WorldWideScience

Sample records for regulatory agency review

  1. Survey of regulatory agency review of generating unit performance

    International Nuclear Information System (INIS)

    Roach, E.M. Jr.; Tarletz, D.B.

    1985-01-01

    Regulatory agencies across the country are being called upon increasingly to monitor the management of electric utilities. Such activity, which once was relatively rare, is now common. Most frequently this oversight centers around the operating performance of generating units, both nuclear and fossil. There are, perhaps, several reasons for this increased interest in the efficient operation of generating units: increased fuel costs and fuel cost differentials, increased lead times and costs for construction of new generating units, and increased dependence on existing units because of construction programs being revised to meet decreased load growth. The monitoring of generating units has taken the form of after the fact evaluation of performance on a case-by-case basis and the implementation of productivity incentive programs. Performance standards are used in these contexts both to measure the adequacy of unit performance and to implement incentives in the form of rewards or penalties. The standard used may be a subjective test of prudent performance or some numerical index of plant performance, e.g., equivalent availability, capacity factor or heat rate. Some of the activity by regulators is reviewed in applying subjective and numerical standards and the considerations involved in applying such standards are discussed

  2. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  3. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  4. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  5. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  6. 75 FR 54917 - Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency...

    Science.gov (United States)

    2010-09-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0294] Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency Action Review Meeting AGENCY: Nuclear Regulatory Commission. ACTION: Request for comment. SUMMARY: It is the policy of the U.S. Nuclear Regulatory Commission...

  7. Bioremediation, regulatory agencies and public acceptance of this technology

    International Nuclear Information System (INIS)

    Westlake, D. W. S.

    1997-01-01

    The technology of bioremediation, i.e. the utilization of microorganisms to degrade environmental pollutants, the dangers and consequences inherent in the large-scale use of microbial organisms in such processes, and the role of regulatory agencies in the utilization and exploitation of bioremediation technologies, were discussed. Factors influencing public acceptance of bioremediation as a satisfactory tool for cleaning up the environment vis-a-vis other existing and potential rehabilitation techniques were also reviewed. The ambiguity of regulatory agencies in the matter of bioremediation was noted. For example, there are many regulatory hurdles relative to the testing, use and approval of transgenic microorganisms for use in bioremediation. On the other hand, the use and release of engineered plants is considered merely another form of hybrid and their endorsement is proceeding rapidly. With regard to public acceptance, the author considered bioremediation technology as too recent, with not enough successful applications to attract public attention. Although the evidence suggests that bioremediation is environmentally safe, the efficacy, reliability and predictability of the various technologies have yet to be demonstrated. 25 refs

  8. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

    Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

  9. Regulatory Powers in Public Procurement Law of Peruvian Administrative Agencies

    Directory of Open Access Journals (Sweden)

    Juan Carlos Morón Urbina

    2017-12-01

    Full Text Available Peruvian law has explicitly recognized regulatory powers to administrative agencies, which allows them to have a preponderant role in the production of rules in public procurement. Although these delegations of legislative authority are positively defined, distortions in the system of legal sources arise when agencies exceed delegated powers or when measures issued by administrative entities are mistaken for regulations. This paper aims to identify regulatory powers of Peruvian administrative agencies, as well as the regulatory measures they issue, and their relation with other sources of law.

  10. Review of hazardous chemical regulation at nuclear facilities by the Nuclear Regulatory Commission and other federal agencies. Hearing before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-Ninth Congress, Second Session, March 14, 1986

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    Seven witnesses from agencies and the nuclear industry testified on the status of chemical regulation at nuclear facilities, the potential for accidents, and the quality of emergency plans in the event of a release of chemical substances. Impetus for the review came from incidents at Kerr-McGhee's Sequoyah plant in Oklahoma and the release of uranium hexafluoride, as well as a pattern of accidents which occur after the potential hazard has already been identified. The witnesses included Richard Krimm of the Federal Emergency Management Agency, James Makris of the Environmental Protection Agency, John Miles of the Occupational Safety and Health Administration, Nunxio Palladino of the Nuclear Regulatory Commission, and representatives of DOE and Kerr-McGee. Additional materials submitted for the record follows the testimony

  11. Court-agency interaction in environmental policymaking: the cases of the Nuclear Regulatory Commission and the Environmental Protection Agency

    International Nuclear Information System (INIS)

    Thomas, L.W.

    1981-01-01

    This study examines the increasingly active participation of courts in the administrative process as well as agency responses to court-imposed policy shifts. More specifically, it is an investigation of the interaction between the federal courts, primarily the Supreme Court and the District of Columbia Court of Appeals, and two federal regulatory agencies, the Nuclar Regulatory Commission and the Environmental Protection Agency. There are five objectives to the study. The first is to examine the natura of court-agency interaction and to determine the extent to which patterns of judicial review of administrative actions can be discerned. The second is to examine the effect of court orders on agency programs and policies. The third is to assess the anticipatory dimension of court-agency relations. The fourth is to inquire into the recurring dimension of court-agency interaction and to determine its effect on subsequent court decisions. The last is to assess the institutional capacity of courts to deal with scientific and technological issues. This study indicates that judicial review has a substantial effect on the NRC's and the EPA's decision-making activities. Few, if any, recent major policy decisions of the two agencies have not been scrutinized closely by federal appellate courts. During the past decade, the courts have blocked policy initiative on numerous occasions and have been the primary source of change in others. In addition, the mere anticipation of judicial review was found to be a factor motivating the two agencies to make reasoned decisions

  12. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  13. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents.

    Science.gov (United States)

    Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

    2014-01-01

    The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

  14. Information resources in state regulatory agencies-a California perspective

    Energy Technology Data Exchange (ETDEWEB)

    DiZio, S.M. [California Environmental Protection Agency, Sacramento (United States)

    1990-12-31

    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.

  15. 76 FR 18457 - Regulatory Review Schedule; Tribal Consultation

    Science.gov (United States)

    2011-04-04

    ... that the NIGC provide tribal gaming commissions access to licensing information via an online database... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Tribal Consultation AGENCY: National Indian Gaming Commission. ACTION: Notice of Regulatory...

  16. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... of the economy, productivity, competition, jobs, the environment, public health or safety, or State... Steve Fruh, Environmental Protection Agency, Air and Radiation, 1200 Pennsylvania Ave, NW, Washington, DC 20460 Phone: 919 541-2837 Fax: 919 541-4991 Email: fruh.steve@epamail.epa.gov RIN: 2060-AP69...

  17. Knowledge Management Implementation In Indonesia Nuclear Energy Regulatory Agency (BAPETEN)

    International Nuclear Information System (INIS)

    Nurwidi Astuti, Y.H.

    2016-01-01

    Full text: Indonesian Nuclear Energy Regulatory Agency (BAPETEN) acquires the task and function to control the safety, security and safeguards in the field of nuclear energy through the development of legislation, licensing services, inspection and enforcement. Which is supported by review and assessment, emergency preparedness. Knowledge Management (KM) is importance for BAPETEN to achieve the Regulatory body effectiveness and product innovation. The Chairman of BAPETEN has set policies statement for KM implementation. To implement a knowledge management program, BAPETEN creates KM guidelines that includes blueprint and roadmap KM programme based on a KM readiness survey. The KM readiness survey involves 20% of staff who represent each unit and discussions with the senior manager of BAPETEN, and the result of readiness survey produce 13 KM BAPETEN initiatives strategic. After the initiative strategic has been obtained, BAPETEN creates the Roadmap of BAPETEN Knowledge Management for 2015–2019 programme for KM People with the activity sozialization of KM Guidebook, workshop SMART knowledge worker, nurture Community of practices (COP) and develop social network analysis (SNE). KM Process with activity focus group discussion, KM Readyness survey, KM Statement, KM Bapeten Guidebook, knowledge mapping, knowledge harvesting. KM Technology with activity develop knowledge system or portal, e-learning. (author

  18. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

    Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  19. Review of the International Atomic Energy Agency International database on reactor pressure vessel materials and US Nuclear Regulatory Commission/Oak Ridge National Laboratory embrittlement data base

    International Nuclear Information System (INIS)

    Wang, J.A.; Kam, F.B.K.

    1998-02-01

    The International Atomic Energy Agency (IAEA) has supported neutron radiation effects information exchange through meetings and conferences since the mid-1960s. Through an International Working Group on Reliability of Reactor Pressure Components, information exchange and research activities were fostered through the Coordinated Research Program (CRP) sponsored by the IAEA. The final CRP meeting was held in November 1993, where it was recommended that the IAEA coordinate the development of an International Database on Reactor Pressure Vessel Material (IDRPVM) as the first step in generating an International Database on Aging Management. The purpose of this study was to provide special technical assistance to the NRC in monitoring and evaluating the IAEA activities in developing the IAEA IDRPVM, and to compare the IDRPVM with the Nuclear Regulatory Commission (NRC) - Oak Ridge National Laboratory (ORNL) Power Reactor Embrittlement Data Base (PR-EDB) and provide recommendations for improving the PR-EDB. A first test version of the IDRPVM was distributed at the First Meeting of Liaison Officers to the IAEA IDRPVM, in November 1996. No power reactor surveillance data were included in this version; the testing data were mainly from CRP Phase III data. Therefore, because of insufficient data and a lack of power reactor surveillance data received from the IAEA IDRPVM, the comparison is made based only on the structure of the IDRPVM. In general, the IDRPVM and the EDB have very similar data structure and data format. One anticipates that because the IDRPVM data will be collected from so many different sources, quality assurance of the data will be a difficult task. The consistency of experimental test results will be an important issue. A very wide spectrum of material characteristics of RPV steels and irradiation environments exists among the various countries. Hence the development of embrittlement prediction models will be a formidable task. 4 refs., 2 figs., 4 tabs

  20. 40 CFR 166.25 - Agency review.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Agency review. 166.25 Section 166.25... Health Exemptions § 166.25 Agency review. (a) General. The Agency will review all requests as... is needed. The Agency will review the application and other available data necessary to make a...

  1. 14 CFR 1262.308 - Agency review.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false Agency review. 1262.308 Section 1262.308... PROCEEDINGS Procedures for Considering Applications § 1262.308 Agency review. (a) Within 30 calendar days of... applicant or agency counsel may seek Agency review of the decision; or, the NASA Administrator, upon the...

  2. 31 CFR 6.15 - Agency review.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Agency review. 6.15 Section 6.15... EQUAL ACCESS TO JUSTICE ACT Procedures for Considering Applications § 6.15 Agency review. Either the applicant or agency counsel may seek review of the initial decision on the fee application, or the agency...

  3. 49 CFR 1016.309 - Agency review.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Agency review. 1016.309 Section 1016.309... Agency review. In the event the adjudicative officer is not the entire Board, the applicant or agency counsel may seek review of the initial decision on the fee application, or the Board may review the...

  4. Safety Culture Implementation in Indonesian Nuclear Energy Regulatory Agency (BAPETEN)

    International Nuclear Information System (INIS)

    Nurwidi Astuti, Y.H.; Dewanto, P.

    2016-01-01

    The Indonesia Nuclear Energy Act no. 10 of 1997 clearly stated that Nuclear Energy Regulatory Agency (BAPETEN) is the Nuclear Regulatory Body. This is the legal basis of BAPETEN to perform regulatory functions on the use of nuclear energy in Indonesia, including regulation, authorisation, inspection and enforcement. The Independent regulatory functions are stipulated in Article 4 and Article 14 of the Nuclear Energy Act no. 10 (1997) which require the government to establish regulatory body that is reporting directly to the president and has responsibility to control of the use of nuclear energy. BAPETEN has been start fully its functioning on January 4, 1999. In it roles as a regulatory body, the main aspect that continues and always to be developed is the safety culture. One of the objectives of regulatory functions is “to increase legal awareness of nuclear energy of the user to develop safety culture” (Article 15, point d), while in the elucidation of article 15 it is stipulated that “safety culture is that of characteristics and attitudes in organizations and individual that emphasise the importance of safety”.

  5. Decisions by regulatory agencies: are they evidence-based?

    Directory of Open Access Journals (Sweden)

    Furberg Curt D

    2007-04-01

    Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

  6. 76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

    Science.gov (United States)

    2011-02-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 27 and 29 FAA Public Forum To Conduct Regulatory Review AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of public meeting. SUMMARY: The FAA announces an informal meeting to discuss the FAA rotorcraft rules, 14...

  7. 78 FR 23199 - NASA FAR Supplement Regulatory Review No. 1

    Science.gov (United States)

    2013-04-18

    ... 2700-AE01 NASA FAR Supplement Regulatory Review No. 1 AGENCY: National Aeronautics and Space Administration. ACTION: Proposed rule. SUMMARY: NASA is updating the NASA FAR Supplement (NFS) with the goal of... existing regulations. The revisions to this rule are part of NASA's retrospective plan under EO 13563...

  8. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  9. Carbon Capture and Storage Legal and Regulatory Review. Edition 2

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

  10. 46 CFR 505.5 - Agency review.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Agency review. 505.5 Section 505.5 Shipping FEDERAL MARITIME COMMISSION GENERAL AND ADMINISTRATIVE PROVISIONS ADMINISTRATIVE OFFSET § 505.5 Agency review. (a... request to review a disputed debt must be submitted to the Commission official who provided notification...

  11. 50 CFR 296.10 - Agency review.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Agency review. 296.10 Section 296.10..., DEPARTMENT OF COMMERCE CONTINENTAL SHELF FISHERMEN'S CONTINGENCY FUND § 296.10 Agency review. (a) Within 30..., NMFS, or his designee, for a review of the initial determination. (b) The petitioner may submit written...

  12. 17 CFR 204.6 - Agency review.

    Science.gov (United States)

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Agency review. 204.6 Section... COLLECTION Administrative Offset § 204.6 Agency review. (a) To the extent that a debt owed has not been... request to review a disputed debt must be submitted to the Commission official who provided notification...

  13. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

  14. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  15. Guideline for regulatory agencies in evaluating contents of root cause analysis by operators

    International Nuclear Information System (INIS)

    Hata, Takaya; Makino, Maomi; Kosaka, Atsuhiko

    2008-01-01

    'Guideline for Regulatory Agencies in Evaluating Contents of Root cause Analysis by Operators' was enacted as the policy for new inspection system in Japan. The objective is to indicate the view point to verify the appropriateness of the corrective actions and preventive actions implemented by operators based on root cause analysis and its analysis results. This guideline is leading to take four points into special consideration for adequate application. They are encouragement of further activities of the operators, flexible interpretation of the intention, versatility of the analysis methods and concepts and consideration of no blame culture. Moreover, as view point for regulatory agencies, it indicates with special emphasis that neutrality of the analyzing party, objectivity of analysis result, and logicality of the analysis method are ensured. This guideline shall be continuously reviewed through integration of lessons learned from active use in future. (author)

  16. 19 CFR 212.27 - Agency review.

    Science.gov (United States)

    2010-04-01

    ... IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT Procedures for Considering Applications § 212.27 Agency review... 19 Customs Duties 3 2010-04-01 2010-04-01 false Agency review. 212.27 Section 212.27 Customs... determination and alternative findings of fact and conclusions of law with the Commission. Upon receipt of the...

  17. 5 CFR 179.305 - Agency review.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Agency review. 179.305 Section 179.305 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT CIVIL SERVICE REGULATIONS CLAIMS COLLECTION STANDARDS Administrative Offset § 179.305 Agency review. (a) A debtor may dispute the existence of the debt, the amount of...

  18. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  19. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

  20. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  1. CCS: Legal and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA has estimated that the broad deployment of low-carbon energy technologies could reduce projected 2050 emissions to half 2005 levels -- and that CCS could contribute about one-fifth of those reductions. Reaching that goal, however, would require around 100 CCS projects to be implemented by 2020 and over 3 000 by 2050.

  2. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  3. Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments.

    Science.gov (United States)

    1982-12-13

    In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.

  4. IAEA Mission Concludes Peer Review of Slovenia's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an eight-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety at the Slovenian Nuclear Safety Administration (SNSA). The team reviewed measures taken to address the recommendations and suggestions made during an earlier Integrated Regulatory Review Service (IRRS) mission conducted in 2011. The IRRS team said in its preliminary findings that Slovenia had made significant progress since the review in 2011. The team identified a good practice in the country's nuclear regulatory system additional to those identified in 2011 and made new recommendations and suggestions to SNSA and the Government to strengthen the effectiveness of the country's regulatory framework in line with IAEA Safety Standards. ''By hosting a follow-up mission, Slovenia demonstrated its commitment to enhance its regulatory programmes, including by implementing the recommendations of the 2011 mission,'' said Petr Krs, mission leader and Vice Chairman of the Czech Republic's State Office for Nuclear Safety. SNSA's Director, Andrej Stritar, welcomed the progress noted by the team, while also emphasizing that the mission highlighted important future nuclear safety challenges for Slovenia. The five-member review team, comprising experts from Belgium, the Czech Republic, France and Romania, as well as four IAEA staff members, conducted the mission at the request of the Slovenian Government from 9 to 16 September 2014. The main observations of the IRRS Review team included the following: SNSA has made significant progress in addressing the findings of the 2011 IRRS mission and has demonstrated commitment to effective implementation of the IRRS programme; The economic situation in Slovenia might in the short and long term affect SNSA's ability to maintain its capacity and competence; and A radioactive waste disposal project is stalled and the licensing

  5. Review of NRC Regulatory processes and functions

    International Nuclear Information System (INIS)

    1980-01-01

    The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

  6. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  7. 77 FR 59567 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2012-09-28

    ... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to... Immigration Review 8 CFR Parts 1003, 1103, 1208, 1211, 1212, 1215, 1216, 1235 [EOIR No. 178] RIN 1125-AA71 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Executive Office for Immigration Review, Department of...

  8. Averting Regulatory Enforcement: Evidence from New Source Review

    Energy Technology Data Exchange (ETDEWEB)

    Keohane, N.O.; Mansur, E.T.; Voynov, A. [Yale University, New York, NY (USA)

    2009-09-15

    This paper explores firms' response to regulatory enforcement. New Source Review (NSR), a provision of the Clean Air Act, imposes stringent emissions limitations on significantly modified older power plants. In 1999, the Environmental Protection Agency (EPA) sued owners of 46 plants for NSR violations. We study how electricity companies respond to both the perceived threat of future action, and the action itself. A discrete choice model estimates plants likelihood of being named in lawsuits increases with large historic emissions and investments. On the eve of the lawsuits, emissions at plants with a one standard deviation greater probability of being sued fell approximately 10%.

  9. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

  10. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  11. 77 FR 12896 - Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66458; File No. 600-9] Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency Registration February 24, 2012. I... Act provides that in the event any self- regulatory organization is no longer in existence or has...

  12. 77 FR 12898 - Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66461; File No. 600-7] Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency Registration February 24, 2012... the event any self-regulatory organization is no longer in existence or has ceased to do business in...

  13. 75 FR 21012 - Extension of Agency Information Collection Activity Under OMB Review: Highway Corporate Security...

    Science.gov (United States)

    2010-04-22

    ... Information Collection Activity Under OMB Review: Highway Corporate Security Review (CSR) AGENCY... (ICR), OMB control number 1652-0036, abstracted below to the Office of Management and Budget (OMB) for... collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments...

  14. Regulatory review of NPP Krsko Periodic Safety Review

    International Nuclear Information System (INIS)

    Lovincic, D.; Muehleisen, A.; Persic, A.

    2004-01-01

    At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

  15. Relationship between Saskatchewan government regulatory agencies and the oil and gas industry

    International Nuclear Information System (INIS)

    Lechner, L.J.; Mathieson, B.

    1998-01-01

    The roles and responsibilities of various government agencies as they interact with the oil and gas industry in Saskatchewan were described. The regulatory agencies featured in this paper were Saskatchewan Energy and Mines (SEM), Saskatchewan Environment and Resource Management (SERM), and Saskatchewan Agriculture and Food (SAF). The management of land sales, seismic activities, exploration and oil and gas production activities were reviewed. While each of the agencies has a different mandate, they have a common goal regarding petroleum resources, and that is to ensure that the oil and gas industry carries out its activities in a sustainable manner while protecting and conserving the environment. The mandate of SEM is to facilitate the discovery, development and use of Saskatchewan's energy and mineral resources. SERM's mandate is to manage, enhance and protect Saskatchewan's natural and environmental resources such as fish, wildlife, lands, forests, parks, air, water and soil, for conservation, recreation, social and economic purposes. The mandate of SAF is to manage crown land in the province and to control surface access to these lands

  16. Formal independence of regulatory agencies and Varieties of Capitalism

    DEFF Research Database (Denmark)

    Guardiancich, Igor; Guidi, Mattia

    2016-01-01

    The Varieties of Capitalism literature posits that national economic institutions reflect the mode of coordination of a country’s market actors. Despite the importance of this claim and a rich literature on the emergence of regulatory capitalism, few studies test such prediction for Independent...

  17. 76 FR 41585 - Regulation and Independent Regulatory Agencies

    Science.gov (United States)

    2011-07-14

    ... permitted by law, such decisions should be made only after consideration of their costs and benefits (both... concerning public participation, integration and innovation, flexible approaches, and science. To the extent... public a plan, consistent with law and reflecting its resources and regulatory priorities and processes...

  18. Independent regulatory agencies and rules harmonization for the electricity sector and renewables in the Mediterranean region

    International Nuclear Information System (INIS)

    Cambini, Carlo; Franzi, Donata

    2013-01-01

    The paper analyses the existing regulatory framework for the electricity and renewables sectors, and the role of regulatory agencies in Northern Africa and Middle East countries, under the promotion by the European Union. Using data collected through an original survey directed at regulators, ministry departments and energy companies of the southern Mediterranean, the study is aimed at assessing the extent of agencies' independence looking at three main dimensions of independence: regulatory instruments available to regulators and decision making autonomy; regulators' organizational autonomy; and regulators accountability. Results show that those countries having established an independent regulator have a more credible regulatory framework than those countries in which such a body does not exist. In particular, the analysis shows that Turkey, Croatia and Jordan have defined a regulatory framework that limits administrative expropriation and, consequently, creates an environment more suitable for attracting investments in the electricity and renewables sector. On the institutional ground, this is probably related with the harmonization of regulatory standards promoted by the European Union through the neighboring policy, for the Jordan case, and the membership perspective, in the Turkish and Croatian cases. - Highlights: • We analyze the existing regulatory framework in Northern Africa and Middle East countries. • We construct an original dataset through a survey directed to national regulators. • The extent of agencies' independence has been assessed in different dimensions. • These dimensions are decision making autonomy; organizational autonomy; and accountability. • Few countries have defined a regulatory framework limiting administrative expropriation

  19. Regulatory Review of Early Site Permit Applications

    International Nuclear Information System (INIS)

    Scott, Michael L.

    2004-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has received and is reviewing three applications for early site permits (ESPs). The ESP process allows early resolution of site-related issues affecting possible construction and operation of a new nuclear power plant. The nuclear industry views a successful and predictable ESP process as an important step in assessing whether to seek authorization to construct and operate a new generation of nuclear power reactors in the United States. Because consideration of ESP applications is a first-of-a-kind activity, a number of issues have emerged prior to and during the reviews of the first three applications. Issues have included the need for design information at the ESP stage, accident analyses, quality assurance, and seismic analyses. The NRC has been working to resolve identified issues to support a Commission decision on whether to issue an ESP approximately 33-37 months after receipt of each ESP application. (authors)

  20. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: Senior international nuclear safety and radiation protection experts today concluded a ten-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in the United Kingdom (UK). The Integrated Regulatory Review Service (IRRS) mission team said in its preliminary findings that the UK had made considerable progress since reviews in 2006 and 2009. It also identified good practices in the country's nuclear regulatory system. In addition to following up previous missions, a key objective was to review the effectiveness of the role of the Office of Nuclear Regulation (ONR), the UK's nuclear regulator, in ensuring the safety of radioactive waste management and decommissioning, occupational radiation protection, and public and environmental exposures, including emergency planning and response. The mission also considered the response of the UK's regulatory regime to the implications of the Fukushima Daichi accident had been timely and effective. Recommendations and suggestions were made to the ONR and the Government aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards, the control of radioactive discharges and environmental monitoring. 'The staff of ONR is clearly dedicated to their mission to secure the protection of people and society from the hazards of the nuclear industry. I am confident that ONR will use the results of this mission to further enhance their regulatory programs', said Bill Borchardt, mission leader and former Executive Director of the United States Nuclear Regulatory Commission (NRC). 'The staff were open and cooperative in their discussions; they provided the fullest practicable assistance, and accepted advice from the Team for continuous improvement in their regulatory work'. ONR's Chief Executive, John Jenkins, said that the full report of the IRRS mission will enhance regulatory effectiveness in the UK

  1. Bureaucratic Minimal Squawk Behavior: Theory and Evidence from Regulatory Agencies

    OpenAIRE

    Clare Leaver

    2009-01-01

    This paper argues that bureaucrats are susceptible to `minimal squawk` behavior. I develop a simple model in which a desire to avoid criticism can prompt, otherwise public-spirited, bureaucrats to behave inefficiently. Decisions are taken to keep interest groups quiet and mistakes out of the public eye. The policy implications of this behavior are at odds with the received view that agencies should be structured to minimise the threat of `capture`. I test between theories of bureaucratic beha...

  2. 78 FR 34386 - Agency Forms Undergoing Paperwork Act Review

    Science.gov (United States)

    2013-06-07

    ... representatives in state regulatory agencies in the 50 states and the District of Columbia primarily via telephone.... Nursing homes and skilled nursing facilities are also excluded, unless they have a unit or wing meeting...

  3. 76 FR 76413 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-12-07

    ... representatives in state regulatory agencies in the 50 states and the District of Columbia primarily via telephone... exclusively are excluded. Nursing homes and skilled nursing facilities are also excluded, unless they have a...

  4. 5 CFR 430.312 - OPM review of agency systems.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false OPM review of agency systems. 430.312... PERFORMANCE MANAGEMENT Managing Senior Executive Performance § 430.312 OPM review of agency systems. (a) Agencies must submit proposed SES performance management systems to OPM for approval. (b) OPM will review...

  5. 76 FR 47527 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2011-08-05

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Chapter VII [Docket No. 110711380-1379-01] RIN 0694-XA37 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Bureau of Industry and Security, Commerce. ACTION: Notice of inquiry. SUMMARY: The Bureau of Industry and Security (BIS...

  6. 75 FR 39932 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-07-13

    ...; Comment Request; Recognition Application for Sustainable Water Leadership Program (Renewal) AGENCY... Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval... to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention...

  7. 75 FR 5786 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-02-04

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Steel Plants: Electric Arc... [email protected] , or by mail to: EPA Docket Center (EPA/DC), Environmental Protection Agency...., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and...

  8. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    1993-04-01

    This document is intended to be used by International regulatory review teams in reviewing the activities of a regulatory body as applicable to the regulation of nuclear power plants. The mission will, however, take note of any other activities of the regulatory body when drawing up the review report. The document does not specifically deal with the functions of a regulatory body responsible for other types of nuclear facilities or related nuclear activities, but it is intended that the concepts presented in the document could be applied where appropriate. Refs

  9. Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Stevenson, J D

    1976-04-01

    Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria.

  10. Survey of extreme load design regulatory agency licensing requirements for nuclear power plants

    International Nuclear Information System (INIS)

    Stevenson, J.D.

    1976-01-01

    Since 1965, when extreme load requirements began to be considered explicitly in nuclear power plant design, there has been a gradual divergence in requirements imposed by national regulatory agencies. However, nuclear plant safety is an international problem because of the potential international effects of any postulated plant failure. For this reason this paper has been prepared in an attempt to highlight the differences in national criteria currently used in the extreme load design of nuclear plant facilities. No attempt has been made to evaluate the relative merit of the criteria established by the various national regulatory agencies. This paper presents the results of a recent survey made of national atomic energy regulatory agencies and major nuclear steam supply design agencies, which requested a summary of current licensing criteria associated with earthquake, extreme wind (tornado), flood, airplane crash and accident (pipe break) loads applicable within the various national jurisdictions. Also presented are a number of comparisons which are meant to illustrate the differences in national regulatory criteria. (Auth.)

  11. Regulatory review - on the brink of renewal

    International Nuclear Information System (INIS)

    Braunstein, L.A.

    1993-01-01

    Under the Atomic Energy Act of 1954, US commercial nuclear energy plants are licensed to operate for 40 years each. Congress selected the 40-year term not on the basis of safety, technical, or environmental issues, but on the basis of the 40-year amortization period generally used by electric utilities for large capital investments. And nuclear power plants may apply to have their licenses renewed. Licenses for about 47 plants - totalling about 34,000 megawatts (MW) of capacity - will expire between 2000 and 2014. By 2000, 63 reactors will be more than 20 years old. Without license renewal, utilities would have to retire about 5,000 MW of capacity every year between 2010 and 2030. Moreover, the Department of Energy (DOE) estimates that renewing licenses of existing nuclear plants for 20 years would save the nation's consumers about $350 billion. The NRC has concluded that the current safety of plants, as they operate today, is adequate. Therefore, in promulgating the final rule, the commission wanted to ensure that the applicants address those technical matters that are unique to the period of plant operation beyond the initial 40 years. For this reason, the rule includes language stating that the relicensing process would examine age-related degradation unique to license renewal. Interpretation of this language is adding regulatory uncertainty to the license renewal process. NRC is reviewing its interpretation; it also has indicated that it would like to smooth out the process through the review of an actual renewal application. Utility executives, however, seem unwilling to make proposals to their boards to commit large capital investments without a clear end-point in sight. It appears that the industry is now hesitating at the renewal office door - with NRC waiting for an application, and the industry holding back

  12. Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

    Science.gov (United States)

    Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

    2014-12-01

    The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  13. A regulatory review for products containing glutathione

    Directory of Open Access Journals (Sweden)

    Nur Hidayah Abd Rahim

    2016-01-01

    Full Text Available Glutathione is a potent antioxidant as well as has important role for DNA synthesis and repair, protein synthesis, amino acid transport, and enzyme activation. Besides this, Glutathione products are now mainly selling as whitening agent which are mainly marketing through social media (Facebook and different websites. Information is not available whether glutathione product are following the regulatory guidelines of National Pharmaceutical Control Bureau of Malaysia (NPCB for selling, advertisement and promotion. This review was carried out by extracting information about glutathione from scientific database using PubMed, Cochrane Library and Embase. Analysis of the available information, case example of glutathione products showed that a brand of glutathione (Glutacaps HQ did not show the product's registration number from NPCB, and also did not show the name, address, contact number of the advertiser, and even not found the name of the manufacture. Without providing the above mentioned information, the product is selling and promoting through social media (fb which is not allowed by the NPCB guidelines part 4.14. So far, only two clinical trials were conducted on glutathione supplementation for 4 weeks duration. There was no serious or systematic adverse effects reported in clinical trials. As the two clinic trials resulted contradictory outcomes, further studies needed for conformation of the clinic benefits of glutathione. Otherwise, random use of glutathione may be risk for the health of the people. Besides, the marketer mainly promoting glutathione as the skin whitening beauty product instead of using as health supplement, it may cause additional and serious risk to the users as the manufacturer not providing sufficient information about the product, its registration number, manufacturing company, etc.

  14. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  15. Completed EO 12866 Regulatory Reviews by Calendar Year

    Data.gov (United States)

    Executive Office of the President — Annual data set of draft rules reviewed by OMB under Executive Orders 12291 and 12866. The data provide information by agency, length of review in days, and economic...

  16. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

    2010-01-01

    Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

  17. Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts today concluded an eight-day mission to review Spain's nuclear regulator, the Nuclear Safety Council (CSN). At the request of the Spanish Government, the International Atomic Energy Agency assembled a peer-review team of five high-level regulatory experts from four nations and two IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined CSN's progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety and security regulatory aspects of all facilities and activities in Spain. The first mission reviewed Spain's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. The mission also included a peer review of the security activities within the regulatory framework. IRRS team leader Luis Reyes, Senior Executive of the US Nuclear Regulatory Commission, said today, 'In 2008, the mission found particular strengths in CSN's policy, its regulatory framework and its regulatory activities. We made a number of suggestions and recommendations for further improvement of the regulatory framework. CSN should be commended for the significant amount of efforts in addressing all the findings identified in 2008 mission.' The review team found that CSN has made significant progress toward improving its regulatory activities. Most of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. Additional findings are being addressed in accordance with a comprehensive and systematic action plan, in particular efforts to revise the CSN Statute. Complementing the CSN strengths identified during the 2008 mission, the 2011 IRRS team noted the following strengths: Improvements in regulatory

  18. 77 FR 46411 - Agency Information Collection Activities Under OMB Review

    Science.gov (United States)

    2012-08-03

    ... orderly procedures for membership and disciplinary actions. The Commission's review of decisions of... disciplinary, membership denial, registration, and member responsibility actions to the Commission for review... AGENCY: Commodity Futures Trading Commission. ACTION: Notice; Information Collection 3038-0043, Rules...

  19. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

    Lim, Ji Han; Lee, Kyung Joo; Choi, Young Sung

    2017-01-01

    This paper examine the meaning and principle of enforcement through examples from other countries. Regulatory enforcement is the last stage of safety regulation and how it is exercised when one failing to meet regulatory requirements can have significant ripple effect across the industry. Thus, right philosophy and principle should be established. It is not recommended to emphasize neither deterrence approach nor behavior modification approach. This should be also taken into consideration when setting up the principle and system of regulatory enforcement. In the process of Vienna Declaration, Europe and the U.S showed the fundamental differences in their approaches to safety regulation. Considering this, it is required to remain cautious at all times on what to be improved in the aspect of internal consistency within our system and also in the aspect of procedure.

  20. Driven by expertise and insulation?: the autonomy of European regulatory agencies

    OpenAIRE

    Ossege, Christoph

    2015-01-01

    Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs). Yet, we know little about ERAs' actual autonomy, nor about factors shaping it. This article studies ERAs' actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise -the "raison d'être" and main resource of expert bodies- provides...

  1. IAEA Mission Concludes Peer Review of Viet Nam's Radiation and Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded a 10-day International Atomic Energy Agency (IAEA) mission to review how Viet Nam's regulatory framework for nuclear and radiation safety has incorporated recommendations and suggestions from an earlier review, conducted in 2009. The Integrated Regulatory Review Service (IRRS) follow-up mission, requested by the Viet Nam Agency for Radiation and Nuclear Safety (VARANS), also reviewed the development of the regulatory safety infrastructure to support Viet Nam's nuclear power programme. The eight-member team comprised senior regulatory experts from Canada, France, Pakistan, Slovenia, United Arab Emirates and the United States of America, as well as three IAEA staff members. The IRRS team said in its preliminary assessment that Viet Nam had made progress since 2009, but that some key recommendations still needed to be addressed. Particular strengths identified by the team included: The commitment of VARANS staff to develop legislation and regulations in the field of nuclear and radiation safety; VARANS' efforts to implement practices that are in line with IAEA Safety Standards and internationally recognized good practices; A willingness to receive feedback regarding the efforts to establish and implement a regulation programme; and Progress made in developing the regulatory framework to support the introduction of nuclear power. The team identified the following areas as high-priority steps to further strengthen radiation and nuclear safety in Viet Nam: The effective independence of the regulatory decision-making process needs to be urgently addressed; Additional resources are needed to regulate existing radiation facilities and activities, as well as the country's research reactor; Efforts to increase the capacity of VARANS to regulate the developing nuclear power programme should continue; The draft Master Plan for the Development of Nuclear Power Infrastructure should be finalized

  2. Linking an agency strategic review to increase knowledge management: San Francisco County Human Service Agency.

    Science.gov (United States)

    Harrison, Lindsay

    2012-01-01

    Led by the agency director, the agency engaged in a Strategic Review, based on a comprehensive assessment of agency performance that identified strategies to improve organizational effectiveness through increased data-informed practice and knowledge management. The Strategic Review gathered information on staff perceptions, perceptions of external stakeholders, changing citywide and neighborhood demographics, policy mandates, and budget and workload issues. The need for the review was based upon multiple, substantial changes not addressed in the 2000 Strategic Plan, including the 2004 merger of the Department of Human Services and the Department of Aging and Adult Services, changes among the executive management team, transitions among key political entities, new policy mandates and changing budget allocations. This case study describes the Strategic Review process and content, summarizing key challenges and lessons related to addressing workload demands, fostering positive staff attitudes, balancing internal and external information needs, and integrating data use and planning processes across the agency. Copyright © Taylor & Francis Group, LLC

  3. The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

    Science.gov (United States)

    Dillon, Lindsey; Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

    2018-04-01

    We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

  4. Organizational behavior of regulatory agencies: a case study of the Bureau of Consumer Services in the Pennsylvania Public Utility Commission

    Energy Technology Data Exchange (ETDEWEB)

    Silver, J.H.

    1981-01-01

    Regulatory agencies operate in a complex field of organizations and interest groups. The variety of behaviors that occur in the regulatory field are not satisfactorily explained by current interpretative frameworks. Regulatory agencies are at once criticized and praised. They flourish as organizational entities, yet they exhibit behavior that is often inexplicable. Notions like clientele capture, the politics of regulation, exchange theory, and institutionalized organizations do not singly explain the vagaries of regulatory behavior. A merger of these viewpoints, however, provides a foundation for a comprehensive interpretative framework. A bureau of consumer services within a state public utility commission is viewed as an institutionalized organization. From this perspective, a variety of ritual behaviors, based upon symbolic and tangible interorganizational exchanges are observed and characterized. The outcome of these exchanges is the establishment of the Bureau of Consumer Services as a legitimate regulatory agent with significant impact upon the formulation of regulatory policy in the formal proceedings of the Pennsylvania Public Utility Commission.

  5. Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies

    Directory of Open Access Journals (Sweden)

    Christoph Ossege

    2015-03-01

    Full Text Available Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs. Yet, we know little about ERAs’ actual autonomy, nor about factors shaping it. This article studies ERAs’ actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise—the “raison d’être” and main resource of expert bodies—provides ERAs with a potentially powerful means to increase autonomy. Relying on a rational institutionalist framework within which ERAs enjoy substantive discretion to pursue their goals, the study empirically compares three powerful ERAs—the European Medicines Agency, the European Chemicals Agency, and the European Food Safety Authority. Based on the analysis of 39 semi-structured expert interviews, findings show that expertise is a crucial explanation for ERAs’ substantive autonomy from the Commission. Towards research intensive private stakeholders, the role of expertise becomes less pronounced. Instead, ERAs are more successful in protecting their autonomy by engaging in the risk-averse interpretation of the regulatory framework and by adapting rules over time to adapt their needs: they engage in “procedural insulation”. Political salience provides a scope condition for ERAs to use expert knowledge and rulemaking competences more strategically—potentially undermining scientific quality.

  6. 77 FR 12594 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-03-01

    ... Script. Refusal Questions Form.. 62 1 2/60 Individual Consent Form. 250 1 3/60 Contact Information Form... Screening 92 1 5/60 Survey. Informed Consent........ 50 1 1/60 Interview Questionnaire. 50 1 1 Network Size...-12-12BL] Agency Forms Undergoing Paperwork Reduction Act Review The Agency for Toxic Substances and...

  7. Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-01-01

    The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

  8. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Science.gov (United States)

    2010-06-18

    ... and FDA-2008-E-0267] Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration, HHS. ACTION... determination because of the submission of applications to the Director of Patents and Trademarks, Department of...

  9. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  10. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to changes in internal and external conditions by dynamically coordinating their gene expression profiles. Our ability to make quantitative measurements in these biochemical circuits has deepened our understanding of what kinds of computations genetic regulatory networks can perform, and with what reliability. These advances have motivated researchers to look for connections between the architecture and function of genetic regulatory networks. Transmitting information between a network's inputs and outputs has been proposed as one such possible measure of function, relevant in certain biological contexts. Here we summarize recent developments in the application of information theory to gene regulatory networks. We first review basic concepts in information theory necessary for understanding recent work. We then discuss the functional complexity of gene regulation, which arises from the molecular nature of the regulatory interactions. We end by reviewing some experiments that support the view that genetic networks responsible for early development of multicellular organisms might be maximizing transmitted 'positional information'. (topical review)

  11. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. 76 FR 13549 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-14

    ...'s regulatory program more effective and less burdensome in achieving its regulatory objectives by... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Chapter IX 50 CFR.... 13563 AGENCY: National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Request for...

  13. 78 FR 27169 - Regulatory Flexibility Act Review

    Science.gov (United States)

    2013-05-09

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Chapter... parts 174, 177, 191, and 192... 2013 2014 Transportation of Natural and Other Gas by Pipeline; Annual... review of some of 49 CFR parts 106, 107, 171. The full analysis document for the hazardous materials...

  14. Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies

    Science.gov (United States)

    Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis

    2017-01-01

    Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy. PMID:28949463

  15. 78 FR 9991 - Agency Information Collection Activities; Information Collection Renewal; Submission for OMB Review

    Science.gov (United States)

    2013-02-12

    ... Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, Transition... a securitization. The Agencies, on August 30, 2012, proposed three rules (Basel III) that would... Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, Transition Provisions, and Prompt...

  16. 76 FR 38654 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-07-01

    ... consent for an interview. After the data collection phase, a multidisciplinary case review team (CRT) will... Post-Partum HIV- FIMR/HIV Maternal 300 1 1.5 infected Women. Interview Form. Daniel L. Holcomb, Reports...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  17. 75 FR 65489 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-10-25

    ... children. The three environmental chemicals, Bisphenol A (BPA), phthalates, and mercury have been selected...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and...

  18. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

  19. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

  20. Review of radioactive waste management research in the Agency

    International Nuclear Information System (INIS)

    2002-01-01

    The report presents a concise summary of the Programme of Radioactive Waste Management Research carried out by the Agency in the period 1996 to 2001. It not only provides information, which is relevant to the Agency's responsibilities, but also offers an input to the government's development of a policy for managing solid radioactive waste in the UK. The research projects have included laboratory and field scientific studies, reviews of existing scientific data and understanding, development of assessment methodologies, and development of technical support software and databases. The Agency has participated widely in internationally-supported projects and on jointly-funded projects amongst UK regulators, advisory bodies and industry

  1. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo [and others

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system.

  2. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system

  3. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  4. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  5. A Review on the Regulatory Strategy of Human Factors Engineering Consideration in Pakistan Nuclear Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Sohail, Sabir [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Seong Nam [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    In this paper, the legal and regulatory infrastructure available in Pakistan for HFE requirements is assessed, and the methodology for strengthening of legal infrastructure is presented. The regulatory strategy on evaluation of HFE consideration should provide reviewers with guidance on review process. Therefore, the suggested methodology is based on preparation of guidance documents such as checklist, working procedures, S and Gs etc.; incorporation of PRM elements in regulatory system; and finally the development of PRM implementation criteria. Altogether, the scheme provide the enhancement in regulatory infrastructure and also the effective and efficient review process. The Three Mile Island (TMI) accident brought the general consensus among the nuclear community on the integration of human factors engineering (HFE) principles in all phases of nuclear power. This notion has further strengthened after the recent Fukushima nuclear accident. Much effort has been put over to incorporate the lesson learned and continuous technical evolution on HFE to device different standards. The total of 174 ergonomics standards are alone identified by Dul et al. (2004) published by International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) and number of standards and HFE guidelines (S and Gs) are also published by organizations like Institute for Electrical and Electronics Engineering (IEEE), International Electrotechnical Commission (IEC), International Atomic Energy Agency (IAEA), United States Nuclear Regulatory Commission (USNRC), etc. The ambition of effective review on HFE integration in nuclear facility might be accomplished through the development of methodology for systematic implementation of S and Gs. Such kind of methodology would also be beneficial for strengthening the regulatory framework and practices for countries new in the nuclear arena and with small scale nuclear program. The objective of paper is to review the

  6. Transportation of Large Wind Components: A Permitting and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2016-09-01

    This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

  7. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

  8. International nuclear safety experts complete IAEA peer review of German regulatory system

    International Nuclear Information System (INIS)

    2008-01-01

    Full text: An international expert team has today completed a two-week IAEA review of Germany's nuclear regulatory system. The team identified good practices within the system and gave advice on some areas for further improvement. The IAEA has conveyed the initial findings to German authorities but the final report will be submitted within two months. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency (IAEA) assembled a team of 14 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. Experts from Canada, the Czech Republic, Finland, France, Japan, the Netherlands, Republic of Korea, Spain, Switzerland, the UK, the US and from the IAEA took part in the mission, which was conducted from 7 to 19 September in Bonn, Stuttgart and Berlin. The main basis for the review was a well-prepared self-assessment made by the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wuerttemberg (UM BW). 'The team members were impressed by the extensive preparation and dedication of the staff both at BMU and UM BW to excellence in nuclear safety,' said Mike Weightman, IRRS Team Leader and Chief Inspector of the UK nuclear regulatory body, the Nuclear Directorate of the Health and Safety Executive. 'We hope the IRRS mission will facilitate further improvements in the safety regulation of nuclear power in Germany and throughout the world.' 'Germany's invitation to undergo such a detailed review is a clear demonstration of its openness and commitment to continuously improve nuclear safety regulation,' said Philippe Jamet, Director of the IAEA's Nuclear Installation Safety Division. Among the particular strengths of BMU and UM BW associated with their

  9. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: International safety experts last week concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Poland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that Poland's nuclear regulator, Panstwowa Agencja Atomistyki (PAA), has a clear commitment to safety, a high level of transparency, competent staff and leadership, and a good recognition of challenges ahead related to Poland's efforts to develop nuclear power. ''Poland's regulatory framework and the work of PAA give high confidence of strong radiation protection for the Polish people. Further, there has been significant progress in the development of Poland's regulatory framework in preparation for the challenge of regulating nuclear power,'' said team leader Robert Lewis, a senior executive in the US Nuclear Regulatory Commission. The mission was conducted at the request of the Government of Poland from 15-25 April. The team was made up of 11 regulatory experts from Belgium, the Czech Republic, Finland, France, the Republic of Korea, Slovakia, Slovenia, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as five IAEA staff members. The IRRS review team was very thorough in its review, and we welcome its advice on how to continue to improve our programmes to protect people and the environment , said Janusz Wlodarski, President of PAA. The team interviewed members of PAA and officials from various ministries, as well as key players in the Polish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. Among its main observations the IRRS review team identified the following good practices: Applying the considerable experience of PAA's senior management to regulatory issues; The introduction of changes to Poland's laws and regulations following broad public consultation at an early stage in

  10. 40 CFR 82.180 - Agency review of SNAP submissions.

    Science.gov (United States)

    2010-07-01

    ... available during the review period that may influence the Agency's evaluation of a substitute, the submitter... decision. Sale or manufacture of new substitutes may commence after the initial 90-day notification period... communicate that decision or the need for additional data to the submitter. Sale or manufacture of existing...

  11. 77 FR 6803 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-02-09

    ... pregnant during Health Questionnaire/ 750 1 20/60 NHANES 1999-2010. Consent Form. 3. State/local vital...-11CE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and... about the pregnant women at the time of interview. Having information on their children's birth...

  12. 77 FR 37051 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-06-20

    ... Year 1 and Year 2. Informed Consent Form... 4,404 1 2/60 Non-Responder Interview. 792 1 5/60 Kimberly S...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...-minute interview will be conducted with a 10% sample of non-responders (up to 792 individuals). In order...

  13. 75 FR 68360 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-11-05

    ...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention... screener questionnaire will be used to determine participation eligibility and obtain oral consent. Approximately 7,000 individuals will be approached and screened (through a 2-minute interview) for eligibility...

  14. 75 FR 6671 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-02-10

    ... programs implemented a new consent form. This form asked participants for permission for CDC to contact...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention... prevention behaviors, CDC will conduct telephone interviews of 425 Matter of Balance program participants six...

  15. 75 FR 24706 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-05-05

    ... parent consent 214 1 10/60 form. Child Clinic Visit--Case 107 1 1.5 children packet. Parent Clinic Visit...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...; (4) a telephone interview focusing on pregnancy-related events and early life history (biological...

  16. 76 FR 55915 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-09-09

    ... type 2 diabetes DPRP Application Form........ 120 1 1 prevention programs. DPRP Evaluation Data... mechanism for recognizing organizations that deliver effective, community-based type 2 diabetes prevention...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  17. 75 FR 36371 - Agency Information Collection Activities Under OMB Review

    Science.gov (United States)

    2010-06-25

    ... AGENCY: Commodity Futures Trading Commission. ACTION: Notice; Information Collection 3038-0019, Stocks of... forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature...: [email protected] and refer to OMB Control No. 3038-0019. SUPPLEMENTARY INFORMATION: Title: Stocks of Grain...

  18. 77 FR 76045 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-12-26

    ... case classification (disease staging system). Recommendations for revisions in the case definition were... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-13-0573] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  19. 77 FR 40363 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-07-09

    ... Methicillin-resistant Staphylococcus aureus (MRSA) among Patients Recently Discharged from Acute Care... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day-12-12II] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  20. 78 FR 40151 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-07-03

    ... resistant Staphylococcus aureus ABCs Case Report Form. ABCs Invasive Pneumococcal 10 41 10/60 Disease in... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day 13-13DB] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  1. 75 FR 20601 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-04-20

    .... Proposed Project Asthma Information Reporting System (AIRS)--New--Air Pollution and Respiratory Health... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-10-09CK] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and prevention...

  2. 78 FR 24422 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-04-25

    ... System (AIRS) (0920-0853, Expiration 06/30/2013)--Extension--Air Pollution and Respiratory Health Branch... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-13-0853] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

  3. International nuclear safety experts conclude IAEA peer review of China's regulatory system

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior experts on nuclear safety regulation today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the People's Republic of China. The team identified good practices within the system and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of the People's Republic of China. The final report will be submitted to China by Autumn 2010. At the request of Chinese authorities, the IAEA assembled a team of 22 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission is a peer review based on the IAEA Safety Standards . It is not an inspection, nor an audit. The experts came from 15 different countries: Australia, Canada, the Czech Republic, Finland, France, Hungary, Japan, Pakistan, the Republic of Korea, Slovenia, South Africa, Sweden, the United Kingdom, Ukraine and the United States. Mike Weightman, the United Kingdom's Head of Nuclear Directorate, HSE and HM Chief Inspector of Nuclear Installations said: ''I was honoured and pleased to lead such a team of senior regulatory experts from around the world, and I was impressed by their commitment, experience and hard work to provide their best advice possible. We had very constructive interactions with the Chinese authority to maximize the beneficial impact of the mission.'' The scope of the mission included the regulation of nuclear and radiation safety of the facilities and activities regulated by the Ministry of Environmental Protection (MEP) National Nuclear Safety Administration (NNSA). The mission was conducted from 18 to 30 July, mainly in Beijing. To observe Chinese regulatory activities, the IRRS team visited several nuclear facilities, including a nuclear power plant, a manufacturer of safety components for nuclear power plants, a research reactor, a fuel cycle facility, a waste management facility

  4. Inspection methods for physical protection Task III review of other agencies' physical security activities for research reactors

    International Nuclear Information System (INIS)

    In Task I of this project, the current Nuclear Regulatory Commission (NRC) position-on physical security practices and procedures at research reactors were reviewed. In the second task, a sampling of the physical security plans was presented and the three actual reactor sites described in the security plans were visited. The purpose of Task III is to review other agencies' physical security activities for research reactors. During this phase, the actions, procedures and policies of two domestic and two foreign agencies other than the NRC that relate to the research reactor community were examined. The agencies examined were: International Atomic Energy Agency; Canadian Atomic Energy Control Board; Department of Energy; and American Nuclear Insurers

  5. The Independence of the Media and Its Regulatory Agencies: Shedding new light on formal and actual independence against the national context

    NARCIS (Netherlands)

    Schultz, W.; Valcke, P.; Irion, K.

    2014-01-01

    Media independence is vital for democracies, and so is the independence of the regulatory bodies governing it. The Independence of the Media and its Regulatory Agencies explores the complex relationship between media governance and independence of media regulatory authorities within Europe, which

  6. Nuclear Experts Complete IAEA Follow-up Review of German Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts concluded a seven-day mission to review the German Regulatory System, conducted from 4-10 September in Bonn, Stuttgart and Berlin. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency assembled a peer-review team of six high-level regulatory experts from six nations (Finland, France, the Netherlands, Switzerland, the UK, the US and three IAEA senior staff members) to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined the progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review at both the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wurttemberg (UM BW). The first mission reviewed Germany's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. IRRS team leader, Mr. McCree, of the US Nuclear Safety Commission (USNRC), said, ''This was an important IRRS mission, particularly given the recent Fukushima Daiichi Nuclear Power Plant accident and the related insights which underscore the importance of having an independent, credible nuclear safety regulator.'' ''The IRRS team identified several strengths of the German nuclear safety regulators, including the prompt and coordinated incident response activities of BMU and UM BW to the Fukushima accident. Some suggestions were also made to further strengthen nuclear safety regulations concerning the future work of BMU,'' he said. The review team found that important progress has been made toward

  7. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading

  8. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

    Science.gov (United States)

    Dufield, Dawn; Neubert, Hendrik; Garofolo, Fabio; Kirkovsky, Leo; Stevenson, Lauren; Dumont, Isabelle; Kaur, Surinder; Xu, Keyang; Alley, Stephen C; Szapacs, Matthew; Arnold, Mark; Bansal, Surendra; Haidar, Sam; Welink, Jan; Le Blaye, Olivier; Wakelin-Smith, Jason; Whale, Emma; Ishii-Watabe, Akiko; Bustard, Mark; Katori, Noriko; Amaravadi, Lakshmi; Aubry, Anne-Françoise; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Duggan, Jeff; Fluhler, Eric; Gorovits, Boris; Gupta, Swati; Hayes, Roger; Ho, Stacy; Ingelse, Benno; King, Lindsay; Lévesque, Ann; Lowes, Steve; Ma, Mark; Musuku, Adrien; Myler, Heather; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wilson, Amanda; Woolf, Eric; Xue, Li; Yang, Tong-Yuan

    2014-01-01

    The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

  9. 75 FR 21871 - Spring 2010 Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Review 10/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Tad Wysor, Environmental...: wysor.tad@epamail.epa.gov Tom Eagles, Environmental Protection Agency, Air and Radiation, 6103A...

  10. The IAEA Integrated Regulatory Review Service Mission to Sweden in February 2012

    International Nuclear Information System (INIS)

    2012-01-01

    The Swedish Government decided on January 22, 2009 to mandate the Swedish Radiation Safety Authority, SSM, to apply for an international review of the Authority and its areas of supervision, an 'IRRS' (Integrated Regulatory Review Service) carried out by the International Atomic Energy Agency (IAEA). On February 25, 2009, SSM made a formal request to the IAEA for an IRRS in Sweden. The time period for the IRRS mission was later agreed to be 6-17 February, 2012. This report summarises the project's progress immediately prior to the IRRS mission in February 2012. The report contains the findings from the self assessment performed by SSM staff. It also contains a plan to implement measures to remedy deficiencies that have been identified and to improve the radiation safety work of the Authority

  11. Conduct of regulatory review and assessment during the licensing process for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants (IAEA Safety Series No. 50-C-G) and is concerned with the review and assessment by the regulatory body of all information submitted in support of licence applications, in the various phases of the licensing process. The purpose of the Guide is to provide information, recommendations and guidance for the conduct of these activities. The scope of the review and assessment will encompass the safety aspects of siting, construction, commissioning, operation and decommissioning of each nuclear power plant

  12. Safety experts complete second IAEA regulatory review of UK nuclear regulator

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: Nuclear safety experts today concluded a 10-day mission to peer-review the UK Nuclear Regulator: Health and Safety Executive (HSE), Nuclear Directorate (ND). At the request of the UK Government, the International Atomic Energy Agency assembled a team of ten high-level regulatory experts from eight nations to conduct the Integrated Regulatory Review Service (IRRS) mission. The mission was the second of three planned IRRS missions for the United Kingdom. The first was held in March 2006 to begin a process to assess the nation's readiness to regulate and license new reactor designs, considered as a result of the Energy Policy review initiated by the British Prime Minister and the Secretary of State for Trade and Industry (DTI) in 2005. The IRRS team leader Mr. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission, stated, ''The IAEA IRRS serves an important role in both benchmarking against its safety standards and in promoting dialogue between nuclear safety regulators from around the world.'' During the 2nd mission the IRRS the team reviewed HSE/ND progress since the first IRRS mission and recent regulatory developments, the regulation of operating power plants and fuel cycle facilities, the inspection and enforcement programme for nuclear power plants and fuel cycle facilities, and the emergency preparedness and response programme. The IAEA found that HSE/ND has made significant progress toward improving its effectiveness in regulating existing nuclear power plants and in preparing to license new nuclear reactors designs. Many of the findings identified in the 2006 report had been fully addressed and therefore could be considered closed, the others are being addressed in accordance with a comprehensive action plan. IRRS team members visited the Heysham 1 Nuclear Power Plant near Lancaster, the Sellafield site at Cumbria and the Strategic Control Centre at Hutton, and they met senior managers from HSE and a UK

  13. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  14. An Assessment of the Efficiency of Government Regulatory Agencies in Nigeria. Case of the National Agency for Food and Drugs Administration and Control

    Directory of Open Access Journals (Sweden)

    Aiwanehi Barbara Ofuani

    2015-09-01

    Full Text Available This study examines Business, Government and Society interrelationships. It eventually narrowed down to assessing the efficiency of government regulatory agencies, in fulfilling the role of government in protecting consumers from unscrupulous practices of businesses. The National Agency for Food and Drugs Administration and Control (NAFDAC was chosen for the study. Since the expectations of the consumers are paramount here, the stakeholder approach method was used for assessing the efficiency of NAFDAC. Literature and previous empirical studies on the topic were examined. For representativeness, data was collected utilizing the survey research design through Questionnaire distributed to 200 respondents in some areas of Lagos Mainland in Lagos state, using the convenience sampling method. 187 copies of the questionnaire representing 93.5% were returned and usable. Descriptive statistics was used to analyze the responses to questions regarding the efficiency of NAFDAC and a hypothesis tested using a one-sample T-test. The findings ran contrary to results from some previous studies. Instead, consumer awareness of the existence of NAFDAC as a regulatory agency and its functions were established, along with a high rate of consumer education. The assessment of its efficiency also showed a high rating. Recommendations were made that the study be replicated in other states of Nigeria and further studies carried out to evaluate its efficiency under previous and current directors for improvement purposes.

  15. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Bulgaria. The Integrated Regulatory Review Service (IRRS) mission, conducted at the request of the Government of Bulgaria, identified a series of good practices and made recommendations to help enhance the overall performance of the regulatory system. IRRS missions, which were initiated in 2006, are peer reviews based on the IAEA Safety Standards; they are not inspections or audits. ''Bulgaria has a clear national policy and strategy for safety, which are well in line with international standards and practices and contribute to a high level of nuclear safety,'' said Mission Team Leader Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of the Slovak Republic. The mission team, which conducted the review from 8 to 19 April, was made up of 16 senior regulatory experts from 16 nations, and six IAEA staff. ''The results of the IRRS mission will be valuable for the future development and reinforcement of the Bulgarian Nuclear Safety Agency (BNRA). The use of international standards and good practices helps to improve global harmonization in all areas of nuclear safety and radiation protection,'' said Sergey Tzotchev, Chairman of the BNRA. Among the main observations in its preliminary report, the IRRS mission team found that BNRA operates as an independent regulatory body and conducts its regulatory processes in an open and transparent manner. In line with the IAEA Action Plan on Nuclear Safety, the mission reviewed the regulatory implications for Bulgaria of the March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station in Japan. It found that the BNRA's response to the lessons learned from that accident was both prompt and effective. Strengths and good practices identified by the IRRS team include the following: A no-blame policy is enshrined in law for

  16. 49 CFR 659.29 - Oversight agency safety and security reviews.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Oversight agency safety and security reviews. 659... Role of the State Oversight Agency § 659.29 Oversight agency safety and security reviews. At least... safety program plan and system security plan. Alternatively, the on-site review may be conducted in an on...

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

    Science.gov (United States)

    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.

  18. 77 FR 12896 - Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66459; File No. 600-11] Self-Regulatory..., 2006), 72 FR 814 (Jan. 8, 2007). Section 19(a)(3) of the Act \\14\\ provides that in the event any self-regulatory organization is no longer in existence or has ceased to do business in the capacity specified in...

  19. Senior expert group for the review of the Agency`s programme of activities. Opening remarks by the Director General

    Energy Technology Data Exchange (ETDEWEB)

    ElBaradei, M [International Atomic Energy Agency, Vienna (Austria)

    1998-03-23

    The document reproduces the opening remarks made by the Director General of the IAEA on 23 March 1998 at the first meeting of the Senior Expert Group for the review of the Agency`s programme and activities. The Director General explains his considerations in establishing the group, and the major challenges facing the safe use of nuclear energy and technologies

  20. A review of NRC regulatory processes and functions

    International Nuclear Information System (INIS)

    1981-05-01

    A reexamination by the ACRS of the Regulatory Process has been made. Objectives were to provide in a single source, ACRS' understanding of the Regulatory Process and to point out perceived weaknesses and to make appropriate recommendations for change

  1. International nuclear safety experts conclude IAEA peer review of Canada's regulatory system

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: An international team of nuclear safety experts today completed a two-week IAEA review of the regulatory framework and effectiveness of the Canadian Nuclear Safety Commission (CNSC). The team identified good practices within the system and gave advice on some areas for improvement. The IAEA has conveyed initial findings to Canadian authorities; the final report will be submitted by autumn. The International Atomic Energy Agency (IAEA) assembled a team of nuclear, radiation, and waste safety experts at the request of the Government of Canada, to conduct an Integrated Regulatory Review Service (IRRS) mission. The mission from 31 May to 12 June was a peer review based on IAEA Standards, not an inspection, nor an audit. The scope of the mission included sources, facilities and activities regulated by the CNSC: the operation of nuclear power plants (NPPs), research reactors and fuel cycle facilities; the refurbishment or licensing of new NPPs; uranium mining; radiation protection and environmental protection programmes; and the implementation of IAEA Code of Conduct on Safety and Security of Radioactive Sources. The 21-member team from 13 IAEA States and from the IAEA itself reviewed CNSC's work in all relevant areas: legislative and governmental responsibilities; responsibilities and functions; organization; activities of the regulatory body, including the authorization process, review and assessment, inspection and enforcement, the development of regulations, as well as guides and its the management system of CNSC. The basis for the review was a well-prepared self-assessment by the CNSC, including an evolution of its strengths and proposed actions to improve its regulatory effectiveness. Mr. Shojiro Matsuura, IRRS Team Leader and President of the Japanese Nuclear Safety Research Association, said the team 'was impressed by the extensive preparation at all CNSC staff levels.' 'We identified a number of good practices and made recommendations and suggestions

  2. 77 FR 5250 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment Request

    Science.gov (United States)

    2012-02-02

    ... currently valid Office of Management and Budget (OMB) control number. On November 23, 2011, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), published a notice... agencies, Shagufta Ahmed, by mail to the Office of Information and Regulatory Affairs, Office of Management...

  3. Regulatory review of releases from HIFAR of radioactive airborne effluent

    International Nuclear Information System (INIS)

    Westall, D.J.; Macnab, D.I.

    1996-01-01

    Full text: The Nuclear Safety Bureau (NSB) was set up by legislation in 1992 as an independent Commonwealth corporate body reporting to the Minister for Health and Family Services. Its functions include monitoring and reviewing the safety of nuclear plant owned or operated by the Australian Nuclear Science and Technology Organisation (ANSTO). The NSB sets requirements for authorisation of the operation of the HIFAR research reactor, and may impose restrictions and conditions on its operation. The authorisation for the operation of HIFAR includes a requirement for arrangements for the treatment, safe storage and disposal of solid, liquid and gaseous radioactive wastes from the reactor. The objective is to establish conditions which would ensure that radiation exposure to plant personnel and the public from radioactive wastes are within acceptable limits and that releases are maintained as low as reasonably achievable. The NSB has developed expectations based on international best practice, against which to review HIFAR's arrangements for satisfying the requirement and achieving the objective. Arrangements for the release of airborne radioactive effluent from HIFAR were reviewed by the NSB as part of an overall review of the upgrade of safety documentation for HIFAR. The NSB's expectations for the review were drawn from the International Atomic Energy Agency (IAEA) Basic Safety Standards (Safety Series No 115-I) and the National Health and Medical Research Council (NHMRC) Recommendations for Limiting Exposure to Ionizing Radiation (1995). These expectations included a hierarchy of primary dose limits, stack discharge limits and reference levels for HIFAR aimed at ensuring that radiation doses to the public due to airborne effluent are less than the national dose limits and ANSTO's dose constraints, and are as low as reasonably achievable. An approach favoured by the operator is to work directly to a primary dose limit using an airborne dispersion computer program to

  4. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  5. International Expert Team Concludes IAEA Peer Review of Finland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: International safety experts today concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Finland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that the Radiation and Nuclear Safety Authority of Finland (STUK) is a competent and highly credible regulator that is open and transparent and derives great strength from the technical competence of its staff. ''Finland's comprehensive regulatory framework allows STUK to operate in practice as an independent regulatory body,'' said team leader Philippe Jamet, a commissioner of the French regulatory body ASN. The mission was conducted at the request of the Government of Finland from 15-26 October. The team interviewed members of STUK and officials from various ministries, as well as key players in the Finnish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. The team was made up of 18 members from Bulgaria, Canada, the Czech Republic, France, Germany, Iceland, Ireland, Romania, the Russian Federation, South Africa, Slovakia, Slovenia, Spain, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as six IAEA staff members. 'The IRRS mission and preparation for it was a unique occasion that involved the whole organization, provided motivation for improvement of the safety framework in Finland and assists STUK review its mission', said Tero Varjoranta, Director General of STUK. The IRRS team identified a number of good practices and achievements, including: - STUK's excellence in its safety assessment of nuclear power plants and waste repositories, in particular its demonstration that long-term political commitment is a necessity to sustain the creation of a waste repository as well as its regulatory oversight of medical applications of radiation sources; and - STUK's excellent record in

  6. Regulatory Aspect of Periodic Safety Review Performed in Nuclear Power Plants in the Slovak Republic

    International Nuclear Information System (INIS)

    Baszo, Z.

    2010-01-01

    The paper deals with the regulatory aspect of Nuclear Power Plant (NPP) Periodic Safety Review (PSR) as a part of license renewal process in the Slovak Republic. It summarizes the history of activities similar to PSR performed in the past for NPPs operated in the Slovak Republic. Furthermore, it describes both the requirements involved in the current Slovak legislation to be met by licensee in the Slovak Republic in this field and the procedures concerning the PSR as well. The objective and rules of PSR to be performed for NPPs in the Slovak Republic were derived from the internationally accepted International Atomic Energy Agency (IAEA) document and have been implemented into national legislation. PSR of two twin units located in Bohunice NPP and Mochovce NPP, respectively, has been initiated in the Slovak Republic based on evaluation of each area to be reviewed (safety factors) using recent methodology and practice. Other significant factors, such as ageing, modifications of NPP and the safe operation for a specified future period, have to be assessed in the frame of PSR. Report on performed PSR outlines the results of review for each area, the corrective plan, which considering mutual relations between assessed areas specifies the issues to be solved with the aim to eliminate shortcomings identified in the frame of PSR and to adopt safety improvements. The findings from PSR in the evaluated areas also serve as a source of information for updating of all documents to be attached to the written application of licensee for renewal of a nuclear power plant operating license. The presented procedure describes how the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) has reviewed the documents submitted during PSR. Based on results of submitted documents evaluation and licensee application for license renewal the license for next 10 years operation has been issued for Bohunice NPP. At present, similar procedure for Mochovce NPP unit 1 and 2 is underway.(author).

  7. 77 FR 28467 - Identifying and Reducing Regulatory Burdens

    Science.gov (United States)

    2012-05-14

    ... online wherever practicable. Sec. 3. Setting Priorities. In implementing and improving their... regulatory priorities, to promote public participation in retrospective review, to modernize our regulatory..., agencies shall give priority, consistent with law, to those initiatives that will produce significant...

  8. The Senses of Agency and Ownership: A Review.

    Science.gov (United States)

    Braun, Niclas; Debener, Stefan; Spychala, Nadine; Bongartz, Edith; Sörös, Peter; Müller, Helge H O; Philipsen, Alexandra

    2018-01-01

    Usually, we do not question that we possess a body and act upon the world. This pre-reflective awareness of being a bodily and agentive self can, however, be disrupted by different clinical conditions. Whereas sense of ownership (SoO) describes the feeling of mineness toward one's own body parts, feelings or thoughts, sense of agency (SoA) refers to the experience of initiating and controlling an action. Although SoA and SoO naturally coincide, both experiences can also be made in isolation. By using many different experimental paradigms, both experiences have been extensively studied over the last years. This review introduces both concepts, with a special focus also onto their interplay. First, current experimental paradigms, results and neurocognitive theories about both concepts will be presented and then their clinical and therapeutic relevance is discussed.

  9. NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.E.

    1995-09-01

    New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

  10. 75 FR 16809 - Agency Information Collection Activities; Submission for OMB Review; Proposed Collection; Comment...

    Science.gov (United States)

    2010-04-02

    ... Form 450 Executive Branch Confidential Financial Disclosure Report to the Office of Management and...: Title: Executive Branch Confidential Financial Disclosure Report. Agency Form Number: OGE Form 450. OMB... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Submission for OMB Review...

  11. 77 FR 19680 - Extension of Agency Information Collection Activity Under OMB Review: Rail Transportation Security

    Science.gov (United States)

    2012-04-02

    ... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration [Docket No. TSA-2006-26514] Extension of Agency Information Collection Activity Under OMB Review: Rail Transportation Security AGENCY: Transportation Security Administration, DHS. ACTION: 30-day Notice. SUMMARY: This notice announces that the...

  12. 77 FR 15114 - Extension of Agency Information Collection Activity Under OMB Review: Transportation Security...

    Science.gov (United States)

    2012-03-14

    ... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Transportation Security Officer (TSO) Medical Questionnaire AGENCY: Transportation Security Administration, DHS. ACTION: 30-day Notice. SUMMARY: This notice...

  13. 75 FR 2556 - Extension of Agency Information Collection Activity Under OMB Review: Transportation Security...

    Science.gov (United States)

    2010-01-15

    ... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Transportation Security Officer (TSO) Medical Questionnaire AGENCY: Transportation Security Administration, DHS. ACTION: 30-day notice. SUMMARY: This notice...

  14. The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

    IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

  15. 42 CFR 456.171 - Medicaid agency review of need for admission.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Medicaid agency review of need for admission. 456.171 Section 456.171 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Hospitals Medical, Psychiatric, and Social Evaluations and Admission Review § 456.171 Medicaid agency review...

  16. As agências reguladoras e o modelo constitucional brasileiro / Regulatory Agencies and the Constitutional Brazilian System

    Directory of Open Access Journals (Sweden)

    Ana Carolina Borges de Oliveira

    2018-05-01

    Full Text Available Purpose – This article tackles the role of the regulatory agencies and, therefore, verifies the separation of powers model adopted by the Brazilian Constitution, focused on how the constitutional Brazilian system adopted the liberal principle of the separation of powers. Methodology/approach/design – This research analyzes Montesquieu’s theory of separation of powers and its influence on the constitutional Brazilian system. It studies the model proposed by Jürgen Habermas, who proposes a discursive theory of law. Finally, it examines the regulatory phenomenon in Brazil, as well as the structure and the roles played by regulatory agencies in acts. Findings – It is concluded that the role of regulatory agencies in the constitutional Brazilian system can be framed as the new actor in the policy formation process that culminates in decisions about laws and policies. Resumo Propósito – O presente estudo pretende investigar o papel normativo das agências reguladoras e, por conseguinte, verificar se o modelo de separação de poderes adotado pela atual Constituição Federal estaria superado, ou seja, busca-se analisar se há uma incompatibilidade entre o modelo constitucional brasileiro e a atividade normativa desenvolvida pelas agências reguladoras no Brasil. Metodologia/abordagem/design – A presente pesquisa terá como pressupostos teóricos a teoria da separação de poderes desenvolvida por Montesquieu e sua influência nas ordens política e jurídica brasileiras. Adotará, também, como base teórica, o modelo proposto por Jürgen Habermas. Por fim, analisará o fenômeno regulatório no Brasil, bem como a estrutura e os papéis desempenhados pelas agências reguladoras no atual sistema; a fim de verificar se é possível defender que a teoria da separação dos poderes proposta pela Constituição Federal de 1988 está superada Resultados – Conclui-se que o papel desempenhado pelas agências reguladoras no contexto jur

  17. 75 FR 14163 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-03-24

    ... resulted in at least 1351 school dismissals due to rapidly increasing absenteeism among students or staff... information; the organization/agency; phone number of the organization/agency; and e-mail address. There is no...

  18. The accountability of the brazilian regulatory agencies: the experience of the National Petroleum Agency; O controle externo das agencias reguladoras: o caso da Agencia Nacional do Petroleo

    Energy Technology Data Exchange (ETDEWEB)

    Pinto Junior, Helder Queiroz; Borges, Heloisa Lopes [Universidade Federal do Rio de Janeiro (UFRJ), RJ (Brazil). Inst. de Economia. Grupo de Economia da Energia

    2004-07-01

    During the reform process for which passed the Brazilian Oil and Gas Industry, the academic debate was centered mostly in the sectorial restructuring process, in the contract designs and regulatory environment for the industries in change, particularly the desired attributes of its institutions. The debate tends, in the present, to converge towards the existence of different possible combinations between market structures and institutional structures (the regulators among them) that would lead to a desirable result. Thus, the various characteristics and configurations, originally appointed as necessary conditions for the success of any reform, are not dealt with such great deference anymore. The hypothesis that the existence of a independent regulator is a determinant choice for the success of structural and institutional reforms was relaxed as general rule, but there are still strong economic reasons to justify the option, adopted in Brazil. The creation of the Oil National Agency (ANP), the Brazilian regulator for the Oil and Gas Industry is a recent phenomenon. And few studies specifically approach the issue of its accountability, institutional role that in Brazil is delegated mostly, but not exclusively, to the National Court of Accounts (Tribunal de Contas da Uniao). Therefore, the objective of this work will be to discuss the different possibilities of accountability over the ANP, evaluating the paper and the functions of the TCU and the forms of external control on the Agency, pointing out the possibilities, the impediments and the challenges, as well as the economic consequences to the Natural Gas Industry of the current configuration. (author)

  19. Agency rivalry in a shared regulatory space and its impact on social welfare

    DEFF Research Database (Denmark)

    Gedefaw Abate, Tenaw; Nielsen, Rasmus; Nielsen, Max

    2018-01-01

    for the best interest of the people, they can have their own rational agendas; such as career advancement, self-aggrandizement and loyalty for a particular political ideology. We show that when officials are non-benevolent and agencies have unequal relative decision-making power, it is likely that a more...

  20. Comparison of ISO 9000 and recent software life cycle standards to nuclear regulatory review guidance

    International Nuclear Information System (INIS)

    Preckshot, G.G.; Scott, J.A.

    1998-01-01

    Lawrence Livermore National Laboratory is assisting the Nuclear Regulatory Commission with the assessment of certain quality and software life cycle standards to determine whether additional guidance for the U.S. nuclear regulatory context should be derived from the standards. This report describes the nature of the standards and compares the guidance of the standards to that of the recently updated Standard Review Plan

  1. Mapping knowledge investments in the aftermath of Hurricane Katrina: a new approach for assessing regulatory agency responses to environmental disaster

    International Nuclear Information System (INIS)

    Frickel, Scott; Campanella, Richard; Vincent, M. Bess

    2009-01-01

    In the aftermath of large-scale disasters, the public's dependency on federal and state agencies for information about public safety and environmental risk is acute. While formal rules and procedures are in place to guide policy decisions in environmental risk assessment of spatially concentrated hazards such as regulated waste sites or vacant city lots, standard procedures for risk assessment seem potentially less well-suited for urban-scale disaster zones where environmental hazards may be widely dispersed and widely varying. In this paper we offer a new approach for the social assessment of regulatory science in response to large-scale disaster, illustrating our methodology through a socio-spatial analysis of the U.S. Environmental Protection Agency's (EPA) hazard assessment in New Orleans, Louisiana, following Hurricane Katrina in 2005. We find that the agency's commitment of epistemic resources or 'knowledge investments' varied considerably across the flood-impacted portion of the city, concentrating in poorer and disproportionately African American neighborhoods previously known to be heavily contaminated. We address some of the study's social and policy implications, noting the multidimensionality and interactive nature of knowledge investments and the prospects for deepening and extending this approach through comparative research

  2. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Science.gov (United States)

    2012-05-02

    ... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

  3. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Science.gov (United States)

    2010-12-09

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... adults. It should be used as adjunctive therapy in patients who have responded inadequately to several...

  4. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Science.gov (United States)

    2011-06-23

    ... drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA... after high-dose methotrexate therapy in osteosarcoma and is also indicated to diminish the toxicity and...

  5. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Science.gov (United States)

    2012-05-03

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

  6. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  7. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Science.gov (United States)

    2011-03-17

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... in patients who have received at least one prior systemic therapy. Subsequent [[Page 14672

  8. 78 FR 68905 - Agency Information Collection (Wrist Conditions Disability Benefits Questionnaire) Under OMB Review

    Science.gov (United States)

    2013-11-15

    ... Number: 2900-NEW (Wrist Conditions Disability Benefits Questionnaire). Type of Review: New data... Conditions Disability Benefits Questionnaire) Under OMB Review AGENCY: Veterans Benefits Administration...- NEW (Wrist Conditions Disability Benefits Questionnaire)'' in any correspondence. FOR FURTHER...

  9. 78 FR 68908 - Agency Information Collection (Ankle Conditions Disability Benefits Questionnaire) Under OMB Review

    Science.gov (United States)

    2013-11-15

    ...: 2900--NEW (Ankle Conditions Disability Benefits Questionnaire). Type of Review: New data collection... Conditions Disability Benefits Questionnaire) Under OMB Review AGENCY: Veterans Benefits Administration...-- NEW (Ankle Conditions Disability Benefits Questionnaire)'' in any correspondence. FOR FURTHER...

  10. 76 FR 13420 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-03-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency... Resources and Services Administration (HRSA) publishes abstracts of information collection requests under... Act of 1995: Proposed Project: The Division of Independent Review Grant Reviewer Recruitment Form (OMB...

  11. 77 FR 7244 - Agency Information Collection (Supplier Perception Survey) Activity Under OMB Review

    Science.gov (United States)

    2012-02-10

    ... Perception Survey) Activity Under OMB Review AGENCY: Office of Acquisition, Logistics and Construction... Veterans Affairs Supplier Perception Survey. OMB Control Number: 2900-2900-0751. Type of Review: Extension... and logistics operations across VA enterprise. An agency may not conduct or sponsor, and a person is...

  12. 42 CFR 456.372 - Medicaid agency review of need for admission.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Medicaid agency review of need for admission. 456.372 Section 456.372 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND... Medicaid agency review of need for admission. Medical and other professional personnel of the Medicaid...

  13. 75 FR 2866 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-01-19

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet--Form FDA 3601 AGENCY: Food and Drug Administration, HHS... of information has been submitted to the Office of Management and Budget (OMB) for review and...

  14. 78 FR 8543 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-02-06

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration, HHS... of information has been submitted to the Office of Management and Budget (OMB) for review and...

  15. 76 FR 7866 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-02-11

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet, Form 3546 AGENCY: Food and Drug Administration, HHS. ACTION... information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the...

  16. 76 FR 4117 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-01-24

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice... has been submitted to the Office of Management and Budget (OMB) for review and clearance under the...

  17. 78 FR 38077 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-06-25

    ... the World Wide Web. The survey is a fully automated Web data collection effort and is handled... NATIONAL SCIENCE FOUNDATION Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: National Science Foundation. ACTION: Submission for OMB Review; Comment Request...

  18. 76 FR 31683 - Agency Information Collection (Supporting Statement Regarding Marriage) Activity under OMB Review

    Science.gov (United States)

    2011-06-01

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0115] Agency Information Collection (Supporting Statement Regarding Marriage) Activity under OMB Review AGENCY: Veterans Benefits Administration... Marriage, VA Form 21-4171. OMB Control Number: 2900-0115. Type of Review: Extension of a currently approved...

  19. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

  20. 77 FR 70780 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-11-27

    ... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... notice. Proposed Project Generic Clearance for the Collection of Qualitative Feedback on Agency Service... Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork...

  1. 78 FR 26033 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-05-03

    ... precision requirements or power calculations that justify the proposed sample size, the expected response... Collection of Qualitative Feedback on Agency Service Delivery--NEW--Epidemiology and Analysis Program Office... Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under...

  2. 77 FR 27062 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-05-08

    ... calculations that justify the proposed sample size, the expected response rate, methods for assessing potential... Project NIOSH Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery--NEW... Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency...

  3. 75 FR 9223 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-03-01

    ... school dismissals due to rapidly increasing absenteeism among students or staff that impacted at least.... Optional data elements include: name of person submitting information; the organization/agency; phone number of the organization/agency; and e-mail address. There is no cost to respondents other than their...

  4. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  5. 76 FR 66312 - Agency Information Collection Activities: Submission for Review; Information Collection Request...

    Science.gov (United States)

    2011-10-26

    ... information collection (2) Title of the Form/Collection: Science and Technology, Biodefense Knowledge Center... (DHS), Science and Technology, Biodefense Knowledge Center (BKC) AGENCY: Science and Technology... to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should...

  6. 77 FR 67057 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment Request

    Science.gov (United States)

    2012-11-08

    ... unless it displays a currently valid Office of Management and Budget (OMB) control number. On July 30, 2012, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC... the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive...

  7. 76 FR 51123 - Agency Information Collection Activities; Submission for OMB Review and Approval; Joint Comment...

    Science.gov (United States)

    2011-08-17

    ... clearly the definition of capital used in any aspect of its internal capital adequacy assessment process (ICAAP) and document any changes in the internal definition of capital. Section 41 requires banks to... regulatory or accounting). The agencies' burden estimates for these information collection requirements are...

  8. 76 FR 8940 - Regulatory Review of Existing DOT Regulations

    Science.gov (United States)

    2011-02-16

    ... interested in comments about factors that the Department should consider in setting priorities and selecting... set forth in our semi-annual Regulatory Agenda published in the Federal Register (see Appendix D to... rulemaking priorities. Moreover, under 49 CFR part 5, anyone may petition the Department for rulemaking or...

  9. 78 FR 78971 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-12-27

    ... review and the information required in a request for review. In the event that we place an article of...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

  10. An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment.

    Science.gov (United States)

    Calabrese, Edward J

    2015-04-01

    The Genetics Panel of the National Academy of Sciences' Committee on Biological Effects of Atomic Radiation (BEAR) recommended the adoption of the linear dose-response model in 1956, abandoning the threshold dose-response for genetic risk assessments. This recommendation was quickly generalized to include somatic cells for cancer risk assessment and later was instrumental in the adoption of linearity for carcinogen risk assessment by the Environmental Protection Agency. The Genetics Panel failed to provide any scientific assessment to support this recommendation and refused to do so when later challenged by other leading scientists. Thus, the linearity model used in cancer risk assessment was based on ideology rather than science and originated with the recommendation of the NAS BEAR Committee Genetics Panel. Historical documentation in support of these conclusions is provided in the transcripts of the Panel meetings and in previously unexamined correspondence among Panel members.

  11. 75 FR 53311 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-08-31

    ...; customer satisfaction surveying; ethnography/observational studies; and mystery shopping. The data will be... improvements in people's health. To do this, the agency is defining specific health protection goals to... development, implementation and satisfaction regarding public health services, products, communication...

  12. 75 FR 65487 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-10-25

    ...; customer satisfaction surveying; ethnography/observational studies; and mystery shopping. The data will be... improvements in people's health. To do this, the agency is defining specific health protection goals to... development, implementation and satisfaction regarding public health services, products, communication...

  13. 76 FR 77855 - Criteria for Identifying Material Licensees for the U. S. Nuclear Regulatory Commission's Agency...

    Science.gov (United States)

    2011-12-14

    ... effectiveness, including a review of approved deviations from the action matrix, and (5) to ensure that trends in industry and licensee performance are recognized and appropriately addressed. ADDRESSES: A copy of... below. (1) Strategic Plan--Licensee has an event that results in the failure to meet a strategic outcome...

  14. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    International Nuclear Information System (INIS)

    Wilmot, Roger D.

    2011-02-01

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  15. Treatment of differing professional opinions in the regulatory review process

    International Nuclear Information System (INIS)

    Shapar, H.K.

    1978-01-01

    The Nuclear Regulatory Commission is an independent body whose purpose is to assure that civilian nuclear activities are consistent with the public health and safety and environmental protection. To this effect, Congress has vested it with the necessary control powers. The question here is how to reconcile diverging opinions expressed within NRC by executives and technicians during the enquiry pocedure for licensing of nuclear installations. The diversity of professional viewpoints should be viewed as a positive factor strengthening the regulatory process and should therefore be maintained. However, decisions must be made; therefore some viewpoints will not prevail but that should not be construed as a signal that the internal discussion process is condemned. NRC staff are entitled to express their views and not subjected to professional and administrative sanctions for doing so. (NEA) [fr

  16. Nuclear regulatory review of licensee self-assessment (LSA)

    International Nuclear Information System (INIS)

    2003-01-01

    Licensee self-assessment (LSA) by nuclear power plant operators is described as all the activities that a licensee performs in order to identify opportunities for improvements. An LSA is part of an organisation's holistic management system, which must include other process elements. Particularly important elements are: a process for choosing which identified potential improvements should be implemented and a process of project management for implementing the improvements chosen. Nuclear regulators expect the licensee to run an effective LSA programme, which reflects the licensee's 'priority to safety'. Based on contributions from members of the NEA Committee on Nuclear Regulatory Activities (CNRA), this publication provides an overview of the current regulatory philosophy on and approaches to LSA as performed by licensees. The publication's intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  17. Health Physics Society Comments to U.S. Environmental Protection Agency Regulatory Reform Task Force.

    Science.gov (United States)

    Ring, Joseph; Tupin, Edward; Elder, Deirdre; Hiatt, Jerry; Sheetz, Michael; Kirner, Nancy; Little, Craig

    2018-05-01

    The Health Physics Society (HPS) provided comment to the U.S. Environmental Protection Agency (EPA) on options to consider when developing an action plan for President Trump's Executive Order to evaluate regulations for repeal, replacement, or modification. The HPS recommended that the EPA reconsider their adherence to the linear no-threshold (LNT) model for radiation risk calculations and improve several documents by better addressing uncertainties in low-dose, low dose-rate (LDDR) radiation exposure environments. The authors point out that use of the LNT model near background levels cannot provide reliable risk projections, use of the LNT model and collective-dose calculations in some EPA documents is inconsistent with the recommendations of international organizations, and some EPA documents have not been exposed to the public comment rule-making process. To assist in establishing a better scientific basis for the risks of low dose rate and low dose radiation exposure, the EPA should continue to support the "Million Worker Study," led by the National Council on Radiation Protection and Measurement.

  18. 76 FR 3821 - Improving Regulation and Regulatory Review

    Science.gov (United States)

    2011-01-21

    ... private sector, and the public as a whole. (b) To promote that open exchange, each agency, consistent with... environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based... are potentially subject to such rulemaking. Sec. 3. Integration and Innovation. Some sectors and...

  19. Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

    Science.gov (United States)

    Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

    2017-01-01

    Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general

  20. Nuclear Regulatory Commission's antitrust review process: an analysis of the impacts

    International Nuclear Information System (INIS)

    1981-06-01

    The Nuclear Regulatory Commission's (NRC) antitrust process is reviewed and its impacts to small systems and applicant systems are studied. This process takes the form of a description of the NRC's antitrust review process as implemented, a generic categorization of potential impacts and individual case-by-case studies of four different utilities

  1. Systematic review of qualitative literature on occupational health and safety legislation and regulatory enforcement planning and implementation.

    Science.gov (United States)

    MacEachen, Ellen; Kosny, Agnieszka; Ståhl, Christian; O'Hagan, Fergal; Redgrift, Lisa; Sanford, Sarah; Carrasco, Christine; Tompa, Emile; Mahood, Quenby

    2016-01-01

    The ability of occupational health and safety (OHS) legislation and regulatory enforcement to prevent workplace injuries and illnesses is contingent on political, economic, and organizational conditions. This systematic review of qualitative research articles considers how OHS legislation and regulatory enforcement are planned and implemented. A comprehensive search of peer-reviewed, English-language articles published between 1990 and 2013 yielded 11 947 articles. We identified 34 qualitative articles as relevant, 18 of which passed our quality assessment and proceeded to meta-ethnographic synthesis. The synthesis yielded four main themes: OHS regulation formation, regulation challenges, inspector organization, and worker representation in OHS. It illuminates how OHS legislation can be based on normative suppositions about worker and employer behavior and shaped by economic and political resources of parties. It also shows how implementation of OHS legislation is affected by "general duty" law, agency coordination, resourcing of inspectorates, and ability of workers to participate in the system. The review identifies methodological gaps and identifies promising areas for further research in "grey" zones of legislation implementation.

  2. Problems and experience of regulatory review associated with plant construction and commissioning

    International Nuclear Information System (INIS)

    Commander, W.

    1979-01-01

    The work of the Assessment Branch of NII covering the regulatory review during design safety assessment, construction, commissioning and operation is described commencing with the nuclear licensing procedure through licence variations and conditions attached to the licence, to the final stages of plant construction up to commercial operation and full power production. The importance of the application of safety assessment principles is outlined, the importance of the Safety Inspectorate Schedule described, and the need to retain organisational and regulatory flexibility emphasised. (author)

  3. Regulatory instrument review: Management of aging of LWR [light water reactor] major safety-related components

    International Nuclear Information System (INIS)

    Werry, E.V.

    1990-10-01

    This report comprises Volume 1 of a review of US nuclear plant regulatory instruments to determine the amount and kind of information they contain on managing the aging of safety-related components in US nuclear power plants. The review was conducted for the US Nuclear Regulatory Commission (NRC) by the Pacific Northwest Laboratory (PNL) under the NRC Nuclear Plant Aging Research (NPAR) Program. Eight selected regulatory instruments, e.g., NRC Regulatory Guides and the Code of Federal Regulations, were reviewed for safety-related information on five selected components: reactor pressure vessels, steam generators, primary piping, pressurizers, and emergency diesel generators. Volume 2 will be concluded in FY 1991 and will also cover selected major safety-related components, e.g., pumps, valves and cables. The focus of the review was on 26 NPAR-defined safety-related aging issues, including examination, inspection, and maintenance and repair; excessive/harsh testing; and irradiation embrittlement. The major conclusion of the review is that safety-related regulatory instruments do provide implicit guidance for aging management, but include little explicit guidance. The major recommendation is that the instruments be revised or augmented to explicitly address the management of aging

  4. 78 FR 75926 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-12-13

    ... Geographic Classification Review Board (MGCRB) in reviewing and making decisions regarding hospitals... the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk... Deborah Larwood at 410-786-9500). 2. Type of Information Collection Request: Extension without change of a...

  5. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    Science.gov (United States)

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  6. Overall review strategy for the Nuclear Regulatory Commission's High-Level Waste Repository Program

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-11-01

    The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. These reviews are in support of the Commission's construction authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supporting performance assessments, analyses, and research

  7. Carbon Capture and Storage: Legal and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA has estimated that the broad deployment of low-carbon energy technologies could reduce projected 2050 emissions to half 2005 levels -- and that CCS could contribute about one-fifth of those reductions. Reaching that goal, however, would require around 100 CCS projects to be implemented by 2020 and over 3000 by 2050.

  8. 76 FR 55393 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-09-07

    ... potential short-term and long-term health effects among children who lived in FEMA-provided temporary... adverse health effects among children who resided in Federal Emergency Management Agency (FEMA)-provided.... Proposed Project Children's Health After the Storms (CHATS)--New--National Center for Environmental Health...

  9. 75 FR 3736 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-01-22

    ... Career Development (OWCD), Centers for Disease Control and Prevention (CDC). Background and Brief... activities to professionals worldwide. Employees of hospitals, universities, medical centers, laboratories, State and Federal agencies, and State and local health departments apply for training to learn up-to...

  10. 78 FR 16269 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-03-14

    ...-0017, Expiration 03/31/ 2013)--Revision--Scientific Education and Professional Development Program... activities to professionals worldwide. Employees of hospitals, universities, medical centers, laboratories, state and federal agencies, and state and local health departments apply for training to learn up-to...

  11. 75 FR 70929 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-11-19

    ... national anti-terrorism policies and assigned specific missions to federal departments and agencies. The... respond to acts of biological, chemical, or radiological terrorism and other public health emergencies... equipment inventories. The collection of personal identifiable information for the purpose of communication...

  12. 77 FR 58142 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-09-19

    ...). Background and Brief Description Violence is an important public health problem. In the United States... two years ago may well miss the mark. Local and Federal criminal justice agencies such as the Federal.... Ultimately, this information will guide states in designing programs that reduce multiple forms of violence...

  13. 76 FR 71119 - Agency Information Collection Activity Under OMB Review

    Science.gov (United States)

    2011-11-16

    ... safety and security of each rail transit agency within the State's jurisdiction. To comply with Section... security oversight activities. FTA uses the annual information submitted by the States to monitor implementation of the program. If a State fails to comply with Section 5330, FTA may withhold up to five percent...

  14. 77 FR 76492 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-12-28

    ... up. To compound the problem, many pediatric audiologists may be proficient evaluating children age 5... Agencies (DSHPSHWA), Healthcare Resources and Services Administration (HRSA), University of Maine Center..., on-demand access by the audiologists. Financial cost is minimized because no mailing fee will be...

  15. 75 FR 81327 - Agency Information Collection Activity Under OMB Review

    Science.gov (United States)

    2010-12-27

    ... developing transportation plans and programs to serve the transportation needs of urbanized areas over 50,000... activities involved in developing the Unified Planning Work Program (UPWP), the Metropolitan Transportation... DEPARTMENT OF TRANSPORTATION Federal Transit Administration [FTA Docket No. FTA-2010-0048] Agency...

  16. 76 FR 53714 - Agency Information Collection Activity Under OMB Review

    Science.gov (United States)

    2011-08-29

    ... organizations (MPOs), states, and local public bodies in developing transportation plans and programs to serve... DEPARTMENT OF TRANSPORTATION Federal Transit Administration [FTA Docket No. FTA-2011-0049] Agency... report annually to Congress, the Secretary of Transportation and to the Federal Transit Administrator on...

  17. 78 FR 20897 - Agency Information Collection Activities Under OMB Review

    Science.gov (United States)

    2013-04-08

    ... developing an outreach and communications campaign designed to change consumer behavior. Since these systems... AGENCY: Commodity Futures Trading Commission. ACTION: Notice. SUMMARY: The Office of Consumer Outreach...: Nisha Smalls, Office of Consumer Outreach, Commodity Futures Trading Commission, 1155 21st Street NW...

  18. 76 FR 41797 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-07-15

    .... Proposed Project Community Assessment and Engagement Process--New--Division of Health Assessment and... implement ATSDR's programs, the agency works with communities by listening to and understanding their health concerns and seeking their guidance on where, when, and how to take public health actions. Communities in...

  19. 75 FR 76517 - Agency Information Collection Activity under OMB Review

    Science.gov (United States)

    2010-12-08

    ... DEPARTMENT OF TRANSPORTATION Federal Transit Administration [FTA Docket No. 2010-0043] Agency... of request for comments. SUMMARY: The Federal Transit Administration invites public comment about our... FTA funds to purchase rolling stock. Grantees are also required to keep a copy of the certification in...

  20. 76 FR 52672 - Agency Information Collection Activities: Submission for OMB Review; Comment Request, Level 1...

    Science.gov (United States)

    2011-08-23

    ...-2011-0012] Agency Information Collection Activities: Submission for OMB Review; Comment Request, Level 1 Assessment and Level 3 Evaluations for the Center for Domestic Preparedness (CDP) AGENCY: Federal... . SUPPLEMENTARY INFORMATION: Collection of Information Title: Level 1 Assessment and Level 3 Evaluations for the...

  1. 76 FR 39880 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-07-07

    ... resulted in an NAI decision, FDA estimates that 1,378 of the facilities certified under ISO 13485:2003 by...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... ISO 13485:2003 Voluntary Audit Report Submission Program AGENCY: Food and Drug Administration, HHS...

  2. 78 FR 63496 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical...

    Science.gov (United States)

    2013-10-24

    ... submission of responses. Agency: DOL-OWCP. Title of Collection: Medical Travel Refund Request. OMB Control... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Travel Refund Request ACTION: Notice. SUMMARY: The Department...

  3. 76 FR 16475 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to...

  4. 75 FR 68025 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-11-04

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to...

  5. 75 FR 75724 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-12-06

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to...

  6. 75 FR 51531 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-08-20

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing...

  7. 75 FR 26844 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-05-12

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to...

  8. 75 FR 71187 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-11-22

    ... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Office of the Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part of its continuing effort to...

  9. 77 FR 3844 - Agency Information Collection (Architect-Engineer Fee Proposal) Activity Under OMB Review

    Science.gov (United States)

    2012-01-25

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0208] Agency Information Collection (Architect--Engineer Fee Proposal) Activity Under OMB Review AGENCY: Veterans Health Administration... . Please refer to ``OMB Control No. 2900-0208.'' SUPPLEMENTARY INFORMATION: Titles: a. Architect--Engineer...

  10. 78 FR 6822 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-01-31

    ... business and will help prospective applicants understand what they need to do to meet the small business...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Fee Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION...

  11. 75 FR 2874 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-01-19

    ... will help prospective applicants understand what they need to do to meet the small business criteria...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Small Business Qualification and Certification AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  12. 78 FR 39714 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-07-02

    ... available financial products and services available to them; (2) the evaluation tool that the trainers will... BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No CFPB-2013-0019] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Bureau of Consumer Financial Protection...

  13. 77 FR 2306 - Agency Information Collection Activities: Submission for OMB Review; Comment Request, Federal...

    Science.gov (United States)

    2012-01-17

    ... Request, Federal Hotel and Motel Fire Safety Declaration Form AGENCY: Federal Emergency Management Agency... information collection abstracted below to the Office of Management and Budget for review and clearance in... Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the...

  14. 75 FR 32539 - Agency Information Collection (Dental Patient Satisfaction Survey) Activities Under OMB Review

    Science.gov (United States)

    2010-06-08

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-New (VA Form 10-0503)] Agency Information Collection (Dental Patient Satisfaction Survey) Activities Under OMB Review AGENCY: Veterans Health...).'' Title: Survey of Healthcare Experiences, Dental Patient Satisfaction Survey, VA Form 10-0503. OMB...

  15. 77 FR 56714 - Agency Information Collection (Annual-Final Report and Account) Activities Under OMB Review

    Science.gov (United States)

    2012-09-13

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0017] Agency Information Collection (Annual-Final Report and Account) Activities Under OMB Review AGENCY: Veterans Benefits Administration...), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of...

  16. 77 FR 29751 - Agency Information Collection Activity Under OMB Review: Automotive Fuel Economy Reports

    Science.gov (United States)

    2012-05-18

    ...-0059] Agency Information Collection Activity Under OMB Review: Automotive Fuel Economy Reports AGENCY... Transportation on whether a manufacturer will comply with an applicable average fuel economy standard for the... R. Katz, Fuel Economy Division, Office of International Policy, Fuel Economy and Consumer Programs...

  17. 76 FR 2198 - Agency Information Collection: Emergency Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-01-12

    ... organizations; and other stakeholders to reach out, engender trust, reduce stigma, and encourage our Nation's... are experiencing mental health crises and provide confident and trustworthy counseling. To be... Collection: Emergency Submission for OMB Review; Comment Request AGENCY: Veterans Health Administration...

  18. 77 FR 71430 - New Agency Information Collection Activity Under OMB Review: Public Transportation Baseline...

    Science.gov (United States)

    2012-11-30

    ... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration New Agency Information Collection Activity Under OMB Review: Public Transportation Baseline Assessment for Security Enhancement... voluntary site visits with security and operating officials of public transportation systems. This program...

  19. 78 FR 77484 - Extension of Agency Information Collection Activity Under OMB Review: Pipeline System Operator...

    Science.gov (United States)

    2013-12-23

    ... Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South... Information Collection Activity Under OMB Review: Pipeline System Operator Security Information AGENCY... Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of...

  20. 75 FR 49943 - New Agency Information Collection Activity Under OMB Review: Pipeline System Operator Security...

    Science.gov (United States)

    2010-08-16

    ... INFORMATION CONTACT: Joanna Johnson, Office of Information Technology, TSA-11, Transportation Security... Collection Activity Under OMB Review: Pipeline System Operator Security Information AGENCY: Transportation... System Operator Security Information. Type of Request: New collection. OMB Control Number: Not yet...

  1. 77 FR 33808 - Agency Information Collection; Activity Under OMB Review: Airline Service Quality Performance...

    Science.gov (United States)

    2012-06-07

    ... DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket ID Number RITA 2008-0002] Agency Information Collection; Activity Under OMB Review: Airline Service Quality.... SUPPLEMENTARY INFORMATION: OMB Approval No. 2138-0041 Title: Airline Service Quality Performance -Part 234. Form...

  2. 76 FR 40451 - Agency Information Collection (Application for Ordinary Life Insurance) Activity Under OMB Review

    Science.gov (United States)

    2011-07-08

    ... reduced automatically by one-half from its present face value on the day before a policyholder's 65th and... (Application for Ordinary Life Insurance) Activity Under OMB Review AGENCY: Veterans Benefits Administration...) of 1995 [[Page 40452

  3. 76 FR 40453 - Agency Information Collection (Application for VA Education Benefits) Activity Under OMB Review

    Science.gov (United States)

    2011-07-08

    ... (Application for VA Education Benefits) Activity Under OMB Review AGENCY: Veterans Benefits Administration... Education Benefits, VA Form 22-1990. b. Application for Family Member to Use Transferred Benefits, VA Form 22-1990E. [[Page 40454

  4. 77 FR 4822 - Extension of Agency Information Collection Activity Under OMB Review: Flight Training for Aliens...

    Science.gov (United States)

    2012-01-31

    ...] Extension of Agency Information Collection Activity Under OMB Review: Flight Training for Aliens and Other... aliens and other designated individuals seeking flight instruction (``candidates'') from Federal Aviation.... Information Collection Requirement Title: Flight Training for Aliens and Other Designated Individuals...

  5. 75 FR 29567 - Extension of Agency Information Collection Activity Under OMB Review: Aviation Security Customer...

    Science.gov (United States)

    2010-05-26

    ... business card that directs customers to an online portal. All responses are voluntary and there is no... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Aviation Security Customer Satisfaction Performance...

  6. 78 FR 46594 - Extension of Agency Information Collection Activity Under OMB Review: Aviation Security Customer...

    Science.gov (United States)

    2013-08-01

    ... business card that directs customers to an online portal, a customer satisfaction card with survey... DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension of Agency Information Collection Activity Under OMB Review: Aviation Security Customer Satisfaction Performance...

  7. 76 FR 71993 - Extension of Agency Information Collection Activity Under OMB Review: TSA Claims Management Program

    Science.gov (United States)

    2011-11-21

    ... Information Collection Activity Under OMB Review: TSA Claims Management Program AGENCY: Transportation... Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management... the nature of the information collection and its expected burden. TSA published a Federal Register...

  8. 78 FR 46997 - Agency Information Collection Activities: Submission for Review; Information Collection Request...

    Science.gov (United States)

    2013-08-02

    ... Security, Science & Technology Directorate, Cyber Security Division. (4) Affected public who will be asked... DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS-2013-0047] Agency Information Collection Activities: Submission for Review; Information Collection Request for the Department of Homeland Security...

  9. 77 FR 43843 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-07-26

    ... clinical investigators who provide financial information to the sponsors of marketing applications. Under... Request; Financial Disclosure by Clinical Investigators AGENCY: Food and Drug Administration, HHS. ACTION... submitted the following proposed collection of information to OMB for review and clearance. Financial...

  10. 78 FR 79079 - Agency Information Collection (Dental Patient Satisfaction Survey); Activities under OMB Review

    Science.gov (United States)

    2013-12-27

    ... Patient Satisfaction Survey); Activities under OMB Review AGENCY: Veterans Health Administration...- 0764 (Dental Patient Satisfaction Survey)'' in any correspondence. FOR FURTHER INFORMATION CONTACT...-0764 (Dental Patient Satisfaction Survey)'' in any correspondence).'' SUPPLEMENTARY INFORMATION: Title...

  11. 75 FR 56998 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-09-17

    ... its expert judgment about consumer behavior, perceptions, and similar information related to consumer... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2010-0046] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer Focus Groups...

  12. Regulatory requirements on PSA level 2: Review, aspects and applications

    International Nuclear Information System (INIS)

    Husarcek, J.

    2003-01-01

    The general requirements concerning utility obligations, probabilistic safety criteria (CDF should not exceed 1.0E-4/reactor year and LERF should not exceed 1.0E-5/reactor year), documentation and results, living PSA requirements and major steps in level 2 PSA are presented. PSA developments in Slovakia, collection and assembly of information, plant damage states, containment performance and failure modes, severe accident progression analyses, containment failure modes and source terms as a part of performed level 2 PSA are discussed. The PSA applications in design and operation evaluation, support to plant upgrade and modifications are also described. At the end, the following conclusion is made: more extensive PSA application needs to foster the exchange of experience and communication between PSA specialists, non-PSA engineers, designers, and the regulatory body staff responsible for safety assessment, inspection and enforcement

  13. Reviewing the regulatory barriers for nanomedicine: global questions and challenges.

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

  14. Defense Contract Audit Agency Reviews of Price Proposals

    National Research Council Canada - National Science Library

    1998-01-01

    .... Auditors perform field pricing reviews of contractor price proposals when procurement office information is insufficient to perform the cost or price analysis needed to negotiate contract prices...

  15. 75 FR 20568 - Agency Information Collection Activities Under OMB Review

    Science.gov (United States)

    2010-04-20

    ...: The United Kingdom, Australia, Brazil, Germany, Canada, France, Spain, New Zealand, Singapore, Taiwan... time needed to review instructions; develop, acquire, install, and utilize technology and systems for...

  16. Organization and practices on regulatory review in the licensing process of nuclear power plants in Spain

    International Nuclear Information System (INIS)

    Trueba, P.

    1979-01-01

    The actual organisation, practices and experience of the JEN Nuclear Safety Department on the regulatory review in the licensing process of nuclear power plants in Spain, are presented. Topics to be covered are: The structure, organisation, staff and principal functional areas of the NSD, the academic qualifications and work experience of the NSD personnel, recruiting and training, the conduct of the regulatory review during the licensing process and working procedures, the manpower and coverage of the different technical areas, the principal problems and conclusions. (author)

  17. Organisation and experience of the regulatory review in the United Kingdom

    International Nuclear Information System (INIS)

    Gausden, R.; Woods, P.B.

    1979-01-01

    Regulatory requirements and stages of the review in the UK are outlined. The organisation, management and working procedures of the Inspectorate are described and the effort and timescale which have been found necessary for a satisfactory safety review is discussed. A number of problem areas in the review situation have been identified from experience and these are discussed and possible solutions proposed. They include the importance of early review of generic aspects of systems which are being considered for licensing, the place of safety principles and of detailed engineering assessment in the review process, the independence of the regulatory group's activities in its study of major technical issues and the use which should be made of outside expertise. (auth.)

  18. Assistance to Oil and Gas State Agencies and Industry through Continuation of Environmental and Production Data Management and a Water Regulatory Initiative

    Energy Technology Data Exchange (ETDEWEB)

    Grunewald, Ben; Arthur, Dan; Langhus, Bruce; Gillespie, Tom; Binder, Ben; Warner, Don; Roberts, Jim; Cox, D.O.

    2002-05-31

    This grant project was a major step toward completion of the Risk Based Data Management System (RBDMS) project. Additionally the project addresses the needs identified during the projects initial phases. By implementing this project, the following outcomes were sought: (1) State regulatory agencies implemented more formalized environmental risk management practices as they pertain to the production of oil and gas, and injection via Class II wells. (2) Enhancement of oil and gas production by implementing a management system supporting the saving of abandoned or idle wells located in areas with a relatively low environmental risk of endangering underground sources of drinking water (USDWs) in a particular state. (3) Verification that protection of USDWs is adequate and additional restrictions of requirements are not necessary in areas with a relatively low environmental risk. (4) Standardization of data and information maintained by state regulatory agencies and decrease the regulatory cost burden on producers operating in multiple states, and (5) Development of a system for electronic data transfer among operators and state regulatory agencies and reduction of overall operator reporting burdens.

  19. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-10-15

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

  20. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    International Nuclear Information System (INIS)

    Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

    2008-01-01

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

  1. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    International Nuclear Information System (INIS)

    Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

    2009-06-01

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  2. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

    2009-06-15

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  3. Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron L [National Renewable Energy Laboratory (NREL), Golden, CO (United States)

    2017-12-19

    Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

  4. 75 FR 12753 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-03-17

    ... United States and the volume of laboratory tests available certainly warrant such a model. The Laboratory... or studies demonstrating practice effectiveness in the peer reviewed literature, but that they... literature. Healthcare organizations and facilities (laboratories, hospitals, clinics) will have the...

  5. 76 FR 63924 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-10-14

    ...), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease... review and/or onsite investigations by TB control staff. The purpose of this information collection...

  6. Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

    International Nuclear Information System (INIS)

    2006-01-01

    Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

  7. Consumer agency in cannabis supply - Exploring auto-regulatory documents of the cannabis social clubs in Spain.

    Science.gov (United States)

    Belackova, Vendula; Wilkins, Chris

    2018-04-01

    There is growing experience with the not-for-profit, consumer-driven cannabis social club (CSC) model that builds on self-supply, self-organization and harm-reduction; these are principles upon which people who use drugs (PWUD) have been engaging for decades. Recent legalization of cannabis in a number of jurisdictions and the related challenges in regulating production, sale, taxation and health-related matters have raised interest in non-commercial models of cannabis supply. The "codes of conduct" (CsoC) of CSC federations in Spain might reveal whether a consumer-based model could overcome these challenges. To examine the content of the CSC auto-regulatory documents, an online search using key terms to identify the CsoC was conducted. Six documents were found; analysis of the main thematic categories and overarching themes was conducted. It was discussed how these corresponded to the areas of cannabis policy regulation and what the main limitations of the CSC model were. The CsoC detailed the rules for CSC administration, not-for-profit aims, "invitation only" and other conditions of membership, collective cultivation and security as well as for operation of the consumption venue and health-related initiatives. The themes in the CsoC overlapped with cannabis regulatory areas as outlined internationally. Concern over cannabis prices and potency was missing in the CsoC. The potential strengths of the CSC model might include safe environment for peer-delivered harm reduction practice, preventing illicit transactions, quality control, shifting economic surplus to the consumers and increased consumer responsibility. The limitations of the CSC model include high threshold, disguised motives, tax revenue and the risk of both under- and over-regulation. CSCs represent an opportunity to enhance consumer agency and responsibility. The right "to be self-supplied" with psychoactive substances can be granted to consumer associations - but authorities need to provide a

  8. International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

  9. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Science.gov (United States)

    2012-05-07

    ... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...

  10. Safety research and development in relation to regulatory review in the UKAEA

    International Nuclear Information System (INIS)

    Ablitt, J.F.

    1979-01-01

    The basic functions of the regulatory review process are defined in principle, and the need for constructive interplay between regulation on the one hand and research and development on the other, in order to avoid the dangers of being over-restrictive or too permissive, is established. A number of practical examples from operating experience are quoted, which illustrate the chosen theme. (author)

  11. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Science.gov (United States)

    2011-03-21

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the...,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's...

  12. A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

    Science.gov (United States)

    Cole, Jack E.; And Others

    Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

  13. Integrated Regulatory Review Service (IRRS) Guidelines for the Preparation and Conduct of IRRS Missions

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA Integrated Regulatory Review Service (IRRS) was established to strengthen and enhance the effectiveness of national regulatory infrastructure for nuclear safety, radiation safety, radioactive waste and transport safety, and the security of radioactive sources, while recognizing the ultimate responsibility of each Member State to ensure safety in these areas. The IRRS process sets out to accomplish this expressed purpose through consideration of both technical and policy issues of a regulatory nature against IAEA safety standards and, where appropriate, good practice elsewhere. The regulatory review process directly draws upon the wide-ranging international experience and expertise of IRRS review team members. Peer exchange on technical and policy issues gives insight into the efficiency and effectiveness of the legal and governmental framework and regulatory infrastructure for safety. Through this process, opportunities for improvement are explored and potential improvement strategies identified which may be shared with other States. IRRS missions provide an opportunity for sharing regulatory experiences, harmonizing regulatory approaches among States, and creating mutual learning opportunities among regulators. IRRS discussions focus on issues arising from the State's self-assessment and the evaluation of technical areas and policy issues. The IAEA Fundamental Safety Principles (IAEA Safety Standards Series No. SF-1) provide the basis for IAEA safety standards and IAEA safety related programmes. In support of effective regulation, the IAEA has established safety standards in the area of the Governmental, Legal and Regulatory Framework for Safety (IAEA Safety Standards Series No. GSR Part 1). These safety standards form a core component of an IRRS review. Other requirements and guidance, such as The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3) and Radiation Protection and Safety of Radiation Sources

  14. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    Energy Technology Data Exchange (ETDEWEB)

    Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

    2011-02-15

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  15. 77 FR 57092 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-09-17

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Consumer Response to Health Claims and Disclaimers About the Relationship... has been submitted to the Office of Management and Budget (OMB) for review and clearance under the...

  16. 78 FR 36190 - Agency Information Collection Activities; Submission for OMB Review; IT Dashboard Feedback Mechanism

    Science.gov (United States)

    2013-06-17

    ... Information Collection Activities; Submission for OMB Review; IT Dashboard Feedback Mechanism AGENCY: Office... to review and approve a previously approved information collection requirement regarding IT Dashboard... identified by Information Collection 3090- 0285, IT Dashboard Feedback Mechanism, by any of the following...

  17. 75 FR 41920 - Agency Information Collection; Activity Under OMB Review; Airline Service Quality Performance...

    Science.gov (United States)

    2010-07-19

    ... DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket ID Number RITA 2008-0002] Agency Information Collection; Activity Under OMB Review; Airline Service Quality...: Airline Service Quality Performance--Part 234. Form No.: BTS Form 234. Type Of Review: Re-instatement of...

  18. 77 FR 41410 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-07-13

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Document; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

  19. 78 FR 26782 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-05-08

    ... intended goals. The PDUFA V Commitment Letter specifies that the assessments be conducted by an independent...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

  20. 78 FR 53758 - Agency Information Collection Activities: Submission for OMB Review; Comment Request: Insurance...

    Science.gov (United States)

    2013-08-30

    ... Review; Comment Request: Insurance Sales Consumer Protections AGENCY: Federal Deposit Insurance... comment for 60 days on renewal of its Insurance Sales Consumer Protections information collection, which... Sales Consumer Protections. OMB Number: 3064-0140. Frequency of Response: Once--reviewing/updating...

  1. 76 FR 56503 - Agency Information Collection (Report of Treatment in Hospital) Activity Under OMB Review

    Science.gov (United States)

    2011-09-13

    ... of Treatment in Hospital) Activity Under OMB Review AGENCY: Veterans Benefits Administration... Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below... Treatment in Hospital, VA FL 29-551. OMB Control Number: 2900-0119. Type of Review: Extension of a currently...

  2. 75 FR 30036 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-05-28

    ....282(a)(1)(i) through (a)(1)(iii)). In the event that an article of food has been refused admission... in a request for review. In the event that an article of food has been placed under hold under...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  3. 75 FR 53278 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-08-31

    ... Federal Hazardous Substances Act, and the Flammable Fabrics Act, as amended by the Consumer Product Safety... of Management and Budget Review; Comment Request; Procedures for Export of Noncomplying Goods AGENCY... Office of Management and Budget (``OMB'') for review and clearance under the Paperwork Reduction Act of...

  4. 75 FR 60463 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-09-30

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

  5. 75 FR 57962 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-09-23

    ... identified in FDA's official establishment inventory plus 1,220 very small apple juice manufacturers and 230...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax...

  6. 78 FR 65673 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public...

    Science.gov (United States)

    2013-11-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency... and communication functionality with which to identify and contact qualified potential grant reviewers... pool has the necessary skills and diversity to meet our evolving need for qualified reviewers. If DIR...

  7. 75 FR 25267 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-05-07

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the... advertisements. Section 904(a)(1) of the act, as amended by the Tobacco Control Act, requires each tobacco...

  8. 78 FR 66939 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-11-07

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written... well as advertisements intended for dissemination or publication within 120 days following marketing...

  9. 78 FR 34107 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-06-06

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... of information has been submitted to the Office of Management and Budget (OMB) for review and... warnings be displayed on packaging and advertising for each brand of smokeless tobacco ``in accordance with...

  10. 75 FR 2871 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-01-19

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... of information has been submitted to the Office of Management and Budget (OMB) for review and... as to whether the device could be corrected by labeling, change of labeling, change of advertising...

  11. 75 FR 39543 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-07-09

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... of information has been submitted to the Office of Management and Budget (OMB) for review and... specified health warning label statements required to appear in advertising and packaging. FDA is required...

  12. 77 FR 39343 - Agency Information Collection (Financial Status Report) Activities Under OMB Review

    Science.gov (United States)

    2012-07-02

    ... (Financial Status Report) Activities Under OMB Review AGENCY: Office of Management, Department of Veterans....'' SUPPLEMENTARY INFORMATION: Title: Financial Status Report, VA Form 5655. OMB Control Number: 2900-0165. Type of Review: Extension of a currently approved collection. Abstract: Claimants complete VA Form 5655 to report...

  13. 78 FR 47699 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-08-06

    ... risk management practices in these non-hospital settings. In a small study, the National Institute for... on research-to-practice principles and will be assisted by a strong network of dental professional... (CDC) publishes a list of information collection requests under review by the Office of Management and...

  14. 77 FR 75167 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-12-19

    ... (NACCHO) and Knowledge Networks will disseminate the study results to the public through reports prepared for/by CDC, NACCHO and Knowledge Networks and through peer-reviewed journal articles and related... draw a sample of participants has many advantages. First, because the panel is already recruited...

  15. 78 FR 307 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-01-03

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and.../AIDS Strategic Plan. (3) reporting has been changed from quarterly to semiannual. (4) the number of... how these efforts have contributed to a reduction in HIV transmission; (2) improve ease of reporting...

  16. 78 FR 33096 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-06-03

    ... Disease Control and Prevention (CDC). Background and Brief Description This project involves a... the participant prior to the testing session. We also included the time needed to review the informed... is to study the natural history of lung disease. For this study, we plan on interviewing and...

  17. 75 FR 6670 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-02-10

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and... application of Federal regulations. The regulations in 42 Part 70 were developed to facilitate Federal action... permit issued by State health authority. 42 CFR 70.4 Report by the master of a Master of a vessel or 1...

  18. 78 FR 4149 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-01-18

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and... forms based on the type of respondent: an ill traveler, or the master of a vessel or conveyance engaged... application of Federal regulations. The regulations in 42 Part 70 were developed to facilitate Federal action...

  19. 78 FR 20920 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2013-04-08

    ... such as medicines taken, food eaten, hobbies, jobs, etc. In addition, ATSDR asks questions on... manner. The benefits to using the EI Generic Clearance include submission of a standardized OMB review...., breathing, eating, touching), and number of other sources of the chemical(s) (e.g., products used, jobs...

  20. 76 FR 32212 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-06-03

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and....gov . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by... to fill funding gaps in programs that deal with the leading causes of death and disability. Block...

  1. 76 FR 65512 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-10-21

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and....gov . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503... parents; brand ambassadors; educators; school leadership; program implementers; community representatives...

  2. 77 FR 11539 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-02-27

    ... (CDC) publishes a list of information collection requests under review by the Office of Management and... . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by... where participants include: Middle school students age 11 to 14 years; middle school parents; brand...

  3. 78 FR 52214 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Derricks...

    Science.gov (United States)

    2013-08-22

    ... (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information... review and approval for continued use, without change, in accordance with the Paperwork Reduction Act... Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725...

  4. 76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-07-26

    ... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

  5. 76 FR 46322 - Agency Information Collection Activities Under OMB Review; Renewal of a Currently Approved...

    Science.gov (United States)

    2011-08-02

    ... has forwarded the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval: Recreation Visitor Use Surveys. The ICR describes the nature of the... Department of the Interior at the Office of Management and Budget, Office of Information and Regulatory...

  6. 77 FR 29336 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-05-17

    ... Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and...., Washington, DC 20460; and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and... recycled asphalt pavement and subsequent affected facilities up to, but not including, the first storage...

  7. Knowledge management for efficient quantitative analyses during regulatory reviews.

    Science.gov (United States)

    Krudys, Kevin; Li, Fang; Florian, Jeffry; Tornoe, Christoffer; Chen, Ying; Bhattaram, Atul; Jadhav, Pravin; Neal, Lauren; Wang, Yaning; Gobburu, Joga; Lee, Peter I D

    2011-11-01

    Knowledge management comprises the strategies and methods employed to generate and leverage knowledge within an organization. This report outlines the activities within the Division of Pharmacometrics at the US FDA to effectively manage knowledge with the ultimate goal of improving drug development and advancing public health. The infrastructure required for pharmacometric knowledge management includes provisions for data standards, queryable databases, libraries of modeling tools, archiving of analysis results and reporting templates for effective communication. Two examples of knowledge management systems developed within the Division of Pharmacometrics are used to illustrate these principles. The benefits of sound knowledge management include increased productivity, allowing reviewers to focus on research questions spanning new drug applications, such as improved trial design and biomarker development. The future of knowledge management depends on the collaboration between the FDA and industry to implement data and model standards to enhance sharing and dissemination of knowledge.

  8. Regulatory instrument review: Aging management of LWR cables, containment and basemat, reactor coolant pumps, and motor-operated valves

    International Nuclear Information System (INIS)

    Werry, E.V.; Somasundaram, S.

    1995-09-01

    The results of Stage 2 of the Regulatory Instrument Review are presented in this volume. Selected regulatory instruments, such as the Code of Federal Regulations (CFR), US Nuclear Regulatory Commission (NRC), Regulatory Guides, and ASME Codes, were investigated to determine the extent to which these regulations apply aging management to selected safety-related components in nuclear power plants. The Regulatory Instrument Review was funded by the NRC under the Nuclear Plant Aging Research (NPAR) program. Stage 2 of the review focused on four safety-related structures and components; namely, cables, containment and basemat, reactor coolant pumps, and motor-operated valves. The review suggests that the primary-emphasis of the regulatory instruments was on the design, construction, start-up, and operation of a nuclear power plant, and that aging issues were primarily addressed after an aging-related problem was recognized. This Stage 2 review confirms the results of the prior review; (see Regulatory Instrument Review: Management of Aging of LWR Major Safety-Related Components NUREG/CR-5490. The observations indicate that the regulations generally address management of age-related degradation indirectly. Specific age-related degradation phenomena frequently are dealt with in bulletins and notices or through generic issues, letters, etc. The major recommendation of this report, therefore, is that the regulatory instruments should more directly and explicitly address the aging phenomenon and the management of the age-related degradation process

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

    Science.gov (United States)

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

    2016-12-01

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

  10. The NEA International FEP Database and its use in support of regulatory review

    International Nuclear Information System (INIS)

    Sumerling, T.

    1999-01-01

    A working group of the Nuclear Energy Agency has developed a database of features, events and processes (FEPs) relevant to the assessment of the long-term safety of radioactive waste disposal facilities. The Environment Agency participated in this work as described in a previous report, R and D Technical Report P97. This report describes work done in order to (i) provide an electronic version of the NEA International FEP Database in a convenient form suited to the Agency's needs; (ii) determine procedures for use of the Database in support of the Agency's review of an applicant's safety case for solid radioactive disposal, and in other appropriate Agency activities. Section 1 of the report outlines the objectives and work done. Section 2 gives an overview of the current status, development and international use of the NEA FEP Database. Alternative uses of the Database by the Agency, and procedures for use, are discussed in Section 3. Two alternative procedures for use of the Database in scientific and technical review of an applicant's safety case are outlined and compared; these provide a framework for orderly identification and discussion of technical issues within the review. It is concluded that the way in which the Database is used will depend on the circumstances and also the aims and preferences of the Agency. Detailed procedures for the use of the Database are best defined for the specific circumstances, taking account of the level of information available from the applicant, and the time and resources which the Agency may wish to devote to a given phase of review. The NEA FEP Database has been developed as a tool to assist in performing or reviewing safety assessments of radioactive waste disposal facilities. The principle of the Database, and also the software framework, may be equally applicable to other technical or scientific assessments, e.g. of landfill facilities or river catchment pollution studies. Since the Database is now available to the Agency

  11. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  12. 42 CFR 435.136 - State agency implementation requirements for one-time notice and annual review system.

    Science.gov (United States)

    2010-10-01

    ...-time notice and annual review system. 435.136 Section 435.136 Public Health CENTERS FOR MEDICARE... agency implementation requirements for one-time notice and annual review system. An agency must— (a...) Establish an annual review system to identify individuals who meet the requirements of § 435.135 (a) or (c...

  13. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  14. A Review on the Needs of Independent Information Channel for Regulatory Body

    International Nuclear Information System (INIS)

    Raza, Hamid Saeed; Choi, Kwang Sik

    2010-01-01

    For a regulatory body it is very important to be independent not only in its actions but also in its information gathering channels. It is thus required for an organization to get requisite information for their decision making, as well as to prevail over information asymmetries. For corporate culture, information channels sometimes prove to be extensive enough to rune valuable resources and sometime base delays. The paper will reveal nature of an independent information channel. This review will additionally confer a scenario; a regulatory body may face in case of solely depending upon licensee for its information gathering. Working in the wake of this paper comprises review of allied published materials. It might be more helpful for interested ones to persist this effort by ensuring stakeholder involvement i.e. by making this sensitive topic alive through seminars and working groups

  15. IAEA Team Concludes Peer Review of Sweden's Nuclear Regulatory Framework, 17 February 2012, Stockholm, Sweden

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Sweden. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of Sweden, noted good practices in the country's nuclear regulatory system and also made recommendations and suggestions for the Swedish Radiation Safety Authority (SSM) and the government. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''Throughout the mission, the IRRS team received full cooperation from SSM staff in its review of Sweden's regulatory, technical and policy issues,'' said Georg Schwarz, mission leader and Deputy Director General of the Swiss nuclear regulator (ENSI). 'The staff were open and candid in their discussions and provided the fullest practicable assistance', he commented. The main observations of the IRRS Review team included the following: SSM operates as an independent regulator in an open and transparent manner with well-organized regulatory processes; SSM is receptive to feedback and strives to maintain a culture of continuous learning; and Following the TEPCO Fukushima Daiichi accident, SSM responded promptly to public demand for information and communicated effectively with the national government, the public and other interested parties. Good practices identified by the IRRS team included, though they are not limited to, the following: The consolidation of the two previous national regulatory authorities into SSM was successful; Overall, SSM's management system is comprehensive and contributes to staff efficiency and effectiveness; The nuclear power plant refurbishment programme as required by SSM enhanced safety; and Sweden's regulatory framework for high-level waste disposal is comprehensive and technically sound. The IRRS Review team identified

  16. 76 FR 39343 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-07-06

    ... proposes to use to set priorities for the retrospective review of its regulations; (2) identifies an... agency use in setting priorities? The factors ED will use in setting priorities for the retrospective... existing regulations), and priorities, requirements, definitions, and selection criteria governing...

  17. 76 FR 79141 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2011-12-21

    ... initial notice within a reasonable time after establishing a customer relationship in two additional..., requires an agency to review its rules that have a significant economic impact upon a substantial number of... be amended or rescinded * * * to minimize any significant economic impact of the rules upon a...

  18. 76 FR 17572 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-30

    ... businesses and the public. Agencies must consider approaches that maintain freedom of choice and flexibility... regulations, invites interested members of the public to submit comments on its preliminary plan to review....regulations.gov . Additional Instructions. In general, comments received, including attachments and other...

  19. The role of radiation regulatory agencies of the Republic of the Philippines in the education and training of workers occupationally exposed to radiation

    International Nuclear Information System (INIS)

    Perio Peralta, Agnette de

    2008-01-01

    In the Republic of the Philippines, there are two national radiation regulatory agencies. One is the Philippine Nuclear Research Institute (PNRI) which has the regulatory mandate over radioactive materials. The other one is the Bureau of Health Devices and Technology (BHDT) which has the regulatory mandate over radiation devices. Since a major requirement in regulating use of radiation sources is the appropriate qualification of the workers occupationally exposed to radiation, the paper discusses the strategies and activities of these two agencies to ensure that these workers have the necessary education and training to do their work properly. Some of these are the conduct of training courses in cooperation with the relevant professional societies, conduct of distance aided training in cooperation with the IAEA, initiation and active involvement in the establishment and continued existence of the masteral degree program in medical physics which was established with IAEA technical assistance, assistance to lawmakers in drafting pertinent legislation, and creation of joint technical working groups to ensure harmonization of standards and regulations, among others. The Philippines has adopted a national policy that users of radiation and radioactive materials have the primary responsibility for radiation safety. The PNRI and the BHDT have adopted strategies which have been very useful in the effective implementation of their regulations. (author)

  20. OECD Nuclear Energy Agency. 5 activity report. 1976

    International Nuclear Information System (INIS)

    1977-01-01

    The main activities of the Agency are reviewed: nuclear power trends; regulatory aspects of nuclear power; technical developments: Eurochemic, Halden, Dragon, food irradiation; gas-cooled fast reactors, isotopic batteries; nuclear data Centers

  1. OECD Nuclear Energy Agency. 3. Activity report, 1974

    International Nuclear Information System (INIS)

    1975-01-01

    The main activities of the Agency are reviewed: study of nuclear power trends; regulatory aspects of nuclear power; technical developments: Eurochemic, Halden, Dragon, food irradiation, gas-cooled fast reactors, direct conversion, isotopic batteries; nuclear energy information

  2. 78 FR 64022 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Program To...

    Science.gov (United States)

    2013-10-25

    ... for OMB Review; Comment Request; Program To Prevent Smoking in Hazardous Areas of Underground Coal... Administration (MSHA) sponsored information collection request (ICR) titled, ``Program to Prevent Smoking in... electronic submission of responses. Agency: DOL-MSHA. Title of Collection: Program To Prevent Smoking in...

  3. 76 FR 30700 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Proposed...

    Science.gov (United States)

    2011-05-26

    ... agencies, and others to promote reductions in toxic chemical releases. Industrial facilities use the TRI... Activities; Submission to OMB for Review and Approval; Proposed Collections; Toxic Chemical Release Reporting... that manufacture, process, or otherwise use specified toxic chemicals in amounts above reporting...

  4. 76 FR 21800 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Generic...

    Science.gov (United States)

    2011-04-18

    ... precision requirements or power calculations that justify the proposed sample size, the expected response... Activities: Submission for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative... Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service...

  5. 42 CFR 456.6 - Review by State medical agency of appropriateness and quality of services.

    Science.gov (United States)

    2010-10-01

    ... and quality of services. 456.6 Section 456.6 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES... Provisions § 456.6 Review by State medical agency of appropriateness and quality of services. (a) The... professional health personnel of the appropriateness and quality of Medicaid services. (b) The purpose of this...

  6. 75 FR 21716 - Agency Information Collection; Activity Under OMB Review; Airline Service Quality Performance...

    Science.gov (United States)

    2010-04-26

    ... RITA 2008-0002] Agency Information Collection; Activity Under OMB Review; Airline Service Quality... Reports'' pursuant to 14 CFR 234.4 and 234.6. These reports are used to monitor the quality of air service.... SUPPLEMENTARY INFORMATION: OMB Approval No. 2138-0041. Title: Airline Service Quality Performance--Part 234...

  7. 77 FR 18306 - Agency Information Collection; Activity Under OMB Review; Airline Service Quality Performance

    Science.gov (United States)

    2012-03-27

    ... 2008-0002] Agency Information Collection; Activity Under OMB Review; Airline Service Quality...'' pursuant to 14 CFR 234.4 and 234.6. These reports are used to monitor the quality of air service that... INFORMATION: OMB Approval No. 2138-0041. Title: Airline Service Quality Performance Reports--Part 234. Form No...

  8. 75 FR 1119 - Agency Information Collection (Supplier Perception Survey) Activity Under OMB Review

    Science.gov (United States)

    2010-01-08

    ... (Supplier Perception Survey) Activity Under OMB Review AGENCY: Office of Acquisition, Logistics and...).'' SUPPLEMENTARY INFORMATION: Title: Department of Veterans Affairs Supplier Perception Survey. OMB Control Number..., and a person is not required to respond to a collection of information unless it displays a currently...

  9. 76 FR 61149 - Agency Information Collection (Disability Benefits Questionnaires-Group 4) Activity Under OMB Review

    Science.gov (United States)

    2011-10-03

    ... Collection (Disability Benefits Questionnaires--Group 4) Activity Under OMB Review AGENCY: Veterans Benefits... INFORMATION: Titles: Cranial Nerve Conditions Disability Benefits Questionnaire, VA Form 21- 0960C3. Narcolepsy Disability Benefits Questionnaire, VA Form 21-0960C6. Fibromyalgia Disability Benefits...

  10. 75 FR 76081 - Agency Information Collection (Disability Benefits Questionnaires) Activity Under OMB Review

    Science.gov (United States)

    2010-12-07

    ... (Disability Benefits Questionnaires) Activity Under OMB Review AGENCY: Veterans Benefits Administration... Disease (IHD) Disability Benefits Questionnaire, VA Form 21-0960a-1. b. Hairy Cell and Other B-Cell Leukemias Disability Benefits Questionnaire, VA Form 21-0960b-1. c. Parkinson's Disease Disability Benefits...

  11. 76 FR 33029 - Agency Information Collection (Disability Benefits Questionnaires-Group 1) Under OMB Review

    Science.gov (United States)

    2011-06-07

    ... Collection (Disability Benefits Questionnaires--Group 1) Under OMB Review AGENCY: Veterans Benefits... Benefits Questionnaire, VA Form 21-0960B-2. b. Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease) Disability Benefits Questionnaire, VA Form 21-0960C-2. c. Peripheral Nerve Conditions (Not Including Diabetic...

  12. 76 FR 35950 - Agency Information Collection (Disability Benefits Questionnaires-Group 3) Activity Under OMB Review

    Science.gov (United States)

    2011-06-20

    ... Collection (Disability Benefits Questionnaires--Group 3) Activity Under OMB Review AGENCY: Veterans Benefits... Questionnaire, VA Form 21-0960C-5. b. Headaches (Including Migraine Headaches), Disability Benefits Questionnaire, VA Form 21-0960C-8. c. Multiple Sclerosis (MS), Disability Benefits Questionnaire, VA Form 21...

  13. 78 FR 59099 - Agency Information Collection (Disability Benefits Questionnaires) Under OMB Review

    Science.gov (United States)

    2013-09-25

    ... (Disability Benefits Questionnaires) Under OMB Review AGENCY: Veterans Benefits Administration, Department of... INFORMATION: Titles: a. Ischemic Heart Disease (IHD) Disability Benefits Questionnaire, VA Form 21-0960a-1. b. Hairy Cell and Other B-Cell Leukemias Disability Benefits Questionnaire, VA Form 21-0960b-1. c...

  14. 76 FR 33417 - Agency Information Collection (Disability Benefits Questionnaires-Group 2) Activity Under OMB Review

    Science.gov (United States)

    2011-06-08

    ... Collection (Disability Benefits Questionnaires--Group 2) Activity Under OMB Review AGENCY: Veterans Benefits... Questionnaire, VA Form 21-0960A-2. b. Hypertension Disability Benefits Questionnaire, VA Form 21- 0960A-3. c. Non-ischemic Heart Disease (including Arrhythmias and Surgery, Disability Benefits Questionnaire, VA...

  15. 76 FR 56506 - Agency Information Collection (Complaint of Employment Discrimination) Activity Under OMB Review

    Science.gov (United States)

    2011-09-13

    ... (Complaint of Employment Discrimination) Activity Under OMB Review AGENCY: Office of Human Resources and...: Title: Complaint of Employment Discrimination, VA Form 4939. OMB Control Number: 2900-0716. Type of... applicants for employment who believe they were denied employment based on race, color, religion, gender...

  16. 78 FR 77679 - Agency Information Collection Activities: Submission for OMB Review; Comment Request Re...

    Science.gov (United States)

    2013-12-24

    ... providers through qualitative research methods such as focus groups, in-depth interviews, and/or qualitative... Review; Comment Request Re: Information Collection for Qualitative Research AGENCY: Federal Deposit... days on a proposed new information collection entitled Information Collection for Qualitative Research...

  17. 77 FR 7242 - Agency Information Collection (Contract for Training and Employment): Activity Under OMB Review

    Science.gov (United States)

    2012-02-10

    ... Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 (202... for Training and Employment): Activity Under OMB Review AGENCY: Veterans Benefits Administration... . Please refer to ``OMB Control No. 2900-0677.'' SUPPLEMENTARY INFORMATION: Title: Contract for Training...

  18. 75 FR 33898 - Agency Information Collection (Monthly Certification of Flight Training) Activity Under OMB Review

    Science.gov (United States)

    2010-06-15

    ... collection of information through http://www.Regulations.gov or to VA's OMB Desk Officer, OMB Human Resources... Certification of Flight Training) Activity Under OMB Review AGENCY: Veterans Benefits Administration, Department... Flight Training (under Chapters 30 and 32, Title 38 U.S.C.; Chapters 1606 and 1607, Title 10 U.S.C.; and...

  19. 75 FR 42818 - Agency Information Collection; Activity Under OMB Review; Collection of Safety Culture Data for...

    Science.gov (United States)

    2010-07-22

    ... Collection; Activity Under OMB Review; Collection of Safety Culture Data for Program Evaluation AGENCY... . SUPPLEMENTARY INFORMATION: Title: Collection of Safety Culture Data for Program Evaluation. Type of Request... data on the nation's transportation system is an important component of BTS' responsibility to the...

  20. 76 FR 27381 - Agency Information Collection (Financial Statement) Activity Under OMB Review

    Science.gov (United States)

    2011-05-11

    ... (Financial Statement) Activity Under OMB Review AGENCY: Veterans Benefits Administration, Department of... . Please refer to ``OMB Control No. 2900-0047.'' SUPPLEMENTARY INFORMATION: Title: Financial Statement, VA.../assumers meet the creditworthiness requirements. The data is also used to determine a borrower's financial...

  1. 78 FR 62638 - Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management...

    Science.gov (United States)

    2013-10-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB) Title: Low Income Home Energy Assistance Program (LIHEAP) Grantee Needs Assessment. OMB No.: New Collection. Description: This information collection is a...

  2. 76 FR 29796 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Refuse...

    Science.gov (United States)

    2011-05-23

    ... for OMB Review; Comment Request; Refuse Piles and Impounding Structures, Recordkeeping and Reporting... Administration (MSHA) sponsored information collection request (ICR) titled, ``Refuse Piles and Impounding... to submit annual reports and certification on refuse piles and impoundments to the agency and to keep...

  3. 76 FR 29237 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-05-20

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Hazardous Waste Generator Standards.... Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; and (2) OMB, by mail to... Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Jim O'Leary...

  4. 49 CFR Attachment 4 - State and Local Agency Review of Impact Statements

    Science.gov (United States)

    2010-10-01

    ... 4 Attachment 4 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL..., Attach. 4 Attachment 4—State and Local Agency Review of Impact Statements 1. OBM Revised Circular No. A... proposed project in the case of federally assisted projects (Part I of A-95) generally takes place prior to...

  5. 75 FR 16458 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-04-01

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Plastic Parts and Products... Protection Agency (EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C... . Title: NESHAP for Plastic Parts and Products Surface Coating (Renewal). ICR Numbers: EPA ICR Number 2044...

  6. 75 FR 1053 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-01-08

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Surface Coating of Plastic... Protection Agency (EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C... electronic docket, go to www.regulations.gov . Title: NSPS for Surface Coating of Plastic Parts for Business...

  7. 75 FR 80825 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-12-23

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pet Event Tracking Network--State, Federal Cooperation To Prevent Spread of Pet Food Related... Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of...

  8. 76 FR 70469 - Extension of Agency Information Collection Activity Under OMB Review: TSA Airspace Waiver Program

    Science.gov (United States)

    2011-11-14

    ... Information Collection Activity Under OMB Review: TSA Airspace Waiver Program AGENCY: Transportation Security... Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB... information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment...

  9. 78 FR 37561 - Extension of Agency Information Collection Activity Under OMB Review: TSA Customer Comment Card

    Science.gov (United States)

    2013-06-21

    ... Information Collection Activity Under OMB Review: TSA Customer Comment Card AGENCY: Transportation Security... Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB... information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment...

  10. 77 FR 4054 - Extension of Agency Information Collection Activity Under OMB Review: TSA Customer Comment Card

    Science.gov (United States)

    2012-01-26

    ... Information Collection Activity Under OMB Review: TSA Customer Comment Card AGENCY: Transportation Security... Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB... information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment...

  11. 78 FR 42821 - Agency Information Collection (Brand Name or Equal) Activities Under OMB Review

    Science.gov (United States)

    2013-07-17

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0585] Agency Information Collection (Brand...-77, Brand Name or Equal (was 852.210-77). OMB Control Number: 2900-0585. Type of Review: Revision of... are proposing to offer an item that is alleged to be equal to the brand name item stated in the bid...

  12. 78 FR 42593 - Agency Information Collection (Brand Name or Equal) Activities Under OMB Review

    Science.gov (United States)

    2013-07-16

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0585] Agency Information Collection (Brand...-77, Brand Name or Equal (was 852.210- 77). OMB Control Number: 2900-0585. Type of Review: Extension... are proposing to offer an item that is alleged to be equal to the brand name item stated in the bid...

  13. 78 FR 43969 - Agency Information Collection (Brand Name or Equal) Activities Under OMB Review

    Science.gov (United States)

    2013-07-22

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0585] Agency Information Collection (Brand Name or Equal) Activities Under OMB Review Correction Notice document 2013-17006, appearing on page 42593, in the issue of Tuesday, July 16, 2013 was withdrawn by the Department of Veterans Affairs. It...

  14. 78 FR 65386 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Eligibility...

    Science.gov (United States)

    2013-10-31

    ... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Eligibility Data Form: Uniformed Services Employment and Reemployment... continuity between the paper VETS 1010 form and the electronic version of the form. This information...

  15. 77 FR 25188 - Extension of Agency Information Collection Activity Under OMB Review: Enhanced Security...

    Science.gov (United States)

    2012-04-27

    ... general aviation (GA) aircraft operators who wish to fly into and/or out of Ronald Reagan Washington.... Information Collection Requirement Title: Enhanced Security Procedures at Ronald Reagan Washington National...] Extension of Agency Information Collection Activity Under OMB Review: Enhanced Security Procedures at Ronald...

  16. 78 FR 9048 - Agency Information Collection Activities: Proposed Collection; Submission for OMB Review...

    Science.gov (United States)

    2013-02-07

    ... and secondary public school districts. The EEOC uses EEO-5 data to investigate charges of employment discrimination against elementary and secondary public school districts. The data also are used for research. The... Collection; Submission for OMB Review: Elementary-Secondary Staff Information Report AGENCY: Equal Employment...

  17. 75 FR 63187 - Agency Information Collection Activities: Submission for OMB Review Comment Request: Supplemental...

    Science.gov (United States)

    2010-10-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration on Aging Agency Information Collection Activities: Submission for OMB Review Comment Request: Supplemental Form to the Financial Status Report for... form to the Financial Status Report for all AoA Title III Grantees provides an understanding of how...

  18. 78 FR 15975 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Job Clubs...

    Science.gov (United States)

    2013-03-13

    ... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Job Clubs Study ACTION: Notice; correction. SUMMARY: The Department... comments on site visits to job clubs. The document contained incorrect dates. FOR FURTHER INFORMATION...

  19. 76 FR 51371 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-08-18

    ... recall to comply with Sec. 107.260 for a total of 650 hours. As noted, we have added a new table 2 to... Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice... collection of information to OMB for review and clearance. Infant Formula Recall Regulations--21 CFR 107.230...

  20. 78 FR 6150 - Agency Forms Submitted for OMB Review, Request for Comments

    Science.gov (United States)

    2013-01-29

    ... home addresses of all employees hired within the last year (new-hires). Form BA-6a, Form BA-6 Address... RAILROAD RETIREMENT BOARD Agency Forms Submitted for OMB Review, Request for Comments Summary: In... collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the...

  1. 78 FR 44981 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Plan Asset...

    Science.gov (United States)

    2013-07-25

    ... technological collection techniques or other forms of information technology, e.g., permitting electronic... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Plan Asset Transactions Determined by In-House Asset Managers Under...

  2. 76 FR 71039 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-11-16

    ... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, (301) 796-7651... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0555] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  3. 75 FR 81616 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-12-28

    .... FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0447] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  4. 77 FR 24961 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-04-26

    ... Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0902] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  5. 76 FR 28043 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-05-13

    ... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3794... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0015] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  6. 77 FR 64523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-10-22

    ..., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0471] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  7. 77 FR 66620 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-11-06

    .... FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0748] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  8. 76 FR 40374 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-07-08

    ... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0237] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  9. 77 FR 41984 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-07-17

    ... II, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0708] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  10. 77 FR 38303 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-06-27

    ... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0253] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  11. 78 FR 33847 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-06-05

    ... CONTACT: Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0172] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  12. 77 FR 72353 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2012-12-05

    ... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7726, Ila... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0813] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  13. 78 FR 27969 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-05-13

    ... CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1131] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  14. 75 FR 49495 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-08-13

    ...: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0248] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  15. 76 FR 27328 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-05-11

    ... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0042] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  16. 76 FR 11786 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-03-03

    ... Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  17. 76 FR 10605 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-02-25

    ... CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0597] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  18. 78 FR 42960 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-07-18

    .... Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0242] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  19. 76 FR 59139 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-09-23

    ... Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0481] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  20. 75 FR 39531 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-07-09

    ...: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0174] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  1. 76 FR 20680 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-04-13

    ... CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0627] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment...

  2. 77 FR 19649 - Notice of Submission for OMB Review; Federal Student Aid; Guaranty Agency Financial Report

    Science.gov (United States)

    2012-04-02

    ... Financial Report SUMMARY: The Guaranty Agency Financial Report (GAFR), U.S. Department of Education (ED... Financial Report. OMB Control Number: 1845-0026. Type of Review: Revision. Total Estimated Number of Annual... consolidation loans; (4) remit to ED default and wage garnishment collections. ED also uses report data to...

  3. 76 FR 17656 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-03-30

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... proposed collection of information has been submitted to the Office of Management and Budget (OMB) for... an historical file containing the labeling and advertisements in use on the date of initial listing...

  4. 78 FR 64979 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of...

    Science.gov (United States)

    2013-10-30

    ... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death ACTION: Notice. SUMMARY: The Department of Labor (DOL...

  5. 78 FR 73864 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

    Science.gov (United States)

    2013-12-09

    ... information to inform program and policy decision-making. Need and Proposed Use of the Information: ASPE's..., validating and verifying information, processing and maintaining information, and disclosing and providing...-30D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

  6. 76 FR 78673 - New Agency Information Collection Activity Under OMB Review: Exercise Information System (EXIS)

    Science.gov (United States)

    2011-12-19

    ... Collection Activity Under OMB Review: Exercise Information System (EXIS) AGENCY: Transportation Security... burden for the TSA Exercise Information System (EXIS). EXIS is a web portal designed to serve... Requirement Title: Exercise Information System (EXIS). Type of Request: New collection. OMB Control Number...

  7. 76 FR 78265 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-12-16

    ... Identifier CMS-10412] Agency Information Collection Activities: Submission for OMB Review; Comment Request... broad authority to authorize experimental, pilot, or demonstration projects likely to assist in... test and deliver innovative services and approaches to better and more efficiently meet the needs of...

  8. 77 FR 18304 - Agency Information Collection; Activity Under OMB Review; Report of Financial and Operating...

    Science.gov (United States)

    2012-03-27

    ... current financial position of the carrier. Financial trend lines are extended into the future to analyze... RITA 2008-0002] Agency Information Collection; Activity Under OMB Review; Report of Financial and... Desk Officer. SUPPLEMENTARY INFORMATION: OMB Approval No. 2138-0013 Title: Report of Financial and...

  9. 78 FR 41953 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor...

    Science.gov (United States)

    2013-07-12

    ... DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor Organization and Auxiliary Reports ACTION: Notice. SUMMARY: The Department of Labor (DOL) is submitting the Office of Labor Management Standards (OLMS) sponsored information...

  10. 75 FR 69658 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-11-15

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Experimental Use Permits (EUPs) for... activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of... instrument or form, if applicable. Abstract: The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA...

  11. 76 FR 4656 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-01-26

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Plant-Incorporated Protectants; CBI... collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a... requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants sometimes...

  12. 76 FR 35448 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-06-17

    ...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Protection Act of 1996, which amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the...: Table 1--Estimated Annual Reporting Burden \\1\\ Number of Average burden Activity Number of responses per...

  13. 78 FR 13052 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2013-02-26

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Steel Plants: Electric Arc... (EPA/DC), Environmental Protection Agency, Enforcement and Compliance Docket and Information Center, mail code 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB at: Office of...

  14. 76 FR 45261 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0157... Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  15. International Expert Team Concludes IAEA Peer Review of Slovakia's Regulatory Framework for Nuclear Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded an 11-day mission to review the regulatory framework for nuclear safety in Slovakia. At the request of the Slovak Government, the IAEA assembled a team of 12 senior regulatory experts from 12 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Nuclear Regulatory Authority of the Slovak Republic (UJD SR). The international experts also met officials from the Public Health Authority of the Slovak Republic (UVZ SR) regarding the regulation of occupational radiation protection in nuclear facilities. The mission is a peer review based on the IAEA Safety Standards. Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of Slovak Republic, declared that ''The IRRS mission has a great value for the future development and orientation of the UJD SR.'' ''Slovakia has established a regulatory framework for nuclear safety which is in line with international standards and practice,'' said Mission Team Leader Andrej Stritar, Director of the Slovenian Nuclear Safety Administration. The main observations of the IRRS Review team included: UJD SR operates with independence and transparency; UJD SR has developed and implemented a systematic training approach to meet its competence needs; and in response to the accident at TEPCO's Fukushima Daiichi Nuclear Power Station, UJD SR has reacted and communicated to interested parties, including the public. The good practices identified by the IRRS Review Team include: UJD SR has a comprehensive and well-formalized strategic approach to informing and consulting interested parties; UJD SR has developed and implemented a structured approach to training and developing its staff; and Detailed legal requirements provide a solid basis for on-site and off-site response in nuclear emergencies coordinated with local authorities. The IRRS Review team identified areas for further improvement and believes

  16. 75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under...). VIMPAT injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  17. 75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under... (lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  18. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  19. Audit Oversight: Followup Review of the Military Department Audit Agencies Peer Review

    National Research Council Canada - National Science Library

    2004-01-01

    .... The external quality control review should determine whether the reviewed audit organization's internal quality control system was adequate and operating effectively to provide reasonable assurance...

  20. Risk Assessment Review Group report to the U.S. Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Lewis, H.W.; Budnitz, R.J.; Kouts, H.J.C.; Loewenstein, W.B.; Rowe, W.D.; von Hippel, F.; Zachariasen, F.

    1978-09-01

    The Risk Assessment Review Group was organized by the U.S. Nuclear Regulatory Commission on July 1, 1977, with four elements to its charter: clarify the achievements and limitations of WASH-1400, the ''Rasmussen Report''; assess the peer comments thereon, and responses to those comments; study the present state of such risk assessment methodology; and recommend to the Commission how (and whether) such methodology can be used in the regulatory and licensing process. Areas of study include: risk assessment methodologies; statistical issues; completeness; the data base; and the WASH-1400 assessment of the damage to human health from radiation after a postulated accident. Specific items discussed include: Browns Ferry; common cause failure; human factors; format and scrutability; the peer review process; earthquakes; risk perception; allegations by UCS concerning WASH-1400 treatment of quality assurance and quality control; current role of probabilistic methods in the regulatory process; acts of violence; ATWS; influence of design defects in quality assurance failures; and calculation of population doses from given releases of radionuclides

  1. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

  2. Cross-border temporary agency work : Social sustainability of a business model (too often) based on regulatory arbitrage

    NARCIS (Netherlands)

    Houwerzijl, Mijke; Rombouts, Bas

    Presentation held at the European Regional Congress of the International Society for Labour and Social Security Law (ISLSSL) on Temporary Agency Work in the context of cross-border movement & service provision within the EU.

  3. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation.

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Most countries have applied multiple strategies to mitigate health care worker absenteeism. The success of these

  4. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    Background A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Conclusion Most countries have applied multiple strategies to mitigate health care

  5. Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

  6. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Directory of Open Access Journals (Sweden)

    Kisakye AN

    2016-11-01

    Full Text Available Angela N Kisakye,1 Raymond Tweheyo,1 Freddie Ssengooba,1 George W Pariyo,2 Elizeus Rutebemberwa,1 Suzanne N Kiwanuka1 1Department of Health Policy Planning and Management, Makerere University School of Public Health, Kampala, Uganda; 2Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Background: A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods: A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results: Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1 organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs; 2 prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3 contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4 multifaceted work interventions being implemented in most settings; 5 the possibility of using financial and incentive regulatory mechanisms

  7. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  8. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

  9. Review of voluntary and regulatory carbon reporting by companies around the world

    International Nuclear Information System (INIS)

    Borie, Sylvain; Decq, Juliette; Wang, Xin; Alberola, Emilie; Afriat, Marion; Gourdon, Thomas

    2016-01-01

    What countries have instituted regulations requiring companies to measure their greenhouse gas (GHG) emissions? How could these regulations be strengthened to help meet the '2 deg. C' goal adopted by all member countries at the COP21 summit? In what ways do new French regulations on reporting of significant GHG emissions constitute a major advance in carbon reporting? To complement recent news focusing on reporting of carbon emissions in France, Carbone 4 offers its readers this review to put voluntary and regulatory carbon reporting mechanisms used by companies in a global perspective

  10. Delegação e controle político das agências reguladoras no Brasil Delegation and political control of the regulatory agencies in Brazil

    Directory of Open Access Journals (Sweden)

    Fernanda Meirelles

    2006-08-01

    Full Text Available A partir de um esforço de sistematização dos mecanismos de controle político previstos no modelo institucional originalmente concebido para as agências reguladoras, este artigo avalia os mecanismos de controle político presentes no arcabouço institucional das agências reguladoras independentes (ARIs brasileiras e analisa as alterações relacionadas ao controle político introduzidas pelo projeto de lei encaminhado pelo governo ao Congresso em 12 de abril de 2004. Após contextualizar o debate sobre o controle político das ARIs no Brasil, o artigo discute as relações entre delegação e responsabilização. Em seguida, na busca de um parâmetro para avaliar o modelo brasileiro de agências reguladoras (ARs, identifica os instrumentos de controle político utilizados na experiência americana. Finalmente, avalia a realidade institucional atual das ARIs brasileiras e comenta as contribuições do recente projeto de lei em relação ao controle político das agências.This article systematizes the political control mechanisms provided by the institutional model originally conceived for the regulatory agencies in order to assess the political control mechanisms in the institutional framework of the Brazilian independent regulatory agencies (IRAs and analyze the political control changes introduced by the law proposed by the government to Congress in April 12, 2004. After putting into context the debate on political control over the Brazilian IRAs, the article discusses the relationship between delegation and accountability. Then, so as to find a parameter for assessing the Brazilian regulatory agency model, it identifies the political control mechanisms used by the American experience. Finally, it assesses the current institutional situation of the Brazilian IRAs and comments on the contribution of the recent law proposal in relation to agency political control.

  11. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts yesterday concluded an 11-day mission to review the regulatory framework for nuclear and radiation safety in Greece. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of the Government of the Hellenic Republic, noted good practices in the country's nuclear regulatory system and also identified issues for improvement for the Greek Atomic Energy Commission (GAEC) and the Greek competent authorities. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''The IRRS team enjoyed excellent cooperation from the GAEC throughout its mission,'' said Tom Ryan, mission leader and Director of Regulations and Information Management at the Radiological Protection Institute of Ireland. ''The GAEC staff were very open and candid in their discussions and provided the fullest practicable assistance.'' The main observations of the IRRS Review team included: While the Greek Government's commitment to safety is being demonstrated through its actions, the development of a comprehensive national policy and strategy expressed in a consolidated statement would provide a valuable framework and guidance for future actions in terms of safety; and GAEC has effective independence. The Greek government has ensured that GAEC is effectively independent in its safety-related decision-making and that it has functional separation from entities having responsibility or interests that could unduly influence its decision making. Strengths and good practices identified by the IRRS team included: Greece actively participates in the global safety regime including all relevant safety conventions; The nation's radiation monitoring system for the detection of illicit trafficking contributes significantly to identifying potential radiation emergencies due to events within or outside the country

  12. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  13. A review of diazinon use, contamination in surface waters, and regulatory actions in California across water years 1992-2014.

    Science.gov (United States)

    Wang, Dan; Singhasemanon, Nan; Goh, Kean S

    2017-07-01

    Diazinon is an organophosphorus insecticide that has been widely used in the USA and in California resulting in contamination of surface waters. Several federal and state regulations have been implemented with the aim of reducing its impact to human health and the environment, e.g., the cancellation of residential use products by the USEPA and dormant spray regulations by the California Department of Pesticide Regulation. This study reviewed the change in diazinon use and surface water contamination in accordance with the regulatory actions implemented in California over water years 1992-2014. We observed that use amounts began declining when agencies announced the intention to regulate certain use patterns and continued to decline after the implementation of those programs and regulations. The reduction in use amounts led to a downward trend in concentration data and exceedance frequencies in surface waters. Moreover, we concluded that diazinon concentrations in California's surface waters in recent years (i.e., water years 2012-2014) posed a de minimis risk to aquatic organisms.

  14. Energy policy of the International Energy Agency (IEA) countries. General review of the year 1990

    International Nuclear Information System (INIS)

    1992-01-01

    This book is a general review on energy policy leaded by Members countries of International Energy Agency (IEA) during the year 1990. This book describes also the trends and the recent events which have affected energy demand, energy conservation, energy efficiency, energy supply and energy source development. This annual review gives the IEA energy forecasting for the next years, till year 2001. A detailed study of energy policy in Federal Republic of Germany, Austria, Denmark, Greece, Ireland and Japan is given. The policy of fifteen another Members countries, which have been analyzed the previous years, is recapitulated and briefly brought up to date

  15. A review of the methods used by the US Environmental Protection Agency to assess the financial impacts of the repository regulations

    International Nuclear Information System (INIS)

    Pflum, C.G.; Mattson, S.R.; Matthusen, A.C.

    1994-01-01

    All Federal agencies must consider the financial impacts of their regulations. When costs significantly outweigh benefits, the Office of Management and Budget can recommend that Congress not provide the funds needed to implement the regulation. Without funds, the agency is forced to either revise or retract the regulation. This has happened previously with a regulation on uranium mill tailings proposed by the US Nuclear Regulatory Commission (NRC) and it could happen again with the US Environmental Protection Agency (EPA) regulations that govern the disposal of high-level radioactive waste (HLW). The EPA (1985, 1992) claims that its regulation: ''Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Waste'' (40 CFR Part 191 or standards) does not increase costs above what the US Department of Energy (DOE) would spend anyway or, at most, what the DOE would spend to comply with 10 CFR Part 60: a regulation promulgated by the NRC. This report reviews and disputes the EPA claim. In Chapter 2 a summary of the basis for the EPA claim is presented and in Chapter 3 a critique of the basis of the claim is presented. This critique finds the EPA basis unrealistic, incomplete, and misleading. According to the EPA, a repository at Yucca Mountain would easily meet 40 CFR Part 191 even without the use of special engineered barriers. Because the NRC regulation (10 CFR Part 60) requires engineered barriers, the EPA places the onus for regulatory costs on the NRC. We disagree; the EPA standards drive regulatory costs as much as NRC regulations. The EPA has the higher responsibility for setting the overall standard for safety while the NRC can only implement this standard

  16. Pioglitazone utilization, efficacy & safety in Indian type 2 diabetic patients: A systematic review & comparison with European Medicines Agency Assessment Report.

    Science.gov (United States)

    Pai, Sarayu A; Kshirsagar, Nilima A

    2016-11-01

    With pioglitazone ban and subsequent revoking in India along with varying regulatory decisions in other countries, it was decided to carry out a systematic review on its safety, efficacy and drug utilization in patients with type 2 diabetes mellitus (T2DM) in India and compare with the data from the European Medicines Agency Assessment Report (EMA-AR). Systematic review was performed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching Medline/PubMed, Google Scholar and Science Direct databases using 'pioglitazone AND India AND human' and 'pioglitazone AND India AND human AND patient' and compared with EMA-AR. Spontaneous reports in World Health Organization VigiBase from India were compared with VigiBase data from other countries. Sixty six publications, 26 (efficacy), 32 (drug utilization) and eight (safety), were retrieved. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. Incidence of bladder cancer in pioglitazone exposed and non-exposed patients was not significantly different in an Indian retrospective cohort study. There were two cases and a series of eight cases of bladder cancer published but none reported in VigiBase. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Reporting of CTs and adverse drug reactions to Clinical Trials Registry of India and Pharmacovigilance Programme of India, respectively, along with compliance studies with warning given in package insert and epidemiological studies with larger sample size are needed.

  17. Applications of pharmacogenomics in regulatory science: a product life cycle review.

    Science.gov (United States)

    Tan-Koi, W C; Leow, P C; Teo, Y Y

    2018-05-22

    With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

  18. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  19. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  20. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  1. Recent Findings on Tax-Related Regulatory Burden on SMMEs in South Africa. Literature Review and Policy Options

    OpenAIRE

    Doubell Chamberlain; Anja Smith

    2006-01-01

    Regulatory compliance costs impose a deadweight burden on firms and therefore should be minimised. In achieving this goal, it is necessary to embrace a process of smart regulation, rather than focus on deregulation. Tax compliance cost is one type of regulatory costs that is often viewed to have a large negative impact on SMMEs. To gauge the impact of this cost on small business in South Africa, this document reviews three available studies on the impact of tax compliance costs on South Afric...

  2. Amoco-US Environmental Protection Agency, pollution prevention project, Yorktown, Virginia: Project peer review. Report of the Peer Review Committee of the Amoco/EPA Pollution Prevention Project at the Yorktown, Virginia refinery

    International Nuclear Information System (INIS)

    Klee, H.; Podar, M.

    1991-01-01

    The Amoco/EPA Pollution Prevention Project involved a number of representatives from federal and Virginia regulatory agencies, and Amoco's refining business. Participants believed that the Project could benefit from a broader perspective than these organizations along might provide. The Project Work Group selected an independent Peer Review Process which was conducted by Resource for the Future (RFF), a Washington DC think tank. A group of technical, policy and environmental experts from diverse backgrounds served as Peer Review members. The Peer Review Committee met on three occasions to discuss (1) the Project Work Plan (2) sampling data and interpretation and (3) project conclusions and recommendations. The focus of the meeting was on the general scope and content of the project

  3. The regulatory review: general comments, current status of review, identification of critical issues

    International Nuclear Information System (INIS)

    Vigfusson, J.; Franck, E.

    2004-01-01

    Typically, a lot of interesting and important details add up to give a coherent and convincing picture of a safe repository. A good portion of these details must be studied and the scientific basis of the system must be clearly understood by the reviewing authority in order to be able to pass a judgement on the safety case. HSK has already received a large part of the documentation relating to the project, including the three high level documents that summarize the synthesis of the geological information, the demonstration of repository design and construction feasibility and the safety case. After a first look at the contents of the documentation we would like to complement Nagra on the maturity and clarity of the presentation in these reports. At this early stage, we shall not present any review judgements. The reviewer usually is dependent upon having not only the high level documents but also all the detailed reference reports in front of him in order to do his job, and HSK is still receiving very relevant documents. Thus we are still at the very beginning of our review. Here, we offer some comments of general nature about the review process and mention a few points that seem to be uppermost in our mind at this stage. (author)

  4. 36 CFR 1260.60 - What are agency responsibilities with regard to mandatory review requests for White House...

    Science.gov (United States)

    2010-07-01

    ... responsibilities with regard to mandatory review requests for White House originated information? 1260.60 Section... responsibilities with regard to mandatory review requests for White House originated information? When an agency receives a mandatory review request from NARA for consultation on declassification of White House...

  5. 77 FR 76291 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2012-12-27

    ...The Bureau of Consumer Financial Protection (Bureau), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. The Bureau is soliciting comments concerning its proposed information collection titled, ``Clearance for Consumer Attitudes, Understanding, and Behaviors with Respect to Financial Services and Products.'' The proposed collection has been submitted to the Office of Management and Budget (OMB) for review and approval. A copy of the submission, including copies of the proposed collection and supporting documentation, may be obtained by contacting the agency contact listed below.

  6. Systematic review regulatory principles of non-coding RNAs in cardiovascular diseases.

    Science.gov (United States)

    Li, Yongsheng; Huo, Caiqin; Pan, Tao; Li, Lili; Jin, Xiyun; Lin, Xiaoyu; Chen, Juan; Zhang, Jinwen; Guo, Zheng; Xu, Juan; Li, Xia

    2017-08-16

    Cardiovascular diseases (CVDs) continue to be a major cause of morbidity and mortality, and non-coding RNAs (ncRNAs) play critical roles in CVDs. With the recent emergence of high-throughput technologies, including small RNA sequencing, investigations of CVDs have been transformed from candidate-based studies into genome-wide undertakings, and a number of ncRNAs in CVDs were discovered in various studies. A comprehensive review of these ncRNAs would be highly valuable for researchers to get a complete picture of the ncRNAs in CVD. To address these knowledge gaps and clinical needs, in this review, we first discussed dysregulated ncRNAs and their critical roles in cardiovascular development and related diseases. Moreover, we reviewed >28 561 published papers and documented the ncRNA-CVD association benchmarking data sets to summarize the principles of ncRNA regulation in CVDs. This data set included 13 249 curated relationships between 9503 ncRNAs and 139 CVDs in 12 species. Based on this comprehensive resource, we summarized the regulatory principles of dysregulated ncRNAs in CVDs, including the complex associations between ncRNA and CVDs, tissue specificity and ncRNA synergistic regulation. The highlighted principles are that CVD microRNAs (miRNAs) are highly expressed in heart tissue and that they play central roles in miRNA-miRNA functional synergistic network. In addition, CVD-related miRNAs are close to one another in the functional network, indicating the modular characteristic features of CVD miRNAs. We believe that the regulatory principles summarized here will further contribute to our understanding of ncRNA function and dysregulation mechanisms in CVDs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  7. 42 CFR Appendix to Subpart G of... - Interim Procedures and Criteria for Review by Health Systems Agencies of Applications Under...

    Science.gov (United States)

    2010-10-01

    ... Health Systems Agencies of Applications Under Section 1625 of the Public Health Service Act Appendix to..., App. Appendix to Subpart G of Part 124—Interim Procedures and Criteria for Review by Health Systems... section 1625 of the Act, health systems agencies shall use the procedures and criteria stated below. A...

  8. 77 FR 39343 - Agency Information Collection (Income-Net Worth and Employment Statement) Activity Under OMB Review

    Science.gov (United States)

    2012-07-02

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0002] Agency Information Collection (Income-Net Worth and Employment Statement) Activity Under OMB Review AGENCY: Veterans Benefits Administration... . Please refer to ``OMB Control No. 2900-0002.'' SUPPLEMENTARY INFORMATION: Title: Income-Net Worth and...

  9. 75 FR 56662 - Agency Information Collection (Income-Net Worth and Employment Statement) Activity Under OMB Review

    Science.gov (United States)

    2010-09-16

    ... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0002] Agency Information Collection (Income-Net Worth and Employment Statement) Activity Under OMB Review AGENCY: Veterans Benefits Administration... . Please refer to ``OMB Control No. 2900-0002.'' SUPPLEMENTARY INFORMATION: Title: Income-Net Worth and...

  10. 44 CFR Appendix A to Part 353 - Memorandum of Understanding Between Federal Emergency Management Agency and Nuclear Regulatory...

    Science.gov (United States)

    2010-10-01

    ... NRC that an emergency, unforeseen contingency, or other reason would prevent FEMA from providing a... they are revised to correct deficiencies noted in the Federal review. If, in FEMA's view, the plans...

  11. Review of NRC Commission Papers on Regulatory Basis for Licensing and Regulating Reprocessing Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Yeong; Shin, Hyeong Ki [KINS, Daejeon (Korea, Republic of)

    2016-05-15

    Spent nuclear fuel (SNF) accumulated in nuclear power plant has been a serious issue in most countries with operating nuclear power plants. Direct disposal of SNF could be a solution of the problem but many countries including the Republic of Korea have had a hard time selecting a site for high level waste repository because of low public acceptance. SNF recycling technologies consisting of reprocessing and transmutation have been developed so as to reduce the final volume of the disposed radioactive waste and to diminish the radiotoxicity of the waste. The Republic of Korea is now developing pyroprocessing and sodium-cooled fast reactor (SFR) technology to be used for the recycling of the wastes. KAERI has a plan to construct a pyroprocessing facility with a capacity of 30 tHM/y and a facility manufacturing TRU fuel for SFR by 2025. However, to license these facility and secure the safety, the current regulatory system related to SNF treatment needs to be improved and amended since the system has been developed focusing on facilities to examine irradiated nuclear materials. Status of reprocessing facility regulations developed by U.S.NRC was reviewed based on SECY papers. U.S.NRC has approved the development of a new rule referred to nationally as '10CFR Part 7x'. Existing 10CFR 50 and 70 has been evolved mainly for nuclear power plants and fuel cycle facilities whose radiological hazard is much lower than reprocessing plants respectively. U.S.NRC also derived many regulatory gaps including safety assessment methods, technical specification, general design criteria and waste classification and continue to develop the regulatory framework limited in scope to the resolution of Gap 5.

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

    International Nuclear Information System (INIS)

    Wagner, John C.; Parks, Cecil V.; Mueller, Don; Gauld, Ian C.

    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, transport 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

  13. Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

    Energy Technology Data Exchange (ETDEWEB)

    Warwick, W.M.

    1990-09-01

    The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

  14. Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

    Science.gov (United States)

    Pérez-Ibarbia, Leire; Majdanski, Tobias; Schubert, Stephanie; Windhab, Norbert; Schubert, Ulrich S

    2016-10-10

    Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Yellin's review of the Nuclear Regulatory Commission's Reactor Safety Study: comment

    International Nuclear Information System (INIS)

    Wilson, R.

    1976-01-01

    Joel Yellin (Bell J. Economics, Vol. 7, No. 1 (Spr. 1976)) reviewed the Reactor Safety Study (WASH-1400, or Rasmussen Report) published by the Nuclear Regulatory Commission and makes several criticisms. Wilson finds that some of these criticisms are much overstated, while others, although valid, are mainly criticisms of presentation. To be useful for public policy, reactor risks--and indeed all nuclear risks--must be compared with other risks society faces. Wilson feels that the Rasmussen Report is weak in these comparisons, primarily because there exist few estimates of risk in other places, but that the comparisons he does make indeed confirm that the risk is smaller than Yellin suggests. 20 references

  16. 77 FR 3211 - USACE's Plan for Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2012-01-23

    ... for Retrospective Review Under E.O. 13563 AGENCY: U.S. Army Corps of Engineers, DoD. ACTION: Extension..., ``Improving Regulation and Regulatory Review'' (E.O.), issued on January 18, 2011, directs federal agencies to... Regulatory mission; thus, USACE believes they are a significant rule warranting review pursuant to E.O. 13563...

  17. Regulatory role of prolactin in paternal behavior in male parents: A narrative review

    Directory of Open Access Journals (Sweden)

    F Hashemian

    2016-01-01

    Full Text Available In all mammalian species, a combination of neuroendocrine and experiential factors contributes to the emergence of remarkable behavioral changes observed in parental behavior. Yet, our understanding of neuroendocrine bases of paternal behavior in humans is still preliminary and more research is needed in this area. In the present review, the authors summarized hormonal bases of paternal behavior in both human and nonhuman mammalian species and focused on studies on the regulatory role of prolactin in occurrence of paternal behavior. All peer-reviewed journal articles published before 2015 for each area discussed (parental brain, hormonal bases of maternal behavior, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in nonhuman mammalian species, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in humans were searched by PubMed, Medline, and Scopus for original research and review articles. Publications between 1973 and 2015 were included. Similar to female parents, elevated prolactin levels in new fathers most probably contribute to child-caring behavior and facilitate behavioral and emotional states attributed to child care. Moreover, elevated parental prolactin levels after childbirth decrease the parents′ libidos so that they invest more in parental care than in fertility behavior. According to the available clinical studies, elevation in the amounts of prolactin levels after childbirth in male parents are probably associated with paternal behavior observed in humans.

  18. NRC review of passive reactor design certification testing programs: Overview and regulatory perspective

    International Nuclear Information System (INIS)

    Levin, A.E.

    1993-01-01

    Reactor vendors are developing new designs for future deployment, including open-quotes passiveclose quotes light water reactors (LWRs), such as General Electric's (G.E.'s) simplified boiling water reactor (SBWR) and Westinghouse's AP600, which depend primarily on inherent processes, such as national convection and gravity feed, for safety injection and emergency core cooling. The U.S. Nuclear Regulatory Commission (NRC) has implemented a new process, certification of standardized reactor designs, for licensing these Plants. Part 52 of Title 10 of the Code of Federal Regulations (10CFR52) contains the requirements that vendors must meet for design certification. One important section, 10CFR52.47, reads open-quotes Certification of a standard design which . . . utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if: (1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; and (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses. . . . The vendors have initiated programs to test innovative features of their designs and to develop data bases needed to validate their analytical codes, as required by the design certification rule. Accordingly, the NRC is reviewing and evaluating the vendors programs to ensure that they address adequately key issues concerning safety system performance. This paper provides an overview of the NRC's review process and regulatory perspective

  19. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  20. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2001-05-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  1. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

    Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

  2. Nuclear Regulatory Commission staff development of the license application review plan for a high-level radioactive waste repository

    International Nuclear Information System (INIS)

    Johnson, R.L.; Holonich, J.J.; Lee, M.P.; Delligatti, M.S.

    1993-01-01

    The Nuclear Regulatory Commission staff has recently started a new initiative to develop the License Application Review Plan (LARP) which the staff will use in its reviews of the U.S. Department of Energy's (DOE's) license application (LA) for a geologic repository for the disposal of high-level radioactive waste (HLW). This paper describes the staff's approach for developing the LARP, the development schedule and current status, the organization and content of the LARP, and the staff's LA review strategy. Therefore, it gives a preview of the draft LARP which will be made available in late 1993. It also describes how the LARP will be used as guidance to the staff in conducting reviews of regulatory and technical issues important to the licensing of a geologic repository. Finally, the benefits to the NRC staff, DOE, and other parties are discussed

  3. Review and evaluation of the Nuclear Regulatory Commission safety research program for Fiscal Year 1983. Report to the Congress

    International Nuclear Information System (INIS)

    1982-02-01

    Public Law 95-209 includes a requirement that the Advisory Committee on Reactor Safeguards submit an annual report to Congress on the safety research program of the Nuclear Regulatory Commission. This report presents the results of the ACRS review and evaluation of the NRC safety research program for Fiscal Year 1983. The report contains a number of comments and recommendations

  4. Standard Review Plan for a petition for rulemaking on radioactive waste streams below regulatory concern: Expedited review in accordance with Appendix B to 10 CFR, Part 2

    International Nuclear Information System (INIS)

    Larkins, P.M.

    1989-10-01

    The Standard Review Plan (SRP) provides guidance to staff reviewers acting on rulemaking petitions in an expeditious manner to exempt from regulation radioactive waste determined to be Below Regulatory Concern (BRC), as called for in the Low-Level Radioactive Waste Policy Amendments Act of 1985. The review plan is designed to ensure the quality and uniformity of staff reviews and to present a well-defined basis for the staff's evaluation of BRC petitions. The plan serves to improve the understanding of the staff's review by interested members of the public and the industry. It also provides information about the BRC rulemaking process to a wider audience. 6 refs., 7 figs

  5. Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

    Science.gov (United States)

    Sheets, Rebecca L; Zhou, TieQun; Knezevic, Ivana

    2016-03-01

    Clinical development of prophylactic HIV/AIDS vaccines presents many scientific challenges that result in challenges for regulators reviewing clinical trial applications (CTAs). The World Health Organization (WHO) has the responsibility to provide technical support to these regulators. The search for an HIV/AIDS vaccine will only succeed through well-designed, -conducted and -controlled human efficacy studies reviewed and approved by regulators in countries worldwide, particularly in countries where the epidemic has hit hardest, such as in sub-Saharan Africa and Asia. This review summarizes the current candidates in development and focuses on challenges regulators face when reviewing CTAs, such as the evolving landscape of "standard of prevention," trials in adolescents, adaptive trial designs, correlates of protection and their analysis, and access to successful vaccines. There are many unknowns in the field of HIV/AIDS vaccine development and often, there is not a clear right or wrong approach because of the scientific challenges described in this review. Consequently, regulators should not feel that decisions need be made in isolation, when there are many available international collaborative efforts and opportunities to seek expert advice. The WHO provides many such opportunities and support to regulators across the globe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. 12 CFR 19.135 - Applications for stay or review of disciplinary actions imposed by registered clearing agencies.

    Science.gov (United States)

    2010-01-01

    ... Involving the Federal Securities Laws § 19.135 Applications for stay or review of disciplinary actions... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Applications for stay or review of disciplinary actions imposed by registered clearing agencies. 19.135 Section 19.135 Banks and Banking COMPTROLLER OF...

  7. 76 FR 44089 - Agency Information Collection (Offer To Purchase and Contract of Sale) Activity Under OMB Review

    Science.gov (United States)

    2011-07-22

    ... Purchase and Contract of Sale) Activity Under OMB Review AGENCY: Veterans Benefits Administration... Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the... Purchase and Contract of Sale, VA Form 26-6705. b. Credit Statement of Prospective Purchaser, VA Form 26...

  8. 75 FR 39204 - Notice of Public Information Collections Being Reviewed by the U.S. Agency for International...

    Science.gov (United States)

    2010-07-08

    ... Emergency Relief Information. Type of Review: Renewal of Information Collection. Purpose: The purpose of... AGENCY FOR INTERNATIONAL DEVELOPMENT Notice of Public Information Collections Being Reviewed by... International Development (USAID) is making efforts to reduce the paperwork burden. USAID invites the general...

  9. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    International Nuclear Information System (INIS)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-01-01

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  10. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    Energy Technology Data Exchange (ETDEWEB)

    Lores, Marta, E-mail: marta.lores@usc.es; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  11. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018

  12. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review.

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

  13. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

    Science.gov (United States)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

  14. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

    Science.gov (United States)

    Enzmann, Harald; Broich, Karl

    2013-01-01

    For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

  15. Delegation, Presidential Regimes, and Latin American Regulatory Agencies Delegación, regimenes presidenciales y agencias reguladoras en América Latina

    Directory of Open Access Journals (Sweden)

    Jacint Jordana

    2010-04-01

    Full Text Available During the 1990s, a large number of regulatory agencies were created or reformed in different sectors in Latin American countries. Almost all included political delegation mechanisms, intended as formal rules to enhance credible commitments to time-consistent policies. In this paper, using an original data set of agencies’ head tenure in the telecommunications and finance regulatory agencies, we discuss if these mechanisms worked as planned, and find a divergence between actual mandates and the formally established fixed terms, effected by means of systematic early resignations. Our findings reveal, however, some consistent patterns of behavior. Stronger legislative presidential power reduced effective delegation to some extent, and agencies’ organizational strengths protected them from patron-age. We also confirmed the existence of some significant differences be-tween the two sectors examined. Having slightly weaker delegation rules, delegation practices were also less effective in telecommunications than in financial services, contrary to expectations about credible commitments. Durante los años 1990, muchas agencias reguladoras fueron creadas o reformadas en diferentes sectores en los países latinoamericanos. Casi todas incluyeron mecanismos de delegación política, entendidos como reglas formales para mejorar los compromisos creíbles sobre políticas que requieren coherencia en el tiempo. En este trabajo, utilizando un conjunto de datos originales sobre los responsables de las agencias reguladoras de las telecomunicaciones y de las finanzas, se discute si estos mecanismos funcionaron como estaba previsto, identificándose una divergencia entre los mandatos reales y los términos formalmente establecidos, debido a la existencia de numerosas renuncias anticipadas. Nuestros hallazgos revelan, sin embargo, algunos patrones consistentes de comportamiento: un mayor poder presidencial sobre el legislativo reduce la delegación efectiva

  16. [Priority setting of health interventions. Review of criteria, approaches and role of assessment agencies].

    Science.gov (United States)

    Varela-Lema, Leonor; Atienza-Merino, Gerardo; López-García, Marisa

    This study was carried out to develop an explicit health priority setting methodology to support decision-making regarding the technologies to be assessed for inclusion in the National Health Service service portfolio. The primary objective is to identify and analyse the criteria, approaches and conceptual frameworks used for national/international priority setting. An exhaustive review of the literature was carried out. For this purpose, a search of the main biomedical databases was performed and assessment agency websites were reviewed, among other sources. In general terms, it was found that there are no standardised criteria for priority setting, although some consensus and common trends have been identified regarding key elements (criteria, models and strategies, key actors, etc.). Globally, 8 key domains were identified: 1) need for intervention; 2) health outcomes; 3) type of benefit of the intervention; 4) economic consequences; 5) existing knowledge on the intervention/quality of and uncertainties regarding the evidence; 6) implementation and complexity of the intervention/feasibility; 7) priority, justice and ethics; and 8) overall context. The review provides a thorough analysis of the relevant issues and offers key recommendations regarding considerations for developing a national prioritisation framework. Findings are envisioned to be useful for different public organisations that are aiming to establish healthcare priorities. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. 76 FR 4708 - Agency Information Collection Activities: Submission for OMB Review; Comment Request, OMB No...

    Science.gov (United States)

    2011-01-26

    ...; Logistics Capability Assessment Tool (LCAT) AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2010-0061...-1, LCAT Booklet. SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the information...

  18. 76 FR 70470 - Extension of Agency Information Collection Activity Under OMB Review: Law Enforcement Officer...

    Science.gov (United States)

    2011-11-14

    ...This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0034, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on August 10, 2011, 76 FR 49504. The collection involves TSA gathering information from Territorial, Tribal, Federal, municipal, county, state, and authorized railroad law enforcement agencies who have requested the Law Enforcement Officer (LEO) Flying Armed training course.

  19. Special evaluation review of the Agency's training course programme 1986-1995

    International Nuclear Information System (INIS)

    1996-12-01

    During discussions at the 1994 Policy Review Seminar, Member States supported the principle that socio-economic impact and cost-benefit be considered important factors in the approval of technical co-operation programmes. In line with this principle, it was considered timely to conduct an evaluation of the Agency's Training Course Programme, to assist the Department of Technical Co-operation in focusing this programme on relevant subjects, consistent with the objectives and trends of, and complementary to, the entire Technical Co-operation Programme. The main purpose of the evaluation was to (a) assess the continued relevance, effectiveness and impact of the Training Course Programme in its present form as a means of technology transfer to developing Member States; and (b) propose possible alternatives for handling the demand by Member States for training through regional and interregional training courses. 10 tab

  20. A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers.

    Science.gov (United States)

    Henry, Barbara J; Carlin, Joseph P; Hammerschmidt, Jon A; Buck, Robert C; Buxton, L William; Fiedler, Heidelore; Seed, Jennifer; Hernandez, Oscar

    2018-05-01

    Per- and polyfluoroalkyl substances (PFAS) are a group of fluorinated substances that are in the focus of researchers and regulators due to widespread presence in the environment and biota, including humans, of perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA). Fluoropolymers, high molecular weight polymers, have unique properties that constitute a distinct class within the PFAS group. Fluoropolymers have thermal, chemical, photochemical, hydrolytic, oxidative, and biological stability. They have negligible residual monomer and oligomer content and low to no leachables. Fluoropolymers are practically insoluble in water and not subject to long-range transport. With a molecular weight well over 100 000 Da, fluoropolymers cannot cross the cell membrane. Fluoropolymers are not bioavailable or bioaccumulative, as evidenced by toxicology studies on polytetrafluoroethylene (PTFE): acute and subchronic systemic toxicity, irritation, sensitization, local toxicity on implantation, cytotoxicity, in vitro and in vivo genotoxicity, hemolysis, complement activation, and thrombogenicity. Clinical studies of patients receiving permanently implanted PTFE cardiovascular medical devices demonstrate no chronic toxicity or carcinogenicity and no reproductive, developmental, or endocrine toxicity. This paper brings together fluoropolymer toxicity data, human clinical data, and physical, chemical, thermal, and biological data for review and assessment to show that fluoropolymers satisfy widely accepted assessment criteria to be considered as "polymers of low concern" (PLC). This review concludes that fluoropolymers are distinctly different from other polymeric and nonpolymeric PFAS and should be separated from them for hazard assessment or regulatory purposes. Grouping fluoropolymers with all classes of PFAS for "read across" or structure-activity relationship assessment is not scientifically appropriate. Integr Environ Assess Manag 2018;14:316-334. © 2018 The Authors

  1. 75 FR 19647 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-04-15

    ... supporting documentation should be addressed to Karen Jagielski, Attorney, Division of Advertising Practices... submitted to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk...

  2. 78 FR 16270 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-03-14

    ... the provider in decision making for patient management. Form Number: CMS-10152 (OCN: 0938-0968... Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory...

  3. THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATION

    Directory of Open Access Journals (Sweden)

    Canol KANDEMİR

    2013-07-01

    Full Text Available TÜRKİYE’DE DÜZENLEYİCİ KURULUŞLAR AÇISINDAN MUHASEBE HİLELERİNİN ÖNLENMESİ VE ORTAYA ÇIKARILMASI SORUMLULUĞU: HUKUKÎ DURUM VE FİİLÎ UYGULAMAÖzet: Düzenleyici kuruluşların yaklaşımı ve uygulamaları muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunun kapsamının açıklığa kavuşturulmasına yardımcı olabilmektedir. Bu kuruluşların kamunun büyük bir çoğunluğunu adîl ve yansız bir şekilde temsil edeceği varsayılmaktadır. Ayrıca aldıkları kararlar ve karar alma mantıkları hem araştırmacılara, hem de finansal bilgi kullanıcılarına olası hile şüphelileri, bu kuruluşların sorumlulardan özellikle önlemesi ve ortaya çıkarmasını istedikleri hile yöntemleri, hilelerin cezaî yönleri, hilelerin önlenmesi ve ortaya çıkarılmasında temel sorumluluklar ve denetim beklenti boşluğu konularında önemli ipuçları verebilmektedir. Yine bunlar ilgili standart, yasa ve diğer düzenlemelerin oluşturulması ve uygulanmasında önemli etki sahibi olmaktadır. Bu nedenle, bağımsız denetimle ilgili faktörleri de kapsayan bir dizi değişken ile muhasebe hileleri arasında istatistiksel olarak anlamlı bir ilişki olup olmadığını sınayan bir çalışma yapılmış ve sonuç olarak Türkiye’deki düzenleyici kuruluşun muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunu aynı tarafa, müşteri işletme ve yönetimine yüklediği bulunmuştur. Araştırmanın bulguları Türkiye’de bir denetim-beklenti boşluğu olmadığına da işaret etmektedir.THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATIONAbstract: Self-regulatory agencies’ way of understanding and practices can help clarify the scope of the responsibility for preventing and detecting frauds. They are assumed to represent a vast majority of the public in an unbiased and

  4. 76 FR 9584 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-02-18

    ... Services Administration, HHS. ACTION: Correction of Burden Table. SUMMARY: The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency...

  5. 75 FR 61765 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-10-06

    ... Services Administration, HHS. ACTION: Correction in Burden Table. SUMMARY: The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency...

  6. 75 FR 13759 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-03-23

    ... Products'' and North American Industry Classification System (NAICS) code 325510, ``Paint and Coating... Emission Standards for Automobile Refinish Coatings AGENCY: Environmental Protection Agency. ACTION: Notice... coatings and coating components. Manufacturers of automobile refinish coatings and coating components fall...

  7. 76 FR 29763 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-05-23

    ... precision requirements or power calculations that justify the proposed sample size, the expected response... Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY... ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' Also include...

  8. 76 FR 36139 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Generic...

    Science.gov (United States)

    2011-06-21

    ... requirements or power calculations that justify the proposed sample size, the expected response rate, methods... for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY: Federal Emergency...): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of...

  9. 78 FR 69099 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-11-18

    ... Investment Justification Template; FEMA Form 089-26, RCGCP (Sample) Detailed Project Plan Template; FEMA Form... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2013-0033... Request AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: The Federal Emergency...

  10. 75 FR 14165 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2010-03-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency... entry. These systems must be multi-agency and be comprised of the key public and private agencies that... family outcome indicators and provide a theory of change, or rationale, on how a specific ECCS activity...

  11. Review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors

    Energy Technology Data Exchange (ETDEWEB)

    Kobayashi, Tetsuya; Araki, Masaaki; Ohba, Toshinobu; Torii, Yoshiya [Japan Atomic Energy Agency, Tokai, Ibaraki (Japan); Takeuchi, Masaki [Nuclear Safety Commission (Japan)

    2012-03-15

    JRR-3(Japan Research Reactor No.3) with the thermal power of 20MW is a light water moderated and cooled, swimming pool type research reactor. JRR-3 has been operated without major troubles. This paper presents about review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors. In addition, some topics concerning damages in JRR-3 due to the Great East Japan Earthquake are presented. (author)

  12. Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

    International Nuclear Information System (INIS)

    Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

    2008-01-01

    The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

  13. Regulatory analysis for amendments to regulations for the environmental review for renewal of nuclear power plant operating licenses. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This regulatory analysis provides the supporting information for a proposed rule that will amend the Nuclear Regulatory Commission's environmental review requirements for applications for renewal of nuclear power plant operating licenses. The objective of the proposed rulemaking is to improve regulatory efficiency by providing for the generic evaluation of certain environmental impacts associated with nuclear plant license renewal. After considering various options, the staff identified and analyzed two major alternatives. With Alternative A, the existing regulations would not be amended. This option requires that environmental reviews be performed under the existing regulations. Alternative B is to assess, on a generic basis, the environmental impacts of renewing the operating license of individual nuclear power plants, and define the issues that will need to be further analyzed on a case-by-case basis. In addition, Alternative B removes from NRC's review certain economics-related issues. The findings of this assessment are to be codified in 10 CFR 51. The staff has selected Alternative B as the preferred alternative

  14. 78 FR 44403 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2013-07-23

    ... agenda (the Agenda) in accordance with Public Law 96-354, ``The Regulatory Flexibility Act,'' and... goals; (2) support for the Strategic Plan organizational excellence objectives; (3) a governmental... Flexibility Act Section 610 of the Regulatory Flexibility Act (RFA) requires agencies to conduct a review...

  15. Promoting Implementation of Safety Culture in Nuclear Application for Industrial Facilities; an Important Role of Nuclear Energy Regulatory Agency in Indonesia

    Energy Technology Data Exchange (ETDEWEB)

    Setianingsih, Lilis Susanti [KINS-KAIST Master Degree Program, Daejeon (Korea, Republic of)

    2012-03-15

    Implementation of nuclear energy for industrial purposes has reached its highest peak. BAPETEN, as Nuclear Energy Regulatory Agency of Indonesia has published regulations regarding nuclear energy utilization. As high risk associating such utilization requires direct and thoroughly supervision in order to assure its compliance to safety and security aspect, procedures related to operational activities must by fully applied. Radiation Protection Program as one type of procedures that must be available in nuclear energy utilization operation is intended to provide operators specifically technical guidance to avoid undesired negative effects of incidents or accidents. It is the responsibility of managerial level in a company to provide the procedures and to further supervise their application in the field. Radiation workers, those are all employees working in or within radiation area must understand how to execute the procedures properly. The radiation protection program is intended to protect workers, member of community and property as well as the environment from the negative impacts of nuclear utilization operational due to its radiation exposure. Safety culture, a compound of nature derived from behavior of organization and people within the organization to pay a full attention and give main priority in radiation safety matters, is expected to be achieved by implementing the radiation protection program as safety habits at the work place. It requires a management commitment to ensure that all aspect in safety and, whenever necessary, security are accomplished within the radiation protection program in order to build a safety culture in a radiation work place. Government Regulation No. 33 2007 about Safety for Ionizing Radiation and Security for Radioactive Source and Government Regulation No. 29 2008 regarding Licensing for Utilization of Ionizing Radiation and Nuclear Material present regulation and arrangement related to radiation protection program as a basic

  16. Promoting Implementation of Safety Culture in Nuclear Application for Industrial Facilities; an Important Role of Nuclear Energy Regulatory Agency in Indonesia

    International Nuclear Information System (INIS)

    Setianingsih, Lilis Susanti

    2012-01-01

    Implementation of nuclear energy for industrial purposes has reached its highest peak. BAPETEN, as Nuclear Energy Regulatory Agency of Indonesia has published regulations regarding nuclear energy utilization. As high risk associating such utilization requires direct and thoroughly supervision in order to assure its compliance to safety and security aspect, procedures related to operational activities must by fully applied. Radiation Protection Program as one type of procedures that must be available in nuclear energy utilization operation is intended to provide operators specifically technical guidance to avoid undesired negative effects of incidents or accidents. It is the responsibility of managerial level in a company to provide the procedures and to further supervise their application in the field. Radiation workers, those are all employees working in or within radiation area must understand how to execute the procedures properly. The radiation protection program is intended to protect workers, member of community and property as well as the environment from the negative impacts of nuclear utilization operational due to its radiation exposure. Safety culture, a compound of nature derived from behavior of organization and people within the organization to pay a full attention and give main priority in radiation safety matters, is expected to be achieved by implementing the radiation protection program as safety habits at the work place. It requires a management commitment to ensure that all aspect in safety and, whenever necessary, security are accomplished within the radiation protection program in order to build a safety culture in a radiation work place. Government Regulation No. 33 2007 about Safety for Ionizing Radiation and Security for Radioactive Source and Government Regulation No. 29 2008 regarding Licensing for Utilization of Ionizing Radiation and Nuclear Material present regulation and arrangement related to radiation protection program as a basic

  17. Omega-3 fatty acids and cardiovascular disease: summary of the 2016 agency of healthcare research and quality evidence review

    Science.gov (United States)

    We summarize the 2016 update of the 2004 Agency of Healthcare Research and Quality's evidence review of omega-3 fatty acids and cardiovascular disease (CVD). The overall findings for the effects of marine oil supplements on intermediate CVD outcomes remain largely unchanged. There is high strength o...

  18. Senior expert group for the review of the Agency's programme of activities. Opening remarks by the Director General

    International Nuclear Information System (INIS)

    ElBaradei, M.

    1998-01-01

    The document reproduces the opening remarks made by the Director General of the IAEA on 23 March 1998 at the first meeting of the Senior Expert Group for the review of the Agency's programme and activities. The Director General explains his considerations in establishing the group, and the major challenges facing the safe use of nuclear energy and technologies

  19. 77 FR 26824 - Agency Information Collection; Activity Under OMB Review; Submission of Audit Reports-Part 248

    Science.gov (United States)

    2012-05-07

    ... RITA 2008-0002] Agency Information Collection; Activity Under OMB Review; Submission of Audit Reports.... SUPPLEMENTARY INFORMATION: OMB Approval No. 2138-0004. Title: Submission of Audit Reports--Part 248. Form No...: BTS collects independent audited financial reports from U.S. certificated air carriers. Carriers not...

  20. 78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Science.gov (United States)

    2013-02-19

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... introduction of byproduct material into products or materials and transfer of the products or materials to..., Office of Information and Regulatory Affairs (3150-0001), NEOB-10202, Office of Management and Budget...

  1. Comparing the Medicaid Retrospective Drug Utilization Review Program Cost-Savings Methods Used by State Agencies.

    Science.gov (United States)

    Prada, Sergio I

    2017-12-01

    The Medicaid Drug Utilization Review (DUR) program is a 2-phase process conducted by Medicaid state agencies. The first phase is a prospective DUR and involves electronically monitoring prescription drug claims to identify prescription-related problems, such as therapeutic duplication, contraindications, incorrect dosage, or duration of treatment. The second phase is a retrospective DUR and involves ongoing and periodic examinations of claims data to identify patterns of fraud, abuse, underutilization, drug-drug interaction, or medically unnecessary care, implementing corrective actions when needed. The Centers for Medicare & Medicaid Services requires each state to measure prescription drug cost-savings generated from its DUR programs on an annual basis, but it provides no guidance or unified methodology for doing so. To describe and synthesize the methodologies used by states to measure cost-savings using their Medicaid retrospective DUR program in federal fiscal years 2014 and 2015. For each state, the cost-savings methodologies included in the Medicaid DUR 2014 and 2015 reports were downloaded from Medicaid's website. The reports were then reviewed and synthesized. Methods described by the states were classified according to research designs often described in evaluation textbooks. In 2014, the most often used prescription drugs cost-savings estimation methodology for the Medicaid retrospective DUR program was a simple pre-post intervention method, without a comparison group (ie, 12 states). In 2015, the most common methodology used was a pre-post intervention method, with a comparison group (ie, 14 states). Comparisons of savings attributed to the program among states are still unreliable, because of a lack of a common methodology available for measuring cost-savings. There is great variation among states in the methods used to measure prescription drug utilization cost-savings. This analysis suggests that there is still room for improvement in terms of

  2. Selected review of regulatory standards and licensing issues for nuclear power plants

    International Nuclear Information System (INIS)

    Stevenson, J.D.; Thomas, F.A.

    1982-11-01

    This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

  3. Regulatory controls for NORM contamination: Emerging issues and strategies

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

    Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

  4. The regulatory review of construction license application and the supporting safety case

    International Nuclear Information System (INIS)

    Heinonen, Jussi

    2014-01-01

    Finland is one of the foremost countries in the world in developing the disposal of spent fuel. The construction license application for the Olkiluoto spent fuel disposal facility was submitted to the authorities at the end of 2012 and the facility is expected to start operation around 2020. This has been a long-term project with over 30 years of parallel development of the repository project and the regulatory approach to spent fuel management. In 1983 the government made a strategic decision on the objectives and target time schedule for the research, development and technical planning of nuclear waste management. While an export and international disposal solution was still the preferred option, this decision required the licensees without this possibility to prepare for disposal in Finland and it also gave the time line for the milestones on the way to an operating disposal facility by 2020. The licensing procedure for a disposal facility has several steps that are similar to all nuclear facilities in Finland and are defined in Nuclear Energy Act and Decree (1987, 1988). These licensing steps are: - Decision-in-principle is required for a nuclear facility having considerable general significance. This is essentially a political decision: the government decides if the construction project is in line with the overall good of society. The decision can be applied for one or more sites, the host municipality has a veto right and the parliament has the choice of ratifying or not ratifying the decision. - Construction license is granted by the government and authorises the construction of the disposal facility. The actual construction is regulated by STUK and includes several review and approval steps, hold points and viewpoints. - Operational license is granted by the government and authorises the operation of the facility for a certain period. The operational license is needed before nuclear waste can be disposed. The first step in the licensing process was reached

  5. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

    Science.gov (United States)

    Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

    2013-12-01

    The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. Lessons Learned from Characterization, Performance Assessment, and EPA Regulatory Review of the 1996 Actinide Source Term for the Waste Isolation Pilot Plant

    International Nuclear Information System (INIS)

    Larson, K.W.; Moore, R.C.; Nowak, E.J.; Papenguth, H.W.; Jow, H.

    1999-01-01

    The Waste Isolation Pilot Plant (WIPP) is a US Department of Energy (DOE) facility for the permanent disposal of transuranic waste from defense activities. In 1996, the DOE submitted the Title 40 CFR Part 191 Compliance Certification Application for the Waste Isolation Pilot Plant (CCA) to the US Environmental Protection Agency (EPA). The CCA included a probabilistic performance assessment (PA) conducted by Sandia National Laboratories to establish compliance with the quantitative release limits defined in 40 CFR 191.13. An experimental program to collect data relevant to the actinide source term began around 1989, which eventually supported the 1996 CCA PA actinide source term model. The actinide source term provided an estimate of mobile dissolved and colloidal Pu, Am, U, Th, and Np concentrations in their stable oxidation states, and accounted for effects of uncertainty in the chemistry of brines in waste disposal areas. The experimental program and the actinide source term included in the CCA PA underwent EPA review lasting more than 1 year. Experiments were initially conducted to develop data relevant to the wide range of potential future conditions in waste disposal areas. Interim, preliminary performance assessments and actinide source term models provided insight allowing refinement of experiments and models. Expert peer review provided additional feedback and confidence in the evolving experimental program. By 1995, the chemical database and PA predictions of WIPP performance were considered reliable enough to support the decision to add an MgO backfill to waste rooms to control chemical conditions and reduce uncertainty in actinide concentrations, especially for Pu and Am. Important lessons learned through the characterization, PA modeling, and regulatory review of the actinide source term are (1) experimental characterization and PA should evolve together, with neither activity completely dominating the other, (2) the understanding of physical processes

  7. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  8. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  9. 78 FR 44122 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

    Science.gov (United States)

    2013-07-23

    ... Bonnie McGregor, Federal Trade Investigator, Division of Advertising Practices, Bureau of Consumer... Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission...

  10. 76 FR 72706 - Agency Information Collection Activities; Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-11-25

    ... products or brand imagery in television shows, motion pictures, or the Internet; (4) how much industry... of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for...

  11. 77 FR 44241 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2012-07-27

    ...: 0938-1016); Frequency: Reporting--Occasionally; Affected Public: Business or other for-profit, Not-for..., Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc...

  12. 78 FR 71623 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2013-11-29

    ... Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to establish new regulatory..., chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of...

  13. 76 FR 66756 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

    Science.gov (United States)

    2011-10-27

    ... necessary to substantiate their compliance with nondiscrimination and affirmative action contractual obligations. This information collection is subject to the PRA. A Federal agency generally cannot conduct or...

  14. 78 FR 9711 - Agency Information Collection Activities; Submission for OMB Review; Comment Request: Crisis...

    Science.gov (United States)

    2013-02-11

    ... Request: Crisis Counseling Assistance and Training Program AGENCY: Federal Emergency Management Agency.... FEMA has codified Section 416 of the Stafford Act at section 44 CFR 206.171 entitled Crisis Counseling... coordinate with FEMA in administering the Crisis Counseling Assistance and Training Program (CCP). FEMA and...

  15. 77 FR 70798 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Community...

    Science.gov (United States)

    2012-11-27

    ... Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to oira... Program's (NFIP) Community Rating System (CRS) to document the activities that communities have undertaken... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2010-0012...

  16. 76 FR 19978 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2011-04-11

    ... evaluation of consumer products and product use, by providing insight and information into consumer... CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2010-0088] Agency Information Collection... Exposure Survey AGENCY: Consumer Product Safety Commission. ACTION: Notice. SUMMARY: The U.S. Consumer...

  17. 77 FR 66075 - Agency Information Collection Activities; Emergency Clearance Submission for Expedited OMB Review...

    Science.gov (United States)

    2012-11-01

    ... Ethics. [FR Doc. 2012-26101 Filed 10-31-12; 8:45 am] BILLING CODE 6345-03-P ... OFFICE OF GOVERNMENT ETHICS Agency Information Collection Activities; Emergency Clearance... 201-A Ethics in Government Act Access Form AGENCY: Office of Government Ethics (OGE). ACTION...

  18. 75 FR 43995 - Agency Information Collection Activities: Submission for OMB Review; Comment Request, OMB No...

    Science.gov (United States)

    2010-07-27

    ...; FEMA/EMI Independent Study Course Enrollment and Test Answer Sheet AGENCY: Federal Emergency Management... Course Enrollment and Test Answer Sheet (paper and electronic). SUMMARY: The Federal Emergency Management... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2010-0026...

  19. 75 FR 79378 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Science.gov (United States)

    2010-12-20

    ... Environmental Protection Agency. FDA received a comment relating to the cruelty and sadism of animal testing. In... Request; Testing Communications on FDA-Regulated Products Used in Animals AGENCY: Food and Drug... Communications on FDA-Regulated Products Used in Animals.'' Also include the FDA docket number found in brackets...

  20. 75 FR 3903 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-01-25

    ..., confidential business information (CBI), or other information whose public disclosure is restricted by statute. For further information about the electronic docket, go to http://www.regulations.gov . Title: Green...; Comment Request; GreenChill Advanced Refrigeration Partnership AGENCY: Environmental Protection Agency...