Sample records for regulatory research programs

  1. 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.

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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.

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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...

  19. 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...

  20. 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...

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. [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).

  13. 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 ...

  14. 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 ...

  15. 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 ...

  16. 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 ...

  17. 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 ...

  18. 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 ...

  19. 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 ...

  20. 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...

  1. 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...

  2. 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 ...

  3. 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 ...

  4. 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 ...

  5. 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...

  6. 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...

  7. 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 ...

  8. 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

  9. 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.

  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. 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 ...

  12. 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...

  13. 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.

  14. 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.

  15. 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...

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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

  1. 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…

  2. 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.

  3. 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.

  4. 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

  5. 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…

  6. 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 ...

  7. 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

  8. 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…

  9. 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.

  10. 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...

  11. 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…

  12. 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...

  13. 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...

  14. 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…

  15. 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...

  16. 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

  17. 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...

  18. 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...

  19. 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...

  20. 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.

  1. 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...

  2. 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…

  3. 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...

  4. 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.

  5. 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…

  6. 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...

  7. 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...

  8. 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...

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. 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

  1. 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

  2. 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.

  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. 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...

  5. 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...

  6. 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.

  7. 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...

  8. 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

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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.

  17. 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.

  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. [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.

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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.

  11. 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...

  12. 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...

  13. 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.

  14. 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…

  15. 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…

  16. 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

  17. 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...

  18. 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.

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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

  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. 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…

  15. 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.

  16. 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.

  17. 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...

  18. 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...

  19. #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.

  20. 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.

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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…

  8. 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

  9. 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.

  10. 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

  11. 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...

  12. 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

  13. 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

  14. 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 ...

  15. 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 ...

  16. 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...

  17. 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...

  18. 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...

  19. 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…

  20. 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

  1. #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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. [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".

  10. 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...

  11. 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)

  12. 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...

  13. 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.

  14. 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

  15. 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

  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. 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.

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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.

  5. 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...

  6. 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...

  7. 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…

  8. 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...

  9. 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...

  10. [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.

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. 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

  19. 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

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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.

  8. 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.

  9. 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...

  10. 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...

  11. 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

  12. 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

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  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. 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.

  3. 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.

  4. 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

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. 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.

  1. 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...

  2. 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...

  3. 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

  4. 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

  5. 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

  6. 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...

  7. 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...

  8. 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...

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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...

  18. 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).

  19. 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.

  20. [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.

  1. 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

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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...

  12. 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...

  13. 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.

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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.

  4. 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.

  5. 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.

  6. 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...

  7. 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…

  8. 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…

  9. Watershed monitoring and modelling and USA regulatory compliance.

    PubMed

    Turner, B G; Boner, M C

    2004-01-01

    The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.

  10. The Gene Therapy Resource Program: A Decade of Dedication to Translational Research by the National Heart, Lung, and Blood Institute.

    PubMed

    Flotte, Terence R; Daniels, Eric; Benson, Janet; Bevett-Rose, Jeneé M; Cornetta, Kenneth; Diggins, Margaret; Johnston, Julie; Sepelak, Susan; van der Loo, Johannes C M; Wilson, James M; McDonald, Cheryl L

    2017-12-01

    Over a 10-year period, the Gene Therapy Resource Program (GTRP) of the National Heart Lung and Blood Institute has provided a set of core services to investigators to facilitate the clinical translation of gene therapy. These services have included a preclinical (research-grade) vector production core; current Good Manufacturing Practice clinical-grade vector cores for recombinant adeno-associated virus and lentivirus vectors; a pharmacology and toxicology core; and a coordinating center to manage program logistics and to provide regulatory and financial support to early-phase clinical trials. In addition, the GTRP has utilized a Steering Committee and a Scientific Review Board to guide overall progress and effectiveness and to evaluate individual proposals. These resources have been deployed to assist 82 investigators with 172 approved service proposals. These efforts have assisted in clinical trial implementation across a wide range of genetic, cardiac, pulmonary, and blood diseases. Program outcomes and potential future directions of the program are discussed.

  11. 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.

  12. 17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

  13. 17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

  14. 17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

  15. 17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

  16. 17 CFR 240.17d-2 - Program for allocation of regulatory responsibility.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... self-regulatory organizations may file with the Commission within ninety (90) days of the effective... allocating among the self-regulatory organizations the responsibility to receive regulatory reports from persons who are members or participants of more than one of such self-regulatory organizations to examine...

  17. AFO Manure Management - Oregon: Plan Review and Public Notice of Substantial Changes

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

    PubMed Central

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

    2017-01-01

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

  19. Patients come from populations and populations contain patients. A two-stage scientific and ethics review: The next adaptation for single institutional review boards.

    PubMed

    Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

    2017-08-01

    For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

  20. Integrating Transcriptomic and Proteomic Data Using Predictive Regulatory Network Models of Host Response to Pathogens

    PubMed Central

    Chasman, Deborah; Walters, Kevin B.; Lopes, Tiago J. S.; Eisfeld, Amie J.; Kawaoka, Yoshihiro; Roy, Sushmita

    2016-01-01

    Mammalian host response to pathogenic infections is controlled by a complex regulatory network connecting regulatory proteins such as transcription factors and signaling proteins to target genes. An important challenge in infectious disease research is to understand molecular similarities and differences in mammalian host response to diverse sets of pathogens. Recently, systems biology studies have produced rich collections of omic profiles measuring host response to infectious agents such as influenza viruses at multiple levels. To gain a comprehensive understanding of the regulatory network driving host response to multiple infectious agents, we integrated host transcriptomes and proteomes using a network-based approach. Our approach combines expression-based regulatory network inference, structured-sparsity based regression, and network information flow to infer putative physical regulatory programs for expression modules. We applied our approach to identify regulatory networks, modules and subnetworks that drive host response to multiple influenza infections. The inferred regulatory network and modules are significantly enriched for known pathways of immune response and implicate apoptosis, splicing, and interferon signaling processes in the differential response of viral infections of different pathogenicities. We used the learned network to prioritize regulators and study virus and time-point specific networks. RNAi-based knockdown of predicted regulators had significant impact on viral replication and include several previously unknown regulators. Taken together, our integrated analysis identified novel module level patterns that capture strain and pathogenicity-specific patterns of expression and helped identify important regulators of host response to influenza infection. PMID:27403523

  1. Children and violence: the role of children's regulation in the marital aggression-child adjustment link.

    PubMed

    Cummings, E Mark; El-Sheikh, Mona; Kouros, Chrystyna D; Buckhalt, Joseph A

    2009-03-01

    Exposure to marital psychological and physical abuse has been established as a risk factor for children's socio-emotional, behavioral, and cognitive problems. Understanding the processes by which children develop symptoms of psychopathology and deficits in cognitive functioning in the context of marital aggression is imperative for developing efficient and effective treatment programs for children and families, and has far-reaching mental health implications. The present paper outlines our research program, Child Regulation and Exposure to Marital Aggression, which focuses on children's emotional and physiological reactivity and regulation as pathways in the marital aggression-child development link. Findings from our research program, which highlight the importance of children's regulatory processes for understanding children's adjustment in contexts of intimate partner violence, are presented, and future directions in this line of inquiry are outlined.

  2. Chemical Technology Division: Progress report, January 1, 1987--June 30, 1988

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

    Not Available

    1989-02-01

    This progress report summarizes the research and development efforts conducted in the Chemical Technology Division (Chem Tech) during the period January 1, 1987, to June 30, 1988. The following major areas are covered: waste management and environmental programs, radiochemical and reactor engineering programs, basic science and technology, Nuclear Regulatory Commission programs, and administrative resources and facilities. The Administrative Summary, an appendix, presents a comprehensive listing of publications, oral presentations, awards and recognitions, and patents of Chem Tech staff members during this period. A staffing level and financial summary and lists of seminars and Chem Tech consultants for the period aremore » also included.« less

  3. Emergent self-regulatory activity among young children during scientific inquiry: An analysis of six kindergarten children

    NASA Astrophysics Data System (ADS)

    Lomangino, Adrienne Gelpi

    2000-10-01

    This qualitative investigation extends the study of self-regulation to examine young children's developing self-regulated learning competencies. The framework for this research draws upon social cognitive, developmental, and sociocultural perspectives on self-regulation and research on children's scientific thinking. Taking a multiple case study approach, this study examines six kindergarten children's emerging self-regulatory competencies during inquiry-based science instruction. Data were collected during two inquiry-based science programs of study, one pertaining to light and shadow and a second pertaining to motion on inclined planes. Data sources included: videotaped records of the instruction, transcriptions of the videotapes, interviews with the children and teacher, student work, and field notes. Taking an inductive approach to analysis, patterns in the children's activity were identified through a recursive process of defining and refining categories that characterized the children's verbal and behavioral activity. Each case study examines a child's behavior within each phase of the inquiry for evidence of emerging self-regulatory competence. Analysis revealed nascent forms of goal-setting and planning, monitoring, resource management, seeking social assistance, and evaluating. Monitoring activity occurred more frequently than planning or evaluating. For several children, animating materials served to promote motivation. Children's efforts to support peers' activity and monitor the meaning of ongoing discourse contrast with common assumptions about children's attention to others' thinking. Variations in self-regulatory activity were found across phases of instruction. The children exhibited interpersonal self-regulatory efforts, in which monitoring and control of the self was entwined with the activity of others. Joint participation also played a critical role in supporting the metacognitive demands of self-regulation and prompting metacognitive awareness. However, planning and self-evaluation were constrained by the opportunities provided within the instruction for engaging in self-regulatory activity.

  4. Lessons Learned from an Industry, Government and University Collaboration to Restore Stream Habitats and Mitigate Effects

    NASA Astrophysics Data System (ADS)

    Jones, Nicholas E.; Scrimgeour, Garry J.; Tonn, William M.

    2017-01-01

    Restoration ecologists conduct both basic and applied research using a diversity of funding and collaborative models. Over the last 17 years we have assessed the effectiveness of a stream compensation project in Canada's north, where an independent university-based research program was a condition of the regulatory approval process. This resulted in a non-traditional university-government-industry partnership. Here we share seven lessons that we learned from our collective experiences with the research partnership and use the Ekati diamond mine as a case study to illustrate and support lessons learned. Our advice includes opinions on the importance of: engaging collaborators early, defining roles and responsibilities, data sharing and standardization, the use of natural streams to set restoration targets, expect setbacks and surprises, treating restoration as an opportunity to experiment, and how to define success. Many of the lessons learned are broadly applicable to those whom embark on research collaborations among industry, universities, and consulting companies within a regulatory framework and may be of particular value to collaborators in early stages of their career.

  5. Columbus Closure Project Released without Radiological Restrictions

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

    Henderson, G.

    2007-07-01

    The Columbus Closure Project (CCP), a historic radiological research complex, was cleaned up for future use without radiological restriction in 2006. The CCP research and development site contributed to national defense, nuclear fuel fabrication, and the development of safe nuclear reactors in the United States until 1988 when research activities were concluded for site decommissioning. In November of 2003, the Ohio Field Office of the U.S. Department of Energy contracted ECC/E2 Closure Services, LLC (Closure Services) to complete the removal of radioactive contamination from of a 1955 era nuclear sciences area consisting of a large hot cell facility, research reactormore » building and underground piping. The project known as the Columbus Closure Project (CCP) was completed in 27 months and brought to a close 16 years of D and D in Columbus, Ohio. This paper examines the project innovations and challenges presented during the Columbus Closure Project. The examination of the CCP includes the project regulatory environment, the CS safety program, accelerated clean up innovation, project execution strategies and management of project waste issues and the regulatory approach to site release 'without radiological restrictions'. (authors)« less

  6. A Comparative Encyclopedia of DNA Elements in the Mouse Genome

    PubMed Central

    Yue, Feng; Cheng, Yong; Breschi, Alessandra; Vierstra, Jeff; Wu, Weisheng; Ryba, Tyrone; Sandstrom, Richard; Ma, Zhihai; Davis, Carrie; Pope, Benjamin D.; Shen, Yin; Pervouchine, Dmitri D.; Djebali, Sarah; Thurman, Bob; Kaul, Rajinder; Rynes, Eric; Kirilusha, Anthony; Marinov, Georgi K.; Williams, Brian A.; Trout, Diane; Amrhein, Henry; Fisher-Aylor, Katherine; Antoshechkin, Igor; DeSalvo, Gilberto; See, Lei-Hoon; Fastuca, Meagan; Drenkow, Jorg; Zaleski, Chris; Dobin, Alex; Prieto, Pablo; Lagarde, Julien; Bussotti, Giovanni; Tanzer, Andrea; Denas, Olgert; Li, Kanwei; Bender, M. A.; Zhang, Miaohua; Byron, Rachel; Groudine, Mark T.; McCleary, David; Pham, Long; Ye, Zhen; Kuan, Samantha; Edsall, Lee; Wu, Yi-Chieh; Rasmussen, Matthew D.; Bansal, Mukul S.; Keller, Cheryl A.; Morrissey, Christapher S.; Mishra, Tejaswini; Jain, Deepti; Dogan, Nergiz; Harris, Robert S.; Cayting, Philip; Kawli, Trupti; Boyle, Alan P.; Euskirchen, Ghia; Kundaje, Anshul; Lin, Shin; Lin, Yiing; Jansen, Camden; Malladi, Venkat S.; Cline, Melissa S.; Erickson, Drew T.; Kirkup, Vanessa M; Learned, Katrina; Sloan, Cricket A.; Rosenbloom, Kate R.; de Sousa, Beatriz Lacerda; Beal, Kathryn; Pignatelli, Miguel; Flicek, Paul; Lian, Jin; Kahveci, Tamer; Lee, Dongwon; Kent, W. James; Santos, Miguel Ramalho; Herrero, Javier; Notredame, Cedric; Johnson, Audra; Vong, Shinny; Lee, Kristen; Bates, Daniel; Neri, Fidencio; Diegel, Morgan; Canfield, Theresa; Sabo, Peter J.; Wilken, Matthew S.; Reh, Thomas A.; Giste, Erika; Shafer, Anthony; Kutyavin, Tanya; Haugen, Eric; Dunn, Douglas; Reynolds, Alex P.; Neph, Shane; Humbert, Richard; Hansen, R. Scott; De Bruijn, Marella; Selleri, Licia; Rudensky, Alexander; Josefowicz, Steven; Samstein, Robert; Eichler, Evan E.; Orkin, Stuart H.; Levasseur, Dana; Papayannopoulou, Thalia; Chang, Kai-Hsin; Skoultchi, Arthur; Gosh, Srikanta; Disteche, Christine; Treuting, Piper; Wang, Yanli; Weiss, Mitchell J.; Blobel, Gerd A.; Good, Peter J.; Lowdon, Rebecca F.; Adams, Leslie B.; Zhou, Xiao-Qiao; Pazin, Michael J.; Feingold, Elise A.; Wold, Barbara; Taylor, James; Kellis, Manolis; Mortazavi, Ali; Weissman, Sherman M.; Stamatoyannopoulos, John; Snyder, Michael P.; Guigo, Roderic; Gingeras, Thomas R.; Gilbert, David M.; Hardison, Ross C.; Beer, Michael A.; Ren, Bing

    2014-01-01

    Summary As the premier model organism in biomedical research, the laboratory mouse shares the majority of protein-coding genes with humans, yet the two mammals differ in significant ways. To gain greater insights into both shared and species-specific transcriptional and cellular regulatory programs in the mouse, the Mouse ENCODE Consortium has mapped transcription, DNase I hypersensitivity, transcription factor binding, chromatin modifications, and replication domains throughout the mouse genome in diverse cell and tissue types. By comparing with the human genome, we not only confirm substantial conservation in the newly annotated potential functional sequences, but also find a large degree of divergence of other sequences involved in transcriptional regulation, chromatin state and higher order chromatin organization. Our results illuminate the wide range of evolutionary forces acting on genes and their regulatory regions, and provide a general resource for research into mammalian biology and mechanisms of human diseases. PMID:25409824

  7. A comparative encyclopedia of DNA elements in the mouse genome.

    PubMed

    Yue, Feng; Cheng, Yong; Breschi, Alessandra; Vierstra, Jeff; Wu, Weisheng; Ryba, Tyrone; Sandstrom, Richard; Ma, Zhihai; Davis, Carrie; Pope, Benjamin D; Shen, Yin; Pervouchine, Dmitri D; Djebali, Sarah; Thurman, Robert E; Kaul, Rajinder; Rynes, Eric; Kirilusha, Anthony; Marinov, Georgi K; Williams, Brian A; Trout, Diane; Amrhein, Henry; Fisher-Aylor, Katherine; Antoshechkin, Igor; DeSalvo, Gilberto; See, Lei-Hoon; Fastuca, Meagan; Drenkow, Jorg; Zaleski, Chris; Dobin, Alex; Prieto, Pablo; Lagarde, Julien; Bussotti, Giovanni; Tanzer, Andrea; Denas, Olgert; Li, Kanwei; Bender, M A; Zhang, Miaohua; Byron, Rachel; Groudine, Mark T; McCleary, David; Pham, Long; Ye, Zhen; Kuan, Samantha; Edsall, Lee; Wu, Yi-Chieh; Rasmussen, Matthew D; Bansal, Mukul S; Kellis, Manolis; Keller, Cheryl A; Morrissey, Christapher S; Mishra, Tejaswini; Jain, Deepti; Dogan, Nergiz; Harris, Robert S; Cayting, Philip; Kawli, Trupti; Boyle, Alan P; Euskirchen, Ghia; Kundaje, Anshul; Lin, Shin; Lin, Yiing; Jansen, Camden; Malladi, Venkat S; Cline, Melissa S; Erickson, Drew T; Kirkup, Vanessa M; Learned, Katrina; Sloan, Cricket A; Rosenbloom, Kate R; Lacerda de Sousa, Beatriz; Beal, Kathryn; Pignatelli, Miguel; Flicek, Paul; Lian, Jin; Kahveci, Tamer; Lee, Dongwon; Kent, W James; Ramalho Santos, Miguel; Herrero, Javier; Notredame, Cedric; Johnson, Audra; Vong, Shinny; Lee, Kristen; Bates, Daniel; Neri, Fidencio; Diegel, Morgan; Canfield, Theresa; Sabo, Peter J; Wilken, Matthew S; Reh, Thomas A; Giste, Erika; Shafer, Anthony; Kutyavin, Tanya; Haugen, Eric; Dunn, Douglas; Reynolds, Alex P; Neph, Shane; Humbert, Richard; Hansen, R Scott; De Bruijn, Marella; Selleri, Licia; Rudensky, Alexander; Josefowicz, Steven; Samstein, Robert; Eichler, Evan E; Orkin, Stuart H; Levasseur, Dana; Papayannopoulou, Thalia; Chang, Kai-Hsin; Skoultchi, Arthur; Gosh, Srikanta; Disteche, Christine; Treuting, Piper; Wang, Yanli; Weiss, Mitchell J; Blobel, Gerd A; Cao, Xiaoyi; Zhong, Sheng; Wang, Ting; Good, Peter J; Lowdon, Rebecca F; Adams, Leslie B; Zhou, Xiao-Qiao; Pazin, Michael J; Feingold, Elise A; Wold, Barbara; Taylor, James; Mortazavi, Ali; Weissman, Sherman M; Stamatoyannopoulos, John A; Snyder, Michael P; Guigo, Roderic; Gingeras, Thomas R; Gilbert, David M; Hardison, Ross C; Beer, Michael A; Ren, Bing

    2014-11-20

    The laboratory mouse shares the majority of its protein-coding genes with humans, making it the premier model organism in biomedical research, yet the two mammals differ in significant ways. To gain greater insights into both shared and species-specific transcriptional and cellular regulatory programs in the mouse, the Mouse ENCODE Consortium has mapped transcription, DNase I hypersensitivity, transcription factor binding, chromatin modifications and replication domains throughout the mouse genome in diverse cell and tissue types. By comparing with the human genome, we not only confirm substantial conservation in the newly annotated potential functional sequences, but also find a large degree of divergence of sequences involved in transcriptional regulation, chromatin state and higher order chromatin organization. Our results illuminate the wide range of evolutionary forces acting on genes and their regulatory regions, and provide a general resource for research into mammalian biology and mechanisms of human diseases.

  8. Nuclear Forensic Science: Analysis of Nuclear Material Out of Regulatory Control

    DOE PAGES

    Kristo, Michael J.; Gaffney, Amy M.; Marks, Naomi; ...

    2016-05-11

    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. Our 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. Furthermore, the development of chronometric methods for age dating nuclearmore » 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.« less

  9. 78 FR 64397 - Mississippi Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... text of the program amendment available at www.regulations.gov . A. Mississippi Surface Coal Mining... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 924...; S2D2SSS08011000SX066A00033F13XS501520] Mississippi Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement...

  10. 30 CFR 944.15 - Approval of Utah regulatory program amendments.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

  11. 30 CFR 944.15 - Approval of Utah regulatory program amendments.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

  12. 30 CFR 944.15 - Approval of Utah regulatory program amendments.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

  13. 30 CFR 944.15 - Approval of Utah regulatory program amendments.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

  14. 30 CFR 944.15 - Approval of Utah regulatory program amendments.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 816/817.61; 850; Memorandum of Agreement between the Board and Division of Oil, Gas, and Mining and... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Approval of Utah regulatory program amendments..., DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE UTAH § 944...

  15. A pilot outreach program for small quantity generators of hazardous waste.

    PubMed Central

    Brown, M S; Kelley, B G; Gutensohn, J

    1988-01-01

    The Massachusetts Department of Environmental Management initiated a pilot project to improve compliance with hazardous waste regulations and management of hazardous wastes with auto body shops around the state. The program consisted of mass mailings, a series of workshops throughout the state, a coordinated inspection program by the state regulatory agency, and technology transfer. At the start of the program in January 1986, approximately 650 of the estimated 2,350 auto body shops in the state had notified EPA of their waste generating activities; by January 1987, approximately 1,200 shops had done so. Suggestions for improving program efforts include tailoring the outreach effort to the industry, government-sponsored research and development directed at the needs of small firms, mandatory participation in hazardous waste transportation programs, and better coordination by EPA of its information collection and distribution program. PMID:3421393

  16. Long-Term Farm Policy to Succeed the Agriculture and Food Act of 1981 (Research, Extension, and Teaching). Part 5. Hearings before the Subcommittee on Departmental Operations, Research, and Foreign Agriculture of the Committee on Agriculture, House of Representatives, Ninety-Eighth Congress, Second Session (June 6, 7, 12, and 13, 1984).

    ERIC Educational Resources Information Center

    Congress of the U.S., Washington, DC. House Committee on Agriculture.

    This congressional hearing is the fifth of five volumes examining various aspects of agricultural research, extension, and teaching as a prelude to determining what changes are to be made in Title XIV of the farm bill. Focuses are the U.S. Department of Agriculture (USDA) biotechnology program plans and regulatory concerns and the public benefits…

  17. 40 CFR 73.86 - State regulatory autonomy.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State regulatory autonomy. 73.86 Section 73.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... regulatory autonomy. Nothing in this subpart shall preclude a State or State regulatory authority from...

  18. Contact Us - Division of Mining, Land, and Water

    Science.gov Websites

    Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land Coal Regulatory Program 550 W. 7th Ave., Suite 900D Anchorage, AK 99501-3577 Phone: (907) 269-8650 Fax

  19. Regulatory Aspects Of Implementing Electrokinetic Remediation

    EPA Science Inventory

    A better understanding of the environmental impact of hazardous waste management practices has led to new environmental laws and a comprehensive regulatory program. This program is designed to address remediation of past waste management practices and to ensure that the hazardou...

  20. 75 FR 79049 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

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

  1. 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

  2. 76 FR 79231 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... Extend the Penny Pilot Program December 15, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange... Chapter V, Section 33 (Penny Pilot Program) of the Rules of the Boston Options Exchange Group, LLC (``BOX... penny increments on BOX (``Penny Pilot Program''). II. Self-Regulatory Organization's Statement of the...

  3. 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...

  4. 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.

  5. REFINE WETLAND REGULATORY PROGRAM

    EPA Science Inventory

    The Tribes will work toward refining a regulatory program by taking a draft wetland conservation code with permitting incorporated to TEB for review. Progress will then proceed in developing a permit tracking system that will track both Tribal and fee land sites within reservati...

  6. Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

    PubMed

    Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

    2014-08-01

    The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

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

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2008-01-01

    NASA's Agency-wide.resource for identifying and managing risks associated with changing environmental regulations Goals of the RRAC PC: 1) Proactively. detect, analyze and communicate environmental regulatory risks to NASA Programs and facilities; 2) Communicate with regulators and participate in the mitigation of such risks; and 3) Provide centralized support on emerging regulations to NASA HQ Environmental Management Division. When significant regulatory changes are identified, timely communication is essential. Communication of changing requirements to the regulatory stakeholders - NASA Programs and Facilities. Communication of potential issues to management and, when appropriate, back to the regulating agency.

  8. 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

  9. 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.

  10. Peer support in anesthesia: turning war stories into wellness.

    PubMed

    Vinson, Amy E; Randel, Gail

    2018-06-01

    Peer support, a method of providing for the well being of healthcare providers following adverse or stressful events, is garnering increased attention in light of the increased prevalence and awareness of burnout, depression and suicidality in physicians. In this review, we will summarize the evolution of the 'second victim,' explore methods of support and examine how new regulatory requirements are changing the peer support landscape. As peer support and the second victim are investigated more, themes are emerging regarding the natural history of recovery. As these are delineated, more targeted peer support models are being developed. One major change in 2017 is the institution of new Accreditation Council for Graduate Medical Education's Common Program Requirements, now including topics targeted on well being. Effective and accessible peer support is developing in many departments nationwide and can only be expected to continue, given new regulatory requirements. As these programs develop, and research on their effect continues, best practices will likely emerge.

  11. ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH

    Cancer.gov

    ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH, designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices.

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

    INSTRUMENTATION DIVISION STAFF

    To develop state-of-the-art instrumentation required for experimental research programs at BNL, and to maintain the expertise and facilities in specialized high technology areas essential for this work. Development of facilities is motivated by present BNL research programs and anticipated future directions of BNL research. The Division's research efforts also have a significant impact on programs throughout the world that rely on state-of-the-art radiation detectors and readout electronics. Our staff scientists are encouraged to: Become involved in challenging problems in collaborations with other scientists; Offer unique expertise in solving problems; and Develop new devices and instruments when not commercially available. Scientistsmore » from other BNL Departments are encouraged to bring problems and ideas directly to the Division staff members with the appropriate expertise. Division staff is encouraged to become involved with research problems in other Departments to advance the application of new ideas in instrumentation. The Division Head integrates these efforts when they evolve into larger projects, within available staff and budget resources, and defines the priorities and direction with concurrence of appropriate Laboratory program leaders. The Division Head also ensures that these efforts are accompanied by strict adherence to all ES and H regulatory mandates and policies of the Laboratory. The responsibility for safety and environmental protection is integrated with supervision of particular facilities and conduct of operations.« less

  13. Children and Violence: The Role of Children’s Regulation in the Marital Aggression–Child Adjustment Link

    PubMed Central

    Cummings, E. Mark; El-Sheikh, Mona; Kouros, Chrystyna D.; Buckhalt, Joseph A.

    2010-01-01

    Exposure to marital psychological and physical abuse has been established as a risk factor for children’s socio-emotional, behavioral, and cognitive problems. Understanding the processes by which children develop symptoms of psychopathology and deficits in cognitive functioning in the context of marital aggression is imperative for developing efficient and effective treatment programs for children and families, and has far-reaching mental health implications. The present paper outlines our research program, Child Regulation and Exposure to Marital Aggression, which focuses on children’s emotional and physiological reactivity and regulation as pathways in the marital aggression–child development link. Findings from our research program, which highlight the importance of children’s regulatory processes for understanding children’s adjustment in contexts of intimate partner violence, are presented, and future directions in this line of inquiry are outlined. PMID:19247833

  14. 78 FR 13002 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938... Mining Reclamation and Enforcement (``OSM''), Interior. ACTION: Proposed rule; public comment period and... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or the ``Act...

  15. 75 FR 21889 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ...--Resetting Fixed Interest Rate 3245-AG03 286 504 Program Governance Regulations 3245-AG04 287 Small Business...). It also conforms SBA rules for the section 7(a) Business Loan Program and the Certified Development... Part XVI Small Business Administration ###Semiannual Regulatory Agenda### [[Page 21890

  16. 75 FR 35508 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

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

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

    PubMed

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

    2016-05-01

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

  18. Low-rank coal study: national needs for resource development. Volume 6. Peat

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

    Not Available

    1980-11-01

    The requirements and potential for development of US peat resources for energy use are reviewed. Factors analyzed include the occurrence and properties of major peat deposits; technologies for extraction, dewatering, preparation, combustion, and conversion of peat to solid, liquid, or gaseous fuels; environmental, regulatory, and market constraints; and research, development, and demonstration (RD and D) needs. Based on a review of existing research efforts, recommendations are made for a comprehensive national RD and D program to enhance the use of peat as an energy source.

  19. Summary of the National Toxicology Program benzidine dye initiative.

    PubMed Central

    Morgan, D L; Dunnick, J K; Goehl, T; Jokinen, M P; Matthews, H B; Zeiger, E; Mennear, J H

    1994-01-01

    The benzidine dye initiative is a research program established by the National Toxicology Program to generate an integrated body of scientific information regarding the potential health risks associated with exposure to benzidine- and benzidine-congener-derived dyes. Because an in-depth evaluation of each of the hundreds of benzidine-congener-derived dyes was considered impractical, the research program was designed to study the metabolism and disposition, genetic toxicity, and in vivo toxicity and carcinogenicity of two primary benzidine congeners, 3,3'-dimethylbenzidine and 3,3'-dimethoxybenzidine, and a select group of prototypical dyes derived from those amines. It was anticipated that by applying the basic information generated in these extensive studies, it would be possible to make regulatory decisions about other dyes after conducting only a minimal number of experiments such as studies of disposition and metabolism, and in vitro mutagenicity. This paper summarizes the results of studies conducted to evaluate the metabolism, disposition, mutagenicity, toxicity, and carcinogenicity of representative benzidine congeners and derived dyes. PMID:7925189

  20. 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

  1. 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.

  2. 7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 15 2013-01-01 2013-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

  3. 7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 15 2014-01-01 2014-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

  4. 7 CFR 4284.906 - State laws, local laws, regulatory commission regulations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 15 2012-01-01 2012-01-01 false State laws, local laws, regulatory commission...-Added Producer Grant Program General § 4284.906 State laws, local laws, regulatory commission regulations. If there are conflicts between this subpart and State or local laws or regulatory commission...

  5. 13 CFR 108.585 - Voluntary decrease in NMVC Company's Regulatory Capital.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...'s Regulatory Capital. 108.585 Section 108.585 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Managing the Operations of a NMVC Company Voluntary Decrease in Regulatory Capital § 108.585 Voluntary decrease in NMVC Company's Regulatory Capital. You must...

  6. [Programmed necrosis mediated by receptor-interacting protein 3: a new target for liver disease research].

    PubMed

    Zhang, J; Jing, Y; Li, Y N; Zhou, L; Wang, B M

    2016-09-20

    Hepatocyte death mainly includes apoptosis and necrosis and is a critical process in the pathophysiological mechanism of liver injury caused by various reasons. Recent studies have shown that key regulatory molecules in the inhibition of apoptosis such as caspase cannot be used as targets for inhibiting disease progression in clinical practice. In recent years, programmed necrosis mediated by receptor-interacting protein 3(RIP3)becomes a new hot research topic. It not only plays an important role in inducing inflammatory response, but also is closely regulated by intracellular signal factors, and it is a type of active cell death which can be interfered with. Compared with apoptosis, programmed necrosis is accompanied by the release of various inflammatory factors, which significantly affects local immune microenvironment. RIP3-mediated programmed necrosis has been taken seriously in many diseases. Although its mechanism of action in liver disease remains unclear, the results of recent studies confirmed its important role in the development of liver disease. This article reviews the research advances in the role of RIP3-mediated programmed necrosis signaling pathway in liver disease of various causes and investigates the possibility of RIP3-mediated programmed necrosis as a new target in the treatment of liver disease.

  7. 78 FR 35056 - Effectiveness of the Reactor Oversight Process Baseline Inspection Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0125] Effectiveness of the Reactor Oversight Process... the effectiveness of the reactor oversight process (ROP) baseline inspection program with members of... Nuclear Reactor Regulations, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301...

  8. 76 FR 6587 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-159-FOR; OSM 2010-0017] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

  9. 76 FR 12849 - Kentucky Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... (underground mining). The text of the Kentucky regulations can be found in the administrative record and online... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 [KY-252-FOR; OSM-2009-0011] Kentucky Regulatory Program AGENCY: Office of Surface Mining Reclamation...

  10. 77 FR 46346 - Ohio Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [OH-254-FOR; Docket ID OSM-2012-0012] Ohio Regulatory Program AGENCY: Office of Surface Mining... under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Ohio's proposed...

  11. 76 FR 12920 - Pennsylvania Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-09

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 [PA-157-FOR; OSM 2010-0011] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). In response to a required...

  12. Nome Offshore Mining Information

    Science.gov Websites

    Lands Coal Regulatory Program Large Mine Permits Mineral Property and Rights Mining Index Land potential safety concerns, prevent overcrowding, and provide for efficient processing of the permits and Regulatory Program Large Mine Permitting Mineral Property Management Mining Fact Sheets Mining Forms APMA

  13. 75 FR 6404 - Regulatory Site Visit Training Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408) 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...

  14. 7 CFR 2.79 - Administrator, Agricultural Marketing Service.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 1 2014-01-01 2014-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

  15. 7 CFR 2.79 - Administrator, Agricultural Marketing Service.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 1 2012-01-01 2012-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

  16. 7 CFR 2.79 - Administrator, Agricultural Marketing Service.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

  17. 7 CFR 2.79 - Administrator, Agricultural Marketing Service.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Administrator, Agricultural Marketing Service. 2.79... for Marketing and Regulatory Programs § 2.79 Administrator, Agricultural Marketing Service. (a... following delegations of authority are made by the Under Secretary for Marketing and Regulatory Programs to...

  18. 76 FR 6589 - West Virginia Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 948 [WV-116-FOR; OSM-2009-0008] West Virginia Regulatory Program AGENCY: Office of Surface Mining... Mining Reclamation and Enforcement (OSM) characterized the change as non-substantive, and did not note...

  19. Study of the impacts of regulations affecting the acceptance of Integrated Community Energy Systems: public utility, energy facility siting and municipal franchising regulatory programs in Arizona. Preliminary background report

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

    Feurer, D.A.; Weaver, C.L.; Gallagher, K.C.

    1980-01-01

    This report is one of a series of preliminary reports describing the laws and regulatory programs of the United States and each of the 50 states affecting the siting and operation of energy generating facilities likely to be used in Integrated Community Energy Systems (ICES). Public utility regulatory statutes, energy facility siting programs, and municipal franchising authority are examined to identify how they may impact on the ability of an organization, whether or not it be a regulated utility, to construct and operate an ICES. This report describes laws and regulatory programs in Arizona. The Arizona state constitution establishes themore » Arizona Corporation Commission to regulate public service corporations. Within the area of its jurisdiction, the Commission has exclusive power and may not be interfered with by the legislature except in one narrow instance as described in the case Corporation Commission v. Pacific Greyhound Lines.« less

  20. Beyond regulatory compression: confronting the liminal spaces of health research regulation

    PubMed Central

    Taylor-Alexander, Samuel; Dove, Edward S.; Fletcher, Isabel; Ganguli Mitra, Agomoni; McMillan, Catriona; Laurie, Graeme

    2016-01-01

    ABSTRACT Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this ‘regulatory turn’ by drawing on the anthropological concept of liminality. We offer the term ‘regulatory compression’ to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the ‘in-between’, liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of ‘processual regulation’, a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation. PMID:28058061

  1. Quality Management Program

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

    Not Available

    1991-10-01

    According to {section} 35.32, Quality Management Program,'' of 10 CFR Part 35, Medical Use of Byproduct Material,'' applicants or licensees, as applicable, are required to establish a quality management (QM) program. This regulatory guide provides guidance to licensees and applicants for developing policies and procedures for the QM program. This guide does not restrict or limit the licensee from using other guidance that may be equally useful in developing a QM program, e.g., information available from the Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology. Any information collection activities mentioned in this regulatory guide aremore » contained as requirements in 10 CFR Part 35, which provides the regulatory basis for this guide. This information collection requirements in 10 CFR Part 35 have been cleared under OMB Clearance No. 3150-0010.« less

  2. Implementation of a commercial-grade dedication program - Benefits and lessons learned

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

    Harrington, M.; MacFarlane, I.

    1991-01-01

    The recent issuance of industry guidelines, the Nuclear Management and Resources Council procurement initiative, and a US Nuclear Regulatory Commission NRC generic letter on commercial-grade item dedication (CGD) has been viewed by many utility managers and executives as only adding to the existing burden of compliance with regulatory requirements. While the incorporation of these documents into existing CGD programs has created additional costs, the resulting enhanced dedication programs have also produced benefits beyond regulatory compliance, and some lessons have been learned. This paper discusses the benefits and the lessons learned during implementation of an enhanced CGD program at New Hampshiremore » Yankee's (NHY's) Seabrook nuclear plant. Based on NHY's experience, it is believed that the benefits described in this paper can be realized by other utilities implementing CGD programs.« less

  3. Contributions of acid rain research to the forest science-policy interface: learning from the national acid precipitation assessment program.

    Treesearch

    Charles E. Peterson; David S. Shriner

    2004-01-01

    During the 1970s, there was growing concern by scientists, policy officials and the general public in the USA over the possible effects of acid rain on human health and the environment (crops, forests, water, etc.). The lack of science-based information needed for policy and regulatory decisions led Congress to create an interagency task force in 1980 called the...

  4. Genetic toxicology in the 21st century: Reflections and future ...

    EPA Pesticide Factsheets

    A symposium at the 40th anniversary of the Environmental Mutagen Society, held from October 24–28, 2009 in St. Louis, MO, surveyed the current status and future directions of genetic toxicology. This article summarizes the presentations and provides a perspective on the future. An abbreviated history is presented, highlighting the current standard battery of genotoxicity assays and persistent challenges. Application of computational toxicology to safety testing within a regulatory setting is discussed as a means for reducing the need for animal testing and human clinical trials, and current approaches and applications of in silico genotoxicity screening approaches across the pharmaceutical industry were surveyed and are reported here. The expanded use of toxicogenomics to illuminate mechanisms and bridge genotoxicity and carcinogenicity, and new public efforts to use high-throughput screening technologies to address lack of toxicity evaluation for the backlog of thousands of industrial chemicals in the environment are detailed. The Tox21 project involves coordinated efforts of four U.S. Government regulatory/research entities to use new and innovative assays to characterize key steps in toxicity pathways, including genotoxic and nongenotoxic mechanisms for carcinogenesis. Progress to date, highlighting preliminary test results from the National Toxicology Program is summarized. Finally, an overview is presented of ToxCast™, a related research program of the

  5. 76 FR 64043 - Iowa 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 915 [Docket No. IA-016-FOR; Docket ID: OSM-2011-0014] Iowa Regulatory Program AGENCY: Office of Surface Mining.... SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a...

  6. 78 FR 63909 - Missouri 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 925... 08011000 SX066A00033 F13XS501520] Missouri Regulatory Program AGENCY: Office of Surface Mining Reclamation... hearing on proposed amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM...

  7. 32 CFR 300.2 - DLA FOIA regulatory precedence.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 2 2014-07-01 2014-07-01 false DLA FOIA regulatory precedence. 300.2 Section 300.2 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) FREEDOM OF INFORMATION ACT PROGRAM DEFENSE LOGISTICS AGENCY FREEDOM OF INFORMATION ACT PROGRAM General...

  8. 10 CFR 4.510 - Self-evaluation.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Self-evaluation. 4.510 Section 4.510 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission § 4.510 Self-evaluation. (a) The...

  9. 76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... NRC staff's evaluation of the suitability of using Revision 3 of the Nuclear Energy Institute's (NEI... NUCLEAR REGULATORY COMMISSION [NRC-2011-0228] Interim Staff Guidance on Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance...

  10. 3 CFR 13579 - Executive Order 13579 of July 11, 2011. Regulation and Independent Regulatory Agencies

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., streamline, expand, or repeal them in accordance with what has been learned. Such retrospective analyses... agency's regulatory program more effective or less burdensome in achieving the regulatory objectives. Sec...

  11. International Piping Integrity Research Group (IPIRG) Program. Final report

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

    Wilkowski, G.; Schmidt, R.; Scott, P.

    1997-06-01

    This is the final report of the International Piping Integrity Research Group (IPIRG) Program. The IPIRG Program was an international group program managed by the U.S. Nuclear Regulatory Commission and funded by a consortium of organizations from nine nations: Canada, France, Italy, Japan, Sweden, Switzerland, Taiwan, the United Kingdom, and the United States. The program objective was to develop data needed to verify engineering methods for assessing the integrity of circumferentially-cracked nuclear power plant piping. The primary focus was an experimental task that investigated the behavior of circumferentially flawed piping systems subjected to high-rate loadings typical of seismic events. Tomore » accomplish these objectives a pipe system fabricated as an expansion loop with over 30 meters of 16-inch diameter pipe and five long radius elbows was constructed. Five dynamic, cyclic, flawed piping experiments were conducted using this facility. This report: (1) provides background information on leak-before-break and flaw evaluation procedures for piping, (2) summarizes technical results of the program, (3) gives a relatively detailed assessment of the results from the pipe fracture experiments and complementary analyses, and (4) summarizes advances in the state-of-the-art of pipe fracture technology resulting from the IPIRG program.« less

  12. [Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

    PubMed

    Sato, Yoji

    2014-01-01

    In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

  13. 77 FR 9273 - WORKSHOP Sponsored by the Nuclear Regulatory Commission and the Electric Power Research Institute...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-16

    ... Commission and the Electric Power Research Institute on the Treatment of Probabilistic Risk Assessment.... SUMMARY: The U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research (RES), in cooperation with the Electric Power Research Institute (EPRI), will hold a joint workshop on the Treatment of...

  14. Small grant management in health and behavioral sciences: Lessons learned.

    PubMed

    Sakraida, Teresa J; D'Amico, Jessica; Thibault, Erica

    2010-08-01

    This article describes considerations in health and behavioral sciences small grant management and describes lessons learned during post-award implementation. Using the components by W. Sahlman [Sahlman, W. (1997). How to write a great business plan. Harvard Business Review, 75(4), 98-108] as a business framework, a plan was developed that included (a) building relationships with people in the research program and with external parties providing key resources, (b) establishing a perspective of opportunity for research advancement, (c) identifying the larger context of scientific culture and regulatory environment, and (d) anticipating problems with a flexible response and rewarding teamwork. Small grant management included developing a day-to-day system, building a grant/study program development plan, and initiating a marketing plan. Copyright 2010 Elsevier Inc. All rights reserved.

  15. "Going the Extra Mile in Downscaling: Why Downscaling is not ...

    EPA Pesticide Factsheets

    This presentation provides an example of doing additional work for preprocessing global climate model data for use in regional climate modeling simulations with the Weather Research and Forecasting (WRF) model. In this presentation, results from 15 months of downscaling the Community Earth System Model (CESM) were shown, both using the out-of-the-box downscaling of CESM and also with a modification to setting the inland lake temperatures. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  16. Accountability Studies on Air Pollution and Health: the HEI Experience.

    PubMed

    Boogaard, Hanna; van Erp, Annemoon M; Walker, Katherine D; Shaikh, Rashid

    2017-12-01

    Assessing health effects of air quality interventions is of ever-increasing interest. Given the prominent role Health Effects Institute (HEI) has played in accountability research, this review focuses on HEI's recent experiences, the challenges it has encountered, and provides possible directions for future research. Most accountability studies to date have focused on effects of relatively short-term, local-scale, and sometimes temporary interventions. Only a few recent accountability studies have sought to investigate large-scale, multiyear regulatory programs. Common challenges encountered include lack of statistical power, how to account appropriately for background trends in air quality and health, and difficulties in direct attribution of changes in air pollution and health to a single intervention among many regulatory actions. New methods have been developed for accountability research that has shown promise addressing some of those challenges, including use of causal inference methods. These and other approaches that would enhance the attribution of changes in air quality and health directly to an intervention should continue to be further explored. In addition, integration of social and behavioral sciences in accountability research is warranted, and climate related co-benefits and dis-benefits may be considered.

  17. Regulating chemical hazards in Japan, West Germany, France, the United Kingdom, and the European community: a comparative examination. Final report

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

    Coppock, R.

    This report is an outgrowth of a National Research Council program initiative to gain a cross-national perspective on the role scientific information has played in hazardous chemical regulation. Although this study is not meant to be evaluative, it is designed to help assess by comparison the decision-making and regulatory mechanisms in U.S. hazard assessment. The chapters on the individual countries are divided into three components: (1) relevant political and administrative traditions that influence expectations about and mechanisms of hazard regulation; (2) a compilation of the relevant statuatory instruments; and (3) the scope of the regulatory jurisdiction. The last category dividesmore » the laws into those which govern industrial plants, emmissions and discharges, worker protection, industrial substances, poisons, agricultural chemicals, food additives, and contaminants, consumer products, transport, chemical waste, and victim compensation. The study concludes with a discussion of ways in which such multinational perspectives might be used to strengthen the regulatory process of the U.S.« less

  18. Biomass Burning Emissions – The Importance of Reducing Uncertainties for Improved Regulatory Decision; an EPA Perspective

    EPA Science Inventory

    Biomass burning emissions from wildland and prescribed fires can have far reaching impacts in several of EPA’s regulatory programs under the Clean Air Act, ultimately affecting decisions on actions taken under State Implementation Plans (SIPs), and programs such as Visibility and...

  19. 77 FR 73966 - Utah Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 [SATS No. UT-049-FOR; Docket ID OSM-2012-0015] Utah Regulatory Program AGENCY: Office of Surface Mining... Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Utah proposes to revise references to...

  20. 76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ...: This document announces the Agricultural Marketing Service's (AMS) plans to review the National Organic... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-11-0005; NOP-11-01] Regulatory Flexibility Act: Section 610 Review of National Organic Program...

  1. Communicating with "Neglected" Farmers on Regulatory Programs.

    ERIC Educational Resources Information Center

    Animal and Plant Health Inspection Service (USDA), Washington, DC.

    Workshop recommendations resulting from an Animal and Plant Health Service (APHS) Seminar on ways of reaching "neglected" farmers and enlisting their support for the APHS regulatory programs are provided. The "neglected" farmer is identified as those low-income/minority group marginal farmers who cannot be reached by ordinary means, e.g., poor…

  2. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  3. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  4. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  5. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  6. 10 CFR 4.541-4.548 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.541-4.548 Section 4.541-4.548 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.541-4.548 [Reserved] ...

  7. 10 CFR 4.552-4.559 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.552-4.559 Section 4.552-4.559 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.552-4.559 [Reserved] ...

  8. 10 CFR 4.504-4.509 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.504-4.509 Section 4.504-4.509 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.504-4.509 [Reserved] ...

  9. 10 CFR 4.531-4.539 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.531-4.539 Section 4.531-4.539 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.531-4.539 [Reserved] ...

  10. 10 CFR 4.561-4.569 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.561-4.569 Section 4.561-4.569 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.561-4.569 [Reserved] ...

  11. 10 CFR 4.512-4.529 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.512-4.529 Section 4.512-4.529 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.512-4.529 [Reserved] ...

  12. 10 CFR 4.571-4.999 - [Reserved

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false [Reserved] 4.571-4.999 Section 4.571-4.999 Energy NUCLEAR REGULATORY COMMISSION NONDISCRIMINATION IN FEDERALLY ASSISTED PROGRAMS OR ACTIVITIES RECEIVING FEDERAL... Programs or Activities Conducted by the U.S. Nuclear Regulatory Commission §§ 4.571-4.999 [Reserved] ...

  13. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  14. 75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation...

  15. 78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2003-N-0453] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug...

  16. 30 CFR 902.10 - State regulatory program approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  17. MULTI-MEDIA MICROBIOLOGICAL RISK ASSESSMENT METHODOLOGY FOR MUNICIPAL WASTEWATER SLUDGES

    EPA Science Inventory

    In order to reduce the risk of municipal sludge to acceptable levels, the U.S. EPA has undertaken a regulatory program based on risk assessment and risk management. The key to such a program is the development of a methodology which allows the regulatory agency to quantify the re...

  18. 78 FR 5726 - Nationwide Permit Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-28

    ... of Engineers Regulatory Home Page at http://www.usace.army.mil/Missions/CivilWorks/Regulatory... DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers 33 CFR Part 330 RIN 0710-AA60 Nationwide Permit Program AGENCY: U.S. Army Corps of Engineers, DoD. ACTION: Final rule. SUMMARY: The U.S...

  19. Workplace Wellness Programs: How Regulatory Flexibility Might Undermine Success

    PubMed Central

    2014-01-01

    The Patient Protection and Affordable Care Act revised the law related to workplace wellness programs, which have become part of the nation’s broader health strategy. Health-contingent programs are required to be reasonably designed. However, the regulatory requirements are lax and might undermine program efficacy in terms of both health gains and financial return. I propose a method for the government to support a best-practices approach by considering an accreditation or certification process. Additionally I discuss the need for program evaluation and the potential for employers to be subject to litigation if programs are not carefully implemented. PMID:25211713

  20. PAA, WSH, and CIS Overview Self-Study #47656

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

    Schroeder, Rachel Anne

    This course presents an overview of the Department of Energy’s (DOE’s) regulatory requirements relevant to the Price-Anderson Amendments Act (PAAA, also referred to as nuclear safety), worker safety and health (WSH), and classified information security (CIS) that are enforceable under the DOE enforcement program; describes the DOE enforcement process; and provides an overview of Los Alamos National Laboratory’s (LANL’s) internal compliance program relative to these DOE regulatory requirements. The LANL PAAA Program is responsible for maintaining LANL’s internal compliance program, which ensures the prompt identification, screening, and reporting of noncompliances to DOE regulatory requirements pertaining to nuclear safety, WSH, andmore » CIS to build the strongest mitigation position for the Laboratory with respect to civil or other penalties.« less

  1. Barriers to investigator-initiated deep brain stimulation and device research

    PubMed Central

    Malone, Donald; Okun, Michael S.; Booth, Joan; Machado, Andre G.

    2014-01-01

    The success of device-based research in the clinical neurosciences has overshadowed a critical and emerging problem in the biomedical research environment in the United States. Neuroprosthetic devices, such as deep brain stimulation (DBS), have been shown in humans to be promising technologies for scientific exploration of neural pathways and as powerful treatments. Large device companies have, over the past several decades, funded and developed major research programs. However, both the structure of clinical trial funding and the current regulation of device research threaten investigator-initiated efforts in neurologic disorders. The current atmosphere dissuades clinical investigators from pursuing formal and prospective research with novel devices or novel indications. We review our experience in conducting a federally funded, investigator-initiated, device-based clinical trial that utilized DBS for thalamic pain syndrome. We also explore barriers that clinical investigators face in conducting device-based clinical trials, particularly in early-stage studies or small disease populations. We discuss 5 specific areas for potential reform and integration: (1) alternative pathways for device approval; (2) eliminating right of reference requirements; (3) combining federal grant awards with regulatory approval; (4) consolidation of oversight for human subjects research; and (5) private insurance coverage for clinical trials. Careful reformulation of regulatory policy and funding mechanisms is critical for expanding investigator-initiated device research, which has great potential to benefit science, industry, and, most importantly, patients. PMID:24670888

  2. 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.

  3. Directed evolution of a synthetic phylogeny of programmable Trp repressors.

    PubMed

    Ellefson, Jared W; Ledbetter, Michael P; Ellington, Andrew D

    2018-04-01

    As synthetic regulatory programs expand in sophistication, an ever increasing number of biological components with predictable phenotypes is required. Regulators are often 'part mined' from a diverse, but uncharacterized, array of genomic sequences, often leading to idiosyncratic behavior. Here, we generate an entire synthetic phylogeny from the canonical allosteric transcription factor TrpR. Iterative rounds of positive and negative compartmentalized partnered replication (CPR) led to the exponential amplification of variants that responded with high affinity and specificity to halogenated tryptophan analogs and novel operator sites. Fourteen repressor variants were evolved with unique regulatory profiles across five operators and three ligands. The logic of individual repressors can be modularly programmed by creating heterodimeric fusions, resulting in single proteins that display logic functions, such as 'NAND'. Despite the evolutionarily limited regulatory role of TrpR, vast functional spaces exist around this highly conserved protein scaffold and can be harnessed to create synthetic regulatory programs.

  4. Air toxics regulatory issues facing urban settings.

    PubMed Central

    Olden, K; Guthrie, J

    1996-01-01

    Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of dose/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early waming signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies, both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. PMID:8933026

  5. 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

  6. 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

  7. Addressing challenges of training a new generation of clinician-innovators through an interdisciplinary medical technology design program: Bench-to-Bedside.

    PubMed

    Loftus, Patrick D; Elder, Craig T; D'Ambrosio, Troy; Langell, John T

    2015-01-01

    Graduate medical education has traditionally focused on training future physicians to be outstanding clinicians with basic and clinical science research skills. This focus has resulted in substantial knowledge gains, but a modest return on investment based on direct improvements in clinical care. In today's shifting healthcare landscape, a number of important challenges must be overcome to not only improve the delivery of healthcare, but to prepare future physicians to think outside the box, focus on and create healthcare innovations, and navigate the complex legal, business and regulatory hurdles of bringing innovation to the bedside. We created an interdisciplinary and experiential medical technology design competition to address these challenges and train medical students interested in moving new and innovative clinical solutions to the forefront of medicine. Medical students were partnered with business, law, design and engineering students to form interdisciplinary teams focused on developing solutions to unmet clinical needs. Over the course of six months teams were provided access to clinical and industry mentors, $500 prototyping funds, development facilities, and non-mandatory didactic lectures in ideation, design, intellectual property, FDA regulatory requirements, prototyping, market analysis, business plan development and capital acquisition. After four years of implementation, the program has supported 396 participants, seen the development of 91 novel medical devices, and launched the formation of 24 new companies. From our perspective, medical education programs that develop innovation training programs and shift incentives from purely traditional basic and clinical science research to also include high-risk innovation will see increased student engagement in improving healthcare delivery and an increase in the quality and quantity of innovative solutions to medical problems being brought to market.

  8. 75 FR 21899 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ....regulations.gov. FOR FURTHER INFORMATION CONTACT: Hada Flowers, Supervisor, Regulatory Secretariat Branch... Flexibility Analysis Required: Yes Agency Contact: Hada Flowers, Supervisor, Regulatory Secretariat, DOD/ GSA... Email: hada.flowers@gsa.gov RIN: 9000-AK92 301. FAR CASE 2006-005, HUBZONE PROGRAM REVISIONS Legal...

  9. Protecting workers and the environment: An environmental NGO's perspective on nanotechnology

    NASA Astrophysics Data System (ADS)

    Balbus, John M.; Florini, Karen; Denison, Richard A.; Walsh, Scott A.

    2007-01-01

    Nanotechnology, the design and manipulation of materials at the atomic scale, may well revolutionize many of the ways our society manufactures products, produces energy, and treats diseases. New materials based on nanotechnology are already reaching the market in a wide variety of consumer products. Some of the observed properties of nanomaterials call into question the adequacy of current methods for determining hazard and exposure and for controlling resulting risks. Given the limitations of existing regulatory tools and policies, we believe two distinct kinds of initiatives are needed: first, a major increase in the federal investment in nanomaterial risk research; second, rapid development and implementation of voluntary standards of care pending development of adequate regulatory safeguards in the longer term. Several voluntary programs are currently at various stages of evolution, though the eventual outputs of each of these are still far from clear. Ultimately, effective regulatory safeguards are necessary to provide a level playing field for industry while adequately protecting human health and the environment. This paper reviews the existing toxicological literature on nanomaterials, outlines and analyzes the current regulatory framework, and provides our recommendations, as an environmental non-profit organization, for safe nanotechnology development.

  10. Cyber security evaluation of II&C technologies

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

    Thomas, Ken

    The Light Water Reactor Sustainability (LWRS) Program is a research and development program sponsored by the Department of Energy, which is conducted in close collaboration with industry to provide the technical foundations for licensing and managing the long-term, safe and economical operation of current nuclear power plants The LWRS Program serves to help the US nuclear industry adopt new technologies and engineering solutions that facilitate the continued safe operation of the plants and extension of the current operating licenses. Within the LWRS Program, the Advanced Instrumentation, Information, and Control (II&C) Systems Technologies Pathway conducts targeted research and development (R&D) tomore » address aging and reliability concerns with the legacy instrumentation and control and related information systems of the U.S. operating light water reactor (LWR) fleet. The II&C Pathway is conducted by Idaho National Laboratory (INL). Cyber security is a common concern among nuclear utilities and other nuclear industry stakeholders regarding the digital technologies that are being developed under this program. This concern extends to the point of calling into question whether these types of technologies could ever be deployed in nuclear plants given the possibility that the information in them can be compromised and the technologies themselves can potentially be exploited to serve as attack vectors for adversaries. To this end, a cyber security evaluation has been conducted of these technologies to determine whether they constitute a threat beyond what the nuclear plants already manage within their regulatory-required cyber security programs. Specifically, the evaluation is based on NEI 08-09, which is the industry’s template for cyber security programs and evaluations, accepted by the Nuclear Regulatory Commission (NRC) as responsive to the requirements of the nuclear power plant cyber security regulation found in 10 CFR 73.54. The evaluation was conducted by a cyber security team with expertise in nuclear utility cyber security programs and experience in conducting these evaluations. The evaluation has determined that, for the most part, cyber security will not be a limiting factor in the application of these technologies to nuclear power plant applications.« less

  11. Review of the Environmental Protection Agency’s Common Sense Initiative (The National Shipbuilding Research Program)

    DTIC Science & Technology

    1996-03-01

    Falls Church, VA 22042 Robert Yancey Jr., President Aahland Petroleum P.O. Box 391 Ashland KY 41114 ROSTER - PRINTING SECTOR SUBCOMMlTTEE, CSI Co...Regulatory Initiative Project Workgroup ChaiR: Rick Johns Statement of Project Objective: To explore auto specific concerns with the Title V...and Recycling Workgroup Chair: Rick Reibstein, Massachusetts OTA Solving the “Obscure Policy” Problem Statement of Project or Activity Objective: TO

  12. 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

  13. 78 FR 66671 - Oklahoma Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 936...; S2D2SSS08011000SX066A00033F13XS501520] Oklahoma Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement... amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing...

  14. 78 FR 73912 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

    ... Rule Change To Extend the Pilot Program That Eliminated the Position and Exercise Limits for Options on... amend its rules to extend the pilot program that eliminated position and exercise limits for physically..., because not all self- regulatory organizations (``SROs'') have adopted similar rules eliminating position...

  15. 75 FR 71473 - Self-Regulatory Organizations; the Depository Trust Company; Notice of Filing of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... the Requirement To Maintain a Balance Certificate in the Fast Automated Securities Transfer Program... custody a balance certificate. II. Self-Regulatory Organization's Statement of the Purpose of, and... Proposed Rule Change Under DTC's FAST program, DTC leaves securities in the form of balance certificates in...

  16. 75 FR 7641 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing of Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... Fast Automated Securities Transfer Program February 5, 2010. Pursuant to Section 19(b)(1) of the... American Depositary Receipts (``ADRs'') that are a part of DTC's Fast Automated Securities Transfer Program (``FAST''). II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the...

  17. BioTapestry now provides a web application and improved drawing and layout tools

    PubMed Central

    Paquette, Suzanne M.; Leinonen, Kalle; Longabaugh, William J.R.

    2016-01-01

    Gene regulatory networks (GRNs) control embryonic development, and to understand this process in depth, researchers need to have a detailed understanding of both the network architecture and its dynamic evolution over time and space. Interactive visualization tools better enable researchers to conceptualize, understand, and share GRN models. BioTapestry is an established application designed to fill this role, and recent enhancements released in Versions 6 and 7 have targeted two major facets of the program. First, we introduced significant improvements for network drawing and automatic layout that have now made it much easier for the user to create larger, more organized network drawings. Second, we revised the program architecture so it could continue to support the current Java desktop Editor program, while introducing a new BioTapestry GRN Viewer that runs as a JavaScript web application in a browser. We have deployed a number of GRN models using this new web application. These improvements will ensure that BioTapestry remains viable as a research tool in the face of the continuing evolution of web technologies, and as our understanding of GRN models grows. PMID:27134726

  18. BioTapestry now provides a web application and improved drawing and layout tools.

    PubMed

    Paquette, Suzanne M; Leinonen, Kalle; Longabaugh, William J R

    2016-01-01

    Gene regulatory networks (GRNs) control embryonic development, and to understand this process in depth, researchers need to have a detailed understanding of both the network architecture and its dynamic evolution over time and space. Interactive visualization tools better enable researchers to conceptualize, understand, and share GRN models. BioTapestry is an established application designed to fill this role, and recent enhancements released in Versions 6 and 7 have targeted two major facets of the program. First, we introduced significant improvements for network drawing and automatic layout that have now made it much easier for the user to create larger, more organized network drawings. Second, we revised the program architecture so it could continue to support the current Java desktop Editor program, while introducing a new BioTapestry GRN Viewer that runs as a JavaScript web application in a browser. We have deployed a number of GRN models using this new web application. These improvements will ensure that BioTapestry remains viable as a research tool in the face of the continuing evolution of web technologies, and as our understanding of GRN models grows.

  19. 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

  20. New Jersey state information handbook: Formerly Utilized Sites Remedial Action Program

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

    None

    Under the implied authority of the Atomic Energy Act of 1954, as amended, radiological surveys and research work has been conducted to determine radiological conditions at former MED/AEC sites. As of this time, 31 sites in 13 states have been identified that require or may require remedial action. This volume is one of a series produced under contract with DOE, Office of Nuclear Waste Management, by POLITECH CORPORATION to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Remedial Action Program. This Information Handbook seriesmore » contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the state of New Jersey. It contains: a description of the state executive branch structure; a summary of relevant state statutes and regulations; a description of the structure of the state legislature, identification of the officers and committee chairmen, and a summary of recent relevant legislative action; and the full text of relevant statutes and regulations. The loose-leaf format used in these volumes will allow the material to be updated periodically as the Remedial Action Program progresses.« less

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

    Sattison, M.B.; Thatcher, T.A.; Knudsen, J.K.

    The US Nuclear Regulatory Commission (NRC) has been using full-power. Level 1, limited-scope risk models for the Accident Sequence Precursor (ASP) program for over fifteen years. These models have evolved and matured over the years, as have probabilistic risk assessment (PRA) and computer technologies. Significant upgrading activities have been undertaken over the past three years, with involvement from the Offices of Nuclear Reactor Regulation (NRR), Analysis and Evaluation of Operational Data (AEOD), and Nuclear Regulatory Research (RES), and several national laboratories. Part of these activities was an RES-sponsored feasibility study investigating the ability to extend the ASP models to includemore » contributors to core damage from events initiated with the reactor at low power or shutdown (LP/SD), both internal events and external events. This paper presents only the LP/SD internal event modeling efforts.« less

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

    PubMed

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

    2017-01-01

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

  3. Regulatory logic of pan-neuronal gene expression in C. elegans

    PubMed Central

    Stefanakis, Nikolaos; Carrera, Ines; Hobert, Oliver

    2015-01-01

    While neuronal cell types display an astounding degree of phenotypic diversity, most if not all neuron types share a core panel of terminal features. However, little is known about how pan-neuronal expression patterns are genetically programmed. Through an extensive analysis of the cis-regulatory control regions of a battery of pan-neuronal C.elegans genes, including genes involved in synaptic vesicle biology and neuropeptide signaling, we define a common organizational principle in the regulation of pan-neuronal genes in the form of a surprisingly complex array of seemingly redundant, parallel-acting cis-regulatory modules that direct expression to broad, overlapping domains throughout the nervous system. These parallel-acting cis-regulatory modules are responsive to a multitude of distinct trans-acting factors. Neuronal gene expression programs therefore fall into two fundamentally distinct classes. Neuron type-specific genes are generally controlled by discrete and non-redundantly acting regulatory inputs, while pan-neuronal gene expression is controlled by diverse, coincident and seemingly redundant regulatory inputs. PMID:26291158

  4. T-Reg Comparator: an analysis tool for the comparison of position weight matrices

    PubMed Central

    Roepcke, Stefan; Grossmann, Steffen; Rahmann, Sven; Vingron, Martin

    2005-01-01

    T-Reg Comparator is a novel software tool designed to support research into transcriptional regulation. Sequence motifs representing transcription factor binding sites are usually encoded as position weight matrices. The user inputs a set of such weight matrices or binding site sequences and our program matches them against the T-Reg database, which is presently built on data from the Transfac [E. Wingender (2004) In Silico Biol., 4, 55–61] and Jaspar [A. Sandelin, W. Alkema, P. Engstrom, W. W. Wasserman and B. Lenhard (2004) Nucleic Acids Res., 32, D91–D94]. Our tool delivers a detailed report on similarities between user-supplied motifs and motifs in the database. Apart from simple one-to-one relationships, T-Reg Comparator is also able to detect similarities between submatrices. In addition, we provide a user interface to a program for sequence scanning with weight matrices. Typical areas of application for T-Reg Comparator are motif and regulatory module finding and annotation of regulatory genomic regions. T-Reg Comparator is available at . PMID:15980506

  5. T-Reg Comparator: an analysis tool for the comparison of position weight matrices.

    PubMed

    Roepcke, Stefan; Grossmann, Steffen; Rahmann, Sven; Vingron, Martin

    2005-07-01

    T-Reg Comparator is a novel software tool designed to support research into transcriptional regulation. Sequence motifs representing transcription factor binding sites are usually encoded as position weight matrices. The user inputs a set of such weight matrices or binding site sequences and our program matches them against the T-Reg database, which is presently built on data from the Transfac [E. Wingender (2004) In Silico Biol., 4, 55-61] and Jaspar [A. Sandelin, W. Alkema, P. Engstrom, W. W. Wasserman and B. Lenhard (2004) Nucleic Acids Res., 32, D91-D94]. Our tool delivers a detailed report on similarities between user-supplied motifs and motifs in the database. Apart from simple one-to-one relationships, T-Reg Comparator is also able to detect similarities between submatrices. In addition, we provide a user interface to a program for sequence scanning with weight matrices. Typical areas of application for T-Reg Comparator are motif and regulatory module finding and annotation of regulatory genomic regions. T-Reg Comparator is available at http://treg.molgen.mpg.de.

  6. Recent Progress and Development of Crystal Structure Analysis of Enzymes and Other Proteins

    NASA Astrophysics Data System (ADS)

    Tanokura, Masaru; Nagata, Koji; Miyazono, Ken-Ichi; Miyakawa, Takuya; Okai, Masahiko

    Structural biology has made tremendous progress in this decade. Here we briefly introduce the Target Proteins Research Program, a national project promoted by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan. The program aims to reveal the structure and function of proteins that are of great importance in both academic research and industrial application. We also summarize the results of structure-function analyses of (i) transcriptional regulatory proteins useful for the breading of drought and heat stress tolerant crops, (ii) useful enzymes for the production of chiral compounds, and (iii) useful enzymes for the degradation of environmental pollution substances. These results can be utilized in various areas of industries, to enhance food production, to improve the efficiency of pharmaceutical compound production, and to promote the bioremediation of contaminated soil and water.

  7. 77 FR 25872 - Oklahoma Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). None of the revisions that Oklahoma proposed to... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma...

  8. 78 FR 64255 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-28

    ... Amending Commentary .07 to Rule 904 To Extend the Pilot Program That Eliminated the Position Limits for... that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY'') (``SPY Pilot Program...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

  9. Regulatory Organizations and Their Requirements. MAS-113. Waste Isolation Division (WID). Management and Supervisor Training (MAST) Program.

    ERIC Educational Resources Information Center

    Westinghouse Electric Corp., Carlsbad, NM.

    This learning module, which is part of a management and supervisor training program for managers and supervisors employed at the Department of Energy's Waste Isolation Division, is designed to enable trainees to identify regulatory organizations and oversight groups and monitor and provide guidance in the implementation of the requirements of…

  10. 40 CFR 96.287 - Change in regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) NOX BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units § 96.287 Change in regulatory status. (a) Notification. If a CAIR SO2 opt-in unit becomes a CAIR SO2 unit under § 96.204, then the CAIR designated representative shall notify in writing...

  11. 77 FR 61462 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change Proposing a Pilot Program To... change to create and implement, on a pilot basis, a Lead Market Maker (``LMM'') Issuer Incentive Program...

  12. Identification and Comparison of Academic Self Regulatory Learning Strategy Use of Students Enrolled in Traditional and Accelerated Baccalaureate Degree Nursing Programs

    ERIC Educational Resources Information Center

    Mullen, Patricia A.

    2009-01-01

    Objective: To explore and compare the use of metacognitive, cognitive, and environmental resource management self regulatory learning (SRL) strategies used by a national sample of students enrolled in traditional and accelerated baccalaureate nursing programs. Background: Learner focused reforms in nursing education require students to assume more…

  13. 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...

  14. Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children's early self-regulation development: study protocol for a cluster randomized controlled trial.

    PubMed

    Howard, Steven J; Vasseleu, Elena; Neilsen-Hewett, Cathrine; Cliff, Ken

    2018-01-24

    For children with low self-regulation in the preschool years, the likelihood of poorer intellectual, health, wealth and anti-social outcomes in adulthood is overwhelming. Yet this knowledge has not yielded a framework for understanding self-regulatory change, nor generated particularly successful methods for enacting this change. Reconciling insights from cross-disciplinary theory, research and practice, this study seeks to implement a newly developed program of low-cost and routine practices and activities for supporting early self-regulatory development within preschool contexts and to evaluate its effect on children's self-regulation, executive function and school readiness; and educator perceived knowledge, attitudes and self-efficacy related to self-regulation. The Early Start to Self-Regulation study is a cluster randomized, controlled trial for evaluating benefits of the Preschool Situational Self-Regulation Toolkit (PRSIST) program, when implemented by early childhood educators, compared with routine practice. The PRSIST program combines professional learning, adult practices, child activities and connections to the home to support children's self-regulation development. Fifty preschool centers in New South Wales, Australia, will be selected to ensure a range of characteristics, namely: National Quality Standards (NQS) ratings, geographic location and socioeconomic status. After collection of baseline child and educator data, participating centers will then be randomly allocated to one of two groups, stratified by NQS rating: (1) an intervention group (25 centers) that will implement the PRSIST program; or (2) a control group (25 centers) that will continue to engage in practice as usual. Primary outcomes at the child level will be two measures of self-regulation: Head-Toes-Knees-Shoulders task and the PRSIST observational assessment. Secondary outcomes at the child level will be adult-reported measures of child self-regulation, executive function and school readiness. Outcomes at the educator level will involve a survey of their perceived knowledge, attitudes and self-efficacy for supporting children's self-regulatory development. In all cases, data collectors will be blinded to group allocation. This is the first randomized controlled trial of a new program to foster early self-regulation, using low-cost practices and activities that are aligned with early-years contexts, routines and practices. Results will provide important information about the efficacy of this approach and evaluate its underlying model of self-regulatory change. Australian New Zealand Clinical Trials Registry, ACTRN12617001568303 . Registered on 21 November 2017.

  15. Energy use in the marine transportation industry: Task III. Efficiency improvements; Task IV. Industry future. Final report, Volume IV. [Projections for year 2000

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

    None

    1977-12-01

    Tasks III and IV measure the characteristics of potential research and development programs that could be applied to the maritime industry. It was necessary to identify potential operating scenarios for the maritime industry in the year 2000 and determine the energy consumption that would result given those scenarios. After the introductory chapter the operational, regulatory, and vessel-size scenarios for the year 2000 are developed in Chapter II. In Chapter III, future cargo flows and expected levels of energy use for the baseline 2000 projection are determined. In Chapter IV, the research and development programs are introduced into the future USmore » flag fleet and the energy-savings potential associated with each is determined. The first four appendices (A through D) describe each of the generic technologies. The fifth appendix (E) contains the baseline operating and cost parameters against which 15 program areas were evaluated. (MCW)« less

  16. Air Sensor Guidebook | Science Inventory | US EPA

    EPA Pesticide Factsheets

    This Air Sensor Guidebook has been developed by the U.S. EPA to assist those interested in potentially using lower cost air quality sensor technologies for air quality measurements. Its development was in direct response to a request for such a document following a recent scientific conference (Apps and Sensors for Air Pollution-2012). Low cost air quality sensors ($100-$2500) are now commercially available in a wide variety of designs and capabilities. This is an emerging technology area and one that is quickly evolving. Even so, their availability has resulted in questions from many as to how they might be used appropriately. This document attempts to provide useful information concerning some of those questions. 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 pol

  17. So, You Think You Have an Idea: A Practical Risk Reduction-Conceptual Model for Academic Translational Research

    PubMed Central

    Schwartz, John; Macomber, Christopher

    2017-01-01

    Translational research for new drugs, medical devices, and diagnostics encompasses aspects of both basic science and clinical research, requiring multidisciplinary skills and resources that are not all readily available in either a basic laboratory or clinical setting alone. We propose that, to be successful, “translational” research ought to be understood as a defined process from basic science through manufacturing, regulatory, clinical testing all the way to market. The authors outline a process which has worked well for them to identify and commercialize academic innovation. The academic environment places a high value on novelty and less value on whether, among other things, data are reproducible, scalable, reimbursable, or have commercial freedom to operate. In other words, when investors, strategic companies, or other later stage stakeholders evaluate academic efforts at translational research the relative lack of attention to clinical, regulatory, reimbursement, and manufacturing and intellectual property freedom to operate almost universally results in more questions and doubts about the potential of the proposed product, thereby inhibiting further interest. This contrasts with industry-based R&D, which often emphasizes manufacturing, regulatory and commercial factors. Academics do not so much choose to ignore those necessary and standard elements of translation development, but rather, they are not built into the culture or incentive structure of the university environment. Acknowledging and addressing this mismatch of approach and lack of common language in a systematic way facilitates a more effective “translation” handoffs of academic project concepts into meaningful clinical solutions help translational researchers more efficiently develop and progress new and better medical products which address validated needs. The authors provide an overview and framework for academic researchers to use which will help them define the elements of a market-driven translational program (1) problem identification and validation; (2) defining the conceptual model of disease; and (3) risk evaluation and mitigation strategies. PMID:28952508

  18. Strategies to overcome clinical, regulatory, and financial challenges in the implementation of personalized medicine.

    PubMed

    Tsimberidou, Apostolia M; Ringborg, Ulrik; Schilsky, Richard L

    2013-01-01

    This article highlights major developments over the last decade in personalized medicine in cancer. Emerging data from clinical studies demonstrate that the use of targeted agents in patients with targetable molecular aberrations improves clinical outcomes. Despite a surge of studies, however, significant gaps in knowledge remain, especially in identifying driver molecular aberrations in patients with multiple aberrations, understanding molecular networks that control carcinogenesis and metastasis, and most importantly, discovering effective targeted agents. Implementation of personalized medicine requires continued scientific and technological breakthroughs; standardization of tumor tissue acquisition and molecular testing; changes in oncology practice and regulatory standards for drug and device access and approval; modification of reimbursement policies by health care payers; and innovative ways to collect and analyze electronic patient information that are linked to prospective clinical registries and rapid learning systems. Informatics systems that integrate clinical, laboratory, radiologic, molecular, and economic data will improve clinical care and will provide infrastructure to enable clinical research. The initiative of the EurocanPlatform aims to overcome the challenges of implementing personalized medicine in Europe by sharing patients, biologic materials, and technological resources across borders. The EurocanPlatform establishes a complete translational cancer research program covering the drug development process and strengthening collaborations among academic centers, pharmaceutical companies, regulatory authorities, health technology assessment organizations, and health care systems. The CancerLinQ rapid learning system being developed by ASCO has the potential to revolutionize how all stakeholders in the cancer community assemble and use information obtained from patients treated in real-world settings to guide clinical practice, regulatory decisions, and health care payment policy.

  19. Proceedings of the IREAPS Technical Symposium (8th) held in Baltimore, Maryland on September 15-17, 1981 (The National Shipbuilding Research Program)

    DTIC Science & Technology

    1981-09-01

    comments to regulatory bodies as well as conducted independent studies to establish guidelines for use in the development of cost effective regulations. We...operational life of the respective ships. Several authors (10-14) studied the effect of hull roughness on changes in power requirements. A plot of increasing...SHIP PRODUCTION COMMITTEE FACILITIES AND ENVIRONMENTAL EFFECTS SURFACE PREPARATION AND COATINGS DESIGN/PRODUCTION INTEGRATION HUMAN RESOURCE

  20. RSAT 2018: regulatory sequence analysis tools 20th anniversary.

    PubMed

    Nguyen, Nga Thi Thuy; Contreras-Moreira, Bruno; Castro-Mondragon, Jaime A; Santana-Garcia, Walter; Ossio, Raul; Robles-Espinoza, Carla Daniela; Bahin, Mathieu; Collombet, Samuel; Vincens, Pierre; Thieffry, Denis; van Helden, Jacques; Medina-Rivera, Alejandra; Thomas-Chollier, Morgane

    2018-05-02

    RSAT (Regulatory Sequence Analysis Tools) is a suite of modular tools for the detection and the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, including from genome-wide datasets like ChIP-seq/ATAC-seq, (ii) motif scanning, (iii) motif analysis (quality assessment, comparisons and clustering), (iv) analysis of regulatory variations, (v) comparative genomics. Six public servers jointly support 10 000 genomes from all kingdoms. Six novel or refactored programs have been added since the 2015 NAR Web Software Issue, including updated programs to analyse regulatory variants (retrieve-variation-seq, variation-scan, convert-variations), along with tools to extract sequences from a list of coordinates (retrieve-seq-bed), to select motifs from motif collections (retrieve-matrix), and to extract orthologs based on Ensembl Compara (get-orthologs-compara). Three use cases illustrate the integration of new and refactored tools to the suite. This Anniversary update gives a 20-year perspective on the software suite. RSAT is well-documented and available through Web sites, SOAP/WSDL (Simple Object Access Protocol/Web Services Description Language) web services, virtual machines and stand-alone programs at http://www.rsat.eu/.

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

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

    NONE

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

  2. 77 FR 55877 - Initial Test Program of Condensate and Feedwater Systems for Light-Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

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

  3. 78 FR 55765 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Draft..., ``Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN-FIRE).'' In... integral part of NRC-approved fire protection programs. However, compensatory measures are not expected to...

  4. 78 FR 57319 - Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...-AB20 Children's Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; kidSAFE... proposed self-regulatory guidelines submitted by the kidSAFE Seal Program (``kidSAFE''), owned and operated... part of the SUPPLEMENTARY INFORMATION section below. Write ``kidSAFE Application for Safe Harbor...

  5. Cancer nanotechnology research in the United States and China: cooperation to promote innovation.

    PubMed

    Schneider, Julie A; Grodzinski, Piotr; Liang, Xing-Jie

    2011-01-01

    The application of nanotechnology to cancer research is a promising area for US-China cooperation. Cancer is a major public health burden in both countries, and progress in cancer nanotechnology research is increasing in several fields, including imaging, biomarker detection, and targeted drug delivery. The United States and China are international leaders in nanotechnology research, and have both launched national programs to support nanotechnology efforts in the recent past. The accelerating trend of co-authorship among US and Chinese nanotechnology researchers demonstrates that individual scientists already recognize the potential for cooperation, providing a strong platform for creating additional partnerships in pre-competitive research areas. Mechanisms that could help to enhance US-China cancer nanotechnology partnerships include: developing new programs for bi-directional training and exchange; convening workshops focused on specific scientific topics of high priority to both countries; and joint support of collaborative research projects by US and Chinese funders. In addition to the accelerating scientific progress, expanded cooperation will stimulate important dialog on regulatory, policy, and technical issues needed to lay the groundwork for US and Chinese scientists to move greater numbers of cancer nanotechnology applications into the clinic. Copyright © 2011 John Wiley & Sons, Inc.

  6. A Multi-step Transcriptional and Chromatin State Cascade Underlies Motor Neuron Programming from Embryonic Stem Cells.

    PubMed

    Velasco, Silvia; Ibrahim, Mahmoud M; Kakumanu, Akshay; Garipler, Görkem; Aydin, Begüm; Al-Sayegh, Mohamed Ahmed; Hirsekorn, Antje; Abdul-Rahman, Farah; Satija, Rahul; Ohler, Uwe; Mahony, Shaun; Mazzoni, Esteban O

    2017-02-02

    Direct cell programming via overexpression of transcription factors (TFs) aims to control cell fate with the degree of precision needed for clinical applications. However, the regulatory steps involved in successful terminal cell fate programming remain obscure. We have investigated the underlying mechanisms by looking at gene expression, chromatin states, and TF binding during the uniquely efficient Ngn2, Isl1, and Lhx3 motor neuron programming pathway. Our analysis reveals a highly dynamic process in which Ngn2 and the Isl1/Lhx3 pair initially engage distinct regulatory regions. Subsequently, Isl1/Lhx3 binding shifts from one set of targets to another, controlling regulatory region activity and gene expression as cell differentiation progresses. Binding of Isl1/Lhx3 to later motor neuron enhancers depends on the Ebf and Onecut TFs, which are induced by Ngn2 during the programming process. Thus, motor neuron programming is the product of two initially independent transcriptional modules that converge with a feedforward transcriptional logic. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. "Updates to Model Algorithms & Inputs for the Biogenic ...

    EPA Pesticide Factsheets

    We have developed new canopy emission algorithms and land use data for BEIS. Simulations with BEIS v3.4 and these updates in CMAQ v5.0.2 are compared these changes to the Model of Emissions of Gases and Aerosols from Nature (MEGAN) and evaluated the simulations against observations. This has resulted in improvements in model evaluations of modeled isoprene, NOx, and O3. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  8. "Total Deposition (TDEP) Maps" | Science Inventory | US EPA

    EPA Pesticide Factsheets

    The presentation provides an update on the use of a hybrid methodology that relies on measured values from national monitoring networks and modeled values from CMAQ to produce of maps of total deposition for use in critical loads and other ecological assessments. Additionally, comparisons of the deposition values from the hybrid approach are compared with deposition estimates from other methodologies. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air pollution problem, but also in developing emission control policies and regulations for air quality improvements.

  9. 78 FR 73911 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

    ... 3120 To Extend the Pilot Program That Eliminated the Position Limits for Options on SPDR S&P 500 ETF... extend the pilot program that eliminated the position limits for options on SPDR S&P 500 ETF (``SPY...- regulatory organizations (``SROs'') have adopted similar rules eliminating position limits on SPY and market...

  10. Motivational Regulatory Styles of Graduate Students Enrolled in Online Prescribed and Elective Courses

    ERIC Educational Resources Information Center

    Wasmanski, Stephanie Lynn

    2018-01-01

    The purpose of this study was to explore the regulatory styles, as identified in Ryan and Deci's Self-Determination Theory, of graduate students enrolled in prescribed and elective courses, in a fully online Master of Education degree program. A sample consisting of 53 participants, enrolled in a master's degree program in education at a state…

  11. 77 FR 38116 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-26

    ...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Proposing a Pilot Program To Create a Lead Market Maker Issuer Incentive Program for...'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to create and implement, on a pilot basis, a...

  12. [Introduction of Quality Management System Audit in Medical Device Single Audit Program].

    PubMed

    Wen, Jing; Xiao, Jiangyi; Wang, Aijun

    2018-01-30

    The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

  13. Progress Cleaning the Air: Voluntary Partnership Program Accomplishments

    EPA Pesticide Factsheets

    EPA voluntary clean air partnership programs work in tandem with regulatory programs to protect public health and the environment. This page highlights accomplishments of selected partnership programs.

  14. Summary of DOE/PERF water program review.

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

    Veil, J.; Gasper, J.; Puder, M.

    2006-01-31

    For many years, the U.S. Department of Energy (DOE) has supported and sponsored various types of water research relating to the oil and gas industry through its Office of Fossil Energy and its National Energy Technology Laboratory (NETL). In early 2005, the Petroleum Environmental Research Forum (PERF) submitted a proposal to DOE for funding an upcoming PERF meeting that would feature water research in the petroleum industry. PERF is a nonprofit organization created in 1986 to provide a stimulus to and a forum for the collection, exchange, and analysis of research information related to the development of technology concerning themore » petroleum industry, and a mechanism for establishing joint research projects in that field. Additional information on PERF can be accessed at http://www.perf.org. DOE agreed to provide funding to hold a review of its water research program in conjunction with the fall 2005 PERF meeting. Argonne National Laboratory (Argonne) was asked to coordinate and host the meeting, which was referred to as the DOE/PERF Water Program Review. The program review was held on November 1-4, 2005, in Annapolis, Maryland, at the Historic Inns of Annapolis. The purpose of the program review was to provide a forum for sharing information, reviewing current programs (especially recent unpublished research), and reviewing industry and regulatory needs regarding water use and reuse issues. PERF and DOE/NETL can use this information to plan for future water-related research projects. The water program review provided a unique opportunity in several ways. First, DOE was able to have all of the contractors currently receiving DOE funds for water research present in one room at the same time. Each contractor described his or her research and was able to learn about the research being conducted by the other researchers. Second, this forum allowed representatives of many large oil and gas companies to hear about the DOE research projects and offer their reactions to DOE and the researchers. Third, most oil and gas meetings focus on either upstream (the exploration and production sector) or downstream (the refining sector) issues. Typically, there is little overlap in content between the two industry sectors. At the program review, attendees with upstream and downstream orientations were able to spend much of their time in joint sessions and could learn more about the other sector.« less

  15. RCRA, superfund and EPCRA hotline training module. Introduction to: Used oil (40 cfr part 266, subparts e, and part 279) updated July 1996

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

    NONE

    1996-07-01

    The module reviews the various regulatory requirements associated with used oil management. The goal of the training module is to provide an overview of the used oil management program and to explain the different regulatory scenarios that can apply to used oil. The module begins by briefly tracing the developmental history of the regulations concerning used oil. A summary of the present used oil management program, as well as a brief summary of the former program, provides a basic comparison and introduction to both programs.

  16. Unraveling the Tangled Skein: The Evolution of Transcriptional Regulatory Networks in Development.

    PubMed

    Rebeiz, Mark; Patel, Nipam H; Hinman, Veronica F

    2015-01-01

    The molecular and genetic basis for the evolution of anatomical diversity is a major question that has inspired evolutionary and developmental biologists for decades. Because morphology takes form during development, a true comprehension of how anatomical structures evolve requires an understanding of the evolutionary events that alter developmental genetic programs. Vast gene regulatory networks (GRNs) that connect transcription factors to their target regulatory sequences control gene expression in time and space and therefore determine the tissue-specific genetic programs that shape morphological structures. In recent years, many new examples have greatly advanced our understanding of the genetic alterations that modify GRNs to generate newly evolved morphologies. Here, we review several aspects of GRN evolution, including their deep preservation, their mechanisms of alteration, and how they originate to generate novel developmental programs.

  17. Ethical and regulatory challenges of research using pervasive sensing and other emerging technologies: IRB perspectives.

    PubMed

    Nebeker, Camille; Harlow, John; Espinoza Giacinto, Rebeca; Orozco-Linares, Rubi; Bloss, Cinnamon S; Weibel, Nadir

    2017-01-01

    Vast quantities of personal health information and private identifiable information are being created through mobile apps, wearable sensors, and social networks. While new strategies and tools for obtaining health data have expanded researchers' abilities to design and test personalized and adaptive health interventions, the deployment of pervasive sensing and computational techniques to gather research data is raising ethical challenges for Institutional Review Boards (IRBs) charged with protecting research participants. To explore experiences with, and perceptions about, technology-enabled research, and identify solutions for promoting responsible conduct of this research we conducted focus groups with human research protection program and IRB affiliates. Our findings outline the need for increased collaboration across stakeholders in terms of: (1) shared and dynamic resources that improve awareness of technologies and decrease potential threats to participant privacy and data confidentiality, and (2) development of appropriate and dynamic standards through collaboration with stakeholders in the research ethics community.

  18. Evolution of Stored-Product Entomology: Protecting the World Food Supply.

    PubMed

    Hagstrum, David W; Phillips, Thomas W

    2017-01-31

    Traditional methods of stored-product pest control were initially passed from generation to generation. Ancient literature and archaeology reveal hermetic sealing, burning sulfur, desiccant dusts, and toxic botanicals as early control methods. Whereas traditional nonchemical methods were subsequently replaced by synthetic chemicals, other traditional methods were improved and integrated with key modern pesticides. Modern stored-product integrated pest management (IPM) makes decisions using knowledge of population dynamics and threshold insect densities. IPM programs are now being fine-tuned to meet regulatory and market standards. Better sampling methods and insights from life histories and ecological studies have been used to optimize the timing of pest management. Over the past 100 years, research on stored-product insects has shifted from being largely concentrated within 10 countries to being distributed across 65 countries. Although the components of IPM programs have been well researched, more research is needed on how these components can be combined to improve effectiveness and assure the security of postharvest food as the human population increases.

  19. Oceans and Coasts

    EPA Pesticide Factsheets

    An overview of EPA’s oceans, coasts, estuaries and beaches programs and the regulatory (permits/rules) and non-regulatory approaches for managing their associated environmental issues, such as water pollution and climate change.

  20. 30 CFR 906.10 - State regulatory program approval.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Natural Resources, Division of Minerals and Geology, Centennial Building, room 215, 1313 Sherman Street..., the Colorado Department of Natural Resources was deemed the regulatory authority in Colorado for...

  1. Spectral analysis of resting cardiovascular variables and responses to oscillatory LBNP before and after 6 degree head dowm bedrest

    NASA Technical Reports Server (NTRS)

    Knapp, Charles F.; Evans, J. M.; Patwardhan, A.; Levenhagen, D.; Wang, M.; Charles, John B.

    1991-01-01

    A major focus of our research program is to develop noninvasive procedures for determining changes in cardiovascular function associated with the null gravity environment. We define changes in cardiovascular function to be (1) the result of the regulatory system operating at values different from 'normal' but with an overall control system basically unchanged by the null gravity exposure, or (2) the result of operating with a control system that has significantly different regulatory characteristics after an exposure. To this end, we have used a model of weightlessness that consisted of exposing humans to 2 hrs. in the launch position, followed by 20 hrs. of 6 deg head down bedrest. Our principal objective was to use this model to measure cardiovascular responses to the 6 deg head down bedrest protocol and to develop the most sensitive 'systems identification' procedure for indicating change. A second objective, related to future experiments, is to use the procedure in combination with experiments designed to determine the degree to which a regulatory pathway has been altered and to determine the mechanisms responsible for the changes.

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

    USGS Publications Warehouse

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

    2001-01-01

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

  3. COST EFFECTIVE REGULATORY APPROACHES TO ENHANCE DOMESTIC OIL & GAS PRODUCTION AND ENSURE THE PROTECTION OF THE ENVIRONMENT

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

    Ben Grunewald; Paul Jehn; Tom Gillespie

    The Environmental Information Management Suite/Risk Based Data Management System (EIMS/RBDMS) and Cost Effective Regulatory Approach (CERA) programs continue to be successful. All oil and gas state regulatory programs participate in these efforts. Significant accomplishments include: streamline regulatory approaches, enhancing environmental protection, and making oil and gas data available via the Internet. Oil and gas companies worldwide now have access to data on state web sites. This reduces the cost of exploration and enables companies to develop properties in areas that would have been cost prohibited for exploration. Early in project, GWPC and State Oil and Gas agencies developed the EIMSmore » and CERA strategic plan to prioritize long term development and implementation. The planning process identifies electronic commerce and coal bed methane as high priorities. The group has involved strategic partners in industry and government to develop a common data exchange process. Technical assistance to Alaska continues to improve their program management capabilities. New initiatives in Alaska include the development of an electronic permit tracking system. This system allows managers to expedite the permitting process. Nationwide, the RBDMS system is largely completed with 22 states and one Indian Nation now using this nationally accepted data management system. Additional remaining tasks include routine maintenance and the installation of the program upon request for the remaining oil and gas states. The GWPC in working with the BLM and MMS to develop an XML schema to facilitate electronic permitting and reporting (Appendix A, B, and C). This is a significant effort and, in years to come, will increase access to federal lands by reducing regulatory barriers. The new initiatives are coal bed methane and e-commerce. The e-commerce program will provide industry and BLM/MMS access to the millions of data points housed in the RBDMS system. E-commerce will streamline regulatory approaches and allow small operators to produce energy from areas that have become sub-economic for the major producers. The GWPC is working with states to develop a coal bed methane program, which will both manage the data and develop a public education program on the benefits of produced water. The CERA program benefits all oil and gas states by reducing the cost of regulatory compliance, increasing environmental protection, and providing industry and regulatory agencies a discussion forum. Activities included many small and large group forum settings for discussions of technical and policy issues as well as the ongoing State Class II UIC peer review effort. The accomplishments detailed in this report will be the basis for the next initiative which is RBDMS On-Line. RBDMS On-Line will combine data mining, electronic permitting and electronic reporting with .net technology. Industry, BLM, GWPC and all Oil and Gas states are partnering this effort.« less

  4. Accelerating drug development and approval.

    PubMed

    Cole, Patrick

    2010-01-01

    Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority review voucher program. These initiatives represent different approaches to finding treatments for rare and widespread but neglected diseases, as well as speeding the development process for pharmaceutical and biological agents more generally. Commercial incentives, streamlined regulatory processing, exploratory trial designs, research assistance and cash infusions are all means of promoting drug development being explored in the United States, Europe and beyond. In some cases, such as fast track designation and priority review vouchers, regulatory agencies have turned their own processes into incentives, offering advantageous alternative routes to product approval, like a faster lane on the highway for vehicles carrying multiple passengers. In 2009, regulatory agencies and the governments they represent also had to confront two tremendous challenges: the global recession and the H1N1 influenza virus pandemic. These tests have been met with increased funding in the former case and coordinated efforts to develop, approve and stockpile H1N1 vaccines in the latter.

  5. Waste management technology development and demonstration programs at Brookhaven National Laboratory

    NASA Technical Reports Server (NTRS)

    Kalb, Paul D.; Colombo, Peter

    1991-01-01

    Two thermoplastic processes for improved treatment of radioactive, hazardous, and mixed wastes were developed from bench scale through technology demonstration: polyethylene encapsulation and modified sulfur cement encapsulation. The steps required to bring technologies from the research and development stage through full scale implementation are described. Both systems result in durable waste forms that meet current Nuclear Regulatory Commission and Environmental Protection Agency regulatory criteria and provide significant improvements over conventional solidification systems such as hydraulic cement. For example, the polyethylene process can encapsulate up to 70 wt pct. nitrate salt, compared with a maximum of about 20 wt pct. for the best hydraulic cement formulation. Modified sulfur cement waste forms containing as much as 43 wt pct. incinerator fly ash were formulated, whereas the maximum quantity of this waste in hydraulic cement is 16 wt pct.

  6. 30th Annual Drug Information Association (DIA) Europe 2018 (April 17-19, 2018 - Basel, Switzerland).

    PubMed

    Hamaui Cuadrado, S; Guinart Vidal, M

    2018-05-01

    The Drug Information Association (DIA) Europe held its annual meeting from April 17-19, 2018, in Basel, Switzerland. The key topics discussed in the 3-day meeting were related to pharmacovigilance, clinical development, patient engagement, data and data standards, preclinical development and early-phase clinical research, regulatory science, translational medicine and science, and value and access. The program was principally focused on the current opportunities and future landscape of the healthcare system as a result of the increasingly innovative technologies and effective utilization of big data. In addition, the critical need for collaboration and partnership between all the stakeholders of the healthcare system was highlighted. This report covers some of the regulatory sessions presented at the meeting in which regulators, payers, industry and patients presented their perspectives for discussion. Copyright 2018 Clarivate Analytics.

  7. 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.

  8. 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

  9. 77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

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

  10. 77 FR 1775 - Self-Regulatory Organizations; Chicago Mercantile Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66102; File No. SR-CME-2011-22] Self-Regulatory... Change To Establish Certain Fee Programs in Connection With Its OTC Interest Rate Swap Clearing Offering...)(2). I. Self-Regulatory Organization's Statement of Terms of Substance of the Proposed Rule Change...

  11. 78 FR 20997 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    .... Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Its Option Trading Rules to Extend the Operation of Its Pilot Program Regarding Minimum...

  12. Quality Training and Learning in Aviation: Problems of Alignment

    NASA Technical Reports Server (NTRS)

    Moore, Phillip J.; Lehrer, Henry R.; Telfer, Ross A.

    2001-01-01

    The challenge of producing training programs that lead to quality learning outcomes is ever present in aviation, especially when economic and regulatory pressures are brought into the equation. Previous research by Telfer & Moore (1997) indicates the importance of appropriate alignment of beliefs about learning across all levels of an organization from the managerial level, through the instructor/check and training level, to the pilots and other crew. This paper argues for a central focus on approaches to learning and training that encourage understanding, problem solving and application. Recent research in the area is emphasized as are methods and techniques for enhancing deeper learning.

  13. Lessons from Initiating the First Veterans Health Administration (VA) Women's Health Practice-based Research Network (WH-PBRN) Study.

    PubMed

    Pomernacki, Alyssa; Carney, Diane V; Kimerling, Rachel; Nazarian, Deborah; Blakeney, Jill; Martin, Brittany D; Strehlow, Holly; Yosef, Julia; Goldstein, Karen M; Sadler, Anne G; Bean-Mayberry, Bevanne A; Bastian, Lori A; Bucossi, Meggan M; McLean, Caitlin; Sonnicksen, Shannan; Klap, Ruth; Yano, Elizabeth M; Frayne, Susan M

    2015-01-01

    The Veterans Health Administration (VA) Women's Health Practice-Based Research Network (WH-PBRN) was created to foster innovations for the health care of women veterans. The inaugural study by the WH-PBRN was designed to identify women veterans' own priorities and preferences for mental health services and to inform refinements to WH-PBRN operational procedures. Addressing the latter, this article reports lessons learned from the inaugural study. WH-PBRN site coordinators at the 4 participating sites convened weekly with the study coordinator and the WH-PBRN program manager to address logistical issues and identify lessons learned. Findings were categorized into a matrix of challenges and facilitators related to key study elements. Challenges to the conduct of PBRN-based research included tracking of regulatory documents; cross-site variability in some regulatory processes; and troubleshooting logistics of clinic-based recruitment. Facilitators included a central institutional review board, strong relationships between WH-PBRN research teams and women's health clinic teams, and the perception that women want to help other women veterans. Our experience with the inaugural WH-PBRN study demonstrated the feasibility of establishing productive relationships between local clinicians and researchers, and of recruiting a special population (women veterans) in diverse sites within an integrated health care system. This identified strengths of a PBRN approach. © Copyright 2015 by the American Board of Family Medicine.

  14. 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

  15. Project development teams: a novel mechanism for accelerating translational research.

    PubMed

    Sajdyk, Tammy J; Sors, Thomas G; Hunt, Joe D; Murray, Mary E; Deford, Melanie E; Shekhar, Anantha; Denne, Scott C

    2015-01-01

    The trend in conducting successful biomedical research is shifting from individual academic labs to coordinated collaborative research teams. Teams of experienced investigators with a wide variety of expertise are now critical for developing and maintaining a successful, productive research program. However, assembling a team whose members have the right expertise requires a great deal of time and many resources. To assist investigators seeking such resources, the Indiana Clinical and Translational Sciences Institute (Indiana CTSI) created the Project Development Teams (PDTs) program to support translational research on and across the Indiana University-Purdue University Indianapolis, Indiana University, Purdue University, and University of Notre Dame campuses. PDTs are multidisciplinary committees of seasoned researchers who assist investigators, at any stage of research, in transforming ideas/hypotheses into well-designed translational research projects. The teams help investigators capitalize on Indiana CTSI resources by providing investigators with, as needed, mentoring and career development; protocol development; pilot funding; institutional review board, regulatory, and/or nursing support; intellectual property support; access to institutional technology; and assistance with biostatistics, bioethics, recruiting participants, data mining, engaging community health, and collaborating with other investigators.Indiana CTSI leaders have analyzed metrics, collected since the inception of the PDT program in 2008 from both investigators and team members, and found evidence strongly suggesting that the highly responsive teams have become an important one-stop venue for facilitating productive interactions between basic and clinical scientists across four campuses, have aided in advancing the careers of junior faculty, and have helped investigators successfully obtain external funds.

  16. Building a roadmap to biomarker qualification: challenges and opportunities.

    PubMed

    Amur, Shashi G; Sanyal, Sarmistha; Chakravarty, Aloka G; Noone, Marianne H; Kaiser, James; McCune, Susan; Buckman-Garner, ShaAvhree Y

    2015-01-01

    The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

  17. The U.S.-Russian radiation health effects research program in the Southern Urals.

    PubMed

    Seligman, P J

    2000-07-01

    The Joint Coordinating Committee for Radiation Effects Research (JCCRER) was established through a bilateral U.S.-Russian agreement to support research and exchange information on radiation health effects. The U.S. member agencies include the Department of Energy (DOE), Nuclear Regulatory Commission (NRC), Department of Health and Human Services (DHHS), Department of Defense (DoD), National Aeronautics and Space Administration (NASA), and Environmental Protection Agency (EPA). The Russians are represented by the Ministries of Emergencies (EMERCOM), Atomic Energy (MINATOM) and Health (MINZDRAV), and the Russian Academy of Sciences (IBRAE). The focus of this research is on the workers from the Mayak Production Association (MAYAK) in the Southern Urals and on the neighboring populations along the Techa River exposed to contamination from the plant. The goal of the program is to better define the relationship between the health effects and the chronic low dose and dose-rate exposure, these data being essential to validate current radiation protection standards and practices. The current primary areas of JCCRER research include dose reconstruction, epidemiologic health studies, molecular epidemiology/biodosimetry, and the creation of tissue banks. The organization of the ongoing research conducted under the aegis of the JCCRER and the rationale for this work are described.

  18. 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

  19. 7th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG), May 8–10, 2014, Helsinki, Finland

    PubMed Central

    Mlinac, Anita; Hinzmann, Rolf

    2014-01-01

    Abstract International experts in the fields of diabetes, diabetes technology, endocrinology, mobile health, sport science, and regulatory issues gathered for the 7th Annual Symposium on Self-Monitoring of Blood Glucose (SMBG). The aim of this meeting was to facilitate new collaborations and research projects to improve the lives of people with diabetes. The 2014 meeting comprised a comprehensive scientific program, parallel interactive workshops, and two keynote lectures. PMID:25211215

  20. Vessels, Marinas and Ports

    EPA Pesticide Factsheets

    An overview of EPA’s vessels (recreational/commercial/military), marinas, and ports programs and the regulatory (permits/rules) and non-regulatory approaches for addressing their associated environmental impacts, such as air and water pollution.

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