Sample records for regulatory research programs performance

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

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

    Jennings, S.D.

    1990-04-01

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

  2. U.S. Nuclear Regulatory Commission natural analogue research program

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

    Kovach, L.A.; Ott, W.R.

    1995-09-01

    This article describes the natural analogue research program of the U.S. Nuclear Regulatory Commission (US NRC). It contains information on the regulatory context and organizational structure of the high-level radioactive waste research program plan. It also includes information on the conditions and processes constraining selection of natural analogues, describes initiatives of the US NRC, and describes the role of analogues in the licensing process.

  3. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  4. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  5. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  6. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  7. 10 CFR 1.45 - Office of Nuclear Regulatory Research.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

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

    DiZio, S.M.

    Various state regulatory agencies have expressed a need for networking with information gatherers/researchers to produce a concise compilation of primary information so that the basis for regulatory standards can be scientifically referenced. California has instituted several programs to retrieve primary information, generate primary information through research, and generate unique regulatory standards by integrating the primary literature and the products of research. This paper describes these programs.

  9. Evaluation of training programs and entry-level qualifications for nuclear-power-plant control-room personnel based on the systems approach to training

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

    Haas, P M; Selby, D L; Hanley, M J

    1983-09-01

    This report summarizes results of research sponsored by the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research to initiate the use of the Systems Approach to Training in the evaluation of training programs and entry level qualifications for nuclear power plant (NPP) personnel. Variables (performance shaping factors) of potential importance to personnel selection and training are identified, and research to more rigorously define an operationally useful taxonomy of those variables is recommended. A high-level model of the Systems Approach to Training for use in the nuclear industry, which could serve as a model for NRC evaluation of industrymore » programs, is presented. The model is consistent with current publically stated NRC policy, with the approach being followed by the Institute for Nuclear Power Operations, and with current training technology. Checklists to be used by NRC evaluators to assess training programs for NPP control-room personnel are proposed which are based on this model.« less

  10. Mission Risk Reduction Regulatory Change Management

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2007-01-01

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

  11. 5 CFR 470.201 - Purposes of research programs.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Purposes of research programs. 470.201... PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Research Programs § 470.201 Purposes of research programs. The purposes of research programs undertaken...

  12. 5 CFR 470.201 - Purposes of research programs.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Purposes of research programs. 470.201... PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Research Programs § 470.201 Purposes of research programs. The purposes of research programs undertaken...

  13. 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...

  14. 5 CFR 470.205 - Initiation of research programs.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Initiation of research programs. 470.205... PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Research Programs § 470.205 Initiation of research programs. OPM will announce opportunities for research...

  15. 5 CFR 470.205 - Initiation of research programs.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Initiation of research programs. 470.205... PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Research Programs § 470.205 Initiation of research programs. OPM will announce opportunities for research...

  16. AZOrange - High performance open source machine learning for QSAR modeling in a graphical programming environment

    PubMed Central

    2011-01-01

    Background Machine learning has a vast range of applications. In particular, advanced machine learning methods are routinely and increasingly used in quantitative structure activity relationship (QSAR) modeling. QSAR data sets often encompass tens of thousands of compounds and the size of proprietary, as well as public data sets, is rapidly growing. Hence, there is a demand for computationally efficient machine learning algorithms, easily available to researchers without extensive machine learning knowledge. In granting the scientific principles of transparency and reproducibility, Open Source solutions are increasingly acknowledged by regulatory authorities. Thus, an Open Source state-of-the-art high performance machine learning platform, interfacing multiple, customized machine learning algorithms for both graphical programming and scripting, to be used for large scale development of QSAR models of regulatory quality, is of great value to the QSAR community. Results This paper describes the implementation of the Open Source machine learning package AZOrange. AZOrange is specially developed to support batch generation of QSAR models in providing the full work flow of QSAR modeling, from descriptor calculation to automated model building, validation and selection. The automated work flow relies upon the customization of the machine learning algorithms and a generalized, automated model hyper-parameter selection process. Several high performance machine learning algorithms are interfaced for efficient data set specific selection of the statistical method, promoting model accuracy. Using the high performance machine learning algorithms of AZOrange does not require programming knowledge as flexible applications can be created, not only at a scripting level, but also in a graphical programming environment. Conclusions AZOrange is a step towards meeting the needs for an Open Source high performance machine learning platform, supporting the efficient development of highly accurate QSAR models fulfilling regulatory requirements. PMID:21798025

  17. AZOrange - High performance open source machine learning for QSAR modeling in a graphical programming environment.

    PubMed

    Stålring, Jonna C; Carlsson, Lars A; Almeida, Pedro; Boyer, Scott

    2011-07-28

    Machine learning has a vast range of applications. In particular, advanced machine learning methods are routinely and increasingly used in quantitative structure activity relationship (QSAR) modeling. QSAR data sets often encompass tens of thousands of compounds and the size of proprietary, as well as public data sets, is rapidly growing. Hence, there is a demand for computationally efficient machine learning algorithms, easily available to researchers without extensive machine learning knowledge. In granting the scientific principles of transparency and reproducibility, Open Source solutions are increasingly acknowledged by regulatory authorities. Thus, an Open Source state-of-the-art high performance machine learning platform, interfacing multiple, customized machine learning algorithms for both graphical programming and scripting, to be used for large scale development of QSAR models of regulatory quality, is of great value to the QSAR community. This paper describes the implementation of the Open Source machine learning package AZOrange. AZOrange is specially developed to support batch generation of QSAR models in providing the full work flow of QSAR modeling, from descriptor calculation to automated model building, validation and selection. The automated work flow relies upon the customization of the machine learning algorithms and a generalized, automated model hyper-parameter selection process. Several high performance machine learning algorithms are interfaced for efficient data set specific selection of the statistical method, promoting model accuracy. Using the high performance machine learning algorithms of AZOrange does not require programming knowledge as flexible applications can be created, not only at a scripting level, but also in a graphical programming environment. AZOrange is a step towards meeting the needs for an Open Source high performance machine learning platform, supporting the efficient development of highly accurate QSAR models fulfilling regulatory requirements.

  18. 76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-22

    ... and support the adoption of improved designs or processes. \\1\\ A deterministic approach to regulation... longstanding goal to move toward more risk-informed, performance- based approaches in its regulatory programs... regulatory approach that would continue to ensure the safe and secure use of nuclear material. As part of...

  19. Bibliography of reports on research sponsored by the NRC Office of Nuclear Regulatory Research, July--December 1976

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

    Buchanan, J.R.

    A bibliography of 148 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period July through December 1976 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are sorted by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  20. Medical research misconduct need regulatory reforms.

    PubMed

    Bedi, Neeraj

    2014-10-01

    The medical research misconduct has become a global problem. Except from countries like the USA, China, and Germany the exact figures of misconduct are not available. The research misconduct include fabricating the data, falsifying data, and plagiarism. The irresponsible research practices are publishing research data more than once, conflicts of interest is not declared, selective reporting of data and including an author who has not contributed at all and many more. About 2% of scientists have been found to admit the fabricating the data and 33% researchers were involved in irresponsible research practices. There is no formal regulatory programs available to monitor the research projects. Few developed countries like the USA, Germany, and China tried to develop programs which can monitor the medical research misconduct. There is a need to develop a regulatory system at national and institutional level to regulate the research activity to ensure that good ethical and scientific standards are practiced by medical researchers.

  1. Assessment of composite motif discovery methods.

    PubMed

    Klepper, Kjetil; Sandve, Geir K; Abul, Osman; Johansen, Jostein; Drablos, Finn

    2008-02-26

    Computational discovery of regulatory elements is an important area of bioinformatics research and more than a hundred motif discovery methods have been published. Traditionally, most of these methods have addressed the problem of single motif discovery - discovering binding motifs for individual transcription factors. In higher organisms, however, transcription factors usually act in combination with nearby bound factors to induce specific regulatory behaviours. Hence, recent focus has shifted from single motifs to the discovery of sets of motifs bound by multiple cooperating transcription factors, so called composite motifs or cis-regulatory modules. Given the large number and diversity of methods available, independent assessment of methods becomes important. Although there have been several benchmark studies of single motif discovery, no similar studies have previously been conducted concerning composite motif discovery. We have developed a benchmarking framework for composite motif discovery and used it to evaluate the performance of eight published module discovery tools. Benchmark datasets were constructed based on real genomic sequences containing experimentally verified regulatory modules, and the module discovery programs were asked to predict both the locations of these modules and to specify the single motifs involved. To aid the programs in their search, we provided position weight matrices corresponding to the binding motifs of the transcription factors involved. In addition, selections of decoy matrices were mixed with the genuine matrices on one dataset to test the response of programs to varying levels of noise. Although some of the methods tested tended to score somewhat better than others overall, there were still large variations between individual datasets and no single method performed consistently better than the rest in all situations. The variation in performance on individual datasets also shows that the new benchmark datasets represents a suitable variety of challenges to most methods for module discovery.

  2. Bibliography of reports on research sponsored by the NRC office of nuclear regulatory research, July--December 1977

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

    Buchanan, J.R.

    A bibliography of 198 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period July through December 1977 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are arranged first by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  3. Bibliography of reports on research sponsored by the NRC Office of Nuclear Regulatory Research, November 1975--June 1976

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

    Buchanan, J.R.

    1976-09-30

    A bibliography of 152 reports published by contractors of the NRC Office of Nuclear Regulatory Research during the period November 1975 through June 1976 is presented along with abstracts from the Nuclear Safety Information Center computer file. The bibliography has been sorted into the subject categories used by NRC to organize the research program. Within the subject categories, the reports are sorted by contractor organization and then chronologically. A brief description of the NRC research program precedes the bibliography.

  4. Regulatory physiology discipline science plan

    NASA Technical Reports Server (NTRS)

    1991-01-01

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

  5. 5 CFR 470.205 - Initiation of research programs.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Initiation of research programs. 470.205 Section 470.205 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  6. THE USEPA'S LANDFILL RESEARCH AND REGULATORY STRATEGY

    EPA Science Inventory

    The priorities and initiatives of Environmental Protection Agency's landfill research and regulatory program over the next five years will be described. This will include municipal solid waste landfills as well as abandoned hazardous waste landfills.

    Regarding municipals s...

  7. The National Shipbuilding Research Program. Analysis of Wash Water Treatment Efficiency for Copper and Zinc

    DTIC Science & Technology

    2000-12-15

    per trillion for tributyltin (“ TBT ”). This regulatory action lead to an intensive research effort to develop a treatment method for ship’s wash water...antifoulant coating systems, including tributyltin , copper and zinc. In 1997 The Commonwealth of Virginia established an effluent discharge limit of 50 parts...waste stream that could consistently remove TBT to levels below this discharge standard. This work is currently being performed by the Center for

  8. 76 FR 4919 - Regulatory Site Visit Training Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0046] Regulatory Site Visit Training Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is...

  9. Proceedings of the seminar on Leak-Before-Break: Progress in regulatory policies and supporting research

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

    Kashima, K.; Wilkowski, G.M.

    1988-03-01

    The third in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at TEPCO Hall in the Tokyo Electric Power Company's (TEPCO) Electric Power Museum on May 14 and 15, 1987. The seminar updated the international policies and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utility representatives, fabricators of nuclear power plants, research organizations, and university professors. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA), Dr. H. Schultz (GRS, W. Germany), Dr. P. Milella (ENEA-DISP, Italy), Dr. C. Faidy, P. Jamet,more » and S. Bhandari (EDF/Septen, CEA/CEN, and Framatome, France), and Mr. T. Fukuzawa (MITI, Japan). Dr. F. Nilsson presented revised nondestructive inspection requirements relative to LBB in Sweden. In addition, several papers on the supporting research programs discussed regulatory policy. Questions following the presentations of the papers focused on the impact of various LBB policies or the impact of research findings. Supporting research programs were reviewed on the first and second day by several participants from the US, Japan, Germany, Canada, Italy, Sweden, England, and France.« less

  10. Development of Greenhouse Gas Emissions Model (GEM) for Heavy- & Medium-Duty Vehicle Compliance

    EPA Science Inventory

    A regulatory vehicle simulation program was designed for determining greenhouse gas (GHG) emissions and fuel consumption by estimating the performance of technologies, verifying compliance with the regulatory standards and estimating the overall benefits of the program.

  11. Publications of the space physiology and countermeasures program, regulatory physiology discipline: 1980 - 1990

    NASA Technical Reports Server (NTRS)

    Wallace-Robinson, Janice; Dickson, Katherine J.; Hess, Elizabeth; Powers, Janet V.

    1992-01-01

    A 10-year cumulative bibliography of publications resulting from research supported by the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program of NASA's Life Sciences Division is provided. Primary subjects included in this bibliography are circadian rhythms, endocrinology, fluid and electrolyte regulation, hematology, immunology, metabolism and nutrition, temperature regulation, and general regulatory physiology. General physiology references are also included. Principal investigators whose research tasks resulted in publication are identified by asterisk. Publications are identified by a record number corresponding with their entry in the Life Sciences Bibliographic Database, maintained at the George Washington University.

  12. Bridging Research and Environmental Regulatory Processes: The Role of Knowledge Brokers

    PubMed Central

    Pennell, Kelly G.; Thompson, Marcella; Rice, James W.; Senier, Laura; Brown, Phil; Suuberg, Eric

    2013-01-01

    Federal funding agencies increasingly require research investigators to ensure that federally-sponsored research demonstrates broader societal impact. Specifically, the National Institutes of Environmental Health Sciences (NIEHS) Superfund Research Program (SRP) requires research centers to include research translation and community engagement cores to achieve broader impacts, with special emphasis on improving environmental health policies through better scientific understanding. This paper draws on theoretical insights from the social sciences to show how incorporating knowledge brokers in research centers can facilitate translation of scientific expertise to influence regulatory processes and thus promote public health. Knowledge brokers connect academic researchers with decision-makers, to facilitate the translation of research findings into policies and programs. In this article, we describe the stages of the regulatory process and highlight the role of the knowledge broker and scientific expert at each stage. We illustrate the cooperation of knowledge brokers, scientific experts and policymakers using a case from the Brown University (Brown) SRP. We show how the Brown SRP incorporated knowledge brokers to engage scientific experts with regulatory officials around the emerging public health problem of vapor intrusion. In the Brown SRP, the knowledge broker brought regulatory officials into the research process, to help scientific experts understand the critical nature of this emerging public health threat, and helped scientific experts develop a research agenda that would inform the development of timely measures to protect public health. Our experience shows that knowledge brokers can enhance the impact of environmental research on public health by connecting policy decision-makers with scientific experts at critical points throughout the regulatory process. PMID:24083557

  13. The use of performance standards by AAALAC International to evaluate ethical review in European institutions.

    PubMed

    Guillen, Javier

    2010-02-01

    During the past several decades, society has become increasingly concerned about the welfare of animals used in research. Today, the public asks scientists to justify the use of research animals and to be accountable for their welfare. Research institutions, government bodies and other regulatory authorities have developed mechanisms to ensure that researchers follow the principles of the 3Rs and use and care for research animals in an ethical manner. Additionally, organizations such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) have developed voluntary programs that can help researchers to ensure that they are caring for research animals appropriately. The author discusses how AAALAC International uses performance standards to evaluate the ethical review processes of European institutions.

  14. Leak-Before-Break: Further developments in regulatory policies and supporting research

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

    Wilkowski, G.M.; Chao, K.-S.

    1990-02-01

    The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A papermore » by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately.« less

  15. 10 CFR 26.717 - Fitness-for-duty program performance data.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Fitness-for-duty program performance data. 26.717 Section 26.717 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Recordkeeping and Reporting Requirements § 26.717 Fitness-for-duty program performance data. (a) Licensees and other entities shall collect...

  16. 10 CFR 26.717 - Fitness-for-duty program performance data.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Fitness-for-duty program performance data. 26.717 Section 26.717 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Recordkeeping and Reporting Requirements § 26.717 Fitness-for-duty program performance data. (a) Licensees and other entities shall collect...

  17. 10 CFR 26.717 - Fitness-for-duty program performance data.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Fitness-for-duty program performance data. 26.717 Section 26.717 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Recordkeeping and Reporting Requirements § 26.717 Fitness-for-duty program performance data. (a) Licensees and other entities shall collect...

  18. 10 CFR 26.717 - Fitness-for-duty program performance data.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Fitness-for-duty program performance data. 26.717 Section 26.717 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Recordkeeping and Reporting Requirements § 26.717 Fitness-for-duty program performance data. (a) Licensees and other entities shall collect...

  19. 10 CFR 26.717 - Fitness-for-duty program performance data.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Fitness-for-duty program performance data. 26.717 Section 26.717 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Recordkeeping and Reporting Requirements § 26.717 Fitness-for-duty program performance data. (a) Licensees and other entities shall collect...

  20. 76 FR 38119 - Privacy Act of 1974; System of Records

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    .../ Regulatory Information Number (RIN) and title, by any of the following methods: * Federal Rulemaking Portal... System Name: Human Research Protection Program (HRPP) Records (September 11, 2008, 73 FR 52838). Changes: * * * * * System Name: Delete entry and replace with ``Research Regulatory Oversight Records.'' System location...

  1. Collaborative investigations of in-service irradiated material from the Japan Power Demonstration Reactor pressure vessel

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

    Corwin, W.R.; Broadhead, B.L.; Suzuki, M.

    1997-02-01

    There is a need to validate the results of irradiation effects research by the examination of material taken directly from the wall of a pressure vessel that has been irradiated during normal service. Just such an evaluation is currently being conducted on material from the wall of the pressure vessel from the Japan Power Demonstration Reactor (JPDR). The research is being jointly performed at the Tokai Research Establishment of the Japan Atomic Energy Research Institute (JAERI) and by the Nuclear Regulatory Commission (NRC)-funded Heavy-Section Steel Irradiation Program at the Oak Ridge National Laboratory (ORNL).

  2. 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

  3. 5 CFR 470.201 - Purposes of research programs.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 470.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to... under this subpart are to stimulate and conduct personnel management research which: (a) Develops new...

  4. 5 CFR 470.203 - Eligible parties.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Research Programs § 470.203 Eligible parties. Research may be conducted by the Office of Personnel Management, or under contract or...

  5. 5 CFR 470.301 - Program expectations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration... improved personnel methods. (b) The demonstration project must be proposed in a research context. The project plan must include a research design which contains: (1) Measurable goals or objectives; (2...

  6. 5 CFR 470.301 - Program expectations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration... improved personnel methods. (b) The demonstration project must be proposed in a research context. The project plan must include a research design which contains: (1) Measurable goals or objectives; (2...

  7. 5 CFR 470.301 - Program expectations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration... improved personnel methods. (b) The demonstration project must be proposed in a research context. The project plan must include a research design which contains: (1) Measurable goals or objectives; (2...

  8. 5 CFR 470.301 - Program expectations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration... improved personnel methods. (b) The demonstration project must be proposed in a research context. The project plan must include a research design which contains: (1) Measurable goals or objectives; (2...

  9. Government regulation of forestry practices on private forest land in the United States: an assessment of state government responsibilities and program performance

    Treesearch

    Paul V. Ellefson; Michael A. Kilgore; James E. Granskog

    2006-01-01

    In 2003, a comprehensive assessment of state government, forest practice regulatory programs in the United States was undertaken. Involved was an extensive review of the literature and information gathering h m program administration in all 50 states. The assessment determined that regulatory programs focus on a wide range of forestry practices applied to private...

  10. [Regulatory science: modern trends in science and education for pharmaceutical products].

    PubMed

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  11. Syphilis

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  12. Tickborne Diseases

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  13. Tuberculosis (TB)

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  14. 10 CFR 26.23 - Performance objectives.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Performance objectives. 26.23 Section 26.23 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Program Elements § 26.23 Performance objectives. Fitness-for-duty programs must— (a) Provide reasonable assurance that individuals are trustworthy and reliable as...

  15. 10 CFR 26.23 - Performance objectives.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Performance objectives. 26.23 Section 26.23 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Program Elements § 26.23 Performance objectives. Fitness-for-duty programs must— (a) Provide reasonable assurance that individuals are trustworthy and reliable as...

  16. 10 CFR 26.23 - Performance objectives.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Performance objectives. 26.23 Section 26.23 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Program Elements § 26.23 Performance objectives. Fitness-for-duty programs must— (a) Provide reasonable assurance that individuals are trustworthy and reliable as...

  17. 10 CFR 26.23 - Performance objectives.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Performance objectives. 26.23 Section 26.23 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Program Elements § 26.23 Performance objectives. Fitness-for-duty programs must— (a) Provide reasonable assurance that individuals are trustworthy and reliable as...

  18. 10 CFR 26.23 - Performance objectives.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Performance objectives. 26.23 Section 26.23 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Program Elements § 26.23 Performance objectives. Fitness-for-duty programs must— (a) Provide reasonable assurance that individuals are trustworthy and reliable as...

  19. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

  20. Primary Immune Deficiency Diseases

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  1. Wiskott-Aldrich Syndrome (WAS)

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  2. Respiratory Syncytial Virus (RSV): Treatment

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  3. Rocky Mountain Spotted Fever

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  4. Protocol Coordinator | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

  5. 5 CFR 470.201 - Purposes of research programs.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... knowledge, techniques, and materials about personnel management; (b) Seeks solutions to personnel management... Section 470.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  6. 5 CFR 470.201 - Purposes of research programs.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... knowledge, techniques, and materials about personnel management; (b) Seeks solutions to personnel management... Section 470.201 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  7. National Institute of Allergy and Infectious Diseases

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  8. Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome (WHIMS)

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  9. Types of HIV/AIDS Antiretroviral Drugs

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  10. 40 CFR 80.158 - Product transfer documents (PTDs).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... exempt base gasoline to be used for research, development, or test purposes only, the following warning must also be stated on the PTD: “For use in research, development, and test programs only.” (6) The...) Use of product codes and other non-regulatory language. (1) Product codes and other non-regulatory...

  11. United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

    PubMed

    Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

    2014-05-01

    The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  12. 78 FR 35330 - Initial Test Programs for Water-Cooled Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

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

  13. Hyper-Immunoglobulin E Syndrome (HIES) or Job's Syndrome

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  14. 77 FR 7960 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... Identifier No. 373 Secure Handling of 1601-AA52 Ammonium Nitrate Program (Reg Plan Seq No. 53). 374 Homeland...) Proposed Rule Stage 373. Secure Handling of Ammonium Nitrate Program Regulatory Plan: This entry is Seq. No... performance standards to 33 CFR part 151, subparts C and D, for discharges of ballast water. It supports the...

  15. The National Shipbuilding Research Program. Ship Breaking: Environmental Health and Safety Regulatory Overview

    DTIC Science & Technology

    1999-09-27

    facility in Alang , India, where ship scrapping typically is performed on beach front property, allowing toxins, oils, PCBs, asbestos, and chromates...in Alang are operated in a manner that endanger the health and safety of their laborers and that government enforcement of...Id. According to the Baltimore Sun, none of the men who work at the Alang facility wear hard hats, safety harnesses, or respirators even though each

  16. Design Considerations in Development of a Mobile Health Intervention Program: The TEXT ME and TEXTMEDS Experience

    PubMed Central

    Thakkar, Jay; Barry, Tony; Thiagalingam, Aravinda; Redfern, Julie; McEwan, Alistair L; Rodgers, Anthony

    2016-01-01

    Background Mobile health (mHealth) has huge potential to deliver preventative health services. However, there is paucity of literature on theoretical constructs, technical, practical, and regulatory considerations that enable delivery of such services. Objectives The objective of this study was to outline the key considerations in the development of a text message-based mHealth program; thus providing broad recommendations and guidance to future researchers designing similar programs. Methods We describe the key considerations in designing the intervention with respect to functionality, technical infrastructure, data management, software components, regulatory requirements, and operationalization. We also illustrate some of the potential issues and decision points utilizing our experience of developing text message (short message service, SMS) management systems to support 2 large randomized controlled trials: TEXT messages to improve MEDication adherence & Secondary prevention (TEXTMEDS) and Tobacco, EXercise and dieT MEssages (TEXT ME). Results The steps identified in the development process were: (1) background research and development of the text message bank based on scientific evidence and disease-specific guidelines, (2) pilot testing with target audience and incorporating feedback, (3) software-hardware customization to enable delivery of complex personalized programs using prespecified algorithms, and (4) legal and regulatory considerations. Additional considerations in developing text message management systems include: balancing the use of customized versus preexisting software systems, the level of automation versus need for human inputs, monitoring, ensuring data security, interface flexibility, and the ability for upscaling. Conclusions A merging of expertise in clinical and behavioral sciences, health and research data management systems, software engineering, and mobile phone regulatory requirements is essential to develop a platform to deliver and manage support programs to hundreds of participants simultaneously as in TEXT ME and TEXTMEDS trials. This research provides broad principles that may assist other researchers in developing mHealth programs. PMID:27847350

  17. Design Considerations in Development of a Mobile Health Intervention Program: The TEXT ME and TEXTMEDS Experience.

    PubMed

    Thakkar, Jay; Barry, Tony; Thiagalingam, Aravinda; Redfern, Julie; McEwan, Alistair L; Rodgers, Anthony; Chow, Clara K

    2016-11-15

    Mobile health (mHealth) has huge potential to deliver preventative health services. However, there is paucity of literature on theoretical constructs, technical, practical, and regulatory considerations that enable delivery of such services. The objective of this study was to outline the key considerations in the development of a text message-based mHealth program; thus providing broad recommendations and guidance to future researchers designing similar programs. We describe the key considerations in designing the intervention with respect to functionality, technical infrastructure, data management, software components, regulatory requirements, and operationalization. We also illustrate some of the potential issues and decision points utilizing our experience of developing text message (short message service, SMS) management systems to support 2 large randomized controlled trials: TEXT messages to improve MEDication adherence & Secondary prevention (TEXTMEDS) and Tobacco, EXercise and dieT MEssages (TEXT ME). The steps identified in the development process were: (1) background research and development of the text message bank based on scientific evidence and disease-specific guidelines, (2) pilot testing with target audience and incorporating feedback, (3) software-hardware customization to enable delivery of complex personalized programs using prespecified algorithms, and (4) legal and regulatory considerations. Additional considerations in developing text message management systems include: balancing the use of customized versus preexisting software systems, the level of automation versus need for human inputs, monitoring, ensuring data security, interface flexibility, and the ability for upscaling. A merging of expertise in clinical and behavioral sciences, health and research data management systems, software engineering, and mobile phone regulatory requirements is essential to develop a platform to deliver and manage support programs to hundreds of participants simultaneously as in TEXT ME and TEXTMEDS trials. This research provides broad principles that may assist other researchers in developing mHealth programs. ©Jay Thakkar, Tony Barry, Aravinda Thiagalingam, Julie Redfern, Alistair L McEwan, Anthony Rodgers, Clara K Chow. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 15.11.2016.

  18. The Path to a Cure for Hepatitis C in People With HIV

    MedlinePlus

    ... of the Director Office of the Chief Science Management & Operations Administrative Services Office of Biodefense Research & Surety Communications ... Office of Clinical Research Policy and Regulatory Planning Operations Support Program Planning Analysis ... Office of Acquisitions Scientific Review Program Division ...

  19. 5 CFR 470.301 - Program expectations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ....301 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.301 Program expectations. (a) Demonstration projects permit the Office of Personnel...

  20. Flow Induced Vibration Program at Argonne National Laboratory

    NASA Astrophysics Data System (ADS)

    1984-01-01

    The Argonne National Laboratory's Flow Induced Vibration Program, currently residing in the Laboratory's Components Technology Division is discussed. Throughout its existence, the overall objective of the program was to develop and apply new and/or improved methods of analysis and testing for the design evaluation of nuclear reactor plant components and heat exchange equipment from the standpoint of flow induced vibration. Historically, the majority of the program activities were funded by the US Atomic Energy Commission, the Energy Research and Development Administration, and the Department of Energy. Current DOE funding is from the Breeder Mechanical Component Development Division, Office of Breeder Technology Projects; Energy Conversion and Utilization Technology Program, Office of Energy Systems Research; and Division of Engineering, Mathematical and Geosciences, office of Basic Energy Sciences. Testing of Clinch River Breeder Reactor upper plenum components was funded by the Clinch River Breeder Reactor Plant Project Office. Work was also performed under contract with Foster Wheeler, General Electric, Duke Power Company, US Nuclear Regulatory Commission, and Westinghouse.

  1. Taiwan industrial cooperation program technology transfer for low-level radioactive waste final disposal - phase I.

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

    Knowlton, Robert G.; Cochran, John Russell; Arnold, Bill Walter

    2007-01-01

    Sandia National Laboratories and the Institute of Nuclear Energy Research, Taiwan have collaborated in a technology transfer program related to low-level radioactive waste (LLW) disposal in Taiwan. Phase I of this program included regulatory analysis of LLW final disposal, development of LLW disposal performance assessment capabilities, and preliminary performance assessments of two potential disposal sites. Performance objectives were based on regulations in Taiwan and comparisons to those in the United States. Probabilistic performance assessment models were constructed based on limited site data using software including GoldSim, BLT-MS, FEHM, and HELP. These software codes provided the probabilistic framework, container degradation, waste-formmore » leaching, groundwater flow, radionuclide transport, and cover infiltration simulation capabilities in the performance assessment. Preliminary performance assessment analyses were conducted for a near-surface disposal system and a mined cavern disposal system at two representative sites in Taiwan. Results of example calculations indicate peak simulated concentrations to a receptor within a few hundred years of LLW disposal, primarily from highly soluble, non-sorbing radionuclides.« less

  2. Defining Tobacco Regulatory Science Competencies.

    PubMed

    Wipfli, Heather L; Berman, Micah; Hanson, Kacey; Kelder, Steven; Solis, Amy; Villanti, Andrea C; Ribeiro, Carla M P; Meissner, Helen I; Anderson, Roger

    2017-02-01

    In 2013, the National Institutes of Health and the Food and Drug Administration funded a network of 14 Tobacco Centers of Regulatory Science (TCORS) with a mission that included research and training. A cross-TCORS Panel was established to define tobacco regulatory science (TRS) competencies to help harmonize and guide their emerging educational programs. The purpose of this paper is to describe the Panel's work to develop core TRS domains and competencies. The Panel developed the list of domains and competencies using a semistructured Delphi method divided into four phases occurring between November 2013 and August 2015. The final proposed list included a total of 51 competencies across six core domains and 28 competencies across five specialized domains. There is a need for continued discussion to establish the utility of the proposed set of competencies for emerging TRS curricula and to identify the best strategies for incorporating these competencies into TRS training programs. Given the field's broad multidisciplinary nature, further experience is needed to refine the core domains that should be covered in TRS training programs versus knowledge obtained in more specialized programs. Regulatory science to inform the regulation of tobacco products is an emerging field. The paper provides an initial list of core and specialized domains and competencies to be used in developing curricula for new and emerging training programs aimed at preparing a new cohort of scientists to conduct critical TRS research. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. RSAT 2015: Regulatory Sequence Analysis Tools.

    PubMed

    Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

    2015-07-01

    RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

  4. 78 FR 19711 - Center for Devices and Radiological Health: Experiential Learning Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ... Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research... medical device establishments, including, research, manufacturing, academia, and health care facilities.... Clinical use of orthopedic bone void Observation of surgical filler devices. procedures (posterolateral...

  5. NIEHS/FDA CLARITY-BPA research program update.

    PubMed

    Heindel, Jerrold J; Newbold, Retha R; Bucher, John R; Camacho, Luísa; Delclos, K Barry; Lewis, Sherry M; Vanlandingham, Michelle; Churchwell, Mona I; Twaddle, Nathan C; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A; Flaws, Jodi; Howard, Paul C; Walker, Nigel J; Zoeller, R Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T

    2015-12-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S. Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. Published by Elsevier Inc.

  6. NIEHS/FDA CLARITY-BPA research program update

    PubMed Central

    Heindel, Jerrold J.; Newbold, Retha R.; Bucher, John R.; Camacho, Luísa; Delclos, K. Barry; Lewis, Sherry M.; Vanlandingham, Michelle; Churchwell, Mona I.; Twaddle, Nathan C.; McLellen, Michelle; Chidambaram, Mani; Bryant, Matthew; Woodling, Kellie; Gamboa da Costa, Gonçalo; Ferguson, Sherry A.; Flaws, Jodi; Howard, Paul C.; Walker, Nigel J.; Zoeller, R. Thomas; Fostel, Jennifer; Favaro, Carolyn; Schug, Thaddeus T.

    2016-01-01

    Bisphenol A (BPA) is a chemical used in the production of numerous consumer products resulting in potential daily human exposure to this chemical. The FDA previously evaluated the body of BPA toxicology data and determined that BPA is safe at current exposure levels. Although consistent with the assessment of some other regulatory agencies around the world, this determination of BPA safety continues to be debated in scientific and popular publications, resulting in conflicting messages to the public. Thus, the National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), and U.S Food and Drug Administration (FDA) developed a consortium-based research program to link more effectively a variety of hypothesis-based research investigations and guideline-compliant safety testing with BPA. This collaboration is known as the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA). This paper provides a detailed description of the conduct of the study and a midterm update on progress of the CLARITY-BPA research program. PMID:26232693

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

    PubMed Central

    Magnusson, Roger; Reeve, Belinda

    2015-01-01

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

  8. RSAT: regulatory sequence analysis tools.

    PubMed

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

    2008-07-01

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

  9. Key Performance Indicators in the Evaluation of the Quality of Radiation Safety Programs.

    PubMed

    Schultz, Cheryl Culver; Shaffer, Sheila; Fink-Bennett, Darlene; Winokur, Kay

    2016-08-01

    Beaumont is a multiple hospital health care system with a centralized radiation safety department. The health system operates under a broad scope Nuclear Regulatory Commission license but also maintains several other limited use NRC licenses in off-site facilities and clinics. The hospital-based program is expansive including diagnostic radiology and nuclear medicine (molecular imaging), interventional radiology, a comprehensive cardiovascular program, multiple forms of radiation therapy (low dose rate brachytherapy, high dose rate brachytherapy, external beam radiotherapy, and gamma knife), and the Research Institute (including basic bench top, human and animal). Each year, in the annual report, data is analyzed and then tracked and trended. While any summary report will, by nature, include items such as the number of pieces of equipment, inspections performed, staff monitored and educated and other similar parameters, not all include an objective review of the quality and effectiveness of the program. Through objective numerical data Beaumont adopted seven key performance indicators. The assertion made is that key performance indicators can be used to establish benchmarks for evaluation and comparison of the effectiveness and quality of radiation safety programs. Based on over a decade of data collection, and adoption of key performance indicators, this paper demonstrates one way to establish objective benchmarking for radiation safety programs in the health care environment.

  10. Policy uncertainty and corporate performance in government-sponsored voluntary environmental programs.

    PubMed

    Liu, Ning; Tang, Shui-Yan; Zhan, Xueyong; Lo, Carlos Wing-Hung

    2018-08-01

    This study combines insights from the policy uncertainty literature and neo-institutional theory to examine corporate performance in implementing a government-sponsored voluntary environmental program (VEP) during 2004-2012 in Guangzhou, China. In this regulatory context, characterized by rapid policy changes, corporate performance in VEPs is affected by government surveillance, policy uncertainty, and peer pressures. Specifically, if VEP participants have experienced more government surveillance, they tend to perform better in program implementation. Such positive influence of government surveillance is particularly evident among those joining under high and low, rather than moderate uncertainty. Participants also perform better if they belong to an industry with more certified VEP firms, but worse if they are located in a regulatory jurisdiction with more certified VEP firms. At a moderate level of policy uncertainty, within-industry imitation is most likely to occur but within-jurisdiction imitation is least likely to occur. Copyright © 2018 Elsevier Ltd. All rights reserved.

  11. 77 FR 56239 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-12

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

  12. 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

  13. Personal Protective Equipment in Animal Research

    PubMed Central

    Villano, Jason S; Follo, Janet M; Chappell, Mark G; Jr, Morris T Collins

    2017-01-01

    The occupational health and safety program is an integral component of a comprehensive animal care and use program. It is important to mitigate the risk of exposures of animal care and research personnel to allergens and physical, chemical, radiologic, and biologic hazards during the conduct of various tasks. This need is especially true in infectious disease and biocontainment research. One aspect of the program is the provision of personal protective equipment (PPE). Commercially available PPE should be carefully evaluated based on their material composition and performance according to manufacturer data. To help institutions and end users by providing them guidance on choosing appropriate PPE, we here discuss the regulatory framework, device standards, and materials engineering for various PPE, including gloves, shoe covers, head caps, gowns, aprons, masks, hearing and eye protection devices, and respirators. Ultimately, the choice of appropriate PPE is based on the risk assessment, which should include consideration for personnel comfort, correct device fitting, and the containment level for the hazard used. PMID:28662749

  14. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins, Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency cooperation that is vital to supporting NASA's mission.

  15. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency cooperation that is vital to supporting NASA's mission.

  16. Alaska | Midmarket Solar Policies in the United States | Solar Research |

    Science.gov Websites

    developers may offer community solar programs. State Incentive Programs Program Administrator Incentive decisions. Utility Incentive Programs Check with local utilities for midscale solar incentives. Resources and utility policies and incentive programs. Net Metering and Interconnection Regulatory Commission of

  17. 20 CFR 669.560 - Are there regulatory and/or statutory waiver provisions that apply to WIA section 167?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION, DEPARTMENT OF LABOR NATIONAL FARMWORKER JOBS PROGRAM UNDER TITLE I OF THE WORKFORCE INVESTMENT ACT Performance Accountability, Planning and Waiver Provision § 669.560 Are there regulatory and/or...

  18. Meta-Analysis of Single-Case Design Research on Self-Regulatory Interventions for Academic Performance

    ERIC Educational Resources Information Center

    Perry, Valerie; Albeg, Loren; Tung, Catherine

    2012-01-01

    The current study examined the effects of self-regulatory interventions on reading, writing, and math by conducting a meta-analysis of single-case design research. Self-regulatory interventions have promise as an effective approach that is both minimally invasive and involves minimal resources. Effects of the interventions were analyzed by…

  19. 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…

  20. Preliminary results of the U.S. Nuclear Regulatory Commission collaborative research program to assess tsunami hazard for nuclear power plants on the Atlantic and gulf coasts

    USGS Publications Warehouse

    Kammerer, A.M.; ten Brink, Uri S.; Twitchell, David C.; Geist, Eric L.; Chaytor, Jason D.; Locat, J.; Lee, H.J.; Buczkowski, Brian J.; Sansoucy, M.

    2008-01-01

    In response to the 2004 Indian Ocean Tsunami, the United States Nuclear Regulatory Commission (US NRC) initiated a long-term research program to improve understanding of tsunami hazard levels for nuclear facilities in the United States. For this effort, the US NRC organized a collaborative research program with the United States Geological Survey (USGS) and other key researchers for the purpose of assessing tsunami hazard on the Atlantic and Gulf Coasts of the United States. The initial phase of this work consisted principally of collection, interpretation, and analysis of available offshore data and information. Necessarily, the US NRC research program includes both seismic- and landslide-based tsunamigenic sources in both the near and the far fields. The inclusion of tsunamigenic landslides, an important category of sources that impact tsunami hazard levels for the Atlantic and Gulf Coasts over the long time periods of interest to the US NRC is a key difference between this program and most other tsunami hazard assessment programs. Although only a few years old, this program is already producing results that both support current US NRC activities and look toward the long-term goal of probabilistic tsunami hazard assessment. This paper provides a summary of results from several areas of current research. An overview of the broader US NRC research program is provided in a companion paper in this conference.

  1. Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research.

    PubMed

    Huang, Elaine; Cauley, Jacqueline; Wagner, Jennifer K

    2017-04-01

    In 2015, President Obama announced plans for the Precision Medicine Initiative ® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of Us SM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program-to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare-might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participants who become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies-developed under a protectionist paradigm in response to scandalous research practices with confined populations-dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined, and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement, and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities, and increase levels of distrust in science.

  2. The planarian regeneration transcriptome reveals a shared but temporally shifted regulatory program between opposing head and tail scenarios.

    PubMed

    Kao, Damian; Felix, Daniel; Aboobaker, Aziz

    2013-11-16

    Planarians can regenerate entire animals from a small fragment of the body. The regenerating fragment is able to create new tissues and remodel existing tissues to form a complete animal. Thus different fragments with very different starting components eventually converge on the same solution. In this study, we performed an extensive RNA-seq time-course on regenerating head and tail fragments to observe the differences and similarities of the transcriptional landscape between head and tail fragments during regeneration. We have consolidated existing transcriptomic data for S. mediterranea to generate a high confidence set of transcripts for use in genome wide expression studies. We performed a RNA-seq time-course on regenerating head and tail fragments from 0 hours to 3 days. We found that the transcriptome profiles of head and tail regeneration were very different at the start of regeneration; however, an unexpected convergence of transcriptional profiles occurred at 48 hours when head and tail fragments are still morphologically distinct. By comparing differentially expressed transcripts at various time-points, we revealed that this divergence/convergence pattern is caused by a shared regulatory program that runs early in heads and later in tails.Additionally, we also performed RNA-seq on smed-prep(RNAi) tail fragments which ultimately fail to regenerate anterior structures. We find the gene regulation program in response to smed-prep(RNAi) to display the opposite regulatory trend compared to the previously mentioned share regulatory program during regeneration. Using annotation data and comparative approaches, we also identified a set of approximately 4,800 triclad specific transcripts that were enriched amongst the genes displaying differential expression during the regeneration time-course. The regeneration transcriptome of head and tail regeneration provides us with a rich resource for investigating the global expression changes that occurs during regeneration. We show that very different regenerative scenarios utilize a shared core regenerative program. Furthermore, our consolidated transcriptome and annotations allowed us to identity triclad specific transcripts that are enriched within this core regulatory program. Our data support the hypothesis that both conserved aspects of animal developmental programs and recent evolutionarily innovations work in concert to control regeneration.

  3. Advancing Vocational Education Through Research and Development.

    ERIC Educational Resources Information Center

    Bureau of Occupational and Adult Education (DHEW/OE), Washington, DC. Div. of Research and Demonstration.

    This report contains information about the legislative and regulatory framework for Section 131 (a) of part C of the U.S. Commissioner of Education's Vocational Education Research Programs; the planning and its procedures leading to the determination of the program priority areas for fiscal year 1976 and the transition quarter; the processes used…

  4. Federal Highway Administration Research and Technology National Household Travel Survey Program

    DOT National Transportation Integrated Search

    2017-08-01

    This evaluation of the National Household Travel Survey (NHTS) Program addresses three key questions: 1) What is the breadth and depth of NHTS usage? 2) What impact does the NHTS Program have on policy, project, or regulatory decision making? 3) How ...

  5. When do chronic differences in self-regulation count? Regulatory focus effects in easy and difficult soccer tasks.

    PubMed

    Vogel, Tobias; Genschow, Oliver

    2013-04-01

    Research on regulatory focus theory (Higgins, 1997) suggests that performance increases if instructions fit with sportspersons' dispositions. Sportspersons who chronically focus on wins (i.e., promotion-oriented individuals) perform best if instructions frame the objective as a promotion goal (e.g., "Try to hit!"). By contrast, sportspersons who chronically focus on losses (i.e., prevention-oriented individuals) perform best if instructions frame the objective as a prevention goal (e.g., "Try not to miss!"). Recent theorizing also suggests that regulatory focus interacts with task difficulty. In an experiment, we assessed soccer performance as a function of chronic focus, instructional focus, and task difficulty. Results support that task difficulty moderates the effects of fit on performance; fitting instructions to match the sportsperson's chronic regulatory focus improved performance in the easy rather than the difficult task. Findings are discussed regarding the role of regulatory fit in altering subjective pressure during sports performance.

  6. California's program: Indoor air problems aren't amenable to regulation

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

    Wesolowski, J.

    In 1982, California's legislature established an Indoor Air Quality Program (CIAQP) in the Department of Health Services to carry out research on the nature and extent of the indoor air problem (excluding industrial worksites), to find appropriate mitigation measures, and to promote and coordinate the efforts of other state agencies. Since indoor air problems usually are not amenable to regulatory solutions, regulatory authority was not included in the mandate. The program conducts research into a wide range of contaminants--radon, asbestos, formaldehyde, carbon monoxide, volatile organic compounds, environmental tobacco smoke (ETS), as well as into biological aerosols that cause such diseasesmore » as Legionnaires disease, tuberculosis, allergies, and asthma. Studies are also carried out to better understand the Sick Building Syndrome. The research includes field surveys to determine the exposure of the population to specific contaminants and experiments in the laboratory to develop protocols for reducing exposures. The research emphasizes measurement of exposure--concentration multiplied by the time a person is exposed--as opposed to measurement of concentration only.« less

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

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

  8. Assessment of Current Inservice Inspection and Leak Monitoring Practices for Detecting Materials Degradation in Light Water Reactors

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

    Anderson, Michael T.; Simonen, Fredric A.; Muscara, Joseph

    2016-09-01

    An assessment was performed to determine the effectiveness of existing inservice inspection (ISI) and leak monitoring techniques, and recommend improvements, as necessary, to the programs as currently performed for light water reactor (LWR) components. Information from nuclear power plant (NPP) aging studies and from the U. S. Nuclear Regulatory Commission’s Generic Aging Lessons Learned (GALL) report (NUREG-1801) was used to identify components that have already experienced, or are expected to experience, degradation. This report provides a discussion of the key aspects and parameters that constitute an effective ISI program and a discussion of the basis and background against which themore » effectiveness of the ISI and leak monitoring programs for timely detection of degradation was evaluated. Tables based on the GALL components were used to systematically guide the process, and table columns were included that contained the ISI requirements and effectiveness assessment. The information in the tables was analyzed using histograms to reduce the data and help identify any trends. The analysis shows that the overall effectiveness of the ISI programs is very similar for both boiling water reactors (BWRs) and pressurized water reactors (PWRs). The evaluations conducted as part of this research showed that many ISI programs are not effective at detecting degradation before its extent reached 75% of the component wall thickness. This work should be considered as an assessment of NDE practices at this time; however, industry and regulatory activities are currently underway that will impact future effectiveness assessments. A number of actions have been identified to improve the current ISI programs so that degradation can be more reliably detected.« less

  9. An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies

    PubMed Central

    Beaver, Julia A.; Tzou, Abraham; Blumenthal, Gideon M.; McKee, Amy E.; Kim, Geoffrey; Pazdur, Richard; Philip, Reena

    2016-01-01

    As technologies evolve, and diagnostics move from detection of single biomarkers toward complex signatures, an increase in the clinical use and regulatory submission of complex signatures is anticipated. However, to date, no complex signatures have been approved as companion diagnostics. In this article, we will describe the potential benefit of complex signatures and their unique regulatory challenges including analytical performance validation, complex signature simulation, and clinical performance evaluation. We also will review the potential regulatory pathways for clearance, approval, or acceptance of complex signatures by the U.S. Food and Drug Administration (FDA). These regulatory pathways include regulations applicable to in vitro diagnostic devices, including companion diagnostic devices, the potential for labeling as a complementary diagnostic, and the biomarker qualification program. PMID:27993967

  10. Implementing a Comprehensive Research Compliance Program: A Handbook for Research Officers

    ERIC Educational Resources Information Center

    Dade, Aurali, Ed.; Olafson, Lori, Ed.; DiBella, Suzan M., Ed.

    2015-01-01

    The senior research compliance administrator has emerged as a critically important position as universities and other research organizations face an increasingly intricate regulatory environment. These administrators are tasked with a special challenge: ensuring that their institutions conduct safe, ethical, and compliant research while also…

  11. Assessing the satisfaction and burden within an academic animal care and use program.

    PubMed

    Norton, John N; Reynolds, Randall P; Chan, Cliburn; Valdivia, Raphael H; Staats, Herman F

    2017-09-01

    Although animal research requires adherence to various regulations and standards, the manner in which compliance is maintained and the degree of additional constraints varies between institutions. Regulatory burden, particularly if institutionally imposed, has become a concern for institutions as increased regulatory expectations result in decreased resources available for research efforts. Faculty, research staff, and support staff engaged in animal research were surveyed to determine what institutional animal care and use committee (IACUC) processes were considered burdensome, the perceived value of some suggested modifications, and satisfaction with the IACUC administrative office and the animal resource unit. Although the results revealed overwhelming satisfaction with the IACUC administrative office and the animal resource unit, several IACUC processes were deemed burdensome, and therefore there would be value in modifying IACUC processes. When comparing the value of modifying IACUC processes, different groups within the animal care and use program (ACUP) tended to have different responses on many of the topics. This survey identified several perceived burdensome IACUC processes that would likely benefit individuals if modified. In today's environment of shrinking budgets for biomedical research, minimizing regulatory burden-particularly unnecessary, self-imposed burden-in the ACUP is particularly important to ensure that costs, time, and effort are appropriate to achieve animal welfare and quality of research endeavors.-Norton, J. N., Reynolds, R. P., Chan, C., Valdivia, R. H., Staats, H. F. Assessing the satisfaction and burden within an academic animal care and use program. © FASEB.

  12. Quality assurance and quality improvement in U.S. clinical molecular genetic laboratories.

    PubMed

    Chen, Bin; Richards, C Sue; Wilson, Jean Amos; Lyon, Elaine

    2011-04-01

    A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing. 2011 by John Wiley & Sons, Inc.

  13. OVERVIEW OF ECOTOXICOLOGY RESEARCH PROGRAMS AND MEDAKA RESEARCH AT THE US EPA NATIONAL HEALTH AND ENVIRONMENTAL EFFECTS LABORATORY'S MID-CONTINENT ECOLOGY DIVISION

    EPA Science Inventory

    The US Environmental Protection Agency is a regulatory agency of the federal government whose mission it is to protect human health and to safeguard the natural environment -- air, water, land -- upon which life depends. The EPA has several Program and Regional Offices that for...

  14. An integrative and applicable phylogenetic footprinting framework for cis-regulatory motifs identification in prokaryotic genomes.

    PubMed

    Liu, Bingqiang; Zhang, Hanyuan; Zhou, Chuan; Li, Guojun; Fennell, Anne; Wang, Guanghui; Kang, Yu; Liu, Qi; Ma, Qin

    2016-08-09

    Phylogenetic footprinting is an important computational technique for identifying cis-regulatory motifs in orthologous regulatory regions from multiple genomes, as motifs tend to evolve slower than their surrounding non-functional sequences. Its application, however, has several difficulties for optimizing the selection of orthologous data and reducing the false positives in motif prediction. Here we present an integrative phylogenetic footprinting framework for accurate motif predictions in prokaryotic genomes (MP(3)). The framework includes a new orthologous data preparation procedure, an additional promoter scoring and pruning method and an integration of six existing motif finding algorithms as basic motif search engines. Specifically, we collected orthologous genes from available prokaryotic genomes and built the orthologous regulatory regions based on sequence similarity of promoter regions. This procedure made full use of the large-scale genomic data and taxonomy information and filtered out the promoters with limited contribution to produce a high quality orthologous promoter set. The promoter scoring and pruning is implemented through motif voting by a set of complementary predicting tools that mine as many motif candidates as possible and simultaneously eliminate the effect of random noise. We have applied the framework to Escherichia coli k12 genome and evaluated the prediction performance through comparison with seven existing programs. This evaluation was systematically carried out at the nucleotide and binding site level, and the results showed that MP(3) consistently outperformed other popular motif finding tools. We have integrated MP(3) into our motif identification and analysis server DMINDA, allowing users to efficiently identify and analyze motifs in 2,072 completely sequenced prokaryotic genomes. The performance evaluation indicated that MP(3) is effective for predicting regulatory motifs in prokaryotic genomes. Its application may enhance progress in elucidating transcription regulation mechanism, thus provide benefit to the genomic research community and prokaryotic genome researchers in particular.

  15. Innovation in organ transplantation: A meeting report.

    PubMed

    Fishman, Jay A; Greenwald, Melissa

    2018-05-09

    This workshop targeted opportunities to stimulate transformative innovation in organ transplantation. Participants reached consensus regarding the following: (1) Mechanisms are needed to improve the coordination of policy and oversight activities, given overlapping responsibilities for transplantation and clinical investigation among federal agencies. Innovative clinical trials span traditional administrative boundaries and include stakeholders with diverse interests. Participants identified the need for a governmental interagency working group to coordinate nationwide transplant-related activities. (2) Improvements are required in clinical metrics for transplantation, with alignment of performance goals across transplantation organizations and any development of data requirements being consistent with those goals. Database coordination among clinical centers, organ procurement organizations, regulatory agencies, and payers would facilitate research and better inform policy. New data requirements should provide actionable insights into clinical performance. (3) Innovative research seen as potentially adversely affecting Program-Specific Reports may reduce centers' participation. Cutting-edge research requires mitigation of risk-aversive behaviors created by reporting of clinical outcomes data. Participants proposed a new review process in advance of implementation of clinical trials to guide "carve-outs" of transplant center outcomes data from Program-Specific Reports. Clinical transplantation will be advanced by the development of a shared and comprehensive research agenda to facilitate coordination of research and policy. © 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.

  16. Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.

    PubMed

    Scully, Christopher G; Forrest, Shawn; Galeotti, Loriano; Schwartz, Suzanne B; Strauss, David G

    2015-04-01

    The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients. Published by Elsevier Inc.

  17. A 10-Year Review of the Food Science Summer Scholars Program: A Model for Research Training and for Recruiting Undergraduate Students into Graduate Programs and Careers in Food Science

    ERIC Educational Resources Information Center

    Roberts, Angela J.; Robbins, Janette; McLandsborough, Lynne; Wiedmann, Martin

    2010-01-01

    A pressing problem facing regulatory agencies, academia, and the food industry is a shortage of qualified food science graduates, particularly those with advanced degrees (that is, M.S. or Ph.D.). In 2000, the Cornell Institute of Food Science established the annual Food Science Summer Scholars Program as an experiential summer research program…

  18. Office of River Protection Advanced Low-Activity Waste Glass Research and Development Plan

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

    Kruger, A. A.; Peeler, D. K.; Kim, D. S.

    2015-11-23

    The U.S. Department of Energy Office of River Protection (ORP) has initiated and leads an integrated Advanced Waste Glass (AWG) program to increase the loading of Hanford tank wastes in glass while meeting melter lifetime expectancies and process, regulatory, and product performance requirements. The integrated ORP program is focused on providing a technical, science-based foundation for making key decisions regarding the successful operation of the Hanford Tank Waste Treatment and Immobilization Plant (WTP) facilities in the context of an optimized River Protection Project (RPP) flowsheet. The fundamental data stemming from this program will support development of advanced glass formulations, keymore » product performance and process control models, and tactical processing strategies to ensure safe and successful operations for both the low-activity waste (LAW) and high-level waste vitrification facilities. These activities will be conducted with the objective of improving the overall RPP mission by enhancing flexibility and reducing cost and schedule.« less

  19. 7 CFR 3415.15 - Evaluation factors.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AGRICULTURE BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM Scientific Peer Review of Research Grant...; and (7) Appropriateness to regulation of biotechnology and risk assessment. (b) Qualifications of... personnel, facilities, and instrumentation. (c) Relevance of project to solving biotechnology regulatory...

  20. 78 FR 58385 - Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ... ResDAC Research Data Assistance Center RIA Regulatory Impact Analysis RHC Rural Health Clinic SNF... Community Health Applied Research Network. We believe that the proposals in this proposed rule benefited...

  1. The Use of Frames Analysis in Evaluating Capacity-Building in Local Coastal Programs in Louisiana

    ERIC Educational Resources Information Center

    Norris-Raynbird, Carla

    2008-01-01

    Frames theory has been widely used to explain the dynamics of group processes and decision-making. Some researchers have applied frames theory to policy adoption and implementation. Following from this, my research applies frames analysis to a regulatory program in coastal Louisiana. The data derive from a pre-Hurricane Katrina study of the…

  2. REAL-TIME MONITORING OF DIOXINS AND OTHER ...

    EPA Pesticide Factsheets

    This project is part of EPA's EMPACT program which was begun in 1998 and is jointly administered by EPA's Office of Research and Development, the National Center for Environmental Research and Quality Assurance (NCERQA), and the National Center for Environmental Assessment. The program was developed to provide understandable environmental information on various research initiatives to the public in a timely manner on various issues of importance. This particular project involves development of the application of an on-line, real time, trace organic air toxic monitor, with special emphasis on dioxin-related compounds. Research efforts demonstrate the utility and usefulness of the Resonance Enhanced Multi-Photon Ionization (REMPI) analytical method for trace organics control, monitoring, and compliance assurance. Project objectives will be to develop the REMPI instrumental method into a tool that will be used for assessment of potential dioxin sources, control and prevention of dioxin formation in known sources, and communication of facility performance. This will be accomplished through instrument development, laboratory verification, thermokinetic modelling, equilibrium modelling, statistical determinations, field validation, program publication and presentation, regulatory office support, and development of data communication/presentation procedures. For additional information on this EMPACT project, visit the website at http://www.epa.gov/appcdwww/crb/empa

  3. JV Task 92 - Alcoa/Retec SFE and SPME

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

    Steven Hawthorne

    2009-02-15

    This report summarizes the work performed by the Energy & Environmental Research Center (EERC) under the U.S. Department of Energy Jointly Sponsored Research Program JV Task 92, which is a continuation of JV9. Successful studies performed in 1999 through the end of 2008 demonstrated the potential for using selective supercritical fluid extraction (SFE) and a solid-phase microextraction (SPME) method for measuring sediment pore water polycyclic aromatic hydrocarbons (PAHs) to mimic the bioavailability of PAHs from manufactured gas plant and aluminum smelter soils and sediments both in freshwater and saltwater locations. The studies that the EERC has performed with the commercialmore » partners have continued to generate increased interest in both the regulatory communities and in the industries that have historically produced or utilized coal tar products. Both ASTM International and the U.S. Environmental Protection Agency (EPA) have accepted the pore water method developed at the EERC as standard methods. The studies have demonstrated the effectiveness of our techniques in predicting bioavailability of PAHs from ca. 250 impacted and background field sediments and soils. The field demonstrations from the final years of the project continued to build the foundation data for acceptance of our methods by the regulatory communities. The JV92 studies provide the single largest database in the world that includes measures of PAH bioavailability along with biological end points. These studies clearly demonstrated that present regulatory paradigms based on equilibrium partitioning greatly overpredict bioavailability. These investigations also laid the foundation for present (non-JV) studies being applied to PAHs and polychlorinated biphenyls (PCBs) at EPA Superfund sites, investigations into PAH and PCB bioavailability at U.S Department of Defense sites, and the application of the techniques to investigating the bioavailability of chlorinated dioxins and furans from impacted sediments.« less

  4. 10 CFR 26.415 - Audits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Audits. 26.415 Section 26.415 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.415 Audits. (a) Licensees and other entities who implement an FFD program under this subpart shall ensure that audits are performed to assure...

  5. 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.

  6. 76 FR 37766 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-28

    ..., Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), [email protected] Agricultural Research Service Title: Supplemental Nutrition Assistance Program Connection Resource Sharing Form... Supplemental Nutrition Assistance Program (SNAP) and the Food Stamp Nutrition Connection became the SNAP-ED...

  7. ORNL Remedial Action Program strategy (FY 1987-FY 1992)

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

    Trabalka, J.R.; Myrick, T.E.

    1987-12-01

    Over 40 years of Oak Ridge National Laboratory (ORNL) operations have produced a diverse legacy of contaminated inactive facilities, research areas, and waste disposal areas that are potential candidates for remedial action. The ORNL Remedial Action Program (RAP) represents a comprehensive effort to meet new regulatory requirements and ensure adequate protection of on-site workers, the public, and the environment by providing appropriate corrective measures at over 130 sites contaminated historically with radioactive, hazardous chemical, or mixed wastes. A structured path of program planning, site characterization, alternatives assessment, technology development, engineering design, continued site maintenance and surveillance, interim corrective action, andmore » eventual site closure or decommissioning is required to meet these objectives. This report documents the development of the Remedial Action Program, through its preliminary characterization, regulatory interface, and strategy development activities. It provides recommendations for a comprehensive, long-term strategy consistent with existing technical, institutional, and regulatory information, along with a six-year plan for achieving its initial objectives. 53 refs., 8 figs., 12 tabs.« less

  8. 75 FR 18575 - Mandatory Reporting of Greenhouse Gases: Injection and Geologic Sequestration of Carbon Dioxide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... perfluorocarbon QA/QC quality assurance/quality control R&D research and development RFA Regulatory Flexibility... Climate Change.'' Joint Global Change Research Institute, Battelle Pacific Northwest Division. PNWD-3602... research, demonstration, and deployment programs throughout the world, are building confidence that...

  9. 77 FR 74347 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... regulation, CIGIE adhered to the regulatory philosophy and the applicable principles of regulation as set... research (if the request is from an educational institution) or scientific research (if the request is from... operating one or more programs of scholarly research. (2) The term ``non-commercial scientific institution...

  10. 77 FR 42673 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-20

    .... 552). In issuing this regulation, CIGIE adhered to the regulatory philosophy and the applicable... research (if the request is from an educational institution) or scientific research (if the request is from... operating one or more programs of scholarly research. (2) The term ``non-commercial scientific institution...

  11. The impact of mindfulness education on elementary school students: Evaluation of the Master Mind Program

    PubMed Central

    Parker, Alison E.; Kupersmidt, Janis B.; Mathis, Erin T.; Scull, Tracy M.; Sims, Calvin

    2016-01-01

    Children need to be equipped with the skills to respond effectively to stress and prevent poor decision-making surrounding alcohol and tobacco use. Training and practice in mindfulness is one possible avenue for building children's skills. Recent research has revealed that mindfulness education in the classroom may play a role in enhancing children's self-regulatory abilities. Thus, the goal of the current study was to extend existing research in mindfulness education in classrooms and conduct an assessment of the feasibility and effectiveness of a new mindfulness education, substance abuse prevention program for 4th and 5th grade children (Master Mind). Two elementary schools were randomly assigned to be an intervention group (N = 71) or waitlist control group (N = 40). Students in the intervention group were taught the four-week Master Mind program by their regular classroom teachers. At pre- and post-intervention time points, students completed self-reports of their intentions to use substances and an executive functioning performance task. Teachers rated students on their behavior in the classroom. Findings revealed that students who participated in the Master Mind program, as compared to those in the wait-list control condition, showed significant improvements in executive functioning skills (girls and boys), as well as a marginally significant increase in self-control abilities (boys only). In addition, significant reductions were found in aggression and social problems (girls and boys), as well as anxiety (girls only). No significant differences across groups were found for intentions to use alcohol or tobacco. Teachers implemented the program with fidelity; both teachers and students positively rated the structure and content of the Master Mind program, providing evidence of program satisfaction and feasibility. Although generalization may be limited by the small sample size, the findings suggest that mindfulness education may be beneficial in increasing self-regulatory abilities, which is important for substance abuse prevention. PMID:27057208

  12. The impact of mindfulness education on elementary school students: Evaluation of the Master Mind Program.

    PubMed

    Parker, Alison E; Kupersmidt, Janis B; Mathis, Erin T; Scull, Tracy M; Sims, Calvin

    Children need to be equipped with the skills to respond effectively to stress and prevent poor decision-making surrounding alcohol and tobacco use. Training and practice in mindfulness is one possible avenue for building children's skills. Recent research has revealed that mindfulness education in the classroom may play a role in enhancing children's self-regulatory abilities. Thus, the goal of the current study was to extend existing research in mindfulness education in classrooms and conduct an assessment of the feasibility and effectiveness of a new mindfulness education, substance abuse prevention program for 4 th and 5 th grade children ( Master Mind ). Two elementary schools were randomly assigned to be an intervention group (N = 71) or waitlist control group (N = 40). Students in the intervention group were taught the four-week Master Mind program by their regular classroom teachers. At pre- and post-intervention time points, students completed self-reports of their intentions to use substances and an executive functioning performance task. Teachers rated students on their behavior in the classroom. Findings revealed that students who participated in the Master Mind program, as compared to those in the wait-list control condition, showed significant improvements in executive functioning skills (girls and boys), as well as a marginally significant increase in self-control abilities (boys only). In addition, significant reductions were found in aggression and social problems (girls and boys), as well as anxiety (girls only). No significant differences across groups were found for intentions to use alcohol or tobacco. Teachers implemented the program with fidelity; both teachers and students positively rated the structure and content of the Master Mind program, providing evidence of program satisfaction and feasibility. Although generalization may be limited by the small sample size, the findings suggest that mindfulness education may be beneficial in increasing self-regulatory abilities, which is important for substance abuse prevention.

  13. Environmental exposures and health impacts of PFAS ...

    EPA Pesticide Factsheets

    Environmental exposures and health impacts of PFAS The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  14. The role of research and development on safety regulation

    DOT National Transportation Integrated Search

    1995-10-01

    A review of regulatory actions taken by the Federal Aviation Administration (FAA) over approximately the past thirty years was made to identify which of these actions were preceded by or triggered by research and development (R&D) programs. The focus...

  15. Full-Scale Cask Testing and Public Acceptance of Spent Nuclear Fuel Shipments - 12254

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

    Dilger, Fred; Halstead, Robert J.; Ballard, James D.

    Full-scale physical testing of spent fuel shipping casks has been proposed by the National Academy of Sciences (NAS) 2006 report on spent nuclear fuel transportation, and by the Presidential Blue Ribbon Commission (BRC) on America's Nuclear Future 2011 draft report. The U.S. Nuclear Regulatory Commission (NRC) in 2005 proposed full-scale testing of a rail cask, and considered 'regulatory limits' testing of both rail and truck casks (SRM SECY-05-0051). The recent U.S. Department of Energy (DOE) cancellation of the Yucca Mountain project, NRC evaluation of extended spent fuel storage (possibly beyond 60-120 years) before transportation, nuclear industry adoption of very largemore » dual-purpose canisters for spent fuel storage and transport, and the deliberations of the BRC, will fundamentally change assumptions about the future spent fuel transportation system, and reopen the debate over shipping cask performance in severe accidents and acts of sabotage. This paper examines possible approaches to full-scale testing for enhancing public confidence in risk analyses, perception of risk, and acceptance of spent fuel shipments. The paper reviews the literature on public perception of spent nuclear fuel and nuclear waste transportation risks. We review and summarize opinion surveys sponsored by the State of Nevada over the past two decades, which show consistent patterns of concern among Nevada residents about health and safety impacts, and socioeconomic impacts such as reduced property values along likely transportation routes. We also review and summarize the large body of public opinion survey research on transportation concerns at regional and national levels. The paper reviews three past cask testing programs, the way in which these cask testing program results were portrayed in films and videos, and examines public and official responses to these three programs: the 1970's impact and fire testing of spent fuel truck casks at Sandia National Laboratories, the 1980's regulatory and demonstration testing of MAGNOX fuel flasks in the United Kingdom (the CEGB 'Operation Smash Hit' tests), and the 1980's regulatory drop and fire tests conducted on the TRUPACT II containers used for transuranic waste shipments to the Waste Isolation Pilot Plant in New Mexico. The primary focus of the paper is a detailed evaluation of the cask testing programs proposed by the NRC in its decision implementing staff recommendations based on the Package Performance Study, and by the State of Nevada recommendations based on previous work by Audin, Resnikoff, Dilger, Halstead, and Greiner. The NRC approach is based on demonstration impact testing (locomotive strike) of a large rail cask, either the TAD cask proposed by DOE for spent fuel shipments to Yucca Mountain, or a similar currently licensed dual-purpose cask. The NRC program might also be expanded to include fire testing of a legal-weight truck cask. The Nevada approach calls for a minimum of two tests: regulatory testing (impact, fire, puncture, immersion) of a rail cask, and extra-regulatory fire testing of a legal-weight truck cask, based on the cask performance modeling work by Greiner. The paper concludes with a discussion of key procedural elements - test costs and funding sources, development of testing protocols, selection of testing facilities, and test peer review - and various methods of communicating the test results to a broad range of stakeholder audiences. (authors)« less

  16. Motivation and Career-Development Training Programs: Use of Regulatory Focus to Determine Program Effectiveness

    ERIC Educational Resources Information Center

    Anthony, Peter J.; Weide, Jeffrey

    2015-01-01

    The purpose of this study was to focus on the relationship between career-development training programs and the motivation of employees. The study used a qualitative method and a phenomenological design using semistructured interviews conducted with a script of open-ended questions. Two main components of the research design were the modified van…

  17. 75 FR 81120 - North Dakota Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... North Dakota's program and program amendments at 30 CFR 934.15, 934.16, and 934.30. II. Submission of... proposes revisions to the North Dakota Century Code at Chapter 38-14.1-24(18) (Environmental protection... applications--operation plans--maps and plans) and Article 69-05.2-22-07(2) and (4)(i) (Performance standards...

  18. Performance Assessment Program for the Savannah River Site Liquid Waste Facilities - 13610

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

    Rosenberger, Kent H.

    2013-07-01

    The Liquid Waste facilities at the U.S. Department of Energy's (DOE) Savannah River Site (SRS) are operated by Liquid Waste Operations contractor Savannah River Remediation LLC (SRR). A separate Performance Assessment (PA) is prepared to support disposal operations at the Saltstone Disposal Facility and closure evaluations for the two liquid waste tank farm facilities at SRS, F-Tank Farm and H-Tank Farm. A PA provides the technical basis and results to be used in subsequent documents to demonstrate compliance with the pertinent requirements identified in operations and closure regulatory guidance. The Saltstone Disposal Facility is subject to a State of Southmore » Carolina industrial solid waste landfill permit and the tank farms are subject to a state industrial waste water permit. The three Liquid Waste facilities are also subject to a Federal Facility Agreement approved by the State, DOE and the Environmental Protection Agency (EPA). Due to the regulatory structure, a PA is a key technical document reviewed by the DOE, the State of South Carolina and the EPA. As the waste material disposed of in the Saltstone Disposal Facility and the residual material in the closed tank farms is also subject to reclassification prior to closure via a waste determination pursuant to Section 3116 of the Ronald W. Reagan National Defense Authorization Act of Fiscal Year 2005, the U.S. Nuclear Regulatory Commission (NRC) is also a reviewing agency for the PAs. Pursuant to the Act, the NRC also has a continuing role to monitor disposal actions to assess compliance with stated performance objectives. The Liquid Waste PA program at SRS represents a continual process over the life of the disposal and closure operations. When the need for a PA or PA revision is identified, the first step is to develop a conceptual model to best represent the facility conditions. The conceptual model will include physical dimensions of the closed system, both the engineered and natural system, and modeling input parameters associated with the modeled features, both initial values (at the time of facility closure) and degradation rates/values. During the development of the PA, evaluations are conducted to reflect not only the results associated with the best available information at the time but also to evaluate potential uncertainties and sensitivities associated with the modeled system. While the PA will reflect the modeled system results from the best available information, it will also identify areas for future work to reduce overall PA uncertainties moving forward. DOE requires a PA Maintenance Program such that work continues to reduce model uncertainties, thus bolstering confidence in PA results that support regulatory decisions. This maintenance work may include new Research and Development activities or modeling as informed by previous PA results and other new information that becomes available. As new information becomes available, it is evaluated against previous PAs and appropriate actions are taken to ensure continued confidence in the regulatory decisions. Therefore, the PA program is a continual process that is not just the development of a PA but seeks to incorporate new information to reduce overall model uncertainty and provide continuing confidence in regulatory decisions. (author)« less

  19. 78 FR 23960 - Annual Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... Medical Evidence Development and Surveillance (IMEDS) Program, methods for using observational electronic... research projects to advance regulatory science. The Foundation acts as a neutral third party to establish...

  20. Overview of the U.S. Nuclear Regulatory Commission collaborative research program to assess tsunami hazard for nuclear power plants on the Atlantic and Gulf Coasts

    USGS Publications Warehouse

    Kammerer, A.M.; ten Brink, Uri S.; Titov, V.V.

    2017-01-01

    In response to the 2004 Indian Ocean Tsunami, the United States Nuclear Regulatory Commission (US NRC) initiated a long-term research program to improve understanding of tsunami hazard levels for nuclear facilities in the United States. For this effort, the US NRC organized a collaborative research program with the United States Geological Survey (USGS) and the National Oceanic and Atmospheric Administration (NOAA) with a goal of assessing tsunami hazard on the Atlantic and Gulf Coasts of the United States. Necessarily, the US NRC research program includes both seismic- and landslide-based tsunamigenic sources in both the near and the far fields. The inclusion of tsunamigenic landslides, an important category of sources that impact tsunami hazard levels for the Atlantic and Gulf Coasts is a key difference between this program and most other tsunami hazard assessment programs. The initial phase of this work consisted of collection, interpretation, and analysis of available offshore data, with significant effort focused on characterizing offshore near-field landslides and analyzing their tsunamigenic potential and properties. In the next phase of research, additional field investigations will be conducted in key locations of interest and additional analysis will be undertaken. Simultaneously, the MOST tsunami generation and propagation model used by NOAA will first be enhanced to include landslide-based initiation mechanisms and then will be used to investigate the impact of the tsunamigenic sources identified and characterized by the USGS. The potential for probabilistic tsunami hazard assessment will also be explore in the final phases of the program.

  1. 30 CFR 810.3 - Authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Authority. 810.3 Section 810.3 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PERMANENT PROGRAM... operations performance standards and design requirements applicable under regulatory programs which are at...

  2. 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

  3. 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

  4. Transforming Research Management Systems at Mayo Clinic

    ERIC Educational Resources Information Center

    Smith, Steven C.; Gronseth, Darren L.

    2011-01-01

    In order for research programs at academic medical centers and universities to survive and thrive in the increasingly challenging economic, political and regulatory environment, successful transformation is extremely important. Transformation and quality management techniques are increasingly well established in medical practice organizations. In…

  5. 30 CFR 761.16 - Submission and processing of requests for valid existing rights determinations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) Requirements for property rights demonstration. You must provide a property rights demonstration under... matter Regulatory authority Regulatory program 2 (d) Public roads Does not matter Regulatory authority Regulatory program 2 (e) Occupied dwellings Does not matter Regulatory authority Regulatory program 2 (f...

  6. Performance Assessment Institute-NV

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

    Lombardo, Joesph

    2012-12-31

    The National Supercomputing Center for Energy and the Environment’s intention is to purchase a multi-purpose computer cluster in support of the Performance Assessment Institute (PA Institute). The PA Institute will serve as a research consortium located in Las Vegas Nevada with membership that includes: national laboratories, universities, industry partners, and domestic and international governments. This center will provide a one-of-a-kind centralized facility for the accumulation of information for use by Institutions of Higher Learning, the U.S. Government, and Regulatory Agencies and approved users. This initiative will enhance and extend High Performance Computing (HPC) resources in Nevada to support critical nationalmore » and international needs in "scientific confirmation". The PA Institute will be promoted as the leading Modeling, Learning and Research Center worldwide. The program proposes to utilize the existing supercomputing capabilities and alliances of the University of Nevada Las Vegas as a base, and to extend these resource and capabilities through a collaborative relationship with its membership. The PA Institute will provide an academic setting for interactive sharing, learning, mentoring and monitoring of multi-disciplinary performance assessment and performance confirmation information. The role of the PA Institute is to facilitate research, knowledge-increase, and knowledge-sharing among users.« less

  7. Student-Led Project Teams: Significance of Regulation Strategies in High- and Low-Performing Teams

    ERIC Educational Resources Information Center

    Ainsworth, Judith

    2016-01-01

    We studied group and individual co-regulatory and self-regulatory strategies of self-managed student project teams using data from intragroup peer evaluations and a postproject survey. We found that high team performers shared their research and knowledge with others, collaborated to advise and give constructive criticism, and demonstrated moral…

  8. 75 FR 60263 - Federal Acquisition Regulation; Offering a Construction Requirement-8(a) Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... geographical area where the work is to be performed. However, the SBA regulation requires the offering letters... September 30, 1993. This rule is not a major rule under 5 U.S.C. 804. B. Regulatory Flexibility Act The Regulatory Flexibility Act does not apply to this rule. This final rule does not constitute a significant FAR...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

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

  10. 77 FR 27075 - National Institute on Drug Abuse Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-08

    ... personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Regulatory..., Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS, Room 4227, MSC 9550, 6001... Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes...

  11. Postdoctoral pharmacy industry fellowships: a descriptive analysis of programs and postgraduate positions.

    PubMed

    Melillo, Stephanie; Gangadharan, Amy; Johnson, Hiliary; Schleck, Patrick; Steinberg, Michael; Alexander, James G

    2012-01-01

    Postdoctoral pharmacy industry fellowship programs and the employment of fellowship graduates are described. A list of postgraduate industry fellowships was gathered from the 2009 ASHP Midyear Clinical Meeting. Data regarding program characteristics were collected using the Personnel Placement Service database and program-specific brochures. After data compilation, a standardized survey was sent in January 2010 via e-mail to the point of contact for all programs to confirm the accuracy of the program's characteristics. Only academically affiliated industry fellowship programs were analyzed. Retrospective data were collected regarding the first position of employment for all fellows who graduated from the program between 2005 and 2009 and the position of those same individuals at the time of survey completion. Surveys were sent to 64 postgraduate industry fellowship programs affiliated with a school of pharmacy, 56 (87.5%) of whom responded. The departmental breakdown for positions offered (n = 75) across all academically affiliated industry fellowship programs (including nonresponders) was as follows: medical affairs (38.7%, n = 29), clinical research (32.0%, n = 24), regulatory affairs (9.3%, n = 7), commercial (8.0%, n = 6), health economics and outcomes research (8.0%, n = 6), and pharmacovigilance (4.0%, n = 3). Data from fellows during years 1-5 after completion of the industry fellowship indicated that 90.5% of former fellows remained in the industry (n = 238). The postgraduate industry fellowship programs surveyed indicated that the majority of fellowship graduates continued to hold positions in industry after program completion. The majority of industry fellowships and subsequent job placements occurred in the areas of medical affairs, clinical research, and regulatory affairs.

  12. Initiation of depleted uranium oxide and spent fuel testing for the spent fuel sabotage aerosol ratio program.

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

    Gregson, Michael Warren; Mo, Tin; Sorenson, Ken Bryce

    The authors provide a detailed overview of an on-going, multinational test program that is developing aerosol data for some spent fuel sabotage scenarios on spent fuel transport and storage casks. Experiments are being performed to quantify the aerosolized materials plus volatilized fission products generated from actual spent fuel and surrogate material test rods, due to impact by a high-energy-density device. The program participants in the United States plus Germany, France and the United Kingdom, part of the international Working Group for Sabotage Concerns of Transport and Storage Casks (WGSTSC) have strongly supported and coordinated this research program. Sandia National Laboratoriesmore » has the lead role for conducting this research program; test program support is provided by both the US Department of Energy and the US Nuclear Regulatory Commission. The authors provide a summary of the overall, multiphase test design and a description of all explosive containment and aerosol collection test components used. They focus on the recently initiated tests on 'surrogate' spent fuel, unirradiated depleted uranium oxide and forthcoming actual spent fuel tests, and briefly summarize similar results from completed surrogate tests that used non-radioactive, sintered cerium oxide ceramic pellets in test rods.« less

  13. How Analysis Informs Regulation:Success and Failure of ...

    EPA Pesticide Factsheets

    How Analysis Informs Regulation:Success and Failure of Evolving Approaches to Polyfluoroalkyl Acid Contamination The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  14. Developing Decontamination Tools and Approaches to ...

    EPA Pesticide Factsheets

    Developing Decontamination Tools and Approaches to Address Indoor Pesticide Contamination from Improper Bed Bug Treatments The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  15. A Method for Improved Interpretation of "Spot" Biomarker Data ...

    EPA Pesticide Factsheets

    A Method for Improved Interpretation of "Spot" Biomarker Data The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  16. 30 CFR 810.4 - Responsibility.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PERMANENT PROGRAM...) The Director shall ensure that performance standards and design requirements at least as stringent as... State regulatory authority shall ensure that performance standards and design requirements at least as...

  17. 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...

  18. 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...

  19. 77 FR 33253 - Regulatory Guide 8.33, Quality Management Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

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

  20. 7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

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

    PubMed

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

    2015-06-01

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

  2. The effects of age, glucose ingestion and gluco-regulatory control on episodic memory.

    PubMed

    Riby, Leigh Martin; Meikle, Andrew; Glover, Cheryl

    2004-09-01

    Previous research has been inconclusive regarding the impact of glucose ingestion and gluco-regulatory control on cognitive performance in healthy older adults. The aim of this research was to determine whether glucose specifically enhanced episodic memory in an older population. In addition, the link between individual differences in glucose regulation and the magnitude of the enhancement effect was examined. A within subjects, counterbalanced, crossover design was used with 20 participants (60-80 year olds), each serving as his/her control. Episodic memory was tested by presenting unrelated paired associates followed by immediate and delayed cued recall, and delayed recognition, under single and dual task conditions. In addition, a battery of cognitive tests was administered, including tests of semantic memory, working memory and speed of processing. Glucose ingestion was found to largely facilitate performance of episodic memory. Furthermore, subsidiary analyses found that gluco-regulatory efficiency predicted episodic memory performance in both control and glucose conditions. A boost in performance after glucose ingestion was particularly seen in the episodic memory domain. Notably, strong evidence was provided for the utility of gluco-regulatory control measures as indicators of cognitive decline in the elderly.

  3. 10 CFR 71.121 - Internal inspection.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...

  4. 10 CFR 71.121 - Internal inspection.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...

  5. 10 CFR 71.121 - Internal inspection.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...

  6. 10 CFR 71.121 - Internal inspection.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...

  7. 10 CFR 71.121 - Internal inspection.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... performed for each work operation where necessary to assure quality. If direct inspection of processed... REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Quality Assurance § 71... execute a program for inspection of activities affecting quality by or for the organization performing the...

  8. "I can be happy even when I lose the game": the influence of chronic regulatory focus and primed self-construal on exergamers' mood.

    PubMed

    Jin, Seung-A Annie

    2010-08-01

    This research explored the effects of priming interdependent self-construals (collective self ) versus independent self-construals (private self ) on exergame players' mood in response to negative performance feedback. An experiment was conducted to test the interaction effects of self-construal priming as a situational factor and game players' chronic regulatory focus as an individual difference factor. To this end, the author leveraged a video-game console (Wii) and an exergame (Dance Dance Revolution) in a controlled, randomized 2 x 2 (experimental priming: interdependent self-construal vs. independent self-construal x game players' chronic promotion regulatory focus: low vs. high) between-subjects factorial design experiment (N = 58). The results of a two-way analysis of variance demonstrated the proposed interaction effect between primed self-construal and game players' chronic regulatory focus on the game players' mood in response to negative performance. The theoretical mechanism underlying the two-way interaction is explicated by regulatory focus and the primed self-construals is explicated by regulatory focus theory and two-basket theory. Practical implications for game developers and theoretical contributions to video-game research are discussed.

  9. A Roadmap for Academic Health Centers to Establish Good Laboratory Practice-Compliant Infrastructure

    PubMed Central

    Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

    2012-01-01

    Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration (FDA) regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take prior to the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials. PMID:22373618

  10. Annual report on the AECB research and support program, 1997--1998. Report number INFO-0698

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

    NONE

    1998-12-31

    The AECB-funded extramural Research and Support Program provides access to independent advice, expertise, and information via contracts placed in the private sector and with other agencies and organizations in Canada and elsewhere. This report presents information on the scope of activities in the Program during the year and describes how the Program was managed, organized, and carried out. Information on individual sub-programs is presented in such fields as nuclear reactors, fuel cycle facilities, uranium mines and mills, waste management, dosimetry, health physics, and regulatory process development. A list of individual projects and their expenditures is appended.

  11. 10 CFR 72.176 - Audits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE Quality Assurance § 72.176 Audits. The... assurance program and to determine the effectiveness of the program. The audits must be performed in... 10 Energy 2 2010-01-01 2010-01-01 false Audits. 72.176 Section 72.176 Energy NUCLEAR REGULATORY...

  12. 77 FR 27827 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... margin calculations for these portfolios and perform ``what if'' analyses. The portfolio margining... Change Relating to Adoption of Interest Rate Futures Contracts Portfolio Margining Program With Eris... adopt an interest rate futures contracts portfolio margining program with Eris Exchange, LLC (``Eris...

  13. 30 CFR 710.12 - Special exemption for small operators.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Special exemption for small operators. 710.12... INTERIOR INITIAL PROGRAM REGULATIONS INITIAL REGULATORY PROGRAM § 710.12 Special exemption for small... the Director a limited exemption from the performance standards of this chapter. The exemption shall...

  14. TH-D-204-00: The Pursuit of Radiation Oncology Performance Excellence

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

    NONE

    The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

  15. TH-D-204-01: The Pursuit of Radiation Oncology Performance Excellence

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

    Sternick, E.

    The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

  16. Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States

    PubMed Central

    Kasiske, BL; Salkowski, N; Wey, A; Israni, AK; Snyder, JJ

    2016-01-01

    Every 6 months, the Scientific Registry of Transplant Recipients (SRTR) publishes evaluations of every solid organ transplant program in the US, including evaluations of 1-year patient and graft survival. The Centers for Medicare & Medicaid Services (CMS) and the Organ Procurement and Transplantation Network (OPTN) Membership and Professional Standards Committee (MPSC) use SRTR’s 1-year evaluations for regulatory review of transplant programs. Concern has been growing that the regulatory scrutiny of transplant programs with lower than expected outcomes is harmful, causing programs to undertake fewer high-risk transplants and leading to unnecessary organ discards. As a result, CMS raised its threshold for a “Condition-Level Deficiency” designation of observed relative to expected 1-year graft or patient survival from 1.50 to 1.85. Exceeding this threshold in the current SRTR outcomes report and in one of the four previous reports leads to scrutiny that may result in loss of Medicare funding. For its part, OPTN is reviewing a proposal from the MPSC to also change its performance criteria thresholds for program review, to review programs with “substantive clinical differences.” We review the details and implications of these changes in transplant program oversight. PMID:27401597

  17. A tale of two tasks: reversing the self-regulatory resource depletion effect.

    PubMed

    Converse, Patrick D; Deshon, Richard P

    2009-09-01

    This research examined the self-regulatory depletion model (e.g., M. Muraven & R. F. Baumeister, 2000). Although numerous studies support this model's prediction of decrements in self-regulation across tasks, the majority of this research has relied on a single paradigm in which two tasks are performed in succession. Other work related to learned industriousness (R. Eisenberger, 1992) and adaptation-level theory (H. Helson, 1964) indicates that self-regulatory behavior may remain stable or even improve as a result of prior self-regulatory activities in situations involving additional tasks. Three studies examined these differing perspectives with 2- and 3-task designs. Results indicated that, relative to low initial self-regulatory exertion, high exertion can lead to poorer or better subsequent self-regulation. These findings are consistent with an adaptation view of self-regulation, suggesting that the depletion effect may be only part of the picture of self-regulatory behavior over time.

  18. Advances in Behavioral Laboratory Methods that Inform Tobacco Regulatory Science: A TCORS Working Group Special Issue

    PubMed Central

    Wright, M. Jerry; Valentine, Gerald

    2017-01-01

    Objective The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) created unprecented enabling conditions for establishing national regulatory policy that reduces the burden of public health and societal problems associated with tobacco product use. The Center for Tobacco Products (CTP), created by the FDA to implement the TCA, developed a first-of-its-kind FDA/National Institutes of Health (NIH) collaborative program to fund Tobacco Centers of Regulatory Science (TCORS). Methods To assist the TCORS with addressing research priorites, working groups (WGs) comprised of FDA-CTP liasions and TCORS investigators were formed. Under the direction of the Center for Evaluation and Coordination of Trainin and Research (CECTR), the TCORS WGs seek to develop tangible work products in their respective areas of focus. Results The focus of the behavioral pharmacology WG evolved from publishing a narrow paper on behavioral methods in electronic cigarette research to a collection of papers on advances in behavioral laboratory methods that may inform tobacco regulatory science. Conclusion This Special Issue contains articles that address all of the CTP research priorities and demonstrates how advances in behavioral laboratory methods made by TCORS investigators can inform FDA efforst to regulate tobacco products. PMID:29152546

  19. On-Going International Research Program on Irradiated Concrete Conducted by DOE, EPRI and Japan Research Institutions. Roadmap, Achievements and Path Forward

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

    Le Pape, Yann; Rosseel, Thomas M.

    The Joint Department of Energy (DOE)-Electric Power Research Institute (EPRI) Program (Light Water Reactor Sustainability (LWRS) Program–Material Pathway–Concrete and Long-Term Operation (LTO) Program) and US Nuclear Regulatory Commission (NRC) research studies aim at understanding the most prominent degradation modes and their effects on the long-term operation of concrete structures to nuclear power generation. Based on the results of the Expanded Materials Degradation Analysis (EMDA), (NUREG/CR-7153, ORNL/TM-2011/545), irradiated concrete and alkali-silica reaction (ASR)-affected concrete structures are the two prioritized topics of on-going research. This report focuses specifically on the topic of irradiated concrete and summarizes the main accomplishments obtained by thismore » joint program, but also provides an overview of current relevant activities domestically and internationally. Possible paths forward are also suggested to help near-future orientation of this program.« less

  20. Agricultural use of municipal wastewater treatment plant ...

    EPA Pesticide Factsheets

    Agricultural use of municipal wastewater treatment plant sewage sludge as a source of per- and polyfluoroalkyl substance (PFAS) contamination in the environment The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  1. 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

  2. [The Influence of the Functioning of Brain Regulatory Systems onto the Voluntary Regulation of Cognitive Performance in Children. Report 2. Neuropsychological and Electrophysiological Assessment of Brain Regulatory Functions in Children Aged 10-12 with Learning Difficulties].

    PubMed

    Semenova, O A; Machinskaya, R I

    2015-01-01

    A total number of 172 children aged 10-12 were electrophysiologically and neuropsychologically assessed in order to analyze the influence of the functioning of brain regulatory systems onto the voluntary regulation of cognitive performance during the preteen years. EEG patterns associated with the nonoptimal functioning of brain regulatory systems, particularly fronto-thalamic, limbic and fronto-striatal structures were significantly more often observed in children with learning and behavioral difficulties, as compared to the control group. Neuropsychological assessment showed that the nonoptimal functioning of different brain regulatory systems specifically affect the voluntary regulation of cognitive performance. Children with EEG patterns of fronto-thalamic nonoptimal functioning demonstrated poor voluntary regulation such as impulsiveness and difficulties in continuing the same algorithms. Children with EEG patterns of limbic nonoptimal functioning showed a less pronounced executive dysfunction manifested only in poor switching between program units within a task. Children with EEG patterns of fronto-striatal nonoptimal functioning struggled with such executive dysfunctions as motor and tactile perseverations and emotional-motivational deviations such as poor motivation and communicative skills.

  3. Load research manual. Volume 3: Load research for advanced technologies

    NASA Astrophysics Data System (ADS)

    1980-11-01

    Technical guidelines for electric utility load research are presented. Special attention is given to issues raised by the load reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. The manual includes guides to load research literature and glossaries of load research and statistical terms. Special load research procedures are presented for solar, wind, and cogeneration technologies.

  4. Validating module network learning algorithms using simulated data.

    PubMed

    Michoel, Tom; Maere, Steven; Bonnet, Eric; Joshi, Anagha; Saeys, Yvan; Van den Bulcke, Tim; Van Leemput, Koenraad; van Remortel, Piet; Kuiper, Martin; Marchal, Kathleen; Van de Peer, Yves

    2007-05-03

    In recent years, several authors have used probabilistic graphical models to learn expression modules and their regulatory programs from gene expression data. Despite the demonstrated success of such algorithms in uncovering biologically relevant regulatory relations, further developments in the area are hampered by a lack of tools to compare the performance of alternative module network learning strategies. Here, we demonstrate the use of the synthetic data generator SynTReN for the purpose of testing and comparing module network learning algorithms. We introduce a software package for learning module networks, called LeMoNe, which incorporates a novel strategy for learning regulatory programs. Novelties include the use of a bottom-up Bayesian hierarchical clustering to construct the regulatory programs, and the use of a conditional entropy measure to assign regulators to the regulation program nodes. Using SynTReN data, we test the performance of LeMoNe in a completely controlled situation and assess the effect of the methodological changes we made with respect to an existing software package, namely Genomica. Additionally, we assess the effect of various parameters, such as the size of the data set and the amount of noise, on the inference performance. Overall, application of Genomica and LeMoNe to simulated data sets gave comparable results. However, LeMoNe offers some advantages, one of them being that the learning process is considerably faster for larger data sets. Additionally, we show that the location of the regulators in the LeMoNe regulation programs and their conditional entropy may be used to prioritize regulators for functional validation, and that the combination of the bottom-up clustering strategy with the conditional entropy-based assignment of regulators improves the handling of missing or hidden regulators. We show that data simulators such as SynTReN are very well suited for the purpose of developing, testing and improving module network algorithms. We used SynTReN data to develop and test an alternative module network learning strategy, which is incorporated in the software package LeMoNe, and we provide evidence that this alternative strategy has several advantages with respect to existing methods.

  5. Cellular Therapies Clinical Research Roadmap: Lessons learned on how to move a cellular therapy into a clinical trial

    PubMed Central

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.

    2014-01-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311

  6. 75 FR 71693 - Pesticide Program Dialogue Committee; Announcement of New Membership and Notice of Public Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-24

    ...; Comparative Safety Statements for Pesticide Product Labeling; and Public Health Work Group. Discussion topics... Century Science and Integrated Testing and Assessment Strategies: Transitioning Research to Regulatory...

  7. 7 CFR 3415.15 - Evaluation factors.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., AND EXTENSION SERVICE, DEPARTMENT OF AGRICULTURE BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM...) Novelty, uniqueness and originality; and (7) Appropriateness to regulation of biotechnology and risk... solving biotechnology regulatory uncertainty for United States agriculture. (1) Scientific contribution of...

  8. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

    PubMed

    Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

    2016-05-01

    Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

  9. An inventory of ambulance service regulatory programs in California.

    PubMed

    Narad, R A

    1998-01-01

    Ambulance regulation in California is the responsibility of numerous agencies on the state and local levels. By identifying and analyzing the variety of programs used in one state, this study establishes a framework for evaluation of state and local regulatory programs elsewhere. This study surveyed all California local EMS agencies (LEMSAs: California's equivalent of regional EMS organizations) to identify the types of regulatory programs used, the foci of these programs (e.g., equipment and personnel), and their application (e.g., public and private providers). All data acquired were analyzed using population parameters rather than inferential statistics. A response rate of 100% was obtained. Among the regulatory tools used are ordinances, contracts, and franchises. Regulatory standards vary widely as do their applications. Large counties and those that operate their own LEMSA have more extensive regulatory programs than do smaller counties and those who participate in multicounty agencies. Many of the enforcement mechanisms available are weak. This study suggests several policy implications for California and other states. The wide variation in the types of regulatory programs and the standards that are used suggest that the purpose and impact of regulatory programs should be studied further. The decentralization of the ambulance regulatory program and the lack of integration of ambulance regulations into EMS system planning also raise policy questions. In addition, the role of multicounty EMS agencies, as it relates to regulation of ambulance services, should be reviewed.

  10. 10 CFR 26.4 - FFD program applicability to categories of individuals.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ....4 Section 26.4 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative... unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable... health and safety; (2) Performing health physics or chemistry duties required as a member of the onsite...

  11. 10 CFR 26.4 - FFD program applicability to categories of individuals.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ....4 Section 26.4 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Administrative... unescorted access to nuclear power reactor protected areas by the licensees in § 26.3(a) and, as applicable... health and safety; (2) Performing health physics or chemistry duties required as a member of the onsite...

  12. Residential Central Air Conditioning and Heat Pump Installation – Workshop Outcomes

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

    Goetzler, William; Zogg, Robert; Young, Jim

    DOE's Building Technologies Office works with researchers and industry partners to develop and deploy technologies that can substantially reduce energy consumption in residential and commercial buildings. This report aims to advance BTO’s energy savings, emissions reduction, and other program goals by identifying research and development (R&D), demonstration and deployment, and other non-regulatory initiatives for improving the design and installation of residential central air conditioners (CAC) and central heat pumps (CHP). Improving the adoption of CAC/CHP design and installation best practices has significant potential to reduce equipment costs, improve indoor air quality and comfort, improve system performance, and most importantly, reducemore » household energy consumption and costs for heating and cooling by addressing a variety of common installation issues.« less

  13. 75 FR 34962 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-154-FOR; OSM 2010-0002] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control...

  14. Low-income minority fathers' control strategies and children's regulatory skills

    PubMed Central

    Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

    2015-01-01

    The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

  15. MODEL EVALUATION SCIENCE TO MEET TODAY'S QUALITY ASSURANCE REQUIREMENTS FOR REGULATORY USE: ADDRESSING UNCERTAINTY, SENSITIVITY, AND PARAMETERIZATION

    EPA Science Inventory

    The EPA/ORD National Exposure Research Lab's (NERL) UA/SA/PE research program addresses both tactical and strategic needs in direct support of ORD's client base. The design represents an integrated approach in achieving the highest levels of quality assurance in environmental de...

  16. MEETING IN TUCSON: MODEL EVALUATION SCIENCE TO MEET TODAY'S QUALITY ASSURANCE REQUIREMENTS FOR REGULATORY USE: ADDRESSING UNCERTAINTY, SENSITIVITY, AND PARAMETERIZATION

    EPA Science Inventory

    The EPA/ORD National Exposure Research Lab's (NERL) UA/SA/PE research program addresses both tactical and strategic needs in direct support of ORD's client base. The design represents an integrated approach in achieving the highest levels of quality assurance in environmental dec...

  17. 76 FR 16714 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-160-FOR; OSM 2010-0019] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation...

  18. Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.

    PubMed

    Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, C T; Jacobs, Danny O

    2006-07-27

    Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks.

  19. Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation

    PubMed Central

    Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, CT; Jacobs, Danny O

    2006-01-01

    Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved and streamlined regulatory processes for individual academic centers as well as larger research networks. PMID:16872540

  20. 10 CFR 26.77 - Management actions regarding possible impairment.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Section 26.77 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Management Actions and... competently perform his or her duties. (b) If an individual appears to be impaired or the individual's fitness... perform drug and alcohol tests or implement the determination of fitness process otherwise required by...

  1. 10 CFR 26.77 - Management actions regarding possible impairment.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Section 26.77 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Management Actions and... competently perform his or her duties. (b) If an individual appears to be impaired or the individual's fitness... perform drug and alcohol tests or implement the determination of fitness process otherwise required by...

  2. 10 CFR 26.77 - Management actions regarding possible impairment.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Section 26.77 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Management Actions and... competently perform his or her duties. (b) If an individual appears to be impaired or the individual's fitness... perform drug and alcohol tests or implement the determination of fitness process otherwise required by...

  3. 10 CFR 26.77 - Management actions regarding possible impairment.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 26.77 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Management Actions and... competently perform his or her duties. (b) If an individual appears to be impaired or the individual's fitness... perform drug and alcohol tests or implement the determination of fitness process otherwise required by...

  4. 10 CFR 26.77 - Management actions regarding possible impairment.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Section 26.77 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Management Actions and... competently perform his or her duties. (b) If an individual appears to be impaired or the individual's fitness... perform drug and alcohol tests or implement the determination of fitness process otherwise required by...

  5. 10 CFR 26.205 - Work hours.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.205 Work hours. (a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5... paragraphs (b)(1) through (b)(5) of this section, the calculated work hours must include all time performing...

  6. 10 CFR 26.205 - Work hours.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.205 Work hours. (a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5... paragraphs (b)(1) through (b)(5) of this section, the calculated work hours must include all time performing...

  7. 10 CFR 26.205 - Work hours.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.205 Work hours. (a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5... paragraphs (b)(1) through (b)(5) of this section, the calculated work hours must include all time performing...

  8. NUTRIENT RESPONSE IN GREAT LAKES WETLANDS

    EPA Science Inventory

    The U.S. EPA National Health and Environmental Effects Laboratory's Aquatic Stressor Framework and associated Nutrient Implementation Plan define scientific and regulatory needs, and lay-out research goals too for a cross divisional program to investigate stressor-response relati...

  9. 5 CFR 470.307 - Notification responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Section 470.307 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.307 Notification responsibilities. (a) 5 U.S.C. 4703 requires notification of...

  10. 5 CFR 470.317 - Project evaluation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Project evaluation. 470.317 Section 470.317 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration...

  11. SPATIAL PREDICTION OF AIR QUALITY DATA

    EPA Science Inventory

    Site-specific air quality monitoring data have been used extensively in both scientific and regulatory programs. As such, these data provide essential information to the public, environmental managers, and the atmospheric research community. Currently, air quality management prac...

  12. Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

    PubMed Central

    Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

    2015-01-01

    While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of underfortified products and enforcement of applicable fortification standards. Only by taking concrete steps to improve the entire regulatory system that is built on a cooperative working relationship between regulatory agencies and food producers will a nutrition strategy that uses fortification see its intended health effects. PMID:26374804

  13. Responding to the changing regulatory scene

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

    Wise, P.

    1995-12-31

    The regulatory approach of the Illinois Environmental Protection Agency (EPA) is discussed in this paper. Three areas receive emphasis: (1) the changing relations between the US EPA and the states, (2) the new emphasis on pollution prevention techniques, and (3) a new environmental amnesty project. Budgetary considerations, performance partnerships, and nonregulatory compliance assistance are briefly outlined in relation to these topics. Results of the environmental amnesty program for small business, called Clean Break, are briefly reported.

  14. Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!

    PubMed

    Petrella, Brenda L

    2015-11-03

    This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research. Copyright © 2015 John Wiley & Sons, Inc.

  15. Developmental Scientist | Center for Cancer Research

    Cancer.gov

    PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides quality assurance and regulatory compliance support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Developmental Scientist will: Provide support and advisement to the development of the T Cell receptor gene therapy protocols. Establishes, implements and maintains standardized processes and assesses performance to make recommendations for improvement. Provides support and guidance to the cellular therapy or vector production facilities at the NIH Clinical Center engaged in the manufacture of patient-specific therapies. Manufactures cellular therapy products for human use. Develops and manufactures lentiviral and/or retroviral vectors. Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance. Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines. Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer. Serves as a leader/mentor to administrative staff and prepares employee performance evaluations. Develops and implements procedures/programs to ensure effective and efficient business and operational processes. Identifies potential bottlenecks in upcoming development processes and works with team members and senior management for resolution. Analyzes and tracks initiatives and contracts. Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, laboratory and office supplies to ensure compliance with appropriate government regulations. Coordinates the administrative, fiscal, contractual, and quality aspects of all projects. Ensures that internal budgets, schedules and performance requirements are met. Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available. Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted. Regularly interacts with senior or executive management both internally and externally, on matters concerning several functional areas such as operations, quality control and quality assurance. Participates in planning facility or operations modifications, upgrades and renovations. Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control. Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads and evaluating overall performance. This position is located in Bethesda, Maryland.

  16. How decision reversibility affects motivation.

    PubMed

    Bullens, Lottie; van Harreveld, Frenk; Förster, Jens; Higgins, Tory E

    2014-04-01

    The present research examined how decision reversibility can affect motivation. On the basis of extant findings, it was suggested that 1 way it could affect motivation would be to strengthen different regulatory foci, with reversible decision making, compared to irreversible decision making, strengthening prevention-related motivation relatively more than promotion-related motivation. If so, then decision reversibility should have effects associated with the relative differences between prevention and promotion motivation. In 5 studies, we manipulated the reversibility of a decision and used different indicators of regulatory focus motivation to test these predictions. Specifically, Study 1 tested for differences in participants' preference for approach versus avoidance strategies toward a desired end state. In Study 2, we used speed and accuracy performance as indicators of participants' regulatory motivation, and in Study 3, we measured global versus local reaction time performance. In Study 4, we approached the research question in a different way, making use of the value-from-fit hypothesis (Higgins, 2000, 2002). We tested whether a fit between chronic regulatory focus and focus induced by the reversibility of the decision increased participants' subjective positive feelings about the decision outcome. Finally, in Study 5, we tested whether regulatory motivation, induced by decision reversibility, also influenced participants' preference in specific product features. The results generally support our hypothesis showing that, compared to irreversible decisions, reversible decisions strengthen a prevention focus more than a promotion focus. Implications for research on decision making are discussed.

  17. Self-Regulatory Training for Helping Students with Special Needs to Learn Mathematics

    ERIC Educational Resources Information Center

    Kang, Yanrong

    2010-01-01

    Previous research suggests that self-regulation interventions are effective in improving students' self-regulatory skill and school performance in a wide variety of educational domains. Inspired by social cognitive theory (Schunk & Zimmerman, 1997) and goal setting theory (Locke & Latham, 1990), I designed, implemented, and examined the beneficial…

  18. 75 FR 60375 - Utah Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-30

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-047-FOR; Docket ID OSM-2010-0012] Utah Regulatory Program AGENCY: Office of Surface Mining... amendment to the Utah regulatory program (hereinafter, the ``Utah program'') under the Surface Mining...

  19. How "fun/importance" fit affects performance: relating implicit theories to instructions.

    PubMed

    Bianco, Amy T; Higgins, E Tory; Klem, Adena

    2003-09-01

    People experience a regulatory fit when they employ means of goal pursuit that fit their regulatory orientation, and this fit increases motivation that can enhance performance. The present studies extend previous research on regulatory fit to the classic motivational variables of fun and importance. They also examine for the first time the effect on performance of the fit between individuals' implicit theories about a task's fun or importance and their strategic engagement of the task as fun or important as induced by task instructions. In all three studies, task performance was better when the external task instructions "fit" rather than did not fit participants' implicit theory for the task. The implications of these findings for understanding the motivational effects of fun and importance are discussed.

  20. [Computer simulation of thyroid regulatory mechanisms in health and malignancy].

    PubMed

    Abduvaliev, A A; Gil'dieva, M S; Khidirov, B N; Saĭdalieva, M; Saatov, T S

    2010-07-01

    The paper describes a computer model for regulation of the number of thyroid follicular cells in health and malignancy. The authors'computer program for mathematical simulation of the regulatory mechanisms of a thyroid follicular cellular community cannot be now referred to as good commercial products. For commercialization of this product, it is necessary to draw up a direct relation of the introduced corrected values from the actually existing normal values, such as the peripheral blood concentrations of thyroid hormones or the mean values of endocrine tissue mitotic activity. However, the described computer program has been also used in researches by our scientific group in the study of thyroid cancer. The available biological experimental data and theoretical provisions on thyroid structural and functional organization at the cellular level allow one to construct mathematical models for quantitative analysis of the regulation of the size of a cellular community of a thyroid follicle in health and abnormalities, by using the method for simulation of the regulatory mechanisms of living systems and the equations of cellular community regulatory communities.

  1. Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

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

    Moe, Wayne L.

    This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

  2. Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

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

    Moe, Wayne Leland

    This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However,more » it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory importance of key DOE reactor research initiatives should be assessed early in the technology development process. Quality assurance requirements supportive of later licensing activities must also be attached to important research activities to ensure resulting data is usable in that context. Early regulatory analysis and licensing approach planning thus provides a significant benefit to the formulation of research plans and also enables the planning and development of a compatible AdvSMR licensing framework, should significant modification be required.« less

  3. DNA context represents transcription regulation of the gene in mouse embryonic stem cells

    NASA Astrophysics Data System (ADS)

    Ha, Misook; Hong, Soondo

    2016-04-01

    Understanding gene regulatory information in DNA remains a significant challenge in biomedical research. This study presents a computational approach to infer gene regulatory programs from primary DNA sequences. Using DNA around transcription start sites as attributes, our model predicts gene regulation in the gene. We find that H3K27ac around TSS is an informative descriptor of the transcription program in mouse embryonic stem cells. We build a computational model inferring the cell-type-specific H3K27ac signatures in the DNA around TSS. A comparison of embryonic stem cell and liver cell-specific H3K27ac signatures in DNA shows that the H3K27ac signatures in DNA around TSS efficiently distinguish the cell-type specific H3K27ac peaks and the gene regulation. The arrangement of the H3K27ac signatures inferred from the DNA represents the transcription regulation of the gene in mESC. We show that the DNA around transcription start sites is associated with the gene regulatory program by specific interaction with H3K27ac.

  4. DNA context represents transcription regulation of the gene in mouse embryonic stem cells.

    PubMed

    Ha, Misook; Hong, Soondo

    2016-04-14

    Understanding gene regulatory information in DNA remains a significant challenge in biomedical research. This study presents a computational approach to infer gene regulatory programs from primary DNA sequences. Using DNA around transcription start sites as attributes, our model predicts gene regulation in the gene. We find that H3K27ac around TSS is an informative descriptor of the transcription program in mouse embryonic stem cells. We build a computational model inferring the cell-type-specific H3K27ac signatures in the DNA around TSS. A comparison of embryonic stem cell and liver cell-specific H3K27ac signatures in DNA shows that the H3K27ac signatures in DNA around TSS efficiently distinguish the cell-type specific H3K27ac peaks and the gene regulation. The arrangement of the H3K27ac signatures inferred from the DNA represents the transcription regulation of the gene in mESC. We show that the DNA around transcription start sites is associated with the gene regulatory program by specific interaction with H3K27ac.

  5. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

    PubMed Central

    Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

    2015-01-01

    Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

  6. Load research manual. Volume 2: Fundamentals of implementing load research procedures

    NASA Astrophysics Data System (ADS)

    1980-11-01

    This manual will assist electric utilities and state regulatory authorities in investigating customer electricity demand as part of cost-of-service studies, rate design, marketing research, system design, load forecasting, rate reform analysis, and load management research. Load research procedures are described in detail. Research programs at three utilities are compared: Carolina Power and Light Company, Long Island Lighting Company, and Southern California Edison Company. A load research bibliography and glossaries of load research and statistical terms are also included.

  7. Training physician-scientists: a model for integrating research into psychiatric residency.

    PubMed

    Back, Sudie E; Book, Sarah W; Santos, Alberto B; Brady, Kathleen T

    2011-01-01

    the number of physicians engaged in research careers has declined significantly over the past two decades. Physicians with in-depth experience and formal training in research design, development, implementation, statistical analysis, and interpretation of scientific information are rare. in response to this shortage, the Medical University of South Carolina (MUSC) launched an NIH-funded research track in 2006 to address the institutional, financial, and regulatory barriers to research training during residency. The primary aim was to incorporate a research track within a 4-year psychiatric residency program for physicians. A secondary goal was to extend recruitment into earlier phases of medical training by offering summer research fellowships to medical and undergraduate students. this article describes the program including core mechanisms of training, recruitment, and outcomes to date. the program provides a model to effectively integrate research training during residency without increasing the number of years of residency training. The training components described herein should be exportable to other psychiatric residency training programs and potentially other specialties of medicine.

  8. 77 FR 8185 - Ohio Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [SATS No. OH-252-FOR; Docket ID OSM 2011-0003] Ohio Regulatory Program AGENCY: Office of Surface Mining... amendment to the Ohio regulatory program (the ``Ohio program'') under the Surface Mining Control and...

  9. Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

    PubMed

    Califf, Robert M

    2006-01-01

    As randomized controlled trials have become the 'gold standard' for medical research, a complex regulatory structure for the conduct of clinical trials has emerged. However, this structure has not been adequately assessed to ensure that regulations governing human subjects research actually produce the desired effects. Our purpose is to identify some of the major shortcomings in the current regulatory system of human clinical trials oversight, and to propose some potential solutions to these problems. We discuss the evolution of the current US regulatory environment and its application in the context of several widely-used drug therapies. Despite numerous randomized controlled trials, performed within a structure of extensive documentation and data collection, serious shortcomings in a number of pharmaceutical therapies were not detected until after the drugs were approved and widely adopted by clinicians. The current system of regulatory bureaucracy in clinical trials has led to an extremely expensive research paradigm that, in spite of complex systems of oversight and exhaustive data collection, cannot be shown to adequately ensure the integrity of the research process and the protection of human research subjects. Some parts of the system, including Research Ethics Review Boards, may not be well-suited to carrying out their core mission of overseeing research conduct, and other aspects of clinical trials regulatory structure, such as monitoring/auditing review and adverse event reporting, may constitute a waste of money and resources. Misdirected data collection and adverse events reporting divert valuable resources and hamper development of large, simple clinical trials powered to definitively answer important research questions. Careful scrutiny of the utility of current or proposed regulatory schemes is required to ensure the integrity of human subjects research and to enhance the effectiveness of research dollars.

  10. 5 CFR 470.309 - Public hearing.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.309... present their written or oral views concerning the proposed demonstration project. The notice of public...

  11. 5 CFR 470.313 - Project implementation regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Project implementation regulations. 470.313 Section 470.313 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  12. 5 CFR 470.313 - Project implementation regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Project implementation regulations. 470.313 Section 470.313 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  13. 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

  14. 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

  15. 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.

  16. 78 FR 63911 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926...; S2D2SSS08011000 SX066A00033 F13XS501520] Montana Regulatory Program AGENCY: Office of Surface Mining Reclamation... regulatory program (hereinafter, the ``Montana program'') under the Surface Mining Control and Reclamation...

  17. 77 FR 4461 - New Mexico Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... [SATS No. NM-048-FOR; Docket ID OSM-2010-0014] New Mexico Regulatory Program AGENCY: Office of Surface... approving an amendment to the New Mexico regulatory program (the ``New Mexico program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). New Mexico proposed non...

  18. Load research manual. Volume 3. Load research for advanced technologies

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

    Brandenburg, L.; Clarkson, G.; Grund, Jr., C.

    1980-11-01

    This three-volume manual presents technical guidelines for electric utility load research. Special attention is given to issues raised by the load data reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. The manual includes guides to load research literature and glossaries of load research and statistical terms. In Volume 3, special load research procedures are presented for solar, wind, and cogeneration technologies.

  19. Evaluation of Policy and Research Interventions in Science and Technology: Consequence Assessment of Regulatory and Technology Transfer Programs

    ERIC Educational Resources Information Center

    Dias, Mary Beatrice

    2011-01-01

    This research contributes to efforts in assessment studies related to science and technology interventions. The work presented in this thesis focuses on understanding the effects of policies that influence science and technology interventions, and determining the impact of science and technology interventions themselves. Chapter 1 explores how…

  20. Carousel: A Moral Framework for Inquiring into the Culture of Prisons and Academe.

    ERIC Educational Resources Information Center

    Mullen, Carol A.

    The moral framework of a carousel is used to advance possible connections between the institutional and regulatory life within prisons and teacher education programs. The moral paradigm case narrated is based on the researcher's field experience in a prison as a researcher-teacher. Connections are drawn to restrictions within a correctional…

  1. Human Factors Engineering Program Review Model (NUREG-0711)Revision 3: Update Methodology and Key Revisions

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

    OHara J. M.; Higgins, J.; Fleger, S.

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. NUREG-0711 is the first document to be addressed. We present the methodology used to update NUREG-0711 and summarize the main changes made. Finally, we discuss the current status of the update program and the future plans.« less

  2. Opportunities to Apply the 3Rs in Safety Assessment Programs

    PubMed Central

    Sewell, Fiona; Edwards, Joanna; Prior, Helen; Robinson, Sally

    2016-01-01

    Abstract Before a potential new medicine can be administered to humans it is essential that its safety is adequately assessed. Safety assessment in animals forms an integral part of this process, from early drug discovery and initial candidate selection to the program of recommended regulatory tests in animals. The 3Rs (replacement, reduction, and refinement of animals in research) are integrated in the current regulatory requirements and expectations and, in the EU, provide a legal and ethical framework for in vivo research to ensure the scientific objectives are met whilst minimizing animal use and maintaining high animal welfare standards. Though the regulations are designed to uncover potential risks, they are intended to be flexible, so that the most appropriate approach can be taken for an individual product. This article outlines current and future opportunities to apply the 3Rs in safety assessment programs for pharmaceuticals, and the potential (scientific, financial, and ethical) benefits to the industry, across the drug discovery and development process. For example, improvements to, or the development of, novel, early screens (e.g., in vitro, in silico, or nonmammalian screens) designed to identify compounds with undesirable characteristics earlier in development have the potential to reduce late-stage attrition by improving the selection of compounds that require regulatory testing in animals. Opportunities also exist within the current regulatory framework to simultaneously reduce and/or refine animal use and improve scientific outcomes through improvements to technical procedures and/or adjustments to study designs. It is important that approaches to safety assessment are continuously reviewed and challenged to ensure they are science-driven and predictive of relevant effects in humans. PMID:28053076

  3. Subtask 4.8 - Fate and Control of Mercury and Trace Elements

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

    Pavlish, John; Lentz, Nicholas; Martin, Christopher

    2011-12-31

    The Center for Air Toxic Metals® (CATM®) Program at the Energy & Environmental Research Center (EERC) continues to focus on vital basic and applied research related to the fate, behavior, measurement, and control of trace metals, especially mercury, and the impact that these trace metals have on human health and the environment. For years, the CATM Program has maintained an international perspective, performing research and providing results that apply to both domestic and international audiences, with reports distributed in the United States and abroad. In addition to trace metals, CATM’s research focuses on other related emissions and issues that impactmore » trace metal releases to the environment, such as SO x, NO x, CO 2, ash, and wastewater streams. Of paramount interest and focus has been performing research that continues to enable the power and industrial sectors to operate in an environmentally responsible manner to meet regulatory standards. The research funded by the U.S. Department of Energy’s (DOE’s) National Energy Technology Laboratory (NETL) through CATM has allowed significant strides to be made to gain a better understanding of trace metals and other emissions, improve sampling and measurement techniques, fill data gaps, address emerging technical issues, and develop/test control technologies that allow industry to cost-effectively meet regulatory standards. The DOE NETL–CATM research specifically focused on the fate and control of mercury and trace elements in power systems that use CO 2 control technologies, such as oxycombustion and gasification systems, which are expected to be among those technologies that will be used to address climate change issues. In addition, research addressed data gaps for systems that use conventional and multipollutant control technologies, such as electrostatic precipitators, selective catalytic reduction units, flue gas desulfurization systems, and flue gas-conditioning methods, to understand mercury interactions, develop better control strategies and, in some cases, prevent mercury from being reemitted. This research also addressed stakeholder concerns and questions related to sampling and analytical methods for mercury, especially for continuous mercury monitors and sorbent trap methods for future compliance. Advancements were made toward the development of a much simpler dry-based method for measurement of halogens and trace metals. Finally, this research resulted in significant outcomes related to mercury and selenium concentrations in freshwater fish and how it is associated with other elements, thereby potentially impacting health; this has greatly enhanced the understanding of the second-order mechanism of mercury toxicity. The outcomes of this research have been shared with stakeholders in various domestic and international forums, working groups, conferences, educational settings, and published documents, with information available and accessible to those most impacted or interested in timely and current results on toxic metals. This subtask was funded through the EERC–DOE Joint Program on Research and Development for Fossil Energy-Related Resources Cooperative Agreement No. DE-FC26-08NT43291.« less

  4. 30 CFR 735.14 - Coverage of grants.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... other personnel; (4) New or revised organizational structures; (5) Information and communications... approved State regulatory program; (2) Providing supporting and administrative services required by the State regulatory program; (3) Providing equipment required for the regulatory program and its support...

  5. Research papers and publications (1981-1987): Workload research program

    NASA Technical Reports Server (NTRS)

    Hart, Sandra G. (Compiler)

    1987-01-01

    An annotated bibliography of the research reports written by participants in NASA's Workload Research Program since 1981 is presented, representing the results of theoretical and applied research conducted at Ames Research Center and at universities and industrial laboratories funded by the program. The major program elements included: 1) developing an understanding of the workload concept; 2) providing valid, reliable, and practical measures of workload; and 3) creating a computer model to predict workload. The goal is to provide workload-related design principles, measures, guidelines, and computational models. The research results are transferred to user groups by establishing close ties with manufacturers, civil and military operators of aerospace systems, and regulatory agencies; publishing scientific articles; participating in and sponsoring workshops and symposia; providing information, guidelines, and computer models; and contributing to the formulation of standards. In addition, the methods and theories developed have been applied to specific operational and design problems at the request of a number of industry and government agencies.

  6. 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...

  7. 10 CFR 5.515 - Compensation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Compensation. 5.515 Section 5.515 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING... that are performed under similar working conditions. ...

  8. 10 CFR 5.515 - Compensation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Compensation. 5.515 Section 5.515 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING... that are performed under similar working conditions. ...

  9. 10 CFR 5.515 - Compensation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Compensation. 5.515 Section 5.515 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING... that are performed under similar working conditions. ...

  10. 10 CFR 5.515 - Compensation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Compensation. 5.515 Section 5.515 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING... that are performed under similar working conditions. ...

  11. 10 CFR 5.515 - Compensation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Compensation. 5.515 Section 5.515 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION PROGRAMS OR ACTIVITIES RECEIVING... that are performed under similar working conditions. ...

  12. Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the clInical and Translational Science Award Consortium: developing and implementing a sponsor-investigators training program.

    PubMed

    Holbein, M E Blair; Berglund, Jelena Petrovic; O'Reilly, Erin K; Hartman, Karen; Speicher, Lisa A; Adamo, Joan E; O'Riordan, Gerri; Brown, Jennifer Swanton; Schuff, Kathryn G

    2014-06-01

    The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers. A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role. The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation. The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

  13. An Overview Of The Ecosystem Services Research Program Decision Support Framework

    EPA Science Inventory

    There is an increasing understanding that top-down regulatory and technology driven responses are not sufficient to address current and emerging environmental challenges such as climate change, sustainable communities, and environmental justice. Such problems require ways to dee...

  14. 5 CFR 470.315 - Project modification and extension.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Project modification and extension. 470.315 Section 470.315 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to...

  15. 5 CFR 470.305 - Submission of proposals for demonstration projects.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... projects. 470.305 Section 470.305 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.305 Submission of proposals for demonstration projects. (a) OPM...

  16. 5 CFR 470.315 - Project modification and extension.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ....315 Section 470.315 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to... plan without the approval of the Office of Personnel Management. OPM will inform the agency of...

  17. Regulatory Implications of Using Constructed Wetlands to Treat Selenium-Laden Wastewater

    Treesearch

    A. Dennis Lemly; Harry M. Ohlendorf

    2002-01-01

    The practice of using constructed wetlands to treat selenium-laden wastewater is gaining popularity in the linited States and elsewhere. However, proponents of treatment wetlands often overlook important ecological liabilities and regulatory implications when developing new methods and applications. Their research studies typically seek to answer a basic performance...

  18. Process Mining Techniques for Analysing Patterns and Strategies in Students' Self-Regulated Learning

    ERIC Educational Resources Information Center

    Bannert, Maria; Reimann, Peter; Sonnenberg, Christoph

    2014-01-01

    Referring to current research on self-regulated learning, we analyse individual regulation in terms of a set of specific sequences of regulatory activities. Successful students perform regulatory activities such as analysing, planning, monitoring and evaluating cognitive and motivational aspects during learning not only with a higher frequency…

  19. Translating New Science Into the Drug Review Process

    PubMed Central

    Rouse, Rodney; Kruhlak, Naomi; Weaver, James; Burkhart, Keith; Patel, Vikram; Strauss, David G.

    2017-01-01

    In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. The Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry. The Division is able to rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. This article reviews the Division’s recent work and future directions, highlighting development and validation of biomarkers; novel humanized animal models; translational predictive safety combining in vitro, in silico, and in vivo clinical biomarkers; chemical and biomedical informatics tools for safety predictions; novel approaches to speed the development of complex generic drugs, biosimilars, and antibiotics; and precision medicine. PMID:29568713

  20. 78 FR 37850 - Quality Assurance Program Requirements (Operations)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

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

  1. 30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

  2. 30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

  3. 30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

  4. 30 CFR 931.15 - Approval of New Mexico regulatory program amendments.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Approval of New Mexico regulatory program..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE NEW MEXICO § 931.15 Approval of New Mexico regulatory program amendments. The following is a list of the dates...

  5. Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

    PubMed

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

    2015-04-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2008-01-01

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

  7. Stereotype Fit Effects for Golf Putting Nonexperts

    PubMed Central

    Grimm, Lisa R.; Lewis, Benjamin; Maddox, W. Todd; Markman, Arthur B.

    2015-01-01

    Research has connected stereotype threat and regulatory fit by showing improved performance for individuals with negative stereotypes when they focused on minimizing potential losses. In the current study, non-Black participants, who were non-experts at golf putting, were told that a golf-putting task was diagnostic of natural athletic ability (i.e., negative stereotype) or sports intelligence (i.e., positive stereotype). Participants tried to maximize earned points or minimize lost points assigned after every putt, which was calculated based on the distance to a target. We demonstrate better performance for participants experiencing a fit between their global task stereotype and the task goal, and argue that regulatory fit allows for increased attention on the strategies beneficial for task performance. Interestingly, we find that performance of individuals high in working memory capacity suffers greatly when those individuals experience a regulatory mismatch. PMID:27162703

  8. Management of Disused Radioactive Sealed Sources in Egypt - 13512

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

    Mohamed, Y.T.; Hasan, M.A.; Lasheen, Y.F.

    The future safe development of nuclear energy and progressive increasing use of sealed sources in medicine, research, industry and other fields in Egypt depends on the safe and secure management of disused radioactive sealed sources. In the past years have determined the necessity to formulate and apply the integrated management program for radioactive sealed sources to assure harmless and ecological rational management of disused sealed sources in Egypt. The waste management system in Egypt comprises operational and regulatory capabilities. Both of these activities are performed under legislations. The Hot Laboratories and Waste Management Center HLWMC, is considered as a centralizedmore » radioactive waste management facility in Egypt by law 7/2010. (authors)« less

  9. 77 FR 31486 - Virginia Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-29

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 946 [VA-126-FOR; OSM-2008-0012] Virginia Regulatory Program AGENCY: Office of Surface Mining Reclamation... an amendment to the Virginia regulatory program under the Surface Mining Control and Reclamation Act...

  10. 30 CFR 710.2 - Objectives.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

  11. 30 CFR 710.2 - Objectives.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

  12. 30 CFR 710.2 - Objectives.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

  13. 30 CFR 710.2 - Objectives.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... REGULATIONS INITIAL REGULATORY PROGRAM § 710.2 Objectives. The objectives of the initial regulatory program... resulting from surface coal mining operations during the interval between enactment of the Act and adoption of a permanent State or Federal regulatory program; and (b) Coordinate the State and Federal...

  14. Advanced reactors and associated fuel cycle facilities: safety and environmental impacts.

    PubMed

    Hill, R N; Nutt, W M; Laidler, J J

    2011-01-01

    The safety and environmental impacts of new technology and fuel cycle approaches being considered in current U.S. nuclear research programs are contrasted to conventional technology options in this paper. Two advanced reactor technologies, the sodium-cooled fast reactor (SFR) and the very high temperature gas-cooled reactor (VHTR), are being developed. In general, the new reactor technologies exploit inherent features for enhanced safety performance. A key distinction of advanced fuel cycles is spent fuel recycle facilities and new waste forms. In this paper, the performance of existing fuel cycle facilities and applicable regulatory limits are reviewed. Technology options to improve recycle efficiency, restrict emissions, and/or improve safety are identified. For a closed fuel cycle, potential benefits in waste management are significant, and key waste form technology alternatives are described. Copyright © 2010 Health Physics Society

  15. A Phenomenological Analysis of the Self-Regulatory Behaviours of a Group of Young Adults in a Vocational Education and Training Business Program

    ERIC Educational Resources Information Center

    Liveris, Christine; Cavanagh, Rob

    2012-01-01

    National Vocational Education and Training (VET) reforms have resulted in an increasing proportion of young adults in VET programs in Western Australia. A challenge for practitioners is to help them develop skills and attributes to facilitate lifelong learning. A need for further research into the self-regulation behaviour of this cohort has been…

  16. Dynamics and function of distal regulatory elements during neurogenesis and neuroplasticity

    PubMed Central

    Thakurela, Sudhir; Sahu, Sanjeeb Kumar; Garding, Angela; Tiwari, Vijay K.

    2015-01-01

    Gene regulation in mammals involves a complex interplay between promoters and distal regulatory elements that function in concert to drive precise spatiotemporal gene expression programs. However, the dynamics of the distal gene regulatory landscape and its function in the transcriptional reprogramming that underlies neurogenesis and neuronal activity remain largely unknown. Here, we performed a combinatorial analysis of genome-wide data sets for chromatin accessibility (FAIRE-seq) and the enhancer mark H3K27ac, revealing the highly dynamic nature of distal gene regulation during neurogenesis, which gets progressively restricted to distinct genomic regions as neurons acquire a post-mitotic, terminally differentiated state. We further find that the distal accessible and active regions serve as target sites for distinct transcription factors that function in a stage-specific manner to contribute to the transcriptional program underlying neuronal commitment and maturation. Mature neurons respond to a sustained activity of NMDA receptors by epigenetic reprogramming at a large number of distal regulatory regions as well as dramatic reorganization of super-enhancers. Such massive remodeling of the distal regulatory landscape in turn results in a transcriptome that confers a transient loss of neuronal identity and gain of cellular plasticity. Furthermore, NMDA receptor activity also induces many novel prosurvival genes that function in neuroprotective pathways. Taken together, these findings reveal the dynamics of the distal regulatory landscape during neurogenesis and uncover novel regulatory elements that function in concert with epigenetic mechanisms and transcription factors to generate the transcriptome underlying neuronal development and activity. PMID:26170447

  17. Headquarters summary reports

    NASA Technical Reports Server (NTRS)

    1992-01-01

    The status is summarized of the NASA sponsored involvement in high speed civil transport research and technology, including major cooperative efforts. That involvement is currently focussed on the High Speed Research Program. The program goals are an acceptable level of ozone depletion or sonic boom, the definition of which is a regulatory and political process. The HSRP goal is to provide technical bases for acceptability criteria. Community noise is currently regulated, and it seems clear that HSCT aircraft will have to comply with at least the spirit of the current subsonic constraint, FAR 36, Stage 3.

  18. A prospective approach to coastal geography from satellite. [technological forecasting

    NASA Technical Reports Server (NTRS)

    Munday, J. C., Jr.

    1981-01-01

    A forecasting protocol termed the "prospective approach' was used to examine probable futures relative to coastal applications of satellite data. Significant variables include the energy situation, the national economy, national Earth satellite programs, and coastal zone research, commercial activity, and regulatory activity. Alternative scenarios for the period until 1986 are presented. Possible response by state/local remote sensing centers include operational applications for users, input to geo-base information systems (GIS), development of decision-making algorithms using GIS data, and long term research programs for coastal management using merged satellite and traditional data.

  19. 77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555... State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington...

  20. 77 FR 49749 - Procedures for Assessment and Collection of Regulatory Fees; Assessment and Collection of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-17

    ... regulatory fees. Although the Commission has made a number of discrete changes to the regulatory fee program... Commission has made a number of discrete changes to the regulatory fee program since 1994, we have not...

  1. French Regulatory practice and experience feedback on steam generator tube integrity

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

    Sandon, G.

    1997-02-01

    This paper summarizes the way the French Safety Authority applies regulatory rules and practices to the problem of steam generator tube cracking in French PWR reactors. There are 54 reactors providing 80% of French electrical consumption. The Safety Authority closely monitors the performance of tubes in steam generators, and requires application of a program which deals with problems prior to the actual development of leakage. The actual rules regarding such performance are flexible, responding to the overall performance of operating steam generators. In addition there is an inservice inspection service to examine tubes during shutdown, and to monitor steam generatorsmore » for leakage during operation, with guidelines for when generators must be pulled off line.« less

  2. Self-Regulatory Skill Among Children with and without Developmental Coordination Disorder: An Exploratory Study.

    PubMed

    Sangster Jokić, Claire A; Whitebread, David

    2016-11-01

    Children with developmental coordination disorder (DCD) experience difficulty learning and performing everyday motor tasks due to poor motor coordination. Recent research applying a cognitive learning paradigm has argued that children with DCD have less effective cognitive and metacognitive skills with which to effectively acquire motor skills. However, there is currently limited research examining individual differences in children's use of self-regulatory and metacognitive skill during motor learning. This exploratory study aimed to compare the self-regulatory performance of children with and without DCD. Using a mixed methods approach, this study observed and compared the self-regulatory behavior of 15 children with and without DCD, aged between 7 and 9 years, during socially mediated motor practice. Observation was conducted using a quantitative coding scheme and qualitative analysis of video-recorded sessions. This paper will focus on the results of quantitative analysis, while data arising from the qualitative analysis will be used to support quantitative findings. In general, findings indicate that children with DCD exhibit less independent and more ineffective self-regulatory skill during motor learning than their typically developing peers. In addition, children with DCD rely more heavily on external support for effective regulation and are more likely to exhibit negative patterns of motivational regulation. These findings provide further support for the notion that children with DCD experience difficulty effectively self-regulating motor learning. Implications for practice and directions for future research are discussed.

  3. #2) EPA Perspective - Exposure and Effects Prediction and ...

    EPA Pesticide Factsheets

    Outline •Biomarkers as a risk assessment tool–exposure assessment & risk characterization•CDC’s NHANES as a source of biomarker data–history, goals & available data•Review of NHANES publications (1999-2013)–chemicals, uses, trends & challenges•NHANES biomarker case study–recommendations for future research The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  4. New and evolving rare diseases research programs at the National Institutes of Health.

    PubMed

    Groft, S C; Rubinstein, Y R

    2013-01-01

    Research emphasis on rare diseases and orphan products remains a major focus of the research Institutes and Centers of National Institutes of Health (NIH). NIH provides more than USD 31 billion annually in biomedical research and research support. This research is the basis of many of the health advances in rare and common diseases. Numerous efforts and a major emphasis by the public and private sector initiatives have resulted in an increase of interventions and diagnostics for rare diseases. Newer translational research programs provide a more systematic and coordinated approach to rare diseases research and orphan products development. The approach that is offered requires extensive public-private partnerships with the pharmaceutical industry, contract research organizations, philanthropic foundations, medical and scientific advisory boards, patient advocacy groups, the academic research community, research and regulatory scientists, government funding agencies, and the public. Each program is unique and requires lengthy planning and collaborative efforts to reach programmatic goals. © 2013 S. Karger AG, Basel.

  5. 5 CFR 470.303 - Eligible parties.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.303... demonstration projects under 5 U.S.C. 4701(a)(1) and 4701(b) may conduct demonstration projects after approval...

  6. 5 CFR 470.305 - Submission of proposals for demonstration projects.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 1 2011-01-01 2011-01-01 false Submission of proposals for demonstration projects. 470.305 Section 470.305 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS PERSONNEL MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements...

  7. 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...

  8. A MAPPING BASED ON PHYSICO-CHEMICAL FEATURES: LESSONS LEARNT

    EPA Science Inventory

    The ban on animal testing of cosmetic products for systemic toxicity in Europe is foreseen in 2013. Several research programs involving the public and private sectors have been initiated with the aim of fulfilling regulatory requirements and complying with this transformative shi...

  9. 5 CFR 470.317 - Project evaluation.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Project evaluation. 470.317 Section 470... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.317 Project evaluation. (a) Compliance evaluation. OPM will review the operation of the...

  10. 5 CFR 470.317 - Project evaluation.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Project evaluation. 470.317 Section 470... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.317 Project evaluation. (a) Compliance evaluation. OPM will review the operation of the...

  11. The Effects of a Mindfulness and Biofeedback Program on the On- and Off-Task Behaviors of Students with Emotional Behavioral Disorders

    ERIC Educational Resources Information Center

    Rush, Karena S.; Golden, Maria E.; Mortenson, Bruce P.; Albohn, Daniel; Horger, Melissa

    2017-01-01

    Research suggests that mind-body techniques are useful for enhancing self-regulatory behaviors, including attention and emotional regulation. The majority of research in this area focuses on adult behavior. However, there has been a growing interest in using mindfulness techniques with children and more recently, in the school setting. Students…

  12. Work-related road safety in Australia, the United Kingdom and the United States of America: an overview of regulatory approaches and recommendations to enhance strategy and practice

    PubMed Central

    Stuckey, R; Pratt, SG; Murray, W

    2015-01-01

    Work-related travel and transport by road is fundamental for industry, government and organisations. Traditionally, road safety interventions at societal level have focussed on improving road and vehicle engineering and changing road-user behaviour through transport laws and safety campaigns. Crash data indicate that significant numbers of road-user fatalities occur while driving to or for work. Therefore, workplace initiatives can improve both road and worker safety. This paper reviews regulatory approaches to work-related road safety (WRRS) in Australia, the United Kingdom and United States, identifying significant and consistent gaps in policy, management and research. In all three countries, responsibility for managing and regulating WRRS is spread across government agencies, without a single coordinating body. This paper makes the case that integrating management of WRRS into regulatory and non-regulatory occupational health and safety (OHS) initiatives would foster and support collaboration between research and practice communities, ensuring a comprehensive evidence base for future programs. PMID:26279686

  13. NASA Workshop on Biological Adaptation

    NASA Technical Reports Server (NTRS)

    Morey-Holton, Emily (Editor); Tischler, Marc (Editor)

    1988-01-01

    A workshop was convened to review the current program in Space Biology Biological Adaptation Research and its objectives and to identify future research directions. Two research areas emerged from these deliberations: gravitational effects on structures and biomineralization and gravity affected regulatory mechanisms. The participants also recommended that research concentrate on rapidly growing animals, since gravity effects may be more pronounced during growth and development. Both research areas were defined and future research directions were identified. The recommendations of the workshop will assist the Life Sciences Division of NASA in it assessment and long-range planning of these areas of space biology. Equally important, the workshop was intended to stimulate thought and research among those attending so that they would, in turn, interest, excite, and involve other members of the academic community in research efforts relevant to these programs.

  14. Distinct gene regulatory programs define the inhibitory effects of liver X receptors and PPARG on cancer cell proliferation.

    PubMed

    Savic, Daniel; Ramaker, Ryne C; Roberts, Brian S; Dean, Emma C; Burwell, Todd C; Meadows, Sarah K; Cooper, Sara J; Garabedian, Michael J; Gertz, Jason; Myers, Richard M

    2016-07-11

    The liver X receptors (LXRs, NR1H2 and NR1H3) and peroxisome proliferator-activated receptor gamma (PPARG, NR1C3) nuclear receptor transcription factors (TFs) are master regulators of energy homeostasis. Intriguingly, recent studies suggest that these metabolic regulators also impact tumor cell proliferation. However, a comprehensive temporal molecular characterization of the LXR and PPARG gene regulatory responses in tumor cells is still lacking. To better define the underlying molecular processes governing the genetic control of cellular growth in response to extracellular metabolic signals, we performed a comprehensive, genome-wide characterization of the temporal regulatory cascades mediated by LXR and PPARG signaling in HT29 colorectal cancer cells. For this analysis, we applied a multi-tiered approach that incorporated cellular phenotypic assays, gene expression profiles, chromatin state dynamics, and nuclear receptor binding patterns. Our results illustrate that the activation of both nuclear receptors inhibited cell proliferation and further decreased glutathione levels, consistent with increased cellular oxidative stress. Despite a common metabolic reprogramming, the gene regulatory network programs initiated by these nuclear receptors were widely distinct. PPARG generated a rapid and short-term response while maintaining a gene activator role. By contrast, LXR signaling was prolonged, with initial, predominantly activating functions that transitioned to repressive gene regulatory activities at late time points. Through the use of a multi-tiered strategy that integrated various genomic datasets, our data illustrate that distinct gene regulatory programs elicit common phenotypic effects, highlighting the complexity of the genome. These results further provide a detailed molecular map of metabolic reprogramming in cancer cells through LXR and PPARG activation. As ligand-inducible TFs, these nuclear receptors can potentially serve as attractive therapeutic targets for the treatment of various cancers.

  15. Barred from better medicine? Reexamining regulatory barriers to the inclusion of prisoners in research

    PubMed Central

    Huang, Elaine; Cauley, Jacqueline

    2017-01-01

    Abstract In 2015, President Obama announced plans for the Precision Medicine Initiative® (PMI), an ambitious longitudinal project aimed at revolutionizing medicine. Integral to this Initiative is the recruitment of over one million Americans into a volunteer research cohort, the All of UsSM Research Program. The announcement has generated much excitement but absent is a discussion of how the All of Us Research Program—to be implemented within the context of social realities of mass incarcerations and racial disparities in criminal justice and healthcare—might excaberate health disparities. We examine how attainment of Initiative's stated goals of reflecting the diversity of the American population and including all who are interested in participating might be impeded by regulatory and administrative barriers to the involvement of participants who become incarcerated during longitudinal studies. Changes have been proposed to the federal policy for human subjects research protections, but current regulations and administrative policies—developed under a protectionist paradigm in response to scandalous research practices with confined populations—dramatically limit research involving prisoners. Our review provides rationale for the development of Initiative policies that anticipate recruitment and retention obstacles that might frustrate inclusivity and exacerbate health disparities. Furthermore, we question the effective ban on biomedical and behavioral research involving prisoners and advocate for regulatory reforms that restore participatory research rights of prisoners. Disparities in health and justice are intertwined, and without regulatory reforms to facilitate participatory research rights of prisoners and careful planning of viable and responsible recruitment, engagement, and retention strategies, Initiative could miss discovery opportunities, exacerbate health disparities, and increase levels of distrust in science. PMID:28852561

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

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

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

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

  17. Extractive sampling and optical remote sensing of F100 aircraft engine emissions.

    PubMed

    Cowen, Kenneth; Goodwin, Bradley; Joseph, Darrell; Tefend, Matthew; Satola, Jan; Kagann, Robert; Hashmonay, Ram; Spicer, Chester; Holdren, Michael; Mayfield, Howard

    2009-05-01

    The Strategic Environmental Research and Development Program (SERDP) has initiated several programs to develop and evaluate techniques to characterize emissions from military aircraft to meet increasingly stringent regulatory requirements. This paper describes the results of a recent field study using extractive and optical remote sensing (ORS) techniques to measure emissions from six F-15 fighter aircraft. Testing was performed between November 14 and 16, 2006 on the trim-pad facility at Tyndall Air Force Base in Panama City, FL. Measurements were made on eight different F100 engines, and the engines were tested on-wing of in-use aircraft. A total of 39 test runs were performed at engine power levels that ranged from idle to military power. The approach adopted for these tests involved extractive sampling with collocated ORS measurements at a distance of approximately 20-25 nozzle diameters downstream of the engine exit plane. The emission indices calculated for carbon dioxide, carbon monoxide, nitric oxide, and several volatile organic compounds showed very good agreement when comparing the extractive and ORS sampling methods.

  18. 75 FR 79949 - Revision of Delegation of Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... Marketing and Regulatory Programs (MRP) to the Deputy Under Secretary for MRP to establish the order in..., Chief of Staff, Marketing and Regulatory Programs, USDA, 1400 Independence Avenue, SW., Washington, DC... Marketing and Regulatory Programs (MRP) has delegated to the Deputy Under Secretary for MRP the following...

  19. Participatory Workplace Wellness Programs: Reward, Penalty, and Regulatory Conflict

    PubMed Central

    Pomeranz, Jennifer L

    2015-01-01

    Context In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. Methods To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments’ regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Findings Employers’ practices and the federal departments’ regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments’ regulations may be interpreted as conflicting with Congress's legislation, which mentions penalties only for health-contingent wellness programs. Furthermore, the regulatory protections for employees applicable to health-contingent wellness programs do not apply to participatory programs. Conclusions Either Congress or the federal agencies should address the conflict among employers’ practices, the wellness regulations, and the ADA and also consider additional protections for employees. Employers can avoid ethical and legal complications by offering voluntary programs with positive incentives. PMID:26044631

  20. Regulatory perspectives and research activities at the FDA on the use of phantoms with in vivo diagnostic devices

    NASA Astrophysics Data System (ADS)

    Agrawal, Anant; Gavrielides, Marios A.; Weininger, Sandy; Chakrabarti, Kish; Pfefer, Joshua

    2008-02-01

    For a number of years, phantoms have been used to optimize device parameters and validate performance in the primary medical imaging modalities (CT, MRI, PET/SPECT, ultrasound). Furthermore, the FDA under the Mammography Quality Standards Act (MQSA) requires image quality evaluation of mammography systems using FDA-approved phantoms. The oldest quantitative optical diagnostic technology, pulse oximetry, also benefits from the use of active phantoms known as patient simulators to validate certain performance characteristics under different clinically-relevant conditions. As such, guidance provided by the FDA to its staff and to industry on the contents of pre-market notification and approval submissions includes suggestions on how to incorporate the appropriate phantoms in establishing device effectiveness. Research at the FDA supports regulatory statements on the use of phantoms by investigating how phantoms can be designed, characterized, and utilized to determine critical device performance characteristics. These examples provide a model for how novel techniques in the rapidly growing field of optical diagnostics can use phantoms during pre- and post-market regulatory testing.

  1. 77 FR 26149 - Access Authorization Fees

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-03

    ... Regulatory Affairs of OMB. List of Subjects 10 CFR Part 11 Hazardous materials--transportation... licensees for work performed under the Material Access Authorization Program (MAAP) and the Information... assigned duties which require access to special nuclear material (plutonium, uranium-233, and uranium...

  2. Poker Flats Mine - Div. of Mining, Land, and Water

    Science.gov Websites

    Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land Fishery Water Resources Factsheets Forms banner image of landscape Poker Flats Mine Home Mining Coal Regulatory Program Poker Flats Mine Mining Coal Regulatory Program Info Chickaloon Chuit Watershed Chuitna

  3. USEPA BIOMONITORING AND BIOINDICATORS CONCEPTS NEEDED TO EVALUATE THE BIOLOGICAL INTEGRITY OF AQUATIC SYSTEMS

    EPA Science Inventory

    This chapter presents the current uses, concepts and anticipated future directions of biomonitoring and bioindicators in the regulatory and research programs of the United States Environmental Protection Agency (USEPA). The chapter provides a historical look on how biomonitoring ...

  4. US EPA BIOMONITORING AND BIOINDICATOR CONCEPTS NEEDED TO EVALUATE THE BIOLOGICAL INTEGRITY OF AQUATIC SYSTEMS

    EPA Science Inventory

    This chapter presents the current uses, concepts and anticipated future directions of biomonitoring and bioindicators in the regulatory and research programs of the United States Environmental Protection Agency (USEPA). The chapter provides a historical look on how biomonitoring ...

  5. 5 CFR 470.311 - Final project approval.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... MANAGEMENT RESEARCH PROGRAMS AND DEMONSTRATIONS PROJECTS Regulatory Requirements Pertaining to Demonstration Projects § 470.311 Final project approval. (a) The Office of Personnel Management will consider all timely...) The Office of Personnel Management shall provide a copy of the final version of the project plan to...

  6. USEPA BIOMONITORING AND BIOINDICATOR CONCEPTS NEEDED TO EVALUATE THE BIOLOGICAL INTEGRITY OF AQUATIC SYSTEMS

    EPA Science Inventory

    This chapter presents the current uses, concepts and anticipated future directions of biomonitoring and bioindicators in the regulatory and research programs of the United States Environmental Protection Agency (USEPA). The chapter provides a historical look on how biomonitoring...

  7. ENVIRONMENTAL IMMUNOCHEMISTRY AT THE U.S. EPA, NATIONAL EXPOSURE RESEARCH LABORATORY'S HUMAN EXPOSURE BRANCH

    EPA Science Inventory

    Immunoehemical methods are responding to the changing needs of regulatory and monitoring programs and are meeting new analytical challenges as they arise. Recent advances in environmental immunoehemistry have expanded the role of immunoassays from field screening methods to hig...

  8. Iterative performance assessments as a regulatory tool for evaluating repository safety: How experiences from SKI Project-90 were used in formulating the new performance assessment project SITE-94

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

    Andersson, J.

    1993-12-31

    The Swedish Nuclear Power Inspectorate, SKI, regulatory research program has to prepare for the process of licensing a repository for spent nuclear fuel, by building up the necessary knowledge and review capacity. SKIs main strategy for meeting this demand is to develop an independent performance assessment capability. SKIs first own performance assessment project, Project-90, was completed in 1991 and is now followed by a new project, SITE-94. SITE-94 is based on conclusions reached within Project-90. An independent review of Project-90, carried out by a NEA team of experts, has also contributed to the formation of the project. Another important reasonmore » for the project is that the implementing organization in Sweden, SKB, has proposed to submit an application to start detailed investigation of a repository candidate site around 1997. SITE-94 is a performance assessment of a hypothetical repository at a real site. The main objective of the project is to determine how site specific data should be assimilated into the performance assessment process, and to evaluate how uncertainties inherent in site characterization will influence performance assessment results. This will be addressed by exploring multiple interpretations, conceptual models, and parameters consistent with the site data. The site evaluation will strive for consistency between geological, hydrological, rock mechanical, and geochemical descriptions. Other important elements of SITE-94 are the development of a practical and defensible methodology for defining, constructing and analyzing scenarios, the development of approaches for treatment of uncertainties, evaluation of canister integrity, and the development and application of an appropriate quality assurance plan for performance assessments.« less

  9. Actions and Achievements of Self-Regulated Learning in Personal Environments. Research on Students Participating in the Graduate Program in Preschool Education at the University of Granada

    ERIC Educational Resources Information Center

    Chaves-Barboza, Eduardo; Trujillo-Torres, Juan Manuel; López-Núñez, Juan Antonio; Sola-Martínez, Tomás

    2017-01-01

    This paper is intended to study the self-regulated learning (SRL) process in personal learning environments (PLEs) among students participating in the Graduate Program for Preschool Education at the University of Granada (Spain). The study is focused on self-regulatory actions carried out by students, and on their self-regulated learning…

  10. Translational Neuroscience as a Tool for Intervention Development in the Context of High-Adversity Families

    PubMed Central

    Fisher, Philip A.

    2017-01-01

    The use of theory-driven models to develop and evaluate family-based intervention programs has a long history in psychology. Some of the first evidence-based parenting programs to address child problem behavior, developed in the 1970s, were grounded in causal models derived from longitudinal developmental research. The same translational strategies can also be applied to designing programs that leverage emerging scientific knowledge about the effects of early adverse experiences on neurobiological systems to reduce risk and promote well-being. By specifying not only behavioral targets but also affected underlying neural systems, interventions can become more precise and efficient. This chapter describes the development of a program of research focusing on an intervention for young children in foster care. The intervention emerged from social learning theory research and employs a translational neuroscience approach. The conceptual model guiding the research, which incorporates behavioral domains as well as stress-regulatory neural systems, is described. Finally, future directions for translational neuroscience in family-based intervention research are considered. PMID:27589501

  11. #2 - An Empirical Assessment of Exposure Measurement Error ...

    EPA Pesticide Factsheets

    Background• Differing degrees of exposure error acrosspollutants• Previous focus on quantifying and accounting forexposure error in single-pollutant models• Examine exposure errors for multiple pollutantsand provide insights on the potential for bias andattenuation of effect estimates in single and bipollutantepidemiological models The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  12. Why do water quality monitoring programs succeed or fail? A qualitative comparative analysis of regulated testing systems in sub-Saharan Africa.

    PubMed

    Peletz, Rachel; Kisiangani, Joyce; Bonham, Mateyo; Ronoh, Patrick; Delaire, Caroline; Kumpel, Emily; Marks, Sara; Khush, Ranjiv

    2018-05-31

    Water quality testing is critical for guiding water safety management and ensuring public health. In many settings, however, water suppliers and surveillance agencies do not meet regulatory requirements for testing frequencies. This study examines the conditions that promote successful water quality monitoring in Africa, with the goal of providing evidence for strengthening regulated water quality testing programs. We compared monitoring programs among 26 regulated water suppliers and surveillance agencies across six African countries. These institutions submitted monthly water quality testing results over 18 months. We also collected qualitative data on the conditions that influenced testing performance via approximately 821 h of semi-structured interviews and observations. Based on our qualitative data, we developed the Water Capacity Rating Diagnostic (WaterCaRD) to establish a scoring framework for evaluating the effects of the following conditions on testing performance: accountability, staffing, program structure, finances, and equipment & services. We summarized the qualitative data into case studies for each of the 26 institutions and then used the case studies to score the institutions against the conditions captured in WaterCaRD. Subsequently, we applied fuzzy-set Qualitative Comparative Analysis (fsQCA) to compare these scores against performance outcomes for water quality testing. We defined the performance outcomes as the proportion of testing Targets Achieved (outcome 1) and Testing Consistency (outcome 2) based on the monthly number of microbial water quality tests conducted by each institution. Our analysis identified motivation & leadership, knowledge, staff retention, and transport as institutional conditions that were necessary for achieving monitoring targets. In addition, equipment, procurement, infrastructure, and enforcement contributed to the pathways that resulted in strong monitoring performance. Our identification of institutional commitment, comprising motivation & leadership, knowledge, and staff retention, as a key driver of monitoring performance was not surprising: in weak regulatory environments, individuals and their motivations take-on greater importance in determining institutional and programmatic outcomes. Nevertheless, efforts to build data collection capacity in low-resource settings largely focus on supply-side interventions: the provision of infrastructure, equipment, and training sessions. Our results indicate that these interventions will continue to have limited long-term impacts and sustainability without complementary strategies for motivating or incentivizing water supply and surveillance agency managers to achieve testing goals. More broadly, our research demonstrates both an experimental approach for diagnosing the systems that underlie service provision and an analytical strategy for identifying appropriate interventions. Copyright © 2018 The Authors. Published by Elsevier GmbH.. All rights reserved.

  13. The role of self-regulatory efficacy, moral disengagement and guilt on doping likelihood: A social cognitive theory perspective.

    PubMed

    Ring, Christopher; Kavussanu, Maria

    2018-03-01

    Given the concern over doping in sport, researchers have begun to explore the role played by self-regulatory processes in the decision whether to use banned performance-enhancing substances. Grounded on Bandura's (1991) theory of moral thought and action, this study examined the role of self-regulatory efficacy, moral disengagement and anticipated guilt on the likelihood to use a banned substance among college athletes. Doping self-regulatory efficacy was associated with doping likelihood both directly (b = -.16, P < .001) and indirectly (b = -.29, P < .001) through doping moral disengagement. Moral disengagement also contributed directly to higher doping likelihood and lower anticipated guilt about doping, which was associated with higher doping likelihood. Overall, the present findings provide evidence to support a model of doping based on Bandura's social cognitive theory of moral thought and action, in which self-regulatory efficacy influences the likelihood to use banned performance-enhancing substances both directly and indirectly via moral disengagement.

  14. Integration of a splicing regulatory network within the meiotic gene expression program of Saccharomyces cerevisiae

    PubMed Central

    Munding, Elizabeth M.; Igel, A. Haller; Shiue, Lily; Dorighi, Kristel M.; Treviño, Lisa R.; Ares, Manuel

    2010-01-01

    Splicing regulatory networks are essential components of eukaryotic gene expression programs, yet little is known about how they are integrated with transcriptional regulatory networks into coherent gene expression programs. Here we define the MER1 splicing regulatory network and examine its role in the gene expression program during meiosis in budding yeast. Mer1p splicing factor promotes splicing of just four pre-mRNAs. All four Mer1p-responsive genes also require Nam8p for splicing activation by Mer1p; however, other genes require Nam8p but not Mer1p, exposing an overlapping meiotic splicing network controlled by Nam8p. MER1 mRNA and three of the four Mer1p substrate pre-mRNAs are induced by the transcriptional regulator Ume6p. This unusual arrangement delays expression of Mer1p-responsive genes relative to other genes under Ume6p control. Products of Mer1p-responsive genes are required for initiating and completing recombination and for activation of Ndt80p, the activator of the transcriptional network required for subsequent steps in the program. Thus, the MER1 splicing regulatory network mediates the dependent relationship between the UME6 and NDT80 transcriptional regulatory networks in the meiotic gene expression program. This study reveals how splicing regulatory networks can be interlaced with transcriptional regulatory networks in eukaryotic gene expression programs. PMID:21123654

  15. Transcriptional master regulator analysis in breast cancer genetic networks.

    PubMed

    Tovar, Hugo; García-Herrera, Rodrigo; Espinal-Enríquez, Jesús; Hernández-Lemus, Enrique

    2015-12-01

    Gene regulatory networks account for the delicate mechanisms that control gene expression. Under certain circumstances, gene regulatory programs may give rise to amplification cascades. Such transcriptional cascades are events in which activation of key-responsive transcription factors called master regulators trigger a series of gene expression events. The action of transcriptional master regulators is then important for the establishment of certain programs like cell development and differentiation. However, such cascades have also been related with the onset and maintenance of cancer phenotypes. Here we present a systematic implementation of a series of algorithms aimed at the inference of a gene regulatory network and analysis of transcriptional master regulators in the context of primary breast cancer cells. Such studies were performed in a highly curated database of 880 microarray gene expression experiments on biopsy-captured tissue corresponding to primary breast cancer and healthy controls. Biological function and biochemical pathway enrichment analyses were also performed to study the role that the processes controlled - at the transcriptional level - by such master regulators may have in relation to primary breast cancer. We found that transcription factors such as AGTR2, ZNF132, TFDP3 and others are master regulators in this gene regulatory network. Sets of genes controlled by these regulators are involved in processes that are well-known hallmarks of cancer. This kind of analyses may help to understand the most upstream events in the development of phenotypes, in particular, those regarding cancer biology. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Load research manual. Volume 1. Load research procedures

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

    Brandenburg, L.; Clarkson, G.; Grund, Jr., C.

    1980-11-01

    This three-volume manual presents technical guidelines for electric utility load research. Special attention is given to issues raised by the load data reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. In Volumes 1 and 2, procedures are suggested for determining data requirements for load research, establishing the size and customer composition of a load survey sample, selecting and using equipment to record customer electricity usage, processing data tapes from the recording equipment, and analyzing the data. Statistical techniques used in customer sampling are discussedmore » in detail. The costs of load research also are estimated, and ongoing load research programs at three utilities are described. The manual includes guides to load research literature and glossaries of load research and statistical terms.« less

  17. SATRAT: Staphylococcus aureus transcript regulatory network analysis tool.

    PubMed

    Gopal, Tamilselvi; Nagarajan, Vijayaraj; Elasri, Mohamed O

    2015-01-01

    Staphylococcus aureus is a commensal organism that primarily colonizes the nose of healthy individuals. S. aureus causes a spectrum of infections that range from skin and soft-tissue infections to fatal invasive diseases. S. aureus uses a large number of virulence factors that are regulated in a coordinated fashion. The complex regulatory mechanisms have been investigated in numerous high-throughput experiments. Access to this data is critical to studying this pathogen. Previously, we developed a compilation of microarray experimental data to enable researchers to search, browse, compare, and contrast transcript profiles. We have substantially updated this database and have built a novel exploratory tool-SATRAT-the S. aureus transcript regulatory network analysis tool, based on the updated database. This tool is capable of performing deep searches using a query and generating an interactive regulatory network based on associations among the regulators of any query gene. We believe this integrated regulatory network analysis tool would help researchers explore the missing links and identify novel pathways that regulate virulence in S. aureus. Also, the data model and the network generation code used to build this resource is open sourced, enabling researchers to build similar resources for other bacterial systems.

  18. The research program coordinator: an example of effective management.

    PubMed

    Merry, Lisa; Gagnon, Anita J; Thomas, Julia

    2010-01-01

    Careers in clinical research management are increasingly common. Despite nurses' important role in clinical research, their status as research professionals is underrecognized. In this article, we describe the role of a "program coordinator" (PC) in the context of a complex research program on migration and reproductive health. The PC role expands beyond the usual role of a research coordinator because he or she is involved in all aspects of the program of research and his or her responsibilities include research, education, clinical, and administration components. He or she ensures optimal organization and continuity across several studies and ensures ethical and scientific standards are applied for each individual study. His or her clinical knowledge assures data are accurate and subjects are safe. In addition, he or she assists with applying for funding, the maintenance of research partnerships, and dissemination of research findings; he or she supports students' learning and completes all regulatory aspects related to the program of research. Key to the PC role is relationship building and the application of Good Clinical Practice principles. The advanced role of a PC also warrants opportunities for professional development and a competitive salary. A PC is an effective approach for research management and a natural role for professional nurse. Copyright 2010 Elsevier Inc. All rights reserved.

  19. The Brown Superfund Basic Research Program: A Multistakeholder Partnership Addresses Real-World Problems in Contaminated Communities

    PubMed Central

    Senier, Laura; Hudson, Benjamin; Fort, Sarah; Hoover, Elizabeth; Tillson, Rebecca; Brown, Phil

    2008-01-01

    The NIEHS funds several basic and applied research programs, many of which also require research translation or outreach. This paper reports on a project by the Brown University Superfund Basic Research Program (SBRP), in which outreach and research translation teams collaborated with state regulatory agency personnel and community activists on a legislative initiative to mitigate the financial impacts of living in a contaminated community. The Environmentally Compromised Home Ownership (ECHO) program makes home equity loans of up to $25,000 available to qualified applicants. This collaboration provides a case study in community engagement and demonstrates how research translation and outreach activities that are clearly differentiated yet well integrated can improve a suite of basic and applied research. Although engaging diverse constituencies can be difficult, community-engaged translation and outreach have the potential to make research findings more useful to communities, address some of the social impacts of contamination, and empower stakeholders to pursue their individual and collectively-held goals for remediation. The NIEHS has recently renewed its commitment to community-engaged research and advocacy, making this an optimal time to reflect on how basic research programs that engage stakeholders through research translation and outreach can add value to the overall research enterprise. PMID:18677987

  20. Brown Superfund Basic research Program: a multistakeholder partnership addresses real-world problems in contaminated communities.

    PubMed

    Senier, Laura; Hudson, Benjamin; Fort, Sarah; Hoover, Elizabeth; Tillson, Rebecca; Brown, Phil

    2008-07-01

    The NIEHS funds several basic and applied research programs, many of which also require research translation or outreach. This paper reports on a project by the Brown University Superfund Basic Research Program (SBRP), in which outreach and research translation teams collaborated with state regulatory agency personnel and community activists on a legislative initiative to mitigate the financial impacts of living in a contaminated community. The Environmentally Compromised Home Ownership (ECHO) program makes home equity loans of up to $25,000 available to qualified applicants. This collaboration provides a case study in community engagement and demonstrates how research translation and outreach activities that are clearly differentiated yet well-integrated can improve a suite of basic and applied research. Although engaging diverse constituencies can be difficult community-engaged translation and outreach have the potential to make research findings more useful to communities, address some of the social impacts of contamination, and empower stakeholders to pursue their individual and collectively held goals for remediation. The NIEHS has recently renewed its commitment to community-engaged research and advocacy, making this an optimal time to reflect on how basic research programs that engage stakeholders through research translation and outreach can add value to the overall research enterprise.

  1. Prospective Activities outlined for Regulatory Approval in Ghana Overview

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

    Abrefah, R.G.; Odoi, H.C.; Mo, S.C.

    The Ghana Research Reactor-1 (GHARR-1) is one of Chinese’s Miniature Neutron Source Reactor (MNSR) which was purchased under a tripartite agreement between Ghana, China and the IAEA. The reactor was installed in 1994 and has since been in operation without any incident. It has been used chiefly for Neutron Activation Analysis (NAA) and Training of students in the field of Nuclear Engineering. The GHARR-1 has been earmarked for the Conversion of Core from HEU to LEU which is in accordance with the GTRI program and other related and/or associated programs. Over the past few years the National Nuclear Research Institutemore » (NNRI), the Operating Organization of the Research Reactor for the Ghana Atomic Energy Commission (GAEC), has undertaken various tasks in order to implement the replacement of the reactor core. After completion, of the neutronic calculations, results showed that that an LEU fuel of 12.5% enrichment was desirable. However, recent developments have shown that an LEU fuel with 13% enrichment will be fabricated by the manufacturers, which is captured in a fuel specification document sent to NNRI by the CIAE. It is therefore imperative that all neutronic and thermal hydraulic calculation be done again to help acquire regulatory approval. Furthermore, the radiation exposure to personnel involved in the conversion must be estimated to help convince our regulators. This paper outlines the processes and activities that will enable us meet regulatory requirements.« less

  2. Biosimilars: The US Regulatory Framework.

    PubMed

    Christl, Leah A; Woodcock, Janet; Kozlowski, Steven

    2017-01-14

    With the passage of the Biologics Price Competition and Innovation Act of 2009, the US Food and Drug Administration established an abbreviated pathway for developing and licensing biosimilar and interchangeable biological products. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a "totality of the evidence" that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. Although questions and concerns about the biosimilars pathway remain and may slow uptake, a robust scientific program has been put in place. With three biosimilars already licensed and numerous development programs under way, clinicians can expect to see many new biosimilars come onto the US market in the coming decade. [Note added in proof: Since the writing of this article, a fourth biosimilar has been approved.].

  3. [Role of researchers and employees of the Military Medical Academy in development of the system of military medical supply].

    PubMed

    Miroshnichenko, Iu V; Kononov, V N; Perfil'ev, A B

    2013-12-01

    The Military Medical Academy has been solving theoretical and practical issues, concerning development of military medical supply, for 215 years. At different time periods and according to needs of military medicine and pharmacy researches and employees of the Academy aimed efforts to: development of the theory and practice of medical supply organization, regulatory basis of the system of medical supply, development of new samples of medical equipment, development of medicine manufacturing technologies and methods of quality control, researches in the area of medicine radiochemistry, forensic chemistry and toxicology, herbal and mineral water analysis and etc. At the present time there are the following education programs at the Academy: "Pharmacy", magister program "Management of medical supply", program for resident physicians "Management and economics of pharmacy".

  4. Recent evaluations of crack-opening-area in circumferentially cracked pipes

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

    Rahman, S.; Brust, F.; Ghadiali, N.

    1997-04-01

    Leak-before-break (LBB) analyses for circumferentially cracked pipes are currently being conducted in the nuclear industry to justify elimination of pipe whip restraints and jet shields which are present because of the expected dynamic effects from pipe rupture. The application of the LBB methodology frequently requires calculation of leak rates. The leak rates depend on the crack-opening area of the through-wall crack in the pipe. In addition to LBB analyses which assume a hypothetical flaw size, there is also interest in the integrity of actual leaking cracks corresponding to current leakage detection requirements in NRC Regulatory Guide 1.45, or for assessingmore » temporary repair of Class 2 and 3 pipes that have leaks as are being evaluated in ASME Section XI. The objectives of this study were to review, evaluate, and refine current predictive models for performing crack-opening-area analyses of circumferentially cracked pipes. The results from twenty-five full-scale pipe fracture experiments, conducted in the Degraded Piping Program, the International Piping Integrity Research Group Program, and the Short Cracks in Piping and Piping Welds Program, were used to verify the analytical models. Standard statistical analyses were performed to assess used to verify the analytical models. Standard statistical analyses were performed to assess quantitatively the accuracy of the predictive models. The evaluation also involved finite element analyses for determining the crack-opening profile often needed to perform leak-rate calculations.« less

  5. STANDARD EVALUATION PROCEDURES FOR SUBMITTED DEVELOPMENTAL NEUROTOXICITY DATA

    EPA Science Inventory

    As a NAFTA-inspired multi-governmental initiative, experts from the US EPA (Office of Research and Development, Office of Pesticide Program, or OPP) and the PMRA (Pest Management Regulatory Agency) of Health Canada formed a working group to create a document that would serve as a...

  6. A Higher Education Agenda for the 97th Congress.

    ERIC Educational Resources Information Center

    Educational Record, 1981

    1981-01-01

    Recommendations by the American Council on Education for priorities in federal legislation are made concerning student aid, institutional and program aid, research support, armed forces, tax credits and incentives, medical services, social reforms, employment and handicapped policies, truth-in-testing, regulatory reform, and equal education. (MSE)

  7. 78 FR 35808 - Proposed priority-Rehabilitation Training: Rehabilitation Long-Term Training Program-Vocational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ..., Labor, and the Social Security Administration. The goal of this conference was to explore several..., research report, 1-15. Proposed Priority The Assistant Secretary for Special Education and Rehabilitative... practicable--the costs of cumulative regulations; (3) In choosing among alternative regulatory approaches...

  8. Regulatory Focus as a Mediator of the Influence of Initiating Structure and Servant Leadership on Employee Behavior

    ERIC Educational Resources Information Center

    Neubert, Mitchell J.; Kacmar, K. Michele; Carlson, Dawn S.; Chonko, Lawrence B.; Roberts, James A.

    2008-01-01

    In this research, the authors test a model in which the regulatory focus of employees at work mediates the influence of leadership on employee behavior. In a nationally representative sample of 250 workers who responded over 2 time periods, prevention focus mediated the relationship of initiating structure to in-role performance and deviant…

  9. Determinants of Services Sourcing Performance

    DTIC Science & Technology

    2010-12-16

    resources toward those factors that have the greatest impact on performance and avoid the inefficient use of resources on those factors that have...little or no impact . C. RESEARCH OBJECTIVES The objective of this research is to address existing gaps in the literature and to offer service contract...Research Question 2: Which determinant(s) have the greatest impact on the key contract outcomes of service quality and regulatory and statutory compliance

  10. The good and bad of being fair: effects of procedural and interpersonal justice behaviors on regulatory resources.

    PubMed

    Johnson, Russell E; Lanaj, Klodiana; Barnes, Christopher M

    2014-07-01

    The justice literature has paid considerable attention to the beneficial effects of fair behaviors for recipients of such behaviors. It is possible, however, that exhibiting fair behaviors may come at a cost for actors. In this article, we integrate ego depletion theory with organizational justice research in order to examine the consequences of justice behaviors for actors. We used an experience-sampling method in a sample of managerial employees to examine the relations of performing procedural justice and interpersonal justice behaviors with subsequent changes in actors' regulatory resources. Our results indicate that procedural justice behaviors are draining, whereas interpersonal justice behaviors are replenishing for actors. Depletion, in turn, adversely affected the performance of citizenship behavior, and depletion mediated relations of justice behavior with citizenship. Furthermore, 2 traits that impact self-regulatory skills--extraversion and neuroticism--moderated the replenishing effects of engaging in interpersonal justice behaviors. We conclude by discussing implications and avenues for future research.

  11. Overview of the program to assess the reliability of emerging nondestructive techniques open testing and study of flaw type effect on NDE response

    NASA Astrophysics Data System (ADS)

    Meyer, Ryan M.; Komura, Ichiro; Kim, Kyung-cho; Zetterwall, Tommy; Cumblidge, Stephen E.; Prokofiev, Iouri

    2016-02-01

    In February 2012, the U.S. Nuclear Regulatory Commission (NRC) executed agreements with VTT Technical Research Centre of Finland, Nuclear Regulatory Authority of Japan (NRA, former JNES), Korea Institute of Nuclear Safety (KINS), Swedish Radiation Safety Authority (SSM), and Swiss Federal Nuclear Safety Inspectorate (ENSI) to establish the Program to Assess the Reliability of Emerging Nondestructive Techniques (PARENT). The goal of PARENT is to investigate the effectiveness of current emerging and perspective novel nondestructive examination procedures and techniques to find flaws in nickel-alloy welds and base materials. This is done by conducting a series of open and blind international round-robin tests on a set of large-bore dissimilar metal welds (LBDMW), small-bore dissimilar metal welds (SBDMW), and bottom-mounted instrumentation (BMI) penetration weld test blocks. The purpose of blind testing is to study the reliability of more established techniques and included only qualified teams and procedures. The purpose of open testing is aimed at a more basic capability assessment of emerging and novel technologies. The range of techniques applied in open testing varied with respect to maturity and performance uncertainty and were applied to a variety of simulated flaws. This paper will include a brief overview of the PARENT blind and open testing techniques and test blocks and present some of the blind testing results.

  12. Integrating co-morbid depression and chronic physical disease management: identifying and resolving failures in self-regulation.

    PubMed

    Detweiler-Bedell, Jerusha B; Friedman, Michael A; Leventhal, Howard; Miller, Ivan W; Leventhal, Elaine A

    2008-12-01

    Research suggests that treatments for depression among individuals with chronic physical disease do not improve disease outcomes significantly, and chronic disease management programs do not necessarily improve mood. For individuals experiencing co-morbid depression and chronic physical disease, demands on the self-regulation system are compounded, leading to a rapid depletion of self-regulatory resources. Because disease and depression management are not integrated, patients lack the understanding needed to prioritize self-regulatory goals in a way that makes disease and depression management synergistic. A framework in which the management of co-morbidity is considered alongside the management of either condition alone offers benefits to researchers and practitioners and may help improve clinical outcomes.

  13. Integrating Co-Morbid Depression and Chronic Physical Disease Management: Identifying and Resolving Failures in Self-Regulation

    PubMed Central

    Detweiler-Bedell, Jerusha B.; Friedman, Michael A.; Leventhal, Howard; Miller, Ivan W.; Leventhal, Elaine A.

    2008-01-01

    Research suggests that treatments for depression among individuals with chronic physical disease do not improve disease outcomes significantly, and chronic disease management programs do not necessarily improve mood. For individuals experiencing co-morbid depression and chronic physical disease, demands on the self-regulation system are compounded, leading to a rapid depletion of self-regulatory resources. Because disease and depression management are not integrated, patients lack the understanding needed to prioritize self-regulatory goals in a way that makes disease and depression management synergistic. A framework in which the management of co-morbidity is considered alongside the management of either condition alone offers benefits to researchers and practitioners and may help improve clinical outcomes. PMID:18848740

  14. Legal, regulatory & institutional issues facing distributed resources development

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

    NONE

    This report describes legal, regulatory, and institutional considerations likely to shape the development and deployment of distributed resources. It is based on research co-sponsored by the National Renewable Energy Laboratory (NREL) and four investor-owned utilities (Central & South West Services, Cinergy Corp., Florida Power Corporation, and San Diego Gas & Electric Company). The research was performed between August 1995 and March 1996 by a team of four consulting firms experienced in energy and utility law, regulation, and economics. It is the survey phase of a project known as the Distributed Resources Institutional Analysis Project.

  15. Updating Human Factors Engineering Guidelines for Conducting Safety Reviews of Nuclear Power Plants

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

    O, J.M.; Higgins, J.; Stephen Fleger - NRC

    The U.S. Nuclear Regulatory Commission (NRC) reviews the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed to the periodicmore » update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool. To this end, the NRC is updating its guidance to stay current with recent research on human performance, advances in HFE methods and tools, and new technology being employed in plant and control room design. This paper describes the role of HFE guidelines in the safety review process and the content of the key HFE guidelines used. Then we will present the methodology used to develop HFE guidance and update these documents, and describe the current status of the update program.« less

  16. Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

    PubMed

    Fisher, Adam C; Lee, Sau L; Harris, Daniel P; Buhse, Lucinda; Kozlowski, Steven; Yu, Lawrence; Kopcha, Michael; Woodcock, Janet

    2016-12-30

    Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.

  17. 75 FR 18048 - Oklahoma Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... due to a labor strike; (4) Where climatic conditions preclude abatement within 90 days, or where, due to climatic conditions, abatement within 90 days clearly would cause more environmental harm than it... have takings implications. This determination is based on the analysis performed for the counterpart...

  18. Manufacturing/Cell Therapy Specialist | Center for Cancer Research

    Cancer.gov

    Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides cell culture experience to work on innovative Vector Production and T-cell therapies for cancer treatment, and responsible for cell culture media preparation, vector production, and/or cell processing and cell expansion in the cGMP clinical manufacturing facility in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB). KEY ROLES/RESPONSIBILITIES-THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL Performs testing of raw materials, intermediates, and final products by following analytical methods Maintains, calibrates and operates equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assay Tracks and tests products according to protocols Maintains lab in an optimal state Monitors and trends data, completes routine record review of test data and related documents for in-process testing, drug substance and drug product release Generates CoAs for product release Assists in the preparation of dossiers and data packages for interactions between Surgery Branch and Regulatory agencies Develops, revises, and reviews SOPs, qualification/validation protocols and reports Participates in investigations regarding out of specifications (OOS) results; address and manage deviations related to analytical procedures Provides updates at daily and weekly meetings Monitors the GMP systems currently in place to ensure compliance with documented policies Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate Gathers metric information for use in continuous improvement of areas of responsibility May develop testing and analysis methods and procedures in accordance with established guidelines

  19. An experimental investigation of the effects of alarm processing and display on operator performance

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

    O`Hara, J.; Brown, W.; Hallbert, B.

    1998-03-01

    This paper describes a research program sponsored by the US Nuclear Regulatory Commission to address the human factors engineering (HFE) aspects of nuclear power plant alarm systems. The overall objective of the program is to develop HFE review guidance for advanced alarm systems. As part of this program, guidance has been developed based on a broad base of technical and research literature. In the course of guidance development, aspects of alarm system design for which the technical basis was insufficient to support complete guidance development were identified. The primary purpose of the research reported in this paper was to evaluatemore » the effects of three of these alarm system design characteristics on operator performance in order to contribute to the understanding of potential safety issues and to provide data to support the development of design review guidance in these areas. Three alarm system design characteristics studied were (1) alarm processing (degree of alarm reduction), (2) alarm availability (dynamic prioritization and suppression), and (3) alarm display (a dedicated tile format, a mixed tile and message list format, and a format in which alarm information is integrated into the process displays). A secondary purpose was to provide confirmatory evidence of selected alarm system guidance developed in an earlier phase of the project. The alarm characteristics were combined into eight separate experimental conditions. Six, two-person crews of professional nuclear power plant operators participated in the study. Following training, each crew completed 16 test trials which consisted of two trials in each of the eight experimental conditions (one with a low-complexity scenario and one with a high-complexity scenario). Measures of process performance, operator task performance, situation awareness, and workload were obtained. In addition, operator opinions and evaluations of the alarm processing and display conditions were collected. No deficient performance was observed in any of the experimental conditions, providing confirmatory support for many design review guidelines. The operators identified numerous strengths and weaknesses associated with individual alarm design characteristics.« less

  20. Creative Research Ethics in the Enterprise University: What Price Academic Freedom?

    ERIC Educational Resources Information Center

    O'Neill, John

    2013-01-01

    Between 1990 and 2010, the New Zealand university adopted an enterprise form. The nature of academic work changed commensurate with changes in the external regulatory and funding environment, the internal performative research culture, the proliferation of trans-national researcher networks, and the growing managerial codification of acceptable…

  1. Who Are You More Likely to Help? The Effects of Expected Outcomes and Regulatory Focus on Prosocial Performance.

    PubMed

    Xiao, Fengqiu; Zheng, Zhiwei; Zhang, Heyi; Xin, Ziqiang; Chen, Yinghe; Li, Yiwei

    2016-01-01

    Prosocial behavior refers to a broad category of actions that benefit other people or the society. Compared with other factors that affect prosocial performance, prosocial outcomes, consisting of prosocial gains and prosocial non-losses have received less attention up to now. In the current research, we explored the influences of different types of expected outcomes and regulatory focus on prosocial performance. Studies 1a and 1b examined the differences in prosocial performance elicited by prosocial gain (e.g., enhancing others' access to clean water) and prosocial non-loss outcomes (e.g., protecting others from suffering dirty water). We found that the expected prosocial non-loss outcomes induced greater prosocial performance compared with the expected prosocial gain outcomes. Studies 2a and 2b examined the effects of dispositional and situational regulatory focus on prosocial loss aversion. We found that differences in prosocial performance between two expected prosocial outcomes were reduced when promotion focus was primed; whereas a primed prevention focus did not significantly increase this difference. Additionally, participants displayed a greater prosocial loss aversion in the prevention focus condition than in the promotion focus condition. The reason for the non-significant interaction between regulatory focus and expected prosocial outcome was discussed.

  2. Who Are You More Likely to Help? The Effects of Expected Outcomes and Regulatory Focus on Prosocial Performance

    PubMed Central

    Xiao, Fengqiu; Zheng, Zhiwei; Zhang, Heyi; Xin, Ziqiang; Chen, Yinghe; Li, Yiwei

    2016-01-01

    Prosocial behavior refers to a broad category of actions that benefit other people or the society. Compared with other factors that affect prosocial performance, prosocial outcomes, consisting of prosocial gains and prosocial non-losses have received less attention up to now. In the current research, we explored the influences of different types of expected outcomes and regulatory focus on prosocial performance. Studies 1a and 1b examined the differences in prosocial performance elicited by prosocial gain (e.g., enhancing others’ access to clean water) and prosocial non-loss outcomes (e.g., protecting others from suffering dirty water). We found that the expected prosocial non-loss outcomes induced greater prosocial performance compared with the expected prosocial gain outcomes. Studies 2a and 2b examined the effects of dispositional and situational regulatory focus on prosocial loss aversion. We found that differences in prosocial performance between two expected prosocial outcomes were reduced when promotion focus was primed; whereas a primed prevention focus did not significantly increase this difference. Additionally, participants displayed a greater prosocial loss aversion in the prevention focus condition than in the promotion focus condition. The reason for the non-significant interaction between regulatory focus and expected prosocial outcome was discussed. PMID:27824909

  3. 76 FR 34815 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...We are issuing a final decision on an amendment to the Wyoming regulatory program (the ``Wyoming program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). Our decision approves in part, disapproves in part and defers in part the amendment. Wyoming proposed to amend Chapters 1, 2, 4, 5, and Appendix A of the Land Quality Division (LQD) Coal Rules and Regulations to address required program amendments and other deficiencies identified by OSMRE, and to improve and clarify rules relating to requirements for vegetation measurements and performance standards. Specifically, the proposed changes clarify baseline vegetation requirements and revegetation reclamation plan requirements, clarify revegetation success standards and codify normal husbandry practices, reorganize and clarify species diversity and shrub density requirements, and revise and add definitions supporting those proposed changes. Wyoming also proposed changes to its rules in Chapters 2, 4, and 5 regarding cultural and historic resources, prime farmland, siltation structures and impoundments, and operator information. Wyoming revised its program to be consistent with the corresponding Federal regulations and SMCRA, clarify ambiguities, and improve operational efficiency.

  4. 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

  5. Use of Advanced Tsunami Hazard Assessment Techniques and Tsunami Source Characterizations in U.S. and International Nuclear Regulatory Activities

    NASA Astrophysics Data System (ADS)

    Kammerer, A. M.; Godoy, A. R.

    2009-12-01

    In response to the 2004 Indian Ocean Tsunami, as well as the anticipation of the submission of license applications for new nuclear facilities, the United States Nuclear Regulatory Commission (US NRC) initiated a long-term research program to improve understanding of tsunami hazard levels for nuclear power plants and other coastal facilities in the United States. To undertake this effort, the US NRC organized a collaborative research program jointly undertaken with researchers at the United States Geological Survey (USGS) and the National Oceanic and Atmospheric Administration (NOAA) for the purpose of assessing tsunami hazard on the Atlantic and Gulf Coasts of the United States. This study identified and modeled both seismic and landslide tsunamigenic sources in the near- and far-field. The results from this work are now being used directly as the basis for the review of tsunami hazard at potential nuclear plant sites. This application once again shows the importance that the earth sciences can play in addressing issues of importance to society. Because the Indian Ocean Tsunami was a global event, a number of cooperative international activities have also been initiated within the nuclear community. The results of US efforts are being incorporated into updated regulatory guidance for both the U.S. Nuclear Regulatory Commission and the United Nation’s International Atomic Energy Agency (IAEA). Coordinated efforts are underway to integrate state-of-the art tsunami warning tools developed by NOAA into NRC and IAEA activities. The goal of the warning systems project is to develop automated protocols that allow scientists at these agencies to have up-to-the minute user-specific information in hand shortly after a potential tsunami has been identified by the US Tsunami Warning System. Lastly, USGS and NOAA scientists are assisting the NRC and IAEA in a special Extra-Budgetary Program (IAEA EBP) on tsunami being coordinated by the IAEA’s International Seismic Safety Center. This IAEA EBP is focused on sharing lessons learned, tsunami hazard assessment techniques, and numerical tools among UN Member States. The complete body of basic and applied research undertaken in these many projects represents the combined effort of a diverse group of marine geologists, geophysicists, geotechnical engineers, seismologists and hydrodynamic modelers at multiple organizations.

  6. 7 CFR 322.15 - APHIS review of permit applications; denial or cancellation of permits.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS... charge of research or regulatory programs relative to bees; and any other qualified governmental or... an exotic bee disease or parasite, or an undesirable species or subspecies of honeybee. Danger of...

  7. 7 CFR 322.15 - APHIS review of permit applications; denial or cancellation of permits.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS... charge of research or regulatory programs relative to bees; and any other qualified governmental or... an exotic bee disease or parasite, or an undesirable species or subspecies of honeybee. Danger of...

  8. 7 CFR 322.15 - APHIS review of permit applications; denial or cancellation of permits.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS... charge of research or regulatory programs relative to bees; and any other qualified governmental or... an exotic bee disease or parasite, or an undesirable species or subspecies of honeybee. Danger of...

  9. 7 CFR 322.15 - APHIS review of permit applications; denial or cancellation of permits.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS... charge of research or regulatory programs relative to bees; and any other qualified governmental or... an exotic bee disease or parasite, or an undesirable species or subspecies of honeybee. Danger of...

  10. 7 CFR 322.15 - APHIS review of permit applications; denial or cancellation of permits.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (Continued) ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE BEES, BEEKEEPING BYPRODUCTS... charge of research or regulatory programs relative to bees; and any other qualified governmental or... an exotic bee disease or parasite, or an undesirable species or subspecies of honeybee. Danger of...

  11. 78 FR 40403 - Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-05

    ... from today's proposed determination. There currently is no statutory definition of portable ACs. DOE...\\ Transparency Media Research. Air Conditioning Systems Market--Global Scenario, Trends, Industry Analysis, Size... amended by the Small Business Regulatory Enforcement Fairness Act of 1996) requires preparation of an...

  12. India's growing participation in global clinical trials.

    PubMed

    Gupta, Yogendra K; Padhy, Biswa M

    2011-06-01

    Lower operational costs, recent regulatory reforms and several logistic advantages make India an attractive destination for conducting clinical trials. Efforts for maintaining stringent ethical standards and the launch of Pharmacovigilance Program of India are expected to maximize the potential of the country for clinical research. Copyright © 2011. Published by Elsevier Ltd.

  13. Access and benefit sharing (ABS) under the convention on biological diversity (CBD): implications for microbial biological control

    USDA-ARS?s Scientific Manuscript database

    Researchers and implementers of biological control are confronted with a variety of scientific, regulatory and administrative challenges to their biological control programs. One developing challenge will arise from the implementation of provisions of the Convention on Biological Diversity (CBD) co...

  14. EXTRAPOLATING ACUTE MORTALITY OF AMPELISCA ABDITA TO POPULATION RISK USING A POPULATION MODEL AND MONITORING DATA

    EPA Science Inventory

    Ten-day acute mortality of the benthic amphipod, Ampelisca abdita, is used in a number of regulatory, research, and monitoring programs to evaluate chemical contamination of marine sediments. Although this endpoint has proven to be valuable for characterizing the relative toxicit...

  15. Academic-Industry Collaboration under Federal Grants and Cooperative Agreements: Financial, Administrative, and Regulatory Compliance

    ERIC Educational Resources Information Center

    Ferreira, William F.

    2011-01-01

    Federal sponsorship of collaboration between academic institutions and industry is on the rise. Many government programs emphasize cooperation between universities and the commercial sector as a means to merge basic and applied research, promote economic development, and enhance knowledge dissemination. The intersection between academia and…

  16. 76 FR 36887 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... methods: Federal eRulemaking Portal: http://www.regulations.gov . Identify comments by ``Docket No. SBA... (76 FR 13532). SBA received 11 comments in Regulations.gov from a mix of small business trade organizations, a small business owner, an SBA loan program participating lender, an advocacy and research...

  17. EXPERIENCES WITH USING PROBABILISTIC EXPOSURE ANALYSIS METHODS IN THE U.S. EPA

    EPA Science Inventory

    Over the past decade various Offices and Programs within the U.S. EPA have either initiated or increased the development and application of probabilistic exposure analysis models. These models have been applied to a broad range of research or regulatory problems in EPA, such as e...

  18. [Integrative parent-infant psychotherapy for early regulatory and relationship disorders].

    PubMed

    Papousek, Mechthild; de Chuquisengo, Ruth Wollwerth

    2006-01-01

    The author introduces both the concept and practice of Integrative Parent-Infant Psychotherapy (IPI-P), a treatment specifically designed for the most frequent developmental problems and psychological needs of infants and their parents. Based on growing knowledge from interdisciplinary infancy research, both basic and clinical, IPI-P has been developed and practised in the "Munich Interdisciplinary Research and Intervention Program" for early regulatory and relationship disorders since the early nineties. Preverbal parent-infant communication represents both the port of entry into the system and the main focus of diagnostics, developmental counselling, interaction guidance, or psychodynamic psychotherapy of distorted communication and distressed/disordered relationships. The method of videomicroanalysis during video-feedback with the parent has proven particularly efficient--while observing, reliving and working through brief episodes of recorded parent-infant interaction. The author illustrates the diagnostic and therapeutic procedures with excerpts from psychotherapy of a toddler with an age-specific regulatory disorder in the context of severely distressed primary relationships.

  19. Commercial grade item (CGI) dedication of MDR relays for nuclear safety related applications

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

    Das, R.K.; Julka, A.; Modi, G.

    1994-08-01

    MDR relays manufactured by Potter and Brumfield (P and B) have been used in various safety related applications in commercial nuclear power plants. These include emergency safety features (ESF) actuation systems, emergency core cooling systems (ECCS) actuation, and reactor protection systems. The MDR relays manufactured prior to May 1990 showed signs of generic failure due to corrosion and outgassing of coil varnish. P and B has made design changes to correct these problems in relays manufactured after May 1990. However, P and B does not manufacture the relays under any 10CFR50 Appendix B quality assurance (QA) program. They manufacture themore » relays under their commercial QA program and supply these as commercial grade items. This necessitates CGI Dedication of these relays for use in nuclear-safety-related applications. This paper presents a CGI dedication program that has been used to dedicate the MDR relays manufactured after May 1990. The program is in compliance with current Nuclear Regulatory Commission (NRC) and Electric Power Research Institute (EPRI) guidelines and applicable industry standards; it specifies the critical characteristics of the relays, provides the tests and analysis required to verify the critical characteristics, the acceptance criteria for the test results, performs source verification to qualify P and B for its control of the critical characteristics, and provides documentation. The program provides reasonable assurance that the new MDR relays will perform their intended safety functions.« less

  20. Computational methods for prediction of RNA interactions with metal ions and small organic ligands.

    PubMed

    Philips, Anna; Łach, Grzegorz; Bujnicki, Janusz M

    2015-01-01

    In the recent years, it has become clear that a wide range of regulatory functions in bacteria are performed by riboswitches--regions of mRNA that change their structure upon external stimuli. Riboswitches are therefore attractive targets for drug design, molecular engineering, and fundamental research on regulatory circuitry of living cells. Several mechanisms are known for riboswitches controlling gene expression, but most of them perform their roles by ligand binding. As with other macromolecules, knowledge of the 3D structure of riboswitches is crucial for the understanding of their function. The development of experimental methods allowed for investigation of RNA structure and its complexes with ligands (which are either riboswitches' substrates or inhibitors) and metal cations (which stabilize the structure and are also known to be riboswitches' inhibitors). The experimental probing of different states of riboswitches is however time consuming, costly, and difficult to resolve without theoretical support. The natural consequence is the use of computational methods at least for initial research, such as the prediction of putative binding sites of ligands or metal ions. Here, we present a review on such methods, with a special focus on knowledge-based methods developed in our laboratory: LigandRNA--a scoring function for the prediction of RNA-small molecule interactions and MetalionRNA--a predictor of metal ions-binding sites in RNA structures. Both programs are available free of charge as a Web servers, LigandRNA at http://ligandrna.genesilico.pl and MetalionRNA at http://metalionrna.genesilico.pl/. © 2015 Elsevier Inc. All rights reserved.

  1. Bovine Tuberculosis and the Establishment of an Eradication Program in the United States: Role of Veterinarians

    PubMed Central

    Palmer, Mitchell V.; Waters, W. Ray

    2011-01-01

    The significance of the identification of Mycobacterium bovis as a zoonotic pathogen in 1882 was not initially recognized. After years of research by veterinarians, and other scientists, the importance of M. bovis as a pathogen and the public health ramifications, were appreciated. Veterinarians played pivotal roles in the creation of improved meat and milk inspection, diagnosis of M. bovis infected cattle, and in time, a bovine tuberculosis eradication program that would impact every cattle producer in the country. After overcoming many challenges, the 93-year-long program has decreased disease prevalence from 5% to <0.001%. Today, years of hard work by practitioners, researchers and regulatory officials alike, have yielded a program with a net benefit of almost $160 million per year. PMID:21647341

  2. NEGOTIATING STRUCTURAL VULNERABILITY FOLLOWING REGULATORY CHANGES TO A PROVINCIAL METHADONE PROGRAM IN VANCOUVER, CANADA: A QUALITATIVE STUDY

    PubMed Central

    McNeil, Ryan; Kerr, Thomas; Anderson, Solanna; Maher, Lisa; Keewatin, Chereece; Milloy, MJ; Wood, Evan; Small, Will

    2015-01-01

    While regulatory frameworks governing methadone maintenance therapy (MMT) require highly regimented treatment programs that shape treatment outcomes, little research has examined the effects of regulatory changes to these programs on those receiving treatment, and located their experiences within the wider context of socialstructural inequities. In British Columbia (BC), Canada, provincial regulations governing MMT have recently been modified, including: replacing the existing methadone formulation with Methadose® (pre-mixed and 10 times more concentrated); prohibiting pharmacy delivery of methadone; and, prohibiting pharmacies incentives for methadone dispensation. We undertook this study to examine the impacts of these changes on a structurally vulnerable population enrolled in MMT in Vancouver, BC. Qualitative interviews were conducted with 34 people enrolled in MMT and recruited from two ongoing observational prospective cohort studies comprised of drug-using individuals in the six-month period in 2014 following these regulatory changes. Interview transcripts were analyzed thematically, and by drawing on the concept of ‘structural vulnerability’. Findings underscore how these regulatory changes disrupted treatment engagement, producing considerable health and social harms. The introduction of Methadose® precipitated increased withdrawal symptoms. The discontinuation of pharmacy delivery services led to interruptions in MMT and codispensed HIV medications due to constraints stemming from their structural vulnerability (e.g., poverty, homelessness). Meanwhile, the loss of pharmacy incentives limited access to material supports utilized by participants to overcome barriers to MMT, while diminishing their capacity to assert some degree of agency in negotiating dispensation arrangements with pharmacies. Collectively, these changes functioned to compromise MMT engagement and increased structural vulnerability to harm, including re-initiation of injection drug use and participation in high-risk incomegenerating strategies. Greater attention to the impacts of social-structural inequities on MMT engagement is needed when modifying MMT programs, especially as other jurisdictions are adopting similar changes. Comprehensive environmental supports should be provided to minimize adverse outcomes during transitional periods. PMID:25875323

  3. Scientific and Legal Perspectives on Science Generated for Regulatory Activities

    PubMed Central

    Henry, Carol J.; Conrad, James W.

    2008-01-01

    This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information. PMID:18197313

  4. Scientific and legal perspectives on science generated for regulatory activities.

    PubMed

    Henry, Carol J; Conrad, James W

    2008-01-01

    This article originated from a conference that asked "Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?" In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at "external" information.

  5. Dysregulation of haematopoietic stem cell regulatory programs in acute myeloid leukaemia.

    PubMed

    Basilico, Silvia; Göttgens, Berthold

    2017-07-01

    Haematopoietic stem cells (HSC) are situated at the apex of the haematopoietic differentiation hierarchy, ensuring the life-long supply of mature haematopoietic cells and forming a reservoir to replenish the haematopoietic system in case of emergency such as acute blood loss. To maintain a balanced production of all mature lineages and at the same time secure a stem cell reservoir, intricate regulatory programs have evolved to control multi-lineage differentiation and self-renewal in haematopoietic stem and progenitor cells (HSPCs). Leukaemogenic mutations commonly disrupt these regulatory programs causing a block in differentiation with simultaneous enhancement of proliferation. Here, we briefly summarize key aspects of HSPC regulatory programs, and then focus on their disruption by leukaemogenic fusion genes containing the mixed lineage leukaemia (MLL) gene. Using MLL as an example, we explore important questions of wider significance that are still under debate, including the importance of cell of origin, to what extent leukaemia oncogenes impose specific regulatory programs and the relevance of leukaemia stem cells for disease development and prognosis. Finally, we suggest that disruption of stem cell regulatory programs is likely to play an important role in many other pathologies including ageing-associated regenerative failure.

  6. Integrative Genomic Analyses Yields Cell Cycle Regulatory Programs with Prognostic Value

    PubMed Central

    Cheng, Chao; Lou, Shaoke; Andrews, Erik H.; Ung, Matthew H.; Varn, Frederick S.

    2016-01-01

    Liposarcoma is the second most common form of sarcoma, which has been categorized into four molecular subtypes, which are associated with differential prognosis of patients. However, the transcriptional regulatory programs associated with distinct histological and molecular subtypes of liposarcoma have not been investigated. This study uses integrative analyses to systematically define the transcriptional regulatory programs associated with liposarcoma. Likewise, computational methods are used to identify regulatory programs associated with different liposarcoma subtypes as well as programs that are predictive of prognosis. Further analysis of curated gene sets was used to identify prognostic gene signatures. The integration of data from a variety sources including gene expression profiles, transcription factor (TF) binding data from ChIP-seq experiments, curated gene sets, and clinical information of patients indicated discrete regulatory programs (e.g., controlled by E2F1 and E2F4) with significantly different regulatory activity in one or multiple subtypes of liposarcoma with respect to normal adipose tissue. These programs were also shown to be prognostic, wherein liposarcoma patients with higher E2F4 or E2F1 activity associated with unfavorable prognosis. A total of 259 gene sets were significantly associated with patient survival in liposarcoma, among which >50% are involved in cell cycle and proliferation. PMID:26856934

  7. Collegiate Aviation Research and Education Solutions to Critical Safety Issues

    NASA Technical Reports Server (NTRS)

    Bowen, Brent (Editor)

    2002-01-01

    This Conference Proceedings is a collection of 6 abstracts and 3 papers presented April 19-20, 2001 in Denver, CO. The conference focus was "Best Practices and Benchmarking in Collegiate and Industry Programs". Topics covered include: satellite-based aviation navigation; weather safety training; human-behavior and aircraft maintenance issues; disaster preparedness; the collegiate aviation emergency response checklist; aviation safety research; and regulatory status of maintenance resource management.

  8. Load research manual. Volume 2. Fundamentals of implementing load research procedures

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

    Brandenburg, L.; Clarkson, G.; Grund, Jr., C.

    This three-volume manual presents technical guidelines for electric utility load research. Special attention is given to issues raised by the load data reporting requirements of the Public Utility Regulatory Policies Act of 1978 and to problems faced by smaller utilities that are initiating load research programs. In Volumes 1 and 2, procedures are suggested for determining data requirements for load research, establishing the size and customer composition of a load survey sample, selecting and using equipment to record customer electricity usage, processing data tapes from the recording equipment, and analyzing the data. Statistical techniques used in customer sampling are discussedmore » in detail. The costs of load research also are estimated, and ongoing load research programs at three utilities are described. The manual includes guides to load research literature and glossaries of load research and statistical terms.« less

  9. Use of diagnostic accuracy as a metric for evaluating laboratory proficiency with microarray assays using mixed-tissue RNA reference samples.

    PubMed

    Pine, P S; Boedigheimer, M; Rosenzweig, B A; Turpaz, Y; He, Y D; Delenstarr, G; Ganter, B; Jarnagin, K; Jones, W D; Reid, L H; Thompson, K L

    2008-11-01

    Effective use of microarray technology in clinical and regulatory settings is contingent on the adoption of standard methods for assessing performance. The MicroArray Quality Control project evaluated the repeatability and comparability of microarray data on the major commercial platforms and laid the groundwork for the application of microarray technology to regulatory assessments. However, methods for assessing performance that are commonly applied to diagnostic assays used in laboratory medicine remain to be developed for microarray assays. A reference system for microarray performance evaluation and process improvement was developed that includes reference samples, metrics and reference datasets. The reference material is composed of two mixes of four different rat tissue RNAs that allow defined target ratios to be assayed using a set of tissue-selective analytes that are distributed along the dynamic range of measurement. The diagnostic accuracy of detected changes in expression ratios, measured as the area under the curve from receiver operating characteristic plots, provides a single commutable value for comparing assay specificity and sensitivity. The utility of this system for assessing overall performance was evaluated for relevant applications like multi-laboratory proficiency testing programs and single-laboratory process drift monitoring. The diagnostic accuracy of detection of a 1.5-fold change in signal level was found to be a sensitive metric for comparing overall performance. This test approaches the technical limit for reliable discrimination of differences between two samples using this technology. We describe a reference system that provides a mechanism for internal and external assessment of laboratory proficiency with microarray technology and is translatable to performance assessments on other whole-genome expression arrays used for basic and clinical research.

  10. 76 FR 69741 - Statement of Organization, Functions, and Delegations of Authority: Office of the Assistant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-09

    ... serves as the Department's Senior Grants Executive and the Division Director. The Division Director provides leadership, guidance, and oversight to constituent organizations, and coordinates long and short... grants programs and processes; develops pertinent HHS-wide regulatory guidance, policies, and performance...

  11. Integrated Module and Gene-Specific Regulatory Inference Implicates Upstream Signaling Networks

    PubMed Central

    Roy, Sushmita; Lagree, Stephen; Hou, Zhonggang; Thomson, James A.; Stewart, Ron; Gasch, Audrey P.

    2013-01-01

    Regulatory networks that control gene expression are important in diverse biological contexts including stress response and development. Each gene's regulatory program is determined by module-level regulation (e.g. co-regulation via the same signaling system), as well as gene-specific determinants that can fine-tune expression. We present a novel approach, Modular regulatory network learning with per gene information (MERLIN), that infers regulatory programs for individual genes while probabilistically constraining these programs to reveal module-level organization of regulatory networks. Using edge-, regulator- and module-based comparisons of simulated networks of known ground truth, we find MERLIN reconstructs regulatory programs of individual genes as well or better than existing approaches of network reconstruction, while additionally identifying modular organization of the regulatory networks. We use MERLIN to dissect global transcriptional behavior in two biological contexts: yeast stress response and human embryonic stem cell differentiation. Regulatory modules inferred by MERLIN capture co-regulatory relationships between signaling proteins and downstream transcription factors thereby revealing the upstream signaling systems controlling transcriptional responses. The inferred networks are enriched for regulators with genetic or physical interactions, supporting the inference, and identify modules of functionally related genes bound by the same transcriptional regulators. Our method combines the strengths of per-gene and per-module methods to reveal new insights into transcriptional regulation in stress and development. PMID:24146602

  12. 75 FR 46877 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-04

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-156-FOR; OSM 2010-0004] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... Pennsylvania program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of...

  13. 30 CFR 701.1 - Scope.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

  14. 30 CFR 701.1 - Scope.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

  15. 30 CFR 701.1 - Scope.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

  16. 30 CFR 701.1 - Scope.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... regulatory program required by the Act. (b) The following regulations apply to the permanent regulatory program: (1) Subchapter C on State program application, approval, withdrawal, and grants, and Federal program implementation; (2) Subchapter D on surface coal mining and reclamation operations on Federal...

  17. 77 FR 34888 - Kentucky Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-255-FOR; OSM-2012-0004] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

  18. 76 FR 50436 - Kentucky Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-254-FOR; OSM-2011-0005] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation... Program (hereinafter, the ``Kentucky program'') under the Surface Mining Control and Reclamation Act of...

  19. Incorporating information from the U.S. Department of Energy low-dose program into regulatory decision-making: three policy integration challenges.

    PubMed

    Locke, Paul A

    2009-11-01

    The U.S. Department of Energy (U.S. DOE) sponsors a research program aimed at gaining a better understanding of how low-dose radiation affects cellular functioning and progression toward disease. There have been calls to incorporate into regulatory decision-making the scientific information that this program has produced. After a discussion of the evolution of radiation protection law and the weight-of-evidence approach that agencies employ, this paper offers some preliminary thoughts about how to approach this complex and important policy question. Three implementation challenges are identified and discussed. The first implementation challenge involves explaining low-dose effects in a systems biology model. The second challenge arises when issues of population susceptibility are juxtaposed against molecular and mechanistic studies, such as those that make up much of the U.S. DOE low-dose program. The third challenge concerns integrating the results of radiation epidemiology, especially epidemiologic studies among cohorts that are exposed to low dose and low-dose rate radiation, with the results of U.S. DOE low-dose studies.

  20. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon; Duda, Kristen

    2008-01-01

    This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

  1. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

  2. 17 CFR 37.1501 - Chief compliance officer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... facility's self-regulatory program that is requested by the board of directors or the regulatory oversight... compliance office review, look-back, internal or external audit finding, self-reported error, or validated...) Supervising the swap execution facility's self-regulatory program with respect to trade practice surveillance...

  3. Regulatory role of calpain in neuronal death

    PubMed Central

    Cheng, Si-ying; Wang, Shu-chao; Lei, Ming; Wang, Zhen; Xiong, Kun

    2018-01-01

    Calpains are a group of calcium-dependent proteases that are over activated by increased intracellular calcium levels under pathological conditions. A wide range of substrates that regulate necrotic, apoptotic and autophagic pathways are affected by calpain. Calpain plays a very important role in neuronal death and various neurological disorders. This review introduces recent research progress related to the regulatory mechanisms of calpain in neuronal death. Various neuronal programmed death pathways including apoptosis, autophagy and regulated necrosis can be divided into receptor interacting protein-dependent necroptosis, mitochondrial permeability transition-dependent necrosis, pyroptosis and poly (ADP-ribose) polymerase 1-mediated parthanatos. Calpains cleave series of key substrates that may lead to cell death or participate in cell death. Regarding the investigation of calpain-mediated programed cell death, it is necessary to identify specific inhibitors that inhibit calpain mediated neuronal death and nervous system diseases. PMID:29623944

  4. 42 CFR 421.110 - Requirements for approval of an agreement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE CONTRACTING Intermediaries § 421.110 Requirements for... regulatory authorities of the State or States in which it, or any subcontractor performing some or all of its... only providers located in a single State; (5) Has acted in good faith to achieve effective cooperation...

  5. 10 CFR 26.209 - Self-declarations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Self-declarations. 26.209 Section 26.209 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.209 Self-declarations. (a) If an individual is performing, or being assessed for, work under a waiver of one or more of the requirements...

  6. 10 CFR 26.209 - Self-declarations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Self-declarations. 26.209 Section 26.209 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.209 Self-declarations. (a) If an individual is performing, or being assessed for, work under a waiver of one or more of the requirements...

  7. 10 CFR 26.209 - Self-declarations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Self-declarations. 26.209 Section 26.209 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.209 Self-declarations. (a) If an individual is performing, or being assessed for, work under a waiver of one or more of the requirements...

  8. 10 CFR 26.209 - Self-declarations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Self-declarations. 26.209 Section 26.209 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.209 Self-declarations. (a) If an individual is performing, or being assessed for, work under a waiver of the requirements contained in § 26...

  9. 10 CFR 26.209 - Self-declarations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Self-declarations. 26.209 Section 26.209 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.209 Self-declarations. (a) If an individual is performing, or being assessed for, work under a waiver of the requirements contained in § 26...

  10. Improving oversight of the graduate medical education enterprise: one institution's strategies and tools.

    PubMed

    Afrin, Lawrence B; Arana, George W; Medio, Franklin J; Ybarra, Angela F N; Clarke, Harry S

    2006-05-01

    Accreditation organizations, financial stakeholders, legal systems, and regulatory agencies have increased the need for accountability in educational processes and curricular outcomes of graduate medical education. This demand for greater programmatic monitoring has placed pressure on institutions with graduate medical education (GME) programs to develop greater oversight of these programs. Meeting these challenges requires development of new GME management strategies and tools for institutional GME administrators to scrutinize programs, while still allowing these programs the autonomy to develop and implement educational methods to meet their unique training needs. At the Medical University of South Carolina (MUSC), senior administrators in the college of medicine felt electronic information management was a critical strategy for success and thus proceeded to carefully select an electronic residency management system (ERMS) to provide functionality for both individual programs and the GME enterprise as a whole. Initial plans in 2002 for a phased deployment had to be changed to a much more rapid deployment due to regulatory issues. Extensive communication and cooperation among MUSC's GME leaders resulted in a successful deployment in 2003. Evaluation completion rates have substantially improved, duty hours are carefully monitored, patient safety has improved through more careful oversight of residents' procedural privileges, regulators have been pleased, and central GME administrative visibility of program performance has dramatically improved. The system is now being expanded to MUSC's medical school and other health professions colleges. The authors discuss lessons learned and opportunities and challenges ahead, which include improving tracking of development of procedural competency, establishing and monitoring program performance standards, and integrating the ERMS with GME reimbursement systems.

  11. Validation of Skeletal Muscle cis-Regulatory Module Predictions Reveals Nucleotide Composition Bias in Functional Enhancers

    PubMed Central

    Kwon, Andrew T.; Chou, Alice Yi; Arenillas, David J.; Wasserman, Wyeth W.

    2011-01-01

    We performed a genome-wide scan for muscle-specific cis-regulatory modules (CRMs) using three computational prediction programs. Based on the predictions, 339 candidate CRMs were tested in cell culture with NIH3T3 fibroblasts and C2C12 myoblasts for capacity to direct selective reporter gene expression to differentiated C2C12 myotubes. A subset of 19 CRMs validated as functional in the assay. The rate of predictive success reveals striking limitations of computational regulatory sequence analysis methods for CRM discovery. Motif-based methods performed no better than predictions based only on sequence conservation. Analysis of the properties of the functional sequences relative to inactive sequences identifies nucleotide sequence composition can be an important characteristic to incorporate in future methods for improved predictive specificity. Muscle-related TFBSs predicted within the functional sequences display greater sequence conservation than non-TFBS flanking regions. Comparison with recent MyoD and histone modification ChIP-Seq data supports the validity of the functional regions. PMID:22144875

  12. 30 CFR 701.2 - Objective.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

  13. 30 CFR 701.2 - Objective.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

  14. 30 CFR 701.2 - Objective.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

  15. 30 CFR 701.2 - Objective.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

  16. 30 CFR 701.2 - Objective.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... definitions that apply to the regulation of coal exploration and surface coal mining and reclamation... REGULATORY PROGRAM § 701.2 Objective. The regulations in this part give— (a) A general overview of the regulatory program to be implemented by the State or Federal regulatory authority; (b) The applicability of...

  17. Gender Difference Does Not Mean Genetic Difference: Externalizing Improves Performance in Mental Rotation

    ERIC Educational Resources Information Center

    Moe, Angelica

    2012-01-01

    The fear of underperforming owing to stereotype threat affects women's performance in tasks such as mathematics, chess, and spatial reasoning. The present research considered mental rotation and explored effects on performance and on regulatory focus of instructions pointing to different explanations for gender differences. Two hundred and one…

  18. 75 FR 36589 - Financial Crimes Enforcement Network; Amendment to the Bank Secrecy Act Regulations-Definitions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... regulatory research into the operation of the prepaid industry, we have encountered a number of distinct...: (1) Establish written AML programs that are reasonably designed to prevent the MSB from being used to... limitations of descriptive terms are easily understood. The term ``stored value'' gained a foothold following...

  19. Integration of the Newborn Behavioral Observations (NBO) System into Care Settings for High-Risk Newborns

    ERIC Educational Resources Information Center

    McManus, Beth M.

    2015-01-01

    Research suggests that early self-regulatory difficulties among high-risk newborns can lead to poor interactional difficulties and negative long-term cognitive and social-emotional outcomes if not identified and treated early. This article describes why an individualized, developmentally supportive, relationship-based program, such as the Newborn…

  20. EVALUATING THE ECOLOGICAL SIGNIFICANCE OF LABORATORY RESPONSE DATA TO PREDICT POPULATION-LEVEL EFFECTS FOR THE ESTUARINE AMPHIPOD, AMPILISCA ABDITA

    EPA Science Inventory

    Ten-day acute mortality of the benthic amphipod Ampelisca abdita is used in a number of regulatory, research, and monitoring programs to evaluate chemical contamination of marine sediments. Although this endpoint has proven to be valuable for characterizing the relative toxicitie...

  1. A Review of Information for Managing Aging in Nuclear Power Plants

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

    WC Morgan; JV Livingston

    1995-09-01

    Age related degradation effects in safety related systems of nuclear power plants should be managed to prevent safety margins from eroding below the acceptable limits provided in plant design bases. The Nuclear Plant Aging Research (NPAR) Pro- gram, conducted under the auspices of the U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research, and other related aging management programs are developing technical information on managing aging. The aging management process central to these efforts consists of three key elements: 1) selecting structures, systems, and components (SSCs) in which aging should be controlled; 2) understanding the mechanisms and rates ofmore » degradation in these SSCs; and 3) managing degradation through effective inspection, surveillance, condition monitoring, trending, record keeping, mainten- ance, refurbishment, replacement, and adjustments in the operating environment and service conditions. This document concisely reviews and integrates information developed under the NPAR Program and other aging management studies and other available information related to understanding and managing age-related degradation effects and provides specific refer- ences to more comprehensive information on the same subjects.« less

  2. 1996 LMITCO environmental monitoring program report for the Idaho National Engineering and Environmental Laboratory

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

    NONE

    1997-09-01

    This report describes the calendar year 1996 environmental surveillance and compliance monitoring activities of the Lockheed Martin Idaho Technologies Company Environmental Monitoring Program performed at the Idaho National Engineering and Environmental Laboratory (INEEL). Results of sampling performed by the Radiological Environmental Surveillance, Site Environmental Surveillance, Drinking Water, Effluent Monitoring, Storm Water Monitoring, Groundwater Monitoring, and Special Request Monitoring Programs are included in this report. The primary purposes of the surveillance and monitoring activities are to evaluate environmental conditions, to provide and interpret data, to verify compliance with applicable regulations or standards, and to ensure protection of human health and themore » environment. This report compares 1996 data with program-specific regulatory guidelines and past data to evaluate trends.« less

  3. Comparing biomarker measurements to a normal range: when ...

    EPA Pesticide Factsheets

    This commentary is the second of a series outlining one specific concept in interpreting biomarkers data. In the first, an observational method was presented for assessing the distribution of measurements before making parametric calculations. Here, the discussion revolves around the next step, the choice of using standard error of the mean or the calculated standard deviation to compare or predict measurement results. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA’s mission to protect human health and the environment. HEASD’s research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA’s strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  4. Space medicine research publications: 1984-1986

    NASA Technical Reports Server (NTRS)

    Wallace, Janice S.

    1988-01-01

    A list is given of the publications of investigators supported by the Biomedical Research and Clinical Medicine Programs of the Space Medicine and Biology Branch, Life Sciences Division, Office of Space Science and Applications. It includes publications entered into the Life Sciences Bibliographic Database by the George Washington University as of December 31, 1986. Publications are organized into the following subject areas: Clinical Medicine, Space Human Factors, Musculoskeletal, Radiation and Environmental Health, Regulatory Physiology, Neuroscience, and Cardiopulmonary.

  5. The role of research-article writing motivation and self-regulatory strategies in explaining research-article abstract writing ability.

    PubMed

    Lin, Ming-Chia; Cheng, Yuh-Show; Lin, Sieh-Hwa; Hsieh, Pei-Jung

    2015-04-01

    The purpose of the study was to investigate the effects of research-article writing motivation and use of self-regulatory writing strategies in explaining second language (L2) research-article abstract writing ability, alongside the L2 literacy effect. Four measures were administered: a L2 literacy test, a research abstract performance assessment, and inventories of writing motivation and strategy. Participants were L2 graduate students in Taiwan (N=185; M age=25.8 yr., SD=4.5, range=22-53). Results of structural equation modeling showed a direct effect of motivation on research-article writing ability, but no direct effect of strategy or indirect effect of motivation via strategy on research-article writing ability, with L2 literacy controlled. The findings suggest research-article writing instruction should address writing motivation, besides L2 literacy.

  6. Strawman II. Recommendations for a regulatory program for mining waste and materials under Subtitle D of the Resource Conservation and Recovery Act. Final report

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

    Not Available

    1990-05-21

    The package, referred to as 'Strawman II', is a working document that represents EPA's latest staff position on an effective program to regulate wastes and other materials uniquely associated with noncoal mining. Strawman II does not represent a proposed rule. The package consists of two parts: (1) the Foreward, which describes the pre-rulemaking Strawman process, a background and overview of the mining waste program as envisioned in the package, and discussions of major issues concerning the program and its scope; and (2) the Regulatory Approach, presented as '40 CFR XXX, XXY, and XXZ' to reflect how the program might appearmore » in regulatory language. Discussions and amplifications of specific points are also interspersed throughout the Regulatory Approach. EPA encourages all interested parties to convey their views on any and all aspects of the program concept.« less

  7. Radiation Damage In Reactor Cavity Concrete

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

    Field, Kevin G; Le Pape, Yann; Naus, Dan J

    License renewal up to 60 years and the possibility of subsequent license renewal to 80 years has established a renewed focus on long-term aging of nuclear generating stations materials, and recently, on concrete. Large irreplaceable sections of most nuclear generating stations include concrete. The Expanded Materials Degradation Analysis (EMDA), jointly performed by the Department of Energy, the Nuclear Regulatory Commission and Industry, identified the urgent need to develop a consistent knowledge base on irradiation effects in concrete. Much of the historical mechanical performance data of irradiated concrete does not accurately reflect typical radiation conditions in NPPs or conditions out tomore » 60 or 80 years of radiation exposure. To address these potential gaps in the knowledge base, The Electric Power Research Institute and Oak Ridge National Laboratory are working to disposition radiation damage as a degradation mechanism. This paper outlines the research program within this pathway including: (i) defining the upper bound of the neutron and gamma dose levels expected in the biological shield concrete for extended operation (80 years of operation and beyond), (ii) determining the effects of neutron and gamma irradiation as well as extended time at temperature on concrete, (iii) evaluating opportunities to irradiate prototypical concrete under accelerated neutron and gamma dose levels to establish a conservative bound and share data obtained from different flux, temperature, and fluence levels, (iv) evaluating opportunities to harvest and test irradiated concrete from international NPPs, (v) developing cooperative test programs to improve confidence in the results from the various concretes and research reactors, (vi) furthering the understanding of the effects of radiation on concrete (see companion paper) and (vii) establishing an international collaborative research and information exchange effort to leverage capabilities and knowledge.« less

  8. 76 FR 64047 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  9. 76 FR 36040 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  10. 78 FR 16204 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-14

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  11. 76 FR 80310 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-23

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Wyoming regulatory program (hereinafter, the ``Wyoming program'') under the Surface Mining...

  12. 76 FR 67635 - Alaska Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 902... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Alaska regulatory program (hereinafter, the ``Alaska program'') under the Surface Mining...

  13. 76 FR 64045 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  14. 76 FR 76111 - Montana Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926... Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment period and... amendment to the Montana regulatory program (hereinafter, the ``Montana program'') under the Surface Mining...

  15. 77 FR 25874 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Mining Reclamation and Enforcement (OSM), Interior. ACTION: Final rule; removal of required amendment... regulatory program (the ``Pennsylvania program'') regulations under the Surface Mining Control and...

  16. 77 FR 1430 - Maryland Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-10

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 920... Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule; extension of the comment... the Maryland regulatory program (the ``Maryland program'') under the Surface Mining Control and...

  17. Integrated NHANES: uses in national policy.

    PubMed

    Woteki, Catherine E

    2003-02-01

    The National Nutrition Monitoring and Related Research Program (NNMRRP) arose from Congressional concern about lack of information regarding the occurrence in the American population of undernutrition and diet-related risk factors for chronic diseases. Congressional appropriations and executive branch decisions about budget priorities have been the major determinants of the scope and number of nutrition monitoring surveys and surveillance activities fielded and therefore the information available for policy and research uses. The nutrition data collected in the NNMRRP are used by federal agencies, the private sector and academia for a variety of purposes, including public policy (e.g., development and evaluation of monitoring and surveillance, regulatory and nutrition programs), normative standards (e.g., growth charts, reference data for hematological and biochemical indicators of nutritional status or Dietary Reference Intakes) and research (e.g., cross-sectional, longitudinal and time-trends studies of dietary and nutritional status, health status, disease morbidity and mortality). Although the importance of the NNMRRP to national policy is difficult to quantify, in a 5-y period 97 proposed and final regulations citing NNMRRP data were published in the Federal Register by federal agencies responsible for nutrition and food safety programs. The NNMRRP-derived dietary and nutritional status data are essential information for quantitative risk assessments increasingly relied on by regulatory agencies as the basis for programmatic decisions and regulations development. Users of NNMRRP data in government agencies, academic institutions and the private sector have come to recognize the value of data from the surveys and surveillance systems for a wide variety of programmatic and research purposes.

  18. 75 FR 20269 - Regulatory Reporting Requirements for the Indian Community Development Block Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-19

    ...-AC79 Regulatory Reporting Requirements for the Indian Community Development Block Grant Program AGENCY... final rule revises the reporting requirements for the Indian Community Development Block Grants (ICDBG... Indian Community Development Block Grant (ICDBG) program. The purpose of the ICDBG program is the...

  19. 78 FR 52224 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... Trader Continuing Education Program (S501) is a computer-based education program developed by many of the... Continuing Education Program, which is developed and maintained by the Securities Industry Regulatory Council... change will authorize the Exchange to administer different CE programs to differently registered...

  20. Framework for a National Testing and Evaluation Program ...

    EPA Pesticide Factsheets

    Abstract:The National STEPP Program seeks to improve water quality by accelerating the effective implementation and adoption of innovative stormwater management technologies. Itwill attempt to accomplish this by establishing practices through highly reliable, and cost-effective Stormwater control measures (SCM) testing, evaluation, and verification services. The program will aim to remove barriers to innovation, minimize duplicative performance evaluation needs, increase confidence that regulatory requirements are met by creating consistency among testing and evaluation protocols, and establishing equity between public domain and proprietary SCM evaluation approaches.The Environmental Technology Verification Program, established by the U.S. Environmental Protection Agency (EPA) 18 years ago, was the only national program of its kindin the stormwater sector, but is now defunct, leaving a national leadership void. The STEPP initiative was triggered in part by regulatory demands in the government and private sectors to fill this vacuum. A concerted focus and study of this matter led to the release of a Water Environment Federation (WEF) white paper entitled “Investigation into the Feasibility of a National Testing and Evaluation Program for Stormwater Products and Practices” in February 2014. During this second phase of the STEPP initiative, and with EPA support, five analogous technology evaluation programs related to both stormwater and non-stormwater were an

  1. RCRA, superfund and EPCRA hotline training module. Introduction to: Municipal solid waste disposal facility criteria updated July 1996

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

    NONE

    1996-07-01

    The module provides a summary of the regulatory criteria for municipal solid waste landfills (MSWLFs) and provides the statutory authority under RCRA and the Clean Water Act (CWA) directing EPA to develop the MSWLF criteria in 40 CFR Part 258. It gives the part 258 effective date and the compliance dates for providing demonstrations to satisfy individual regulatory requirements. It identifies the types of facilities that qualify for the small landfill exemption. It explains the requirements of each subpart of part 258 as they apply to states with EPA-approved MSWLF permit programs and states without approved permit programs. It comparesmore » the MSWLF environmental performance standards described in part 258 to the corresponding requirements for hazardous waste TSDFs in part 264, which are generally more stringent.« less

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

    Selkirk, J.K.

    The National Toxicology Program (NTP) was organized to support national public health programs by initiating research designed to understand the physiological, metabolic, and genetic basis for chemical toxicity. The primary mandated responsibilities of NTP were in vivo and vitro toxicity testing of potentially hazardous chemicals; broadening the spectrum of toxicological information on known hazardous chemicals; validating current toxicological assay systems as well as developing new and innovative toxicity testing technology; and rapidly communicating test results to government agencies with regulatory responsibilities and to the medical and scientific communities. 2 figs.

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

    J. Carmack; L. Braase; F. Goldner

    The mission of the Advanced Fuels Campaign (AFC) is to perform Research, Development, and Demonstration (RD&D) activities for advanced fuel forms (including cladding) to enhance the performance and safety of the nation’s current and future reactors, enhance proliferation resistance of nuclear fuel, effectively utilize nuclear energy resources, and address the longer-term waste management challenges. This includes development of a state of the art Research and Development (R&D) infrastructure to support the use of a “goal oriented science based approach.” AFC uses a “goal oriented, science based approach” aimed at a fundamental understanding of fuel and cladding fabrication methods and performancemore » under irradiation, enabling the pursuit of multiple fuel forms for future fuel cycle options. This approach includes fundamental experiments, theory, and advanced modeling and simulation. One of the most challenging aspects of AFC is the management, integration, and coordination of major R&D activities across multiple organizations. AFC interfaces and collaborates with Fuel Cycle Technologies (FCT) campaigns, universities, industry, various DOE programs and laboratories, federal agencies (e.g., Nuclear Regulatory Commission [NRC]), and international organizations. Key challenges are the development of fuel technologies to enable major increases in fuel performance (safety, reliability, power and burnup) beyond current technologies, and development of characterization methods and predictive fuel performance models to enable more efficient development and licensing of advanced fuels. Challenged with the research and development of fuels for two different reactor technology platforms, AFC targeted transmutation fuel development and focused ceramic fuel development for Advanced LWR Fuels.« less

  4. 2012 Global Summit on Regulatory Science (GSRS-2012)--modernizing toxicology.

    PubMed

    Miller, Margaret A; Tong, Weida; Fan, Xiaohui; Slikker, William

    2013-01-01

    Regulatory science encompasses the tools, models, techniques, and studies needed to assess and evaluate product safety, efficacy, quality, and performance. Several recent publications have emphasized the role of regulatory science in improving global health, supporting economic development and fostering innovation. As for other scientific disciplines, research in regulatory science is the critical element underpinning the development and advancement of regulatory science as a modern scientific discipline. As a regulatory agency in the 21st century, the Food and Drug Administration (FDA) has an international component that underpins its domestic mission; foods, drugs, and devices are developed and imported to the United States from across the world. The Global Summit on Regulatory Science, an international conference for discussing innovative technologies, approaches, and partnerships that enhance the translation of basic science into regulatory applications, is providing leadership for the advancement of regulatory sciences within the global context. Held annually, this international conference provides a platform where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as developing a harmonized strategy to improve global public health through global collaboration.

  5. A comparison of the results of regulatory compliance inspections in 1999 by the states of Texas, Maine, and Washington.

    PubMed

    Brown, B J; Emery, R J; Stock, T H; Lee, E S

    2004-03-01

    Inspection outcome data provided by the state of Washington Department of Health, Division of Radiation Protection, for licensees of radioactive materials was encoded according to a system established by the Texas Department of Health, Bureau of Radiation Control. The data, representing calendar year 1999 inspection activities, were then analyzed and the results compared to previously published studies for the same year in the states of Texas and Maine. Despite significant differences in regulatory program size, age, and geographic proximity, the most frequently cited violation for radioactive materials licensees were shown to be similar for all three states. Of particular note were the violations that were identified to be consistently issued in all three states. These included physical inventories and utilization logs not performed, not available, or incomplete; leak testing not performed or not performed on schedule; inadequate or unapproved operating and safety procedures; radiation survey and disposal records not available or incomplete; detection or measurement instrument calibration not performed or records not available; and radiation surveys or sampling not performed or performed with a noncalibrated instrument. Comparisons were made in an attempt to generate a summary of the most commonly issued violations that could be generalized to users of radioactive materials across the United States. A generalized list of common violations would be an invaluable tool for radiation protection programs, serving to aid in the reduction of the overall instance of program non-compliance. Any reduction in instances of non-compliance would result in the conservation of finite public health resources that might then be directed to other pressing public health matters.

  6. Overview of NRC Proactive Management of Materials Degradation (PMMD) Program

    NASA Astrophysics Data System (ADS)

    Carpenter, C. E. Gene; Hull, Amy; Oberson, Greg

    Materials degradation phenomena, if not appropriately managed, have the potential to adversely impact the design functionality and safety margins of nuclear power plant (NPP) systems, structures and components (SSCs). Therefore, the U.S. Nuclear Regulatory Commission (NRC) has initiated an over-the-horizon multi-year research Proactive Management of Materials Degradation (PMMD) Research Program, which is presently evaluating longer time frames (i.e., 80 or more years) and including passive long-lived SSCs beyond the primary piping and core internals, such as concrete containment and cable insulation. This will allow the NRC to (1) identify significant knowledge gaps and new forms of degradation; (2) capture current knowledge base; and, (3) prioritize materials degradation research needs and directions for future efforts. This effort is being accomplished in collaboration with the U.S. Department of Energy's (DOE) LWR Sustainability (LWRS) program. This presentation will discuss the activities to date, including results, and the path forward.

  7. Participatory workplace wellness programs: reward, penalty, and regulatory conflict.

    PubMed

    Pomeranz, Jennifer L

    2015-06-01

    POLICY POINTS: Workplace wellness programs that provide incentives for completing a health risk assessment are a form of participatory programs. There are legal and ethical concerns when employers assess penalties for not completing a health risk assessment, raising questions about the voluntariness of such a program. The Departments of Treasury, Labor, and Health and Human Services' 2013 regulations for participatory programs and employers' current practices conflict with the Equal Employment Opportunity Commission's prevailing interpretation of the Americans with Disabilities Act of 1990. In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments' regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Employers' practices and the federal departments' regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments' regulations may be interpreted as conflicting with Congress's legislation, which mentions penalties only for health-contingent wellness programs. Furthermore, the regulatory protections for employees applicable to health-contingent wellness programs do not apply to participatory programs. Either Congress or the federal agencies should address the conflict among employers' practices, the wellness regulations, and the ADA and also consider additional protections for employees. Employers can avoid ethical and legal complications by offering voluntary programs with positive incentives. © 2015 Milbank Memorial Fund.

  8. 78 FR 11617 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Surface Mining Reclamation and Enforcement (OSM), Interior. ACTION: Proposed rule; reopening of comment... regulatory program (the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of...

  9. Stereotype Threat Reinterpreted as a Regulatory Mismatch

    PubMed Central

    Grimm, Lisa R.; Markman, Arthur B.; Maddox, W. Todd; Baldwin, Grant C.

    2008-01-01

    Research documents performance decrements resulting from the activation of a negative task-relevant stereotype. We combine a number of strands of work to identify causes of stereotype threat in a way that allows us to reverse the effects and improve the performance of individuals with negative task-relevant stereotypes. We draw on prior work suggesting that negative stereotypes induce a prevention focus, and other research suggesting that people exhibit greater flexibility when their regulatory focus matches the reward structure of the task. This work suggests that stereotype threat effects emerge from a prevention focus combined with tasks that have an explicit or implicit gains reward structure. We find flexible performance can be induced in individuals who have a negative task-relevant stereotype by using a losses reward structure. We demonstrate the interaction of stereotypes and the reward structure of the task using chronic stereotypes and GRE math problems (Experiment 1), and primed stereotypes and a category learning task (Experiments 2a and 2b). We discuss implications of this research for other work on stereotype threat. PMID:19159133

  10. Creating an effort tracking tool to improve therapeutic cancer clinical trials workload management and budgeting.

    PubMed

    James, Pam; Bebee, Patty; Beekman, Linda; Browning, David; Innes, Mathew; Kain, Jeannie; Royce-Westcott, Theresa; Waldinger, Marcy

    2011-11-01

    Quantifying data management and regulatory workload for clinical research is a difficult task that would benefit from a robust tool to assess and allocate effort. As in most clinical research environments, The University of Michigan Comprehensive Cancer Center (UMCCC) Clinical Trials Office (CTO) struggled to effectively allocate data management and regulatory time with frequently inaccurate estimates of how much time was required to complete the specific tasks performed by each role. In a dynamic clinical research environment in which volume and intensity of work ebbs and flows, determining requisite effort to meet study objectives was challenging. In addition, a data-driven understanding of how much staff time was required to complete a clinical trial was desired to ensure accurate trial budget development and effective cost recovery. Accordingly, the UMCCC CTO developed and implemented a Web-based effort-tracking application with the goal of determining the true costs of data management and regulatory staff effort in clinical trials. This tool was developed, implemented, and refined over a 3-year period. This article describes the process improvement and subsequent leveling of workload within data management and regulatory that enhanced the efficiency of UMCCC's clinical trials operation.

  11. 75 FR 1830 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

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

  12. 10 CFR 26.103 - Determining a confirmed positive test result for alcohol.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Determining a confirmed positive test result for alcohol. 26.103 Section 26.103 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting... fitness indicates that the donor is fit to safely and competently perform his or her duties. ...

  13. 10 CFR 26.103 - Determining a confirmed positive test result for alcohol.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Determining a confirmed positive test result for alcohol. 26.103 Section 26.103 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting... fitness indicates that the donor is fit to safely and competently perform his or her duties. ...

  14. 10 CFR 26.103 - Determining a confirmed positive test result for alcohol.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Determining a confirmed positive test result for alcohol. 26.103 Section 26.103 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting... fitness indicates that the donor is fit to safely and competently perform his or her duties. ...

  15. 10 CFR 26.103 - Determining a confirmed positive test result for alcohol.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Determining a confirmed positive test result for alcohol. 26.103 Section 26.103 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting... fitness indicates that the donor is fit to safely and competently perform his or her duties. ...

  16. 10 CFR 26.205 - Work hours.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Work hours. 26.205 Section 26.205 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.205 Work hours. (a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5...

  17. 10 CFR 26.103 - Determining a confirmed positive test result for alcohol.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Determining a confirmed positive test result for alcohol. 26.103 Section 26.103 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Collecting... fitness indicates that the donor is fit to safely and competently perform his or her duties. ...

  18. 10 CFR 26.205 - Work hours.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Work hours. 26.205 Section 26.205 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS Managing Fatigue § 26.205 Work hours. (a) Individuals subject to work hour controls. Any individual who performs duties identified in § 26.4(a)(1) through (a)(5...

  19. The effect of self-regulatory and metacognitive strategy instruction on impoverished students' assessment achievement in physics

    NASA Astrophysics Data System (ADS)

    Fouche, Jaunine

    The purpose of this nonequivalent control group design study was to evaluate the effectiveness of metacognitive and self-regulatory strategy use on the assessment achievement of 215 9th-grade, residential physics students from low socioeconomic status (low-SES) backgrounds. Students from low-SES backgrounds often lack the self-regulatory habits and metacognitive strategies to improve academic performance. In an effort to increase these scores and to increase student self-regulation and metacognition with regard to achievement in physics, this study investigated the use of metacognitive and self-regulatory strategies specifically as they apply to students' use of their own assessment data. Traditionally, student performance data is used by adults to inform instructional and curricular decisions. However, students are rarely given or asked to evaluate their own performance data. Moreover, students are not shown how to use this data to plan for or inform their own learning. It was found that students in the overall and algebra-ready treatment groups performed significantly better than their control group peers. These results are favorable for inclusion of strategies involving self-regulation and metacognition in secondary physics classrooms. Although these results may be applicable across residential, impoverished populations, further research is needed with non-residential populations.

  20. 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

  1. Testing Methods for Challenging the National Wetland Plant List: Using Tsuga canadensis (L.) Carr. (Eastern Hemlock) as a Case Study

    DTIC Science & Technology

    2017-07-01

    ESRI (Nature Conservancy and Environmental Systems Research Institute). 1994. Field Methods . In Field Methods for Vegetation Mapping: United States...ER D C/ CR RE L TR -1 7- 9 Wetlands Regulatory Assistance Program (WRAP) Testing Methods for Challenging the National Wetland Plant List...Robert W. Lichvar and Jennifer J. Goulet July 2017 Approved for public release; distribution is unlimited. The U.S. Army Engineer Research

  2. Characterization of the evolution of the pharmaceutical regulatory environment.

    PubMed

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main mission of public health protection has remained a constant feature over the years; and (iii) since the 1970s other factors such as public health promotion, international harmonization, innovation, and agency modernization are playing more important role in regulatory agency thinking and actions.

  3. 75 FR 34960 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-155-FOR; OSM 2010-0003] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act...

  4. 78 FR 9807 - Utah Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-12

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944... Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We are approving an amendment to the Utah regulatory program (the ``Utah program'') under the Surface Mining...

  5. Aquifer Storage and Recovery as a Viable Climate Change Adaptation Technique: Sustainable Development under the Current Regulatory Framework

    EPA Science Inventory

    A holistic investigation of aquifer storage and recovery (ASR) technique and application in the U.S. is being conducted as a part of the USEPA Water Resources Adaptation Program (WRAP). The research focus is to evaluate the potential of ASR application as a practical climate chan...

  6. Wallops and its role in depressed metabolism

    NASA Technical Reports Server (NTRS)

    Holton, E. M.

    1973-01-01

    Facilities and organization at the Wallops station are reviewed and some current research work is described that pertains to noise abatement studies as well as some testing phases on V/STOL aircraft. Radiation biology results of various space flights are reviewed and some efforts for the Regulatory Biology Program, involving depressed metabolism aspects of space travel are detailed.

  7. Geneticizing Ethnicity and Diet: Anti-doping Science and Its Social Impact in the Age of Post-genomics.

    PubMed

    Hyun, Jaehwan

    2017-01-01

    While gene doping and other technological means of sport enhancement have become a topic of ethical debate, a major outcome from genomic research in sports is often linked to the regulation of doping. In particular, researchers within the field of anti-doping science, a regulatory science that aims to develop scientific solutions for regulating doped athletes, have conducted genomic research on anabolic-androgenic steroids. Genomic knowledge on anabolic-androgenic steroids, a knowledge base that has been produced to improve doping regulation, has caused the 'geneticization' of cultural objects such as ethnic identities and dietary habits. Through examining how anti-doping genomic knowledge and its media representation unnecessarily reify cultural objects in terms of genomics, I argue that Ethical, Legal, and Social Implications (ELSI) research programs in human enhancement should include the social impacts of anti-doping science in their discussions. Furthermore, this article will propose that ELSI scholars begin their academic analysis on anti-doping science by engaging with the recent ELSI scholarship on genomics and race and consider the regulatory and political natures of anti-doping research.

  8. Geneticizing Ethnicity and Diet: Anti-doping Science and Its Social Impact in the Age of Post-genomics

    PubMed Central

    Hyun, Jaehwan

    2017-01-01

    While gene doping and other technological means of sport enhancement have become a topic of ethical debate, a major outcome from genomic research in sports is often linked to the regulation of doping. In particular, researchers within the field of anti-doping science, a regulatory science that aims to develop scientific solutions for regulating doped athletes, have conducted genomic research on anabolic-androgenic steroids. Genomic knowledge on anabolic-androgenic steroids, a knowledge base that has been produced to improve doping regulation, has caused the ‘geneticization’ of cultural objects such as ethnic identities and dietary habits. Through examining how anti-doping genomic knowledge and its media representation unnecessarily reify cultural objects in terms of genomics, I argue that Ethical, Legal, and Social Implications (ELSI) research programs in human enhancement should include the social impacts of anti-doping science in their discussions. Furthermore, this article will propose that ELSI scholars begin their academic analysis on anti-doping science by engaging with the recent ELSI scholarship on genomics and race and consider the regulatory and political natures of anti-doping research. PMID:28536601

  9. AFO Manure Management - Minnesota: Feedlot Registration

    EPA Pesticide Factsheets

    Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

  10. Nuclear safety. Technical progress journal, October 1996--December 1996

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

    None

    The five papers in this issue address various issues associated with the behavior of high burnup fuels, especially under reactivity initiated accident (RIA) conditions. The mechanisms and parameters that have an effect on the fuel behavior are detailed, based on tests and analyses. The ultimate goal of the research reported is the development of new regulatory criteria for high burnup fuel under design basis accident conditions. Specific topics of the papers, which are abstracted individually in the database, are: (1) regulatory assessment of test data for RIAs, (2) high burnup fuel transient behavior under RIA conditions, (3) NSRR/RIA experiments withmore » high burnup PWR fuels, (4) the Russian RIA research program, and (5) RIA simulation experiments on the intermediate and high burnup test rods. The papers are contributed from the United States, France, Japan, and Russia.« less

  11. Nuclear Forensic Science: Analysis of Nuclear Material Out of Regulatory Control

    NASA Astrophysics Data System (ADS)

    Kristo, Michael J.; Gaffney, Amy M.; Marks, Naomi; Knight, Kim; Cassata, William S.; Hutcheon, Ian D.

    2016-06-01

    Nuclear forensic science seeks to identify the origin of nuclear materials found outside regulatory control. It is increasingly recognized as an integral part of a robust nuclear security program. This review highlights areas of active, evolving research in nuclear forensics, with a focus on analytical techniques commonly employed in Earth and planetary sciences. Applications of nuclear forensics to uranium ore concentrates (UOCs) are discussed first. UOCs have become an attractive target for nuclear forensic researchers because of the richness in impurities compared to materials produced later in the fuel cycle. The development of chronometric methods for age dating nuclear materials is then discussed, with an emphasis on improvements in accuracy that have been gained from measurements of multiple radioisotopic systems. Finally, papers that report on casework are reviewed, to provide a window into current scientific practice.

  12. Space medicine research publications: 1987-1988

    NASA Technical Reports Server (NTRS)

    1991-01-01

    A list of publications of investigators supported by the Biomedical Research and Clinical Programs of the Life Sciences Division, Office of Space Science and Applications is given. Included are publications entered into the Life Sciences Bibliographic Database by the George Washington University as of 31 December 1988. Principal Investigators whose research tasks resulted in publication are identified by asterisk. Publications are organized into the following subject areas: space physiology and countermeasures (cardiopulmonary, musculoskeletal, neuroscience, and regulatory physiology), space human factors, environmental health, radiation health, clinical medicine, and general space medicine.

  13. Using principles from emergency management to improve emergency response plans for research animals.

    PubMed

    Vogelweid, Catherine M

    2013-10-01

    Animal research regulatory agencies have issued updated requirements for emergency response planning by regulated research institutions. A thorough emergency response plan is an essential component of an institution's animal care and use program, but developing an effective plan can be a daunting task. The author provides basic information drawn from the field of emergency management about best practices for developing emergency response plans. Planners should use the basic principles of emergency management to develop a common-sense approach to managing emergencies in their facilities.

  14. Function of university reactors in operator licensing training for nuclear utilities

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

    Wicks, F.

    1985-11-01

    The director of the Division of the US Nuclear Regulatory Commission in generic letter 84-10, dated April 26, 1984, spoke the requirement that applicants for senior reactor operator licenses for power reactors shall have performed then reactor startups. Simulator startups were not acknowledged. Startups performed on a university reactor are acceptable. The content and results of a five-day program combining instruction and experiments with the Rensselaer reactor are summarized.

  15. 78 FR 52587 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-23

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70228; File No. 4-663] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan..., Inc. and the Topaz Exchange, LLC August 19, 2013. On July 2, 2013, the Financial Industry Regulatory...

  16. Federal High Performance Computing and Communications Program. The Department of Energy Component.

    ERIC Educational Resources Information Center

    Department of Energy, Washington, DC. Office of Energy Research.

    This report, profusely illustrated with color photographs and other graphics, elaborates on the Department of Energy (DOE) research program in High Performance Computing and Communications (HPCC). The DOE is one of seven agency programs within the Federal Research and Development Program working on HPCC. The DOE HPCC program emphasizes research in…

  17. AFO Manure Management - Michigan: Manure Transfer Requirements

    EPA Pesticide Factsheets

    Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

  18. Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research

    PubMed Central

    King, Kevin; Grazette, Luanda P.; Paltoo, Dina N.; McDevitt, John T.; Sia, Samuel K.; Barrett, Paddy M.; Apple, Fred S.; Gurbel, Paul A.; Weissleder, Ralph; Leeds, Hilary; Iturriaga, Erin J.; Rao, Anupama; Adhikari, Bishow; Desvigne-Nickens, Patrice; Galis, Zorina S.; Libby, Peter

    2016-01-01

    Point-of-care technologies (POC or POCT) are enabling innovative cardiovascular diagnostics that promise to improve patient care across diverse clinical settings. The National Heart, Lung, and Blood Institute convened a working group to discuss POCT in cardiovascular medicine. The multidisciplinary working group, which included clinicians, scientists, engineers, device manufacturers, regulatory officials, and program staff, reviewed the state of the POCT field; discussed opportunities for POCT to improve cardiovascular care, realize the promise of precision medicine, and advance the clinical research enterprise; and identified barriers facing translation and integration of POCT with existing clinical systems. A POCT development roadmap emerged to guide multidisciplinary teams of biomarker scientists, technologists, health care providers, and clinical trialists as they: 1) formulate needs assessments; 2) define device design specifications; 3) develop component technologies and integrated systems; 4) perform iterative pilot testing; and 5) conduct rigorous prospective clinical testing to ensure that POCT solutions have substantial effects on cardiovascular care. PMID:26977455

  19. [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.

  20. RSAT 2015: Regulatory Sequence Analysis Tools

    PubMed Central

    Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A.; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M.; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

    2015-01-01

    RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. PMID:25904632

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

    Wichman, K.; Tsao, J.; Mayfield, M.

    The regulatory application of leak before break (LBB) for operating and advanced reactors in the U.S. is described. The U.S. Nuclear Regulatory Commission (NRC) has approved the application of LBB for six piping systems in operating reactors: reactor coolant system primary loop piping, pressurizer surge, safety injection accumulator, residual heat removal, safety injection, and reactor coolant loop bypass. The LBB concept has also been applied in the design of advanced light water reactors. LBB applications, and regulatory considerations, for pressurized water reactors and advanced light water reactors are summarized in this paper. Technology development for LBB performed by the NRCmore » and the International Piping Integrity Research Group is also briefly summarized.« less

  2. PhyloGibbs-MP: Module Prediction and Discriminative Motif-Finding by Gibbs Sampling

    PubMed Central

    Siddharthan, Rahul

    2008-01-01

    PhyloGibbs, our recent Gibbs-sampling motif-finder, takes phylogeny into account in detecting binding sites for transcription factors in DNA and assigns posterior probabilities to its predictions obtained by sampling the entire configuration space. Here, in an extension called PhyloGibbs-MP, we widen the scope of the program, addressing two major problems in computational regulatory genomics. First, PhyloGibbs-MP can localise predictions to small, undetermined regions of a large input sequence, thus effectively predicting cis-regulatory modules (CRMs) ab initio while simultaneously predicting binding sites in those modules—tasks that are usually done by two separate programs. PhyloGibbs-MP's performance at such ab initio CRM prediction is comparable with or superior to dedicated module-prediction software that use prior knowledge of previously characterised transcription factors. Second, PhyloGibbs-MP can predict motifs that differentiate between two (or more) different groups of regulatory regions, that is, motifs that occur preferentially in one group over the others. While other “discriminative motif-finders” have been published in the literature, PhyloGibbs-MP's implementation has some unique features and flexibility. Benchmarks on synthetic and actual genomic data show that this algorithm is successful at enhancing predictions of differentiating sites and suppressing predictions of common sites and compares with or outperforms other discriminative motif-finders on actual genomic data. Additional enhancements include significant performance and speed improvements, the ability to use “informative priors” on known transcription factors, and the ability to output annotations in a format that can be visualised with the Generic Genome Browser. In stand-alone motif-finding, PhyloGibbs-MP remains competitive, outperforming PhyloGibbs-1.0 and other programs on benchmark data. PMID:18769735

  3. Reducing drinking water supply chemical contamination: risks from underground storage tanks.

    PubMed

    Enander, Richard T; Hanumara, R Choudary; Kobayashi, Hisanori; Gagnon, Ronald N; Park, Eugene; Vallot, Christopher; Genovesi, Richard

    2012-12-01

    Drinking water supplies are at risk of contamination from a variety of physical, chemical, and biological sources. Ranked among these threats are hazardous material releases from leaking or improperly managed underground storage tanks located at municipal, commercial, and industrial facilities. To reduce human health and environmental risks associated with the subsurface storage of hazardous materials, government agencies have taken a variety of legislative and regulatory actions--which date back more than 25 years and include the establishment of rigorous equipment/technology/operational requirements and facility-by-facility inspection and enforcement programs. Given a history of more than 470,000 underground storage tank releases nationwide, the U.S. Environmental Protection Agency continues to report that 7,300 new leaks were found in federal fiscal year 2008, while nearly 103,000 old leaks remain to be cleaned up. In this article, we report on an alternate evidence-based intervention approach for reducing potential releases from the storage of petroleum products (gasoline, diesel, kerosene, heating/fuel oil, and waste oil) in underground tanks at commercial facilities located in Rhode Island. The objective of this study was to evaluate whether a new regulatory model can be used as a cost-effective alternative to traditional facility-by-facility inspection and enforcement programs for underground storage tanks. We conclude that the alternative model, using an emphasis on technical assistance tools, can produce measurable improvements in compliance performance, is a cost-effective adjunct to traditional facility-by-facility inspection and enforcement programs, and has the potential to allow regulatory agencies to decrease their frequency of inspections among low risk facilities without sacrificing compliance performance or increasing public health risks. © 2012 Society for Risk Analysis.

  4. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  5. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  6. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  7. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  8. 21 CFR 312.86 - Focused FDA regulatory research.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Focused FDA regulatory research. 312.86 Section... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical...

  9. HFE Process Guidance and Standards for potential application to updating NRC guidance

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

    Jacques Hugo; J. J. Persensky

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) reviews and evaluates the human factors engineering (HFE) programs of applicants for nuclear power plant construction permits, operating licenses, standard design certifications, and combined operating licenses. The purpose of these safety reviews is to help ensure that personnel performance and reliability are appropriately supported. Detailed design review procedures and guidance for the evaluations is provided in three key documents: the Standard Review Plan (NUREG-0800), the HFE Program Review Model (NUREG-0711), and the Human-System Interface Design Review Guidelines (NUREG-0700). These documents were last revised in 2007, 2004 and 2002, respectively. The NRC is committed tomore » the periodic update and improvement of these guidance documents to ensure that they remain state-of-the-art design evaluation tools. Thus, the NRC has initiated a project with BNL to update the NRC guidance to remain current with recent research on human performance, advances in HFE methods and tools, and new technology. INL supported Brookhaven National Lab (BNL) to update the detailed HFE review criteria contained in NUREG-0711 and NUREG-0700 based on (1) feedback obtained from end users, (2) the results of NRC research and development efforts supporting the NRC staff’s HFE safety reviews, and (3) other material the project staff identify as applicable to the update effort. INL submitted comments on development plans and sections of NUREGs 0800, 0711, and 0700. The contractor prepared the report attached here as the deliverable for this work.« less

  10. The JRC Nanomaterials Repository: A unique facility providing representative test materials for nanoEHS research.

    PubMed

    Totaro, Sara; Cotogno, Giulio; Rasmussen, Kirsten; Pianella, Francesca; Roncaglia, Marco; Olsson, Heidi; Riego Sintes, Juan M; Crutzen, Hugues P

    2016-11-01

    The European Commission has established a Nanomaterials Repository that hosts industrially manufactured nanomaterials that are distributed world-wide for safety testing of nanomaterials. In a first instance these materials were tested in the OECD Testing Programme. They have then also been tested in several EU funded research projects. The JRC Repository of Nanomaterials has thus developed into serving the global scientific community active in the nanoEHS (regulatory) research. The unique Repository facility is a state-of-the-art installation that allows customised sub-sampling under the safest possible conditions, with traceable final sample vials distributed world-wide for research purposes. This paper describes the design of the Repository to perform a semi-automated subsampling procedure, offering high degree of flexibility and precision in the preparation of NM vials for customers, while guaranteeing the safety of the operators, and environmental protection. The JRC nanomaterials are representative for part of the world NMs market. Their wide use world-wide facilitates the generation of comparable and reliable experimental results and datasets in (regulatory) research by the scientific community, ultimately supporting the further development of the OECD regulatory test guidelines. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  11. Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

    PubMed

    Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

    2017-10-01

    The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  12. AFO Manure Management - Nevada: CAFO Drainage Collection Requirements

    EPA Pesticide Factsheets

    Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

  13. AFO Manure Management - Virginia: Nutrient Management Inspector Qualifications

    EPA Pesticide Factsheets

    Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

  14. AFO Manure Management - California: Implementing TMDL Wasteload Allocations

    EPA Pesticide Factsheets

    Compendium of State Approaches for Manure Management, Part A -- Example of program features for manure management that have a regulatory basis, such as permit provisions and other regulatory program elements.

  15. 10 CFR 63.144 - Quality assurance program change.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  16. 75 FR 43208 - Withdrawal of Regulatory Guide 5.17

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

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

  17. Current Regulations and Regulatory Actions

    EPA Pesticide Factsheets

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

  18. Monitoring quality of care at dialysis facilities: a case for regulatory parsimony--and beyond.

    PubMed

    Stivelman, John C

    2012-10-01

    With the issuance of the new Conditions for Coverage in 2008 and the implementation of the Prospective Payment System in 2011, the Centers for Medicare & Medicaid Services has fundamentally altered the regulatory landscape of quality in the ESRD program. Although these changes-largely through use of tools comparing individual facility performance to regional and national quality expectations-have increased facility accountability for the quality of patient care in many quarters, they have also complicated both substance and process of facility adherence to quality rules in that component of the program. This editorial critically assesses the main quality tools now in use for dialysis facilities and reviews the issues arising from their conjoint use. A scheme for improving the effectiveness of each quality tool is proposed, and an assessment of their future value and effectiveness in quality improvement is offered.

  19. Economic approaches to measuring the significance of food safety in international trade.

    PubMed

    Caswell, J A

    2000-12-20

    International trade in food products has expanded rapidly in recent years. This paper presents economic approaches for analyzing the effects on trade in food products of the food safety requirements of governments and private buyers. Important economic incentives for companies to provide improved food safety arise from (1) public incentives such as ex ante requirements for sale of a product with sufficient quality and ex post penalties (liability) for sale of products with deficient quality, and (2) private incentives for producing quality such as internal performance goals (self-regulation) and the external (certification) requirements of buyers. The World Trade Organization's Sanitary Phytosanitary Agreement facilitates scrutiny of the benefits and costs of country-level regulatory programs and encourages regulatory rapprochement on food safety issues. Economists can help guide risk management decisions by providing estimates of the benefits and costs of programs to improve food safety and by analyzing their effect on trade in food products.

  20. Drug and alcohol abuse: the bases for employee assistance programs in the nuclear-utility industry

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

    Radford, L.R.; Rankin, W.L.; Barnes, V.

    This report describes the nature, prevalence, and trends of drug and alcohol abuse among members of the US adult population and among personnel in non-nuclear industries. Analogous data specific to the nuclear utility industry are not available, so these data were gathered in order to provide a basis for regulatory planning. The nature, prevalence, and trend inforamtion was gathered using a computerized literature, telephone discussions with experts, and interviews with employee assistance program representatives from the Seattle area. This report also evaluates the possible impacts that drugs and alcohol might have on nuclear-related job performance, based on currently available nuclearmore » utility job descriptions and on the scientific literature regarding the impairing effects of drugs and alcohol on human performance. Employee assistance programs, which can be used to minimize or eliminate job performance decrements resulting from drug or alcohol abuse, are also discussed.« less

  1. 75 FR 76758 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63430; File No. 4-618] Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Plan for the Allocation of Regulatory Responsibilities Between BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago Board Options Exchange, Inc., Chicago...

  2. 40 CFR 97.287 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units § 97.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2... authority and the Administrator of such change in the CAIR SO2 opt-in unit's regulatory status, within 30...

  3. 30 CFR 730.12 - Requirements for regulatory programs in States.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

  4. 30 CFR 730.12 - Requirements for regulatory programs in States.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

  5. 30 CFR 730.12 - Requirements for regulatory programs in States.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... imposition of a Federal program for regulation of surface coal mining and reclamation operations. Regulation..., DEPARTMENT OF THE INTERIOR PERMANENT REGULATORY PROGRAMS FOR NON-FEDERAL AND NON-INDIAN LANDS GENERAL... each State in which coal exploration and surface coal mining and reclamation operations are or may be...

  6. 40 CFR 97.87 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Change in regulatory status. 97.87 Section 97.87 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) FEDERAL NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS Individual Unit Opt-ins...

  7. 78 FR 33122 - Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0081] Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of Principles and Policy for the Agreement State Program AGENCY: Nuclear.... Nuclear Regulatory Commission (NRC) is proposing revisions to its policy statements on Agreement State...

  8. 30 CFR 906.15 - Approval of Colorado regulatory program amendments.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Colorado regulatory program amendments. 906.15 Section 906.15 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE COLORADO...

  9. 77 FR 36014 - Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

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

  10. Monitoring the Performance of Educational Institutions: A Spur for the Implementation of Systemic Changes in Higher Education. Part Two

    ERIC Educational Resources Information Center

    Karelina, Irina Georgievna; Sobolev, Alexander Borisovich; Sorokin, Sviatoslav Olegovich

    2016-01-01

    The article discusses a comprehensive reporting and monitoring framework used to evaluate the performance of state and private higher education institutions. By analyzing diversified indicators including regulatory compliance, organizational and economic indicators, training and research, and other metrics, the authors spotlight key developments…

  11. Quality control for federal clean water act and safe drinking water act regulatory compliance.

    PubMed

    Askew, Ed

    2013-01-01

    QC sample results are required in order to have confidence in the results from analytical tests. Some of the AOAC water methods include specific QC procedures, frequencies, and acceptance criteria. These are considered to be the minimum controls needed to perform the method successfully. Some regulatory programs, such as those in 40 CFR Part 136.7, require additional QC or have alternative acceptance limits. Essential QC measures include method calibration, reagent standardization, assessment of each analyst's capabilities, analysis of blind check samples, determination of the method's sensitivity (method detection level or quantification limit), and daily evaluation of bias, precision, and the presence of laboratory contamination or other analytical interference. The details of these procedures, their performance frequency, and expected ranges of results are set out in this manuscript. The specific regulatory requirements of 40 CFR Part 136.7 for the Clean Water Act, the laboratory certification requirements of 40 CFR Part 141 for the Safe Drinking Water Act, and the ISO 17025 accreditation requirements under The NELAC Institute are listed.

  12. The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.

    PubMed

    Kessler, Larry G; Barnhart, Huiman X; Buckler, Andrew J; Choudhury, Kingshuk Roy; Kondratovich, Marina V; Toledano, Alicia; Guimaraes, Alexander R; Filice, Ross; Zhang, Zheng; Sullivan, Daniel C

    2015-02-01

    The development and implementation of quantitative imaging biomarkers has been hampered by the inconsistent and often incorrect use of terminology related to these markers. Sponsored by the Radiological Society of North America, an interdisciplinary group of radiologists, statisticians, physicists, and other researchers worked to develop a comprehensive terminology to serve as a foundation for quantitative imaging biomarker claims. Where possible, this working group adapted existing definitions derived from national or international standards bodies rather than invent new definitions for these terms. This terminology also serves as a foundation for the design of studies that evaluate the technical performance of quantitative imaging biomarkers and for studies of algorithms that generate the quantitative imaging biomarkers from clinical scans. This paper provides examples of research studies and quantitative imaging biomarker claims that use terminology consistent with these definitions as well as examples of the rampant confusion in this emerging field. We provide recommendations for appropriate use of quantitative imaging biomarker terminological concepts. It is hoped that this document will assist researchers and regulatory reviewers who examine quantitative imaging biomarkers and will also inform regulatory guidance. More consistent and correct use of terminology could advance regulatory science, improve clinical research, and provide better care for patients who undergo imaging studies. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  13. 75 FR 14372 - Fixed Assets, Member Business Loans, and Regulatory Flexibility Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-25

    ... of the impact of the expansion and developing a sound financial plan. The FCU has performed poorly... these economic times when MBL delinquencies and MBL charge-offs have increased. The below table... Off MBLs 0.15 1.18 1.05 0.81 1.70 This trend in losses and delinquencies is becoming increasingly...

  14. 76 FR 23513 - Public and Closed Meeting To Discuss Comments on Draft Regulatory Basis for Rulemaking Revising...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-27

    ..., ``Security Performance (Adversary) Characteristics for Physical Security Programs for 10 CFR [Title 10 of the..., ``Physical Protection of Plants and Materials,'' that would apply during the storage of SNF at an ISFSI and... facilities licensed to store SNF through a combination of these existing security regulations and the...

  15. Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships.

    PubMed

    Taylor, Patrick L

    2013-01-01

    The most contentious, unresolved issue in biomedicine in the last twenty-five years has been how to best address compensated partnerships between academic researchers and the pharmaceutical industry. Law and policy deliberately promote these partnerships through intellectual property law, research funding programs, and drug and device approval pathways while simultaneously condemning them through conflict-of-interest (COI) regulations. These regulations have not been subjected to the close scrutiny that is typically utilized in administrative law to evaluate and improve regulatory systems. This Article suggests that the solution to this standoff in biomedical law and policy lies in an informed, empirical approach. Such an approach must both recognize such partnerships' legal and practical variations, as well as classify them based on their benefit to innovation and their harm to research biases. Ultimately, this approach must facilitate administrative reforms that would convert what is now an inherently arbitrary, yet widespread, regulatory regime into an epistemically rich mechanism for distinguishing between harmful and beneficial partnerships.

  16. Maternal self-confidence during the first four months postpartum and its association with anxiety and early infant regulatory problems.

    PubMed

    Matthies, Lina Maria; Wallwiener, Stephanie; Müller, Mitho; Doster, Anne; Plewniok, Katharina; Feller, Sandra; Sohn, Christof; Wallwiener, Markus; Reck, Corinna

    2017-11-01

    Maternal self-confidence has become an essential concept in understanding early disturbances in the mother-child relationship. Recent research suggests that maternal self-confidence may be associated with maternal mental health and infant development. The current study investigated the dynamics of maternal self-confidence during the first four months postpartum and the predictive ability of maternal symptoms of depression, anxiety, and early regulatory problems in infants. Questionnaires assessing symptoms of depression (Edinburgh Postnatal Depression Scale), anxiety (State-Trait Anxiety Inventory), and early regulatory problems (Questionnaire for crying, sleeping and feeding) were completed in a sample of 130 women at three different time points (third trimester (T1), first week postpartum (T2), and 4 months postpartum (T3). Maternal self-confidence increased significantly over time. High maternal trait anxiety and early infant regulatory problems negatively contributed to the prediction of maternal self-confidence, explaining 31.8% of the variance (R=.583, F 3,96 =15.950, p<.001). Our results emphasize the transactional association between maternal self-confidence, regulatory problems in infants, and maternal mental distress. There is an urgent need for appropriate programs to reduce maternal anxiety and to promote maternal self-confidence in order to prevent early regulatory problems in infants. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. 78 FR 56217 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Shrimp Fisheries of the Gulf of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.), and... fundamental fisheries information. The described research is part of a long-term observer program that began... development and evaluation of fisheries management and regulatory options. The EFP would exempt the activities...

  18. The Emergence of High-Stakes Accountability Policies in Teacher Preparation: An Examination of the U.S. Department of Education's Proposed Regulations

    ERIC Educational Resources Information Center

    Tatto, Maria Teresa; Savage, Corey; Liao, Wei; Marshall, Stefanie L.; Goldblatt, Paul; Contreras, Leonardo Medel

    2016-01-01

    Using a sociological framework this article explores the emergence and possible consequences of the 2015 U.S. Department of Education's proposed federal regulatory policy on teacher education programs and alternative route providers. After describing the key features of the policy, we examine the research literature looking for evidence of the…

  19. Empowering the Middle: A High School Study Skills Program and Its Impact on Academic Achievement and Self-Efficacy

    ERIC Educational Resources Information Center

    Simmons, Stephanie Yvette

    2017-01-01

    This study examined the impact of a self-regulatory skills course on the academic achievement and self-efficacy of 11th-grade students. The researcher compared intervention and control groups participants' pre- and posttest scores on the General Self-Efficacy Scale and the Learning and Study Skills Assessment Inventory-High School version. Scores…

  20. Human Research Program Exploration Medical Capability

    NASA Technical Reports Server (NTRS)

    Barsten, Kristina

    2010-01-01

    NASA s Human Research Program (HRP) conducts and coordinates research projects that provide human health and performance countermeasures, knowledge, technologies, and tools to enable safe, reliable, and productive human space exploration. The Program is divided into 6 major elements, which a) Provide the Program s knowledge and capabilities to conduct research, addressing the human health and performance risks. b) Advance the readiness levels of technology and countermeasures to the point of transfer to the customer programs and organizations. The National Space Biomedical Research Institute (NSBRI) is a partner with the HRP in developing a successful research program. 3

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