Environmental Regulatory Update Table, December 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, August 1990

International Nuclear Information System (INIS)

Houlberg, L.M.; Nikbakht, A.; Salk, M.S.

1990-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, October 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-12-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-10-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

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

Science.gov (United States)

2012-03-02

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

Environmental Regulatory Update Table, August 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

1991-09-01

This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July 1991

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1991-08-01

This Environmental Regulatory Update Table (July 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

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

International Nuclear Information System (INIS)

Cambini, Carlo; Franzi, Donata

2013-01-01

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

Environmental Regulatory Update Table, January--February 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1994-01-01

The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table November--December 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May--June 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, May/June 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-07-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, March--April 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E. [Oak Ridge National Lab., TN (United States). Health Sciences Research Div.; Salk, M.S. [Oak Ridge National Lab., TN (United States). Environmental Sciences Div.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table July/August 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, November--December 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1993-01-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, July--August 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, September/October 1993

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January--February 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1994-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, September--October 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-11-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, March/April 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental regulatory update table, July/August 1994

International Nuclear Information System (INIS)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

1994-09-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

ROLE, INTERESTS AND CRITICS OF CREDIT RATING AGENCIES

Directory of Open Access Journals (Sweden)

Suzana Baresa

2012-06-01

Full Text Available Key role of credit rating agencies is reducing the asymmetry information about credit quality (of governments, business entities or securities between issuers and investors, and ensuring a common standard of measuring the creditworthiness. Credit rating agencies are engaged in the sale of opinions about creditworthiness in the form of an alphabetical letter or symbol, which represents a unique ranking. Their opinion is not a guarantee, but it largely dictates the costs and the profits in the financial markets. This work shows the influence of credit rating agencies to investors and publishers, and their role as market regulators. Conflict of interest is a fundamental problem, which is caused by their way of doing business, it arises from their two main objectives: profit and market regulation, which will be explored in the work. Looking back in history credit rating agencies often selected goal of making a profit at the cost of market regulation, therefore they have caused the collapse of the market, and founded themselves criticized by the public.

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

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

Directory of Open Access Journals (Sweden)

Christoph Ossege

2015-03-01

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

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

Environmental Regulatory Update Table, January/February 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

1992-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action. This table is for January/February 1992.

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

Science.gov (United States)

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

2014-01-01

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

Environmental sciences division: Environmental regulatory update table July 1988

International Nuclear Information System (INIS)

Langston, M.E.; Nikbakht, A.; Salk, M.S.

1988-08-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Environmental Regulatory Update Table, March/April 1993. Revision 1

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

1993-05-01

The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Politically Induced Regulatory Risk and Independent Regulatory Agencies

OpenAIRE

Strausz, Roland

2015-01-01

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

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

International Nuclear Information System (INIS)

Hata, Takaya; Makino, Maomi; Kosaka, Atsuhiko

2008-01-01

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

Public Interest vs. Interest Groups: Allowance Allocation in the EU Emission Trading Scheme

Energy Technology Data Exchange (ETDEWEB)

Anger, Niels; Oberndorfer, Ulrich (Centre for European Economic Research, Mannheim (Germany)); Boehringer, Christoph (Carl von Ossietzky Univ., Oldenburg (Germany))

2008-07-01

We assess the political-economy determinants of allowance allocation in the EU Emissions Trading Scheme (EU ETS). A common-agency model suggests that the government considers the preferences of sectoral interest groups when allocating emissions permits, so that industries with a more powerful lobby face a lower regulatory burden. An empirical analysis of the first trading phase of the EU ETS corroborates our theoretical prediction, but also reveals that the political-economy determinants of permit allocation are more complex. Employing instrumental-variable estimation technique, we find that large carbon emitters that were represented by powerful interest groups received higher levels of emissions allowances

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

Science.gov (United States)

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

2018-04-01

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

76 FR 33028 - Agency Information Collection (Requirements for Interest Rate Reduction Refinancing Loans...

Science.gov (United States)

2011-06-07

... (Requirements for Interest Rate Reduction Refinancing Loans) Activity Under OMB Review AGENCY: Veterans Benefits...: Requirements for Interest Rate Reduction Refinancing Loans. OMB Control Number: 2900-0601. Type of Review..., insured, or direct loan with a new loan at a lower interest rate provided that the veteran still owns the...

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

OpenAIRE

Ossege, Christoph

2015-01-01

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

Regulatory controls for NORM contamination: Emerging issues and strategies

International Nuclear Information System (INIS)

Wennerberg, Linda

1992-01-01

Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

The Effects of Rising Interest Rates on Electric Utility Stock Prices: Regulatory Considerations and Approaches

Energy Technology Data Exchange (ETDEWEB)

Kihm, Steve [Seventhwave, Madison, WI (United States); Satchwell, Andrew [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Cappers, Peter [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2017-07-26

This technical brief identifies conditions under which utility regulators should consider implementing policy approaches that seek to mitigate negative outcomes due to an increase in interest rates. Interest rates are a key factor in determining a utility’s cost of equity and investors find value when returns exceed the cost of equity. Through historical observations of periods of rising and falling interest rates and application of a pro forma financial tool, we identify the key drivers of utility stock valuations and estimate the degree to which those valuations might be affected by increasing interest rates.3 We also analyze the efficacy of responses by utility regulators to mitigate potential negative financial impacts. We find that regulators have several possible approaches to mitigate a decline in value in an environment of increasing interest rates, though regulators must weigh the tradeoffs of improving investor value with potential increases in customer costs. Furthermore, the range of approaches reflects today’s many different electric utility regulatory models and regulatory responses to a decline in investor value will fit within state-specific models.

77 FR 70741 - Agency Information Collection Extension

Science.gov (United States)

2012-11-27

... Management and Budget (OMB) to revise a currently-approved data collection under the provisions of the... analysis tools for federal/state agencies, AFV suppliers, vehicle fleet managers, and other interested... sent to the: DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and...

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

International Nuclear Information System (INIS)

Elliott, Kevin C.; Volz, David C.

2012-01-01

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345–1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

Energy Technology Data Exchange (ETDEWEB)

Elliott, Kevin C., E-mail: ke@sc.edu [University of South Carolina, Department of Philosophy, USC NanoCenter (United States); Volz, David C. [University of South Carolina, Department of Environmental Health Sciences, Arnold School of Public Health (United States)

2012-01-15

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

Addressing conflicts of interest in nanotechnology oversight: lessons learned from drug and pesticide safety testing

Science.gov (United States)

Elliott, Kevin C.; Volz, David C.

2012-01-01

Financial conflicts of interest raise significant challenges for those working to develop an effective, transparent, and trustworthy oversight system for assessing and managing the potential human health and ecological hazards of nanotechnology. A recent paper in this journal by Ramachandran et al., J Nanopart Res, 13:1345-1371 (2011) proposed a two-pronged approach for addressing conflicts of interest: (1) developing standardized protocols and procedures to guide safety testing; and (2) vetting safety data under a coordinating agency. Based on past experiences with standardized test guidelines developed by the international Organization for Economic Cooperation and Development (OECD) and implemented by national regulatory agencies such as the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA), we argue that this approach still runs the risk of allowing conflicts of interest to influence toxicity tests, and it has the potential to commit regulatory agencies to outdated procedures. We suggest an alternative approach that further distances the design and interpretation of safety studies from those funding the research. In case the two-pronged approach is regarded as a more politically feasible solution, we also suggest three lessons for implementing this strategy in a more dynamic and effective manner.

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

NARCIS (Netherlands)

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

2014-01-01

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

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

Science.gov (United States)

Shorter, Edward

2008-01-01

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

The liberal state and the rogue agency: FDA’s regulation of drugs for mood disorders, 1950s–1970s☆

Science.gov (United States)

Shorter, Edward

2013-01-01

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into “rogues,” regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional “cop” agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions. PMID:18343498

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

Energy Technology Data Exchange (ETDEWEB)

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

2002-05-31

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

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

International Nuclear Information System (INIS)

Lechner, L.J.; Mathieson, B.

1998-01-01

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

76 FR 24836 - Regulatory Approach for Commercial Orbital Human Spaceflight

Science.gov (United States)

2011-05-03

... human spaceflight. The FAA will share its current philosophy, but is most interested in the public's... for Commercial Orbital Human Spaceflight AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... information from the public on the regulatory approach to commercial orbital human spaceflight by the FAA...

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

Directory of Open Access Journals (Sweden)

Aiwanehi Barbara Ofuani

2015-09-01

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

77 FR 65840 - Chrysanthemum White Rust Regulatory Status and Restrictions

Science.gov (United States)

2012-10-31

... Regulatory Status and Restrictions AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Advance... for our advance notice of proposed rulemaking that solicits public comment on whether and how we... importation of plant material that is a host of CWR. This action will allow interested persons additional time...

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

International Nuclear Information System (INIS)

Nurwidi Astuti, Y.H.

2016-01-01

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

43 CFR 19.4 - Liaison with other governmental agencies and submission of views by interested persons.

Science.gov (United States)

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Liaison with other governmental agencies and submission of views by interested persons. 19.4 Section 19.4 Public Lands: Interior Office of the Secretary of the Interior WILDERNESS PRESERVATION National Wilderness Preservation System § 19.4 Liaison with other governmental agencies and...

Nuclear regulatory decision making

International Nuclear Information System (INIS)

Wieland, Patricia; Almeida, Ivan Pedro Salati de

2011-01-01

The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

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...

The Independence of Vietnam Regulatory Body

International Nuclear Information System (INIS)

Nguyen, Hoang Anh; Choi, Kwang Sik

2011-01-01

In the field of peaceful purposes, the activity of nuclear agencies is often divided into 2 systems: the nuclear application system and the safety system. Depending on the magnitude of atomic energy application development, the responsibility of the safety system was assigned to a few agencies in each country. In Vietnam, the nuclear safety responsibility is assigned primarily to the radiation and nuclear safety agency. However, the provisions of the normative system of law prevailing in other sectors such as investment, construction, electricity or environmental protection, many agencies are responsible for ensuring safety in each sector, leading to a conflict of interest among those agencies. This is the weakness in the management system of Vietnam compared to other countries with nuclear power development. The purpose of this paper is to analyze the state of Vietnam's legal framework in nuclear safety regulation and its dependence of regulatory body aspects and promoting the way to overcome it

Regulatory difficulties in a developing country

International Nuclear Information System (INIS)

Jacobs, W.R. Jr.

1978-01-01

The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

77 FR 8082 - Regulatory Flexibility Agenda

Science.gov (United States)

2012-02-13

... Required: Yes. Agency Contact: Alicia Goldin, Division of Trading and Markets, Securities and Exchange.../01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of... Withdrawn 10/01/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Alicia Goldin, Division of...

Agency-communion and interest in prosocial behavior: social motives for assimilation and contrast explain sociocultural inconsistencies.

Science.gov (United States)

Gebauer, Jochen E; Sedikides, Constantine; Lüdtke, Oliver; Neberich, Wiebke

2014-10-01

Identifying the "prosocial personality" is a classic project in personality psychology. However, personality traits have been elusive predictors of prosocial behavior, with personality-prosociality relations varying widely across sociocultural contexts. We propose the social motives perspective to account for such sociocultural inconsistencies. According to this perspective, a focal quality of agency (e.g., competence, independence, openness) is the motive to swim against the social tide-agentic social contrast. Conversely, a focal quality of communion (e.g., warmth, interdependence, agreeableness) is the motive to swim with the social tide-communal social assimilation. We report two cross-sectional studies. Study 1 (N = 131,562) defined social context at the country level (11 European countries), whereas Study 2 (N = 56,395) defined it at the country level (11 European countries) and the city level (296 cities within these countries). Communion predicted interest in prosocial behavior comparatively strongly in sociocultural contexts where such interest was common and comparatively weakly where such interest was uncommon. Agency predicted interest in prosocial behavior comparatively strongly in sociocultural contexts where such interest was uncommon and comparatively weakly where such interest was common. The results supported the social motives perspective. Also, the findings help to reestablish the importance of personality for understanding prosociality. © 2013 Wiley Periodicals, Inc.

Bureaucratic Minimal Squawk Behavior: Theory and Evidence from Regulatory Agencies

OpenAIRE

Clare Leaver

2009-01-01

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

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

Science.gov (United States)

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

2017-01-01

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

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

OpenAIRE

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-01-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

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

Directory of Open Access Journals (Sweden)

Ana Carolina Borges de Oliveira

2018-05-01

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

Bank Interest Margin and Default Risk under Basel III Capped Capital Adequacy Accord and Regulatory Deposit Insurance Fund Protection

OpenAIRE

Chuen-Ping Chang; Shi Chen

2015-01-01

We study the optimal bank interest margin and default risk under the capped ratio schedule of government capital instruments in the Basel III Capital Adequacy Accord and the Deposit Insurance Fund arrangement program. We show that an increase in the capped ratio (a decrease in the capped government capital injection) increases the default risk in the bank¡¯s equity return at a reduced interest margin. Regulatory deposit insurance fund protection reinforces the reduced bank interest margin and...

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

DEFF Research Database (Denmark)

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

2018-01-01

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

Sustainability, natural and organic cosmetics: consumer, products, efficacy, toxicological and regulatory considerations

Directory of Open Access Journals (Sweden)

Bruno Fonseca-Santos

2015-03-01

Full Text Available The interest in sustainable products has increased along the years, since the choice of products, packaging and production processes have a great impact on the environment. These products are classified by regulatory agencies in different categories, aggregating advantages to the product and increasing the demand by consumers. However, there is no harmonization in guidelines of these certifying agencies and each cosmetic industry formulates their product and packaging in a more rational way, which causes less damage to the environment. Many cosmetic products have in their formulation natural products that perform a specific biological function, but these products should be evaluated on efficacy and toxicological aspects. The aim of this article is to approach sustainability, natural and organic cosmetics, considering the consumer and the efficacy, toxicological and regulatory aspects.

76 FR 59066 - Notice of Regulatory Review Plan

Science.gov (United States)

2011-09-23

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

Regulatory theory: commercially sustainable markets rely upon satisfying the public interest in obtaining credible goods.

Science.gov (United States)

Warren-Jones, Amanda

2017-10-01

Regulatory theory is premised on the failure of markets, prompting a focus on regulators and industry from economic perspectives. This article argues that overlooking the public interest in the sustainability of commercial markets risks markets failing completely. This point is exemplified through health care markets - meeting an essential need - and focuses upon innovative medicines as the most desired products in that market. If this seemingly invulnerable market risks failure, there is a pressing need to consider the public interest in sustainable markets within regulatory literature and practice. Innovative medicines are credence goods, meaning that the sustainability of the market fundamentally relies upon the public trusting regulators to vouch for product quality. Yet, quality is being eroded by patent bodies focused on economic benefits from market growth, rather than ensuring innovatory value. Remunerative bodies are not funding medicines relative to market value, and market authorisation bodies are not vouching for robust safety standards or confining market entry to products for 'unmet medical need'. Arguably, this failure to assure quality heightens the risk of the market failing where it cannot be substituted by the reputation or credibility of providers of goods and/or information such as health care professionals/institutions, patient groups or industry.

77 FR 22624 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

Science.gov (United States)

2012-04-16

... and non- discriminatory terms. In addition, the proposed increased NYSE CSII fee and fee cap are the... Discretionary e-Quotes and verbal agency interest by floor brokers). B. Self-Regulatory Organization's Statement..., and all written communications relating to the proposed rule change between the Commission and any...

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

Science.gov (United States)

1982-12-13

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

75 FR 7526 - Withdrawal of Regulatory Guide

Science.gov (United States)

2010-02-19

...'s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2010-0052] Withdrawal of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.56, ``Maintenance of Water Purity in Boiling...

The changing regulatory environment

International Nuclear Information System (INIS)

Caron, G.

1999-01-01

The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

Commentary: IARC Monographs Program and public health under siege by corporate interests.

Science.gov (United States)

Infante, Peter F; Melnick, Ronald; Vainio, Harri; Huff, James

2018-04-01

The International Agency for Research on Cancer (IARC) evaluates causes of cancer with help from independent international experts in an open and transparent manner. Countries, research and regulatory agencies, and other organizations adopt IARC evaluations for communication of human cancer hazards, and for strategies to prevent cancer. Scientists worldwide endorse IARC cancer evaluations and process. Those with economic interests, however, challenge IARC's cancer evaluations, most recently for glyphosate and red and processed meats, and are conducting a campaign including intervention from US Congressional Representatives to discredit IARC's review process and to undermine financial support-a campaign intimidating to IARC and Working Group members. Challenges to scientific interpretations serve to advance science and should be resolved by scientific experts who do not have conflicts of interest. Such interference does not bode well for the free flow of scientific information that informs and protects the public from risks of cancer. © 2018 Wiley Periodicals, Inc.

76 FR 24539 - Final Regulatory Guide: Issuance, Availability

Science.gov (United States)

2011-05-02

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . Electronic copies... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

75 FR 42170 - Final Regulatory Guide: Issuance, Availability

Science.gov (United States)

2010-07-20

... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0425] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

75 FR 48381 - Final Regulatory Guide: Issuance, Availability

Science.gov (United States)

2010-08-10

... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0274] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Regulatory Guide...

75 FR 22868 - Withdrawal of Regulatory Guide

Science.gov (United States)

2010-04-30

...'s public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are also available for inspection at the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2010-0167] Withdrawal of Regulatory Guide AGENCY: Nuclear...

49 CFR 659.41 - Conflict of interest.

Science.gov (United States)

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Conflict of interest. 659.41 Section 659.41... Agency § 659.41 Conflict of interest. The oversight agency shall prohibit a party or entity from providing services to both the oversight agency and rail transit agency when there is a conflict of interest...

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

Science.gov (United States)

Belackova, Vendula; Wilkins, Chris

2018-04-01

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

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

75 FR 79049 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-12-17

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2008-0427] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3.12...

75 FR 45173 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-08-02

... ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2008-0638] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.151...

76 FR 18262 - Notice of issuance of Regulatory Guide

Science.gov (United States)

2011-04-01

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0277] Notice of issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.44...

76 FR 14107 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-03-15

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0276] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.43...

76 FR 14108 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-03-15

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0275] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.50...

78 FR 44165 - Nuclear Regulatory Commission Enforcement Policy

Science.gov (United States)

2013-07-23

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0159] Nuclear Regulatory Commission Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Enforcement policy; request for comment. SUMMARY: The U.S... Policy. In SRM-SECY-12-0047, ``Revisions to the Nuclear Regulatory Commission Enforcement Policy,'' dated...

Expert views on regulatory preparedness for managing the risks of nanotechnologies.

Directory of Open Access Journals (Sweden)

Christian E H Beaudrie

Full Text Available The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254 of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies' ability to oversee their growing use and application in society.

75 FR 52999 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-08-30

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition... NUCLEAR REGULATORY COMMISSION [NRC-2009-0556] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.35...

75 FR 45171 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-08-02

... ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide... NUCLEAR REGULATORY COMMISSION [NRC-2010-0072] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3.13...

75 FR 37842 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-06-30

... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition... NUCLEAR REGULATORY COMMISSION [NRC-2009-0396] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 2.5...

75 FR 43207 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-07-23

... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0282] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.141...

75 FR 33361 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-06-11

....gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for inspection at the... NUCLEAR REGULATORY COMMISSION [NRC-2009-0308] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.28...

75 FR 16525 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-04-01

... http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2009-0413] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.11...

75 FR 27599 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-05-17

...'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2009-0492] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Regulatory Guide 6.7...

Current regulatory and licensing status for byproduct sources, facilities and applications

International Nuclear Information System (INIS)

Tingey, G.L.; Jensen, G.A.; Hazelton, R.F.

1985-02-01

Public use of nuclear byproducts, especially radioactive isotopes, will require approval by various regulatory agencies. Use of cesium-137 as an irradiation source for sterilizing medical products will require US Nuclear Regulatory Commission (NRC) approval. Two applications have been filed with NRC, and approval is expected soon. Widespread use of irradiation for food products depends on a favorable ruling by the Food and Drug Administration (FDA). A ruling is pending that would permit irradiation of fruits and vegetables up to 100 krad. NRC also controls the use of isotopes in remote power generators, but little regulatory action has been required in recent years. Recent development of radioluminescent (RL) lighting for runway lights has led to interest by commercial manufacturers. At the present time, a license has been issued to at least one manufacturer for sale of tritium-powered runway lights. 28 refs., 1 fig

75 FR 16202 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-03-31

... Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available... NUCLEAR REGULATORY COMMISSION [NRC-2008-0644] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide (RG) 1.126...

75 FR 81675 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-12-28

... through the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc... NUCLEAR REGULATORY COMMISSION [NRC-2010-0031] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 4.16...

75 FR 20399 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-04-19

... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0418] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 6.9...

76 FR 31382 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-05-31

... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.2...

40 CFR 73.86 - State regulatory autonomy.

Science.gov (United States)

2010-07-01

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

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

International Nuclear Information System (INIS)

Perio Peralta, Agnette de

2008-01-01

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

75 FR 12804 - Withdrawal of Regulatory Guide 8.6

Science.gov (United States)

2010-03-17

... ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0103] Withdrawal of Regulatory Guide 8.6 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 8.6, ``Standard Test Procedure for Geiger-M...

75 FR 20868 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2010-04-21

... available through the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc... NUCLEAR REGULATORY COMMISSION [NRC-2009-0351] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.68.2...

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

Science.gov (United States)

Hojo, Taisuke

2017-01-01

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

Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

Science.gov (United States)

Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

2013-01-01

The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254) of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies’ ability to oversee their growing use and application in society. PMID:24244662

Reduction of regulatory risk: a network economic approach

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2007-01-01

Several definitions of regulatory risk are known from the literature. From the perspective of regulatory reform it is important to differentiate between the impact of a given regulatory scheme on the firm's risk exposure and the risk arising from discretionary behavior of regulatory agencies. Whereas the conse-quences of effective regulation in principle are known and accepted, excessive regulatory discretion may cause a strong need for regulatory reform. Regulatory reform focussing on the re...

76 FR 6587 - Pennsylvania Regulatory Program

Science.gov (United States)

2011-02-07

... [PA-159-FOR; OSM 2010-0017] Pennsylvania Regulatory Program AGENCY: Office of Surface Mining... remove a required amendment to the Pennsylvania regulatory program (the ``Pennsylvania program'') under... program amendment codified in the Federal regulations, Pennsylvania has submitted information that it...

75 FR 21871 - Spring 2010 Regulatory Agenda

Science.gov (United States)

2010-04-26

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

75 FR 2894 - Withdrawal of Regulatory Guide 1.148

Science.gov (United States)

2010-01-19

... downloading through the NRC's public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are also available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0013] Withdrawal of Regulatory Guide 1.148 AGENCY: Nuclear...

75 FR 70044 - Withdrawal of Regulatory Guide 1.39

Science.gov (United States)

2010-11-16

... downloading through the NRC's public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doollectionsc-c . Regulatory guides are also available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0354] Withdrawal of Regulatory Guide 1.39 AGENCY: Nuclear...

76 FR 35922 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-06-20

.... Proposed Revision 1 of Regulatory Guide (RG) 8.4, ``Personnel Monitoring Device--Direct-Reading Pocket...'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Notice of Issuance of Regulatory Guide AGENCY...

76 FR 28102 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-05-13

..., Probabilistic Risk Assessment Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research, U.S... results of risk analyses are used to help justify regulatory action. As such, the principles, process, and... NUCLEAR REGULATORY COMMISSION [NRC-2009-0385] Notice of Issuance of Regulatory Guide AGENCY...

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

78 FR 28244 - Agency Information Collection Activities; Proposed Collection; Comment Request

Science.gov (United States)

2013-05-14

... Licensing of Production and Utilization Facilities,'' specifies technical information and data to be... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0085] Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC...

New drugs and indications in 2011. France is better focused on patients' interests after the Mediator scandal, but stagnation elsewhere.

Science.gov (United States)

2012-04-01

Progress in the pharmaceutical sector accounted for only a tiny proportion of the hundred or so new products and indications analysed by Prescrire in 2011. About 1 in 6 new products had more harms than benefits, while more than half of all new products provided no advantages over existing options. One worrisome trend was the expansion of "umbrella" ranges for self-medication. As in previous years, drug regulatory agencies continued to grant marketing authorisation prematurely or on the basis of inadequate evaluation. This was especially true for paediatric medicines, despite some limited progress. In the wake of the Mediator disaster, the French health authorities in charge of patient protection, including the drug regulatory agency, finally reacted by withdrawing many old drugs with negative harm-benefit balances and made an effort to increase transparency and to provide better information on drug-related harms. European authorities showed no signs of similar improvements in early 2012. Drug companies continue to promote their products aggressively, which is not in patients' best interests. The medicalisation of life continues apace, with more and more direct-to-consumer advertising. The Mediator disaster was a wake-up call for French policy makers. In late 2011, several new regulations serving patients' interests were adopted, including greater transparency and better management of conflicts of interest, but as yet, with no major breakthrough in attitudes and procedures.

Environmental Protection Agency Semiannual Regulatory Agenda

Science.gov (United States)

2010-12-20

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

Data Management in a Regulatory Context

Directory of Open Access Journals (Sweden)

Niels Grønning

2017-07-01

Full Text Available With the implementation of Article 57(2 in 2012 the European Medicines Agency (EMA embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by both internal and external factors, the EMA have through the European Union telematics strategy laid the foundation for the regulatory-driven services that may be expected from the community the coming years. Supported by standardization initiatives (e.g., ISO Identification of Medicinal Products, the EMA is gradually building an information management-driven approach to data utilization and exploitation within drug evaluation and approval. Primarily driven by the increasing demand for signal detection, the EMA is additionally hoping to leverage the establishment of defined information models and supporting controlled terms to safeguard future activities within the community. Collectively, the overall community may seek to gain from the overall digitalization roadmap proposed by the EMA and interesting opportunities may be sought as part of the transition. Already now pharmaceutical companies are gradually adapting to this new paradigm and actively seeking to explore how they may leverage the future EMA operating model to serve internal business requirements. If successful, the collective efforts from industry and regulators may lead to an unprecedented product oversight and offer regulators the opportunity to proactively drive corrective actions and, therefore, improve patient safety.

Development of safety performance indicators of regulatory interest (SAFPER) in Pakistan

International Nuclear Information System (INIS)

Khatoon, Abida

2002-01-01

Safety performance indicators provide a very useful tool for monitoring operational safety of a nuclear power plant. Utilities in many countries have developed plant specific indicators for the assessment of their performance and safety. Regulators can make use of some of these indicators for their regulatory assessment. In addition to these regulatory bodies in some countries have also developed programs for the formulation of safety performance indicators which are used in monitoring operational safety and regulatory decision making. Realizing its usefulness Directorate of Nuclear Safety and Radiation Protection (DNSRP-the regulatory body in Pakistan) has also initiated a country specific program for the development of Safety Performance Indicators (SAFPER) based on data provided by the utility and that collected during the course of regulatory inspections. Selected areas of NPP operation to be monitored are: - Significant events; - Safety systems performance; - Barriers integrity; - Environment protection; - Workers radiation safety; and - Emergency Preparedness. One of the objectives of this program is also to monitor the effectiveness of DNSRP regulatory activities. IAEA framework is taken as one of the bases for our program. Safety performance will be assessed on the basis of Performance Indicators and inspection findings. DNSRP program as shown in Appendix includes the indicators in use and under development. It is felt that the term Safety Performance Indicators may be termed as 'SAFPER Indicators' to be used by the Regulators, as it is clear from this presentation that utility safety performance indicators together with the regulatory effectiveness indicators constitute the measure for the adequate safety to the public and the environment. Additional research is still necessary for: - indicator definition for the proposed and under developed indicators; - data collection systems; - thresholds; - trend analysis; - goal setting (benefit from the trend can be

The trade in human organs in Tamil Nadu: the anatomy of regulatory failure.

Science.gov (United States)

Muraleedharan, Vangal R; Jan, Stephen; Ram Prasad, S

2006-01-01

There has been much recent interest in the trade in human organs in India. This paper examines both the extent to which regulatory controls through the Transplantation of Human Organs Act (1994) are effective in curbing commercialization and the nature of the constraints on the effective implementation of this Act. The study, a politico-economic analysis of health sector regulation, is based on a stakeholder analysis drawing on the views of key decision makers, service providers, organ donors and recipients. The findings indicate widespread acknowledgement of an organs trade and highlight four major constraints on the effective implementation of the Act: the commercial interests of middlemen and service providers, the ambiguities and loopholes in the Act; the low monitoring capacity of the regulatory authorities, and the pressures and responsibilities exerted upon the Authorizing Committees. A feature of the Act is that its implementation is subject to a major incentive compatibility constraint - it is seemingly not in the interests of any of the key players, including the regulatory authorities, to restrict the organ trade. To some extent, this institutional problem is created by the specific nature of the regulatory intervention, and, as a consequence, measures involving straightforward redrafting of the regulation might go some way to addressing this incentive problem. Another solution may entail a 'harm-reduction' strategy involving a controlled trade where procurement and organ matching is carried out by a government agency (this would require, however, the prior resolution of the broader ethical question concerning the legitimacy of such trade).

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2010-04-26

... Regulatory Commission Federal Housing Finance Agency Federal Maritime Commission Federal Mediation and... that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for.... Regulatory Flexibility Analysis Required -- whether an analysis is required by the Regulatory Flexibility Act...

The Agency's publications

Energy Technology Data Exchange (ETDEWEB)

NONE

1961-09-15

With regard to bulk and substance, by far the most important part of the IAEA publishing is the publication of the proceedings of the scientific conferences, symposia and seminars held by the Agency, either alone or in co-operation with the United Nations specialized agencies or scientific unions. At present, the production time between the holding of a conference and the publication of its proceedings by the Agency is between 9 and 12 months. Another important group of publications is the directories, safety manuals and monographs Of the Directory of Nuclear Reactors, three volumes have so far been issued, in which detailed information is given about the power, research, test and experimental reactors in operation or under construction in different parts of the world. International Directory of Radioisotope Teletherapy equipment lists available equipment with considerable technical data and approximate prices. In the 'Safety Series', are included manuals on the safe handling of radioisotopes, the safe transport of radioactive materials, etc., which contain the regulations applied to the Agency's own operations or to operations assisted by the Agency. The Series also includes manuals which are informative rather than regulatory, such as the Health Physics and Medical Addenda to the manual on the Safe Handling of Radioisotopes, a report on radioactive waste disposal into the sea, a guide for the safe operation of critical assemblies and research reactors, notes on the Regulations for the Safe Transport of Radioactive Materials, and a manual on the use of film-badge dosimeters. The Review Series consists of monographs on different subjects written by experts in the particular fields. They are published in their original language and in some cases a translation into one or even two other working languages is included. The 'Bibliographical Series' includes bibliographies of the world-wide literature in different branches of nuclear science and technology. One of the

The Agency's publications

International Nuclear Information System (INIS)

1961-01-01

With regard to bulk and substance, by far the most important part of the IAEA publishing is the publication of the proceedings of the scientific conferences, symposia and seminars held by the Agency, either alone or in co-operation with the United Nations specialized agencies or scientific unions. At present, the production time between the holding of a conference and the publication of its proceedings by the Agency is between 9 and 12 months. Another important group of publications is the directories, safety manuals and monographs Of the Directory of Nuclear Reactors, three volumes have so far been issued, in which detailed information is given about the power, research, test and experimental reactors in operation or under construction in different parts of the world. International Directory of Radioisotope Teletherapy equipment lists available equipment with considerable technical data and approximate prices. In the 'Safety Series', are included manuals on the safe handling of radioisotopes, the safe transport of radioactive materials, etc., which contain the regulations applied to the Agency's own operations or to operations assisted by the Agency. The Series also includes manuals which are informative rather than regulatory, such as the Health Physics and Medical Addenda to the manual on the Safe Handling of Radioisotopes, a report on radioactive waste disposal into the sea, a guide for the safe operation of critical assemblies and research reactors, notes on the Regulations for the Safe Transport of Radioactive Materials, and a manual on the use of film-badge dosimeters. The Review Series consists of monographs on different subjects written by experts in the particular fields. They are published in their original language and in some cases a translation into one or even two other working languages is included. The 'Bibliographical Series' includes bibliographies of the world-wide literature in different branches of nuclear science and technology. One of the

75 FR 9444 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2010-03-02

... Utilization Facilities,'' specifies technical information and data to be provided to the NRC or maintained by... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0063] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...

Collective statement on the role of research in a nuclear regulatory context

International Nuclear Information System (INIS)

2001-01-01

In the present context of deregulation and privatisation of the nuclear industry, maintaining an adequate level of nuclear safety research is a primary concern for nuclear regulators, researchers and nuclear power plant licensees, as well as for government officials and the public. While these different stakeholders may have common concerns and interests, there may also be differences. At the international level, it is important to understand that divisions exist both within and among countries, not only in national cultures but also in the way regulators, researchers and licensees view the rote of research. An international gathering under the auspices of the OECD Nuclear Energy Agency (NEA) took place in June 2001, bringing together heads of nuclear regulatory bodies of NEA Member countries, senior regulators, senior executives of research organisations and leaders from the nuclear industry to discuss their perceptions of the rote of research in a nuclear regulatory context. This collective statement represents an international consensus on a rationale for regulatory research for currently operating nuclear reactors and for future reactors, and sets forth specific recommendations to NEA standing technical committees and Member countries. The intended audience is primarily nuclear safety regulators, senior researchers and industry leaders. Government authorities, nuclear power plant operators and the general public may also be interested. (author)

Regulatory Assistance, Stakeholder Outreach, and Coastal and Marine Spatial Planning Activities in Support of Marine and Hydrokinetic Energy Deployment

Energy Technology Data Exchange (ETDEWEB)

Geerlofs, Simon H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Copping, Andrea E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Van Cleve, Frances B. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Blake, Kara M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hanna, Luke A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2011-09-01

This fiscal year 2011 progress report summarizes activities carried out under DOE Water Power Task 2.1.7, Permitting and Planning. Activities under Task 2.1.7 address the concerns of a wide range of stakeholders with an interest in the development of the marine and hydrokinetic (MHK) energy industry, including regulatory and resource management agencies, tribes, nongovernmental organizations, and industry.

76 FR 64043 - Iowa Regulatory Program

Science.gov (United States)

2011-10-17

...) Requirements for permits for special categories of mining. 27--40.41(207) Permanent regulatory program--small... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 915 [Docket No. IA-016-FOR; Docket ID: OSM-2011-0014] Iowa Regulatory Program AGENCY: Office of Surface Mining...

Environmental Regulatory Update Table, January/February 1995

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

Environmental Regulatory Update Table, January/February 1995

International Nuclear Information System (INIS)

Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

1995-03-01

The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action

Regulatory Support of Treatment of Savannah River Site Purex Waste

International Nuclear Information System (INIS)

Reid, L.T.

2009-01-01

This paper describes the support given by federal and state regulatory agencies to Savannah River Site (SRS) during the treatment of an organic liquid mixed waste from the Plutonium Extraction (Purex) process. The support from these agencies allowed (SRS) to overcome several technical and regulatory barriers and treat the Purex waste such that it met LDR treatment standards. (authors)

Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

Science.gov (United States)

Johnson, Branden B; Finkel, Adam M

2016-06-01

Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks. © 2016 Society for Risk Analysis.

How are things going. Obtaining feedback in a regulatory environment

International Nuclear Information System (INIS)

McGuire, J.V.; Walsh, M.E.; Boegel, A.J.; Morisseau, D.S.; Persendky, J.J.

1984-08-01

This study tested two procedures to gather feedback for a federal agency about its regulatory actions and its licensees' practices. The procedures, a workshop and a mailed survey, targeted a data source new to the agency. Results to date find the feedback workshop useful and the new data source cooperative and valuable. Participation in the workshops is surprising, given their historical backdrop, structure, and psychological literatures. These findings suggest that agencies may be ignoring important data sources for ill-informed reasons. Also, the findings suggest a possible need to restructure existing channels of communication between a regulatory agency and its licensees

76 FR 20052 - Notice of Issuance of Regulatory Guide

Science.gov (United States)

2011-04-11

... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0187] Notice of Issuance of Regulatory Guide AGENCY... Guide 1.149, ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License...

Delegação e controle político das agências reguladoras no Brasil Delegation and political control of the regulatory agencies in Brazil

Directory of Open Access Journals (Sweden)

Fernanda Meirelles

2006-08-01

Full Text Available A partir de um esforço de sistematização dos mecanismos de controle político previstos no modelo institucional originalmente concebido para as agências reguladoras, este artigo avalia os mecanismos de controle político presentes no arcabouço institucional das agências reguladoras independentes (ARIs brasileiras e analisa as alterações relacionadas ao controle político introduzidas pelo projeto de lei encaminhado pelo governo ao Congresso em 12 de abril de 2004. Após contextualizar o debate sobre o controle político das ARIs no Brasil, o artigo discute as relações entre delegação e responsabilização. Em seguida, na busca de um parâmetro para avaliar o modelo brasileiro de agências reguladoras (ARs, identifica os instrumentos de controle político utilizados na experiência americana. Finalmente, avalia a realidade institucional atual das ARIs brasileiras e comenta as contribuições do recente projeto de lei em relação ao controle político das agências.This article systematizes the political control mechanisms provided by the institutional model originally conceived for the regulatory agencies in order to assess the political control mechanisms in the institutional framework of the Brazilian independent regulatory agencies (IRAs and analyze the political control changes introduced by the law proposed by the government to Congress in April 12, 2004. After putting into context the debate on political control over the Brazilian IRAs, the article discusses the relationship between delegation and accountability. Then, so as to find a parameter for assessing the Brazilian regulatory agency model, it identifies the political control mechanisms used by the American experience. Finally, it assesses the current institutional situation of the Brazilian IRAs and comments on the contribution of the recent law proposal in relation to agency political control.

Romania - NPP PLiM Between Regulatory Requirement / Oversight and Operator Safety / Financial Interest

International Nuclear Information System (INIS)

Goicea, Lucian

2012-01-01

Cernavoda Unit 1 PLiM started in the first third of its design life, to develop as regulatory requirements of the components of standards and programmes and to benefit by earlier implementation of the measures for achieving maximum operating life. CNCAN regulatory present approach on the utility PLiM combines the regulatory requirements on management system, ageing management provisions of periodic safety review, detailed technical requirements of ageing programmes and different techniques focusing only on safety issues. (author)

76 FR 16570 - Interest Rate Risk

Science.gov (United States)

2011-03-24

... NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 741 RIN 3133-AD66 Interest Rate Risk AGENCY... regulations to require Federally insured credit unions to have a written policy addressing interest rate risk... Risk Management for Credit Unions with Large Positions in Fixed Rate Mortgages; 06-CU-16 Inter-Agency...

Through the regulatory hoop

International Nuclear Information System (INIS)

Kirner, N.P.

1985-01-01

There are many regulatory hoops through which waste generators, brokers, and disposal site operators must jump to dispose of waste safely. As the proposed exclusionary date of January 1, 1986, approaches, these regulatory hoops have the distinct possibility of multiplying or at least changing shape. The state of Washington, in its role as an Agreement State with the US Nuclear Regulatory Commission, licenses and inspects the commercial operator of the Northwest Compact's low-level radioactive waste disposal site on the Hanford Reservation. Washington has received as much as 53%, or 1.4 million cubic feet per year, of the nation's total volume of waste disposed. To control such a large volume of waste, a regulatory program involving six agencies has developed over the years in Washington

76 FR 41585 - Regulation and Independent Regulatory Agencies

Science.gov (United States)

2011-07-14

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

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

Science.gov (United States)

Scroggins, Sharon; Duda, Kristen

2008-01-01

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

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

Science.gov (United States)

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

2010-04-01

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

78 FR 1624 - Fall 2012 Regulatory Agenda

Science.gov (United States)

2013-01-08

...), studies or analyses of the possible need for regulatory action, requests for public comment on the need... (NESHAP): Reinforced Plastic Composites Production To comment or learn more about these retrospective.... Agency Contact: Hans Scheifele, Environmental Protection Agency, Office of Chemical Safety and Pollution...

Summary and analysis of public comments on NUREG-1317: Regulatory options for nuclear plant license renewal: Final report

International Nuclear Information System (INIS)

Ligon, D.M.; Seth, S.S.

1989-03-01

On August 29, 1988, the US Nuclear Regulatory Commission (NRC) issued an Advance Notice of Proposed Rulemaking on nuclear plant license renewal and solicited public comments on NUREG-1317, ''Regulatory Options for Nuclear Plant License Renewal.'' NUREG-1317 presents a discussion of fifteen topics involving technical, environmental, and procedural issues and poses a set of related questions. As part of its ongoing task for the NRC, The MITRE Corporation has summarized and analyzed the public comments received. Fifty-three written comments were received. Of these, 83 percent were from nuclear industry representatives; the remaining comments represented federal and state agencies, public interest groups, and a private citizen

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

Science.gov (United States)

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

2014-12-01

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

77 FR 28467 - Identifying and Reducing Regulatory Burdens

Science.gov (United States)

2012-05-14

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

78 FR 1634 - Regulatory Agenda

Science.gov (United States)

2013-01-08

... amendments include updates to organizational information, use of the term ``disability'' in lieu of the term.../00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W. Cosgrove, External...

78 FR 44329 - Regulatory Agenda

Science.gov (United States)

2013-07-23

... amendments include updates to organizational information, use of the term ``disability'' in lieu of the term.../00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W. Cosgrove, External...

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...

7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

Science.gov (United States)

2010-01-01

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

77 FR 15142 - Updated Nuclear Regulatory Commission Fiscal Years 2008-2013 Strategic Plan

Science.gov (United States)

2012-03-14

... 2008-2013 Strategic Plan AGENCY: Nuclear Regulatory Commission. ACTION: Strategic plan. SUMMARY: The U...-1614, Volume 5, ``U.S. Nuclear Regulatory Commission, Fiscal Years [FY] 2008-2013 Strategic Plan,'' dated February 2012. The updated FY 2008-2013 strategic plan describes the agency's mission and...

Intergovernmental organisation activities: European Atomic Energy Community, International Atomic Energy Agency, OECD Nuclear Energy Agency

International Nuclear Information System (INIS)

Anon.

2012-01-01

European Atomic Energy Community: Proposed legislative instruments, Adopted legislative instruments, Non-legislative instruments, Other activities (meetings). International Atomic Energy Agency: IAEA Action Plan on Nuclear Safety. OECD Nuclear Energy Agency: The Russian Federation to join the OECD Nuclear Energy Agency; Participation by the regulatory authorities of India and the United Arab Emirates in the Multinational Design Evaluation Programme (MDEP); NEA International Workshop on Crisis Communication, 9-10 May 2012; International School of Nuclear Law: 2013; Next NEA International Nuclear Law Essentials Course

AgSat Areas of Interest

Data.gov (United States)

Farm Service Agency, Department of Agriculture — The AgSat Areas of Interest map contains area polygons where satellite imagery will be collected for the Farm Service Agency (FSA) to provide imagery coverage for...

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

International Nuclear Information System (INIS)

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

2009-01-01

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

76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

Science.gov (United States)

2011-10-04

...-2016 Strategic Plan AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment... comment on draft NUREG-1614, Volume 5. ``U.S. Nuclear Regulatory Commission, FY 2012-2016 Strategic Plan,'' dated September 2011. The NRC's draft FY 2012-2016 strategic plan describes the agency's mission and...

US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

Science.gov (United States)

McHughen, Alan; Smyth, Stuart

2008-01-01

This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

Federal Energy Regulatory Commission (FERC) Regions

Data.gov (United States)

Department of Homeland Security — Federal Energy Regulatory Commission (FERC) Regions. FERC is an independent agency that regulates the interstate transmission of electricity, natural gas, and oil....

77 FR 8902 - Draft Regulatory Guide: Issuance, Availability Decommissioning of Nuclear Power Reactors

Science.gov (United States)

2012-02-15

... Decommissioning of Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide... draft regulatory guide (DG) DG-1271 ``Decommissioning of Nuclear Power Reactors.'' This guide describes... Regulatory Guide 1.184, ``Decommissioning of Nuclear Power Reactors,'' dated July 2000. This proposed...

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

State Arts Agencies 1965-2003. Whose Interests to Serve?

National Research Council Canada - National Science Library

Lowell, Julia

2004-01-01

... (referred to as state arts agencies, or SAAs). In fiscal year (FY) 2003, a record 43 of 56 SAAs reported year-over-year declines in the general fund appropriations budgeted to them by their state legislatures...

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

78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

Science.gov (United States)

2013-07-01

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9830-1] Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... Environmental Protection Agency (EPA) issued for public comment a document entitled, ``Technical Guidance for...

Canadian and international approaches to regulatory effectiveness

International Nuclear Information System (INIS)

Lojk, R.

2014-01-01

Regulatory effectiveness is an important attribute of any regulator, particularly nuclear regulators. As the nuclear industry has matured, and as the social landscape has changed, so have views on what constitutes regulatory effectiveness. Canada has evolved its regulatory structure and modernized its legislative framework and technical requirements and guidance over time. In addition, Canada continues to collaborate with international agencies, particularly the NEA and the IAEA, to ensure that there is a common understanding of the indicators and key attributes of regulatory effectiveness. This paper discusses Canadian and international views on the subject, including perspectives from other industries. (author)

5 CFR 550.806 - Interest computations.

Science.gov (United States)

2010-01-01

... agency shall compound interest by dividing the applicable interest rate (expressed as a decimal) by 365... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Interest computations. 550.806 Section... ADMINISTRATION (GENERAL) Back Pay § 550.806 Interest computations. (a)(1) Interest begins to accrue on the date...

The Energy Regulatory Commission. The Regulation of Natural Gas in Mexico

International Nuclear Information System (INIS)

1995-01-01

In May of 1995 the Congress approved amendments to the Regulatory Law of Constitutional article 27 on Petroleum. This legal reform fundamentally redefined the petroleum industry and authorizes the private sector to construct, operate, and own natural gas transportation, storage and distribution systems-activities previously reserved to the state. To complement these reforms and to implement the legislative mandate of the Regulatory Law on Petroleum, the Natural Gas Regulation (Reglamento de Gas Natural) was issued in November 1995. The regulation reconciles the interests of the various natural gas industry participants and signifies a Federal Commitment to promote comprehensive development of the industry. In parallel with the development of the substantive legal framework, the law of the Comision Reguladora de Energia (CRE) was also enacted by Congress in October 1995 to strength the institutional framework and implemented the legal changes. This law defines the CRE as an agency of the Energy Ministry with technical, operational, and budgetary autonomy, and responsibility for implementing natural gas industry regulation. (Author)

48 CFR 2009.570 - NRC organizational conflicts of interest.

Science.gov (United States)

2010-10-01

... conflicts of interest. 2009.570 Section 2009.570 Federal Acquisition Regulations System NUCLEAR REGULATORY COMMISSION COMPETITION AND ACQUISITION PLANNING CONTRACTOR QUALIFICATIONS Organizational Conflicts of Interest 2009.570 NRC organizational conflicts of interest. ...

O lugar da política na atuação das agências reguladoras independentes brasileiras: reflexões sobre a separação dos poderes no Estado moderno / The Role of Politics in the Brazilian Independent Regulatory Agencies: Reflections on the Separation of Powers in the Modern State

Directory of Open Access Journals (Sweden)

Milton Carvalho Gomes

2017-04-01

Full Text Available Purpose – The purpose of the proposed article is to investigate the practice of politics in the performance of activities of Brazilian independent regulatory agencies Methodology/approach/design – ... The approach is based on the study of theories about separation of state powers and functions, evaluating the application of these theories in the understanding of the role played by independent regulatory agencies in Brazil Findings – It was concluded that the independence granted by the National Congress to the Brazilian regulatory agencies implied in the expansion of the space of politics in its operation, placing these agencies in a unique position in the context of the separation of powers, changing the traditional institutional arrangement of submission to the executive branch. Practical implications (if applicable –The conclusions permit new reflections on the limits of the influence of the President of the Republic and of the sectoral ministries in the decisions taken by the regulatory agencies, both in the decisions of a technical nature and those of a political nature, allowing the expansion of the debate on the instruments of democratic legitimation of these decisions. Originality/value (optional – The text is original, since there are few in-depth studies in Brazil about the space for politics in the field of independent regulatory agencies, usually understood as purely technical / administrative entities.

21 CFR 312.86 - Focused FDA regulatory research.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

Regulatory framework for the management of radioactive wastes in Argentina

International Nuclear Information System (INIS)

D'Amato, E.; Siraky, G.; Petraitis, E.; Novo, R.

2000-01-01

The legal and regulatory framework within which the radioactive waste management is carried out in Argentina are exposed. The activities of the Nuclear Regulatory Authority (ARN) in relation to facility inspections, safety assessments and collaboration with international agencies in the matter are also presented. Further, the regulatory criteria applied to waste management are reported. (author)

Electricity and telecommunications regulatory institutions in small and developing countries

Energy Technology Data Exchange (ETDEWEB)

Stern, J. [London Business School, London (United Kingdom)

2000-09-01

The spread of utility liberalisation and privatisation to middle and low income developing countries raises the problem of whether and how they can establish an effective regulatory capability of whether the supply of regulatory services is likely to be insufficient. The paper presents evidence on the size of electricity regulatory agencies in 24 mainly middle and lower income countries as well as the number of high-level, specialist regulatory staff and the potential resource pool from post-school education. The paper also discusses how far the problem can be alleviated and/or avoided by the use of regulation by contract, regulation by multi-national regulatory agency or contracting-out. The paper concludes that such solutions are unlikely to be generally effective but that informal exchanges of information and pooling of resources between national regulators on a market-driven basis, as seen in Southern Africa and the EU, is a promising option. The paper concludes by pointing to the need to ascertain the minimum required regulatory capability in developing countries as perceived by Governments and potential investors. (author)

Regulatory practices and safety standards for nuclear power plants

International Nuclear Information System (INIS)

1989-01-01

The International Symposium on Regulatory Practices and Safety Standards for Nuclear Power Plants was jointly organized by the International Atomic Energy Agency (IAEA), for Nuclear Energy Agency of the OECD and the Government of the Federal Republic of Germany with the objective of providing an international forum for the exchange of information on regulatory practices and safety standards for nuclear power plants. The Symposium was held in Munich, Federal Republic of Germany, from 7 to 10 November 1988. It was attended by 201 experts from some 32 Member States and 4 international organizations. Fifty-one papers from 19 Member States and 2 international organizations were presented and discussed in 5 technical sessions covering the following subjects: National Regulatory Practices and Safety Standards (14 papers); Implementation of Regulatory Practices - Technical Issues (8 papers); Implementation of Regulatory Practices - Operational Aspects (8 papers); Developments and Trends in Safety Standards and Practices (11 papers); International Aspects (10 papers). A separate abstract was prepared for each of these papers. Refs, figs and tabs

A nova cobrança por bagagens despachadas e a Agência Nacional de Aviação Civil (ANAC: corporativismo ou mediação de interesses? / The New Fee for Checked Baggage and the National Civil Aviation Agency (ANAC: Corporatism or Mediation of Interests?

Directory of Open Access Journals (Sweden)

Alfredo Ribeiro da Cunha Lobo

2018-05-01

Full Text Available Purpose – To verify if the deregulation by the National Civil Aviation Agency, which granted airlines permission to charge consumers for checked baggage, follows corporatist theory or the regulatory state assumptions. Methodology/approach/design – The theoretical underpinnings that will base the research rely on Mihaïl Manoïlescu's corporative theory and on the construct of Regulatory State, from the perspective of the mediating activity of regulatory agencies. This study applies the current federal legislation to the subject and analyzes the results of the recent researches regarding the values of the air tickets practiced in Brazil, with the objective of verifying if the deregulation for checked baggage fulfilled the interests of airlines, consumers or both. Findings – The change brought by the National Civil Aviation Agency is closely related to its prerogatives granted by the regulatory state and cannot be explained by corporatism assumptions. Resumo Propósito – Verificar se a desregulação da franquia de bagagem pela Agência Nacional de Aviação Civil, que permitiu que as companhias aéreas passassem a cobrar dos consumidores por passagem despachada, detinha relação com pressupostos da teoria corporativista ou do Estado regulador. Metodologia/abordagem/design – Inicialmente, serão firmados os pressupostos teóricos que fundamentarão a pesquisa, especialmente quanto à teoria corporativista de Mihaïl Manoïlescu e sua aplicação aos interesses das empresas aéreas e dos consumidores, bem como ao Estado Regulador e à atividade mediadora das agências reguladoras. Posteriormente, será analisada a aplicação da legislação federal vigente ao tema e os resultados das recentes pesquisas referentes aos valores das passagens aéreas praticados no Brasil, com objetivo de verificar se, com a desregulação da franquia de bagagem, houve atendimento aos interesses das empresas aéreas, dos consumidores ou de ambos. Resultados

76 FR 7762 - Drinking Water: Regulatory Determination on Perchlorate

Science.gov (United States)

2011-02-11

...-9262-8] RIN 2040-AF08 Drinking Water: Regulatory Determination on Perchlorate AGENCY: Environmental...'s) regulatory determination for perchlorate in accordance with the Safe Drinking Water Act (SDWA... substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of...

Formal independence of regulatory agencies and Varieties of Capitalism

DEFF Research Database (Denmark)

Guardiancich, Igor; Guidi, Mattia

2016-01-01

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

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)

78 FR 54517 - Water Quality Standards Regulatory Clarifications

Science.gov (United States)

2013-09-04

... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

77 FR 23770 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2012-04-20

...: The financial markets as a whole should benefit from [limit order display] because the price discovery... revised tier sizes and corresponding liquidity minimum amounts are in the best interest of the market for...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1...

78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

Science.gov (United States)

2013-11-25

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement AGENCY: Nuclear Regulatory Commission. ACTION: Conceptual example of a... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

The Australian radiation protection and Nuclear Safety Agency

International Nuclear Information System (INIS)

Macnab, D.; Burn, P.; Rubendra, R.

1998-01-01

The author talks about the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the new regulatory authority which will combine the existing resources of the Australian Radiation Laboratory and the Nuclear Safety Bureau. Most uses of radiation in Australia are regulated by State or Territory authorities, but there is presently no regulatory authority for Commonwealth uses of radiation. To provide for regulation of the radiation practices of the Commonwealth, the Australian Government has decided to establish the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) and a Bill has passed through the House of Representatives and will go to the Spring sitting of the Senate. The new agency will subsume the resources and functions of the Nuclear Safety Bureau and the Australian Radiation Laboratory, with additional functions including the regulation of radiation protection and nuclear safety of Commonwealth practices. Another function of ARPANSA will be the promotion of uniform regulatory requirements for radiation protection across Australia. This will be done by developing, in consultation with the States and Territories, radiation health policies and practices for adoption by the Commonwealth, States and Territories. ARPANSA will also provide research and services for radiation health, and in support of the regulatory and uniformity functions. The establishment of ARPANSA will ensure that the proposed replacement research reactor, the future low level radioactive waste repository and other Commonwealth nuclear facilities and radiation practices are subject to a regulatory regime which reflects the accumulated experience of the States and Territories and best international practice, and meets public expectations

Highlights of the EPA innovative regulatory strategies workshop: Market-based incentives and other innovations for air pollution control. Summary of workshop discussion sessions. Held in Washington, DC on January 15-17, 1992

International Nuclear Information System (INIS)

1992-06-01

The Clean Air Act Amendments of 1990 allow, and in some cases require, States to adopt market-based strategies or other innovative types of air pollution control. The U.S. Environmental Protection Agency's (EPA's) innovative regulatory strategies program seeks to encourage and facilitate, as appropriate, the development, demonstration, and implementation of a wide range of innovative regulatory air pollution programs, including market-based, informational, and pollution prevention approaches. The 3-day national workshop, attended by over two hundred people from Federal, State, and local agencies, industry, environmental and public interest groups, and the academic community highlighted issues associated with a variety of innovative, market-based strategies which are currently being developed or used by State and local authorities around the country

76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

Science.gov (United States)

2011-01-04

... guidance, including memoranda and letters, may no longer be relied upon to the extent they are inconsistent... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the...

Mobile Source Emissions Regulatory Compliance Data Inventory

Data.gov (United States)

U.S. Environmental Protection Agency — The Mobile Source Emissions Regulatory Compliance Data Inventory data asset contains measured summary compliance information on light-duty, heavy-duty, and non-road...

76 FR 59767 - Interest Rates; Notice

Science.gov (United States)

2011-09-27

... SMALL BUSINESS ADMINISTRATION Interest Rates; Notice AGENCY: Small Business Administration. The Small Business Administration publishes an interest rate called the optional ``peg'' rate (13 CFR 120... fluctuating interest rate SBA loans. This rate will be 3.125 (3\\1/8\\) percent for the October-December quarter...

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Directory of Open Access Journals (Sweden)

Dipak Dilip Gadade

2016-12-01

Full Text Available Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.

Science.gov (United States)

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-12-01

Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Characterization of the evolution of the pharmaceutical regulatory environment.

Science.gov (United States)

Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

2013-01-01

This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

Independence and the Irish Environmental Protection Agency: A Comparative Assessment

OpenAIRE

Shipan, Charles

2006-01-01

The Environmental Protection Agency is one of the most prominent regulatory agencies in Ireland. Created in 1992, one of the hallmarks of this agency is its independence from other parts of government. Yet little is known about the actual extent of its independence. Independence and the Irish Environmental Protection Agency: A Comparative Assessment addresses several key questions about the agency's independence. Why was independence such a primary justification for the creation of this a...

7 CFR 4274.325 - Interest rates.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Interest rates. 4274.325 Section 4274.325 Agriculture... (IRP) § 4274.325 Interest rates. (a) Loans made by the Agency pursuant to this subpart shall bear interest at a fixed rate of 1 percent per annum over the term of the loan. (b) Interest rates charged by...

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

Science.gov (United States)

2012-07-11

...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... regulatory time of compliance for a low-level radioactive waste disposal facility, allowing licensees the... system, and revising the NRC's licensing requirements for land disposal of radioactive waste. DATES: The...

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Science.gov (United States)

2013-04-26

...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

The regulatory process for uranium mines in Canada -general overview and radiation health and safety in uranium mine-mill facilities

International Nuclear Information System (INIS)

Dory, A.B.

1982-01-01

This presentation is divided into two main sections. In the first, the author explores the issues of radiation and tailings disposal, and then examines the Canadian nuclear regulatory process from the point of view of jurisdiction, objectives, philosophy and mechanics. The compliance inspection program is outlined, and the author discussed the relationships between the AECB and other regulatory agencies, the public and uranium mine-mill workers. The section concludes with an examination of the stance of the medical profession on nuclear issues. In part two, the radiological hazards for uranium miners are examined: radon daughters, gamma radiation, thoron daughters and uranium dust. The author touches on new regulations being drafted, the assessment of past exposures in mine atmospheres, and the regulatory approach at the surface exploration stage. The presentation concludes with the author's brief observations on the findings of other uranium mining inquiries and on future requirements in the industry's interests

INTEREST RATE REGIME AND THE PERFORMANCE OF THE NIGERIAN CAPITAL MARKET

Directory of Open Access Journals (Sweden)

Edirin Jeroh

2015-12-01

Full Text Available This study x-ray’s the interest rates regime in Nigeria as it affects the performance of the Nigerian Capital Market. In order to achieve this objective, relevant data for a period of 33 years spanning from 1981 – 2013 were obtained from the Factbook of the Nigerian Stock Exchange, CBN Statistical Bulletin as well as the annual accounts of quoted firms for the relevant years. The data obtained were analysed with the Ordinary Least Square (OLS technique. The result from our analysis reveal among others that changes in interest rate regimes have majorly influenced the level of the performance of the Nigerian Capital Market. Based on the above, we recommend that capital market regulators and other regulatory agencies should keep an eye on movements in interest rates and the Minimum Rediscount Rate (MRR (now MPR and watch their trend. We also recommend that efforts must be put in place to establish a policy review and reassessment mechanism that would help in assessing the impact of selected policy measures on the economy so that policy makers would know the effectiveness and efficiency of designed policies and be guided in the policy review and development process in the country.

Regulatory Assistance, Stakeholder Outreach, and Coastal and Marine Spatial Planning Activities In Support Marine and Hydrokinetic Energy Deployment: Task 2.1.7 Permitting and Planning Fiscal Year 2012 Year-End Report

Energy Technology Data Exchange (ETDEWEB)

Geerlofs, Simon H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hanna, Luke A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Judd, Chaeli R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Blake, Kara M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2012-09-01

This fiscal year 2012 year-end report summarizes activities carried out under DOE Water Power task 2.1.7, Permitting and Planning. Activities under Task 2.1.7 address the concerns of a wide range of stakeholders with an interest in the development of the MHK industry, including regulatory and resource management agencies, tribes, NGOs, and industry.

Self-interest without selfishness: the hedonic benefit of imposed self-interest.

Science.gov (United States)

Berman, Jonathan Z; Small, Deborah A

2012-10-01

Despite commonsense appeal, the link between self-interest and happiness remains elusive. One reason why individuals may not feel satisfied with self-interest is that they feel uneasy about sacrificing the needs of others for their own gain. We propose that externally imposing self-interest allows individuals to enjoy self-benefiting outcomes that are untainted by self-reproach for failing to help others. Study 1 demonstrated that an imposed self-interested option (a reward) leads to greater happiness than does choosing between a self-interested option and a prosocial option (a charity donation). Study 2 demonstrated that this effect is not driven by choice in general; rather, it is the specific trade-off between benefiting the self and benefiting others that inhibits happiness gained from self-interest. We theorize that the agency inherent in choice reduces the hedonic value of self-interest. Results of Study 3 find support for this mechanism.

Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

International Nuclear Information System (INIS)

Kadambi, N. Prasad

2005-01-01

Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

IAEA Mission Sees Significant Progress in Georgia’s Regulatory Framework, Challenges Ahead

International Nuclear Information System (INIS)

2018-01-01

An International Atomic Energy Agency (IAEA) team of experts said Georgia has made significant progress in strengthening its regulatory framework for nuclear and radiation safety. The team also pointed to challenges ahead as Georgia seeks to achieve further progress. The Integrated Regulatory Review Service (IRRS) team concluded a 10-day mission on 28 February to assess the regulatory safety framework in Georgia. The mission was conducted at the request of the Government and hosted by the Agency of Nuclear and Radiation Safety (ANRS), which is responsible for regulatory oversight in the country. IRRS missions are designed to strengthen the effectiveness of the national safety regulatory infrastructure, while recognizing the responsibility of each State to ensure nuclear and radiation safety. Georgia uses radioactive sources in medicine and industry and operates radioactive waste management facilities. It has decommissioned its only research reactor and has no nuclear power plants. In recent years, the Government and ANRS, with assistance from the IAEA, introduced new safety regulations and increased the number of regulatory inspections.

Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)

International Nuclear Information System (INIS)

Bergren, C.L.

1992-01-01

The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)

Regulatory approaches to hydrocarbon contamination from underground storage tanks

International Nuclear Information System (INIS)

Daugherty, S.J.

1991-01-01

Action or lack of action by the appropriate regulatory agency is often the most important factor in determining remedial action or closure requirements for hydrocarbon contaminated sites. This paper reports that the diversity of regulatory criteria is well known statewide and well documented nationally. In California, the diversity of approaches is due to: that very lack of a clear understanding of the true impact of hydrocarbon contamination: lack of state or federal standards for soil cleanup, and state water quality objectives that are not always achievable; vagueness in the underground storage tank law; and the number and diversity of agencies enforcing the underground storage tank regulations

Corporate Social Responsibility and Labour Agency

DEFF Research Database (Denmark)

Lund-Thomsen, Peter; Coe, Neil M.

2015-01-01

to which the measures advocated in a new, emerging policy paradigm on CSR in GPNs enabled labour agency at Nike’s main football supplier factory in Pakistan. We argue that while such CSR policies can create enhanced space for labour agency, that potential agency is also shaped (i) by wider economic forces......This article examines the circumstances under which corporate social responsibility (CSR) initiatives facilitate and/or constrain labour agency in global production networks (GPNs). Using a case study of Nike’s CSR approach in the football manufacturing industry of Pakistan, we explore the extent...... within the global economy and (ii) relationships with local/national actors and regulatory frameworks. Understanding the intersection of these dimensions becomes vital to interpreting the potential for, and activation of, labour agency within CSR-influenced GPNs....

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas

Directory of Open Access Journals (Sweden)

Varley Dias Sousa

Full Text Available ABSTRACT Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs and Regional Reference Authorities (RRAs. This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report as tools for strengthening health systems. Based on a narrative (nonsystematic review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data and data- and work-sharing (inter-agency data. The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1 the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics and 2 the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.

Science.gov (United States)

Sousa, Varley Dias; Ramalho, Pedro I; Silveira, Dâmaris

2016-05-01

Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems. Based on a narrative (nonsystematic) review of RRA regulatory transparency, transparency status was classified as one of two types: public disclosure of information (intra-agency data) and data- and work-sharing (inter-agency data). The risks/benefits of public disclosure of medicine-related information were assessed, taking into account 1) the involvement and roles of multiple stakeholders (health care professionals, regulators, industry, community, and academics) and 2) the protection of commercial and personal confidential data. Inter-agency data- and work-sharing was evaluated in the context of harmonization and cooperation projects that focus on regulatory convergence. Technical and practical steps for establishing an openness directive for the pharmaceutical regulatory environment are proposed to improve and strengthen health systems in the Americas. Addressing these challenges requires leadership from entities such as the Pan American Health Organization to steer and support collaborative regional alliances that advance the development and establishment of a trustworthy regulatory environment and a sustainable public health system in the Americas, using international successful initiatives as reference and taking into account the domestic characteristics and experiences of each individual country.

76 FR 9819 - Agency Information Collection Activities: Proposed Collection; Generic Clearance for the...

Science.gov (United States)

2011-02-22

...; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery; Correction AGENCY...: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... Regulatory Commission, Office of Personnel Management, Small Business Administration, and U.S. Agency for...

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)

Regulatory Control of Radiation Sources. Safety Guide

International Nuclear Information System (INIS)

2009-01-01

This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

Directory of Open Access Journals (Sweden)

Janis eAncans

2012-08-01

Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

78 FR 44403 - Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2013-07-23

... agenda (the Agenda) in accordance with Public Law 96-354, ``The Regulatory Flexibility Act,'' and... goals; (2) support for the Strategic Plan organizational excellence objectives; (3) a governmental... Flexibility Act Section 610 of the Regulatory Flexibility Act (RFA) requires agencies to conduct a review...

Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

Science.gov (United States)

Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

2013-01-01

Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

75 FR 79449 - Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory...

Science.gov (United States)

2010-12-20

... Administration 79677 Office of Personnel Management 79679 Pension Benefit Guaranty Corporation 79681 Small... National Indian Gaming Commission 79706 Postal Regulatory Commission 79708 AGENCY AGENDAS Cabinet... Register twice each year since 1983 and has been available online since 1995. To further the objective of...

77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

Science.gov (United States)

2012-11-27

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0285] Regulatory Guide 1.182, ``Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission... withdrawing Regulatory Guide (RG)1.182, Revision (Rev.) 0, ``Assessing and Managing Risk Before Maintenance...

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

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

Science.gov (United States)

2012-03-02

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

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

Science.gov (United States)

2011-03-14

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

7 CFR 761.4 - Conflict of interest.

Science.gov (United States)

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Conflict of interest. 761.4 Section 761.4 Agriculture... SPECIAL PROGRAMS GENERAL PROGRAM ADMINISTRATION General Provisions § 761.4 Conflict of interest. The Agency enforces conflict of interest policies to maintain high standards of honesty, integrity, and...

Implications of draft ICRP recommendations: the View of the OECD Nuclear Energy Agency

International Nuclear Information System (INIS)

Magnusson, S.; Lazo, T.

2006-01-01

Full text: The OECD Nuclear Energy Agency has taken an active interest in the work being performed by the International Commission on Radiological Protection (ICRP) to develop a new set of general recommendations. As several key junctures, the Nea, through the lead of its Committee on Radiation Protection and Public Health (C.R.P.P.H.) has performed in-depth analyses of the possible implications that draft ICRP materials, in order to inform policy makers of the regulatory and application implications that would result should draft ICRP Recommendations for a system of radiological protection be published. Comments from the Nea have constructively contributed to the ICRP development process, and it is hoped that the final ICRP recommendations in this area will be developed to best serve the needs of national and international radiation protection policy makers, regulators and implementers. Having assessed and commented on previous drafts, the C.R.P.P.H. has co-ordinated the views of all the relevant standing technical committees within the OECD Nuclear Energy Agency to provide constructive suggestions as to how the text could be usefully improved. Comments were requested from the Nea committees dealing with radioactive waste management, nuclear safety, nuclear regulatory activities, nuclear development and nuclear science. The present paper summarises the results of the C.R.P.P.H. review process related to the new ICRP recommendations. (author)

Electric restructuring: Observations about what is in the public interest

Energy Technology Data Exchange (ETDEWEB)

Hoecker, J.

1996-12-31

Opinions regarding restructuring of the U.S. electric utility industry are presented in the paper. A brief assessment is made of Federal Energy Regulatory Commission orders requiring open access transmission services and open access same-time information systems. Three subtopics are pursued in some detail: competition between renewables and conservation, the role of government, and the impact of government on the market for renewables. It is concluded that renewable programs can be incorporated into competitive markets through regulatory agencies.

IRT‑Sofia, HEU to LEU conversion: regulatory approval tasks solution overview

International Nuclear Information System (INIS)

Mitev, Mladen; Belousov, Sergey; Dimitrov, Dobromir

2014-01-01

The HEU to LEU conversion of the IRT–Sofia research reactor of the Institute for Nuclear Research and Nuclear Energy of the Bulgarian Academy of Sciences was jointly studied with the Argonne National Laboratory as a part of the RERTR Programme. The main purpose of the collaboration consisted in accomplishment of safety analyses and preparation of documents used for regulatory approval tasks solution. The main steps and results which are fundamental for the preparation of IRT–Sofia Safety Analyses Report including Operating Limits and Conditions are presented in this paper. The documents prepared by INRNE in accordance with the European nuclear safety requirements and IAEA recommendations were submitted for approval to the Bulgarian Nuclear Regulatory Agency at the end of 2010. Key words: research reactor, safety analyses report, Nuclear Regulatory Agency

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

Science.gov (United States)

2013-05-09

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

78 FR 1570 - Semiannual Regulatory Agenda

Science.gov (United States)

2013-01-08

... Deregulatory Priorities. Gregory H. Woods, General Counsel. Energy Efficiency and Renewable Energy--Proposed... Action 10/01/12 77 FR 59719 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Stephen Witkowski, Phone: 202 586-7463, Email: stephen[email protected] . RIN: 1904-AB90 [FR Doc. 2012-31497...

7 CFR 3565.210 - Maximum interest rate.

Science.gov (United States)

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Maximum interest rate. 3565.210 Section 3565.210... AGRICULTURE GUARANTEED RURAL RENTAL HOUSING PROGRAM Loan Requirements § 3565.210 Maximum interest rate. The interest rate for a guaranteed loan must not exceed the maximum allowable rate specified by the Agency in...

OECD Nuclear Energy Agency. 5 activity report. 1976

International Nuclear Information System (INIS)

1977-01-01

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

76 FR 39242 - Federal Acquisition Regulation; TINA Interest Calculations

Science.gov (United States)

2011-07-05

... pricing data. This rule replaces the term ``simple interest'' as the requirement for calculating interest...-AL73 Federal Acquisition Regulation; TINA Interest Calculations AGENCIES: Department of Defense (DoD... interest calculations be applied to Government overpayments as a result of defective cost or pricing data...

76 FR 72497 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2011-11-23

... displays a currently valid Office of Management and Budget (OMB) control number. The Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, has approved the agencies... Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room...

75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Science.gov (United States)

2010-05-13

... regulatory issues and their potential impact on investors and the securities markets. The Committee will lend... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Securities and...

The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

Science.gov (United States)

Haas, Manuel; Mantua, Valentina; Haberkamp, Marion; Pani, Luca; Isaac, Maria; Butlen-Ducuing, Florence; Vamvakas, Spiros; Broich, Karl

2015-04-01

Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

A tale of three labels: translating the JUPITER trial data into regulatory claims.

Science.gov (United States)

Ridker, Paul M

2011-08-01

Whether a pivotal randomized trial will be interpreted in a similar and consistent manner by different regulatory agencies is uncertain as policy perspectives may play a role in data interpretation and the translation of trial results into clinical practice. Using a contemporary example, to compare and contrast regulatory claims in the United States, Europe, and Canada that derive from a pivotal clinical trial. The recently completed JUPITER trial of rosuvastatin as compared to placebo conducted among 17,802 men and women with LDL-C JUPITER trial provides an opportunity to compare and contrast how regulatory agencies in the United States, Canada, and Europe chose to interpret an identical database. Labeling indications based on earlier statin trials of primary and secondary prevention were also reviewed. JUPITER demonstrated a 44% reduction (p JUPITER trial population by stipulating that those eligible for treatment should be older men and women with hsCRP >2 mg/L, plus one additional risk factor for heart disease. The Canadian label is silent on age and hsCRP (the major trial inclusion criterion), stipulating instead that treatment can be considered for those with 'at least two conventional risk factors for cardiovascular disease,' a group more inclusive than that studied. In contrast, the European Medicines Agency label limits treatment only to 'high risk individuals' ignoring hsCRP and using instead a post hoc definition of 'high risk' that comprised a subgroup of less than 10% of the study population who contributed but 67 events to the study total and did not show statistical significance when compared to placebo. None of the regulatory labels included the trial primary endpoint; instead, each focused on separate and different components of the primary endpoint. Similar discrepancies were found between European and North American regulatory agencies with regard to earlier pivotal trials of statins for primary prevention, but not for secondary prevention. The

Decommissioning of uranium mines and mills - Canadian regulatory approach and experience

International Nuclear Information System (INIS)

Whitehead, W.

1986-09-01

At the time of the recent closures of the Agnew Lake, Beaverlodge and Madawaska Mines Limited uranium mining and milling facilities, several relevant regulatory initiatives, including the development of decommissioning criteria, were underway, or contemplated. In the absence of precedents, the regulatory agencies and companies involved adopted approaches to the decommissioning of these facilities that reflected site specific circumstances, federal and provincial regulatory requirements, and generally accepted principles of good engineering practice and environmental protection. This paper summarizes related historical and current regulatory policies, requirements and guidelines; including those implemented at the three decommissioned sites

Regulatory aspects of criticality control in Australia

International Nuclear Information System (INIS)

Zimin, Sergei

2003-01-01

With the creation of Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) the Australian approach to criticality safety was revisited. Consistency with international best practices is required by the Act that created ARPANSA and this was applied to practices in criticality safety adopted in other countries. This required extensive regulatory efforts both in auditing the major Australian Nuclear Operator, Australian Nuclear Science and Technology Organisation (ANSTO), and assessing the existing in Australia criticality safety practices and implementing the required changes using the new legislative power of ARPANSA. The adopted regulatory approach is formulated through both the issued by ARPANSA licenses for nuclear installations (including reactors, fuel stores and radioactive waste stores) and the string of new regulatory documents, including the Regulatory Assessment Principles and the Regulatory Assessment Guidelines for criticality safety. The main features of the adopted regulation include the requirements of independent peer-review, ongoing refresher training coupled with annual accreditation and the reliance on the safe design rather than on an administrative control. (author)

PRA research and the development of risk-informed regulation at the U.S. nuclear regulatory commission

International Nuclear Information System (INIS)

Siu, Nathan; Collins, Dorothy

2008-01-01

Over the years, Probabilistic Risk Assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, Human Reliability Analysis (HRA), and Pressurized Thermal Shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities

Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

International Nuclear Information System (INIS)

Bosnjak, J.

2016-01-01

The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

Institutional change and political decision-making in the creation of the Brazilian National Health Surveillance Agency.

Science.gov (United States)

Piovesan, Márcia Franke; Labra, Maria Eliana

2007-06-01

This article examines the decision-making process that led to the creation of the Brazilian National Health Surveillance Agency (ANVISA) in 1999. The authors begin by discussing the history of the Agency's predecessor, the Health Surveillance Secretariat, and the need for its modernization to adjust the quality of the products under its control to domestic and international demands. From the theoretical perspective of neo-institutionalism, the article goes on to analyze the social and political context surrounding the debate on the proposed alternatives to adjust Health Surveillance to new rules in line with such requirements, focusing especially on the formulation of the new policy, the decision-making arena, and the actors with specific interests in the sector. The research drew on extensive documentary and media material, plus interviews with key actors. The article concludes that a determinant factor for the creation of ANVISA was the favorable domestic political context, fostering a positive correlation of forces that (in an extremely short timeframe, 1998-1999) allowed the creation of the first regulatory agency in the social policies area in Brazil.

Hormesis in Regulatory risk assessment - Science and Science Policy.

Science.gov (United States)

Gray, George

2011-01-01

This brief commentary will argue that whether hormesis is considered in regulatory risk assessment is a matter less of science than of science policy. I will first discuss the distinction between science and science policy and their roles in regulatory risk assessment. Then I will focus on factors that influence science policy, especially as it relates to the conduct of risk assessments to inform regulatory decisions, with a focus on the U.S. Environmental Protection Agency (EPA). The key questions will then be how does hormesis interact with current concepts of science and science policy for risk assessment? Finally, I look ahead to factors that may increase, or decrease, the likelihood of hormesis being incorporated into regulatory risk assessment.

Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

Science.gov (United States)

Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

2017-06-01

The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

4th IEA International CCS Regulatory Network Meeting

Energy Technology Data Exchange (ETDEWEB)

NONE

2012-07-01

On 9 and 10 May 2012, the IEA International CCS Regulatory Network (Network), launched in Paris in May 2008 to provide a neutral forum for CCS regulators, policy makers and stakeholders to share updates and views on CCS regulatory developments, held its fourth meeting at the International Energy Agency (IEA) offices in Paris, France. The aim of the meeting was to: provide an update on government efforts to develop and implement carbon capture and storage (CCS) legal and regulatory frameworks; and consider ways in which governments are dealing with some of the more difficult or complex aspects of CCS regulation. This report summarises the proceedings of the meeting.

OECD Nuclear Energy Agency. 3. Activity report, 1974

International Nuclear Information System (INIS)

1975-01-01

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

78 FR 73237 - Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB...

Science.gov (United States)

2013-12-05

...-0088] Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB... entities over which the agency exercises regulatory authority. Recent trends lead the agency to estimate.... Requesters are not required to keep copies of any records or reports [[Page 73238

A National Regulatory Authority set up in a developing country: case of Mali

International Nuclear Information System (INIS)

Kone, Nagantie

2008-01-01

Full text: The Republic of Mali is member of the International Atomic Energy Agency since 1961. Of since the creation of the IAEA, some African countries are members. The technical cooperation with the Agency started in the years 1975. Through that cooperation, many pacific uses of nuclear techniques have been introduced, then developed at different levels in many socio- economic domains as medicine, agriculture, research, and so on. That development of nuclear techniques use has occurred without legislation at all or in some limited cases with part of the legislation of the colonizing country), in a precise field (like radiography in medicine). Later the need of regulatory infrastructure implementation started. That implementation has followed several ways in the different African countries. Also, it started earlier in countries which had advanced activities in nuclear techniques and very later in others. Most if not all of these infrastructure (say regulatory board) were created by the greatest users of the nuclear techniques, the Ministry of Health in most cases or Energy Commission for Countries having a research reactor. After the years 90, the Agency has developed new vision in the implementation of Regulatory Authorities. The new innovation was: 1-) Development of Regulatory Authority with independent statute (decisions and finance); 2-) Assuming post graduate training in developing countries to come other the lack of human resources. That new strategy of the IAEA has facilitated the apparition and development of several new regulatory authorities. We are going to develop here the progress done by one of these new regulatory authorities, through five years being. (author)

Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

Science.gov (United States)

Ancans, Janis

2012-01-01

Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

77 FR 61592 - Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public...

Science.gov (United States)

2012-10-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-110-000] Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public Utilities Commission.... 825(h), Arkansas Electric Cooperative Corporation, Mississippi Delta Energy Agency, and its two...

Measuring and Modeling the U.S. Regulatory Ecosystem

Science.gov (United States)

Bommarito, Michael J., II; Katz, Daniel Martin

2017-09-01

Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

77 FR 12897 - Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling...

Science.gov (United States)

2012-03-02

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66460; File No. 600-10] Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling Clearing Agency Registration...(a)(3) of the Act \\14\\ provides that in the event any self-regulatory organization is no longer in...

77 FR 7968 - Semiannual Regulatory Agenda

Science.gov (United States)

2012-02-13

... Regulation Sequence No. Title Identifier No. 392 Non-Federal Oil and Gas 1024-AD78 Rights. National Park.... Timetable: Action Date FR Cite NPRM 07/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact... anaconda, and Beni anaconda. Timetable: Action Date FR Cite ANPRM 01/31/08 73 FR 5784 ANPRM Comment Period...

The Regulatory Independence of FANR

International Nuclear Information System (INIS)

ALNuaimi, Fatema; Choi, Kwang Shik

2012-01-01

Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

The Regulatory Independence of FANR

Energy Technology Data Exchange (ETDEWEB)

ALNuaimi, Fatema; Choi, Kwang Shik [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

2012-05-15

Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

Innovative training techniques in the Canadian nuclear regulatory environment

International Nuclear Information System (INIS)

Martin, D.J.

1996-01-01

One of the contributors to the safety of nuclear installations is properly-trained personnel. This applies equally to the staff of a regulatory agency, as they are charged with the task of evaluating the safety of installations and operations involving radioactive materials. In 1990, the nuclear regulatory agency of Canada, the Atomic Energy Control Board, set up a Training Center to train AECB staff and to provide assistance to foreign regulatory agencies who had asked for such assistance. In setting up the Training Centre, the authors considered factors which adversely affect the efficacy of training courses. The technical content must, of course, be of sufficiently high quality, but there are other, significant factors which are independent of the content: consider a presentation in which the lecturer shows a slide which is unreadable from the back of the room. The training value of this slide is zero, even though the content may be sound. Pursuing this thought, they decided to examine the mechanics of presentations and the form of training materials, with a view to optimizing their effectiveness in training. The results of this examination were that they decided to use three technologies as the basis for production of training, support and presentation materials. This paper briefly describes these technologies and their advantages. The technologies are: desktop publishing, video and multimedia

Understanding Agency Problems in Headquarters-Subsidiary Relationships in Multinational Corporations

DEFF Research Database (Denmark)

Kostova, Tatiana; Nell, Phillip Christopher; Hoenen, Anne Kristin

2016-01-01

This paper proposes an agency model for headquarters-subsidiary relationships in multinational organizations with headquarters as the principal and the subsidiary as the agent. As a departure from classical agency theory, our model is developed for the unit level of analysis and considers two root...... causes of the agency problem—self-interest and bounded rationality. We argue that in the organizational setting, one cannot assume absolute self-interest and perfect rationality of agents (subsidiaries) but should allow them to vary. We explain subsidiary-level variation through a set of internal...... organizational and external social conditions in which the headquarters-subsidiary agency dyad is embedded. We then discuss several agency scenarios reflecting various levels of self-interest and rationality that lead to different manifestations of the agency problem. The proposed framework can inform more...

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

Energy Technology Data Exchange (ETDEWEB)

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

2004-07-01

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

Regulatory Framework for Controlling the Research Reactor Decommissioning Project

International Nuclear Information System (INIS)

Melani, Ai; Chang, Soon Heung

2009-01-01

Decommissioning is one of important stages in construction and operation of research reactors. Currently, there are three research reactors operating in Indonesia. These reactors are operated by the National Nuclear Energy Agency (BATAN). The age of the three research reactors varies from 22 to 45 years since the reactors reached their first criticality. Regulatory control of the three reactors is conducted by the Nuclear Energy Regulatory Agency (BAPETEN). Controlling the reactors is carried out based on the Act No. 10/1997 on Nuclear Energy, Government Regulations and BAPETEN Chairman Decrees concerning the nuclear safety, security and safeguards. Nevertheless, BAPETEN still lack of the regulation, especially for controlling the decommissioning project. Therefore, in the near future BAPETEN has to prepare the regulations for decommissioning, particularly to anticipate the decommissioning of the oldest research reactors, which probably will be done in the next ten years. In this papers author give a list of regulations should be prepared by BAPETEN for the decommissioning stage of research reactor in Indonesia based on the international regulatory practice

Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

Science.gov (United States)

Phartiyal, P.

2015-12-01

The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

Nuclear Regulatory Commission Information Digest 1992 edition

International Nuclear Information System (INIS)

Olive, K.

1992-03-01

The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. This digest is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and industry it regulates. In general, the data cover 1975 through 1991, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

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

Science.gov (United States)

2013-02-12

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

IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

International Nuclear Information System (INIS)

2018-01-01

An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

Efficiency and the public interest: QF transmission and the Energy Policy Act of 1992

International Nuclear Information System (INIS)

Fox-Penner, P.

1993-01-01

Prior to the enactment of the Energy Policy Act of 1992 (Act), most Federal Energy Regulatory Commission (FERC or Commission) deliberations involving transmission services did not occur in transmission rate or service proceedings per se. The Commission conducted a number of general inquiries or studies of the subject, including setting the terms and conditions of transmission services as part of merger proceedings and open-quotes market-basedclose quotes pricing proceedings. With the passage of the Act, the FERC is likely to be asked to confront the advisability of requiring transmission services in a more direct manner. The Act permits open-quotes[a]ny electric utility, Federal power marketing agency, or any other person generating electrical energy for sale for resaleclose quotes to petition the Commission for a wheeling order. The FERC may order wheeling in accordance with section 212 of the Federal Power Act (FPA) and a finding that such wheeling would open-quotes otherwise be in the public interest.close quotes When compounded with the need to find that wheeling is in the public interest, the requirements set forth in section 212 are considerable. This article focuses on an important area of section 212 criteria, namely the interplay between between the public interest and economic efficiency criteria in the case of Public Utility Regulatory Policies Act of 1978 (PURPA) Qualifying Facilities (QF). Two recent proceedings in which the FERC considered the need to provide power transmission service guarantees for QFs are analyzed from the standpoint of public and private economic welfare. The two proceedings are the merger of Utah Power ampersand Light Company, PacifiCorp, PC/UP ampersand L Merging Corporation (Utah) and the Western Systems Power Pool application (WSPP)

75 FR 1734 - Children’s Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; i-SAFE...

Science.gov (United States)

2010-01-13

... Proposed Self-Regulatory Guidelines; i-SAFE, Inc. Application for Safe Harbor AGENCY: Federal Trade... for public comment concerning proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the... approval self-regulatory guidelines that would implement the Rule's protections.\\3\\ \\1\\ 64 FR 59888 (1999...

Regulatory Control of Radiation Sources. Safety Guide (Arabic Edition)

International Nuclear Information System (INIS)

2012-01-01

This Safety Guide is intended to assist States in implementing the requirements established in Safety Standards Series No. GS-R-1, Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, for a national regulatory infrastructure to regulate any practice involving radiation sources in medicine, industry, research, agriculture and education. The Safety Guide provides advice on the legislative basis for establishing regulatory bodies, including the effective independence of the regulatory body. It also provides guidance on implementing the functions and activities of regulatory bodies: the development of regulations and guides on radiation safety; implementation of a system for notification and authorization; carrying out regulatory inspections; taking necessary enforcement actions; and investigating accidents and circumstances potentially giving rise to accidents. The various aspects relating to the regulatory control of consumer products are explained, including justification, optimization of exposure, safety assessment and authorization. Guidance is also provided on the organization and staffing of regulatory bodies. Contents: 1. Introduction; 2. Legal framework for a regulatory infrastructure; 3. Principal functions and activities of the regulatory body; 4. Regulatory control of the supply of consumer products; 5. Functions of the regulatory body shared with other governmental agencies; 6. Organization and staffing of the regulatory body; 7. Documentation of the functions and activities of the regulatory body; 8. Support services; 9. Quality management for the regulatory system.

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

Energy Technology Data Exchange (ETDEWEB)

O`Donnell, E.

1995-12-31

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

The “In-House Agency Work” in the PTS and the Union Movement of Agency Workers

Directory of Open Access Journals (Sweden)

Chang-De Liu

2016-07-01

Full Text Available The number of agency workers in the PTS had increased rapidly since 2008, while a total of around 200 agency workers represented 20% of the PTS employees during recent years. However, most of agency works in the PTS were “long-term core jobs” rather than “temporary peripheral jobs,” and the recruitment, remuneration and benefits of agency workers were actually decided by the user enterprise, the PTS, rather than the employment agency. The agency employment in the PTS, therefore, had become the “in-house agency work” which broke the rules of related employment laws. According to the findings based on the questionnaire survey and in-depth interviews, the PTS agency workers were relatively young and high-educated, but most of them suffered from job insecurity and wage discrimination. Most interviewees were discontent with poor working conditions while highly evaluated and identified with the public interests that the PTS pursued. In 2013, the PTS agency employees established a union and urged the management for a transition to standard employment. Nevertheless, the standard employees and their union (the PTS union spoke out against the “total transition plan,” and forced the employer laid off 6 agency workers while a total of 130 agency workers were successfully transited. The union movement of the PTS agency workers is unique for its two characteristics, including the internalization of public interests among the PTS members, and the young generation’s disobedience to the capitalism under the crisis of pauperization of work.

Regulatory cross-cutting topics for fuel cycle facilities.

Energy Technology Data Exchange (ETDEWEB)

Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott; Louie, David

2013-10-01

This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security, Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)

78 FR 34386 - Agency Forms Undergoing Paperwork Act Review

Science.gov (United States)

2013-06-07

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

A Contextualized Model of Headquarters-subsidiary Agency Problems

DEFF Research Database (Denmark)

Kostova, Tatiana; Nell, Phillip Christopher; Hoenen, Anne Kristin

This paper proposes an agency model for headquarters-subsidiary relationships in multinational organizations with headquarters as the principal and the subsidiary as the agent. As a departure from classical agency theory, our model is developed for the unit level of analysis and considers two root...... in which the headquarters-subsidiary dyad is embedded. We then discuss several agency scenarios that lead to different manifestations of the agency problem. The framework informs more relevant applications of agency theory in organizational studies and motivates future research....... causes of the agency problem – self-interest and bounded rationality. We argue that one cannot assume absolute self-interest and perfect rationality of agents but should allow them to vary. We explain subsidiary-level variation through a set of internal organizational and external social conditions...

Regulatory pathways for vaccines for developing countries.

Science.gov (United States)

Milstien, Julie; Belgharbi, Lahouari

2004-01-01

Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world. PMID:15042235

40 CFR 233.4 - Conflict of interest.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Conflict of interest. 233.4 Section 233.4 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) OCEAN DUMPING 404 STATE PROGRAM REGULATIONS General § 233.4 Conflict of interest. Any public officer or employee who has a direct...

17 CFR 240.19d-2 - Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory...

Science.gov (United States)

2010-04-01

... disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any... the appropriate regulatory agency may file with the Commission a written motion for a stay of...

48 CFR 1503.101-370 - Personal conflicts of interest.

Science.gov (United States)

2010-10-01

... AGENCY GENERAL IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST Safeguards 1503.101-370 Personal conflicts of interest. (a) Each EPA employee (including special employees) engaged in source... conflicts of interest. The employee shall inform the Source Selection Authority (SSA) in writing if his/her...

Regulatory review of probabilistic safety assessment (PSA) level 1

International Nuclear Information System (INIS)

2000-02-01

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

Regulatory Framework for Conducting Clinical Research in Canada.

Science.gov (United States)

Alas, Josmar K; Godlovitch, Glenys; Mohan, Connie M; Jelinski, Shelly A; Khan, Aneal A

2017-09-01

Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

Regulatory review of probabilistic safety assessment (PSA) Level 2

International Nuclear Information System (INIS)

2001-07-01

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

Regulatory challenges for the licensing of future nuclear plants: A public interest perspective

International Nuclear Information System (INIS)

Lyman, Edwin S.

2001-01-01

Regulatory challenges concerned with licensing of advanced NPPs must ensure that economic imperatives do not have adverse impacts on safety, risk of radiological sabotage, waste management and disposal, non-proliferation, full opportunity for public participation. This presentation explains the mentioned issues using pebble bed reactor as an example

Lessons learnt from stakeholder engagement in the UK Environment Agency

International Nuclear Information System (INIS)

Chandler, Steve

2004-01-01

The Environment Agency has many reasons and occasions for engaging with stakeholders and does so very frequently. Many of these are relatively formal, often statutory, consultations which are part of the determination of regulatory permits. Other consultations are part of the Agency's role as developer, for example in the construction of flood defence schemes. The Agency also consults nationally on its significant policies, such as the stocking of salmon fisheries. This paper gives some examples of lessons learnt from the Agency's own stakeholder engagements and also from our participation in those led by other organizations. In the next section it also describes the Agency's current approach to stakeholder consultation and engagement. (author)

76 FR 61046 - TARP Conflicts of Interest

Science.gov (United States)

2011-10-03

... conflict may depend on a variety of factors, including the type of conflict, the scope of work under the... DEPARTMENT OF THE TREASURY 31 CFR Part 31 RIN 1505-AC05 TARP Conflicts of Interest AGENCY... interim rule that provided guidance on conflicts of interest pursuant to Section 108 of the Emergency...

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

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

Science.gov (United States)

2013-09-11

... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Draft..., ``Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN-FIRE).'' In... caused by impaired fire protection features at nuclear power plants. The report documents the history of...

Agency Theory

DEFF Research Database (Denmark)

Linder, Stefan; Foss, Nicolai Juul

Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting and informational conditions, the theory addresses problems of ex...... ante (“hidden characteristics”) as well as ex post information asymmetry (“hidden action”), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

Agency Theory

DEFF Research Database (Denmark)

Linder, Stefan; Foss, Nicolai Juul

2015-01-01

Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting, and informational conditions, the theory addresses problems of ex...... ante (‘hidden characteristics’) as well as ex post information asymmetry (‘hidden action’), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

76 FR 76413 - Agency Forms Undergoing Paperwork Reduction Act Review

Science.gov (United States)

2011-12-07

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

Contribution of a fuzzy expert system to regulatory impact analysis

Directory of Open Access Journals (Sweden)

Marco Antônio da Cunha

2015-09-01

Full Text Available Regulatory Impact Analysis (RIA has been consolidating in Brazilian regulatory agencies throughout the last decades. The RIA methodology aims to examine the regulatory process, measure the costs and benefits generated, as well as other effects of social, political or economic nature caused by a new or an existing regulation. By analysing each regulatory option, the expert or regulator faces a myriad of variables, usually of qualitative nature, that are difficult to measure and with a high degree of uncertainty. This research complements the existing literature, given the scarcity of decision support models in RIA that – regardless of the problem treated – incorporate the tacit knowledge of the regulation expert. This paper proposes an exploratory approach using a Fuzzy Expert System, which therefore helps to enrich the decision process in the final stage of comparison of the regulatory options.

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...

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.

Preparation of safety and regulatory document for BARC Facilities

International Nuclear Information System (INIS)

Prasad, S.S.; Jayarajan, K.

2017-01-01

In India, the necessary codes and safety guidelines for achieving the safety objectives are provided by the Atomic Energy Regulatory Board (AERB), which are in conformity with the principles of radiation protection as formulated by the International Council of Radiation Protection (ICRP) and International Atomic Energy Agency (IAEA). The same is followed by BARC Safety Council (BSC), which is the regulatory body for the BARC facilities. In addition to all types of fuel cycle facilities, BSC regulates safety of many types of conventional facilities. Many such types of facilities and projects are not under the regulatory purview of AERB. Therefore, the Council has also initiated a programme for development and publication of safety documents for installations in BARC in the fields/ topics yet not addressed by IAEA or AERB. This makes the task pioneering, as some of the areas taken up for defining the regulatory requirements are new, where standard regulatory documents are not available

77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

Science.gov (United States)

2012-10-22

...-Basis Hurricane and Hurricane Missiles AGENCY: Nuclear Regulatory Commission. ACTION: Proposed interim...-ISG-024, ``Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles....221, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants.'' DATES: Submit...

Strengthening Regulatory Competence in Pakistan

International Nuclear Information System (INIS)

Sadiq, M.

2016-01-01

Capacity building of Pakistan Nuclear Regulatory Authority is considered an essential element in pursuit of its vision to become a world class regulatory body. Since its inception in 2001, PNRA has continuously endeavoured to invest in its people, develop training infrastructure and impart sound knowledge and professional skills with the aim to improve its regulatory effectiveness. The use of nuclear and radioactive material in Pakistan has increased manifold in recent years, thus induction of more manpower was needed for regulatory oversight. PNRA adopted two pronged approach for meeting the manpower demand (a) employment of university graduates through fast track recruitment drive and (b) induction of graduates by offering fellowships for Master degree programs. Although, the newly employed staff was selected on the basis of their excellent academic qualifications in basic and applied sciences, but they required rigorous knowledge and skills in regulatory perspectives. In order to implement a structured training program, PNRA conducted Training Needs Assessment (TNA) and identified competency gaps of the regulatory staff in legal, technical, regulatory practice and behavioural domains. PNRA took several initiatives for capacity building which included establishment of a training centre for sustainability of trainings, initiation of a fellowship scheme for Master program, attachment of staff at local institutes for on-the-job training and placement at foreign regulatory bodies and organizations for technical development with the assistance of IAEA. The above strategies have been very beneficial in competence building of the PNRA staff to perform all regulatory activities indigenously for nuclear power plants, research reactors and radiation facilities. Provision of vibrant technical support to IAEA and Member States in various programs by PNRA is a landmark of these competence development efforts. This paper summarizes PNRA initiatives and the International Atomic

75 FR 79811 - Department Regulatory Agenda; Semiannual Summary

Science.gov (United States)

2010-12-20

....S.C. 602), DOT's printed agenda entries include only: 1. The Agency's agenda preamble; 2. Rules that... Regulatory Flexibility Act. Printing of these entries is limited to fields that contain information required... transfer of the functions from the Office of Emergency Transportation (OET) to the Office of Intelligence...

75 FR 21723 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

Science.gov (United States)

2010-04-26

... Commission National Science Foundation Office of Government Ethics Office of Management and Budget Office of Personnel Management Peace Corps Pension Benefit Guaranty Corporation Postal Regulatory Commission Railroad... individual data fields. To see a listing of all of an agency's entries, a user can select the agency without...

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

International Nuclear Information System (INIS)

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

1976-12-01

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

Principles of good regulatory research

International Nuclear Information System (INIS)

Rogers, K.

1991-01-01

The Commissioner of the US Regulatory Commission addresses several important research-related subjects. The paper describes the Agency philosophy with respect to independence, openness, efficiency, clarity, and reliability; research philosophy with respect to the need for research, the need for quality, and the need for efficiency; research areas with respect to plant aging, human factors, severe accident analysis, advanced reactors, and radioactive waste management; and systems approach to reactor operations, training, licensing, and maintenance

Data Science and Political Economy: Application to Financial Regulatory Structure

Directory of Open Access Journals (Sweden)

Sharyn O'Halloran

2016-11-01

Full Text Available The development of computational data science techniques in natural language processing and machine learning algorithms to analyze large and complex textual information opens new avenues for studying the interaction between economics and politics. We apply these techniques to analyze the design of financial regulatory structure in the United States since 1950. The analysis focuses on the delegation of discretionary authority to regulatory agencies in promulgating, implementing, and enforcing financial sector laws and overseeing compliance with them. Combining traditional studies with the new machine learning approaches enables us to go beyond the limitations of both methods and offer a more precise interpretation of the determinants of financial regulatory structure.

Is Dual Agency in Real Estate Transactions a Cause for Concern?

OpenAIRE

Vrinda Kadiyali; Jeffrey T. Prince; Daniel H. Simon

2009-01-01

We study dual agency in residential real estate, where the same agent/agency represents both the buyer and seller. We assess the extent to which dual agency suffers from an inherent conflict of interest, where the dual agent furthers the interest of one client at the expense of the other client’s, as well as principal-agent incentive misalignment where the agent furthers her own interest at the expense of one or both clients. And, we examine how these incentive conflicts affect agent behavior...

Professional Self-Regulation and the Public Interest in Canada

Directory of Open Access Journals (Sweden)

Tracey L. Adams

2016-09-01

Full Text Available The regulation of professional groups has often been justified as being in the public interest. In recent decades, policymakers in Anglo-American countries have questioned whether self-regulating professions have truly served the public interest, or whether they have merely acted in their own interests. This paper draws on legislative records and policy reports to explore meanings attached to professional self-regulation and the public interest in Canada by state actors over the past 150 years. The findings point to a shift in the definition of the public interest away from service quality and professional interests, towards efficiency, human rights, consumer choice, and in some contexts business interests. Changing views of the public interest contribute to regulatory change.

78 FR 25128 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amended...

Science.gov (United States)

2013-04-29

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69362A; File No. 600-23] Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amended Application for Registration as a Clearing Agency; Correction AGENCY: Securities and Exchange Commission. ACTION: Notice; correction. SUMMARY...

Transparency of nuclear regulatory activities

International Nuclear Information System (INIS)

2007-01-01

One of the main missions of nuclear regulators is to protect the public, and this cannot be completely achieved without public confidence. The more a regulatory process is transparent, the more such confidence will grow. Despite important cultural differences across countries, a number of common features characterise media and public expectations regarding any activity with an associated risk. A common understanding of transparency and main stakeholders' expectations in the field of nuclear safety were identified during this workshop, together with a number of conditions and practices aimed at improving the transparency of nuclear regulatory activities. These conditions and practices are described herein, and will be of particular interest to all those working in the nuclear regulatory field. Their implementation may, however, differ from one country to another depending on national context. (authors)

Regulatory Promotion of Emergent CCS Technology

Energy Technology Data Exchange (ETDEWEB)

Davies, Lincoln; Uchitel, Kirsten; Johnson, David

2014-01-01

Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensive regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.

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

Science.gov (United States)

2012-02-02

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

A global regulatory science agenda for vaccines.

Science.gov (United States)

Elmgren, Lindsay; Li, Xuguang; Wilson, Carolyn; Ball, Robert; Wang, Junzhi; Cichutek, Klaus; Pfleiderer, Michael; Kato, Atsushi; Cavaleri, Marco; Southern, James; Jivapaisarnpong, Teeranart; Minor, Philip; Griffiths, Elwyn; Sohn, Yeowon; Wood, David

2013-04-18

The Decade of Vaccines Collaboration and development of the Global Vaccine Action Plan provides a catalyst and unique opportunity for regulators worldwide to develop and propose a global regulatory science agenda for vaccines. Regulatory oversight is critical to allow access to vaccines that are safe, effective, and of assured quality. Methods used by regulators need to constantly evolve so that scientific and technological advances are applied to address challenges such as new products and technologies, and also to provide an increased understanding of benefits and risks of existing products. Regulatory science builds on high-quality basic research, and encompasses at least two broad categories. First, there is laboratory-based regulatory science. Illustrative examples include development of correlates of immunity; or correlates of safety; or of improved product characterization and potency assays. Included in such science would be tools to standardize assays used for regulatory purposes. Second, there is science to develop regulatory processes. Illustrative examples include adaptive clinical trial designs; or tools to analyze the benefit-risk decision-making process of regulators; or novel pharmacovigilance methodologies. Included in such science would be initiatives to standardize regulatory processes (e.g., definitions of terms for adverse events [AEs] following immunization). The aim of a global regulatory science agenda is to transform current national efforts, mainly by well-resourced regulatory agencies, into a coordinated action plan to support global immunization goals. This article provides examples of how regulatory science has, in the past, contributed to improved access to vaccines, and identifies gaps that could be addressed through a global regulatory science agenda. The article also identifies challenges to implementing a regulatory science agenda and proposes strategies and actions to fill these gaps. A global regulatory science agenda will enable

Nuclear Regulatory Commission Information Digest: 1993 edition

International Nuclear Information System (INIS)

1993-03-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the U.S. Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1992, with exceptions noted. Information on generating capacity and average capacity factor for operating U.S. commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed. Comments and/or suggestions on the data presented are welcomed and should be directed to Karen Olive, United States Nuclear Regulatory Commission, Office of the Controller, Division of Budget and Analysis, Washington, D.C. 20555. For detailed and complete information about tables and figures, refer to the source publications

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

Regulatory and Stakeholder Involvement is Key to Successful Project Completion

International Nuclear Information System (INIS)

Ballinger, K. S.; Coleman, S. J.; Shoemake, J. M.; Olds, T. E.

2006-01-01

Public involvement participation is an integral and effective component of the U.S. Department of Energy's (DOE) activities that ensures crucial decisions are made with the benefit and consideration of public perspectives. This component brings a broad range of diverse viewpoints and values into DOE's decision-making processes before end decision points are reached. Early involvement enables DOE to make more informed decisions, improve quality through collaborative efforts, and helps to build mutual understanding and trust between DOE and the public it serves. During the cold war, the production of thousands of nuclear warheads was an outstanding engineering achievement that created materials and technologies that were vital to national interest and security; however, it also created a legacy of perplexing toxic nuclear waste. The significant challenges presented by the liquid and solid nuclear wastes stored at the Hanford Site, were formally acknowledged by the U.S. Congress when it directed DOE to establish the Office of River Protection (ORP). The office was assigned the single, dedicated mission of retrieving, treating, and disposing of all waste contained in 177 huge underground storage tanks at the Hanford Site in Southeastern Washington State. As part of this on-going mission of cleanup, the Office of River Protection must make sound decisions that uphold not only the Department of Energy's interests, but more importantly, the interests of the state of Washington. Public participation is an open, ongoing, two-way communication, both formal and informal, between DOE and its stakeholders, regulatory agencies and Tribal governments. Similarly, public information is a means to keep the public informed of progress or to status ongoing activities and/or issues. Another facet of this process is that various laws and regulations govern public participation and information when it comes to Hanford cleanup, including the Hanford Federal Facility Agreement and Consent

7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

Science.gov (United States)

2010-01-01

... Administrator with respect to management, information systems, budgets, and other such matters. (a) The... 7 Agriculture 11 2010-01-01 2010-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program...

7 CFR 773.19 - Interest rate, terms, security requirements, and repayment.

Science.gov (United States)

2010-01-01

... 7 Agriculture 7 2010-01-01 2010-01-01 false Interest rate, terms, security requirements, and... SERVICE AGENCY, DEPARTMENT OF AGRICULTURE SPECIAL PROGRAMS SPECIAL APPLE LOAN PROGRAM § 773.19 Interest rate, terms, security requirements, and repayment. (a) Interest rate. The interest rate will be fixed...

Regulatory Office for Network Industries

International Nuclear Information System (INIS)

2005-01-01

The main goal of the economic regulation of network industries is to ensure a balance between the interests of consumers and investors and to encourage providing high-quality goods and services. The task of the regulatory authority is to protect the interests of consumers against monopolistic behaviour of regulated enterprises. At the same time, the regulatory office has to protect the interests of investors by giving them an opportunity to achieve an adequate return on their investments. And last, but not least, the regulatory office has to provide regulated enterprises with appropriate incentives to make them function in an efficient and effective manner and to guarantee the security of delivery of energies and related services. All this creates an efficient regulatory framework that is capable of attracting the required amount and type of investments. This also means providing third party access to the grids, the opening of energy markets, the un-bundling of accounts according to production, distribution, transmission and other activities and the establishment of a transparent and stable legislative environment for regulated companies, investors and consumers. Otherwise, in the long run consumers may suffer from a serious deterioration of service quality, although in the short run they are protected against increased prices. Under the Act No. 276/2001 Coll. on Regulation of Network Industries and on amendment of some acts the Office for Regulation of Network Industries has been commissioned to implement the main objectives of regulation of network industries. By network industries the Act No. 276/2001 Coll. on Regulation means the following areas: (a) Production, purchase, transit and distribution of electricity; (b) Production, purchase, transit and distribution of gas; (c) Production, purchase and distribution of heat; (d) Water management activities relating to the operation of the public water supply system or the public sewerage system; (e) Water management

Regulação deliberativa: em busca do interesse público na regulação de contratos de concessão de longo prazo / Deliberative Regulation: Searching the Public Interest on the Regulation of Long-Term Concession Contracts

Directory of Open Access Journals (Sweden)

Milton Carvalho Gomes

2018-05-01

Full Text Available Purpose – The purpose of this article is to propose a regulatory model that allows the maintenance of the public interest in situations governed by long-term public contracts, through deliberative democracy tools, and the regulatory agencies have the role of mediation of the deliberative process. Methodology/approach/design – This articles approach is based on the analysis of justifying theories of regulation by the public interest, of theories that refute this possibility (public choice, and of theories that turn to the regulatory design as a way of avoiding the distortion of the purposes of regulation, to assess the possible ways of deliberative regulation of long-term public procurement, as well as the role of agencies in this context. Findings – It was concluded that by means of deliberative procedures, regulation can be constructed to assure the service to the public interest, as well as to maintain it over time, and independent regulatory agencies have the role of mediating the deliberative process between the social actors, public and private, interested. It was also found that deliberative regulation broadens the legitimacy of regulatory acts and reinforces its independence from other spheres of government, with positive results in terms of regulatory governance. Practical implications – The conclusions propose new developments on the regulatory process, form, participants, democratic legitimacy, as well as on the role of independent regulatory Agencies in this process, being able to have immediate application in the modeling of the decision-making process in the regulation of long-term concession contracts. Originality/value – The text is original, as it proposes a new debate in Brazil, about a real difficulty that is the regulation of long-term public contracts and their constant adaptation to the dynamic of variable public interests throughout the time, proposing ways to be followed to solve the issue. Resumo Propósito �

Study on the establishment of efficient plan for regulatory activities at NPPs

Energy Technology Data Exchange (ETDEWEB)

Lee, Sang Hun; Son, Mun Gyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of); Kang, Chang Sun; Yun, Jeong Ik; Ko, Hyun Seok; Lee, Young Wook [Seoul National Univ., Seoul (Korea, Republic of)

2001-03-15

In-operation regulatory activities at sites are very important and it should be improved to cope with accidents efficiently and quickly. In case of site survey and safety regulatory inspection regulatory system based on not regulatory headquarter but site regional office should be constructed. In other words, safety assurance and pending problem management considering site situation are needed. In this study, regulatory system at Nuclear Power Plant sites all over the world were reviewed and effective regulatory system of Korea are suggested to maximize the efficiency of license and regulatory manpower and consider the interest of local government and residents.

Delegation, Presidential Regimes, and Latin American Regulatory Agencies Delegación, regimenes presidenciales y agencias reguladoras en América Latina

Directory of Open Access Journals (Sweden)

Jacint Jordana

2010-04-01

Full Text Available During the 1990s, a large number of regulatory agencies were created or reformed in different sectors in Latin American countries. Almost all included political delegation mechanisms, intended as formal rules to enhance credible commitments to time-consistent policies. In this paper, using an original data set of agencies’ head tenure in the telecommunications and finance regulatory agencies, we discuss if these mechanisms worked as planned, and find a divergence between actual mandates and the formally established fixed terms, effected by means of systematic early resignations. Our findings reveal, however, some consistent patterns of behavior. Stronger legislative presidential power reduced effective delegation to some extent, and agencies’ organizational strengths protected them from patron-age. We also confirmed the existence of some significant differences be-tween the two sectors examined. Having slightly weaker delegation rules, delegation practices were also less effective in telecommunications than in financial services, contrary to expectations about credible commitments. Durante los años 1990, muchas agencias reguladoras fueron creadas o reformadas en diferentes sectores en los países latinoamericanos. Casi todas incluyeron mecanismos de delegación política, entendidos como reglas formales para mejorar los compromisos creíbles sobre políticas que requieren coherencia en el tiempo. En este trabajo, utilizando un conjunto de datos originales sobre los responsables de las agencias reguladoras de las telecomunicaciones y de las finanzas, se discute si estos mecanismos funcionaron como estaba previsto, identificándose una divergencia entre los mandatos reales y los términos formalmente establecidos, debido a la existencia de numerosas renuncias anticipadas. Nuestros hallazgos revelan, sin embargo, algunos patrones consistentes de comportamiento: un mayor poder presidencial sobre el legislativo reduce la delegación efectiva

Regulatory authority infrastructure for Namibia

International Nuclear Information System (INIS)

Shangula, K.

2001-01-01

The Republic of Namibia is participating in the International Atomic Energy Agency's Model Project for the Improvement of National Regulatory Authority Infrastructures in Member States. The paper illustrates our experience in solving problems and difficulties confronted in establishing an effective regulatory authority operating within the existing national infrastructure that should be supported by the Government. An effective regulatory authority is seen as part of the wider administrative scope of our Government through ministerial mandates given by the State from time to time, guaranteeing its independence when implementing legal provisions under statutes. Sections of the report illustrate our experience in the following areas: 1. National radiation protection policy 2. Structure of our national regulatory authority 3. Laws and regulations 4. Provisions for notification, authorization and registration 5. In-depth security measures for radiation sources and radioactive material 6. Systems for the inspection of radiation sources, radioactive materials, enforcement of legal provisions 7. Extent of the applications of radiation sources and radioactive materials in the country. The paper provides information regarding existing Government policy on radiation protection; structure and legal aspects of the national regulatory, including statutes and regulations; the extent of application and uses of radiation sources and security of radioactive materials; human resources: strengths and constraints; management practices and financing of regulatory authority; and plans for emergency recovery of orphan sources. National plans for management of disused sources, recovery of orphan sources, abnormal emergencies, communication of information to affected persons on exposure effects, and the safety training of persons using these applications are discussed. the paper provides a summary and some suggestions of the way forward for Namibia. (author)

Nuclear Regulatory Commission Information Digest, 1991 edition

International Nuclear Information System (INIS)

Olive, K.L.

1991-03-01

The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, and the areas NRC licenses. This digest is a compilation of NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1990, with exceptions noted. For operating US commercial nuclear power reactors, information on generating capacity and average capacity factor is obtained from Monthly Operating Reports submitted to the NRC directly by the licensee. This information is reviewed for consistency only. No independent validation and/or verification is performed by the NRC. For detailed and complete information about tables and figures, refer to the source publications. This digest is published annually for the general use of the NRC staff and is available to the public. 30 figs., 12 tabs

78 FR 29364 - Seminole Electric Cooperative, Inc., and Florida Municipal Power Agency v. Duke Energy Florida...

Science.gov (United States)

2013-05-20

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-63-000] Seminole Electric Cooperative, Inc., and Florida Municipal Power Agency v. Duke Energy Florida, Inc.; Notice of... of the Federal Energy Regulatory Commission (Commission), 18 CFR 385.206 and sections 206, 306, and...

76 FR 78181 - Prohibition Against Conflicts of Interest in Certain Securitizations

Science.gov (United States)

2011-12-16

... 3235-AL04 Prohibition Against Conflicts of Interest in Certain Securitizations AGENCY: Securities and...'') on material conflicts of interest in connection with certain securitizations (the ``ABS Conflicts... the ABS Conflicts Proposal until January 13, 2012. This action will allow interested persons...

Mission Risk Reduction Regulatory Change Management

Science.gov (United States)

Scroggins, Sharon

2007-01-01

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

Transfer of Canadian nuclear regulatory technology

International Nuclear Information System (INIS)

Harvie, J.D.

1985-10-01

This paper discusses the Canadian approach to the regulation of nuclear power reactors, and its possible application to CANDU reactors in other countries. It describes the programs which are in place to transfer information on licensing matters to egulatory agencies in other countries, and to offer training on nuclear safety regulation as it is practised in Canada. Experience to date in the transfer of regulatory technology is discussed. 5 refs

76 FR 2747 - Reports, Forms and Recordkeeping Requirements, Agency Information Collection Activity Under OMB...

Science.gov (United States)

2011-01-14

... entities over which the agency exercises regulatory authority. Recent trends lead the agency to estimate... confidential business information provisions of 49 CFR Part 512. Requesters are not required to keep copies of any records or reports submitted to us. As a result, the cost imposed to keep records would be zero...

Regulatory aspects of mixed waste

International Nuclear Information System (INIS)

Boyle, R.R.; Orlando, D.A.

1990-01-01

Mixed waste is waste that satisfies the definition of low-level radioactive waste in the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) and contains hazardous waste that is either: (1) listed as a hazardous waste in 40 CFR 261, Subpart D; or (2) causes the waste to exhibit any of the characteristics identified in 40 CFR 261, Subpart C. Low-level radioactive waste is defined in the LLRWPAA as radioactive material that is not high level waste, spent nuclear fuel, or byproduct material, as defined in Section 11e(2) of the Atomic Energy Act of 1954, and is classified as low-level waste by the U.S. Nuclear Regulatory Commission (NRC). This paper discusses dual regulatory (NRC and Environmental Protection Agency) responsibility, overview of joint NRC/EPA guidance, workshops, national mixed waste survey, and principal mixed waste uncertainties

Development of Questionnaire for Self-Assessment of Regulatory Capture

Energy Technology Data Exchange (ETDEWEB)

Muhmood, Ul Hassan; Lee, Young Eal [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2014-10-15

Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture.

Development of Questionnaire for Self-Assessment of Regulatory Capture

International Nuclear Information System (INIS)

Muhmood, Ul Hassan; Lee, Young Eal; Choi, Kwang Sik

2014-01-01

Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture

78 FR 50409 - Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric...

Science.gov (United States)

2013-08-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL13-84-000] Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric Company, LLC, Southwest... 306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the Federal Energy Regulatory...

U.S. Nuclear Regulatory Commission Process for Risk-Informing the Nuclear Waste Arena

International Nuclear Information System (INIS)

Leslie, B. W.

2003-01-01

The U.S. Nuclear Regulatory Commission (NRC) is increasing the use of risk insights and information in its regulation of nuclear materials and waste. The objective of this risk-informed regulatory effort is to improve the effectiveness and efficiency of the agency, while maintaining or increasing its focus on safety. The agency's Office of Nuclear Material Safety and Safeguards (NMSS) proposed a five-step process to carry out a framework for increasing the use of risk information and insights in its regulation of nuclear materials and waste. The office is carrying out the five-step process to risk-inform the nuclear materials and waste arenas. NMSS's actions included forming a Risk Task Group and the use of case studies to test and complete screening criteria for identifying candidate regulatory applications amenable for risk-informing. Other actions included involving stakeholders through enhanced public participation, developing safety goals for materials and waste regulatory applications, and establishing a risk training program for staff. Through the case studies, NRC staff found the draft screening criteria to be effective in deciding regulatory areas that may be amenable to an increased use of risk insights. NRC staff also found that risk information may have the potential to reduce regulatory burden and improve staff's efficiency in making decisions, while maintaining safety. Finally, staff found that it would be possible to develop safety goals for the nuclear materials and waste arenas

Wetlands: The changing regulatory landscape

International Nuclear Information System (INIS)

Glick, R.M.

1993-01-01

Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his open-quotes environmental presidency.close quotes As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is open-quotes buildableclose quotes from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands

Blockchains and Bitcoin: Regulatory responses to cryptocurrencies

OpenAIRE

Guadamuz, Andres; Marsden, Chris

2015-01-01

This paper examines Bitcoin from a legal and regulatory perspective, answering several important questions.\\ud \\ud We begin by explaining what Bitcoin is, and why it matters. We describe problems with Bitcoin as a method of implementing a cryptocurrency. This introduction to cryptocurrencies allows us eventually to ask the inevitable question: is it legal? What are the regulatory responses to the currency? Can it be regulated?\\ud \\ud We make clear why virtual currencies are of interest, how s...

77 FR 24 - Prohibition Against Conflicts of Interest in Certain Securitizations

Science.gov (United States)

2012-01-03

... 3235-AL04 Prohibition Against Conflicts of Interest in Certain Securitizations AGENCY: Securities and...'') on material conflicts of interest in connection with certain securitizations (the ``ABS Conflicts... Conflicts Proposal until February 13, 2012. This action will allow interested persons additional time to...

Credit Rating Agencies, Financial Regulations and the Capital Markets

NARCIS (Netherlands)

K. Shahzad (Khurram)

2013-01-01

textabstractThis thesis studies the role of credit rating agencies (CRAs) in capital markets, and the effects of two important regulatory decisions that are taken to improve the quality of information available to the capital markets. In particular, this thesis examines a) the importance of credit

Regulatory perspectives of concept assessment

International Nuclear Information System (INIS)

Flavelle, Peter A.

1987-09-01

The Atomic Energy Control Board is the head agency for the regulatory review of the Assessment of the Canadian Concept for Nuclear Fuel Waste Disposal being done by Atomic Energy of Canada Limited and Ontario Hydro. This paper describes the regulatory perspective of how the Concept Assessment could demonstrate the feasibility of a disposal conforming to regulatory requirements. The long-term aspects of Concept Assessment encourage the use of various predictive techniques for different time scales. Each technique will have a different potential for establishing confidence in the predictions. The predicted performance of a facility during operation should have a very high confidence, as it can be based on standard engineering calculations and the predictions can be validated later by monitoring during operation. The predictions of the transient period following closure of the facility should achieve a medium level of confidence, since they can be based on extrapolations of predictions of operational performance, using models that can be calibrated with monitoring data and with averaged input data derived from natural analog studies. Predictions based on fundamental processes will have a medium level of confidence when made to intermediate times after closure. Long-term predictions using generic or typical input data or Monte Carlo calculations of simplified models will have the least confidence and yet they can still contribute to the confidence that the disposal concept will conform to regulatory requirements

78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Science.gov (United States)

2013-02-19

...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... introduction of byproduct material into products or materials and transfer of the products or materials to..., Office of Information and Regulatory Affairs (3150-0001), NEOB-10202, Office of Management and Budget...

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities. Japan

International Nuclear Information System (INIS)

2017-01-01

The NEA has updated, in coordination with the Permanent Delegation of Japan to the OECD, the report on the Regulatory and Institutional Framework for Nuclear Activities in Japan. This country report provides comprehensive information on the regulatory and institutional framework governing nuclear activities in Japan. It provides a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. Content: I - General Regulatory Regime: Introduction; Mining regime; Radioactive substances and equipment; Nuclear installations (Reactor Regulation, Emergency response); Trade in nuclear materials and equipment; Radiological protection; Radioactive waste management; Nuclear safeguards and nuclear security; Transport; Nuclear third party liability. II - Institutional Framework: Regulatory and supervisory authorities (Cabinet Office, Nuclear Regulation Authority (NRA), Ministry of Economy, Trade and Industry (METI), The Agency for Natural Resources and Energy (ANRE), Ministry of Land, Infrastructure, Transport and Tourism (MLIT), Ministry of Education, Culture, Sports, Science and Technology (MEXT)); Advisory bodies (Atomic Energy Commission (AEC), Reactor Safety Examination Committee, Nuclear Fuel Safety Examination Committee, Radiation Council, Other advisory bodies); Public and semi-public agencies (Japan Atomic Energy Agency (JAEA), National Institutes for Quantum and Radiological Science and Technology (QST), Nuclear Damage Compensation and Decommissioning Facilitation Corporation (NDF), Nuclear Waste Management Organisation (NUMO))

Southern state radiological emergency preparedness and response agencies

International Nuclear Information System (INIS)

1988-11-01

This Report provides information on the state agencies assigned to radioactive materials transportation incidents in 16 Southern States Energy Board member states. For each, the report lists the agencies with primary authority for preparedness and response, their responsibilities and personnel within the agencies who can offer additional information on their radioactive materials transportation programs. The report also lists each state's emergency team members and its laboratory and analytical capabilities. Finally, the governor's designee for receiving advance notification of high-level radioactive materials and spent fuel shipments under 10 CFR Parts 71 and 73 of the US Nuclear Regulatory Commission's regulations is listed for each state. Part 71 requires prenotification for large quantity radioactive waste shipments. Part 73 addresses prenotification for spent nuclear reactor fuel shipments

77 FR 38397 - Agency Information Collection (Interest Rate Reduction Refinancing Loan Worksheet) Activities...

Science.gov (United States)

2012-06-27

... . Please refer to ``OMB Control No. 2900- 0386.'' SUPPLEMENTARY INFORMATION: Title: Interest Rate Reduction... guaranty on all interest rate reduction refinancing loan and provide a receipt as proof that the funding... ensure lenders computed the funding fee and the maximum permissible loan amount for interest rate...

77 FR 6517 - Economic Development Administration Regulatory Revision; Comment Period Extension

Science.gov (United States)

2012-02-08

... DEPARTMENT OF COMMERCE Economic Development Administration 13 CFR Parts 300, 301, 302, 303, 304... Development Administration Regulatory Revision; Comment Period Extension AGENCY: Economic Development.... SUMMARY: On December 7, 2011, the Department of Commerce's Economic Development Administration (EDA...

Training the staff of the regulatory body for nuclear facilities: A competency framework

International Nuclear Information System (INIS)

2001-11-01

The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

Training the staff of the regulatory body for nuclear facilities: A competency framework

International Nuclear Information System (INIS)

2002-11-01

The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

[Regulatory supervision and radiation survey in the area of location of former military technical bases].

Science.gov (United States)

Shandala, N K; Kiselev, S M; Titov, A V; Seregin, V A; Isaev, D V; Akhromeev, S V; Filonova, A A; Semenova, M P; Gimadova, T I; Aladova, R A; Kosnikov, A S; Shchelkanova, E S; Luk'ianets, A I

2013-01-01

Activities related to the rehabilitation of areas and facilities of the temporary storage of spent nuclear fuel and radioactive waste (SNF and RW) at Andreeva Bay and Gremikha on the Kola Peninsula and in the Primorsky Krai in the Russian Far East is an important component of the regulatory functions of the Federal Medical biological Agency (FMBA of Russia). Technical support to the FMBA of Russia in this activity is provided by A.L Burnazyan Federal Medical Biophysical Center Main research interests include evaluation of radiological threats to determine the priority directions of regulation, a detailed analysis of the radiation situation at areas, territories and in vicinity of temporary waste storage facilities, radiation control and environmental monitoring, the development of digital maps and geoinformation systems, project expertise in the field of rehabilitation of PVC including the management of SNF and RW Implementation of these natural, practical and theoretical works is completed by development a set of regulatory documents ensuring adherence to radiation safety for the stuff population and the environment, and the also documents governing the management of SNF and RW waste in the territories of PVC.

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.)

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.

7 CFR 1951.241 - Special provision for interest rate change.

Science.gov (United States)

2010-01-01

... 7 Agriculture 14 2010-01-01 2009-01-01 true Special provision for interest rate change. 1951.241... Community and Direct Business Programs Loans and Grants § 1951.241 Special provision for interest rate... interest rate charged by FmHA or its successor agency under Public Law 103-354 to water and waste disposal...

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Denmark

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister for the Environment/Minister of Transport and Energy; Minister of Justice; Minister of Defence; National Board of Health; Emergency Management Agency); 2. Advisory bodies (The Danish Ministry of Energy, Supply and Climate and the Danish Energy Agency); 3. Public and semi-public agencies (Risoe National Laboratory)

76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

Science.gov (United States)

2011-02-03

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

76 FR 20892 - Prohibition Against Payment of Interest on Demand Deposits

Science.gov (United States)

2011-04-14

... Interest on Demand Deposits AGENCY: Board of Governors of the Federal Reserve System. ACTION: Notice of... proposed amendments that would repeal Regulation Q, Prohibition Against Payment of Interest on Demand... interest on demand deposits by institutions that are member banks of the Federal Reserve System set forth...

40 CFR 13.12 - Interest and charges pending waiver or review.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Interest and charges pending waiver or review. 13.12 Section 13.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL CLAIMS COLLECTION STANDARDS Collection § 13.12 Interest and charges pending waiver or review. Interest, penalty...

22 CFR 213.13 - Interest and charges pending waiver or review.

Science.gov (United States)

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Interest and charges pending waiver or review. 213.13 Section 213.13 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT CLAIMS COLLECTION Collection § 213.13 Interest and charges pending waiver or review. Interest, penalty charges and...

76 FR 48908 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2011-08-09

...-mail addresses, school information/grades, employment information/histories, and works of writing... minimized, including the use of automated collection techniques or other forms of information technology... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0160] Agency Information Collection Activities...

Role of the Nuclear Regulatory Authority in the final disposal of radioactive wastes in Argentina

International Nuclear Information System (INIS)

Petraitis, E.J.; Siraky, G.; Novo, R.G.

1998-01-01

This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. The activities of the Nuclear Regulatory Authority (ARN) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. (author) [es

7 CFR 1403.9 - Late payment interest and administrative charges.

Science.gov (United States)

2010-01-01

... apply: (i) To debts owed by Federal agencies and State and local governments. Interest on debts owed by... the rate of interest charged by the U.S. Treasury for funds borrowed by CCC on the day the debt became... shall be expressed as an annual rate of interest which CCC charges on delinquent debts. The late payment...

75 FR 20810 - Proposed Information Collection; Comment Request; Statement of Financial Interests, Regional...

Science.gov (United States)

2010-04-21

... Collection; Comment Request; Statement of Financial Interests, Regional Fishery Management Councils AGENCY... must provide an update of their statements at any time any such financial interest is acquired, or... financial interest in any Council fishery. These interests include harvesting, processing, lobbying...

Development of joint regulatory guidance on the management of higher activity radioactive wastes on nuclear licensed sites - 16095

International Nuclear Information System (INIS)

Bacon, Mick; Ilett, Doug; Whittall, Andy

2009-01-01

In 2006 the UK Government's response (1) to recommendations by its Committee on Radioactive Waste Management (CoRWM) established, in England and Wales, that geological disposal, supported by safe and secure interim storage, is the preferred route for the long-term management of higher-activity radioactive waste (i.e. that which is not suitable for near-surface disposal). It also gave the responsibility for delivering the programme for a deep geological repository to the Nuclear Decommissioning Authority (NDA). The Scottish Government has a policy of long term, near site, near surface safe and secure interim storage. To support the open and transparent approach promised by Government, the Health and Safety Executive (HSE), the Environment Agency and the Scottish Environment Protection Agency (SEPA) are developing joint guidance on the management of higher-activity radioactive waste to explain regulatory objectives in securing safe and secure interim storage and the associated management of radioactive wastes. The guidance comes in two parts: - Guidance on the regulatory process; - Technical guidance modules. The guidance promotes a cradle to grave approach to radioactive waste management and by aligning the regulatory interests of environmental and safety regulators it delivers one of the Government's 'Better Regulation' objectives. This paper describes the process by which the joint guidance was produced with particular emphasis on stakeholder engagement. It describes the key features of the guidance, including the concept of the radioactive waste management case (RWMC). Finally the problems encountered with dissemination and implementation are discussed together with measures taken by the regulators to improve these aspects. (1) : UK Government and the devolved administrations, 'Response to the Report and Recommendations from the Committee on Radioactive Waste Management (CoRWM)', (PB 12303) October 2006. www

Nuclear Regulatory Commission Issuances: Opinions and decisions of the Nuclear Regulatory Commission with selected orders. Progress report, January 1, 1996--June 30, 1996. Volume 43, pages 1-358

International Nuclear Information System (INIS)

1997-01-01

The hardbound edition of the Nuclear Regulatory Issuances is a final compilation of the monthly issuances. It includes all legal precedents for the agency within a six month period. This is the forty-third volume of issuances

Nuclear Regulatory Commission Issuances: Opinions and decisions of the Nuclear Regulatory Commission with selected orders. Progress report, January 1, 1996--June 30, 1996. Volume 43, pages 1-358

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-05-01

The hardbound edition of the Nuclear Regulatory Issuances is a final compilation of the monthly issuances. It includes all legal precedents for the agency within a six month period. This is the forty-third volume of issuances.

The role of effective communications in Nuclear Regulatory Commission licensing

International Nuclear Information System (INIS)

Counsil, W.G.

1991-01-01

Communications are essential to the licensing and general regulatory program of the Nuclear Regulatory Commission. This paper attempts to identify and address certain aspects of, and approaches to, maintaining effective and efficient communications. It considers, from the perspective of the high-level radioactive waste repository program, both internal communication within the DOE itself and external communication with the Nuclear Regulatory Commission and interested parties. Many of the points presented are based on lessons learned from electric utility experience with nuclear plants

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

International Nuclear Information System (INIS)

Anon.

1986-01-01

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

The natural gas industry and interest rates

International Nuclear Information System (INIS)

Yoon, Y.J.

1995-01-01

In discussing the impact of Federal Energy Regulatory Commission (FERC) Order 636, the latest rule on the restructuring and deregulation of the US natural gas industry, the effect of interest rates on the success of the FERC policy is often overlooked. The thesis of this paper is that interest rates play an important role in integrating seasonal gas markets and in stimulating investment in storage infrastructure. We propose a model to analyse the equilibrium condition for an efficient gas market. Also analysed are the implications of pipeline rate design of FERC 636 for gas despatch decisions. (author)

78 FR 61153 - Post-Employment Conflict of Interest Regulations; Exempted Senior Employee Positions

Science.gov (United States)

2013-10-03

... Regulations; Exempted Senior Employee Positions AGENCY: Office of Government Ethics (OGE). ACTION: Final rule... notice of the revocation of certain regulatory exemptions of senior employee positions at the Securities... employee'' for a period of one year from knowingly making, with the intent to influence, any communication...

Regulatory issues of natural gas distribution; Aspectos regulatorios acerca da distribuicao de gas natural

Energy Technology Data Exchange (ETDEWEB)

Leite, Fabio Augusto C.C.M.; Costa, Hirdan Katarina de M. [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Faculdade de Direito

2004-07-01

In these past few years, natural gas in Brazil has arised as one of the alternatives for the energetic crisis suffered by the country. Such situation was one of the motives for its expansion, rising, after that, the importance of the regulation of its distribution. The regulation of canalized natural gas distribution can be found in the Federal Constitution, after Constitutional Amendment n. 05/95, in the article n. 25, para. 2nd, which say that belongs to the Federal States the concession or direct exercise of canalized natural gas services, now clearly classified as a public service. In order of these events, its imperative the analysis of natural gas distribution's public service, because it belongs to the Federal States. According to this situation, the study of the new regulatory function of the Administration and the tracing of action for the regulatory state agencies are the main goals of this work. As so, the present research aims to focus the reflexes from the actual dimension of natural gas distribution, specially referring to its regulatory statements, the limitations of state agencies, the National Petroleum Agency and the market where distribution belongs, and particularly the open access of new agents. (author)

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...

Factors Influencing Trust in Agencies That Disseminate Tobacco Prevention Information.

Science.gov (United States)

Ranney, Leah M; Jarman, Kristen L; Baker, Hannah M; Vu, Maihan; Noar, Seth M; Goldstein, Adam O

2018-04-01

Several health-related agencies administer national and targeted public education campaigns to provide health information and change health-related behaviors. The trust the public has in these agencies as the source of the message impacts the effectiveness of their communication campaigns. In this study, we explore the perceived trust of agencies that communicate health messages in the tobacco control field. As part of a larger tobacco regulatory science study, we conducted six 90-min focus groups comprising 41 participants. Five main themes emerged pertinent to the agency: (1) its integrity, (2) its competence, (3) its motives, (4) how it is portrayed in the media, and (5) skepticism and mistrust about it. Given the significant resources spent on health messaging to the public and potential benefits offered by this communication, an understanding of public trust in the agencies as the source of health messages is important. Findings suggest health information may be ignored or discounted when there is mistrust in the agency sending those messages.

18 CFR 367.2540 - Account 254, Other regulatory liabilities.

Science.gov (United States)

2010-04-01

... accounts, imposed on the service company by the ratemaking actions of regulatory agencies. (See Definitions § 367.1(a)(38).) (b) The amounts included in this account are to be established by those credits which... authorized to charge for its services; or refunds to customers, not provided for in other accounts, will be...

77 FR 40385 - Withdrawal of Regulatory Guide 7.3; Procedures for Picking Up and Receiving Packages of...

Science.gov (United States)

2012-07-09

... Picking Up and Receiving Packages of Radioactive Material AGENCY: Nuclear Regulatory Commission. ACTION.... Nuclear Regulatory Commission (NRC or Commission) is withdrawing RG 7.3, ``Procedures for Picking Up and... Public Document Room (PDR) reference staff at 1-800-397-4209, or 301-415-4737, or by email at PDR...

77 FR 72296 - Public Meeting of the U.S.-Canada Regulatory Cooperation Council (RCC) Motor Vehicles Working Group

Science.gov (United States)

2012-12-05

... the initiatives identified in the Joint Action Plan, bilateral working groups led by senior officials... Plan, bilateral working groups led by senior officials from regulatory agencies have developed work... Vehicles Working Group AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION...

7 CFR 37.8 - Financial interest of official.

Science.gov (United States)

2010-01-01

... REGULATIONS PROGRAM TO ASSESS ORGANIC CERTIFYING AGENCIES § 37.8 Financial interest of official. No auditor or other Department official shall review any programs or documents concerning a certification program in...

Status report on NRC's current below regulatory concern activities

International Nuclear Information System (INIS)

Dragonette, K.S.

1988-01-01

The concept of below regulatory concern (BRC) is not new to the Nuclear Regulatory Commission (NRC) or its predecessor agency, the Atomic Energy Commission. The regulations and licensing decisions have involved limited and de facto decisions on BRC since the beginning. For example, consumer products containing radioactive materials have been approved for distribution to persons exempt from licensing for some time and procedures for survey and release of equipment have traditionally been a part of many licensees' radiation safety programs. However, these actions have generally been ad hoc decisions in response to specific needs and have not been necessarily consistent. The need to deal with this regulatory matter has been receiving attention from both Congress and the NRC Commissioners. NRC response has grown from addressing specific waste streams, to generic rulemaking for wastes, and finally to efforts to develop a broad generic BRC policy. Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 addressed NRC actions on specific waste streams. In response, NRC issued guidance on rulemaking petitions for specific wastes. NRC also issued an advance notice of proposed rulemaking indicating consideration of Commission initiated regulations to address BRC wastes in a generic manner. The Commissioners have directed staff to develop an umbrella policy for all agency decisions concerning levels of risk or dose that do not require government regulation

Challenges in Establishing New Regulatory Body in Sri Lanka

International Nuclear Information System (INIS)

Hikkaduwa Liyanage, A.R.

2016-01-01

Sri Lanka's involvement with Nuclear Science and Technology began in 1957 when it became a member of the International Atomic Energy Agency. This was followed by the establishment of the Radioisotope Centre of the University of Colombo in 1962 and the establishment of the Atomic Energy Authority (AEA) in 1969 by the Atomic Energy Authority Act no. 19 of 1969. The Atomic Energy Authority Act delegated two main responsibilities to the AEA, namely, promotion of the utilization of nuclear technology for the benefit of the people of Sri Lanka, and protection of workers engaged in using radiation and radioisotopes and the public from harmful effects of ionizing radiation. Until 2014, the Atomic Energy Authority functioned as the national regulatory authority on use of radiation and radioisotopes, the national organization responsible for facilitating the use of nuclear technology in medical, industrial and agricultural sectors and as the focal point of the International Atomic Energy Agency in Sri Lanka. With the expansion of uses of radiation in Sri Lanka and commencement of use of high activity sources by the AEA for development and business activities, the need for an independent regulatory authority was realized. The importance of establishment of independent regulatory body for Sri Lanka was also emphasized by the IAEA in several advisory missions conducted in Sri Lanka and as results; a new Act on Atomic Energy was promulgated.

Inspection and enforcement by the regulatory body 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 should be used in conjunction with that document. The purpose of this Guide is to provide information, guidance and recommendations to assist Member States in (1) establishing and conducting a regulatory inspection programme for nuclear power plants, (2) establishing requirements for the applicant/licensee in regard to regulatory inspection, (3) establishing a system for enforcing compliance with the requirements and decisions of the regulatory body

77 FR 36010 - Agency Information Collection Activities; Agency Information Collection Activities; Proposed...

Science.gov (United States)

2012-06-15

... Respondents, Local Jails and State Prisons ACTION: 60-day notice. The Department of Justice (DOJ), Office of..., students, the media, others interested in criminal justice statistics, and the general public. (5) An... DEPARTMENT OF JUSTICE Office of Justice Programs [OMB No. 1121-0249] Agency Information Collection...

Economic analysis requirements in support of orbital debris regulatory policy

Science.gov (United States)

Greenberg, Joel S.

1996-10-01

As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

Congressional interest and input

International Nuclear Information System (INIS)

Donnelly, W.H.

1985-01-01

While congressional interest in nonproliferation policy has been evident since the 1940s, the 1970s were propitious for efforts by Congress to exert influence in this sphere. Its suspicions of the executive branch had been stirred by controversies over Vietnam and Watergate at the beginning of the decade; by the end of the decade, Congress was able to curtail the unrestrained freedom of the executive branch to carry out the vaguely stated policies of the Atomic Energy Act of 1954. Congressional nonproliferation interests were further amplified during the decade by pressures from the expanding environmental movement, which included a strong antinuclear plank. This was to bring down the powerful Atomic Energy Commission (AEC). The Energy Reorganization Act of 1974 abolished the AEC and divided its responsibilities between the new Energy Research and Development Administration (ERDA), later to become the Department of Energy (DOE), and the new Nuclear Regulatory Commission

76 FR 54986 - NRC Enforcement Policy

Science.gov (United States)

2011-09-06

... NUCLEAR REGULATORY COMMISSION 10 CFR Chapter I [NRC-2011-0209] NRC Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Proposed enforcement policy revision; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is soliciting comments from interested...

Creating a comprehensive, efficient, and sustainable nuclear regulatory structure. A Process Report from the U.S. Department of Energy's Material Protection, Control and Accounting Program

International Nuclear Information System (INIS)

Davis, Gregory E.; Brownell, Lorilee; Wright, Troy L.; Tuttle, John D.; Cunningham, Mitchel E.; O'Brien, Patricia E.

2006-01-01

This paper describes the strategies and process used by the U.S. Department of Energy's (DOE) nuclear Material Protection, Control and Accounting (MPC and A) Regulatory Development Project (RDP) to restructure its support for MPC and A regulations in the Russian Federation. The RDP adopted a project management approach to defining, implementing, and managing an effective nuclear regulatory structure. This approach included defining and developing the regulatory documents necessary to provide the Russian Federation with a comprehensive regulatory structure that supports an effective and sustainable MPC and A Program in Russia. This effort began in February 2005, included a series of three multi-agency meetings in April, June, and July, and culminated in August 2005 in a mutually agreed-upon plan to define and populate the nuclear regulatory system in the Russian Federation for non-military, weapons-usable material. This nuclear regulatory system will address all non-military Category I and II nuclear material at the Russian Federal Atomic Energy Agency (Rosatom), the Russian Agency for Industry (Rosprom), and the Federal Agency for Marine and River Transport (FAMRT) facilities; nuclear material in transport and storage; and nuclear material under the oversight of the Federal Environmental, Industrial and Nuclear Supervisory Service of Russia (Rostechnadzor). The Russian and U.S. MPC and A management teams approved the plan, and the DOE National Nuclear Security Administration's (NNSA) NA-255, Office of Infrastructure and Sustainability (ONIS), is providing funding. The Regulatory Development Project is managed by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy's (DOE) NNSA

Food irradiation regulatory development in the U.S

International Nuclear Information System (INIS)

Miller, S.A.; Coleman, E.C.

1985-01-01

The Food and Drug Administration's involvement in food irradiation dates back more than thirty years. The agency has been involved with the wholesomeness testing of the irradiated foods from both nutritional and toxicological standpoints. Knowledge about the nutritional and toxicological aspects of irradiated foods is fundamental in the development of a regulatory strategy for assuring the safe use of such foods. (author)

Standard specification for agencies performing nondestructive testing

CERN Document Server

American Society for Testing and Materials. Philadelphia

2009-01-01

1.1 This specification covers minimum requirements for agencies performing nondestructive testing (NDT). 1.2 When using this specification to assess the capability of, or to accredit NDT agencies, Guide E 1359 shall be used as a basis for the survey. It can be supplemented as necessary with more detail in order to meet the auditor's specific needs. 1.3 This specification can be used as a basis to evaluate testing or inspection agencies, or both, and is intended for use for the qualifying or accrediting, or both, of testing or inspection agencies, public or private. 1.4 The use of SI or inch-pound units, or combination thereof, will be the responsibility of the technical committee whose standards are referred to in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to...

U.S. Nuclear Regulatory Commission fiscal year 1980 supplemental budget request

International Nuclear Information System (INIS)

1979-01-01

The proposed supplemental will enable the Nuclear Regulatory Commission to implement necessary additional effort arising from the agency's assessment of the accident at the Three Mile Island Unit 2 facility on March 28, 1979. The TMI accident has had a major impact on all NRC program areas, in particular on research activities and reactor operations. In addition, funds are requested to enhance the agency's Waste Management program to reflect the recommendations of the President's Interagency Review Group on Waste Management. Specific activities involved in this effort will include developing regulatory guidance, developing a licensing review capability and completing a plan for the site characterization review, all in support of the preparation of NRC guidelines necessary to conduct a construction authorization review. FY 1980 appropriations did not include funds to cover these requirements. A detailed analysis across program lines of the supplemental request is contained in this report

Queer in STEM Organizations: Workplace Disadvantages for LGBT Employees in STEM Related Federal Agencies

Directory of Open Access Journals (Sweden)

Erin A. Cech

2017-02-01

Full Text Available Lesbian, gay, bisexual, and transgender (LGBT individuals in U.S. workplaces often face disadvantages in pay, promotion, and inclusion and emergent research suggests that these disadvantages may be particularly pernicious within science and engineering environments. However, no research has systematically examined whether LGBT employees indeed encounter disadvantages in science, technology, engineering and math (STEM organizations. Using representative data of over 30,000 workers employed in six STEM-related federal agencies (the Department of Energy, the Environmental Protection Agency, the National Science Foundation, NASA, the Nuclear Regulatory Commission, and the Department of Transportation, over 1000 of whom identify as LGBT, we compare the workplace experiences of LGBT employees in STEM-related federal agencies with those of their non-LGBT colleagues. Across numerous measures along two separate dimensions of workplace experiences—perceived treatment as employees and work satisfaction—LGBT employees in STEM agencies report systematically more negative workplace experiences than their non-LGBT colleagues. Exploring how these disadvantages vary by agency, supervisory status, age cohort, and gender, we find that LGBT persons have more positive experiences in regulatory agencies but that supervisory status does not improve LGBT persons’ experiences, nor do the youngest LGBT employees fare better than their older LGBT colleagues. LGBT-identifying men and women report similar workplace disadvantages. We discuss the implications of these findings for STEM organizations and STEM inequality more broadly.

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...

Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

2000-09-01

This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

Innovations in the Delivery of Regulatory Services in Australia

International Nuclear Information System (INIS)

Dillich, J.

2016-01-01

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the country’s primary authority on radiation protection and nuclear safety. ARPANSA aims to promote safety, security, and emergency preparedness through efficient and effective regulation of nuclear installations, controlled facilities, and radiation sources. Recent initiatives to improve regulation by ‘cutting red tape’ and reducing regulatory burden have been introduced. ARPANSA’s Regulatory Delivery Model emphasises the key elements to good regulation and describes initiatives such as baseline inspection schedule, Performance Objectives and Criteria, and performance deficiencies. These and other initiatives have streamlined inspection efforts, increased risk-based oversight and risk-informed decision making, leading to increased efficiencies for both regulator and licence holder. In addition, ARPANSA has introduced 12 key performance indicators in its self-assessment of regulatory performance against the Australian Government’s Regulator Performance Framework. (author)

Current and future applications of PRA in regulatory activities

Energy Technology Data Exchange (ETDEWEB)

Speis, T.P.; Murphy, J.A.; Cunningham, M.A. [Nuclear Regulatory Commission, Washington, DC (United States)] [and others

1995-04-01

Probabilistic Risk Assessments (PRAs) have proven valuable in providing the regulators, the nuclear plant operators, and the reactor designers insights into plant safety, reliability, design and operation. Both the NRC Commissioners and the staff have grown to appreciate the valuable contributions PRAs can have in the regulatory arena, though I will admit the existence of some tendencies for strict adherence to the deterministic approach within the agency and the public at large. Any call for change, particularly one involving a major adjustment in approach to the regulation of nuclear power, will meet with a certain degree of resistance and retrenchment. Change can appear threatening and can cause some to question whether the safety mission is being fulfilled. This skepticism is completely appropriate and is, in fact, essential to a proper transition towards risk and performance-based approaches. Our task in the Office of Nuclear Regulatory Research is to increase the PRA knowledge base within the agency and develop appropriate guidance and methods needed to support the transitioning process.

Sequence-based model of gap gene regulatory network.

Science.gov (United States)

Kozlov, Konstantin; Gursky, Vitaly; Kulakovskiy, Ivan; Samsonova, Maria

2014-01-01

The detailed analysis of transcriptional regulation is crucially important for understanding biological processes. The gap gene network in Drosophila attracts large interest among researches studying mechanisms of transcriptional regulation. It implements the most upstream regulatory layer of the segmentation gene network. The knowledge of molecular mechanisms involved in gap gene regulation is far less complete than that of genetics of the system. Mathematical modeling goes beyond insights gained by genetics and molecular approaches. It allows us to reconstruct wild-type gene expression patterns in silico, infer underlying regulatory mechanism and prove its sufficiency. We developed a new model that provides a dynamical description of gap gene regulatory systems, using detailed DNA-based information, as well as spatial transcription factor concentration data at varying time points. We showed that this model correctly reproduces gap gene expression patterns in wild type embryos and is able to predict gap expression patterns in Kr mutants and four reporter constructs. We used four-fold cross validation test and fitting to random dataset to validate the model and proof its sufficiency in data description. The identifiability analysis showed that most model parameters are well identifiable. We reconstructed the gap gene network topology and studied the impact of individual transcription factor binding sites on the model output. We measured this impact by calculating the site regulatory weight as a normalized difference between the residual sum of squares error for the set of all annotated sites and for the set with the site of interest excluded. The reconstructed topology of the gap gene network is in agreement with previous modeling results and data from literature. We showed that 1) the regulatory weights of transcription factor binding sites show very weak correlation with their PWM score; 2) sites with low regulatory weight are important for the model output; 3

The rise of regulatory capitalism and the decline of auditor independence: A critical and experimental examination of auditors' conflicts of interests

DEFF Research Database (Denmark)

Warming-Rasmussen, Bent

2009-01-01

This study investigates the decline of auditor independence coinciding with the rise of regulatory capitalism. A critical analysis supported by experimental evidence reveals regulatory capitalism's influence on auditor independence. Regulatory capitalism began in the United States during the 1970s...... that now promote and diffuse regulatory capitalism worldwide. Regulatory capitalism is further facilitated by the Sarbanes-Oxley Act and the PCAOB that provide interconnections of powerful non-democratic private regulators such as the IFAC and IAASB. An experiment reveals auditors' ethical predisposition...... to provide consistently high quality independence judgments required by IFAC's code of ethics. The majority of this sample of 174 Danish auditors was not consistently independent in the context of client economic factors, indicating that the code of ethics' appeal to auditors' altruistic behavior has failed...

THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATION

Directory of Open Access Journals (Sweden)

Canol KANDEMİR

2013-07-01

Full Text Available TÜRKİYE’DE DÜZENLEYİCİ KURULUŞLAR AÇISINDAN MUHASEBE HİLELERİNİN ÖNLENMESİ VE ORTAYA ÇIKARILMASI SORUMLULUĞU: HUKUKÎ DURUM VE FİİLÎ UYGULAMAÖzet: Düzenleyici kuruluşların yaklaşımı ve uygulamaları muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunun kapsamının açıklığa kavuşturulmasına yardımcı olabilmektedir. Bu kuruluşların kamunun büyük bir çoğunluğunu adîl ve yansız bir şekilde temsil edeceği varsayılmaktadır. Ayrıca aldıkları kararlar ve karar alma mantıkları hem araştırmacılara, hem de finansal bilgi kullanıcılarına olası hile şüphelileri, bu kuruluşların sorumlulardan özellikle önlemesi ve ortaya çıkarmasını istedikleri hile yöntemleri, hilelerin cezaî yönleri, hilelerin önlenmesi ve ortaya çıkarılmasında temel sorumluluklar ve denetim beklenti boşluğu konularında önemli ipuçları verebilmektedir. Yine bunlar ilgili standart, yasa ve diğer düzenlemelerin oluşturulması ve uygulanmasında önemli etki sahibi olmaktadır. Bu nedenle, bağımsız denetimle ilgili faktörleri de kapsayan bir dizi değişken ile muhasebe hileleri arasında istatistiksel olarak anlamlı bir ilişki olup olmadığını sınayan bir çalışma yapılmış ve sonuç olarak Türkiye’deki düzenleyici kuruluşun muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunu aynı tarafa, müşteri işletme ve yönetimine yüklediği bulunmuştur. Araştırmanın bulguları Türkiye’de bir denetim-beklenti boşluğu olmadığına da işaret etmektedir.THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATIONAbstract: Self-regulatory agencies’ way of understanding and practices can help clarify the scope of the responsibility for preventing and detecting frauds. They are assumed to represent a vast majority of the public in an unbiased and

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

75 FR 48731 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2010-08-11

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62655; File No. SR-FINRA-2010-042] Self... Change To Adopt FINRA Rule 4160 (Verification of Assets) August 5, 2010. Pursuant to Section 19(b)(1) of... rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory...

78 FR 73211 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2013-12-05

... Education Grants. The survey will allow the NRC to collect information that is not otherwise available from... minimized, including the use of automated collection techniques or other forms of information technology... NUCLEAR REGULATORY COMMISSION [NRC-2013-0256] Agency Information Collection Activities: Proposed...

The Pro-Cyclical Impact of Basel III Regulatory Capital on Bank Capital Risk

OpenAIRE

Song, Guoxiang

2014-01-01

To raise the quality of regulatory capital, Basel III capital rules recognize unrealized gains and losses on all available-for-sale (AFS) securities in Common Equity Tier 1 Capital (CET1). However, by examining the correlations between U.S. GDP growth rate, interest rates and regulatory capital ratios computed using Basel III regulatory capital definition for six U.S. global systemically important banks (G-SIBs) since 2007, this chapter finds that Basel III regulatory capital will enhance the...

[The regulatory regime and the health insurance industry in Brazil].

Science.gov (United States)

Costa, Nilson do Rosário

2008-01-01

This paper analyzes the regulatory regime for health insurance and prepayment schemes in Brazil. It describes the ideas that have influenced the creation of the Agência Nacional de Saúde Suplementar-ANS (National Agency of Supplementary Health) in 2000, showing that the independent agency model was a direct result of the privatization process and of the induction of new competition mechanisms in a natural state monopoly. The paper concludes that the prepayment firms in Brazil are facing a new institutional environment as refers to their market entry or exit conditions.

76 FR 65909 - Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency...

Science.gov (United States)

2011-10-24

... Efficiency, Transparency, and Burden Reduction AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS...-regulatory changes to increase transparency and to become a better business partner. As explained in the plan...

78 FR 49267 - Conflict of Interest Waiver

Science.gov (United States)

2013-08-13

... FEDERAL COMMUNICATIONS COMMISSION Conflict of Interest Waiver AGENCY: Federal Communications Commission. ACTION: Notice of waiver of section 4(b) of the Communications Act of 1934. SUMMARY: Notice is hereby given that the Commission granted a waiver of the financial relationship prohibition contained in...

Regulatory guidelines for biosimilars in Malaysia.

Science.gov (United States)

Abas, Arpah

2011-09-01

The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

Science.gov (United States)

Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

2017-11-01

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

U.S. Nuclear Regulatory Commission bases for control of solid materials

International Nuclear Information System (INIS)

Meck, R.A.; Cardille, F.P.; Feldman, C.; Gnugnoli, G.N.; Huffert, A.M.; Klementowicz, S.P.

2002-01-01

The U.S. Nuclear Regulatory Commission (NRC) is considering whether to proceed with rulemaking on the control of solid materials with very low levels of associated radioactivity. The current implementation of clearance by NRC licensees is the context for the decision. Inputs to the decision include information gathering efforts of the Commission in the areas of public workshops, dose assessments and inventories, the recommendations of the National Academies' National Research Council (NAs) on regulatory alternatives, and participation in international efforts by the International Atomic Energy Agency (IAEA). (author)

As agências reguladoras independentes e o Tribunal de Contas da União: conflito de jurisdições? The independent regulatory agencies and the Federal Court of Accounts: a jurisdictional conflict?

Directory of Open Access Journals (Sweden)

Eduardo Granha Magalhães Gomes

2006-08-01

Full Text Available Este artigo analisa a emergência, no Brasil, de agências reguladoras independentes (ARIs e suas especificidades quanto ao desenho institucional; analisa ainda a evolução recente da atuação do Tribunal de Contas da União (TCU no contexto da nova gestão pública. No desenho das ARIs têm destaque os mecanismos que lhes conferem independência política, dada a natureza de suas atribuições e competências. Por outro lado, o TCU vem ampliando seu campo de atuação, passando a avaliar não mais apenas os aspectos formais da legalidade de procedimentos, mas também o desempenho e resultados alcançados por órgãos e entidades públicas. O TCU passa a atuar no acompanhamento e avaliação do desempenho das agências. O artigo analisa a interface entre independência e controle, discutindo possíveis conflitos institucionais entre as agências reguladoras e o TCU.This article analyzes the emergence of the independent regulatory agencies (IRAs in Brazil and their specificities as to their institutional design. It also discusses the recent developments in the Federal Court of Accounts' actions within the new public management context. IRAs were designed with emphasis on the features that give them political independence, considering the nature of their attributions and capabilities. On the other hand, the Federal Court of Accounts (FCA has broadened its area of activities, assessing not only the formal aspects of the legality of procedures, but also the performance and the results of organisms and public institutions. The FCA is tracking and assessing the agencies' performance. The article analyzes the interface between independence and control, discussing possible institutional conflicts between regulatory agencies and the FCA.

5 CFR 6401.102 - Prohibited financial interests.

Science.gov (United States)

2010-01-01

... ETHICAL CONDUCT FOR EMPLOYEES OF THE ENVIRONMENTAL PROTECTION AGENCY § 6401.102 Prohibited financial... having outside employment with or holding stock or any other financial interest in companies that... apply to companies with subsidiaries in these areas but do not include retail distributors to the...

75 FR 36724 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

Science.gov (United States)

2010-06-28

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62329; File No. SR-OCC-2010-09] Self-Regulatory... on the proposed rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). I. Self-Regulatory... futures any futures contracts on Sprott Physical Gold Shares. II. Self-Regulatory Organization's Statement...

77 FR 20890 - Proposed Information Collection (Interest Rate Reduction Refinancing Loan Worksheet) Activity...

Science.gov (United States)

2012-04-06

... (Interest Rate Reduction Refinancing Loan Worksheet) Activity: Comment Request AGENCY: Veterans Benefits... to determine whether lenders computed the loan amount on interest rate reduction refinancing loans.... Title: Interest Rate Reduction Refinancing Loan Worksheet, VA Form 26-8923. OMB Control Number: 2900...

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United States

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Special nuclear material; Source material; By-product material; Agreement state programmes); 4. Nuclear installations (Initial licensing; Operation and inspection, including nuclear safety; Operating licence renewal; Decommissioning; Emergency response); 5. Radiological protection (Protection of workers; Protection of the public); 6. Radioactive waste management (High-level waste; Low-level waste; Disposal at sea; Uranium mill tailings; Formerly Utilized Sites Remedial Action Program - FUSRAP); 7. Non-proliferation and exports (Exports of source material, special nuclear material, production or utilisation facilities and sensitive nuclear technology; Exports of components; Exports of by-product material; Exports and imports of radiation sources; Conduct resulting in the termination of exports or economic assistance; Subsequent arrangements; Technology exports; Information and restricted data); 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Nuclear Regulatory Commission - NRC; Department of Energy - DOE; Department of Labor - DOL; Department of Transportation - DOT; Environmental Protection Agency - EPA); 2. Public and semi-public agencies: A. Cabinet-level departments (Department of

Does GLP enhance the quality of toxicological evidence for regulatory decisions?

Science.gov (United States)

Borgert, Christopher J.; Becker, Richard A.; Carlton, Betsy D.; Hanson, Mark; Kwiatkowski, Patricia L.; Sue Marty, Mary; McCarty, Lynn S.; Quill, Terry F.; Solomon, Keith; Van Der Kraak, Glen; Witorsch, Raphael J.; Don Yi, Kun

2016-01-01

There is debate over whether the requirements of GLP are appropriate standards for evaluating the quality of toxicological data used to formulate regulations. A group promoting the importance of non-monotonic dose responses for endocrine disruptors contend that scoring systems giving primacy to GLP are biased against non-GLP studies from the literature and are merely record-keeping exercises to prevent fraudulent reporting of data from non-published guideline toxicology studies. They argue that guideline studies often employ insensitive species and outdated methods, and ignore the perspectives of subject-matter experts in endocrine disruption, who should be the sole arbiters of data quality. We believe regulatory agencies should use both non-GLP and GLP studies, that GLP requirements assure fundamental tenets of study integrity not typically addressed by journal peer-review, and that use of standardized test guidelines and GLP promotes consistency, reliability, comparability, and harmonization of various types of studies used by regulatory agencies worldwide. This debate suffers two impediments to progress: a conflation of different phases of study interpretation and levels of data validity, and a misleading characterization of many essential components of GLP and regulatory toxicology. Herein we provide clarifications critical for removing those impediments. PMID:27208076

An Analysis of Differences in Terms of Professional Interests Based on the Project to Replace IAS 39

Directory of Open Access Journals (Sweden)

Cláudia Daniela Ferreira da Mota Carvalho

2015-08-01

Full Text Available The professional interests of the various stakeholders groups are often seen as obstacles to full accounting harmonization. Studying different professional interests in the accounting domain is significant for organizations involved in the international accounting harmonization process, insofar as it enables them to identify the main obstacles to face in order to achieve full harmonization. Thus, this article is aimed at analyzing the differences in terms of professional interests by addressing the participation of various stakeholders groups in the process of issuing/modifying standards of the International Accounting Standards Board (IASB. Based on content analysis, we examined the comment letters sent to the IASB in the context of the first part of the first phase of the project to replace the International Accounting Standard (IAS 39, entitled "Financial Instruments - Recognition and Measurement", by the International Financial Reporting Standard (IFRS 9, on its turn entitled "Financial Instruments". Respondents were identified according to the stakeholders group, and, later, the collected data underwent a nonparametric chi-square test. The results of this study indicate there are significant differences between the answers obtained from the various stakeholders groups involved in the process of issuing or reviewing a standard of the IASB, above all made clear between the group of financial preparers and the regulatory and/or standard-setting agencies and the professional associations related to accounting.

A strategy for regulatory action when new adverse effects of a licensed product emerge.

Science.gov (United States)

Aronson, Jeffrey K; Price, Deirdre; Ferner, Robin E

2009-01-01

Regulatory agencies grant product licences (marketing authorizations) for medicinal products in the light of evidence that the balance between benefit and harm in the population is favourable. Here we consider a framework for allowing regulatory agencies to make rational decisions when reviewing product licences in the light of new information about harms that change that balance. The regulator can revoke the product licence, restrict the product's availability or change the 'label' in different ways. We examine the features of the adverse effect that may be relevant in making the decision: namely, individual differences in susceptibility; the possibility of monitoring; and the availability of protective strategies. The balance of benefit and harm, and the time-course and dose relation of the adverse effect play important roles in the decision-making process. We set out how these factors can help determine the logical response to new information on the balance between benefit and harm, and provide a series of relevant examples. We believe that when regulatory agencies have to decide how to amend the product licence of a drug when new serious adverse effects cause concern, they would find it useful to adopt a framework of this kind, using different strategies for different cases. Our proposed framework could also be useful in risk management planning during drug development.

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.

What is `Agency'? Perspectives in Science Education Research

Science.gov (United States)

Arnold, Jenny; Clarke, David John

2014-03-01

The contemporary interest in researching student agency in science education reflects concerns about the relevance of schooling and a shift in science education towards understanding learning in science as a complex social activity. The purpose of this article is to identify problems confronting the science education community in the development of this new research agenda and to argue that there is a need for research in science education that attends to agency as a social practice. Despite increasing interest in student agency in educational research, the term 'agency' has lacked explicit operationalisation and, across the varied approaches, such as critical ethnography, ethnographies of communication, discourse analysis and symbolic interactionism, there has been a lack of coherence in its research usage. There has also been argument concerning the validity of the use of the term 'agency' in science education research. This article attempts to structure the variety of definitions of 'student agency' in science education research, identifies problems in the research related to assigning intentionality to research participants and argues that agency is a kind of discursive practice. The article also draws attention to the need for researchers to be explicit in the assumptions they rely upon in their interpretations of social worlds. Drawing upon the discursive turn in the social sciences, a definition of agency is provided, that accommodates the discursive practices of both individuals and the various functional social groups from whose activities classroom practice is constituted. The article contributes to building a focused research agenda concerned with understanding and promoting student agency in science.

[Conflict of interests in clinical research].

Science.gov (United States)

Alves, Elaine Maria de Oliveira; Tubino, Paulo

2007-01-01

In clinical research there is a real possibility to have some conflict of interests. Even for the researcher, the identification of these conflicts cannot be clear. There are many aspects to be considered, involving all participants of the process: the research subject, the researcher, the institution where the research is carried through, the sponsor, the ethics committees, the regulating agencies, the scientific community and the society. The conclusion is that conflicts of interests are common and inevitable in the academic field. The challenge is not to eradicate them, but to recognize them and to manage them properly. The only acceptable way to do this is to expose clearly the conflicts of interests and always to submit the clinical research projects to the ethics committees.

Examining Agency Theory in Training & Development: Understanding Self-Interest Behaviors in the Organization

Science.gov (United States)

Azevedo, Ross E.; Akdere, Mesut

2011-01-01

Agency theory has been discussed widely in the business and management literature. However, to date there has been no investigation about its utility and implications for problems in training & development. Whereas organizations are still struggling to develop and implement effective training programs, there is little emphasis on the self-interest…

76 FR 15055 - Proposed Information Collection (Requirements for Interest Rate Reduction Refinancing Loans...

Science.gov (United States)

2011-03-18

... (Requirements for Interest Rate Reduction Refinancing Loans); Comment Request AGENCY: Veterans Benefits... to refinance a delinquent VA-guaranteed loan with a lower interest rate. DATES: Written comments and... techniques or the use of other forms of information technology. Title: Requirements for Interest Rate...

Drug-device combination products: regulatory landscape and market growth.

Science.gov (United States)

Bayarri, L

2015-08-01

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Public trust and better communication is still needed

International Nuclear Information System (INIS)

Cho, H.S.

2007-01-01

Korean nuclear regulatory agency (KINS) has recently changed its 'safety philosophy': The final goal of nuclear safety should he achievement of psychological and emotional security of people rather than simple attainment of engineering safety targets. This significant progress is not widely known for public. But, its new attitude was confirmed when a nuclear reactor for research purpose, which was located in a metropolitan city, leaked a small amount of radioactive materials in 2005. The agency focused on the fact itself that radioactive materials were released into environment although its amount of radioactivity was negligible from engineering perspective. Does this mean that 'science-technology centrism' which has widely pervaded nuclear circle begin to collapse from the regulatory agency? There has been certain degree of advancement in openness of information, increasing transparency, communication efforts toward public and local. people. However, it should he noted that regulatory activity has not attained enough trust from public. Four points are pointed out for regulatory agency to get further people's trust. First, nuclear agency's institutional independence is still uncertain. The Ministry of Science and Technology, which is in charge of nuclear safety by controlling KINS, at the same time promotes nuclear industry by managing nuclear R and D activities. Cultural aspects should also be noted. People tend to regard regulatory agency as 'friends' of nuclear. Second, regulatory activities are passive and not preventive in many cases. It is needed to make people convince that the regulatory agency defend their interest first when it competes with the interest of industry. Third, communication with public is lacking. Even transparent procedure and openness of information may result in limiting public access if its content and meaning are not fully communicated. Fourth, knowing more about media is needed. Understanding news production processes may contribute to

Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

Energy Technology Data Exchange (ETDEWEB)

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

1976-12-01

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

Independence in regulatory decision making - INSAG-17. A report by the International Nuclear Safety Advisory Group

International Nuclear Information System (INIS)

2003-01-01

This report is intended to promote a common understanding among legislators and other political decision makers, nuclear safety regulators and licensees of the concept of independence in regulatory decision making and how to achieve it. Other interest groups, such as non-governmental organizations and members of the public interested in the regulation of nuclear safety, may also find the report useful. The principles concerning the independence of regulatory organizations are developed and discussed in publications in the IAEA's Safety Standards Series. Although the principles relating to protecting the independence of the regulatory body provide the necessary basis for independence in regulatory decision making, there are additional factors and features that require attention to ensure independence in the decision making by the regulatory body. This INSAG report highlights and discusses a number of such factors and features

Redesigning the regulatory framework for ambulatory care services in New York.

Science.gov (United States)

Chokshi, Dave A; Rugge, John; Shah, Nirav R

2014-12-01

Policy Points: The landscape of ambulatory care services in the United States is rapidly changing on account of payment reform, primary care transformation, and the rise of convenient care options such as retail clinics. New York State has undertaken a redesign of regulatory policy for ambulatory care rooted in the Triple Aim (better health, higher-quality care, lower costs)-with a particular emphasis on continuity of care for patients. Key tenets of the regulatory approach include defining and tracking the taxonomy of ambulatory care services as well as ensuring that convenient care options do not erode continuity of care for patients. While hospitals remain important centers of gravity in the health system, services are increasingly being delivered through ambulatory care. This shift to ambulatory care is giving rise to new delivery structures, such as retail clinics and urgent care centers, as well as reinventing existing ambulatory care capacity, as seen with the patient-centered medical home model and the movement toward team-based care. To protect the public's interests, oversight of ambulatory care services must keep pace with these rapid changes. With this purpose, in January 2013 the New York Public Health and Health Planning Council undertook a redesign of the regulatory framework for the state's ambulatory care services. This article describes the principles undergirding the framework as well as the regulatory recommendations themselves. We explored and analyzed the regulation of ambulatory care services in New York in accordance with the available gray and peer-reviewed literature and legislative documents. The deliberations of the Public Health and Health Planning Council informed our review. The vision of high-performing ambulatory care should be rooted in the Triple Aim (better health, higher-quality care, lower costs), with a particular emphasis on continuity of care for patients. There is a pressing need to better define the taxonomy of ambulatory

Uneasy money: the Instituto Carlos Slim de la Salud, tobacco philanthropy and conflict of interest in global health.

Science.gov (United States)

Burch, Tiffany; Wander, Nathaniel; Collin, Jeff

2010-12-01

In May 2007, the Instituto Carso de la Salud-now Instituto Carlos Slim de la Salud (ICSS)-was endowed with US$500 million to focus on priority health issues in Latin America, notably issues of 'globalisation and non-communicable diseases'. ICSS was soon criticised, however, on the grounds that its funding was derived from tobacco industry profits and that its founder Carlos Slim Hélu remained an active industry principal. Collaboration with ICSS was said to run counter to the WHO Framework Convention on Tobacco Control. The Institute's then Executive President Julio Frenk disputed these charges. This research employs an archive of tobacco industry documents triangulated with materials from commercial, media, regulatory and NGO sources to examine the financial relations between Slim and the tobacco industry. The paper analyses Slim's continuing service to the industry and role in ICSS. It demonstrates a prima facie conflict of interest between ICSS's health mission and its founder's involvement in cigarette manufacturing and marketing, reflected on ICSS's website as a resounding silence on issues of tobacco and health. It is concluded that the reliance of international health agencies upon the commercial sector requires more robust institutional policies to effectively regulate conflicts of interest.

Investigation of the feasibility of toll and transit agency equity sharing : white paper.

Science.gov (United States)

2010-04-12

This research project frames the institutional constraints and opportunities for equity sharing that currently exist in the highway, transit and toll agency realms and identifies statutory, regulatory and/or policy changes that may be requried. It al...

76 FR 1105 - Guidance on Reporting Interest Paid to Nonresident Aliens

Science.gov (United States)

2011-01-07

...-BJ01 Guidance on Reporting Interest Paid to Nonresident Aliens AGENCY: Internal Revenue Service (IRS... and paid to nonresident alien individuals. These proposed regulations affect persons making payments.... bank deposit interest paid to any nonresident alien individual must be reported annually to the IRS. On...

Qualifications and training of staff of the regulatory body for nuclear power plants

International Nuclear Information System (INIS)

1979-01-01

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 Agency's Safety Series No.50-C-G, entitled ''Governmental Organization for the Regulation of Nuclear Power Plants: A Code of Practice'', and is mainly concerned with the qualifications and training requirements of the staff of bodies regulating nuclear power plants. It is not concerned with staff for regulating other phases of the fuel cycle, such as fuel fabrication and management. This Guide provides recommendations and guidance for establishing the qualifications required for the staff of the regulatory body. These requirements include academic training, work experience and other abilities. It also establishes the training programmes and activities necessary for personnel within the regulatory body

76 FR 22450 - Agency Information Collection Activities; Proposed Information Collection Requirements; Comment...

Science.gov (United States)

2011-04-21

... Officer, (202) 452-3829, Division of Research and Statistics, Board of Governors of the Federal Reserve... the information collection, including the validity of the methodology and assumptions used; (c) Ways... measures (such as regulatory or accounting). The agencies' burden estimates for these information...

Communicating River Level Data and Information to Stakeholders with Different Interests

Science.gov (United States)

Macleod, K.; Sripada, S.; Ioris, A.; Arts, K.; van der Wal, R.

2012-12-01

There is a need to increase the effectiveness of how river level data are communicated to a range of stakeholders with an interest in river level information to increase the use of data collected by regulatory agencies. Currently, river level data is provided to members of the public through a web site without any formal engagement with river users having taken place. In our research project called wikiRivers, we are working with the suppliers of river level data as well as the users of this data to explore and improve from the user perspective how river level data and information is made available online. We are focusing on the application of natural language generation technology to create textual summaries of river level data tailored for specific interest groups. These tailored textual summaries will be presented among other modes of information presentation (e.g. maps and visualizations) with the aim to increase communication effectiveness. Natural language generation involves developing computational models that use non-linguistic input data to produce natural language as their output. Acquiring accurate correct system knowledge for natural language generation is a key step in developing such an effective computer software system. In this paper we set out the needs for this project based on discussions with the stakeholder who supplies the river level data and current cyberinfrastructure and report on what we have learned from those individuals and groups who use river level data. Stages in the wikiRivers stakeholder identification, engagement and cyberinfrastructure development. S1- interviews with collectors and suppliers of river level data. S2- river level data stakeholder analysis, including analysis of their interests in individual river networks in Scotland and what they require from the cyberinfrastructure. S3-5 Iterative development and testing of cyberinfrastructure and modelling of river level data with domain and stakeholder knowledge.

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2010-01-01

Concerning International regulatory activities, we find for the european atomic energy community an entry into force of the lisbon treaty (2009), it amends the treaty on European union and replaces the treaty establishing the European Community by the new treaty on the functioning of the European Union; more, an amendment to council regulation on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (2009). About International atomic energy agency is reported an open-ended meeting of technical and legal experts for sharing of information on states implementation of the code of conduct on the safety and security of radioactive sources and its supplementary guidance on the import and export of radioactive sources (2010). (N.C.)

Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC and A Program

International Nuclear Information System (INIS)

Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy; Piskarev, Alexander; O'Brien, Patricia E.; Wright, Troy L.; Schlegel, Stephen C.; Hazel, Michael J.; Miller, Daniel R.; Tuttle, John D.; Kovchegin, Dmitry

2009-01-01

The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under their control. This regulatory development has been accomplished as part of the U.S.-Russian MPC and A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC and A regulations.

Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

Science.gov (United States)

Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G

2015-10-01

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. Copyright © 2015 Elsevier Inc. All rights reserved.

Multi-agency radiation survey and site investigation manual (MARSIM). Final report

International Nuclear Information System (INIS)

1997-12-01

The MARSSIM provides information on planning, conducting, evaluating, and documenting building surface and surface soil final status radiological surveys for demonstrating compliance with dose or risk-based regulations or standards. The MARSSIM is a multi-agency consensus document that was developed collaboratively by four Federal agencies having authority and control over radioactive materials: Department of Defense (DOD), Department of Energy (DOE), Environmental Protection Agency (EPA), and Nuclear Regulatory Commission (NRC). The MARSSIM's objective is to describe a consistent approach for planning, performing, and assessing building surface and surface soil final status surveys to meet established dose or risk-based release criteria, while at the same time encouraging an effective use of resources

Multi-agency radiation survey and site investigation manual (MARSIM). Final report

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-12-01

The MARSSIM provides information on planning, conducting, evaluating, and documenting building surface and surface soil final status radiological surveys for demonstrating compliance with dose or risk-based regulations or standards. The MARSSIM is a multi-agency consensus document that was developed collaboratively by four Federal agencies having authority and control over radioactive materials: Department of Defense (DOD), Department of Energy (DOE), Environmental Protection Agency (EPA), and Nuclear Regulatory Commission (NRC). The MARSSIM`s objective is to describe a consistent approach for planning, performing, and assessing building surface and surface soil final status surveys to meet established dose or risk-based release criteria, while at the same time encouraging an effective use of resources.

The independent inspection agency as an instrument of quality assurance

International Nuclear Information System (INIS)

Sancho, J.; Cuallado, G.

1982-01-01

The collaboration between Independent Inspection Agencies (IIA) and the regulatory body of a country in supervising the equipment and services directly related to the safety of its nuclear installations can be a valid solution, forming part of the system set up to guarantee satisfactory compliance with the safety parameters established for the purpose of avoiding damage to persons and property. In the light of the experience accumulated in recent years, the IIA in Spain is not a single body or a State body but may be chosen from among all legally established Inspection Agencies (IA). As described in detail in the paper, the IA is selected on the basis of an agreement between the owner of the facility and the supplier; it must present certain specific characteristics and is approved by the regulatory body. For a country with intermediate technological capacity and an industrial base sufficient to assimilate imported nuclear technologies, this participation of the IIA can result in significant advantages. On one side, the regulatory body exercising higher-level supervision of the work and of the units participating in the project, including of course the IIA, can reduce its allocation of personnel and of technical and material resources. On the other side, the IIA are also converted into an agency for the transfer of technology. The paper describes the principles governing their independence, structure, organization, internal control, external control, activities and scope of work. Similarly, the necessary criteria are laid down for the issue of reports and certificates, the handling of operational deviations, the system of appointing inspectors and auditors, and the method by which they should be trained, evaluated and certified. Lastly, the paper shows how the non-nuclear part of the facility is supervised in Spain and describes the role which has been played by the country's industrial and professional associations. (author)

Call for Expressions of Interest: Capacity development of Myanmar's ...

International Development Research Centre (IDRC) Digital Library (Canada)

... support, but usually for one-off projects, which the donor agency often designs and leads. ... Expressions of interest will detail how the institution's strategy for ... consultants, equipment, international travel, research expenses, evaluation, ...

78 FR 49530 - Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop

Science.gov (United States)

2013-08-14

...] Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop AGENCY: Food and Drug... for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the... American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD...

United States Nuclear Regulatory Commission information digest: 1997 edition. Volume 9

International Nuclear Information System (INIS)

1997-05-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, NRC licensed activities, and general information on domestic and world-wide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1996, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

Pleiotropy constrains the evolution of protein but not regulatory sequences in a transcription regulatory network influencing complex social behaviours

Directory of Open Access Journals (Sweden)

Daria eMolodtsova

2014-12-01

Full Text Available It is increasingly apparent that genes and networks that influence complex behaviour are evolutionary conserved, which is paradoxical considering that behaviour is labile over evolutionary timescales. How does adaptive change in behaviour arise if behaviour is controlled by conserved, pleiotropic, and likely evolutionary constrained genes? Pleiotropy and connectedness are known to constrain the general rate of protein evolution, prompting some to suggest that the evolution of complex traits, including behaviour, is fuelled by regulatory sequence evolution. However, we seldom have data on the strength of selection on mutations in coding and regulatory sequences, and this hinders our ability to study how pleiotropy influences coding and regulatory sequence evolution. Here we use population genomics to estimate the strength of selection on coding and regulatory mutations for a transcriptional regulatory network that influences complex behaviour of honey bees. We found that replacement mutations in highly connected transcription factors and target genes experience significantly stronger negative selection relative to weakly connected transcription factors and targets. Adaptively evolving proteins were significantly more likely to reside at the periphery of the regulatory network, while proteins with signs of negative selection were near the core of the network. Interestingly, connectedness and network structure had minimal influence on the strength of selection on putative regulatory sequences for both transcription factors and their targets. Our study indicates that adaptive evolution of complex behaviour can arise because of positive selection on protein-coding mutations in peripheral genes, and on regulatory sequence mutations in both transcription factors and their targets throughout the network.

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

The waste isolation pilot plant: A new regulatory environment

International Nuclear Information System (INIS)

Frei, M.W.; Schneider, S.P.; Saris, E.C.; Austin, P.W.

1993-01-01

The US Department of Energy (DOE) is ready to embark on a multiyear test program, using radioactive waste, at the Waste Isolation Pilot Plant (WIPP). The WIPP is a deep geologic repository, constructed in ancient salt beds in southeastern New Mexico. It was authorized by Congress in 1979 as a research and development facility to demonstrate safe disposal of the nation's defense transuranic (TRU) waste. Nonradioactive testing in the repository has been under way for several years. The DOE is now ready to begin underground experiments at WIPP with small amounts of TRU waste. Radioactive waste testing in an actual repository environment will reduce uncertainties associated with predictions of long-term repository performance. However, the authority for DOE to begin this new phase of the test program no longer resides within the department. The WIPP is now subject to a new level of regulatory oversight by the Environmental Protection Agency (EPA) and other federal agencies, as set forth by Public Law 102-579, the WIPP Land Withdrawal Act, signed by the President on October 30, 1992. This paper discusses the act's new regulatory requirements for WIPP

Turning a page of Agency history

Energy Technology Data Exchange (ETDEWEB)

NONE

1969-07-01

Recent developments, and especially the new and critical interest of developing countries, have helped to mark the turning of a page in the Agency's history. If the present situation in the economics of nuclear power does not change there is a danger that developing countries will lag further and further behind the advanced countries in its use. Shortage of resources impose a brake on Agency efforts to promote benefits of nuclear techniques, especially by technical assistance. These were some of the points made by Dr. Sigvard Eklund, the Director General, when he presented the Agency's annual report to the Economic and Social Council (ECOSOC) in July. (author)

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

Development of an international BRC [Below Regulatory Concern] limit

International Nuclear Information System (INIS)

Kennedy, W.E. Jr.

1987-07-01

The International Atomic Energy Agency (IAEA) has recently investigated the exemption from regulatory control of radiation sources containing limited quantities of radioactive materials. Early efforts were entitled de minimis and were aimed at establishing a philosophical basis and radiation dose limits. The main objectives of more recent work on exemption are to illustrate a method for developing practical radiological criteria, to establish generic criteria, and to determine the practicability of the preliminary exemption principles. The method used to develop the criteria relies on models to evaluate the potential radiation exposure pathways and scenarios for individuals and population groups potentially present following the unrestricted release of materials. This paper describes the assessment methods, presents the generic results expressed in terms of the limiting concentrations of selected radionuclides in municipal waste, and provides a comparison with recent regulatory efforts in the United States for considering selected wastes being Below Regulatory Concern (BRC). 17 refs., 4 tabs

76 FR 18813 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2011-04-05

... change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and...

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

Science.gov (United States)

2011-10-26

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

Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?

Science.gov (United States)

Kim, Daria

2017-08-01

This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information-the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA's policies. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

The nuclear regulatory challenge of judging safety back fits

International Nuclear Information System (INIS)

2002-01-01

The economic pressures of electricity market competition have led nuclear power plant operators to seek ways to increase electricity production and to reduce operating costs at their plants. Corresponding pressures on the regulatory bodies include operator demand to reduce regulatory burdens perceived as unnecessary and general resistance to consider safety back-fits sought by the regulator. The purpose of this report is to describe potential situations giving rise to safety back-fit questions and to discuss regulatory approaches for judging the back-fits. The intended audience for this report is primarily nuclear regulators, although the information and ideas may also be of interest to nuclear operating organisations, other industry organisations and the general public. (author)

Conflict of interest: nurses at risk!

Science.gov (United States)

Erlen, Judith A

2008-01-01

Conflict of interest as it relates to healthcare is gaining increasing attention. Pharmaceutical companies and manufacturers that produce medical devices are coming under greater scrutiny because of the influence that their marketing practices may have on the patient management decisions made by healthcare professionals. The result is that healthcare agency administrators are developing conflict of interest policies and procedures for their professional employees. The driving force behind many of these policies is the need to maintain the trust of the public by refraining from questionable professional conduct. This article presents 2 hypothetical cases to provide nurses with an understanding of the concept of conflict of interest and the ethical considerations this issue raises, and describes the subtle and not-so-subtle influences on professional practice decisions. Recommendations are offered to help nurses avoid conflict of interest and preserve their professional integrity. It is incumbent upon nurses to become cognizant of the types of situations that may present a conflict of interest for them and to take the necessary steps to avoid such professional impropriety.

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.

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Directory of Open Access Journals (Sweden)

Emel Mashaki Ceyhan

2018-01-01

Full Text Available Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP in order to facilitate the TITCK progress toward agency goals.Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA, Health Canada, Singapore's Health Science Authority (HSA, and the Saudi Arabia Food and Drug Administration (SFDA.Results: The TITCK performs a full review for all new active substance (NAS applications. Submission of a Certificate of Pharmaceutical product (CPP with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized.Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP process by sharing GMP inspection outcomes and certificates issued by

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

75 FR 56501 - Information Collection; Land Management Agency Volunteer Surveys

Science.gov (United States)

2010-09-16

... Information Collection; Land Management Agency Volunteer Surveys AGENCY: Forest Service, USDA. ACTION: Notice... and test models of volunteer management; supply information to LMA program managers and other... is seeking comments from all interested individuals and organizations on the new information...

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

Science.gov (United States)

2013-02-06

...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... to industry's drug development processes and (2) a venue for sharing information about project...

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

Science.gov (United States)

2012-02-13

... Sequence No. Title Identifier No. 377 Claims Procedures Under 1625-AA03 the Oil Pollution Act of 1990 (USCG... Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jeremy F. Olson, Senior Procurement Analyst... Procedures Under the Oil Pollution Act of 1990 (USCG-2004- 17697) Legal Authority: 33 U.S.C. 2713 and 2714...

75 FR 33752 - Defense Federal Acquisition Regulation Supplement; Organizational Conflicts of Interest in Major...

Science.gov (United States)

2010-06-15

... Conflicts of Interest in Major Defense Acquisition Programs AGENCY: Defense Acquisition Regulations System... extended an additional 30 days to provide additional time for interested parties to review the proposed... interested parties to review the proposed DFARS changes. Ynette R. Shelkin, Editor, Defense Acquisition...

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

76 FR 61453 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Proposed Rule Change...

Science.gov (United States)

2011-10-04

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65433; File No. SR-C2-2011-024] Self-Regulatory... change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory... Office of the Secretary and at the Commission. II. Self-Regulatory Organization's Statement of the...

77 FR 31060 - Self-Regulatory Organizations; the Options Clearing Corporation; Notice of Filing and of Proposed...

Science.gov (United States)

2012-05-24

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67021; File No. SR-OCC-2012-07] Self-Regulatory... from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization... equity options. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for...

76 FR 76777 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2011-12-08

... loans with the security structured to ``pass through'' the principal and interest payments made by the... same as those that apply to members reporting transactions in corporate bonds and Agency Debt... volume of TBA transactions, the concentration of trading in such securities, and the pricing disparity...

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

Ito, Juichiro; Takita, Masami

2011-01-01

The current regulatory requirements on digital instrumentation and control system have been reviewed by JNES, considering international trend discussed in DICWG (Digital Instrumentation and Control Working Group) of MDEP (Multinational Design Evaluation Program). MDEP DICWG held in OECD/NEA (Organisation for Economic Co-operation and Development/Nuclear Energy Agency) gives the opportunity to identify the convergence of applicable standards. The working group's activities include: identifying and prioritising the member countries' challenges, practices, and needs regarding standards and regulatory guidance regarding digital instrumentation and control; identifying areas of importance and needs for convergence of existing standards and guidance or development of new standards; sharing of information; and identifying common positions among the member countries for areas of particular importance and need. The DICWG drafted common positions on specific issues which are based on the existing standards, national regulatory guidance, best practices, and group inputs using an agreed upon process and framework. Five general common positions are under discussion in this fiscal year. Simplicity in Design, Software Common Cause Failures, Software Tools, Data communication, Verification and Validation throughout the life cycle of safety systems using digital computers. In addition, the technical evaluation of standards of the Japan Electric Association about digital system for safety was made to support NISA (Nuclear and Industrial Safety Agency). (author)

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.

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

Science.gov (United States)

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Protecting sensitive systems and data in an open agency

Science.gov (United States)

Hunt, Douglas B.; Tompkins, Frederick G.

1987-01-01

This paper focuses on the policy and definitional issues associated with providing adequate and reasonable levels of protection for sensitive systems and data in an agency whose basic charter mandates the open sharing of information and transfer of technology into the market economy. An information model based on current Federal regulatory issuances is presented. A scheme for determining sensitivity levels, based on a categorization taxonomy,is provided.

The Regulatory Framework for Privacy and Security

Science.gov (United States)

Hiller, Janine S.

The internet enables the easy collection of massive amounts of personally identifiable information. Unregulated data collection causes distrust and conflicts with widely accepted principles of privacy. The regulatory framework in the United States for ensuring privacy and security in the online environment consists of federal, state, and self-regulatory elements. New laws have been passed to address technological and internet practices that conflict with privacy protecting policies. The United States and the European Union approaches to privacy differ significantly, and the global internet environment will likely cause regulators to face the challenge of balancing privacy interests with data collection for many years to come.

¿Entes de regulación o control? Imprecisiones del "moderno" esquema de regulación: reflexiones y enseñanzas del caso argentino Regulatory or control agencies? Impreciseness of the 'modern' regulation scheme: thoughts and teachings from the Argentine case