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...

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

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

Outcomes of the First Review Meeting of the Joint Convention

International Nuclear Information System (INIS)

Linsley, G.

2003-01-01

The First Review Meeting of the Joint Convention was held from 3 to 14 November 2003 in Vienna. It was attended by representatives of 33 Contracting Parties (350 persons registered). The scope of applications includes: Waste and spent fuel from the operation of NPPs; Waste from use of radionuclides in medicine and industry; Spent sealed sources; Discharges from regulated nuclear facilities; Waste from mining and processing of uranium. The content of the Joint Convention and obligation of the Contracting Parties are reviewed in the report. The review process is also described. The effectiveness of review mechanism is discussed. Some technical issues are also discussed, such as: the wide variety of long term spent fuel and radioactive waste management policies; clearance; decommissioning; regulatory independence; discharges to the environment; Management of disused sealed sources etc. Some good practices have been identified and comments are given

Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

International Nuclear Information System (INIS)

2010-01-01

nuclear regulators. Such missions also help to build mutual confidence between States in the field of nuclear regulation.'' The IRRS team identified several strengths in the U.S. regulatory system, including: The achievement of a mature safety regulation system that meets its clearly defined strategic goals, organizational values, and the NRC's principles of good regulation; A transparent licensing process that accepts input from public citizens and environmental reviews, and ensures that key documents are publicly available; and A high level of human resource development, due to rigorous staff training at all levels and efforts to ensure long-term knowledge management. The IRRS team also made suggestions to improve the overall performance of the U.S. regulatory system. Examples include: The NRC should consider increasing its effort to use IAEA safety standards in its own regulations; The NRC should develop a fully integrated management system that will coordinate a number of programs and processes that are currently not fully integrated; and The NRC should incorporate lessons learned by the practice of other nations using licensee-conducted periodic safety reviews as a way to improve the NRC's assessment process. IAEA Deputy Director General Denis Flory said, ''I have been impressed by the worldwide interest and international participation in the IAEA's IRRS program. I appreciate the U.S. willingness to invite this mission and demonstrate the value of this service for all nations.'' General information about the Integrated Regulatory Review Service (IRRS) and previous missions can be found on the IAEA website. (IAEA)

75 FR 42742 - Alaska Village Electric Cooperative; Notice of Environmental Site Review and Scoping Meeting

Science.gov (United States)

2010-07-22

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 13272-001] Alaska Village Electric Cooperative; Notice of Environmental Site Review and Scoping Meeting July 15, 2010. a. Project No.: 13272-001. b. Name of Project: Old Harbor Hydroelectric Project. c. Location: On Mountain Creek, near the town of Old Harbor, Kodiak Island...

Use of prioritization in meeting regulatory requirements

International Nuclear Information System (INIS)

Bowling, M.L.; Sommers, D.A.; Girvin, L.M.

1993-01-01

The use of prioritization in the allocation of resources is certainly not a new idea. However, the degree to which prioritization must now be used is much greater than ever before. In the past, utilities generally allocated the necessary resources to meet all regulatory requirements and commitments. Prioritization was then applied to the remaining nonregulatory but required needs. This approach to resource allocation is no longer appropriate for the current and projected economic and operating environment. Key reasons for this conclusion are discussed in this paper by staff from Virginia Power

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.

78 FR 68044 - Erie Boulevard Hydropower, L.P.; Notice of Scoping Meetings and Environmental Site Review and...

Science.gov (United States)

2013-11-13

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 7320-042] Erie Boulevard Hydropower, L.P.; Notice of Scoping Meetings and Environmental Site Review and Soliciting Scoping Comments.... Date filed: July 1, 2013. d. Applicant: Erie Boulevard Hydropower, L.P. e. Name of Project: Chasm...

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)

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)

Strategies of bringing drug product marketing applications to meet current regulatory standards.

Science.gov (United States)

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

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

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

Use of PSA in the regulatory process. Report of the specialist's meeting. Working material

International Nuclear Information System (INIS)

1994-01-01

The objective of this meeting was to focus on the role of the regulator in relation to PSA, to give a picture of the present status, and near term plans, of the requirements placed on licensees and of the uses, formal and informal, made of PSA in regulatory decision making. One such use, in which there is currently much interest, is known as Risk-Based Regulation. This term has various connotations but essentially refers to a more flexible and efficient application of Technical Specifications in the interests of gains in both economy and safety. The position in many countries is one of change in the use of PSA by regulators, and hence any report can only give a snapshot in time. It has to be noted that a number of countries, with important nuclear power programmes, were not represented at the meeting, and so the overall picture is not as comprehensive as might have been hoped. The field of the discussion in the meeting was divided into three areas, progressed in three working groups, namely: Regulatory requirements related to PSA, Regulatory uses of PSA, and Risk-Based Regulation. The outcomes are covered in the next three sections. The fifth section of this report gives the overall conclusions of the meeting and the final section makes some recommendations for future IAEA activities in these areas. Refs, figs, tabs

Safety experts complete second IAEA regulatory review of UK nuclear regulator

International Nuclear Information System (INIS)

2009-01-01

Government senior adviser. IAEA IRRS Coordinator Mr. Gustavo Caruso said, ''The HSE/ND at all levels were enthusiastic and very interested in obtaining advice relating to the application of the IAEA safety standards for their further development.'' In the light of the UK Government decision to move the regulatory body to a Statutory Corporation, IRRS team members conducted a review of the transition arrangements put in place by HSE/ND. It was concluded that it is of vital importance to take several fundamental principles into account during and after the transition: adequate legal authority, effective independence, technical and managerial competence and human and financial resources to fulfil all regulatory responsibilities and functions. ND has developed and is implementing a comprehensive programme for this transition process. Mr. Tomihiro Taniguchi, IAEA Deputy Director General, said, ''This is especially important and timely in the context of the world wide nuclear 'vita nova' - providing input to the new entrants as well as the rapidly expanding current nuclear programmes, without adequate regulatory competence and resources.'' Mike Weightman, Head of ND and HM Chief Inspector of Nuclear Installations said: ''The Nuclear Directorate welcomes this important peer review of our regulatory arrangements and practices as part of our continuing to strive to be at the cutting edge of nuclear regulation worldwide. This review comes at a most important time for us with the Government's proposal to provide us with more freedom and independence to better meet challenges of a changing nuclear industry. We are committed to taking the necessary measures to address the findings made in the IAEA report, when it is finalised, and welcome the recognition of several of our practices as good examples for nuclear regulators around the world.'' (IAEA)

75 FR 26743 - Pacific Gas and Electric Company; Notice of Environmental Site Review and Technical Meetings To...

Science.gov (United States)

2010-05-12

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12779-005] Pacific Gas and Electric Company; Notice of Environmental Site Review and Technical Meetings To Discuss Information and Monitoring Needs for a License Application for a Pilot Project May 5, 2010. a. Type of Application: Draft Pilot License Application. b. Project N...

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)

Use of probabilistic safety assessment in the regulatory process. Report of the technical committee meeting. Working material

International Nuclear Information System (INIS)

1994-01-01

A Technical Committee Meeting (TCM) was organized between 5-8 December 1994 to discuss and review the international situation in connection with the use made, whether formally or informally, by regulatory bodies of probabilistic safety assessment (PSA) in the course of their work, and the related question of the use and value of adopting probabilistic safety criteria (PSC) as an aid to judging the results of PSAs. The document includes the output from the four working groups, as well as 11 papers from the 12 papers presented to the TCM. A separate abstract was prepared for each paper. Refs, figs, tabs

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)

75 FR 65485 - Sunshine Act Meeting

Science.gov (United States)

2010-10-25

... Asia-Pacific Economic Cooperation-- 33rd Transportation Working Group Meeting. 2. Commission Review of... Agreement, FMC Agreement No. 011223. 3. Staff Briefing Regarding China Maritime Regulatory Issues. Contact...

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.

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...

Proceedings of the Advanced Turbine Systems annual program review meeting

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-12-31

Goals of the 8-year program are to develop cleaner, more efficient, and less expensive gas turbine systems for utility and industrial electric power generation, cogeneration, and mechanical drive units. During this Nov. 9-11, 1994, meeting, presentations on energy policy issues were delivered by representatives of regulatory, industry, and research institutions; program overviews and technical reviews were given by contractors; and ongoing and proposed future projects sponsored by university and industry were presented and displayed at the poster session. Panel discussions on distributed power and Advanced Gas Systems Research education provided a forum for interactive dialog and exchange of ideas. Exhibitors included US DOE, Solar Turbines, Westinghouse, Allison Engine Co., and GE.

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

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...

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

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

Perceived success/failure and attributions associated with self-regulatory efficacy to meet physical activity recommendations for women with arthritis.

Science.gov (United States)

Spink, Kevin S; Brawley, Lawrence R; Gyurcsik, Nancy C

2016-10-01

The relationship between attributional dimensions women assign to the cause of their perceived success or failure at meeting the recommended physical activity dose and self-regulatory efficacy for future physical activity was examined among women with arthritis. Women (N = 117) aged 18-84 years, with self-reported medically-diagnosed arthritis, completed on-line questions in the fall of 2013 assessing endurance physical activity, perceived outcome for meeting the recommended levels of endurance activity, attributions for one's success or failure in meeting the recommendations, and self-regulatory efficacy to schedule/plan endurance activity over the next month. The main theoretically-driven finding revealed that the interaction of the stability dimension with perceived success/failure was significantly related to self-regulatory efficacy for scheduling and planning future physical activity (β = 0.35, p = .002). Outcomes attributed to more versus less stable factors accentuated differences in self-regulatory efficacy beliefs following perceived success and failure at being active. It appears that attributional dimensions were associated with self-regulatory efficacy in women with arthritis. This suggests that rather than objectively observed past mastery experience, women's subjective perceptions and explanations of their past experiences were related to efficacy beliefs, especially following a failure experience.

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

International Nuclear Information System (INIS)

2011-01-01

within the Slovenian nuclear industry and coordination with international stakeholders was considered effective. Further lessons learned will also need to be adequately addressed. Among the good practices identified by the IRRS Review Team were: The development of SSNA's quality management system, through which it will be able to improve its regulatory effectiveness; and SNSA has developed, maintains and uses an integrated information management system. The IRRS Review Team also identified certain issues warranting attention or in need of improvement. It believes that consideration of these would enhance the overall performance of the future regulatory system: Slovenia should develop a national policy and strategy for nuclear safety which would be supported by a national co-ordinated plan to ensure the appropriate national infrastructure is in place; Consideration should be given to possible alternative methods of financing SNSA to provide it with the flexibility to meet its regulatory responsibilities while also ensuring it operates effectively. This should include provision for research and development; SNSA should develop and implement a process for carrying out a systematic review of the organisational structure, competencies and resource needed for it to effectively discharge its current and future responsibilities; and The Government should make the necessary provision for the Low and Intermediate Level Waste Repository to ensure radioactive waste can be disposed at the appropriate time. Background The IRRS mission to Slovenia was conducted from 25 September to 4 October, mainly in Ljubljana. The team also visited several nuclear and radiation facilities, including the nuclear power plant, the research reactor and the country's emergency response centres. The IRRS reviewed the following regulatory areas: responsibilities and functions of the government; the global nuclear safety regime; responsibilities and functions of the regulatory body; the management system of

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

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

Proceedings of the fuels technology contractors review meeting

Energy Technology Data Exchange (ETDEWEB)

Malone, R.D. [ed.

1993-11-01

The Fuels Technology Contractors Review Meeting was held November 16-18, 1993, at the Morgantown Energy Technology Center (METC) in Morgantown, West Virginia. This meeting was sponsored and hosted by METC, the Office of Fossil Energy, U.S. Department of Energy (DOE). METC periodically provides an opportunity to bring together all of the R&D participants in a DOE-sponsored contractors review meeting to present key results of their research and to provide technology transfer to the active research community and to the interested public. This meeting was previously called the Natural Gas Technology Contractors Review Meeting. This year it was expanded to include DOE-sponsored research on oil shale and tar sands and so was retitled the Fuels Technology Contractors Review Meeting. Current research activities include efforts in both natural gas and liquid fuels. The natural gas portion of the meeting included discussions of results summarizing work being conducted in fracture systems, both natural and induced; drilling, completion, and stimulation research; resource characterization; delivery and storage; gas to liquids research; and environmental issues. The meeting also included project and technology summaries on research in oil shale, tar sands, and mild coal gasification, and summaries of work in natural-gas fuel cells and natural-gas turbines. The format included oral and poster session presentations. Individual papers have been processed separately for inclusion in the Energy Science and Technology database.

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.)

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

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.

Upgrading nuclear regulatory infrastructure in Armenia

International Nuclear Information System (INIS)

Martirosyan, A.; Amirjanyan, A.; Kacenelenbogen, S.

2010-01-01

Armenia is contemplating an upgrade to its national power generation capacity to meet replacement and future energy needs. Unit 2 of ANPP is scheduled for shutdown after replacement power generation capacities are in place. A recent alternative energy study indicates viability of the nuclear option to replace this capacity. Some technology-specific proposals are being considered by the Ministry of Energy of Armenia. It is likely that the reactor technology decision will be made in the not too distant future. The existing reactor continues to be operated in the regulatory framework developed in the Soviet Union and adopted in Armenia. Given the interest in the new reactor, Armenia launched a project to review the existing system of regulation and to bring it into harmony with modern practice in preparation for the new reactor project development. The new regulatory framework will be needed as a basis for any potential tendering process. The US NRC and ANRA have agreed to perform a review and update nuclear legislation and the system of regulation in this area. The first step in this process was to develop an action plan for such program. The action plan describes the overall strategy of ANRA to modify existing or develop new processes and requirements, identifies the major Laws that need to be reviewed given practical legal considerations to construct and operate the reactor and Armenia's international obligations under various conventions. This work included review of existing models of regulation in different countries with 'small' nuclear program, including IAEA recommendations as well as existing legislation in Armenia in this area and development of a strategy for the regulatory model development. In addition, the plan to develop requirements for ANRA staffing and training needs to meet its regulatory obligations under the new reactor development process was developed

Guidelines on how to meet the requirement to keep all exposures as low as reasonably achievable. Regulatory guide

International Nuclear Information System (INIS)

1997-01-01

The purpose of Regulatory Guide G-129 (E) is to provide Atomic Energy Control Board (AECB) licensees with guidelines on how to meet the forthcoming AECB regulatory requirement to keep doses received by workers and members of the public As Low As Reasonably Achievable (ALARA), social and economic factors taken into account. it is realized that the scope for realistic dose reductions will vary depending on the nature of the licensed activity. Therefore, criteria are given in section D for determining if doses can be deemed to be as low as reasonably achievable without further evaluation. The elements that the AECB considers to be essential in the approach to ALARA are described in section E and are summarized as follows: a demonstrated management commitment to the ALARA principle; the implementation of ALARA through a licensee's organization and management, provision of resources, training, establishment of action levels, documentation and other measures; and regular operational reviews. The above elements will be the focus of any AECB assessment to verify compliance with the requirement to keep radiation exposures as low as reasonably achievable. (author)

Review of Meeting Objectives

International Nuclear Information System (INIS)

Braams, B.J.; Chung, H.-K.

2011-01-01

This is the 21st meeting of the International Atomic and Molecular Data Centres Network. The traditional DCN meeting objectives are: to exchange information about activities in the Centres and review progress; to coordinate work in the Centres; to assess priorities in data evaluation and data production; to make plans for specific evaluations; and to evaluate and revise procedures for collection and exchange of bibliographical and numerical data. All of these are objectives for the present meeting too. In addition to the presentations from DCN and prospective DCN members we have two participants from outside the field of fusion data: Dr N. Mason will tell us about coordination of the Virtual Atomic and Molecular Data Centre and Dr S. Simakov will describe the manner in which nuclear structure and cross-section database development is coordinated by our colleagues in the Nuclear Data Section. In the discussions on Thursday and Friday there are two topics that need special attention this year: the future of our bibliographical data compilation and ways in which we can strengthen data evaluation activities, all with emphasis on collision processes and plasma-material interaction. The first 3 Data Centre Network meetings were held in 1977, 1980 and 1982 and the reports of those meetings make interesting reading and can still provide inspiration for the present meeting. I show some excerpts in the presentation. In 1977 the emphasis was on the coordination of the bibliographical database, AMBDAS, and a collision data index, CIAMDA, as the initial activities of the Network and of the newly formed IAEA A+M Data Unit. In 1980 the central topic of discussion at the meeting shifted to the numerical database and to data evaluation. The Network recommended that numerical data be reviewed by a selected group of scientists and that no unevaluated numerical A+M collision data should be distributed by the IAEA. The report of the meeting in 1982 shows that the bibliographical

76 FR 47089 - Regulatory Review Schedule; Cancellation of Consultation Meetings

Science.gov (United States)

2011-08-04

... Consultation-- Wild Horse Resort Casino, 1, 2, 3, 4, 5 Southwest. Scottsdale, AZ. September 19-20, 2011 NIGC Regional Training..... Sky Ute Casino Resort 3, 4, 5 Ignacio, CO. September 27-28, 2011 NIGC Consultation-- Turning Stone Casino, NY... 3, 5 Northeast. November 7-12, 2011 USET Annual Meeting........ Mississippi...

Regulatory inspection of nuclear power plants in NEA member countries

International Nuclear Information System (INIS)

Gronow, W.S.; Ilani, O.

1977-01-01

The increasing use of nuclear power and public interest in the safety controls led to the proposal by the sub-Committe on Licensing of the NEA Committee on the Safety of Nuclear Installations for a specialist meeting on regulatory inspection practices. This report which was prepared at the request of the sub-Committee to assist in the exchange of views and experience at the meeting reviews the response to a questionnaire on the systems employed, the scope and objectives and the effort involved in regulatory inspection throughout all stages of the life of a nuclear power plant. Other aspects of regulatory inspection activities are discussed including documentation, procedures for changes in technical specification and modifications to plant, powers and duties of regulatory inspection personnel and actions to be taken in the event of an accident or emergency. The report concludes with some comments on those aspects of regulatory inspection practices where further information and an exchange of experience might prove to be beneficial to Member countries. (author)

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

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

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

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.)

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

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

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.

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

75 FR 70951 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Laboratory Annual Review at Hanford Observatory for Physics... Physics, National Science Foundation, (703) 292-7373. Purpose of Meeting: To provide an evaluation of the...

76 FR 26775 - Advisory Committee on Reactor Safeguards Meeting of the ACRS Subcommittee on EPR; Cancellation to...

Science.gov (United States)

2011-05-09

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards Meeting of the ACRS Subcommittee on EPR; Cancellation to May 11, 2011, ACRS Meeting-- Federal Register Notice The Federal Register Notice for the ACRS Subcommittee Meeting on the design certification application review of the U.S...

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...

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

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.

Fifth review meeting of the contracting parties of the joint convention

International Nuclear Information System (INIS)

Brennecke, Peter

2015-01-01

The 5 th Review Meeting of the ''Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management'' was held at International Atomic Energy Agency (IAEA) Headquarters in Vienna on 11 to 22 May 2015. Sixty-one of sixty-nine Contracting Parties with more than 700 delegates and the OECD/NEA as an observer attended the meeting. Within this regularly scheduled meeting every three years it is checked in which way the contracting parties meet the objectives of the Joint Convention, i.e., the respective national radioactive waste management policy and its implementation is critically reviewed, the respective reached safety level discussed and - where necessary - improvements suggested. As a result the Contracting Parties in particular concur that the 5 th Review Meeting encouraged constructive exchanges and sharing of knowledge. Some highlights of good progress and significant accomplishments since the 4 th Review Meeting include, e.g., the implementation of national policies, strategies and programs for spent fuel and radioactive waste management or the construction and commissioning of storage facilities and repositories for spent fuel and radioactive waste. The 6 th Review Meeting of the Contracting Parties to the Joint Convention will be held at IAEA Headquarters in Vienna on 21 May to 1 June 2018.

76 FR 8381 - Proposal Review for Physics; Notice of Meeting

Science.gov (United States)

2011-02-14

... NATIONAL SCIENCE FOUNDATION Proposal Review for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Proposal Review for the Center for Magnetic Self-Organization in...

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

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...

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

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

the notification of nuclear and radiation safety-related events; Provisions established by the BNRA to manage its technical support organisations provide a good basis to use them effectively; The process to establish and keep updated regulations and guidelines is well structured and involves, as necessary, relevant interested parties; The BNRA has a policy of transparency and openness with the public, which covers in an effective manner the provision of information on safety-related events and protective actions during emergencies; and There is a complete national dose registry system that includes provision for comprehensive information gathering, which allows for thorough cause-effect analyses to be performed. The IRRS team identified the following areas where the overall performance of the regulatory system could be enhanced: Demarcation of the respective roles of state authorities in the area of radiation protection safety, and establishment of formal coordination and cooperation of their regulatory functions; BNRA's resources and competence for oversight of future facilities and activities; BNRA's establishment of an integrated management system that contributes to meeting its goals in an efficient manner; BNRA procedures used for the review and assessment process for all facilities and activities; and Inspection processes, including the development and implementation of planned and systematic inspection programmes that cover all facilities and activities, and coordination among different regulatory organisations. A final report will be submitted to the Government of Bulgaria in about three months. The BNRA announced to the mission that the report will be made publicly available. The IAEA encourages nations to invite a follow-up IRRS mission about two years after the initial mission has been completed. Background The team reviewed the legal and regulatory framework for nuclear and radiation safety, addressing all facilities and activities regulated by BNRA

Results of the 3rd Review Meeting of the Convention on Nuclear Safety and Preparatory Works for the 4th Meeting

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik; Kim, Woong Sik

2006-01-01

The 3 rd Review Meeting of the Convention on Nuclear Safety (CNS) took place from April 11-22, 2005. Fifty out of fifty-five Contracting Parties (CPs) participated with over 500 delegates in attendance. It was concluded that all CPs in attendance were in compliance with the requirements of the CNS. It was also noted that although the focus tends to be on the triennial national reports and review meetings, the CNS should emphasize an ongoing process that continually promotes the advancement of nuclear safety. With regard to this continuity process, the President of the 3 rd Review Meeting sent to all the CPs a message to remind of the lessons offered and learned from the Meeting and to put them into action as well. The president also asked that the CPs start in earnest later this year their preparations for the Forth Meeting in 2008. This paper introduces the results of the 3 rd Review Meeting and presents some suggestions on preparatory works that should be done for the next Review Meeting

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

75 FR 7633 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on EPR; Notice...

Science.gov (United States)

2010-02-22

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on EPR; Notice of Meeting The ACRS U.S. Evolutionary Power Reactor (EPR) Subcommittee will hold a....S. EPR Design Certification Document Review. The Subcommittee will gather information, analyze...

78 FR 16301 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2013-03-14

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics... Physics, National Science Foundation, Arlington, VA (703) 292-4432. [[Page 16302

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

Conference report. Fourth review meeting of the parties of the Joint Convention

International Nuclear Information System (INIS)

Brennecke, Peter

2012-01-01

The Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management, the first legal instrument to directly address these topics on a global scale, was opened for signature 29 September 1997. It entered into force 18 June 2001. The Convention calls for triannual review meetings of the Contracting Parties. Each Contracting Party is required to submit a national report to each review meeting that addresses measures taken to implement each of the obligations of the Convention. The first review meeting took place in 2003. The 4 th review meeting of this Convention took place from 14 to 23 May 2012 at the International Atomic Energy Agency (IAEA) Headquarter in Vienna/Austria. (orig.)

76 FR 66998 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2011-10-28

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

77 FR 14441 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2012-03-09

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Annual Review Site Visit at Hanford Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

76 FR 19147 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2011-04-06

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: LIGO Laboratory Annual Review at Livingston Observatory for Physics...: Partially Closed. Contact Person: Thomas Carruthers, Program Director, Division of Physics, National Science...

75 FR 81315 - Earth Sciences Proposal Review Panel; Notice of Meeting

Science.gov (United States)

2010-12-27

... NATIONAL SCIENCE FOUNDATION Earth Sciences Proposal Review Panel; Notice of Meeting In accordance... announces the following meeting. Name: Proposal Review Panel in Earth Sciences (1569). Date and Time... Kelz, Program Director, Instrumentation & Facilities Program, Division of Earth Sciences, Room 785...

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

76 FR 67439 - External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic...

Science.gov (United States)

2011-11-01

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-053; FRL-9485-1] External Peer Review Meeting for... review draft does not represent EPA policy. The public may register to attend this peer review meeting as... to consider the comments from the external peer review meeting, along with public comments received...

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: �

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: �

75 FR 15460 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-03-29

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting. Name: Proposal Review Panel for Physics, LIGO Site Visit in Louisiana (1208...

77 FR 69505 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2012-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting. Name: LIGO Operations Proposal and Annual Review in Physics (1208). Date...

Subsurface barrier feasibility evaluation: External review meeting report

International Nuclear Information System (INIS)

Lindberg, S.L.; Rouse, J.K.

1994-12-01

The Westinghouse Hanford Company -- Tank Waste Remediation System Division (TWRS) Program is evaluating subsurface barrier technologies for potential use in supporting remediation of the Hanford Tank Farms for the US Department of Energy, Richland Operations Office (DOE-RL). An External Review Team (ERT) was assembled to perform an independent technical review of the work performed to-date supporting the evaluation process. A set of draft documents was forwarded to the ERT for their review, and a meeting was held August 10 through 12, 1994, to facilitate comments and resolutions. This document summarizes the meeting, the comments provided by the ERT, and the ongoing work to resolve the comments and support a pending decision by The US Department of Energy, Richland Operations Office; the Washington State Department of Ecology; and the US Environmental Protection Agency

Regulatory activities

International Nuclear Information System (INIS)

2001-01-01

This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

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

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

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

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

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

Results of 6th Review Meeting and Perspective of the 7th Review Meeting of the Convention on Nuclear Safety

International Nuclear Information System (INIS)

Lee, Sukho; Kim, Manwoong; You, Jeongwon; Lee, Youngeal

2017-01-01

This paper highlighted the objective and role of the Convention on Nuclear Safety organized by the IAEA. The Convention provides Member States to demonstrate and share how to maintain and improve the level of nuclear safety. The results of the 6 th review meeting were implemented for safety improvements and to prepare for 7 th national report. Seven and a half months before the 7 th Review Meeting, the National Report has submitted on steps and measures taken to implement Convention obligations. The Contracting Parties reviewed each other’s reports, and exchanged written questions, written answers and comments. The discussions in the Country Group sessions were generally good with a lively and frank exchange of information. The Country Groups noted the significant measures taken by Contracting Parties to improve nuclear safety and identified a number of good practices to be shared with all Contracting Parties.

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

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...

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

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

78 FR 15373 - Center for Scientific Review; Notice of Closed Meeting

Science.gov (United States)

2013-03-11

....S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C...). Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review Officer, Center for Scientific Review, National...

76 FR 36931 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-06-23

... U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C...: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of...

75 FR 51082 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-08-18

... U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C... Conference Call). Contact Person: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review...

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

Proceedings of the 24th NSRR technical review meeting

Energy Technology Data Exchange (ETDEWEB)

Uetsuka, Hiroshi; Fuketa, Toyoshi; Suzuki, Motoe [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment] [and others

2001-09-01

The 24th NSRR Technical Review Meeting was held at Tranomon Pastoral, Tokyo, on November 13 and 14, 2000. The purpose of the meeting was to present and discuss the recent progress of the NSRR program and other LWR fuel safety researches at JAERI. Twenty-one papers, including five by foreign institutes, were presented and discussed regarding fuel behavior during normal operation, reactivity initiated accident (RIA) and loss-of-coolant accident (LOCA) and FP release behavior during severe accident. The meeting was a great help in planning future research and promoting research cooperation. This proceeding contains the papers presented in the meeting. (author)

75 FR 5355 - Sunshine Act; Meeting Notice

Science.gov (United States)

2010-02-02

...). (Contact: Dominick Orlando, 301-415-6749.) This meeting will be webcast live at the Web address, http://www... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act; Meeting Notice AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission. DATES: Weeks of February 1, 8, 15, 22, March 1, 8, 2010. PLACE...

77 FR 60116 - Human Studies Review Board; Notification of a Public Meeting

Science.gov (United States)

2012-10-02

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0718; FRL-9736-4] Human Studies Review Board; Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

77 FR 74004 - Human Studies Review Board; Notification of a Public Meeting

Science.gov (United States)

2012-12-12

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0892; FRL-9761-4] Human Studies Review Board; Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries.

Science.gov (United States)

van den Wijngaart, Annoek; Bégin, France; Codling, Karen; Randall, Philip; Johnson, Quentin W

2013-06-01

Considerable efforts have been made over the past decade to address vitamin and mineral deficiencies. An increasing number of countries in the Association of Southeast Asian Nations (ASEAN) are adopting mandatory food fortification as one of the primary strategies to overcome these deficiencies. Experience shows that fortified foods can reach large parts of the population, including the poor, if the fortification is done on a mandatory rather than a voluntary basis and if the food vehicle is widely consumed. To review the importance of regulatory monitoring as an essential component of food fortification efforts in selected ASEAN countries, with special focus on the available information on regulatory monitoring systems for iodized salt and fortified wheat flour. The role of regulatory monitoring in strengthening food fortification programs was discussed during a joint regional meeting of the World Health Organization, UNICEF, the Flour Fortification Initiative, the Global Alliance for Improved Nutrition, the Micronutrient Initiative, and the World Bank on regulatory monitoring of salt and wheat flour fortification programs in Asia, which took place in Manila, Philippines, on 27-29 September 2011. This paper reviews the regulatory monitoring systems of selected ASEAN countries that participated in this meeting. Problems and challenges in regulatory monitoring systems for iodized salt and fortified wheat flour in selected ASEAN countries are identified, and a description of the role of regulatory monitoring in strengthening food fortification initiatives, particularly of salt and flour, and highlights of areas for improvement are presented. Regulatory monitoring consists of monitoring activities conducted at the production level, at customs warehouses, and at retail stores by concerned regulatory authorities, and at the production level by producers themselves, as part of quality control and assurance efforts. Unless there are appropriate enforcement and quality

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

78 FR 57383 - Human Studies Review Board; Notification of a Public Meeting

Science.gov (United States)

2013-09-18

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2013-0626; FRL-9900-98-ORD] Human Studies Review Board; Notification of a Public Meeting AGENCY: U.S. Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

76 FR 80938 - Human Studies Review Board; Notification of a Public Meeting

Science.gov (United States)

2011-12-27

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0954; FRL-9611-6] Human Studies Review Board; Notification of a Public Meeting AGENCY: U.S. Environmental Protection Agency. ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the...

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.

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

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

Report of a consultants' meeting on a review of the methods used for leak rate measurements for WWER 440/230 confinements and WWER/440/213 containments. Extrabudgetary programme on the safety of WWER NPPS

International Nuclear Information System (INIS)

1995-01-01

During the meeting the first two days were given to the presentations of the papers, after which the meeting was divided into working groups which prepared the experts' positions on the following topics: requirements of the National Regulatory Authorities on confinement/containment leak rate testing methods; local leak rate test methods; integral leak rate test methods; structural integrity testing; methods of evaluation of leak rate test results. The reports prepared by each working group were reviewed in plenary sessions and the final conclusions were discussed and agreed upon in the plenary meeting. 16 refs, 6 tabs

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...

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...

75 FR 80511 - Center for Scientific Review; Notice of Closed Meeting

Science.gov (United States)

2010-12-22

...: Cognition and Perception. Date: January 19-20, 2011. Time: 12 p.m. to 6 p.m. Agenda: To review and evaluate... (Virtual Meeting). Contact Person: Weijia Ni, PhD, Scientific Review Officer, Center for Scientific Review...

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

76 FR 59697 - Human Studies Review Board (HSRB); Notification of a Public Meeting

Science.gov (United States)

2011-09-27

... public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0693; FRL-9472-4] Human Studies Review Board (HSRB); Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice...

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

76 FR 17121 - Human Studies Review Board (HSRB); Notification of a Public Meeting

Science.gov (United States)

2011-03-28

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0124; FRL-9287-1] Human Studies Review Board (HSRB); Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... public meeting of the HSRB to advise the Agency on EPA's scientific and ethical reviews of research with...

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

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

75 FR 4090 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-01-26

... El Camino Real, San Diego, CA 92130. Contact Person: William A. Greenberg, PhD., Scientific Review... (Virtual Meeting). Contact Person: Fouad A. El-Zaatari, PhD., Scientific Review Officer, Center for... for Scientific Review Special Emphasis Panel, Small Business: Experimental Cancer Therapeutics. Date...

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

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

Science.gov (United States)

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

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)

77 FR 27804 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2012-05-11

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation announces the following meeting: Name: Centers for Chemical Innovation (CCI) Solar Fuels: Powering the...

75 FR 3493 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-01-21

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: University of Nebraska Site Visit in Physics (1208). Date and Time... Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd., Arlington, VA...

75 FR 57298 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-09-20

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: University of Notre Dame Site Visit in Physics (1208). Date and Time..., Program Director for Physics Education and Disciplinary Research, National Science Foundation, 4201 Wilson...

75 FR 63865 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-10-18

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting. Name: Michigan State University Site Visit in Physics (1208). Date and Time... Reidy, Program Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd...

Regulatory practices for nuclear power plants in India

International Nuclear Information System (INIS)

Bajaj, S.S.

2013-01-01

The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB is responsible for the stipulation and enforcement of rules and regulations pertaining to nuclear and radiological safety. This paper describes the regulatory process followed by AERB for ensuring the safety of nuclear power plants (NPPs) during their construction as well as operation. This regulatory process has been continuously evolving to cater to the new developments in reactor technology. Some of the recent initiatives taken by AERB in this direction are briefly described. Today, AERB faces new challenges like simultaneous review of a large number of new projects of diverse designs, a fast growing nuclear power program and functioning of operating plants in a competitive environment. This paper delineates how AERB is gearing up to meet these challenges in an effective manner. (author)

Regulatory activities; Actividades regulatorias

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information.

The core to regulatory reform

International Nuclear Information System (INIS)

Partridge, J.W. Jr.

1993-01-01

Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

77 FR 12605 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-03-01

..., (Virtual Meeting). Contact Person: Eduardo A Montalvo, Ph.D., Scientific Review Officer, Center for... Person: Allen Richon, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes...: Chemistry, Biochemistry, Biophysics, and Bioengineering. Date: March 15-20, 2012. Time: 11 a.m. to 5 p.m...

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

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

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.

76 FR 2107 - Human Studies Review Board; Notice of Public Meeting

Science.gov (United States)

2011-01-12

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0970; FRL-9252-3] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

75 FR 32461 - Human Studies Review Board; Notice of Public Meeting

Science.gov (United States)

2010-06-08

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0381; FRL-9159-9] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

75 FR 61748 - Human Studies Review Board; Notice of Public Meeting

Science.gov (United States)

2010-10-06

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0797' FRL-9211-1] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

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)

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

12 CFR 567.2 - Minimum regulatory capital requirement.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Minimum regulatory capital requirement. 567.2... Regulatory Capital Requirements § 567.2 Minimum regulatory capital requirement. (a) To meet its regulatory capital requirement a savings association must satisfy each of the following capital standards: (1) Risk...

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…

KWOC [Key-Word-Out-of-Context] Index of US Nuclear Regulatory Commission Regulatory Guide Series

International Nuclear Information System (INIS)

Jennings, S.D.

1990-04-01

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

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

78 FR 52206 - Center For Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-08-22

...: Biophysics, Biochemistry and Chemistry. Date: September 18-19, 2013. Time: 8:00 a.m. to 3:00 p.m. Agenda: To..., Bethesda, MD 20892 (Virtual Meeting). Contact Person: John L Bowers, Ph.D., Scientific Review Officer..., Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701...

78 FR 36789 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-06-19

.... Contact Person: Aruna K Behera, Ph.D., Scientific Review Officer, Center for Scientific Review, National...: Biochemistry & Macromolecular Biophysics. Date: July 15-17, 2013. Time: 8:00 a.m. to 12:00 p.m. Agenda: To..., Bethesda, MD 20892 (Virtual Meeting). Contact Person: James W Mack, Ph.D., Scientific Review Officer...

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)

78 FR 25101 - Proposal Review Panel for Physics, Notice of Meeting

Science.gov (United States)

2013-04-29

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics, Notice of Meeting In accordance... Physics, 1208 Date and Time: Tuesday, April 30, 2013; 8:00 a.m.-6:00 p.m., Wednesday, May 1, 2013, 8:00 a... Meeting: Partially Closed. Contact Person: Mark Coles, Director of Large Facilities, Division of Physics...

75 FR 67142 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-01

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance... announces the following meeting: Name: Site Visit to the Center for the Physics of Living Cells 1208. Dates... Physics of Living Cells (CPLC). Agenda Monday, November 8, 2010 9 a.m.-11:55 a.m.--Open--Directors...

75 FR 2878 - Center for Scientific Review; Amended Notice of Meeting

Science.gov (United States)

2010-01-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Molecular Neuropharmacology and Signaling Study Section, February 4, 2010, 8 a.m. to February 5, 2010, 5 p.m., Hotel Monaco...

1990 DOE/SANDIA crystalline photovoltaic technology project review meeting

Energy Technology Data Exchange (ETDEWEB)

Ruby, D.S. (ed.)

1990-07-01

This document serves as the proceedings for the annual project review meeting held by Sandia's Photovoltaic Cell Research Division and Photovoltaic Technology Division. It contains information supplied by each organization making a presentation at the meeting, which was held August 7 through 9, 1990 at the Sheraton Hotel in Albuquerque, New Mexico. Sessions were held to discuss national photovoltaic programs, one-sun crystalline silicon cell research, concentrator silicon cell research, concentrator 3-5 cell research, and concentrating collector development.

75 FR 64306 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-10-19

... Transmission System. Hydro H-1 P-12107-005 Granite County, Montana. H-2 P-2496-222 Eugene Water and Electric... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice October 14... Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b: Agency Holding Meeting: Federal Energy Regulatory Commission...

Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

Energy Technology Data Exchange (ETDEWEB)

Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

2008-06-01

Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

1988-year of high integrity container evaluation, controversy and regulatory action

International Nuclear Information System (INIS)

Jones, D.

1989-01-01

During 1988, the Nuclear Regulatory Commission(NRC) completed review of and prepared technical evaluation reports on several topical reports describing containers designed to meet the 10CFR61 requirements for high integrity containers (HICs). An all metal Ferralium container and a stainless steel/polyethylene lined container were approved by the NRC. However, the NRC did not approve any containers designed from polyethylene material. The NRC staff concluded that polyethylene containers do not meet the structural stability requirements of Part 61, and unless they are combined with some engineered structure or overpack, they are not adequate for disposal of low-level radioactive wastes that require disposal in a structurally stable form. In conflict with these NRC findings, the State of South Carolina Department of Health and Environmental Control (SCDHEC) has given interim approval for continued use of polyethylene containers at the Barnwell disposal site with some restrictions on how the containers are buried depending on the classification of the waste. This paper reviews the applicable federal regulations, presents a chronology of events describing how the controversy over high integrity containers evolved from 1980 to 1989, summarizes the technical issues involved and suggests an approach that waste generators should follow during this situation of regulatory uncertainty

78 FR 65344 - Center for Scientific Review Amended Notice of Meeting

Science.gov (United States)

2013-10-31

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Molecular Neuropharmacology and Signaling Study Section, October 7, 2013, 8:00 a.m. to October 8, 2013, 12:00 p.m., The Dupont...

Proceedings of the fuel cells `95 review meeting

Energy Technology Data Exchange (ETDEWEB)

George, T.J.

1995-08-01

This document contains papers presented at the Fuel Cells `95` Review Meeting. Topics included solid oxide fuel cells; DOE`s transportation program; ARPA advanced fuel cell development; molten carbonate fuel cells; and papers presented at a poster session. Individual papers have been processed separately for the U.S. DOE databases.

RNAi technologies in agricultural biotechnology: The Toxicology Forum 40th Annual Summer Meeting.

Science.gov (United States)

Sherman, James H; Munyikwa, Tichafa; Chan, Stephen Y; Petrick, Jay S; Witwer, Kenneth W; Choudhuri, Supratim

2015-11-01

During the 40th Annual Meeting of The Toxicology Forum, the current and potential future science, regulations, and politics of agricultural biotechnology were presented and discussed. The meeting session described herein focused on the technology of RNA interference (RNAi) in agriculture. The general process by which RNAi works, currently registered RNAi-based plant traits, example RNAi-based traits in development, potential use of double stranded RNA (dsRNA) as topically applied pesticide active ingredients, research related to the safety of RNAi, biological barriers to ingested dsRNA, recent regulatory RNAi science reviews, and regulatory considerations related to the use of RNAi in agriculture were discussed. Participants generally agreed that the current regulatory framework is robust and appropriate for evaluating the safety of RNAi employed in agricultural biotechnology and were also supportive of the use of RNAi to develop improved crop traits. However, as with any emerging technology, the potential range of future products, potential future regulatory frameworks, and public acceptance of the technology will continue to evolve. As such, continuing dialogue was encouraged to promote education of consumers and science-based regulations. Copyright © 2015 Elsevier Inc. All rights reserved.

Integrated Data Collection Analysis (IDCA) Program — Quarterly Review Meeting

Energy Technology Data Exchange (ETDEWEB)

Sandstrom, Mary M. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Brown, Geoffrey W. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Warner, Kirstin F. [Naval Surface Warfare Center (IHD-NSWC), Indian Head, MD (United States). Indian Head Division; Sorensen, Daniel N. [Naval Surface Warfare Center (IHD-NSWC), Indian Head, MD (United States). Indian Head Division; Remmers, Daniel L. [Naval Surface Warfare Center (IHD-NSWC), Indian Head, MD (United States). Indian Head Division; Shelley, Timothy J. [Air Force Research Lab. (AFRL/RXQF), Tyndall AFB, FL (United States); Reyes, Jose A. [Applied Research Associates, Inc., Tyndall AFB, FL (United States); Phillips, Jason J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Hsu, Peter C. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Reynolds, John G. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

2011-12-05

On November 9 and 10, 2011 the IDCA had the annual quarterly meeting. The meeting started the afternoon of the first day with a tour of the NSWC IHD explosives safety testing and analysis facilities. The meeting on the second day addressed the formal sponsor review and further technical issues for the IDCA. Examination of the IHD equipment during the tour, lead to a long discussion on liquid test methods. The discussion resulted in revision of liquid test methods in the impact test and selection of a new liquid test standard. In addition, modifications to friction, spark and thermal test methods were discussed.

The 1991 DOE/Sandia Crystalline Photovoltaic Technology Project Review Meeting

Science.gov (United States)

Whipple, M. L.

1991-07-01

This document serves as the proceedings for the manual project review meeting held by Sandia's Photovoltaic Technology Research Division. It contains information supplied by each organization making a presentation at the meeting, which was held July 30 through 31, 1991 at the Sheraton Hotel in Albuquerque, New Mexico. Sessions were held to discuss national photovoltaic programs, one-sun crystalline silicon cell research, concentrator silicon cell research, and concentrating collector development.

75 FR 54156 - Center for Scientific Review; Amended Notice of Meeting

Science.gov (United States)

2010-09-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Language and Communication Study Section, October 4, 2010, 8 a.m. to October 5, 2010, 5 p.m., Ritz Carlton Hotel, 1150 22nd...

75 FR 56554 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-16

... Health, 6701 Rockledge Drive, Room 4122, MSC 7802, Bethesda, MD 20892, 301-435-1212, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations... meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center...

Nanomaterial categorization for assessing risk potential to facilitate regulatory decision-making.

Science.gov (United States)

Godwin, Hilary; Nameth, Catherine; Avery, David; Bergeson, Lynn L; Bernard, Daniel; Beryt, Elizabeth; Boyes, William; Brown, Scott; Clippinger, Amy J; Cohen, Yoram; Doa, Maria; Hendren, Christine Ogilvie; Holden, Patricia; Houck, Keith; Kane, Agnes B; Klaessig, Frederick; Kodas, Toivo; Landsiedel, Robert; Lynch, Iseult; Malloy, Timothy; Miller, Mary Beth; Muller, Julie; Oberdorster, Gunter; Petersen, Elijah J; Pleus, Richard C; Sayre, Philip; Stone, Vicki; Sullivan, Kristie M; Tentschert, Jutta; Wallis, Philip; Nel, Andre E

2015-01-01

For nanotechnology to meet its potential as a game-changing and sustainable technology, it is important to ensure that the engineered nanomaterials and nanoenabled products that gain entry to the marketplace are safe and effective. Tools and methods are needed for regulatory purposes to allow rapid material categorization according to human health and environmental risk potential, so that materials of high concern can be targeted for additional scrutiny, while material categories that pose the least risk can receive expedited review. Using carbon nanotubes as an example, we discuss how data from alternative testing strategies can be used to facilitate engineered nanomaterial categorization according to risk potential and how such an approach could facilitate regulatory decision-making in the future.

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)

77 FR 2738 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-01-19

... Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Hepatobiliary Pathophysiology... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

75 FR 54156 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-03

... Committee: Digestive, Kidney and Urological Systems Integrated Review Group, Gastrointestinal Mucosal... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

77 FR 1699 - Center for Scientific Review: Notice of Closed Meetings

Science.gov (United States)

2012-01-11

... Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Gastrointestinal Mucosal... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review: Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

75 FR 22819 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-04-30

[email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special... 20892, 301-435- 0903, [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special...

75 FR 25303 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Regulatory...

Science.gov (United States)

2010-05-07

...: Wednesday, May 19, 2010--1 p.m. until 5 p.m. The Subcommittee will review Draft Final Regulatory Guide 1.216 (previously DG-1203) ``Containment Structural Integrity Evaluation for Internal Pressure Loadings Above Design... the time allotted to present oral statements can be obtained from the website cited above or by...

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.

77 FR 45366 - Center for Scientific Review; Notice of Closed Meeting

Science.gov (United States)

2012-07-31

....S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C..., Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review...

78 FR 27243 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-05-09

... U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C... Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review...

International Conference on Effective Nuclear Regulatory Systems: Sustaining Improvements Globally. Book of Abstracts

International Nuclear Information System (INIS)

2016-01-01

The objective of this conference is to review and assess ways of further improving the effectiveness of regulatory systems for nuclear facilities and activities for both nuclear safety and nuclear security. The action items in the summary presented by the President of the conference held in 2013 in Ottawa, the lessons of the Fukushima Daiichi accident, the discussions at other international conferences and at international experts’ meetings conducted within the framework of the IAEA Action Plan on Nuclear Safety, as well as the CNS and the principles outlined in the Vienna Declaration on Nuclear Safety, will continue to have a significant impact on regulatory systems. All the aforementioned need to be taken into account to sustain improvements to regulatory systems. The expected outcomes of the conference are: - Enhanced safety and security of nuclear installations worldwide; - Challenges in regulating radiation sources and radioactive waste addressed; - Enhanced international cooperation for sustaining regulatory effectiveness; - Strengthened and sustained regulatory competence for nuclear safety and security; and - Strategies and actions for the future identified, as well as issues for consideration by governments, regulatory bodies and international organizations.

75 FR 9451 - Sunshine Act Meetings

Science.gov (United States)

2010-03-02

... Tuesday, March 2, 2010 9:30 a.m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This meeting will be webcast live at the Web address-- http://www.nrc.gov , Week of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meetings Agency Holding the Meetings...

77 FR 27468 - Center for Scientific Review, Notice of Closed Meetings

Science.gov (United States)

2012-05-10

..., (Virtual Meeting). Contact Person: Edwin C Clayton, Ph.D., Scientific Review Officer, Center for Scientific...-408-9041, [email protected] . Name of Committee: Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Synthetic and Biological Chemistry B Study Section. Date: May 30-31, 2012. Time: 8...

78 FR 26644 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-05-07

...: Digestive, Kidney and Urological Systems Integrated Review Group; Xenobiotic and Nutrient Disposition and... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

78 FR 28599 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-05-15

... Committee: Digestive, Kidney and Urological Systems Integrated Review Group, Kidney Molecular Biology and... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

78 FR 54258 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-09-03

... Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Clinical, Integrative and... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

77 FR 511 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-01-05

...: Digestive, Kidney and Urological Systems Integrated Review Group, Clinical, Integrative and Molecular... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

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

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

76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

Science.gov (United States)

2011-09-07

... ENVIRONMENTAL PROTECTION AGENCY [EPA/100/J-11/001; FRL-9460-1] External Peer Review Meeting for... attend this peer review meeting as observers. Time will be set aside for observers to give brief oral... the draft document, EPA intends to consider the comments from the external peer review meeting along...

78 FR 6125 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-01-29

..., [email protected] . Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

76 FR 65738 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-10-24

..., Bethesda, MD 20892, (301) 435-1166, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the...

78 FR 19724 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-04-02

... 20892, (301) 594-1245, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing...

77 FR 65568 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-10-29

..., (301) 435- 2398, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the...

76 FR 11500 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-02

... 20892, (301) 435-1045, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing...

77 FR 73474 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-12-10

... 20892, (301) 806-3323, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the...

76 FR 4924 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-01-27

..., (301) 435- 2344, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing...

77 FR 48526 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-08-14

..., Bethesda, MD 20892, 301-435- 1050, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing...

78 FR 78984 - Center For Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-12-27

... 7852, Bethesda, MD 20892, 301-435- 1050, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing...

75 FR 70272 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-11-17

... 7759, Bethesda, MD 20892, 301-435- 2889, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the...

78 FR 67375 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-11-12

..., Room 6214, MSC 7804, Bethesda, MD 20892, (301) 435-5877, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and...-435- 1050, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting...

77 FR 73475 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-12-10

..., Bethesda, MD 20892, 301-402-4454, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the...

76 FR 8751 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-02-15

..., Bethesda, MD 20892, 301-435- 0903, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of...-1215, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due...

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...

Supporting design reviews with pre-meeting virtual reality environments

NARCIS (Netherlands)

van den Berg, Marc Casper; Hartmann, Timo; de Graaf, Robin S.

2017-01-01

The purpose of this paper is to explore how design reviews can be supported with pre-meeting virtual reality environments. Previous research has not systematically investigated how virtual environments can be used to communicate the design intent (to clients) and to communicate feedback (to design

78 FR 69141 - Sunshine Act Meeting

Science.gov (United States)

2013-11-18

... POSTAL REGULATORY COMMISSION Sunshine Act Meeting TIME AND DATE: Wednesday, December 11, 2013, at.... STATUS: Part of this meeting will be open to the public. The rest of the meeting will be closed to the... December 11, 2013 meeting includes the items identified below. PORTIONS OPEN TO THE PUBLIC: 1. Report from...

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

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

75 FR 4428 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-01-27

....m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meeting Notice DATES: Weeks of January... Plans (Public Meeting). (Contact: Quynh Nguyen, 301-415-5844.) This meeting will be webcast live at the...

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.'

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...

76 FR 44942 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-07-27

...: Sensation and Perception. Date: August 17-18, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate... (Virtual Meeting). Contact Person: John Bishop, PhD, Scientific Review Officer, Center for Scientific..., MD 20892 (Telephone Conference Call) Contact Person: Samuel C. Edwards, PhD, Chief, Center for...

Safeguards inventory and process monitoring regulatory comparison

Energy Technology Data Exchange (ETDEWEB)

Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

2013-06-27

Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

75 FR 4882 - Meeting of the ACRS Subcommittee on EPR; Notice of Meeting

Science.gov (United States)

2010-01-29

... NUCLEAR REGULATORY COMMISSION Advisory Committee On Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on EPR; Notice of Meeting The ACRS U.S. Evolutionary Power Reactor (EPR) Subcommittee will hold a... with Open Items concerning the U.S. EPR Design Certification (DCD) Application and the Calvert Cliffs...

78 FR 50144 - Rehabilitation Research and Development Service Scientific Merit Review Board; Notice of Meetings

Science.gov (United States)

2013-08-16

... Review Board; Notice of Meetings The Department of Veterans Affairs (VA) gives notice under the Federal... Development Service Scientific Merit Review Board will meet from 8 a.m. to 5 p.m. on the dates indicated below: Subcommittee Date(s) Location Career Development Award Program.... August 6, 2013........ VHA National...

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%.

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...

76 FR 29746 - Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Mercury Review Panel

Science.gov (United States)

2011-05-23

... Public Meeting of the SAB Mercury Review Panel AGENCY: Environmental Protection Agency (EPA). ACTION... Office announces a public meeting of the SAB Mercury Review Panel. DATES: The meeting will be held on... FACA and EPA policy, notice is hereby given that the SAB Mercury Review Panel will hold a public...

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)

76 FR 72208 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-11-22

... 20892, (301) 402-4411, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis Panel, Studies in...

75 FR 9911 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-03-04

... 20892. 301-435-1169. [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee...-408-9164. [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis...

75 FR 11895 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-03-12

.... (301) 435- 1258. [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict...

75 FR 56115 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-15

... days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name.... (301) 435- 1046. [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis..., Bethesda, MD 20892. 301-435- 1052. [email protected]csr.nih.gov . Name of Committee: Biobehavioral and Behavioral...

78 FR 61376 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-10-03

...-1215, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for...-435-1137, [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis...

77 FR 62246 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-10-12

[email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special..., 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435-1165, [email protected]csr.nih.gov...

76 FR 63315 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-10-12

[email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special... Rockledge Drive, Room 5110, MSC 7854, Bethesda, MD 20892, (301) 435-1174, [email protected]csr.nih.gov . Name of...

75 FR 8370 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-02-24

[email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special..., Bethesda, MD 20892. 301-435-1159. [email protected]csr.nih.gov . This notice is being published less than 15...

77 FR 14533 - Center for Scientific Review: Notice of Closed Meetings

Science.gov (United States)

2012-03-12

..., Bethesda, MD 20892, 301-408- 9971, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of...-435-1236, [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis...

75 FR 9908 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-03-04

..., Room 4102, MSC 7814, Bethesda, MD 20892, (301) 435-1786, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project...

76 FR 12980 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-09

[email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special..., Bethesda, MD 20892, 301-435-1022, [email protected]csr.nih.gov . Name of Committee: Center for Scientific...

76 FR 13421 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-11

..., Room 3136, MSC 7759, Bethesda, MD 20892. (301) 435-1258. [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and.... [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special Emphasis Panel, Cancer...

IAEA meeting: International conference of national regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials

Energy Technology Data Exchange (ETDEWEB)

Englefield, Chris [UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group, Environment Agency (United Kingdom)

2001-06-01

The meeting was the outcome of one of the actions arising from an IAEA sponsored meeting held in Dijon in 1998 on these issues. The action plan included inter alia the production of a 'Code of Conduct' (published December 2000), the production of a scheme for the 'Categorisation of Sources' (published December 2000) and a meeting to share experience and knowledge about the issues of illicit or inadvertent movements of radioactive materials across international borders. This was the major focus of the meeting held in Buenos Aires. The meeting was attended by 130 delegates representing 70 countries, the EU and the IAEA. This means that over half of the 131 IAEA Member States were present, a measure of the level of significance that is attached to the initiating issue of 'illicit trafficking'.The meeting was chaired by Dan Beninson (Argentina) and the Technical Secretariat was led by Alfonso Bilbao of IAEA. I attended as the UK delegate, in my capacity as Chairman of the UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group. The national papers were so numerous that it is not practicable to try to summarise them all here. However, a general impression will be given. The majority of papers submitted explained the regulatory structures extant in the speakers' home countries. It was useful to understand the level of development of regulatory arrangements in the Member States represented. These ranged from the highly developed such as those of EU Member States, the US and some South American states, to the very simple. In some cases, speakers frankly admitted that regulatory systems were virtually non-existent, but that as IAEA Members, their countries were ready and willing to improve their arrangements, with the assistance of IAEA . Some general conclusions may be derived: (i) A personal view is that IAEA and Member States have not clarified their risk assessment thinking: as RP practitioners we tend to concentrate on

75 FR 31798 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-06-04

... Beach and Executive Meeting Center, 701 West Ocean Boulevard, Long Beach, CA 90831. Contact Person...: Center for Scientific Review Special Emphasis Panel, ARRA: Risk Prevention and Health Behavior Across the...

75 FR 6413 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-02-09

... a.m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meeting Notice DATES: Weeks of February.... Briefing on Regional Programs--Programs, Performance, and Future Plans (Public Meeting). (Contact: Richard...

75 FR 70955 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Science.gov (United States)

2010-11-19

... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... the draft safety culture policy statement for medical licensees. A copy of the agenda for the meeting...

78 FR 55266 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-09-10

... the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... evaluate grant applications. Place: Torrance Marriott South Bay, 3635 Fashion Way, Torrance, CA 90503...

University Research Consortium annual review meeting program

International Nuclear Information System (INIS)

1996-07-01

This brochure presents the program for the first annual review meeting of the University Research Consortium (URC) of the Idaho National Engineering Laboratory (INEL). INEL is a multiprogram laboratory with a distinctive role in applied engineering. It also conducts basic science research and development, and complex facility operations. The URC program consists of a portfolio of research projects funded by INEL and conducted at universities in the United States. In this program, summaries and participant lists for each project are presented as received from the principal investigators

University Research Consortium annual review meeting program

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-07-01

This brochure presents the program for the first annual review meeting of the University Research Consortium (URC) of the Idaho National Engineering Laboratory (INEL). INEL is a multiprogram laboratory with a distinctive role in applied engineering. It also conducts basic science research and development, and complex facility operations. The URC program consists of a portfolio of research projects funded by INEL and conducted at universities in the United States. In this program, summaries and participant lists for each project are presented as received from the principal investigators.

A quick look at the post accident review meeting (PARM)

International Nuclear Information System (INIS)

Dastur, A.; Osborne, R.; Pendergast, D.; Primeau, D.B.; Snell, V.G.; Torgerson, D.

1986-01-01

The IAEA sponsored Post-Accident Review Meeting (PARM) for Chernobyl took place in Vienna from August 25 to 29, 1986. A report by the International Nuclear Safety Advisory Group (INSAG) and the group of experts supporting them is under preparation and will be available later in September. In view of the importance of the meeting, this report has been prepared by the AECL Conference delegation to provide more rapid feedback. Since digestion of the information will take much more time, we have attempted to stick to what we heard, avoiding speculation unless absolutely necessary. Since the Chernobyl event was so serious, it is essential that the root causes be identified, in order to avoid a related occurrence. It is necessary that the design and operation of CANDU reactors be carefully reviewed to identify, if any, of the lessons have any relevance. This must be done thoroughly and without complacency

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

Regulatory control of nuclear power plants

International Nuclear Information System (INIS)

2002-01-01

The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

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...

Joint IAEA/NEA workshop proceedings on regulatory review of plant safety analysis - Abstracts, Summary and Conclusions

International Nuclear Information System (INIS)

Lacey, Derek; Drozd, Andrzej; Husarcek, Jan; Modro, Mike

1999-01-01

Based on the final discussion, the seminar was a valuable exchange of information and helpful in understanding the safety analysis and regulatory review issues. It gave a chance for some countries to see 'where they are' regulatory-wise with respect to other countries. There was a strong support for a follow-up workshop within the next two years. A general opinion expressed by most of the participants was that the suggested next seminar should be based more on an 'overall safety analysis' review rather than on very detailed presentations on specific issues. Also, there should be more discussions on Emergency Operating Procedures (EOPs) and emergency planning. In addition, to establish a 'common language', the development of a glossary of terms would be most helpful. In general, all of the participating countries are adapting regulatory and licensing practices previously developed by other countries. Such an approach allows to utilise and rely on a broad experience of countries with a well established nuclear power industry, strong regulatory organisation and licensing practices. Since there are obvious differences in engineering traditions and in countries' legal/regulatory frameworks, questions arise about how to reconcile these differences in adapting and developing practices suitable for a given country. It was advised as a good practice to identify from the very beginning what needs to be done and the goals to be accomplished not only in the perspective of safety and technical requirements but also in the context of the economical, political, legal and regulatory situation in a given country. There has to be a consistency in any approach, but one can never follow 'blindly' the others. It became quite obvious that the needs of countries with a big nuclear program are very different from those of 'small' countries. Adaptation of other countries' rules is a big effort in itself (e.g., Romania applying Canadian regulations). In addition, the French-German co

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)

Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

International Nuclear Information System (INIS)

2011-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

75 FR 57779 - Science Advisory Board Staff Office; Notification of a Public Meeting of the SAB Dioxin Review Panel

Science.gov (United States)

2010-09-22

... a Public Meeting of the SAB Dioxin Review Panel AGENCY: Environmental Protection Agency (EPA...) Staff Office announces a public meeting of the SAB Dioxin Review Panel to continue its review of EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments, External Review Draft...

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to 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. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

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

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.

75 FR 8155 - Sunshine Act; Notice of Meeting

Science.gov (United States)

2010-02-23

....m. Briefing on Uranium Recovery (Public Meeting) (Contact: Dominick Orlando, 301-415-6749). This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act; Notice of Meeting DATES: Weeks of....m. Affirmation Session (Public Meeting) (Tentative). Entergy Nuclear Operations, Inc. (Indian Point...

First interim project review meeting on management of water hyacinth

International Nuclear Information System (INIS)

1980-01-01

The first project planning meeting was held in New Delhi during 1978 and the second, a project review meeting, in Papua New Guinea during June 1979, both funded by UNEP. Reports from the regional coordinators for Bangladesh, Malaysia, Sri Lanka, Fiji and India are presented. Also presented are reports from the national coordinators for Malaysia, Bangladesh and India. Two visits (a visit to India, Bangladesh and Sri Lanka to study the feasibility of making a film on the work done with water hyacinth and a visit to the U.S. by the regional project coordinator) are also described

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.

Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

NARCIS (Netherlands)

de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.

2012-01-01

Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We

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

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

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

Proceedings of the black liquor research program review fifth meeting

Energy Technology Data Exchange (ETDEWEB)

1988-09-01

On June 14--17, 1988 the participants and invited guests of the Cooperative Program in Kraft Recovery gathered in Charleston, South Carolina, to review progress on four major black liquor research programs being executed at the Institute of Paper Chemistry, the University of Maine, the National Bureau of Standards, and the University of Florida. These programs include: (1) Black Liquor Properties; (2) Black Liquor Droplet Formation; (3) Black Liquor Nozzle Evaluation; and (4) Black Liquor Combustion. In addition to the objectives of previous meetings, this meeting made a direct attempt to gather ideas on how to improve our ability to move from new technology concepts to commercial implementation. Also attached is the agenda for the Charleston meeting. The first two days were involved with updates and reviews of the four major black liquor programs. A half day was spent discussing pathways to implementation and developing thoughts on what industry, DOE and academia could do to facilitate commercial implementation of the research results. This publication is a summary of the presentations made in Charleston and the industry responses to the research work. Readers are cautioned that the contents are in-progress updates on the status of the research and do not represent referred technical papers. Any questions regarding the content should be referred to the principal investigators of the project.

77 FR 26790 - Meeting of the Public Safety Officer Medal of Valor Review Board

Science.gov (United States)

2012-05-07

... Safety Officer Medal of Valor Review Board AGENCY: Office of Justice Programs (OJP), Bureau of Justice... meeting (via conference call-in) of the Public Safety Officer Medal of Valor Review Board (``Board'') to... INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory functions...

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.

Recent regulatory issues in Finland

International Nuclear Information System (INIS)

Laaksonen, J.; Tiipana, P.

2001-01-01

This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

76 FR 60933 - Proposal Review Panel for Human Resource Development; Notice of Meeting

Science.gov (United States)

2011-09-30

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Human Resource Development; Notice of..., Proposal Review Panel Human Resource Development ( 1199). Date/Time: October 17, 2011; 5 p.m. to 10 p.m... Meeting: Part-Open. Contact Person: Kelly Mack, Division of Human Resource Development, Room 815, National...

76 FR 14674 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-17

...-435- 1033, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for... 4142, [[Page 14675

Improved cost-benefit techniques in the US Nuclear Regulatory Commission

Energy Technology Data Exchange (ETDEWEB)

Cronin, F.J.; Nesse, R.J.; Vaeth, M.; Wusterbarth, A.R.; Currie, J.W.

1983-06-01

The major objective of this report is to help the US Nuclear Regulatory Commission (NRC) in its regulatory mission, particularly with respect to improving the use of cost-benefit analysis and the economic evaluation of resources within the NRC. The objectives of this effort are: (1) to identify current and future NRC requirements (e.g., licensing) for valuing nonmarket goods; (2) to identify, highlight, and present the relevant efforts of selected federal agencies, some with over two decades of experience in valuing nonmarket goods, in this area; and (3) to review methods for valuing nonmarket impacts and to provide estimats of their magnitudes. Recently proposed legislation may result in a requirement for not only more sophisticated valuation analyses, but more extensive applications of these techniques to issues of concern to the NRC. This paper is intended to provide the NRC with information to more efficiently meet such requirements.

Regional and International Networking to Support the Energy Regulatory Commission of Thailand

Energy Technology Data Exchange (ETDEWEB)

Lavansiri, Direk; Bull, Trevor

2010-09-15

The Energy Regulatory Commission of Thailand is a new regulatory agency. The structure of the energy sector; the tradition of administration; and, the lack of access to experienced personnel in Thailand all pose particular challenges. The Commission is meeting these challenges through regional and international networking to assist in developing policies and procedures that allow it to meet international benchmarks.

78 FR 25309 - Proposal Review Panel Physics; Notice of Meeting

Science.gov (United States)

2013-04-30

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel Physics; Notice of Meeting In accordance with..., 2013 8:30 a.m.-6:30 p.m. May 15, 2013 8:30 a.m.-6:00 p.m. Place: University of Maryland, College Park... Physics Frontier Center; National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Telephone...

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...

Cracking in LWR RPV head penetrations. Working material. Proceedings of a specialists meeting

International Nuclear Information System (INIS)

1995-01-01

The IAEA Specialists' Meeting on Cracking in LWR RPV Head Penetrations was held at the ASTM Headquarters, Philadelphia, Pennsylvania, on May 2-4, 1995. It was attended by 39 participants from 12 countries. The meeting was held in the framework of the IAEA International Working Group on Life Management of Nuclear Power Plants (IWG-LMNPP) and was organized and sponsored by the Oak Ridge National Laboratory and the U.S. Nuclear Regulatory Commission. The purpose of the meeting was to review experience in the field for ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. Presentations were aimed at achieving a better understanding of the behaviour of reactor component materials, providing guidance and recommendations to assure reliability and adequate performance, and proposing directions for further investigations. Refs, figs and tabs

Cracking in LWR RPV head penetrations. Working material. Proceedings of a specialists meeting

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-12-31

The IAEA Specialists` Meeting on Cracking in LWR RPV Head Penetrations was held at the ASTM Headquarters, Philadelphia, Pennsylvania, on May 2-4, 1995. It was attended by 39 participants from 12 countries. The meeting was held in the framework of the IAEA International Working Group on Life Management of Nuclear Power Plants (IWG-LMNPP) and was organized and sponsored by the Oak Ridge National Laboratory and the U.S. Nuclear Regulatory Commission. The purpose of the meeting was to review experience in the field for ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. Presentations were aimed at achieving a better understanding of the behaviour of reactor component materials, providing guidance and recommendations to assure reliability and adequate performance, and proposing directions for further investigations. Refs, figs and tabs.

Technical meeting to 'Review of national programmes on fast reactors and accelerator driven systems (ADS)'. Working material

International Nuclear Information System (INIS)

2003-01-01

36th Annual Meeting of the Technical Working Group on Fast Reactors, the IAEA Technical Meeting (TM) on 'Review of National Programmes on Fast Reactors and Accelerator Driven Systems (ADS)', hosted by the Korean Atomic Energy Research Institute (KAERI) was attended by TWG-FR Members and Advisers from the following Member States (MS) and International Organizations: Brazil, France, Germany, India, Japan, the Republic of Kazakhstan, the Republic of Korea, the Russian Federation, the United Kingdom, the United States of America, and the OECD/NEA. The objectives of the meeting were to: 1) exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); 2) review the progress since the 35th TWG-FR Annual Meeting, including the status of the actions; 3) consider meeting arrangements for 2003 and 2004; 4) review the Agency's co-ordinated research activities in the field of FRs and ADS, as well as co-ordination of the TWG-FR's activities with other organizations. The participants made presentations on the status of the respective national programmes on FR and ADS development. A summary of the highlights for the period since the 35th TWG-FR Annual Meeting

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

77 FR 58526 - Pacific Fishery Management Council; Public Meeting; Work Session To Review Proposed Salmon...

Science.gov (United States)

2012-09-21

... Fishery Management Council; Public Meeting; Work Session To Review Proposed Salmon Methodology Changes...), Commerce. ACTION: Notice of a public meeting. SUMMARY: The Pacific Fishery Management Council's Salmon Technical Team (STT), Scientific and Statistical Committee (SSC) Salmon Subcommittee, and Model Evaluation...

75 FR 70952 - Proposal Review Panel for Physics; Notice of Meeting

Science.gov (United States)

2010-11-19

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Physics; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation... Director for Elementary Particle Physics, National Science Foundation, 4201 Wilson Blvd., Arlington, VA...

76 FR 24921 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-05-03

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation..., Program Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation...

78 FR 4464 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2013-01-22

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463, as amended), the National Science Foundation... Chemistry, Room 1055, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230, (703) 292...

76 FR 12996 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-03-09

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463 as amended), the National Science Foundation... Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation, 4201...

76 FR 6499 - Proposal Review Panel for Chemistry; Notice of Meeting

Science.gov (United States)

2011-02-04

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Chemistry; Notice of Meeting In accordance with the Federal Advisory Committee Act (Pub. L. 92- 463 as amended), the National Science Foundation... Director, Chemistry Centers Program, Division of Chemistry, Room 1055, National Science Foundation, 4201...

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

78 FR 3041 - Notice of Sunshine Act Meetings

Science.gov (United States)

2013-01-15

..., 2013--Tentative Thursday, January 31, 2013 9:00 a.m. Briefing on Public Participation in NRC Regulatory Decision-Making (Public Meeting) (Contact: Lance Rakovan, 301-415-2589). This meeting will be webcast live...

[NCRP comments on radiation protection related reports, proposed standards, and meetings

International Nuclear Information System (INIS)

1991-01-01

Two NCRP Reports, two Annual Meeting Proceedings and one Commentary have been published during this period. NCRP Report No. 105, Radiation Protection for Medical and Allied Health Personnel is a rewrite and update of NCRP Report No. 48, which had the same title and which it supersedes. The primary objective of the new report is to update the material to include new radiation sources used in medicine. NCRP Report No. 106, Limit for Exposure to ''Hot Particles'' on the Skin was prepared in response to a request from the Nuclear Regulatory Commission. The report addresses the potential biological effect of microscopic radioactive particles on the skin and reviews the presently available information on the subject. Proceedings No. 10, Radon, is the proceedings of the 24th Annual Meeting of the NCRP. Proceedings No. 11, Radiation Protection Today---The NCRP at Sixty Years is the proceedings of the 25th Annual Meeting of the NCRP. Commentary No. 5, Review of the Publication, Living Without Landfills, was recently released. Also included is a list of NCRP committee reports which were released in the current reporting period

Nuclear regulatory decision making

International Nuclear Information System (INIS)

2005-01-01

The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear utilities operate their plants at all times in an acceptably safe manner. In meeting this objective, the regulatory body should strive to ensure that its regulatory decisions are technically sound, consistent from case to case, and timely. In addition, the regulator must be aware that its decisions and the circumstances surrounding those decisions can affect how its stakeholders, such as government policy makers, the industry it regulates, and the public, view it as an effective and credible regulator. In order to maintain the confidence of those stakeholders, the regulator should make sure that its decisions are transparent, have a clear basis in law and regulations, and are seen by impartial observers to be fair to all parties. Based on the work of a Nuclear Energy Agency (NEA) expert group, this report discusses some of the basic principles and criteria that a regulatory body should consider in making decisions and describes the elements of an integrated framework for regulatory decision making. (author)

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...

75 FR 80083 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Science.gov (United States)

2010-12-21

... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of Meeting. SUMMARY: The U.S. Nuclear... the draft safety culture policy statement for medical licensees. Contingent upon the outcome of the...

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

76 FR 1442 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-01-10

...-451- 8504. [email protected] . Name of Committee: Digestive, Kidney and Urological Systems... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

78 FR 57866 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-09-20

..., 301- 237-1487, [email protected] . Name of Committee: Digestive, Kidney and Urological Systems... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as [[Page...

77 FR 2286 - Northern Illinois Hydropower, LLC; Notice of Meeting

Science.gov (United States)

2012-01-17

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12717-002] Northern Illinois Hydropower, LLC; Notice of Meeting a. Date and Time of Meeting: Thursday, January 26, 2012 from 11... Meeting: Commission staff will meet with Northern Illinois Hydropower, LLC to discuss potentially moving...

Reactor safety review of permanent changes

International Nuclear Information System (INIS)

Lam, K.F.

1997-01-01

Operational compliance engineers review all changes as part of a change control process. Each change, permanent or temporary, is required to undergo an intricate review process to ensure that the benefits associated with the change outweigh the risk. For permanent changes, it is necessary to ensure that the proposed design meets the nuclear safety requirements, conforms to the licensing requirements and complies with regulatory requirements. In addition, during installation of the permanent change and prior to in-service, a configuration management process is in place to align the change with operating and maintenance documents. (author)

77 FR 24228 - Proposal Review Panel for Social and Economic Sciences; Notice of Meeting

Science.gov (United States)

2012-04-23

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Social and Economic Sciences; Notice of...; Division of Social and Economic Sciences, Room 990, National Science Foundation, 4201 Wilson Boulevard... Science Foundation announces the following meeting: Name: Site visit review of the Nanoscale Science and...

78 FR 32260 - Center For Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-05-29

..., (301) 827-6390, [email protected] . Name of Committee: Digestive, Kidney and Urological Systems... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

77 FR 56855 - Center For Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-09-14

... 20892, 301-806-2515, [email protected] . Name of Committee: Digestive, Kidney and Urological Systems... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

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.

Using the IRRS to Strengthen Regulatory Competence in Ireland

International Nuclear Information System (INIS)

Smith, K.

2016-01-01

In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up

Regulatory issues associated with the Multi-Purpose (MPC) system

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

1994-01-01

The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

Second public meeting of Governor Kaine's Independent Virginia Tech Incident Review Panel

OpenAIRE

Owczarski, Mark

2007-01-01

The second public meeting of Governor Kaine's Independent Virginia Tech Incident Review Panel will convene on Monday, May 21, at The Inn at Virginia Tech and Skelton Conference Center Latham Ballroom, 901 Prices Fork Road in Blacksburg.

78 FR 46358 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-07-31

..., (Telephone Conference Call). Contact Person: Careen K Tang-Toth, Ph.D., Scientific Review Officer, Center for... Emphasis Panel; Member Conflict: Cognition and Perception. Date: August 28-29, 2013. Time: 8:00 a.m. to 6... Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Mark Lindner, Ph.D., Scientific...

78 FR 13364 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-02-27

... Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Fouad A El-Zaatari, Ph.D... Etiology of Gastro- Intestinal Cancer. Date: March 21, 2013. Time: 12:00 p.m. to 2:00 p.m. Agenda: To... Research Integrated Review Group; AIDS-associated Opportunistic Infections and Cancer Study Section. Date...

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...

Proceedings of the specialists' meeting on regulatory inspection practices in nuclear power plants

International Nuclear Information System (INIS)

1977-01-01

The sessions and contributions of this conference are dealing with: the general problems of regulatory inspection of nuclear power plants and overall national practices (in Canada, France, Germany, Italy, Spain, the United States), specific problems and practical experience of regulatory inspection during site study, evaluation, design, manufacturing and construction of nuclear plants (in Finland, Germany, Spain, Sweden, Great-Britain, United States), quality insurance issues, pressure component regulations, specific problems and practical experience of regulatory inspection during commissioning (in Spain, Sweden, Great-Britain and United States), specific problems and practical experience of regulatory inspection during operation (in Spain, Great-Britain, Unites States, Italy and Sweden), special aspects of regulatory inspection (notably public information issues in Sweden and in Great-Britain, inspection of nuclear fuel transportation in Spain, enforcement programme in the USA)

Medical students review of formative OSCE scores, checklists, and videos improves with student-faculty debriefing meetings.

Science.gov (United States)

Bernard, Aaron W; Ceccolini, Gabbriel; Feinn, Richard; Rockfeld, Jennifer; Rosenberg, Ilene; Thomas, Listy; Cassese, Todd

2017-01-01

Performance feedback is considered essential to clinical skills development. Formative objective structured clinical exams (F-OSCEs) often include immediate feedback by standardized patients. Students can also be provided access to performance metrics including scores, checklists, and video recordings after the F-OSCE to supplement this feedback. How often students choose to review this data and how review impacts future performance has not been documented. We suspect student review of F-OSCE performance data is variable. We hypothesize that students who review this data have better performance on subsequent F-OSCEs compared to those who do not. We also suspect that frequency of data review can be improved with faculty involvement in the form of student-faculty debriefing meetings. Simulation recording software tracks and time stamps student review of performance data. We investigated a cohort of first- and second-year medical students from the 2015-16 academic year. Basic descriptive statistics were used to characterize frequency of data review and a linear mixed-model analysis was used to determine relationships between data review and future F-OSCE performance. Students reviewed scores (64%), checklists (42%), and videos (28%) in decreasing frequency. Frequency of review of all metric and modalities improved when student-faculty debriefing meetings were conducted (p<.001). Among 92 first-year students, checklist review was associated with an improved performance on subsequent F-OSCEs (p = 0.038) by 1.07 percentage points on a scale of 0-100. Among 86 second year students, no review modality was associated with improved performance on subsequent F-OSCEs. Medical students review F-OSCE checklists and video recordings less than 50% of the time when not prompted. Student-faculty debriefing meetings increased student data reviews. First-year student's review of checklists on F-OSCEs was associated with increases in performance on subsequent F-OSCEs, however this

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...

France - Convention on Nuclear Safety. Sixth National report for the 2014 review meeting

International Nuclear Information System (INIS)

2013-07-01

of Conduct on the Safety of Research Reactors, which reiterates most of the provisions of this present Convention. For this report, France took into account the lessons learned with the five previous reports: it is a self-standing document, which has been developed mostly on the basis of existing documents and reflects the views of the regulatory body and the licensees. Hence, for every chapter in which the regulatory body is not the only entity to express its own views, a three-fold structure was adopted: firstly a description of the regulations by the regulatory authority, followed by an overview presented by the licensees of their measures for regulatory compliance, and finally an analysis by the regulatory authority of licensee measures. This report is structured according to the Guidelines on National Reports, as revised at the special meeting of August 2012. The presentation progresses 'article by article', with each one giving rise to a separate chapter at the beginning of which the corresponding text of the Convention appears in a box with a half-tone background. After the introduction, which presents certain general aspects as well as national nuclear policy, the summary gives a description of the main changes that have taken place since the fifth national report and the safety prospects for the next three years. Part C covers general considerations (chapters 4 to 6), part D summarises general safety considerations (chapter 10 to 16), part F presents the safety of facilities (chapter 17 to 19), and finally part G presents international cooperation measures (chapter 20). The report is supplemented by eight appendices. With regard to the steps taken at the national level further to the TEPCO's Fukushima Daiichi nuclear power plant accident (hereinafter referred to as the Fukushima Daiichi accident), the Officers meeting of 29 October 2012 recommended including a general presentation in a sub-chapter of the Summary. Finally, further to the meeting of the

77 FR 63847 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-10-17

... Emphasis Panel; PAR-10-235: Climate Change and Health. Date: November 8, 2012. Time: 11:30 a.m. to 6:30 p.m... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review... applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting...

78 FR 70567 - Center for Scientific Review; Amended Notice of Meeting

Science.gov (United States)

2013-11-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review... Institutes of Health, 6701 Rockledge Drive, Room 3091, Bethesda, MD, 20892 which was published in the Federal Register on September 18, 2013, 78 FR 57399. The meeting will be held at the Bethesda Marriott Hotel, 5151...

78 FR 64510 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-10-29

... Digestive, Urinary, Cardiovascular and Pulmonary Systems. Date: November 13, 2013. Time: 12:00 p.m. to 2:30... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5...

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...

77 FR 18268 - Proposal Review Panel for Engineering Education and Centers; Notice of Meeting

Science.gov (United States)

2012-03-27

... NATIONAL SCIENCE FOUNDATION Proposal Review Panel for Engineering Education and Centers; Notice of... Science Foundation announces the following meeting: Name: Proposal Review Panel for Engineering Education...--ERC Research Program 3:30 p.m.--7:30 p.m. Closed--ERC Education Program Thursday, March 29, 2012 8 a.m...

Proceedings of the Fuel Cells `97 Review Meeting

Energy Technology Data Exchange (ETDEWEB)

None

1998-01-01

The Federal Energy Technology Center (FETC) sponsored the Fuel Cells '97 Review Meeting on August 26-28, 1997, in Morgantown, West Virginia. The purpose of the meeting was to provide an annual forum for the exchange of ideas and discussion of results and plans related to the research on fuel cell power systems. The total of almost 250 conference participants included engineers and scientists representing utilities, academia, and government from the U.S. and eleven other countries: Canada, China, India, Iran, Italy, Japan, Korea, Netherlands, Russia, Taiwan, and the United Kingdom. On first day, the conference covered the perspectives of sponsors and end users, and the progress reports of fuel-cell developers. Papers covered phosphoric, carbonate, and solid oxide fuel cells for stationary power applications. On the second day, the conference covered advanced research in solid oxide and other fuel cell developments. On the third day, the conference sponsored a workshop on advanced research and technology development. A panel presentation was given on fuel cell opportunities. Breakout sessions with group discussions followed this with fuel cell developers, gas turbine vendors, and consultants.

Meeting regulatory standards with BeO ceramic TLD

International Nuclear Information System (INIS)

Gammage, R.B.; Christian, D.J.

1978-01-01

Measurements of exposures below 1 mR are possible with BeO ceramic TLD by signal recording that discriminates against an interfering pyroelectric incandescence. Performance under environmental monitoring conditions is considered in light of current regulatory criteria. Factors such as reproducibility and batch uniformity are satisfactory. An anomalous energy dependence causes an over-response that will probably require use of an energy compensation shield

78 FR 4476 - Sunshine Act; Meeting Notice

Science.gov (United States)

2013-01-22

...: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public and Closed. Week of... live at the Web address--www.nrc.gov. 9:00 a.m. Briefing on Public Participation in NRC Regulatory Decision- Making (Public Meeting) (Contact: Lance Rakovan, 301-415-2589). This meeting will be webcast live...

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

Proceedings of the natural gas RD&D contractors review meeting, Volume II

Energy Technology Data Exchange (ETDEWEB)

Malone, R.D. [ed.

1995-04-01

This is volume II of papers which were presented at the natural gas RD&D contractors review meeting. Topics include: natural gas upgrading, storage, well drilling, completion, and stimulation. Individual papers were processed separately for the United States Department of Energy databases.

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

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

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

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

Role of technical and scientific support organization In Indonesian regulatory body

International Nuclear Information System (INIS)

Yusri Heni, N.A.; Zarkasih, A.S.; Liliana, Y.P.; Salman, S.

2007-01-01

Indonesian Nuclear Energy Regulatory Agency (BAPETEN) has the function in controlling the utility of nuclear energy through regulation, licensing and inspection, with the aim, interalia, to ensure the welfare, the security and the peace of people, to assure the safety and the health of workers and public, and the environmental protection, and to prevent diversion of purpose of the nuclear material utilization (Article 14 and 15 of Act no 10, 1997 on Nuclear Energy). The role and quality of technical and scientific expertise in supporting regulatory systems are importance increase the effectiveness and public confidence. The Center for Regulatory Assessment of Nuclear Installation and Nuclear Material and Center for Regulatory Assessment of Radiation Facilities and Radioactive Sources as part of BAPETEN organization has a function as technical and scientific support for regulatory systems. The purpose of this function is to provide technical and scientific basis for decisions and activities regarding nuclear and radiation safety during regulatory processes, such as in the developing and establishing regulation, technical verification for licensing, assessment of inspection funding and enforcement. In order to meet the quality and effectiveness of technical and scientific result activity, those two centers for regulatory assesment used internal and external technical experts and joint cooperation with universities, research institutes or laboratories. The development of technical and scientific strategic planning in enhancing nuclear and radiation safety is done by the following increasing of : Human resources and expertise by internal and external training or on the job training; number for computer code to perform safety analysis, capability and quality for review and assessment, national and international cooperation, etc. (author)

Removal of regulatory controls for materials and sites

International Nuclear Information System (INIS)

2004-01-01

Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

78 FR 78985 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-12-27

... 7890, Bethesda, MD 20892, (301) 435-1741, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle..., (301) 435-1741, [email protected]csr.nih.gov . Name of Committee: Risk, Prevention and Health Behavior...

76 FR 14036 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-15

..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific... 7852, Bethesda, MD 20892, (301) 435-1166, [email protected]csr.nih.gov . Name of Committee: Center for...

78 FR 79705 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-12-31

... 20892-7844, 301-435-1033 [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of..., MD 20892, 301- 435-1722, [email protected]csr.nih.gov . Name of Committee: Emerging Technologies and...

Reactor safety: a discussion by officials of the Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Anders, W.A.; Rusche, B.C.; Stello, V. Jr.; Minogue, R.B.

1976-01-01

William A. Anders, Chairman of the Nuclear Regulatory Commission (NRC), and several senior officials spoke to the Joint Committee on Atomic Energy on the subject of nuclear safety, improvements in reactor plant safety, and quality assurance. The NRC, during its first year of organization, has developed new initiatives to improve safety and safeguards regulations. Anders stressed that NRC is not stifling internal discussion of opposing views, that it has been honest with the public, and that operating reactors are meeting rigorous safety standards. Other speakers discussed comparative safety of old and new reactors. Backfitting of older plants with new features is done when substantial safety protection can be added, but detuning an integrated system is not done indiscriminately. Officials of NRC do not agree with former General Electric employees, who testified that the regulatory procedure is inadequate. Safety improvements since August 28, 1962 and outlines of the review process are included in the Appendixes

76 FR 17625 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review; Public Meeting

Science.gov (United States)

2011-03-30

...: Participants will present summary data, and discuss data needs and treatments. Special Accommodations The... the South Atlantic; Southeast Data, Assessment, and Review; Public Meeting AGENCY: National Marine... of Southeast Data and Review (SEDAR) 26 data webinar for Caribbean Silk snapper, Queen snapper, and...

Program and Abstracts: DOE Solar Program Review Meeting 2004, 25--28 October 2004, Denver, Colorado

Energy Technology Data Exchange (ETDEWEB)

2004-10-01

This booklet contains the agenda and abstracts for the 2004 U.S. DOE Solar Energy Technologies Program Review Meeting. The meeting was held in Denver, Colorado, October 25-28, 2004. More than 240 abstracts are contained in this publication. Topic areas for the research papers include laboratory research, program management, policy analysis, and deployment of solar technologies.

76 FR 17928 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-31

...- 0684, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for... Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD 20892, 301-435- 1777, [email protected]csr.nih.gov . Name of...

77 FR 65004 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-10-24

..., [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific..., 6701 Rockledge Drive, Room 6210, MSC 7804, Bethesda, MD 20892, 301-435- 1211, [email protected]csr.nih.gov...

75 FR 27351 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-05-14

... 20892, 301-435- 0952, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... Rockledge Drive, Room 5116, MSC 7854, Bethesda, MD 20892, (301) 435- 1171, [email protected]csr.nih.gov . Name of...

76 FR 33322 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-06-08

...-402-4454, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for..., 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301)435-3504, [email protected]csr.nih.gov . Name...

75 FR 41212 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-07-15

..., Bethesda, MD 20892, 301-435- 1259, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of... Health, 6701 Rockledge Drive, Room 5202, MSC 7850, Bethesda, MD 20892, (301) 435-0910, [email protected]csr.nih...

75 FR 55591 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-13

...-435- 0952, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center... Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435- 1781, [email protected]csr.nih.gov . Name of...

75 FR 4830 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-01-29

..., (301) 435-1767, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center... Health, 6701 Rockledge Drive, Room 3184, MSC 7848, Bethesda, MD 20892, (301) 435-4445, [email protected]csr.nih...

75 FR 75484 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-12-03

.... [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific..., Room 4205, MSC 7814, Bethesda, MD 20892. 301-435- 1501. [email protected]csr.nih.gov . This notice is being...

75 FR 57965 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-09-23

... Rockledge Drive, Room 1102, MSC 7760, Bethesda, MD 20892, (301) 435-1747, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by... 20892, 301-435- 1211, [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special...

78 FR 72684 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-12-03

...-1246, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for... Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435- 1775, [email protected]csr.nih.gov...

75 FR 3240 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-01-20

... notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by... 20892, 301-254-9975, [email protected]csr.nih.gov . Name of Committee: Center for Scientific Review Special..., Room 6164, MSC 7892, Bethesda, MD 20892, (301) 435- 1041, [email protected]csr.nih.gov . Name of Committee...

75 FR 64736 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-10-20

...-1215, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for... Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-594- 7945, [email protected]csr.nih...

76 FR 12124 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-04

...-435-1501, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for..., (301) 435-1258, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the...

78 FR 45252 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-07-26

... 7852, Bethesda, MD 20892, 301-435- 1775, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle... Health, 6701 Rockledge Drive, Room 3130, MSC 7850, Bethesda, MD 20892, 301-435-3009, [email protected]csr.nih.gov...

76 FR 36555 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-06-22

...-1219, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for..., Room 5187, MSC 7840, Bethesda, MD 20892, 301-435- 1236, [email protected]csr.nih.gov . Name of Committee...

77 FR 37685 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-06-22

..., (301) 806-2515, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center... Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, 301-451-3493, [email protected]csr.nih.gov...

77 FR 38849 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-06-29

... 20892, 301-435-1038, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435-1165, [email protected]csr.nih...

78 FR 66754 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-11-06

..., Bethesda, MD 20892, 301-435- 0677, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of... 7844, Bethesda, MD 20892, (301) 806-3323, [email protected]csr.nih.gov . Name of Committee: Center for...

75 FR 48977 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-08-12

.... [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific..., Room 5181, MSC 7844, Bethesda, MD 20892. 301-435- 1033. [email protected]csr.nih.gov . Name of Committee: Center...

76 FR 22716 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-04-22

.... [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific..., Room 6170, MSC 7892, Bethesda, MD 20892, 301-435- 4514. [email protected]csr.nih.gov . Name of Committee...

78 FR 13361 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-02-27

...-435- 1211, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for..., Bethesda, MD 20892, 301-435-1050, [email protected]csr.nih.gov . This notice is being published less than 15 days...

75 FR 4095 - Center For Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2010-01-26

..., (301) 435-1233, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center... Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301-435- 1175, [email protected]csr.nih.gov . Name of...

76 FR 6803 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-02-08

... 20892, (301) 435-1219, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... Health, 6701 Rockledge Drive, Room 4811, MSC 7850, Bethesda, MD 20892 301-435-1203, [email protected]csr.nih.gov...

76 FR 31966 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-06-02

..., Bethesda, MD 20892, 301-435- 1259, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of... Health, 6701 Rockledge Drive, Room 4811, MSC 7850, Bethesda, MD 20892, 301-435-1203, [email protected]csr.nih.gov...

78 FR 48179 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2013-08-07

... 20892, (301) 435- 1712, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301-435- 5575, [email protected]csr.nih...

76 FR 28793 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-05-18

...-435- 0696, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Oncology 2..., Room 6214, MSC 7804, Bethesda, MD 20892, 301-451- 3493, [email protected]csr.nih.gov . This notice is being...

77 FR 59198 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-09-26

... 20892, (301) 435-1741, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee... Institutes of Health, 6701 Rockledge Drive, Room 5170, MSC 7840, Bethesda, MD 20892, 301-435-2406, [email protected]csr...

76 FR 17929 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-03-31

...-435- 1050, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for... Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435- 1775, [email protected]csr.nih.gov...

Managing Regulatory Body Competence

International Nuclear Information System (INIS)

2013-01-01

In 2001, the IAEA published TECDOC 1254, which examined the way in which the recognized functions of a regulatory body for nuclear facilities results in competence needs. Using the systematic approach to training (SAT), TECDOC 1254 provided a framework for regulatory bodies for managing training and developing and their maintaining their competence. It has been successfully used by many regulators. The IAEA has also introduced a methodology and an assessment tool - Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) - which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2009, the IAEA established a steering committee (supported by a bureau) with the mission to advise the IAEA on how it could best assist Member States to develop suitable competence management systems for their regulatory bodies. The committee recommended the development of a safety report on managing staff competence as an integral part of a regulatory body's management system. This Safety Report was developed in response to this request. It supersedes TECDOC 1254, broadens its application to regulatory bodies for all facilities and activities, and builds upon the experience gained through the application of TECDOC 1254 and SARCoN and the feedback received from Member States. This Safety Report applies to the management of adequate competence as needs change, and as such is equally applicable to the needs of States 'embarking' on a nuclear power programme. It also deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an 'embarking' State's regulatory system

Studies on fuels with low fission gas release. Proceedings of a technical committee meeting

International Nuclear Information System (INIS)

1997-10-01

For more than a decade, the IAEA has organized various specialists meetings to discuss advances in nuclear fuel technology for non-water cooled reactors. In order to review progress in research and development of fuels with low fission gas release for light water reactors, fast reactors and research reactors, an IAEA Technical Committee meeting was organized in October 1996. At the invitation of the Government of the Russian Federation, the meeting was held in Moscow. Experts from seven Member States and one international organization participated. The objective of the meeting was to exchange topical information on such fuels, to evaluate their advantages and drawbacks, and to explore their commercial utilization. The present volume contains the full text of the sixteen papers presented at the meeting. The information compiled in these proceedings should be useful for engineers, scientists and managers from nuclear fuel development organizations, fuel fabrication plants, utilities and regulatory bodies who are involved in the analysis of fuel behaviour under normal and accident conditions. Refs, figs, tabs

Technical meeting (TM) to 'Review of national programmes on fast reactors and accelerator driven systems (ADS)'. Technical Working Group on Fast Reactors (TWG-FR) (37th annual meeting). Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

2004-07-01

The objectives of the 37th Annual Meeting of the Technical Working Group on Fast Reactors, were to: 1) exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); 2) review the progress since the 36th TWG-FR Annual Meeting, including the status of the actions; 3) consider meeting arrangements for 2004 and 2005; 4) review the Agency's co-ordinated research activities in the field of FRs and ADS, as well as co-ordination of the TWG-FR's activities with other organizations. The participants made presentations on the status of the respective national programmes on FR and ADS development. A summary of the highlights for the period since the 36th TWG-FR Annual Meeting is included in this proceedings. Annex IV contains the Review of National Programs on Fast Reactors and Accelerator Driven Systems (ADS), and the TWG-FR Activity Report for the Period May 2003-April 2004.

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.

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...

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

International Nuclear Officials Discuss IAEA Peer Reviews of Nuclear Safety Regulations

International Nuclear Information System (INIS)

2011-01-01

Full text: Senior nuclear regulators today concluded a Workshop on the Lessons Learned from the IAEA Integrated Regulatory Review Service (IRRS) Missions. The U.S. Nuclear Regulatory Commission (NRC) hosted the workshop, in cooperation with the International Atomic Energy Agency, in Washington, DC, from 26 to 28 October 2011. About 60 senior regulators from 22 IAEA Member States took part in this workshop. The IRRS programme is an international peer review service offered by the IAEA to its Member States to provide an objective evaluation of their nuclear safety regulatory framework. The review is based on the internationally recognized IAEA Safety Standards. ''The United States Nuclear Regulatory Commission was pleased to host the IAEA's IRRS meeting this week. The discussions over the past three days have provided an important opportunity for regulators from many countries to come together to strengthen the international peer review process,'' said U.S. NRC Chairman Gregory B. Jaczko. ''Especially after the Fukushima Daiichi accident, the global community recognizes that IRRS missions fill a vital role in strengthening nuclear safety and security programs around the world, and we are proud to be a part of this important effort.'' The IAEA Action Plan on Nuclear Safety includes actions focused towards strengthening the existing IAEA peer reviews, incorporating lessons learned and improving their effectiveness. The workshop provided a platform for the exchange of information, experience and lessons learned from the IRRS missions, as well as expectations for the IRRS programme for the near future. Further improvements in the planning and implementation of the IRRS missions in the longer term were discussed. A strong commitment of all relevant national authorities to the IRRS programme was identified as a key element of an effective regulatory framework. The conclusions of the workshop will be issued in November 2011 and the main results will be reported to the IAEA

Assessment of regulatory effectiveness. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1999-09-01

This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

Streamlining the license renewal review process

International Nuclear Information System (INIS)

Dozier, J.; Lee, S.; Kuo, P.T.

2001-01-01

The staff of the NRC has been developing three regulatory guidance documents for license renewal: the Generic Aging Lessons Learned (GALL) report, Standard Review Plan for License Renewal (SRP-LR), and Regulatory Guide (RG) for Standard Format and Content for Applications to Renew Nuclear Power Plant Operating Licenses. These documents are designed to streamline the license renewal review process by providing clear guidance for license renewal applicants and the NRC staff in preparing and reviewing license renewal applications. The GALL report systematically catalogs aging effects on structures and components; identifies the relevant existing plant programs; and evaluates the existing programs against the attributes considered necessary for an aging management program to be acceptable for license renewal. The GALL report also provides guidance for the augmentation of existing plant programs for license renewal. The revised SRP-LR allows an applicant to reference the GALL report to preclude further NRC staff evaluation if the plant's existing programs meet the criteria described in the GALL report. During the review process, the NRC staff will focus primarily on existing programs that should be augmented or new programs developed specifically for license renewal. The Regulatory Guide is expected to endorse the Nuclear Energy Institute (NEI) guideline, NEI 95-10, Revision 2, entitled 'Industry Guideline for Implementing the Requirements of 10 CFR Part 54 - The License Renewal Rule', which provides guidance for preparing a license renewal application. This paper will provide an introduction to the GALL report, SRP-LR, Regulatory Guide, and NEI 95-10 to show how these documents are interrelated and how they will be used to streamline the license renewal review process. This topic will be of interest to domestic power utilities considering license renewal and international ICONE participants seeking state-of-the-art information about license renewal in the United States

Regulatory body core competencies: when should a regulator contract a TSO?

International Nuclear Information System (INIS)

Wieland, Patricia; Salati de Almeida, Ivan P.; Almeida, Claudio U.; Costa, Eduardo M.

2008-01-01

The main nuclear regulatory functions are authorization, safety review and assessment, inspection and enforcement and development of regulations and guides. Additionally, the following supplementary functions may be executed by the regulatory body: research and development, emergency response and international cooperation. In order to function properly, the regulatory body should also have the following support functions: general management, logistics, training, communication and information, information technology support, institutional relationship, internal controls and audits, ombudsman and legal support. Technical Support Organizations (TSOs) may assist the regulatory body in meeting the challenges in a rapid growing and changing environment. Specially when there is a temporary need for a wider technical expertise diversity, short time to finish a project or when the cost of developing and maintaining infrastructure of their own laboratories for analysis and research is too high and may deviate the focus on the regulator's mission. Decision on the 'size' of the regulatory body and on what can be contracted to a Technical Support Organization (TSO) depends on the resources and capabilities needed to fulfil the regulatory functions efficiently. It is important to establish the core competencies that must be at the regulatory body, keeping the focus on the regulatory goals and define the real need to contract a TSO, weighting the benefits and disadvantages. As a contribution to the definition of the regulatory core competencies, the paper discusses what is essential to be kept at the regulatory body and what can be delegated to a TSO; how to manage and control the work of the TSO; the cost effectiveness of contracting, sharing of tacit knowledge; how to handle eventual conflicts between the parties involved in the licensing process; contract types and risk evaluation, concerning the dependence on a TSO, eventual change of partners and the intellectual capital

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

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

Exploring self-regulatory strategies for eating behaviour in Danish adolescents

DEFF Research Database (Denmark)

Nureeva, Liliya; Brunsø, Karen; Lähteenmäki, Liisa

2016-01-01

– Focusing on improving adolescents’ self-regulatory skills in the domain of eating behaviour is a promising approach in developing future interventions. Originality/value – The present article explores self-regulatory strategies for eating behaviour in adolescence and discusses their relevance.......Purpose – Healthy eating behaviour in adolescence may be negatively affected by lack of self-regulation. The purpose of this paper is to discuss strategies for regulating eating behaviour as formulated by adolescents themselves. Design/methodology/approach – Self-regulatory strategies were elicited...... with concept mapping, which is a group-based method. Three meetings were conducted with each of four school classes in Denmark. Participants in the 12-15-year age group were recruited for the study. At the first meeting, participants had to complete the phrase “Things I can do to ensure my healthy eating are...

Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

Energy Technology Data Exchange (ETDEWEB)

Farah, A., E-mail: amjad.farah@uoit.ca [University of Ontario Institute of Technology, Oshawa, ON (Canada)

2015-07-01

Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

Nuclear security regulatory framework analysis for small modular reactors in Canada and abroad

International Nuclear Information System (INIS)

Farah, A.

2015-01-01

Small Modular Reactors (SMRs) are gaining global attention as a potential solution for future power plants due to claims of flexibility and cost effectiveness, while maintaining or increasing safety and security. With the change of design and the potential deployment in remote areas, however, challenges arise from a regulatory standpoint, to meet the safety and security regulations while maintaining economic feasibility. This work comprises of a review of the nuclear security regulatory frameworks in place for SMRs in Canada, USA and the IAEA; how they compare to each other, and to those of large reactors. The goal is to gauge what needs to be adjusted in order to address the changes in design between the two reactor sizes. Some key challenges concern the type of reactor, transportation of reactor components and fuel to remote areas, reduced security staff, and increased complexity of emergency planning and evacuation procedures. (author)

Twenty-third water reactor safety information meeting. Volume 3, structural and seismic engineering, primary systems integrity, equipment operability and aging, ECCS strainer blockage research and regulatory issues

Energy Technology Data Exchange (ETDEWEB)

Monteleone, S. [comp.] [Brookhaven National Lab., Upton, NY (United States)

1996-03-01

This three-volume report contains papers presented at the Twenty- Third Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, October 23-25, 1995. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Italy, Japan, Norway, Russia, Sweden, and Switzerland. This document, Volume 3, presents topics in Structural & Seismic Engineering, Primary Systems Integrity, Equipment Operability and Aging, and ECCS Strainer Blockage Research & Regulatory Issues. Individual papers have been cataloged separately.

Twenty-third water reactor safety information meeting. Volume 3, structural and seismic engineering, primary systems integrity, equipment operability and aging, ECCS strainer blockage research and regulatory issues

International Nuclear Information System (INIS)

Monteleone, S.

1996-03-01

This three-volume report contains papers presented at the Twenty- Third Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, October 23-25, 1995. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Italy, Japan, Norway, Russia, Sweden, and Switzerland. This document, Volume 3, presents topics in Structural ampersand Seismic Engineering, Primary Systems Integrity, Equipment Operability and Aging, and ECCS Strainer Blockage Research ampersand Regulatory Issues. Individual papers have been cataloged separately

76 FR 3916 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2011-01-21

... 7848, Bethesda, MD 20892, (301) 435-4445, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle... 20892, 301-435- 0677, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the...

77 FR 72362 - Center for Scientific Review; Notice of Closed Meetings

Science.gov (United States)

2012-12-05

..., Bethesda, MD 20892, (301) 435-1165, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of... 20892, 301-435- 1775, [email protected]csr.nih.gov . This notice is being published less than 15 days prior to...

Promoting Regulatory Reform: The African Health Profession Regulatory Collaborative (ARC) for Nursing and Midwifery Year 4 Evaluation.

Science.gov (United States)

Kelley, Maureen A; Spangler, Sydney A; Tison, Laura I; Johnson, Carla M; Callahan, Tegan L; Iliffe, Jill; Hepburn, Kenneth W; Gross, Jessica M

2017-10-01

As countries across sub-Saharan Africa work towards universal health coverage and HIV epidemic control, investments seek to bolster the quality and relevance of the health workforce. The African Health Profession Regulatory Collaborative (ARC) partnered with 17 countries across East, Central, and Southern Africa to ensure nurses and midwives were authorized and equipped to provide essential HIV services to pregnant women and children with HIV. Through ARC, nursing leadership teams representing each country identify a priority regulatory function and develop a proposal to strengthen that regulation over a 1-year period. Each year culminates with a summative congress meeting, involving all ARC countries, where teams present their projects and share lessons learned with their colleagues. During a recent ARC Summative Congress, a group survey was administered to 11 country teams that received ARC Year 4 grants to measure advancements in regulatory function using the five-stage Regulatory Function Framework, and a group questionnaire was administered to 16 country teams to measure improvements in national nursing capacity (February 2011-2016). In ARC Year 4, eight countries implemented continuing professional development projects, Botswana revised their scope of practice, Mozambique piloted a licensing examination to assess HIV-related competencies, and South Africa developed accreditation standards for HIV/tuberculosis specialty nurses. Countries reported improvements in national nursing leaders' teamwork, collaborations with national organizations, regional networking with nursing leaders, and the ability to garner additional resources. ARC provides an effective, collaborative model to rapidly strengthen national regulatory frameworks, which other health professional cadres or regions may consider using to ensure a relevant health workforce, authorized and equipped to meet the emerging demand for health services.

Report of a consultants meeting on draft guidelines for WWER 440/213 containment evaluation

International Nuclear Information System (INIS)

Andrieu, R.; Barre, F.; Birbraer, A.N.

1995-01-01

This report has been prepared at two Consultants' Meetings of experts from France, Germany, Russia, Slovakia, Spain and Ukraine, organized within the framework of the IAEA Extrabudgetary Programme on the Safety of WWER NPPs. In view of the limited time available and the complexity of the task the present report should be treated as a draft, which will be sent to the national regulatory bodies for review and further improvement. The next meeting on the subject will be held in June 1996 with the participation of representatives of all countries operating WWER 440/213 reactors with bubbler condenser containments. During the meeting, the acceptance criteria and review requirements formulated in the IAEA NUSS Series and those in force in the Russian Federation, the United States of America, Germany, France, the Czech Republic, and Slovakia have been taken into consideration. The equivalence of the technical goals which are aimed to be achieved by applying comparable national criteria has been checked in order to avoid multiple addressing the issues and to assure the completeness of the acceptance criteria necessary to assess the design of the containment systems. 48 refs, 12 tabs

Technical meeting to 'Review of national programmes on fast reactors and accelerator driven systems (ADS)'. Working material

International Nuclear Information System (INIS)

2002-01-01

The 35th Annual Meeting of the Technical Working Group on Fast Reactors TWG-FR, previously International Working Group on Fast Reactors (IWG-FR, created in 1967), was hosted by the Forschungszentrum Karlsruhe (FZK) and was attended by TWG-FR members and advisers from the following Member States: Brazil, China, France, Germany, India, Japan, the Republic of Kazakhstan, the Republic of Korea, the Russian Federation, and the United States of America. The objectives of the meeting were: to exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); to review the progress since the 34th TWG-FR Annual Meeting, including the status of the actions; to consider meeting arrangements for 2002 and 2003; to review the Agency's co-ordinated research activities in the field of FRs and ADS, as well as co-ordination of the TWG-FR's activities with other organizations

Technical meeting to 'Review of national programmes on fast reactors and accelerator driven systems (ADS)'. Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-07-01

The 35th Annual Meeting of the Technical Working Group on Fast Reactors TWG-FR, previously International Working Group on Fast Reactors (IWG-FR, created in 1967), was hosted by the Forschungszentrum Karlsruhe (FZK) and was attended by TWG-FR members and advisers from the following Member States: Brazil, China, France, Germany, India, Japan, the Republic of Kazakhstan, the Republic of Korea, the Russian Federation, and the United States of America. The objectives of the meeting were: to exchange information on the national programmes on Fast Reactors (FR) and Accelerator Driven Systems (ADS); to review the progress since the 34th TWG-FR Annual Meeting, including the status of the actions; to consider meeting arrangements for 2002 and 2003; to review the Agency's co-ordinated research activities in the field of FRs and ADS, as well as co-ordination of the TWG-FR's activities with other organizations.

Prediction of adaptive self-regulatory responses to arthritis pain anxiety in exercising adults: does pain acceptance matter?

Science.gov (United States)

Cary, Miranda Ashley; Gyurcsik, Nancy C; Brawley, Lawrence R

2015-01-01

Exercising for ≥ 150 min/week is a recommended strategy for self-managing arthritis. However, exercise nonadherence is a problem. Arthritis pain anxiety may interfere with regular exercise. According to the fear-avoidance model, individuals may confront their pain anxiety by using adaptive self-regulatory responses (eg, changing exercise type or duration). Furthermore, the anxiety-self-regulatory responses relationship may vary as a function of individuals' pain acceptance levels. To investigate pain acceptance as a moderator of the pain anxiety-adaptive self-regulatory responses relationship. The secondary objective was to examine whether groups of patients who differed in meeting exercise recommendations also differed in pain-related and self-regulatory responses. Adults (mean [± SD] age 49.75 ± 13.88 years) with medically diagnosed arthritis completed online measures of arthritis pain-related variables and self-regulatory responses at baseline, and exercise participation two weeks later. Individuals meeting (n=87) and not meeting (n=49) exercise recommendations were identified. Hierarchical multiple regression analysis revealed that pain acceptance moderated the anxiety-adaptive self-regulatory responses relationship. When pain anxiety was lower, greater pain acceptance was associated with less frequent use of adaptive responses. When anxiety was higher, adaptive responses were used regardless of pain acceptance level. MANOVA findings revealed that participants meeting the recommended exercise dose reported significantly lower pain and pain anxiety, and greater pain acceptance (Pself-regulatory capacity to cope with additional challenges to exercise adherence (eg, busy schedule).

76 FR 4113 - Independent Scientific Peer Review Panel Meeting on an In Vitro

Science.gov (United States)

2011-01-24

... antagonist activity. These studies were funded primarily by a Small Business Innovation Research (SBIR) grant... Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical... Toxicological Methods (NICEATM); Announcement of an Independent Scientific Peer Review Panel Meeting on an In...

78 FR 6854 - Health Services Research and Development Service Scientific Merit Review Board; Notice of Meeting

Science.gov (United States)

2013-01-31

... DEPARTMENT OF VETERANS AFFAIRS Health Services Research and Development Service Scientific Merit... Research and Development Service Scientific Merit Review Board will meet on February 13-14, 2013, at the... research. Applications are reviewed for scientific and technical merit. Recommendations regarding funding...

Risk-based Regulatory Evaluation Program methodology

International Nuclear Information System (INIS)

DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

1987-01-01

The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

75 FR 69069 - Science Advisory Board Staff Office Notification of a Public Meeting of the SAB Lead Review Panel

Science.gov (United States)

2010-11-10

... Time) and December 7, 2010 from 8:30 a.m. to 12:30 p.m. (Eastern Time). ADDRESSES: The face-to-face... SAB Lead Review Panel will hold a public face-to-face meeting to peer review two draft EPA documents... an oral presentation at a public face-to-face meeting will be limited to five minutes, with no more...

Regulatory oversight of safety culture in nuclear installations - New IAEA developments

International Nuclear Information System (INIS)

Kerhoas, Anne; )

2012-01-01

Ms. Anne Kerhoas described the IAEA work on guidance for regulatory oversight of safety culture. She summarised the various IAEA, OECD/NEA and ANS meetings that have been held on the topic between 1995 and 2011. The IAEA has carried out two recent projects with the Bulgarian and Romanian regulatory bodies to develop a safety culture oversight program. The work was funded by the Norwegian government and has involved 30 experts from 17 different countries. Draft guidance for regulators on how to monitor licensee safety culture has also been produced (IAEA-TECDOC-DD1070). The document is intended to provide practical guidance on oversight strategies and is applicable to a wide range of nuclear installations, including nuclear power plants, fuel cycle facilities, research reactors and waste management facilities. A number of principles for regulatory oversight of safety culture were summarised. For example, the primary responsibility for safety remains with the licensee, safety culture oversight should be performed at all stages of the life cycle of the nuclear installation, and multiple data collection methods should be used. The overall approach to safety culture described in the draft IAEA Tech doc includes a range of approaches to build up a meaningful picture of the licensee's safety culture. These include interviews, observations, review of documents, review of events, discussions and surveys. The importance of ongoing discussion with the licensee throughout the process to develop a deeper shared understanding of issues was emphasised. The results of the Chester 2 workshop will be used as an input to finalization of the draft Tech Doc

Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

Science.gov (United States)

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

2015-01-01

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

75 FR 44266 - Submission for OMB Review; Comment Request; Application for the Pharmacology Research Associate...

Science.gov (United States)

2010-07-28

... Management and Budget (OMB) a request to review and approve the information collection listed below. This... university as meeting all the requirements leading to a doctorate may be hired as PRAT Fellows. The purpose... Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974...

Proceedings of the natural gas RD&D contractors review meeting, Volume I

Energy Technology Data Exchange (ETDEWEB)

Malone, R.D.

1995-04-01

This report contains papers which were presented at the natural gas contractors review meeting held on April 4-6, 1995. Topics were concerned with resource and reserves, low permeability reservoir characterization, natural fracture detection, drilling, completion, and stimulation, and natural gas upgrading. Individual papers were processed separately for the United States Department of Energy databases.

17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.

Science.gov (United States)

2010-04-01

... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...

77 FR 77073 - York Haven Power Company, LLC; Notice of Meeting

Science.gov (United States)

2012-12-31

... Company, LLC; Notice of Meeting On Wednesday, January 9, 2013, Commission staff will meet with York Haven Power Company, LLC (applicant) in Washington, DC. The purpose of the meeting is to discuss the required... begin at 10 a.m. at the Federal Energy Regulatory Commission headquarters building located at 888 First...

Continuing education requirements among State Occupational Therapy Regulatory Boards in the United States of America

Directory of Open Access Journals (Sweden)

Savannah R. Hall

2016-10-01

Full Text Available Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination.

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.

Proceedings of the advanced coal-fired power systems `95 review meeting, Volume II

Energy Technology Data Exchange (ETDEWEB)

McDaniel, H.M.; Mollot, D.J.; Venkataraman, V.K.

1995-06-01

This report contains papers which were presented at the advanced coal-fired power sytems review meeting. This is volume II. Topics include: hot gas filter issues, hazardous air pollutants, sorbent development, and separation technologies. Individual papers were processed separately for the United States Department of Energy databases.

Working with the institutional review board.

Science.gov (United States)

Byerly, Wesley G

2009-01-15

Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.

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

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

Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings

Energy Technology Data Exchange (ETDEWEB)

DiSabatino, A; Biswas, D; DeMicco, M; Fisher, L E; Hafner, R; Haslam, J; Mok, G; Patel, C; Russell, E

2007-04-12

This Packaging Review Guide (PRG) provides guidance for Department of Energy (DOE) review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE Order 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his or her review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. This PRG is generally organized at the section level in a format similar to that recommended in Regulatory Guide 7.9 (RG 7.9). One notable exception is the addition of Section 9 (Quality Assurance), which is not included as a separate chapter in RG 7.9. Within each section, this PRG addresses the technical and regulatory bases for the review, the manner in which the review is accomplished, and findings that are generally applicable for a package that meets the approval standards. This Packaging Review Guide (PRG) provides guidance for DOE review and approval of packagings to transport fissile and Type B quantities of radioactive material. It fulfills, in part, the requirements of DOE O 460.1B for the Headquarters Certifying Official to establish standards and to provide guidance for the preparation of Safety Analysis Reports for Packagings (SARPs). This PRG is intended for use by the Headquarters Certifying Official and his review staff, DOE Secretarial offices, operations/field offices, and applicants for DOE packaging approval. The primary objectives of this PRG are to: (1) Summarize the regulatory requirements for package approval; (2) Describe the technical review procedures by which DOE determines that these requirements have been satisfied; (3) Establish and maintain the quality and uniformity of reviews; (4) Define the base from which to evaluate proposed changes in scope

75 FR 41858 - Notice of FERC Staff Attendance at the Southwest Power Pool ICT Stakeholder Policy Committee Meeting

Science.gov (United States)

2010-07-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of FERC Staff Attendance at the Southwest Power Pool ICT Stakeholder Policy Committee Meeting July 12, 2010. The Federal Energy Regulatory... is part of the Commission's ongoing outreach efforts. ICT Stakeholder Policy Committee Meeting July...

77 FR 5471 - Announcement of Public Meeting on the Consumer Confidence Report (CCR) Rule Retrospective Review

Science.gov (United States)

2012-02-03

... Announcement of Public Meeting on the Consumer Confidence Report (CCR) Rule Retrospective Review AGENCY... stakeholder input on the Consumer Confidence Report (CCR) Rule as part of the agency's Retrospective Review of... Safe Drinking Water Act (SDWA, section 1414(c)). The Consumer Confidence Report, or CCR, is an annual...

Proceedings of a specialist meeting on boron reactivity transients

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-07-01

The CSNI Specialist Meeting on Boron Dilution Reactivity Transients was hosted by the Penn State University in collaboration with the US Nuclear Regulatory Commission and the TRAC Users Group. More than 70 experts from 12 OECD countries, as well as experts from Russia and other non-OECD countries attended the meeting. Thirty papers were presented in five technical sessions. The purpose of the meeting was to bring together experts involved in the different activities related to boron dilution transients. The experts came from all involved parties, including research organizations, regulatory authorities, vendors and utilities. Information was openly shared and discussed on the experimental results, plant and systems analysis, numerical analysis of mixing and probability and consequences of these transients. Regulatory background and licensing implications were also included to provide the proper frame work for the technical discussion. Each of these areas corresponded to a separate session. The meeting focused on the thermal-hydraulic aspects because of the current interest in that subject and the significant amount of new technical information being generated. Three papers of the same conference are already available in INIS as individual reports: Potential for boron dilution during small-break LOCAs in PWRs (Ref. number: 27029412); Analysis of boron dilution in a four-loop PWR (Ref. number: 27051651); Probability and consequences of a rapid boron dilution sequence in a PWR (Ref. number: 27029411)

Regulation of the life cycle of nuclear installations. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1999-06-01

This report arises from the sixth series of peer discussions on regulatory practices entitled 'Regulation of Life Cycle of Nuclear Installations'. Senior regulators from 18 Member States participated in three peer group discussions during 1997-1998. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the nominating organizations, or the IAEA. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to the policies, principles and requirements imposed by regulatory bodies for the safe management of the life cycle of a nuclear installation. The intention of doing this is to assist Member States in the formulation and enhancement of their regulatory control over PLCM by identifying commonly accepted good practices. This report is structured to cover the subject matter under the following main headings: Policies and Principles for the Life Cycle Management of Nuclear Installations; Responsibilities of the Regulatory Body and the Operating Organization; Requirements and Criteria Imposed by the Regulatory Body; Licensing and Regulatory Assessment for Plant Life Cycle Management; and Good Practices

Improving nuclear regulatory effectiveness

International Nuclear Information System (INIS)

2001-01-01

Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

76 FR 36156 - Meetings of Humanities Panel

Science.gov (United States)

2011-06-21

...: Room 415. PROGRAM: This meeting will review applications for Literary Theory and Film in Fellowships... 415. PROGRAM: This meeting will review applications for Literature, Philosophy, and the Arts in Awards...: Room 315. PROGRAM: This meeting will review applications for Philosophy I in Fellowships Program...

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...

17 CFR 201.421 - Commission consideration of determinations by self-regulatory organizations.

Science.gov (United States)

2010-04-01

... determinations by self-regulatory organizations. 201.421 Section 201.421 Commodity and Securities Exchanges... Commission Review § 201.421 Commission consideration of determinations by self-regulatory organizations. (a..., order review of any determination by a self-regulatory organization that could be subject to an...

Improvements of the Regulatory Framework for Nuclear Installations in the Areas of Human and Organizational Factors and Safety Culture

International Nuclear Information System (INIS)

Tronea, M.; Ciurea, C.

2016-01-01

culture. This action has been taken based upon a recommendation received from the 6th Review Meeting of the Contracting Parties to the Convention on Nuclear Safety, to have assessments of the safety culture of the regulatory authority, acknowledging that the culture of the regulator may have an influence on the safety culture of the licencees. A limited exercise for a safety climate survey has been implemented for CNCAN staff involved in the regulatory review and inspection activities for nuclear installations. The same 37 attributes of a strong safety culture promoted by the IAEA have been used, in a slightly adapted form, also for the safety climate survey for CNCAN staff. The experience with the development and improvement of the regulatory framework, regulatory oversight process and safety culture in the regulatory organization are all described in the paper and may prove useful for regulatory authorities of other countries. (author)

Moving toward the automation of the systematic review process: a summary of discussions at the second meeting of International Collaboration for the Automation of Systematic Reviews (ICASR).

Science.gov (United States)

O'Connor, Annette M; Tsafnat, Guy; Gilbert, Stephen B; Thayer, Kristina A; Wolfe, Mary S

2018-01-09

The second meeting of the International Collaboration for Automation of Systematic Reviews (ICASR) was held 3-4 October 2016 in Philadelphia, Pennsylvania, USA. ICASR is an interdisciplinary group whose aim is to maximize the use of technology for conducting rapid, accurate, and efficient systematic reviews of scientific evidence. Having automated tools for systematic review should enable more transparent and timely review, maximizing the potential for identifying and translating research findings to practical application. The meeting brought together multiple stakeholder groups including users of summarized research, methodologists who explore production processes and systematic review quality, and technologists such as software developers, statisticians, and vendors. This diversity of participants was intended to ensure effective communication with numerous stakeholders about progress toward automation of systematic reviews and stimulate discussion about potential solutions to identified challenges. The meeting highlighted challenges, both simple and complex, and raised awareness among participants about ongoing efforts by various stakeholders. An outcome of this forum was to identify several short-term projects that participants felt would advance the automation of tasks in the systematic review workflow including (1) fostering better understanding about available tools, (2) developing validated datasets for testing new tools, (3) determining a standard method to facilitate interoperability of tools such as through an application programming interface or API, and (4) establishing criteria to evaluate the quality of tools' output. ICASR 2016 provided a beneficial forum to foster focused discussion about tool development and resources and reconfirm ICASR members' commitment toward systematic reviews' automation.

78 FR 49750 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

Science.gov (United States)

2013-08-15

... sequence-specific degradation of an RNA. The EPA is beginning to receive applications for regulatory... impact of regulatory actions on health and the environment. FIFRA SAP is a Federal Advisory Committee... the Agency. B. Public Meeting The use of RNA Interference (RNAi) gene silencing technology...

Proceedings of a specialist meeting on regulatory approaches for the control of environmental residues containing naturally occurring radioactive material. Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-07-01

approaches are used nationally and a review of the regulation of NORM is timely. The mining and milling of uranium and thorium ores and the management of the waste generated from such activities is the subject of several safety documents of the IAEA. An assessment of occupational protection conditions in workplaces with high levels of exposure to natural radiation was made through an IAEA Technical Committee Meeting held in 2001. The findings of this meeting are forming the basis for a work plan for future activities in this area and for a Safety Guide on occupational radiation protection in mining and processing of raw material, as well as two related safety reports. However, there is a range of radiation protection issues, arising from the mining, processing, utilisation and disposal of NORM, which have not yet been covered in IAEA safety documents. These include impacts on the public and the environment of the processing of NORM and the associated generation of waste.

Proceedings of a specialist meeting on regulatory approaches for the control of environmental residues containing naturally occurring radioactive material. Working material

International Nuclear Information System (INIS)

2005-01-01

approaches are used nationally and a review of the regulation of NORM is timely. The mining and milling of uranium and thorium ores and the management of the waste generated from such activities is the subject of several safety documents of the IAEA. An assessment of occupational protection conditions in workplaces with high levels of exposure to natural radiation was made through an IAEA Technical Committee Meeting held in 2001. The findings of this meeting are forming the basis for a work plan for future activities in this area and for a Safety Guide on occupational radiation protection in mining and processing of raw material, as well as two related safety reports. However, there is a range of radiation protection issues, arising from the mining, processing, utilisation and disposal of NORM, which have not yet been covered in IAEA safety documents. These include impacts on the public and the environment of the processing of NORM and the associated generation of waste

Safety system upgrades to a research reactor: A regulatory perspective

International Nuclear Information System (INIS)

Lamarre, G.B.; Martin, W.G.

2003-01-01

The NRU (National Research Universal) reactor, located at the Chalk River Laboratories of Atomic Energy of Canada Limited (AECL), first achieved criticality November 3, 1957. AECL continues to operate NRU for research to support safety and reliability studies for CANDU reactors and as a major supplier of medical radioisotopes. Following a detailed systematic review and assessment of NRU's design and the condition of its primary systems, AECL formally notified the Canadian Nuclear Safety Commission's (CNSC) predecessor - the Atomic Energy Control Board - in 1992 of its intention to upgrade NRU's safety systems. AECL proposed seven major upgrades to provide improvements in shutdown capability, heat removal, confinement, and reactor monitoring, particularly during and after a seismic event. From a CNSC perspective, these upgrades were necessary to meet modern safety standards. From the start of the upgrades project, the CNSC provided regulatory oversight aimed at ensuring that AECL maintained a structured approach to the upgrades. The elements of the approach include, but are not limited to, the determination of project milestones and target dates; the formalization of the design process and project quality assurance requirements; the requirements for updated documentation, including safety reports, safety notes and commissioning reports; and the approval and authorization process. This paper details, from a regulatory perspective, the structured approach used in approving the design, construction, commissioning and subsequent operation of safety system upgrades for an existing and operating research reactor, including the many challenges faced when attempting to balance the requirements of the upgrades project with AECL's need to keep NRU operating to meet its important research and production objectives. (author)

Public meetings

CERN Multimedia

Staff Association

2014-01-01

  Public meetings : Come and talk about your future employment conditions !   The Staff Association will come and present the results of our survey on the 2015 five-yearly review. Following the survey, the topics discussed, will be contract policy, recognition of merit (MARS), working time arrangements and family policy. After each meeting and around a cup of coffee or tea you will be able to continue the discussions. Do not hesitate to join us, the five-yearly review, it is with YOU!

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

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

Regulatory Activities for Licensee's Safety Culture

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik

2008-01-01

Weaknesses in safety culture have contributed to a number of incidents/accidents in the nuclear and other high hazard sectors worldwide in the past. These events have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining regulatory oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. This paper presents the findings, conclusions and recommendations of international meetings and other countries' activities on safety culture and gives some suggestions for regulators to consider when planning regulatory oversight for licensee's safety culture

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)

Regulatory viewpoint on nuclear fuel quality assurance

International Nuclear Information System (INIS)

Tripp, L.E.

1976-01-01

Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

NTL 11 spent fuel flask - meeting the challenge of regulatory and technological change

International Nuclear Information System (INIS)

Cory, A.R.

2004-01-01

By June 2005, when shipments of spent fuel for reprocessing from Germany are concluded, the NTL11 flask type will have been responsible for transporting a total of 1500 tonnes of heavy metal in the form of spent fuel. Excluding domestic transports in France and the UK, this represents 25% of the total European spent fuel transported for reprocessing since the flasks came into service in 1977. Approximately 40% of the total for the flask type will have been transported to BNFL's Sellafield facility, the remainder to Cogema at La Hague. The NTL11 flask can justifiably be described as being the workhorse of BNFL's European spent fuel transport business. The NTL11 flask started life under the ownership of Nuclear Transport Limited, an associate company of BNFL, and in recent years the original fleet of five flasks has been absorbed into the BNFL inventory. A recent build programme has seen a further four flasks added to the fleet, an expedient measure to cope with the additional transport requirements imposed by the need to meet the June 2005 deadline for the removal of contracted fuels from Germany. While there have been certain evolutionary changes affecting the package design, there have also been more significant changes in the Design Safety Case. These have sometimes been necessary to meet regulatory changes, or the challenges posed by the regulators. In other cases advantage has been taken of improvements in analytical techniques to demonstrate increased margins of operational safety. Where possible those margins have also been increased by other means, such as taking advantage of commercial trends to reduce package thermal loads. The NTL11 flask was designed around the reactor and fuel characteristics prevailing in the 1970's. Over the lifetime of the flask the responsible engineering teams have faced and met the successive challenges to develop the capability of the Package to face the changing requirements of the industry and the Transport Regulations. Both

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.

78 FR 18680 - Rehabilitation Research and Development Scientific Merit Review Board, Notice of Meeting

Science.gov (United States)

2013-03-27

... DEPARTMENT OF VETERANS AFFAIRS Rehabilitation Research and Development Scientific Merit Review... Service, and the Chief Research and Development Officer on the scientific and technical merit, the mission... Committee Act, 5 U.S.C. App. 2, that a meeting of the Rehabilitation Research and Development Service...

75 FR 40816 - Northern Illinois Hydropower, LLC; Notice of Meeting

Science.gov (United States)

2010-07-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12626-002; Project No. 12717-002] Northern Illinois Hydropower, LLC; Notice of Meeting July 7, 2010. a. Date and Time of Meeting: Thursday, July 22, 2010 from 9 a.m. to 12 p.m. CDT. b. Place: Illinois Historic Preservation...

77 FR 27451 - Boott Hydropower, Inc.; Notice of Section 106 Consultation Meeting

Science.gov (United States)

2012-05-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2790-055] Boott Hydropower, Inc.; Notice of Section 106 Consultation Meeting On May 24, 2012, Federal Energy Regulatory Commission... Historic Preservation, Boott Hydropower, Inc., and any other consulting parties for the section 106 process...

Safety analysis - current and future regulatory challenges

Energy Technology Data Exchange (ETDEWEB)

Jamieson, T., E-mail: Terry.Jamieson@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

2015-07-01

'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

Safety analysis - current and future regulatory challenges

International Nuclear Information System (INIS)

Jamieson, T.

2015-01-01

'Full text:' The current and future regulatory challenges associated with deterministic safety analysis are reviewed, including: 1. The CNSC's and safety control areas. 2. Traditional safety analysis approach. 3. Experience gained and impact. 4. Current analysis and regulatory approaches. 5. Current status. 6. Complexity and challenges In particular, the technical, regulatory and strategic aspects of these challenges are discussed. (author)

Operating the Advanced Test Reactor in today's economic and regulatory environment

International Nuclear Information System (INIS)

Furstenau, R.V.; Patrick, M.E.; Mecham, D.C.

1999-01-01

The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory, is the US Department of Energy's largest and most versatile test reactor. Base programs at ATR are planned well into the 21st century. The ATR and support facilities along with an overview of current programs will be reviewed, but the main focus of the presentation will be on the impact that today's economic and regulatory concerns have had on the operation of this test reactor. Today's economic and regulatory concerns have demanded more work be completed at lower cost while increasing the margin of safety. By the beginning of the 1990 s, federal budgets for research generally and particularly for nuclear research had decreased dramatically. Many national needs continued to require testing in the ATR; but demanded lower cost, increased efficiency, improved performance, and an increased margin of safety. At the same time budgets were decreasing, there was an increase in regulatory compliance activity. The new standards imposed higher margins of safety. The new era of greater openness and higher safety standards complemented research demands to work safer, smarter and more efficiently. Several changes were made at the ATR to meet the demands of the sponsors and public. Such changes included some workforce reductions, securing additional program sponsors, upgrading some facilities, dismantling other facilities, and implementing new safety programs. (author)

ACCU Meeting

CERN Multimedia

PH Department

2011-01-01

DRAFT Agenda for the meeting to be held on Wednesday 15 June 2011 At 9:15 a.m. in room 60-6-002 Chairperson’s remarks Adoption of the agenda Minutes of the previous meeting Matters arising News from the CERN Management Report on services from GS department Update on Safety at CERN Reports from ACCU representatives on other Committees a. Scientific Information Policy Board (SIPB) b. IT Service Review Meeting (ITSRM) c. GS User Commission Users’ Office news Any Other Business Agenda for the next meeting Anyone wishing to raise any points under item 10 is invited to send them to the Chairperson in writing or by e-mail to Michael.Hauschild@cern.ch Michael Hauschild (Secretary) ACCU is the forum for discussion between the CERN Management and the representatives of CERN Users to review the practical means taken by CERN for the work of Users of the Laboratory. The User Representatives to ACCU are (CERN internal telephone numbers in bra...

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

Science.gov (United States)

Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

2017-07-01

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

75 FR 54221 - Government/Industry Aeronautical Charting Forum Meeting

Science.gov (United States)

2010-09-03

... Aeronautical Navigation Services (AeroNav Services) Group, Regulatory Support and Coordination Team, AJW-372...: The ACF is separated into two distinct groups. The Instrument Procedures Group (IPG) will meet October 26, 2010 from 8:30 a.m. to 5 p.m. The Charting Group will meet October 27 and 28, 2010 from 8:30 a.m...

76 FR 12211 - Government/Industry Aeronautical Charting Forum Meeting

Science.gov (United States)

2011-03-04

... Aeronautical Navigation Products Group (AeroNav Products), Regulatory Support and Coordination Team, AJV-3B...: The ACF is separated into two distinct groups. The Instrument Procedures Group (IPG) will meet April 26, 2011 from 8:30 a.m. to 5 p.m. The Charting Group will meet April 27 and 28, 2011 from 8:30 a.m...

Proceedings of the IAEA specialists` meeting on cracking in LWR RPV head penetrations

Energy Technology Data Exchange (ETDEWEB)

Pugh, C.E.; Raney, S.J. [comps.] [Oak Ridge National Lab., TN (United States)

1996-07-01

This report contains 17 papers that were presented in four sessions at the IAEA Specialists` meeting on Cracking in LWR RPV Head Penetrations held at ASTM Headquarters in Philadelphia on May 2-3, 1995. The papers are compiled here in the order that presentations were made in the sessions, and they relate to operational observations, inspection techniques, analytical modeling, and regulatory control. The goal of the meeting was to allow international experts to review experience in the field of ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. The emphasis was to allow a better understanding of RPV material behavior, to provide guidance supporting reliability and adequate performance, and to assist in defining directions for further investigations. The international nature of the meeting is illustrated by the fact that papers were presented by researchers from 10 countries. There were technical experts present form other countries who participated in discussions of the results presented. This present document incorporates the final version of the papers as received from the authors. The final chapter includes conclusions and recommendations. Individual papers have been cataloged separately.

Proceedings of the IAEA specialists' meeting on cracking in LWR RPV head penetrations

International Nuclear Information System (INIS)

Pugh, C.E.; Raney, S.J.

1996-07-01

This report contains 17 papers that were presented in four sessions at the IAEA Specialists' meeting on Cracking in LWR RPV Head Penetrations held at ASTM Headquarters in Philadelphia on May 2-3, 1995. The papers are compiled here in the order that presentations were made in the sessions, and they relate to operational observations, inspection techniques, analytical modeling, and regulatory control. The goal of the meeting was to allow international experts to review experience in the field of ensuring adequate performance of reactor pressure vessel (RPV) heads and penetrations. The emphasis was to allow a better understanding of RPV material behavior, to provide guidance supporting reliability and adequate performance, and to assist in defining directions for further investigations. The international nature of the meeting is illustrated by the fact that papers were presented by researchers from 10 countries. There were technical experts present form other countries who participated in discussions of the results presented. This present document incorporates the final version of the papers as received from the authors. The final chapter includes conclusions and recommendations. Individual papers have been cataloged separately

76 FR 42167 - Rehabilitation Research and Development Service Scientific Merit Review Board; Notice of Meeting

Science.gov (United States)

2011-07-18

... subcommittees of the Board will meet to evaluate merit review applications: August 9--Rehabilitation Engineering... Rehabilitation. August 16--Rehabilitation Engineering and Prosthetics/Orthotics. August 16-17--Psychological... DEPARTMENT OF VETERANS AFFAIRS Rehabilitation Research and Development Service Scientific Merit...

Review of the 25th annual scientific meeting of the International Society for Biological Therapy of Cancer.

Science.gov (United States)

Balwit, James M; Kalinski, Pawel; Sondak, Vernon K; Coulie, Pierre G; Jaffee, Elizabeth M; Gajewski, Thomas F; Marincola, Francesco M

2011-05-12

Led by key opinion leaders in the field, the 25th Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc, recently renamed the Society for Immunotherapy of Cancer, SITC) provided a scientific platform for ~500 attendees to exchange cutting-edge information on basic, clinical, and translational research in cancer immunology and immunotherapy. The meeting included keynote addresses on checkpoint blockade in cancer therapy and recent advances in therapeutic vaccination against cancer induced by Human Papilloma Virus 16. Participants from 29 countries interacted through oral presentations, panel discussions, and posters on topics that included dendritic cells and cancer, targeted therapeutics and immunotherapy, innate/adaptive immune interplay in cancer, clinical trial endpoints, vaccine combinations, countering negative regulation, immune cell trafficking to tumor microenvironment, and adoptive T cell transfer. In addition to the 50 oral presentations and >180 posters on these topics, a new SITC/iSBTc initiative to create evidence-based Cancer Immunotherapy Guidelines was announced. The SITC/iSBTc Biomarkers Taskforce announced the release of recommendations on immunotherapy biomarkers and a highly successful symposium on Immuno-Oncology Biomarkers that took place on the campus of the National Institutes of Health (NIH) immediately prior to the Annual Meeting. At the Annual Meeting, the NIH took the opportunity to publicly announce the award of the U01 grant that will fund the Cancer Immunotherapy Trials Network (CITN). In summary, the Annual Meeting gathered clinicians and scientists from academia, industry, and regulatory agencies from around the globe to interact and exchange important scientific advances related to tumor immunobiology and cancer immunotherapy.

Proceedings of the seventh annual gasification and gas stream cleanup systems contractors review meeting: Volume 1

Energy Technology Data Exchange (ETDEWEB)

Ghate, M.R.; Markel, K.E. Jr.; Jarr, L.A.; Bossart, S.J. (eds.)

1987-08-01

On June 16 through 19, 1987, METC sponsored the Seventh Annual Gasification and Gas Stream Cleanup Systems Contractors Review Meeting which was held at the Sheraton Lakeview Conference Center in Morgantown, West Virginia. The primary purpose of the meeting was threefold: to review the technical progress and current status of the gasification and gas stream cleanup projects sponsored by the Department of Energy; to foster technology exchange among participating researchers and other technical communities; to facilitate interactive dialogues which would identify research needs that would make coal-based gasification systems more attractive economically and environmentally. More than 310 representatives of Government, academia, industry, and foreign energy research organizations attended the 4-day meeting. Fifty-three papers and thirty poster displays were presented summarizing recent developments in the gasification and gas stream cleanup programs. Volume I covers information presented at sessions 1 through 4 on systems for the production of Co-products and industrial fuel gas, environmental projects, and components and materials. Individual papers have been processed for the Energy Data Base.

Proceedings of the seventh annual gasification and gas stream cleanup systems contractors review meeting: Volume 2

Energy Technology Data Exchange (ETDEWEB)

Ghate, M.R.; Markel, K.E. Jr.; Jarr, L.A.; Bossart, S.J. (eds.)

1987-08-01

On June 16 through 19, 1987, METC sponsored the Seventh Annual Gasification and Gas Stream Cleanup Systems Contractors Review Meeting which was held at the Sheraton Lakeview Conference Center in Morgantown, West Virginia. The primary purpose of the meeting was threefold: to review the technical progress and current status of the gasification and gas stream cleanup projects sponsored by the Department of Energy; to foster technology exchange among participating researchers and other technical communities; to facilitate interactive dialogues which would identify research needs that would make coal-based gasification systems more attractive economically and environmentally. More than 310 representatives of Government, academia, industry, and foreign energy research organizations attended the 4-day meeting. Fifty-three papers and thirty poster dsplays were presented summarizing recent developments in the gasification and gas stream cleanup programs. Volume II covers papers presented at sessions 5 and 6 on system for the production of synthesis gas, and on system for the production of power. All papers have been processed for inclusion in the Energy Data Base.

First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

International Nuclear Information System (INIS)

Johnson, R.L.; Linehan, J.J.

1991-01-01

The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

Summary of geologic review group meetings, March 17--18, 1977 and May 26--27, 1977

International Nuclear Information System (INIS)

Frye, J.C.; Crawford, J.H.; Davis, S.N.; Donath, F.A.; Gloyna, E.F.; Krauskopf, K.B.

1977-01-01

As a result of these meetings, the Geologic Review Group made suggestions and recommendations on radioactive waste repository sites, covering priorities for needed data on rock types, retrievable storage, use of Nevada Test Site, non-salt rock types, etc

Regulatory review and confidence building in post-closure safety assessments and safety cases for near surface disposal facilities-IAEA ASAM coordinated research programme

International Nuclear Information System (INIS)

Gonzales, A.; Simeonov, G.; Bennett, D.G.; Nys, V.; Ben Belfadhel, M.

2005-01-01

Some years ago, the IAEA successfully concluded a Coordinated Research Program (CRP) called Islam, which focussed on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities. In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near-surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing 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 a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

76 FR 37375 - Meeting of the Public Safety Officer Medal of Valor Review Board

Science.gov (United States)

2011-06-27

... INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory functions... who wish to participate must register at least seven (7) days in advance of the meeting/conference... registration. Anyone requiring special accommodations should contact Mr. Joy at least seven (7) days in advance...

77 FR 28595 - Sunshine Act Meeting Notice

Science.gov (United States)

2012-05-15

... Power Cooperative; Great River Energy; Hoosier Energy Rural Electric Cooperative, Inc.; Indiana...-000 National Grid Transmission Services Corporation and Bangor Hydro Electric Company. Hydro H-1 P... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice The...

Methodology for the Systematic Assessment of the Regulatory Competence Needs (SARCoN) for Regulatory Bodies of Nuclear Installations

International Nuclear Information System (INIS)

2015-03-01

A regulatory body’s competence is dependent, among other things, on the competence of its staff. A necessary, but not sufficient, condition for a regulatory body to be competent is that its staff can perform the tasks related to the functions of the regulatory body. In 2001, the IAEA published TECDOC 1254, Training the Staff of the Regulatory Body for Nuclear Facilities: A Competency Framework, which examines the manner in which the recognized regulatory functions of a nuclear regulatory body results in competence needs. Using the internationally recognized systematic approach to training, TECDOC 1254 provides a framework for regulatory bodies for managing training and developing, and maintaining the competence of its staff. It has been successfully used by many regulatory bodies all over the world, including States embarking on a nuclear power programme. The IAEA has also introduced a methodology and an assessment tool — Guidelines for Systematic Assessment of Regulatory Competence Needs (SARCoN) — which provides practical guidance on analysing the training and development needs of a regulatory body and, through a gap analysis, guidance on establishing competence needs and how to meet them. In 2013, the IAEA published Safety Reports Series No. 79, Managing Regulatory Body Competence, which provides generic guidance based on IAEA safety requirements in the development of a competence management system within a regulatory body’s integrated management system. An appendix in the Safety Report deals with the special case of building up the competence of regulatory bodies as part of the overall process of establishing an embarking State’s regulatory system. This publication provides guidance for the analysis of required and existing competences to identify those required by the regulatory body to perform its functions and therefore associated needs for acquiring competences. Hence, it is equally applicable to the needs of States embarking on nuclear power

ITER management advisory committee meeting

International Nuclear Information System (INIS)

Yoshikawa, M.

2001-01-01

The ITER Management Advisory Committee (MAC) Meeting was held on 23 February in Garching, Germany. The main topics were: the consideration of the report by the Director on the ITER EDA Status, the review of the Work Programme, the review of the Joint Fund, the review of a schedule of ITER meetings, and the arrangements for termination and wind-up of the EDA

Regulatory aspects for nuclear and radiation applications

International Nuclear Information System (INIS)

Duraisamy, S.

2014-01-01

The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB was constituted on November 15, 1983 and derives its regulatory power from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environment (Protection) Act, 1986. AERB is provided with the necessary powers and mandate to frame safety policies, lay down safety standards and requirements for monitoring and enforcing the safety provisions. AERB follows multi-tier system for its review and assessment, safety monitoring, surveillance and enforcement. While regulating various nuclear and radiation facilities, AERB adopts a graded approach taking into account the hazard potential associated with the facilities being regulated. The regulatory process has been continuous evolving to cater to the new developments in reactor and radiation technologies. The regulatory effectiveness and efficiency of AERB have grown over the last three decades to make it into a robust organization. The radiation protection infrastructure in the country is on a sound footing and is constantly being strengthened based on experience and continued research and development. As one of its mandates AERB prescribes radiation dose limits for the occupational workers and the public, in line with the IAEA Safety Standard and ICRP recommendations. The current dose limits and the radiation safety requirements are more stringent than past. To meet the current safety standards, it is important for the facilities to have state of art radiation monitoring system and programme in place. While recognizing the current system in place, this presentation also highlights certain key radiation protection challenges associated with the implementation of radiation protection standards in the nuclear and radiation facilities especially in the areas of

77 FR 46528 - Sunshine Act Meeting

Science.gov (United States)

2012-08-03

...: Nuclear Regulatory Commission. DATES: Week of August 6, 2012. PLACE: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public and Closed. ADDITIONAL ITEMS TO BE CONSIDERED: Week of... Proceeding (June 18, 2012) (Tentative). This meeting will be webcast live at the Web address--www.nrc.gov...

Pesticide Program Dialogue Committee and Pesticide Regulatory Reform Meetings

Science.gov (United States)

EPA’s Office of Pesticide Programs will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on Wednesday, May 3, from 9:00 a.m. to 4:45 p.m., and on Thursday, May 4, from 8:30 a.m. to noon.

75 FR 30859 - Meeting of the Public Safety Officer Medal of Valor Review Board

Science.gov (United States)

2010-06-02

... INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory functions... participate must register at least seven (7) days in advance of the meeting/conference call by contacting Mr.... Anyone requiring special accommodations should contact Mr. Joy at least seven (7) days in advance of the...

Proceedings of the advanced coal-fired power systems `95 review meeting, Volume I

Energy Technology Data Exchange (ETDEWEB)

McDaniel, H.M.; Mollot, D.J.; Venkataraman, V.K.

1995-06-01

This document contains papers presented at The advanced Coal-Fired Power Systems 1995 Review Meeting. Research was described in the areas of: integrated gasification combined cycle technology; pressurized fluidized-bed combustion; externally fired combined cycles; a summary stauts of clean coal technologies; advanced turbine systems and hot gas cleanup. Individual projects were processed separately for the United States Department of Energy databases.

76 FR 45249 - Fairlawn Hydroelectric Company, LLC; Notice of Public Meeting

Science.gov (United States)

2011-07-28

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12715-003] Fairlawn Hydroelectric Company, LLC; Notice of Public Meeting On August 5, 2011, Office of Energy Projects staff may participate in a public meeting hosted by the U.S. Army Corps of Engineers, Baltimore District (Corps) for the...

Changing emphasis at the NRC's Office of Nuclear Regulatory Research