing plan will change the annual process of allocating halibut between the guided sport and commercial fisheries in Area 2C and Area 3A, establish allocations for each sector, and specify harvest restrictions for guided sport anglers that are intended to limit harvest to the annual guided sport fishery catch limit. In order to provide flexibility for individual commercial and guided sport fishery participants, the proposed catch sharing plan also will authorize annual transfers of commercial halibut quota to charter halibut permit holders for harvest in the guided sport fishery. This action is necessary to achieve the halibut fishery management goals of the North Pacific Fishery Management Council.

  16. 76 FR 31424 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-52; Small Entity Compliance Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of rules appearing in... implement Executive Order 13514, Federal Leadership in Environmental, Energy, and Economic Performance, and...

  17. State planning in New Jersey

    DOT National Transportation Integrated Search

    1998-12-31

    In trying to develop a state plan for to guide regulatory and spending decision-making on land use and spending on transportation facilities and other forms of infrastructure, New Jersey has rejected mandatory compliance in favor of seeking voluntary...

  18. T Cell Receptor Signaling in the Control of Regulatory T Cell Differentiation and Function

    PubMed Central

    Li, Ming O.; Rudensky, Alexander Y.

    2016-01-01

    Regulatory T cells (TReg cells), a specialized T cell lineage, have a pivotal function in the control of self-tolerance and inflammatory responses. Recent studies have revealed a discrete mode of TCR signaling that regulates Treg cell differentiation, maintenance and function and that impacts on gene expression, metabolism, cell adhesion and migration of these cells. Here, we discuss the emerging understanding of TCR-guided differentiation of Treg cells in the context of their function in health and disease. PMID:27026074

  19. Regulatory aspects of total product life cycle.

    PubMed

    Hausman, Ethan D; Altaie, Sousan S

    2004-12-01

    Total Product Life Cycle (TPLC) is a conceptual framework for assessing any product or service (medical or otherwise). This article will address how the Center for Devices and Radiological Health of the U.S. Food and Drug Administration utilizes TPLC in a regulatory paradigm. TPLC will help guide the regulation of market-driven evolution of medical devices and radiation-emitting products from conception, through pre-market development, to widespread market use, and finally to obsolescence and replacement by subsequent generations of products.

  20. Performance testing of the environmental TLD system for the Three Mile Island Nuclear Station.

    PubMed

    Toke, L F; Carson, B H; Baker, G G; McBride, M H; Plato, P A; Miklos, J A

    1984-05-01

    Panasonic UD-801 thermoluminescent dosimeters ( TLDs ) containing two calcium sulfate phosphors were tested under Performance Specification 3.1 established by the American National Standard Institute ( ANSI75 ) and in the U.S. Nuclear Regulatory Commission's Regulatory Guide 4.13 ( NRC77 ). The specific qualifying tests included TLD uniformity, reproducibility, energy dependence and directional dependence. The overall measurement uncertainties and associated confidence levels are within the prescribed guidelines defined in the qualifying requirements for environmental TLDs .

  1. Identifying p53 Transactivation Domain 1-Specific Inhibitors to Alleviate the Side Effects of Prostate Cancer Therapy

    DTIC Science & Technology

    2013-09-01

    further expanded with the exciting   7   development of Tal-effector and CRISPR guided nucleases. Transcription activator-like effector nucleases...also be achieved by the recently developed CRISPR -Cas9 system. CRISPR (Clustered Regulatory Interspaced Short Palindromic Repeats) is widely believed...to be the most efficient method to engineer mammalian genomes. CRISPR RNAs (crRNA) that hybridize to a specific target DNA can be utilized to guide a

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

    Oland, CB

    Boiler owners and operators who need additional generating capacity face a number of legal, political, environmental, economic, and technical challenges. Their key to success requires selection of an adequately sized low-emission boiler and combustion equipment that can be operated in compliance with emission standards established by state and federal regulatory agencies. Recognizing that many issues are involved in making informed selection decisions, the U.S. Department of Energy (DOE), Office of Industrial Technologies (OIT) sponsored efforts at the Oak Ridge National Laboratory (ORNL) to develop a guide for use in choosing low-emission boilers and combustion equipment. To ensure that the guidemore » covers a broad range of technical and regulatory issues of particular interest to the commercial boiler industry, the guide was developed in cooperation with the American Boiler Manufacturers Association (ABMA), the Council of Industrial Boiler Owners (CIBO), and the U.S. Environmental Protection Agency (EPA). The guide presents topics pertaining to industrial, commercial, and institutional (ICI) boilers. Background information about various types of commercially available boilers is provided along with discussions about the fuels that they burn and the emissions that they produce. Also included are discussions about emissions standards and compliance issues, technical details related to emissions control techniques, and other important selection considerations. Although information in the guide is primarily applicable to new ICI boilers, it may also apply to existing boiler installations.« less

  3. Integrating non-coding RNAs in JAK-STAT regulatory networks

    PubMed Central

    Witte, Steven; Muljo, Stefan A

    2014-01-01

    Being a well-characterized pathway, JAK-STAT signaling serves as a valuable paradigm for studying the architecture of gene regulatory networks. The discovery of untranslated or non-coding RNAs, namely microRNAs and long non-coding RNAs, provides an opportunity to elucidate their roles in such networks. In principle, these regulatory RNAs can act as downstream effectors of the JAK-STAT pathway and/or affect signaling by regulating the expression of JAK-STAT components. Examples of interactions between signaling pathways and non-coding RNAs have already emerged in basic cell biology and human diseases such as cancer, and can potentially guide the identification of novel biomarkers or drug targets for medicine. PMID:24778925

  4. 7 CFR 400.162 - Qualification ratios.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Regulatory Information System” distributed by NAIC, 120 West 12th St., Kansas City, MO 64105-1925; (b) Three... Key Rating Guide, A.M. Best, Ambest Road, Oldwick, N.J. 08858-0700; (c) One ratio found in § 400.170(d...

  5. 7 CFR 400.162 - Qualification ratios.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Regulatory Information System” distributed by NAIC, 120 West 12th St., Kansas City, MO 64105-1925; (b) Three... Key Rating Guide, A.M. Best, Ambest Road, Oldwick, N.J. 08858-0700; (c) One ratio found in § 400.170(d...

  6. 7 CFR 400.162 - Qualification ratios.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Regulatory Information System” distributed by NAIC, 120 West 12th St., Kansas City, MO 64105-1925; (b) Three... Key Rating Guide, A.M. Best, Ambest Road, Oldwick, N.J. 08858-0700; (c) One ratio found in § 400.170(d...

  7. 7 CFR 400.162 - Qualification ratios.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Regulatory Information System” distributed by NAIC, 120 West 12th St., Kansas City, MO 64105-1925; (b) Three... Key Rating Guide, A.M. Best, Ambest Road, Oldwick, N.J. 08858-0700; (c) One ratio found in § 400.170(d...

  8. 7 CFR 400.162 - Qualification ratios.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Regulatory Information System” distributed by NAIC, 120 West 12th St., Kansas City, MO 64105-1925; (b) Three... Key Rating Guide, A.M. Best, Ambest Road, Oldwick, N.J. 08858-0700; (c) One ratio found in § 400.170(d...

  9. Quick Tips for Buying Medicines Over the Internet: A Consumer Safety Guide

    MedlinePlus

    ... Laser Products Other Resources State Pharmacy Boards Federal Trade Commission U.S. Customs and Border Protection Spotlight A ... Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance ...

  10. Adverse outcome pathway (AOP) development: Guiding principles and best practices

    EPA Science Inventory

    Adverse outcome pathways (AOPs) represent a conceptual framework that can support greater application of mechanistic data in regulatory decision-making. However, in order for the scientific community to collectively address the daunting challenge of describing relevant toxicologi...

  11. 77 FR 75780 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-64; Small Entity Compliance Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... asterisk (*) next to a rule indicates that a regulatory flexibility analysis has been prepared. Interested... for performance by service employees of the same or similar work at the same location. It requires...

  12. A USNRC perspective on the use of commercial-off-shelf software (COTS) in advanced reactors

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

    Stewart, J.C.

    1997-12-01

    The use of commercially available digital computer systems and components in safety critical systems (nuclear power plant, military, and commercial applications) is increasing rapidly. While this paper focuses on the software aspects of the application most of these continents are applicable to the hardware aspects as well. Commercial dedication (the process of assuring that a commercial grade item will perform its intended safety function) has demonstrated benefits in cost savings and a wide base of user experience, however, care must be taken to avoid difficulties with some aspects of the dedication process such as access to vendor development information, configurationmore » management long term support, and system integration.« less

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

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

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

    1997-02-01

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

  14. Implementation Guide for Minimum Retroreflectivity Requirements for Traffic Signs

    DOT National Transportation Integrated Search

    1998-04-01

    Although the "Manual on Uniform Traffic Control Devices" (MUTCD) stipulates that all warning and regulatory signs be illuminated or reflectorized to show the same color and shape by day or night, there are no specific guidelines for required retroref...

  15. 76 FR 5215 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ... Compliance with Packaging Requirements for Shipment and Receipt of Radioactive Material,'' is temporarily... Code of Federal Regulations, Part 71, ``Packaging and Transportation of Radioactive Material'' (10 CFR... Compliance with Packaging Requirements for Shipments of Radioactive Materials,'' as an acceptable process for...

  16. Sublethal exposure, insecticide resistance, and community stress

    USDA-ARS?s Scientific Manuscript database

    Although a prevalent pest management tool and anthropogenic stressors of widespread occurrence, insecticides are subject to biased perceptions and research demands largely guided by their use, market value, and regulatory requirements. As a result, short-term and simplistic efforts focusing on letha...

  17. Regulating transgenic crops sensibly: lessons from plant breeding, biotechnology and genomics.

    PubMed

    Bradford, Kent J; Van Deynze, Allen; Gutterson, Neal; Parrott, Wayne; Strauss, Steven H

    2005-04-01

    The costs of meeting regulatory requirements and market restrictions guided by regulatory criteria are substantial impediments to the commercialization of transgenic crops. Although a cautious approach may have been prudent initially, we argue that some regulatory requirements can now be modified to reduce costs and uncertainty without compromising safety. Long-accepted plant breeding methods for incorporating new diversity into crop varieties, experience from two decades of research on and commercialization of transgenic crops, and expanding knowledge of plant genome structure and dynamics all indicate that if a gene or trait is safe, the genetic engineering process itself presents little potential for unexpected consequences that would not be identified or eliminated in the variety development process before commercialization. We propose that as in conventional breeding, regulatory emphasis should be on phenotypic rather than genomic characteristics once a gene or trait has been shown to be safe.

  18. Financial constraints in capacity planning: a national utility regulatory model (NUREG). Volume III of III: software description. Final report

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

    None

    1981-10-29

    This volume is the software description for the National Utility Regulatory Model (NUREG). This is the third of three volumes provided by ICF under contract number DEAC-01-79EI-10579. These three volumes are: a manual describing the NUREG methodology; a users guide; and a description of the software. This manual describes the software which has been developed for NUREG. This includes a listing of the source modules. All computer code has been written in FORTRAN.

  19. 75 FR 62893 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... for using portland cement grout to protect prestressing steel from corrosion. The prestressing tendon system of a prestressed concrete containment structure is a principal strength element of the structure... of the structure depends on the functional reliability of the structure's principal strength elements...

  20. 75 FR 7526 - Withdrawal of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-19

    ... water chemistry program. For example, the 2004 revision of the Electric Power Research Institute report... Pressure Boundary'' of Appendix A, ``General Design Criteria for Nuclear Power Plants,'' in Title 10, Part..., which are controlled by regulations and plant technical specifications. For example, in-service...

  1. 75 FR 33853 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ... performance or condition of structures, systems, or components * * * in a manner sufficient to provide reasonable assurance that these structures, systems, and components * * * are capable of fulfilling their... Management System (ADAMS). Comments would be most helpful if received by August 13, 2010. Comments received...

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

    Anderson, James; Goins, Monty; Paul, Pran

    This safety analysis report for packaging (SARP) presents the results of the safety analysis prepared in support of the Consolidated Nuclear Security, LLC (CNS) request for licensing of the Model ES-3100 package with bulk highly enriched uranium (HEU) contents and issuance of a Type B(U) Fissile Material Certificate of Compliance. This SARP, published in the format specified in the Nuclear Regulatory Commission (NRC) Regulatory Guide 7.9 and using information provided in UCID-21218 and NRC Regulatory Guide 7.10, demonstrates that the Y-12 National Security Complex (Y-12) ES-3100 package with bulk HEU contents meets the established NRC regulations for packaging, preparation formore » shipment, and transportation of radioactive materials given in Title 10, Part 71, of the Code of Federal Regulations (CFR) [10 CFR 71] as well as U.S. Department of Transportation (DOT) regulations for packaging and shipment of hazardous materials given in Title 49 CFR. To protect the health and safety of the public, shipments of adioactive materials are made in packaging that is designed, fabricated, assembled, tested, procured, used, maintained, and repaired in accordance with the provisions cited above. Safety requirements addressed by the regulations that must be met when transporting radioactive materials are containment of radioactive materials, radiation shielding, and assurance of nuclear subcriticality.« less

  3. 76 FR 38213 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... quality standards for using Portland Cement grout to protect prestressing steel from corrosion. The prestressing tendon system of a prestressed concrete containment structure is a principal strength element of... strength elements. Thus, any significant deterioration of the prestressing elements caused by corrosion may...

  4. 75 FR 20399 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-19

    ..., Revision 1, ``Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed... Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material,'' was issued with a... during the review of an application to manufacture or distribute sealed sources and devices containing...

  5. 10 CFR 50.55a - Codes and standards.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., standard design approval, and standard design certification application under part 52 of this chapter is..., and components must be designed, fabricated, erected, constructed, tested, and inspected to quality... Operation and Maintenance of Nuclear Power Plants; NRC Regulatory Guide (RG) 1.84, Revision 35, “Design...

  6. NEW APPROACHES IN RISK ANALYSIS OF ENVIRONMENTAL STRESSORS TO HUMAN AND ECOLOGICAL SYSTEMS

    EPA Science Inventory

    We explore the application of novel techniques for improving and integrating risk analysis of environmental stressors to human and ecological systems. Environmental protection decisions are guided by risk assessments serving as tools to develop regulatory policy and other relate...

  7. 76 FR 66089 - Access Authorization Program for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0245] Access Authorization Program for Nuclear Power... Program for Nuclear Power Plants.'' This guide describes a method that NRC staff considers acceptable to... Regulations (10 CFR), section 73.56, ``Personnel Access Authorization Requirements for Nuclear Power Plants...

  8. 75 FR 61530 - Issuance of Regulatory Guides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Materials Code Case Acceptability, ASME Section III,'' and RG 1.147, Rev. 16, ``Inservice Inspection Code Case Acceptability, ASME Section XI, Division 1.'' FOR FURTHER INFORMATION CONTACT: Wallace E. Norris... specific problems or postulated accidents, and data the staff needs in its review of applications for...

  9. Regulatory Reform: Compliance Guide Requirement Has Had Little Effect on Agency Practices

    DTIC Science & Technology

    2001-12-01

    United States General Accounting Office GAO Report to the Ranking Minority Member Committee on Small Business and Entrepreneurship , U.S. Senate...20548 December 28, 2001 The Honorable Christopher S. Bond Ranking Minority Member Committee on Small Business and Entrepreneurship United States

  10. 76 FR 25725 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ....18, Revision 2, ``Information Relevant to Ensuring that Occupational Radiation Exposures at Medical..., techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the..., ``Information Relevant to Ensuring that Occupational Radiation Exposures at Medical Institutions will be As Low...

  11. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)

    PubMed Central

    Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

    2013-01-01

    The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines. PMID:23216470

  12. Design Principles of Regulatory Networks: Searching for the Molecular Algorithms of the Cell

    PubMed Central

    Lim, Wendell A.; Lee, Connie M.; Tang, Chao

    2013-01-01

    A challenge in biology is to understand how complex molecular networks in the cell execute sophisticated regulatory functions. Here we explore the idea that there are common and general principles that link network structures to biological functions, principles that constrain the design solutions that evolution can converge upon for accomplishing a given cellular task. We describe approaches for classifying networks based on abstract architectures and functions, rather than on the specific molecular components of the networks. For any common regulatory task, can we define the space of all possible molecular solutions? Such inverse approaches might ultimately allow the assembly of a design table of core molecular algorithms that could serve as a guide for building synthetic networks and modulating disease networks. PMID:23352241

  13. 10 CFR 36.35 - Source rack protection.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Source rack protection. 36.35 Section 36.35 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Design and Performance... guides to prevent products and product carriers from hitting or touching the rack or mechanism. ...

  14. 77 FR 30030 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at... (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide endorses Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for...

  15. 77 FR 18271 - Terrestrial Environmental Studies for Nuclear Power Stations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-27

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0182] Terrestrial Environmental Studies for Nuclear Power... Environmental Studies for Nuclear Power Stations.'' This guide provides technical guidance that the NRC staff... nuclear power reactors. ADDRESSES: Please refer to Docket ID NRC-2011-0182 when contacting the NRC about...

  16. RNA-Seq Atlas of Glycine max: a guide to the soybean transcriptome

    USDA-ARS?s Scientific Manuscript database

    A first analysis of the Glycine max (L.) Merr. (soybean) transcriptome using next generation sequencing technology and RNA-Sequencing (RNA-Seq) is presented. This analysis will provide an important resource for understanding transcription and gene co-regulatory networks in soybean, the most economic...

  17. 75 FR 45173 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... coolant system for measuring process variables (e.g., pressure, level, and flow). The term ``safety- related'' refers to those structures, systems, and components necessary to ensure (1) the integrity of the... are located in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No...

  18. miRNA*: a passenger stranded in RNA-induced silencing complex?

    PubMed

    Mah, S M; Buske, C; Humphries, R K; Kuchenbauer, F

    2010-01-01

    Processing of the pre-microRNA (pre-miRNA) through Dicer1 generates a miRNA duplex, consisting of a miRNA and miRNA* strand (also termed guide strand and passenger strand, respectively). Despite the general consensus that miRNA*s have no regulatory activity, recent publications have provided evidence that the abundance, possible function, and physiological relevance of miRNA*s have been underestimated. This review provides an account of our current understanding of miRNA* origination and activity, mounting evidence for their unique functions and regulatory mechanisms, and examples of specific miRNA*s from the literature.

  19. Audio visual summary: Implementing PURPA in Mid-America

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

    Not Available

    The audio-visual presentation, Implementing PURPA in Mid-America, is a slide presentation designed to complement deliverable W-101-2, a booklet entitled Implementing PURPA in Mid-America: A Guide to the Public Utility Regulatory Policies Act. The presentation lasts 10 to 12 min and explains the major sections of PURPA, the rules promulgated by the Federal Energy Regulatory Commission to implement PURPA, and the implications of PURPA and its rules. It delineates the rights and responsibilities of citizens who want to sell electricity to utilities, explains the certification process, and discusses the rights and responsibilities of the utilities.

  20. 75 FR 36698 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... information based on the likelihood of pipe breaks of different sizes. The rule would divide all coolant... to and including a ``transition break size,'' and breaks larger than the transition size up to the largest pipe in the reactor coolant system. Selection of the transition size was based upon pipe break...

  1. Business Management for Independent Schools. Fourth Edition.

    ERIC Educational Resources Information Center

    National Association of Independent Schools, Boston, MA.

    This fourth edition of a guide for independent school business managers has been produced in looseleaf format so that changes may be made promptly as decisions of regulatory bodies require modifications in current practice. Fourteen chapters are organized under three broad topic headings. Chapters in part 1, Accounting and Financial Reporting,…

  2. 75 FR 28074 - Advisory Committee on Reactor Safeguards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ..., 2009, (74 FR 52829-52830). Wednesday, June 9, 2010, Conference Room T2-B1, Two White Flint North... Regulatory Guide (RG) 1.216, ``Containment Structural Integrity Evaluation for Internal Pressure Loadings... representatives of the NRC staff regarding draft final RG 1.216, ``Containment Structural Integrity Evaluation for...

  3. Guide for Determining Compliance With the Clean Air Act Standards for Radionuclide Emissions From NRC-Licensed and Non-DOE Federal Facilities: Revision 2

    EPA Pesticide Factsheets

    The requirements described apply to certain facilities licensed by the Nuclear Regulatory Commission (NRC) or its Agreement States to handle radioactive materials. Federal facilities not part of the Department of Energy (DOE) are also covered.

  4. 75 FR 41241 - Draft Regulatory Guide; Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ...: (301) 251-7404 or e-mail [email protected] . SUPPLEMENTARY INFORMATION: I. Introduction The U.S... analysis and testing applicable to Emergency Core Cooling System (ECCS) strainer performance and debris... provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are...

  5. Benchmarking Australian and New Zealand University Meta-Policy in an Increasingly Regulated Tertiary Environment

    ERIC Educational Resources Information Center

    Freeman, Brigid

    2014-01-01

    The agencies responsible for tertiary education quality assurance in Australia and New Zealand have established regulatory regimes that increasingly intersect with tertiary institution policy management. An examination of university meta-policies identified good practices guiding university policy and policy management. Most Australian and half of…

  6. 77 FR 73912 - Used Motor Vehicle Trade Regulation Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ...'') has completed its regulatory review of its Used Motor Vehicle Trade Regulation Rule (``Used Car Rule... revisions to the Spanish translation of the Used Car Buyers Guide and nonsubstantive technical changes to.... SUPPLEMENTARY INFORMATION: I. Background The Commission promulgated the Used Car Rule in 1984 and the Rule...

  7. 77 FR 69508 - Inservice Inspection of Prestressed Concrete Containment Structures With Grouted Tendons

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ... real-time, multiple-strategy approach (i.e., appropriate grout design and installation, installed... is available in ADAMS) is provided the first time that a document is referenced. Revision 2 of... ``Regulatory Guide'' series. This series was developed to describe and make available to the public information...

  8. Risk, Reward, and Regulations: Reshaping the Financial Services Industry.

    ERIC Educational Resources Information Center

    Saul, Ralph S.

    1984-01-01

    Deregulation has had much to do with the competitive drive and vitality of financial services within the United States. The risks and rewards of deregulation for financial institutions are discussed, and principles which should serve as a guide in building any new regulatory structure are examined. (RM)

  9. 75 FR 2894 - Withdrawal of Regulatory Guide 1.148

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-19

    ... Valve Assemblies in Systems Important to Safety in Nuclear Power Plants.'' FOR FURTHER INFORMATION... for Active Valve Assemblies in Systems Important to Safety in Nuclear Power Plants.'' RG 1.148 was... qualifying active mechanical equipment used in nuclear power plants. The NRC is withdrawing RG 1.148 because...

  10. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2013-01-01 2013-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  11. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2014-01-01 2014-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  12. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... assurance program information that duplicates language in quality assurance regulatory guides and quality... 10 Energy 2 2012-01-01 2012-01-01 false Quality assurance program change. 63.144 Section 63.144... REPOSITORY AT YUCCA MOUNTAIN, NEVADA Quality Assurance § 63.144 Quality assurance program change. Changes to...

  13. Multiple species inventory and monitoring technical guide

    Treesearch

    P.N. Manley; B. Van Horne; J.K. Roth; W.J. Zielinski; M.M. McKenzie; T.J. Weller; F.W. Weckerly; C. Vojta

    2006-01-01

    The National Forest Management Act (1976) recognizes the importance of maintaining species and community diversity on National Forest System (NFS) lands as a critical component of our ecological and cultural heritage. Monitoring is required of land management to assess the success of management activities in meeting legal, regulatory, and policy objectives, including...

  14. 77 FR 73056 - Initial Test Programs for Water-Cooled Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0293] Initial Test Programs for Water-Cooled Nuclear Power... (DG), DG-1259, ``Initial Test Programs for Water-Cooled Nuclear Power Plants.'' This guide describes the general scope and depth that the staff of the NRC considers acceptable for Initial Test Programs...

  15. Impact of poultry litter application and land use on E. coli runoff from small agricultural watersheds

    USDA-ARS?s Scientific Manuscript database

    Fecal bacteria contamination of surface waters continues to be a critical water quality concern with serious human health implications, but relatively few land use specific data sets are available to guide management, restoration, policy, and regulatory decisions. In regions with substantial poultr...

  16. 76 FR 4390 - Draft Regulatory Guide: Comment Period Extension and Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ....'' This Federal Register notice stated that electronic copies of DG-1229 were available in the NRC's Agencywide Documents Access and Management System (ADAMS) ( http://www.nrc.gov/reading-rm/adams.html ), under... Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC...

  17. 77 FR 60482 - Regulatory Guide 5.67, Material Control and Accounting for Uranium Enrichment Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... Accounting for Uranium Enrichment Facilities Authorized To Produce Special Nuclear Material of Low Strategic... Accounting for Uranium Enrichment Facilities Authorized to Produce Special Nuclear Material of Low Strategic... INFORMATION CONTACT: Glenn Tuttle, Office of Nuclear Material Safety and Safeguards, Division of Fuel Cycle...

  18. A Guide to Disbursement, Refund, and Repayment.

    ERIC Educational Resources Information Center

    Guthrie, Marty; Rappaport, Renee

    Guidelines are provided to assist in the interpretation of the regulatory requirements regarding disbursement of funds to students under Title IV student aid programs. Attention is also directed to the higher education community's self-regulation initiatives regarding refund and repayment, as well as the Department of Education's regulations in…

  19. 75 FR 1658 - Withdrawal of Regulatory Guide 7.5

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-12

    ..., Washington, DC 20555-0001, telephone: 301-251-7447 or e-mail [email protected] . SUPPLEMENTARY..., e.g., Federal, State, or local government radioactive material shipments transported by government... 301- 415-3548, and by e-mail to [email protected] . Dated at Rockville, Maryland, this 5th day of...

  20. 75 FR 5630 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ... specific parts of the NRC's regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its review of applications for permits and licenses... in license applications and for monitoring and reporting effluent data by licensees. The guidance is...

  1. 77 FR 39745 - Fuel Oil Systems for Emergency Power Supplies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... fuel oil systems for safety-related emergency diesel generators and oil-fueled gas turbine generators... emergency diesel generators and oil-fueled gas turbine generators, including assurance of adequate fuel oil.... The DG-1282 is proposed revision 2 of Regulatory Guide 1.137, ``Fuel Oil Systems for Standby Diesel...

  2. Regulatory Guide on Conducting a Security Vulnerability Assessment

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

    Ek, David R.

    This document will provide guidelines on conducting a security vulnerability assessment at a facility regulated by the Radiation Protection Centre. The guidelines provide a performance approach assess security effectiveness. The guidelines provide guidance for a review following the objectives outlined in IAEA NSS#11 for Category 1, 2, & 3 sources.

  3. 75 FR 27599 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ..., Revision 2, ``Preparation of an Environmental Report To Support a Rulemaking Petition Seeking an Exemption... staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its... preparation of environmental reports (ERs), that are submitted to support a rulemaking petition for an...

  4. 77 FR 63343 - Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... PWR [Pressurized-Water Reactor] Steam Generator Tubes'' (Reference 32) and [Nuclear Energy Institute... maintains the required structural margins of the SG tubes for both normal and accident conditions. Nuclear Energy Institute 97-06, ``Steam Generator Program Guidelines'' (Reference 8), and NRC Regulatory Guide 1...

  5. 77 FR 5063 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Thermal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... Subcommittee on Thermal-Hydraulics Phenomena; Notice of Meeting The ACRS Subcommittee on Thermal-Hydraulics... Regulatory Guide (1.79), ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water... Water Reactors.'' The Subcommittee will hear presentations by and hold discussions with the NRC staff...

  6. CTIC Cablebooks. Volume 2: A Guide for Local Policy.

    ERIC Educational Resources Information Center

    Jesuale, Nancy, Ed.; And Others

    The second in a two-part series, this volume presents 13 chapters discussing many of the most pressing cable policy issues facing local government, describing alternative policy options, and suggesting regulatory procedures successfully used by decision makers in the United States. Topics covered are (1) "The Rationale for Regulation,"…

  7. 75 FR 52999 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... or postulated accidents, and data that the staff needs in its review of applications for permits and... Regulations (10 CFR) Part 20, ``Standards for Protection Against Radiation,'' the associated specific... (i.e. radiation doses in addition to and accounted for separately from the doses received under the...

  8. Regulatory Concerns on the In-Containment Water Storage System of the Korean Next Generation Reactor

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

    Ahn, Hyung-Joon; Lee, Jae-Hun; Bang, Young-Seok

    2002-07-15

    The in-containment water storage system (IWSS) is a newly adopted system in the design of the Korean Next Generation Reactor (KNGR). It consists of the in-containment refueling water storage tank, holdup volume tank, and cavity flooding system (CFS). The IWSS has the function of steam condensation and heat sink for the steam release from the pressurizer and provides cooling water to the safety injection system and containment spray system in an accident condition and to the CFS in a severe accident condition. With the progress of the KNGR design, the Korea Institute of Nuclear Safety has been developing Safety andmore » Regulatory Requirements and Guidances for safety review of the KNGR. In this paper, regarding the IWSS of the KNGR, the major contents of the General Safety Criteria, Specific Safety Requirements, Safety Regulatory Guides, and Safety Review Procedures were introduced, and the safety review items that have to be reviewed in-depth from the regulatory viewpoint were also identified.« less

  9. Implementation of 10 CFR 20.1406 Through Life Cycle Planning for Decommissioning

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

    O'Donnell, E.; Ott, W.R.

    2008-01-15

    The focus of this paper is on a regulatory guide (draft guide DG-4012) being developed by the Office of Nuclear Regulatory Research for the implementation of 10 CFR 20.1406. The draft guide was published in the Federal Register on July 31, 2007 for a 90 day public comment period. Besides being available in the Federal Register, it is also available electronically in NRC's agency data management system (ADAMS). The accession number is ML0712100110. 10 CFR 20.1406 requires license applicants, other than renewals, after August 20, 1997, '..to describe in the application how facility design and procedures for operation will minimize,more » to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize to the extent practicable, the generation of radioactive waste'. The intent of the regulation is to diminish the occurrence and severity of 'legacy sites' by taking measures that will reduce and control contamination and facilitate eventual decommissioning. 10 CFR 20.1406 is significant because it applies to all new facilities and in the very near future (perhaps as soon as the fall of 2007), the U.S. Nuclear Regulatory Commission (NRC) anticipates receiving one or more license applications for new nuclear power plants. The regulatory guide is intended to facilitate that licensing by providing suggestions of things an applicant can do to minimize contamination of the facility and the environment, minimize generation of waste, and to facilitate decommissioning. Over 100 different kinds of activities are covered by license applications submitted to the NRC. They do not all reflect the same potential for contamination of a facility and the environment, or for the generation of radioactive waste. Therefore, an applicant should use sound judgment to evaluate the potential for contamination and the consequences of such contamination in deciding on the extent to which this guide applies to any given facility or activity. Factors which may enter into this decision include form (e.g., dry solids, liquids, gases), inventory, and environmental mobility of unintended releases. The bulk of the guidance presented in the guide will consist of specific design considerations drawn from nuclear industry experience and lessons learned from decommissioning. These design suggestions provide examples of measures which can be combined to support a contaminant management philosophy for a new facility. The principles embodied in this philosophy are threefold: (1) prevention of unintended release, (2) early detection if there is unintended release of radioactive contamination, and (3) prompt and aggressive clean-up should there be an unintended release of radioactive contamination. If the guiding principles are followed through the use of 'good' engineering and science, as well as careful attention to operational practices, it should result in meeting the requirements of 10 CFR 20.1406. All this should be considered in the context of the life cycle of the facility from the early planning stages through the final plans for decommissioning and waste disposal. Some of the mechanisms which can be employed for life cycle planning are described further in the Discussion section. In summary: The principles of the guide are threefold: prevention, early detection, and prompt response. If these guiding principles are followed through the use of 'good' engineering and science, as well as careful attention to operational practices, it should result in meeting the requirements of 10 CFR 20 In summary, the thrust of this guide is for an applicant to use technically sound engineering judgment and a practical risk-informed approach to achieve the objectives of 10 CFR 20.1406. This approach should consider the materials and processes involved (e.g., solids, liquids, gases) and focus on: (1) the relative significance of potential contamination; (2) areas most susceptible to leaks; and (3) the appropriate level of consideration to prevention and control of contamination that should be incorporated in facility design. Since the applicability of the guidance is a facility-by-facility decision, early consultation with the NRC is strongly suggested.« less

  10. 77 FR 74745 - Used Motor Vehicle Trade Regulation Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ...Except as specifically described below, the FTC has completed its regulatory review of its Used Motor Vehicle Trade Regulation Rule (``Used Car Rule'' or ``Rule'') as part of the FTC's systematic review of all current Commission regulations and guides. The Commission has decided to retain the Rule and, in a separate Federal Register document, to amend it by changing the Spanish translation of the Buyers Guide. In addition, the Commission also has decided to issue a notice of proposed rulemaking (``NPR'') soliciting comments on proposed changes to the Rule. In this NPR, the Commission addresses the comments received during its review and invites public comment on the following four proposed changes to the Buyers Guide: adding boxes to the back of the Buyers Guide where dealers would have the option to indicate manufacturers' and other third-party warranties; adding a statement to the Buyers Guide encouraging consumers to seek vehicle history information and directing consumers to an FTC Web site for more information about vehicle histories; adding catalytic converters and airbags to the List of Systems on the back of the Buyers Guide; and adding a statement in Spanish to the English Buyers Guide directing consumers who cannot read the Buyers Guide in English to ask for a copy of it in Spanish.

  11. 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

    PubMed

    Garofolo, Fabio; Rocci, Mario L; Dumont, Isabelle; Martinez, Suzanne; Lowes, Steve; Woolf, Eric; van Amsterdam, Peter; Bansal, Surendra; Barra, Ariadna Cristina Gomes; Bauer, Ronald; Booth, Brian P; Carrasco-Triguero, Montserrat; DeSilva, Binodh; Dunn, John; Gallicano, Keith; Gouty, Dominique; Ho, Stacy; Hucker, Richard; Jemal, Mohammed; Katori, Noriko; Le Blaye, Olivier; Lee, Jean; Li, Wenkui; Michael, Steve; Nehls, Corey; Nicholson, Robert; Ormsby, Eric; Tang, Daniel; Viswanathan, C T; Weiner, Russell; Young, Graeme

    2011-09-01

    The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

  12. Scientific, statistical, practical, and regulatory considerations in design space development.

    PubMed

    Debevec, Veronika; Srčič, Stanko; Horvat, Matej

    2018-03-01

    The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed. The focus is especially on frequently ignored topics, like management of factors and CQAs that will not be included in experimental design, evaluation of risk of failure on design space edges, or modeling scale-up strategy. Moreover, development of a design space that is independent of manufacturing scale is proposed as the preferred approach.

  13. Phylum-Level Conservation of Regulatory Information in Nematodes despite Extensive Non-coding Sequence Divergence

    PubMed Central

    Gordon, Kacy L.; Arthur, Robert K.; Ruvinsky, Ilya

    2015-01-01

    Gene regulatory information guides development and shapes the course of evolution. To test conservation of gene regulation within the phylum Nematoda, we compared the functions of putative cis-regulatory sequences of four sets of orthologs (unc-47, unc-25, mec-3 and elt-2) from distantly-related nematode species. These species, Caenorhabditis elegans, its congeneric C. briggsae, and three parasitic species Meloidogyne hapla, Brugia malayi, and Trichinella spiralis, represent four of the five major clades in the phylum Nematoda. Despite the great phylogenetic distances sampled and the extensive sequence divergence of nematode genomes, all but one of the regulatory elements we tested are able to drive at least a subset of the expected gene expression patterns. We show that functionally conserved cis-regulatory elements have no more extended sequence similarity to their C. elegans orthologs than would be expected by chance, but they do harbor motifs that are important for proper expression of the C. elegans genes. These motifs are too short to be distinguished from the background level of sequence similarity, and while identical in sequence they are not conserved in orientation or position. Functional tests reveal that some of these motifs contribute to proper expression. Our results suggest that conserved regulatory circuitry can persist despite considerable turnover within cis elements. PMID:26020930

  14. Discrepancy-based and anticipated emotions in behavioral self-regulation.

    PubMed

    Brown, Christina M; McConnell, Allen R

    2011-10-01

    Discrepancies between one's current and desired states evoke negative emotions, which presumably guide self-regulation. In the current work we evaluated the function of discrepancy-based emotions in behavioral self-regulation. Contrary to classic theories of self-regulation, discrepancy-based emotions did not predict the degree to which people engaged in self-regulatory behavior. Instead, expectations about how future self-discrepancies would make one feel (i.e., anticipated emotions) predicted self-regulation. However, anticipated emotions were influenced by previous discrepancy-based emotional experiences, suggesting that the latter do not directly motivate self-regulation but rather guide expectations. These findings are consistent with the perspective that emotions do not necessarily direct immediate behavior, but rather have an indirect effect by guiding expectations, which in turn predict goal-directed action.

  15. 75 FR 53169 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-45; Small Entity Compliance Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ... Contract Act, and trade agreements thresholds. The Councils have also used the same methodology to adjust... Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of rules appearing in...-008 Davis. and Reinvestment Act of 2009 (the Recovery Act)-- Buy American Requirements for...

  16. Implementing Ethics Policies in Developing Countries: Ploughing on Parched Ground?

    ERIC Educational Resources Information Center

    Mazonde, Isaac N.; Jackson-Malete, Jose; Sugarman, Jeremy

    2007-01-01

    It is globally expected that universities will ensure that policies guiding researchers' conduct are in place and adhered to. This expectation is not waived in developing countries. Successful implementation of an ethics policy is facilitated by an appropriate national regulatory framework on which to base the argument for compliance. However, it…

  17. Resource Guide: Accountability for English Learners under the ESEA. Non-Regulatory Guidance

    ERIC Educational Resources Information Center

    Office of Elementary and Secondary Education, US Department of Education, 2017

    2017-01-01

    English learners (ELs) are among the fastest-growing populations of students in our nation's public schools. This diverse subgroup of approximately 4.5 million students brings important cultural and linguistic assets to the public education system, but also faces a greater likelihood of lower graduation rates, academic achievement, and college…

  18. 76 FR 30280 - Public Meeting To Discuss the Proposed Rule on Enhanced Weapons, Firearms Background Checks, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... Proposed Rule on Enhanced Weapons, Firearms Background Checks, and Security Event Notifications AGENCY... the proposed enhanced weapons rule, the two draft regulatory guides, and the draft weapons safety.... No formal comments on the proposed enhanced weapons rule or the draft guidance documents will be...

  19. 75 FR 61321 - Domestic Licensing of Production and Utilization Facilities; Updates to Incorporation by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... electronic reading room at http://www.nrc.gov/reading-rm/adams.html . From this page, the public can gain... Regulatory Guides dated April 2009. The NRC's electronic reading room contains later versions of these Draft... in the training provided to examiners. Computer-based training, through the use of animations...

  20. Self-Regulatory Efficacy and Mindset of At-Risk Students: An Exploratory Study

    ERIC Educational Resources Information Center

    Matheson, Ian A.

    2015-01-01

    There is a limited body of research examining how students' beliefs about intelligence and about their abilities relate to different learning environments. As reported here, I examined secondary school students' beliefs, goals, and expectations guided by Zimmerman's (2000) model of self-regulated learning. In this exploratory study, 230 secondary…

  1. The Design of Technology-Rich Learning Environments as Metacognitive Tools in History Education

    ERIC Educational Resources Information Center

    Poitras, Eric; Lajoie, Susanne; Hong, Yuan-Jin

    2012-01-01

    Research has shown that learners do not always engage in appropriate metacognitive and self-regulatory processes while learning complex historical topics. However, little research exists to guide the design of technology-rich learning environments as metacognitive tools in history education. In order to address this issue, we designed a…

  2. Sociocognitive Correlates of Gender-Linked Conduct.

    ERIC Educational Resources Information Center

    Bussey, Kay

    This study of the processes guiding children's gender-linked conduct focused on ages prior to the development of self-regulatory control through the exercise of self-evaluative reactions. The study sample consisted of 29 boys and 33 girls in Australia between 17 and 48 months old. Measures included: (1) a videotaped toy play session in which…

  3. Federal Guidance Report No. 11: Limiting Values Of Radionuclide Intake And Air Concentration And Dose Conversion Factors For Inhalation, Submersion, And Ingestion

    EPA Pesticide Factsheets

    These guides were designed to be implemented by various Federal agencies having regulatory responsibilities for workers in the public sector, such as NRC and OSHA, and by Federal agencies with responsibilities for their own workers, such as DOE and DOD.

  4. IT Legislative and Regulatory Issues Agenda. Higher Education Information Technology Alliance

    ERIC Educational Resources Information Center

    National Association of State Universities and Land-Grant Colleges, 2004

    2004-01-01

    This document represents the higher education and library community's guiding public policy agenda on information technology (IT) for the current year. The Higher Education Information Technology (HEIT) Alliance is a coalition of 11 national higher education and library associations, whose members represent a broad array of stakeholders on college…

  5. 76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... received on or before this date. Although a time limit is given, comments and suggestions in connection... are encouraged at any time. ADDRESSES: Please include Docket ID NRC-2011-0102 in the subject line of... comments to: RADB at 301-492-3446. You can access publicly available documents related to this notice using...

  6. 76 FR 40943 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ..., Revision 3, ``Criteria for Use of Computers in Safety Systems of Nuclear Power Plants.'' FOR FURTHER..., ``Criteria for Use of Computers in Safety Systems of Nuclear Power Plants,'' was issued with a temporary... Fuel Reprocessing Plants,'' to 10 CFR part 50 with regard to the use of computers in safety systems of...

  7. 77 FR 16868 - Quality Verification for Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... Fuel Elements for Use in Research and Test Reactors AGENCY: Nuclear Regulatory Commission. ACTION... Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test Reactors.'' This guide describes... plate-type uranium-aluminum fuel elements used in research and test reactors (RTRs). DATES: Submit...

  8. 78 FR 31614 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-24

    ... for Nuclear Power Plants,'' in support of NRC reviews of early site permit (ESP), standard design... NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants... License Applications for Nuclear Power Plants, (LWR Edition)'' (ML070630003) In addition, this ISG...

  9. Section 1--The Value of Psychology in Health Professional Education

    ERIC Educational Resources Information Center

    Upton, Dominic

    2008-01-01

    The education of nurses, midwives and allied health care professionals in the UK is guided by professional bodies and the over arching Health Professionals Council (HPC)/Nursing and Midwifery Council (NMC). Each of these professional bodies provides regulatory frameworks and guidance notes on the educational content of the degree level programmes…

  10. Interfering with Inner Speech Selectively Disrupts Problem Solving and Is Linked with Real-World Executive Functioning

    ERIC Educational Resources Information Center

    Wallace, Gregory L.; Peng, Cynthia S.; Williams, David

    2017-01-01

    Purpose: According to Vygotskian theory, verbal thinking serves to guide our behavior and underpins critical self-regulatory functions. Indeed, numerous studies now link inner speech usage with performance on tests of executive function (EF). However, the selectivity of inner speech contributions to multifactorial executive planning performance…

  11. 76 FR 41527 - Draft Regulatory Guide: Re-Issuance and Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... and methods that are acceptable to the NRC staff for implementing specific parts of the NRC's..., and fabrication of mixed-oxide fuel or fuel assemblies. DG-3037 provides guidance on how to meet the... publicly disclosed. You may submit comments by any one of the following methods: Federal Rulemaking Web...

  12. 76 FR 24062 - Florida Power and Light Company, St. Lucie, Unit Nos. 1 and 2; Exemption

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... (d) is again required. Regulatory Guide 5.73, Fatigue Management for Nuclear Power Plant Personnel, endorses the Nuclear Energy Institute (NEI) report NEI 06- 11, revision 1, ``Managing Personnel Fatigue at Nuclear Power Plants,'' with certain clarifications, additions and exceptions. The NRC staff has endorsed...

  13. Mentoring for Success in Tobacco Regulatory Science: A Qualitative Study

    PubMed Central

    Russo, Abigail R.; Solis, Amy C.; Villanti, Andrea C.; Wipfli, Heather L.; Kern, Teresa T.; Lawley, Rachel K.; Collins, Lauren K.; Abudayyeh, Haneen S.; Chansky, Melanie C.; Glantz, Stanton A.; Samet, Jonathan M.; Benjamin, Emelia J.

    2017-01-01

    Objectives Our study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). Methods We conducted 22 phone interviews with early career and senior tobacco regulatory scientists from July 2015 to January 2016. All interviews were conducted using a structured interview guide and analyzed using a thematic approach by 2 independent coders. Results TRS presents specific opportunities and challenges to scientists due to its focused goal of informing tobacco regulation. An understanding of US Food and Drug Administration (FDA) research priorities and how science can inform tobacco regulation are essential for effective mentorship in TRS. Careers in TRS can be pursued in various academic and non-academic professional roles; both offer the distinct ability to conduct science that impacts public policy. Early career and senior scientists identified the importance and challenge of providing broad training across the diverse disciplines of TRS. Conclusions Effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making. A training program for mentors specific to TRS has the potential to meet diverse professional needs of mentors and mentees aiming to impact tobacco policy. PMID:28758143

  14. EPRI/NRC-RES fire human reliability analysis guidelines.

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

    Lewis, Stuart R.; Cooper, Susan E.; Najafi, Bijan

    2010-03-01

    During the 1990s, the Electric Power Research Institute (EPRI) developed methods for fire risk analysis to support its utility members in the preparation of responses to Generic Letter 88-20, Supplement 4, 'Individual Plant Examination - External Events' (IPEEE). This effort produced a Fire Risk Assessment methodology for operations at power that was used by the majority of U.S. nuclear power plants (NPPs) in support of the IPEEE program and several NPPs overseas. Although these methods were acceptable for accomplishing the objectives of the IPEEE, EPRI and the U.S. Nuclear Regulatory Commission (NRC) recognized that they required upgrades to support currentmore » requirements for risk-informed, performance-based (RI/PB) applications. In 2001, EPRI and the USNRC's Office of Nuclear Regulatory Research (RES) embarked on a cooperative project to improve the state-of-the-art in fire risk assessment to support a new risk-informed environment in fire protection. This project produced a consensus document, NUREG/CR-6850 (EPRI 1011989), entitled 'Fire PRA Methodology for Nuclear Power Facilities' which addressed fire risk for at power operations. NUREG/CR-6850 developed high level guidance on the process for identification and inclusion of human failure events (HFEs) into the fire PRA (FPRA), and a methodology for assigning quantitative screening values to these HFEs. It outlined the initial considerations of performance shaping factors (PSFs) and related fire effects that may need to be addressed in developing best-estimate human error probabilities (HEPs). However, NUREG/CR-6850 did not describe a methodology to develop best-estimate HEPs given the PSFs and the fire-related effects. In 2007, EPRI and RES embarked on another cooperative project to develop explicit guidance for estimating HEPs for human failure events under fire generated conditions, building upon existing human reliability analysis (HRA) methods. This document provides a methodology and guidance for conducting a fire HRA. This process includes identification and definition of post-fire human failure events, qualitative analysis, quantification, recovery, dependency, and uncertainty. This document provides three approaches to quantification: screening, scoping, and detailed HRA. Screening is based on the guidance in NUREG/CR-6850, with some additional guidance for scenarios with long time windows. Scoping is a new approach to quantification developed specifically to support the iterative nature of fire PRA quantification. Scoping is intended to provide less conservative HEPs than screening, but requires fewer resources than a detailed HRA analysis. For detailed HRA quantification, guidance has been developed on how to apply existing methods to assess post-fire fire HEPs.« less

  15. Strengthening the regulatory system through the implementation and use of a quality management system.

    PubMed

    Eisner, Reinhold; Patel, Rakeshkumar

    2017-04-20

    Quality management systems (QMS), based on ISO 9001 requirements, are applicable to government service organizations such as Health Canada's Biologics and Genetic Therapies Directorate (BGTD). This communication presents the process that the BGTD followed since the early 2000s to implement a quality management system and describes how the regulatory system was improved as a result of this project. BGTD undertook the implementation of a quality management system based on ISO 9001 and containing aspects of ISO 17025 with the goal of strengthening the regulatory system through improvements in the people, processes, and services of the organization. We discuss the strategy used by BGTD to implement the QMS and the benefits that were realized from the various stages of implementation. The eight quality principals upon which the QMS standards of the ISO 9000 series are based were used by senior management as a framework to guide QMS implementation.

  16. Transcription Factor Networks Directing the Development, Function, and Evolution of Innate Lymphoid Effectors

    PubMed Central

    Kang, Joonsoo; Malhotra, Nidhi

    2015-01-01

    Mammalian lymphoid immunity is mediated by fast and slow responders to pathogens. Fast innate lymphocytes are active within hours after infections in mucosal tissues. Slow adaptive lymphocytes are conventional T and B cells with clonal antigen receptors that function days after pathogen exposure. A transcription factor (TF) regulatory network guiding early T cell development is at the core of effector function diversification in all innate lymphocytes, and the kinetics of immune responses is set by developmental programming. Operational units within the innate lymphoid system are not classified by the types of pathogen-sensing machineries but rather by discrete effector functions programmed by regulatory TF networks. Based on the evolutionary history of TFs of the regulatory networks, fast effectors likely arose earlier in the evolution of animals to fortify body barriers, and in mammals they often develop in fetal ontogeny prior to the establishment of fully competent adaptive immunity. PMID:25650177

  17. Spent fuel cask handling at an operating nuclear power plant

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

    Pal, A.C.

    1988-01-01

    The importance of spent fuel handling at operating nuclear power plants cannot be overstated. Because of its highly radioactive nature, however, spent fuel must be handled in thick, lead-lined containers or casks. Thus, all casks for spent fuel handling are heavy loads by the US Nuclear Regulatory Commission's definition, and any load-drop must be evaluated for its potential to damage safety-related equipment. Nuclear Regulatory Guide NUREG-0612 prescribes the regulatory requirements of alternative heavy-load-handling methodologies such as (a) by providing cranes that meet the requirements of NUREG-0554, which shall be called the soft path, or (b) by providing protective devices atmore » all postulated load-drop areas to prevent any damage to safety-related equipment, which shall be called the hard path. The work reported in this paper relates to cask handling at New York Power Authority's James A. FitzPatrick (JAF) plant.« less

  18. The future of yogurt: scientific and regulatory needs1234

    PubMed Central

    German, J Bruce

    2014-01-01

    Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers. PMID:24695899

  19. The future of yogurt: scientific and regulatory needs.

    PubMed

    German, J Bruce

    2014-05-01

    Lactation biology, microbial selection, and human diversity are central themes that could guide investment in scientific research, industrial innovation, and regulatory policy oversight to propel yogurt into the central role for health-promoting food products. The ability of yogurt to provide the nourishing properties of milk together with the live microorganisms from fermentation provides a unique combination of food assets. Academic research must now define the various targets on which these biological assets act to improve health and develop the metrics that can quantitatively document their benefits. The food industry must reconcile that yogurt and its microorganisms cannot be expected to provide measurable benefits for all consumers, at all doses, and at all times. A supportive regulatory oversight must demand safety and yet encourage innovations that support a value proposition for yogurt in health. Health valuation in the marketplace will be driven by parallel innovations, including accurate assessment technologies, validated microbial ingredients, and health-aware consumers.

  20. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

    PubMed

    Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

    2013-09-01

    The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

  1. Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses.

    PubMed

    Fisher, Laurel M; Martinez, Amy S; Richmond, Frances J; Krieger, Mark D; Wilkinson, Eric P; Eisenberg, Laurie S

    2017-01-01

    Children with congenital cochleovestibular abnormalities associated with profound hearing loss have few treatment options if cochlear implantation does not yield benefit. An alternative is the auditory brainstem implant (ABI). Regulatory authority device approvals currently include a structured benefit-risk assessment. Such an assessment, for regulatory purposes or to guide clinical decision making, has not been published, to our knowledge, for the ABI and may lead to the design of a research program that incorporates regulatory authority, family, and professional input. Much structured benefit-risk research has been conducted in the context of drug trials; here we apply this approach to device studies. A qualitative framework organized benefit (speech recognition, parent self-report measures) and risk (surgery- and device-related) information to guide the selection of candidates thought to have potential benefit from ABI. Children with cochleovestibular anatomical abnormalities are challenging for appropriate assessment of candidacy for a cochlear implant or an ABI. While the research is still preliminary, children with an ABI appear to slowly obtain benefit over time. A team of professionals, including audiological, occupational, and educational therapy, affords maximum opportunity for benefit. Pediatric patients who have abnormal anatomy and are candidates for an implantable auditory prosthetic require an individualized, multisystems review. The qualitative benefit-risk assessment used here to characterize the condition, the medical need, potential benefits, risks, and risk management strategies has revealed the complex factors involved. After implantation, continued team support for the family during extensive postimplant therapy is needed to develop maximum auditory skill benefit.

  2. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

    PubMed

    Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

    2016-05-01

    Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

  3. Food Reformulation, Responsive Regulation, and “Regulatory Scaffolding”: Strengthening Performance of Salt Reduction Programs in Australia and the United Kingdom

    PubMed Central

    Magnusson, Roger; Reeve, Belinda

    2015-01-01

    Strategies to reduce excess salt consumption play an important role in preventing cardiovascular disease, which is the largest contributor to global mortality from non-communicable diseases. In many countries, voluntary food reformulation programs seek to reduce salt levels across selected product categories, guided by aspirational targets to be achieved progressively over time. This paper evaluates the industry-led salt reduction programs that operate in the United Kingdom and Australia. Drawing on theoretical concepts from the field of regulatory studies, we propose a step-wise or “responsive” approach that introduces regulatory “scaffolds” to progressively increase levels of government oversight and control in response to industry inaction or under-performance. Our model makes full use of the food industry’s willingness to reduce salt levels in products to meet reformulation targets, but recognizes that governments remain accountable for addressing major diet-related health risks. Creative regulatory strategies can assist governments to fulfill their public health obligations, including in circumstances where there are political barriers to direct, statutory regulation of the food industry. PMID:26133973

  4. 77 FR 4498 - Rules and Regulations Under the Wool Products Labeling Act of 1939

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... Commission requests public comment on the overall costs, benefits, necessity, and regulatory and economic... seeking public comment on the continuing need for the rule or guide as well as its costs and benefits to..., and on the costs and benefits of certain provisions of the Wool Products Labeling Act of 1939. DATES...

  5. ENERGY STAR® Retail Products Platform (RPP): Conditions and Considerations in Evaluating Market Transformation Programs and Evaluation Guidance for RPP

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

    Li, Michael; Banwell, Peter

    2018-01-09

    The purpose of this guide is to provide a resource for state utility regulators, utilities, the evaluation community and regulatory stakeholders on methods to measure energy savings from the ENERGY STAR Retail Products Platform (link is external). The guidelines outlined in this document were developed by evaluation experts.

  6. 75 FR 51134 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ... Wertpapierb[ouml]rse (Frankfurt Stock Exchange) and traded on the Xetra trading system operated by Deutsche B[ouml]rse AG (``DBAG''). DBAG is regulated by the German Federal Financial Supervisory Authority (``Ba.... \\7\\ See ``Guide to the Equity Indices of Deutsche B[ouml]rse,'' at http://www.deutsche-boerse.com for...

  7. Self-Efficacy, Planning and Action Control in an Oral Self-Care Intervention

    ERIC Educational Resources Information Center

    Zhou, Guangyu; Sun, Caiyun; Knoll, Nina; Hamilton, Kyra; Schwarzer, Ralf

    2015-01-01

    To evaluate a theory-guided intervention on oral self-care and examine the possible mechanisms among self-regulatory factors, two brief intervention arms were compared, an information-based education treatment and a self-regulation treatment focusing on planning and action control. Young adults (N = 284; aged 18-29 years) were assessed at baseline…

  8. 77 FR 50727 - Configuration Management Plans for Digital Computer Software Used in Safety Systems of Nuclear...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... comments received on or before this date. Although a time limit is given, comments and suggestions in... guides are encouraged at any time. ADDRESSES: You may access information and comment submissions related... Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-251-7494 or email...

  9. 78 FR 33132 - Quality Verification for Plate-Type Uranium-Aluminum Fuel Elements for Use in Research and Test...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... Fuel Elements for Use in Research and Test Reactors AGENCY: Nuclear Regulatory Commission. ACTION... Research and Test Reactors.'' This guide describes a method that the staff of the NRC considers acceptable... assurance program for verifying the quality of plate-type uranium-aluminum fuel elements used in research...

  10. 77 FR 31655 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the... against burst, as discussed in Regulatory Guide (RG) 1.121, ``Bases for Plugging Degraded PWR [Pressurized... Institute] 97-06, Revision 3, ``Steam Generator Program Guidelines'' (Reference 1) and RG 1.121, ``Bases for...

  11. Infant Mental Health Assessment and Intervention Guidance for Service Providers and Families of Young Children. Service Guideline 4.

    ERIC Educational Resources Information Center

    Connecticut Birth to Three System, Hartford.

    This guide offers assessment and intervention guidelines for the Connecticut Birth to Three system concerning the emotional and psychological well-being of infants and toddlers in the system. Emphasis is on infants and toddlers who exhibit symptoms of traumatic stress disorder, depression or other affective disorders, regulatory disorders, sleep…

  12. 75 FR 47307 - Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... 510(k) program optimally achieves these goals. In September 2009, CDRH convened an internal 510(k...) program and explore actions CDRH could take to strengthen the program and improve the consistency of its... CDRH uses science to guide its regulatory decision making across the total product life cycle of...

  13. Hydropower: A Regulatory Guide to Permitting and Licensing in Idaho, Montana, Oregon, and Washington.

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

    McCoy, Gilbert A.

    1992-12-01

    The design, construction and operation of a hydropower project can result in many potential impacts. These potential impacts are of concern to a host of federal, state, and local authorities. Early consultation with land and water management, fish and wildlife resource protection, and health and human safety-oriented agencies should occur to determine specific concerns and study requirements for each proposed project. This Guide to Permitting and Licensing outlines the characteristic features of attractive hydropower sites; summarizes an array of developmental constraints; illustrates potential environmental impacts and concerns; and summarizes all federal, state, and local permitting and licensing requirements.

  14. Hydropower : A Regulatory Guide to Permitting and Licensing in Idaho, Montana, Oregon, and Washington.

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

    McCoy, Gilbert A.

    1992-12-01

    The design, construction and operation of a hydropower project can result in many potential impacts. These potential impacts are of concern to a host of federal, state, and local authorities. Early consultation with land and water management, fish and wildlife resource protection, and health and human safety-oriented agencies should occur to determine specific concerns and study requirements for each proposed project. This Guide to Permitting and Licensing outlines the characteristic features of attractive hydropower sites; summarizes an array of developmental constraints; illustrates potential environmental impacts and concerns; and summarizes all federal, state, and local permitting and licensing requirements.

  15. Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

    PubMed Central

    2014-01-01

    This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. PMID:24980283

  16. A periodic table for cancer.

    PubMed

    Epstein, Richard J

    2015-01-01

    Cancers exhibit differences in metastatic behavior and drug sensitivity that correlate with certain tumor-specific variables such as differentiation grade, growth rate/extent and molecular regulatory aberrations. In practice, patient management is based on the past results of clinical trials adjusted for these biomarkers. Here, it is proposed that treatment strategies could be fine-tuned upfront simply by quantifying tumorigenic spatial (cell growth) and temporal (genetic stability) control losses, as predicted by genetic defects of cell-cycle-regulatory gatekeeper and genome-stabilizing caretaker tumor suppressor genes, respectively. These differential quantifications of tumor dysfunction may in turn be used to create a tumor-specific 'periodic table' that guides rational formulation of survival-enhancing anticancer treatment strategies.

  17. Nuclear Power 2010 Program Dominion Virginia Power Cooperative Project U.S. Department of Energy Cooperative Agreement DE-FC07-05ID14635 Construction and Operating License Demonstration Project Final Report

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

    Eugene S. Grecheck

    2010-11-30

    This report serves to summarize the major activities completed as part of Virginia Electric and Power Company's North Anna construction and operating license demonstration project with DOE. Project successes, lessons learned, and suggestions for improvement are discussed. Objectives of the North Anna COL project included preparation and submittal of a COLA to the USNRC incorporating ESBWR technology for a third unit a the North Anna Power Station site, support for the NRC review process and mandatory hearing, obtaining NRC approval of the COLA and issuance of a COL, and development of a business case necessary to support a decision onmore » building a new nuclear power plant at the North Anna site.« less

  18. Full-scale 3-D finite element modeling of a two-loop pressurized water reactor for heat transfer, thermal–mechanical cyclic stress analysis, and environmental fatigue life estimation

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

    Mohanty, Subhasish; Soppet, William K.; Majumdar, Saurindranath

    This paper discusses a system-level finite element model of a two-loop pressurized water reactor (PWR). Based on this model, system-level heat transfer analysis and subsequent sequentially coupled thermal-mechanical stress analysis were performed for typical thermal-mechanical fatigue cycles. The in-air fatigue lives of example components, such as the hot and cold legs, were estimated on the basis of stress analysis results, ASME in-air fatigue life estimation criteria, and fatigue design curves. Furthermore, environmental correction factors and associated PWR environment fatigue lives for the hot and cold legs were estimated by using estimated stress and strain histories and the approach described inmore » US-NRC report: NUREG-6909.« less

  19. Chapter 5, "License Renewal and Aging Management for Continued Service

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

    Naus, Dan J

    As of August 2011, there were 104 commercial nuclear power reactors licensed to operate in 31 states in the United States. Initial operating licenses in the United States are granted for a period of 40 years. In order to help assure an adequate energy supply, the USNRC has established a timely license renewal process and clear requirements that are needed to ensure safe plant operation for an extended plant life. The principals of license renewal and the basic requirements that address license renewal are identified as well as additional sources of guidance that can be utilized as part of themore » license renewal process. Aging management program inspections and operating experience related to the concrete and steel containment structures are provided. Finally, several lessons learned are provided based on containment operating experience.« less

  20. GREGOR: evaluating global enrichment of trait-associated variants in epigenomic features using a systematic, data-driven approach.

    PubMed

    Schmidt, Ellen M; Zhang, Ji; Zhou, Wei; Chen, Jin; Mohlke, Karen L; Chen, Y Eugene; Willer, Cristen J

    2015-08-15

    The majority of variation identified by genome wide association studies falls in non-coding genomic regions and is hypothesized to impact regulatory elements that modulate gene expression. Here we present a statistically rigorous software tool GREGOR (Genomic Regulatory Elements and Gwas Overlap algoRithm) for evaluating enrichment of any set of genetic variants with any set of regulatory features. Using variants from five phenotypes, we describe a data-driven approach to determine the tissue and cell types most relevant to a trait of interest and to identify the subset of regulatory features likely impacted by these variants. Last, we experimentally evaluate six predicted functional variants at six lipid-associated loci and demonstrate significant evidence for allele-specific impact on expression levels. GREGOR systematically evaluates enrichment of genetic variation with the vast collection of regulatory data available to explore novel biological mechanisms of disease and guide us toward the functional variant at trait-associated loci. GREGOR, including source code, documentation, examples, and executables, is available at http://genome.sph.umich.edu/wiki/GREGOR. cristen@umich.edu Supplementary data are available at Bioinformatics online. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  1. Advancing the Adverse Outcome Pathway Framework - an ...

    EPA Pesticide Factsheets

    The ability of scientists to conduct whole organism toxicity tests to understand chemical safety has been significantly outpaced by the rapid synthesis of new chemicals. Therefore, to increase efficiencies in chemical risk assessment, scientists are turning to mechanistic-based studies, making greater use of in vitro and in silico methods, to screen for potential environmental and human health hazards. A framework that has gained traction for capturing available knowledge describing the linkage between mechanistic data and apical toxicity endpoints, required for regulatory assessments, is the adverse outcome pathway (AOP). A number of international activities have focused on AOP development and plausible applications to regulatory decision-making. These interactions have prompted dialog between research scientists and regulatory communities to consider how best to use the AOP framework in risk assessment. While expert-facilitated discussions have been instrumental in moving the science of AOPs forward, it was recognized that a survey of the broader scientific community would aid in identifying shortcomings and guiding future initiatives for the AOP framework. To that end, a ?‘Horizon Scanning’ exercise was conducted to solicit questions from the global scientific and regulatory communities concerning the challenges or limitations that must be addressed to realize the full potential of the AOP framework in research and regulatory decision making. The m

  2. A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies.

    PubMed

    White, Michael; Whittaker, Roger; Gándara, Carolina; Stoll, Elizabeth A

    2017-08-01

    Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is nonpathogenic, and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations and how they are administered in the United Kingdom, although many of the principles will be similar for other regions, including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarizes the extant regulatory guidance for gene therapies, categorized as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy.

  3. A Guide to Approaching Regulatory Considerations for Lentiviral-Mediated Gene Therapies

    PubMed Central

    White, Michael; Whittaker, Roger; Gándara, Carolina; Stoll, Elizabeth A.

    2017-01-01

    Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is nonpathogenic, and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations and how they are administered in the United Kingdom, although many of the principles will be similar for other regions, including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarizes the extant regulatory guidance for gene therapies, categorized as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy. PMID:28817344

  4. 77 FR 30029 - Advisory Committee on Reactor Safeguards; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ..., Rockville, Maryland. Wednesday, June 6, 2012, Conference Room T2-B1, 11545 Rockville Pike, Rockville... evaluation of the Fukushima Dai-ichi accident. 12:45 p.m.-2:15 p.m.: Proposed Revision 1 to Regulatory Guide... proprietary, pursuant to 5 U.S.C. 552b(c)(4)]. Thursday, June 7, 2012, Conference Room T2-B1, 11545 Rockville...

  5. 78 FR 29629 - Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-21

    ... Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L....lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969... along longitude 074[deg]37'00'' W. 2 May--3rd Sunday...... Annual Escape from Escape from Fort All...

  6. 76 FR 41148 - Care Labeling of Textile Wearing Apparel and Certain Piece Goods as Amended

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... the overall costs, benefits, necessity, and regulatory and economic impact of the FTC's Rule on Care... periodically. These reviews seek information about the costs and benefits of the rules and guides as well as... modifications, if any, should the Commission make to the Rule to increase its benefits or reduce its costs to...

  7. Transforming of Educational Institutions after GATS--Consequences in Social Relations as Corporation, Competition and State Regulation

    ERIC Educational Resources Information Center

    Jensen, Knud; Michel-Schertges, Dirk

    2010-01-01

    This article presents aspects of the regulatory reform work in public sectors was guided by the OECD in the 1990's manifested in GATS ( 1995 ) strategically planned by and through the Bologna Process and eagerly elaborated by boards and power holders of universities and university colleges. The tendency is privatisation which has as a consequence…

  8. Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

    PubMed Central

    Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

    2015-01-01

    This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

  9. 78 FR 75423 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-11

    ... the proposed rule change is available on the Exchange's Web site at www.nyse.com , at the principal... policies pursued by central banks and economic environments. The Investment Adviser will search for...) (stating that Guide 4 ``permit[s] a fund to invest up to 15% of its assets in illiquid securities''). The...

  10. A Unique Model Platform for C4 Plant Systems and Synthetic Biology

    DTIC Science & Technology

    2015-12-10

    International Conference in Bioinformatics , Sydney, Australia, July 31 - August 2, 2014.  Nielsen LK (2015) Genome scale metabolic and regulatory...the comparison of transcriptome proteome and central metabolome in mature and immature tissue. Preliminary data were obtained suggesting successful...guide the comparison of transcriptome, proteome and central metabolome in mature and immature tissue. Preliminary data were obtained suggesting

  11. A MODIS direct broadcast algorithm for mapping wildfire burned area in the western United States

    Treesearch

    S. P. Urbanski; J. M. Salmon; B. L. Nordgren; W. M. Hao

    2009-01-01

    Improved wildland fire emission inventory methods are needed to support air quality forecasting and guide the development of air shed management strategies. Air quality forecasting requires dynamic fire emission estimates that are generated in a timely manner to support real-time operations. In the regulatory and planning realm, emission inventories are essential for...

  12. Coordination of Ocean Management: A Perspective on the Gulf of Maine,

    DTIC Science & Technology

    1982-11-01

    transportation modes. The U.S. Coast Guard operates two OMEGA stations; the remaining six are operated by host countries under international agreement. The...42 Reasons for a Comprehensive Approach .......................... 43 Regulatory Reform .................................. 44...physical ocean, but that framework falls short in its efforts to guide and coordinate the activities of ocean users. Much of the remaining effort in this

  13. Overview of FDA approval paths optical surgical navigation

    NASA Astrophysics Data System (ADS)

    Jacobs, Paula M.

    2017-02-01

    The development of drugs and devices to guide surgical resection of tumors in the United States requires the approval of the US Food and Drug Administration. Because these combine a drug and a device, the regulatory pathways can be confusing, particularly to academics or small companies. This paper discusses some of the issues and provides some guidance in this area.

  14. 77 FR 70484 - Preoperational Testing of Onsite Electric Power Systems To Verify Proper Load Group Assignments...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... publicly available documents online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . To... reproduce them. NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1... that the staff needs in its review of applications for permits and licenses. The draft regulatory guide...

  15. 75 FR 5632 - Office of New Reactors; Interim Staff Guidance on the Review of Nuclear Power Plant Designs Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-03

    ....8 and Regulatory Guide 1.206, ``Combined License Applications for Nuclear Power Plants (LWR Edition... Management System (ADAMS) Accession No. ML092640035). This ISG provides new guidance information for... (SRP), Section 8.3.1 and Sections 9.5.4 through 9.5.8. The NRC staff issues DC/COL-ISGs to facilitate...

  16. The U. S. Department of Energy SARP review training program

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

    Mauck, C.J.

    1988-01-01

    In support of its radioactive material packaging certification program, the U.S. Department of Energy (DOE) has established a special training workshop. The purpose of the two-week workshop is to develop skills in reviewing Safety Analysis Reports for Packagings (SARPs) and performing confirmatory analyses. The workshop, conducted by the Lawrence Livermore National Laboratory (LLNL) for DOE, is divided into two parts: methods of review and methods of analysis. The sessions covering methods of review are based on the DOE document, ''Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings'' (PRG). The sessions cover relevant DOE Orders and all areas ofmore » review in the applicable Nuclear Regulatory Commission (NRC) Regulatory Guides. The technical areas addressed include structural and thermal behavior, materials, shielding, criticality, and containment. The course sessions on methods of analysis provide hands-on experience in the use of calculational methods and codes for reviewing SARPs. Analytical techniques and computer codes are discussed and sample problems are worked. Homework is assigned each night and over the included weekend; at the conclusion, a comprehensive take-home examination is given requiring six to ten hours to complete.« less

  17. Turning Towards or Turning Away: A Comparison of Mindfulness Meditation and Guided Imagery Relaxation in Patients with Acute Depression.

    PubMed

    Costa, Ana; Barnhofer, Thorsten

    2016-07-01

    Disengaging from maladaptive thinking is an important imperative in the treatment of depression. Mindfulness training is aimed at helping patients acquire relevant skills for this purpose. It remains unclear, however, whether this practice is helpful when patients are acutely depressed. In order to investigate effects of mindfulness on symptoms and self-regulatory capacities in this group, the current study compared a brief training in mindfulness (n = 19) to guided imagery relaxation (n = 18). Participants were introduced to the respective techniques in a single session, and practised daily over one week. Self-reported severity of symptoms, difficulties in emotion-regulation, attentional control, the ability to decentre, and mindfulness were assessed pre and postintervention, and at a one-week follow-up. Symptoms of depression significantly decreased and self-regulatory functioning significantly increased in both groups, with changes being maintained during follow-up. When controlling for change in depressive symptoms, results showed significantly higher improvements in emotion regulation at follow-up in the mindfulness group. The ability to decentre predicted changes in symptoms from pre to postintervention, while mindfulness skills predicted changes in symptoms during the maintenance phase. The findings suggest that both practices can help to instigate reductions in symptoms and enhance self-regulatory functioning in depression. However, in order to improve emotion regulation above levels explained by reductions in symptoms more intentional mental training seems necessary. Furthermore, while the ability to disengage from negative patterns of thinking seems crucial for initial reduction of symptoms, maintenance of gains might require broader skills in mindfulness.

  18. Establishment of a public docket for medical device/radiological health policy statements and operating procedure guides--FDA. Notice.

    PubMed

    1993-07-27

    The Food and Drug Administration (FDA) is announcing that it is establishing a public docket for policy speeches, policy statements, and standard operating procedure guides pertaining to product evaluation and regulatory enforcement for its medical device and radiological health programs. The docket will operate on a 1-year trial basis and will serve both as a repository for critical policy documents generated by the Center for Devices and Radiological Health (CDRH) and as a public display mechanism for access by representatives of the industry and other interested persons. This action is one element of an overall communications initiative to ensure uniform and timely access to important information.

  19. Promoting Adoption of the 3Rs through Regulatory Qualification.

    PubMed

    Walker, Elizabeth Gribble; Baker, Amanda F; Sauer, John-Michael

    2016-12-01

    One mechanism to advance the application of novel safety assessment methodologies in drug development, including in silico or in vitro approaches that reduce the use of animals in toxicology studies, is regulatory qualification. Regulatory qualification, a formal process defined at the the U. S. Food and Drug Administration and the European Medicines Agency, hinges on a central concept of stating an appropriate "context of use" for a novel drug development tool (DDT) that precisely defines how that DDT can be used to support decision making in a regulated drug development setting. When accumulating the data to support a particular "context-of-use," the concept of "fit-for-purpose" often guides assay validation, as well as the type and amount of data or evidence required to evaluate the tool. This paper will review pathways for regulatory acceptance of novel DDTs and discuss examples of safety projects considered for regulatory qualification. Key concepts to be considered when defining the evidence required to formally adopt and potentially replace animal-intensive traditional safety assessment methods using qualified DDTs are proposed. Presently, the use of qualified translational kidney safety biomarkers can refine and reduce the total numbers of animals used in drug development. We propose that the same conceptual regulatory framework will be appropriate to assess readiness of new technologies that may eventually replace whole animal models. © The Author 2016. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  20. Parallel evolution of chordate cis-regulatory code for development.

    PubMed

    Doglio, Laura; Goode, Debbie K; Pelleri, Maria C; Pauls, Stefan; Frabetti, Flavia; Shimeld, Sebastian M; Vavouri, Tanya; Elgar, Greg

    2013-11-01

    Urochordates are the closest relatives of vertebrates and at the larval stage, possess a characteristic bilateral chordate body plan. In vertebrates, the genes that orchestrate embryonic patterning are in part regulated by highly conserved non-coding elements (CNEs), yet these elements have not been identified in urochordate genomes. Consequently the evolution of the cis-regulatory code for urochordate development remains largely uncharacterised. Here, we use genome-wide comparisons between C. intestinalis and C. savignyi to identify putative urochordate cis-regulatory sequences. Ciona conserved non-coding elements (ciCNEs) are associated with largely the same key regulatory genes as vertebrate CNEs. Furthermore, some of the tested ciCNEs are able to activate reporter gene expression in both zebrafish and Ciona embryos, in a pattern that at least partially overlaps that of the gene they associate with, despite the absence of sequence identity. We also show that the ability of a ciCNE to up-regulate gene expression in vertebrate embryos can in some cases be localised to short sub-sequences, suggesting that functional cross-talk may be defined by small regions of ancestral regulatory logic, although functional sub-sequences may also be dispersed across the whole element. We conclude that the structure and organisation of cis-regulatory modules is very different between vertebrates and urochordates, reflecting their separate evolutionary histories. However, functional cross-talk still exists because the same repertoire of transcription factors has likely guided their parallel evolution, exploiting similar sets of binding sites but in different combinations.

  1. International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes.

    PubMed

    Bal-Price, Anna; Crofton, Kevin M; Leist, Marcel; Allen, Sandra; Arand, Michael; Buetler, Timo; Delrue, Nathalie; FitzGerald, Rex E; Hartung, Thomas; Heinonen, Tuula; Hogberg, Helena; Bennekou, Susanne Hougaard; Lichtensteiger, Walter; Oggier, Daniela; Paparella, Martin; Axelstad, Marta; Piersma, Aldert; Rached, Eva; Schilter, Benoît; Schmuck, Gabriele; Stoppini, Luc; Tongiorgi, Enrico; Tiramani, Manuela; Monnet-Tschudi, Florianne; Wilks, Martin F; Ylikomi, Timo; Fritsche, Ellen

    2015-02-01

    A major problem in developmental neurotoxicity (DNT) risk assessment is the lack of toxicological hazard information for most compounds. Therefore, new approaches are being considered to provide adequate experimental data that allow regulatory decisions. This process requires a matching of regulatory needs on the one hand and the opportunities provided by new test systems and methods on the other hand. Alignment of academically and industrially driven assay development with regulatory needs in the field of DNT is a core mission of the International STakeholder NETwork (ISTNET) in DNT testing. The first meeting of ISTNET was held in Zurich on 23-24 January 2014 in order to explore the concept of adverse outcome pathway (AOP) to practical DNT testing. AOPs were considered promising tools to promote test systems development according to regulatory needs. Moreover, the AOP concept was identified as an important guiding principle to assemble predictive integrated testing strategies (ITSs) for DNT. The recommendations on a road map towards AOP-based DNT testing is considered a stepwise approach, operating initially with incomplete AOPs for compound grouping, and focussing on key events of neurodevelopment. Next steps to be considered in follow-up activities are the use of case studies to further apply the AOP concept in regulatory DNT testing, making use of AOP intersections (common key events) for economic development of screening assays, and addressing the transition from qualitative descriptions to quantitative network modelling.

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

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

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

    2006-07-01

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

  3. Adverse Outcome Pathways: From Research to Regulation ...

    EPA Pesticide Factsheets

    An adverse outcome pathway (AOP) organizes existing knowledge on chemical mode of action, starting with a molecular initiating event such as receptor binding, continuing through key events, and ending with an adverse outcome such as reproductive impairment. AOPs can help identify knowledge gaps where more research is needed to understand the underlying mechanisms, aid in chemical hazard characterization, and guide the development of new testing approaches that use fewer or no animals. A September 2014 workshop co-sponsored by NICEATM and PCRM considered how the AOP concept could improve regulatory assessments of chemical toxicity. Scientists from 21 countries, representing industry, academia, regulatory agencies, and special interest groups, attended the workshop, titled Adverse Outcome Pathways: From Research to Regulation. Workshop plenary presentations were followed by breakout sessions that considered regulatory acceptance of AOPs and AOP-based tools, criteria for building confidence in an AOP for regulatory use, and requirements to build quantitative AOPs and AOP networks. Discussions during the closing session emphasized a need to increase transparent and inclusive collaboration, especially with disciplines outside of toxicology. Additionally, to increase impact, working groups should be established to systematically prioritize and develop AOPs. Multiple collaborative projects and follow-up activities resulted from the workshop. This manuscript provides a

  4. 75 FR 554 - Pacific Halibut Fisheries; Limited Access for Guided Sport Charter Vessels in Alaska

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ...NMFS issues regulations creating a limited access system for charter vessels in the guided sport fishery for Pacific halibut in waters of International Pacific Halibut Commission Regulatory Areas 2C (Southeast Alaska) and 3A (Central Gulf of Alaska). This limited access system limits the number of charter vessels that may participate in the guided sport fishery for halibut in these areas. NMFS will issue a charter halibut permit to a licensed charter fishing business owner based on his or her past participation in the charter halibut fishery and to a Community Quota Entity representing specific rural communities. All charter halibut permit holders are subject to limits on the number of permits they may hold and on the number of charter vessel anglers who may catch and retain halibut on permitted charter vessels. This action is necessary to achieve the approved halibut fishery management goals of the North Pacific Fishery Management Council. The intended effect is to curtail growth of fishing capacity in the guided sport fishery for halibut.

  5. An analysis of the early-warning system in emerging markets for reducing the financial crisis

    NASA Astrophysics Data System (ADS)

    Shen, Xiangguang; Song, Xiaozhong

    2009-07-01

    The large number of financial crises in emerging markets over the past ten years has left many observers, both from academia and financial institutions, puzzled by an apparent lack of homogenous causal relations between endogenous economic variables and the bursting of large financial shocks. The frequency of financial crises in the last 20 years can be attributed to the lack of a comprehensive theory of financial regulation to guide policy makers. Existing theories fail to define the range of regulatory models, the causes of regulatory failure, and how to measure and prevent it. Faulty design of regulatory models, and the lack of ongoing performance monitoring incorporating early warning systems, is disrupting economic and social development. The main aim of this article is to propose an early warning system (EWS) which purposes issuing warning signal against the possible financial crisis in the emerging market, and makes the emerging market survived the first wave of the crisis be able to continue their operation in the following years.

  6. SCANS (Shipping Cask ANalysis System) a microcomputer-based analysis system for shipping cask design review: User`s manual to Version 3a. Volume 1, Revision 2

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

    Mok, G.C.; Thomas, G.R.; Gerhard, M.A.

    SCANS (Shipping Cask ANalysis System) is a microcomputer-based system of computer programs and databases developed at the Lawrence Livermore National Laboratory (LLNL) for evaluating safety analysis reports on spent fuel shipping casks. SCANS is an easy-to-use system that calculates the global response to impact loads, pressure loads and thermal conditions, providing reviewers with an independent check on analyses submitted by licensees. SCANS is based on microcomputers compatible with the IBM-PC family of computers. The system is composed of a series of menus, input programs, cask analysis programs, and output display programs. All data is entered through fill-in-the-blank input screens thatmore » contain descriptive data requests. Analysis options are based on regulatory cases described in the Code of Federal Regulations 10 CFR 71 and Regulatory Guides published by the US Nuclear Regulatory Commission in 1977 and 1978.« less

  7. Markov State Models of gene regulatory networks.

    PubMed

    Chu, Brian K; Tse, Margaret J; Sato, Royce R; Read, Elizabeth L

    2017-02-06

    Gene regulatory networks with dynamics characterized by multiple stable states underlie cell fate-decisions. Quantitative models that can link molecular-level knowledge of gene regulation to a global understanding of network dynamics have the potential to guide cell-reprogramming strategies. Networks are often modeled by the stochastic Chemical Master Equation, but methods for systematic identification of key properties of the global dynamics are currently lacking. The method identifies the number, phenotypes, and lifetimes of long-lived states for a set of common gene regulatory network models. Application of transition path theory to the constructed Markov State Model decomposes global dynamics into a set of dominant transition paths and associated relative probabilities for stochastic state-switching. In this proof-of-concept study, we found that the Markov State Model provides a general framework for analyzing and visualizing stochastic multistability and state-transitions in gene networks. Our results suggest that this framework-adopted from the field of atomistic Molecular Dynamics-can be a useful tool for quantitative Systems Biology at the network scale.

  8. Prescription Drug Abuse: Epidemiology, Regulatory Issues, Chronic Pain Management with Narcotic Analgesics

    PubMed Central

    Manubay, Jeanne M.; Muchow, Carrie; Sullivan, Maria A.

    2012-01-01

    Synopsis The epidemic of prescription drug abuse has reached a critical level, which has received national attention. Physicians must learn strategies to effectively treat chronic pain, and help reduce the rates of prescription drug abuse. This chapter will provide insight into the epidemiology of prescription drug abuse, explain regulatory issues, and provide guidelines for the assessment and management of pain, particularly with chronic opioid therapy. The use of informed consent forms, treatment agreements, risk documentation tools, and regular monitoring of the 4 “A's” helps to educate patients, as well as guide management based on treatment goals. By using universal precautions, and being aware of aberrant behaviors, physicians may feel more confident in identifying and addressing problematic behaviors. PMID:21356422

  9. Guidelines for spaceborne microwave remote sensors

    NASA Technical Reports Server (NTRS)

    Litman, V.; Nicholas, J.

    1982-01-01

    A handbook was developed to provide information and support to the spaceborne remote sensing and frequency management communities: to guide sensor developers in the choice of frequencies; to advise regulators on sensor technology needs and sharing potential; to present sharing analysis models and, through example, methods for determining sensor sharing feasibility; to introduce developers to the regulatory process; to create awareness of proper assignment procedures; to present sensor allocations; and to provide guidelines on the use and limitations of allocated bands. Controlling physical factors and user requirements and the regulatory environment are discussed. Sensor frequency allocation achievable performance and usefulness are reviewed. Procedures for national and international registration, the use of non-allocated bands and steps for obtaining new frequency allocations, and procedures for reporting interference are also discussed.

  10. 78 FR 31402 - Safety Zones and Special Local Regulations; Recurring Marine Events in Captain of the Port Long...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-24

    ..., 073[deg]10'58'' W (NAD 83). 11 November 11.1 Charles W. Morgan Anniversary Date: A day during the... 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to... Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide...

  11. 76 FR 13439 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-11

    ... Change To Amend the Dividends Service Guide as It Relates to the Domestic Tax Reporting Service and the U... concerning the purpose of and basis for the proposed rule change and discussed any comments it received on... occurs, DTC participants need to be aware of it so they can properly prepare the IRS Forms 1099 they are...

  12. Riding in silence: a little snowboarding, a lot of small RNAs

    PubMed Central

    2010-01-01

    The recent symposium, RNA silencing: Mechanism, Biology and Applications, organized by Phillip D. Zamore (University of Massachusetts Medical School) and Beverly Davidson (University of Iowa), and held in Keystone, Colorado, brought together scientists working on diverse aspects of RNA silencing, a field that comprises a multitude of gene regulatory pathways guided by microRNAs, small interfering RNAs and PIWI-interacting RNAs. PMID:20230614

  13. Template protocol for clinical trials investigating vaccines--focus on safety elements.

    PubMed

    Bonhoeffer, Jan; Imoukhuede, Egeruan B; Aldrovandi, Grace; Bachtiar, Novilia S; Chan, Eng-Soon; Chang, Soju; Chen, Robert T; Fernandopulle, Rohini; Goldenthal, Karen L; Heffelfinger, James D; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

    2013-11-12

    This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. Management of the aging of critical safety-related concrete structures in light-water reactor plants

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

    Naus, D.J.; Oland, C.B.; Arndt, E.G.

    1990-01-01

    The Structural Aging Program has the overall objective of providing the USNRC with an improved basis for evaluating nuclear power plant safety-related structures for continued service. The program consists of a management task and three technical tasks: materials property data base, structural component assessment/repair technology, and quantitative methodology for continued-service determinations. Objectives, accomplishments, and planned activities under each of these tasks are presented. Major program accomplishments include development of a materials property data base for structural materials as well as an aging assessment methodology for concrete structures in nuclear power plants. Furthermore, a review and assessment of inservice inspection techniquesmore » for concrete materials and structures has been complete, and work on development of a methodology which can be used for performing current as well as reliability-based future condition assessment of concrete structures is well under way. 43 refs., 3 tabs.« less

  15. High Fidelity CFD Analysis and Validation of Rotorcraft Gearbox Aerodynamics Under Operational and Oil-Out Conditions

    NASA Technical Reports Server (NTRS)

    Kunz, Robert F.

    2014-01-01

    This document represents the evolving formal documentation of the NPHASE-PSU computer code. Version 3.15 is being delivered along with the software to NASA in 2013.Significant upgrades to the NPHASE-PSU have been made since the first delivery of draft documentation to DARPA and USNRC in 2006. These include a much lighter, faster and memory efficient face based front end, support for arbitrary polyhedra in front end, flow-solver and back-end, a generalized homogeneous multiphase capability, and several two-fluid modelling and algorithmic elements. Specific capability installed for the NASA Gearbox Windage Aerodynamics NRA are included in this version: Hybrid Immersed Overset Boundary Method (HOIBM) [Noack et. al (2009)] Periodic boundary conditions for multiple frames of reference, Fully generalized immersed boundary method, Fully generalized conjugate heat transfer, Droplet deposition, bouncing, splashing models, and, Film transport and breakup.

  16. International STakeholder NETwork (ISTNET): Creating a ...

    EPA Pesticide Factsheets

    A major problem in developmental neurotoxicity (DNT) risk assessment is the lack of toxicological hazard information for most compounds. Therefore, new approaches are being considered to provide adequate experimental data that allow regulatory decisions. This process requires a matching of regulatory needs on the one hand and the opportunities provided by new test sys-tems and methods on the other hand. Alignment of academically and industrially-driven assay development with regulatory needs in the field of DNT is a core mission of the International STakeholder NETwork (ISNET) in DNT testing. The first meeting of ISTNET was held in Zur-ich on 23-24 January 2014 in order to explore the concept of adverse outcome pathway (AOP) to practical DNT testing. AOPs were considered promising tools to promote test systems develop-ment according to regulatory needs. Moreover, the AOP concept was identified as an important guiding principle to assemble predictive integrated testing strategies (ITSs) for DNT. The recommendations on a roadmap towards AOP-based DNT testing is considered a stepwise approach, operating initially with incomplete AOPs for compound grouping, and focussing on key events of neurodevelopment. Next steps to be considered in follow-up activities are the use of case studies to further apply the AOP concept in regulatory DNT testing, making use of AOP intersections (common key events) for economic development of screening assays, and address-ing the transit

  17. [Task sharing with radiotherapy technicians in image-guided radiotherapy].

    PubMed

    Diaz, O; Lorchel, F; Revault, C; Mornex, F

    2013-10-01

    The development of accelerators with on-board imaging systems now allows better target volumes reset at the time of irradiation (image-guided radiotherapy [IGRT]). However, these technological advances in the control of repositioning led to a multiplication of tasks for each actor in radiotherapy and increase the time available for the treatment, whether for radiotherapy technicians or radiation oncologists. As there is currently no explicit regulatory framework governing the use of IGRT, some institutional experiments show that a transfer is possible between radiation oncologists and radiotherapy technicians for on-line verification of image positioning. Initial training for every technical and drafting procedures within institutions will improve audit quality by reducing interindividual variability. Copyright © 2013. Published by Elsevier SAS.

  18. A health app developer's guide to law and policy: a multi-sector policy analysis.

    PubMed

    Parker, Lisa; Karliychuk, Tanya; Gillies, Donna; Mintzes, Barbara; Raven, Melissa; Grundy, Quinn

    2017-10-02

    Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection. We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions. We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders. We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool.

  19. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    PubMed

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

  20. 76 FR 37690 - Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port Boston Zone

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ... section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we... Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in... Sheep's Island within the following points (NAD 83): 42[deg]18.3' N, 070[deg]55.8' W. 42[deg]18.3' N...

  1. Decentralized authority, increased enforcement guide Mexico's environmental evolution

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

    Ranger, E.M.; Alonzo, A.L.

    1994-01-01

    Environmental regulation in Mexico is evolving into a decentralized system where local authorities assume responsibility for compliance. Articles 25, 27 and 73 of Mexico's constitution establish federal, state and municipal jurisdictions for environmental protection, and empower the federal congress to promulgate environmental legislation. An established federal and local environmental legislative and normative framework, along with increased enforcement, provide the country with a comprehensive regulatory system to prevent and control industrial pollution.

  2. Stepping Stones To Using "Caring for Our Children": National Health and Safety Performance Standards for Out-of-Home Child Care Programs. Protecting Children from Harm.

    ERIC Educational Resources Information Center

    Colorado Univ. Health Sciences Center, Denver.

    Developed in support of state licensing and regulatory agencies as well as state child care, health, and resource and referral agencies, and a variety of other public and private organizations, parents, and advocacy groups, this guide identifies those standards most needed for the prevention of injury, morbidity, and mortality in child care…

  3. Statistical evaluation of the metallurgical test data in the ORR-PSF-PVS irradiation experiment. [PWR; BWR

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

    Stallmann, F.W.

    1984-08-01

    A statistical analysis of Charpy test results of the two-year Pressure Vessel Simulation metallurgical irradiation experiment was performed. Determination of transition temperature and upper shelf energy derived from computer fits compare well with eyeball fits. Uncertainties for all results can be obtained with computer fits. The results were compared with predictions in Regulatory Guide 1.99 and other irradiation damage models.

  4. Nutritional Guidelines and Fermented Food Frameworks

    PubMed Central

    Bell, Victoria; Ferrão, Jorge; Fernandes, Tito

    2017-01-01

    This review examines different nutritional guidelines, some case studies, and provides insights and discrepancies, in the regulatory framework of Food Safety Management of some of the world’s economies. There are thousands of fermented foods and beverages, although the intention was not to review them but check their traditional and cultural value, and if they are still lacking to be classed as a category on different national food guides. For understanding the inconsistencies in claims of concerning fermented foods among various regulatory systems, each legal system should be considered unique. Fermented foods and beverages have long been a part of the human diet, and with further supplementation of probiotic microbes, in some cases, they offer nutritional and health attributes worthy of recommendation of regular consumption. Despite the impact of fermented foods and beverages on gastro-intestinal wellbeing and diseases, their many health benefits or recommended consumption has not been widely translated to global inclusion in world food guidelines. In general, the approach of the legal systems is broadly consistent and their structures may be presented under different formats. African traditional fermented products are briefly mentioned enhancing some recorded adverse effects. Knowing the general benefits of traditional and supplemented fermented foods, they should be a daily item on most national food guides. PMID:28783111

  5. Review of reactor pressure vessel evaluation report for Yankee Rowe Nuclear Power Station (YAEC No. 1735)

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

    Cheverton, R.D.; Dickson, T.L.; Merkle, J.G.

    1992-03-01

    The Yankee Atomic Electric Company has performed an Integrated Pressurized Thermal Shock (IPTS)-type evaluation of the Yankee Rowe reactor pressure vessel in accordance with the PTS Rule (10 CFR 50. 61) and a US Regulatory Guide 1.154. The Oak Ridge National Laboratory (ORNL) reviewed the YAEC document and performed an independent probabilistic fracture-mechnics analysis. The review included a comparison of the Pacific Northwest Laboratory (PNL) and the ORNL probabilistic fracture-mechanics codes (VISA-II and OCA-P, respectively). The review identified minor errors and one significant difference in philosophy. Also, the two codes have a few dissimilar peripheral features. Aside from these differences,more » VISA-II and OCA-P are very similar and with errors corrected and when adjusted for the difference in the treatment of fracture toughness distribution through the wall, yield essentially the same value of the conditional probability of failure. The ORNL independent evaluation indicated RT{sub NDT} values considerably greater than those corresponding to the PTS-Rule screening criteria and a frequency of failure substantially greater than that corresponding to the primary acceptance criterion'' in US Regulatory Guide 1.154. Time constraints, however, prevented as rigorous a treatment as the situation deserves. Thus, these results are very preliminary.« less

  6. Review of reactor pressure vessel evaluation report for Yankee Rowe Nuclear Power Station (YAEC No. 1735)

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

    Cheverton, R.D.; Dickson, T.L.; Merkle, J.G.

    1992-03-01

    The Yankee Atomic Electric Company has performed an Integrated Pressurized Thermal Shock (IPTS)-type evaluation of the Yankee Rowe reactor pressure vessel in accordance with the PTS Rule (10 CFR 50. 61) and a US Regulatory Guide 1.154. The Oak Ridge National Laboratory (ORNL) reviewed the YAEC document and performed an independent probabilistic fracture-mechnics analysis. The review included a comparison of the Pacific Northwest Laboratory (PNL) and the ORNL probabilistic fracture-mechanics codes (VISA-II and OCA-P, respectively). The review identified minor errors and one significant difference in philosophy. Also, the two codes have a few dissimilar peripheral features. Aside from these differences,more » VISA-II and OCA-P are very similar and with errors corrected and when adjusted for the difference in the treatment of fracture toughness distribution through the wall, yield essentially the same value of the conditional probability of failure. The ORNL independent evaluation indicated RT{sub NDT} values considerably greater than those corresponding to the PTS-Rule screening criteria and a frequency of failure substantially greater than that corresponding to the ``primary acceptance criterion`` in US Regulatory Guide 1.154. Time constraints, however, prevented as rigorous a treatment as the situation deserves. Thus, these results are very preliminary.« less

  7. Evo-devo, deep homology and FoxP2: implications for the evolution of speech and language

    PubMed Central

    Scharff, Constance; Petri, Jana

    2011-01-01

    The evolution of novel morphological features, such as feathers, involves the modification of developmental processes regulated by gene networks. The fact that genetic novelty operates within developmental constraints is the central tenet of the ‘evo-devo’ conceptual framework. It is supported by findings that certain molecular regulatory pathways act in a similar manner in the development of morphological adaptations, which are not directly related by common ancestry but evolved convergently. The Pax6 gene, important for vision in molluscs, insects and vertebrates, and Hox genes, important for tetrapod limbs and fish fins, exemplify this ‘deep homology’. Recently, ‘evo-devo’ has expanded to the molecular analysis of behavioural traits, including social behaviour, learning and memory. Here, we apply this approach to the evolution of human language. Human speech is a form of auditory-guided, learned vocal motor behaviour that also evolved in certain species of birds, bats and ocean mammals. Genes relevant for language, including the transcription factor FOXP2, have been identified. We review evidence that FoxP2 and its regulatory gene network shapes neural plasticity in cortico-basal ganglia circuits underlying the sensory-guided motor learning in animal models. The emerging picture can help us understand how complex cognitive traits can ‘descend with modification’. PMID:21690130

  8. Evo-devo, deep homology and FoxP2: implications for the evolution of speech and language.

    PubMed

    Scharff, Constance; Petri, Jana

    2011-07-27

    The evolution of novel morphological features, such as feathers, involves the modification of developmental processes regulated by gene networks. The fact that genetic novelty operates within developmental constraints is the central tenet of the 'evo-devo' conceptual framework. It is supported by findings that certain molecular regulatory pathways act in a similar manner in the development of morphological adaptations, which are not directly related by common ancestry but evolved convergently. The Pax6 gene, important for vision in molluscs, insects and vertebrates, and Hox genes, important for tetrapod limbs and fish fins, exemplify this 'deep homology'. Recently, 'evo-devo' has expanded to the molecular analysis of behavioural traits, including social behaviour, learning and memory. Here, we apply this approach to the evolution of human language. Human speech is a form of auditory-guided, learned vocal motor behaviour that also evolved in certain species of birds, bats and ocean mammals. Genes relevant for language, including the transcription factor FOXP2, have been identified. We review evidence that FoxP2 and its regulatory gene network shapes neural plasticity in cortico-basal ganglia circuits underlying the sensory-guided motor learning in animal models. The emerging picture can help us understand how complex cognitive traits can 'descend with modification'.

  9. Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations

    PubMed Central

    Morales, Daniel R.; Pacurariu, Alexandra; Kurz, Xavier

    2017-01-01

    Aims Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. Methods We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non‐European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted. Results From 1246 screened articles, 229 were eligible for full‐text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill‐over effects were rarely evaluated. Two‐thirds used before–after time series and 15.7% before–after cross‐sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%). Conclusion Whilst impact evaluation of pharmacovigilance and product‐specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs. PMID:29105853

  10. A compact, in vivo screen of all 6-mers reveals drivers of tissue-specific expression and guides synthetic regulatory element design.

    PubMed

    Smith, Robin P; Riesenfeld, Samantha J; Holloway, Alisha K; Li, Qiang; Murphy, Karl K; Feliciano, Natalie M; Orecchia, Lorenzo; Oksenberg, Nir; Pollard, Katherine S; Ahituv, Nadav

    2013-07-18

    Large-scale annotation efforts have improved our ability to coarsely predict regulatory elements throughout vertebrate genomes. However, it is unclear how complex spatiotemporal patterns of gene expression driven by these elements emerge from the activity of short, transcription factor binding sequences. We describe a comprehensive promoter extension assay in which the regulatory potential of all 6 base-pair (bp) sequences was tested in the context of a minimal promoter. To enable this large-scale screen, we developed algorithms that use a reverse-complement aware decomposition of the de Bruijn graph to design a library of DNA oligomers incorporating every 6-bp sequence exactly once. Our library multiplexes all 4,096 unique 6-mers into 184 double-stranded 15-bp oligomers, which is sufficiently compact for in vivo testing. We injected each multiplexed construct into zebrafish embryos and scored GFP expression in 15 tissues at two developmental time points. Twenty-seven constructs produced consistent expression patterns, with the majority doing so in only one tissue. Functional sequences are enriched near biologically relevant genes, match motifs for developmental transcription factors, and are required for enhancer activity. By concatenating tissue-specific functional sequences, we generated completely synthetic enhancers for the notochord, epidermis, spinal cord, forebrain and otic lateral line, and show that short regulatory sequences do not always function modularly. This work introduces a unique in vivo catalog of short, functional regulatory sequences and demonstrates several important principles of regulatory element organization. Furthermore, we provide resources for designing compact, reverse-complement aware k-mer libraries.

  11. Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!

    PubMed

    Petrella, Brenda L

    2015-11-03

    This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research. Copyright © 2015 John Wiley & Sons, Inc.

  12. Underclad cracking of pressure vessel steels for light-water reactors

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

    Lopez, H.F.

    1987-06-01

    Although fracture mechanics analyses have shown that underclad cracks have no detrimental effect on the integrity of thick walled pressure vessels (40 year service), in order to avoid unexpected failures the US Nuclear Regulatory Commission has issued Regulatory Guide 1.43 which sets limits on the extent of fissures permitted and describes acceptable means of controlling the weld cladding processes. Cavitation and intergranular fissuring in SA508-2 and 22NiMoCr37 steels can occur in the presence or absence of intergranular particles. The observations of intergranular fissuring and cavitation in those HAZ free from overlapping effects are attributed to grain boundary segregation. Other probablemore » void nucleation sites are the grain boundary-lath interface intersections which facilitate the formation of grain boundary discontinuities.« less

  13. Cultural Differences in Values as Self-Guides.

    PubMed

    Cheung, Wing-Yee; Maio, Gregory R; Rees, Kerry J; Kamble, Shanmukh; Mane, Sangeetha

    2016-06-01

    Three studies tested whether individualism-collectivism moderates the extent to which values are endorsed as ideal self-guides and ought self-guides, and the consequences for regulatory focus and emotion. Across Studies 1 and 2, individualists endorsed values that are relatively central to the self as stronger ideals than oughts, whereas collectivists endorsed them as ideals and oughts to a similar degree. Study 2 found that individualists justified central values using reasons that were more promotion focused than prevention focused, whereas collectivists used similar amount of prevention-focused and promotion-focused reasons. In Study 3, individualists felt more dejected after violating a central (vs. peripheral) value and more agitated after violating a peripheral (vs. central) value. Collectivists felt a similar amount of dejection regardless of values centrality and more agitation after violating central (vs. peripheral) values. Overall, culture has important implications for how we regulate values that are central or peripheral to our self-concept. © 2016 by the Society for Personality and Social Psychology, Inc.

  14. Key Elements for Judging the Quality of a Risk Assessment

    PubMed Central

    Fenner-Crisp, Penelope A.; Dellarco, Vicki L.

    2016-01-01

    Background: Many reports have been published that contain recommendations for improving the quality, transparency, and usefulness of decision making for risk assessments prepared by agencies of the U.S. federal government. A substantial measure of consensus has emerged regarding the characteristics that high-quality assessments should possess. Objective: The goal was to summarize the key characteristics of a high-quality assessment as identified in the consensus-building process and to integrate them into a guide for use by decision makers, risk assessors, peer reviewers and other interested stakeholders to determine if an assessment meets the criteria for high quality. Discussion: Most of the features cited in the guide are applicable to any type of assessment, whether it encompasses one, two, or all four phases of the risk-assessment paradigm; whether it is qualitative or quantitative; and whether it is screening level or highly sophisticated and complex. Other features are tailored to specific elements of an assessment. Just as agencies at all levels of government are responsible for determining the effectiveness of their programs, so too should they determine the effectiveness of their assessments used in support of their regulatory decisions. Furthermore, if a nongovernmental entity wishes to have its assessments considered in the governmental regulatory decision-making process, then these assessments should be judged in the same rigorous manner and be held to similar standards. Conclusions: The key characteristics of a high-quality assessment can be summarized and integrated into a guide for judging whether an assessment possesses the desired features of high quality, transparency, and usefulness. Citation: Fenner-Crisp PA, Dellarco VL. 2016. Key elements for judging the quality of a risk assessment. Environ Health Perspect 124:1127–1135; http://dx.doi.org/10.1289/ehp.1510483 PMID:26862984

  15. Genetically Modified Food Labeling in China: In Pursuit of a Rational Path.

    PubMed

    Zhu, Xiao; Roberts, Michael T; Wu, Kaijie

    2016-08-01

    Facing a tension between the increasing use of genetically engineered or modified food and consumer concerns over the risks associated with GMOs, China has established a GM food labeling regime through regulations-known as Agro-GMO regulations-to protect consumers' right to know. However, the design and enforcement of this GM food labeling regime is problematic. As a result, the labeling regime is ineffective and inconsistent, leaving consumers' rights unprotected. As the recently amended Food Safety Law in China requires GM food labeling for the first time, this article argues that China should replace the current Agro-GMO food labeling scheme with a special regulatory scheme. A comparative analysis of the GM food labeling systems in the European Union and United States, coupled with a rigorous examination of the problems and barriers of GM food labeling in China, sets a solid foundation by which to propose changes to incorporate into a special regulatory scheme. To this end, this article engages in such an analysis and recommends practical steps to guide the enactment of a special regulatory scheme. The recommendations comport with China's unique legal and political culture, but also could be used by other national regulatory regimes who permit use of GM food while also being committed to improving consumers' right to know.

  16. African wildlife conservation and the evolution of hunting institutions

    NASA Astrophysics Data System (ADS)

    't Sas-Rolfes, Michael

    2017-11-01

    Hunting regulation presents a significant challenge for contemporary global conservation governance. Motivated by various incentives, hunters may act legally or illegally, for or against the interests of conservation. Hunter incentives are shaped by the interactions between unevenly evolving formal and informal institutions, embedded in socio-ecological systems. To work effectively for conservation, regulatory interventions must take these evolving institutional interactions into account. Drawing on analytical tools from evolutionary institutional economics, this article examines the trajectory of African hunting regulation and its consequences. Concepts of institutional dynamics, fit, scale, and interplay are applied to case studies of rhinoceros and lion hunting to highlight issues of significance to conservation outcomes. These include important links between different forms of hunting and dynamic interplay with institutions of trade. The case studies reveal that inappropriate formal regulatory approaches may be undermined by adaptive informal market responses. Poorly regulated hunting may lead to calls for stricter regulations or bans, but such legal restrictions may in turn perversely lead to more intensified and organised illegal hunting activity, further undermining conservation objectives. I conclude by offering insights and recommendations to guide more effective future regulatory interventions and priorities for further research. Specifically, I advocate approaches that move beyond simplistic regulatory interventions toward more complex, but supportive, institutional arrangements that align formal and informal institutions through inclusive stakeholder engagement.

  17. SPES-2, AP600 intergral system test S01007 2 inch CL to core make-up tank pressure balance line break

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

    Bacchiani, M.; Medich, C.; Rigamonti, M.

    1995-09-01

    The SPES-2 is a full height, full pressure experimental test facility reproducing the Westinghouse AP600 reactor with a scaling factor of 1/395. The experimental plant, designed and operated by SIET in Piacenza, consists of a full simulation of the AP600 primary core cooling system including all the passive and active safety systems. In 1992, Westinghouse, in cooperation with ENEL (Ente Nazionale per l` Energia Elettrica), ENEA (Enter per le numove Technlogie, l` Energia e l` Ambient), Siet (Societa Informazioni Esperienze Termoidraulich) and ANSALDO developed an experimental program to test the integrated behaviour of the AP600 passive safety systems. The SPES-2more » test matrix, concluded in November 1994, has examined the AP600 passive safety system response for a range of small break LOCAs at different locations on the primary system and on the passive system lines; single steam generator tube ruptures with passive and active safety systems and a main steam line break transient to demonstrate the boration capability of passive safety systems for rapid cooldown. Each of the tests has provided detailed experimental results for verification of the capability of the analysis methods to predict the integrated passive safety system behaviour. Cold and hot shakedown tests have been performed on the facility to check the characteristics of the plant before starting the experimental campaign. The paper first presents a description of the SPES-2 test facility then the main results of S01007 test {open_quotes}2{close_quotes} Cold Leg (CL) to Core Make-up Tank (CMT) pressure balance line break{close_quotes} are reported and compared with predictions performed using RELAP5/mod3/80 obtained by ANSALDO through agreement with U.S.N.R.C. (U.S. Nuclear Regulatory Commission). The SPES-2 nodalization and all the calculations here presented were performed by ANSALDO and sponsored by ENEL as a part of pre-test predictions for SPES-2.« less

  18. THE CLEAN ENERGY-ENVIRONMENT GUIDE TO ACTION ...

    EPA Pesticide Factsheets

    The Guide to Action identifies and describes sixteen clean energy policies and strategies that are delivering economic and environmental results for states. For each policy, the Guide describes: Objectives and benefits of the policy; Examples of states that have implemented the policy; Responsibilities of key players at the state level, including typical roles of the main stakeholders; Opportunities to coordinate implementation with other federal and state policies, partnerships and technical assistance resources; Best practices for policy design, implementation, and evaluation, including state examples; Action steps for states to take when adopting or modifying their clean energy policies, based on existing state experiences; Resources for additional information on individual state policies, legislative and regulatory language, and analytical tools and methods. States participating in the Clean Energy-Environment State Partnership Program will use the Guide to Action to: Develop their own Clean Energy-Environment Action Plan that is appropriate to their state; Identify the roles and responsibilities of key decision-makers, such as environmental regulators, state legislatures, public utility commissioners, and state energy offices; Access and apply technical assistance resources, models, and tools available for state-specific analyses and program implementation; and Learn from each other as they develop their own clean energy programs and policies.

  19. Learning portfolio models in health regulatory colleges of Ontario, Canada.

    PubMed

    Tompkins, Marianne; Paquette-Frenette, Denise

    2010-01-01

    Health regulatory colleges promote continued competence by requiring members to submit yearly portfolios that document learning. Previous studies conclude that portfolios can be valuable tools to promote continuous learning in health college members, but portfolios are time-consuming to complete and difficult to evaluate. This exploratory study compares the features of portfolio models in regulatory colleges, as a basis for future studies. Data were collected through a document review of the portfolio models described on the Web sites of 14 Canadian health regulatory colleges. All models contain 3 common components of self-directed learning: (1) self-diagnosis, (2) learning plan and activities, and (3) self-evaluation. Several include member profiles and peer feedback. A broad range of formal, nonformal, and informal activities are accepted as evidence of learning; a few colleges restrict learners' freedom in selecting these activities. There is a dual philosophy of learning in portfolio models that includes both humanist and technical paradigms. Low numbers of members are selected for audit of completed portfolios. The possibility of last-minute preparation and the lack of support to members who struggle with self-directed learning methods are issues to be resolved. Although portfolios are designed to enhance learning and reflection, quality cannot be ensured unless compliance is enforced, and learning outcomes are measured. Professionals should be guided regarding how to complete portfolios. More health regulatory colleges should announce the number of portfolios they audit. In general, the number of portfolios audited by each profession may need to be increased.

  20. LAND AND WATER USE CHARACTERISTICS AND HUMAN HEALTH INPUT PARAMETERS FOR USE IN ENVIRONMENTAL DOSIMETRY AND RISK ASSESSMENTS AT THE SAVANNAH RIVER SITE

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

    Jannik, T.; Karapatakis, D.; Lee, P.

    2010-08-06

    Operations at the Savannah River Site (SRS) result in releases of small amounts of radioactive materials to the atmosphere and to the Savannah River. For regulatory compliance purposes, potential offsite radiological doses are estimated annually using computer models that follow U.S. Nuclear Regulatory Commission (NRC) Regulatory Guides. Within the regulatory guides, default values are provided for many of the dose model parameters but the use of site-specific values by the applicant is encouraged. A detailed survey of land and water use parameters was conducted in 1991 and is being updated here. These parameters include local characteristics of meat, milk andmore » vegetable production; river recreational activities; and meat, milk and vegetable consumption rates as well as other human usage parameters required in the SRS dosimetry models. In addition, the preferred elemental bioaccumulation factors and transfer factors to be used in human health exposure calculations at SRS are documented. Based on comparisons to the 2009 SRS environmental compliance doses, the following effects are expected in future SRS compliance dose calculations: (1) Aquatic all-pathway maximally exposed individual doses may go up about 10 percent due to changes in the aquatic bioaccumulation factors; (2) Aquatic all-pathway collective doses may go up about 5 percent due to changes in the aquatic bioaccumulation factors that offset the reduction in average individual water consumption rates; (3) Irrigation pathway doses to the maximally exposed individual may go up about 40 percent due to increases in the element-specific transfer factors; (4) Irrigation pathway collective doses may go down about 50 percent due to changes in food productivity and production within the 50-mile radius of SRS; (5) Air pathway doses to the maximally exposed individual may go down about 10 percent due to the changes in food productivity in the SRS area and to the changes in element-specific transfer factors; and (6) Air pathway collective doses may go down about 30 percent mainly due to the decrease in the inhalation rate assumed for the average individual.« less

  1. Load research manual. Volume 3: Load research for advanced technologies

    NASA Astrophysics Data System (ADS)

    1980-11-01

    Technical guidelines for electric utility load research are presented. Special attention is given to issues raised by the load reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. The manual includes guides to load research literature and glossaries of load research and statistical terms. Special load research procedures are presented for solar, wind, and cogeneration technologies.

  2. Groundwater quality, age, and susceptibility and vulnerability to nitrate contamination with linkages to land use and groundwater flow, Upper Black Squirrel Creek Basin, Colorado, 2013

    USGS Publications Warehouse

    Wellman, Tristan P.; Rupert, Michael G.

    2016-03-03

    The results of this investigation offer the foundational information needed for developing best management practices to mitigate nitrate contamination, basic concepts on water quality to aid public education, and information to guide regulatory measures if policy makers determine this is warranted. Science-based decision making will require continued monitoring and analysis of water quality in the future.

  3. A Management Guide to Asbestos: Medico-Legal, Regulatory, and Hazard Abatement Considerations

    DTIC Science & Technology

    1986-08-01

    1935 between Sumner Simpson, then president of Raybestos-Manhattan, and Vandiver Brown, then general counsel of Johns - Manville , discussing how they...damage suits is skyrocketing. The nation’s largest asbestos producer, the Denver-based Manville Corporation (formerly Johns - Manville ), chose a unique...company that provided coverage at anytime in between? 2 0 In 1947, Johns - Manville signed the first of a series of policies It would hold with Travelers

  4. Self-regulatory skills usage strengthens the relations of self-efficacy for improved eating, exercise, and weight in the severely obese: toward an explanatory model.

    PubMed

    Annesi, James J

    2011-07-01

    Lack of success with behavioral weight-management treatments indicates a need for a better understanding of modifiable psychological correlates. Adults with class 2 and 3 obesity (N = 183; Mean(BMI) = 42.0 kg/m(2)) volunteered for a 26-week nutrition and exercise treatment, based on social cognitive theory, that focused on self-efficacy and self-regulation applied to increasing cardiovascular exercise and fruit and vegetable consumption. Improved self-efficacy for controlled eating significantly predicted increased fruit and vegetable consumption (R(2) = .15). Improved self-efficacy for exercise significantly predicted increased exercise (R(2) = .46). When changes in self-regulatory skill usage were stepped into the 2 previous equations, the variances accounted for significantly increased. Increases in fruit and vegetable consumption and exercise significantly predicted weight loss (R(2) = .38). Findings suggest that behavioral theory should guide research on weight-loss treatment, and a focus on self-efficacy and self-regulatory skills applied to specific nutrition and exercise behaviors is warranted.

  5. Impacts-BRC (below regulatory concern): The microcomputer version

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

    Campbell, J.E.; O'Neal, B.L.

    1989-01-01

    The IMPACTS-BRC computer code was designed for use by the Nuclear Regulatory Commission and industry to evaluate petitions to classify specific waste streams as below regulatory concern (BRC). The code provides a capability for calculating radiation doses to a maximal individual, critical group, and the general population as a result of transportation, treatment, disposal, and post-disposal activities involving low level radioactive waste. Since IMPACTS-BRC is expected to be widely used, the code has been adapted for use on a microcomputer. The microcomputer version of the code provides several features that simplify its use and broaden its applicability. These features includemore » (1) a menu-driven environment, (2) an input editor to simplify creation and editing of input files, (3) default input values and help screens to guide the user in analyzing a particular problem, (4) the ability to perform both parametric studies and Monte Carlo analysis to examine uncertainties, and (5) interactive graphics and statistics output. This paper describes the microcomputer version of IMPACTS-BRC and illustrates its use through an example application. 5 refs., 5 figs., 3 tabs.« less

  6. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

    PubMed

    Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

    2018-02-01

    Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

  7. Evolution of robustness to damage in artificial 3-dimensional development.

    PubMed

    Joachimczak, Michał; Wróbel, Borys

    2012-09-01

    GReaNs is an Artificial Life platform we have built to investigate the general principles that guide evolution of multicellular development and evolution of artificial gene regulatory networks. The embryos develop in GReaNs in a continuous 3-dimensional (3D) space with simple physics. The developmental trajectories are indirectly encoded in linear genomes. The genomes are not limited in size and determine the topology of gene regulatory networks that are not limited in the number of nodes. The expression of the genes is continuous and can be modified by adding environmental noise. In this paper we evolved development of structures with a specific shape (an ellipsoid) and asymmetrical pattering (a 3D pattern inspired by the French flag problem), and investigated emergence of the robustness to damage in development and the emergence of the robustness to noise. Our results indicate that both types of robustness are related, and that including noise during evolution promotes higher robustness to damage. Interestingly, we have observed that some evolved gene regulatory networks rely on noise for proper behaviour. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  8. A guide to large-scale RNA sample preparation.

    PubMed

    Baronti, Lorenzo; Karlsson, Hampus; Marušič, Maja; Petzold, Katja

    2018-05-01

    RNA is becoming more important as an increasing number of functions, both regulatory and enzymatic, are being discovered on a daily basis. As the RNA boom has just begun, most techniques are still in development and changes occur frequently. To understand RNA functions, revealing the structure of RNA is of utmost importance, which requires sample preparation. We review the latest methods to produce and purify a variation of RNA molecules for different purposes with the main focus on structural biology and biophysics. We present a guide aimed at identifying the most suitable method for your RNA and your biological question and highlighting the advantages of different methods. Graphical abstract In this review we present different methods for large-scale production and purification of RNAs for structural and biophysical studies.

  9. The role of self-regulatory skills and automaticity on the effectiveness of a brief weight loss habit-based intervention: secondary analysis of the 10 top tips randomised trial.

    PubMed

    Kliemann, Nathalie; Vickerstaff, Victoria; Croker, Helen; Johnson, Fiona; Nazareth, Irwin; Beeken, Rebecca J

    2017-09-05

    Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (β = .52, 95% Bias Corrected CI .17; .91). As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. This study was prospectively registered with the International Standard Randomised Controlled Trials ( ISRCTN16347068 ) on 26 September 2011.

  10. Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

    PubMed

    Goedecke, Thomas; Morales, Daniel R; Pacurariu, Alexandra; Kurz, Xavier

    2018-03-01

    Evaluating the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review provides a descriptive overview of the analytical methods for impact research. We searched MEDLINE and EMBASE for articles with an empirical analysis evaluating the impact of European Union or non-European Union regulatory actions to safeguard public health published until March 2017. References from systematic reviews and articles from other known sources were added. Regulatory interventions, data sources, outcomes of interest, methodology and key findings were extracted. From 1246 screened articles, 229 were eligible for full-text review and 153 articles in English language were included in the descriptive analysis. Over a third of articles studied analgesics and antidepressants. Interventions most frequently evaluated are regulatory safety communications (28.8%), black box warnings (23.5%) and direct healthcare professional communications (10.5%); 55% of studies measured changes in drug utilization patterns, 27% evaluated health outcomes, and 18% targeted knowledge, behaviour or changes in clinical practice. Unintended consequences like switching therapies or spill-over effects were rarely evaluated. Two-thirds used before-after time series and 15.7% before-after cross-sectional study designs. Various analytical approaches were applied including interrupted time series regression (31.4%), simple descriptive analysis (28.8%) and descriptive analysis with significance tests (23.5%). Whilst impact evaluation of pharmacovigilance and product-specific regulatory interventions is increasing, the marked heterogeneity in study conduct and reporting highlights the need for scientific guidance to ensure robust methodologies are applied and systematic dissemination of results occurs. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  11. Public-Private Leadership Forum; 21st Century Power Partnership

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

    None

    The PPLF convenes stakeholders from across the power sector, spanning electricity supply, delivery, and end-use, and plays a key role in guiding the strategic direction of the Power Partnership. In addition, PPLF members support the implementation of activities set out in the Power Partnership Program of Work. Taken together, the activities of the PPLF span the dynamic landscape of power challenges and opportunities, with a focus on business models, ?nancial tools, and regulatory frameworks.

  12. Environmental monitoring plan

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

    Holland, R.C.

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs.

  13. [Genome-editing: focus on the off-target effects].

    PubMed

    He, Xiubin; Gu, Feng

    2017-10-25

    Breakthroughs of genome-editing in recent years have paved the way to develop new therapeutic strategies. These genome-editing tools mainly include Zinc-finger nucleases (ZFNs), Transcription activator-like effector nucleases (TALENs), and clustered regulatory interspaced short palindromic repeat (CRISPR)/Cas-based RNA-guided DNA endonucleases. However, off-target effects are still the major issue in genome editing, and limit the application in gene therapy. Here, we summarized the cause and compared different detection methods of off-targets.

  14. Compliance with children's television food advertising regulations in Australia.

    PubMed

    Roberts, Michele; Pettigrew, Simone; Chapman, Kathy; Miller, Caroline; Quester, Pascale

    2012-10-05

    The objective of this study was to assess the effectiveness of the Australian co-regulatory system in limiting children's exposure to unhealthy television food advertising by measuring compliance with mandatory and voluntary regulations. An audit was conducted on food and beverage television advertisements broadcast in five major Australian cities during children's programming time from 1st September 2010 to 31st October 2010. The data were assessed against mandatory and voluntary advertising regulations, the information contained in an industry report of breaches, and the Australian Guide to Healthy Eating. During the two months of data collection there were a total of 951 breaches of the combined regulations. This included 619 breaches of the mandatory regulations (CTS) and 332 breaches of the voluntary regulations (RCMI and QSRI). Almost 83% of all food and beverages advertised during children's programming times were for foods classified as 'Extras' in the Australian Guide to Healthy Eating. There were also breaches in relation to the amount of advertising repetition and the use of promotional appeals such as premium offers, competitions, and endorsements by popular children's characters. The self-regulatory systems were found to have flaws in their reporting and there were errors in the Australian Food and Grocery Council's compliance report. This audit suggests that current advertising regulations are inadequate. Regulations need to be closely monitored and more tightly enforced to protect children from advertisements for unhealthy foods.

  15. Evidence for Deep Regulatory Similarities in Early Developmental Programs across Highly Diverged Insects

    PubMed Central

    Zhang, Yinan; Samee, Md. Abul Hassan; Halfon, Marc S.; Sinha, Saurabh

    2014-01-01

    Many genes familiar from Drosophila development, such as the so-called gap, pair-rule, and segment polarity genes, play important roles in the development of other insects and in many cases appear to be deployed in a similar fashion, despite the fact that Drosophila-like “long germband” development is highly derived and confined to a subset of insect families. Whether or not these similarities extend to the regulatory level is unknown. Identification of regulatory regions beyond the well-studied Drosophila has been challenging as even within the Diptera (flies, including mosquitoes) regulatory sequences have diverged past the point of recognition by standard alignment methods. Here, we demonstrate that methods we previously developed for computational cis-regulatory module (CRM) discovery in Drosophila can be used effectively in highly diverged (250–350 Myr) insect species including Anopheles gambiae, Tribolium castaneum, Apis mellifera, and Nasonia vitripennis. In Drosophila, we have successfully used small sets of known CRMs as “training data” to guide the search for other CRMs with related function. We show here that although species-specific CRM training data do not exist, training sets from Drosophila can facilitate CRM discovery in diverged insects. We validate in vivo over a dozen new CRMs, roughly doubling the number of known CRMs in the four non-Drosophila species. Given the growing wealth of Drosophila CRM annotation, these results suggest that extensive regulatory sequence annotation will be possible in newly sequenced insects without recourse to costly and labor-intensive genome-scale experiments. We develop a new method, Regulus, which computes a probabilistic score of similarity based on binding site composition (despite the absence of nucleotide-level sequence alignment), and demonstrate similarity between functionally related CRMs from orthologous loci. Our work represents an important step toward being able to trace the evolutionary history of gene regulatory networks and defining the mechanisms underlying insect evolution. PMID:25173756

  16. Evidence for deep regulatory similarities in early developmental programs across highly diverged insects.

    PubMed

    Kazemian, Majid; Suryamohan, Kushal; Chen, Jia-Yu; Zhang, Yinan; Samee, Md Abul Hassan; Halfon, Marc S; Sinha, Saurabh

    2014-09-01

    Many genes familiar from Drosophila development, such as the so-called gap, pair-rule, and segment polarity genes, play important roles in the development of other insects and in many cases appear to be deployed in a similar fashion, despite the fact that Drosophila-like "long germband" development is highly derived and confined to a subset of insect families. Whether or not these similarities extend to the regulatory level is unknown. Identification of regulatory regions beyond the well-studied Drosophila has been challenging as even within the Diptera (flies, including mosquitoes) regulatory sequences have diverged past the point of recognition by standard alignment methods. Here, we demonstrate that methods we previously developed for computational cis-regulatory module (CRM) discovery in Drosophila can be used effectively in highly diverged (250-350 Myr) insect species including Anopheles gambiae, Tribolium castaneum, Apis mellifera, and Nasonia vitripennis. In Drosophila, we have successfully used small sets of known CRMs as "training data" to guide the search for other CRMs with related function. We show here that although species-specific CRM training data do not exist, training sets from Drosophila can facilitate CRM discovery in diverged insects. We validate in vivo over a dozen new CRMs, roughly doubling the number of known CRMs in the four non-Drosophila species. Given the growing wealth of Drosophila CRM annotation, these results suggest that extensive regulatory sequence annotation will be possible in newly sequenced insects without recourse to costly and labor-intensive genome-scale experiments. We develop a new method, Regulus, which computes a probabilistic score of similarity based on binding site composition (despite the absence of nucleotide-level sequence alignment), and demonstrate similarity between functionally related CRMs from orthologous loci. Our work represents an important step toward being able to trace the evolutionary history of gene regulatory networks and defining the mechanisms underlying insect evolution. © The Author(s) 2014. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  17. Self-regulation of motor vehicle advertising: is it working in Australia?

    PubMed

    Donovan, Robert J; Fielder, Lynda J; Ouschan, Robyn; Ewing, Michael

    2011-05-01

    There is growing concern that certain content within motor vehicle advertising may have a negative influence on driving attitudes and behaviours of viewers, particularly young people, and hence a negative impact on road safety. In response, many developed countries have adopted a self-regulatory approach to motor vehicle advertising. However, it appears that many motor vehicle advertisements in Australia and elsewhere are not compliant with self-regulatory codes. Using standard commercial advertising methods, we exposed three motor vehicle ads that had been the subject of complaints to the Australian Advertising Standards Board (ASB) to, N = 463, 14-55 year olds to assess the extent to which their perceptions of the content of the ads communicated themes that were contrary to the Australian self-regulatory code. All three ads were found to communicate messages contrary to the code (such as the vehicle's speed and acceleration capabilities). However, the ASB had upheld complaints about only one of the ads. Where motor vehicle advertising regulatory frameworks exist to guide motor vehicle advertisers as to what is and what is not acceptable in their advertising, greater efforts are needed to ensure compliance with these codes. One way may be to make it mandatory for advertisers to report consumer pre-testing of their advertising to ensure that undesirable messages are not being communicated to viewers. Copyright © 2010 Elsevier Ltd. All rights reserved.

  18. Relevance and reliability of experimental data in human health risk assessment of pesticides.

    PubMed

    Kaltenhäuser, Johanna; Kneuer, Carsten; Marx-Stoelting, Philip; Niemann, Lars; Schubert, Jens; Stein, Bernd; Solecki, Roland

    2017-08-01

    Evaluation of data relevance, reliability and contribution to uncertainty is crucial in regulatory health risk assessment if robust conclusions are to be drawn. Whether a specific study is used as key study, as additional information or not accepted depends in part on the criteria according to which its relevance and reliability are judged. In addition to GLP-compliant regulatory studies following OECD Test Guidelines, data from peer-reviewed scientific literature have to be evaluated in regulatory risk assessment of pesticide active substances. Publications should be taken into account if they are of acceptable relevance and reliability. Their contribution to the overall weight of evidence is influenced by factors including test organism, study design and statistical methods, as well as test item identification, documentation and reporting of results. Various reports make recommendations for improving the quality of risk assessments and different criteria catalogues have been published to support evaluation of data relevance and reliability. Their intention was to guide transparent decision making on the integration of the respective information into the regulatory process. This article describes an approach to assess the relevance and reliability of experimental data from guideline-compliant studies as well as from non-guideline studies published in the scientific literature in the specific context of uncertainty and risk assessment of pesticides. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Structural responses to the obesity and non-communicable diseases epidemic: the Chilean Law of Food Labeling and Advertising.

    PubMed

    Corvalán, C; Reyes, M; Garmendia, M L; Uauy, R

    2013-11-01

    In 12 July 2012, the Chilean Senate approved the Law of Food Labeling and Advertising, resulting from the joint efforts of a group of health professionals, researchers and legislators who proposed a regulatory framework in support of healthy diets and active living. Its goal was to curb the ongoing epidemic increase of obesity and non-communicable diseases. Two actions included: (i) improving point of food purchase consumer information by incorporating easy-to-understand front-of-packages labeling and specific messages addressing critical nutrients, and (ii) decreasing children's exposure to unhealthy foods by restricting marketing, advertising and sales. We summarize the work related to the law's release and discuss the conclusions reached by the various expert committees that were convened by the Ministry of Health to guide the development of the regulatory norms. Throughout the process, the food industry has overtly expressed its disagreement with the regulatory effort. The final content of the regulatory norms is still pending; however there are suggestions that its implementation will be delayed and might be modified based on the industry lobbying actions. These lessons should contribute to show the need of anticipating and addressing potential barriers to obesity-prevention policy implementation, particularly with respect to the role of the private sector. © 2013 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of the International Association for the Study of Obesity.

  20. Structural damping results from vibration tests of straight piping sections

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

    Ware, A.G.; Thinnes, G.L.

    EG and G Idaho is assisting the USNRC and the Pressure Vessel Research Committee in supporting a final position on revised damping values for structural analyses of nuclear piping systems. As part of this program, a series of vibrational tests on 76-mm and 203-mm (3-in. amd 8-in.) Schedule 40 carbon steel piping was conducted to determine the changes in structural damping due to various parametric effects. The 10-m (33-ft) straight sections of piping were rigidly supported at the ends. Spring, rod, and constant force hangers, as well as a sway brace and snubbers were included as intermediate supports. Excitation wasmore » provided by low-force level hammer inpacts, a hydraulic shaker, and a 445-kN (50-ton) overhead crane. Data was recorded using acceleration, strain, and displacement time histories. This paper presents results from the testing showing the effect of stress level and type of supports on structural damping in piping.« less

  1. Design and operation of internal dosimetry programs

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

    LaBone, T.R.

    1991-01-01

    The proposed revision to USNRC 10 CFR 20 and the USDOE Order 5480.11 require intakes of radioactive material to be evaluated. Radiation dose limits are based on the sum of effective dose equivalent from intakes and the whole body dose from external sources. These significant changes in the regulations will require, at a minimum, a complete review of personnel monitoring programs to determine their adequacy. In this session we will review a systematic method of designing a routine personnel monitoring program that will comply with the requirements of the new regulations. Specific questions discussed are: (a) What are the goalsmore » and objectives of a routine personnel monitoring program (b) When is a routine personnel monitoring program required (c) What are the required capabilities of the routine personnel monitoring program (d) What should be done with the information generated in a personnel monitoring program Specific recommendations and interpretations are given in the session. 5 refs., 3 figs., 33 tabs.« less

  2. Constitutive relations in TRAC-P1A

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

    Rohatgi, U.S.; Saha, P.

    1980-08-01

    The purpose of this document is to describe the basic thermal-hydraulic models and correlations that are in the TRAC-P1A code, as released in March 1979. It is divided into two parts, A and B. Part A describes the models in the three-dimensional vessel module of TRAC, whereas Part B focuses on the loop components that are treated by one-dimensional formulations. The report follows the format of the questions prepared by the Analysis Development Branch of USNRC and the questionnaire has been attached to this document for completeness. Concerted efforts have been made in understanding the present models in TRAC-P1A bymore » going through the FORTRAN listing of the code. Some discrepancies between the code and the TRAC-P1A manual have been found. These are pointed out in this document. Efforts have also been made to check the TRAC references for the range of applicability of the models and correlations used in the code. 26 refs., 5 figs., 1 tab.« less

  3. RAMONA-3B application to Browns Ferry ATWS

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

    Slovik, G.C.; Neymotin, L.Y.; Saha, P.

    1985-01-01

    The Anticipated Transient Without Scram (ATWS) is known to be a dominant accident sequence for possible core melt in a Boiling Water Reactor (BWR). A recent Probabilistic Risk Assessment (PRA) analysis for the Browns Ferry nuclear power plant indicates that ATWS is the second most dominant transient for core melt in BWR/4 with Mark I containment. The most dominant sequence being the failure of long term decay heat removal function of the Residual Heat Removal (RHR) system. Of all the various ATWS scenarios, the Main Steam Isolation Valve (MSIV) closure ATWS sequence was chosen for present analysis because of itsmore » relatively high frequency of occurrence and its challenge to the residual heat removal system and containment integrity. The objective of this paper is to discuss four MSIV closure ATWS calculations using the RAMONA-3B code. The paper is a summary of a report being prepared for the USNRC Severe Accident Sequence Analysis (SASA) program which should be referred to for details. 10 refs., 20 figs., 3 tabs.« less

  4. Prokaryotic Argonautes - variations on the RNA interference theme.

    PubMed

    van der Oost, John; Swarts, Daan C; Jore, Matthijs M

    2014-04-15

    The discovery of RNA interference (RNAi) has been a major scientific breakthrough. This RNA-guided RNA interference system plays a crucial role in a wide range of regulatory and defense mechanisms in eukaryotes. The key enzyme of the RNAi system is Argonaute (Ago), an endo-ribonuclease that uses a small RNA guide molecule to specifically target a complementary RNA transcript. Two functional classes of eukaryotic Ago have been described: catalytically active Ago that cleaves RNA targets complementary to its guide, and inactive Ago that uses its guide to bind target RNA to down-regulate translation efficiency. A recent comparative genomics study has revealed that Argonaute-like proteins are also encoded by prokaryotic genomes. Interestingly, there is a lot of variation among these prokaryotic Argonaute (pAgo) proteins with respect to domain architecture: some resemble the eukaryotic Ago (long pAgo) containing a complete or disrupted catalytic site, while others are truncated versions (short pAgo) that generally contain an incomplete catalytic site. Prokaryotic Agos with an incomplete catalytic site often co-occur with (predicted) nucleases. Based on this diversity, and on the fact that homologs of other RNAi-related protein components (such as Dicer nucleases) have never been identified in prokaryotes, it has been predicted that variations on the eukaryotic RNAi theme may occur in prokaryotes.

  5. Prokaryotic Argonautes - variations on the RNA interference theme

    PubMed Central

    van der Oost, John; Swarts, Daan C.; Jore, Matthijs M.

    2014-01-01

    The discovery of RNA interference (RNAi) has been a major scientific breakthrough. This RNA-guided RNA interference system plays a crucial role in a wide range of regulatory and defense mechanisms in eukaryotes. The key enzyme of the RNAi system is Argonaute (Ago), an endo-ribonuclease that uses a small RNA guide molecule to specifically target a complementary RNA transcript. Two functional classes of eukaryotic Ago have been described: catalytically active Ago that cleaves RNA targets complementary to its guide, and inactive Ago that uses its guide to bind target RNA to down-regulate translation efficiency. A recent comparative genomics study has revealed that Argonaute-like proteins are also encoded by prokaryotic genomes. Interestingly, there is a lot of variation among these prokaryotic Argonaute (pAgo) proteins with respect to domain architecture: some resemble the eukaryotic Ago (long pAgo) containing a complete or disrupted catalytic site, while others are truncated versions (short pAgo) that generally contain an incomplete catalytic site. Prokaryotic Agos with an incomplete catalytic site often co-occur with (predicted) nucleases. Based on this diversity, and on the fact that homologs of other RNAi-related protein components (such as Dicer nucleases) have never been identified in prokaryotes, it has been predicted that variations on the eukaryotic RNAi theme may occur in prokaryotes. PMID:28357239

  6. Masters Thesis- Criticality Alarm System Design Guide with Accompanying Alarm System Development for the Radioisotope Production Laboratory in Richland, Washington

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

    Greenfield, Bryce A.

    2009-12-01

    A detailed instructional manual was created to guide criticality safety engineers through the process of designing a criticality alarm system (CAS) for Department of Energy (DOE) hazard class 1 and 2 facilities. Regulatory and technical requirements were both addressed. A list of design tasks and technical subtasks are thoroughly analyzed to provide concise direction for how to complete the analysis. An example of the application of the design methodology, the Criticality Alarm System developed for the Radioisotope Production Laboratory (RPL) of Richland, Washington is also included. The analysis for RPL utilizes the Monte Carlo code MCNP5 for establishing detector coveragemore » in the facility. Significant improvements to the existing CAS were made that increase the reliability, transparency, and coverage of the system.« less

  7. Geothermal : A Regulatory Guide to Leasing, Permitting, and Licensing in Idaho, Montana, Oregon, and Washington.

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

    Bloomquist, R.Gordon

    1991-10-01

    The actual geothermal exploration and development may appear to be a simple and straightforward process in comparison to the legal and institutional maze which the developer must navigate in order to obtain all of the federal, state, and local leases, permits, licenses, and approvals necessary at each step in the process. Finally, and often most difficult, is obtaining a contract for the sale of thermal energy, brine, steam, or electricity. This guide is designed to help developers interested in developing geothermal resource sites in the Bonneville Power Administration Service Territory in the state of Idaho, Montana, Oregon, and Washington bettermore » understand the federal, state, and local institutional process, the roles and responsibilities of each agency, and how and when to make contact in order to obtain the necessary documents.« less

  8. Load research manual. Volume 3. Load research for advanced technologies

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

    Brandenburg, L.; Clarkson, G.; Grund, Jr., C.

    1980-11-01

    This three-volume manual presents technical guidelines for electric utility load research. Special attention is given to issues raised by the load data reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. The manual includes guides to load research literature and glossaries of load research and statistical terms. In Volume 3, special load research procedures are presented for solar, wind, and cogeneration technologies.

  9. The Experimental Design Assistant.

    PubMed

    Percie du Sert, Nathalie; Bamsey, Ian; Bate, Simon T; Berdoy, Manuel; Clark, Robin A; Cuthill, Innes; Fry, Derek; Karp, Natasha A; Macleod, Malcolm; Moon, Lawrence; Stanford, S Clare; Lings, Brian

    2017-09-01

    Addressing the common problems that researchers encounter when designing and analysing animal experiments will improve the reliability of in vivo research. In this article, the Experimental Design Assistant (EDA) is introduced. The EDA is a web-based tool that guides the in vivo researcher through the experimental design and analysis process, providing automated feedback on the proposed design and generating a graphical summary that aids communication with colleagues, funders, regulatory authorities, and the wider scientific community. It will have an important role in addressing causes of irreproducibility.

  10. Smart Grid Legislative and Regulatory Policies and Case Studies

    EIA Publications

    2011-01-01

    In recent years, a number of U.S. states have adopted or are considering smart grid related laws, regulations, and voluntary or mandatory requirements. At the same time, the number of smart grid pilot projects has been increasing rapidly. The Energy Information Administration (EIA) commissioned SAIC to research the development of smart grid in the United States and abroad. The research produced several documents that will help guide EIA as it considers how best to track smart grid developments.

  11. The Experimental Design Assistant

    PubMed Central

    Bamsey, Ian; Bate, Simon T.; Berdoy, Manuel; Clark, Robin A.; Cuthill, Innes; Fry, Derek; Karp, Natasha A.; Macleod, Malcolm; Moon, Lawrence; Stanford, S. Clare; Lings, Brian

    2017-01-01

    Addressing the common problems that researchers encounter when designing and analysing animal experiments will improve the reliability of in vivo research. In this article, the Experimental Design Assistant (EDA) is introduced. The EDA is a web-based tool that guides the in vivo researcher through the experimental design and analysis process, providing automated feedback on the proposed design and generating a graphical summary that aids communication with colleagues, funders, regulatory authorities, and the wider scientific community. It will have an important role in addressing causes of irreproducibility. PMID:28957312

  12. Human use regulatory affairs advisor (HURAA): learning about research ethics with intelligent learning modules.

    PubMed

    Hu, Xiangen; Graesser, Arthur C

    2004-05-01

    The Human Use Regulatory Affairs Advisor (HURAA) is a Web-based facility that provides help and training on the ethical use of human subjects in research, based on documents and regulations in United States federal agencies. HURAA has a number of standard features of conventional Web facilities and computer-based training, such as hypertext, multimedia, help modules, glossaries, archives, links to other sites, and page-turning didactic instruction. HURAA also has these intelligent features: (1) an animated conversational agent that serves as a navigational guide for the Web facility, (2) lessons with case-based and explanation-based reasoning, (3) document retrieval through natural language queries, and (4) a context-sensitive Frequently Asked Questions segment, called Point & Query. This article describes the functional learning components of HURAA, specifies its computational architecture, and summarizes empirical tests of the facility on learners.

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

    Korsah, K.; Wood, R.T.; Hassan, M.

    This document presents the results of studies sponsored by the Nuclear Regulatory Commission (NRC) to provide the technical basis for environmental qualification of computer-based safety equipment in nuclear power plants. The studies were conducted by Oak Ridge National Laboratory (ORNL), Sandia National Laboratories (SNL), and Brookhaven National Laboratory (BNL). The studies address the following: (1) adequacy of the present test methods for qualification of digital I and C systems; (2) preferred (i.e., Regulatory Guide-endorsed) standards; (3) recommended stressors to be included in the qualification process during type testing; (4) resolution of need for accelerated aging for equipment to be locatedmore » in a benign environment; and (5) determination of an appropriate approach for addressing the impact of smoke in digital equipment qualification programs. Significant findings from the studies form the technical basis for a recommended approach to the environmental qualification of microprocessor-based safety-related equipment in nuclear power plants.« less

  14. HealthMarts, HIPCs (health insurance purchasing cooperatives), MEWAs (multiple employee welfare arrangements), and AHPs (association health plans): a guide for the perplexed.

    PubMed

    Hall, M A; Wicks, E K; Lawlor, J S

    2001-01-01

    This paper considers how pending proposals to authorize new forms of group purchasing arrangements for health insurance would fit and function within the existing, highly complex market and regulatory landscape and whether these proposals are likely to meet their stated objectives and avoid unintended consequences. Cost savings are more likely to result from increased risk segmentation than through true market efficiencies. Thus, these proposals could erode previous market reforms whose goal is increased risk pooling. On the other hand, these proposals contain important enhancements, clarifications, and simplification of state and federal regulatory oversight of group purchasing vehicles. Also, they address some of the problems that have hampered the performance of purchasing cooperatives. On balance, although these proposals should receive cautious and careful consideration, they are not likely to produce a significant overall reduction in premiums or increase in coverage.

  15. Comparisons of ANS, ASME, AWS, and NFPA standards cited in the NRC standard review plan, NUREG-0800, and related documents

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

    Ankrum, A.R.; Bohlander, K.L.; Gilbert, E.R.

    This report provides the results of comparisons of the cited and latest versions of ANS, ASME, AWS and NFPA standards cited in the NRC Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants (NUREG 0800) and related documents. The comparisons were performed by Battelle Pacific Northwest Laboratories in support of the NRC`s Standard Review Plan Update and Development Program. Significant changes to the standards, from the cited version to the latest version, are described and discussed in a tabular format for each standard. Recommendations for updating each citation in the Standard Review Plan are presented.more » Technical considerations and suggested changes are included for related regulatory documents (i.e., Regulatory Guides and the Code of Federal Regulations) citing the standard. The results and recommendations presented in this document have not been subjected to NRC staff review.« less

  16. The use of NUREGs 1199 and 1200 in the Illinois LLW licensing program

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

    Klinger, J.G.; Harmon, D.F.

    1991-12-31

    This paper will describe how the LLW licensing staff of the Illinois Department of Nuclear Safety used NRC`s NUREG 1199, NUREG 1200, NUREG 1300 and Regulatory Guide 4.18 in its licensing program for reviewing and evaluating a LLW disposal facility license application. The paper will discuss how Illinois guidance documents were prepared based on modifications made to these NRC documents which were necessary to take into account site and facility specific considerations, as well as changes required by Illinois statutes and regulatory codes. The paper will review the recent revisions (January 1991) to NUREG 1199 and 1200 and the importancemore » of these revisions. The paper will also discuss recommended modifications to these NRC documents and provide an update on the status of the Department`s review and evaluation of an application for a license to site, construct and operate a LLW disposal facility in Illinois.« less

  17. Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

    PubMed

    Solomon, Cristina; Asmis, Lars M; Spahn, Donat R

    2016-10-01

    Recent years have seen increasing worldwide interest in the use of viscoelastic coagulation monitoring tests, performed using devices such as ROTEM and TEG. The use of such tests to guide haemostatic therapy may help reduce transfusion of allogeneic blood products in bleeding patients and is supported in European guidelines for managing trauma and severe perioperative bleeding. In addition, viscoelastic tests form the basis of numerous published treatment algorithms. However, some publications have stated that viscoelastic tests are not validated. A specific definition of the term validation is lacking and regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have been fulfilled by ROTEM and TEG assays. Viscoelastic tests have been used in pivotal clinical trials, and they are approved for use in most of the world's countries. Provided that locally approved indications are adhered to, the regulatory framework for clinicians to use viscoelastic tests in routine clinical practice is in place.

  18. Economic approaches to measuring the significance of food safety in international trade.

    PubMed

    Caswell, J A

    2000-12-20

    International trade in food products has expanded rapidly in recent years. This paper presents economic approaches for analyzing the effects on trade in food products of the food safety requirements of governments and private buyers. Important economic incentives for companies to provide improved food safety arise from (1) public incentives such as ex ante requirements for sale of a product with sufficient quality and ex post penalties (liability) for sale of products with deficient quality, and (2) private incentives for producing quality such as internal performance goals (self-regulation) and the external (certification) requirements of buyers. The World Trade Organization's Sanitary Phytosanitary Agreement facilitates scrutiny of the benefits and costs of country-level regulatory programs and encourages regulatory rapprochement on food safety issues. Economists can help guide risk management decisions by providing estimates of the benefits and costs of programs to improve food safety and by analyzing their effect on trade in food products.

  19. A multitasking Argonaute: exploring the many facets of C. elegans CSR-1.

    PubMed

    Wedeles, Christopher J; Wu, Monica Z; Claycomb, Julie M

    2013-12-01

    While initial studies of small RNA-mediated gene regulatory pathways focused on the cytoplasmic functions of such pathways, identifying roles for Argonaute/small RNA pathways in modulating chromatin and organizing the genome has become a topic of intense research in recent years. Nuclear regulatory mechanisms for Argonaute/small RNA pathways appear to be widespread, in organisms ranging from plants to fission yeast, Caenorhabditis elegans to humans. As the effectors of small RNA-mediated gene regulatory pathways, Argonaute proteins guide the chromatin-directed activities of these pathways. Of particular interest is the C. elegans Argonaute, chromosome segregation and RNAi deficient (CSR-1), which has been implicated in such diverse functions as organizing the holocentromeres of worm chromosomes, modulating germline chromatin, protecting the genome from foreign nucleic acid, regulating histone levels, executing RNAi, and inhibiting translation in conjunction with Pumilio proteins. CSR-1 interacts with small RNAs known as 22G-RNAs, which have complementarity to 25 % of the protein coding genes. This peculiar Argonaute is the only essential C. elegans Argonaute out of 24 family members in total. Here, we summarize the current understanding of CSR-1 functions in the worm, with emphasis on the chromatin-directed activities of this ever-intriguing Argonaute.

  20. Tiered Approach to Resilience Assessment.

    PubMed

    Linkov, Igor; Fox-Lent, Cate; Read, Laura; Allen, Craig R; Arnott, James C; Bellini, Emanuele; Coaffee, Jon; Florin, Marie-Valentine; Hatfield, Kirk; Hyde, Iain; Hynes, William; Jovanovic, Aleksandar; Kasperson, Roger; Katzenberger, John; Keys, Patrick W; Lambert, James H; Moss, Richard; Murdoch, Peter S; Palma-Oliveira, Jose; Pulwarty, Roger S; Sands, Dale; Thomas, Edward A; Tye, Mari R; Woods, David

    2018-04-25

    Regulatory agencies have long adopted a three-tier framework for risk assessment. We build on this structure to propose a tiered approach for resilience assessment that can be integrated into the existing regulatory processes. Comprehensive approaches to assessing resilience at appropriate and operational scales, reconciling analytical complexity as needed with stakeholder needs and resources available, and ultimately creating actionable recommendations to enhance resilience are still lacking. Our proposed framework consists of tiers by which analysts can select resilience assessment and decision support tools to inform associated management actions relative to the scope and urgency of the risk and the capacity of resource managers to improve system resilience. The resilience management framework proposed is not intended to supplant either risk management or the many existing efforts of resilience quantification method development, but instead provide a guide to selecting tools that are appropriate for the given analytic need. The goal of this tiered approach is to intentionally parallel the tiered approach used in regulatory contexts so that resilience assessment might be more easily and quickly integrated into existing structures and with existing policies. Published 2018. This article is a U.S. government work and is in the public domain in the USA.

  1. Compliance with children’s television food advertising regulations in Australia

    PubMed Central

    2012-01-01

    Background The objective of this study was to assess the effectiveness of the Australian co-regulatory system in limiting children’s exposure to unhealthy television food advertising by measuring compliance with mandatory and voluntary regulations. An audit was conducted on food and beverage television advertisements broadcast in five major Australian cities during children’s programming time from 1st September 2010 to 31st October 2010. The data were assessed against mandatory and voluntary advertising regulations, the information contained in an industry report of breaches, and the Australian Guide to Healthy Eating. Results During the two months of data collection there were a total of 951 breaches of the combined regulations. This included 619 breaches of the mandatory regulations (CTS) and 332 breaches of the voluntary regulations (RCMI and QSRI). Almost 83% of all food and beverages advertised during children’s programming times were for foods classified as ‘Extras’ in the Australian Guide to Healthy Eating. There were also breaches in relation to the amount of advertising repetition and the use of promotional appeals such as premium offers, competitions, and endorsements by popular children’s characters. The self-regulatory systems were found to have flaws in their reporting and there were errors in the Australian Food and Grocery Council’s compliance report. Conclusions This audit suggests that current advertising regulations are inadequate. Regulations need to be closely monitored and more tightly enforced to protect children from advertisements for unhealthy foods. PMID:23039855

  2. Determining Epigenetic Targets: A Beginner's Guide to Identifying Genome Functionality Through Database Analysis.

    PubMed

    Hay, Elizabeth A; Cowie, Philip; MacKenzie, Alasdair

    2017-01-01

    There can now be little doubt that the cis-regulatory genome represents the largest information source within the human genome essential for health. In addition to containing up to five times more information than the coding genome, the cis-regulatory genome also acts as a major reservoir of disease-associated polymorphic variation. The cis-regulatory genome, which is comprised of enhancers, silencers, promoters, and insulators, also acts as a major functional target for epigenetic modification including DNA methylation and chromatin modifications. These epigenetic modifications impact the ability of cis-regulatory sequences to maintain tissue-specific and inducible expression of genes that preserve health. There has been limited ability to identify and characterize the functional components of this huge and largely misunderstood part of the human genome that, for decades, was ignored as "Junk" DNA. In an attempt to address this deficit, the current chapter will first describe methods of identifying and characterizing functional elements of the cis-regulatory genome at a genome-wide level using databases such as ENCODE, the UCSC browser, and NCBI. We will then explore the databases on the UCSC genome browser, which provides access to DNA methylation and chromatin modification datasets. Finally, we will describe how we can superimpose the huge volume of study data contained in the NCBI archives onto that contained within the UCSC browser in order to glean relevant in vivo study data for any locus within the genome. An ability to access and utilize these information sources will become essential to informing the future design of experiments and subsequent determination of the role of epigenetics in health and disease and will form a critical step in our development of personalized medicine.

  3. Proliferation of CD4CD25Foxp3 regulatory T lymphocytes in ex vivo expanded ascitic fluid from primary and recurrent ovarian carcinoma.

    PubMed

    Lee, Shin Wha; Kim, Yong-Man; Lee, Ha-Young; Kim, Dae-Yeon; Kim, Jong-Hyeok; Nam, Joo-Hyun; Kim, Young-Tak

    2010-03-01

    Regulatory T lymphocytes evoke the immune tolerance by suppressing and inactivating cytotoxic T lymphocytes. The objective of this study was to compare the proportion of regulatory T lymphocytes, precisely defined as CD4(+)CD25(high+)Foxp3(+) T lymphocytes, in primary and recurrent ovarian carcinoma before and after ex vivo expansion of ascites with interleukin-2 (IL-2). Ascitic fluid samples were obtained from 26 patients with ovarian carcinoma. Lymphocytes were isolated from ascites and cell markers were analyzed by flow cytometry using anti-CD3/CD4/CD8/CD16/CD56/CD25 and anti-Foxp3 antibodies. Lymphocytes were incubated for 2 to 3 weeks and expanded ex vivo by IL-2 stimulation and their phenotypes were analyzed by flow cytometry. Following ex vivo expansion, ascitic fluid lymphocytes increased by a greater extent in the recurrent group than in the primary group. The proportion of ex vivo-expanded lymphocytes changed as follows; CD4(+) T lymphocytes increased, CD8(+) T lymphocytes decreased, and the proportion of CD3(-)CD16(+)56(+) NK cells was unchanged. The proportion of CD4(+)CD25(high+)Foxp3(+) regulatory T lymphocytes in CD4(+) T lymphocytes increased after ex vivo expansion in both groups, but to a greater degree in the recurrent group. This study showed that regulatory T lymphocytes, neither cytotoxic T lymphocytes nor NK cells, were extensively increased after ex vivo expansion, especially in recurrent ovarian carcinoma. These results may provide information that helps to guide the future development of adoptive immunotherapy against ovarian carcinoma.

  4. Cooperative Tertiary Interaction Network Guides RNA Folding

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

    Behrouzi, Reza; Roh, Joon Ho; Kilburn, Duncan

    2013-04-08

    Noncoding RNAs form unique 3D structures, which perform many regulatory functions. To understand how RNAs fold uniquely despite a small number of tertiary interaction motifs, we mutated the major tertiary interactions in a group I ribozyme by single-base substitutions. The resulting perturbations to the folding energy landscape were measured using SAXS, ribozyme activity, hydroxyl radical footprinting, and native PAGE. Double- and triple-mutant cycles show that most tertiary interactions have a small effect on the stability of the native state. Instead, the formation of core and peripheral structural motifs is cooperatively linked in near-native folding intermediates, and this cooperativity depends onmore » the native helix orientation. The emergence of a cooperative interaction network at an early stage of folding suppresses nonnative structures and guides the search for the native state. We suggest that cooperativity in noncoding RNAs arose from natural selection of architectures conducive to forming a unique, stable fold.« less

  5. xLPR Sim Editor 1.0 User's Guide

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

    Mariner, Paul E.

    2017-03-01

    The United States Nuclear Regulatory Commission in cooperation with the Electric Power Research Institute contracted Sandia National Laboratories to develop the framework of a probabilistic fracture mechanics assessment code called xLPR ( Extremely Low Probability of Rupture) Version 2.0 . The purpose of xLPR is to evaluate degradation mechanisms in piping systems at nuclear power plants and to predict the probability of rupture. This report is a user's guide for xLPR Sim Editor 1.0 , a graphical user interface for creating and editing the xLPR Version 2.0 input file and for creating, editing, and using the xLPR Version 2.0 databasemore » files . The xLPR Sim Editor, provides a user - friendly way for users to change simulation options and input values, s elect input datasets from xLPR data bases, identify inputs needed for a simulation, and create and modify an input file for xLPR.« less

  6. Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations

    PubMed Central

    Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I. Glenn; Lynch, Holly Fernandez; Bierer, Barbara E.

    2017-01-01

    The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and little in the bioethics literature to guide investigators and IRBs faced with navigating the ethical issues it raises. We begin to fill this gap by first defending a non-exceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website ‘terms of use’; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as Appendices. PMID:28207365

  7. What Should Guide Health Policy? A Perspective Beyond Politics.

    PubMed

    Kirch, Darrell G; Ast, Cori

    2017-09-01

    As the U.S. electorate has become increasingly polarized, these divisions are poised to shape legislative and regulatory work in the years ahead. For those whose focus is on the public goods of health care for all, the advancement of science through rigorous research, and the contribution of higher education to the continual improvement of the nation's workforce, there is profound uncertainty about the future. There are several pressing questions facing the nation and academic medicine, including the future of affordable, accessible insurance; acceptance of scientific evidence; sustainable learning and teaching methodologies; and the well-being and preparation of the nation's health workforce to care for an increasingly diverse nation. For those in academic medicine and policy making alike, the authors propose a framework, grounded in scientific evidence and guided by clinical ethics, for designing and evaluating health policy solutions for these and other pressing questions.

  8. Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

    PubMed

    Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E

    2017-03-01

    The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

  9. Multiple Regulatory Modules Are Required for Scale-to-Feather Conversion.

    PubMed

    Wu, Ping; Yan, Jie; Lai, Yung-Chih; Ng, Chen Siang; Li, Ang; Jiang, Xueyuan; Elsey, Ruth M; Widelitz, Randall; Bajpai, Ruchi; Li, Wen-Hsiung; Chuong, Cheng-Ming

    2018-02-01

    The origin of feathers is an important question in Evo-Devo studies, with the eventual evolution of vaned feathers which are aerodynamic, allowing feathered dinosaurs and early birds to fly and venture into new ecological niches. Studying how feathers and scales are developmentally specified provides insight into how a new organ may evolve. We identified feather-associated genes using genomic analyses. The candidate genes were tested by expressing them in chicken and alligator scale forming regions. Ectopic expression of these genes induced intermediate morphotypes between scales and feathers which revealed several major morphogenetic events along this path: Localized growth zone formation, follicle invagination, epithelial branching, feather keratin differentiation, and dermal papilla formation. In addition to molecules known to induce feathers on scales (retinoic acid, β-catenin), we identified novel scale-feather converters (Sox2, Zic1, Grem1, Spry2, Sox18) which induce one or more regulatory modules guiding these morphogenetic events. Some morphotypes resemble filamentous appendages found in feathered dinosaur fossils, whereas others exhibit characteristics of modern avian feathers. We propose these morpho-regulatory modules were used to diversify archosaur scales and to initiate feather evolution. The regulatory combination and hierarchical integration may have led to the formation of extant feather forms. Our study highlights the importance of integrating discoveries between developmental biology and paleontology. © The Author 2017. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  10. Inference and interrogation of a coregulatory network in the context of lipid accumulation in Yarrowia lipolytica.

    PubMed

    Trébulle, Pauline; Nicaud, Jean-Marc; Leplat, Christophe; Elati, Mohamed

    2017-01-01

    Complex phenotypes, such as lipid accumulation, result from cooperativity between regulators and the integration of multiscale information. However, the elucidation of such regulatory programs by experimental approaches may be challenging, particularly in context-specific conditions. In particular, we know very little about the regulators of lipid accumulation in the oleaginous yeast of industrial interest Yarrowia lipolytica . This lack of knowledge limits the development of this yeast as an industrial platform, due to the time-consuming and costly laboratory efforts required to design strains with the desired phenotypes. In this study, we aimed to identify context-specific regulators and mechanisms, to guide explorations of the regulation of lipid accumulation in Y. lipolytica . Using gene regulatory network inference, and considering the expression of 6539 genes over 26 time points from GSE35447 for biolipid production and a list of 151 transcription factors, we reconstructed a gene regulatory network comprising 111 transcription factors, 4451 target genes and 17048 regulatory interactions (YL-GRN-1) supported by evidence of protein-protein interactions. This study, based on network interrogation and wet laboratory validation (a) highlights the relevance of our proposed measure, the transcription factors influence, for identifying phases corresponding to changes in physiological state without prior knowledge (b) suggests new potential regulators and drivers of lipid accumulation and (c) experimentally validates the impact of six of the nine regulators identified on lipid accumulation, with variations in lipid content from +43.2% to -31.2% on glucose or glycerol.

  11. MINER: exploratory analysis of gene interaction networks by machine learning from expression data.

    PubMed

    Kadupitige, Sidath Randeni; Leung, Kin Chun; Sellmeier, Julia; Sivieng, Jane; Catchpoole, Daniel R; Bain, Michael E; Gaëta, Bruno A

    2009-12-03

    The reconstruction of gene regulatory networks from high-throughput "omics" data has become a major goal in the modelling of living systems. Numerous approaches have been proposed, most of which attempt only "one-shot" reconstruction of the whole network with no intervention from the user, or offer only simple correlation analysis to infer gene dependencies. We have developed MINER (Microarray Interactive Network Exploration and Representation), an application that combines multivariate non-linear tree learning of individual gene regulatory dependencies, visualisation of these dependencies as both trees and networks, and representation of known biological relationships based on common Gene Ontology annotations. MINER allows biologists to explore the dependencies influencing the expression of individual genes in a gene expression data set in the form of decision, model or regression trees, using their domain knowledge to guide the exploration and formulate hypotheses. Multiple trees can then be summarised in the form of a gene network diagram. MINER is being adopted by several of our collaborators and has already led to the discovery of a new significant regulatory relationship with subsequent experimental validation. Unlike most gene regulatory network inference methods, MINER allows the user to start from genes of interest and build the network gene-by-gene, incorporating domain expertise in the process. This approach has been used successfully with RNA microarray data but is applicable to other quantitative data produced by high-throughput technologies such as proteomics and "next generation" DNA sequencing.

  12. "Whether I like it or not, it's important": Implicit importance of means predicts self-regulatory persistence and success.

    PubMed

    Critcher, Clayton R; Ferguson, Melissa J

    2016-06-01

    To effectively self-regulate, people must persevere on tasks that they deem important, regardless of whether those tasks are enjoyable. Building on past work that has noted the fundamental role of implicit cognition in guiding effective self-regulation, the present paper tests whether an implicit association between goal means and importance predicts self-regulatory persistence and success. Implicit importance predicted markers of effective self-regulation-better grades, more studying and exercise, and stronger standardized testing performance-over and above, and often better than, explicit beliefs about the importance of that self-regulation, as well as implicit evaluations of those means. In particular, those for whom tasks were fairly taxing to complete (i.e., those for whom this self-regulation required effortful self-control) were those who most benefitted from the implicit association between means and importance. Moreover, when participants were reminded of recent self-regulatory failure that they believed could be overcome through hard work, implicit importance toward the means increased as if to prepare them to achieve self-regulatory persistence. A final study sought to reconcile the present findings with previous work showing the key role that implicit evaluations play in effective self-regulation. We reasoned that means are important precisely because they are associated with valued end-states. Consistent with this account, implicit evaluations of end-states predicted the implicit importance of means, which in turn predicted effective self-regulation. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  13. Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control.

    PubMed

    Hamilton, Kyra; Cornish, Stephen; Kirkpatrick, Aaron; Kroon, Jeroen; Schwarzer, Ralf

    2018-05-01

    With 60-90% of children worldwide reportedly experiencing dental caries, poor oral health in the younger years is a major public health issue. As parents are important to children's oral hygiene practices, we examined the key self-regulatory behaviours of parents for supervising their children's toothbrushing using the health action process approach. Participants (N = 281, 197 mothers) comprised Australian parents of 2- to 5-year-olds. A longitudinal design was used to investigate the sequential mediation chain for the effect of intention (Time 1) on parental supervision for their youngest child's toothbrushing (Time 3), via self-efficacy and planning (Time 2), and action control (Time 3). A latent-variable structural equation model, controlling for baseline behaviour and habit, revealed significant indirect effects from intention via self-efficacy and action control and intention via planning and action control, on parental supervision behaviour. The model was a good fit to the data, explaining 74% of the variance in parents' supervising behaviour for their children's toothbrushing. While national recommendations are provided to guide parents in promoting good oral hygiene practices with their children, current results show the importance of going beyond simple knowledge transmission to support parents' intentions to supervise their children's toothbrushing actually materialize. Current findings make a significant contribution to the cumulative empirical evidence regarding self-regulatory components in health behaviour change and can inform intervention development to increase parents' participation in childhood oral hygiene practices, thus helping to curb rising oral health conditions and diseases. Statement of contribution What is already known on this subject? Self-regulatory skills are important to translate intentions into behaviour. Self-efficacy, planning, and action control are key self-regulatory skills for behaviour change. What does this study add? Self-regulatory skills are needed for parents to supervise their children's toothbrushings. Self-efficacy, planning, and action control are important self-regulatory skills in this context. Future interventions should map these self-regulatory predictors onto behaviour change techniques. © 2018 The British Psychological Society.

  14. Evolution of RNA- and DNA-guided antivirus defense systems in prokaryotes and eukaryotes: common ancestry vs convergence.

    PubMed

    Koonin, Eugene V

    2017-02-10

    Complementarity between nucleic acid molecules is central to biological information transfer processes. Apart from the basal processes of replication, transcription and translation, complementarity is also employed by multiple defense and regulatory systems. All cellular life forms possess defense systems against viruses and mobile genetic elements, and in most of them some of the defense mechanisms involve small guide RNAs or DNAs that recognize parasite genomes and trigger their inactivation. The nucleic acid-guided defense systems include prokaryotic Argonaute (pAgo)-centered innate immunity and CRISPR-Cas adaptive immunity as well as diverse branches of RNA interference (RNAi) in eukaryotes. The archaeal pAgo machinery is the direct ancestor of eukaryotic RNAi that, however, acquired additional components, such as Dicer, and enormously diversified through multiple duplications. In contrast, eukaryotes lack any heritage of the CRISPR-Cas systems, conceivably, due to the cellular toxicity of some Cas proteins that would get activated as a result of operon disruption in eukaryotes. The adaptive immunity function in eukaryotes is taken over partly by the PIWI RNA branch of RNAi and partly by protein-based immunity. In this review, I briefly discuss the interplay between homology and analogy in the evolution of RNA- and DNA-guided immunity, and attempt to formulate some general evolutionary principles for this ancient class of defense systems. This article was reviewed by Mikhail Gelfand and Bojan Zagrovic.

  15. Brownfield to Brightfield Initiative in Oak Ridge, TN - 12346

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

    Hough, Gil; Fairless, Chad

    Experience characterizing, permitting, and restoring 'Brownfield' sites-government or industrial sites with restricted future use due to the presence or potential presence of hazardous substances, pollutants, or contaminants-is being leveraged to identify opportunities for redevelopment into solar power generating facilities which, in this context, are called 'Brightfields'. Brownfield sites offer the expansive land necessary for large photovoltaic (PV) solar farms, but require an in-depth working knowledge of complicated regulatory restrictions and environmental constraints to develop them. As a part of the effort to identify opportunities for redevelopment of Brownfield sites for solar applications, a technical guide, was composed specifically for themore » development of solar generation on restricted use sites. The basis of the technical guide gives specific consideration to environmental requirements and installation methods breaking that into three areas for assessing: 1) levels of contamination, 2) ground penetration requirements, and 3) the requirements for aesthetics and maintenance. Brightfield projects are underway to support the technical guide and expand re-industrialization efforts for the former DOE Gaseous Diffusion Plant in Oak Ridge, TN. There are exciting opportunities to turn Brownfields into Brightfield solar energy solutions for meeting the future renewable energy needs of our country. Brownfields that offer the large surface area required for solar PV farms coupled with the technical guide for the installation of solar farms on restricted use sites supports efforts to develop the solar capacities and expertise to tap this future market. The initial projects designed following the technical guide will provide verification of the installation requirements and beneficial reuse of restricted use sites. (authors)« less

  16. Tornado protection by venting

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

    Cavanagh, C.A.

    1987-01-01

    The purpose of this paper is to demonstrate the ability to protect a modern nuclear power plant from the effects of a tornado by the use of a system of venting in all safety-related structures outside of the containment. The paper demonstrates this by presenting a method of analysis and of equipment selection that fully complies with the intent and the letter of applicable federal regulatory guides. A report of an actual tornado in the City of Kalamazoo, Michigan, suggests that the concept of sealing a plant during a tornado may not always be applicable.

  17. Sarcopenia: pharmacology of today and tomorrow.

    PubMed

    Brotto, Marco; Abreu, Eduardo L

    2012-12-01

    Sarcopenia remains largely undiagnosed and undertreated because of the lack of a universally accepted definition, effective ways to measure it, and identification of the outcomes that should guide treatment efficacy. An ever-growing number of clinicians and researchers along with funding and regulatory agencies have gradually recognized that sarcopenia is a human condition that requires both prevention and treatment. In this article, we review sarcopenia and its common and less known pharmacological treatments, attempt to define sarcopenia in its broader context, and present some new ideas for potential future treatment for this devastating condition.

  18. Targeting the Mevalonate Pathway to Reduce Mortality from Ovarian Cancer

    DTIC Science & Technology

    2017-12-01

    at cis-regulatory elements such as enhancers to facilitate gene transcription. CRISPR /Cas9- mediated ablation of a putative Meis1 enhancer carrying...Tables S4 and S5. 10 Cancer Cell 30, 1–16, July 11, 2016the CRISPR /Cas9-based genomic editing technology. Cas9 and a pair of single guide RNAs (sgRNA... CRISPR /Cas9-mediated deletio sgMeis1, a pair of sgRNAs that target the DMR boundaries. (N) Sequencing of the genomic PCR products from F2/R2 primers shows

  19. A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies.

    PubMed

    Barber, Chris; Antonucci, Vincent; Baumann, Jens-Christoph; Brown, Roland; Covey-Crump, Elizabeth; Elder, David; Elliott, Eric; Fennell, Jared W; Gallou, Fabrice; Ide, Nathan D; Jordine, Guido; Kallemeyn, Jeffrey M; Lauwers, Dirk; Looker, Adam R; Lovelle, Lucie E; McLaughlin, Mark; Molzahn, Robert; Ott, Martin; Schils, Didier; Oestrich, Rolf Schulte; Stevenson, Neil; Talavera, Pere; Teasdale, Andrew; Urquhart, Michael W; Varie, David L; Welch, Dennie

    2017-11-01

    The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Thoughtful nursing practice: reflections on nurse delegation decision-making.

    PubMed

    McInnis, Leigh Ann; Parsons, Lynn C

    2009-12-01

    This article discusses delegation challenges and legal and regulatory oversight associated with delegation in the clinical practice setting. The authors address moral and legal attributes of the roles and responsibilities of health care providers regarding delegating health care interventions. The article also explores guiding principles and rules of delegation within professional standards, national practice guidelines, and state nurse practice acts. Nurse experts provide thoughtful reflection on nursing models and the role of delegation, emphasizing the critical role of delegation in extending the role of the health care professional in patient care services.

  1. Sarcopenia: Pharmacology of Today and Tomorrow

    PubMed Central

    Abreu, Eduardo L.

    2012-01-01

    Sarcopenia remains largely undiagnosed and undertreated because of the lack of a universally accepted definition, effective ways to measure it, and identification of the outcomes that should guide treatment efficacy. An ever-growing number of clinicians and researchers along with funding and regulatory agencies have gradually recognized that sarcopenia is a human condition that requires both prevention and treatment. In this article, we review sarcopenia and its common and less known pharmacological treatments, attempt to define sarcopenia in its broader context, and present some new ideas for potential future treatment for this devastating condition. PMID:22929991

  2. A drug's life: the pathway to drug approval.

    PubMed

    Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A

    2013-10-01

    In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.

  3. Advancing the adverse outcome pathway framework and its ...

    EPA Pesticide Factsheets

    Regulatory agencies worldwide are confronted with the challenging task of assessing the risks of thousands of chemicals to protect both human health and the environment. Traditional toxicity testing largely relies on apical endpoints from whole animal studies, which, in addition to ethical concerns, is costly and time prohibitive. As a result, the utility of mechanism-based in silico, in vitro, and in vivo approaches to support chemical safety evaluations have increasingly been explored. An approach that has gained traction for capturing available knowledge describing the linkage between mechanistic data and apical toxicity endpoints, required for regulatory assessments, is the adverse outcome pathway (AOP) framework. A number of international workshops and expert meetings have been held over the past years focusing on the AOP framework and its applications to chemical risk assessment. Although, these interactions have illustrated the necessity of expert guidance in moving the science of AOPs and their applications forward, there is also the recognition that a broader survey of the scientific community could be useful in guiding future initiatives in the AOP arena. To that end, a Horizon Scanning exercise was conducted to solicit questions from the global scientific community concerning the challenges or limitations that must be addressed in order to realize the full potential of the AOP framework in research and regulatory decision making. Over a 4 month ques

  4. Identification of a new gene regulatory circuit involving B cell receptor activated signaling using a combined analysis of experimental, clinical and global gene expression data

    PubMed Central

    Schrader, Alexandra; Meyer, Katharina; Walther, Neele; Stolz, Ailine; Feist, Maren; Hand, Elisabeth; von Bonin, Frederike; Evers, Maurits; Kohler, Christian; Shirneshan, Katayoon; Vockerodt, Martina; Klapper, Wolfram; Szczepanowski, Monika; Murray, Paul G.; Bastians, Holger; Trümper, Lorenz; Spang, Rainer; Kube, Dieter

    2016-01-01

    To discover new regulatory pathways in B lymphoma cells, we performed a combined analysis of experimental, clinical and global gene expression data. We identified a specific cluster of genes that was coherently expressed in primary lymphoma samples and suppressed by activation of the B cell receptor (BCR) through αIgM treatment of lymphoma cells in vitro. This gene cluster, which we called BCR.1, includes numerous cell cycle regulators. A reduced expression of BCR.1 genes after BCR activation was observed in different cell lines and also in CD10+ germinal center B cells. We found that BCR activation led to a delayed entry to and progression of mitosis and defects in metaphase. Cytogenetic changes were detected upon long-term αIgM treatment. Furthermore, an inverse correlation of BCR.1 genes with c-Myc co-regulated genes in distinct groups of lymphoma patients was observed. Finally, we showed that the BCR.1 index discriminates activated B cell-like and germinal centre B cell-like diffuse large B cell lymphoma supporting the functional relevance of this new regulatory circuit and the power of guided clustering for biomarker discovery. PMID:27166259

  5. Lessons from innovation in drug-device combination products.

    PubMed

    Couto, Daniela S; Perez-Breva, Luis; Saraiva, Pedro; Cooney, Charles L

    2012-01-01

    Drug-device combination products introduced a new dynamic on medical product development, regulatory approval, and corporate interaction that provide valuable lessons for the development of new generations of combination products. This paper examines the case studies of drug-eluting stents and transdermal patches to facilitate a detailed understanding of the challenges and opportunities introduced by combination products when compared to previous generations of traditional medical or drug delivery devices. Our analysis indicates that the largest barrier to introduce a new kind of combination products is the determination of the regulatory center that is to oversee its approval. The first product of a new class of combination products offers a learning opportunity for the regulator and the sponsor. Once that first product is approved, the leading regulatory center is determined, and the uncertainty about the entire class of combination products is drastically reduced. The sponsor pioneering a new class of combination products assumes a central role in reducing this uncertainty by advising the decision on the primary function of the combination product. Our analysis also suggests that this decision influences the nature (pharmaceutical, biotechnology, or medical devices) of the companies that will lead the introduction of these products into the market, and guide the structure of corporate interaction thereon. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. Genome and epigenome engineering CRISPR toolkit for in vivo modulation of cis-regulatory interactions and gene expression in the chicken embryo.

    PubMed

    Williams, Ruth M; Senanayake, Upeka; Artibani, Mara; Taylor, Gunes; Wells, Daniel; Ahmed, Ahmed Ashour; Sauka-Spengler, Tatjana

    2018-02-23

    CRISPR/Cas9 genome engineering has revolutionised all aspects of biological research, with epigenome engineering transforming gene regulation studies. Here, we present an optimised, adaptable toolkit enabling genome and epigenome engineering in the chicken embryo, and demonstrate its utility by probing gene regulatory interactions mediated by neural crest enhancers. First, we optimise novel efficient guide-RNA mini expression vectors utilising chick U6 promoters, provide a strategy for rapid somatic gene knockout and establish a protocol for evaluation of mutational penetrance by targeted next-generation sequencing. We show that CRISPR/Cas9-mediated disruption of transcription factors causes a reduction in their cognate enhancer-driven reporter activity. Next, we assess endogenous enhancer function using both enhancer deletion and nuclease-deficient Cas9 (dCas9) effector fusions to modulate enhancer chromatin landscape, thus providing the first report of epigenome engineering in a developing embryo. Finally, we use the synergistic activation mediator (SAM) system to activate an endogenous target promoter. The novel genome and epigenome engineering toolkit developed here enables manipulation of endogenous gene expression and enhancer activity in chicken embryos, facilitating high-resolution analysis of gene regulatory interactions in vivo . © 2018. Published by The Company of Biologists Ltd.

  7. Determinants of Pregnant Women’s Online Self-Regulatory Activities for Appropriate Gestational Weight Gain

    PubMed Central

    Kim, Hye Kyung; Niederdeppe, Jeff; Guillory, Jamie; Graham, Meredith; Olson, Christine; Gay, Geri

    2015-01-01

    This study examined psychosocial and socio-demographic factors associated with pregnant women’s use of web-based tools to set and monitor personal goals for healthy diet and physical activity. These tools were made available to women participating in a randomized trial testing a web-based intervention to promote appropriate gestational weight gain. We used data from a baseline survey of pregnant women assigned to the intervention group and log data on women’s use of various intervention features (N = 873). Women who believed that appropriate gestational weight gain would lead to healthy outcomes for their child were more likely to engage in online goal-setting and self-monitoring. Less positive outcome expectancy beliefs about the relationship between their own weight and baby’s health partially explains why some at risk subpopulations (e.g., African-American women) were less likely to utilize online self-regulatory tools. This study specifies key psychosocial and motivational factors that guide the construction and monitoring of goals among pregnant women. These findings offer guidance for the design of interventions to promote self-regulatory techniques by identifying groups for whom those features are most likely to be useful, as well as psychological determinants of their use. PMID:25205417

  8. Self-Regulation and Mechanisms of Action in Psychotherapy: A Theory-Based Translational Perspective

    PubMed Central

    Strauman, Timothy J.; Goetz, Elena L.; Detloff, Allison M.; MacDuffie, Katherine E.; Zaunmüller, Luisa; Lutz, Wolfgang

    2012-01-01

    Psychotherapy is a complex, multi-layered process with the potential to bring about changes at multiple levels of functioning, from the neurobiology of the brain to the individual’s role in the social world. Although studies of the mechanisms by which psychotherapy leads to change continue to appear, there remains much to be learned about how psychological interventions work. To guide explorations of how and for whom particular treatment approaches lead to change, researchers can rely on theory to identify potential loci for change and on translational research methods to integrate basic behavioral science and neuroscience with clinical science. In this article, we describe research linking individual differences in the self-regulation of personal goal pursuit with the etiology and treatment of mood disorders. The research draws upon regulatory focus theory as a model of self-regulation and on microintervention designs – controlled laboratory investigations of a specific therapeutic technique – to generate and test hypotheses about how psychological interventions can help to reverse maladaptive self-regulatory processes. PMID:23072383

  9. A quantitative framework for the forward design of synthetic miRNA circuits.

    PubMed

    Bloom, Ryan J; Winkler, Sally M; Smolke, Christina D

    2014-11-01

    Synthetic genetic circuits incorporating regulatory components based on RNA interference (RNAi) have been used in a variety of systems. A comprehensive understanding of the parameters that determine the relationship between microRNA (miRNA) and target expression levels is lacking. We describe a quantitative framework supporting the forward engineering of gene circuits that incorporate RNAi-based regulatory components in mammalian cells. We developed a model that captures the quantitative relationship between miRNA and target gene expression levels as a function of parameters, including mRNA half-life and miRNA target-site number. We extended the model to synthetic circuits that incorporate protein-responsive miRNA switches and designed an optimized miRNA-based protein concentration detector circuit that noninvasively measures small changes in the nuclear concentration of β-catenin owing to induction of the Wnt signaling pathway. Our results highlight the importance of methods for guiding the quantitative design of genetic circuits to achieve robust, reliable and predictable behaviors in mammalian cells.

  10. Precision Cardiovascular Medicine: State of Genetic Testing.

    PubMed

    Giudicessi, John R; Kullo, Iftikhar J; Ackerman, Michael J

    2017-04-01

    In the 15 years following the release of the first complete human genome sequences, our understanding of rare and common genetic variation as determinants of cardiovascular disease susceptibility, prognosis, and therapeutic response has grown exponentially. As such, the use of genomics to enhance the care of patients with cardiovascular diseases has garnered increased attention from clinicians, researchers, and regulatory agencies eager to realize the promise of precision genomic medicine. However, owing to a large burden of "complex" common diseases, emphasis on evidence-based practice, and a degree of unfamiliarity/discomfort with the language of genomic medicine, the development and implementation of genomics-guided approaches designed to further individualize the clinical management of a variety of cardiovascular disorders remains a challenge. In this review, we detail a practical approach to genetic testing initiation and interpretation as well as review the current state of cardiovascular genetic and pharmacogenomic testing in the context of relevant society and regulatory agency recommendations/guidelines. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  11. Research with Pregnant Women: New Insights on Legal Decision-Making

    PubMed Central

    Mastroianni, Anna C.; Henry, Leslie Meltzer; Robinson, David; Bailey, Theodore; Faden, Ruth R.; Little, Margaret O.; Lyerly, Anne Drapkin

    2017-01-01

    Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may—at any time from product conception to marketing—influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns. PMID:28543423

  12. A regulatory framework for shoot stem cell control integrating metabolic, transcriptional, and phytohormone signals.

    PubMed

    Schuster, Christoph; Gaillochet, Christophe; Medzihradszky, Anna; Busch, Wolfgang; Daum, Gabor; Krebs, Melanie; Kehle, Andreas; Lohmann, Jan U

    2014-02-24

    Plants continuously maintain pluripotent stem cells embedded in specialized tissues called meristems, which drive long-term growth and organogenesis. Stem cell fate in the shoot apical meristem (SAM) is controlled by the homeodomain transcription factor WUSCHEL (WUS) expressed in the niche adjacent to the stem cells. Here, we demonstrate that the bHLH transcription factor HECATE1 (HEC1) is a target of WUS and that it contributes to SAM function by promoting stem cell proliferation, while antagonizing niche cell activity. HEC1 represses the stem cell regulators WUS and CLAVATA3 (CLV3) and, like WUS, controls genes with functions in metabolism and hormone signaling. Among the targets shared by HEC1 and WUS are phytohormone response regulators, which we show to act as mobile signals in a universal feedback system. Thus, our work sheds light on the mechanisms guiding meristem function and suggests that the underlying regulatory system is far more complex than previously anticipated. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Clinical pharmacology review of escitalopram for the treatment of depression.

    PubMed

    Pastoor, Devin; Gobburu, Joga

    2014-01-01

    Depression is a serious and debilitating psychiatric condition with serious societal health and economic implications. Escitalopram , the S-enantiomer of racemic citalopram, is an effective treatment for major depressive disorder. This review covers the clinical pharmacology of escitalopram, with emphasis on regulatory approval. Its pharmacokinetics, pharmacodynamics and clinical efficacy for major depressive disorder are evaluated, along with data regarding safety and tolerability. Drug development of escitalopram was heavily guided by prior approval of citalopram. Select safety and efficacy studies for escitalopram in combination with supportive evidence from the results of prior citalopram studies allowed for regulatory approval for acute and maintenance claims in both adults and adolescents, while minimizing burden on the sponsor. Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram. The first generic escitalopram was approved in 2012, along with Abbreviated New Drug Applications. The associated cost savings have helped reduce the burden of weighing the benefits of escitalopram over less-expensive alternatives.

  14. Structure of a Protein Phosphatase 2A Holoenzyme: Insights into B55-Mediated Tau Dephosphorylation

    PubMed Central

    Xu, Yanhui; Chen, Yu; Zhang, Ping; Jeffrey, Philip D.; Shi, Yigong

    2009-01-01

    Summary Protein phosphatase 2A (PP2A) regulates many essential aspects of cellular physiology. Members of the regulatory B/B55/PR55 family are thought to play a key role in the dephosphorylation of Tau, whose hyperphosphorylation contributes to Alzheimer's disease. The underlying mechanisms of the PP2A-Tau connection remain largely enigmatic. Here, we report the complete reconstitution of a Tau dephosphorylation assay and the crystal structure of a heterotrimeric PP2A holoenzyme involving the regulatory subunit Bα. We show that Bα specifically and markedly facilitates dephosphorylation of the phosphorylated Tau in our reconstituted assay. The Bα subunit comprises a seven-bladed β propeller, with an acidic, substrate-binding groove located in the center of the propeller. The β propeller latches onto the ridge of the PP2A scaffold subunit with the help of a protruding β hairpin arm. Structure-guided mutagenesis studies revealed the underpinnings of PP2A-mediated dephosphorylation of Tau. PMID:18922469

  15. Anthology of the renin-angiotensin system: a one hundred reference approach to angiotensin II antagonists.

    PubMed

    Ménard, J

    1993-04-01

    To provide a historical overview of the renin-angiotensin system as a guide to the introduction of a new therapeutic pathway, non-peptide inhibition of a angiotensin II. One hundred references were selected as a personal preference, for their originality or for their potential impact on medicine. This review raises the following questions for future research. (1) Will the long-term cardiovascular effects of angiotensin converting enzyme (ACE) inhibition, angiotensin II antagonism and renin inhibition be similar or not, and dependent or independent of blood pressure levels? (2) What are the local-regional interactions between vasoconstrictor and vasodilator systems, and does the renin-angiotensin system synchronize these regional hemodynamic regulatory mechanisms? (3) If hypertension is the result of an interaction between genetic and environmental factors, do proteins secreted through constitutive pathways contribute to the genetic abnormality (prorenin, angiotensinogen, ACE) while regulated secretion (renin) and other regulatory mechanisms (angiotensin II receptors) provide biological support for the environmental effects?

  16. Repair boundary for parent tube indications within the upper joint zone of hybrid expansion joint (HEJ) sleeved tubes

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

    Cullen, W.K.; Keating, R.F.

    1997-02-01

    In the Spring and Fall of 1994, and the Spring of 1995, crack-like indications were found in the upper hybrid expansion joint (HEJ) region of Steam Generator (S/G) tubes which had been sleeved using Westinghouse HEJ sleeves. As a result of these findings, analytic and test evaluations were performed to assess the effect of the degradation on the structural, and leakage, integrity of the sleeve/tube joint relative to the requirements of the United States Nuclear Regulatory Commission`s (NRC) draft Regulatory Guide (RG) 1.121. The results of these evaluations demonstrated that tubes with implied or known crack-like circumferential parent tube indicationsmore » (PTIs) located 1.1 inches or farther below the bottom of the hardroll upper transition, have sufficient, and significant, integrity relative to the requirements of RG 1.121. Thus, the purpose of this report is to provide background information related to the justification of the modified tube repair boundary.« less

  17. Implantation of an ergonomics administration system in a company: report of an occupational therapist specialist in ergonomics.

    PubMed

    Moraes, Berla; Andrade, Valéria Sousa

    2012-01-01

    This article aims to describe step-by-step the implementation of an ergonomics administration system in a company from March 2009 till March 2011 by an occupational therapist specialist in ergonomics based on the OSHAS 18001 guidelines and the Regulatory Norms 17 manual. The process began with the definition of five requisites with bases on the manual of application of the Regulatory Norms 17: survey; materials individual transportation and discharge; workplace furniture; workplace equipments; work environment and organization of the work to be managed with bases on the OSHAS 18001 guidelines. The following steps were established: sensitization of the company high administration, elaboration and institution of an ergonomics politics, development of ergonomics committees, ergonomics analysis of the work with recommendation of ergonomic improvements, implantation of improvements and evaluation or the results. This research experiment suggests the importance not only of a guiding axle but also of a professional qualification and participation of the company on the implementation of an ergonomics management system.

  18. Emergence of robust growth laws from optimal regulation of ribosome synthesis.

    PubMed

    Scott, Matthew; Klumpp, Stefan; Mateescu, Eduard M; Hwa, Terence

    2014-08-22

    Bacteria must constantly adapt their growth to changes in nutrient availability; yet despite large-scale changes in protein expression associated with sensing, adaptation, and processing different environmental nutrients, simple growth laws connect the ribosome abundance and the growth rate. Here, we investigate the origin of these growth laws by analyzing the features of ribosomal regulation that coordinate proteome-wide expression changes with cell growth in a variety of nutrient conditions in the model organism Escherichia coli. We identify supply-driven feedforward activation of ribosomal protein synthesis as the key regulatory motif maximizing amino acid flux, and autonomously guiding a cell to achieve optimal growth in different environments. The growth laws emerge naturally from the robust regulatory strategy underlying growth rate control, irrespective of the details of the molecular implementation. The study highlights the interplay between phenomenological modeling and molecular mechanisms in uncovering fundamental operating constraints, with implications for endogenous and synthetic design of microorganisms. © 2014 The Authors. Published under the terms of the CC BY 4.0 license.

  19. The European Medicines Agency's approval of new medicines for type 2 diabetes.

    PubMed

    Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

    2018-05-08

    Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

  20. DEVELOPMENT OF HFE SECTIONS OF DG-1145.

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

    HIGGINS,J.C.; OHARA, J.M.; BONGARRA, J.

    2007-03-26

    For the licensing of the current fleet of commercial nuclear power plants (NPPs), the Nuclear Regulatory Commission (NRC) used two key documents, NUREG-0800 and Regulatory Guide (RG) 1.70. RG 1.70 provided guidance to applicants on the contents needed in their Safety Analysis Reports (SARs) submitted as part of their application to construct or operate an NPP. NUREG-0800, the NRC Standard Review Plan (SRP), provides guidance to the NRR staff reviewers on performing their safety reviews of these applications. As part of the preparation for a new wave of improved NPP designs the NRC is in the process of updating themore » SRP and is also developing a new RG designated as draft RG or DG-1145, ''Combined License Applications for Nuclear Power Plants (LWR Edition).'' This will eventually become RG 1.206 and will take the place of RG 1.70. This will provide guidance for combined license (COL) applicants, as well as for other 10CFR Part 52 variations that are permitted.« less

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