Sample records for regulatory analysis technical

  1. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... Justice in Regulatory Analysis.'' The purpose of this guidance is to provide EPA analysts with technical...-566-2363. Mail: Technical Guidance for Assessing Environmental Justice in Regulatory Analysis... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9810-5] Technical Guidance for Assessing...

  2. Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    EPA Science Inventory

    The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyse...

  3. Communicating to Influence Drug Development and Regulatory Decisions: A Tutorial

    PubMed Central

    Mehrotra, S

    2016-01-01

    Pharmacometricians require three skills to be influential: technical, business (e.g., drug development), and soft skills (e.g., communication). Effective communication is required to translate technical and often complicated quantitative findings to interdisciplinary team members in order to influence drug development or regulatory decisions. In this tutorial, we highlight important aspects related to communicating pharmacometric analysis to influence decisions. PMID:27299706

  4. Analysis of potential trade-offs in regulation of disinfection by-products

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

    Cromwell, J.E.; Zhang, X.; Regli, S.

    1992-11-01

    Executive Order 12291 requires the preparation of a Regulatory Impact Analysis (RIA) on all new major federal regulations. The goal of an RIA is to develop and organize information on benefits, costs, and economic impacts so as to clarify trade-offs among alternative regulatory options. This paper outlines explicit methodology for assessing the technical potential for risk-risk tradeoffs. The strategies used to cope with complexities and uncertainties in developing the Disinfection By-Products Regulatory Analysis Model are explained. Results are presented and discussed in light of uncertainties, and in light of the analytical requirements for regulatory impact analysis.

  5. Issues in mass spectrometry between bench chemists and regulatory laboratory managers

    USDA-ARS?s Scientific Manuscript database

    At the 123rd AOAC Annual Meeting in Philadelphia, 45 residue chemists gathered for a roundtable discussion of mass spectrometry (MS) for regulatory purposes involving chemical residues analysis. The session was conceived to address current technical and communication issues about MS between “bench ...

  6. 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...

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

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

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

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

  8. Technical Guidance for Assessing Environmental Justice in ...

    EPA Pesticide Factsheets

    The Technical Guidance for Assessing Environmental Justice in Regulatory Analysis (also referred to as the Environmental Justice Technical Guidance or EJTG) is intended for use by Agency analysts, including risk assessors, economists, and other analytic staff that conduct analyses to evaluate EJ concerns in the context of regulatory actions. Senior EPA managers and decision makers also may find this document useful to understand analytic expectations and to ensure that EJ concerns are appropriately considered in the development of analyses to support regulatory actions under EPA’s action development process. Specifically, the document outlines approaches and methods to help Agency analysts evaluate EJ concerns. The document provides overarching direction to analysts by outlining a series of questions that will ensure the decision maker has appropriate information about baseline risks across population groups, and how those risks are distributed under the options being considered. In addition, the document provides a set of recommendations and requirements as well as best practices for use in analyzing and reporting results from consideration of EJ concerns. These principles will help ensure consistency, quality, and transparency across regulatory actions, while allowing for flexibility needed across different regulatory actions. The purpose of the EJTG is ensure consistency, quality, and transparency in considering environmental justice, while allowing f

  9. 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

  10. Progress, innovation and regulatory science in drug development: the politics of international standard-setting.

    PubMed

    Abraham, John; Reed, Tim

    2002-06-01

    This paper examines international standard-setting in the toxicology of pharmaceuticals during the 1990s, which has involved both the pharmaceutical industry and regulatory agencies in an organization known as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The analysis shows that the relationships between innovation, regulatory science and 'progress' may be more complex and controversial than is often assumed. An assessment of the ICH's claims about the implications of 'technical' harmonization of drug-testing standards for the maintenance of drug safety, via toxicological testing, and the delivery of therapeutic progress, via innovation, is presented. By demonstrating that there is not a technoscientific validity for these claims, it is argued that, within the ICH, a discourse of technological innovation and scientific progress has been used by regulatory agencies and prominent parts of the transnational pharmaceutical industry to legitimize the lowering and loosening of toxicological standards for drug testing. The mobilization and acceptance of this discourse are shown to be pivotal to the ICH's transformation of reductions in safety standards, which are apparently against the interests of patients and public health, into supposed therapeutic benefits derived from promises of greater access to more innovative drug products. The evidence suggests that it is highly implausible that these reductions in the standards of regulatory toxicology are consistent with therapeutic progress for patients, and highlights a worrying aspect embedded in the 'technical trajectories' of regulatory science.

  11. A Regulatory Framework for Nanotechnology

    DTIC Science & Technology

    informed by a map of the regulatory landscape of nanotechnology and a review of the regulatory frameworks for the aviation and biotechnology industries...aviation and biotechnology and maps the regulatory landscape in the United States by examining stakeholders, regulatory entities, and applicable legislation...state of nanotechnology if the limitations of technical expertise are addressed. This expertise can be provided by advisory committees of technical

  12. 78 FR 27963 - Reliability Technical Conference; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-6-000] Reliability Technical Conference; Notice of Technical Conference Take notice that the Federal Energy Regulatory... related to the reliability of the Bulk-Power System. A more formal agenda will be issued at a later date...

  13. Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

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

    Sheehan, M.A.

    1997-04-01

    This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors.

  14. 30 CFR 745.12 - Terms.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... would affect the State's ability to carry out the terms of the cooperative agreement; (f) Terms for... permit application is in compliance with the terms of the regulatory program and a technical analysis of...

  15. 76 FR 67597 - Technical Amendment to Delegation of Authority to the Director of the Division of Trading and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... the Regulatory Flexibility Act or analysis of major rule status under the Small Business Regulatory... anticipate any competitive advantages or disadvantages would be created. \\14\\ 15 U.S.C. 78c(f). \\15\\ 15 U.S.C.... Consideration of the Competitive Effects of Amendment Section 3(f) of the Exchange Act,\\14\\ provides that...

  16. 77 FR 75173 - Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... performing the technical analysis, management assessment, and program evaluation tasks required to address... premarket reviews that meet regulatory review standards. 2. Analysis of elements of the review process... process. This includes analysis of root causes for inefficiencies that may affect review performance and...

  17. National Water Infrastructure Adaptation Assessment, Part I: Climate Change Adaptation Readiness Analysis

    EPA Science Inventory

    The report “National Water Infrastructure Adaptation Assessment” is comprised of four parts (Part I to IV), each in an independent volume. The Part I report presented herein describes a preliminary regulatory and technical analysis of water infrastructure and regulations in the ...

  18. Application of Microprocessor-Based Equipment in Nuclear Power Plants - Technical Basis for a Qualification Methodology

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

    Korsah, K.

    This document (1) summarizes the most significant findings of the ''Qualification of Advanced Instrumentation and Control (I&C) Systems'' program initiated by the Nuclear Regulatory Commission (NRC); (2) documents a comparative analysis of U.S. and European qualification standards; and (3) provides recommendations for enhancing regulatory guidance for environmental qualification of microprocessor-based safety-related systems. Safety-related I&C system upgrades of present-day nuclear power plants, as well as I&C systems of Advanced Light-Water Reactors (ALWRs), are expected to make increasing use of microprocessor-based technology. The Nuclear Regulatory Commission (NRC) recognized that the use of such technology may pose environmental qualification challenges different from current,more » analog-based I&C systems. Hence, it initiated the ''Qualification of Advanced Instrumentation and Control Systems'' program. The objectives of this confirmatory research project are to (1) identify any unique environmental-stress-related failure modes posed by digital technologies and their potential impact on the safety systems and (2) develop the technical basis for regulatory guidance using these findings. Previous findings from this study have been documented in several technical reports. This final report in the series documents a comparative analysis of two environmental qualification standards--Institute of Electrical and Electronics Engineers (IEEE) Std 323-1983 and International Electrotechnical Commission (IEC) 60780 (1998)--and provides recommendations for environmental qualification of microprocessor-based systems based on this analysis as well as on the findings documented in the previous reports. The two standards were chosen for this analysis because IEEE 323 is the standard used in the U.S. for the qualification of safety-related equipment in nuclear power plants, and IEC 60780 is its European counterpart. In addition, the IEC document was published in 1998, and should reflect any new qualification concerns, from the European perspective, with regard to the use of microprocessor-based safety systems in power plants.« less

  19. Security practices and regulatory compliance in the healthcare industry.

    PubMed

    Kwon, Juhee; Johnson, M Eric

    2013-01-01

    Securing protected health information is a critical responsibility of every healthcare organization. We explore information security practices and identify practice patterns that are associated with improved regulatory compliance. We employed Ward's cluster analysis using minimum variance based on the adoption of security practices. Variance between organizations was measured using dichotomous data indicating the presence or absence of each security practice. Using t tests, we identified the relationships between the clusters of security practices and their regulatory compliance. We utilized the results from the Kroll/Healthcare Information and Management Systems Society telephone-based survey of 250 US healthcare organizations including adoption status of security practices, breach incidents, and perceived compliance levels on Health Information Technology for Economic and Clinical Health, Health Insurance Portability and Accountability Act, Red Flags rules, Centers for Medicare and Medicaid Services, and state laws governing patient information security. Our analysis identified three clusters (which we call leaders, followers, and laggers) based on the variance of security practice patterns. The clusters have significant differences among non-technical practices rather than technical practices, and the highest level of compliance was associated with hospitals that employed a balanced approach between technical and non-technical practices (or between one-off and cultural practices). Hospitals in the highest level of compliance were significantly managing third parties' breaches and training. Audit practices were important to those who scored in the middle of the pack on compliance. Our results provide security practice benchmarks for healthcare administrators and can help policy makers in developing strategic and practical guidelines for practice adoption.

  20. Security practices and regulatory compliance in the healthcare industry

    PubMed Central

    Kwon, Juhee; Johnson, M Eric

    2013-01-01

    Objective Securing protected health information is a critical responsibility of every healthcare organization. We explore information security practices and identify practice patterns that are associated with improved regulatory compliance. Design We employed Ward's cluster analysis using minimum variance based on the adoption of security practices. Variance between organizations was measured using dichotomous data indicating the presence or absence of each security practice. Using t tests, we identified the relationships between the clusters of security practices and their regulatory compliance. Measurement We utilized the results from the Kroll/Healthcare Information and Management Systems Society telephone-based survey of 250 US healthcare organizations including adoption status of security practices, breach incidents, and perceived compliance levels on Health Information Technology for Economic and Clinical Health, Health Insurance Portability and Accountability Act, Red Flags rules, Centers for Medicare and Medicaid Services, and state laws governing patient information security. Results Our analysis identified three clusters (which we call leaders, followers, and laggers) based on the variance of security practice patterns. The clusters have significant differences among non-technical practices rather than technical practices, and the highest level of compliance was associated with hospitals that employed a balanced approach between technical and non-technical practices (or between one-off and cultural practices). Conclusions Hospitals in the highest level of compliance were significantly managing third parties’ breaches and training. Audit practices were important to those who scored in the middle of the pack on compliance. Our results provide security practice benchmarks for healthcare administrators and can help policy makers in developing strategic and practical guidelines for practice adoption. PMID:22955497

  1. 77 FR 27814 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... NUCLEAR REGULATORY COMMISSION [Project No. 753; NRC-2012-0019] Model Safety Evaluation for Plant... Regulatory Commission (NRC) is announcing the availability of the model safety evaluation (SE) for plant... the Improved Standard Technical Specification (ISTS), NUREG-1431, ``Standard Technical Specifications...

  2. 10 CFR 63.112 - Requirements for preclosure safety analysis of the geologic repository operations area.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... geologic repository operations area. 63.112 Section 63.112 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC REPOSITORY AT YUCCA MOUNTAIN, NEVADA Technical... repository operations area. The preclosure safety analysis of the geologic repository operations area must...

  3. A historical analysis of the co-evolution of gasoline octane number and spark-ignition engines

    DOE PAGES

    Splitter, Derek A.; Pawlowski, Alex E.; Wagner, Robert M.

    2016-01-06

    In our work, the authors reviewed engine, vehicle, and fuel data since 1925 to examine the historical and recent coupling of compression ratio and fuel antiknock properties (i.e., octane number) in the U.S. light-duty vehicle market. The analysis identified historical timeframes, trends, and illustrated how three factors: consumer preferences, technical capabilities, and regulatory legislation, affect personal mobility. Data showed that throughout history these three factors have a complex and time sensitive interplay. Long term trends in the data were identified where interaction and evolution between all three factors was observed. Transportation efficiency per unit power (gal/ton-mi/hp) was found to bemore » a good metric to integrate technical, societal, and regulatory effects into the evolutional pathway of personal mobility. From this framework, discussions of future evolutionary changes to personal mobility are also presented.« less

  4. 75 FR 59261 - Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical Conference September 17, 2010. On August 19, 2010 the Federal Energy Regulatory Commission announced that a Technical...

  5. 75 FR 57764 - Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical Conference September 14, 2010. On August 19, 2010 the Federal Energy Regulatory Commission announced that a Technical...

  6. Proceedings of the Third International Mobile Satellite Conference (IMSC 1993)

    NASA Technical Reports Server (NTRS)

    Kwan, Robert (Compiler); Rigley, Jack (Compiler); Cassingham, Randy (Editor)

    1993-01-01

    Satellite-based mobile communications systems provide voice and data communications to users over a vast geographic area. The users may communicate via mobile or hand-held terminals, which may also provide access to terrestrial cellular communications services. While the first and second International Mobile Satellite Conferences (IMSC) mostly concentrated on technical advances, this Third IMSC also focuses on the increasing worldwide commercial activities in Mobile Satellite Services. Because of the large service areas provided by such systems, it is important to consider political and regulatory issues in addition to technical and user requirements issues. Topics covered include: the direct broadcast of audio programming from satellites; spacecraft technology; regulatory and policy considerations; advanced system concepts and analysis; propagation; and user requirements and applications.

  7. 76 FR 66078 - Notice of Industry Workshop on Technical and Regulatory Challenges in Deep and Ultra-Deep Outer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ...-0087] Notice of Industry Workshop on Technical and Regulatory Challenges in Deep and Ultra-Deep Outer... and gas exploration and production in deep and ultra-deep OCS waters. Through this workshop, BSEE will... structured venue for consultation among offshore deepwater oil and gas industry and regulatory experts in...

  8. Addendum to the Proceedings of the Third International Mobile Satellite Conference (IMSC 1993)

    NASA Technical Reports Server (NTRS)

    Kwan, Robert (Compiler); Rigley, Jack (Compiler); Cassingham, Randy (Editor)

    1993-01-01

    Satellite-based mobile communications systems provide voice and data communications to users over a vast geographic area. The users may communicate via mobile or hand-held terminals, which may also provide access to terrestrial cellular communications services. This Third IMSC focuses on the increasing worldwide commercial activities in Mobile Satellite Services, along with technical advances in the field. Because of the large service areas provided by such systems, it is important to consider political and regulatory issues in addition to technical and user requirements issues. The official Proceedings presented in 11 sessions include: direct broadcast of audio programming from satellites; spacecraft technology; regulatory and policy considerations; hybrid networks for personal and mobile applications; advanced system concepts and analysis; propagation; and mobile terminal technology; and mobile antenna technology.

  9. Water System Adaptation To Hydrological Changes: Module 8, Regulatory Framework Intersections: Past, Present, and Future

    EPA Science Inventory

    This course will introduce students to the fundamental principles of water system adaptation to hydrological changes, with emphasis on data analysis and interpretation, technical planning, and computational modeling. Starting with real-world scenarios and adaptation needs, the co...

  10. Technical support document: Energy conservation standards for consumer products: Dishwashers, clothes washers, and clothes dryers including: Environmental impacts; regulatory impact analysis

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

    Not Available

    1990-12-01

    The Energy Policy and Conservation Act as amended (P.L. 94-163), establishes energy conservation standards for 12 of the 13 types of consumer products specifically covered by the Act. The legislation requires the Department of Energy (DOE) to consider new or amended standards for these and other types of products at specified times. This Technical Support Document presents the methodology, data and results from the analysis of the energy and economic impacts of standards on dishwashers, clothes washers, and clothes dryers. The economic impact analysis is performed in five major areas: An Engineering Analysis, which establishes technical feasibility and product attributesmore » including costs of design options to improve appliance efficiency. A Consumer Analysis at two levels: national aggregate impacts, and impacts on individuals. The national aggregate impacts include forecasts of appliance sales, efficiencies, energy use, and consumer expenditures. The individual impacts are analyzed by Life-Cycle Cost (LCC), Payback Periods, and Cost of Conserved Energy (CCE), which evaluate the savings in operating expenses relative to increases in purchase price; A Manufacturer Analysis, which provides an estimate of manufacturers' response to the proposed standards. Their response is quantified by changes in several measures of financial performance for a firm. An Industry Impact Analysis shows financial and competitive impacts on the appliance industry. A Utility Analysis that measures the impacts of the altered energy-consumption patterns on electric utilities. A Environmental Effects analysis, which estimates changes in emissions of carbon dioxide, sulfur oxides, and nitrogen oxides, due to reduced energy consumption in the home and at the power plant. A Regulatory Impact Analysis collects the results of all the analyses into the net benefits and costs from a national perspective. 47 figs., 171 tabs. (JF)« less

  11. 77 FR 8095 - Technical Corrections to Commission Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 2 [Docket No. RM11-30-000; Order No. 756] Technical Corrections to Commission Regulations Issued February 8, 2012. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Final rule: correcting amendment. SUMMARY: This document adds...

  12. Technical and Regulatory Guidance Document for Constructed Treatment Wetlands

    DTIC Science & Technology

    2003-12-01

    leachate and acid mine drainage. The purpose of this document is to provide technical and regulatory guidance to help regulators, industry, consultants...Contaminants at Industrial Facilities .....................41 Table 4-12 Typical Landfill Leachate Characteristics and Removal Efficiencies...43 Table 4-14 Landfill Leachate Characteristics

  13. 76 FR 4102 - Smart Grid Interoperability Standards; Supplemental Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-24

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM11-2-000] Smart Grid... Federal Energy Regulatory Commission announced that a Technical Conference on Smart Grid Interoperability... National Institute of Standards and Technology are ready for Commission consideration in a rulemaking...

  14. Using FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) to isolate active regulatory DNA

    PubMed Central

    Simon, Jeremy M.; Giresi, Paul G.; Davis, Ian J.; Lieb, Jason D.

    2013-01-01

    Eviction or destabilization of nucleosomes from chromatin is a hallmark of functional regulatory elements of the eukaryotic genome. Historically identified by nuclease hypersensitivity, these regulatory elements are typically bound by transcription factors or other regulatory proteins. FAIRE (Formaldehyde-Assisted Isolation of Regulatory Elements) is an alternative approach to identify these genomic regions and has proven successful in a multitude of eukaryotic cell and tissue types. Cells or dissociated tissues are crosslinked briefly with formaldehyde, lysed, and sonicated. Sheared chromatin is subjected to phenol-chloroform extraction and the isolated DNA, typically encompassing 1–3% of the human genome, is purified. We provide guidelines for quantitative analysis by PCR, microarrays, or next-generation sequencing. Regulatory elements enriched by FAIRE display high concordance with those identified by nuclease hypersensitivity or ChIP, and the entire procedure can be completed in three days. FAIRE exhibits low technical variability, which allows its use in large-scale studies of chromatin from normal or diseased tissues. PMID:22262007

  15. 78 FR 62360 - PJM Interconnection, L.L.C.; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-21

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER13-2108-000] PJM Interconnection, L.L.C.; Notice of Technical Conference Federal Energy Regulatory Commission (Commission) staff... consider issues related to PJM Interconnection, L.L.C.'s (PJM) proposed demand response plan enhancements...

  16. 76 FR 24831 - Site-Specific Analyses for Demonstrating Compliance With Subpart C Performance Objectives

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... available under ADAMS accession number ML111040419, and the ``Technical Analysis Supporting Definition of... NUCLEAR REGULATORY COMMISSION 10 CFR Part 61 RIN 3150-AI92 [NRC-2011-0012] Site-Specific Analyses...-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance...

  17. 77 FR 75085 - Proposed Significant New Use Rule on Ethoxylated, Propoxylated Diamine Diaryl Substituted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... applications. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous... significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Since this action does not involve any technical standards, section 12(d) of the National Technology...

  18. Home Interactive Media: An Analysis of Potential Abusers of Privacy.

    ERIC Educational Resources Information Center

    Wegner, John M.

    1985-01-01

    Examines potential threats to privacy posed by development of unified interaction systems in the home. Applicability of existing federal laws, constitutional provisions, and regulatory actions, and the possible technical and legislative actions that may be useful in curtailing possible privacy abuses in these systems are analyzed. (Author/MBR)

  19. Genome-Scale Architecture of Small Molecule Regulatory Networks and the Fundamental Trade-Off between Regulation and Enzymatic Activity

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

    Reznik, Ed; Christodoulou, Dimitris; Goldford, Joshua E.

    Metabolic flux is in part regulated by endogenous small molecules that modulate the catalytic activity of an enzyme, e.g., allosteric inhibition. In contrast to transcriptional regulation of enzymes, technical limitations have hindered the production of a genome-scale atlas of small molecule-enzyme regulatory interactions. Here, we develop a framework leveraging the vast, but fragmented, biochemical literature to reconstruct and analyze the small molecule regulatory network (SMRN) of the model organism Escherichia coli, including the primary metabolite regulators and enzyme targets. Using metabolic control analysis, we prove a fundamental trade-off between regulation and enzymatic activity, and we combine it with metabolomic measurementsmore » and the SMRN to make inferences on the sensitivity of enzymes to their regulators. By generalizing the analysis to other organisms, we identify highly conserved regulatory interactions across evolutionarily divergent species, further emphasizing a critical role for small molecule interactions in the maintenance of metabolic homeostasis.« less

  20. Genome-Scale Architecture of Small Molecule Regulatory Networks and the Fundamental Trade-Off between Regulation and Enzymatic Activity

    DOE PAGES

    Reznik, Ed; Christodoulou, Dimitris; Goldford, Joshua E.; ...

    2017-09-12

    Metabolic flux is in part regulated by endogenous small molecules that modulate the catalytic activity of an enzyme, e.g., allosteric inhibition. In contrast to transcriptional regulation of enzymes, technical limitations have hindered the production of a genome-scale atlas of small molecule-enzyme regulatory interactions. Here, we develop a framework leveraging the vast, but fragmented, biochemical literature to reconstruct and analyze the small molecule regulatory network (SMRN) of the model organism Escherichia coli, including the primary metabolite regulators and enzyme targets. Using metabolic control analysis, we prove a fundamental trade-off between regulation and enzymatic activity, and we combine it with metabolomic measurementsmore » and the SMRN to make inferences on the sensitivity of enzymes to their regulators. By generalizing the analysis to other organisms, we identify highly conserved regulatory interactions across evolutionarily divergent species, further emphasizing a critical role for small molecule interactions in the maintenance of metabolic homeostasis.« less

  1. Development of Technical Basis for Burnup Credit Regulatory Guidance in the United States

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

    Parks, Cecil V; Wagner, John C; Mueller, Don

    2011-01-01

    In the United States (U.S.) there has been and continues to be considerable interest in the increased use of burnup credit as part of the safety basis for SNF systems and this interest has motivated numerous technical studies related to the application of burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission initiated a burnup credit research program, with support from the Oak Ridge National Laboratory, to develop regulatory guidance and the supporting technical basis for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Themore » objective of this paper is to summarize the work and significant accomplishments, with references to the technical reports and publications for complete details.« less

  2. 77 FR 36029 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers...

  3. 76 FR 32246 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-03

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update Rule Cross-References and Make Non- Substantive Technical..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  4. 75 FR 61478 - Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-010; RM06-16-011] Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical Conference Comments September 24, 2010. On September 23, 2010, the Federal Energy Regulatory Commission conducted a...

  5. [Multilevel analysis of the technical efficiency of hospitals in the Spanish National Health System by property and type of management].

    PubMed

    Pérez-Romero, Carmen; Ortega-Díaz, M Isabel; Ocaña-Riola, Ricardo; Martín-Martín, José Jesús

    2018-05-11

    To analyze technical efficiency by type of property and management of general hospitals in the Spanish National Health System (2010-2012) and identify hospital and regional explanatory variables. 230 hospitals were analyzed combining data envelopment analysis and fixed effects multilevel linear models. Data envelopment analysis measured overall, technical and scale efficiency, and the analysis of explanatory factors was performed using multilevel models. The average rate of overall technical efficiency of hospitals without legal personality is lower than hospitals with legal personality (0.691 and 0.876 in 2012). There is a significant variability in efficiency under variable returns (TE) by direct, indirect and mixed forms of management. The 29% of the variability in TE es attributable to the Region. Legal personality increased the TE of the hospitals by 11.14 points. On the other hand, most of the forms of management (different to those of the traditional hospitals) increased TE in varying percentages. At regional level, according to the model considered, insularity and average annual income per household are explanatory variables of TE. Having legal personality favours technical efficiency. The regulatory and management framework of hospitals, more than public or private ownership, seem to explain technical efficiency. Regional characteristics explain the variability in TE. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. [Improvement of sanitary and epidemiological safety of rail transport--a requirement of the new legislation of the Russian Federation].

    PubMed

    2012-01-01

    Brief analysis of the legal framework in recent years, both in the sphere of technical regulation, and in the field of sanitary and epidemiological welfare of the population is presented in this article. The necessity of inclusion in the technical regulations for the safety of railway rolling stock and elements of railway infrastructure the requirements for sanitary-epidemiological safety and hygiene regulations has been proved. Fragments of technical regulations for railway equipment and infrastructure elements, including the basic requirements for the sanitary-epidemiological security are presented. The position of authors in the processing of the regulatory framework in the field of sanitary-epidemiological welfare of population in standardization documents in accordance with the requirements of federal law "On technical regulation" has been reflected.

  7. 78 FR 31922 - National Environmental Justice Advisory Council; Notification of Public Teleconference Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... draft Technical Guidance for Assessing Environmental Justice in Regulatory Analysis. There will be a... public comment period, or to submit written public comments, is also Noon, Monday, June 10, 2013. DATES... like to be put on the list to provide public comment, and whether you are submitting written comments...

  8. 77 FR 59768 - Shipping and Transportation; Technical, Organizational, and Conforming Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    .... Abbreviations II. Regulatory History III. Basis and Purpose IV. Background V. Regulatory Analyses A. Regulatory....S.C. United States Code II. Regulatory History We did not publish a notice of proposed rulemaking... its place, the text ``(CG-ENG)''. [[Page 59778

  9. 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

  10. National Gas Survey report to the Federal Energy Regulatory Commission by the Supply-Technical Advisory Task Force on nonconventional natural gas resources. [Coal beds

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

    None

    1978-06-01

    An analysis is presented of the future energy situation in the U.S. with emphasis on the natural gas industry. The analysis results are presented in chapters on historical research efforts, industry criteria for commercialization of coal bed gas, technology for recovering methane from coal beds, identification of problems, legal concerns, and environmental considerations. (JRD)

  11. Boolean Dynamic Modeling Approaches to Study Plant Gene Regulatory Networks: Integration, Validation, and Prediction.

    PubMed

    Velderraín, José Dávila; Martínez-García, Juan Carlos; Álvarez-Buylla, Elena R

    2017-01-01

    Mathematical models based on dynamical systems theory are well-suited tools for the integration of available molecular experimental data into coherent frameworks in order to propose hypotheses about the cooperative regulatory mechanisms driving developmental processes. Computational analysis of the proposed models using well-established methods enables testing the hypotheses by contrasting predictions with observations. Within such framework, Boolean gene regulatory network dynamical models have been extensively used in modeling plant development. Boolean models are simple and intuitively appealing, ideal tools for collaborative efforts between theorists and experimentalists. In this chapter we present protocols used in our group for the study of diverse plant developmental processes. We focus on conceptual clarity and practical implementation, providing directions to the corresponding technical literature.

  12. 76 FR 64083 - Reliability Technical Conference; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Technical Conference; Notice of Technical Conference Take notice that the Federal Energy Regulatory Commission will hold a Technical Conference on Tuesday, November 29, 2011, from 1 p.m. to 5 p.m. and... System. The conference will explore the progress made on the priorities for addressing risks to...

  13. Overview of Variable Renewable Energy Regulatory Issues: A Clean Energy Regulators Initiative Report

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

    Miller, M.; Cox, S.

    This CERI report aims to provide an introductory overview of key regulatory issues associated with the deployment of renewable energy -- particularly variable renewable energy (VRE) sources such wind and solar power. The report draws upon the research and experiences from various international contexts, and identifies key ideas that have emerged from the growing body of VRE deployment experience and regulatory knowledge. The report assumes basic familiarity with regulatory concepts, and although it is not written for a technical audience, directs the reader to further reading when available. VRE deployment generates various regulatory issues: substantive, procedural, and public interest issues,more » and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.« less

  14. 10 CFR 76.87 - Technical safety requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

  15. 10 CFR 76.87 - Technical safety requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

  16. 10 CFR 76.87 - Technical safety requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

  17. 10 CFR 76.87 - Technical safety requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

  18. 10 CFR 76.87 - Technical safety requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Technical safety requirements. 76.87 Section 76.87 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Safety § 76.87 Technical safety requirements. (a) The Corporation shall establish technical safety requirements. In...

  19. Environmental Regulations as Drivers of Materials Obsolescence

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2010-01-01

    This slide presentation reviews the operations of the Principal Center for Regulatory Risk Analysis and Communication (RRAC-PC) and the impact of environmental regulations in making some materials obsolete. The center is NASA's resource for identifying and managing risks associated with changing environmental regulations. To this end the center acts as an regulatory early warning system, to review track and analyze emerging regulations, collaborate with the technical community on regulatory risk analysis and interpretation and to represent NASA's interests to the regulatory agencies. Regulations frequently result in making some materials unavailable forcing a change to another material. Processes may also be changed due to environmental regulations. For example some items that were sprayed with a chemical may now have to be painted or dipped with the chemical. Sometimes a regulation changes the use of a certain product, which does not affect the usage on Earth, but has significant implications in space. An example of this is the use of lead-free solders of basically tin, which don't appear to have any problem on Earth, but in space applications tin whiskers have resulted in several confirmed satellite failures.

  20. 78 FR 70586 - Technical Support Document: Technical Update of the Social Cost of Carbon for Regulatory Impact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ... OFFICE OF MANAGEMENT AND BUDGET Technical Support Document: Technical Update of the Social Cost of... Budget, Executive Office of the President. ACTION: Notice of availability and request for comments. SUMMARY: The Office of Management and Budget (OMB) requests comments on the Technical Support Document...

  1. International Conference on Harmonisation; guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; availability. Notice.

    PubMed

    2004-06-09

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance provides further clarification for preparing the quality components of an application file in the common technical document (CTD) format. The guidance addresses the relationship between linked sections for certain parameters (such as polymorphism and particle size), and it addresses location issues (by indicating the section in which to place requested information). The guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.

  2. 76 FR 43890 - Technical Amendment to Commission Procedures for Filing Applications for Orders for Exemptive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... Small Business Regulatory Enforcement Fairness Act. See 5 U.S.C. 601(2) (for purposes of RFA analysis...\\ See 5 U.S.C. 553(d)(3). II. Consideration of Competitive Effects of Amendment Section 3(f) of the... rules under the Exchange Act, to consider the competitive effects of such rules, if any, and to refrain...

  3. Technical basis for external dosimetry at the Waste Isolation Pilot Plant (WIPP)

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

    Bradley, E.W.; Wu, C.F.; Goff, T.E.

    1993-12-31

    The WIPP External Dosimetry Program, administered by Westinghouse Electric Corporation, Waste Isolation Division, for the US Department of Energy (DOE), provides external dosimetry support services for operations at the Waste Isolation Pilot Plant (WIPP) Site. These operations include the receipt, experimentation with, storage, and disposal of transuranic (TRU) wastes. This document describes the technical basis for the WIPP External Radiation Dosimetry Program. The purposes of this document are to: (1) provide assurance that the WIPP External Radiation Dosimetry Program is in compliance with all regulatory requirements, (2) provide assurance that the WIPP External Radiation Dosimetry Program is derived from amore » sound technical base, (3) serve as a technical reference for radiation protection personnel, and (4) aid in identifying and planning for future needs. The external radiation exposure fields are those that are documented in the WIPP Final Safety Analysis Report.« less

  4. Regulatory Issues and Challenges in Developing Seismic Source Characterizations for New Nuclear Power Plant Applications in the US

    NASA Astrophysics Data System (ADS)

    Fuller, C. W.; Unruh, J.; Lindvall, S.; Lettis, W.

    2009-05-01

    An integral component of the safety analysis for proposed nuclear power plants within the US is a probabilistic seismic hazard assessment (PSHA). Most applications currently under NRC review followed guidance provided within NRC Regulatory Guide 1.208 (RG 1.208) for developing seismic source characterizations (SSC) for their PSHA. Three key components of RG 1.208 guidance is that applicants should: (1) use existing PSHA models and SSCs accepted by the NRC as SSC as a starting point for their SSCs; (2) evaluate new information and data developed since acceptance of the starting model to determine if the model should be updated; and (3) follow guidelines set forth by the Senior Seismic Hazard Analysis Committee (SSHAC) (NUREG/CR-6372) in developing significant updates (i.e., updates should capture SSC uncertainty through representing the "center, body, and range of technical interpretations" of the informed technical community). Major motivations for following this guidance are to ensure accurate representations of hazard and regulatory stability in hazard estimates for nuclear power plants. All current applications with the NRC have used the EPRI-SOG source characterizations developed in the 1980s as their starting point model, and all applicants have followed RG 1.208 guidance in updating the EPRI- SOG model. However, there has been considerable variability in how applicants have interpreted the guidance, and thus there has been considerable variability in the methodology used in updating the SSCs. Much of the variability can be attributed to how different applicants have interpreted the implications of new data, new interpretations of new and/or old data, and new "opinions" of members of the informed technical community. For example, many applicants and the NRC have wrestled with the challenge of whether or not to update SSCs in light of new opinions or interpretations of older data put forth by one member of the technical community. This challenge has been further complicated by: (1) a given applicant's uncertainty in how to revise the EPRI-SOG model, which was developed using a process similar to that dictated by SSHAC for a level 3 or 4 study, without conducting a resource-intensive SSHAC level 3 or higher study for their respective application; and (2) a lack of guidance from the NRC on acceptable methods of demonstrating that new data, interpretations, and opinions are adequately represented within the EPRI-SOG model. Partly because of these issues, initiative was taken by the nuclear industry, NRC and DOE to develop a new base PSHA model for the central and eastern US. However, this new SSC model will not be completed for several years and does not resolve many of the fundamental regulatory and philosophical issues that have been raised during the current round of applications. To ensure regulatory stability and to provide accurate estimates of hazard for nuclear power plants, a dialog must be started between regulators and industry to resolve these issues. Two key issues that must be discussed are: (1) should new data and new interpretations or opinions of old data be treated differently in updated SSCs, and if so, how?; and (2) how can new data or interpretations developed by a small subset of the technical community be weighed against and potentially combined with a SSC model that was originally developed to capture the "center, body and range" of the technical community?

  5. 78 FR 77606 - Security Requirements for Facilities Storing Spent Nuclear Fuel

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... regulatory basis; availability of responses to public comments. SUMMARY: The U.S. Nuclear Regulatory... to Carol Gallagher; telephone: 301-287- 3422; email: [email protected] . For technical... Nuclear Security and Incident Response, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001...

  6. 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

  7. 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

  8. Sustainable hydropower in Lower Mekong Countries: Technical assessment and training travel report

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

    Hadjerioua, Boualem; Witt, Adam M.

    The U.S. Agency for International Development (USAID), through their partnership with the U.S. Department of the Interior (DOI), requested the support of Oak Ridge National Laboratory (ORNL) to provide specialized technical assistance as part of the Smart Infrastructure for the Mekong (SIM) Program in Thailand. Introduced in July 2013 by U.S. Secretary of State John Kerry, SIM is a U.S. Government Inter-Agency program that provides Lower Mekong partner countries with targeted, demand-driven technical and scientific assistance to support environmentally sound, climate conscious and socially equitable infrastructure, clean energy development, and water resources optimization. The U.S. Government is committed to supportingmore » sustainable economic development within the region by providing tools, best practices, technical assistance, and lessons learned for the benefit of partner countries. In response to a request from the Electricity Generating Authority of Thailand (EGAT), a SIM project was developed with two main activities: 1) to promote hydropower sustainability and efficiency through technical assessment training at two existing hydropower assets in Thailand, and 2) the design and implementation of one national and two or three regional science and policy workshops, to be co-hosted with EGAT, to build common understanding of and commitment to environmental and social safeguards for Mekong Basin hydropower projects. The U.S. Department of Energy (DOE) is leading the technical assessment (Activity 1), and has contracted ORNL to provide expert technical assistance focused on increasing efficiency at existing projects, with the goal of increasing renewable energy generation at little to no capital cost. ORNL is the leading national laboratory in hydropower analysis, with a nationally recognized and highly qualified team of scientists addressing small to large-scale systems (basin-, regional-, and national-scale) energy generation optimization analysis for DOE. The mission of the ORNL Water Power Program is to develop technologies, decision-support tools, and methods of analysis that enable holistic management of water-dependent energy infrastructure and natural resources in support of the DOE Energy Efficiency and Renewable Energy Office (DOE-EERE), Federal hydropower agencies, Federal Energy Regulatory Commission (FERC), Nuclear Regulatory Commission (NRC), energy producers, and other entities. In support of SIM, ORNL completed technical assessments of two hydropower plants owned and operated by the Electricity Generating Authority of Thailand (EGAT): Vajiralongkorn (VRK), with an installed capacity of 300 MW, and Rajjaprabha (RPB), with an installed capacity of 240MW. Technical assessment is defined as the assessment of hydropower operation and performance, and the identification of potential opportunities for performance improvement through plant optimization. At each plant, the assessment included an initial analysis of hydropower operating and performance metrics, provided by dam owners. After this analysis, ORNL engaged with the plant management team in a skills exchange, where best practices, operational methods, and technical challenges were discussed. The technical assessment process was outlined to plant management followed by a presentation of preliminary results and analysis based on 50 days of operational data. EGAT has agreed to provide a full year of operational data so a complete and detailed assessment that captures seasonal variability can be completed. The results of these assessments and discussions will be used to develop a set of best practices, training, and procedure recommendations to improve the efficiency of the two assessed plants« less

  9. Single-nucleus analysis of accessible chromatin in developing mouse forebrain reveals cell-type-specific transcriptional regulation.

    PubMed

    Preissl, Sebastian; Fang, Rongxin; Huang, Hui; Zhao, Yuan; Raviram, Ramya; Gorkin, David U; Zhang, Yanxiao; Sos, Brandon C; Afzal, Veena; Dickel, Diane E; Kuan, Samantha; Visel, Axel; Pennacchio, Len A; Zhang, Kun; Ren, Bing

    2018-03-01

    Analysis of chromatin accessibility can reveal transcriptional regulatory sequences, but heterogeneity of primary tissues poses a significant challenge in mapping the precise chromatin landscape in specific cell types. Here we report single-nucleus ATAC-seq, a combinatorial barcoding-assisted single-cell assay for transposase-accessible chromatin that is optimized for use on flash-frozen primary tissue samples. We apply this technique to the mouse forebrain through eight developmental stages. Through analysis of more than 15,000 nuclei, we identify 20 distinct cell populations corresponding to major neuronal and non-neuronal cell types. We further define cell-type-specific transcriptional regulatory sequences, infer potential master transcriptional regulators and delineate developmental changes in forebrain cellular composition. Our results provide insight into the molecular and cellular dynamics that underlie forebrain development in the mouse and establish technical and analytical frameworks that are broadly applicable to other heterogeneous tissues.

  10. Cultural resources regulatory analysis, area overview, and assessment of previous Department of Energy and Kirtland Air Force Base inventories for Sandia National Laboratories, New Mexico

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

    Hoagland, S.R.; Lord, K.J.

    The following regulatory analysis and literature review of archaeological and historic resources on the Sandia National Laboratory/New Mexico (SNL/NM) occupied properties was prepared by the Chambers Group Inc. in January 1992. Based upon compliance surveys of Technical Area I through V undertaken in 1990 and 1991 the report concludes that, although consultation with the Department of Energy and State Historic Preservation Officer will still be required for particular projects, cultural resources should not affect the overall planning and development of future SNL/NM projects. As SNL/NM buildings approach 50 years in age additional analysis and consultations may be required. In ordermore » to protect sensitive resources, the location coordinates and maps provided in the original report are not included here.« less

  11. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

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

    Weiner, Ruth F.; Blink, James A.; Rechard, Robert Paul

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardousmore » constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.« less

  12. A Qualitative Assessment of Current CCF Guidance Based on a Review of Safety System Digital Implementation Changes with Evolving Technology

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

    Korsah, Kofi; Muhlheim, Michael David; Wood, Richard

    The US Nuclear Regulatory Commission (NRC) is initiating a new rulemaking project to develop a digital system common-cause failure (CCF) rule. This rulemaking will review and modify or affirm the NRC's current digital system CCF policy as discussed in the Staff Requirements Memorandum to the Secretary of the Commission, Office of the NRC (SECY) 93-087, Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light Water Reactor (ALWR) Designs, and Branch Technical Position (BTP) 7-19, Guidance on Evaluation of Defense-in-Depth and Diversity in Digital Computer-Based Instrumentation and Control Systems, as well as Chapter 7, Instrumentation and Controls, in NRCmore » Regulatory Guide (NUREG)-0800, Standard Review Plan for Review of Safety Analysis Reports for Nuclear Power Plants (ML033580677). The Oak Ridge National Laboratory (ORNL) is providing technical support to the NRC staff on the CCF rulemaking, and this report is one of several providing the technical basis to inform NRC staff members. For the task described in this report, ORNL examined instrumentation and controls (I&C) technology implementations in nuclear power plants in the light of current CCF guidance. The intent was to assess whether the current position on CCF is adequate given the evolutions in digital safety system implementations and, if gaps in the guidance were found, to provide recommendations as to how these gaps could be closed.« less

  13. 76 FR 20506 - Technical Amendment to Rule 19b-4: Filings With Respect to Proposed Rule Changes by Self...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Rule 19b-4: Filings With Respect to Proposed Rule Changes by Self-Regulatory Organizations AGENCY... the term ``self-regulatory organization'' to mean any national securities exchange, registered... facilities of the self- regulatory organization'' or ``[a]ny statement made generally available'' that...

  14. Effects of Regulatory Self-Questioning on Secondary-Level Students' Problem-Solving Performance

    ERIC Educational Resources Information Center

    Pate, Michael L.; Miller, Greg

    2011-01-01

    A randomized posttest-only control group experimental design was used to determine the effects of regulatory self-questioning on secondary-level career and technical education students' electrical circuit theory test scores. Students who participated in the self-questioning group were asked to answer a list of regulatory questions as they solved…

  15. Developing Technical Skill Assessments

    ERIC Educational Resources Information Center

    Hyslop, Alisha

    2009-01-01

    One of the biggest challenges facing the career and technical education (CTE) community as it works to implement the 2006 Perkins Act is responding to more rigorous requirements for reporting on CTE students' technical skill attainment. The U.S. Department of Education suggested in non-regulatory guidance that states and locals use the number of…

  16. 78 FR 72673 - Midcontinent Independent System Operator, Inc.; Supplemental Notice Concerning Post-Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER13-2124-000] Midcontinent Independent System Operator, Inc.; Supplemental Notice Concerning Post-Technical Conference Comments As announced in the Notice of Technical Conference issued on October 25, 2013, and as required in the...

  17. 75 FR 27552 - Credit Reforms in Organized Wholesale Electric Markets; Further Notice Concerning Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM10-13-000] Credit Reforms in Organized Wholesale Electric Markets; Further Notice Concerning Technical Conference May 10, 2010... technical conference related to the Commission's Notice of Proposed Rulemaking on Credit Reforms in...

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

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

    Rice, R.E.

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

  19. 78 FR 60137 - Shipping and Transportation; Technical, Organizational, and Conforming Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ... INFORMATION: Table of Contents for Preamble I. Abbreviations II. Regulatory History III. Background and... States Code VCDOA Vice Commandant Decision on Appeal II. Regulatory History We did not publish a notice...

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

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

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

    2008-07-01

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

  1. Technical Letter Report: Evaluation and Analysis of a Few International Periodic Safety Review Summary Reports

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

    Chopra, Omesh K.; Diercks, Dwight R.; Ma, David Chia-Chiun

    At the request of the United States (U.S.) government, the International Atomic Energy Agency (IAEA) assembled a team of 20 senior safety experts to review the regulatory framework for the safety of operating nuclear power plants in the United States. This review focused on the effectiveness of the regulatory functions implemented by the NRC and on its commitment to nuclear safety and continuous improvement. One suggestion resulting from that review was that the U.S. Nuclear Regulatory Commission (NRC) incorporate lessons learned from periodic safety reviews (PSRs) performed in other countries as an input to the NRC’s assessment processes. In themore » U.S., commercial nuclear power plants (NPPs) are granted an initial 40-year operating license, which may be renewed for additional 20-year periods, subject to complying with regulatory requirements. The NRC has established a framework through its inspection, and operational experience processes to ensure the safe operation of licensed nuclear facilities on an ongoing basis. In contrast, most other countries do not impose a specific time limit on the operating licenses for NPPs, they instead require that the utility operating the plant perform PSRs, typically at approximately 10-year intervals, to assure continued safe operation until the next assessment. The staff contracted with Argonne National Laboratory (Argonne) to perform a pilot review of selected translated PSR assessment reports and related documentation from foreign nuclear regulatory authorities to identify any potential new regulatory insights regarding license renewal-related topics and NPP operating experience (OpE). A total of 14 PSR assessment documents from 9 countries were reviewed. For all of the countries except France, individual reports were provided for each of the plants reviewed. In the case of France, three reports were provided that reviewed the performance assessment of thirty-four 900-MWe reactors of similar design commissioned between 1978 and 1988. All of the reports reviewed were the regulator’s assessment of the PSR findings rather than the original PSR report, and all but one were English translations from the original language. In these reviews, it was found that most of the countries base their regulatory guidance to some extent (and often to a large extent) on U.S. design codes and standards, NRC regulatory guidance, and U.S. industry guidance. In addition, many of the observed operational technical issues and OpE events reported for U.S. reactors are also cited in the PSR reports. The PSR reports also identified a number of potential technical material/component performance issues and OpE events that are not commonly reported for U.S. plants.« less

  2. 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

  3. 75 FR 26749 - Public Utility District No.1 of Snohomish County, WA; Notice of Technical Conference for the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2157-188] Public Utility District No.1 of Snohomish County, WA; Notice of Technical Conference for the Jackson Hydroelectric Project.... Commission staff will hold a technical conference to discuss the proposed license articles submitted by the...

  4. 77 FR 43280 - Coordination Between Natural Gas and Electricity Markets; Supplemental Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket No. AD12-12-000] Coordination Between Natural Gas and Electricity Markets; Supplemental Notice of Technical Conferences On July 5, 2012... between Natural Gas and Electricity Markets, Docket No. AD12-12-000 (July 5, 2012) (Notice of Technical...

  5. 76 FR 38383 - Albany Engineering Corporation, Town of Stuyvesant, NY; Notice of Site Visit and Technical Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Project No. 2696-033] Albany Engineering Corporation, Town of Stuyvesant, NY; Notice of Site Visit and Technical Meeting On July 12, 2011, Office of Energy Projects staff will participate in a site visit and technical meeting for the Stuyvesant...

  6. 10 CFR 50.36a - Technical specifications on effluents from nuclear power reactors.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Technical specifications on effluents from nuclear power reactors. 50.36a Section 50.36a Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND...; Ineligibility of Certain Applicants § 50.36a Technical specifications on effluents from nuclear power reactors...

  7. 10 CFR 50.36a - Technical specifications on effluents from nuclear power reactors.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Technical specifications on effluents from nuclear power reactors. 50.36a Section 50.36a Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND...; Ineligibility of Certain Applicants § 50.36a Technical specifications on effluents from nuclear power reactors...

  8. 77 FR 6557 - PJM Interconnection, L.L.C.; Supplemental Notice for Staff Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-08

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-4628-000] PJM Interconnection, L.L.C.; Supplemental Notice for Staff Technical Conference Take notice that the staff technical conference in the above captioned proceeding, to be held on February 14, 2012, will include a listen-only...

  9. Genomics in the land of regulatory science.

    PubMed

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

    2015-06-01

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

  10. [Convergence of healthcare regulation in the Americas: history, development, and new challenges].

    PubMed

    Silva, Ana Paula Jucá; Tagliari, Patrícia Oliveira Pereira

    2016-05-01

    The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge. Organizations that already use this tool, such as the International Conference of Drug Regulatory Authorities (ICDRA), Pan American Network for Drug Regulatory Harmonization (PANDRH), International Generic Drug Regulators Programme (IGDRP), and the International Medical Device Regulators Forum (IMDRF), among others, are currently working to gather knowledge, data, and specialists from different countries to build an international technical and scientific standard that can be used for decision-making by local regulators. This would ensure convergence of national regulations despite the need to adapt international standards to local needs, structure, and capacities. The most recent resolutions issued by the World Health Organization recognize the need to bring regulatory systems closer to the reality of national healthcare systems, and underscore the advantages of using existing local guidelines as input for cooperation with regulatory authorities.

  11. 48 CFR 241.201 - Policy.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., and decisions of independent regulatory bodies. This policy does not extend to nonindependent regulatory bodies. (2) Purchases of utility services outside the United States may use— (i) Formats and technical provisions consistent with local practice; and (ii) Dual language forms and contracts. (3) Rates...

  12. 48 CFR 241.201 - Policy.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., and decisions of independent regulatory bodies. This policy does not extend to nonindependent regulatory bodies. (2) Purchases of utility services outside the United States may use— (i) Formats and technical provisions consistent with local practice; and (ii) Dual language forms and contracts. (3) Rates...

  13. 48 CFR 241.201 - Policy.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., and decisions of independent regulatory bodies. This policy does not extend to nonindependent regulatory bodies. (2) Purchases of utility services outside the United States may use— (i) Formats and technical provisions consistent with local practice; and (ii) Dual language forms and contracts. (3) Rates...

  14. 48 CFR 241.201 - Policy.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., and decisions of independent regulatory bodies. This policy does not extend to nonindependent regulatory bodies. (2) Purchases of utility services outside the United States may use— (i) Formats and technical provisions consistent with local practice; and (ii) Dual language forms and contracts. (3) Rates...

  15. 76 FR 79675 - Pomperaug Hydro Project Andrew Peklo III; Notice of Site Visit and Technical Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12790-001] Pomperaug Hydro Project Andrew Peklo III; Notice of Site Visit and Technical Meeting On January 18, 2012, Office of Energy Projects staff will hold a site visit and technical meeting for the proposed Pomperaug Hydro Project (FERC...

  16. Final Rule for Technical Amendments to the Highway and Nonroad Diesel Regulations

    EPA Pesticide Factsheets

    This action corrects errors and omissions from the previous rules, makes minor changes to the regulations to assist entities with regulatory compliance, and makes technical amendments that resulted from discussions with various diesel stakeholders.

  17. Approach for Estimating Exposures and Incremental Health ...

    EPA Pesticide Factsheets

    Approach for Estimating Exposures and Incremental Health Effects from Lead During Renovation, Repair, and Painting Activities in Public and Commercial Buildings” (Technical Approach Document). Also available for public review and comment are two supplementary documents: the detailed appendices for the Technical Approach Document and a supplementary report entitled “Developing a Concentration-Response Function for Pb Exposure and Cardiovascular Disease-Related Mortality.” Together, these documents describes an analysis for estimating exposures and incremental health effects created by renovations of public and commercial buildings (P&CBs). This analysis could be used to identify and evaluate hazards from renovation, repair, and painting activities in P&CBs. A general overview of how this analysis can be used to inform EPA’s hazard finding is described in the Framework document that was previously made available for public comment (79 FR 31072; FRL9910-44). The analysis can be used in any proposed rulemaking to estimate the reduction in deleterious health effects that would result from any proposed regulatory requirements to mitigate exposure from P&CB renovation activities. The Technical Approach Document describes in detail how the analyses under this approach have been performed and presents the results – expected changes in blood lead levels and health effects due to lead exposure from renovation activities.

  18. UMTRA Project water sampling and analysis plan, Durango, Colorado. Revision 1

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

    NONE

    1995-09-01

    Planned, routine ground water sampling activities at the US Department of Energy (DOE) Uranium Mill Tailings Remedial Action (UMTRA) Project site in Durango, Colorado, are described in this water sampling and analysis plan. The plan identifies and justifies the sampling locations, analytical parameters, detection limits, and sampling frequency for the routine monitoring stations at the site. The ground water data are used to characterize the site ground water compliance strategies and to monitor contaminants of potential concern identified in the baseline risk assessment (DOE, 1995a). Regulatory basis for routine ground water monitoring at UMTRA Project sites is derived from themore » US EPA regulations in 40 CFR Part 192 (1994) and EPA standards of 1995 (60 FR 2854). Sampling procedures are guided by the UMTRA Project standard operating procedures (SOP) (JEG, n.d.), the Technical Approach Document (TAD) (DOE, 1989), and the most effective technical approach for the site.« less

  19. 75 FR 27375 - Postal Rate Case Management

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ... POSTAL REGULATORY COMMISSION [Docket No. PI2010-3; Order No. 456] Postal Rate Case Management AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is seeking comments relevant to management of an anticipated exigent postal rate case. It has scheduled a technical conference...

  20. U.S. regulatory research program for implementation of burnup credit in transport casks

    DOT National Transportation Integrated Search

    2001-09-10

    In 1999 the U.S. Nuclear Regulatory Commission (U.S. NRC) initiated a research program to : support the development of technical bases and guidance that would facilitate the implementation of : burnup credit into licensing activities for transport an...

  1. Technical support for the EPA cleanup rule on radioactively contaminated sites

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

    Hull, H.B.; Newman, A.; Wolbarst, A.B.

    1995-12-31

    The U.S. Environmental Protection Agency (EPA) is developing a radiation site cleanup regulation for the protection of the public from radionuclide contamination at sites that are to be cleaned up and released for public use. The regulation will apply to sites under the control of Federal agencies, and to sites licensed by the Nuclear Regulatory Commission (NRC) or NRC Agreement States. The agency is therefore conducting a comprehensive technical analysis aimed at developing information that will be used to support the rule. This presentation describes the regulation and the approach developed to determine how radiological health impacts and volumes ofmore » soil requiring remediation vary as functions of the possible cleanup dose or risk level.« less

  2. Light-Duty Diesel Vehicles: Efficiency and Emissions Attributes and Market Issues

    EIA Publications

    2009-01-01

    This report responds to a request from Senator Jeff Sessions for an analysis of the environmental and energy efficiency attributes of light-duty diesel vehicles. Specifically, the inquiry asked for a comparison of the characteristics of diesel-fueled vehicles with those of similar gasoline-fueled, E85-fueled, and hybrid vehicles, as well as a discussion of any technical, economic, regulatory, or other obstacles to increasing the use of diesel-fueled vehicles in the United States

  3. Genetically engineered crops for biofuel production: regulatory perspectives.

    PubMed

    Lee, David; Chen, Alice; Nair, Ramesh

    2008-01-01

    There are numerous challenges in realizing the potential of biofuels that many policy makers have envisioned. The technical challenges in making the production of biofuels economical and on a scale to replace a significant fraction of transportation fuel have been well described, along with the potential environmental concerns. The use of biotechnology can potentially address many of these technical challenges and environmental concerns, but brings significant regulatory hurdles that have not been discussed extensively in the scientific community. This review will give an overview of the approaches being developed to produce transgenic biofuel feedstocks, particularly cellulosic ethanol, and the regulatory process in the United States that oversees the development and commercialization of new transgenic plants. We hope to illustrate that the level of regulation for transgenic organisms is not proportional to their potential risk to human health or the environment, and that revisions to the regulatory system in the U.S. currently under consideration are necessary to streamline the process.

  4. 78 FR 3893 - Enbridge Energy, Limited Partnership; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-17

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. IS13-17-000] Enbridge Energy... Energy, Limited Partnership's proposed revision to its downstream Nomination Verification Procedure. \\1\\ Enbridge Energy, Limited Partnership, 141 FERC ] 61,246 (2012). Take notice that a technical conference...

  5. 10 CFR 72.28 - Contents of application: Applicant's technical qualifications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Contents of application: Applicant's technical qualifications. 72.28 Section 72.28 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED...

  6. 75 FR 62534 - Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference October 1, 2010. The Federal...-referenced proceeding to explore issues associated with reliability monitoring, enforcement and compliance...

  7. 78 FR 33863 - Relationship Between General Design Criteria and Technical Specification Operability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0179] Relationship Between General Design Criteria and...) 2013-05, ``NRC Position on the Relationship Between General Design Criteria and Technical Specification Operability.'' This RIS clarifies the NRC staff's position on the relationship between the general design...

  8. Estimating technical efficiency in the hospital sector with panel data: a comparison of parametric and non-parametric techniques.

    PubMed

    Siciliani, Luigi

    2006-01-01

    Policy makers are increasingly interested in developing performance indicators that measure hospital efficiency. These indicators may give the purchasers of health services an additional regulatory tool to contain health expenditure. Using panel data, this study compares different parametric (econometric) and non-parametric (linear programming) techniques for the measurement of a hospital's technical efficiency. This comparison was made using a sample of 17 Italian hospitals in the years 1996-9. Highest correlations are found in the efficiency scores between the non-parametric data envelopment analysis under the constant returns to scale assumption (DEA-CRS) and several parametric models. Correlation reduces markedly when using more flexible non-parametric specifications such as data envelopment analysis under the variable returns to scale assumption (DEA-VRS) and the free disposal hull (FDH) model. Correlation also generally reduces when moving from one output to two-output specifications. This analysis suggests that there is scope for developing performance indicators at hospital level using panel data, but it is important that extensive sensitivity analysis is carried out if purchasers wish to make use of these indicators in practice.

  9. 76 FR 3684 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63711; File No. SR-ODD-2011-01] Self-Regulatory... to the Options Disclosure Document Reflecting Certain Changes to Disclosure Regarding Credit Default Options in, and Making Certain Technical Amendments to, the June 2007 Supplement to the Options Disclosure...

  10. 78 FR 59073 - Pacific Gas and Electric Company; Humboldt Bay Independent Spent Fuel Storage Installation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... AGENCY: Nuclear Regulatory Commission. ACTION: License amendment application; issuance. SUMMARY: The U.S...: 301-287- 3422; email: [email protected] . For technical questions, contact the individual(s...: Chris Allen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission...

  11. 75 FR 30812 - Frequency Regulation Compensation in the Organized Wholesale Power Markets; Further Notice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10-11-000] Frequency Regulation Compensation in the Organized Wholesale Power Markets; Further Notice Concerning Technical Conference May 25, 2010. Take notice that on May 26, 2010, the Federal Energy Regulatory Commission staff...

  12. 30 CFR 902.10 - State regulatory program approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false State regulatory program approval. 902.10 Section 902.10 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE..., Technical Library, 1999 Broadway, Suite 3320, Denver, Colorado 80202-5733. [60 FR 33724, June 29, 1995, as...

  13. REGULATING THE ULTIMATE SINK: MANAGING THE RISKS OF GEOLOGIC CO2 STORAGE

    EPA Science Inventory

    The paper addresses the issue of geologic storage (GS) of carbon dioxide (CO2) and discusses the risks and regulatory history of deep underground waste injection on the U.S. mainland and surrounding continental shelf. The treatment focuses on the technical and regulatory aspects ...

  14. 10 CFR 72.26 - Contents of application: Technical specifications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Contents of application: Technical specifications. 72.26 Section 72.26 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

  15. 10 CFR 72.26 - Contents of application: Technical specifications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Contents of application: Technical specifications. 72.26 Section 72.26 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

  16. 78 FR 16849 - Alaska Energy Authority; Notice of Dispute Resolution Panel Meeting and Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14241-000] Alaska Energy Authority; Notice of Dispute Resolution Panel Meeting and Technical Conference On March 8, 2013, Commission staff, in response to the filing of a notice of [[Page 16850

  17. 76 FR 11238 - Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Technical Conference Docket No... Alta Wind VIII, LLC Alta Windpower Development, LLC TGP Development Company, LLC Puget Sound Energy... York Canyon, LLC Green Borders Geothermal, LLC v. Terra-Gen Dixie EL10-36-002 Valley, LLC Terra-Gen...

  18. 10 CFR 35.647 - Additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Additional technical requirements for mobile remote afterloader units. 35.647 Section 35.647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery...

  19. 10 CFR 35.647 - Additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Additional technical requirements for mobile remote afterloader units. 35.647 Section 35.647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery...

  20. 10 CFR 35.647 - Additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Additional technical requirements for mobile remote afterloader units. 35.647 Section 35.647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery...

  1. 10 CFR 35.647 - Additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Additional technical requirements for mobile remote afterloader units. 35.647 Section 35.647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery...

  2. Writing Technical Documents for the Global Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Bonk, Robert J.

    1998-01-01

    States that technical writers in the global pharmaceutical industry write for two audiences: regulatory agencies and healthcare practitioners. Contends that information products that address these audiences must balance the competing forces of business interests, market penetration, and the cultural variables of products so tied to people's…

  3. 75 FR 68780 - Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference November 2, 2010. The... associated with reliability monitoring, enforcement and compliance. The Commission announced the conference...

  4. UAS Integration into the NAS Project

    NASA Technical Reports Server (NTRS)

    Bauer, Jeff

    2010-01-01

    The goal of the UAS Integration in the NAS Project is to contribute capabilities that reduce technical barriers related to the safety and operational challenges associated with enabling routine UAS access to the NAS This goal will be accomplished through a two-phased approach of system-level integration of key concepts, technologies and/or procedures, and demonstrations of integrated capabilities in an operationally relevant environment. Technical objectives include: PHASE 1: a) Validating the key technical areas identified by this project. System-level analyses, a State of the Art Analysis (SOAA), and a ConOps will identify the challenges and barriers preventing routine UAS access to the NAS. b) Developing a national roadmap and gap analysis identifying specific deliverables in the area of operations, procedures, and technologies that will impact future policy decisions. PHASE 2: a) Provide regulators with a methodology for developing airworthiness requirements for UAS and data to support development of certifications standards and regulatory guidance. b) Provide systems-level integrated testing of concepts and/or capabilities that address barriers to routine access to the NAS. Through simulation and flight testing, address issues including separation assurance, communications requirements, and Pilot Aircraft Interfaces (PAIs) in operationally relevant environments

  5. Regulatory aspects in the pharmaceutical development of nanoparticle drug delivery systems designed to cross the intestinal epithelium and M-cells.

    PubMed

    Hussain, Nasir

    2016-11-30

    This article reviews the field of oral uptake of nanoparticles across the gastrointestinal epithelium for the period 2006-2016. Analysis is conducted from the viewpoint of i) M-cell genetics and model development, ii) drug targeting to Peyer's patches and M-cells, and iii) physicochemical interactions of nanoparticles in the intestinal milieu. In light of these recent developments, regulatory considerations in the development of orally-absorbable nanoparticle drug products are discussed and focused on Module 3.2.P sub-sections of the Common Technical Document. Particular attention is paid to novel excipients, ligands and the non-standard method of manufacture. The novelty of this drug delivery system demands not only a multi-disciplinary scientific and regulatory approach but also a risk-adjusted consideration for a system defined by both processes and specifications. Given the current state of scientific development in the field it is suggested (in the author's personal opinion) that the design of nanoparticulate drug delivery systems should be kept as simple as possible (from a regulatory and manufacturing perspective) and to target the entire gastrointestinal epithelium. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

  6. 76 FR 60820 - North American Electric Reliability Corporation; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RD10-8-000] North American Electric Reliability Corporation; Notice of Technical Conference Take notice that the Federal Energy... Conference will explore the risks of leaving dial-up intelligent electronic devices that are part of the Bulk...

  7. 78 FR 8511 - Coordination between Natural Gas and Electricity Markets; Supplemental Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD12-12-000] Coordination between Natural Gas and Electricity Markets; Supplemental Notice of Technical Conference As announced in... the conference. \\1\\ Coordination between Natural Gas and Electricity Markets, Docket No. AD12-12-000...

  8. 78 FR 15719 - Coordination Between Natural Gas and Electricity Markets; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket No. AD12-12-000] Coordination Between Natural Gas and Electricity Markets; Notice of Technical Conference Take notice that the Federal... utilization of pipeline capacity. \\1\\ Coordination between Natural Gas and Electricity Markets, 141 FERC ] 61...

  9. 77 FR 30518 - Town of Springfield, Vermont and Siemens Westinghouse Technical Services, Inc., One Hundred River...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 9648-018] Town of Springfield, Vermont and Siemens Westinghouse Technical Services, Inc., One Hundred River Street, LLC; Notice... 15, 2011 and supplemented on April 27, 2012, the Town of Springfield, Vermont and Siemens...

  10. 77 FR 12637 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... Equities Definition of Approved Person To Exclude Foreign Affiliates, Eliminating the Application Process..., eliminate the application process for approved persons, and make related technical and conforming changes..., eliminate the application process for approved persons, and make related technical and conforming changes...

  11. 77 FR 66194 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-02

    ... Effectiveness of a Proposed Rule Change To Make Technical Change to SPY Position Limit Pilot Program and Representation Regarding Timing of Submission of Pilot Report October 26, 2012. Pursuant to Section 19(b)(1) of... technical amendment to Interpretation and Policy [[Page 66195

  12. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... the circumstances associated with the loss of large areas of the plant due to explosions or fire as...

  13. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... the circumstances associated with the loss of large areas of the plant due to explosions or fire as...

  14. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... the circumstances associated with the loss of large areas of the plant due to explosions or fire as...

  15. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... the circumstances associated with the loss of large areas of the plant due to explosions or fire as...

  16. 77 FR 21555 - Reactive Power Resources; Supplemental Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD12-10-000] Reactive Power... Commission (Commission) announced that a staff Technical Conference on Reactive Power Resources will be held... may register at the following Web page: https://www.ferc.gov/whats-new/registration/reactive-power-4...

  17. 75 FR 81605 - Smart Grid Interoperability Standards; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM11-2-000] Smart Grid Interoperability Standards; Notice of Technical Conference December 21, 2010. Take notice that the Federal Energy... National Institute of Standards and Technology and included in this proceeding are ready for Commission...

  18. 77 FR 24560 - National Highway Traffic Safety Administration Electric Vehicle Safety Technical Symposium

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-24

    ... discuss safety considerations for electric vehicles powered by lithium-ion (Li-ion) batteries. The... technical symposium to discuss regulatory and safety considerations for lithium-ion (Li-ion) battery-powered... Li-ion batteries and Li-ion battery-powered vehicles, as well as presentations by the Department of...

  19. The 1991 International Conference on Aging Aircraft and Structural Airworthiness

    NASA Technical Reports Server (NTRS)

    Harris, Charles E. (Editor)

    1992-01-01

    Technical sessions of the conference included structural performance, nondestructive evaluation, maintenance and repair, international activities, and commuter airlines. Each session was organized to provide a well-rounded view of the subject from the industry, regulatory, and research perspective. Thirty-four presentations were given by the international technical community.

  20. Implementation Plan for Qualification of Sodium-Cooled Fast Reactor Technology Information

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

    Moe, Wayne; Honma, George

    This document identifies and discusses implementation elements that can be used to facilitate consistent and systematic evaluation processes relating to quality attributes of technical information (with focus on SFR technology) that will be used to support licensing of advanced reactor designs. Information may include, but is not limited to, design documents for SFRs, research-and-development (R&D) data and associated documents, test plans and associated protocols, operations and test data, international research data, technical reports, and information associated with past U.S. Nuclear Regulatory Commission (NRC) reviews of SFR designs. The approach for determining acceptability of test data, analysis, and/or other technical informationmore » is based on guidance provided in INL/EXT-15-35805, “Guidance on Evaluating Historic Technology Information for Use in Advanced Reactor Licensing.” The implementation plan can be adopted into a working procedure at each of the national laboratories performing data qualification, or by applicants seeking future license application for advanced reactor technology.« less

  1. 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

  2. Cross-Cutting issues in Regulatory Supervision of Spent Fuel Radioactive Waste and Radioactively Contaminated Land in North-West Russia

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

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

    2006-07-01

    The Norwegian Government is promoting improvements in radiation protection and nuclear safety in North-West Russia. Among priority areas there is the improvement of spent nuclear fuel and radioactive waste management, as well as remediation operations at the Shore Technical Bases operated by Federal Enterprise SevRAO at Andreeva Bay and Gremikha on the Kola Peninsula. The extreme radiological conditions at these sites present novel difficulties for regulatory supervision of operations. The situation at these sites is such that the existing regulations are applicable, and actions to remedy the situation are not permitted under the current regulatory regime. An improved regulatory process,more » including development of special norms and rules, is required to take account of this unusual situation. The Norwegian strategy includes not only support to industrial projects, but also support to Russian Federation regulatory bodies, to ensure that work is carried out in compliance with Russian Federation law, taking account of international recommendations and other national good practice as relevant in the RF. Accordingly, the Norwegian Radiation Protection Authority has set up a programme of cooperation with the Federal Medical-Biological Agency (FMBA), which is the primary radiation protection authority in the RF. The work is carried out with technical input from the Russian Institute of Biophysics and with inputs from western technical support organisations. The overall objective of the work is to promote effective and efficient regulatory supervision of SevRAO activities at Andreeva Bay and Gremikha within the scope of responsibilities of FMBA. This paper describes the results of an initial threat assessment which allows consideration of the cross-cutting issues associated with developing an overall effective site management plan which deals with short- and long-term issues, and protection of workers as well as of the public and the environment, while achieving a timely and effective use of resources in order to solve the problems. (authors)« less

  3. Psychology in nuclear power plants: an integrative approach to safety - general statement

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

    Shikiar, R.

    Since the accident at the Three Mile Island nuclear power plant on March 28, 1979, the commercial nuclear industry in the United States has paid increasing attention to the role of humans in overall plant safety. As the regulatory body with primary responsibility for ensuring public health and safety involving nuclear operations, the United States Nuclear Regulatory Commission (NRC) has also become increasingly involved with the ''human'' side of nuclear operations. The purpose of this symposium is to describe a major program of research and technical assistance that the Pacific Northwest Laboratory is performing for the NRC that deals withmore » the issues of safety at nuclear power plants (NPPs). This program addresses safety from several different levels of analysis, which are all important within the context of an integrative approach to system safety.« less

  4. 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

  5. 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…

  6. 10 CFR 50.36a - Technical specifications on effluents from nuclear power reactors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... reactors. 50.36a Section 50.36a Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND...; Ineligibility of Certain Applicants § 50.36a Technical specifications on effluents from nuclear power reactors..., including expected occurrences, as low as is reasonably achievable, each licensee of a nuclear power reactor...

  7. 10 CFR 50.36a - Technical specifications on effluents from nuclear power reactors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... reactors. 50.36a Section 50.36a Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND...; Ineligibility of Certain Applicants § 50.36a Technical specifications on effluents from nuclear power reactors..., including expected occurrences, as low as is reasonably achievable, each licensee of a nuclear power reactor...

  8. 75 FR 44789 - Northern Natural Gas Company; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP10-841-000] Northern Natural Gas Company; Notice of Technical Conference July 20, 2010. By order dated July 9, 2010 \\1\\ the... discussed in the July 9, 2010 Order. \\1\\ Northern Natural Gas Company, 132 FERC ] 61,021 (2010). FERC...

  9. 76 FR 9614 - Notice of Availability of the Proposed Models for Plant-Specific Adoption of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0039] Notice of Availability of the Proposed Models for..., ``Technical Specifications End States, NEDC-32988-A,'' for Boiling Water Reactor Plants Using the Consolidated... Availability. SUMMARY: The NRC is announcing the availability of the model application (with model no...

  10. 10 CFR 35.2647 - Records of additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... remote afterloader units. 35.2647 Section 35.2647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records § 35.2647 Records of additional technical requirements for mobile remote afterloader units. (a) A licensee shall retain a record of each check for mobile remote afterloader units...

  11. 75 FR 82382 - Electronic Tariff Filings; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-30

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM01-5-000] Electronic... electronic filing of tariff and tariff related materials pursuant to Order No. 714.\\1\\ The technical... implementation of eTariff. \\1\\ Electronic Tariff Filings, Order No. 714, 73 FR 57,515 (Oct. 3, 2008), 124 FERC...

  12. 75 FR 33297 - Western Technical College; Notice of Intent To File License Application, Filing of Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13417-001] Western... License Application and Request to Use the Traditional Licensing Process. b. Project No.: 13417-001. c. Date Filed: December 21, 2009. d. Submitted By: Western Technical College (Western). e. Name of Project...

  13. WOOD PRODUCTS IN THE WASTE STREAM: CHARACTERIZATION AND COMBUSTION EMISSIONS - VOLUME 1. TECHNICAL REPORT

    EPA Science Inventory

    The report gives results of a study of technical, public policy, and regulatory issues that affect the processing and combustion of waste wood for fuel. (NOTE: Waste wood is wood that is separated from a solid-waste stream, processed into a uniform-sized product, and reused for o...

  14. 76 FR 14966 - Supplemental Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ......... Puget Sound Energy, Inc EL10-72-001. Terra-Gen Dixie Valley, LLC, TGP Dixie EL10-29-002. Development...-000. Cedar Creek Wind Energy, LLC RC11-1-000. Milford Wind Corridor Phase I, LLC.... RC11-2-000. Sun... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Supplemental Notice of Technical...

  15. 10 CFR 50.36a - Technical specifications on effluents from nuclear power reactors.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... reactors. 50.36a Section 50.36a Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND...; Ineligibility of Certain Applicants § 50.36a Technical specifications on effluents from nuclear power reactors..., including expected occurrences, as low as is reasonably achievable, each licensee of a nuclear power reactor...

  16. 10 CFR 35.2647 - Records of additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... remote afterloader units. 35.2647 Section 35.2647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records § 35.2647 Records of additional technical requirements for mobile remote afterloader units. (a) A licensee shall retain a record of each check for mobile remote afterloader units...

  17. 10 CFR 35.2647 - Records of additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... remote afterloader units. 35.2647 Section 35.2647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records § 35.2647 Records of additional technical requirements for mobile remote afterloader units. (a) A licensee shall retain a record of each check for mobile remote afterloader units...

  18. 10 CFR 35.2647 - Records of additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... remote afterloader units. 35.2647 Section 35.2647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records § 35.2647 Records of additional technical requirements for mobile remote afterloader units. (a) A licensee shall retain a record of each check for mobile remote afterloader units...

  19. 10 CFR 35.2647 - Records of additional technical requirements for mobile remote afterloader units.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... remote afterloader units. 35.2647 Section 35.2647 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF BYPRODUCT MATERIAL Records § 35.2647 Records of additional technical requirements for mobile remote afterloader units. (a) A licensee shall retain a record of each check for mobile remote afterloader units...

  20. PrediCTC, liquid biopsy in precision oncology: a technology transfer experience in the Spanish health system.

    PubMed

    Alonso-Alconada, L; Barbazan, J; Candamio, S; Falco, J L; Anton, C; Martin-Saborido, C; Fuster, G; Sampedro, M; Grande, C; Lado, R; Sampietro-Colom, L; Crego, E; Figueiras, S; Leon-Mateos, L; Lopez-Lopez, R; Abal, M

    2018-05-01

    Management of metastatic disease in oncology includes monitoring of therapy response principally by imaging techniques like CT scan. In addition to some limitations, the irruption of liquid biopsy and its application in personalized medicine has encouraged the development of more efficient technologies for prognosis and follow-up of patients in advanced disease. PrediCTC constitutes a panel of genes for the assessment of circulating tumor cells (CTC) in metastatic colorectal cancer patients, with demonstrated improved efficiency compared to CT scan for the evaluation of early therapy response in a multicenter prospective study. In this work, we designed and developed a technology transfer strategy to define the market opportunity for an eventual implementation of PrediCTC in the clinical practice. This included the definition of the regulatory framework, the analysis of the regulatory roadmap needed for CE mark, a benchmarking study, the design of a product development strategy, a revision of intellectual property, a cost-effectiveness study and an expert panel consultation. The definition and analysis of an appropriate technology transfer strategy and the correct balance among regulatory, financial and technical determinants are critical for the transformation of a promising technology into a viable technology, and for the decision of implementing liquid biopsy in the monitoring of therapy response in advanced disease.

  1. 75 FR 26225 - Frequency Regulation Compensation in the Organized Wholesale Power Markets; Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10-11-000] Frequency... Meeting Room at the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. All...-Federal Reporters, Inc. (202-347-3700 or 1-800-336-6646). The transcripts will be available for free on...

  2. 77 FR 77165 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ...-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of...\\ notice is hereby given that on December 17, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or the... Equity Technical Update 2012-31 ( http://www.nasdaqtrader.com/TraderNews.aspx?id=ETU2012-31 ). Because...

  3. 75 FR 23759 - Frequency Regulation Compensation in the Organized Wholesale Power Markets; Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10-11-000] Frequency... Meeting Room at the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. All...-Federal Reporters, Inc. (202-347-3700 or 1-800-336-6646). The transcripts will be available for free on...

  4. 77 FR 70517 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68262; File No. SR-CBOE-2012-108] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule Change To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error Accounts November 19...

  5. 77 FR 70511 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68265; File No. SR-CBOE-2012-109] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule Change Related to CBSX To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error...

  6. 78 FR 72729 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70947; File No. SR-OCC-2013-21] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Make Technical Changes to OCC's By-Laws and Rules in Connection with the Modification of the...

  7. 78 FR 62788 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-22

    ... fees for real- time and historic data sets of transactions in TRACE-Eligible Securities \\5\\ that are... data sets; and (3) make other technical amendments. \\5\\ The term TRACE-Eligible Security is defined in... transactions and to establish real-time and historic data sets for Rule 144A transactions. The effective date...

  8. 78 FR 35349 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... Transaction Fees. The Exchange notes that the proposal will have no effect on other fees and dues that may apply to Market Makers including marketing fees, Options Regulatory Fees, market data, and membership...). The proposed rule change will take effect on June 3, 2013. Technical Change In addition to the changes...

  9. 75 FR 9262 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... at the present time, and urged FINRA to study data collected on Asset-Backed Securities before making... to a recent rule change to the Rule 6700 Series,\\7\\ Agency Debt Securities and certain primary market... corporate debt securities;\\12\\ and \\12\\ See id. (14) In Rule 6700 Series, incorporate certain technical...

  10. Review of Technical Studies in the United States in Support of Burnup Credit Regulatory Guidance

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

    Wagner, John C; Parks, Cecil V; Mueller, Don

    2010-01-01

    Taking credit for the reduction in reactivity associated with fuel depletion can enable more cost-effective, higher-density storage, transport, disposal, and reprocessing of spent nuclear fuel (SNF) while maintaining sufficient subcritical margin to establish an adequate safety basis. Consequently, there continues to be considerable interest in the United States (U.S.), as well as internationally, in the increased use of burnup credit in SNF operations, particularly related to storage, transport, and disposal of commercial SNF. This interest has motivated numerous technical studies related to the application of burnup credit, both domestically and internationally, as well as the design of SNF storage, transportmore » and disposal systems that rely on burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission (NRC) initiated a burnup credit research program in 1999, with support from the Oak Ridge National Laboratory (ORNL), to develop regulatory guidance and the supporting technical bases for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Although this NRC research program has not been continuous since its inception, considerable progress has been achieved in many key areas in terms of increased understanding of relevant phenomena and issues, availability of relevant information and data, and subsequently updated regulatory guidance for expanded use of burnup credit. This paper reviews technical studies performed by ORNL for the U.S. NRC burnup credit research program. Examples of topics include reactivity effects associated with reactor operating characteristics, fuel assembly characteristics, burnable absorbers, control rods, spatial burnup distributions, cooling time, and assembly misloading; methods and data for validation of isotopic composition predictions; methods and data for validation of criticality calculations; and operational issues and data related to assembly burnup confirmation. The objective of this paper is to summarize the work and significant accomplishments, with references to the technical reports and publications for complete details, and provide a useful resource to others in the burnup credit community.« less

  11. Technical and economic evaluation of controlled disposal options for very low level radioactive wastes

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

    Robinson, P.J.; Vance, J.N.

    1990-08-01

    Over the past several years, there has been considerable interest by the nuclear industry in the Nuclear Regulatory Commission (NRC) explicitly defined an activity level in plant waste materials at which the radiological impacts would be so low as to be considered Below Regulatory Concern (BRC). In January 1989, Electric Power Research Institute (EPRI) completed an extensive industry research effort to develop the technical bases for establishing criteria for the disposal of very low activity wastes in ordinary disposal facilities. The Nuclear Management and Resources Council (NUMARC), with assistance from the Edison Electric Institute (EEI) and the Electric Power Researchmore » Institute (EPRI), drafted a petition titled: Petition for Rulemaking Regarding Disposal of Below Regulatory Concern Radioactive Wastes from Commercial Nuclear Power Plants.'' Subsequent to the industry making a final decision for submittal of the drafted BRC petition, EPRI was requested to evaluate the technical and economic impact of six BRC options. These options are: take no action in pursuing a BRC waste exemption, petition the NRC for authorization to disposal of any BRC waste in any ordinary disposal facility, limit disposal of BRC waste to the nuclear power plant site, limit disposal of BRC waste to the nuclear power plant site and other utility owned property, petition for a mixed waste exemption, and petition for single waste stream exemptions in sequence (i.e. soil, followed by sewage sludge, etc.). The petition and technical bases were written to support the disposal of any BRC waste type in any ordinary disposal facility. These documents do not provide all of the technical and economic information needed to completely assessment the BRC options. This report provides the technical and economic basis for a range of options concerning disposal of very low activity wastes. 3 figs., 20 tabs.« less

  12. Normative and economic foundations of high-rise construction in the city of Samara

    NASA Astrophysics Data System (ADS)

    Didkovskaya, Olga V.; Bocharov, Aleksey Y.; Ilyina, Marina V.; Mamaeva, Olga A.

    2018-03-01

    Every year the number of free land plots for construction of buildings is steadily decreasing in cities. In this regard, the participants in the investment and construction process are increasingly seeking to maximize the use of land. A logical way for this is to use high-rise construction. However, until recently, builders encountered serious obstacles in the form of lack of special norms and rules for the design of high-rise buildings. It led to the need for individual coordination of each high-rise facility, the development and approval of special technical conditions, the passage of numerous administrative approvals. Thus, investment activity regarding the construction of high-rise buildings in the Russian Federation is reduced. In 2016, there were regulatory changes that substantially alleviated these difficulties. In this article, the authors analyze the features of the town-planning normative-legal field of high-rise construction and its development, track the interrelations between the regulatory regulation of the construction of similar facilities, with the real need, the technical feasibility and economic feasibility of their construction in the urban district of Samara. Conclusions and suggestions are also based on the analysis of the norms of urban zoning, the residential real estate market and the value of land plots.

  13. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

    PubMed

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

    2017-01-01

    Objective . The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods . A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results . Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion . Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

  14. Diversification of transcription factor-DNA interactions and the evolution of gene regulatory networks.

    PubMed

    Rogers, Julia M; Bulyk, Martha L

    2018-04-25

    Sequence-specific transcription factors (TFs) bind short DNA sequences in the genome to regulate the expression of target genes. In the last decade, numerous technical advances have enabled the determination of the DNA-binding specificities of many of these factors. Large-scale screens of many TFs enabled the creation of databases of TF DNA-binding specificities, typically represented as position weight matrices (PWMs). Although great progress has been made in determining and predicting binding specificities systematically, there are still many surprises to be found when studying a particular TF's interactions with DNA in detail. Paralogous TFs' binding specificities can differ in subtle ways, in a manner that is not immediately apparent from looking at their PWMs. These differences affect gene regulatory outputs and enable TFs to rewire transcriptional networks over evolutionary time. This review discusses recent observations made in the study of TF-DNA interactions that highlight the importance of continued in-depth analysis of TF-DNA interactions and their inherent complexity. This article is categorized under: Biological Mechanisms > Regulatory Biology. © 2018 Wiley Periodicals, Inc.

  15. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

    PubMed Central

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

  16. Comprehensive analysis of Arabidopsis expression level polymorphisms with simple inheritance

    PubMed Central

    Plantegenet, Stephanie; Weber, Johann; Goldstein, Darlene R; Zeller, Georg; Nussbaumer, Cindy; Thomas, Jérôme; Weigel, Detlef; Harshman, Keith; Hardtke, Christian S

    2009-01-01

    In Arabidopsis thaliana, gene expression level polymorphisms (ELPs) between natural accessions that exhibit simple, single locus inheritance are promising quantitative trait locus (QTL) candidates to explain phenotypic variability. It is assumed that such ELPs overwhelmingly represent regulatory element polymorphisms. However, comprehensive genome-wide analyses linking expression level, regulatory sequence and gene structure variation are missing, preventing definite verification of this assumption. Here, we analyzed ELPs observed between the Eil-0 and Lc-0 accessions. Compared with non-variable controls, 5′ regulatory sequence variation in the corresponding genes is indeed increased. However, ∼42% of all the ELP genes also carry major transcription unit deletions in one parent as revealed by genome tiling arrays, representing a >4-fold enrichment over controls. Within the subset of ELPs with simple inheritance, this proportion is even higher and deletions are generally more severe. Similar results were obtained from analyses of the Bay-0 and Sha accessions, using alternative technical approaches. Collectively, our results suggest that drastic structural changes are a major cause for ELPs with simple inheritance, corroborating experimentally observed indel preponderance in cloned Arabidopsis QTL. PMID:19225455

  17. Burma (Myanmar) Country Analysis Brief

    EIA Publications

    2016-01-01

    Burma (Myanmar) is an important natural gas producer in Southeast Asia, although its upstream hydrocarbons sector is severely underdeveloped. Financial constraints by Burma’s national oil company, a lack of technical capacity, opaque regulatory policy, insufficient investment by foreign firms, and international sanctions have significantly impeded the country’s efforts to realize its oil and natural gas production potential. These factors have also severely hampered the development of necessary energy infrastructure. However, U.S. and European Union sanctions were eased or suspended in 2012 and 2013 in response to political and economic reforms in Burma.

  18. Environmental Radiation Monitoring at the Areas of the Former Military Technical Bases at the Russian Far East - 12445

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

    Kiselev, Sergey M.; Shandala, Nataliya K.; Titov, Alexey V.

    After termination of operation at the serviced facilities of the nuclear fleet of the former Soviet Union, the Military Technical Base in Sysoeva Bay has been reorganized to the site for SNF and RW temporary storage (STS). The main activities of STS are receipt, storage and transmission to radioactive waste reprocessing. Establishment of the RW management regional centre in the Far-Eastern region at the STS in Sysoeva Bay implies intensification of SNF and RW management in this region that can result in increasing ecological load to the adjacent areas and settlements. Regulatory supervision of the radiation safety at the areasmore » of the Former Military Technical Bases at the Russian Far East is one of the regulatory functions of the Federal Medical Biological Agency (FMBA of Russia). To regulate SNF an RW management and provide the effective response to changing radiation situation, the environmental radiation monitoring system is arranged. For this purpose, wide range of environmental media examinations at the Sysoeva Bay STS was performed by Burnasyan Federal Medical Biophysical Centre - a technical support organization of FMBA of Russia in collaboration with the Federal State Geological Enterprise 'Hydrospecgeology' (Federal Agency for Entrails). Regulation during the RW and SNF management is continuous process, which the FMBA of Russia implements in close cooperation with other Russian responsible authorities - the State Atomic Energy Corporation 'Rosatom' and Federal Agency for Entrails. The Environmental radiation monitoring findings served as a basis for the associated databank arrangement. The radio ecological monitoring system was arranged at the facilities under inspection for the purpose of the dynamic control of the radiation situation. It presupposes regular radiometry inspections in-situ, their analysis and assessment of the radiation situation forecast in the course of the STS remediation main stages. Some new data on the radiation situation at the facilities will appear in future and the prognostic assessment will become more precise. The mentioned natural, practical and theoretical works is a base for the development of the set of regulatory documents to assure radiation protection and safety of workers, public and environment, as well as development of documents to regulate SNF and RW management at the STS facilities. (authors)« less

  19. 78 FR 2308 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-10

    ... Change To Address the Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe... authority of the Exchange to cancel orders (or release routing-related orders) when a technical or systems... Exchange may encounter situations that make it necessary to cancel orders (or release routing- related...

  20. 75 FR 11171 - Transparency Provisions of Section 23 of the Natural Gas Act; Supplemental Notice to Form No. 552...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM07-10-002] Transparency Provisions of Section 23 of the Natural Gas Act; Supplemental Notice to Form No. 552 Technical Conference March 1, 2010. As announced in the Notice of Technical Conference issued on February 22, 2010, a...

  1. 76 FR 78062 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-15

    ... problem and make other technical changes. The proposed change will be operative on December 1, 2011. The... experiences a bona fide systems problem and make other technical changes. The Exchange presently has three... Exchange experienced a bona fide systems problem. The Exchange proposes to amend the Fee Schedule to extend...

  2. 77 FR 53886 - February 2011 Southwest Cold Weather Event Follow-up Technical Conference; Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-04

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-9-000] February 2011... repeat of the loss of approximately 700 megawatts of generation in WECC due to severe cold weather issues. This resulted in 1,000 megawatts of load shedding which affected over 250,000 customers in the WECC...

  3. 75 FR 30387 - Improving Market and Planning Efficiency Through Improved Software; Notice of Agenda and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... Market and Planning Efficiency Through Improved Software; Notice of Agenda and Procedures for Staff... planning models and software. The technical conference will be held from 8 a.m. to 5:30 p.m. (EDT) on June.... Agenda for AD10-12 Staff Technical Conference on Planning Models and Software Federal Energy Regulatory...

  4. 76 FR 59682 - Erie Boulevard Hydropower L.P.; Notice of Dispute Resolution Panel Meeting and Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 7518-012] Erie Boulevard Hydropower L.P.; Notice of Dispute Resolution Panel Meeting and Technical Conference On September 16, 2011, Commission staff, in response to the filing of notice of study dispute by the New York State Department of...

  5. 76 FR 68743 - Western Technical College; Notice of Application Tendered for Filing With the Commission and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ....: 13417-002. c. Date filed: October 21, 2011. d. Applicant: Western Technical College. e. Name of Project... . Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment... and seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First...

  6. 78 FR 49749 - Southern California Edison, City of Banning, California; Notice of Meeting To Conduct a Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 344-023-California; Project No. 14520-000-California] Southern California Edison, City of Banning, California; Notice of Meeting To Conduct a Technical Conference for the San Gorgonio Hydroelectric Project and the Proposed Whitewater Flume Water Power Project a. Date and Time...

  7. 75 FR 53688 - Southern LNG Company, L.L.C.; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP10-829-000] Southern LNG Company, L.L.C.; Notice of Technical Conference August 25, 2010. Take notice that Commission Staff will... Street, NE., Washington, DC 20426. On June 7, 2010, Southern LNG Company, L.L.C. (Southern LNG) filed a...

  8. Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

    NASA Astrophysics Data System (ADS)

    Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

    2013-09-01

    There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

  9. 77 FR 74520 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68393; File No. SR-Phlx-2012-134] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of a Proposal with Respect to the Authority of the Exchange or Nasdaq Options Services LLC (``NOS'') To Cancel Options Orders when a Technical or System Issue Occurs...

  10. 75 FR 501 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61258; File No. SR-Phlx-2009-107] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to a Technical Change to the Exchange's Complex Order Program December 30, 2009. Pursuant to Section 19(b)(1) of the Securities...

  11. 77 FR 74524 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68394; File No. SR-BX-2012-073] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change With Respect to the Authority of the Exchange or Nasdaq Options Services LLC (``NOS'') To Cancel Options Orders When a Technical or System Issu...

  12. 77 FR 70496 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68260; File No. SR-C2-2012-038] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Proposed Rule Change To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error Accounts November 19, 2012....

  13. User Data Package (UDP) for Packaged Cogeneration Systems (PCS)

    DTIC Science & Technology

    1990-05-01

    Standards for PURPA Compliance ............ ...................... 10 1.3 Selected Commercial, Institutional, and Multi-unit Technically Feasible...percent. The Federal Energy Regulatory Commission (FERC), in accordance with Section 201 of the Public Utility Regulatory Policies Act ( PURPA ) of 1978...percent of the time the engine was running, or if 57 percent of the recovered engine heat were stored. Additional requirements for PURPA efficiency that

  14. 78 FR 11795 - Minimum Technical Standards for Class II Gaming Systems and Equipment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-20

    ... threshold amount. The Commission increased that amount in the MICS from $1,000,000 to $3,000,000. The... considered to be small entities for the purposes of the Regulatory Flexibility Act. Small Business Regulatory Enforcement Fairness Act The proposed rule is not a major rule under 5 U.S.C. 804(2), the Small Business...

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

    USGS Publications Warehouse

    Stevens, Peter R.; Nicholson, Thomas J.

    1996-01-01

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

  16. ICH guidelines--implementation of the 3Rs (refinement, reduction, and replacement): incorporating best scientific practices into the regulatory process.

    PubMed

    Ohno, Yasuo

    2002-01-01

    An overview of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is described. ICH was established through cooperation of the regulatory agencies and industrial parties of three main regions involved in pharmaceuticals: the European Union, the United States, and Japan. The purpose of the ICH is to make recommendations to achieve greater harmonization regarding interpretation and application of technical guidelines and requirements for product registration in an effort to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The main purpose of ICH was not to foster the 3Rs per se; however, harmonization of guidelines has eliminated duplications of similar tests to satisfy the specific requirements of each region. The ICH process has contributed to mutual understanding of the regulatory requirements and has decreased the number of unnecessary animal experiments. Specific examples of the contributions of ICH harmonization to the 3Rs are described.

  17. 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

  18. Technical Basis for Physical Fidelity of NRC Control Room Training Simulators for Advanced Reactors

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

    Minsk, Brian S.; Branch, Kristi M.; Bates, Edward K.

    2009-10-09

    The objective of this study is to determine how simulator physical fidelity influences the effectiveness of training the regulatory personnel responsible for examination and oversight of operating personnel and inspection of technical systems at nuclear power reactors. It seeks to contribute to the U.S. Nuclear Regulatory Commission’s (NRC’s) understanding of the physical fidelity requirements of training simulators. The goal of the study is to provide an analytic framework, data, and analyses that inform NRC decisions about the physical fidelity requirements of the simulators it will need to train its staff for assignment at advanced reactors. These staff are expected tomore » come from increasingly diverse educational and experiential backgrounds.« less

  19. 77 FR 39552 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... Exchange or NASDAQ Execution Services To Cancel Orders When a Technical or Systems Issue Occurs and To... the authority of BX or NASDAQ Execution Services (``NES'') to cancel orders when a technical or... issue may occur at BX, NES, or a routing destination that causes BX or NES to cancel orders, if BX or...

  20. 77 FR 39543 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving a Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... the Authority of NASDAQ or NASDAQ Execution Services To Cancel Orders When a Technical or Systems...'') to cancel orders when a technical or systems issue occurs and to describe the operation of an error... causes NASDAQ or NES to cancel orders, if NASDAQ or NES determines that such action is necessary to...

  1. 75 FR 25019 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-06

    ..., Inc. To Make a Technical Adjustment to Its Rules To Allow Sub-Penny Quoting of Certain Securities... adjustment to its rules to allow sub-penny quoting of certain securities priced less than $1.00. The text of... to make a technical adjustment its rules to allow sub-penny quoting of Investment Company Units...

  2. Systems Biology Approach to the Dissection of the Complexity of Regulatory Networks in the S. scrofa Cardiocirculatory System

    PubMed Central

    Martini, Paolo; Sales, Gabriele; Calura, Enrica; Brugiolo, Mattia; Lanfranchi, Gerolamo; Romualdi, Chiara; Cagnin, Stefano

    2013-01-01

    Genome-wide experiments are routinely used to increase the understanding of the biological processes involved in the development and maintenance of a variety of pathologies. Although the technical feasibility of this type of experiment has improved in recent years, data analysis remains challenging. In this context, gene set analysis has emerged as a fundamental tool for the interpretation of the results. Here, we review strategies used in the gene set approach, and using datasets for the pig cardiocirculatory system as a case study, we demonstrate how the use of a combination of these strategies can enhance the interpretation of results. Gene set analyses are able to distinguish vessels from the heart and arteries from veins in a manner that is consistent with the different cellular composition of smooth muscle cells. By integrating microRNA elements in the regulatory circuits identified, we find that vessel specificity is maintained through specific miRNAs, such as miR-133a and miR-143, which show anti-correlated expression with their mRNA targets. PMID:24284405

  3. Technical and Regulatory Guidance for In Situ Chemical Oxidation of Contaminated Soil and Groundwater

    DTIC Science & Technology

    2001-06-01

    B12 6. Former Wood Treatment Facility, Sonoma County , CA . . . . . . . . . . . . . . . . . . . . . B12 7. San Francisco Bay Sites, CA...aromatic hydrocarbons (PAHs) to below regulatory limits. Site: Former Wood Treatment Facility, Sonoma County , CA Technology: Ozone Summary: An array...manufacturing facility, located in Sonoma County , California (Clayton, 2000b). Primary contaminants are pentachlorophenol (PCP) and creosote (i.e., polycyclic

  4. 77 FR 40684 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-10

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67343; File No. SR-Phlx-2012-81] Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change With Respect to the Authority of the Exchange or NASDAQ Execution Services to Cancel Orders When a Technical or System Issue Occurs on the Exchange's NASDAQ OMX PSX...

  5. 77 FR 28905 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-16

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66964; File No. SR-NASDAQ-2012-057] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change With Respect to the Authority of NASDAQ or NASDAQ Execution Services To Cancel Orders When a Technical or System Issue Occurs and To Describe the Operation of...

  6. 77 FR 30576 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing of Proposed Rule Change With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67014; File No. SR-BX-2012-034] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing of Proposed Rule Change With Respect to the Authority of the Exchange or NASDAQ Execution Services to Cancel Orders When a Technical or System Issue Occurs and To Describe the Operation of an...

  7. Involvement of Individuals in the Development of Technical Solutions and Rules of Management for Building Renovation Projects: A Case Study of Latvia

    NASA Astrophysics Data System (ADS)

    Pukite, I.; Grekis, A.; Geipele, I.; Zeltins, N.

    2017-08-01

    In March 2016, the Latvian government approved a new support program for increasing energy efficiency in residential apartment buildings. For the support of renovation of apartment buildings in the period from 2016 to 2023, 166 470 588 EUR will be available. Different persons, such as energy auditors, designers, architects, project managers and builders, will be involved in the process of planning, development and implementation of building renovation. At the development stage of the building renovation project, special attention should be devoted to the first stage - energy audit and technical project development. The problem arises due to the fact that each of these individuals, during the development of technical building documentation, does not work as a completely unified system. The implementation of construction project planning and organisational management system is one of the most important factors to guarantee that the quality of building renovation project is ensured in accordance with the laws and regulatory standards. The paper studies mutual cooperation, professionalism and the role of information feedback of personnel involved in the planning stage of building renovation, which is an essential prerequisite for the renovation process in order to achieve high quality of work and reduce the energy performance indicator. The present research includes the analysis of different technical solutions and their impact on energy efficiency. Mutual harmonisation of technical specifications is also investigated.

  8. 77 FR 58975 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... Mining Control and Reclamation Act of 1977, its legislative history, its implementing regulations, case law, other State or Federal laws and regulations, data, technical literature, or relevant publications...

  9. Septic Systems Guidance, Policy, and Regulations

    EPA Pesticide Factsheets

    EPA has developed several documents outlining its mission, priorities and regulatory authorities as well as guidance and technical information to help communities establish comprehensive septic (onsite) management programs.

  10. Regulatory Requirements and Technical Analysis for Department of Energy Regulated Performance Assessments of Shallow-Trench Disposal of Low-Level Radioactive Waste at the Nevada Test Site

    NASA Astrophysics Data System (ADS)

    Crowe, B.; Black, P.; Tauxe, J.; Yucel, V.; Rawlinson, S.; Colarusso, A.; DiSanza, F.

    2001-12-01

    The National Nuclear Security Administration, Nevada Operations Office (NNSA/NV) operates and maintains two active facilities on the Nevada Test Site (NTS) that dispose Department of Energy (DOE) defense-generated low-level radioactive (LLW), mixed radioactive, and classified waste in shallow trenches, pits and large-diameter boreholes. The operation and maintenance of the LLW disposal sites are self-regulated under DOE Order 435.1, which requires review of a Performance Assessment for four performance objectives: 1) all pathways 25 mrem/yr limit; 2) atmospheric pathways 10 mrem/yr limit; 3) radon flux density of 20 pCi/m2/s; and 4) groundwater resource protection (Safe Drinking Water Act; 4 mrem/yr limit). The inadvertent human intruder is protected under a dual 500- and 100-mrem limit (acute and chronic exposure). In response to the Defense Nuclear Facilities Safety Board Recommendation 92 2, a composite analysis is required that must examine all interacting sources for compliance against both 30 and 100 mrem/yr limits. A small component of classified transuranic waste is buried at intermediate depths in 3-meter diameter boreholes at the Area 5 LLW disposal facility and is assessed through DOE-agreement against the requirements of the Environmental Protection Agency (EPA)'s 40 CFR 191. The hazardous components of mixed LLW are assessed against RCRA requirements. The NTS LLW sites fall directly under three sets of federal regulations and the regulatory differences result not only in organizational challenges, but also in different decision objectives and technical paths to completion. The DOE regulations require deterministic analysis for a 1,000-year compliance assessment supplemented by probabilistic analysis under a long-term maintenance program. The EPA regulations for TRU waste are probabilistically based for a compliance interval of 10,000 years. Multiple steps in the assessments are strongly dependent on assumptions for long-term land use policies. Integrating the different requirements into coherent and consistent sets of conceptual models of the disposal setting, alternative scenarios, and system models of fate, transport and dose-based assessments is technically challenging. Environmental assessments for these sites must be broad-based and flexible to accommodate the multiple objectives.

  11. 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

  12. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.

    PubMed

    Molzon, J A; Giaquinto, A; Lindstrom, L; Tominaga, T; Ward, M; Doerr, P; Hunt, L; Rago, L

    2011-04-01

    The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.

  13. Commercialization of parabolic dish systems

    NASA Technical Reports Server (NTRS)

    Washom, B.

    1982-01-01

    The impact of recent federal tax and regulatory legislation on the commercialization of parabolic solar reflector technology is assessed. Specific areas in need of technical or economic improvement are noted.

  14. Commercialization of parabolic dish systems

    NASA Astrophysics Data System (ADS)

    Washom, B.

    1982-07-01

    The impact of recent federal tax and regulatory legislation on the commercialization of parabolic solar reflector technology is assessed. Specific areas in need of technical or economic improvement are noted.

  15. FY 1987 current fiscal year work plan

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

    Not Available

    This Current Year Work Plan presents a detailed description of the activities to be performed by the Joint Integration Office during FY87. It breaks down the activities into two major work areas: Program Management and Program Analysis. Program Management is performed by the JIO by providing technical planning and guidance for the development of advanced TRU waste management capabilities. This includes equipment/facility design, engineering, construction, and operations. These functions are integrated to allow transition from interim storage to final disposition. JIO tasks include program requirements identification, long-range technical planning, budget development, program planning document preparation, task guidance, task monitoring, informationmore » gathering and task reporting to DOE, interfacing with other agencies and DOE lead programs, integrating public involvement with program efforts, and preparation of program status reports for DOE. Program Analysis is performed by the JIO to support identification and assessment of alternatives, and development of long-term TRU waste program capabilities. This work plan includes: system analyses, requirements analyses, interim and procedure development, legislative and regulatory analyses, dispatch and traffic analyses, and data bases.« less

  16. Technical Report for Calculations of Atmospheric Dispersion at Onsite Locations for Department of Energy Nuclear Facilities

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

    Levin, Alan; Chaves, Chris

    2015-04-04

    The Department of Energy (DOE) has performed an evaluation of the technical bases for the default value for the atmospheric dispersion parameter χ/Q. This parameter appears in the calculation of radiological dose at the onsite receptor location (co-located worker at 100 meters) in safety analysis of DOE nuclear facilities. The results of the calculation are then used to determine whether safety significant engineered controls should be established to prevent and/or mitigate the event causing the release of hazardous material. An evaluation of methods for calculation of the dispersion of potential chemical releases for the purpose of estimating the chemical exposuremore » at the co-located worker location was also performed. DOE’s evaluation consisted of: (a) a review of the regulatory basis for the default χ/Q dispersion parameter; (b) an analysis of this parameter’s sensitivity to various factors that affect the dispersion of radioactive material; and (c) performance of additional independent calculations to assess the appropriate use of the default χ/Q value.« less

  17. Building a Better Canine Warrior

    DTIC Science & Technology

    2017-10-12

    without adversely affecting pe r formance and to develop technical methodology that would dissipate metabolic heat without the expense o f body water...technical methodology that would dissipate metabolic heat without the expense of body water. Neither an increase in dietary salt nor decrease in...from a methodological aspect as well as emerging regulatory issues related to research in working dogs. Data suggested that the effect of high

  18. Control technology appendices for pollution control technical manuals. Final report, June 1982-February 1983

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

    Not Available

    1983-04-01

    The document is one of six technical handbooks prepared by EPA to help government officials granting permits to build synfuels facilities, synfuels process developers, and other interested parties. They provide technical data on waste streams from synfuels facilities and technologies capable of controlling them. Process technologies covered in the manuals include coal gasification, coal liquefaction by direct and idirect processing, and the extraction of oil from shale. The manuals offer no regulatory guidance, allowing the industry flexibility in deciding how best to comply with environmental regulations.

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

    Wellman, Dawn M.; Freshley, Mark D.; Truex, Michael J.

    Current requirements for site remediation and closure are standards-based and are often overly conservative, costly, and in some cases, technically impractical to achieve. Use of risk-informed alternate endpoints provide a means to achieve remediation goals that are permitted by regulations and are protective of human health and the environment. Alternate endpoints enable establishing a path for cleanup that may include intermediate remedial milestones and transition points and/or regulatory alternatives to standards-based remediation. A framework is presented that is centered around developing and refining conceptual models in conjunction with assessing risks and potential endpoints as part of a system-based assessment thatmore » integrates site data with scientific understanding of processes that control the distribution and transport of contaminants in the subsurface and pathways to receptors. This system based assessment and subsequent implementation of the remediation strategy with appropriate monitoring are targeted at providing a holistic approach to addressing risks to human health and the environment. This holistic approach also enables effective predictive analysis of contaminant behavior to provide defensible criteria and data for making long-term decisions. Developing and implementing an alternate endpoint-based approach for remediation and waste site closure presents a number of challenges and opportunities. Categories of these challenges include scientific and technical, regulatory, institutional, and budget and resource allocation issues. Opportunities exist for developing and implementing systems-based approaches with respect to supportive characterization, monitoring, predictive modeling, and remediation approaches.« less

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

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

    O`Donnell, E.

    1995-12-31

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

  1. Technical and Regulatory Guidance for In Situ Chemical Oxidation of Contaminated Soil and Groundwater Second Edition

    DTIC Science & Technology

    2005-01-01

    PA Ozone (full scale) Silty sand underlain by fractured schist and shale Petroleum hydrocarbons Former Wood Treatment Site, Sonoma County , CA...Wood Treatment Site, Sonoma County , California Contaminant: Pentachlorophenol and creosote (i.e., PAHs) Oxidant: Ozone Regulatory Agency Contact...topography is essentially flat and paved, and the facility is located on northern Sonoma County , California. The site subsurface consists of very

  2. Regulatory Mechanisms for Nursing Training and Practice: Meeting Primary Health Care Needs. World Health Organization Technical Report Series No. 738. Report of a WHO Study Group.

    ERIC Educational Resources Information Center

    World Health Organization, Geneva (Switzerland).

    A report on laws and regulations governing nursing education and practice in 81 countries belonging to the World Health Organization and effects on primary health care is presented by an international group of experts. Suggestions for training and licensure are provided to national governments and nursing regulatory bodies to promote the goal of…

  3. Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework

    PubMed Central

    Evitt, Niklaus H.; Mascharak, Shamik; Altman, Russ B.

    2015-01-01

    CRISPR germline editing therapies (CGETs) hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. PMID:26632357

  4. United States Food and Drug Administration Regulation of Gene and Cell Therapies.

    PubMed

    Bailey, Alexander M; Arcidiacono, Judith; Benton, Kimberly A; Taraporewala, Zenobia; Winitsky, Steve

    2015-01-01

    The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products.

  5. Benefits and Costs of Pulp and Paper Effluent Controls Under the Clean Water Act

    NASA Astrophysics Data System (ADS)

    Luken, Ralph A.; Johnson, F. Reed; Kibler, Virginia

    1992-03-01

    This study quantifies local improvements in environmental quality from controlling effluents in the pulp and paper industry. Although it is confined to a single industry, this study is the first effort to assess the actual net benefits of the Clean Water Act pollution control program. An assessment of water quality benefits requires linking regulatory policy, technical effects, and behavioral responses. Regulatory policies mandate specific controls that influence the quantity and nature of effluent discharges. We identify a subset of stream segments suitable for analysis, describe water quality simulations and control cost calculations under alternative regulatory scenarios, assign feasible water uses to each segment based on water quality, and determine probable upper bounds for the willingness of beneficiaries to pay. Because the act imposes uniform regulations that do not account for differences in compliance costs, existing stream quality, contributions of other effluent sources, and recreation potential, the relation between water quality benefits and costs varies widely across sites. This variation suggests that significant positive net benefits have probably been achieved in some cases, but we conclude that the costs of the Clean Water Act as a whole exceed likely benefits by a significant margin.

  6. Integrating legal liabilities in nanomanufacturing risk management.

    PubMed

    Mohan, Mayank; Trump, Benjamin D; Bates, Matthew E; Monica, John C; Linkov, Igor

    2012-08-07

    Among other things, the wide-scale development and use of nanomaterials is expected to produce costly regulatory and civil liabilities for nanomanufacturers due to lingering uncertainties, unanticipated effects, and potential toxicity. The life-cycle environmental, health, and safety (EHS) risks of nanomaterials are currently being studied, but the corresponding legal risks have not been systematically addressed. With the aid of a systematic approach that holistically evaluates and accounts for uncertainties about the inherent properties of nanomaterials, it is possible to provide an order of magnitude estimate of liability risks from regulatory and litigious sources based on current knowledge. In this work, we present a conceptual framework for integrating estimated legal liabilities with EHS risks across nanomaterial life-cycle stages using empirical knowledge in the field, scientific and legal judgment, probabilistic risk assessment, and multicriteria decision analysis. Such estimates will provide investors and operators with a basis to compare different technologies and practices and will also inform regulatory and legislative bodies in determining standards that balance risks with technical advancement. We illustrate the framework through the hypothetical case of a manufacturer of nanoscale titanium dioxide and use the resulting expected legal costs to evaluate alternative risk-management actions.

  7. Anaerobic Digestion

    EPA Pesticide Factsheets

    Inform visitors about the science of AD, the environmental and economic benefits that can be realized through AD projects, and direct visitors to appropriate regulatory information, feasibility tools and technical resources from related EPA programs.

  8. NPDES Permit Writers' Course

    EPA Pesticide Factsheets

    The objective of the NPDES permit writers' course is to provide the basic regulatory framework and technical considerations that support the development of wastewater discharge permits as required under the NPDES Permit Program.

  9. Systems identification and the adaptive management of waterfowl in the United States

    USGS Publications Warehouse

    Williams, B.K.; Nichols, J.D.

    2001-01-01

    Waterfowl management in the United States is one of the more visible conservation success stories in the United States. It is authorized and supported by appropriate legislative authorities, based on large-scale monitoring programs, and widely accepted by the public. The process is one of only a limited number of large-scale examples of effective collaboration between research and management, integrating scientific information with management in a coherent framework for regulatory decision-making. However, harvest management continues to face some serious technical problems, many of which focus on sequential identification of the resource system in a context of optimal decision-making. The objective of this paper is to provide a theoretical foundation of adaptive harvest management, the approach currently in use in the United States for regulatory decision-making. We lay out the legal and institutional framework for adaptive harvest management and provide a formal description of regulatory decision-making in terms of adaptive optimization. We discuss some technical and institutional challenges in applying adaptive harvest management and focus specifically on methods of estimating resource states for linear resource systems.

  10. [Factors affecting the recovery in the intensive care unit].

    PubMed

    Turkov, P N; Nikitin, V V; Antsupova, M A; Podkopaev, V N; Panfilova, R P; Ivanova, I N; Nesterova, L I

    2013-01-01

    Urgency of the problem is defined by economical, regulatory and legislative acts, regional social and moral factors. There is critical situation in Russian Pediatric Healthcare system. This situation is due to inadequate funding, high medical technologies inaccessibility for some Russian children, their adverse health state. The article presents a retrospective analysis of intensive therapy and resuscitation outcomes with technical equipment and work environment assessment in the intensive care unit of Tushinskaya city pediatric clinic for the period from 2007 to 2011. Anaesthetic and emergency care quality and safety depend on several factors: permanent equipment improvement, comprehensive analysis of every fatal case and full implementation of "Anti-epidemic (prophylactic) actions plan" and "Program of monitoring compliance with the sanitary norms".

  11. Discursive constructions of professional identity in policy and regulatory discourse.

    PubMed

    Fealy, Gerard; Hegarty, Josephine-Mary; McNamara, Martin; Casey, Mary; O'Leary, Denise; Kennedy, Catriona; O'Reilly, Pauline; O'Connell, Rhona; Brady, Anne-Marie; Nicholson, Emma

    2018-05-23

    To examine and describe disciplinary discourses conducted through professional policy and regulatory documents in nursing and midwifery in Ireland. A key tenet of discourse theory is that group identities are constructed in public discourses and these discursively-constructed identities become social realities. Professional identities can be extracted from both the explicit and latent content of discourse. Studies of nursing's disciplinary discourse have drawn attention to a dominant discourse that confers nursing with particular identities, which privilege the relational and affective aspects of nursing and in the process, marginalise scientific knowledge and the technical and body work of nursing. We used critical discourse analysis to analyse a purposive sample of nursing and midwifery regulatory and policy documents. We applied a four-part, sequential approach to analysing the selected texts. This involved identifying key words, phrases and statements that indicated dominant discourses that, in turn, revealed latent beliefs and assumptions. The focus of our analysis was on how the discourses construct professional identities. Our analysis indicated recurring narratives that appeared to confer nurses and midwives with three dominant identities: 'the knowledgeable practitioner', the 'interpersonal practitioner' and the 'accountable practitioner'. The discourse also carried assumptions about the form and content of disciplinary knowledge. Academic study of identity construction in discourse is important to disciplinary development by raising nurses' and midwives' consciousness, alerting them to the ways that their own discourse can shape their identities, influence public and political opinion and, in the process, shape public policy on their professions. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  12. A technical review of cellular radio and analysis of a possible protocol

    NASA Astrophysics Data System (ADS)

    Reese, William D.

    1992-09-01

    Radio and television technology made the field of cellular radio possible. This thesis shows the development of radio and television technology from both a historical and technical aspect. A review of the important researchers and their contributions is followed by a technical explanation of the theories behind electromagnetic radiation of radio and television signals and the technology which was developed to implement such transmissions. The evolution of development which the paper outlines begins with some of the first theories about electricity and magnetism and the subsequent mathematical foundation developed to explain them. This is followed by a number of experimental and developmental researchers and their contributions. The bulk of the paper is concentrated on explaining the earliest generations of radio and all generations of television. The major components of both radio and television are described in detail along with an explanation of what they do and how they work. Such components, in many cases, found important uses in fields outside those for which they were developed. A brief overview of the regulatory environment of each technology and the U.S. and international standardization efforts is also included. Finally, the paper illustrates a modern-day application of radio technology--the cellular radio industry. A description of the components and their functions is followed by a possible cellular radio protocol and analysis.

  13. Lessons Learned in Over a Decade of Technical Support for U.S. Nuclear Cyber Security Programmes

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

    Glantz, Clifford S.; Landine, Guy P.; Craig, Philip A.

    Pacific Northwest National Laboratory’s (PNNL) nuclear cyber security team has been providing technical support to the U.S. Nuclear Regulatory Commission (NRC) since 2002. This team has provided cyber security technical experties in conducting cyber security inspections, developing of regulatory rules and guidance, reviewing facility cyber security plans, developing inspection guidance, and developing and teaching NRC inspectors how to conduct cyber security assessments. The extensive experience the PNNL team has gathered has allowed them to compile a lenghty list of recommendations on how to improve cyber security programs and conduct assessments. A selected set of recommendations are presented, including the needmore » to: integrate an array of defenisve strategies into a facility’s cyber security program, coordinate physical and cyber security activities, train phycial security forces to resist a cyber-enabled physical attack, improve estimates of the consequences of a cyber attack, properly resource cyber security assessments, appropropriately account for insider threats, routinely monitor security devices for potential attacks, supplement compliance-based requirements with risk-based decision making, and introduce the concept of resilience into cyber security programs.« less

  14. What Can We Learn About the Processes of Regulation of Tuberculosis Medicines From the Experiences of Health Policy and System Actors in India, Tanzania, and Zambia?

    PubMed

    Sheikh, Kabir; Uplekar, Mukund

    2016-03-09

    The unregulated availability and irrational use of tuberculosis (TB) medicines is a major issue of public health concern globally. Governments of many low- and middle-income countries (LMICs) have committed to regulating the quality and availability of TB medicines, but with variable success. Regulation of TB medicines remains an intractable challenge in many settings, but the reasons for this are poorly understood. The objective of this paper is to elaborate processes of regulation of quality and availability of TB medicines in three LMICs - India, Tanzania, and Zambia - and to understand the factors that constrain and enable these processes. We adopted the action-centred approach of policy implementation analysis that draws on the experiences of relevant policy and health system actors in order to understand regulatory processes. We drew on data from three case studies commissioned by the World Health Organization (WHO), on the regulation of TB medicines in India, Tanzania, and Zambia. Qualitative research methods were used, including in-depth interviews with 89 policy and health system actors and document review. Data were organized thematically into accounts of regulators' authority and capacity; extent of policy implementation; and efficiency, transparency, and accountability. In India, findings included the absence of a comprehensive policy framework for regulation of TB medicines, constraints of authority and capacity of regulators, and poor implementation of prescribing and dispensing norms in the majority private sector. Tanzania had a policy that restricted import, prescribing and dispensing of TB medicines to government operators. Zambia procured and dispensed TB medicines mainly through government services, albeit in the absence of a single policy for restriction of medicines. Three cross-cutting factors emerged as crucially influencing regulatory processes - political and stakeholder support for regulation, technical and human resource capacity of regulatory bodies, and the manner of private actors' influence on regulatory policy and implementation. Strengthening regulation to ensure the quality and availability of TB medicines in LMIC with emerging private markets may necessitate financial and technical inputs to upgrade regulatory bodies, as well as broader political and ethical actions to reorient and transform their current roles. © 2016 by Kerman University of Medical Sciences

  15. Support Center for Regulatory Atmospheric Modeling (SCRAM)

    EPA Pesticide Factsheets

    This technical site provides access to air quality models (including computer code, input data, and model processors) and other mathematical simulation techniques used in assessing air emissions control strategies and source impacts.

  16. The interplay between societal concerns and the regulatory frame on GM crops in the European Union.

    PubMed

    Devos, Yann; Reheul, Dirk; De Waele, Danny; Van Speybroeck, Linda

    2006-01-01

    Recapitulating how genetic modification technology and its agro-food products aroused strong societal opposition in the European Union, this paper demonstrates how this opposition contributed to shape the European regulatory frame on GM crops. More specifically, it describes how this opposition contributed to a de facto moratorium on the commercialization of new GM crop events in the end of the nineties. From this period onwards, the regulatory frame has been continuously revised in order to slow down further erosion of public and market confidence. Various scientific and technical reforms were made to meet societal concerns relating to the safety of GM crops. In this context, the precautionary principle, environmental post-market monitoring and traceability were adopted as ways to cope with scientific uncertainties. Labeling, traceability, co-existence and public information were installed in an attempt to meet the general public request for more information about GM agro-food products, and the specific demand to respect the consumers' and farmers' freedom of choice. Despite these efforts, today, the explicit role of public participation and/or ethical consultation during authorization procedures is at best minimal. Moreover, no legal room was created to progress to an integral sustainability evaluation during market procedures. It remains to be seen whether the recent policy shift towards greater transparency about value judgments, plural viewpoints and scientific uncertainties will be one step forward in integrating ethical concerns more explicitly in risk analysis. As such, the regulatory frame stands open for further interpretation, reflecting in various degrees a continued interplay with societal concerns relating to GM agro-food products. In this regard, both societal concerns and diversely interpreted regulatory criteria can be inferred as signaling a request - and even a quest - to render more explicit the broader-than-scientific dimension of the actual risk analysis.

  17. Generating political priority for regulatory interventions targeting obesity prevention: an Australian case study.

    PubMed

    Baker, Phillip; Gill, Timothy; Friel, Sharon; Carey, Gemma; Kay, Adrian

    2017-03-01

    Effective obesity prevention requires a synergistic mix of population-level interventions including a strong role for government and the regulation of the marketing, labelling, content and pricing of energy-dense foods and beverages. In this paper we adopt the agenda of the Australian Federal Government (AFG) as a case study to understand the factors generating or hindering political priority for such 'regulatory interventions' between 1990 and 2011. Using a theoretically-guided process tracing method we undertook documentary analysis and conducted 27 interviews with a diversity of actors involved in obesity politics. The analysis was structured by a theoretical framework comprising four dimensions: the power of actors involved; the ideas the actors deploy to interpret and portray the issue; the institutional and political context; and issue characteristics. Despite two periods of sustained political attention, political priority for regulatory interventions did not emerge and was hindered by factors from all four dimensions. Within the public health community, limited cohesion among experts and advocacy groups hampered technical responses and collective action efforts. An initial focus on children (child obesity), framing the determinants of obesity as 'obesogenic environments', and the deployment of 'protecting kids', 'industry demonization' and 'economic costs' frames generated political attention. Institutional norms within government effectively selected out regulatory interventions from consideration. The 'productive power' and activities of the food and advertising industries presented formidable barriers, buttressed by a libertarian/neolibertarian rhetoric emphasizing individual responsibility, a negative view of freedom (as free from 'nanny-state' intervention) and the idea that regulation imposes an unacceptable cost on business. Issue complexity, the absence of a supportive evidence base and a strict 'evidence-based' policy-making approach were used as rationales to defer political priority. Overcoming these challenges may be important to future collective action efforts attempting to generate and sustain political priority for regulatory interventions targeting obesity. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. 10 CFR 609.7 - Programmatic, technical and financial evaluation of Applications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... advancement of that technology into the commercial marketplace; (4) The extent to which the requested amount... market, regulatory, legal, financial, technological, and other risks associated with the project and...

  19. 10 CFR 609.7 - Programmatic, technical and financial evaluation of Applications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... advancement of that technology into the commercial marketplace; (4) The extent to which the requested amount... market, regulatory, legal, financial, technological, and other risks associated with the project and...

  20. 10 CFR 609.7 - Programmatic, technical and financial evaluation of Applications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... advancement of that technology into the commercial marketplace; (4) The extent to which the requested amount... market, regulatory, legal, financial, technological, and other risks associated with the project and...

  1. 10 CFR 609.7 - Programmatic, technical and financial evaluation of Applications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... advancement of that technology into the commercial marketplace; (4) The extent to which the requested amount... market, regulatory, legal, financial, technological, and other risks associated with the project and...

  2. 10 CFR 609.7 - Programmatic, technical and financial evaluation of Applications.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... advancement of that technology into the commercial marketplace; (4) The extent to which the requested amount... market, regulatory, legal, financial, technological, and other risks associated with the project and...

  3. A Figure of Merit: Quantifying the Probability of a Nuclear Reactor Accident.

    PubMed

    Wellock, Thomas R

    In recent decades, probabilistic risk assessment (PRA) has become an essential tool in risk analysis and management in many industries and government agencies. The origins of PRA date to the 1975 publication of the U.S. Nuclear Regulatory Commission's (NRC) Reactor Safety Study led by MIT professor Norman Rasmussen. The "Rasmussen Report" inspired considerable political and scholarly disputes over the motives behind it and the value of its methods and numerical estimates of risk. The Report's controversies have overshadowed the deeper technical origins of risk assessment. Nuclear experts had long sought to express risk in a "figure of merit" to verify the safety of weapons and, later, civilian reactors. By the 1970s, technical advances in PRA gave the methodology the potential to serve political ends, too. The Report, it was hoped, would prove nuclear power's safety to a growing chorus of critics. Subsequent attacks on the Report's methods and numerical estimates damaged the NRC's credibility. PRA's fortunes revived when the 1979 Three Mile Island accident demonstrated PRA's potential for improving the safety of nuclear power and other technical systems. Nevertheless, the Report's controversies endure in mistrust of PRA and its experts.

  4. Building Better Environmental Risk Assessments

    PubMed Central

    Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

    2015-01-01

    Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems – examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines. PMID:26301217

  5. Building Better Environmental Risk Assessments.

    PubMed

    Layton, Raymond; Smith, Joe; Macdonald, Phil; Letchumanan, Ramatha; Keese, Paul; Lema, Martin

    2015-01-01

    Risk assessment is a reasoned, structured approach to address uncertainty based on scientific and technical evidence. It forms the foundation for regulatory decision-making, which is bound by legislative and policy requirements, as well as the need for making timely decisions using available resources. In order to be most useful, environmental risk assessments (ERAs) for genetically modified (GM) crops should provide consistent, reliable, and transparent results across all types of GM crops, traits, and environments. The assessments must also separate essential information from scientific or agronomic data of marginal relevance or value for evaluating risk and complete the assessment in a timely fashion. Challenges in conducting ERAs differ across regulatory systems - examples are presented from Canada, Malaysia, and Argentina. One challenge faced across the globe is the conduct of risk assessments with limited resources. This challenge can be overcome by clarifying risk concepts, placing greater emphasis on data critical to assess environmental risk (for example, phenotypic and plant performance data rather than molecular data), and adapting advances in risk analysis from other relevant disciplines.

  6. Identifying Neurofibromin-Specific Regulatory Nodes for Therapeutic Targeting in NF1

    DTIC Science & Technology

    2016-10-01

    adapter protein SPRED1, to function, and we are utilizing the latest technical innovations including CRISPR technology to find genes that regulate...neurofibromin depends on the adapter protein SPRED1, to function, and we are utilizing the latest technical innovations including CRISPR technology...signaling NF1-Null HEK 293T cells have been generated using CRISPR /Cas9 and single clones have been expanded for biochemical assays (Figure 2). NF1-Null

  7. Overview of cancer vaccines

    PubMed Central

    Kudrin, Alex

    2012-01-01

    Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines. PMID:22894970

  8. Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

    2015-03-01

    This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  9. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

    2015-03-01

    This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  10. Developing a strategy and closure criteria for radioactive and mixed waste sites in the ORNL remedial action program: Regulatory interface

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

    Trabalka, J.R.

    1987-09-01

    Some options for stabilization and treatment of contaminated sites can theoretically provide a once-and-for-all solution (e.g., removal or destruction of contaminants). Most realizable options, however, leave contaminants in place (in situ), potentially isolated by physical or chemical, but more typically, by hydrologic measures. As a result of the dynamic nature of the interactions between contaminants, remedial measures, and the environment, in situ stablization measures are likely to have limited life spans, and maintenance and monitoring of performance become an essential part of the scheme. The length of formal institutional control over the site and related questions about future uses ofmore » the land and waters are of paramount importance. Unique features of the ORNL site and environs appear to be key ingredients in achieving the very long term institutional control necessary for successful financing and implementation of in situ stabilization. Some formal regulatory interface is necessary to ensure that regulatory limitations and new guidance which can affect planning and implementation of the ORNL Remedial Action Program are communicated to ORNL staff and potential technical and financial limitations which can affect schedules or alternatives for achievement of long-term site stabilization and the capability to meet environmental regulations are provided to regulatory bodies as early as possible. Such an interface should allow decisions on closure criteria to be based primarily on technical merit and protection of human health and the environment. A plan for interfacing with federal and state regulatory authorities is described. 93 refs., 1 fig., 4 tabs.« less

  11. 77 FR 23117 - Rigging Equipment for Material Handling Construction Standard; Correction and Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

    ...OSHA is correcting its sling standard for construction titled ``Rigging Equipment for Material Handling'' by removing the rated capacity tables and making minor, nonsubstantive revisions to the regulatory text.

  12. A Telecommunications Industry Primer: A Systems Model.

    ERIC Educational Resources Information Center

    Obermier, Timothy R.; Tuttle, Ronald H.

    2003-01-01

    Describes the Telecommunications Systems Model to help technical educators and students understand the increasingly complex telecommunications infrastructure. Specifically looks at ownership and regulatory status, service providers, transport medium, network protocols, and end-user services. (JOW)

  13. 78 FR 52776 - Documents to Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: August 20, 2013...

  14. 76 FR 66311 - Draft Documents To Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    .../DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , or http...

  15. 78 FR 10181 - Documents To Support Submission of an Electronic Common Technical Document; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... obtain the documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmission...BloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: February 8, 2013...

  16. Statistical science: a grammar for research.

    PubMed

    Cox, David R

    2017-06-01

    I greatly appreciate the invitation to give this lecture with its century long history. The title is a warning that the lecture is rather discursive and not highly focused and technical. The theme is simple. That statistical thinking provides a unifying set of general ideas and specific methods relevant whenever appreciable natural variation is present. To be most fruitful these ideas should merge seamlessly with subject-matter considerations. By contrast, there is sometimes a temptation to regard formal statistical analysis as a ritual to be added after the serious work has been done, a ritual to satisfy convention, referees, and regulatory agencies. I want implicitly to refute that idea.

  17. Task 2 - Limits for High-Frequency Conducted Susceptibility Testing - CS114 (NRC-HQ-60-14-D-0015)

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

    Wood, Richard Thomas; Ewing, Paul D.; Moses, Rebecca J.

    2015-09-01

    A principal focus of Task 2 under this project was for ORNL to evaluate the basis for susceptibility testing against high-frequency conducted interference and to establish recommendations to resolve concerns about the severity of test limits for the conducted susceptibility (CS) test, CS114, from MIL-STD-461. The primary concern about the test limit has been characterized by the EPRI EMI Working Group in the following terms: Demonstrating compliance with the CS114 test limits recommended in TR-102323 has proven to be problematic, even for components that have been tested to commercial standards and demonstrated proper operation in industrial applications [6]. Specifically, EPRImore » notes that the CS114 limits approved in regulatory documents are significantly higher than those invoked by the US military and similar commercial standards in the frequency range below 200 kHz. For this task, ORNL evaluated the original approach to establishing the test limit, EPRI technical findings from a review of the limit, and the regulatory basis through which the currently approved limits were accepted. Based on this analysis, strategies have been developed regarding changes to the CS114 limit that can resolve the technical concerns raised by the industry. Guided by the principles that reasonable assurance of safety must not be compromised but excessive conservatism should be reduced, recommendations on a suitable basis for a revised limit have been developed and can be incorporated into the planned Revision 2 of RG 1.180.« less

  18. Modern problems concerned with ensuring safe operation of heat-generating and mechanical equipment in extending its lifetime

    NASA Astrophysics Data System (ADS)

    Rezinskikh, V. F.; Grin', E. A.

    2013-01-01

    The problem concerned with safe and reliable operation of ageing heat-generating and mechanical equipment of thermal power stations is discussed. It is pointed out that the set of relevant regulatory documents serves as the basis for establishing an efficient equipment diagnostic system. In this connection, updating the existing regulatory documents with imparting the required status to them is one of top-priority tasks. Carrying out goal-oriented scientific research works is a necessary condition for solving this problem as well as other questions considered in the paper that are important for ensuring reliable performance of equipment operating for a long period of time. In recent years, the amount of such works has dropped dramatically, although the need for them is steadily growing. Unbiased assessment of the technical state of equipment that has been in operation for a long period of time is an important aspect in solving the problem of ensuring reliable and safe operation of thermal power stations. Here, along with the quality of diagnostic activities, monitoring of technical state performed on the basis of an analysis of statistical field data and results of operational checks plays an important role. The need to concentrate efforts taken in the mentioned problem areas is pointed out, and it is indicated that successful implementation of the outlined measures requires proper organization and efficient operation of a system for managing safety in the electric power industry.

  19. Technical clarity in inter-agency negotiations: Lessons from four hydropower projects

    USGS Publications Warehouse

    Burkardt, Nina; Lamb, Berton Lee; Taylor, Jonathan G.; Waddle, Terry J.

    1995-01-01

    We investigated the effect of technical clarity on success in multi-party negotiations in the Federal Energy Regulatory Commission (FERC) licensing process. Technical clarity is the shared understanding of dimensions such as the geographic extent of the project, range of flows to be considered, important species and life stages, and variety of water uses considered. The results of four hydropower licensing consultations are reported. Key participants were interviewed to ascertain the level of technical clarity present during the consultations and the degree to which the consultations were successful. Technical clarity appears to be a prerequisite for successful outcomes. Factors that enhance technical clarity include simple project design, new rather than existing projects, precise definition of issues, a sense of urgency to reach agreement, a sense of fairness among participants, and consistency in participation. Negotiators should not neglect the critical pre-negotiation steps of defining technical issues and determining appropriate studies, deciding how to interpret studies, and agreeing on responses to study results.

  20. Telemedicine: legal and licensure issues

    NASA Astrophysics Data System (ADS)

    Wood, Michael B.; Whelan, Leo J.

    1995-10-01

    The National Information Infrastructure program offers a great opportunity for the United States to capitalize on remarkable technological advancements over a broad range of applications benefiting society. One such application, telemedicine, has the potential to offer widespread access to sophisticated medical care, curtailed health care delivery costs, and homogeneous health and health-related educational opportunities. However, there are a variety of barriers to widespread application of telemedicine once the technical infrastructure of the information highway is well established and ubiquitous. These barriers include technical limitations, reimbursement issues, equipment and networking costs, and appropriate scientific studies to document efficacy and cost effectiveness. These issues may prove to be only transient disincentives which can be surmounted. Additional barriers exist, however, that may not be as readily resolved by traditional methods of analysis and more widespread practice applications. These political and regulatory obstacles will require clarification of the issues and solutions based on national consensus. It is the purpose of this discussion to amplify on these particular barriers which include licensure and tort jurisdiction.

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

    Boing, L.E.

    This paper presents an overview of the US experiences in the decommissioning technical area. Sections included are: (1) an overview of the magnitude of the problem, (2) a review of the US decommissioning process, (3) regulation of decommissioning, (4) regulatory and funding requirements for decommissioning, and (5) a general overview of all on-going and completed decommissioning projects to date in the US. The final section presents a review of some issues in the decommissioning area currently being debated in the technical specialists community.

  2. Canton hydroelectric project: feasibility study. Final report, appendices

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

    Not Available

    1979-05-01

    These appendices contain legal, environmental, regulatory, technical and economic information used in evaluating the feasibility of redeveloping the hydroelectric power generating facilities at the Upper and Lower Dams of the Farmington River at Collinsville, CT. (LCL)

  3. Roadside sediment control device evaluation program : technical report.

    DOT National Transportation Integrated Search

    2010-03-01

    One of the problems facing designers/engineers in maintaining regulatory compliance with the : Environmental Protection Agency (EPA) and the Texas Commission on Environmental Quality (TCEQ) is : the lack of quantifiable data to assist in selection ef...

  4. 78 FR 22554 - Document to Support Submission of an Electronic Common Technical Document-Specifications for File...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... documents at either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements...Vaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm . Dated: April 10, 2013. Leslie Kux...

  5. 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

  6. Sterile products: advances and challenges in formulation, manufacturing and regulatory aspects--a regulatory review perspective.

    PubMed

    Hussong, David

    2010-09-01

    For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.

  7. Technical approach to groundwater restoration. Final report

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

    Not Available

    1993-11-01

    The Technical Approach to Groundwater Restoration (TAGR) provides general technical guidance to implement the groundwater restoration phase of the Uranium Mill Tailings Remedial Action (UMTRA) Project. The TAGR includes a brief overview of the surface remediation and groundwater restoration phases of the UMTRA Project and describes the regulatory requirements, the National Environmental Policy Act (NEPA) process, and regulatory compliance. A section on program strategy discusses program optimization, the role of risk assessment, the observational approach, strategies for meeting groundwater cleanup standards, and remedial action decision-making. A section on data requirements for groundwater restoration evaluates the data quality objectives (DQO) andmore » minimum data required to implement the options and comply with the standards. A section on sits implementation explores the development of a conceptual site model, approaches to site characterization, development of remedial action alternatives, selection of the groundwater restoration method, and remedial design and implementation in the context of site-specific documentation in the site observational work plan (SOWP) and the remedial action plan (RAP). Finally, the TAGR elaborates on groundwater monitoring necessary to evaluate compliance with the groundwater cleanup standards and protection of human health and the environment, and outlines licensing procedures.« less

  8. Achieving Effective Risk Management Reduction Throughout Decommissioning at the Columbus Closure Project

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

    Anderson, K.D.

    2006-07-01

    Nuclear facility decontamination, dismantlement, and demolition activities provide a myriad of challenges along the path to reaching a safe, effective, and compliant decommissioning. Among the challenges faced during decommissioning, is the constant management and technical effort to eliminate, mitigate, or minimize the potential of risks of radiation exposures and other hazards to the worker, the surrounding community, and the environment. Management strategies to eliminate, mitigate, or minimize risks include incorporating strong safety and As Low As Reasonably Achievable (ALARA) principles into an integrated work planning process. Technical and operational strategies may include utilizing predictive risk analysis tools to establish contaminationmore » limits for demolition and using remote handling equipment to reduce occupational and radiation exposures to workers. ECC and E2 Closure Services, LLC (Closure Services) have effectively utilized these management and technical tools to eliminate, mitigate, and reduce radiation exposures under contract to the U.S. Department of Energy (DOE) for the decontamination and decommissioning Columbus Closure Project (CCP). In particular, Closure Services achieved significant dose reduction during the dismantling, decontamination, and demolition activities for Building JN-1. Management strategies during the interior dismantlement, decontamination, and demolition of the facility demanded an integrated work planning processes that involved project disciplines. Integrated planning processes identified multiple opportunities to incorporate the use of remote handling equipment during the interior dismantling and demolition activities within areas of high radiation. Technical strategies employed predictive risk analysis tools to set upper bounding contamination limits, allowed for the radiological demolition of the building without exceeding administrative dose limits to the worker, general public, and the environment. Adhering to management and technical strategies during the dismantlement, decontamination, and demolition of Building JN-1 enabled Closure Services to achieve strong ALARA performance, maintain absolute compliance under the regulatory requirements and meeting licensing conditions for decommissioning. (authors)« less

  9. 33 CFR 149.620 - What happens when the Commandant (CG-5) reviews and evaluates the construction drawings and...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Marine Safety Center and other Federal agencies having technical expertise, such as the Pipeline and Hazardous Materials Safety Administration and the Federal Energy Regulatory Commission, in order to ensure...

  10. 33 CFR 149.620 - What happens when the Commandant (CG-5) reviews and evaluates the construction drawings and...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Marine Safety Center and other Federal agencies having technical expertise, such as the Pipeline and Hazardous Materials Safety Administration and the Federal Energy Regulatory Commission, in order to ensure...

  11. 33 CFR 149.620 - What happens when the Commandant (CG-5) reviews and evaluates the construction drawings and...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Marine Safety Center and other Federal agencies having technical expertise, such as the Pipeline and Hazardous Materials Safety Administration and the Federal Energy Regulatory Commission, in order to ensure...

  12. 21 CFR 14.160 - Establishment of standing technical advisory committees for human prescription drugs.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and advertising, and regulatory control of the human prescription drugs falling within the... continued approval for marketing; or (3) A particular drug is properly classified as a new drug, an old drug...

  13. Data on Ethanol in Gasoline

    EPA Science Inventory

    Gasoline composition varies for technical, market and regulatory reasons. Knowledge of any one of these is insufficient for understanding the chemical composition of gasoline at any specific location in the U.S. Historical data collected by the National Institute of Petroleum ...

  14. Historical Gasoline Composition Data 1976 - 2010

    EPA Science Inventory

    Gasoline composition varies for technical, market and regulatory reasons. Knowledge of any one of these is insufficient for understanding the chemical composition of gasoline at any specific location in the U.S. Historical data collected by the National Institute of Petroleum ...

  15. Technical basis for nuclear accident dosimetry at the Oak Ridge National Laboratory

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

    Kerr, G.D.; Mei, G.T.

    The Oak Ridge National Laboratory (ORNL) Environmental, Safety, and Health Emergency Response Organization has the responsibility of providing analyses of personnel exposures to neutrons and gamma rays from a nuclear accident. This report presents the technical and philosophical basis for the dose assessment aspects of the nuclear accident dosimetry (NAD) system at ORNL. The issues addressed are regulatory guidelines, ORNL NAD system components and performance, and the interpretation of dosimetric information that would be gathered following a nuclear accident.

  16. The importance of defining technical issues in interagency environmental negotiations

    USGS Publications Warehouse

    Lamb, B.L.; Burkardt, N.; Taylor, J.G.

    2001-01-01

    The role of technical clarity in successful multiparty negotiations was studied. Investigations involved in-depth interviews with the principal participants in six consultations conducted under the U.S. Federal Energy Regulatory Commission’s hydroelectric power project licensing procedures. Technical clarity was especially important in these cases because they concerned science-based questions. The principal issues in the six cases were fish passage, instream flow for fish habitat, and entrainment of fish in hydropower turbines. It was concluded that technical clarity was one of the most critical elements in resolving these conflicts. In the least successful negotiations, parties failed to address the basic values of the dispute before plunging into technical studies. The results of those studies usually highlighted the potential for negative outcomes and increased polarization between the participants. In the most successful negotiations, the various parties shared an understanding of each of their basic values. These shared understandings led to technical studies that cast the negotiation in a positive light and illuminated possible solutions.

  17. The problem of epistemic jurisdiction in global governance: The case of sustainability standards for biofuels.

    PubMed

    Winickoff, David E; Mondou, Matthieu

    2017-02-01

    While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies 'epistemic jurisdiction' - the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory - as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union's Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives - including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.

  18. California methanol assessment. Volume 2: Technical report

    NASA Technical Reports Server (NTRS)

    Otoole, R.; Dutzi, E.; Gershman, R.; Heft, R.; Kalema, W.; Maynard, D.

    1983-01-01

    Energy feedstock sources for methanol; methanol and other synfuels; transport, storage, and distribution; air quality impact of methanol use in vehicles, chemical methanol production and use; methanol utilization in vehicles; methanol utilization in stationary applications; and environmental and regulatory constraints are discussed.

  19. 47 CFR 0.61 - Functions of the Bureau.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... those relating to rates, technical standards, customer service, ownership, competition to cable systems... federal-state/local regulatory relationships. This includes: acting, after Commission assumption of... security, emergency management, disaster management, and related issues. [67 FR 13217, Mar. 21, 2002, as...

  20. 7 CFR 614.3 - Decisions subject to informal appeal procedures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) Soil and Water Conservation Program; (iv) Water Bank Program; (v) Watershed Protection and Flood... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE CONSERVATION OPERATIONS NRCS APPEAL PROCEDURES § 614.3... technical determinations made with respect to: (1) Conservation programs and regulatory requirements...

  1. 7 CFR 614.3 - Decisions subject to informal appeal procedures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...) Soil and Water Conservation Program; (iv) Water Bank Program; (v) Watershed Protection and Flood... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE CONSERVATION OPERATIONS NRCS APPEAL PROCEDURES § 614.3... technical determinations made with respect to: (1) Conservation programs and regulatory requirements...

  2. 10 CFR Appendix A to Part 5 - List of Federal Financial Assistance Administered by the Nuclear Regulatory Commission to Which...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... locations. (c) Technical training courses. Agreements for financial assistance to State and local officials, without full-cost recovery to attend training on nuclear material licensing, inspection and emergency...

  3. 10 CFR 2.1011 - Management of electronic information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....1011 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND...-license application phase. The LSN Administrator shall have the responsibility to— (1) Identify technical... Application Presiding Officer relative to the resolution of any disputes regarding LSN availability, including...

  4. 33 CFR 149.620 - What happens when the Commandant (CG-5P) reviews and evaluates the construction drawings and...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Marine Safety Center and other Federal agencies having technical expertise, such as the Pipeline and Hazardous Materials Safety Administration and the Federal Energy Regulatory Commission, in order to ensure...

  5. 33 CFR 149.620 - What happens when the Commandant (CG-5P) reviews and evaluates the construction drawings and...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Marine Safety Center and other Federal agencies having technical expertise, such as the Pipeline and Hazardous Materials Safety Administration and the Federal Energy Regulatory Commission, in order to ensure...

  6. The Telecommunications Environment and Its Implications for System Design.

    ERIC Educational Resources Information Center

    Learn, Larry L.; McGill, Michael J.

    1984-01-01

    Discusses changing telecommunications environment and effect these changes might have on information systems design. Major telecommunications factors and trends reviewed are classified as technical (application of computer technologies to classical telecommunications problems), economic, and regulatory policy related (divestiture of American…

  7. 78 FR 48516 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... Rotations, Halts and Suspensions'' and Rule 1047A, entitled ``Trading Rotations, Halts or Reopenings'' to... trading for technical issues on Phlx. \\3\\ See Rule 1. An ``Option Exchange Official'' is an Exchange staff...

  8. Solar Technical Assistance Team 2012 Webinars | State, Local, and Tribal

    Science.gov Websites

    sessions are available: What a Successful Solar Market Can Do for You Solar Economics for Policymakers Market? Policy Environments That Draw Manufacturers and Create Jobs Regulatory Strategies for Driving the Distributed Solar Market

  9. 78 FR 68485 - Self-Regulatory Organizations; Topaz Exchange, LLC; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... proposed rule change seeks to create less of a disconnect if the ``primary'' market should be experiencing technical difficulties, an emergency, or other situation that may inhibit it to be connected to the...

  10. 47 CFR 0.61 - Functions of the Bureau.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... those relating to rates, technical standards, customer service, ownership, competition to cable systems... federal-state/local regulatory relationships. This includes: acting, after Commission assumption of... security, emergency management, disaster management, and related issues. [67 FR 13217, Mar. 21, 2002, as...

  11. 47 CFR 0.61 - Functions of the Bureau.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... those relating to rates, technical standards, customer service, ownership, competition to cable systems... federal-state/local regulatory relationships. This includes: acting, after Commission assumption of... security, emergency management, disaster management, and related issues. [67 FR 13217, Mar. 21, 2002, as...

  12. 47 CFR 0.61 - Functions of the Bureau.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... those relating to rates, technical standards, customer service, ownership, competition to cable systems... federal-state/local regulatory relationships. This includes: acting, after Commission assumption of... security, emergency management, disaster management, and related issues. [67 FR 13217, Mar. 21, 2002, as...

  13. 47 CFR 0.61 - Functions of the Bureau.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... those relating to rates, technical standards, customer service, ownership, competition to cable systems... federal-state/local regulatory relationships. This includes: acting, after Commission assumption of... security, emergency management, disaster management, and related issues. [67 FR 13217, Mar. 21, 2002, as...

  14. THE ROLE OF IONORGANIC ION IMBALANCE IN AQUATIC TOXICITY TESTING

    EPA Science Inventory

    This paper assessess the issue of ion imbalance, provides summary of applicable data, presents several successful technical tools to address toxicity resulting from salinity and ion imbalances, and discusses regulatory/compliance options to manage discharges with salinity/ion imb...

  15. 10 CFR 61.13 - Technical analyses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Licenses § 61... characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate... inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification...

  16. 10 CFR 61.13 - Technical analyses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Licenses § 61... characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate... inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification...

  17. 10 CFR 61.13 - Technical analyses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Licenses § 61... characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate... inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification...

  18. 10 CFR 61.13 - Technical analyses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Licenses § 61... characteristics and design features in isolating and segregating the wastes. The analyses must clearly demonstrate... inadvertent intrusion must include demonstration that there is reasonable assurance the waste classification...

  19. Emerging Trends in Regulatory Implementation of MNA

    EPA Science Inventory

    There are two EPA documents relevant to MNA of Chlorinated Solvents: the Technical Protocol for Evaluating Natural Attenuation of Chlorinated Solvents in Ground Water. EPA/600/R-98/128 September, 1998, and Use of Monitored Natural Attenuation at Superfund, RCRA Corrective Action...

  20. Regulatory Supervision of Radiological Protection in the Russian Federation as Applied to Facility Decommissioning and Site Remediation

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

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

    2007-07-01

    The Russian Federation is carrying out major work to manage the legacy of exploitation of nuclear power and use of radioactive materials. This paper describes work on-going to provide enhanced regulatory supervision of these activities as regards radiological protection. The scope includes worker and public protection in routine operation; emergency preparedness and response; radioactive waste management, including treatment, interim storage and transport as well as final disposal; and long term site restoration. Examples examined include waste from facilities in NW Russia, including remediation of previous shore technical bases (STBs) for submarines, spent fuel and radioactive waste management from ice-breakers, andmore » decommissioning of Radio-Thermal-Generators (RTGs) used in navigational devices. Consideration is given to the identification of regulatory responsibilities among different regulators; development of necessary regulatory instruments; and development of regulatory procedures for safety case reviews and compliance monitoring and international cooperation between different regulators. (authors)« less

  1. Resolving the problem of compliance with the ever increasing and changing regulations

    NASA Astrophysics Data System (ADS)

    Leigh, Harley

    1992-01-01

    The most common problem identified at several U.S. Department of Energy (DOE) sites is regulatory compliance. Simply, the project viability depends on identifying regulatory requirements at the beginning of a specific project to avoid possible delays and cost overruns. The Radioisotope Power Systems Facility (RPSF) is using the Regulatory Compliance System (RCS) to deal with the problem that well over 1000 regulatory documents had to be reviewed for possible compliance requirements applicable to the facility. This overwhelming number of possible documents is not atypical of all DOE facilities thus far reviewed using the RCS system. The RCS was developed to provide control and tracking of all the regulatory and institutional requirements on a given project. WASTREN, Inc., developed the RCS through various DOE contracts and continues to enhance and update the system for existing and new contracts. The RCS provides the information to allow the technical expert to assimilate and manage accurate resource information, compile the necessary checklists, and document that the project or facility fulfills all of the appropriate regulatory requirements. The RCS provides on-line information, including status throughout the project life, thereby allowing more intelligent and proactive decision making. Also, consistency and traceability are provided for regulatory compliance documentation.

  2. The in-depth safety assessment (ISA) pilot projects in Ukraine.

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

    Kot, C. A.

    1998-02-10

    Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. Themore » DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments.« less

  3. Application of Wavelet Filters in an Evaluation of ...

    EPA Pesticide Factsheets

    Air quality model evaluation can be enhanced with time-scale specific comparisons of outputs and observations. For example, high-frequency (hours to one day) time scale information in observed ozone is not well captured by deterministic models and its incorporation into model performance metrics lead one to devote resources to stochastic variations in model outputs. In this analysis, observations are compared with model outputs at seasonal, weekly, diurnal and intra-day time scales. Filters provide frequency specific information that can be used to compare the strength (amplitude) and timing (phase) of observations and model estimates. The National Exposure Research Laboratory′s (NERL′s) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA′s mission to protect human health and the environment. AMAD′s research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the Nation′s air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollu

  4. Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

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

    Eberle, Annika; Bhatt, Arpit; Zhang, Yimin

    Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

  5. Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States

    DOE PAGES

    Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; ...

    2017-04-26

    Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain majormore » source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called 'major' or 'minor') has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Finally, our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.« less

  6. Potential Air Pollutant Emissions and Permitting Classifications for Two Biorefinery Process Designs in the United States.

    PubMed

    Eberle, Annika; Bhatt, Arpit; Zhang, Yimin; Heath, Garvin

    2017-06-06

    Advanced biofuel production facilities (biorefineries), such as those envisioned by the United States (U.S.) Renewable Fuel Standard and U.S. Department of Energy's research and development programs, often lack historical air pollutant emissions data, which can pose challenges for obtaining air emission permits that are required for construction and operation. To help fill this knowledge gap, we perform a thorough regulatory analysis and use engineering process designs to assess the applicability of federal air regulations and quantify air pollutant emissions for two feasibility-level biorefinery designs. We find that without additional emission-control technologies both biorefineries would likely be required to obtain major source permits under the Clean Air Act's New Source Review program. The permitting classification (so-called "major" or "minor") has implications for the time and effort required for permitting and therefore affects the cost of capital and the fuel selling price. Consequently, we explore additional technically feasible emission-control technologies and process modifications that have the potential to reduce emissions to achieve a minor source permitting classification. Our analysis of air pollutant emissions and controls can assist biorefinery developers with the air permitting process and inform regulatory agencies about potential permitting pathways for novel biorefinery designs.

  7. International development of methods of analysis for the presence of products of modern biotechnology.

    PubMed

    Cantrill, Richard C

    2008-01-01

    Methods of analysis for products of modern biotechnology are required for national and international trade in seeds, grain and food in order to meet the labeling or import/export requirements of different nations and trading blocks. Although many methods were developed by the originators of transgenic events, governments, universities, and testing laboratories, trade is less complicated if there exists a set of international consensus-derived analytical standards. In any analytical situation, multiple methods may exist for testing for the same analyte. These methods may be supported by regional preferences and regulatory requirements. However, tests need to be sensitive enough to determine low levels of these traits in commodity grain for regulatory purposes and also to indicate purity of seeds containing these traits. The International Organization for Standardization (ISO) and its European counterpart have worked to produce a suite of standards through open, balanced and consensus-driven processes. Presently, these standards are approaching the time for their first review. In fact, ISO 21572, the "protein standard" has already been circulated for systematic review. In order to expedite the review and revision of the nucleic acid standards an ISO Technical Specification (ISO/TS 21098) was drafted to set the criteria for the inclusion of precision data from collaborative studies into the annexes of these standards.

  8. Radiation Protection, Safety and Security Issues in Ghana.

    PubMed

    Boadu, Mary; Emi-Reynolds, Geoffrey; Amoako, Joseph Kwabena; Akrobortu, Emmanuel; Hasford, Francis

    2016-11-01

    Although the use of radioisotopes in Ghana began in 1952, the Radiation Protection Board of Ghana was established in 1993 and served as the national competent authority for authorization and inspection of practices and activities involving radiation sources until 2015. The law has been superseded by an Act of Parliament, Act 895 of 2015, mandating the Nuclear Regulatory Authority of Ghana to take charge of the regulation of radiation sources and their applications. The Radiation Protection Institute in Ghana provided technical support to the regulatory authority. Regulatory and service activities that were undertaken by the Institute include issuance of permits for handling of a radiation sources, authorization and inspection of radiation sources, radiation safety assessment, safety assessment of cellular signal towers, and calibration of radiation-emitting equipment. Practices and activities involving application of radiation are brought under regulatory control in the country through supervision by the national competent authority.

  9. 5 CFR 340.203 - Technical assistance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... expanding career part-time employment opportunities. This assistance shall include but not be limited to: (1) Help in developing part-time career employment programs; (2) Information on public and private sector...-TIME CAREER EMPLOYMENT (PART-TIME, SEASONAL, ON-CALL, AND INTERMITTENT) Regulatory Requirements-Part...

  10. LAND DISPOSAL RESEARCH NEEDS - A FORWARD ORIENTED REVIEW

    EPA Science Inventory

    The U.S. Environmental Protection Agency (EPA) has been a leader in evaluating and developing land disposal methods that will protect human Health and the environment and in providing technical guidance to regulatory agency personnel, practicing engineers, and the public on th...

  11. 7 CFR 614.3 - Decisions subject to informal appeal procedures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Innovation Grants, (E) Ground and Surface Water Conservation Program, (F) Klamath Basin Program, and (G... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE CONSERVATION OPERATIONS NRCS APPEAL PROCEDURES § 614.3... technical determinations made with respect to: (1) Conservation programs and regulatory requirements...

  12. 7 CFR 614.3 - Decisions subject to informal appeal procedures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Innovation Grants, (E) Ground and Surface Water Conservation Program, (F) Klamath Basin Program, and (G... CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE CONSERVATION OPERATIONS NRCS APPEAL PROCEDURES § 614.3... technical determinations made with respect to: (1) Conservation programs and regulatory requirements...

  13. 75 FR 48593 - Pipeline Safety: Periodic Updates of Regulatory References to Technical Standards and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-11

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts... AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT... action allows pipeline operators to use current technologies, improved materials, and updated industry...

  14. 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...

  15. 48 CFR 2015.305 - Proposal evaluation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Proposal evaluation. 2015.305 Section 2015.305 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION CONTRACTING... information to members of the Source Evaluation Panel at the same time technical proposals are distributed for...

  16. 78 FR 23684 - Personnel Access Authorization Requirements for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-22

    ... Nuclear Energy Institute (NEI or the petitioner) on January 25, 2013. The petition was docketed by the NRC... affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical... 22, 2013 / Proposed Rules#0;#0; [[Page 23684

  17. 10 CFR 61.12 - Specific technical information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE... of the land disposal facility and the disposal units. For near-surface disposal, the description must...; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site...

  18. 10 CFR 61.59 - Institutional requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.59 Institutional requirements. (a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the...

  19. 10 CFR 61.12 - Specific technical information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE... of the land disposal facility and the disposal units. For near-surface disposal, the description must...; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site...

  20. 10 CFR 61.12 - Specific technical information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE... of the land disposal facility and the disposal units. For near-surface disposal, the description must...; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site...

  1. 10 CFR 61.12 - Specific technical information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE... of the land disposal facility and the disposal units. For near-surface disposal, the description must...; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site...

  2. 10 CFR 61.59 - Institutional requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.59 Institutional requirements. (a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the...

  3. 10 CFR 61.12 - Specific technical information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE... of the land disposal facility and the disposal units. For near-surface disposal, the description must...; structural stability of backfill, wastes, and covers; contact of wastes with standing water; disposal site...

  4. 10 CFR 61.59 - Institutional requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.59 Institutional requirements. (a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the...

  5. 10 CFR 61.59 - Institutional requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.59 Institutional requirements. (a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the...

  6. 10 CFR 61.59 - Institutional requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.59 Institutional requirements. (a) Land ownership. Disposal of radioactive waste received from other persons may be permitted only on land owned in fee by the...

  7. [Is it possible to improve the preventive usefulness of workers' health surveillance in the current regulatory framework?

    PubMed

    Rodríguez Jareño, Mari Cruz; De Montserrat I Nonó, Jaume

    In Spain, the limited preventive usefulness of health surveillance is determined by the indiscriminate use of nonspecific "generic" health examinations aimed at producing a "fitness for work list", presumably allowing companies to comply with health and safety regulations. This study aimed to produce a technical interpretation of the Spanish Prevention of Risks at Work Act and propose a new conceptual framework to favour greater preventive usefulness of health surveillance within the current regulatory framework. Using qualitative techniques of content analysis, the text of the Law was studied, the key concepts that impeded the fulfilment of the preventive objectives of health surveillance were identified, and a technical interpretation adjusted to regulations was made in order to propose a new conceptual framework RESULTS: This conceptual framework would include: clearly differentiating health surveillance from health examinations (one of its instruments) and from fitness for work evaluations (an independent concept in itself); restricting mandatory health surveillance to situations in which it is "imperative" to carry it out because of the existence of a substantial risk to workers or third parties, including potentially vulnerable workers; and communicating the results of health surveillance through preventive recommendations to the company, reserving fitness for duty certificates -always based on clear, pre-established and justified criteria in relation to risk- for mandatory surveillance. The proposed new conceptual framework falls within the scope of the Spanish Prevention of Risks at Work Act, and its implementation could contribute to improving the preventive usefulness of health surveillance without the need to reform the legislation. Copyright belongs to the Societat Catalana de Salut Laboral.

  8. Opportunities and Barriers to Resource Recovery and Recycling from Shredder Residue in the United States

    NASA Astrophysics Data System (ADS)

    Nayak, Naren; Apelian, Diran

    2014-11-01

    Shredder residue is the by-product remaining after ferrous and nonferrous metals have been recovered from the processing of vehicles, white goods, and peddler scrap. Shredder residue consists of glass, plastics, rubber, dirt, and small amounts of metal. It is estimated that 5-7 million tons of this shredder residue are landfilled each year in the United States. Technical advancements, coupled with European Union directives and the economic climate, have transformed the recycling of shredder residue in Europe. In the United States, however, regulatory controls and the cheap cost of landfill have worked against the advancement of recycling and recovery of this resource. The Argonne National Laboratory, which is funded by the U.S. Department of Energy, has investigated the effectiveness of recycling shredder residue into polymers. Other research has examined the use of shredder residue in waste-to-energy applications. To improve our ability to process and recycle shredder residue, an investigation of the regulatory, economic, and technological challenges was undertaken. The objective was to conduct a comprehensive review of work done to date, to document the composition of typical shredder output and to identify potential recoverable items (residual metals, plastics, rubber, foam, etc.). Along with uncovering potential new markets, the research would identify the technical, regulatory, and economic barriers to developing those markets.

  9. Policy Considerations for Commercializing Natural Gas and Biomass CCUS

    NASA Astrophysics Data System (ADS)

    Abrahams, L.; Clavin, C.

    2017-12-01

    Captured CO2 from power generation has been discussed as an opportunity to improve the environmental sustainability of fossil fuel-based electricity generation and likely necessary technological solution necessary for meeting long-term climate change mitigation goals. In our presentation, we review the findings of a study of natural gas CCUS technology research and development and discuss their applications to biomass CCUS technology potential. Based on interviews conducted with key stakeholders in CCUS technology development and operations, this presentation will discuss these technical and economic challenges and potential policy opportunities to support commercial scale CCUS deployment. In current domestic and electricity and oil markets, CCUS faces economic challenges for commercial deployment. In particular, the economic viability of CCUS has been impacted by the sustained low oil prices that have limited the potential for enhanced oil recovery (EOR) to serve as a near-term utilization opportunity for the captured CO2. In addition, large scale commercial adoption of CCUS is constrained by regulatory inconsistencies and uncertainties across the United States, high initial capital costs, achieving familiarity with new technology applications to existing markets, developing a successful performance track record to acquire financing agreements, and competing against well-established incumbent technologies. CCUS also has additional technical hurdles for measurement, verification, and reporting within states that have existing policy and regulatory frameworks for climate change mitigation. In addition to fossil-fuel based CCUS, we will discuss emerging opportunities to utilize CCUS fueled by gasified biomass resulting in carbon negative power generation with expanded economic opportunities associated with the enhanced carbon sequestration. Successful technology development of CCUS technology requires a portfolio of research leading to technical advances, advances in financial instruments to leverage the benefits of multiple commodity markets (e.g. natural gas, oil, biomass), and policy instruments that address regulatory hurdles posed CCUS technology deployment.

  10. Preparing clinical grade Ag-specific T cells for adoptive immunotherapy trials

    PubMed Central

    DiGiusto, DL; Cooper, LJN

    2007-01-01

    The production of clinical-grade T cells for adoptive immunotherapy has evolved from the ex vivo numerical expansion of tumor-infiltrating lymphocytes to sophisticated bioengineering processes often requiring cell selection, genetic modification and other extensive tissue culture manipulations, to produce desired cells with improved therapeutic potential. Advancements in understanding the biology of lymphocyte signaling, activation, homing and sustained in vivo proliferative potential have redefined the strategies used to produce T cells suitable for clinical investigation. When combined with new technical methods in cell processing and culturing, the therapeutic potential of T cells manufactured in academic centers has improved dramatically. Paralleling these technical achievements in cell manufacturing is the development of broadly applied regulatory standards that define the requirements for the clinical implementation of cell products with ever-increasing complexity. In concert with academic facilities operating in compliance with current good manufacturing practice, the prescribing physician can now infuse T cells with a highly selected or endowed phenotype that has been uniformly manufactured according to standard operating procedures and that meets federal guidelines for quality of investigational cell products. In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use. PMID:17943498

  11. 10 CFR 50.34 - Contents of applications; technical information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of ten. The manufacturing license will require the plant design to be updated no later than 5 years..., each applicant for a design certification, design approval, combined license, or manufacturing license... Section 50.34 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION...

  12. 77 FR 38742 - Non-Power Reactor License Renewal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ...-0087] RIN 3150-AI96 Non-Power Reactor License Renewal AGENCY: Nuclear Regulatory Commission. ACTION... reactors. This contemplated rulemaking would also make conforming changes to address technical issues in existing non-power reactor regulations. The NRC is seeking input from the public, licensees, certificate...

  13. EXPANDING THE ROLE OF ENVIRONMENTAL IMMUNOASSAYS: TECHNICAL CAPABILITIES REGULATORY ISSUES AND COMMUNICATION VEHICLES

    EPA Science Inventory

    Large numbers of samples are commonplace in environmental monitoring and human exposure assessment studies. When the goals of the US Environmental Protection Agency (EPA) Office of research and Development (sound methods, integrated with human and ecological health, common sense...

  14. 18 CFR 153.8 - Required exhibits.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Office of Energy Projects, 888 First Street, NE., Washington, DC 20426; (6) Exhibit E-1. If the LNG... Technical Information Service or the Commission's Office of Energy Projects, 888 First Street, NE....8 Section 153.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION...

  15. 18 CFR 153.8 - Required exhibits.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Office of Energy Projects, 888 First Street, NE., Washington, DC 20426; (6) Exhibit E-1. If the LNG... Technical Information Service or the Commission's Office of Energy Projects, 888 First Street, NE....8 Section 153.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION...

  16. 18 CFR 153.8 - Required exhibits.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Office of Energy Projects, 888 First Street, NE., Washington, DC 20426; (6) Exhibit E-1. If the LNG... Technical Information Service or the Commission's Office of Energy Projects, 888 First Street, NE....8 Section 153.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION...

  17. 18 CFR 153.8 - Required exhibits.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Office of Energy Projects, 888 First Street, NE., Washington, DC 20426; (6) Exhibit E-1. If the LNG... Technical Information Service or the Commission's Office of Energy Projects, 888 First Street, NE....8 Section 153.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION...

  18. 18 CFR 153.8 - Required exhibits.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Office of Energy Projects, 888 First Street, NE., Washington, DC 20426; (6) Exhibit E-1. If the LNG... Technical Information Service or the Commission's Office of Energy Projects, 888 First Street, NE....8 Section 153.8 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION...

  19. 78 FR 70481 - Federal Acquisition Regulation; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... ADMINISTRATION 48 CFR Parts 31 and 52 [FAC 2005-71; Item III; Docket No. 2013-0080; Sequence No. 5] Federal.... DATES: Effective: November 25, 2013. FOR FURTHER INFORMATION CONTACT: The Regulatory Secretariat..., 2013. William Clark, Acting Director, Office of Government-Wide Acquisition Policy, Office of...

  20. 77 FR 41402 - Supplemental Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... Agreements and Procedures. Solar Energy Industries Docket Nos. RM12-10-000. Association. California... Conference on issues related to a petition for rulemaking recently submitted by the Solar Energy Industries... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [AD12-17-000, et al.] Supplemental...

  1. The "Regulatory" State and the Use of "Independent" Agencies as Legitimising Mechanisms of Educational Reform

    ERIC Educational Resources Information Center

    Gouvias, Dionyssios

    2007-01-01

    The emergence--at the dawn of the new millennium--of "independent agencies", "national commissions" and "councils" around the world, has been based and justified on grounds of "impartiality", "reliability", "democratic-principles guardianship", or even "technical competence".…

  2. RESTORING WILD SALMON TO THE PACIFIC NORTHWEST: WHAT DOES RISK ASSESSMENT OFFER?

    EPA Science Inventory

    Over the past two decades, risk assessment has become the most popular analytic approach to evaluate ecological policy options. Its principal use has been to evaluate relatively simple technical questions (e.g., regulatory actions associated with specific chemicals or hazardous ...

  3. 49 CFR 190.331 - Petitions for rulemaking.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... government; (3) The regulatory burden on small businesses, small organizations and small governmental... relevant technical, scientific or other data as available to the petitioner, and any specific known cases... substantial, and information and data related to that impact are available to the petitioner, the Associate...

  4. 10 CFR 61.53 - Environmental monitoring.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

  5. 10 CFR 61.55 - Waste classification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Waste classification. 61.55 Section 61.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.55 Waste classification. (a) Classification of waste for near...

  6. 10 CFR 61.56 - Waste characteristics.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Waste characteristics. 61.56 Section 61.56 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.56 Waste characteristics. (a) The following requirements are...

  7. 10 CFR 61.55 - Waste classification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Waste classification. 61.55 Section 61.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.55 Waste classification. (a) Classification of waste for near...

  8. 10 CFR 61.56 - Waste characteristics.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Waste characteristics. 61.56 Section 61.56 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.56 Waste characteristics. (a) The following requirements are...

  9. 10 CFR 61.55 - Waste classification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Waste classification. 61.55 Section 61.55 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.55 Waste classification. (a) Classification of waste for near...

  10. 10 CFR 61.56 - Waste characteristics.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Waste characteristics. 61.56 Section 61.56 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.56 Waste characteristics. (a) The following requirements are...

  11. 10 CFR 61.53 - Environmental monitoring.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

  12. 10 CFR 61.56 - Waste characteristics.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Waste characteristics. 61.56 Section 61.56 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.56 Waste characteristics. (a) The following requirements are...

  13. 10 CFR 61.53 - Environmental monitoring.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

  14. 10 CFR 61.56 - Waste characteristics.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Waste characteristics. 61.56 Section 61.56 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.56 Waste characteristics. (a) The following requirements are...

  15. 10 CFR 61.53 - Environmental monitoring.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

  16. 10 CFR 61.53 - Environmental monitoring.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.53 Environmental monitoring. (a) At the time a... radionuclides would indicate that the performance objectives of subpart C may not be met. (c) During the land...

  17. Technical and Regulatory Considerations in Using Freight Containers as Industrial Packages

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

    Hawk, Mark B; Opperman, Erich; Natali, Ronald

    2008-01-01

    The US Department of Energy (DOE), Office of Environmental Management (EM), is actively pursuing activities to reduce the radiological risk and clean up the environmental legacy of the nation's nuclear weapons programmes. The EM has made significant progress in recent years in the clean-up and closure of sites and is also focusing on longer term activities necessary for the completion of the clean-up programme. The packaging and transportation of contaminated demolition debris and low level waste materials in a safe and cost effective manner are essential in completing this mission. Toward this end, the US Department of Transportation's Final Rulemore » on Hazardous Materials Regulation issued on 26 January 2004, included a new provision authorising the use of freight containers (e.g. 20 and 40 ft ISO containers) as industrial packages type 2 or 3. This paper will discuss the technical and regulatory considerations in using these newly authorised and large packages for the packaging and transportation of low level waste materials.« less

  18. Regulatory Barriers Blocking Standardization of Interoperability

    PubMed Central

    Zhong, Daidi; Kirwan, Michael J

    2013-01-01

    Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD WG) and Continua Health Alliance, are striving for this purpose. However, factors like the medial device regulation, health policy, and market reality have placed non-technical barriers over the adoption of technical standards throughout the industry. These barriers have significantly impaired the motivations of consumer device vendors who desire to enter the personal health market and the overall success of personal health industry ecosystem. In this paper, we present the affect that these barriers have placed on the health ecosystem. This requires immediate action from policy makers and other stakeholders. The current regulatory policy needs to be updated to reflect the reality and demand of consumer health industry. Our hope is that this paper will draw wide consensus amongst its readers, policy makers, and other stakeholders. PMID:25098204

  19. Regulatory barriers blocking standardization of interoperability.

    PubMed

    Zhong, Daidi; Kirwan, Michael J; Duan, Xiaolian

    2013-07-12

    Developing and implementing a set of personal health device interoperability standards is key to cultivating a healthy global industry ecosystem. The standardization organizations, including the Institute of Electrical and Electronics Engineers 11073 Personal Health Device Workgroup (IEEE 11073-PHD WG) and Continua Health Alliance, are striving for this purpose. However, factors like the medial device regulation, health policy, and market reality have placed non-technical barriers over the adoption of technical standards throughout the industry. These barriers have significantly impaired the motivations of consumer device vendors who desire to enter the personal health market and the overall success of personal health industry ecosystem. In this paper, we present the affect that these barriers have placed on the health ecosystem. This requires immediate action from policy makers and other stakeholders. The current regulatory policy needs to be updated to reflect the reality and demand of consumer health industry. Our hope is that this paper will draw wide consensus amongst its readers, policy makers, and other stakeholders.

  20. Office for Analysis and Evaluation of Operational Data 1994-FY 95 annual report. Volume 9, Number 2

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

    NONE

    This annual report of the US Nuclear Regulatory Commission`s Office for Analysis and Evaluation of Operational Data (AEOD) describes activities conducted during CY 1994 and FY 1995. The report is published in three parts. NUREG-1272, Vol. 9, No. 1, covers power reactors and presents an overview of the operating experience of the nuclear power industry from the NRC perspective, including comments about the trends of some key performance measures. The report also includes the principal findings and issues identified in AEOD studies over the past year and summarizes information from such sources as licensee event reports, diagnostic evaluations, and reportsmore » to the NRC`s Operations Center. NUREG-1272, Vol. 9, No. 2, covers nuclear materials and presents a review of the events and concerns associated with the use of licensed material in nonreactor applications, such as personnel overexposures and medical misadministrations. Both reports also contain a discussion of the Incident Investigation Team program and summarize both the Incident Investigation Team and Augmented Inspection Team reports. Each volume contains a list of the AEOD reports issued from 1980 through FY 1995. NUREG-1272, Vol. 9, No. 3, covers technical training and presents the activities of the Technical Training Center in support of the NRC`s mission.« less

  1. Office for Analysis and Evaluation of Operational Data 1996 annual report. Volume 10, Number 1: Reactors

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

    NONE

    1997-12-01

    This annual report of the US Nuclear Regulatory Commission`s Office for Analysis and Evaluation of Operational Data (AEOD) describes activities conducted during 1996. The report is published in three parts. NUREG-1272, Vol. 10, No. 1, covers power reactors and presents an overview of the operating experience of the nuclear power industry from the NRC perspective, including comments about trends of some key performance measures. The report also includes the principal findings and issues identified in AEOD studies over the past year and summarizes information from such sources as licensee event reports and reports to the NRC`s Operations Center. NUREG-1272, Vol.more » 10, No. 2, covers nuclear materials and presents a review of the events and concerns during 1996 associated with the use of licensed material in nonreactor applications, such as personnel overexposures and medical misadministrations. Both reports also contain a discussion of the Incident Investigation Team program and summarize both the Incident Investigation Team and Augmented Inspection Team reports. Each volume contains a list of the AEOD reports issued from CY 1980 through 1996. NUREG-1272, Vol. 10, No. 3, covers technical training and presents the activities of the Technical Training Center in support of the NRC`s mission in 1996.« less

  2. A domain-specific analysis system for examining nuclear reactor simulation data for light-water and sodium-cooled fast reactors

    DOE PAGES

    Billings, Jay Jay; Deyton, Jordan H.; Forest Hull, S.; ...

    2015-07-17

    Building new fission reactors in the United States presents many technical and regulatory challenges. Chief among the technical challenges is the need to share and present results from new high- fidelity, high- performance simulations in an easily consumable way. In light of the modern multi-scale, multi-physics simulations can generate petabytes of data, this will require the development of new techniques and methods to reduce the data to familiar quantities of interest with a more reasonable resolution and size. Furthermore, some of the results from these simulations may be new quantities for which visualization and analysis techniques are not immediately availablemore » in the community and need to be developed. Our paper describes a new system for managing high-performance simulation results in a domain-specific way that naturally exposes quantities of interest for light water and sodium-cooled fast reactors. It enables easy qualitative and quantitative comparisons between simulation results with a graphical user interface and cross-platform, multi-language input- output libraries for use by developers to work with the data. One example comparing results from two different simulation suites for a single assembly in a light-water reactor is presented along with a detailed discussion of the system s requirements and design.« less

  3. 7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  4. 7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  5. The influence of government actions on innovative activities in the development of environmental technologies to control sulfur dioxide emissions from stationary sources

    NASA Astrophysics Data System (ADS)

    Taylor, Margaret R.

    2001-12-01

    A better understanding of the influence of government actions on innovation is needed to inform future policy endeavors in areas ranging from industrial competitiveness to environmentally sustainable growth. Environmental control technology is a rich area for the study of this influence, since government has stronger incentives to promote innovation in these technologies than does the private sector. This dissertation investigated the case of sulfur dioxide (SO2) control technologies for electric power plants. In studying innovation in these technologies, it was very important to understand the details of these technologies as well as their long organizational history. These technologies have been affected by government actions ranging from government-sponsored research and technology transfer mechanisms to national regulatory events. The dissertation integrated insights from several complementary and repeatable innovation evaluation methods; this approach supported a fuller understanding of innovation while it structured the research results for potential future comparative analysis. Innovative activities were investigated through: patent activity analysis; technical content analysis and researcher co-authorship network analysis in a conference held for over twenty years; learning curve analysis for eighty-eight U.S. power plants; and a dozen expert interviews from a variety of innovative actors. Innovative outcomes were investigated through: analysis of observed improvements in newly installed technologies over time; evaluation of historic cost studies on standardized systems; and expert interviews. Several policy-relevant findings resulted from this dissertation. (1) The existence of national government regulation stimulated inventive activity more than government research support alone. (2) The existence and the anticipation of government regulation appeared to spur inventive activity, while regulatory stringency appeared to drive inventive activity and the communication process underlying knowledge transfer and diffusion. (3) The regulatory-forced adoption of SO2 control technologies led to a learning curve effect in which operating experience with the equipment resulted in significant cost improvements. This learning curve effect is comparable with findings in many other industries and is likely to be useful in predictions of the costs of future environmental technologies. (4) Performance improvements and cost reductions occurred in a quantifiable fashion as the technology became more widely adopted.

  6. EPA's control technology approach to assisting states and regions with air toxics problems: Five case studies

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

    Nolen, S.L.; Dimmick, W.F.

    1990-10-01

    The Environmental Protection Agency (EPA) announced in June 1985 a new strategy to reduce public exposure to toxic air pollutants in the ambient air. Over the next 5-8 years, the strategy called for State and Local authorities to take on more of the lead regulatory role, with the Agency providing technical and financial assistance to their efforts. The shift in emphasis and responsibility from the Federal level to State and Local air toxics programs and the need to transfer expertise from the Federal level to the appropriate State or Local level prompted EPA's Office of Research and Development (ORD) andmore » EPA's Office of Air Quality Planning and Standards (OAQPS) to develop and implement an innovative technical assistance program. This program is called the Control Technology Center (CTC). It has since been expanded to include technical assistance in the area of control of air toxics, particulate matter, and volatile organic compounds (VOCs); emission measurements; and other areas where expertise is available to ORD and OAQPS. During the CTC's first year of operation, operating guidelines were developed and three categories of technical assistance were established. These categories are telephone HOTLINE calls, direct engineering assistance, and technical guidance projects. The CTC HOTLINE is a special telephone number which State and Local Agencies can call for easy access to EPA personnel who can provide prompt assistance in a variety of ways including discussions, references to pertinent literature, and referrals to other EPA personnel. In some cases, a HOTLINE call will require more in-depth engineering analysis indicating a need for direct engineering assistance.« less

  7. Gene Regulatory Networks in Cardiac Conduction System Development

    PubMed Central

    Munshi, Nikhil V.

    2014-01-01

    The cardiac conduction system is a specialized tract of myocardial cells responsible for maintaining normal cardiac rhythm. Given its critical role in coordinating cardiac performance, a detailed analysis of the molecular mechanisms underlying conduction system formation should inform our understanding of arrhythmia pathophysiology and affect the development of novel therapeutic strategies. Historically, the ability to distinguish cells of the conduction system from neighboring working myocytes presented a major technical challenge for performing comprehensive mechanistic studies. Early lineage tracing experiments suggested that conduction cells derive from cardiomyocyte precursors, and these claims have been substantiated by using more contemporary approaches. However, regional specialization of conduction cells adds an additional layer of complexity to this system, and it appears that different components of the conduction system utilize unique modes of developmental formation. The identification of numerous transcription factors and their downstream target genes involved in regional differentiation of the conduction system has provided insight into how lineage commitment is achieved. Furthermore, by adopting cutting-edge genetic techniques in combination with sophisticated phenotyping capabilities, investigators have made substantial progress in delineating the regulatory networks that orchestrate conduction system formation and their role in cardiac rhythm and physiology. This review describes the connectivity of these gene regulatory networks in cardiac conduction system development and discusses how they provide a foundation for understanding normal and pathological human cardiac rhythms. PMID:22628576

  8. Proceedings: pellet fuels conference

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

    Not Available

    1995-12-31

    The conference brought together professionals from the process- engineered-fuels (PEF), utility, paper, plastics, and boiler industries. Although the last two decades have produced technical breakthroughs, efforts to advance PEF must now focus on increasing commercial breakthroughs. Successful commercialization will depend on increasing supplier, consumer, and regulator confidence and support by demonstrating the performance and value of PEF products. Speakers provided updates on how PEF technology is evolving with respect to technical, economic, and regulatory challenges. Actions critical toward full commercialization of PEF were then considered. Discussion groups addressed materials sourcing, fuel processing and transportation, combustion, and ash handling.

  9. COL Application Content Guide for HTGRs: Revision to RG 1.206, Part 1 - Status Report

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

    Wayne Moe

    2012-08-01

    A combined license (COL) application is required by the Nuclear Regulatory Commission (NRC) for all proposed nuclear plants. The information requirements for a COL application are set forth in 10 CFR 52.79, “Contents of Applications; Technical Information in Final Safety Analysis Report.” An applicant for a modular high temperature gas-cooled reactor (HTGR) must develop and submit for NRC review and approval a COL application which conforms to these requirements. The technical information necessary to allow NRC staff to evaluate a COL application and resolve all safety issues related to a proposed nuclear plant is detailed and comprehensive. To this, Regulatorymore » Guide (RG) 1.206, “Combined License Applications for Nuclear Power Plants” (LWR Edition), was developed to assist light water reactor (LWR) applicants in incorporating and effectively formatting required information for COL application review (Ref. 1). However, the guidance prescribed in RG 1.206 presumes a LWR design proposal consistent with the systems and functions associated with large LWR power plants currently operating under NRC license.« less

  10. Facing regulatory challenges of on-line hemodiafiltration.

    PubMed

    Kümmerle, Wolfgang

    2011-01-01

    On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. Copyright © 2011 S. Karger AG, Basel.

  11. The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

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

    Wallace, J.D.; Kleinschmidt, R.; Veevers, P.

    1995-12-31

    Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safetymore » of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.« less

  12. 75 FR 33712 - Withdrawal of the Emission-Comparable Fuel Exclusion Under RCRA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-15

    ...) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical... are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide...

  13. Maintaining project consistency with transportation plans throughout the project life cycle with an emphasis on maintaining air quality conformity: technical report.

    DOT National Transportation Integrated Search

    2016-07-01

    Federal and state transportation planning statutory and regulatory laws require transportation projects to be : consistent with transportation plans and improvement programs before a federal action can be taken on a : project requiring one. Significa...

  14. 77 FR 65188 - Western Area Power Administration; Notice of Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF11-4-002] Western Area Power Administration; Notice of Filing Take notice that on September 12, 2012, Western Area Power Administration submitted revisions to its Open Access Transmission Tariff to correct formatting and technical...

  15. Development and Adoption of a Watershed Approach to Compensatory Mitigation: Experiences in Colorado and California

    EPA Science Inventory

    In this article, we examine the adoption of the watershed approach and its technical methods into regulatory programs in Colorado and California. Specific steps and motives for the adoption are explained. Through close collaboration, regulators have systematically been made aware...

  16. 10 CFR 60.133 - Additional design criteria for the underground facility.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Additional design criteria for the underground facility. 60.133 Section 60.133 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria Design Criteria for the Geologic Repository...

  17. 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...

  18. 77 FR 11109 - Reactive Power Resources; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... options for and cost of installing reactive power equipment at the time of interconnection as well as... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD12-10-000] Reactive Power... the need for reactive power capability among newly interconnecting asynchronous generators and raises...

  19. IAPCS: A COMPUTER MODEL THAT EVALUATES POLLUTION CONTROL SYSTEMS FOR UTILITY BOILERS

    EPA Science Inventory

    The IAPCS model, developed by U.S. EPA`s Air and Energy Engineering Research Laboratory and made available to the public through the National Technical Information Service, can be used by utility companies, architectural and engineering companies, and regulatory agencies at all l...

  20. 76 FR 16417 - Product Cancellation Order for Certain Pesticide Registrations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ...) Regulatory Public Docket in Rm. S- 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA... Shot Phenothrin Wasp & Hornet Tetramethrin Spray. 013283-00013 Rainbow Wasp & Ant Bioallethrin Spray... Neopynamim Tetramethrin Technical. 073510-00008 Marketquest One Permethrin Drop Flea & Tick Control-2. 082498...

  1. 75 FR 66752 - Smart Grid Interoperability Standards; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-29

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM11-2-000] Smart Grid... adoption of Smart Grid Interoperability Standards (Standards) in their States. On October 6, 2010, the....m. Eastern time in conjunction with the NARUC/FERC Collaborative on Smart Response (Collaborative...

  2. Metrology Standards for Quantitative Imaging Biomarkers

    PubMed Central

    Obuchowski, Nancy A.; Kessler, Larry G.; Raunig, David L.; Gatsonis, Constantine; Huang, Erich P.; Kondratovich, Marina; McShane, Lisa M.; Reeves, Anthony P.; Barboriak, Daniel P.; Guimaraes, Alexander R.; Wahl, Richard L.

    2015-01-01

    Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed. More consistent and correct use of terminology and study design principles will improve clinical research, advance regulatory science, and foster better care for patients who undergo imaging studies. © RSNA, 2015 PMID:26267831

  3. NASA Hydrogen Peroxide Propellant Hazards Technical Manual

    NASA Technical Reports Server (NTRS)

    Baker, David L.; Greene, Ben; Frazier, Wayne

    2005-01-01

    The Fire, Explosion, Compatibility and Safety Hazards of Hydrogen Peroxide NASA technical manual was developed at the NASA Johnson Space Center White Sands Test Facility. NASA Technical Memorandum TM-2004-213151 covers topics concerning high concentration hydrogen peroxide including fire and explosion hazards, material and fluid reactivity, materials selection information, personnel and environmental hazards, physical and chemical properties, analytical spectroscopy, specifications, analytical methods, and material compatibility data. A summary of hydrogen peroxide-related accidents, incidents, dose calls, mishaps and lessons learned is included. The manual draws from art extensive literature base and includes recent applicable regulatory compliance documentation. The manual may be obtained by United States government agencies from NASA Johnson Space Center and used as a reference source for hazards and safe handling of hydrogen peroxide.

  4. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    PubMed

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  5. Resolving the problem of compliance with the ever increasing and changing regulations

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

    Leigh, H.

    1991-06-01

    The most common problem identified at several US Department of Energy (DOE) sites is regulatory compliance. Simply, the project viability depends on identifying regulatory requirements at the beginning of a specific project to avoid possible delays and cost overruns. The Radioisotope Power Systems Facility (RFSP) is using the Regulatory Compliance System (RCS) to deal with the problem that well over 1000 regulatory documents had to be reviewed for possible compliance requirements applicable to the facility. This overwhelming number of possible documents is not atypical of all DOE facilities thus far reviewed using the RCS system. The RCS was developed tomore » provide a control and tracking of all the regulatory and institutional requirements on a given project. WASTREN, Inc., developed the RCS through various DOE contracts and continues to enhance and update the system for existing and new contracts. The RCS provides the information to allow the technical expert to assimilate and manage accurate resource information, compile the checklists, and document that the project or facility fulfills all of the appropriate regulatory requirements. The RCS provides on-line information, including status throughput the project life, thereby allowing more intelligent and proactive decision making. Also, consistency and traceability are provided for regulatory compliance documentation. 1 ref., 1 fig.« less

  6. Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.

    PubMed

    Allchurch, Martin Harvey; Barbano, Dirceu Brás Aparecido; Pinheiro, Marie-Hélène; Lazdin-Helds, Janis

    2016-05-01

    This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

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

    Napper, P.R.; Carpenter, W.R.; Garner, R.W.

    By DOE-ID Order 5481.1A, a five year currency review is required of the Safety Analysis Reports of all ID or ID contractor operations having hazards of a type and magnitude not routinely encountered and/or accepted by the public. In keeping with this order, a currency review has been performed of the Advanced Test Reactor Critical Facility (ADTRC) Safety Analysis Report (SAR), Issue 003, 1990. The objectives of this currency review were to: evaluate the content, completeness, clarity of presentation and compliance with NRC Regulatory Guides and DOE Orders, etc., and evaluate the technical content of the SAR, particularly the Technicalmore » Specifications, and to evaluate the safety of continued operation of the ATRC. The reviewers concluded that although improvements may be needed in the overall content, clarity, and demonstration of compliance with current orders and regulations, the safety of the ATRC is in no way compromised and no unreviewed safety questions were identified. 6 figs., 3 tabs.« less

  8. Big Data and Dementia: Charting the Route Ahead for Research, Ethics, and Policy

    PubMed Central

    Ienca, Marcello; Vayena, Effy; Blasimme, Alessandro

    2018-01-01

    Emerging trends in pervasive computing and medical informatics are creating the possibility for large-scale collection, sharing, aggregation and analysis of unprecedented volumes of data, a phenomenon commonly known as big data. In this contribution, we review the existing scientific literature on big data approaches to dementia, as well as commercially available mobile-based applications in this domain. Our analysis suggests that big data approaches to dementia research and care hold promise for improving current preventive and predictive models, casting light on the etiology of the disease, enabling earlier diagnosis, optimizing resource allocation, and delivering more tailored treatments to patients with specific disease trajectories. Such promissory outlook, however, has not materialized yet, and raises a number of technical, scientific, ethical, and regulatory challenges. This paper provides an assessment of these challenges and charts the route ahead for research, ethics, and policy. PMID:29468161

  9. Big Data and Dementia: Charting the Route Ahead for Research, Ethics, and Policy.

    PubMed

    Ienca, Marcello; Vayena, Effy; Blasimme, Alessandro

    2018-01-01

    Emerging trends in pervasive computing and medical informatics are creating the possibility for large-scale collection, sharing, aggregation and analysis of unprecedented volumes of data, a phenomenon commonly known as big data. In this contribution, we review the existing scientific literature on big data approaches to dementia, as well as commercially available mobile-based applications in this domain. Our analysis suggests that big data approaches to dementia research and care hold promise for improving current preventive and predictive models, casting light on the etiology of the disease, enabling earlier diagnosis, optimizing resource allocation, and delivering more tailored treatments to patients with specific disease trajectories. Such promissory outlook, however, has not materialized yet, and raises a number of technical, scientific, ethical, and regulatory challenges. This paper provides an assessment of these challenges and charts the route ahead for research, ethics, and policy.

  10. Bimolecular fluorescence complementation (BiFC) analysis as a probe of protein interactions in living cells.

    PubMed

    Kerppola, Tom K

    2008-01-01

    Protein interactions are a fundamental mechanism for the generation of biological regulatory specificity. The study of protein interactions in living cells is of particular significance because the interactions that occur in a particular cell depend on the full complement of proteins present in the cell and the external stimuli that influence the cell. Bimolecular fluorescence complementation (BiFC) analysis enables direct visualization of protein interactions in living cells. The BiFC assay is based on the association between two nonfluorescent fragments of a fluorescent protein when they are brought in proximity to each other by an interaction between proteins fused to the fragments. Numerous protein interactions have been visualized using the BiFC assay in many different cell types and organisms. The BiFC assay is technically straightforward and can be performed using standard molecular biology and cell culture reagents and a regular fluorescence microscope or flow cytometer.

  11. Regulating outdoor advertisement boards; employing spatial decision support system to control urban visual pollution

    NASA Astrophysics Data System (ADS)

    Wakil, K.; Hussnain, MQ; Tahir, A.; Naeem, M. A.

    2016-06-01

    Unmanaged placement, size, location, structure and contents of outdoor advertisement boards have resulted in severe urban visual pollution and deterioration of the socio-physical living environment in urban centres of Pakistan. As per the regulatory instruments, the approval decision for a new advertisement installation is supposed to be based on the locational density of existing boards and their proximity or remoteness to certain land- uses. In cities, where regulatory tools for the control of advertisement boards exist, responsible authorities are handicapped in effective implementation due to the absence of geospatial analysis capacity. This study presents the development of a spatial decision support system (SDSS) for regularization of advertisement boards in terms of their location and placement. The knowledge module of the proposed SDSS is based on provisions and restrictions prescribed in regulatory documents. While the user interface allows visualization and scenario evaluation to understand if the new board will affect existing linear density on a particular road and if it violates any buffer restrictions around a particular land use. Technically the structure of the proposed SDSS is a web-based solution which includes open geospatial tools such as OpenGeo Suite, GeoExt, PostgreSQL, and PHP. It uses three key data sets including road network, locations of existing billboards and building parcels with land use information to perform the analysis. Locational suitability has been calculated using pairwise comparison through analytical hierarchy process (AHP) and weighted linear combination (WLC). Our results indicate that open geospatial tools can be helpful in developing an SDSS which can assist solving space related iterative decision challenges on outdoor advertisements. Employing such a system will result in effective implementation of regulations resulting in visual harmony and aesthetic improvement in urban communities.

  12. Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers.

    PubMed

    White, Lauren; Ortiz, Zulma; Cuervo, Luis G; Reveiz, Ludovic

    2011-11-01

    To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. A response rate of 74.3% (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8% of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific journal compliance with standards from the International Committee of Medical Journal Editors (ICMJE) and/or the World Association of Medical Editors (WAME).

  13. Tank Level Detection Devices for the Carriage of Oil : Oil Pollution Act of 1990, Section 4110

    DOT National Transportation Integrated Search

    1992-12-29

    This study was conducted to assess the technical feasibility of satisfying the requirements of Section 4110 of the Oil Pollution Act of 1990 (OPA 90), which calls for minimum regulatory standards tank level monitoring devices in teh cargo tanks of ta...

  14. 77 FR 58194 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ....S. Generally Accepted Accounting Principles. Canadian clearing members that use Form 1 report the... Organizations; The Options Clearing Corporation; Notice of Filing of Proposed Rule Change Relating to Financial... technical ``housekeeping'' changes to OCC's By-Laws and Rules relating to financial reporting by Canadian...

  15. 75 FR 40819 - Reliability Standards Development and NERC and Regional Entity Enforcement; Notice Soliciting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10-14-000] Reliability Standards Development and NERC and Regional Entity Enforcement; Notice Soliciting Comments July 7, 2010... technical conference to explore issues pertaining to the development of mandatory Reliability Standards for...

  16. PROTECTING DRINKING WATER BY REDUCING UNCERTAINTIES ASSOCIATED WITH GEOLOGIC CARBON SEQUESTRATION IN DEEP SALINE AQUIFERS

    EPA Science Inventory

    Task 1: Monitoring at Natural Gas Storage Sites (Technical Leader: E. Mehnert)
     
    We will continue searching for useful data in the files of natural gas storage companies and the Federal Energy Regulatory Commission. Our ...

  17. 77 FR 50914 - Anchorage; Change to Cottonwood Island Anchorage, Columbia River, Oregon and Washington

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... under Executive Order 13211. 13. Technical Standards The National Technology Transfer and Advancement... of Proposed Rulemaking A. Regulatory History and Information On June 13, 2011, the Coast Guard...'' comprises small businesses, not-for-profit organizations that are independently owned and operated and are...

  18. 78 FR 79020 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability & PRA; Notice of Meeting The ACRS Subcommittee on Reliability & PRA will hold a..., 2013. Cayetano Santos, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards. [FR...

  19. 78 FR 43971 - Amendment of Class E Airspace; Tri-Cities, TN

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ...-Cities Regional Airport, Tri-Cities, TN. Exclusionary language was omitted in the final rule published in... herein to include the corrective language. Since the regulatory text, as currently described, penetrates... FAA has determined that this regulation only involves an established body of technical regulations for...

  20. 76 FR 72197 - Yuba County Water Agency; Notice of Panel Meeting and Technical Conference Details

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2246-058] Yuba County Water... for the Yuba County Water Agency's (YCWA) Yuba River Hydroelectric Project No. 2246. NMFS disputed the... for anadromous fish; (2) hydrology for anadromous fish; (3) water temperatures for anadromous fish...

  1. 75 FR 79048 - Notice of Availability of the Models for Plant-Specific Adoption of Technical Specifications Task...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ... Specifications (STS) to define a new time limit for restoring inoperable RCS leakage detection instrumentation to... operability of the RCS leakage detection instrumentation. The CLIIP model SE will facilitate expedited... Operability Requirements and Actions for RCS Leakage Instrumentation'' AGENCY: Nuclear Regulatory Commission...

  2. TECHNICAL CHALLENGES INVOLVED IN IMPLEMENTATION OF VOC REACTIVITY-BASED CONTROL OF OZONE

    EPA Science Inventory

    The control of VOC emissions based on their individual contribution to ozone formation has been the subject of intensive discussion and research in the past five years, and has gained a large degree of acceptance in the air pollution regulatory community for certain industrial op...

  3. 78 FR 12252 - Energy Efficiency Program for Commercial and Industrial Equipment: Public Meeting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... parties. DOE is planning to conduct in-depth technical analyses in the following areas: (1) Engineering..., analyses, and processes it anticipates using to determine whether to amend energy conservation standards... impacts, and (10) regulatory impacts. DOE will also conduct several other analyses that support those...

  4. APTI Course 427, Combustion Evaluation. Student Manual.

    ERIC Educational Resources Information Center

    Beard, J. Taylor; And Others

    This student manual supplements a course designed to present fundamental and applied aspects of combustion technology which influence air pollutant emissions. Emphasis is placed on process control of combustion rather than on gas cleaning. The course is intended to provide engineers, regulatory and technical personnel, and others with familiarity…

  5. 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...

  6. 78 FR 49996 - Pipeline Safety: Periodic Updates of Regulatory References to Technical Standards and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ..., natural gas and other types of materials transported by pipeline, it is not possible to establish... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts..., Transportation of Natural and Other Gas by Pipeline: Minimum Federal Safety Standards; 49 CFR part 193, Liquefied...

  7. 77 FR 74180 - Coordination Between Natural Gas and Electricity Markets; Notice of Request for Comments and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD12-12-000] Coordination Between Natural Gas and Electricity Markets; Notice of Request for Comments and Technical Conference Take... communications and information sharing: \\1\\ Coordination Between Natural Gas and Electricity Markets, 141 FERC...

  8. Autonomy, Interdependence, and Social Control: NASA and the Space Shuttle "Challenger."

    ERIC Educational Resources Information Center

    Vaughan, Diane

    1990-01-01

    Shows that the organizations responsible for regulating safety at the National Aeronautics and Space Administration (NASA) failed to identify flaws in management procedures and technical design that, if corrected, might have prevented the "Challenger" tragedy. Regulatory effectiveness was inhibited by the autonomy and interdependence of…

  9. 78 FR 44165 - Nuclear Regulatory Commission Enforcement Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... from NRC-licensed activities for less than 1 year and expanding the use of civil penalties in cases... for Docket ID NRC-2013-0159. Address questions about NRC dockets to Carol Gallagher; telephone: 301-287- 3422; email: [email protected] . For technical questions, contact the individual listed in...

  10. (Computational Toxicology) A systematic evaluation of analogs and automated read-across prediction of estrogenicity: A case study using hindered phenols

    EPA Science Inventory

    Read-across is an important data gap filling technique used within category and analog approaches for regulatory hazard identification and risk assessment. Although much technical guidance is available that describes how to develop category/analog approaches, practical principles...

  11. 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...

  12. 10 CFR 60.112 - Overall system performance objective for the geologic repository after permanent closure.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... repository after permanent closure. 60.112 Section 60.112 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria Performance Objectives § 60.112 Overall system performance objective for the geologic repository after permanent closure...

  13. 10 CFR 60.132 - Additional design criteria for surface facilities in the geologic repository operations area.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... geologic repository operations area. 60.132 Section 60.132 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria Design Criteria for the Geologic Repository Operations Area § 60.132 Additional design criteria for surface facilities in...

  14. The changing face of (eco)toxicology in the 21st Century: New solutions to old problems

    EPA Science Inventory

    Regulatory toxicologists involved in chemical safety assessments either for human or ecological health are being tasked with generating technically-robust data for a rapidly increasing number of chemicals and chemical mixtures. In the US alone, for example, the recently reauthor...

  15. Technological Change in Regulated Industries.

    ERIC Educational Resources Information Center

    Capron, William M., Ed.

    The articles in this volume discuss how well industries operating under government regulation respond to technical innovation: do the effects of regulations vary among industries, and if so, does this result from variations in the regulatory approach, the organization of the firms, or the nature of the technology? Industries considered include…

  16. Workshop: Addressing Regulatory Challenges In Vapor Intrusion: A State-of-the Science Update Focusing On Chlorinated VOCs

    EPA Science Inventory

    The U.S. Environmental Protection Agency's (EPA's) Offices of Research and Devevlopment and Solid Waste and Emergency Response continue to collaborate on providing technical assistance and support to EPA regional offices, other federal agencies, state regulators, and other intere...

  17. 75 FR 51864 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... decisions. Data elements with respect to the SHORT subscription service that would be provided through the... information about technical data elements to support transmission and data-integrity processes between the... for making well-informed investment decisions. Broad access to the information collected by the SHORT...

  18. 75 FR 60488 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... decisions. Data elements with respect to the SHORT subscription service that would be provided through the... information about technical data elements to support transmission and data-integrity processes between the... Securities and Exchange Commission (``Commission''), pursuant to Section 19(b)(1) of the Securities [[Page...

  19. Thaw; New Rules to End the Cable TV Freeze.

    ERIC Educational Resources Information Center

    National Cable Television Association, Inc., Washington, DC.

    The report summarizes the Federal Communications Commission's (FCC) rulemaking of February 3, 1972 for cable television (CATV) concerning what channels must be carried in certain categories of broadcast markets, use of non-broadcast channels, technical standards, and federal/state/local regulatory relationships. The report highlights the rule that…

  20. 75 FR 31430 - Frequency Regulation Compensation in the Organized Wholesale Power Markets; Notice Establishing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-03

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10-11-000] Frequency Regulation Compensation in the Organized Wholesale Power Markets; Notice Establishing Date for Comments May 27, 2010. On May 26, 2010, Commission staff convened a technical conference regarding frequency...

  1. Proceedings of GLOBAL 2013: International Nuclear Fuel Cycle Conference - Nuclear Energy at a Crossroads

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

    NONE

    2013-07-01

    The Global conference is a forum for the discussion of the scientific, technical, social and regulatory aspects of the nuclear fuel cycle. Relevant topics include global utilization of nuclear energy, current fuel cycle technologies, advanced reactors, advanced fuel cycles, nuclear nonproliferation and public acceptance.

  2. The World on a Wire.

    ERIC Educational Resources Information Center

    Cliburn, Jill K.

    1997-01-01

    Northwest Iowa Power Co-op, Northwest Iowa Telephone, and MCI formed Pioneer Holdings to bring the latest telecommunications services to residents, schools, and businesses in rural Iowa. A half-dozen towns and co-ops have joined Pioneer, which gives customers access to all telecom services offered by MCI, as well as technical, regulatory, and…

  3. Telecommunications Policy Research Conference 1987. Program [and] Keynote Address by Morris Tanenbaum.

    ERIC Educational Resources Information Center

    Telecommunications Policy Research Conference, Inc., Washington, DC.

    Panelists, discussants, and speakers at the 20 sessions of this three-day conference on telecommunications policy research are listed under the appropriate sessions in this conference program, as well luncheon and dinner speakers. Topics addressed by the various sessions include: federal regulatory policies and technical change in…

  4. 76 FR 65995 - Airworthiness Directives; EADS CASA (Type Certificate Previously Held by Construcciones...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed... Customer Services (ICS), Technical Services, Avenida de Arag[oacute]n 404, 28022 Madrid, Spain; telephone... not have a significant economic impact, positive or negative, on a substantial number of small...

  5. 77 FR 64053 - Airworthiness Directives; EADS CASA (Type Certificate Previously Held by Construcciones...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-18

    ... regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments... Customer Services (ICS), Technical Services, Avenida de Arag[oacute]n 404, 28022 Madrid, Spain; telephone... not have a significant economic impact, positive or negative, on a substantial number of small...

  6. 10 CFR 61.50 - Disposal site suitability requirements for land disposal.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Disposal site suitability requirements for land disposal. 61.50 Section 61.50 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.50 Disposal site...

  7. 10 CFR 61.51 - Disposal site design for land disposal.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Disposal site design for land disposal. 61.51 Section 61.51 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.51 Disposal site design for land...

  8. 10 CFR 61.50 - Disposal site suitability requirements for land disposal.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Disposal site suitability requirements for land disposal. 61.50 Section 61.50 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.50 Disposal site...

  9. 10 CFR 61.51 - Disposal site design for land disposal.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Disposal site design for land disposal. 61.51 Section 61.51 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.51 Disposal site design for land...

  10. 10 CFR 61.51 - Disposal site design for land disposal.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Disposal site design for land disposal. 61.51 Section 61.51 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.51 Disposal site design for land...

  11. 10 CFR 61.51 - Disposal site design for land disposal.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Disposal site design for land disposal. 61.51 Section 61.51 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.51 Disposal site design for land...

  12. 10 CFR 61.50 - Disposal site suitability requirements for land disposal.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Disposal site suitability requirements for land disposal. 61.50 Section 61.50 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.50 Disposal site...

  13. 10 CFR 61.50 - Disposal site suitability requirements for land disposal.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Disposal site suitability requirements for land disposal. 61.50 Section 61.50 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.50 Disposal site...

  14. 10 CFR 61.50 - Disposal site suitability requirements for land disposal.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Disposal site suitability requirements for land disposal. 61.50 Section 61.50 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.50 Disposal site...

  15. 10 CFR 61.51 - Disposal site design for land disposal.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Disposal site design for land disposal. 61.51 Section 61.51 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.51 Disposal site design for land...

  16. Analysis of polychlorinated n-alkanes in environmental samples.

    PubMed

    Santos, F J; Parera, J; Galceran, M T

    2006-10-01

    Polychlorinated n-alkanes (PCAs), also known as chlorinated paraffins (CPs), are highly complex technical mixtures that contain a huge number of structural isomers, theoretically more than 10,000 diastereomers and enantiomers. As a consequence of their persistence, tendency to bioaccumulation, and widespread and unrestricted use, PCAs have been found in aquatic and terrestrial food webs, even in rural and remote areas. Recently, these compounds have been included in regulatory programs of several international organizations, including the US Environmental Protection Agency and the European Union. Consequently, there is a growing demand for reliable methods with which to analyze PCAs in environmental samples. Here, we review current trends and recent developments in the analysis of PCAs in environmental samples such as air, water, sediment, and biota. Practical aspects of sample preparation, chromatographic separation, and detection are covered, with special emphasis placed on analysis of PCAs using gas chromatography-mass spectrometry. The advantages and limitations of these techniques as well as recent improvements in quantification procedures are discussed.

  17. Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

    DOE PAGES

    Radulescu, Georgeta; Gauld, Ian C.; Ilas, Germina; ...

    2014-11-01

    This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application ofmore » the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.« less

  18. Genetic toxicology at the crossroads-from qualitative hazard evaluation to quantitative risk assessment.

    PubMed

    White, Paul A; Johnson, George E

    2016-05-01

    Applied genetic toxicology is undergoing a transition from qualitative hazard identification to quantitative dose-response analysis and risk assessment. To facilitate this change, the Health and Environmental Sciences Institute (HESI) Genetic Toxicology Technical Committee (GTTC) sponsored a workshop held in Lancaster, UK on July 10-11, 2014. The event included invited speakers from several institutions and the contents was divided into three themes-1: Point-of-departure Metrics for Quantitative Dose-Response Analysis in Genetic Toxicology; 2: Measurement and Estimation of Exposures for Better Extrapolation to Humans and 3: The Use of Quantitative Approaches in Genetic Toxicology for human health risk assessment (HHRA). A host of pertinent issues were discussed relating to the use of in vitro and in vivo dose-response data, the development of methods for in vitro to in vivo extrapolation and approaches to use in vivo dose-response data to determine human exposure limits for regulatory evaluations and decision-making. This Special Issue, which was inspired by the workshop, contains a series of papers that collectively address topics related to the aforementioned themes. The Issue includes contributions that collectively evaluate, describe and discuss in silico, in vitro, in vivo and statistical approaches that are facilitating the shift from qualitative hazard evaluation to quantitative risk assessment. The use and application of the benchmark dose approach was a central theme in many of the workshop presentations and discussions, and the Special Issue includes several contributions that outline novel applications for the analysis and interpretation of genetic toxicity data. Although the contents of the Special Issue constitutes an important step towards the adoption of quantitative methods for regulatory assessment of genetic toxicity, formal acceptance of quantitative methods for HHRA and regulatory decision-making will require consensus regarding the relationships between genetic damage and disease, and the concomitant ability to use genetic toxicity results per se. © Her Majesty the Queen in Right of Canada 2016. Reproduced with the permission of the Minister of Health.

  19. An evaluation of fish early life stage tests for predicting reproductive and longer-term toxicity from plant protection product active substances.

    PubMed

    Wheeler, James R; Maynard, Samuel K; Crane, Mark

    2014-08-01

    The chronic toxicity of chemicals to fish is routinely assessed by using fish early life stage (ELS) test results. Fish full life cycle (FLC) tests are generally required only when toxicity, bioaccumulation, and persistence triggers are met or when there is a suspicion of potential endocrine-disrupting properties. This regulatory approach is based on a relationship between the results of fish ELS and FLC studies first established more than 35 yrs ago. Recently, this relationship has been challenged by some regulatory authorities, and it has been recommended that more substances should undergo FLC testing. In addition, a project proposal has been submitted to the Organisation for Economic Cooperation and Development (OECD) to develop a fish partial life cycle (PLC) test including a reproductive assessment. Both FLC and PLC tests are animal- and resource-intensive and technically challenging and should therefore be undertaken only if there is clear evidence that they are necessary for coming to a regulatory decision. The present study reports on an analysis of a database of paired fish ELS and FLC endpoints for plant protection product active substances from European Union draft assessment reports and the US Environmental Protection Agency Office of Pesticide Programs Pesticide Ecotoxicity Database. Analysis of this database shows a clear relationship between ELS and FLC responses, with similar median sensitivity across substances when no-observed-effect concentrations (NOECs) are compared. There was also no indication that classification of a substance as a mammalian reproductive toxicant leads to more sensitive effects in fish FLC tests than in ELS tests. Indeed, the response of the ELS tests was generally more sensitive than the most sensitive reproduction NOEC from a FLC test. This analysis indicates that current testing strategies and guidelines are fit for purpose and that there is no need for fish full or partial life cycle tests for most plant protection product active substances. © 2014 SETAC.

  20. Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA

    PubMed Central

    Abels, Esther; Pantanowitz, Liron

    2017-01-01

    The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo. This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use. PMID:28584684

  1. Current State of the Regulatory Trajectory for Whole Slide Imaging Devices in the USA.

    PubMed

    Abels, Esther; Pantanowitz, Liron

    2017-01-01

    The regulatory field for digital pathology (DP) has advanced significantly. A major milestone was accomplished when the FDA allowed the first vendor to market their device for primary diagnostic use in the USA and published in the classification order that this device, and substantially equivalent devices of this generic type, should be classified into class II instead of class III as previously proposed. The Digital Pathology Association (DPA) regulatory task force had a major role in the accomplishment of getting the application request for Whole Slide Imaging (WSI) Systems recommended for a de novo . This article reviews the past and emerging regulatory environment of WSI for clinical use in the USA. A WSI system with integrated subsystems is defined in the context of medical device regulations. The FDA technical performance assessment guideline is also discussed as well as parameters involved in analytical testing and clinical studies to demonstrate that WSI devices are safe and effective for clinical use.

  2. Electricity sector liberalization in the European Union: The political economy of regulatory reform

    NASA Astrophysics Data System (ADS)

    Infante Durana, Maria Dolores

    This dissertation looks into the reasons that pushed European countries to liberalize their electricity industries. The analysis of the political process leading to that decision in the areas pioneers of regulatory reform in this sector (United Kingdom, Sweden and the European Commission) shows that the liberalization of the European power sectors does not conform to the traditional theoretical explanations for regulatory reform that put interests and industry-specific considerations at the forefront of the explanation. The central argument of this dissertation is that, contrary to what most of the literature assumes and the theories predict, the primary impetus for the reforms in European electricity sectors did not come from industrial or economic worries, but rather from a neo-liberal turn to the ideas shared by European intellectual and political elites. The reform followed a political spill-over process by which the liberalization policy was emulated and introduced as a direct result of the international and sectoral diffusion of the new "efficiency regime" and the belief in the economic superiority of free markets over any form of government intervention. As an idea-driven policy, liberalization was not always coherent with the stated goals and, with means and ends that were not always consistent with each other, the reforms were often hampered and their results ambiguous. Liberalization transformed energy policy priorities in member states by adding the promotion and development of market-based mechanisms to the previous two of ensuring that security of supply, was adequate and of achieving ambitious environmental targets. By adding economic efficiency (and its political corollary, low prices) to its policy goals, governments effectively rendered the realization of the other two goals all the more difficult. As a result, liberalization did not entail the expected government disengagement from the affairs of the industry. On the contrary, it became increasingly clear that governments would keep intervening in the market-place as competition forces alone could not bring the expected economic, technical and political benefits in a vital industry which continued to have particular technical and economic attributes as well as a strong capacity to influence other policy areas.

  3. Recent advances in understanding Streptomyces

    PubMed Central

    Chater, Keith F.

    2016-01-01

    About 2,500 papers dated 2014–2016 were recovered by searching the PubMed database for Streptomyces, which are the richest known source of antibiotics. This review integrates around 100 of these papers in sections dealing with evolution, ecology, pathogenicity, growth and development, stress responses and secondary metabolism, gene expression, and technical advances. Genomic approaches have greatly accelerated progress. For example, it has been definitively shown that interspecies recombination of conserved genes has occurred during evolution, in addition to exchanges of some of the tens of thousands of non-conserved accessory genes. The closeness of the association of Streptomyces with plants, fungi, and insects has become clear and is reflected in the importance of regulators of cellulose and chitin utilisation in overall Streptomyces biology. Interestingly, endogenous cellulose-like glycans are also proving important in hyphal growth and in the clumping that affects industrial fermentations. Nucleotide secondary messengers, including cyclic di-GMP, have been shown to provide key input into developmental processes such as germination and reproductive growth, while late morphological changes during sporulation involve control by phosphorylation. The discovery that nitric oxide is produced endogenously puts a new face on speculative models in which regulatory Wbl proteins (peculiar to actinobacteria) respond to nitric oxide produced in stressful physiological transitions. Some dramatic insights have come from a new model system for Streptomyces developmental biology, Streptomyces venezuelae, including molecular evidence of very close interplay in each of two pairs of regulatory proteins. An extra dimension has been added to the many complexities of the regulation of secondary metabolism by findings of regulatory crosstalk within and between pathways, and even between species, mediated by end products. Among many outcomes from the application of chromosome immunoprecipitation sequencing (ChIP-seq) analysis and other methods based on “next-generation sequencing” has been the finding that 21% of Streptomyces mRNA species lack leader sequences and conventional ribosome binding sites. Further technical advances now emerging should lead to continued acceleration of knowledge, and more effective exploitation, of these astonishing and critically important organisms. PMID:27990276

  4. Handbook of evaluation of utility DSM programs

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

    Hirst, E.; Reed, J.; Bronfman, B.

    Program evaluation has become a central issue in the world of utility integrated resource planning. The DSM programs that utilities were operating to meet federal requirements or to improve customer relations are now becoming big business. DSM is being considered an important resource in a utility`s portfolio of options. In the last five years, the amount of money that utilities have invested in DSM has grown exponentially in most regulatory jurisdictions. Market analysts are now talking about DSM being a $30 billion industry by the end of the decade. If the large volume of DSM-program investments was not enough tomore » highlight the importance of evaluation, then the introduction of regulatory incentives has really focused the spotlight. This handbook was developed through a process that involved many of those people who represent the diverse constituencies of DSM-program evaluation. We have come to recognize the many technical disciplines that must be employed to evaluate DSM programs. An analysis might start out based on the principles of utility load research to find out what happened, but a combination of engineering and statistical methods must be used to ``triangulate`` an estimate of what would have happened without the program. The difference, of course, is that elusive but prized result of evaluation: what happened as the direct result of the DSM program. Technical performance of DSM measures is not the sole determinant of the answer, either. We also recognize the importance of such behavioral attributes of DSM as persistence and free ridership. Finally, DSM evaluation is meaningless without attention to planning an approach, communicating results to relevant decision-makers, and focusing as much on the process as the impacts of the program. These topics are all covered in this handbook.« less

  5. Handbook of evaluation of utility DSM programs. [Demand-Side Management (DSM)

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

    Hirst, E.; Reed, J.; Bronfman, B.

    Program evaluation has become a central issue in the world of utility integrated resource planning. The DSM programs that utilities were operating to meet federal requirements or to improve customer relations are now becoming big business. DSM is being considered an important resource in a utility's portfolio of options. In the last five years, the amount of money that utilities have invested in DSM has grown exponentially in most regulatory jurisdictions. Market analysts are now talking about DSM being a $30 billion industry by the end of the decade. If the large volume of DSM-program investments was not enough tomore » highlight the importance of evaluation, then the introduction of regulatory incentives has really focused the spotlight. This handbook was developed through a process that involved many of those people who represent the diverse constituencies of DSM-program evaluation. We have come to recognize the many technical disciplines that must be employed to evaluate DSM programs. An analysis might start out based on the principles of utility load research to find out what happened, but a combination of engineering and statistical methods must be used to triangulate'' an estimate of what would have happened without the program. The difference, of course, is that elusive but prized result of evaluation: what happened as the direct result of the DSM program. Technical performance of DSM measures is not the sole determinant of the answer, either. We also recognize the importance of such behavioral attributes of DSM as persistence and free ridership. Finally, DSM evaluation is meaningless without attention to planning an approach, communicating results to relevant decision-makers, and focusing as much on the process as the impacts of the program. These topics are all covered in this handbook.« less

  6. Are Interactions between cis-Regulatory Variants Evidence for Biological Epistasis or Statistical Artifacts?

    PubMed

    Fish, Alexandra E; Capra, John A; Bush, William S

    2016-10-06

    The importance of epistasis-or statistical interactions between genetic variants-to the development of complex disease in humans has been controversial. Genome-wide association studies of statistical interactions influencing human traits have recently become computationally feasible and have identified many putative interactions. However, statistical models used to detect interactions can be confounded, which makes it difficult to be certain that observed statistical interactions are evidence for true molecular epistasis. In this study, we investigate whether there is evidence for epistatic interactions between genetic variants within the cis-regulatory region that influence gene expression after accounting for technical, statistical, and biological confounding factors. We identified 1,119 (FDR = 5%) interactions that appear to regulate gene expression in human lymphoblastoid cell lines, a tightly controlled, largely genetically determined phenotype. Many of these interactions replicated in an independent dataset (90 of 803 tested, Bonferroni threshold). We then performed an exhaustive analysis of both known and novel confounders, including ceiling/floor effects, missing genotype combinations, haplotype effects, single variants tagged through linkage disequilibrium, and population stratification. Every interaction could be explained by at least one of these confounders, and replication in independent datasets did not protect against some confounders. Assuming that the confounding factors provide a more parsimonious explanation for each interaction, we find it unlikely that cis-regulatory interactions contribute strongly to human gene expression, which calls into question the relevance of cis-regulatory interactions for other human phenotypes. We additionally propose several best practices for epistasis testing to protect future studies from confounding. Copyright © 2016 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

  7. What impact will EPPO's new resistance risk assessment guideline have on selection pressure in the European Union?

    PubMed

    Leonard, Paul K; Dutton, Robert

    2002-09-01

    This paper examines practical and regulatory implications, including both costs and benefits, resulting from implementation of EPPO's new resistance risk analysis guideline. Crop-protection companies operating in Europe are preparing risk analyses and management strategies, and are monitoring for resistance. However, this is a complex and expensive process involving technical, commercial and regulatory functions. The actual cost of filling these data gaps is consequently greater than many would have anticipated. The agrochemical industry has a vested interest in managing resistance and is committed to maintaining the essential contribution of crop-protection products to sustainable agriculture. However, with increasing regulatory costs, it is important that regulatory authorities concentrate requirements for resistance risk analyses, management strategies and monitoring where these are most needed. Should these requirements be applied indiscriminately, crop-protection companies will have to consider whether or not it is economically justifiable to make these investments, or whether to remove less profitable uses from product labels. In such situations, minor crops stand to be disproportionately effected. One year after publication, it is too early to measure the guideline's impact on selection pressure. It is already clear that the guideline represents an unprecedented step forward in the regulation and harmonisation of resistance management. There are, however, valid arguments against regulation of resistance management. One of the most important criticisms that is levelled against the latter approach is that, with the best motivation and with appropriate use restrictions on labels, these actions alone do not solve the problem. It is critical that all stakeholders in the crop protection process are made aware of the importance of resistance management and of complying with prescribed strategies.

  8. Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

    PubMed

    Dellepiane, Nora; Pagliusi, Sonia

    2018-06-07

    The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2-5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures. Copyright © 2018.

  9. Are good ideas enough? The impact of socio-economic and regulatory factors on GMO commercialisation.

    PubMed

    Vàzquez-Salat, Núria

    2013-01-01

    In recent years scientific literature has seen an increase in publications describing new transgenic applications. Although technically-sound, these promising developments might not necessarily translate into products available to the consumer. This article highlights the impact of external factors on the commercial viability of Genetically Modified (GM) animals in the pharmaceutical and food sectors. Through the division of the production chain into three Policy Domains -Science, Market and Public- I present an overview of the broad range of regulatory and socio-economic components that impacts on the path towards commercialisation of GM animals. To further illustrate the unique combination of forces that influence each application, I provide an in-depth analysis of two real cases: GM rabbits producing human polyclonal antibodies (pharmaceutical case study) and GM cows producing recombinant human lactoferrin (food case study). The inability to generalise over the commercial success of a given transgenic application should encourage researchers to perform these type of exercises early in the R & D process. Furthermore, through the analysis of these case studies we can observe a change in the biopolitics of Genetically Modified Organisms (GMOs). Contrary to the GM plant biopolitical landscape, developing states such as China and Argentina are placing themselves as global leaders in GM animals. The pro-GM attitude of these states is likely to cause a shift in the political evolution of global GMO governance.

  10. Analysis of a risk prevention document using dependability techniques: a first step towards an effectiveness model

    NASA Astrophysics Data System (ADS)

    Ferrer, Laetitia; Curt, Corinne; Tacnet, Jean-Marc

    2018-04-01

    Major hazard prevention is a main challenge given that it is specifically based on information communicated to the public. In France, preventive information is notably provided by way of local regulatory documents. Unfortunately, the law requires only few specifications concerning their content; therefore one can question the impact on the general population relative to the way the document is concretely created. Ergo, the purpose of our work is to propose an analytical methodology to evaluate preventive risk communication document effectiveness. The methodology is based on dependability approaches and is applied in this paper to the Document d'Information Communal sur les Risques Majeurs (DICRIM; in English, Municipal Information Document on Major Risks). DICRIM has to be made by mayors and addressed to the public to provide information on major hazards affecting their municipalities. An analysis of law compliance of the document is carried out thanks to the identification of regulatory detection elements. These are applied to a database of 30 DICRIMs. This analysis leads to a discussion on points such as usefulness of the missing elements. External and internal function analysis permits the identification of the form and content requirements and service and technical functions of the document and its components (here its sections). Their results are used to carry out an FMEA (failure modes and effects analysis), which allows us to define the failure and to identify detection elements. This permits the evaluation of the effectiveness of form and content of each components of the document. The outputs are validated by experts from the different fields investigated. Those results are obtained to build, in future works, a decision support model for the municipality (or specialised consulting firms) in charge of drawing up documents.

  11. NeuroMind: Past, present, and future.

    PubMed

    Kubben, Pieter L

    2017-01-01

    This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon - (app) developer it explains how technical progress has shaped the world's "most rated and highest rated" neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of "computational neurosurgery" is introduced as a vehicle to reach new horizons in neurosurgery.

  12. NeuroMind: Past, present, and future

    PubMed Central

    Kubben, Pieter L.

    2017-01-01

    This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon – (app) developer it explains how technical progress has shaped the world's “most rated and highest rated” neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of “computational neurosurgery” is introduced as a vehicle to reach new horizons in neurosurgery. PMID:28966822

  13. Confronting Regulatory Cost and Quality Expectations. An Exploration of Technical Change in Minimum Efficiency Performance Standards

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

    Taylor, Margaret; Spurlock, C. Anna; Yang, Hung-Chia

    The dual purpose of this project was to contribute to basic knowledge about the interaction between regulation and innovation and to inform the cost and benefit expectations related to technical change which are embedded in the rulemaking process of an important area of national regulation. The area of regulation focused on here is minimum efficiency performance standards (MEPS) for appliances and other energy-using products. Relevant both to U.S. climate policy and energy policy for buildings, MEPS remove certain product models from the market that do not meet specified efficiency thresholds.

  14. Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China

    PubMed Central

    2015-01-01

    Stem cell-based medicinal products (SCMPs) are emerging as novel therapeutic products. The success of its development depends on the existence of an effective quality control system, which is constituted by quality control technologies, standards, reference materials, guidelines, and the associated management system in accordance with regulatory requirements along product lifespan. However, a worldwide, effective quality control system specific for SCMPs is still far from established partially due to the limited understanding of stem cell sciences and lack of quality control technologies for accurately assessing the safety and biological effectiveness of SCMPs before clinical use. Even though, based on the existing regulations and current stem cell sciences and technologies, initial actions toward the goal of establishing such a system have been taken as exemplified by recent development of new “interim guidelines” for governing quality control along development of SCMPs and new development of the associated quality control technologies in China. In this review, we first briefly introduced the major institutions involved in the regulation of cell substrates and therapeutic cell products in China and the existing regulatory documents and technical guidelines used as critical references for developing the new interim guidelines. With focus only on nonhematopoietic stem cells, we then discussed the principal quality attributes of SCMPs as well as our thinking of proper testing approaches to be established with relevant evaluation technologies to ensure all quality requirements of SCMPs along different manufacturing processes and development stages. At the end, some regulatory and technical challenges were also discussed with the conclusion that combined efforts should be taken to promote stem cell regulatory sciences to establish the effective quality control system for SCMPs. PMID:25471126

  15. 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

  16. Proceedings: 1995 SO{sub 2} control symposium. Volume 1, Sessions 1, 2, 3

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

    NONE

    1995-06-01

    Cosponsored by EPRI, DOE, and EPA, this conference provided a forum for the exchange of economic, technical, and regulatory information on sulfur dioxide control technology. From March 28--31, 1995, participants presented 100 technical papers to an audience of 525 people from around the world. Given in thirteen technical sessions, the papers included regulatory and economic issues, wet and dry SO{sub 2} control processes, emerging technologies, and experience with Clean Air Act Amendments (CAAA) Phase I startups. The fifteenth in a series of symposia over the past two decades, the conference included these key points: the domestic flue gas desulfurization (FGD)more » market is likely to be modest over the next ten years, with most activity overseas; FGD awards could reach over $4 billion a year from 1996--2003, with more than half going to Eastern Europe and Asia; worldwide, at the start of 1994, FGD systems were installed on 609 coal-fired power plants; the average capital cost for Phase I retrofits has been $233/kW; and, trends point to simpler designs, such as towers that operate at higher gas velocities with fewer internals. Published proceedings from these regularly scheduled symposia are valuable resources for engineers and utility planners who need up-to-date information to comply with clean air legislation. Selected papers have been processed separately for inclusion in the Energy Science and Technology database.« less

  17. Proceedings: 1995 SO{sub 2} control symposium. Volume 4, Sessions Ba, 8b

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

    NONE

    1995-06-01

    Cosponsored by EPRI, DOE, and EPA, this conference provided a forum for the exchange of economic, technical, and regulatory information on sulfur dioxide control technology. From March 28--31, 1995, participants presented 100 technical papers to an audience of 525 people from around the world. Given in thirteen technical sessions, the papers included regulatory and economic issues, wet and dry SO{sub 2} control processes, emerging technologies, and experience with Clean Air Act Amendments (CAAA) Phase I startups. The fifteenth in a series of symposia over the past two decades, the conference included these key points: the domestic flue gas desulfurization (FGD)more » market is likely to be modest over the next ten years, with most activity overseas; FGD awards could reach over $4 billion a year from 1996--2003, with more than half going to Eastern Europe and Asia; worldwide, at the start of 1994, FGD systems were installed on 609 coal-fired power plants; the average capital cost for Phase I retrofits has been $233/kW; and, trends point to simpler designs, such as towers that operate at higher gas velocities with fewer internals. Published proceedings from these regularly scheduled symposia are valuable resources for engineers and utility planners who need up-to-date information to comply with clean air legislation. Selected papers have been processed separately for inclusion in the Energy Science and Technology database.« less

  18. WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13-14 May 2009.

    PubMed

    Ferguson, Morag; Shin, Jinho; Knezevic, Ivana; Minor, Philip; Barrett, Alan

    2010-12-06

    In May 2009, WHO convened a meeting of Working Group on Technical Specifications for Manufacturing and Evaluating Yellow Fever (YF) Vaccines, Geneva, Switzerland to initiate revision of the WHO Recommendations (formerly, Requirements) for YF vaccine published in WHO Technical Report Series number 872 (1998). The Working Group, consisting of experts from academia, industry, national regulatory authorities and national control laboratories, reviewed the latest issues of safety, efficacy and quality of YF vaccines and agreed that (i) the revision should focus on live attenuated YF vaccine virus 17D lineage; and that (ii) nonclinical and clinical guidelines for new vaccines prepared from 17D lineage be developed. Copyright © 2010. Published by Elsevier Ltd.. All rights reserved.

  19. An analysis of land use planning and equity issues surrounding hazardous liquid and natural gas transmission pipelines in North Carolina

    NASA Astrophysics Data System (ADS)

    Osland, Anna Christine

    Hazardous liquid and natural gas transmission pipelines have received limited attention by planning scholars even though local development decisions can have broad consequences if a rupture occurs. In this dissertation, I evaluated the implications of land-use planning for reducing risk to transmission pipeline hazards in North Carolina via three investigations. First, using a survey of planning directors in jurisdictions with transmission pipeline hazards, I investigated the land use planning tools used to mitigate pipeline hazards and the factors associated with tool adoption. Planning scholars have documented the difficulty of inducing planning in hazardous areas, yet there remain gaps in knowledge about the factors associated with tool adoption. Despite the risks associated with pipeline ruptures, I found most localities use few mitigation tools, and the adoption of regulatory and informational tools appear to be influenced by divergent factors. Whereas risk perception, commitment, capacity, and community context were associated with total tool and information tool use, only risk perception and capacity factors were associated with regulatory tool use. Second, using interviews of emergency managers and planning directors, I examined the role of agency collaboration for building mitigation capacity. Scholars have highlighted the potential of technical collaboration, yet less research has investigated how inter-agency collaboration shapes mitigation capacity. I identify three categories of technical collaboration, discuss how collaborative spillovers can occur from one planning area to another, and challenge the notion that all technical collaborations result in equal mitigation outcomes. Third, I evaluated characteristics of the population near pipelines to address equity concerns. Surprisingly, I did not find broad support for differences in exposure of vulnerable populations. Nonetheless, my analyses uncovered statistically significant clusters of vulnerable groups within the hazard area. Interestingly, development closer to pipelines was newer than areas farther away, illustrating the failure of land-use planning to reduce development encroachment. Collectively, these results highlight the potential of land-use planning to keep people and development from encroaching on pipeline hazards. While this study indicates that planners in many areas address pipeline hazards, it also illustrates how changes to local practices can further reduce risks to human health, homeland security, and the environment.

  20. "Going the Extra Mile in Downscaling: Why Downscaling is not ...

    EPA Pesticide Factsheets

    This presentation provides an example of doing additional work for preprocessing global climate model data for use in regional climate modeling simulations with the Weather Research and Forecasting (WRF) model. In this presentation, results from 15 months of downscaling the Community Earth System Model (CESM) were shown, both using the out-of-the-box downscaling of CESM and also with a modification to setting the inland lake temperatures. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  1. "Updates to Model Algorithms & Inputs for the Biogenic ...

    EPA Pesticide Factsheets

    We have developed new canopy emission algorithms and land use data for BEIS. Simulations with BEIS v3.4 and these updates in CMAQ v5.0.2 are compared these changes to the Model of Emissions of Gases and Aerosols from Nature (MEGAN) and evaluated the simulations against observations. This has resulted in improvements in model evaluations of modeled isoprene, NOx, and O3. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  2. "Total Deposition (TDEP) Maps" | Science Inventory | US EPA

    EPA Pesticide Factsheets

    The presentation provides an update on the use of a hybrid methodology that relies on measured values from national monitoring networks and modeled values from CMAQ to produce of maps of total deposition for use in critical loads and other ecological assessments. Additionally, comparisons of the deposition values from the hybrid approach are compared with deposition estimates from other methodologies. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  3. Methods for Analyzing the Benefits and Costs of Distributed Photovoltaic Generation to the U.S. Electric Utility System

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

    Denholm, P.; Margolis, R.; Palmintier, B.

    This report outlines the methods, data, and tools that could be used at different levels of sophistication and effort to estimate the benefits and costs of DGPV. In so doing, we identify the gaps in current benefit-cost-analysis methods, which we hope will inform the ongoing research agenda in this area. The focus of this report is primarily on benefits and costs from the utility or electricity generation system perspective. It is intended to provide useful background information to utility and regulatory decision makers and their staff, who are often being asked to use or evaluate estimates of the benefits andmore » cost of DGPV in regulatory proceedings. Understanding the technical rigor of the range of methods and how they might need to evolve as DGPV becomes a more significant contributor of energy to the electricity system will help them be better consumers of this type of information. This report is also intended to provide information to utilities, policy makers, PV technology developers, and other stakeholders, which might help them maximize the benefits and minimize the costs of integrating DGPV into a changing electricity system.« less

  4. SmARTest regulation? Comparing the regulatory structures for ART in the UK and Australia.

    PubMed

    Petersen, Kerry; Johnson, Martin H

    2007-08-01

    Assisted reproductive technologies are regulated in both the UK and Australia, thereby curtailing both reproductive and professional autonomy. Different regulatory models have developed in each jurisdiction, despite the similar legal, scientific and cultural histories of the two jurisdictions. In the UK the regulatory structures are under review, largely in the absence of empirical research on the costs and benefits of regulation. The regulatory structures in each jurisdiction are compared and some key differences identified. The UK regulatory structure governing assisted reproductive technologies is currently simpler, more accountable and more transparent than that in Australia. On the other hand, despite administrative and legislative restrictions (particularly in Victoria), the medical scientists and clinicians in Australia generally have more control than their British counterparts over the technical aspects of their work in the provision of IVF and other treatment services, and to a lesser extent in embryo research. Recent proposals appear to move the UK regulatory structure towards a less accountable and less transparent model, but with no evident increase in reproductive or professional autonomy. It is suggested that this change is not in the interests of patients, doctors and the public, and a different model is outlined for devolution of both authority and accountability to the professions.

  5. 76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No: FDA-2011-N-0002] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... pace with technical and scientific evolutions in the fields of regulatory science, on formulating an...

  6. 75 FR 15423 - U.S. Nuclear Regulatory Commission Technical Evaluation Report for the Phase 1 Decommissioning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... DOE to carry out a high-level radioactive waste management demonstration project at the Western New... solidification of high-level radioactive waste for disposal in a Federal repository for permanent disposal. The... and other facilities where the solidified high-level radioactive waste was stored, the facilities used...

  7. 78 FR 4878 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-23

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

  8. 76 FR 189 - Notice of Availability of the Models for Plant-Specific Adoption of Technical Specifications Task...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-03

    ... Specifications (STS) to define a new time limit for restoring inoperable RCS leakage detection instrumentation to... operability of the RCS leakage detection instrumentation. The CLIIP model SE will facilitate expedited... Operability Requirements and Actions for RCS Leakage Instrumentation'' AGENCY: U.S. Nuclear Regulatory...

  9. Data Networking for the European Academic and Research Community: Is It Important?

    ERIC Educational Resources Information Center

    Williams, David O.; Carpenter, Brian E.

    1992-01-01

    Discussion of data networking in Europe provides background on the current situation in the United States and the Pacific region. The situation in Europe is then addressed, including the present status of national networks, disciplinary networks, and the European Internet; regulatory, political, economic, and technical barriers to progress; and…

  10. 10 CFR 63.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Purpose and nature of findings. 63.101 Section 63.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC REPOSITORY AT YUCCA MOUNTAIN, NEVADA Technical Criteria § 63.101 Purpose and nature of findings. (a)(1...

  11. 10 CFR 60.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Purpose and nature of findings. 60.101 Section 60.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria § 60.101 Purpose and nature of findings. (a)(1) Subpart B of this part...

  12. 10 CFR 60.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Purpose and nature of findings. 60.101 Section 60.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria § 60.101 Purpose and nature of findings. (a)(1) Subpart B of this part...

  13. 78 FR 45003 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-25

    ... securities. Corporate debt securities are fixed-income securities issued by businesses to finance their... fundamental factors such as sales, earnings and cash flow growth; valuation factors such as price/earnings... fundamentals, valuation and technical factors, the security's relative valuation and other qualitative factors...

  14. 77 FR 68768 - Electricity Market Transparency Provisions of Section 220 of the Federal Power Act; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM10-12-000] Electricity Market Transparency Provisions of Section 220 of the Federal Power Act; Notice of Technical Conference...., Washington, DC 20426. \\1\\ Electricity Market Transparency Provisions of Section 220 of the Federal Power Act...

  15. 77 FR 54839 - Clarification of Submission of Requests for Relief or Alternatives From the Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-06

    ... the examination or testing, evaluates the susceptibility to known degradation, mechanisms or failure... and applicants have not been supported by adequate descriptive and detailed technical information... attempted. Sections 50.55a(f)(6)(i) and (g)(6)(i) state that the NRC will evaluate determinations that ASME...

  16. 75 FR 35862 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-23

    ... Exchange notes that a version of the instant filing requesting an extension of the Pilot was formally filed... May 27, 2010, due to technical deficiencies in that filing. The instant version corrects those... the instant filing is consistent with these principles. Specifically an extension will allow the...

  17. 10 CFR Appendix A to Part 5 - List of Federal Financial Assistance Administered by the Nuclear Regulatory Commission to Which...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... locations. (c) Technical training courses. Agreements for financial assistance to State and local officials, without full-cost recovery to attend training on nuclear material licensing, inspection and emergency..., conferences, workshops, and symposia to assist scientific, professional or educational institutions or groups...

  18. 10 CFR Appendix A to Part 5 - List of Federal Financial Assistance Administered by the Nuclear Regulatory Commission to Which...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... locations. (c) Technical training courses. Agreements for financial assistance to State and local officials, without full-cost recovery to attend training on nuclear material licensing, inspection and emergency..., conferences, workshops, and symposia to assist scientific, professional or educational institutions or groups...

  19. 10 CFR Appendix A to Part 5 - List of Federal Financial Assistance Administered by the Nuclear Regulatory Commission to Which...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... locations. (c) Technical training courses. Agreements for financial assistance to State and local officials, without full-cost recovery to attend training on nuclear material licensing, inspection and emergency..., conferences, workshops, and symposia to assist scientific, professional or educational institutions or groups...

  20. 75 FR 12540 - Electronic Tariff Filings; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM01-5-000] Electronic... electronically starting April 1, 2010. One of the required electronic tariff filing's data elements is the Type of Filing Code. \\1\\ Electronic Tariff Filings, Order No. 714, 73 FR 57,515 (Oct. 3, 2008), 124 FERC...

  1. 77 FR 58181 - Power Resources, Inc., Smith Ranch Highland Uranium Project; License Renewal Request, Opportunity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... NUCLEAR REGULATORY COMMISSION [Docket No. 04008964, NRC-2012-0214] Power Resources, Inc., Smith... available in ADAMS) is provided the first time that a document is referenced. The Smith Ranch Highland... (Smith Ranch Technical Report); Accession No. ML12234A539 (Smith Ranch Environmental Report). In addition...

  2. 78 FR 21475 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change, as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-10

    ... and investment policies. The Sub-Adviser will utilize various fundamental and technical research... investment company.\\7\\ The investment adviser to the Fund is AdvisorShares Investments, LLC (the ``Adviser... security that represents an interest in an investment company registered under the Investment Company Act...

  3. 10 CFR 63.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Purpose and nature of findings. 63.101 Section 63.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC REPOSITORY AT YUCCA MOUNTAIN, NEVADA Technical Criteria § 63.101 Purpose and nature of findings. (a)(1...

  4. 10 CFR 60.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Purpose and nature of findings. 60.101 Section 60.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria § 60.101 Purpose and nature of findings. (a)(1) Subpart B of this part...

  5. 10 CFR 60.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Purpose and nature of findings. 60.101 Section 60.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria § 60.101 Purpose and nature of findings. (a)(1) Subpart B of this part...

  6. 10 CFR 63.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Purpose and nature of findings. 63.101 Section 63.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC REPOSITORY AT YUCCA MOUNTAIN, NEVADA Technical Criteria § 63.101 Purpose and nature of findings. (a)(1...

  7. 10 CFR 60.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Purpose and nature of findings. 60.101 Section 60.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES Technical Criteria § 60.101 Purpose and nature of findings. (a)(1) Subpart B of this part...

  8. 10 CFR 63.101 - Purpose and nature of findings.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Purpose and nature of findings. 63.101 Section 63.101 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN A GEOLOGIC REPOSITORY AT YUCCA MOUNTAIN, NEVADA Technical Criteria § 63.101 Purpose and nature of findings. (a)(1...

  9. 77 FR 69507 - Proposed Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ..., ``Revise Shutdown Margin Definition To Address Advanced Fuel Designs'' AGENCY: Nuclear Regulatory... Shutdown Margin Definition to Address Advanced Fuel Designs.'' DATES: Comment period expires on December 19... address newer BWR fuel designs, which may be more reactive at shutdown temperatures above 68[emsp14][deg]F...

  10. 78 FR 28671 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-15

    ... Exchange also proposes to make corresponding grammatical amendments and technical amendments to improve... categories, as proposed paragraphs (a)-(g): (a) General Order Types; (b) Order Execution Modifiers; (c) Order... grammatical amendments. The purpose of this amendment is to clarify that an order execution modifier is not a...

  11. 21 CFR 14.100 - List of standing advisory committees.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... consumption of all tea imported into the United States under 21 U.S.C. 42. (2) Science Board to the Food and... primarily to the agency's Senior Science Advisor and, as needed, to the Commissioner and other appropriate... pace with technical and scientific evolutions in the fields of regulatory science; on formulating an...

  12. 77 FR 22720 - Service Rules for Advanced Wireless Services in the 2000-2020 MHz and 2180-2200 MHz Bands, etc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-17

    ..., encourage innovation and investment in mobile broadband, and provide a stable regulatory environment in... of this spectrum, to encourage innovation and investment in mobile broadband, and to provide a stable... service, technical, assignment, and licensing rules for flexible terrestrial use of spectrum currently...

  13. 75 FR 27330 - Credit Reforms in Organized Wholesale Electric Markets; Notice of Agenda for Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ... Credit Reforms in Organized Wholesale Electric Markets Notice of Proposed Rulemaking\\1\\ regarding whether... Credit Reforms in Organized Electric Markets May 11, 2010 Commission Meeting Room Agenda 9-9:05 a.m... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM10-13-000] Credit Reforms...

  14. WOOD PRODUCTS IN THE WASTE STREAM: CHARACTERIZATION AND COMBUSTION EMISSIONS - VOLUME 2. APPENDICES

    EPA Science Inventory

    The report gives results of a study of technical, public policy, and regulatory issues that affect the processing and combustion of waste wood for fuel. (NOTE: Waste wood is wood that is separated from a solid-waste stream, processed into a uniform-sized product, and reused for o...

  15. 78 FR 33136 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Order Granting Approval to Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... that, due to technical limitations in order management systems and routing networks, such member... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69643; File Nos. SR-BYX-2013-008] Self... the Securities and Exchange Commission (``Commission'') pursuant to Section 19(b)(1) of the Securities...

  16. 10 CFR 61.54 - Alternative requirements for design and operations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section 61.54 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.54 Alternative requirements for... other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for...

  17. 10 CFR 61.54 - Alternative requirements for design and operations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Section 61.54 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.54 Alternative requirements for... other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for...

  18. 10 CFR 61.54 - Alternative requirements for design and operations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Section 61.54 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.54 Alternative requirements for... other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for...

  19. 10 CFR 61.54 - Alternative requirements for design and operations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 61.54 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.54 Alternative requirements for... other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for...

  20. 10 CFR 61.54 - Alternative requirements for design and operations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Section 61.54 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.54 Alternative requirements for... other than those set forth in §§ 61.51 through 61.53 for the segregation and disposal of waste and for...

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