WorldWideScience

Sample records for change regulatory initiatives

  1. A “New Deal” for the profession : Regulatory initiatives, changing knowledge conceptions and the Committee on Accounting Procedure

    NARCIS (Netherlands)

    Detzen, Dominic

    Purpose: The purpose of this paper is to analyze how “New Deal” regulatory initiatives, primarily the Securities Acts and the Securities and Exchange Commission (SEC), changed US auditors’ professional knowledge conception, culminating in the 1938 expansion of the Committee on Accounting Procedure

  2. Opening remarks: regulatory initiatives toward improved technical specifications

    International Nuclear Information System (INIS)

    Edison, G.E.

    1985-01-01

    In order to deal with the numerous problems that have evolved over the years with nuclear power plant technical specifications, the Nuclear Regulatory Commission has undertaken some initiatives for improvement: 1) new operating licenses, 2) change to existing operating reactor technical specifications, 3) a broad-scoped reconsideration of the content of technical specifications, and 4) rule changes. It is believed that reliability and risk assessment techniques can be used in conjunction with manufacturer's recommendations and engineering judgment to better define the appropriate scope and depth for technical specification resulting in focusing attention on high risk-worth systems and avoidance of plant shutdown transients both intentionally and unintentionally through provisions of technical specifications

  3. Initiating Knowledge Management Project in a Regulatory Body in Thailand

    International Nuclear Information System (INIS)

    Pakdee, K.; Apichaibukol, A.

    2016-01-01

    Full text: Thailand is one of countries that have adopted the use of nuclear technology in various applications such as medical, agricultural, industrial and research applications. Recognizing this enormous potential in many applications, the Office of Atoms for Peace (OAP) as a regulatory body under the Ministry of Science and Technology, carries out a variety of activities to disseminate and promote youth, entrepreneurs and public on the awareness of the atomic energy in Thailand. In recent years, “knowledge management” is one of the key factors that contribute to safe, secure and efficient operation of nuclear activities and facilities but also for the regulatory processes as well. In this regards, the OAP is aware and recognize of the importance of studying and initiating nuclear knowledge and human resource development programme in the regulatory body. Even though, the OAP has been initiating the project on nuclear knowledge and human resources for several years but the present status of the projects still remain in primarily stage of the initiating. This paper describes the initiating of nuclear knowledge in the past and present status for knowledge management project in regulatory body in Thailand. (author

  4. 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

  5. The Regulatory Consumer: Prosumer-Driven Local Energy Production Initiatives

    NARCIS (Netherlands)

    Butenko, A.; Cseres, K.

    2015-01-01

    This paper analyzes the (pro)active role consumers could (and are encouraged by the respective policy to) assume in markets that emerged due to European market liberalization and technological changes. These changes expanded consumer markets and changed regulatory architectures accordingly.

  6. The Philippine Regulatory Frameworks, Support Policies, And Initiatives Encouraging Women Entrepreneurship

    OpenAIRE

    EDRALIN, Divina M.

    2007-01-01

    This paper examines the Philippine regulatory frameworks, support policies, initiatives, and barriers to encouraging women entrepreneurship. Currently, women entrepreneurship seems to be nurtured with the right environment, including regulatory frameworks, financial resources and support programs for, as well as business practices and social attitudes in the country towards women entrepreneurs and entrepreneurship in general. However, though many SME-friendly laws and policies exist, their im...

  7. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

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

  8. Fisheries regulatory regimes and resilience to climate change.

    Science.gov (United States)

    Ojea, Elena; Pearlman, Isaac; Gaines, Steven D; Lester, Sarah E

    2017-05-01

    Climate change is already producing ecological, social, and economic impacts on fisheries, and these effects are expected to increase in frequency and magnitude in the future. Fisheries governance and regulations can alter socio-ecological resilience to climate change impacts via harvest control rules and incentives driving fisher behavior, yet there are no syntheses or conceptual frameworks for examining how institutions and their regulatory approaches can alter fisheries resilience to climate change. We identify nine key climate resilience criteria for fisheries socio-ecological systems (SES), defining resilience as the ability of the coupled system of interacting social and ecological components (i.e., the SES) to absorb change while avoiding transformation into a different undesirable state. We then evaluate the capacity of four fisheries regulatory systems that vary in their degree of property rights, including open access, limited entry, and two types of rights-based management, to increase or inhibit resilience. Our exploratory assessment of evidence in the literature suggests that these regulatory regimes vary widely in their ability to promote resilient fisheries, with rights-based approaches appearing to offer more resilience benefits in many cases, but detailed characteristics of the regulatory instruments are fundamental.

  9. An assessment of the contribution of NRC [Nuclear Regulatory Commission] regulatory growth to nuclear plant cost growth using engineering scope changes

    International Nuclear Information System (INIS)

    Cohen, S.

    1987-03-01

    The purpose of this study is to determine the contribution of NRC regulations to the growth in nuclear power plant capital costs using the case study method. The two plants selected for the case studies are Florida Power and Light Company's (FP and L) St. Lucie Unit 1 (SL1) and St. Lucie Unit 2 (SL2). SL1 was constructed in the early 1970s and was granted an operating license in 1976. SL2 was constructed in the late 1970s and early 1980s, and was granted an operating license in 1983. The information bases were the amendments to the contracts between FP and L and its architect-engineer/constructor, i.e., the ''scope changes''. These were examined and analyzed for causation, i.e., NRC-initiated or utility-initiated, and all of the costs associated with scope changes of each type were aggregated to determine the contribution of each. Although the scope changes accounted for only a small fraction of the total cost growth for either plant, they were still used to determine the relative contribution of regulatory growth to cost growth. Unexpectedly, a significantly higher percentage of out-of-scope work (approximately 84%) was attributable to NRC regulatory requirements for SL1 than SL2 (approximately 47%). These results were unexpected because SL2 was constructed during a period in which regulation was considered to be particularly unstable. However, a more detailed analysis of causation indicates that a shift occurred from an ad-hoc mode of regulation in the early 1970s to a more prescriptive process in the late 1970s. Thus the number of formal NRC requirements may not be a valid measure of regulatory stability

  10. Regulatory policy and structural change in the natural gas industry: A transaction cost perspective

    International Nuclear Information System (INIS)

    Sauer, D.G.

    1991-01-01

    The Federal Energy Regulatory Commission has recently promoted policy initiatives designed to substitute market responsive industry practices for the micro-management regulatory practices previously employed. These new policies are expected to generate a flexible gas pricing policy that more accurately reflects market supply and demand conditions. Historically, much of the regulation of this industry was enacted to ensure that pipeline companies would be able to recover the very large up-front investments in immobile equipment that characterize the production, transportation, storage, and distribution of natural gas. The institutional detail available from historical accounts of the development of the industry are used to describe structural change over time. Regulatory policy, the level of asset specificity, and the extent of secondary environmental uncertainty are all shown to exert significant effects on the level of integration into production, storage and marketing

  11. The Political Economy of Regulatory Change

    DEFF Research Database (Denmark)

    Buch-Hansen, Hubert

    2012-01-01

    This article aims to explain the broader evolution of British merger control. To this end it outlines a novel critical political economy perspective on regulation and regulatory change which differs from established political economy approaches, such as the regulatory capitalism/state perspectives...... to the analysis of the evolution of British merger control provides some important new insights, most notably that the content, form, and scope of merger control in Britain have been deeply transformed in accordance with neoliberal ideas since the 1980s and that this process, which was part of a broader...

  12. New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

    DEFF Research Database (Denmark)

    Minssen, Timo

    2014-01-01

    ) and the COMBACTE and TRANSLOCATION projects under NewDrugs4BadBugs program, involving the EU Commission and the pharma industry. But also national initiatives, such as the successful Danish ban and regulations on antibiotic use in animal production, as well as educational efforts (the European Antibiotic Awareness......New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives Posted on March 19, 2014 by Timo Minssen Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given...... on March 7, 2014 at the Broad Institute of MIT and Harvard. The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new...

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

    International Nuclear Information System (INIS)

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

    1991-01-01

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

  14. Regulatory change and monetary policy

    OpenAIRE

    Bank for International Settlements

    2015-01-01

    Report submitted by a Working Group established by the Committee on the Global Financial System and the Markets Committee. The Group was chaired by Ulrich Bindseil (European Central Bank) and William R Nelson (Federal Reserve Board). Financial regulation is evolving, as policymakers seek to strengthen the financial system in order to make it more robust and resilient. Changes in the regulatory environment are likely to have an impact on financial system structure and on the behaviour of finan...

  15. Adapting to an initial self-regulatory task cancels the ego depletion effect.

    Science.gov (United States)

    Dang, Junhua; Dewitte, Siegfried; Mao, Lihua; Xiao, Shanshan; Shi, Yucai

    2013-09-01

    The resource-based model of self-regulation provides a pessimistic view of self-regulation that people are destined to lose their self-control after having engaged in any act of self-regulation because these acts deplete the limited resource that people need for successful self-regulation. The cognitive control theory, however, offers an alternative explanation and suggests that the depletion effect reflects switch costs between different cognitive control processes recruited to deal with demanding tasks. This account implies that the depletion effect will not occur once people have had the opportunity to adapt to the self-regulatory task initially engaged in. Consistent with this idea, the present study showed that engaging in a demanding task led to performance deficits on a subsequent self-regulatory task (i.e. the depletion effect) only when the initial demanding task was relatively short but not when it was long enough for participants to adapt. Our results were unrelated to self-efficacy, mood, and motivation. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. Safety and Security of Radioactive Sources: Initiatives of the Forum of Nuclear Regulatory Bodies in Africa (FNRBA)

    International Nuclear Information System (INIS)

    Severa, R.

    2010-01-01

    Safety and Security of Radioactive Sources: Initiatives of the Forum of Nuclear Regulatory Bodies in Africa(FNRBA) is a regional organization comprising of nuclear regulatory bodies it’s goals are to promote the establishment of regulatory infrastructure in all countries of the Region to adopt joint action plan for implementation of self-assessment and work with Member States to upgrade their regulatory infrastructures, develop and promote a framework for capacity building in areas of radiation and nuclear safety and security, to create an opportunity for mutual support and coordination of regional initiatives by leveraging the development and utilization of regional and international resources and expertise and to serve as reference body on matters relating to nuclear and radiation safety and security in the Region. Radioactive active sources continue to play an increasingly important role in socio-economic activities on the African continent. There is also an ever increasing need to ensure that radioactive sources are utilized in a safe and secure manner

  17. Crisis, criticism, change: Regulatory reform in the wake of nuclear accidents

    International Nuclear Information System (INIS)

    Sexton, Kimberly A.; )

    2015-01-01

    Accidents are a forcing function for change in the nuclear industry. While these events can shed light on needed technical safety reforms, they can also shine a light on needed regulatory system reforms. The TEPCO Fukushima Daiichi nuclear power plant (NPP) accident in Japan is the most recent example of this phenomenon, but it is not the only one. In the wake of the three major accidents that have occurred in the nuclear power industry - Three Mile Island (TMI) in the United States; Chernobyl in Ukraine, in the former Soviet Union; and the Fukushima Daiichi NPP accident in Japan - a commission or committee of experts issued a report (or reports) with harsh criticism of the countries' regulatory system. And each of these accidents prompted changes in the respective regulatory systems. In looking at these responses, however, one must ask if this crisis, criticism, change approach is working and whether regulatory bodies around the world should instead undertake their own systematic reviews, un-prompted by crisis, to better ensure safety. This article will attempt to analyse the issue of regulatory reform in the wake of nuclear accidents by first providing a background in nuclear regulatory systems, looking to international and national legal frameworks. Next, the article will detail a cross-section of current regulatory systems around the world. Following that, the article will analyse the before and after of the regulatory systems in the United States, the Soviet Union and Japan in relation to the TMI, Chernobyl and Fukushima accidents. Finally, taking all this together, the article will address some of the international and national efforts to define exactly what makes a good regulator and provide conclusions on regulatory reform in the wake of nuclear accidents. (author)

  18. Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

    International Nuclear Information System (INIS)

    Illizastigui, P.F.

    2016-01-01

    The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)

  19. Regulatory pressure and income smoothing by banks in response to anticipated changes to the Basel II Accord

    Directory of Open Access Journals (Sweden)

    Chu Yeong Lim

    2017-03-01

    Full Text Available We examine the effects of the revised Basel II rules on bank managers’ discretionary behavior, specifically income smoothing and loan loss provisioning. As the revised rules exert greater regulatory pressure on corporate than retail banking, we predict corporate bank managers to reduce risk-taking activities or increase income smoothing. Analysis of segmental reports reveals greater (less income smoothing in the corporate banking segments of low-capital (high-capital banks during the Basel II period, with their managers recognizing loan loss provisions in a less timely fashion. We find no such effects for retail banking. Although we document an initially negative market reaction to the regulatory announcements, that reaction weakens over time. Overall, the study highlights the unintended consequences of the banking rule changes.

  20. Regulatory pressure and income smoothing by banks in response to anticipated changes to the Basel Ⅱ Accordq

    Institute of Scientific and Technical Information of China (English)

    Chu Yeong Lim; Kevin Ow Yong

    2017-01-01

    We examine the effects of the revised Basel II rules on bank managers’ discretionary behavior, specifically income smoothing and loan loss provisioning. As the revised rules exert greater regulatory pressure on corporate than retail banking, we predict corporate bank managers to reduce risk-taking activities or increase income smoothing. Analysis of segmental reports reveals greater(less) income smoothing in the corporate banking segments of low-capital(high-capital) banks during the Basel II period, with their managers recognizing loan loss provisions in a less timely fashion. We find no such effects for retail banking. Although we document an initially negative market reaction to the regulatory announcements, that reaction weakens over time. Overall,the study highlights the unintended consequences of the banking rule changes.

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

    Science.gov (United States)

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

    2015-01-01

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

  2. Regulatory aspects of management of change - Summary and conclusions

    International Nuclear Information System (INIS)

    2002-01-01

    Nuclear licensees are increasingly required to adapt to a more challenging commercial environment as moves to de-regulate electricity markets gather pace. One of the costs that is often perceived as being amenable to control is staffing, and hence there is significant exploration of new strategies for managing staffing levels. This report presents the outputs from a Workshop convened by the Special Experts' Group in Human and Organisational Factors (SEGHOF) of the Committee for the Safety of Nuclear Installations (CSNI) and organised by the UK Nuclear Installations Inspectorate (NII). The purpose of the workshop was to facilitate the exchange of views on, and approaches towards, the regulation of organisational change. The major risks associated with organisational change were discussed, and a range of regulatory challenges was identified for detailed discussion. There was agreement that the licensee must retain the responsibility to manage its own business but that organisational issues should be subject to regulatory scrutiny if they have the potential to impact on safety. The regulator should be able to demonstrate an approach to oversight of organisational change which is valid, transparent and consistent, and should inform the licensee of its expectations in terms of information supplied, communication and timing. The workshop confirmed that there is significant agreement between regulators concerning the need for licensees to put in place arrangements to manage organisational change. There was also broad consensus on what should constitute the elements of a licensee's management of change process. Differing views were evident about the balance between regulatory scrutiny of the process, as opposed to the outcomes of change, which largely represents differing regulatory regimes and philosophies. However, it was acknowledged that the regulator must be capable of taking an early view of the adequacy of proposed changes, rather than monitoring outcomes alone

  3. Legitimization of regulatory norms: Waterfowl hunter acceptance of changing duck bag limits

    Science.gov (United States)

    Schroeder, Susan A.; Fulton, David C.; Lawrence, Jeffrey S.; Cordts, Steven D.

    2014-01-01

    Few studies have examined response to regulatory change over time, or addressed hunter attitudes about changes in hunting bag limits. This article explores Minnesota waterfowl hunters’ attitudes about duck bag limits, examining attitudes about two state duck bag limits that were initially more restrictive than the maximum set by the U.S. Fish and Wildlife Service (USFWS), but then increased to match federal limits. Results are from four mail surveys that examined attitudes about bag limits over time. Following two bag limit increases, a greater proportion of hunters rated the new bag limit “too high” and a smaller proportion rated it “too low.” Several years following the first bag limit increase, the proportion of hunters who indicated that the limit was “too high” had declined, suggesting hunter acceptance of the new regulation. Results suggest that waterfowl bag limits may represent legal norms that influence hunter attitudes and gain legitimacy over time.

  4. 77 FR 13258 - Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for...

    Science.gov (United States)

    2012-03-06

    ...] Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for Petitions for..., Chief of Staff, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737... process changes APHIS is making to our petition process, go to http://www.aphis.usda.gov/biotechnology/pet...

  5. National Program Initiative to Prevent Illicit Trafficking for Radioactive Materials Out of Regulatory Control at the Border

    International Nuclear Information System (INIS)

    Suharyanta, S.

    2016-01-01

    The existing function of regulatory authority in a country which use a lot of radioactive sources is important key. The regulatory body has to in a position independence from other operators and nuclear research centre activities, so that their justification on Regulatory objective of safety and security can be achieved. The essential function of regulatory authority has to be represented such as development regulations, perform review and assessment, inspection and enforcement, and emergency preparedness and response functions. Under regulatory object coverage is divided into two clusters i.e. licensed nuclear installation and radiation facilities clusters,. There is other regulatory object is radioactive material out of regulatory control. This kind object is new option in the county and there for need priority policy judgement. This paper will discuss the Regulatory infrastructure and functions and it focused on the experience about National Programme Initiative to Prevent Illicit Trafficking for Radioactive Materials out of Regulatory Control at the Border. Regulatory Infrastructure and Functions. In Indonesia the independent regulatory authority ''called BAPETEN'' has been established since early 2000 based on the Act No. 10 year 1997, independent from operator organization and other nuclear research centre. Organization structure of BAPETEN has defined main divisions dealing with developing regulations, perform review and assessments, inspection and enforcement, and emergency preparedness and response, and also covered assessment function as a backup technical support division as a think-tank functions. Regulatory objects are nuclear installations such as three research reactors, Fuel fabrication facility, Isotope production facility, and waste storage facility for spent fuel and dis-used radioactive sources is running well. Recently, Regulatory of radioactive sources out of regulatory control is a new challenges, they need strengthened

  6. In silico modeling of epigenetic-induced changes in photoreceptor cis-regulatory elements.

    Science.gov (United States)

    Hossain, Reafa A; Dunham, Nicholas R; Enke, Raymond A; Berndsen, Christopher E

    2018-01-01

    DNA methylation is a well-characterized epigenetic repressor of mRNA transcription in many plant and vertebrate systems. However, the mechanism of this repression is not fully understood. The process of transcription is controlled by proteins that regulate recruitment and activity of RNA polymerase by binding to specific cis-regulatory sequences. Cone-rod homeobox (CRX) is a well-characterized mammalian transcription factor that controls photoreceptor cell-specific gene expression. Although much is known about the functions and DNA binding specificity of CRX, little is known about how DNA methylation modulates CRX binding affinity to genomic cis-regulatory elements. We used bisulfite pyrosequencing of human ocular tissues to measure DNA methylation levels of the regulatory regions of RHO , PDE6B, PAX6 , and LINE1 retrotransposon repeats. To describe the molecular mechanism of repression, we used molecular modeling to illustrate the effect of DNA methylation on human RHO regulatory sequences. In this study, we demonstrate an inverse correlation between DNA methylation in regulatory regions adjacent to the human RHO and PDE6B genes and their subsequent transcription in human ocular tissues. Docking of CRX to the DNA models shows that CRX interacts with the grooves of these sequences, suggesting changes in groove structure could regulate binding. Molecular dynamics simulations of the RHO promoter and enhancer regions show changes in the flexibility and groove width upon epigenetic modification. Models also demonstrate changes in the local dynamics of CRX binding sites within RHO regulatory sequences which may account for the repression of CRX-dependent transcription. Collectively, these data demonstrate epigenetic regulation of CRX binding sites in human retinal tissue and provide insight into the mechanism of this mode of epigenetic regulation to be tested in future experiments.

  7. Managing education/training resources to survive regulatory change

    International Nuclear Information System (INIS)

    Headley-Walker, L.; DeSain, G.

    1985-01-01

    The road to development of nuclear training and education programs that prepare operators to not only competently operate a commercial nuclear power plant under routine conditions but also acquire the knowledge, experience, and confidence necessary to perform under the rigors of a significant off-normal incident has been filled with speculative opinion, recommendations, disagreement, guidelines, and downright confusion. The US Nuclear Regulatory Commission (NRC) had not produced a regulation that specifically addresses the nature of education/training related to off-normal incidents. No one educational process currently offered fully addresses the ideal solution for those employed in the nuclear industry. The only practical solution must be the result of collaborative efforts between utilities and educational resources. The Regents College Degree Collaboration Model provides a worthy vehicle for positive movement toward this solution and survival of the ever-changing regulatory constraints in education

  8. Nurse leaders' experiences of implementing regulatory changes in sexual health nursing practice in British Columbia, Canada.

    Science.gov (United States)

    Bungay, Vicky; Stevenson, Janine

    2013-05-01

    Most research about regulatory policy change concerning expanded nursing activities has emphasized advanced practice roles and acute care settings. This study is a contribution to the small pool of research concerned with regulatory policy implementation for nurses undertaking expanded nursing practice activities in a public health context. Using the regulatory changes in certified nursing practice in one Canadian province as our starting point, we investigated the experiences of nurse leaders in implementing this change. Using a qualitative interpretive descriptive approach informed by tenets of complexity theory, we examined the experiences of 16 nurse leaders as situated within the larger public health care system in which nurses practice. Two interrelated themes, (a) preparing for certification and (b) the certification process, were identified to illustrate how competing and contrasting demands between health care and regulatory organizations created substantial barriers to policy change. Implications for health service delivery and future research are discussed.

  9. 76 FR 78059 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2011-12-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65927; File No. SR-OCC-2011-15] Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Management of..., future regulatory requirements for clearinghouses could impose liquidity requirements that would be...

  10. 78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

    Science.gov (United States)

    2013-11-20

    ...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... Administration (FDA) is announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms... information on the AGA Web site. If you need special accommodations due to a disability, please contact...

  11. 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

  12. A new MCM modification cycle regulates DNA replication initiation.

    Science.gov (United States)

    Wei, Lei; Zhao, Xiaolan

    2016-03-01

    The MCM DNA helicase is a central regulatory target during genome replication. MCM is kept inactive during G1, and it initiates replication after being activated in S phase. During this transition, the only known chemical change to MCM is the gain of multisite phosphorylation that promotes cofactor recruitment. Because replication initiation is intimately linked to multiple biological cues, additional changes to MCM can provide further regulatory points. Here, we describe a yeast MCM SUMOylation cycle that regulates replication. MCM subunits undergo SUMOylation upon loading at origins in G1 before MCM phosphorylation. MCM SUMOylation levels then decline as MCM phosphorylation levels rise, thus suggesting an inhibitory role of MCM SUMOylation during replication. Indeed, increasing MCM SUMOylation impairs replication initiation, partly through promoting the recruitment of a phosphatase that decreases MCM phosphorylation and activation. We propose that MCM SUMOylation counterbalances kinase-based regulation, thus ensuring accurate control of replication initiation.

  13. Organizational Learning, Building and Sustaining Core Competencies: Knowledge Management Initiatives on Inspection and Regulatory Enforcement in BAPETEN Indonesia

    International Nuclear Information System (INIS)

    Daeng Beta, W. P.; Nurwidi Astuti, Y. H.; Hermawan, A. S.; Syaifulloh, S.

    2016-01-01

    Full text: Regulatory inspection and law enforcement are among the core competencies of the Indonesia Nuclear Energy Regulatory Agency (BAPETEN). Knowledge management (KM) initiatives are based on strategic planning of BAPETEN. KM in BAPETEN is in its early stage, it is realized since 2015–2016, although its elements have stayed in service for 18 years. Its architecture and performance-information are: to conduct risk based inspection for medical, industrial and research facilities; to plan, monitor and evaluate of effective inspection, including standard operating procedures (SOPs); to utilize inspectors for safety security of radiation sources along with coordination with related stakeholders; to enforce the safety and security facilities report to users; to optimize reliable data communication, processing and information technology (B@LIS); to perform regulatory enforcement along with other related stakeholders. KM processes are performed through the “Socialization, Externalization, Combination, Internalization” (SECI) model. Technical knowledge for inspectors are based on the IAEA–TECDOC–1526 plus supporting knowledge. With KM, innovation products can easily be used, because they are documented, distributed in a KM portal, knowledge is shared through the BAPETEN website, B@LIS database and others. Our challenge is that KM initiatives still need a tremendous effort, not only internally, but also externally, especially in coordination and collaboration. Information access brings about not only positive but also negative impacts. Innovations in regulatory inspection and law enforcement in BAPETEN are planned innovations, sustained, and systematically performed. (author

  14. Resilient Prosumer Scenario in a Changing Regulatory Environment—The UniRCon Solution

    Directory of Open Access Journals (Sweden)

    Mihai Sanduleac

    2017-11-01

    Full Text Available Technological developments are pushing for new solutions based upon massive integration of renewable electricity generation in networks already facing many challenges. This paper presents a novel approach to managing the energy transfer towards prosumers making use of smart management of local energy storage. The proposed design (including storage dimensioning is based on several operating scenarios in which the prosumer might operate as: (i a “load only” entity (from a grid perspective, thus exhibiting investment resiliency against regulatory changes and high energy efficiency; or (ii a prosumer, in case regulatory opportunistic profit might be available. This can be realized within a newly proposed Uni-directional Resilient Consumer (UniRCon architecture. The major aim of the proposed architecture is to achieve optimal self-consumption while avoiding curtailment even in a changing regulatory environment like, for example, the total lack of incentives for generation based on renewable energy sources (RES. One of the major advantages of the proposed architecture consists in the adaptability to changes in the regulatory and market environment. The term resilience is used with multiple meanings: (a the prosumer’s financial resilience against regulatory changes when investment calculations assume no-grid injections; (b the prosumer’s technical resilience, with electrical design based on standalone operation; (c the resilience of clusters of interconnected end-user installations with enabled community-level electricity exchange, independent of the existing main grid supply; (d the contribution to grid resilience, by enabling AC microgrid (MG operation in island mode when large portions of the grid are formed by clusters of UniRCon prosumers (the ease of islanding segmentation of the local grid in case of emergencies. For proof of concept, three use-cases are detailed: (i photovoltaic (PV installations connected behind the meter; (ii PV and

  15. The political economy of productive sectors: Explaining regulatory initiatives in the fisheries and dairy sectors in Uganda

    DEFF Research Database (Denmark)

    Kjær, Anne Mette

    of regulation of the fisheries resource. In contrast, Ugandan milk production has boomed since the mid 1990s, and while the quality of the milk used to be highly questionable due to practices such as diluting milk and boiling it in sauce-pans, quality has gradually improved due to regulatory initiatives...

  16. Initiatives related to climate change in Ghana. Towards change in Ghana

    International Nuclear Information System (INIS)

    Wuertenberger, L.; Bunzeck, I.G.; Van Tilburg, X.

    2011-04-01

    To support the development of a National Climate Change Policy Framework (NCCPF) and a further harmonization of climate change related activities in Ghana, the Ministry of Finance and Economic Planning (MoFEP) and the Ministry of Environment, Science and Technology (MEST) expressed demand for a mapping of the most important past and current climate change related initiatives in the country, and of international climate change related funding opportunities, that Ghana might be able to access. The initiatives mapping demonstrates Ghana's longstanding engagement with climate change, dating back to more than 15 years ago. The report shows a multitude of activities including a number of large (5 mln. USD to > 100 mln. USD), GEF or World Bank financed projects, and a range of smaller projects (in the order of 100 000 - 500 000 USD). The majority of current initiatives are related to forestry and REDD. This report concludes with a discussion on observed trends, such as a broadening involvement of MDAs in adaptation initiatives and a focus on low carbon growth, and of points for attention, such as a need for coordination, for private sector involvement and supporting systems (such as institutional capacity, governance and monitoring systems)

  17. Scientific underpinnings of biotechnology regulatory frameworks.

    Science.gov (United States)

    Gleim, Savannah; Smyth, Stuart J

    2018-05-25

    Part of what is presently missing at domestic regulatory levels (and that is important at the international level as well) is a detailed understanding of what the rules of, and for, regulation should be, who the actors, stakeholders and major decision makers are and finally, how to get agreement about the rules. Greater insights into the system of rules that underpin regulatory frameworks for agri-food and biotechnology products in genetically modified (GM) crop- adopting nations will provide value by clarifying the evidence used to commercialize these technologies. This article examines the public documents available from Canada, the United States, the European Union and the Organisation for Economic Cooperation and Development regarding the development of regulatory risk assessment frameworks for products of biotechnology to determine what science grounds these frameworks. The documentation used to provide the initial structure to the existing regulatory frameworks identifies the linkages, connections and relationships that exist between science, risk assessment and regulatory policy. The relationship between risk and regulation has never been more critical to the commercialization of innovative agricultural products. Documenting the role of science-based risk assessment in regulations and how this has changed over the 20 years of experience in regulating GM crops will identify changes in the risk/regulation relationship. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

  18. Changing innovation into a registered product: From concept to regulatory approval.

    Science.gov (United States)

    Rhodes, Linda

    2018-05-01

    Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2008-01-01

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

  20. 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...

  1. 77 FR 40396 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing of Proposed Rule Changes To...

    Science.gov (United States)

    2012-07-09

    ... by the self-regulatory organization. The Commission is publishing this notice to solicit comments on.... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The... principal office and at the Public Reference Room of the Commission. II. Self-Regulatory Organization's...

  2. 17 CFR 249.819 - Form 19b-4, for electronic filing with respect to proposed rule changes by all self-regulatory...

    Science.gov (United States)

    2010-04-01

    ... filing with respect to proposed rule changes by all self-regulatory organizations. 249.819 Section 249..., SECURITIES EXCHANGE ACT OF 1934 Forms for Self-Regulatory Organization Rule Changes and Forms for....819 Form 19b-4, for electronic filing with respect to proposed rule changes by all self-regulatory...

  3. Environmental Regulatory Update Table, December 1989

    International Nuclear Information System (INIS)

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

    1990-01-01

    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

  4. Environmental regulatory update table, March 1989

    International Nuclear Information System (INIS)

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

    1989-04-01

    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

  5. Environmental Regulatory Update Table, April 1989

    International Nuclear Information System (INIS)

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

    1989-05-01

    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 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

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. DOE regulatory reform initiative vitrified mixed waste

    International Nuclear Information System (INIS)

    Carroll, S.J.; Holtzscheiter, E.W.

    1997-01-01

    The US Department of Energy (DOE) is charged with responsibly managing the largest volume of mixed waste in the United States. This responsibility includes managing waste in compliance with all applicable Federal and State laws and regulations, and in a cost-effective, environmentally responsible manner. Managing certain treated mixed wastes in Resource Conservation and Recovery Act (RCRA) permitted storage and disposal units (specifically those mixed wastes that pose low risks from the hazardous component) is unlikely to provide additional protection to human health and the environment beyond that afforded by managing these wastes in storage and disposal units subject to requirements for radiological control. In October, 1995, the DOE submitted a regulatory reform proposal to the Environmental Protection Agency (EPA) relating to vitrified mixed waste forms. The technical proposal supports a regulatory strategy that would allow vitrified mixed waste forms treated through a permit or other environmental compliance mechanism to be granted an exemption from RCRA hazardous waste regulation, after treatment, based upon the inherent destruction and immobilization capabilities of vitrification technology. The vitrified waste form will meet, or exceed the performance criteria of the Environmental Assessment (EA) glass that has been accepted as an international standard for immobilizing radioactive waste components and the LDR treatment standards for inorganics and metals for controlling hazardous constituents. The proposal further provides that vitrified mixed waste would be responsibly managed under the Atomic Energy Act (AEA) while reducing overall costs. Full regulatory authority by the EPA or a State would be maintained until an acceptable vitrified mixed waste form, protective of human health and the environment, is produced

  12. The BC-Alberta intertie : impact of regulatory change

    International Nuclear Information System (INIS)

    Christian, J.; Hughes, K.

    2004-01-01

    The interconnected electricity system between the provinces of British Columbia (BC) and Alberta was discussed with reference to the Cranbrook-Langdon 500 kV line and two 138 kV transmission lines. The lines in British Columbia are owned by BC Hydro and operated by the BC Transmission Corporation, while the lines in Alberta are owned by AltaLink and operated by the Alberta Electric Systems Operator (AESO). The operating terms and conditions are established by an Interconnection Agreement between all parties. The Alberta-BC Intertie was designed to operate at an operating transfer capacity of 1200 MW from BC to Alberta, and 1000 MW from Alberta to BC. The operational limits on Intertie capacity were imposed due to voltage constraints within Alberta during high load periods resulting from insufficient transmission support. It was noted that available capacity is often under-utilized because sometimes it is not economical to schedule into or out of Alberta due to better market conditions in the Pacific Northwest. Transmission users in BC have explicit transmission rights which must be purchased on an hourly basis. However, transmission rights in Alberta follow dispatch of generation through Power Pool bidding. The impact of an under-utilized transmission capacity is higher wholesale prices in both Alberta and in the Pacific Northwest because ratepayers end up paying for the under-used capacity. This presentation also outlined regulatory change in Alberta with reference to consolidation of Alberta's Transmission Administrator, Power Pool Administrator and system controller functions; Alberta's new transmission policy; and, the enhanced role of market surveillance administrator. It also outlined the regulatory change in British Columbia with reference to the creation of the BC Transmission Corporation; the Heritage Contract; and, stepped rates and retail access. The effect of changes on intertie usage in both Alberta and British Columbia were also outlined. 31 refs

  13. 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.

  14. 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.

  15. 17 CFR 249.822 - Form 19b-7, for electronic filing with respect to proposed rule changes by self-regulatory...

    Science.gov (United States)

    2010-04-01

    ... filing with respect to proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A... proposed rule changes by self-regulatory organizations under Section 19(b)(7)(A) of the Securities Exchange Act of 1934. This form shall be used by self-regulatory organizations, as defined in section 3(a)(25...

  16. Changes in Cis-regulatory Elements during Morphological Evolution

    Directory of Open Access Journals (Sweden)

    Yu-Lee Paul

    2012-10-01

    Full Text Available How have animals evolved new body designs (morphological evolution? This requires explanations both for simple morphological changes, such as differences in pigmentation and hair patterns between different Drosophila populations and species, and also for more complex changes, such as differences in the forelimbs of mice and bats, and the necks of amphibians and reptiles. The genetic changes and pathways involved in these evolutionary steps require identification. Many, though not all, of these events occur by changes in cis-regulatory (enhancer elements within developmental genes. Enhancers are modular, each affecting expression in only one or a few tissues. Therefore it is possible to add, remove or alter an enhancer without producing changes in multiple tissues, and thereby avoid widespread (pleiotropic deleterious effects. Ideally, for a given step in morphological evolution it is necessary to identify (i the change in phenotype, (ii the changes in gene expression, (iii the DNA region, enhancer or otherwise, affected, (iv the mutation involved, (v the nature of the transcription or other factors that bind to this site. In practice these data are incomplete for most of the published studies upon morphological evolution. Here, the investigations are categorized according to how far these analyses have proceeded.

  17. 77 FR 1099 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change...

    Science.gov (United States)

    2012-01-09

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

  18. Leading and managing organizational change initiatives

    OpenAIRE

    Peus, Claudia; Frey, Dieter; Gerkhardt, Marit; Fischer, Peter; Traut-Mattausch, Eva

    2009-01-01

    Although indispensable for long-term economic growth, organizational changes are usually met with resistance. This article draws on psychological theories and empirical evidence to highlight why and under what conditions changes lead to resistance and what likely consequences of resistance are. Furthermore, the article discusses the variables that have been identified as success factors for organizational change initiatives. These include individual difference variables and objective characte...

  19. 77 FR 40392 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing of Proposed Rule Changes To...

    Science.gov (United States)

    2012-07-09

    ... prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments.... I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change.... [[Page 40393

  20. 77 FR 52096 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ...'s rules, the financial and regulatory risk management controls and supervisory procedures required...-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  1. 75 FR 2899 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2010-01-19

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-61333; File No. SR-NYSE-2009-117] Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Amending Its... regulatory program. III. Discussion and Commission's Findings After careful review, the Commission finds that...

  2. Accounting for Technological Change in Regulatory Impact Analyses: The Learning Curve Technique

    Energy Technology Data Exchange (ETDEWEB)

    Taylor, Margaret [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fujita, K. Sydny [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2013-04-30

    Regulatory impact assessment is formally required by the U.S. and many other nations in order to help governments weigh the costs and benefits of proposed regulations, particularly as they compare to those of alternative actions and other government priorities. 1 One of the “best practices” of regulatory impact assessments, as established by the OECD, is to use estimates of costs that are grounded in economic theory. Economic theory indicates that changes in compliance costs should be expected over time as a result of factors related to technological innovation. But many U.S. regulatory impact assessments have traditionally employed a practice that is in conflict with this expectation: they take current estimates of the costs of complying with a proposed regulation and project that those costs will remain unchanged over the full time period that the regulation would be in effect.

  3. Initial threat assessment. Radiological risks associated with SevRAO facilities falling within the regulatory supervision responsibilities of FMBA[Russian Federation

    Energy Technology Data Exchange (ETDEWEB)

    Ilin, Leonid; Kochetkov, Oleg; Simakov, Anatoly; Shandala, Natalya; Savkin, Mikhail; Sneve, Malgorzata K.; Boerretzen, Peer; Jaworska, Alicja; Smith, Graham; Barraclough, Ian; Kruse, Phil

    2005-07-01

    The purpose of this initial threat assessment is to obtain a view, from the regulatory perspective of FMBA, of the most important issues which require supervision and regulatory development, regarding work which has to be carried out at the Andreeva Bay and Grcmikha. The main radiological threats have been identified and actions to reduce the threats have been proposed. Situations where regulations and procedures for workers on-site need to be developed have been identified. This will be a basis for further development of Russian regulation and procedures. (Author)

  4. 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.

  5. 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

  6. EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making.

    Science.gov (United States)

    Plueschke, Kelly; McGettigan, Patricia; Pacurariu, Alexandra; Kurz, Xavier; Cave, Alison

    2018-06-14

    A review of European Union (EU)-funded initiatives linked to 'Real World Evidence' (RWE) was performed to determine whether their outputs could be used for the generation of real-world data able to support the European Medicines Agency (EMA)'s regulatory decision-making on medicines. The initiatives were identified from publicly available websites. Their topics were categorised into five areas: 'Data source', 'Methodology', 'Governance model', 'Analytical model' and 'Infrastructure'. To assess their immediate relevance for medicines evaluation, their therapeutic areas were compared with the products recommended for EU approval in 2016 and those included in the EMA pharmaceutical business pipeline. Of 171 originally identified EU-funded initiatives, 65 were selected based on their primary and secondary objectives (35 'Data source' initiatives, 15 'Methodology', 10 'Governance model', 17 'Analytical model' and 25 'Infrastructure'). These 65 initiatives received over 734 million Euros of public funding. At the time of evaluation, the published outputs of the 40 completed initiatives did not always match their original objectives. Overall, public information was limited, data access was not explicit and their sustainability was unclear. The topics matched 8 of 14 therapeutic areas of the products recommended for approval in 2016 and 8 of 15 therapeutic areas in the 2017-2019 pharmaceutical business pipeline. Haematology, gastroenterology or cardiovascular systems were poorly represented. This landscape of EU-funded initiatives linked to RWE which started before 31 December 2016 highlighted that the immediate utilisation of their outputs to support regulatory decision-making is limited, often due to insufficient available information and to discrepancies between outputs and objectives. Furthermore, the restricted sustainability of the initiatives impacts on their downstream utility. Multiple projects focussing on the same therapeutic areas increase the likelihood of

  7. 77 FR 52097 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as...

    Science.gov (United States)

    2012-08-28

    ... financial and regulatory risk management controls and supervisory procedures required by Rule 15c3-5 under...-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving a Proposed Rule Change, as Modified by... that broker-dealers appropriately control the risks associated with market access, so as not to...

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. Changes in cis-regulatory elements of a key floral regulator are associated with divergence of inflorescence architectures.

    Science.gov (United States)

    Kusters, Elske; Della Pina, Serena; Castel, Rob; Souer, Erik; Koes, Ronald

    2015-08-15

    Higher plant species diverged extensively with regard to the moment (flowering time) and position (inflorescence architecture) at which flowers are formed. This seems largely caused by variation in the expression patterns of conserved genes that specify floral meristem identity (FMI), rather than changes in the encoded proteins. Here, we report a functional comparison of the promoters of homologous FMI genes from Arabidopsis, petunia, tomato and Antirrhinum. Analysis of promoter-reporter constructs in petunia and Arabidopsis, as well as complementation experiments, showed that the divergent expression of leafy (LFY) and the petunia homolog aberrant leaf and flower (ALF) results from alterations in the upstream regulatory network rather than cis-regulatory changes. The divergent expression of unusual floral organs (UFO) from Arabidopsis, and the petunia homolog double top (DOT), however, is caused by the loss or gain of cis-regulatory promoter elements, which respond to trans-acting factors that are expressed in similar patterns in both species. Introduction of pUFO:UFO causes no obvious defects in Arabidopsis, but in petunia it causes the precocious and ectopic formation of flowers. This provides an example of how a change in a cis-regulatory region can account for a change in the plant body plan. © 2015. Published by The Company of Biologists Ltd.

  4. Leadership and Safety Management: Regulatory Initiatives for Enhancing Nuclear Safety in the Republic of Korea

    International Nuclear Information System (INIS)

    Yun, C.H.; Park, Y.W.; Choi, K.S.

    2010-01-01

    Since the construction of the first nuclear power plant (NPP) in the Republic of Korea in 1978, a high level of nuclear safety has continued to be maintained. This has been the important basis on which the continuous construction of NPPs has been possible in the country. To date, regulatory initiatives, leaderships and strategies adopting well harmonized regulatory systems and practices of advanced countries have contributed to improving the effectiveness and efficiency of safety regulation and further enhancing nuclear safety. The outcomes have resulted in a high level of safety and performance of Korean NPPs, attributing largely to the safety promotion policy. Recently, with the support of the Korean Ministry of Education, Science and Technology (MEST), the Korea Institute of Nuclear Safety (KINS) established the International Nuclear Safety School and created a Nuclear Safety Master's Degree Programme. Further, it developed multilateral and bilateral cooperation with other agencies to promote global nuclear safety, with the aim of providing knowledge and training to new entrant countries in establishing the safety infrastructure necessary for ensuring an acceptable level of nuclear safety. (author)

  5. 77 FR 65815 - Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name...

    Science.gov (United States)

    2012-10-31

    .... 070726412-1300-02] RIN 0648-BA24 Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name Change; Notice of Effective Date AGENCY: Office of National Marine Sanctuaries... geographical areas to the sanctuary and change the name of the Fagatele Bay National Marine Sanctuary (FBNMS or...

  6. 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.

  7. 78 FR 13103 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending...

    Science.gov (United States)

    2013-02-26

    ... intermediate holding company from the ownership structure of the Exchange. C. Self-Regulatory Organization's...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending Its Rules To..., Inc., Thereby Eliminating NYSE Arca Holdings, Inc. From the Ownership Structure of the Exchange...

  8. 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.

  9. Power plant construction contracting in a changing regulatory environment

    International Nuclear Information System (INIS)

    Person, J.C.

    1993-01-01

    The 1965 blackout in the Northeast provided the wake-up call that spawned in unprecedented program of power plant construction by electric utilities. This building program began in the late 1960s and continued unabated through the 1970s. Beginning in the late 1970s, state regulators began in era of 'prudence' reviews which disallowed as imprudent significant portions of the costs of certain nuclear units being brought on line at the time. This regulatory experience brought about a fundamental change in the way in which utilities evaluated the need for additional capacity. This paper explores construction contracting trends in light of recent developments in the relationship between the electric utility and the state regulator. It is within this context that the utility decides: (1) whether to build, buy, or save; and (2) if the decision is to build, which project planning and administration considerations will maximize the utility's ability to incorporate project costs into the ratebase. In order to put these issues into their proper perspective, this paper first presents a brief overview of the prudence decisions of the past, and the chilling effect of these decisions generally on new project planning. The paper next focuses on the recent changes to the post-construction prudence review model, including the introduction of pre-approval arrangements and rolling prudence reviews. Following that will be a survey of new construction spending decisions in light of these changes. After an analysis of the bases for the prudence disallowances of the past and the application of the lessons learned from these disallowances to contract planning and administration issues of today, the paper will close with a discussion of the relative advantages and disadvantages of the most commonly used contract delivery methods in today's regulatory environment

  10. Modeling Dynamic Regulatory Processes in Stroke

    Science.gov (United States)

    McDermott, Jason E.; Jarman, Kenneth; Taylor, Ronald; Lancaster, Mary; Shankaran, Harish; Vartanian, Keri B.; Stevens, Susan L.; Stenzel-Poore, Mary P.; Sanfilippo, Antonio

    2012-01-01

    The ability to examine the behavior of biological systems in silico has the potential to greatly accelerate the pace of discovery in diseases, such as stroke, where in vivo analysis is time intensive and costly. In this paper we describe an approach for in silico examination of responses of the blood transcriptome to neuroprotective agents and subsequent stroke through the development of dynamic models of the regulatory processes observed in the experimental gene expression data. First, we identified functional gene clusters from these data. Next, we derived ordinary differential equations (ODEs) from the data relating these functional clusters to each other in terms of their regulatory influence on one another. Dynamic models were developed by coupling these ODEs into a model that simulates the expression of regulated functional clusters. By changing the magnitude of gene expression in the initial input state it was possible to assess the behavior of the networks through time under varying conditions since the dynamic model only requires an initial starting state, and does not require measurement of regulatory influences at each time point in order to make accurate predictions. We discuss the implications of our models on neuroprotection in stroke, explore the limitations of the approach, and report that an optimized dynamic model can provide accurate predictions of overall system behavior under several different neuroprotective paradigms. PMID:23071432

  11. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

    Science.gov (United States)

    Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

    2013-01-22

    ± 16.2) and Obama (41.7 ± 11.1). Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.

  12. Multiple regulatory systems coordinate DNA replication with cell growth in Bacillus subtilis.

    Science.gov (United States)

    Murray, Heath; Koh, Alan

    2014-10-01

    In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s) that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes.

  13. 77 FR 25770 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending...

    Science.gov (United States)

    2012-05-01

    ... settings via Regulatory Bulletin. The Mechanism protects Market Makers from the risk associated with an...-Regulatory Organizations; NYSE Amex LLC; Notice of Filing of Proposed Rule Change Amending NYSE Amex Options Rule 928NY Specifying That the Potential Range for the Settings Applicable to the Market Maker Risk...

  14. 77 FR 21785 - Medical Countermeasures Initiative Regulatory Science Symposium

    Science.gov (United States)

    2012-04-11

    ... forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory... information: (1) Your name, (2) title, (3) company or organization (if applicable), (4) mailing address, (5...

  15. When planning is not enough: the self-regulatory effect of implementation intentions on changing snacking habits.

    Science.gov (United States)

    Tam, Leona; Bagozzi, Richard P; Spanjol, Jelena

    2010-05-01

    This study examined whether matching implementation intentions to people's regulatory orientation affects the effectiveness of changing unhealthy snacking habits. Participants' regulatory orientation was either measured (as a chronic trait) or manipulated (as a situational state), and participants were randomly assigned to implementation intention conditions to eat more healthy snacks or avoid eating unhealthy ones. A self-reported online food diary of healthy and unhealthy snacks over a 2-day period. Participants with weak unhealthy snacking habits consumed more healthy snacks when forming any type of implementation intentions (regardless of match or mismatch with their regulatory orientation), while participants with strong unhealthy snacking habits consumed more healthy snacks only when forming implementation intentions that matched their regulatory orientations. RESULTS suggest that implementation intentions that match regulatory orientation heighten motivation intensity and put snacking under intentional control for people with strong unhealthy snacking habits. (c) 2010 APA, all rights reserved.

  16. 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

  17. 77 FR 3646 - Proposed Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary...

    Science.gov (United States)

    2012-01-25

    .... 100908440-1615-01] RIN 0648-BA24 Proposed Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name Change AGENCY: Office of National Marine Sanctuaries (ONMS), National Ocean... in the Federal Register to revise the regulations for the Fagatele Bay National Marine Sanctuary (76...

  18. Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

    Directory of Open Access Journals (Sweden)

    Nguyen Diane

    2013-01-01

    administration: Clinton (122.3 ± 36.4, Bush (29.5 ± 16.2 and Obama (41.7 ± 11.1. Conclusions Most regulatory letters released by FDA headquarters were related to marketing and advertising activities of pharmaceutical companies. The number of regulatory letters was highest during the second Clinton administration, diminished during the Bush administrations, and increased again during the Obama administration. A further assessment of the impact of changes in federal administration on the enforcement activities of the FDA is required.

  19. Testosterone: from initiating change to modulating social organisation in domestic fowl ( Gallus gallus domesticus)

    Science.gov (United States)

    Kent, John P.; Murphy, Kenneth J.; Bannon, Finian J.; Hynes, Niamh M.; Hayden, Thomas J.

    2009-07-01

    Testosterone (T) concentrations in many species are sensitive to seasonal changes and to changes in social conditions. However, the effect of the natural or endogenous T increase in the juvenile on their social behaviour is not well understood. In this study, T and behaviour were measured from the pro-social juvenile to the adult stage in semi-feral domestic fowl. During the pro-social phase T levels and the distance chicks maintained between each other, i.e. inter-individual distance (IID) were low. Then, as T increased, a corresponding increase in IID occurred and continued in males until dispersal to individual adult male territories. In the new and initially stable adult social structure, T declined and IID remained high, indicating a new behavioural mechanism was in place. Males first mated as T levels were declining. They were then challenged; then T increased, and then IID increased again. Adult male T levels fluctuate, being low or declining in a socially stable environment and increasing following a challenge, suggesting a regulatory or modulating role for T. The results are consistent with T having an endogenous role: in the juvenile, driving behavioural change towards adulthood, and in adulthood, a modulating role regulating social organisation.

  20. Rethinking managerial roles in change initiatives

    NARCIS (Netherlands)

    B.A.S. Koene (Bas)

    2017-01-01

    textabstractOrganisational change that is initiated by middle management rather than top management is more likely to gain employee support. This is the conclusion of a recent study co-authored by Bas Koene, assistant professor in RSM’s Department of Organisation and Personnel Management.

  1. 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

  2. Evolution of Cis-Regulatory Elements and Regulatory Networks in Duplicated Genes of Arabidopsis.

    Science.gov (United States)

    Arsovski, Andrej A; Pradinuk, Julian; Guo, Xu Qiu; Wang, Sishuo; Adams, Keith L

    2015-12-01

    Plant genomes contain large numbers of duplicated genes that contribute to the evolution of new functions. Following duplication, genes can exhibit divergence in their coding sequence and their expression patterns. Changes in the cis-regulatory element landscape can result in changes in gene expression patterns. High-throughput methods developed recently can identify potential cis-regulatory elements on a genome-wide scale. Here, we use a recent comprehensive data set of DNase I sequencing-identified cis-regulatory binding sites (footprints) at single-base-pair resolution to compare binding sites and network connectivity in duplicated gene pairs in Arabidopsis (Arabidopsis thaliana). We found that duplicated gene pairs vary greatly in their cis-regulatory element architecture, resulting in changes in regulatory network connectivity. Whole-genome duplicates (WGDs) have approximately twice as many footprints in their promoters left by potential regulatory proteins than do tandem duplicates (TDs). The WGDs have a greater average number of footprint differences between paralogs than TDs. The footprints, in turn, result in more regulatory network connections between WGDs and other genes, forming denser, more complex regulatory networks than shown by TDs. When comparing regulatory connections between duplicates, WGDs had more pairs in which the two genes are either partially or fully diverged in their network connections, but fewer genes with no network connections than the TDs. There is evidence of younger TDs and WGDs having fewer unique connections compared with older duplicates. This study provides insights into cis-regulatory element evolution and network divergence in duplicated genes. © 2015 American Society of Plant Biologists. All Rights Reserved.

  3. 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

  4. 76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2011-10-26

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

  5. 75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-04-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

  6. Pollution prevention: A regulatory update

    International Nuclear Information System (INIS)

    Walzer, A.E.; Maynard, J.W.

    1993-01-01

    Pollution prevention is the emphasis of the 1990s environmental philosophy. This new environmental era was ushered in when President Bush signed the Pollution Prevention Act in October 1990. This law, with its accompanying philosophy, was in response to the realization that end-of-the-pipe treatment, which frequently changed the media in which a pollutant or waste was discharged, was inadequate to protect the environment and human health. Pollution prevention advocates source reduction, where material substitutions and engineering solutions are sought to reduce the volume and toxicity of waste and pollutants. This proactive approach reduces environmental impacts such as those of former waste sites which have produced environmental legacies that will cost billions of dollars and take decades to remediate. This paper describes pollution prevention philosophy and summarizes regulatory pollution prevention requirements. It describes current regulatory trends in the area of pollution prevention, including voluntary programs and enforcement actions. The Pollution Prevention Act of 1990 is described, and pollution prevention initiatives embodied in other laws, including the Clean Air Act, the Clean Water Act, the Emergency Planning and Community Right-To-Know Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, are discussed. A historical overview of waste minimization initiatives within the Department of Energy is given, and other pollution prevention initiatives that affect federal facilities, such as Executive Order 12780, which mandates recycling and the procurement of recycled materials, are also outlined

  7. Evaluating U.S. States climate change initiatives

    International Nuclear Information System (INIS)

    Silva, P.

    2004-01-01

    This paper evaluates sub-federal efforts to mitigate climate change in the United States through a range of climate-relevant initiatives, identifying principal trends and detailing climate-relevant initiatives in several states. These strategies include renewable electricity mandates, State and regional greenhouse gas emissions inventories, mandatory greenhouse gas emissions reporting, State greenhouse gas emissions caps, greenhouse gas emissions reductions from motor vehicles, and greenhouse gas emissions cap-and-trade programs for electric generation in several States. Many municipalities in the United States are also pursuing a range of climate-relevant initiatives, those actions are beyond the scope of this paper, but it should be noted they also influence state and national consideration of climate-relevant initiatives in the United States. (author)

  8. Evaluating U.S. States climate change initiatives

    Energy Technology Data Exchange (ETDEWEB)

    Silva, P

    2004-07-01

    This paper evaluates sub-federal efforts to mitigate climate change in the United States through a range of climate-relevant initiatives, identifying principal trends and detailing climate-relevant initiatives in several states. These strategies include renewable electricity mandates, State and regional greenhouse gas emissions inventories, mandatory greenhouse gas emissions reporting, State greenhouse gas emissions caps, greenhouse gas emissions reductions from motor vehicles, and greenhouse gas emissions cap-and-trade programs for electric generation in several States. Many municipalities in the United States are also pursuing a range of climate-relevant initiatives, those actions are beyond the scope of this paper, but it should be noted they also influence state and national consideration of climate-relevant initiatives in the United States. (author)

  9. 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

  10. 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.

  11. Multiple regulatory systems coordinate DNA replication with cell growth in Bacillus subtilis.

    Directory of Open Access Journals (Sweden)

    Heath Murray

    2014-10-01

    Full Text Available In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes.

  12. Multiple Regulatory Systems Coordinate DNA Replication with Cell Growth in Bacillus subtilis

    Science.gov (United States)

    Murray, Heath; Koh, Alan

    2014-01-01

    In many bacteria the rate of DNA replication is linked with cellular physiology to ensure that genome duplication is coordinated with growth. Nutrient-mediated growth rate control of DNA replication initiation has been appreciated for decades, however the mechanism(s) that connects these cell cycle activities has eluded understanding. In order to help address this fundamental question we have investigated regulation of DNA replication in the model organism Bacillus subtilis. Contrary to the prevailing view we find that changes in DnaA protein level are not sufficient to account for nutrient-mediated growth rate control of DNA replication initiation, although this regulation does require both DnaA and the endogenous replication origin. We go on to report connections between DNA replication and several essential cellular activities required for rapid bacterial growth, including respiration, central carbon metabolism, fatty acid synthesis, phospholipid synthesis, and protein synthesis. Unexpectedly, the results indicate that multiple regulatory systems are involved in coordinating DNA replication with cell physiology, with some of the regulatory systems targeting oriC while others act in a oriC-independent manner. We propose that distinct regulatory systems are utilized to control DNA replication in response to diverse physiological and chemical changes. PMID:25340815

  13. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune...... reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells......Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...

  14. 77 FR 66196 - Self-Regulatory Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-11-02

    ... Accounting Principles (``GAAP''). Canadian clearing members that use Form 1 report the same, and in some... Organizations; Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Financial... financial reporting by Canadian clearing members to reflect the Investment Industry Regulatory Organization...

  15. 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.

  16. 75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-02-01

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

  17. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

  18. Features of heart rate variability capture regulatory changes during kangaroo care in preterm infants

    NARCIS (Netherlands)

    Kommers, D.R.; Joshi, R.; van Pul, C.; Atallah, N.L.; Feijs, L.M.G.; Oei, S.G.; Bambang Oetomo, S.; Andriessen, P.

    2017-01-01

    Objective: To determine whether heart rate variability (HRV) can serve as a surrogate measure to track regulatory changes during kangaroo care, a period of parental coregulation distinct from regulation within the incubator. Study design: Nurses annotated the starting and ending times of kangaroo

  19. Overview of Variable Renewable Energy Regulatory Issues: A Clean Energy Regulators Initiative Report

    Energy Technology Data Exchange (ETDEWEB)

    Miller, M.; Cox, S.

    2014-05-01

    This CERI report aims to provide an introductory overview of key regulatory issues associated with the deployment of renewable energy -- particularly variable renewable energy (VRE) sources such wind and solar power. The report draws upon the research and experiences from various international contexts, and identifies key ideas that have emerged from the growing body of VRE deployment experience and regulatory knowledge. The report assumes basic familiarity with regulatory concepts, and although it is not written for a technical audience, directs the reader to further reading when available. VRE deployment generates various regulatory issues: substantive, procedural, and public interest issues, and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.

  20. Changing the regulation for regulating the change: Innovation-driven regulatory developments for smart grids, smart metering and e-mobility in Italy

    International Nuclear Information System (INIS)

    Lo Schiavo, Luca; Delfanti, Maurizio; Fumagalli, Elena; Olivieri, Valeria

    2013-01-01

    For a long time considered as technologically mature, electric systems are now facing a period of rapid evolution, inspired by climate change concerns. Several studies show that current regulation of natural monopolies does not offer sufficient incentives for network operators (and network users) to participate in this process. Taking Italy as a case study, this paper analyses how energy regulation can change to support the current transformation. We describe the recent regulatory interventions in the domain of smart grids, smart metering and electromobility, with a specific emphasis on the provisions aimed at fostering innovation—an issue that until recently has received almost no attention in the literature nor in the practice of regulation. The progress we observe is considerable in all new areas of concern, and, above all, in the regulator's commitment to provide the right incentives for investments in demonstration projects: the acquisition of experience is regarded as essential to move to more sophisticated regulatory instruments. Finally, regulation is also increasingly concerned with network users, both traditional and new, with the objective to stimulate more active behaviours. - Highlights: ► Regulatory changes in Italy: smart grids, smart metering and electromobility. ► Identification of indicators for regulating innovative investments. ► Demonstration projects for smart grids and EV recharging infrastructures. ► Proposal of an output-based regulation for smart grids. ► Time of Use pricing for residential and small commercial consumers

  1. 76 FR 55148 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt...

    Science.gov (United States)

    2011-09-06

    ...-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change To Adopt Rules for the...-4 thereunder,\\2\\ a proposed rule change to adopt rules for the qualification, listing, and delisting... the Proposal The Exchange proposes rules to adopt a program for the qualification, listing, and...

  2. 75 FR 69491 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange...

    Science.gov (United States)

    2010-11-12

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63266; File No. SR-NYSE-2010-67] Self-Regulatory Organizations; Order Approving Proposed Rule Change by New York Stock Exchange LLC Changing the NYBX Order Execution Sequence November 5, 2010. I. Introduction On September 9, 2010, the New York...

  3. Regulatory point of view of SAT application

    International Nuclear Information System (INIS)

    Juhasz, L.

    2002-01-01

    I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)

  4. Climate change adaptation in regulated water utilities

    Science.gov (United States)

    Vicuna, S.; Melo, O.; Harou, J. J.; Characklis, G. W.; Ricalde, I.

    2017-12-01

    Concern about climate change impacts on water supply systems has grown in recent years. However, there are still few examples of pro-active interventions (e.g. infrastructure investment or policy changes) meant to address plausible future changes. Deep uncertainty associated with climate impacts, future demands, and regulatory constraints might explain why utility planning in a range of contexts doesn't explicitly consider climate change scenarios and potential adaptive responses. Given the importance of water supplies for economic development and the cost and longevity of many water infrastructure investments, large urban water supply systems could suffer from lack of pro-active climate change adaptation. Water utilities need to balance the potential for high regret stranded assets on the one side, with insufficient supplies leading to potentially severe socio-economic, political and environmental failures on the other, and need to deal with a range of interests and constraints. This work presents initial findings from a project looking at how cities in Chile, the US and the UK are developing regulatory frameworks that incorporate utility planning under uncertainty. Considering for example the city of Santiago, Chile, recent studies have shown that although high scarcity cost scenarios are plausible, pre-emptive investment to guard from possible water supply failures is still remote and not accommodated by current planning practice. A first goal of the project is to compare and contrast regulatory approaches to utility risks considering climate change adaptation measures. Subsequently we plan to develop and propose a custom approach for the city of Santiago based on lessons learned from other contexts. The methodological approach combines institutional assessment of water supply regulatory frameworks with simulation-based decision-making under uncertainty approaches. Here we present initial work comparing the regulatory frameworks in Chile, UK and USA evaluating

  5. U.S. regulatory initiatives related to nuclear research and development

    International Nuclear Information System (INIS)

    Carr, K.M.

    1987-01-01

    U.S. Nuclear Regulatory Commission is working to improve its 'early warning system' in order to recognize trends and identify potential safety problems whether the source of the problems relates to a reactor safety system or to a utility management or organizational issue. The Commission has approved the use of performance indicators to provide a more effective means for top NRC management and the Commission to recognize changes in the safety performance of operating reactors. Research also has a leading role in assuring the safety of the evolving nuclear technology. The primary role of NRC's program is to provide a sound technical basis for decisions on the resolution of safety issues for the current generation of plants and safety issues that may arise for future designs. Topical areas essential to resolve the remaining safety issues or uncertainties related to LWR operation are human factors and accident management, life extension and plant aging, studies on containment integrity, severe accident risk analysis and uncertainty resolution, reliability engineering and the analysis of thermal-hydraulic transients. (Nogami, K.)

  6. Evolution of regulatory networks towards adaptability and stability in a changing environment

    Science.gov (United States)

    Lee, Deok-Sun

    2014-11-01

    Diverse biological networks exhibit universal features distinguished from those of random networks, calling much attention to their origins and implications. Here we propose a minimal evolution model of Boolean regulatory networks, which evolve by selectively rewiring links towards enhancing adaptability to a changing environment and stability against dynamical perturbations. We find that sparse and heterogeneous connectivity patterns emerge, which show qualitative agreement with real transcriptional regulatory networks and metabolic networks. The characteristic scaling behavior of stability reflects the balance between robustness and flexibility. The scaling of fluctuation in the perturbation spread shows a dynamic crossover, which is analyzed by investigating separately the stochasticity of internal dynamics and the network structure differences depending on the evolution pathways. Our study delineates how the ambivalent pressure of evolution shapes biological networks, which can be helpful for studying general complex systems interacting with environments.

  7. New Internet Business Initiatives in the Context of Change Management

    Directory of Open Access Journals (Sweden)

    Adam Sofronijević

    2015-05-01

    Full Text Available The paper presents the changing role of the Internet as a framework of several new business initiatives. In the last five years the Internet has evolved from being just a useful tool to a force shaping business strategies and influencing long-term managerial decision making. The paper presents an analysis of several cutting edge business initiatives and relates the success opportunities they have with evolving features of the Internet. The growth of importance of the Internet stresses the need to evaluate the state of local ICT development and precise data in this area for successful new business initiatives and meaningful change management. The paper presents the importance of such an evaluation for engaging change management that may be the crucial factor for the future of business initiatives in the era of ubiquitous, smart Internet.

  8. Designing Work, Family & Health Organizational Change Initiatives.

    Science.gov (United States)

    Kossek, Ellen Ernst; Hammer, Leslie B; Kelly, Erin L; Moen, Phyllis

    2014-01-01

    For decades, leaders and scholars have been advocating change efforts to improve work-life relationships. Yet most initiatives have lacked rigor and not been developed using scientific principles. This has created an evidence gap for employer support of work and personal life as a win-win for productivity and employees' well-being. This paper examines the approach used by the U.S. Work Family Health Network (WFRN) to develop an innovative workplace intervention to improve employee and family health. The change initiative was designed to reduce organizationally based work-family conflict in two contrasting contexts representative of major segments of today's U.S. workforce: health care employees and informational technology professionals. The WFRN Intervention (called STAR) had three theoretically based change elements. They were: 1) increase job control over work time and schedule; 2) increase supervisor social support for family and job effectiveness; and 3) improve organizational culture and job design processes to foster results orientation. Seven practical lessons for developing work-life interventions emerged from this groundbreaking endeavor.

  9. 76 FR 50796 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-08-16

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Increase the Position Limit for Options on the Standard and Poor's... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  10. Federal guide for a radiological response: Supporting the Nuclear Regulatory Commission during the initial hours of a serious accident

    International Nuclear Information System (INIS)

    Hogan, R.T.

    1993-11-01

    This document is a planning guide for those Federal agencies that work with the Nuclear Regulatory commission (NRC) during the initial hours of response to a serious radiological emergency in which the NRC is the Lead Federal Agency (LFA). These Federal agencies are: DOE, EPA, USDA, HHS, NOAA, and FEMA. This guide is intended to help these agencies prepare for a prompt response. Instructions are provided on receiving the initial notification, the type of person to send to the scene, the facility at which people are needed, how to get them to that facility, and what they should do when they arrive. Federal agencies not specifically mentioned in this guide may also be asked to support the NRC

  11. RESISTANCE TO CHANGE AND ERP IMPLEMENTATION SUCCESS: THE MODERATING ROLE OF CHANGE MANAGEMENT INITIATIVES

    Directory of Open Access Journals (Sweden)

    Zafar U. Ahmed

    2006-01-01

    Full Text Available Enterprise Resource Planning (ERP is a useful tool that builds strong capabilities, improves performance, supports better decision making, and provides competitive advantage for businesses. ERP aims to help the management by setting better business practices and equipping them with the right information to take timely decision. In any new technology implementation, one of the issues that need to be addressed is the resistance to change. Many implementations have failed due to strong resistance from the end users. Thus, the main purpose of this paper is to test the impact of resistance to change on ERP's implementation success and how change management initiatives acts in the capacity of a moderating role. Using data collected from 69 manufacturing organizations through a mail survey, it was found that resistance to change is negatively related to achievement of predetermined goals (b = –0.930, p < 0.01 and usersatisfaction (b = –0.952, p < 0.01. Further, change management initiatives did not moderate the relationship between resistance and predetermined goals but it moderated the relationship between resistance and user satisfaction. In addition, change management initiatives have a direct positive impact on user satisfaction. This research concludes that the human factor is very important in ERP's implementation.

  12. Regulatory changes raise troubling questions for genomic testing.

    Science.gov (United States)

    Evans, Barbara J; Dorschner, Michael O; Burke, Wylie; Jarvik, Gail P

    2014-11-01

    By 6 October 2014, many laboratories in the United States must begin honoring new individual data access rights created by recent changes to federal privacy and laboratory regulations. These access rights are more expansive than has been widely understood and pose complex challenges for genomic testing laboratories. This article analyzes regulatory texts and guidances to explore which laboratories are affected. It offers the first published analysis of which parts of the vast trove of data generated during next-generation sequencing will be accessible to patients and research subjects. Persons tested at affected laboratories seemingly will have access, upon request, to uninterpreted gene variant information contained in their stored variant call format, binary alignment/map, and FASTQ files. A defect in the regulations will subject some non-CLIA-regulated research laboratories to these new access requirements unless the Department of Health and Human Services takes swift action to avert this apparently unintended consequence. More broadly, all affected laboratories face a long list of daunting operational, business, compliance, and bioethical issues as they adapt to this change and to the Food and Drug Administration's recently announced plan to publish draft guidance outlining a new oversight framework for lab-developed tests.

  13. 77 FR 47472 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2012-08-08

    ... proposed rule change to make certain amendments that, in part, clarified the operation of the new Market... equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market...-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Approving Proposed Rule Change, as Modified by...

  14. A new method for measuring the thermal regulatory properties of phase change material (PCM) fabrics

    International Nuclear Information System (INIS)

    Wan, X; Fan, J

    2009-01-01

    Several methods already exist for the measurement of the thermal regulatory properties of fabrics containing phase change materials (PCMs). However, they do not adequately simulate the actual use condition; consequently the measurements may not have relevance to the performance of PCM fabrics in actual use. Here we report on the development of a new method, which better simulates the real use situation. In this method, a hot plate, simulating the human body, generates a constant amount of heat depending on the type of human activity to be simulated. The hot plate covered by the PCM fabric is then exposed to a thermal transient simulating a wearer moving from one thermal environment to another; the changes of surface temperature and heat loss of the hot plate are then recorded and used to characterize the thermal regulatory properties of the PCM fabrics

  15. 77 FR 38879 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2012-06-29

    ... marketable non-displayed interest, the Market Maker would be required to re-enter a quotation for purposes of...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Adding New... Securities Exchange Act of 1934 (``Act'') \\1\\ and Rule 19b-4 thereunder,\\2\\ a proposed rule change to add new...

  16. 75 FR 53998 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-09-02

    ... characteristics and risks of security futures. \\6\\ 15 U.S.C. 78o-3(b)(6). B. Self-Regulatory Organization's...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Security Futures Risk Disclosure Statement August 27, 2010...

  17. Regulatory changes to renewable energy support schemes: An international investment law perspective

    OpenAIRE

    Paleckaite, Gintare

    2014-01-01

    Thesist analyzes how regulatory changes related to renewable energy investment support schemes can be perceived under international investment law standards and how possible decisions of international investment law tribunals could impact investment in this sector. This research is based on case studies of two states: Spain and the Czech Republic and claims against them. These cases will assist in analyzing the effects of the amendment/revocation of renewable energy support schemes. Answers t...

  18. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  19. Robustness and accuracy in sea urchin developmental gene regulatory networks

    Directory of Open Access Journals (Sweden)

    Smadar eBen-Tabou De-Leon

    2016-02-01

    Full Text Available Developmental gene regulatory networks robustly control the timely activation of regulatory and differentiation genes. The structure of these networks underlies their capacity to buffer intrinsic and extrinsic noise and maintain embryonic morphology. Here I illustrate how the use of specific architectures by the sea urchin developmental regulatory networks enables the robust control of cell fate decisions. The Wnt-βcatenin signaling pathway patterns the primary embryonic axis while the BMP signaling pathway patterns the secondary embryonic axis in the sea urchin embryo and across bilateria. Interestingly, in the sea urchin in both cases, the signaling pathway that defines the axis controls directly the expression of a set of downstream regulatory genes. I propose that this direct activation of a set of regulatory genes enables a uniform regulatory response and a clear cut cell fate decision in the endoderm and in the dorsal ectoderm. The specification of the mesodermal pigment cell lineage is activated by Delta signaling that initiates a triple positive feedback loop that locks down the pigment specification state. I propose that the use of compound positive feedback circuitry provides the endodermal cells enough time to turn off mesodermal genes and ensures correct mesoderm vs. endoderm fate decision. Thus, I argue that understanding the control properties of repeatedly used regulatory architectures illuminates their role in embryogenesis and provides possible explanations to their resistance to evolutionary change.

  20. Success factors for strategic change initiatives: a qualitative study of healthcare administrators' perspectives.

    Science.gov (United States)

    Kash, Bita Arbab; Spaulding, Aaron; Johnson, Christopher E; Gamm, Larry

    2014-01-01

    Success factors related to the implementation of change initiatives are well documented and discussed in the management literature, but they are seldom studied in healthcare organizations engaged in multiple strategic change initiatives. The purpose of this study was to identify key success factors related to implementation of change initiatives based on rich qualitative data gathered from health leader interviews at two large health systems implementing multiple change initiatives. In-depth personal interviews with 61 healthcare leaders in the two large systems were conducted and inductive qualitative analysis was employed to identify success factors associated with 13 change initiatives. Results from this analysis were compared to success factors identified in the literature, and generalizations were drawn that add significantly to the management literature, especially to that in the healthcare sector. Ten specific success factors were identified for the implementation of change initiatives. The top three success factors were (1) culture and values, (2) business processes, and (3) people and engagement. Two of the identified success factors are unique to the healthcare sector and not found in the literature on change models: service quality and client satisfaction (ranked fourth of 10) and access to information (ranked ninth). Results demonstrate the importance of human resource functions, alignment of culture and values with change, and business processes that facilitate effective communication and access to information to achieve many change initiatives. The responses also suggest opportunities for leaders of healthcare organizations to more formally recognize the degree to which various change initiatives are dependent on one another.

  1. The waste isolation pilot plant regulatory compliance program

    International Nuclear Information System (INIS)

    Mewhinney, J.A.; Kehrman, R.F.

    1996-01-01

    The passage of the WIPP Land Withdrawal Act of 1992 (LWA) marked a turning point for the Waste Isolation Pilot Plant (WIPP) program. It established a Congressional mandate to open the WIPP in as short a time as possible, thereby initiating the process of addressing this nation's transuranic (TRU) waste problem. The DOE responded to the LWA by shifting the priority at the WIPP from scientific investigations to regulatory compliance and the completion of prerequisites for the initiation of operations. Regulatory compliance activities have taken four main focuses: (1) preparing regulatory submittals; (2) aggressive schedules; (3) regulator interface; and (4) public interactions

  2. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  3. 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.

  4. NRC regulatory information conference: Proceedings

    International Nuclear Information System (INIS)

    1989-09-01

    This volume of the report provides the proceedings from the Nuclear Regulatory Commission (NRC) Regulatory Information Conference that was held at the Mayflower Hotel, Washington, DC, on April 18, 19, and 20, 1989. This conference was held by the NRC and chaired by Dr. Thomas E. Mosley, Director, Office of Nuclear Reactor Regulations (NRR) and coordinated by S. Singh Bajwa, Chief, Technical Assistance Management Section, NRR. There were approximately 550 participants from nine countries at the conference. The countries represented were Canada, England, Italy, Japan, Mexico, Spain, Taiwan, Yugoslavia, and the United States. The NRC staff discussed with nuclear industry its regulatory philosophy and approach and the bases on which they have been established. Furthermore, the NRC staff discussed several initiatives that have been implemented recently and their bases as well as NRC's expectations for new initiatives to further improve safety. The figures contained in Appendix A to the volume correspond to the slides that were shown during the presentations. Volume 2 of this report contains the formal papers that were distributed at the beginning of the Regulatory Information Conference and other information about the conference

  5. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  6. 77 FR 67427 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change...

    Science.gov (United States)

    2012-11-09

    ... Rules provide updates related to anti-money laundering legislation applicable to customers, clarify... proposed rule change will have any impact or impose any burden on competition. C. Self-Regulatory...

  7. Regulatory assessment of brand changes in the commercial tobacco product market.

    Science.gov (United States)

    Wayne, G Ferris; Connolly, G N

    2009-08-01

    Regulatory oversight of tobacco product design has gained momentum in the US and internationally. Appropriate standards for assessing commercial brands and characterising product features must be considered a priority. An area of potential concern is in-market design changes adopted within a single commercial brand over time. Internal tobacco industry documents were identified and used to assess internal discussion of product guidelines and practices regarding in-market brand changes. Commercial tobacco products undergo a constant process of revision in-market, beginning at the most basic level of physical product characteristics and components, and including every aspect of design. These revisions commonly exceed guidelines for acceptable product variance adopted within the industry. While consumer and market testing is conducted to ensure that products remain acceptable to users, explicit marketing often may not accompany brand changes. In the absence of such marketing, it should not be assumed that a brand remains unchanged. For manufacturers, assessment of competitor brands includes identification and analysis of non-routine changes; that is, those changes likely to significantly alter the character of a given brand. Regulators must adopt a similar practice in determining standards for product evaluation in the face of ongoing commercial product revision.

  8. Comparative regulatory approaches for groups of new plant breeding techniques.

    Science.gov (United States)

    Lusser, Maria; Davies, Howard V

    2013-06-25

    This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven 'New Plant Breeding Techniques' (NPBTs). It presents the outcomes of preliminary discussions and in some cases the initial decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions. Copyright © 2013 Elsevier B.V. All rights reserved.

  9. Extensive evolutionary changes in regulatory element activity during human origins are associated with altered gene expression and positive selection.

    Directory of Open Access Journals (Sweden)

    Yoichiro Shibata

    2012-06-01

    Full Text Available Understanding the molecular basis for phenotypic differences between humans and other primates remains an outstanding challenge. Mutations in non-coding regulatory DNA that alter gene expression have been hypothesized as a key driver of these phenotypic differences. This has been supported by differential gene expression analyses in general, but not by the identification of specific regulatory elements responsible for changes in transcription and phenotype. To identify the genetic source of regulatory differences, we mapped DNaseI hypersensitive (DHS sites, which mark all types of active gene regulatory elements, genome-wide in the same cell type isolated from human, chimpanzee, and macaque. Most DHS sites were conserved among all three species, as expected based on their central role in regulating transcription. However, we found evidence that several hundred DHS sites were gained or lost on the lineages leading to modern human and chimpanzee. Species-specific DHS site gains are enriched near differentially expressed genes, are positively correlated with increased transcription, show evidence of branch-specific positive selection, and overlap with active chromatin marks. Species-specific sequence differences in transcription factor motifs found within these DHS sites are linked with species-specific changes in chromatin accessibility. Together, these indicate that the regulatory elements identified here are genetic contributors to transcriptional and phenotypic differences among primate species.

  10. 77 FR 42349 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Defining a...

    Science.gov (United States)

    2012-07-18

    ... ATP Holders via Regulatory Bulletin regarding the rule change. The Exchange plans to issue notice....\\7\\ \\7\\ See Notice, supra note 3, at 32158. III. Discussion The Commission finds that the proposed...

  11. 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...

  12. The regulatory mechanism in the U.S. lessons learned

    International Nuclear Information System (INIS)

    Roberts, T.M.

    1987-01-01

    The U.S. Nuclear Regulatory Commission is responsible for the regulation of the commercial uses of nuclear power in the United States in order to protect the public health and safety. The NRC has undertaken a number of initiatives to incorporate the experience gained from the over 25 years of commercial nuclear power plant operation. These initiatives are aimed at improving the regulatory structure currently in place by providing for a more predictable and stable regulatory environment and by more efficiently and effectively focusing the activities of utilities on the safe operation of their facilities. (author)

  13. Safety culture competition - expectations of a regulatory authority

    International Nuclear Information System (INIS)

    Keil, D.; Gloeckle, W.

    2000-01-01

    The accident at the Chernobyl nuclear power station on April 26, 1986 influenced the development of reactor safety and promulgated two basic concepts especially in Germany. On the one hand, extensive measures of in-plant accident management have greatly reduced the so-called residual risk. On the other hand, a comprehensive safety approach has been initiated which comprises the nuclear power plant as a system together with people, technology, and organization and also includes safety culture. In a modern regulatory concept based on the dynamic development of safety, the authority's classical regulatory function of controlling is supplemented by the objective of promoting safety. While preserving the division of responsibilities between the regulatory authority and plant operators, the authority uses 'constructive critical dialog' as a tool to enhance safety. Besides the regulatory assessment of safety culture on the basis of indications or indicators, also the continuous promotion of safety culture in a dialog with plant operators is seen as one of the duties of a regulatory authority. Continued efforts are necessary to maintain the high level of safety culture in German nuclear power plants. Operators are expected to establish a safety management which assigns top priority to safety issues, and which pursues the goal of supervising and promoting safety culture. Developments on the deregulated electricity markets must not lead to safety aspects ranking second to economic aspects. Moreover, also under changed boundary conditions, only the safe operation of nuclear power plants ensures economic viability. (orig.) [de

  14. Structural changes of the regulatory proteins bound to the thin filaments in skeletal muscle contraction by X-ray fiber diffraction

    International Nuclear Information System (INIS)

    Sugimoto, Yasunobu; Takezawa, Yasunori; Matsuo, Tatsuhito; Ueno, Yutaka; Minakata, Shiho; Tanaka, Hidehiro; Wakabayashi, Katsuzo

    2008-01-01

    In order to clarify the structural changes related to the regulation mechanism in skeletal muscle contraction, the intensity changes of thin filament-based reflections were investigated by X-ray fiber diffraction. The time course and extent of intensity changes of the first to third order troponin (TN)-associated meridional reflections with a basic repeat of 38.4 nm were different for each of these reflections. The intensity of the first and second thin filament layer lines changed in a reciprocal manner both during initial activation and during the force generation process. The axial spacings of the TN-meridional reflections decreased by ∼0.1% upon activation relative to the relaxing state and increased by ∼0.24% in the force generation state, in line with that of the 2.7-nm reflection. Ca 2+ -binding to TN triggered the shortening and a change in the helical symmetry of the thin filaments. Modeling of the structural changes using the intensities of the thin filament-based reflections suggested that the conformation of the globular core domain of TN altered upon activation, undergoing additional conformational changes at the tension plateau. The tail domain of TN moved together with tropomyosin during contraction. The results indicate that the structural changes of regulatory proteins bound to the actin filaments occur in two steps, the first in response to the Ca 2+ -binding and the second induced by actomyosin interaction

  15. Current and new developments in transport and regulatory issues concerning radioisotopes: managing change for minimum business impact

    International Nuclear Information System (INIS)

    Bennett, Neil; Coppell, David; Rogers, David; Schrader, John

    2004-01-01

    Changes in the regulatory framework governing the Radiation Processing Industry have the potential to make a real business impact on day-to-day profitability. Many areas of the Radiation Processing Industry are affected by changes in the regulatory framework within which these areas are managed. When planning for such changes the transportation element in the shipment of sealed cobalt radiation sources is an area that is often neglected by some parts of the distribution chain. A balance must be struck between the cobalt supplier and the facility operator/customer that rests upon how much the customer needs to know about the intricacies of cobalt shipment. The objective of this paper is to highlight areas of possible business impact and reassure the users of sealed radiation sources that the global suppliers of these products are used to negotiating local variations in regulations governing the physical transportation of radiation sources, changes in regulations governing the design, manufacture and use of transportation containers and changes in the availability of commercial shippers and shipping routes. The major suppliers of industrial quantities of cobalt-60 are well placed to lead their customers through this complex process as a matter of routine

  16. Activities relating to PSA in the regulatory process

    International Nuclear Information System (INIS)

    Campbell, J.F.; Grint, G.C.

    1994-01-01

    In addition to the IAEA activities concerning the use of PSA in the regulatory process there are two other international initiatives in this area by the European Commission and the OECD's Committee for Nuclear Regulatory Authorities (CRNA). The paper gives a brief outline of these activities as well as introducing an update on the regulatory use of PSA in the UK. 3 refs, 3 tabs

  17. Crystal structure of the regulatory subunit of archaeal initiation factor 2B (aIF2B) from hyperthermophilic archaeon Pyrococcus horikoshii OT3: a proposed structure of the regulatory subcomplex of eukaryotic IF2B

    International Nuclear Information System (INIS)

    Kakuta, Yoshimitsu; Tahara, Maino; Maetani, Shigehiro; Yao, Min; Tanaka, Isao; Kimura, Makoto

    2004-01-01

    Eukaryotic translation initiation factor 2B (eIF2B) is the guanine-nucleotide exchange factor for eukaryotic initiation factor 2 (eIF2). eIF2B is a heteropentameric protein composed of α-ε subunits. The α, β, and δ subunits form a regulatory subcomplex, while the γ and ε form a catalytic subcomplex. Archaea possess homologues of α, β, and δ subunits of eIF2B. Here, we report the three-dimensional structure of an archaeal regulatory subunit (aIF2Bα) from the hyperthermophilic archaeon Pyrococcus horikoshii OT3 determined by X-ray crystallography at 2.2 A resolution. aIF2Bα consists of two subdomains, an N-domain (residues 1-95) and a C-domain (residues 96-276), connected by a long α-helix (α5: 78-106). The N-domain contains a five helix bundle structure, while the C-domain folds into the α/β structure, thus showing similarity to D-ribose-5-phosphate isomerase structure. The presence of two molecules in the crystallographic asymmetric unit and the gel filtration analysis suggest a dimeric structure of aIF2Bα in solution, interacting with each other by C-domains. Furthermore, the crystallographic 3-fold symmetry generates a homohexameric structure of aIF2Bα; the interaction is primarily mediated by the long α-helix at the N-domains. This structure suggests an architecture of the three subunits, α, β, and δ, in the regulatory subcomplex within eIF2B

  18. Regulatory T cells predict the time to initial treatment in early stage chronic lymphocytic leukemia.

    Science.gov (United States)

    Weiss, Lukas; Melchardt, Thomas; Egle, Alexander; Grabmer, Christoph; Greil, Richard; Tinhofer, Inge

    2011-05-15

    Early stage chronic lymphocytic leukemia is characterized by a highly variable course of disease. Because it is believed that regulatory T cells (T(regs) ) are potent suppressors of antitumor immunity, the authors hypothesized that increased T(regs) may favor disease progression. T(reg) levels (cluster of differentiation 3 [CD3]-positive, [CD4]-positive, CD25-positive, and CD127-negative) in peripheral blood from 102 patients were analyzed by flow cytometry. Statistical analysis was used to evaluate correlations with clinical data. The relative T(reg) numbers in CD4-positive T cells were significantly greater in patients with chronic lymphocytic leukemia compared with the numbers in a control group of 170 healthy individuals (P = .001). Patients were divided into 2 groups using a median T(reg) value of 9.7% (the percentage of CD4-positive T cells). Patients with higher T(reg) levels had a significantly shorter time to initial treatment (median, 5.9 years) compared with patients who had lower T(reg) levels (median, 11.7 years; log-rank P = .019). Furthermore, T(reg) levels (the percentage of CD4-positive T cells) had significant prognostic power to predict the time to initial treatment in univariate analysis (P = .023) and in multivariate Cox regression analysis that included the variables Rai stage, immunoglobulin heavy-chain variable region gene mutational status, chromosomal aberrations, and CD38 expression (P = .028). Higher T(reg) levels had significant and independent prognostic power for predicting the time to initial treatment in patients with low to intermediate stage chronic lymphocytic leukemia. 2010 American Cancer Society.

  19. Action Learning--A Process Which Supports Organisational Change Initiatives

    Science.gov (United States)

    Joyce, Pauline

    2012-01-01

    This paper reflects on how action learning sets (ALSs) were used to support organisational change initiatives. It sets the scene with contextualising the inclusion of change projects in a masters programme. Action learning is understood to be a dynamic process where a team meets regularly to help individual members address issues through a highly…

  20. The air quality and regional climate effects of widespread solar power generation under a changing regulatory environment

    Science.gov (United States)

    Millstein, D.; Zhai, P.; Menon, S.

    2011-12-01

    Over the past decade significant reductions of NOx and SOx emissions from coal burning power plants in the U.S. have been achieved due to regulatory action and substitution of new generation towards natural gas and wind power. Low natural gas prices, ever decreasing solar generation costs, and proposed regulatory changes, such as to the Cross State Air Pollution Rule, promise further long-run coal power plant emission reductions. Reduced power plant emissions have the potential to affect ozone and particulate air quality and influence regional climate through aerosol cloud interactions and visibility effects. Here we investigate, on a national scale, the effects on future (~2030) air quality and regional climate of power plant emission regulations in contrast to and combination with policies designed to aggressively promote solar electricity generation. A sophisticated, economic and engineering based, hourly power generation dispatch model is developed to explore the integration of significant solar generation resources (>10% on an energy basis) at various regions across the county, providing detailed estimates of substitution of solar generation for fossil fuel generation resources. Future air pollutant emissions from all sectors of the economy are scaled based on the U.S. Environmental Protection Agency's National Emission Inventory to account for activity changes based on population and economic projections derived from county level U.S. Census data and the Energy Information Administration's Annual Energy Outlook. Further adjustments are made for technological and regulatory changes applicable within various sectors, for example, emission intensity adjustments to on-road diesel trucking due to exhaust treatment and improved engine design. The future year 2030 is selected for the emissions scenarios to allow for the development of significant solar generation resources. A regional climate and air quality model (Weather Research and Forecasting, WRF model) is

  1. Preliminary regulatory assessment of nuclear power plants vulnerabilities

    International Nuclear Information System (INIS)

    Kostadinov, V.; Petelin, S.

    2004-01-01

    Preliminary attempts to develop models for nuclear regulatory vulnerability assessment of nuclear power plants are presented. Development of the philosophy and computer tools could be new and important insight for management of nuclear operators and nuclear regulatory bodies who face difficult questions about how to assess the vulnerability of nuclear power plants and other nuclear facilities to external and internal threats. In the situation where different and hidden threat sources are dispersed throughout the world, the assessment of security and safe operation of nuclear power plants is very important. Capability to evaluate plant vulnerability to different kinds of threats, like human and natural occurrences and terrorist attacks and preparation of emergency response plans and estimation of costs are of vital importance for assurance of national security. On the basis of such vital insights, nuclear operators and nuclear regulatory bodies could plan and optimise changes in oversight procedures, organisations, equipment, hardware and software to reduce risks taking into account security and safety of nuclear power plants operation, budget, manpower, and other limitations. Initial qualitative estimations of adapted assessments for nuclear applications are shortly presented. (author)

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

    Science.gov (United States)

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

    2017-04-01

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

  3. 76 FR 25328 - New Mexico Green Initiatives, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

    Science.gov (United States)

    2011-05-04

    ... Mexico Green Initiatives, LLC's application for market-based rate authority, with an accompanying rate... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-3431-000] New Mexico Green Initiatives, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for...

  4. Incremental change or initial differences? Testing two models of marital deterioration.

    Science.gov (United States)

    Lavner, Justin A; Bradbury, Thomas N; Karney, Benjamin R

    2012-08-01

    Most couples begin marriage intent on maintaining a fulfilling relationship, but some newlyweds soon struggle, and others continue to experience high levels of satisfaction. Do these diverse outcomes result from an incremental process that unfolds over time, as prevailing models suggest, or are they a manifestation of initial differences that are largely evident at the start of the marriage? Using 8 waves of data collected over the first 4 years of marriage (N = 502 spouses, or 251 newlywed marriages), we tested these competing perspectives first by identifying 3 qualitatively distinct relationship satisfaction trajectory groups and then by determining the extent to which spouses in these groups were differentiated on the basis of (a) initial scores and (b) 4-year changes in a set of established predictor variables, including relationship problems, aggression, attributions, stress, and self-esteem. The majority of spouses exhibited high, stable satisfaction over the first 4 years of marriage, whereas declining satisfaction was isolated among couples with relatively low initial satisfaction. Across all predictor variables, initial values afforded stronger discrimination of outcome groups than did rates of change in these variables. Thus, readily measured initial differences are potent antecedents of relationship deterioration, and studies are now needed to clarify the specific ways in which initial indices of risk come to influence changes in spouses' judgments of relationship satisfaction. PsycINFO Database Record (c) 2012 APA, all rights reserved.

  5. 76 FR 4968 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change...

    Science.gov (United States)

    2011-01-27

    ...-Regulatory Organizations; NYSE Arca, Inc.; Order Granting Approval of Proposed Rule Change Relating to Listing and Trading Shares of the AdvisorShares Active Bear ETF January 19, 2011. I. Introduction On... of the security or investment in the portfolio. \\14\\ Under accounting procedures followed by the Fund...

  6. 77 FR 67851 - Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-11-14

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68177; File No. SR-BOX-2012-003] Self-Regulatory Organizations; BOX Options Exchange LLC; Order Approving Proposed Rule Change To Amend the Price Improvement Period November 7, 2012. I. Introduction On July 25, 2012, BOX Options Exchange LLC (``Exchange...

  7. Workshop: Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis: Modeling Climate Change Impacts and Associated Economic Damages (2010 - part 1)

    Science.gov (United States)

    The purpose of this workshop Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis. focused on conceptual and methodological issues - integrated assessment modeling and valuation.

  8. 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)

  9. Kynurenine 3-Monooxygenase Gene Associated With Nicotine Initiation and Addiction: Analysis of Novel Regulatory Features at 5′ and 3′-Regions

    Directory of Open Access Journals (Sweden)

    Hassan A. Aziz

    2018-06-01

    Full Text Available Tobacco smoking is widespread behavior in Qatar and worldwide and is considered one of the major preventable causes of ill health and death. Nicotine is part of tobacco smoke that causes numerous health risks and is incredibly addictive; it binds to the α7 nicotinic acetylcholine receptor (α7nAChR in the brain. Recent studies showed α7nAChR involvement in the initiation and addiction of smoking. Kynurenic acid (KA, a significant tryptophan metabolite, is an antagonist of α7nAChR. Inhibition of kynurenine 3-monooxygenase enzyme encoded by KMO enhances the KA levels. Modulating KMO gene expression could be a useful tactic for the treatment of tobacco initiation and dependence. Since KMO regulation is still poorly understood, we aimed to investigate the 5′ and 3′-regulatory factors of KMO gene to advance our knowledge to modulate KMO gene expression. In this study, bioinformatics methods were used to identify the regulatory sequences associated with expression of KMO. The displayed differential expression of KMO mRNA in the same tissue and different tissues suggested the specific usage of the KMO multiple alternative promoters. Eleven KMO alternative promoters identified at 5′-regulatory region contain TATA-Box, lack CpG Island (CGI and showed dinucleotide base-stacking energy values specific to transcription factor binding sites (TFBSs. The structural features of regulatory sequences can influence the transcription process and cell type-specific expression. The uncharacterized LOC105373233 locus coding for non-coding RNA (ncRNA located on the reverse strand in a convergent manner at the 3′-side of KMO locus. The two genes likely expressed by a promoter that lacks TATA-Box harbor CGI and two TFBSs linked to the bidirectional transcription, the NRF1, and ZNF14 motifs. We identified two types of microRNA (miR in the uncharacterized LOC105373233 ncRNA, which are like hsa-miR-5096 and hsa-miR-1285-3p and can target the miR recognition

  10. Cost-benefit and regulatory decision making

    International Nuclear Information System (INIS)

    Harvie, J.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

  11. The African Health Profession Regulatory Collaborative for Nurses and Midwives

    Directory of Open Access Journals (Sweden)

    McCarthy Carey F

    2012-08-01

    Full Text Available Abstract Background More than thirty-five sub-Saharan African countries have severe health workforce shortages. Many also struggle with a mismatch between the knowledge and competencies of health professionals and the needs of the populations they serve. Addressing these workforce challenges requires collaboration among health and education stakeholders and reform of health worker regulations. Health professional regulatory bodies, such as nursing and midwifery councils, have the mandate to reform regulations yet often do not have the resources or expertise to do so. In 2011, the United States of America Centers for Disease Control and Prevention began a four-year initiative to increase the collaboration among national stakeholders and help strengthen the capacity of health professional regulatory bodies to reform national regulatory frameworks. The initiative is called the African Health Regulatory Collaborative for Nurses and Midwives. This article describes the African Health Regulatory Collaborative for Nurses and Midwives and discusses its importance in implementing and sustaining national, regional, and global workforce initiatives. Discussion The African Health Profession Regulatory Collaborative for Nurses and Midwives convenes leaders responsible for regulation from 14 countries in East, Central and Southern Africa. It provides a high profile, south-to-south collaboration to assist countries in implementing joint approaches to problems affecting the health workforce. Implemented in partnership with Emory University, the Commonwealth Secretariat, and the East, Central and Southern African College of Nursing, this initiative also supports four to five countries per year in implementing locally-designed regulation improvement projects. Over time, the African Health Regulatory Collaborative for Nurses and Midwives will help to increase the regulatory capacity of health professional organizations and ultimately improve regulation and

  12. 78 FR 15394 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change...

    Science.gov (United States)

    2013-03-11

    ...-Regulatory Organizations; New York Stock Exchange LLC; Order Approving Proposed Rule Change Adopting... paragraph (d) it contains a provision establishing how the transition period from NYSE Rule 477 will work... to announce the effective date of the new rules at least 30 days in advance in an Information...

  13. 76 FR 21085 - Self-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2011-04-14

    ...-Regulatory Organizations; NASDAQ Stock Market, LLC; Order Approving Proposed Rule Change To Amend The NASDAQ OMX Group, Inc. By- Laws April 8, 2011. I. Introduction On February 8, 2011, The NASDAQ Stock Market... vote cast either ``for'' or ``against'' that director's election. In its filing, NASDAQ noted that...

  14. Glucose- and nitrogen sensing and regulatory mechanisms in Saccharomyces cerevisiae

    DEFF Research Database (Denmark)

    Rødkaer, Steven V; Færgeman, Nils J.

    2014-01-01

    Pro- and eukaryotic cells are constantly challenged by varying concentrations of nutrients in their environment. Perceiving and adapting to such changes are therefore crucial for cellular viability. Thus, numerous specialized cellular receptors continuously sense and react to the availability...... of nutrients such as glucose and nitrogen. When stimulated, these receptors initiate various cellular signaling pathways, which in concert constitute a complex regulatory network. To ensure a highly specific response, these pathways and networks cross-communicate with each other and are regulated at several...

  15. 77 FR 38694 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2012-06-28

    ... matrix will be an effective means of assessing related fees. For instance, the proposed fee structure...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate... Organization's Statement of the Terms of the Substance of the Proposed Rule Change FINRA is proposing to amend...

  16. Transformational Leadership and Organizational Change during Agile and DevOps Initiatives

    Science.gov (United States)

    Mayner, Stephen W.

    2017-01-01

    Organizational change initiatives are more likely to fail than to succeed, especially when the change challenges corporate culture and norms. Researchers have explored factors that contribute to change failure, to include the relationship between leadership behaviors and change success. Peer reviewed studies have yet to examine these variables in…

  17. 76 FR 63969 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2011-10-14

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1 to Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated... Account Statements) in the Consolidated FINRA Rulebook (``Notice''). The Notice contained incorrect...

  18. Industry and forest wetlands: Cooperative research initiatives

    International Nuclear Information System (INIS)

    Shepard, J.P.; Lucier, A.A.; Haines, L.W.

    1993-01-01

    In 1989 the forest products industry responded to a challenge of the National Wetlands Policy Forum to initiate a cooperative research program on forest wetlands management organized through the National Council of the Paper Industry for Air and Stream Improvement (NCASI). The objective is to determine how forest landowners can manage wetlands for timber production while protecting other wetland functions such as flood storage, water purification, and food chain/wildlife habitat support. Studies supported by the NCASI in 9 states are summarized. Technical support on wetland regulatory issues to member companies is part of the research program. Since guidelines for recognizing wetlands for regulatory proposed have changed frequently, the NCASI has recommend an explicit link between wetland delineation and a classification system that considers difference among wetland types in vegetation, soils, hydrology, appearance, landscape position, and other factors. 16 refs

  19. IAEA regulatory initiatives for the air transport of large quantities of radioactive materials

    International Nuclear Information System (INIS)

    Luna, R.E.; Wangler, M.W.; Selling, H.A.

    1992-01-01

    The International Atomic Energy Agency (IAEA) has been laboring since 1988 over a far reaching change to its model regulations (IAEA, 1990) for the transport of radioactive materials (RAM). This change could impact the manner in which certain classes of radioactive materials are shipped by air and change some of the basic tenets of radioactive material transport regulations around the world. The impetus for this effort was spawned in part by the decision of the Japanese government to move large quantities of reprocessed plutonium by air from France to Japan. The exploration of options for overflights of United States and Canadian airspace (among others) and landings in Anchorage, Alaska, generated intense debate in the US and countries that might have been overflown. The debate centered on general questions of the need to air transport plutonium in large quantities, package survival in an accident, prenotification, emergency response, routing, safeguards and other facets of the proposed operations. In the US, which already had the most stringent regulations for packaging of plutonium shipped by air (NUREG-0360), there was immediate additional legislative action to increase the stringency by requiring demonstration that an aircraft carrying plutonium in certified packagings could undergo a severe crash without release of plutonium (the Murkowski amendment). In the United Kingdom there was an official inquiry that resulted in a high visibility report (ACTRAM 88) and a conclusion that the IAEA should examine regulatory needs in the general area of air transport

  20. The young and adolescents: Initiating change in children’s eating behavior

    Science.gov (United States)

    Limited success in existing interventions for initiating dietary behavior change among children is forcing a more detailed analysis of how to promote change. The mediating variable model provides a conceptual framework for understanding how behavior change interventions work and integrates more basi...

  1. Outlines of a general theory of cancer initiation in the cell

    Energy Technology Data Exchange (ETDEWEB)

    Ladik, J.J. [Friedrich Alexander Univ. Erlangen-Nuremberg, Erlangen (Germany)

    1996-12-31

    According to the central dogma of molecular biology information flows in the living cell from DNA through RNA to proteins. Therefore most investigations of cancer initiation try to explain those effects of carcinogen binding to- or radiation hits on DNA which lead to the first steps of the malignant transformations. On the other hand recent detailed theoretical investigations have shown that proteins are good-disordered hopping conductors (their conductivity is in the order of well conducting amorphous glasses). Their conductivity is substantially influenced by binding of chemicals or by effects or radiations causing conformational changes and/or destroying bonds in them which can lead to their inactivation as regulation enzymes. One can easily visualize also how such changes become hereditary. It seems that if we look at the cell as a complicated self-regulatory system, primary changes both at their DNA or regulatory protein molecules caused by external agents can disturb its self-regulation and transform it in this way into another stationary, possibly precancerous state.

  2. 78 FR 68893 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2013-11-15

    ... that the size of the BBO equals the minimum quote size. Number of market makers actively quoting...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Tier Size Pilot of FINRA Rule 6433 (Minimum Quotation Size...

  3. Workshop: Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis: Modeling Climate Change Impacts and Associated Economic Damages (2011 - part 2)

    Science.gov (United States)

    The purpose of this workshop Improving the Assessment and Valuation of Climate Change Impacts for Policy and Regulatory Analysis. focused on conceptual and methodological issues - estimating impacts and valuing damages on a sectoral basis.

  4. The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration to Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

    Science.gov (United States)

    Manley, Geoffrey T; MacDonald, Christine L; Markowitz, Amy; Stephenson, Diane; Robbins, Ann; Gardner, Raquel C; Winkler, Ethan A; Bodien, Yelena; Taylor, Sabrina; Yue, John K; Kannan, Lakshmi; Kumar, Allison; McCrea, Michael; Wang, Kevin K W

    2017-03-31

    The Traumatic Brain Injury Endpoints Development (TED) Initiative is a 5-year, Department of Defense (DoD) funded project that is working toward the ultimate goal of developing better designed clinical trials, leading to more precise diagnosis, and effective treatments for traumatic brain injury (TBI). TED is comprised of leading academic clinician-scientists, along with innovative industry leaders in biotechnology and imaging technology, patient advocacy organizations, and philanthropists, working collaboratively with regulatory authorities, specifically the US Food and Drug Administration (FDA). The goals of the TED Initiative are to gain consensus and validation of TBI clinical outcome assessment measures and biomarkers for endorsement by global regulatory agencies for use in drug and device development processes. This manuscript summarizes the Initiative's Stage 1 progress over the first 18 months, including intensive engagement with a number of FDA divisions responsible for review and validation of biomarkers and clinical outcome assessments, progression into the prequalification phase of FDA's Medical Device Development Tool program for a candidate set of neuroimaging biomarkers, and receipt of FDA's Recognition of Research Importance Letter regarding TBI. Other signal achievements relate to the creation of the TED Metadataset, harmonizing study measures across eight major TBI studies, and the leadership role played by TED investigators in the conversion of the NINDS TBI Common Data Elements (CDEs) to Clinical Data Interchange Standards Consortium (CDISC) standards. This paper frames both the near-term expectations and the Initiative's long-term vision to accelerate approval of treatments for patients affected by TBI in urgent need of effective therapies.

  5. Deliberations on nuclear safety regulatory system in a changing industrial environment

    International Nuclear Information System (INIS)

    Kim, H.J.

    2001-01-01

    Nuclear safety concern, which may accompany such external environmental factors as privatization and restructuring of the electric power industry, is emerging as an international issue. In order to cope with the concern about nuclear safety, it is important to feedback valuable experiences of advanced countries that restructured their electric power industries earlier and further to reflect the current safety issues, which are raised internationally, fully into the nuclear safety regulatory system. This paper is to review the safety issues that might take place in the process of increasing competition in the nuclear power industry, and further to present a basic direction and effective measures for ensuring nuclear safety in response thereto from the viewpoint of safety regulation. It includes a political direction for a regulatory body's efforts to rationalize and enforce efficiently its regulation. It proposes to ensure that regulatory specialty and regulatory cost are stably secured. Also, this paper proposes maintaining a sound nuclear safety regulatory system to monitor thoroughly the safety management activities of the industry, which might be neglected as a result of focusing on reduction of the cost for producing electric power. (author)

  6. 76 FR 67238 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS...

    Science.gov (United States)

    2011-10-31

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-65619, File No. SR-BATS-2011-032] Self-Regulatory Organizations; BATS Exchange, Inc.; Order Approving Proposed Rule Change by BATS Exchange, Inc. To Adopt Rules Applicable to Auctions Conducted by the Exchange for Exchange-Listed Securities October 25, 2011. I. Introduction On August 22, 2011,...

  7. 75 FR 1439 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding...

    Science.gov (United States)

    2010-01-11

    ...(a)(iv). Finally, because DMMs no longer act as agent for orders on the Display Book under the rules... fails to follow the Policy would not be in violation the Order Display rule \\8\\ and/or the Firm Quote...-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Rescinding NYSE Information...

  8. The Energy Regulatory Commission (1). Law of the Comision Reguladora de Energia

    International Nuclear Information System (INIS)

    1995-01-01

    The Energy Regulatory Commission. Reforms to the Electric Energy Public Service Law (1992) and the Regulatory Law of Article 27 on Petroleum (1995) have brought about fundamental changes in the electric and natural gas industries. The legal reforms explicitly permit the private sector to construct, operate, and own, systems of electric generation and natural gas transportation, storage and distribution. The participation of the private sector in these areas required a redefinition in the government regulatory institutions. Accordingly the Federal Congress enacted the law of the Comision Reguladora de Energia (CRE) in 1995. The CRE law expands the scope of the CRE's authority and the breadth of its powers beyond those established when it was initially created in 1993. The CRE commenced operations in January 1994 as a decentralized technical and consultative body of the Energy Ministry. The decree that created the Commission limited the scope of its authority to an analysis and consultative role applicable only to the electric industry. (Author)

  9. 78 FR 69732 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2013-11-20

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend FINRA Rule 8312 (FINRA BrokerCheck Disclosure) To Include Information About Members and Their Associated Persons of Any Registered National Securities Exchange That Uses the CRD System for...

  10. 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

  11. 77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

    Science.gov (United States)

    2012-08-30

    ... the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for... seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related... them on Regulations.gov without change, including any business or personal information that you provide...

  12. 75 FR 80553 - Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to...

    Science.gov (United States)

    2010-12-22

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63558; File No. SR-NYSEAmex-2010-100] Self-Regulatory Organizations; NYSE Amex LLC; Order Approving a Proposed Rule Change Relating to Complex Orders December 16, 2010. I. Introduction On October 20, 2010, NYSE Amex LLC (``NYSE Amex'' or the ``Exchange...

  13. 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)

  14. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

    Virginia Power has two nuclear plants, North Anna and Surry Power Stations, which have two units each for a total of four nuclear units. In 1992, the Nuclear Regulatory Commission solicited comments from the nuclear industry to obtain their ideas for reducing the regulatory burden on nuclear facilities. Pursuant to the new regulatory climate, Virginia Power developed an internal program to evaluate and assess the regulatory and self-imposed requirements to which they were committed, and to pursue regulatory relief or internal changes where possible and appropriate. The criteria were that public safety must be maintained, and savings must be significant. Up to the date of the conference, over US$22 million of one-time saving had been effected, and US$2.75 million in annual savings

  15. Communication Regulatory Science: Mapping a New Field.

    Science.gov (United States)

    Noar, Seth M; Cappella, Joseph N; Price, Simani

    2017-12-13

    Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

  16. Characterizing costs and benefits of uncertain future regulatory requirements on the U.S. natural gas industry

    International Nuclear Information System (INIS)

    Godec, M.L.; Smith, G.E.; Fitzgibbon, T.

    1995-01-01

    Environmental regulatory requirements at both the state and federal level are constantly changing, making it difficult for industry and R ampersand D program managers to project future compliance requirements and costs. Even if a company is trying to keep abreast of various proposed regulatory initiatives, the number of possible combinations of initiatives that could occur in the future seems virtually limitless. Uncertainty associated with potential future environmental compliance requirements makes the identification and evaluation of future investment and R ampersand D opportunities exceedingly difficult, and makes the process of systematic strategic planning increasingly complex. This paper describes a methodology for accounting for uncertain future environmental compliance costs in a systematic, comprehensive manner. Through analysis of proposed initiatives for making future environmental requirements more stringent, forecasting the likelihood of occurrence and potential timing of each initiative, and estimating potential future compliance costs associated with each initiative, a thorough process for incorporating regulatory uncertainty into strategic planning and project evaluation is described. This approach can be used for evaluating R ampersand D opportunities to determine where development of new technologies or assessment of risks posed by industry operations may have the greatest impact on future industry costs of compliance. This approach could also be used to account for the uncertainty of future environmental costs in corporate strategic planning or for factoring future compliance costs into project evaluation. This approach could also be enhanced through use in conjunction with other modeling and forecasting systems that could consider a broad range of impacts, including impacts on gas production, industry activity levels, and tax revenues

  17. 75 FR 65541 - Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To...

    Science.gov (United States)

    2010-10-25

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-63132; File No. SR-Phlx-2010-118] Self-Regulatory Organizations; Order Approving Proposed Rule Change by NASDAQ OMX PHLX, Inc. To Expand the $.50 Strike Price Program October 19, 2010. On August 25, 2010, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange...

  18. 75 FR 38584 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62395; File No. SR-Phlx-2010-18] Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX PHLX (``Phlx'' or...

  19. 78 FR 28680 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Withdrawal of Proposed Rule Change...

    Science.gov (United States)

    2013-05-15

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69545; File No. SR-ICC-2013-03] Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Withdrawal of Proposed Rule Change Relating to Recovery and Resolution Arrangements May 9, 2013. On March 7, 2013, ICE Clear Credit LLC (``ICC'') filed with the...

  20. Regulatory reform in Mexico's natural gas sector

    International Nuclear Information System (INIS)

    1996-01-01

    In recent years Mexico has implemented remarkable structural changes in its economy. However, until recently its large and key energy sector was largely unreformed. This is now changing. In 1995 the Mexican Government introduced legislative changes permitting private sector involvement in natural gas storage, transportation and distribution. Subsequent directives set up a detailed regulatory framework. These developments offer considerable promise, not only for natural gas sector development but also for growth in the closely linked electricity sector. This study analyses the changes which have taken place and the rationale for the regulatory framework which has been established. The study also contains recommendations to assist the Government of Mexico in effectively implementing its natural gas sector reforms and in maximizing the benefits to be realised through the new regulatory framework. (author)

  1. Cost-benefit considerations in regulatory decision-making

    International Nuclear Information System (INIS)

    Harvie, J.D.

    1996-01-01

    The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost-benefit issues and work towards some consensus of opinion among stakeholders; a task force on the subject could be an appropriate starting point'. (author)

  2. Financing urban adaptation to climate change impacts mapping of existing initiatives

    International Nuclear Information System (INIS)

    Eschalier, Claire; Leseur, Alexia; Archambault, Sabrina; Joubert, Marion; Larrue, Clement; Rossin, Nicolas; Salenson, Irene

    2015-01-01

    In June 2015, CDC Climat research, in partnership with AFD, published a mapping of the types of initiatives available for the financing of urban adaptation to climate change, offering additional options to more conventional sources of funding for climate change and sustainable development (national budget transfers, Official Development Aid, etc.). Based on the review of 27 main initiatives, the report shows a strong prevalence of initiatives supporting soft adaptation measures (strategy planning, capacity building, project design, technical assistance, etc). These are in a position to help support the development of a coherent portfolio of bankable projects. The mapping also reveals that local intermediaries (regional and local banks, national development funds, etc.) play a significant role in financing urban adaptation to climate change. Several key factor of success for the cities' access to these sources of funding are also identified, among which liaising with international development stakeholders (such as multilateral and bilateral donors) at the local level, and the identification of various co-benefits and synergies between the economic, environmental and climate impacts. (authors)

  3. 77 FR 55885 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Withdrawal of Proposed Rule Change...

    Science.gov (United States)

    2012-09-11

    ...-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Withdrawal of Proposed Rule Change To Modify Exchange Rule 3307 To Institute a Five Millisecond Delay in the Execution Time of Marketable Orders on... millisecond delay in the execution time of marketable orders on NASDAQ OMX PSX. Notice of the proposed rule...

  4. 75 FR 38585 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To...

    Science.gov (United States)

    2010-07-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62396; File No. SR-BX-2010-012] Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order Approving a Proposed Rule Change To Codify Prices for Co-Location Services June 28, 2010. I. Introduction On January 29, 2010, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange...

  5. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  6. Recent Advances in Drug Development and Regulatory Science in China.

    Science.gov (United States)

    Chen, Jie; Zhao, Naiqing

    2018-01-01

    As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval processes, and to harmonize its regulatory science with international standards, the China Food and Drug Administration (CFDA) has initiated a series of major changes to its policies and regulations. This paper presents a snapshot of China's pharmaceutical market, and research and development status, and introduces technical guidelines pertaining to clinical trials and new drug applications. The recent wave of ground-breaking reforms in CFDA's regulatory science is discussed. Examples of clinical trials and new drug applications are provided throughout the discussion.

  7. Exploring the Process of Implementing Healthy Workplace Initiatives: Mapping to Kotter's Leading Change Model.

    Science.gov (United States)

    Chappell, Stacie; Pescud, Melanie; Waterworth, Pippa; Shilton, Trevor; Roche, Dee; Ledger, Melissa; Slevin, Terry; Rosenberg, Michael

    2016-10-01

    The aim of this study was to use Kotter's leading change model to explore the implementation of workplace health and wellbeing initiatives. Qualitative interviews were conducted with 31 workplace representatives with a healthy workplace initiative. None of the workplaces used a formal change management model when implementing their healthy workplace initiatives. Not all of the steps in Kotter model were considered necessary and the order of the steps was challenged. For example, interviewees perceived that communicating the vision, developing the vision, and creating a guiding coalition were integral parts of the process, although there was less emphasis on the importance of creating a sense of urgency and consolidating change. Although none of the workplaces reported using a formal organizational change model when implementing their healthy workplace initiatives, there did appear to be perceived merit in using the steps in Kotter's model.

  8. Predicting the effect of climate change on wildfire behavior and initial attack success

    Energy Technology Data Exchange (ETDEWEB)

    Riley, William; Fried, Jeremy S.; Gilless, J. Keith; Riley, William J.; Moody, Tadashi J.; Simon de Blas, Clara; Hayhoe, Katharine; Moritz, Max; Stephens, Scott; Torn, Margaret

    2007-12-01

    This study focused on how climate change-induced effects on weather will translate into changes in wildland fire severity and outcomes in California, particularly on the effectiveness of initial attack at limiting the number of fires that escape initial attack. The results indicate that subtle shifts in fire behavior of the sort that might be induced by the climate changes anticipated for the next century are of sufficient magnitude to generate an appreciable increase in the number of fires that escape initial attack. Such escapes are of considerable importance in wildland fire protection planning, given the high cost to society of a catastrophic escape like those experienced in recent decades in the Berkeley-Oakland, Santa Barbara, San Diego, or Los Angeles areas. However, at least for the three study areas considered, it would appear that relatively modest augmentations to existing firefighting resources might be sufficient to compensate for change-induced changes in wildland fire outcomes.

  9. Regulatory use of risk information - initial developments at Slovenian Nuclear Safety Administration

    International Nuclear Information System (INIS)

    Muehleisen, A.; Koncar, M.; Vojnovic, D.; Persic, A.

    2004-01-01

    Similarly to other regulators worldwide, the SNSA intends to enhance the use of PSA and risk insights in its activities in order to ensure a better and more focused regulatory oversight as well as improved interface with a licensee. The main aim of the SNSA is to establish PSA as a standard tool to complement the deterministic based regulation for a variety of regulatory tasks. The PSA applications should, in particular, support the decision making process as well as the interactions with the Krsko NPP. As a first step in the internal use of PSA, PSA event analysis and risk based performance indicators are being introduced. In 2004, the SNSA will start introducing risk follow up and risk informed inspections. By mid 2005 the legal basis for the use of PSA will be also established in Slovenian legislation. (author)

  10. Changes to Regulatory Systems for more Efficient Nuclear Energy Deployment: An Industry Viewpoint

    International Nuclear Information System (INIS)

    Pelin, H.

    2016-01-01

    Nuclear energy is required to play a much larger role in the energy mix in most credible energy scenarios that address climate change (680 GW additional capacity by 2050 according to IEA, 1000 GW according to World Nuclear Association). To reach these ambitious targets, a concerted effort will be required involving industry, governments and regulators. Changes to regulatory systems and processes – including licensing (design, site, operation), export control, security and waste - is one important area that can stimulate faster and more cost effective development of nuclear capacity. In the past, regulators were mainly concerned with authorizing a limited number of reactors from a limited number of designs under a national standard. Today regulators need resources to assess a wider range of designs, while each licensee needs to complete a thorough safety assessment even if the design has been assessed and approved elsewhere. These developments are the inevitable consequence of globalization and competition within the industry. This paper examines the current state of nuclear regulation in relation to the main attributes of good regulation as defined by the OECD. It further looks at ongoing efforts among regulators to share experience or harmonize requirements, such as within MDEP, or to agree common safety levels, such as in WENRA, in order to reach common positions and improve their regulatory approaches. Finally, it will assess the work of industry to demonstrate the benefits – both in terms of efficiency as well as safety – of harmonised regulations notably through the activities of the World Nuclear Association/CORDEL Working Group. (author)

  11. Future nuclear regulatory challenges. A report by the NEA Committee on Nuclear Regulatory Activities

    International Nuclear Information System (INIS)

    1998-01-01

    Future challenges are considered that may arise from technical, socio-economic and political issues; organizational, management and human aspects; and international issues. The perceived challenges have been grouped into four categories, each covered by a chapter. Technical issues are addressed that many present regulatory challenges in the future: ageing nuclear power plants. External changes to industry are considered next that have an effect on regulators, privatization, cost reduction consequences, commercialization etc. It is followed by the impacts of internal changes: organizational, managerial, human-resources, licensing, staff training etc. Finally, international issues are discussed with potential regulatory impact. (R.P.)

  12. Interleukin-2 and STAT5 in regulatory T cell development and function

    OpenAIRE

    Mahmud, Shawn A.; Manlove, Luke S.; Farrar, Michael A.

    2013-01-01

    Interleukin-2 and its downstream target STAT5 have effects on many aspects of immune function. This has been perhaps best documented in regulatory T cells. In this review we summarize the initial findings supporting a role for IL2 and STAT5 in regulatory T cell development and outline more recent studies describing how this critical signaling pathway entrains regulatory T cell differentiation and affects regulatory T cell function.

  13. Attenuating initial beliefs: increasing the acceptance of anthropogenic climate change information by reflecting on values.

    Science.gov (United States)

    van Prooijen, Anne-Marie; Sparks, Paul

    2014-05-01

    Anthropogenic climate change information tends to be interpreted against the backdrop of initial environmental beliefs, which can lead to some people being resistant toward the information. In this article (N = 88), we examined whether self-affirmation via reflection on personally important values could attenuate the impact of initial beliefs on the acceptance of anthropogenic climate change evidence. Our findings showed that initial beliefs about the human impact on ecological stability influenced the acceptance of information only among nonaffirmed participants. Self-affirmed participants who were initially resistant toward the information showed stronger beliefs in the existence of climate change risks and greater acknowledgment that individual efficacy has a role to play in reducing climate change risks than did their nonaffirmed counterparts. © 2013 Society for Risk Analysis.

  14. Access to the decision-making process: opportunities for public involvement in the facility decommissioning process of the United States Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Cameron, F.X.

    1996-01-01

    This paper discusses recent initiatives taken by the United States Nuclear Regulatory Commission NRC) to effectively involve the public in decommissioning decisions. Initiatives discussed include the Commission's rulemaking to establish the radiological criteria for decommissioning, as well as public involvement methods that have been used on a site-by-site basis. As un example of public involvement, the NRC is currently in the process of developing generic rules on the radiological criteria for the decontamination and decommissioning of NRC-licensed sites. Not only was this proposed rule developed through an extensive and novel approach for public involvement, but it also establishes the basic provisions that will govern public involvement in future NRC decisions on the decommissioning of individual sites. The aim is to provide the public with timely information about all phases of the NRC staff to express concerns and make recommendations. Th NRC recognizes the value and the necessity of effective public involvement in its regulatory activities and has initiated a number of changes to its regulatory program to accomplish this. From the NRC's perspective, it is much easier and less costly to incorporate these mechanisms for public involvement into the regulatory program early in the process, rather than try to add them after considerable public controversy on an action has already been generated. The historical antecedents for initiatives mentioned, as well as 'lessons learned' from prior experience are also discussed. (author)

  15. Fisheries and Oceans Canada climate change risk assessment initiative

    Energy Technology Data Exchange (ETDEWEB)

    Dalpe, R. [Fisheries and Oceans, Ottawa, ON (Canada)

    2005-07-01

    This paper provided an overview of an initiative undertaken by the Department of Fisheries and Oceans (DFO) Canada to assess the risks associated with climate change on Canada's waterways and aquatic resources over the next 10 to 20 years. It discussed the risk associated with changes in water temperature and level in increasing the vulnerability of fish stocks and ecosystems. A decrease in water levels is also an issue as it will render current infrastructure ineffective. Storm surges can also have an impact on coastal community infrastructure. The purpose of the assessment was to provide DFO management with a structured understanding of the major climate change factors that pose risks to DFO's operations and to establish priorities in identifying appropriate risk mitigation responses. The presentation discussed the different stages of the initiative (planning, identification and evaluation of risk, validation, and reporting), its' challenges and benefits, as well as lessons learned from this exercises. Lessons learned from the project are as follows: get senior level buy-in from the outset; engage the right people; make it easy for others to be engaged; validate results and risk management response; be ready for surprises; and build in some flexibility to the process. figs.

  16. 77 FR 39288 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending...

    Science.gov (United States)

    2012-07-02

    ... (i) ``ATP Holders,'' as that term is defined in Rule 900.2NY(5); (ii) Sponsored Participants, as that term is defined in Rule 900.2NY(77); and (iii) non-ATP Holder broker-dealers and vendors that request... change as described in Items I, II, and III below, which Items have been prepared by the self-regulatory...

  17. 75 FR 13614 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing of Proposed Rule Change To...

    Science.gov (United States)

    2010-03-22

    ... to handle the additional traffic associated with the listing and trading of $1 strikes where the...-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing of Proposed Rule Change To Establish Strike... 1012 (Series of Options Open for Trading) to establish strike-price intervals for options on Index...

  18. Hanford tanks initiative plan

    International Nuclear Information System (INIS)

    McKinney, K.E.

    1997-01-01

    Abstract: The Hanford Tanks Initiative (HTI) is a five-year project resulting from the technical and financial partnership of the U.S. Department of Energy's Office of Waste Management (EM-30) and Office of Science and Technology Development (EM-50). The HTI project accelerates activities to gain key technical, cost performance, and regulatory information on two high-level waste tanks. The HTI will provide a basis for design and regulatory decisions affecting the remainder of the Tank Waste Remediation System's tank waste retrieval Program

  19. Facing regulatory challenges of on-line hemodiafiltration.

    Science.gov (United States)

    Kümmerle, Wolfgang

    2011-01-01

    On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. Copyright © 2011 S. Karger AG, Basel.

  20. Current products and future plan of regulatory research for risk-informed regulation in Korea

    International Nuclear Information System (INIS)

    Sung, Key Yong; Lee, Chang Ju; Kim, Woong Sik; Kim, Hho Jung

    2003-01-01

    The first phase of a regulatory research project for risk-informed regulation (RIR) and applications (RIA) was finished in March of 2002. Various results that could be useful for preparing Korean RIR system have been developed. One of the remarkable outputs is development of reactor safety goals and acceptance criteria for RIR and RIA in Korea. The Safety Goal has a 4-tier hierarchical structure and each tier has specified goals classified for their usage. Regulatory review guides for probabilistic safety assessment (PSA) including level-1, level-2 and low power and shutdown PSA have been updated by reflecting new information obtained from not only the overseas documents but also experience and insights from regulatory review in Korea. In addition, draft regulatory guides for risk-informed in-service inspection, in-service testing, importance ranking of motor-operated valves, and AOT/STI change of Technical Specifications have been developed for preparing ongoing and future licensing work. Risk-based inspection guides with inspection items selected from a viewpoint of risk importance have been suggested for Korean standard NPPs as well. In the second phase of a research project (April of 2002 to March of 2005), two regulatory research projects on RIR were initiated. One is a study on institutionalization of risk-informed and performance-based regulation. Main topics of this project are evaluation of benefit and characteristics of RIR, development of optimized Korean RIR model, impact analysis for the change of current regulation framework, and suggestion of RIR-related laws and rules. The other is focusing on the development in the areas of a regulatory audit PSA model and regulatory guides for risk monitoring, and application techniques of risk information to the significance determination of plant performance indicators and inspection findings. It is expected that a concrete scheme and detailed regulatory techniques for embodiment of RIR system in Korea will be

  1. Regulatory heterochronies and loose temporal scaling between sea star and sea urchin regulatory circuits.

    Science.gov (United States)

    Gildor, Tsvia; Hinman, Veronica; Ben-Tabou-De-Leon, Smadar

    2017-01-01

    It has long been argued that heterochrony, a change in relative timing of a developmental process, is a major source of evolutionary innovation. Heterochronic changes of regulatory gene activation could be the underlying molecular mechanism driving heterochronic changes through evolution. Here, we compare the temporal expression profiles of key regulatory circuits between sea urchin and sea star, representative of two classes of Echinoderms that shared a common ancestor about 500 million years ago. The morphologies of the sea urchin and sea star embryos are largely comparable, yet, differences in certain mesodermal cell types and ectodermal patterning result in distinct larval body plans. We generated high resolution temporal profiles of 17 mesodermally-, endodermally- and ectodermally-expressed regulatory genes in the sea star, Patiria miniata, and compared these to their orthologs in the Mediterranean sea urchin, Paracentrotus lividus. We found that the maternal to zygotic transition is delayed in the sea star compared to the sea urchin, in agreement with the longer cleavage stage in the sea star. Interestingly, the order of gene activation shows the highest variation in the relatively diverged mesodermal circuit, while the correlations of expression dynamics are the highest in the strongly conserved endodermal circuit. We detected loose scaling of the developmental rates of these species and observed interspecies heterochronies within all studied regulatory circuits. Thus, after 500 million years of parallel evolution, mild heterochronies between the species are frequently observed and the tight temporal scaling observed for closely related species no longer holds.

  2. Ca2+-induced PRE-NMR changes in the troponin complex reveal the possessive nature of the cardiac isoform for its regulatory switch.

    Directory of Open Access Journals (Sweden)

    Nicole M Cordina

    Full Text Available The interaction between myosin and actin in cardiac muscle, modulated by the calcium (Ca2+ sensor Troponin complex (Tn, is a complex process which is yet to be fully resolved at the molecular level. Our understanding of how the binding of Ca2+ triggers conformational changes within Tn that are subsequently propagated through the contractile apparatus to initiate muscle activation is hampered by a lack of an atomic structure for the Ca2+-free state of the cardiac isoform. We have used paramagnetic relaxation enhancement (PRE-NMR to obtain a description of the Ca2+-free state of cardiac Tn by describing the movement of key regions of the troponin I (cTnI subunit upon the release of Ca2+ from Troponin C (cTnC. Site-directed spin-labeling was used to position paramagnetic spin labels in cTnI and the changes in the interaction between cTnI and cTnC subunits were then mapped by PRE-NMR. The functionally important regions of cTnI targeted in this study included the cTnC-binding N-region (cTnI57, the inhibitory region (cTnI143, and two sites on the regulatory switch region (cTnI151 and cTnI159. Comparison of 1H-15N-TROSY spectra of Ca2+-bound and free states for the spin labeled cTnC-cTnI binary constructs demonstrated the release and modest movement of the cTnI switch region (∼10 Å away from the hydrophobic N-lobe of troponin C (cTnC upon the removal of Ca2+. Our data supports a model where the non-bound regulatory switch region of cTnI is highly flexible in the absence of Ca2+ but remains in close vicinity to cTnC. We speculate that the close proximity of TnI to TnC in the cardiac complex is favourable for increasing the frequency of collisions between the N-lobe of cTnC and the regulatory switch region, counterbalancing the reduction in collision probability that results from the incomplete opening of the N-lobe of TnC that is unique to the cardiac isoform.

  3. 10 CFR 2.801 - Initiation of rulemaking.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Initiation of rulemaking. 2.801 Section 2.801 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING PROCEEDINGS AND ISSUANCE OF ORDERS Rulemaking § 2.801 Initiation of rulemaking. Rulemaking may be initiated by the Commission at its own...

  4. 77 FR 36014 - Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors

    Science.gov (United States)

    2012-06-15

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0134] Initial Test Program of Emergency Core Cooling... for public comment draft regulatory guide (DG), DG-1277, ``Initial Test Program of Emergency Core..., entitled, ``Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors,'' is...

  5. Regulatory approaches for addressing dissolved oxygen concerns at hydropower facilities

    Energy Technology Data Exchange (ETDEWEB)

    Peterson, Mark J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Cada, Glenn F. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Sale, Michael J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Eddlemon, Gerald K. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2003-03-01

    Low dissolved oxygen (DO) concentrations are a common water quality problem downstream of hydropower facilities. At some facilities, structural improvements (e.g. installation of weir dams or aerating turbines) or operational changes (e.g., spilling water over the dam) can be made to improve DO levels. In other cases, structural and operational approaches are too costly for the project to implement or are likely to be of limited effectiveness. Despite improvements in overall water quality below dams in recent years, many hydropower projects are unable to meet state water quality standards for DO. Regulatory agencies in the U.S. are considering or implementing dramatic changes in their approach to protecting the quality of the Nation’s waters. New policies and initiatives have emphasized flexibility, increased collaboration and shared responsibility among all parties, and market-based, economic incentives. The use of new regulatory approaches may now be a viable option for addressing the DO problem at some hydropower facilities. This report summarizes some of the regulatory-related options available to hydropower projects, including negotiation of site-specific water quality criteria, use of biological monitoring, watershed-based strategies for the management of water quality, and watershed-based trading. Key decision points center on the health of the local biological communities and whether there are contributing impacts (i.e., other sources of low DO effluents) in the watershed. If the biological communities downstream of the hydropower project are healthy, negotiation for site-specific water quality standards or biocriteria (discharge performance criteria based on characteristics of the aquatic biota) might be pursued. If there are other effluent dischargers in the watershed that contribute to low DO problems, watershed-scale strategies and effluent trading may be effective. This report examines the value of regulatory approaches by reviewing their use in

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

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne L. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2017-08-23

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-05-01

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

  8. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

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

  9. Regulatory environment and its impact on the market value of investor-owned electric utilities

    Science.gov (United States)

    Vishwanathan, Raman

    While other regulated industries have one by one been exposed to competitive reform, electric power, for over eighty years, has remained a great monopoly. For all those years, the vertically integrated suppliers of electricity in the United States have been assigned exclusive territorial (consumer) franchises and have been closely regulated. This environment is in the process change because the electric power industry is currently undergoing some dramatic adjustments. Since 1992, a number of states have initiated regulatory reform and are moving to allow retail customers to choose their energy supplier. There has also been a considerable federal government role in encouraging competition in the generation and transmission of electricity. The objective of this research is to investigate the reaction of investors to the prevailing regulatory environment in the electric utility industry by analyzing the market-to-book value for investor-owned electric utilities in the United States as a gauge of investor concern or support for change. In this study, the variable of interest is the market valuation of utilities, as it captures investor confidence to changes in the regulatory environment. Initially a classic regression model is analyzed on the full sample (of the 96 investor-owned utilities for the years 1992 through 1996), providing a total number of 480 (96 firms over 5 years) observations. Later fixed- and random-effects models are analyzed for the same full-sample model specified in the previous analysis. Also, the analysis is carried forward to examine the impact of the size of the utility and its degree of reliability on nuclear power generation on market values. In the period of this study, 1992--1996, the financial security markets downgraded utilities that were still operating in a regulated environment or had a substantial percentage of their power generation from nuclear power plants. It was also found that the financial market was sensitive to the size of

  10. A unified architecture of transcriptional regulatory elements

    DEFF Research Database (Denmark)

    Andersson, Robin; Sandelin, Albin Gustav; Danko, Charles G.

    2015-01-01

    Gene expression is precisely controlled in time and space through the integration of signals that act at gene promoters and gene-distal enhancers. Classically, promoters and enhancers are considered separate classes of regulatory elements, often distinguished by histone modifications. However...... and enhancers are considered a single class of functional element, with a unified architecture for transcription initiation. The context of interacting regulatory elements and the surrounding sequences determine local transcriptional output as well as the enhancer and promoter activities of individual elements....

  11. 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

  12. Changes of optical, dielectric, and structural properties of Si15Sb85 phase change memory thin films under different initializing laser power

    International Nuclear Information System (INIS)

    Huang Huan; Zhang Lei; Wang Yang; Han Xiaodong; Wu Yiqun; Zhang Ze; Gan Fuxi

    2011-01-01

    Research highlights: → We study the optical, dielectric, and structural characteristics of Si 15 Sb 85 phase change memory thin films under a moving continuous-wave laser initialization. → The optical and dielectric constants, absorption coefficient of Si 15 Sb 85 change regularly with the increasing laser power. → The optical band gaps of Si 15 Sb 85 irradiated upon different power lasers were calculated. → HRTEM images of the samples were observed and the changes of optical and dielectric constants are determined by crystalline structures changes of the films. - Abstract: The optical, dielectric, and structural characteristics of Si 15 Sb 85 phase change memory thin films under a moving continuous-wave laser initialization are studied by using spectroscopic ellipsometry and high-resolution transmission electron microscopy. The dependence of complex refractive index, dielectric functions, absorption coefficient, and optical band gap of the films on its crystallization extents formed by the different initialization laser power are analyzed in detail. The structural change from as-deposited amorphous phase to distorted rhombohedra-Sb-like crystalline structure with the increase of initialization laser power is clearly observed with sub-nanometer resolution. The optical and dielectric constants, the relationship between them, and the local atomic arrangements of this new phase change material can help explain the phase change mechanism and design the practical phase change memory devices.

  13. 77 FR 38351 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List...

    Science.gov (United States)

    2012-06-27

    ... copper market is the third largest metals market in terms of physical volume. Much of the copper traded...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Shares of iShares Copper Trust Pursuant to NYSE Arca Equities Rule 8.201 June 22, 2012. Pursuant to Section...

  14. 75 FR 64767 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing of Proposed Rule Change To...

    Science.gov (United States)

    2010-10-20

    ...-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing of Proposed Rule Change To Amend BATS Y-Exchange Rules To Conform to the Current Rules of BATS Exchange October 13, 2010. Pursuant to Section 19(b... hereby given that on October 4, 2010, BATS Y-Exchange, Inc. (the ``Exchange'' or ``BYX'') filed with the...

  15. Governing climate change transnationally: assessing the evidence from a database of sixty initiatives

    OpenAIRE

    Harriet Bulkeley; Liliana Andonova; Karin Bäckstrand; Michele Betsill; Daniel Compagnon; Rosaleen Duffy; Ans Kolk; Matthew Hoffmann; David Levy; Peter Newell; Tori Milledge; Matthew Paterson; Philipp Pattberg; Stacy VanDeveer

    2012-01-01

    With this paper we present an analysis of sixty transnational governance initiatives and assess the implications for our understanding of the roles of public and private actors, the legitimacy of governance ‘beyond’ the state, and the North–South dimensions of governing climate change. In the first part of the paper we examine the notion of transnational governance and its applicability in the climate change arena, reflecting on the history and emergence of transnational governance initiative...

  16. Development of multipurpose regulatory PSA model

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Sung, Key Yong; Kim, Hho Jung; Yang, Joon Eon; Ha, Jae Joo

    2004-01-01

    Generally, risk information for nuclear facilities comes from the results of Probabilistic safety assessment (PSA). PSA is a systematic tool to ensure the safety of nuclear facilities, since it is based on thorough and consistent application of probability models. In particular, the PSA has been widely utilized for risk-informed regulation (RIR), including various licensee-initiated risk-informed applications (RIA). In any regulatory decision, the main goal is to make a sound safety decision based on technically defensible information. Also, due to the increased public requests for giving a safety guarantee, the regulator should provide the visible means of safety. The use of PSA by the regulator can give the answer on this problem. Therefore, in order to study the applicability of risk information for regulatory safety management, it is a demanding task to prepare a well-established regulatory PSA model and tool. In 2002, KINS and KAERI together made a research cooperation to form a working group to develop the regulatory PSA model - so-called MPAS model. The MPAS stands for multipurpose probabilistic analysis of safety. For instance, a role of the MPAS model is to give some risk insights in the preparation of various regulatory programs. Another role of this model is to provide an independent risk information to the regulator during regulatory decision-making, not depending on the licensee's information

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

    International Nuclear Information System (INIS)

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

    1995-01-01

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

  18. Altered expression of the cell cycle regulatory protein cyclin D1 in the rat dentate gyrus after adrenalectomy-induced granular cell lass

    NARCIS (Netherlands)

    Postigo, JA; Van der Werf, YD; Korf, J; Krugers, HJ

    1998-01-01

    The loss of dentate gyrus (DG) granular cells after removal of the rat adrenal glands (ADX) is mediated by a process that is apoptotic in nature. The present study was initiated to compare changes in the immunocytochemical distribution of the cell-cycle regulatory protein cyclin D1, which has been

  19. Cooperation of Ukrainian regulatory authorities in the SIP

    Energy Technology Data Exchange (ETDEWEB)

    Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

    2003-07-01

    The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

  20. 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)

  1. Changes in peripheral blood level of regulatory T cells in patients with malignant melanoma during treatment with dendritic cell vaccination and low-dose IL-2

    DEFF Research Database (Denmark)

    Bjoern, J; Brimnes, M K; Andersen, M H

    2011-01-01

    In this study, changes in peripheral blood regulatory T cell (Treg) levels were evaluated in 46 progressive patients with melanoma treated with a dendritic cell-based vaccine and concomitant low-dose IFN-α and IL-2. The regulatory subset of CD4 T cells, characterized by CD25(high......) , was prospectively analysed in fresh blood, and treatment-associated quantitative and qualitative changes were analysed. By the 4th vaccine, patients showed a marked increase in CD4+ CD25(high) T cell subset from 6% to 22% (P...

  2. Changes in peripheral blood level of regulatory T cells in patients with malignant melanoma during treatment with dendritic cell vaccination and low-dose IL-2

    DEFF Research Database (Denmark)

    Bjoern, J; Brimnes, M K; Andersen, M H

    2011-01-01

    In this study, changes in peripheral blood regulatory T cell (Treg) levels were evaluated in 46 progressive patients with melanoma treated with a dendritic cell-based vaccine and concomitant low-dose IFN-a and IL-2. The regulatory subset of CD4 T cells, characterized by CD25(high......) , was prospectively analysed in fresh blood, and treatment-associated quantitative and qualitative changes were analysed. By the 4th vaccine, patients showed a marked increase in CD4+ CD25(high) T cell subset from 6% to 22% (P...

  3. The past, present, and future of the U.S. electric power sector: Examining regulatory changes using multivariate time series approaches

    Science.gov (United States)

    Binder, Kyle Edwin

    The U.S. energy sector has undergone continuous change in the regulatory, technological, and market environments. These developments show no signs of slowing. Accordingly, it is imperative that energy market regulators and participants develop a strong comprehension of market dynamics and the potential implications of their actions. This dissertation contributes to a better understanding of the past, present, and future of U.S. energy market dynamics and interactions with policy. Advancements in multivariate time series analysis are employed in three related studies of the electric power sector. Overall, results suggest that regulatory changes have had and will continue to have important implications for the electric power sector. The sector, however, has exhibited adaptability to past regulatory changes and is projected to remain resilient in the future. Tests for constancy of the long run parameters in a vector error correction model are applied to determine whether relationships among coal inventories in the electric power sector, input prices, output prices, and opportunity costs have remained constant over the past 38 years. Two periods of instability are found, the first following railroad deregulation in the U.S. and the second corresponding to a number of major regulatory changes in the electric power and natural gas sectors. Relationships among Renewable Energy Credit prices, electricity prices, and natural gas prices are estimated using a vector error correction model. Results suggest that Renewable Energy Credit prices do not completely behave as previously theorized in the literature. Potential reasons for the divergence between theory and empirical evidence are the relative immaturity of current markets and continuous institutional intervention. Potential impacts of future CO2 emissions reductions under the Clean Power Plan on economic and energy sector activity are estimated. Conditional forecasts based on an outlined path for CO2 emissions are

  4. Resilient Cities Initiative on Climate Change in Latin America and ...

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

    Resilient Cities Initiative on Climate Change in Latin America and the Caribbean ... and Development Knowledge Network will help strengthen decision-making and ... represent a serious threat for fast-growing small- and medium-sized cities. ... guidance on how to integrate gender practices into climate resilient plans for ...

  5. 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

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

    Science.gov (United States)

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

    2013-06-01

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

  7. Reconstructing the regulatory circuit of cell fate determination in yeast mating response.

    Science.gov (United States)

    Shao, Bin; Yuan, Haiyu; Zhang, Rongfei; Wang, Xuan; Zhang, Shuwen; Ouyang, Qi; Hao, Nan; Luo, Chunxiong

    2017-07-01

    Massive technological advances enabled high-throughput measurements of proteomic changes in biological processes. However, retrieving biological insights from large-scale protein dynamics data remains a challenging task. Here we used the mating differentiation in yeast Saccharomyces cerevisiae as a model and developed integrated experimental and computational approaches to analyze the proteomic dynamics during the process of cell fate determination. When exposed to a high dose of mating pheromone, the yeast cell undergoes growth arrest and forms a shmoo-like morphology; however, at intermediate doses, chemotropic elongated growth is initialized. To understand the gene regulatory networks that control this differentiation switch, we employed a high-throughput microfluidic imaging system that allows real-time and simultaneous measurements of cell growth and protein expression. Using kinetic modeling of protein dynamics, we classified the stimulus-dependent changes in protein abundance into two sources: global changes due to physiological alterations and gene-specific changes. A quantitative framework was proposed to decouple gene-specific regulatory modes from the growth-dependent global modulation of protein abundance. Based on the temporal patterns of gene-specific regulation, we established the network architectures underlying distinct cell fates using a reverse engineering method and uncovered the dose-dependent rewiring of gene regulatory network during mating differentiation. Furthermore, our results suggested a potential crosstalk between the pheromone response pathway and the target of rapamycin (TOR)-regulated ribosomal biogenesis pathway, which might underlie a cell differentiation switch in yeast mating response. In summary, our modeling approach addresses the distinct impacts of the global and gene-specific regulation on the control of protein dynamics and provides new insights into the mechanisms of cell fate determination. We anticipate that our

  8. Influence of changes in initial conditions for the simulation of dynamic systems

    Energy Technology Data Exchange (ETDEWEB)

    Kotyrba, Martin [Department of Informatics and Computers, University of Ostrava, 30 dubna 22, Ostrava (Czech Republic)

    2015-03-10

    Chaos theory is a field of study in mathematics, with applications in several disciplines including meteorology, sociology, physics, engineering, economics, biology, and philosophy. Chaos theory studies the behavior of dynamical systems that are highly sensitive to initial conditions—a paradigm popularly referred to as the butterfly effect. Small differences in initial conditions field widely diverging outcomes for such dynamical systems, rendering long-term prediction impossible in general. This happens even though these systems are deterministic, meaning that their future behavior is fully determined by their initial conditions, with no random elements involved. In this paperinfluence of changes in initial conditions will be presented for the simulation of Lorenz system.

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

    International Nuclear Information System (INIS)

    Moe, Wayne Leland

    2015-01-01

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

  10. A review of NRC regulatory processes and functions

    International Nuclear Information System (INIS)

    1981-05-01

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

  11. Regulatory Initiatives for Control and Release of Technologically Enhanced Naturally-Occurring Radioactive Material

    International Nuclear Information System (INIS)

    Egidi, P.V.

    1999-01-01

    Current drafts of proposed standards and suggested State regulations for control and release of technologically-enhanced naturally-occurring radioactive material (TENORM), and standards for release of volumetrically-contaminated material in the US are reviewed. These are compared to the recommendations of the International Atomic Energy Association (IAEA) Safety Series and the European Commission (EC) proposals. Past regulatory efforts with respect to TENORM in the US dealt primarily with oil-field related wastes. Currently, nine states (AK, GA, LA, MS, NM, OH, OR SC, TX) have specific regulations pertaining to TENORM, mostly based on uranium mill tailings cleanup criteria. The new US proposals are dose- or risk-based, as are the IAEA and EC recommendations, and are grounded in the linear no threshold hypothesis (LNT). TENORM wastes involve extremely large volumes, particularly scrap metal and mine wastes. Costs to control and dispose of these wastes can be considerable. The current debate over the validity of LNT at low doses and low dose rates is particularly germane to this discussion. Most standards setting organizations and regulatory agencies base their recommendations on the LNT. The US Environmental Protection Agency has released a draft Federal Guidance Report that recommends calculating health risks from low-level exposure to radionuclides based on the LNT. However, some scientific and professional organizations are openly questioning the validity of LNT and its basis for regulations, practices, and costs to society in general. It is not clear at this time how a non-linear regulatory scheme would be implemented

  12. Regulatory Initiatives for Control and Release of Technologically Enhanced Naturally-Occurring Radioactive Materials

    Energy Technology Data Exchange (ETDEWEB)

    Egidi, P.V.

    1999-03-02

    Current drafts of proposed standards and suggested State regulations for control and release of technologically-enhanced naturally-occurring radioactive material (TENORM), and standards for release of volumetrically-contaminated material in the US are reviewed. These are compared to the recommendations of the International Atomic Energy Association (IAEA) Safety Series and the European Commission (EC) proposals. Past regulatory efforts with respect to TENORM in the US dealt primarily with oil-field related wastes. Currently, nine states (AK, GA, LA, MS, NM, OH, OR SC, TX) have specific regulations pertaining to TENORM, mostly based on uranium mill tailings cleanup criteria. The new US proposals are dose- or risk-based, as are the IAEA and EC recommendations, and are grounded in the linear no threshold hypothesis (LNT). TENORM wastes involve extremely large volumes, particularly scrap metal and mine wastes. Costs to control and dispose of these wastes can be considerable. The current debate over the validity of LNT at low doses and low dose rates is particularly germane to this discussion. Most standards setting organizations and regulatory agencies base their recommendations on the LNT. The US Environmental Protection Agency has released a draft Federal Guidance Report that recommends calculating health risks from low-level exposure to radionuclides based on the LNT. However, some scientific and professional organizations are openly questioning the validity of LNT and its basis for regulations, practices, and costs to society in general. It is not clear at this time how a non-linear regulatory scheme would be implemented.

  13. Will changes in phenology track climate change? A study of growth initiation timing in coast Douglas-fir

    Science.gov (United States)

    Kevin Ford; Connie Harrington; Sheel Bansal; Peter J. Gould; Brad St. Clair

    2016-01-01

    Under climate change, the reduction of frost risk, onset of warm temperatures and depletion of soil moisture are all likely to occur earlier in the year in many temperate regions. The resilience of tree species will depend on their ability to track these changes in climate with shifts in phenology that lead to earlier growth initiation in the spring. Exposure to warm...

  14. 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)

  15. Controlled initiation of chromosomal replication in Escherichia coli requires functional Hda protein.

    Science.gov (United States)

    Camara, Johanna Eltz; Skarstad, Kirsten; Crooke, Elliott

    2003-05-01

    Regulatory inactivation of DnaA helps ensure that the Escherichia coli chromosome is replicated only once per cell cycle, through accelerated hydrolysis of active replication initiator ATP-DnaA to inactive ADP-DnaA. Analysis of deltahda strains revealed that the regulatory inactivation of DnaA component Hda is necessary for maintaining controlled initiation but not for cell growth or viability.

  16. Initiating and continuing behaviour change within a weight gain prevention trial: a qualitative investigation.

    Science.gov (United States)

    Kozica, Samantha; Lombard, Catherine; Teede, Helena; Ilic, Dragan; Murphy, Kerry; Harrison, Cheryce

    2015-01-01

    Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program. In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis. A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649) that participated in the prevention trial. Four behaviour change groups emerged were identified from participant interviews: (i) no change, (ii) relapse, (iii) intermittent and (iv) continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant's ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress. Initiating and continuing behaviour change is a complex process. Our

  17. Knowledge Management Initiatives Used to Maintain Regulatory Expertise in Transportation and Storage of Radioactive Materials - 12177

    Energy Technology Data Exchange (ETDEWEB)

    Lindsay, Haile; Garcia-Santos, Norma; Saverot, Pierre; Day, Neil; Gambone Rodriguez, Kimberly; Cruz, Luis; Sotomayor-Rivera, Alexis; Vechioli, Lucieann; Vera, John; Pstrak, David [United States Nuclear Regulatory Commission, Mail Stop EBB-03D-02M, 6003 Executive Boulevard, Rockville, MD 20852 (United States)

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) was established in 1974 with the mission to license and regulate the civilian use of nuclear materials for commercial, industrial, academic, and medical uses in order to protect public health and safety, and the environment, and promote the common defense and security. Currently, approximately half (∼49%) of the workforce at the NRC has been with the Agency for less than six years. As part of the Agency's mission, the NRC has partial responsibility for the oversight of the transportation and storage of radioactive materials. The NRC has experienced a significant level of expertise leaving the Agency due to staff attrition. Factors that contribute to this attrition include retirement of the experienced nuclear workforce and mobility of staff within or outside the Agency. Several knowledge management (KM) initiatives have been implemented within the Agency, with one of them including the formation of a Division of Spent Fuel Storage and Transportation (SFST) KM team. The team, which was formed in the fall of 2008, facilitates capturing, transferring, and documenting regulatory knowledge for staff to effectively perform their safety oversight of transportation and storage of radioactive materials, regulated under Title 10 of the Code of Federal Regulations (10 CFR) Part 71 and Part 72. In terms of KM, the SFST goal is to share critical information among the staff to reduce the impact from staff's mobility and attrition. KM strategies in place to achieve this goal are: (1) development of communities of practice (CoP) (SFST Qualification Journal and the Packaging and Storing Radioactive Material) in the on-line NRC Knowledge Center (NKC); (2) implementation of a SFST seminar program where the seminars are recorded and placed in the Agency's repository, Agency-wide Documents Access and Management System (ADAMS); (3) meeting of technical discipline group programs to share knowledge within specialty areas; (4

  18. A proposed Regulatory Guide basis for spent fuel decay heat

    International Nuclear Information System (INIS)

    Hermann, O.W.; Parks, C.V.; Renier, J.P.

    1991-01-01

    A proposed revision to Regulatory Guide 3.54, ''Spent Fuel Heat Generation in an Independent Spent Fuel Storage Installation'' has been developed for the US Nuclear Regulatory Commission. The proposed revision includes a data base of decay heat rates calculated as a function of burnup, specific power, cooling time, initial fuel 235 U enrichment and assembly type (i.e., PWR or BWR). Validation of the calculational method was done by comparison with existing measured decay heat rates. Procedures for proper use of the data base, adjustment formulae accounting for effects due to differences in operating history and initial enrichment, and a defensible safety factor were derived. 15 refs., 6 tabs

  19. The influence of the Children's Food and Beverage Advertising Initiative: change in children's exposure to food advertising on television in Canada between 2006-2009.

    Science.gov (United States)

    Potvin Kent, M; Wanless, A

    2014-04-01

    To assess whether children's exposure to television food/beverage advertising has changed since the implementation of the self-regulatory Canadian Children's Food and Beverage Advertising Initiative (CAI). Data on 11 advertised food/beverage categories (candy, chocolate bars, cookies, portable snacks, cheese, yogurt, cereal, juices, soft drinks, diet soft drinks and fast food) were purchased from Nielsen Media Research for May 2006, 2009 and 2011 for the broadcasting markets of Toronto and Vancouver. The number of advertisements aired on 27 television stations between 0600 hours-1200 hours was determined in Toronto and Vancouver for May 2006, 2009 and 2011 and the percentage change in the number of spots between May 2006 and May 2011 on all stations, on children's specialty stations and on generalist stations was then calculated. The average number food/beverage spots seen by children aged 2-11 was determined for May 2006 and 2009 and the percentage change was calculated. On children's specialty channels, a 4.5% decrease in total spots aired was observed while spots aired on generalist stations increased by 44% (Toronto) and 45% (Vancouver). On all stations, children's total average exposure to food/beverage advertising increased by 16.8% in Toronto and 6.4% in Vancouver between 2006 and 2009. Significant increases were seen in snacks and yogurt in both cities, and in fast food in Toronto. On children's specialty channels, children's exposure to the food/beverage categories considered increased by 5.4% in Toronto and by 2.5% in Vancouver. Despite improvements in the volume of spots on children's specialty channels, children's exposure to food and beverage advertising has increased since the implementation of the CAI. The current self-regulatory system is failing to protect children from food marketing high in fat, sugar and sodium on television. Government regulation needs to be considered.

  20. Transforming public utility commissions in the new regulatory environment: Some issues and ideas for managing change

    Energy Technology Data Exchange (ETDEWEB)

    Wirick, D.W.; Davis, V.W.; Burns, R.E.; Jones, D.N.

    1996-07-01

    In the face of sweeping changes in utility markets and regulatory practices, public utility commissions are being forced to change in fundamental ways--to substantially transform themselves rather than to make only incremental changes in their operations. Managing this process of radical change is complicated by the fact that for the foreseeable future some portions of utility markets (e.g., water utilities) will function much as they have before. Some envision commissions in the future that are more externally focussed, that rely more on dispute resolution than adjudicatory proceedings, that concentrate on identifying and understanding competitive markets, that are more automated, and that are more likely to question old assumptions and definitions. This report identifies the considerations commissions might apply for identifying what mix of skills or fields of experise should compromise the technical staff. Factors are also identified which point towards a sectoral arrangement of staff and those factors which point toward a functional approach.

  1. X-ray diffraction study of microstructural changes during fatigue damage initiation in pipe steels: Role of the initial dislocation structure

    International Nuclear Information System (INIS)

    Pinheiro, B.; Lesage, J.; Pasqualino, I.; Bemporad, E.; Benseddiq, N.

    2013-01-01

    The present work is the second part of an ongoing study of microstructural changes during fatigue damage initiation in pipe steels [B. Pinheiro et al., Mat. Sci. Eng., A 532 (2012) 158–166]. Microdeformations and residual stresses (macrostresses) are evaluated by X-ray diffraction during alternating bending fatigue tests on samples taken from an API 5L X60 grade steel pipe. Microdeformations are evaluated from the full width at half maximum (FWHM) of the diffraction peak and residual stresses are estimated from the peak shift. Here, to understand the role of the initial dislocation structure, annealed samples are considered. As previously found for as-machined samples, the evolution of microdeformations shows three regular successive stages, but now with an increase during the first stage. The amplitude of each stage is accentuated with increasing stress amplitude, while its duration is reduced. Residual stresses show a similar trend, with stages of the same durations than those observed for FWHM, respectively. Additionally, changes in density and distribution of dislocations are observed by transmission electron microscopy combined with the technique of focused ion beam. The results are very encouraging for the development of a future indicator of fatigue damage initiation for pipe steels based on microstructural changes measured by X-ray diffraction

  2. X-ray diffraction study of microstructural changes during fatigue damage initiation in pipe steels: Role of the initial dislocation structure

    Energy Technology Data Exchange (ETDEWEB)

    Pinheiro, B., E-mail: bianca@lts.coppe.ufrj.br [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University Lille 1, Boulevard Paul Langevin, Cité Scientifique, 59655 Villeneuve d' Ascq (France); Lesage, J. [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University Lille 1, Boulevard Paul Langevin, Cité Scientifique, 59655 Villeneuve d' Ascq (France); Pasqualino, I. [Subsea Technology Laboratory (LTS), Ocean Engineering Department, COPPE/Federal University of Rio de Janeiro, PO Box 68508, Cidade Universitária, CEP 21945-970, Rio de Janeiro/RJ (Brazil); Bemporad, E. [University of Rome “ROMA TRE”, Mechanical and Industrial Eng. Dept., Via Vasca Navale 79, 00146 Rome (Italy); Benseddiq, N. [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University Lille 1, Boulevard Paul Langevin, Cité Scientifique, 59655 Villeneuve d' Ascq (France)

    2013-09-15

    The present work is the second part of an ongoing study of microstructural changes during fatigue damage initiation in pipe steels [B. Pinheiro et al., Mat. Sci. Eng., A 532 (2012) 158–166]. Microdeformations and residual stresses (macrostresses) are evaluated by X-ray diffraction during alternating bending fatigue tests on samples taken from an API 5L X60 grade steel pipe. Microdeformations are evaluated from the full width at half maximum (FWHM) of the diffraction peak and residual stresses are estimated from the peak shift. Here, to understand the role of the initial dislocation structure, annealed samples are considered. As previously found for as-machined samples, the evolution of microdeformations shows three regular successive stages, but now with an increase during the first stage. The amplitude of each stage is accentuated with increasing stress amplitude, while its duration is reduced. Residual stresses show a similar trend, with stages of the same durations than those observed for FWHM, respectively. Additionally, changes in density and distribution of dislocations are observed by transmission electron microscopy combined with the technique of focused ion beam. The results are very encouraging for the development of a future indicator of fatigue damage initiation for pipe steels based on microstructural changes measured by X-ray diffraction.

  3. 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

  4. Evolving Role of the Power Sector Regulator: A Clean Energy Regulators Initiative Report

    Energy Technology Data Exchange (ETDEWEB)

    Zinaman, O.; Miller, M.; Bazilian, M.

    2014-04-01

    This paper seeks to briefly characterize the evolving role of power sector regulation. Given current global dynamics, regulation of the power sector is undergoing dramatic changes. This transformation is being driven by various factors including technological advances and cost reductions in renewable energy, energy efficiency, and demand management; increasing air pollution and climate change concerns; and persistent pressure for ensuring sustainable economic development and increased access to energy services by the poor. These issues add to the already complex task of power sector regulation, of which the fundamental remit remains to objectively and transparently ensure least-cost service delivery at high quality. While no single regulatory task is trivial to undertake, it is the prioritization and harmonization of a multitude of objectives that exemplifies the essential challenge of power sector regulation. Evolving regulatory roles can be understood through the concept of existing objectives and an additional layer of emerging objectives. Following this categorization, we describe seven existing objectives of power sector regulators and nine emerging objectives, highlighting key challenges and outlining interdependencies. This essay serves as a preliminary installment in the Clean Energy Regulatory Initiative (CERI) series, and aims to lay the groundwork for subsequent reports and case studies that will explore these topics in more depth.

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

    International Nuclear Information System (INIS)

    Remick, F.J.

    1994-01-01

    One of the major objectives of the Office of Research is to ensure availability of sound technical information for timely decision making in support of the NRC's safety mission. The Office of Research is changing some of its emphasis to better meet the expected needs of the NRC's regulatory offices. Long-standing programs in support of operating reactors are nearing completion. These programs include plant aging and severe accident research for currently operating plants. This meeting will also address the new challenges faced by the NRC in its review of the advanced light water and non-light water reactors. As plant aging and severe accident research programs are nearing completion, the research activities are coming to focus on the emerging technologies, for example, digital instrumentation and control systems, both as replacement equipment for operating plants and as the technology of choice and necessity for the advanced reactors. Necessity, because analog equipment is becoming obsolete. Other examples include the use of new materials in operating plants, human factors considerations in the design and operation of the advanced plants, thermal-hydraulic characteristics of the advanced reactors, and new construction techniques

  6. Recurrent rewiring and emergence of RNA regulatory networks.

    Science.gov (United States)

    Wilinski, Daniel; Buter, Natascha; Klocko, Andrew D; Lapointe, Christopher P; Selker, Eric U; Gasch, Audrey P; Wickens, Marvin

    2017-04-04

    Alterations in regulatory networks contribute to evolutionary change. Transcriptional networks are reconfigured by changes in the binding specificity of transcription factors and their cognate sites. The evolution of RNA-protein regulatory networks is far less understood. The PUF (Pumilio and FBF) family of RNA regulatory proteins controls the translation, stability, and movements of hundreds of mRNAs in a single species. We probe the evolution of PUF-RNA networks by direct identification of the mRNAs bound to PUF proteins in budding and filamentous fungi and by computational analyses of orthologous RNAs from 62 fungal species. Our findings reveal that PUF proteins gain and lose mRNAs with related and emergent biological functions during evolution. We demonstrate at least two independent rewiring events for PUF3 orthologs, independent but convergent evolution of PUF4/5 binding specificity and the rewiring of the PUF4/5 regulons in different fungal lineages. These findings demonstrate plasticity in RNA regulatory networks and suggest ways in which their rewiring occurs.

  7. Pervasive and stochastic changes in the TCR repertoire of regulatory T-cell-deficient mice.

    Science.gov (United States)

    Zheng, Lingjie; Sharma, Rahul; Kung, John T; Deshmukh, Umesh S; Jarjour, Wael N; Fu, Shu Man; Ju, Shyr-Te

    2008-04-01

    We hypothesize that regulatory T-cell (Treg)-deficient strains have an altered TCR repertoire in part due to the expansion of autoimmune repertoire by self-antigen. We compared the Vbeta family expression profile between B6 and Treg-lacking B6.Cg-Foxp3(sf)(/Y) (B6.sf) mice using fluorescent anti-Vbeta mAbs and observed no changes. However, while the spectratypes of 20 Vbeta families among B6 mice were highly similar, the Vbeta family spectratypes of B6.sf mice were remarkably different from B6 mice and from each other. Significant spectratype changes in many Vbeta families were also observed in Treg-deficient IL-2 knockout (KO) and IL-2Ralpha KO mice. Such changes were not observed with anti-CD3 mAb-treated B6 mice or B6 CD4+CD25- T cells. TCR transgenic (OT-II.sf) mice displayed dramatic reduction of clonotypic TCR with concomitant increase in T cells bearing non-transgenic Vbeta and Valpha families, including T cells with dual receptors expressing reduced levels of transgenic Valpha and endogenous Valpha. Collectively, the data demonstrate that Treg deficiency allows polyclonal expansion of T cells in a stochastic manner, resulting in widespread changes in the TCR repertoire.

  8. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Science.gov (United States)

    2012-02-28

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

  9. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

    The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

  10. Knowledge management in the Argentine Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Chahab, Martin

    2006-01-01

    In 2006, the Argentine Nuclear Regulatory Authority has initiated a regulatory knowledge management process to face the loss of knowledge resulting from retiring experts, the generation gap, and the existing need to train new human resources. A number of projects have been started together with the technical assistance of the National Public Administration Institute to preserve knowledge and render it explicit for the coming generations. These projects include 'The History of the Expert's Learning Process' in which the majority of the most critical experts have been interviewed so far. The results of this project help envision a training structure and prospective projects. An Internet Site has also been created on the Intranet in order to render knowledge explicit and facilitate the tools for knowledge management initiatives. Furthermore, ARN's knowledge map project has also been started. (author) [es

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

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

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

  12. Initiating and continuing behaviour change within a weight gain prevention trial: a qualitative investigation.

    Directory of Open Access Journals (Sweden)

    Samantha Kozica

    Full Text Available Preventing obesity is an international health priority. In Australia, young women who live in rural communities are at high risk of unhealthy weight gain. Interventions which engage young women and support sustainable behaviour change are needed and comprehensive evaluation of such interventions generates knowledge for population scale-up. This qualitative sub-study aims to identify enablers and barriers to behaviour change initiation and continuation within a community weight gain prevention program.In-depth semi-structured interviews were conducted with program participants 6 months after baseline. All interviews were audio-taped and transcribed verbatim. Transcripts were analysed independently by two investigators via thematic analysis.A total of 28 women with a mean age of 39.9±6.2years and a BMI of 28.6±5.2kg/m2 were purposively recruited from the larger cohort (n = 649 that participated in the prevention trial.Four behaviour change groups emerged were identified from participant interviews: (i no change, (ii relapse, (iii intermittent and (iv continued change. Factors influencing behaviour change initiation and continuation included realistic program expectations and the participant's ability to apply the core program elements including: setting small, achievable behaviour change goals, problem solving and using self-management techniques. Personal knowledge, skills, motivation, self-efficacy, accountability and perceived social and environmental barriers also affected behaviour change. Satisfaction with personal program progress and the perceived amount of program supports required to achieve ongoing behaviour change varied amongst participants. Women who relapsed expressed a desire for more intensive and regular support from health professionals, identified more barriers unrelated to the program, anticipated significant weight loss and had lower satisfaction with their progress.Initiating and continuing behaviour change is a complex

  13. Evolutionary changes of Hox genes and relevant regulatory factors provide novel insights into mammalian morphological modifications.

    Science.gov (United States)

    Li, Kui; Sun, Xiaohui; Chen, Meixiu; Sun, Yingying; Tian, Ran; Wang, Zhengfei; Xu, Shixia; Yang, Guang

    2018-01-01

    The diversity of body plans of mammals accelerates the innovation of lifestyles and the extensive adaptation to different habitats, including terrestrial, aerial and aquatic habitats. However, the genetic basis of those phenotypic modifications, which have occurred during mammalian evolution, remains poorly explored. In the present study, we synthetically surveyed the evolutionary pattern of Hox clusters that played a powerful role in the morphogenesis along the head-tail axis of animal embryos and the main regulatory factors (Mll, Bmi1 and E2f6) that control the expression of Hox genes. A deflected density of repetitive elements and lineage-specific radical mutations of Mll have been determined in marine mammals with morphological changes, suggesting that evolutionary changes may alter Hox gene expression in these lineages, leading to the morphological modification of these lineages. Although no positive selection was detected at certain ancestor nodes of lineages, the increased ω values of Hox genes implied the relaxation of functional constraints of these genes during the mammalian evolutionary process. More importantly, 49 positively-selected sites were identified in mammalian lineages with phenotypic modifications, indicating adaptive evolution acting on Hox genes and regulatory factors. In addition, 3 parallel amino acid substitutions in some Hox genes were examined in marine mammals, which might be responsible for their streamlined body. © 2017 The Authors. Integrative Zoology published by International Society of Zoological Sciences, Institute of Zoology/Chinese Academy of Sciences and John Wiley & Sons Australia, Ltd.

  14. 77 FR 68162 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

    Science.gov (United States)

    2012-11-15

    ... discuss Regulatory Guide 1.79, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors,'' Revision 2, and Regulatory Guide 1.79.1, ``Initial Test Program of Emergency Core...

  15. Advances in Canadian regulatory practice

    International Nuclear Information System (INIS)

    Waddington, J.G.

    1993-03-01

    The new General Amendments to the Regulations, new recommendations on dose limits, developments in techniques and safety thinking, and aging of plant are all contributing to the need for a significant number of new regulatory document on a wide range of topics. this paper highlights a number of initiatives taken in response to these pressures, giving a brief background to the initiative and, where possible, outlining some of the ideas in the document licensing guides on new dose limits, dosimetry, safety analysis, reliability, fault tree analysis, reporting requirements, human factors, software, the ALARA principle, backfitting and the licensing process. (Author) 29 refs., fig., 4 tabs

  16. Governing and Managing Customer-initiated Engineering Change – An in-depth case study of a global industrial supplier

    DEFF Research Database (Denmark)

    Sommer, Anita Friis; Storbjerg, Simon Haahr; Dukovska-Popovska, Iskra

    2013-01-01

    or externally by for instance customers. Managing initiated engineering changes is a vital source for improving product performance and radically reducing change costs. Customer-initiated engineering change is an area growing in importance decreasing product life cycles and increasing demand for customisation....... Through an in-depth case study, this paper investigates which process and what governance setup is appropriate to manage customer initiated engineering changes, referred to as request management. The paper includes a proposal for a request management framework and a task-based iterative process model...

  17. Regulatory system reform of occupational health and safety in China.

    Science.gov (United States)

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  18. Climate change considerations for the Port Hope area initiative

    International Nuclear Information System (INIS)

    Kirklady, J.; Morassutti, M.; Tamm, J.; Coutts, P.; Chambers, D.

    2006-01-01

    The Port Hope Area Initiative (PHAI) is a community-based program intended to develop a safe and long-term (approximately 500 years) solution for the management of historic low-level radioactive waste (LLRW) that has been present in the Port Hope area for many years. The PHAI undertakings involve the construction and management of two Long-Term Low-Level Radioactive Waste Management Facilities (referred to as the LTWMFs) in Port Hope and in Port Granby. These undertakings are currently undergoing detailed examination through the Environmental Screening process under the Canadian Environmental Assessment Act. The purpose of the study described in this paper was to provide information necessary to satisfy the requirements of the Scope of Environmental Assessment for the Port Hope and Port Granby Projects. In particular, the purpose of the study was to satisfy the requirements to evaluate greenhouse gas (GHG) emissions from the proposed PHAI initiatives and to evaluate the potential effect of climate change parameters on the two Projects. The Port Hope and Port Granby Projects will contribute to Ontario's GHG emission inventory due to vehicle exhaust from excavation equipment and haul trucks during the construction phase of the LTWMFs. The construction phase of the Projects is of relatively short duration, and the contribution of GHGs from each Project was determined to be insignificant compared to Ontario's GHG emissions from the Construction and Transportations sectors. The proposed project elements associated with the Port Hope and Port Granby Projects were each evaluated with respect to potential sensitivities to future change in climate parameters. Considering the potential changes to climate, a screening analysis of each element of the LTWMFs was undertaken. Because it is considered likely that the current design level storms will be exceeded within the next 500 years, it was determined that the storm water management system was potentially sensitive to changes

  19. Can community change be measured for an outcomes-based initiative? A comparative case study of the success by 6 initiative.

    Science.gov (United States)

    Minich, Lisa; Howe, Steven; Langmeyer, Daniel; Corcoran, Kevin

    2006-12-01

    One of the challenges facing nonprofit organizations today is the demand for measurable results. Increasingly, these organizations are focusing less on program outputs and program outcomes in favor of community outcomes or changes demonstrated in the larger community. Success by 6(R) is a popular United Way initiative that emphasizes defining and measuring community outcomes. In this paper, we describe our work with 24 Success by 6(R) initiatives around the country. It is clear that not all of these initiatives are measuring community outcomes. Of those initiatives that are experiencing some success measuring community outcomes, similar measurement strategies are reported. Additionally, our experience suggests several United Way employees express dissatisfaction with the logic model as a framework for defining and measuring community outcomes although no preferred alternative model is identified. Evaluators working with community-wide initiatives must find ways to communicate the differences between program and community outcomes to key stakeholders and funders.

  20. Regulatory Risk Management of Advanced Nuclear Power Plants

    International Nuclear Information System (INIS)

    George, Glenn R.

    2002-01-01

    Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

  1. 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...

  2. A methodology for analyzing precursors to earthquake-initiated and fire-initiated accident sequences

    International Nuclear Information System (INIS)

    Budnitz, R.J.; Lambert, H.E.; Apostolakis, G.

    1998-04-01

    This report covers work to develop a methodology for analyzing precursors to both earthquake-initiated and fire-initiated accidents at commercial nuclear power plants. Currently, the U.S. Nuclear Regulatory Commission sponsors a large ongoing project, the Accident Sequence Precursor project, to analyze the safety significance of other types of accident precursors, such as those arising from internally-initiated transients and pipe breaks, but earthquakes and fires are not within the current scope. The results of this project are that: (1) an overall step-by-step methodology has been developed for precursors to both fire-initiated and seismic-initiated potential accidents; (2) some stylized case-study examples are provided to demonstrate how the fully-developed methodology works in practice, and (3) a generic seismic-fragility date base for equipment is provided for use in seismic-precursors analyses. 44 refs., 23 figs., 16 tabs

  3. The Proline Regulatory Axis and Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Phang, James Ming; Liu, Wei; Hancock, Chad; Christian, Kyle J., E-mail: phangj@mail.nih.gov [Metabolism and Cancer Susceptibility Section, Basic Research Laboratory, Center for Cancer Research, Frederick National Laboratory for Cancer Research, Frederick, MD (United States)

    2012-06-21

    Studies in metabolism and cancer have characterized changes in core pathways involving glucose and glutamine, emphasizing the provision of substrates for building cell mass. But recent findings suggest that pathways previously considered peripheral may play a critical role providing mechanisms for cell regulation. Several of these mechanisms involve the metabolism of non-essential amino acids, for example, the channeling of glycolytic intermediates into the serine pathway for one-carbon transfers. Historically, we proposed that the proline biosynthetic pathway participated in a metabolic interlock with glucose metabolism. The discovery that proline degradation is activated by p53 directed our attention to the initiation of apoptosis by proline oxidase/dehydrogenase. Now, however, we find that the biosynthetic mechanisms and the metabolic interlock may depend on the pathway from glutamine to proline, and it is markedly activated by the oncogene MYC. These findings add a new dimension to the proline regulatory axis in cancer and present attractive potential targets for cancer treatment.

  4. Frameworks for Change: Four Recurrent Themes for Quality in Early Childhood Curriculum Initiatives

    Science.gov (United States)

    Burgess, Jennifer; Fleet, Alma

    2009-01-01

    This paper reports on the first phase of a case study that investigated how early childhood teachers experience organisational change. As one of three levels of quality improvement, State government-funded curriculum initiatives were developed with an aim to promote change. Three curriculum documents, one each focusing on literacy, pedagogy and…

  5. Evaluating confidence in the impact of regulatory nutrient reduction and assessing the competing impact of climate change

    Science.gov (United States)

    Irby, I.; Friedrichs, M. A. M.

    2017-12-01

    Human impacts on the Chesapeake Bay through increased nutrient run-off as a result of land-use change, urbanization, and industrialization, have resulted in a degradation of water quality over the last half-century. These direct impacts, compounded with human-induced climate changes such as warming, rising sea level, and changes in precipitation, have elevated the conversation surrounding the future of the Bay's water quality. As a result, in 2010, a Total Maximum Daily Load (TMDL) was established for the Chesapeake Bay that limited nutrient and sediment input in an effort to increase dissolved oxygen. This research utilizes a multiple model approach to evaluate confidence in the estuarine water quality modeling portion of the TMDL. One of the models is then used to assess the potential impact climate change may have on the success of currently mandated nutrient reduction levels in 2050. Results demonstrate that although the models examined differ structurally and in biogeochemical complexity, they project a similar attainment of regulatory water quality standards after nutrient reduction, while also establishing that meeting water quality standards is relatively independent of hydrologic conditions. By developing a Confidence Index, this research identifies the locations and causes of greatest uncertainty in modeled projections of water quality. Although there are specific locations and times where the models disagree, this research lends an increased degree of confidence in the appropriateness of the TMDL levels and in the general impact nutrient reductions will have on Chesapeake Bay water quality under current environmental conditions. However, when examining the potential impacts of climate change, this research shows that the combined impacts of increasing temperature, sea level, and river flow negatively affect dissolved oxygen throughout the Chesapeake Bay and impact progress towards meeting the water quality standards associated with the TMDL with

  6. Calling the doctor: a qualitative study of patient-initiated physician consultation among rural older adults.

    Science.gov (United States)

    Stoller, Eleanor Palo; Grzywacz, Joseph G; Quandt, Sara A; Bell, Ronny A; Chapman, Christine; Altizer, Kathryn P; Arcury, Thomas A

    2011-08-01

    Guided by Leventhal's self-regulatory model and Cockerham's theory of health lifestyles, we explore two questions regarding physician consultation among elderly rural adults: What symptom characteristics prompt patient-initiated physician consultation? Do participants' accounts of responses to symptoms, including the decision to consult a physician, incorporate descriptions of change over time? We analyze data from semistructured in-depth interviews with 62 older rural adults. Accounts of decisions to initiate contact with physicians support prior research. Some symptoms encouraged immediate consultation; others prompted periods of monitoring and lay management. Physicians were most often contacted if changes were new, unusually severe, persisted or worsened, or failed to respond to lay treatment. We characterize participants' responses to symptoms as bricolages to highlight their construction from available materials. Incorporating the integrating concept of bricolage and Cockerham's emphasis on both general dispositions and symptom-specific responses represents an important extension of Leventhal's conceptualization of illness behavior, including patient-initiated physician consultation.

  7. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

    Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

  8. Environmental concerns and regulatory initiatives related to hydraulic fracturing in shale gas formations: potential implications for North American gas supply

    Energy Technology Data Exchange (ETDEWEB)

    Sumi, Lisa [Earthworks (Canada)

    2010-09-15

    Shale gas resources have been referred to as a game changer for North America and it is expected that shale gas will account for over 30% of the natural gas production in North America by 2020. However, the development of this resource has raised several concerns, notably in terms of water use and contamination; more stringent regulations could be implemented in the coming years. The aim of this paper is to present the effect that more stringent regulations would have on gas development in the Marcellus shale, which accounts for 20% of North American shale gas production. Information on hydraulic fracturing and its environmental impacts is provided herein, along with information on the regulatory initiatives underway in the Marcellus shale region. This paper pointed out that novel regulations relating to shale gas development could significantly reduce the growth in shale gas production.

  9. 78 FR 1562 - Improving Government Regulations; Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2013-01-08

    ... agenda incorporates the objective and criteria, when applicable, of the regulatory reform program under the Executive Order and other regulatory guidance. It contains DoD issuances initiated by DoD... statutory administration requirements as required. Starting with the fall 2007 edition, the Internet became...

  10. 77 FR 55430 - Arkansas Regulatory Program and Abandoned Mine Land Reclamation Plan

    Science.gov (United States)

    2012-09-10

    ... of its regulatory program and abandoned mine land reclamation plan, make grammatical changes, correct... portions of its regulatory program and abandoned mine land reclamation plan, make grammatical changes... Streams. PART 785--REQUIREMENTS FOR PERMITS FOR SPECIAL CATEGORIES OF MINING 785.13, 785.14, 785.15...

  11. Fatores determinantes para modificações da terapia antirretroviral inicial Factors determining changes in initial antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Denise Girão Limaverde Lima

    2012-04-01

    Full Text Available OBJETIVO: Investigar os fatores determinantes das mudanças da terapia antirretroviral (TARV inicial dos pacientes assistidos em hospital de referência em AIDS do Ceará. MÉTODOS: O estudo descritivo e exploratório utilizou a análise dos formulários de solicitação de início ou modificação de tratamento do ano de 2008, acompanhando as mudanças de terapia durante o primeiro ano de tratamento. Os dados foram analisados nos programas Statistical Package for the Social Sciences (SPSS e Epi Info, utilizando ANOVA e teste exato do coeficiente de contingência, com significância de p OBJECTIVE: To investigate factors determining changes in initial antiretroviral therapy (ART in patients attended to in an AIDS tertiary care hospital in Ceará, Brazil. METHODS: This descriptive and exploratory study used the analysis of request to initiate or change treatment forms in the year of 2008, and the changes in therapy were followed through the first year of treatment. Data were analyzed with SPSS and EpiInfo by using ANOVA and the exact test of the coefficient of contingency, with significance at p < 0.05. RESULTS: From 301 patients initiating ART, 22.1% (n = 68 needed a change in the first year. These patients were mostly males, aged 20 to 39 years; with only one ART changed needed in 86.8% of the cases (n = 59. Reports of two or three changes in regimen were observed. Zidovudine was the drug most often changed, followed by lopinavir/ritonavir and efavirenz. A significant association was found between changes in initial regimens and the report of adverse reactions (p < 0.001. Conclusion: The main factor determining changes in the initial ART was an adverse reaction report. Most patients had one change in the initial ART over the first year of treatment. ART monitoring contributed to a better control of the specific drug therapy.

  12. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

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

  13. 78 FR 19057 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing Proposed Rule Changes...

    Science.gov (United States)

    2013-03-28

    ... categories. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the... by ICEEU. A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the.... 78q-1(b)(3)(F). B. Self-Regulatory Organization's Statement on Burden on Competition ICE Clear Europe...

  14. Synthetic tetracycline-inducible regulatory networks: computer-aided design of dynamic phenotypes

    Directory of Open Access Journals (Sweden)

    Kaznessis Yiannis N

    2007-01-01

    Full Text Available Abstract Background Tightly regulated gene networks, precisely controlling the expression of protein molecules, have received considerable interest by the biomedical community due to their promising applications. Among the most well studied inducible transcription systems are the tetracycline regulatory expression systems based on the tetracycline resistance operon of Escherichia coli, Tet-Off (tTA and Tet-On (rtTA. Despite their initial success and improved designs, limitations still persist, such as low inducer sensitivity. Instead of looking at these networks statically, and simply changing or mutating the promoter and operator regions with trial and error, a systematic investigation of the dynamic behavior of the network can result in rational design of regulatory gene expression systems. Sophisticated algorithms can accurately capture the dynamical behavior of gene networks. With computer aided design, we aim to improve the synthesis of regulatory networks and propose new designs that enable tighter control of expression. Results In this paper we engineer novel networks by recombining existing genes or part of genes. We synthesize four novel regulatory networks based on the Tet-Off and Tet-On systems. We model all the known individual biomolecular interactions involved in transcription, translation, regulation and induction. With multiple time-scale stochastic-discrete and stochastic-continuous models we accurately capture the transient and steady state dynamics of these networks. Important biomolecular interactions are identified and the strength of the interactions engineered to satisfy design criteria. A set of clear design rules is developed and appropriate mutants of regulatory proteins and operator sites are proposed. Conclusion The complexity of biomolecular interactions is accurately captured through computer simulations. Computer simulations allow us to look into the molecular level, portray the dynamic behavior of gene regulatory

  15. The role of regulatory uncertainty in certificate markets: A case study of the Swedish/Norwegian market

    International Nuclear Information System (INIS)

    Fagiani, Riccardo; Hakvoort, Rudi

    2014-01-01

    Price volatility in green certificate markets reflects uncertainty over future prices, representing a major source of risk for renewable energy generators. Price risk is considered the principal deficiency of this market-based policy since it causes investors to require higher returns. Moreover, investors are exposed to regulatory risk; namely, the risk that a change in the regulation will materially impact the certificate price. Regulatory uncertainty is reflected in market volatility exacerbating certificate price risk. Using an econometric approach, we investigate the role of regulatory changes on price volatility in the Swedish certificate market. The results of our analysis indicate that regulatory changes strongly affect certificate markets, resulting in periods of higher volatility. Moreover, we analyze whether certificate price volatility has changed after creating a joint Swedish/Norwegian market. Results indicate that the ambivalence surrounding the creation of this bigger market led to a period of increased price volatility between 2010 and 2011. Overall, this article brings a better understanding of the role of regulatory uncertainty on certificate markets, and gives evidence for its negative impact in terms of increased price volatility. - Highlights: • Paper analyzes the impact of regulatory changes on certificate price volatility. • Regulatory changes affect market volatility and price risk. • Regulatory uncertainty harms certificate markets. • The bigger Swedish/Norwegian market has not resulted in lower volatility yet

  16. 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)

  17. Regulatory system reform of occupational health and safety in China

    Science.gov (United States)

    WU, Fenghong; CHI, Yan

    2015-01-01

    With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

  18. 75 FR 39714 - Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of Rule Change by...

    Science.gov (United States)

    2010-07-12

    ... have been prepared by the self-regulatory organization. The Commission is publishing this notice to....C. 78a. \\3\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of the.... II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed...

  19. Institutional transformation: An analysis of change initiatives at NSF ADVANCE institutions

    Science.gov (United States)

    Plummer, Ellen W.

    The purpose of this study was to examine how institutional culture promoted or impeded the implementation of round one and two NSF ADVANCE initiatives designed to improve academic climates for women in science and engineering. This study was conducted in two phases. In phase one, 35 participants from 18 institutions were interviewed to answer three research questions. Participants identified a policy, process, or program designed to improve academic cultures for women in science and engineering fields. Participants also identified strategies that promoted the implementation of these efforts, and discussed factors that impeded these efforts. In phase two, site visits were conducted at two institutions to answer a fourth research question. How did institutional culture shape the design and implementation of faculty search processes? Policies, processes, and programs were implemented by participants at the institutional, departmental, and individual levels and included family friendly and dual career policies at the institutional level, improved departmental faculty search and climate improvement processes, and mentoring programs and training for department heads at the individual level. Communication and leadership strategies were key to the successful implementation of policies, processes, and programs designed to achieve institutional transformation. Communication strategies involved shaping change messages to reach varied audiences often with the argument that change efforts would improve the climate for everyone not just women faculty members. Administrative and faculty leaders from multiple levels proved important to change efforts. Institutional Transformation Institutional culture shaped initiatives to improve faculty search processes. Faculty leaders in both settings used data to persuade faculty members of the need for change. At one site, data that included national availability information was critical to advancing the change agenda. At the other site

  20. 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

  1. Regulatory control, nuclear safety regulation and waste management in Spain

    International Nuclear Information System (INIS)

    Martin, A.

    2000-01-01

    This article presents the challenges that faces the spanish regulatory authority. The deregulation of electricity industry imposes severe changes in nuclear power economics and forces nuclear power to compete with other sources of electricity. A pressure is perceived for regulatory effectiveness primarily since the cost of regulation is a component of the cost of the product. This effectiveness gain in regulatory control will be reached through systematic strategic analysis, formulation and implementation. The regulatory aspects of plant life extension and of waste management are examined

  2. 77 FR 73056 - Initial Test Programs for Water-Cooled Nuclear Power Plants

    Science.gov (United States)

    2012-12-07

    ... Plants AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; request for comment... (DG), DG-1259, ``Initial Test Programs for Water-Cooled Nuclear Power Plants.'' This guide describes... (ITPs) for light water cooled nuclear power plants. DATES: Submit comments by January 31, 2013. Comments...

  3. NASA NDATC Global Climate Change Education Initiative

    Science.gov (United States)

    Bennett, B.; Wood, E.; Meyer, D.; Maynard, N.; Pandya, R. E.

    2009-12-01

    This project aligns with NASA’s Strategic Goal 3A - “Study Earth from space to advance scientific understanding and meet societal needs and focuses on funding from the GCCE Funding Category 2: Strengthen the Teaching and Learning About Global Climate Change Within Formal Education Systems. According to the Intergovernmental Panel on Climate Change Report (2007) those communities with the least amount of resources will be most vulnerable, and least likely to adapt to the impacts brought on by a changing climate. Further, the level of vulnerability of these communities is directly correlated with their ability to implement short, medium and long range mitigation measures. The North Dakota Association of Tribal Colleges (NDATC) has established a climate change education initiative among its six member Tribal Colleges and Universities (TCUs). The goal of this project is to enhance the TCUs capacity to educate their constituents on the science of climate change and mitigation strategies specifically as they apply to Indian Country. NDATC is comprised of six American Indian tribally chartered colleges (TCUs) which include: Cankdeska Cikana Community College, serving the Spirit Lake Dakota Nation; Fort Berthold Community College, serving the Mandan, Hidatsa, and Arikara Nation; Sitting Bull College, serving the Hunkpapa Lakota and Dakota Nation; Turtle Mountain Community College, serving the Turtle Mountain Band of Chippewa; Sisseton Wahpeton College serving the Sisseton and Wahpeton Dakota Nation, and United Tribes Technical College, serving over 70 Tribal groups from across the United States. The purpose of this project is to (1) increase awareness of climate change and its potential impacts in Indian Country through education for students, faculty and presidents of the TCUs as well as Tribal leadership; (2) increase the capacity of TCUs to respond to this global threat on behalf of tribal people; (3) develop climate change mitigation strategies relevant to Indian

  4. Sulfur dioxide initiates global climate change in four ways

    International Nuclear Information System (INIS)

    Ward, Peter L.

    2009-01-01

    Global climate change, prior to the 20th century, appears to have been initiated primarily by major changes in volcanic activity. Sulfur dioxide (SO 2 ) is the most voluminous chemically active gas emitted by volcanoes and is readily oxidized to sulfuric acid normally within weeks. But trace amounts of SO 2 exert significant influence on climate. All major historic volcanic eruptions have formed sulfuric acid aerosols in the lower stratosphere that cooled the earth's surface ∼ 0.5 o C for typically three years. While such events are currently happening once every 80 years, there are times in geologic history when they occurred every few to a dozen years. These were times when the earth was cooled incrementally into major ice ages. There have also been two dozen times during the past 46,000 years when major volcanic eruptions occurred every year or two or even several times per year for decades. Each of these times was contemporaneous with very rapid global warming. Large volumes of SO 2 erupted frequently appear to overdrive the oxidizing capacity of the atmosphere resulting in very rapid warming. Such warming and associated acid rain becomes extreme when millions of cubic kilometers of basalt are erupted in much less than one million years. These are the times of the greatest mass extinctions. When major volcanic eruptions do not occur for decades to hundreds of years, the atmosphere can oxidize all pollutants, leading to a very thin atmosphere, global cooling and decadal drought. Prior to the 20th century, increases in atmospheric carbon dioxide (CO 2 ) followed increases in temperature initiated by changes in SO 2 . By 1962, man burning fossil fuels was adding SO 2 to the atmosphere at a rate equivalent to one 'large' volcanic eruption each 1.7 years. Global temperatures increased slowly from 1890 to 1950 as anthropogenic sulfur increased slowly. Global temperatures increased more rapidly after 1950 as the rate of anthropogenic sulfur emissions increased. By

  5. 75 FR 50013 - Self-Regulatory Organizations; NYSE Amex, Inc.; Notice of Filing and Immediate Effectiveness of...

    Science.gov (United States)

    2010-08-16

    ... been prepared by the self-regulatory organization. NYSE Amex filed the proposed rule change as a ``non.... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The... its filing with the Commission, the self-regulatory organization included statements concerning the...

  6. 77 FR 24748 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-04-25

    ... Traded TBA April 18, 2012. I. Introduction On March 1, 2012, the Financial Industry Regulatory Authority... (``MBS'') traded ``to be announced'' or ``TBA.'' The proposed rule change was published for comment in... TBA (``MBS TBA'') are a specific type of Asset-Backed Security.\\6\\ FINRA has proposed to amend its...

  7. The regulatory approach for spent nuclear storage and conditioning facility: The Hanford example

    International Nuclear Information System (INIS)

    Sellers, E.D.; Mooers, G.C. III; Daschke, K.D.; Driggers, S.A.; Timmins, D.C.

    1996-01-01

    Hearings held before the House Subcommittee on Energy and Mineral Resources in March 1994, requested that officials of federal agencies and other experts explore options for providing regulatory oversight of the US Department of Energy (DOE) facilities and operations. On January, 25, 1995, the DOE, supported by the White House Office of Environmental Quality and the Office of Management and Budget, formally initiated an Advisory Committee on External Regulation of DOE Nuclear Safety. In concert with this initiative and public opinion, the DOE Richland Operations Office has initiated the K Basin Spent Nuclear Fuel Project -- Regulatory Policy. The DOE has established a program to move the spent nuclear fuel presently stored in the K Basins to a new storage facility located in the 200 East Area of the Hanford Site. New facilities will be designed and constructed for safe conditioning and interim storage of the fuel. In implementing this Policy, DOE endeavors to achieve in these new facilities ''nuclear safety equivalency'' to comparable US Nuclear Regulatory Commission (NRC)-licensed facilities. The DOE has established this Policy to take a proactive approach to better align its facilities to the requirements of the NRC, anticipating the future possibility of external regulation. The Policy, supplemented by other DOE rules and directives, form the foundation of an enhanced regulatory, program that will be implemented through the DOE K Basin Spent Nuclear Fuel Project (the Project)

  8. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

    Joosen, B.P.M.; Haentjens, M.; Wessels, B.

    2015-01-01

    With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks,

  9. 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

  10. Impact of regulatory science on global public health

    Directory of Open Access Journals (Sweden)

    Meghal Patel

    2012-07-01

    Full Text Available Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

  11. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

  12. Influencing organisational change in the NHS: lessons learned from workplace wellness initiatives in practice.

    Science.gov (United States)

    Blake, Holly; Lloyd, Scott

    2008-01-01

    This article presents a discussion of the key issues in influencing organisational change in NHS settings, in the development of workplace wellness interventions to improve employee health and wellbeing. To tackle poor public health and associated rising healthcare costs, there must be a focus on the root cause of many preventable diseases - unhealthy lifestyle choices. Workplace wellness initiatives are now an important prevention strategy adopted by socially responsible organisations to target the health and wellbeing of working age adults. Lessons learned from initiatives in secondary care suggest that effective implementation requires change in organisational 'health culture', through a combination of education, behaviour change intervention, needs-based facilities, and services and strategies for developing supportive and health-promoting work environments. Most of all, employers must demonstrate a commitment to health and wellness that is fully integrated with their mission, values and long-term vision, paving the way for sustainable lifestyle changes. Evaluation systems must be in place to measure the impact and outcomes of wellness schemes.

  13. 78 FR 69168 - Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed...

    Science.gov (United States)

    2013-11-18

    ... approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70848; File No. SR-NSCC-2013-10] Self-Regulatory Organizations; National Securities Clearing Corporation; Order Approving Proposed Rule Change To...

  14. APPROVAL OF WASTE TREATMENT AND IMMOBILIZATION PLANT CONTRACTOR-INITIATED AUTHORIZATION BASIS AMENDMENT REQUESTS (ABAR)

    International Nuclear Information System (INIS)

    JONES GL

    2008-01-01

    The objective is to describe the process used by the Office of River Protection (ORP) for evaluating and implementing Contractor-initiated changes to the Waste Treatment and Immobilization Plant (WTP) Authorization Basis (AB). The WTP Project's history has provided a unique challenge for establishing and maintaining an ORP-approved AB during design and construction. Until operations begin, the project cannot implement the classic Unreviewed Safety Question (USQ) process to determine when ORP approval of Contractor-initiated changes is required. A 'quasiUSQ' process has been implemented that defines when AB changes could occur. The three types of AB changes are (1) Limited Scope Changes, (2) Authorization Basis Deviations, and (3) Authorization Basis Amendment Request (ABAR). DOE RL/REG 97-13, 'Office of River Protection Position on Contractor-Initiated Changes to the Authorization Basis', describes the process the WTP Contractor must follow to make changes to the AB, with and without ORP approval. The process uses a 'safety evaluation' process that is similar to the USQ process but at a more qualitative level. The maturation of the WTP Contractor's facility design and activities, and other changing conditions, resulted in a process that allows the Contractor to make changes to the AB without ORP approval; however, those changes that may significantly affect nuclear safety do require ORP approval. This process balances the WTP regulatory principle of efficiency with assurance that adequate safety will not be compromised. The process has reduced the number of ABARs requiring ORP approval and reduced the potential for delays in design and procurement activities

  15. Features of Heart Rate Variability Capture Regulatory Changes During Kangaroo Care in Preterm Infants.

    Science.gov (United States)

    Kommers, Deedee R; Joshi, Rohan; van Pul, Carola; Atallah, Louis; Feijs, Loe; Oei, Guid; Bambang Oetomo, Sidarto; Andriessen, Peter

    2017-03-01

    To determine whether heart rate variability (HRV) can serve as a surrogate measure to track regulatory changes during kangaroo care, a period of parental coregulation distinct from regulation within the incubator. Nurses annotated the starting and ending times of kangaroo care for 3 months. The pre-kangaroo care, during-kangaroo care, and post-kangaroo care data were retrieved in infants with at least 10 accurately annotated kangaroo care sessions. Eight HRV features (5 in the time domain and 3 in the frequency domain) were used to visually and statistically compare the pre-kangaroo care and during-kangaroo care periods. Two of these features, capturing the percentage of heart rate decelerations and the extent of heart rate decelerations, were newly developed for preterm infants. A total of 191 kangaroo care sessions were investigated in 11 preterm infants. Despite clinically irrelevant changes in vital signs, 6 of the 8 HRV features (SD of normal-to-normal intervals, root mean square of the SD, percentage of consecutive normal-to-normal intervals that differ by >50 ms, SD of heart rate decelerations, high-frequency power, and low-frequency/high-frequency ratio) showed a visible and statistically significant difference (P heart rate decelerations. HRV-based features may be clinically useful for capturing the dynamic changes in autonomic regulation in response to kangaroo care and other changes in environment and state. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. From frequent hurricanes to the Deepwater Horizon oil spill in coastal Louisiana: the impact of regulatory change

    Directory of Open Access Journals (Sweden)

    So-Min Cheong

    2014-06-01

    Full Text Available The issue of whether adaptations to past disasters can impede adaptation to new disasters of a different type or intensity will be analyzed by examining the transition from frequent hurricanes to the Deepwater Horizon oil spill in coastal Louisiana. In particular, the effects of changed regulatory structures from the Stafford Act to the Oil Pollution Act of 1990 in response to the Deepwater Horizon oil spill are investigated. The article describes how the federal, state, and local governments adjust. In addition, it illustrates the shifting focus on the environment with the activation of the Oil Pollution Act and the Clean Water Act. It wraps up with a discussion of the uncertainty that is pervasive in the case of the oil spill derived from changed regulations and the novelty of the disaster.

  17. Regulatory Inspection of Nuclear Power Plants in NEA Member Countries

    International Nuclear Information System (INIS)

    1978-01-01

    Based on the replies to a questionnaire, this report gives a description and comparative evaluation of the regulatory inspection activities in several NEA Member countries. The questionnaire which was circulated to all Member countries requested details on the organisation, system, scope and objectives of nuclear regulatory inspection and the effort required throughout all stages of the life of a nuclear plant including the use of independent bodies or consultants. Additional information was requested on the documentation concerned with regulatory inspections, incident and accident reporting procedures, and the duties, powers and bases for recruitment of regulatory personnel with the object of covering all related aspects. However, because of the differences in national practices and perhaps in the interpretation of the questionnaire, it proved to be extremely difficult to make an evaluation and comparison of inspection activities and effort involved in these Member countries. This report, which includes a section on the nuclear power programme in Member countries, should therefore only be regarded as an initial review but it provides a useful contribution to the exchange of experience and views on regulatory inspection practices

  18. Regulatory governance of telecommunications liberalisation in Taiwan

    International Nuclear Information System (INIS)

    Cheng, Kuo-Tai; Hebenton, Bill

    2008-01-01

    This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

  19. Regulatory governance of telecommunications liberalisation in Taiwan

    Energy Technology Data Exchange (ETDEWEB)

    Cheng, Kuo-Tai [Department of Regional Studies in Humanity and Social Sciences, National Hsin-Chu University of Education, No. 521 Nan-Da Road, Hsin-Chu 300 (China); Hebenton, Bill [School of Law, University of Manchester, M13 9PP (United Kingdom)

    2008-12-15

    This paper examines the changing role of government and market in regulating the telecommunications sector from since 1996 in Taiwan. It contextualises the theoretical aspects of regulatory governance for institutional design and practices, and reviews the concepts and mechanisms for appraising privatisation and regulatory systems. Using a conceptual framework for researching privatisation and regulation, it describes the process and issues pertinent to telecommunications liberalisation and privatisation in Taiwan, supported by a brief presentation of theoretical points of view as well as practitioners' views. The paper presents results concerning criteria for appraising privatisation and regulatory governance and considers policy lessons that can be learned from the experiences of the Taiwanese telecommunications sector's liberalisation. (author)

  20. Dynamic regulation of the transcription initiation landscape at single nucleotide resolution during vertebrate embryogenesis

    NARCIS (Netherlands)

    C. Nepal (Chirag); Y. Hadzhiev (Yavor); C. Previti (Christopher); V. Haberle (Vanja); N. Li (Nan); H. Takahashi (Hiroyuki); A.M. Suzuki (Ana Maria); Y. Sheng (Ying); R.F. Abdelhamid (Rehab); S. Anand (Santosh); P.A. Gehrig (Paola A.); A. Akalin (Altuna); C. Kockx (Christel); A. Van Der Sloot (Antoine); W.F.J. van IJcken (Wilfred); O. Armant (Olivier); S. Rastegar (Sepand); C. Watson (Craig); U. Strähle (Uwe); E. Stupka (Elia); P. Carninci (Piero); B. Lenhard (Boris); F. Müller (Ferenc)

    2013-01-01

    textabstractSpatiotemporal control of gene expression is central to animal development. Core promoters represent a previously unanticipated regulatory level by interacting with cis-regulatory elements and transcription initiation in different physiological and developmental contexts. Here, we

  1. Identifying Cis-Regulatory Changes Involved in the Evolution of Aerobic Fermentation in Yeasts

    Science.gov (United States)

    Lin, Zhenguo; Wang, Tzi-Yuan; Tsai, Bing-Shi; Wu, Fang-Ting; Yu, Fu-Jung; Tseng, Yu-Jung; Sung, Huang-Mo; Li, Wen-Hsiung

    2013-01-01

    Gene regulation change has long been recognized as an important mechanism for phenotypic evolution. We used the evolution of yeast aerobic fermentation as a model to explore how gene regulation has evolved and how this process has contributed to phenotypic evolution and adaptation. Most eukaryotes fully oxidize glucose to CO2 and H2O in mitochondria to maximize energy yield, whereas some yeasts, such as Saccharomyces cerevisiae and its relatives, predominantly ferment glucose into ethanol even in the presence of oxygen, a phenomenon known as aerobic fermentation. We examined the genome-wide gene expression levels among 12 different yeasts and found that a group of genes involved in the mitochondrial respiration process showed the largest reduction in gene expression level during the evolution of aerobic fermentation. Our analysis revealed that the downregulation of these genes was significantly associated with massive loss of binding motifs of Cbf1p in the fermentative yeasts. Our experimental assays confirmed the binding of Cbf1p to the predicted motif and the activator role of Cbf1p. In summary, our study laid a foundation to unravel the long-time mystery about the genetic basis of evolution of aerobic fermentation, providing new insights into understanding the role of cis-regulatory changes in phenotypic evolution. PMID:23650209

  2. Areas of Inquiry : Guiding FSSD practitioners at the beginning of a change initiative towards sustainability

    OpenAIRE

    Hogenboom, Michaela; Mireault, Amy; Stolz, Thaela

    2012-01-01

    This research aims to support sustainability practitioners at the beginning of a change initiative towards sustainability to increase the success of the change. Moving towards sustainability is a complex journey and requires radical and structural transformational change in companies. Mutual understanding of the company and the practitioner is required to design a suitable change process. Existing tools related to sustainability, change management, corporate analysis and assessment were analy...

  3. Initiation of health-behaviour change among employees participating in a web-based health risk assessment with tailored feedback

    Directory of Open Access Journals (Sweden)

    Kraaijenhagen Roderik A

    2011-03-01

    Full Text Available Abstract Background Primary prevention programs at the worksite can improve employee health and reduce the burden of cardiovascular disease. Programs that include a web-based health risk assessment (HRA with tailored feedback hold the advantage of simultaneously increasing awareness of risk and enhancing initiation of health-behaviour change. In this study we evaluated initial health-behaviour change among employees who voluntarily participated in such a HRA program. Methods We conducted a questionnaire survey among 2289 employees who voluntarily participated in a HRA program at seven Dutch worksites between 2007 and 2009. The HRA included a web-based questionnaire, biometric measurements, laboratory evaluation, and tailored feedback. The survey questionnaire assessed initial self-reported health-behaviour change and satisfaction with the web-based HRA, and was e-mailed four weeks after employees completed the HRA. Results Response was received from 638 (28% employees. Of all, 86% rated the program as positive, 74% recommended it to others, and 58% reported to have initiated overall health-behaviour change. Compared with employees at low CVD risk, those at high risk more often reported to have increased physical activity (OR 3.36, 95% CI 1.52-7.45. Obese employees more frequently reported to have increased physical activity (OR 3.35, 95% CI 1.72-6.54 and improved diet (OR 3.38, 95% CI 1.50-7.60. Being satisfied with the HRA program in general was associated with more frequent self-reported initiation of overall health-behaviour change (OR 2.77, 95% CI 1.73-4.44, increased physical activity (OR 1.89, 95% CI 1.06-3.39, and improved diet (OR 2.89, 95% CI 1.61-5.17. Conclusions More than half of the employees who voluntarily participated in a web-based HRA with tailored feedback, reported to have initiated health-behaviour change. Self-reported initiation of health-behaviour change was more frequent among those at high CVD risk and BMI levels. In

  4. 49 CFR 40.297 - Does anyone have the authority to change a SAP's initial evaluation?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Does anyone have the authority to change a SAP's... the Return-to-Duty Process § 40.297 Does anyone have the authority to change a SAP's initial... managed-care provider, any service agent) may change in any way the SAP's evaluation or recommendations...

  5. 75 FR 15470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2010-03-29

    ...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change FINRA is proposing... (Disclosure of Price and Concessions in Selling Agreements) and the deletion of NASD Rule 2770 (Disclosure of Price in Selling Agreements). FINRA Rule 5160 was approved by the Commission on January 25, 2010 \\5\\ and...

  6. Mutational robustness of gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Aalt D J van Dijk

    Full Text Available Mutational robustness of gene regulatory networks refers to their ability to generate constant biological output upon mutations that change network structure. Such networks contain regulatory interactions (transcription factor-target gene interactions but often also protein-protein interactions between transcription factors. Using computational modeling, we study factors that influence robustness and we infer several network properties governing it. These include the type of mutation, i.e. whether a regulatory interaction or a protein-protein interaction is mutated, and in the case of mutation of a regulatory interaction, the sign of the interaction (activating vs. repressive. In addition, we analyze the effect of combinations of mutations and we compare networks containing monomeric with those containing dimeric transcription factors. Our results are consistent with available data on biological networks, for example based on evolutionary conservation of network features. As a novel and remarkable property, we predict that networks are more robust against mutations in monomer than in dimer transcription factors, a prediction for which analysis of conservation of DNA binding residues in monomeric vs. dimeric transcription factors provides indirect evidence.

  7. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

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

  8. Below regulatory concern standards: The limits of state and local authority

    International Nuclear Information System (INIS)

    Silverman, D.J.

    1990-01-01

    The paper discusses: (1) the scope of the Nuclear Regulatory Commission's authority to develop and implement below regulatory concern or BRC standards; and (2) the limitations on the legal authority of states and local governments to create impediments to full implementation of such standards. The paper demonstrates that the NRC is acting well within its statutory authority in developing BRC regulations and guidelines, and that the ability of state and local governments to impede generators' use of those regulations and guidelines on the basis of legal or regulatory initiatives is substantially circumscribed. While some generators may be reluctant, as a result of political factors, to utilize BRC standards, the decision whether or not to use such standards should not be made without careful consideration of the applicable legal and regulatory limitations on state and local authority

  9. 76 FR 61444 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing of Proposed Rule Change To...

    Science.gov (United States)

    2011-10-04

    ... interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory... IV below. The self-regulatory organization has prepared summaries, set forth in Sections A, B and C...

  10. Nuclear regulations: current status and proposed initiatives

    International Nuclear Information System (INIS)

    Domondon, D.B.; Valdezco, E.M.; Mateo, A.J.; Parami, V.K.

    1996-01-01

    The science Act of 1958 created the Philippine Atomic Energy Commission, presently known as the Philippine Nuclear Research Institute (PNRI), under the Department of Science and Technology (DOST). The PNRI is tasked with the dual role of promotion and control of the peaceful applications of atomic energy. To carry its mandate of regulation and control on the use of raioisotopes in various fields, the PNRI had promulgated and issued specific regulations known as the Code of PNRI regulations. This paper summarizes the activities undertaken by PNRI in the continuing process of review and subsequent revisions of the Code of PNRI regulations and related guidance documents. It highlights proposed modifications in the present regulations in an attempt to adopt the new international basic safety standards, the practical problems and related issues attendant to the implementation of these new standards, among others. In line with the overall objective of PNRI to ensure the safe application of nuclear energy and radiation technology in various fields, the institute conducted a series of regulatory information conferences to provide an opportunity for members of the regulatory staff of the PNRI and licenses to discuss safety initiatives and regulatory issues. This paper will also provide an in-depth assessment of the lessons learned from these conferences which were conducted by sector or by specific applications for a more focused approach, e.g. radiopharmaceuticals, industrial radiography, research, among others. Licensees' feedback on the PNRI regulatory process are presented as part of the overall objective of enhancing the operational experiences of the licensing, review and evaluation group as well as that of inspection, enforcement and compliance. Several proposed initiatives for consideration of the PNRI to further strengthen its regulatory functions are also briefly outlined. (author)

  11. Regulatory Expectations for Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-05-15

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

  12. Regulatory Expectations for Safety Culture

    International Nuclear Information System (INIS)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung

    2014-01-01

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety

  13. Risk-based regulation: A regulatory perspective

    International Nuclear Information System (INIS)

    Scarborough, J.C.

    1993-01-01

    In the early development of regulations for nuclear power plants, risk was implicitly considered through qualitative assessments and engineering reliability principles and practices. Examples included worst case analysis, defense in depth, and the single failure criterion. However, the contributions of various systems, structures, components and operator actions to plant safety were not explicitly assessed since a methodology for this purpose had not been developed. As a consequence of the TMI accident, the use of more quantitative risk methodology and information in regulation such as probabilistic risk analysis (PRA) increased. The use of both qualitative and quantitative consideration of risk in regulation has been a set of regulations and regulatory guides and practices that ensure adequate protection of public health and safety. Presently, the development of PRA techniques has developed to the point that safety goals, expressed in terms of risk, have been established to help guide further regulatory decision making. This paper presents the personal opinions of the author as regards the use of risk today in nuclear power plant regulation, areas of further information needs, and necessary plans for moving toward a more systematic use of risk-based information in regulatory initiatives in the future

  14. 42 CFR 476.96 - Review period and reopening of initial denial determinations and changes as a result of DRG...

    Science.gov (United States)

    2010-10-01

    ... determinations and changes as a result of DRG validations. 476.96 Section 476.96 Public Health CENTERS FOR... initial denial determinations and changes as a result of DRG validations. (a) General timeframe. A QIO or... initial denial determination or a change as a result of a DRG validation. (b) Extended timeframes. (1) An...

  15. 76 FR 77877 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing of Proposed Rule Change To...

    Science.gov (United States)

    2011-12-14

    .... \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the...). II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed... self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the...

  16. Increased T-regulatory cells within lymphocyte follicles in moderate COPD

    DEFF Research Database (Denmark)

    Plumb, J; Smyth, L J C; Adams, H R

    2009-01-01

    Lymphoid follicles in the lung parenchyma are a characteristic feature of chronic obstructive pulmonary disease (COPD). There are reports of altered CD4 T-regulatory cell numbers in COPD lungs, but the location of these cells within COPD lung tissue specific follicles has not been investigated......, as well as lymphoid clusters lacking organisation. The percentage of CD4 cells that were T-regulatory cells were significantly increased (p = 0.02) within COPD (16%) follicles compared with smokers (10%) and nonsmokers (8%). In contrast, there was no change (p>0.05) in the percentage of T-regulatory cells...... in clusters or the subepithelium between groups. Lymphoid follicles in COPD patients have increased T-regulatory cells. Therefore, T-regulatory activity may be altered within COPD lymphoid follicles....

  17. Dramatic changes in 67 miRNAs during initiation of first wave of spermatogenesis in Mus musculus testis: global regulatory insights generated by miRNA-mRNA network analysis.

    Science.gov (United States)

    Sree, Sreesha; Radhakrishnan, Karthika; Indu, Sivankutty; Kumar, Pradeep G

    2014-09-01

    We mapped global changes in miRNA and mRNA profiles spanning the first wave of spermatogenesis using prepubertal (Postnatal Day 8 [P8]), pubertal (P16), and adolescent (P24) Mus musculus testes and identified the differential expression of 67 miRNAs and 8226 mRNAs. These two data sets were integrated into miRNA-dependent regulatory networks based on miRWalk predictions. In a network representing the P8 to P16 transition, downregulation of four miRNAs and upregulation of 19 miRNAs were linked with 81 upregulated target mRNAs and 228 downregulated target mRNAs, respectively. Furthermore, during the P16 to P24 transition, two miRNAs were downregulated, and eight miRNAs were upregulated, which linked with 64 upregulated mRNAs and 389 downregulated mRNAs, respectively. Only three of the miRNAs present in the network (miR-34b-5p, miR-34c, and miR-449a) showed a progressive increase from P8 through P16 to P24, while the remaining miRNAs in the network showed statistically significant changes in their levels either during the P8 to P16 transition or during the P16 to P24 transition. Analysis of the chromosomal location of these differentially expressed miRNAs showed that 14 out of 25 miRNAs upregulated from P8 to P16, and 18 out of 40 miRNAs upregulated from P8 to P24 were X-linked. This is suggestive of their escape from meiotic sex chromosome inactivation and postmeiotic sex chromatin. This integrated network of miRNA-level and mRNA-level changes in mouse testis during the first wave of spermatogenesis is expected to build a base for evaluating the role of miRNA-mediated gene expression regulation in maturing mammalian testis. © 2014 by the Society for the Study of Reproduction, Inc.

  18. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

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

  19. 77 FR 3152 - New Mexico: Final Authorization of State-Initiated Changes and Incorporation-by-Reference of...

    Science.gov (United States)

    2012-01-23

    ... relations, Penalties, Reporting and recordkeeping requirements, Water pollution control, Water supply... Mexico: Final Authorization of State-Initiated Changes and Incorporation-by-Reference of State Hazardous.... SUMMARY: During a review of New Mexico's regulations, the EPA identified a variety of State-initiated...

  20. Regional changes over time in initial virological response rates to combination antiretroviral therapy across Europe

    DEFF Research Database (Denmark)

    Bannister, W; Kirk, O; Gatell, J

    2006-01-01

    BACKGROUND: Changes in virologic response to initial combination antiretroviral therapy (cART) over calendar time may indicate improvements in cART or emergence of primary resistance. Regional variations may identify differences in available antiretroviral drugs or patient management. METHODS.......026) and time (P changes were observed (south, P = 0.061; central west, P ....001; north: P = 0.070; east, P = 0.001). CONCLUSIONS: There was some evidence of regional differences in initial virologic response to cART. Improvements over time were observed, suggesting that so far, the effect of primary resistance has not been of sufficient magnitude to prevent increasing suppression...

  1. Regulatory practices for nuclear power plants in India

    International Nuclear Information System (INIS)

    Bajaj, S.S.

    2013-01-01

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

  2. 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.

  3. 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.

  4. 42 CFR 476.93 - Opportunity to discuss proposed initial denial determination and changes as a result of a DRG...

    Science.gov (United States)

    2010-10-01

    ... determination and changes as a result of a DRG validation. 476.93 Section 476.93 Public Health CENTERS FOR... initial denial determination and changes as a result of a DRG validation. Before a QIO reaches an initial denial determination or makes a change as a result of a DRG validation, it must— (a) Promptly notify the...

  5. Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

    Science.gov (United States)

    Wang, Hui-Po; Wang, Chun-Li

    2018-04-01

    The concept of Pharmacovigilance Planning and Risk Minimization Planning (PVP/RMP), initiated by the International Conference on Harmonization (ICH), addressed an important conceptual change from monitoring the safety of individual medicine to proactively conducting risk prevention for the minimization of medication error. However, the implementation of PVP/RMP is a challenge in societies like Taiwan where irrational medication and co-medication is prevalent. It is even more difficult in Taiwan where two regulatory bodies are governing pharmaceutical affairs, namely Taiwan Food and Drug Administration (TFDA) in charge of Western Medicine (WM) and the Department of Chinese Medicine and Pharmacy (DCMP) in charge of Traditional Chinese Medicine (TCM). There are thus dual-tract drug approval panels, two GMP controls and two independent adverse drug event reporting systems. This rendered irrational co-medication of WM and TCM undetectable and the standard tools for monitoring pharmacovigilance inapplicable. The bilateral regulatory system is conceptually unscientific in accordance with PVP/RMP and unethical from humanity point of view. The first part of this review delivers (1) social aspects of polypharmacy in Taiwan; (2) regulatory aspects of pharmaceutical administration; (3) risks undermined in the bilateral regulatory system and (4) pharmacoepidemiology in relation to the risk of polypharmacy. As evidence-based medicine (EBM) forms the fundamental risk-benefit assessment on medication, the second part of this review delivers (1) the scientific aspects of the beauty and the odds of biological system that governs host-xenobiotics interaction; (2) conceptual evolution from product management (pharmacovigilance) to risk management (PVP/RMP); (3) non-biased due process is essential for risk-benefit assessment on medicinal products and (4) the opinion of the authors on system building for safe medication. Copyright © 2018. Published by Elsevier B.V.

  6. B7-H4-Ig treatment of normal mice changes lymphocyte homeostasis and increases the potential of regulatory T cells

    DEFF Research Database (Denmark)

    Kristensen, Nanna N; Schmidt, Esben G W; Rasmussen, Susanne

    2013-01-01

    Enteroantigens (eAgs) drive tolerogenic and inflammatory immune responses in the gut and are of importance for sustained immune homeostasis in colonic mucosa. Decline of regulatory activity in the gut mucosa might result in chronic colitis. B7-H4 is a co-inhibitory receptor expressed by professio......Enteroantigens (eAgs) drive tolerogenic and inflammatory immune responses in the gut and are of importance for sustained immune homeostasis in colonic mucosa. Decline of regulatory activity in the gut mucosa might result in chronic colitis. B7-H4 is a co-inhibitory receptor expressed...... of severe combined immune-deficient (SCID) mice undergoing T cell transfer colitis did not influence the course of disease probably reflecting the lack of Tregs in this model of chronic colitis. In conclusion, we show that treatment with B7-H4-Ig in vivo changes lymphocyte homeostasis and increases...

  7. 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.

  8. Preliminary Development of Regulatory PSA Models for SFR

    International Nuclear Information System (INIS)

    Choi, Yong Won; Shin, Andong; Bae, Moohoon; Suh, Namduk; Lee, Yong Suk

    2013-01-01

    Well developed PRA methodology exists for LWR (Light Water Reactor) and PHWR (Pressurized Heavy Water Reactor). Since KAERI is developing a prototype SFR targeting to apply for a license by 2017, KINS needs to have a PRA models to assess the safety of this prototype reactor. The purpose of this study is to develop the regulatory PSA models for the independent verification of the SFR safety. Since the design of the prototype SFR is not mature yet, we have tried to develop the preliminary models based on the design data of KAERI's previous SFR design. In this study, the preliminary initiating events of level 1 internal event for SFR were selected through reviews of existing PRA (LWR, PRISM, ASTRID and KALIMER-600) models. Then, the event tree for each selected initiating event was developed. The regulatory PRA models of SFR developed are preliminary in a sense, because the prototype SFR design is not mature and provided yet. Still it might be utilized for the forthcoming licensing review in assessing the risk of safety issues and the configuration control of the design

  9. 78 FR 61424 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of...

    Science.gov (United States)

    2013-10-03

    ... decommission the DTCC Trade Risk Pro service as more fully described below. II. Self-Regulatory Organization's... no Members that currently use Trade Risk Pro. (C) Self-Regulatory Organization's Statement on...-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change...

  10. Initial Atomic Motion Immediately Following Femtosecond-Laser Excitation in Phase-Change Materials.

    Science.gov (United States)

    Matsubara, E; Okada, S; Ichitsubo, T; Kawaguchi, T; Hirata, A; Guan, P F; Tokuda, K; Tanimura, K; Matsunaga, T; Chen, M W; Yamada, N

    2016-09-23

    Despite the fact that phase-change materials are widely used for data storage, no consensus exists on the unique mechanism of their ultrafast phase change and its accompanied large and rapid optical change. By using the pump-probe observation method combining a femtosecond optical laser and an x-ray free-electron laser, we substantiate experimentally that, in both GeTe and Ge_{2}Sb_{2}Te_{5} crystals, rattling motion of mainly Ge atoms takes place with keeping the off-center position just after femtosecond-optical-laser irradiation, which eventually leads to a higher symmetry or disordered state. This very initial rattling motion in the undistorted lattice can be related to instantaneous optical change due to the loss of resonant bonding that characterizes GeTe-based phase change materials. Based on the amorphous structure derived by first-principles molecular dynamics simulation, we infer a plausible ultrafast amorphization mechanism via nonmelting.

  11. Initiation of TNF Inhibitor Therapy and Change in Physiologic Measures in Psoriasis

    Science.gov (United States)

    Wu, Jashin J.; Liu, Liyan; Asgari, Maryam M.; Curtis, Jeffrey R.; Harrold, Leslie; Salman, Craig; Herrinton, Lisa J.

    2014-01-01

    Background Psoriasis may predispose to cardiovascular disease and diabetes. However, the role of TNF inhibitor in mediating this risk is controversial. Objective To assess this relationship, we estimated change in metabolic physiologic measures before and after initiation of TNF inhibitor therapy compared with methotrexate therapy among psoriasis patients. Methods We conducted a retrospective cohort study, 2007–2012, using computerized clinical data for 1,274 new users of TNF inhibitor and 979 new users of methotrexate therapy to compare change in blood pressure, lipids, triglycerides, fasting plasma glucose, and body mass index before and after start of TNF inhibitors or methotrexate. The study was restricted to new users. We computed within-person change in each measure, so that each patient served as their own control. In addition, we compared TNF inhibitor patients to methotrexate patients, by computing the adjusted difference in their group means. In secondary analyses, we examined phototherapy as a comparator. Results Among starters of TNF inhibitor and MTX therapy, within-person change in physiologic measures at 6 months did not differ significantly. We observed no important or significant changes in any of the physiologic measures with initiation of TNF inhibitor compared with methotrexate. The same results were found in subgroup analyses focused on men, and on those with hypertension, diabetes mellitus, or obesity. The same results were observed with phototherapy, except that diastolic blood pressure declined by 0.6 mm Hg within-person during the 6 months after starting phototherapy (p<0.05). Conclusions The study provides no evidence for improvement of physiologic measures associated with the metabolic syndrome resulting from TNF inhibitor use for psoriasis. PMID:24708441

  12. 75 FR 4894 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and...

    Science.gov (United States)

    2010-01-29

    ... processing accounts will be revised from a tiered structure to a flat monthly charge per account. A change...-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and Immediate...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The purpose of the...

  13. 77 FR 74722 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-12-17

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68401; File No. SR-CME-2012-42] Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Order Approving Proposed Rule Change Regarding the Valuation of... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  14. 77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Science.gov (United States)

    2012-07-09

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-67333; File No. SR-OCC-2012-07] Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Relating to Adjustment... to approve a proposed rule change of a self-regulatory organization if it finds that such proposed...

  15. Foreign capital, forest change and regulatory compliance in Congo Basin forests

    International Nuclear Information System (INIS)

    Brandt, Jodi S; Nolte, Christoph; Agrawal, Arun; Steinberg, Jessica

    2014-01-01

    Tropical forest change is driven by demand in distant markets. Equally, investments in tropical forest landscapes by capital originating from distant emerging economies are on the rise. Understanding how forest outcomes vary by investment source is therefore becoming increasingly important. We empirically evaluate the relationship between investment source and deforestation from 2000 to 2010 in the Republic of Congo. A Congolese forestry code was implemented in 2000 to mitigate degradation of production forests by standardizing all logging in the country according to sustainable forest management (SFM) guidelines. Following the implementation of this law, the majority (73%) of Congo’s production forests were managed by European (40%) and Asian (33%) companies. European concessions had the highest rates of total and core deforestation, followed by Asian concessions, indicating that the fragmentation of intact forests in Congo is strongly associated with industrial logging fueled by foreign capital. European concession holders were also far more likely to comply with SFM policies, followed by Asian concessions, suggesting that compliance with Sustainable Forest Management policies may not mitigate degradation in tropical production forests. Further evaluation of the relationship between investment source, regulatory compliance, and outcomes in tropical countries is essential for effective conservation of tropical forest ecosystems. (paper)

  16. Foreign capital, forest change and regulatory compliance in Congo Basin forests

    Science.gov (United States)

    Brandt, Jodi S.; Nolte, Christoph; Steinberg, Jessica; Agrawal, Arun

    2014-04-01

    Tropical forest change is driven by demand in distant markets. Equally, investments in tropical forest landscapes by capital originating from distant emerging economies are on the rise. Understanding how forest outcomes vary by investment source is therefore becoming increasingly important. We empirically evaluate the relationship between investment source and deforestation from 2000 to 2010 in the Republic of Congo. A Congolese forestry code was implemented in 2000 to mitigate degradation of production forests by standardizing all logging in the country according to sustainable forest management (SFM) guidelines. Following the implementation of this law, the majority (73%) of Congo’s production forests were managed by European (40%) and Asian (33%) companies. European concessions had the highest rates of total and core deforestation, followed by Asian concessions, indicating that the fragmentation of intact forests in Congo is strongly associated with industrial logging fueled by foreign capital. European concession holders were also far more likely to comply with SFM policies, followed by Asian concessions, suggesting that compliance with Sustainable Forest Management policies may not mitigate degradation in tropical production forests. Further evaluation of the relationship between investment source, regulatory compliance, and outcomes in tropical countries is essential for effective conservation of tropical forest ecosystems.

  17. Canada's regulatory framework: The Canadian Nuclear Safety Commission's regulatory framework

    International Nuclear Information System (INIS)

    Howard, D.

    2011-01-01

    non-proliferation of nuclear weapons and nuclear explosive devices; dissemination of scientific, technical and regulatory information concerning the activities of CNSC, and the effects on the environment, on the health and safety of persons, of the development, production, possession, transport and use of nuclear substances. The prime responsibility for safety including the management of low- and intermediate-level radioactive waste rests with the licensee in possession of the nuclear material. While neither the NSCA nor its associated regulations define radioactive waste, Regulatory Policy P-290, Managing Radioactive Waste, asserts that radioactive waste is any liquid, gaseous or solid material that contains a nuclear substance, as defined in section 2 of the NSCA and for which the owner of the material foresees no further use and the owner had declared as waste. By definition, a radioactive waste may contain non-radioactive constituents. Radioactive waste is therefore regulated in the same manner as all other materials that contain a nuclear substance. The generation of radioactive waste cannot be prevented entirely but it should be kept to the minimum practicable as an essential objective of radioactive waste management. This objective is in line with CNSC Regulatory Policy P-290. Waste minimization relates to both volume and activity and to both the waste generated by an initial undertaking and the secondary waste resulting from the management of radioactive waste. The chemical characteristics of the waste should also be controlled at source in order to facilitate subsequent processing. As part of the CNSC's effort to improve and modernize its Regulatory Framework, the CNSC is considering several upgrades to the Framework. The CNSC as part of its licensing framework introduced Safety and Control Areas. One of the Safety and Control Areas is waste management. To address the SCA of waste management, the CNSC will be implementing a requirement that each licensee

  18. CoryneRegNet 4.0 – A reference database for corynebacterial gene regulatory networks

    Directory of Open Access Journals (Sweden)

    Baumbach Jan

    2007-11-01

    Full Text Available Abstract Background Detailed information on DNA-binding transcription factors (the key players in the regulation of gene expression and on transcriptional regulatory interactions of microorganisms deduced from literature-derived knowledge, computer predictions and global DNA microarray hybridization experiments, has opened the way for the genome-wide analysis of transcriptional regulatory networks. The large-scale reconstruction of these networks allows the in silico analysis of cell behavior in response to changing environmental conditions. We previously published CoryneRegNet, an ontology-based data warehouse of corynebacterial transcription factors and regulatory networks. Initially, it was designed to provide methods for the analysis and visualization of the gene regulatory network of Corynebacterium glutamicum. Results Now we introduce CoryneRegNet release 4.0, which integrates data on the gene regulatory networks of 4 corynebacteria, 2 mycobacteria and the model organism Escherichia coli K12. As the previous versions, CoryneRegNet provides a web-based user interface to access the database content, to allow various queries, and to support the reconstruction, analysis and visualization of regulatory networks at different hierarchical levels. In this article, we present the further improved database content of CoryneRegNet along with novel analysis features. The network visualization feature GraphVis now allows the inter-species comparisons of reconstructed gene regulatory networks and the projection of gene expression levels onto that networks. Therefore, we added stimulon data directly into the database, but also provide Web Service access to the DNA microarray analysis platform EMMA. Additionally, CoryneRegNet now provides a SOAP based Web Service server, which can easily be consumed by other bioinformatics software systems. Stimulons (imported from the database, or uploaded by the user can be analyzed in the context of known

  19. Chronic stress and peripheral pain: Evidence for distinct, region-specific changes in visceral and somatosensory pain regulatory pathways.

    Science.gov (United States)

    Zheng, Gen; Hong, Shuangsong; Hayes, John M; Wiley, John W

    2015-11-01

    Chronic stress alters the hypothalamic-pituitary-adrenal (HPA) axis and enhances visceral and somatosensory pain perception. It is unresolved whether chronic stress has distinct effects on visceral and somatosensory pain regulatory pathways. Previous studies reported that stress-induced visceral hyperalgesia is associated with reciprocal alterations of endovanilloid and endocannabinoid pain pathways in DRG neurons innervating the pelvic viscera. In this study, we compared somatosensory and visceral hyperalgesia with respect to differential responses of peripheral pain regulatory pathways in a rat model of chronic, intermittent stress. We found that chronic stress induced reciprocal changes in the endocannabinoid 2-AG (increased) and endocannabinoid degradation enzymes COX-2 and FAAH (decreased), associated with down-regulation of CB1 and up-regulation of TRPV1 receptors in L6-S2 DRG but not L4-L5 DRG neurons. In contrast, sodium channels Nav1.7 and Nav1.8 were up-regulated in L4-L5 but not L6-S2 DRGs in stressed rats, which was reproduced in control DRGs treated with corticosterone in vitro. The reciprocal changes of CB1, TRPV1 and sodium channels were cell-specific and observed in the sub-population of nociceptive neurons. Behavioral assessment showed that visceral hyperalgesia persisted, whereas somatosensory hyperalgesia and enhanced expression of Nav1.7 and Nav1.8 sodium channels in L4-L5 DRGs normalized 3 days after completion of the stress phase. These data indicate that chronic stress induces visceral and somatosensory hyperalgesia that involves differential changes in endovanilloid and endocannabinoid pathways, and sodium channels in DRGs innervating the pelvic viscera and lower extremities. These results suggest that chronic stress-induced visceral and lower extremity somatosensory hyperalgesia can be treated selectively at different levels of the spinal cord. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Transcriptome profiling reveals regulatory mechanisms underlying Corolla Senescence in Petunia

    Science.gov (United States)

    Genetic regulatory mechanisms that govern petal natural senescence in petunia is complicated and unclear. To identify key genes and pathways that regulate the process, we initiated a transcriptome analysis in petunia petals at four developmental time points, including petal opening without anthesis ...

  1. Debris flow-induced topographic changes: effects of recurrent debris flow initiation.

    Science.gov (United States)

    Chen, Chien-Yuan; Wang, Qun

    2017-08-12

    Chushui Creek in Shengmu Village, Nantou County, Taiwan, was analyzed for recurrent debris flow using numerical modeling and geographic information system (GIS) spatial analysis. The two-dimensional water flood and mudflow simulation program FLO-2D were used to simulate debris flow induced by rainfall during typhoon Herb in 1996 and Mindulle in 2004. Changes in topographic characteristics after the debris flows were simulated for the initiation of hydrological characteristics, magnitude, and affected area. Changes in topographic characteristics included those in elevation, slope, aspect, stream power index (SPI), topographic wetness index (TWI), and hypsometric curve integral (HI), all of which were analyzed using GIS spatial analysis. The results show that the SPI and peak discharge in the basin increased after a recurrence of debris flow. The TWI was higher in 2003 than in 2004 and indicated higher potential of landslide initiation when the slope of the basin was steeper. The HI revealed that the basin was in its mature stage and was shifting toward the old stage. Numerical simulation demonstrated that the parameters' mean depth, maximum depth, affected area, mean flow rate, maximum flow rate, and peak flow discharge were increased after recurrent debris flow, and peak discharge occurred quickly.

  2. Strengthening Regulatory Effectiveness in India – Lessons Learnt from Fukushima Accident

    International Nuclear Information System (INIS)

    Solanki, R.

    2016-01-01

    Following the Fukushima Daiichi accident in Japan, one of the most important lessons learnt, among other things, was the issue of strengthening the effectiveness of the regulatory bodies. Immediately after the Fukushima accident, National level safety audits were conducted on all operating NPPs in India to review safety of NPPs in India. A national action plan has been prepared to implement the identified short term, midterm and long term measures. The assessment indicates that national response to the Fukushima Accident for safety assessment of NPPs and subsequent actions and initiatives taken for safety enhancement of the NPPs in India are in-line with the objectives of the IAEA Action plan. This paper highlights the actions taken by India in the light of Fukushima Daiichi accident in order to strengthen the regulatory effectiveness through improvements in the existing core processes, challenges faced, Insights gained from the recent initiatives on safety performance indicators and assessment of safety culture, relevant observations of IRRS mission report and Indian perspectives on the further cooperation among the member states for enhancing the regulatory effectiveness for nuclear oversight of regulated organizations. (author)

  3. Integrated Initiating Event Performance Indicators

    International Nuclear Information System (INIS)

    S. A. Eide; Dale M. Rasmuson; Corwin L. Atwood

    2005-01-01

    The U.S. Nuclear Regulatory Commission Industry Trends Program (ITP) collects and analyses industry-wide data, assesses the safety significance of results, and communicates results to Congress and other stakeholders. This paper outlines potential enhancements in the ITP to comprehensively cover the Initiating Events Cornerstone of Safety. Future work will address other cornerstones of safety. The proposed Tier 1 activity involves collecting data on ten categories of risk-significant initiating events, trending the results, and comparing early performance with prediction limits (allowable numbers of events, above which NRC action may occur). Tier 1 results would be used to monitor industry performance at the level of individual categories of initiating events. The proposed Tier 2 activity involves integrating the information for individual categories of initiating events into a single risk-based indicator, termed the Baseline Risk Index for Initiating Events or BRIIE. The BRIIE would be evaluated yearly and compared against a threshold. BRIIE results would be reported to Congress on a yearly basis

  4. 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...

  5. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

    Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

    1977-09-01

    This study develops hypothesis about the relation between the structure and drafting of safeguards regulatory documents and the ability of document users to understand and implement them in a way that reflects the intent and requirements of the NRC. Four decisions are needed to improve communication: (1) Should improvement of safeguards regulatory documents as communication instruments be an explicit NRC program. (2) What specific methods of communication should be the focus of improvement efforts. (3) What actions to improve communications are feasible and desirable. (4) How should the NRC divide its available effort and resources among desirable actions in order to provide the most effective communication through regulatory documents. This volume contains: introduction, conceptual bases, legal requirements, targets, choice of documents, preparation of documents, readability, and further study of recommended changes in structure and drafting

  6. Accurately measuring sea level change from space: an ESA Climate Change Initiative for MSL closure budget studies

    DEFF Research Database (Denmark)

    Legeais, Jean-Francois; Cazenave, Anny; Larnicol, Gille

    Sea level is a very sensitive index of climate change and variability. Sea level integrates the ocean warming, mountain glaciers and ice sheet melting. Understanding the sea level variability and changes implies an accurate monitoring of the sea level variable at climate scales, in addition...... to understanding the ocean variability and the exchanges between ocean, land, cryosphere, and atmosphere. That is why Sea Level is one of the Essential Climate Variables (ECV) selected in the frame of the ESA Climate Change Initiative (CCI) program. It aims at providing long-term monitoring of the sea level ECV...... validation, performed by several groups of the ocean and climate modeling community. At last, the main improvements derived from the algorithms development dedicated to the 2016 full reprocessing of the dataset are described. Efforts have also focused on the improvement of the sea level estimation...

  7. The role of women in nuclear - attracting public participation in regulatory decision-making process

    Science.gov (United States)

    Mohamad Jais, Azlina; Hassan, Najwa

    2018-01-01

    Public participation is vital in demonstrating transparency and enhancing effectiveness of a nuclear regulatory process. As such, it is necessary for nuclear practitioners to involve the public in key nuclear delivery milestones. This paper specifically discusses challenges faced in attracting public participation throughout the nuclear regulatory decision-making process, and highlights the roles of women in nuclear (WiN) in initiating the said public discourse.

  8. Governing climate change transnationally: assessing the evidence from a database of sixty initiatives

    NARCIS (Netherlands)

    Bulkeley, H.; Andanova, L.; Bäckstrand, K.; Betsill, M.; Compagnon, D.; Duffy, R.; Kolk, A.; Hoffmann, M.; Levy, D.; Newell, P.; Milledge, T.; Paterson, M.; Pattberg, P.; VanDeveer, S.

    2012-01-01

    With this paper we present an analysis of sixty transnational governance initiatives and assess the implications for our understanding of the roles of public and private actors, the legitimacy of governance ‘beyond’ the state, and the North-South dimensions of governing climate change. In the first

  9. Governing Climate Change Transnationally: Assessing the Evidence from a Survey of Sixty Initiatives

    NARCIS (Netherlands)

    Bulkeley, H.; Andonova, L.; Backstrand, K.; Betsill, M.; Compagnon, D.; Duffy, R.; Levy, D.; Hofmann, M.; Kolk, A.; Paterson, M.; Pattberg, P.H.; VanDeveer, S.

    2012-01-01

    With this paper we present an analysis of sixty transnational governance initiatives and assess the implications for our understanding of the roles of public and private actors, the legitimacy of governance 'beyond' the state, and the North-South dimensions of governing climate change. In the first

  10. 78 FR 48732 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Changes to...

    Science.gov (United States)

    2013-08-09

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

  11. X-ray diffraction study of microstructural changes during fatigue damage initiation in steel pipes

    Energy Technology Data Exchange (ETDEWEB)

    Pinheiro, B., E-mail: bianca@lts.coppe.ufrj.br [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University of Lille 1, Boulevard Paul Langevin, Cite Scientifique, 59655 Villeneuve d' Ascq (France); Lesage, J. [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University of Lille 1, Boulevard Paul Langevin, Cite Scientifique, 59655 Villeneuve d' Ascq (France); Pasqualino, I. [Subsea Technology Laboratory (LTS), Ocean Engineering Department, COPPE/Federal University of Rio de Janeiro, PO Box 68508, Cidade Universitaria, CEP 21945-970, Rio de Janeiro/RJ (Brazil); Benseddiq, N. [Laboratory of Mechanics of Lille (LML), UMR CNRS 8107, University of Lille 1, Boulevard Paul Langevin, Cite Scientifique, 59655 Villeneuve d' Ascq (France); Bemporad, E. [Interdepartmental Laboratory of Electron Microscopy (LIME), University of Rome TRE, Via Della Vasca Navale 79, 00146 Rome (Italy)

    2012-01-15

    Highlights: Black-Right-Pointing-Pointer In this work we study the fatigue damage evolution in an API 5L X60 steel. Black-Right-Pointing-Pointer Microstructural changes and residual stresses are evaluated during fatigue tests. Black-Right-Pointing-Pointer Microdeformations and macro residual stresses are estimated by X-ray diffraction. Black-Right-Pointing-Pointer Results are discussed in view of an indicator of fatigue damage initiation. Black-Right-Pointing-Pointer This indicator could allow the prediction of residual life before macrocracking. - Abstract: Steel pipes used in the oil and gas industry undergo the action of cyclic loads that can cause their failure by fatigue. A consistent evaluation of the fatigue damage during the initiation phase should fundamentally be based on a nanoscale approach, i.e., at the scale of the dislocation network, in order to take into account the micromechanisms of fatigue damage that precede macrocrack initiation and propagation until the final fracture. In this work, microstructural changes related to fatigue damage initiation are investigated in the API 5L X60 grade steel, used in pipe manufacturing. Microdeformations and macro residual stress are evaluated using X-ray diffraction in real time during alternating bending fatigue tests performed on samples cut off from an X60 steel pipe. The aim of this ongoing work is to provide ground for further development of an indicator of fatigue damage initiation in X60 steel. This damage indicator could allow a good residual life prediction of steel pipes previously submitted to fatigue loading, before macroscopic cracking, and help to increase the reliability of these structures.

  12. Advancing towards commonsense regulation of mixed waste: Regulatory update

    International Nuclear Information System (INIS)

    Porter, C.L.

    1996-01-01

    The author previously presented the basis for regulating mixed waste according to the primary hazard (either chemical or radiological) in order to avoid the inefficient practice of open-quotes dual regulationclose quotes of mixed waste. In addition to covering the technical basis, recommendations were made on how to capitalize upon a window of opportunity for implementation of a open-quotes primary hazards approachclose quotes. Some of those recommendations have been pursued and the resulting advances on the regulatory front are exciting. This paper chronicles those pursuits, presents in capsule form the massive amount of data assembled, and summarizes the changing regulatory framework. The data supports the premise that disposal of stabilized mixed waste in a low-level radioactive waste (LLW) disposal facility is protective of human health and the environment. Based on that premise, proposed regulatory changes, if finalized, will eliminate much of the open-quotes dual regulationclose quotes of mixed waste

  13. Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

    International Nuclear Information System (INIS)

    Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

    1989-10-01

    This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

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

    International Nuclear Information System (INIS)

    2002-01-01

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

  15. U.S. Department of Energy & Nuclear Regulatory Commission Advanced Fuel Cycle Research & Development Seminar Series FY 2007 & 2008

    Energy Technology Data Exchange (ETDEWEB)

    Grandy, Christopher [Argonne National Lab. (ANL), Argonne, IL (United States)

    2008-08-01

    In fiscal year 2007, the Advanced Burner Reactor project initiated an educational seminar series for the Department of Energy (DOE) and Nuclear Regulatory Commission (NRC) personnel on various aspects of fast reactor fuel cycle closure technologies. This important work was initiated to inform DOE and NRC personnel on initial details of sodium-cooled fast reactor, separations, waste form, and safeguard technologies being considered for the Advanced Fuel Cycle Research and Development program, and to learn the important lesson from the licensing process for the Clinch River Breeder Reactor Plant that educating the NRC staff early in the regulatory process is very important and critical to a project success.

  16. Harmonisation within atmospheric dispersion modelling for regulatory purposes. Proceedings. Vol. 2

    International Nuclear Information System (INIS)

    Suppan, P.

    2004-01-01

    Dispersion modelling has proved to be a very effective tool to assess the environmental impact of human activities on air quality already at the early planning stage. Environmental assessments during planning are required by the EU directive 85/337/EEC. Only models can give detailed information on the distribution of pollutants with high spatial and temporal resolution, while they allow the decision-maker to devise a range of scenarios, in which the various processes determining the environmental impact can be easily simulated and changed. In June 1991, the Joint Research Centre of the European Commission started an initiative on the sharing of information and possible harmonisation of new approaches to atmospheric dispersion modelling and model evaluation. This initiative has fostered a series of conferences that have been concerned with improvement of ''modelling culture'' in Europe. The 9 th International Conference on Harmonisation within atmospheric dispersion modelling for regulatory purposes in Garmisch-Partenkirchen, in Germany/ Bavaria, 1-4 June, 2004, will continue the efforts of the previous conferences. The conference has a role as a forum where users and decision-makers can bring their requirements to the attention of scientists. It is also a natural forum for discussing environmental issues related to the European union enlargement process. The scope of this conference is covered by the following topics: Validation and inter-comparison of models: Model evaluation methodology, experiences with implementation of EU directives; regulatory modelling, short distance dispersion modelling, urban scale and street canyon modelling: Meteorology and air quality, mesoscale meteorology and air quality modelling, environmental impact assessment: Air pollution management and decision support systems. (orig.)

  17. 75 FR 30081 - Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-05-28

    ...-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to the Risk Management Interface May 24, 2010. Pursuant to Section 19(b)(1) of the...-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The Exchange...

  18. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. 42 CFR 476.94 - Notice of QIO initial denial determination and changes as a result of a DRG validation.

    Science.gov (United States)

    2010-10-01

    ... changes as a result of a DRG validation. 476.94 Section 476.94 Public Health CENTERS FOR MEDICARE... changes as a result of a DRG validation. (a) Notice of initial denial determination—(1) Parties to be... retrospective review, (excluding DRG validation and post procedure review), within 3 working days of the initial...

  20. FORECAST: Regulatory effects cost analysis software annual

    International Nuclear Information System (INIS)

    Lopez, B.; Sciacca, F.W.

    1991-11-01

    Over the past several years the NRC has developed a generic cost methodology for the quantification of cost/economic impacts associated with a wide range of new or revised regulatory requirements. This methodology has been developed to aid the NRC in preparing Regulatory Impact Analyses (RIAs). These generic costing methods can be useful in quantifying impacts both to industry and to the NRC. The FORECAST program was developed to facilitate the use of the generic costing methodology. This PC program integrates the major cost considerations that may be required because of a regulatory change. FORECAST automates much of the calculations typically needed in an RIA and thus reduces the time and labor required to perform these analysis. More importantly, its integrated and consistent treatment of the different cost elements should help assure comprehensiveness, uniformity, and accuracy in the preparation of needed cost estimates

  1. Exploring Opportunities for Promoting Synergies between Climate Change Adaptation and Mitigation in Forest Carbon Initiatives

    Directory of Open Access Journals (Sweden)

    Eugene L. Chia

    2016-01-01

    Full Text Available There is growing interest in designing and implementing climate change mitigation and adaptation (M + A in synergy in the forest and land use sectors. However, there is limited knowledge on how the planning and promotion of synergies between M + A can be operationalized in the current efforts to mitigate climate change through forest carbon. This paper contributes to fill this knowledge gap by exploring ways of planning and promoting M + A synergy outcomes in forest carbon initiatives. It examines eight guidelines that are widely used in designing and implementing forest carbon initiatives. Four guiding principles with a number of criteria that are relevant for planning synergy outcomes in forest carbon activities are proposed. The guidelines for developing forest carbon initiatives need to demonstrate that (1 the health of forest ecosystems is maintained or enhanced; (2 the adaptive capacity of forest-dependent communities is ensured; (3 carbon and adaptation benefits are monitored and verified; and (4 adaptation outcomes are anticipated and planned in forest carbon initiatives. The forest carbon project development guidelines can encourage the integration of adaptation in forest carbon initiatives. However, their current efforts guiding projects and programs to deliver biodiversity and environmental benefits, ecosystem services, and socioeconomic benefits are not considered explicitly as efforts towards enhancing adaptation. An approach for incentivizing and motivating project developers, guideline setters, and offset buyers is imperative in order to enable existing guidelines to make clear contributions to adaptation goals. We highlight and discuss potential ways of incentivizing and motivating the explicit planning and promotion of adaptation outcomes in forest carbon initiatives.

  2. 77 FR 39781 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing of Proposed Rule Change To...

    Science.gov (United States)

    2012-07-05

    ... would be for an IPO. \\3\\ 15 U.S.C. 77a. Significant regulatory concerns, including accounting fraud... accounting fraud or subject to other concealed and undisclosed legal or regulatory problems. For purposes of...

  3. Northern Eurasia Future Initiative: Facing the Challenges of Global Change in the 21st century

    Science.gov (United States)

    Groisman, Pavel; Gutman, Garik; Gulev, Sergey; Maksyutov, Shamil; Qi, Jiaguo

    2016-04-01

    During the past 12 years, the Northern Eurasia Earth Science Partnership Initiative (NEESPI) - an interdisciplinary program of internationally-supported Earth systems and science research - has addressed large-scale and long-term manifestations of climate and environmental changes over Northern Eurasia and their impact on the Global Earth system. With more than 1500 peer-reviewed journal publications and 40 books to its credit, NEESPI's activities resulted in significant scientific outreach. This created a new research realm through self-organization of NEESPI scientists in a broad research network, accumulation of knowledge while developing new tools (observations, models, and collaborative networks) and producing new, exciting results that can be applied to directly support decision-making for societal needs. This realm was summed up at the Synthesis NEESPI Workshop in Prague, Czech Republic (April 9-12, 2015) where it was decided to shift gradually the foci of regional studies in Northern Eurasia towards applications with the following major Science Question: " What dynamic and interactive change(s) will affect societal well-being, activities, and health, and what might be the mitigation and adaptation strategies that could support sustainable development and decision-making activities in Northern Eurasia?". To answer this question requires a stronger socio-economic component in the ongoing and future regional studies focused on sustainable societal development under changing climatic and environmental conditions, especially, under conditions when societal decision-making impacts and feeds back on the environment. This made the NEESPI studies closer to the ICSU research initiative "Future Earth". Accordingly, the NEESPI Research Team decided to reorganize in the nearest future NEESPI into "Northern Eurasia Future Initiative" (NEFI) and began development of its Programmatic White Paper (in preparation at the time of this abstract submission). The NEFI research

  4. Steam Generator tube integrity -- US Nuclear Regulatory Commission perspective

    International Nuclear Information System (INIS)

    Murphy, E.L.; Sullivan, E.J.

    1997-01-01

    In the US, the current regulatory framework was developed in the 1970s when general wall thinning was the dominant degradation mechanism; and, as a result of changes in the forms of degradation being observed and improvements in inspection and tube repair technology, the regulatory framework needs to be updated. Operating experience indicates that the current U.S. requirements should be more stringent in some areas, while in other areas they are overly conservative. To date, this situation has been dealt with on a plant-specific basis in the US. However, the NRC staff is now developing a proposed steam generator rule as a generic framework for ensuring that the steam generator tubes are capable of performing their intended safety functions. This paper discusses the current U.S. regulatory framework for assuring steam generator (SG) tube integrity, the need to update this regulatory framework, the objectives of the new proposed rule, the US Nuclear Regulatory Commission (NRC) regulatory guide (RG) that will accompany the rule, how risk considerations affect the development of the new rule, and some outstanding issues relating to the rule that the NRC is still dealing with

  5. 50-Ma Initiation of Hawaiian-Emperor Bend Records Major Change in Pacific Plate Motion

    Science.gov (United States)

    Sharp, Warren D.; Clague, David A.

    2006-09-01

    The Hawaiian-Emperor bend has played a prominent yet controversial role in deciphering past Pacific plate motions and the tempo of plate motion change. New ages for volcanoes of the central and southern Emperor chain define large changes in volcanic migration rate with little associated change in the chain's trend, which suggests that the bend did not form by slowing of the Hawaiian hot spot. Initiation of the bend near Kimmei seamount about 50 million years ago (MA) was coincident with realignment of Pacific spreading centers and early magmatism in western Pacific arcs, consistent with formation of the bend by changed Pacific plate motion.

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

    International Nuclear Information System (INIS)

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

    2008-01-01

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

  7. RAF/9/049: Enhancing and Sustaining the National Regulatory Bodies for safety

    International Nuclear Information System (INIS)

    Keter, C.J.

    2017-01-01

    The main objective of this project is to enhance regulatory infrastructure, sustainability and cooperation among national regulatory bodies. This will support strengthening of the existing regulatory framework and capacity building in the region. Self-Assessment using the Self-Assessment Regulatory Infrastructure for Safety (SARIS) was completed on 26th May 2016. Changes made to the legislation is ongoing. The Nuclear Regulatory Bill 2017 is at an advanced stage and about to be tabled to Cabinet. The project objectives shall be addressed under a new project, RAF/9/058 – Improving the Regulatory Framework for the Control of Radiation Sources in Member States. Two major tasks for Kenya to focus include Review of regulations on waste safety, radiation sources and on safety of NPP and advising on drafting of radiation safety guides

  8. Energy in the Environment - Initiatives 2004-08

    Energy Technology Data Exchange (ETDEWEB)

    Paul Jehn

    2009-09-11

    Under the Energy and Environment Initiative, the GWPC/GWPRF will expand the oil and gas electronic commerce initiatives used to enhance the Risk Based Data Management System (RBDMS) and the Cost Effective Regulatory Approach (CERA). The GWPC/GWPRF has identified the following priorities for work efforts during the time period that will act as the base from which selections for each work period will be proposed. Work tasks will be presented for each reporting period by the GWPC from areas selected from the general list of priorities.

  9. Value Assessment in the Regulatory Context.

    Science.gov (United States)

    Miller, Kathleen L; Woodcock, Janet

    2017-02-01

    Value assessments are made on new drugs before they even enter the market. Regulators at the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration make a clinical benefit-risk assessment to determine whether to approve a new drug. Benefits of a drug are typically quantified directly, as an assessment of efficacy. CDER defines risk as the intersection of the severity of possible harm and the probability of that harm. For a novel drug to be approved, its benefits and risks must be well understood, and the trade-off between the two must be acceptable. To assist with these benefit-risk value assessments, CDER has two ongoing initiatives: the Patient-Focused Drug Development Initiative that aims to substantially increase the role of patient voice in the regulatory process, and a transparency initiative that focuses on creating a structured framework for benefit-risk assessment. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  10. Protection of people and environment from radiation risk through good regulatory practice

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  11. 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

  12. Alberta Energy and Utilities Board, regulatory highlights for 1998

    International Nuclear Information System (INIS)

    1999-01-01

    This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta's energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB's position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board's efforts in the area of timely stakeholder consultation was highlighted. tabs., figs

  13. 78 FR 43947 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-07-22

    .... I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change... Basis for, the Proposed Rule Change In its filing with the Commission, the self-regulatory organization... because it will provide member organizations with greater flexibility in managing their personnel...

  14. Evolution of cichlid vision via trans-regulatory divergence

    Directory of Open Access Journals (Sweden)

    O’Quin Kelly E

    2012-12-01

    Full Text Available Abstract Background Phenotypic evolution may occur through mutations that affect either the structure or expression of protein-coding genes. Although the evolution of color vision has historically been attributed to structural mutations within the opsin genes, recent research has shown that opsin regulatory mutations can also tune photoreceptor sensitivity and color vision. Visual sensitivity in African cichlid fishes varies as a result of the differential expression of seven opsin genes. We crossed cichlid species that express different opsin gene sets and scanned their genome for expression Quantitative Trait Loci (eQTL responsible for these differences. Our results shed light on the role that different structural, cis-, and trans-regulatory mutations play in the evolution of color vision. Results We identified 11 eQTL that contribute to the divergent expression of five opsin genes. On three linkage groups, several eQTL formed regulatory “hotspots” associated with the expression of multiple opsins. Importantly, however, the majority of the eQTL we identified (8/11 or 73% occur on linkage groups located trans to the opsin genes, suggesting that cichlid color vision has evolved primarily via trans-regulatory divergence. By modeling the impact of just two of these trans-regulatory eQTL, we show that opsin regulatory mutations can alter cichlid photoreceptor sensitivity and color vision at least as much as opsin structural mutations can. Conclusions Combined with previous work, we demonstrate that the evolution of cichlid color vision results from the interplay of structural, cis-, and especially trans-regulatory loci. Although there are numerous examples of structural and cis-regulatory mutations that contribute to phenotypic evolution, our results suggest that trans-regulatory mutations could contribute to phenotypic divergence more commonly than previously expected, especially in systems like color vision, where compensatory changes in the

  15. Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

    Science.gov (United States)

    Benda, Norbert; Brandt, Andreas

    2018-01-01

    Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

  16. End of FY10 report - used fuel disposition technical bases and lessons learned : legal and regulatory framework for high-level waste disposition in the United States.

    Energy Technology Data Exchange (ETDEWEB)

    Weiner, Ruth F.; Blink, James A. (Lawrence Livermore National Laboratory, Livermore, CA); Rechard, Robert Paul; Perry, Frank (Los Alamos National Laboratory, Los Alamos, NM); Jenkins-Smith, Hank C. (University of Oklahoma, Norman, OK); Carter, Joe (Savannah River Nuclear Solutions, Aiken, SC); Nutt, Mark (Argonne National Laboratory, Argonne, IL); Cotton, Tom (Complex Systems Group, Washington DC)

    2010-09-01

    This report examines the current policy, legal, and regulatory framework pertaining to used nuclear fuel and high level waste management in the United States. The goal is to identify potential changes that if made could add flexibility and possibly improve the chances of successfully implementing technical aspects of a nuclear waste policy. Experience suggests that the regulatory framework should be established prior to initiating future repository development. Concerning specifics of the regulatory framework, reasonable expectation as the standard of proof was successfully implemented and could be retained in the future; yet, the current classification system for radioactive waste, including hazardous constituents, warrants reexamination. Whether or not consideration of multiple sites are considered simultaneously in the future, inclusion of mechanisms such as deliberate use of performance assessment to manage site characterization would be wise. Because of experience gained here and abroad, diversity of geologic media is not particularly necessary as a criterion in site selection guidelines for multiple sites. Stepwise development of the repository program that includes flexibility also warrants serious consideration. Furthermore, integration of the waste management system from storage, transportation, and disposition, should be examined and would be facilitated by integration of the legal and regulatory framework. Finally, in order to enhance acceptability of future repository development, the national policy should be cognizant of those policy and technical attributes that enhance initial acceptance, and those policy and technical attributes that maintain and broaden credibility.

  17. 77 FR 306 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing of...

    Science.gov (United States)

    2012-01-04

    ...). \\2\\ 17 CFR 240.19b-4. Self-Regulatory Organization's Statement of the Terms of Substance of the... contained in Chapter XXIVB. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change In its filing with the Commission, the self-regulatory organization...

  18. Regulatory Guide 1.79 safety injection recirculation test requirements, fact or fiction

    International Nuclear Information System (INIS)

    Roberts, J.K.

    1976-01-01

    The overwhelming concern of the general public in this day of state nuclear initiatives is the basic question, ''is nuclear power safe.'' Much of this concern has focused on the emergency core cooling systems. This public attention spotlights the testing organization's responsibility during startup of proving the operation and reliability of the emergency core cooling systems. The standard established by the Nuclear Regulatory Commission for testing emergency core cooling systems is Regulatory Guide 1.79 ''Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors''. The nuclear industry must satisfy the testing requirements of Regulatory Guide 1.79 to meet their responsibility to the public; and to prevent future embarrassment when questioned on the adequacy of emergency core cooling systems

  19. Regulatory Risk Reduction for Advanced Reactor Technologies - FY2016 Status and Work Plan Summary

    International Nuclear Information System (INIS)

    Moe, Wayne Leland

    2016-01-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy's (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  20. Synthetic fuels and the environment: an environmental and regulatory impacts analysis

    Energy Technology Data Exchange (ETDEWEB)

    None

    1980-06-01

    Since July 1979 when DOE/EV-0044 report Environmental Analysis of Synthetic Liquid fuels was published the synthetic fuels program proposals of the Administration have undergone significant modifications. The program year for which the development goal of 1.5 million barrels per day is to be reached has been changed from 1990 to 1995. The program plan is now proposed to have two stages to ensure, among other things, better environmental protection: an initial stage emphasizing applied research and development (R and D), including environmental research, followed by a second stage that would accelerate deployment of those synthetic fuel technologies then judged most ready for rapid deployment and economic operation within the environmental protection requirements. These program changes have significantly expanded the scope of technologies to be considered in this environmental analysis and have increased the likelihood that accelerated environmental R and D efforts will be successful in solving principal environmental and worker safety concerns for most technologies prior to the initiation of the second stage of the accelerated deployment plan. Information is presented under the following section headings: summary; study description; the technologies and their environmental concerns (including, coal liquefaction and gasification, oil shale production, biomass and urban waste conversion); regulatory and institutional analyses; and environmental impacts analysis (including air and water quaility analyses, impacts of carbon dioxide and acid rain, water availability, solid and hazardous wastes, coal mining environmental impacts, transportation issues, community growth and change, and regional impacts). Additional information is presented in seventeen appendixes. (JGB)

  1. Broadband ICT policies in Southern Africa: Initiatives and dynamic spectrum regulation

    CSIR Research Space (South Africa)

    Olwal, T

    2013-05-01

    Full Text Available regulatory agencies. These ICT regulatory agencies had been established with the aim of liberalizing the telecommunications sector to ensure that governments are not the direct providers of telecom services, but the regulators [1]. Moreover, due to out... goals demand liberal and dynamic spectrum regulation policies designed at a country level and more importantly across a majority of countries in the same region. This paper highlights various initiatives aimed at formulating the all...

  2. Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

    International Nuclear Information System (INIS)

    Kostova, M.; Howard, D.; Elder, P.

    2013-01-01

    The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

  3. Unique Regulatory Approach for Licensing the Port Hope Remediation Project in Canada - 13315

    Energy Technology Data Exchange (ETDEWEB)

    Kostova, M.; Howard, D.; Elder, P. [Directorate of Nuclear Cycle and Facilities Regulation, Canadian Nuclear Safety Commission, 280, Slater Street, Ottawa, Ontario K1P 5S9 (Canada)

    2013-07-01

    The Port Hope remediation project is a part of a larger initiative of the Canadian Federal Government the Port Hope Area Initiative (PHAI) which is based upon a community proposal. The Government of Canada, through Natural Resources Canada (NRCan) is investing $1.28 billion over 10 years to clean up historic low-level radioactive waste in the Port Hope Area and to provide long-term safe management of the low-level radioactive wastes in the Port Hope Area. These wastes arose from the activities of a former Federal Crown Corporation (Eldorado Nuclear) and its private sector predecessors. In Canada, historic waste are defined as low-level radioactive waste that was managed in a manner no longer considered acceptable, but for which the original producer cannot reasonably be held responsible or no longer exists and for which the Federal Government has accepted responsibility. In Canada, under the current regulatory framework, the environmental remediation is not considered as a distinct phase of the nuclear cycle. The regulatory approach for dealing with existing sites contaminated with radioactive residues is defined on the basis of risk and application of existing regulations. A unique regulatory approach was taken by the Canadian Nuclear Safety Commission (CNSC) to address the various licensing issues and to set out the requirements for licensing of the Port Hope Project within the current regulatory framework. (authors)

  4. Continuous improvement of the regulatory framework for the control of medical exposure

    International Nuclear Information System (INIS)

    Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2008-01-01

    One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

  5. Integrated systems approach identifies risk regulatory pathways and key regulators in coronary artery disease.

    Science.gov (United States)

    Zhang, Yan; Liu, Dianming; Wang, Lihong; Wang, Shuyuan; Yu, Xuexin; Dai, Enyu; Liu, Xinyi; Luo, Shanshun; Jiang, Wei

    2015-12-01

    Coronary artery disease (CAD) is the most common type of heart disease. However, the molecular mechanisms of CAD remain elusive. Regulatory pathways are known to play crucial roles in many pathogenic processes. Thus, inferring risk regulatory pathways is an important step toward elucidating the mechanisms underlying CAD. With advances in high-throughput data, we developed an integrated systems approach to identify CAD risk regulatory pathways and key regulators. Firstly, a CAD-related core subnetwork was identified from a curated transcription factor (TF) and microRNA (miRNA) regulatory network based on a random walk algorithm. Secondly, candidate risk regulatory pathways were extracted from the subnetwork by applying a breadth-first search (BFS) algorithm. Then, risk regulatory pathways were prioritized based on multiple CAD-associated data sources. Finally, we also proposed a new measure to prioritize upstream regulators. We inferred that phosphatase and tensin homolog (PTEN) may be a key regulator in the dysregulation of risk regulatory pathways. This study takes a closer step than the identification of disease subnetworks or modules. From the risk regulatory pathways, we could understand the flow of regulatory information in the initiation and progression of the disease. Our approach helps to uncover its potential etiology. We developed an integrated systems approach to identify risk regulatory pathways. We proposed a new measure to prioritize the key regulators in CAD. PTEN may be a key regulator in dysregulation of the risk regulatory pathways.

  6. Changing our regulatory structure to accommodate a competitive environment

    International Nuclear Information System (INIS)

    Roman, A. J.

    1996-01-01

    The efficiency of various regulatory schemes were assessed based on the assumption that certain aspects of transmission and distribution will have to be regulated even after deregulation comes into effect. Price regulation and incentive regulation are the two main forms used to ensure equitable availability of various transmission/wheeling services to distributors, and service quality, wheeling, and prices to be charged by distributors to customers. It was found on balance that only effective market forces spur efficiency, and regulations are only second best. Incentive regulation was not considered to be significantly more efficient than price regulation. The effectiveness of either form will depend upon market conditions and the skill of the regulator

  7. The ESA climate change initiative: Satellite data records for essential climate variables

    DEFF Research Database (Denmark)

    Hollmann, R.; Merchant, C.J.; Saunders, R.

    2013-01-01

    The European Space Agency (ESA) has launched the Climate Change Initiative (CCI) to provide satellite-based climate data records (CDRs) that meet the challenging requirements of the climate community. The aim is to realize the full potential of the long-term Earth observation (EO) archives...... that both ESA and third parties have established. This includes aspects of producing a CDR, which involve data acquisition, calibration, algorithm development, validation, maintenance, and provision of the data to the climate research community. The CCI is consistent with several international efforts...... targeting the generation of satellite derived climate data records. One focus of the CCI is to provide products for climate modelers who increasingly use satellite data to initialize, constrain, and validate models on a wide range of space and time scales....

  8. Clustering excellence to exert transformative change: the Hartford Geriatric Nursing Initiative (HGNI).

    Science.gov (United States)

    McBride, Angela Barron; Watman, Rachael; Escobedo, Marcus; Beilenson, John

    2011-01-01

    This paper describes how the John A. Hartford Foundation sought to maximize the influence of its various geriatric nursing projects by organizing and managing them collectively as the Hartford Geriatric Nursing Initiative (HGNI). This initiative aimed to develop a shared identity, encouraged cross-pollination of efforts, convened project leaders to address opportunities and problems, launched across-project collaborations, and created tools and resources to support overall efforts. This paper ends with some reflections on the processes implemented to maximize HGNI effectiveness, particularly the importance of forging a common identity in order to encourage expanded solutions. The HGNI can serve as an example of how intersecting interests can fuel new ideas, thus helping others think more strategically about change efforts in the future. Copyright © 2011 Elsevier Inc. All rights reserved.

  9. 77 FR 27529 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Granting Accelerated Approval of...

    Science.gov (United States)

    2012-05-10

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66922; File No. SR-ICC-2012-05] Self-Regulatory... Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed... of the Comptroller of the Currency, U.K. Financial Services Authority, or any other regulatory body...

  10. 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...

  11. Regulatory networks, legal federalism, and multi-level regulatory systems

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

    Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...

  12. High fat diet-induced changes of mouse hepatic transcription and enhancer activity can be reversed by subsequent weight loss

    DEFF Research Database (Denmark)

    Siersbæk, Majken; Varticovski, Lyuba; Yang, Shutong

    2017-01-01

    Abstract Epigenetic factors have been suggested to play an important role in metabolic memory by trapping and maintaining initial metabolic changes within the transcriptional regulatory machinery. In this study we fed mice a high fat diet (HFD) for seven weeks followed by additional five weeks...... for efficient treatment of early obesity-associated changes to hepatic complications by simple weight loss intervention without persistent reprograming of the liver transcriptome....

  13. Changes in healthcare-associated Staphylococcus aureus bloodstream infections after the introduction of a national hand hygiene initiative.

    Science.gov (United States)

    Barnett, Adrian G; Page, Katie; Campbell, Megan; Brain, David; Martin, Elizabeth; Rashleigh-Rolls, Rebecca; Halton, Kate; Hall, Lisa; Jimmieson, Nerina; White, Katherine; Paterson, David; Graves, Nicholas

    2014-08-01

    Interventions that prevent healthcare-associated infection should lead to fewer deaths and shorter hospital stays. Cleaning hands (with soap or alcohol) is an effective way to prevent the transmission of organisms, but rates of compliance with hand hygiene are sometimes disappointingly low. The National Hand Hygiene Initiative in Australia aimed to improve hand hygiene compliance among healthcare workers, with the goal of reducing rates of healthcare-associated infection. We examined whether the introduction of the National Hand Hygiene Initiative was associated with a change in infection rates. Monthly infection rates for healthcare-associated Staphylococcus aureus bloodstream infections were examined in 38 Australian hospitals across 6 states. We used Poisson regression and examined 12 possible patterns of change, with the best fitting pattern chosen using the Akaike information criterion. Monthly bed-days were included to control for increased hospital use over time. The National Hand Hygiene Initiative was associated with a reduction in infection rates in 4 of the 6 states studied. Two states showed an immediate reduction in rates of 17% and 28%, 2 states showed a linear decrease in rates of 8% and 11% per year, and 2 showed no change in infection rates. The intervention was associated with reduced infection rates in most states. The failure in 2 states may have been because those states already had effective initiatives before the national initiative's introduction or because infection rates were already low and could not be further reduced.

  14. ARTIST (Asian regional tobacco industry scientist team): Philip Morris' attempt to exert a scientific and regulatory agenda on Asia.

    Science.gov (United States)

    Tong, E K; Glantz, S A

    2004-12-01

    To describe how the transnational tobacco industry has collaborated with local Asian tobacco monopolies and companies to promote a scientific and regulatory agenda. Analysis of previously secret tobacco industry documents. Transnational tobacco companies began aggressively entering the Asia market in the 1980s, and the current tobacco industry in Asia is a mix of transnational and local monopolies or private companies. Tobacco industry documents demonstrate that, in 1996, Philip Morris led an organisation of scientific representatives from different tobacco companies called the Asian Regional Tobacco Industry Science Team (ARTIST), whose membership grew to include monopolies from Korea, China, Thailand, and Taiwan and a company from Indonesia. ARTIST was initially a vehicle for PM's strategies against anticipated calls for global smoke-free areas from a World Health Organization secondhand smoke study. ARTIST evolved through 2001 into a forum to present scientific and regulatory issues faced primarily by Philip Morris and other transnational tobacco companies. Philip Morris' goal for the organisation became to reach the external scientific and public health community and regulators in Asia. The Asian tobacco industry has changed from an environment of invasion by transnational tobacco companies to an environment of participation with Philip Morris' initiated activities. With this participation, tobacco control efforts in Asia face new challenges as Philip Morris promotes and integrates its scientific and regulatory agenda into the local Asian tobacco industry. As the local Asian tobacco monopolies and companies can have direct links with their governments, future implementation of effective tobacco control may be at odds with national priorities.

  15. Nuclear Regulatory Commission probabilistic risk assessment implementation program: A status report

    International Nuclear Information System (INIS)

    Rubin, M.P.; Caruso, M.A.

    1996-01-01

    The US Nuclear Regulatory Commission (NRC) is undertaking a number of activities intended to increase the consideration of risk significance in its decision processes and the effective use of risk-based technologies in its regulatory activities. Although the NRC is moving toward risk-informed regulation throughout its areas of responsibilities, this paper focuses primarily on those issues associated with reactor regulation. As the NRC completed significant milestones in its development of probabilistic risk assessment (PRA) methodology and gained considerable experience in the limited application of risk assessment to selected regulatory activities, it became evident that a much broader use of risk informed approaches offered advantages to both the NRC and the US commercial nuclear industry. This desire to enhance the use of risk assessment is driven by the clear belief that application of PRA methods will result in direct improvements in nuclear power plant operational safety from the perspective of both the regulator and the plant operator. The NRC believed that an overall policy on the use of PRA methods in nuclear regulatory activities should be established so that the many potential applications of PRA could be implemented in a consistent and predictable manner that would promote regulatory stability and efficiency. This paper describes the key activities that the NRC has undertaken to implement the initial stages of an integrated risk-informed regulatory framework

  16. Pain acceptance, psychological functioning, and self-regulatory fatigue in temporomandibular disorder.

    Science.gov (United States)

    Eisenlohr-Moul, Tory A; Burris, Jessica L; Evans, Daniel R

    2013-12-01

    A growing body of evidence suggests that chronic pain patients suffer from chronic self-regulatory fatigue: difficulty controlling thoughts, emotions, and behavior. Pain acceptance, which involves responding to pain and related experiences without attempts to control or avoid them (pain willingness), and pursuit of valued life activities regardless of pain (activity engagement) has been associated with various favorable outcomes in chronic pain patients, including better psychological functioning. The study presented here tested the hypotheses that pain acceptance is associated with less psychological distress, higher psychological well-being, and reduced self-regulatory fatigue in temporomandibular disorder (TMD) patients, particularly for those with longer pain duration. Cross-sectional data were provided by 135 TMD patients during an initial evaluation at a university-based tertiary orofacial pain clinic. Results of hierarchical linear regression models indicated that, controlling for pain severity, pain willingness is associated with less psychological distress and lower self-regulatory fatigue, and activity engagement is associated with greater psychological well-being. Furthermore, the effect of pain willingness on psychological distress was moderated by pain duration such that pain willingness was more strongly associated with less psychological distress in patients with longer pain duration; this moderating effect was fully mediated by self-regulatory fatigue. These findings suggest pain willingness may buffer against self-regulatory fatigue in those with longer pain duration, and such conservation of self-regulatory resources may protect against psychological symptoms.

  17. Changes in RANKL during the first two years after cART initiation in HIV-infected cART naïve adults

    DEFF Research Database (Denmark)

    Mathiesen, Inger Hee Mabuza; Salem, Mohammad; Gerstoft, Jan

    2017-01-01

    accelerated bone loss could be mediated by increased soluble RANKL (sRANKL) levels associated with CD4+ T cell recovery. METHODS: We used multiplex immunoassays to determine sRANKL and OPG concentrations in plasma from 48 HIV patients at baseline and 12, 24, 48 and 96 weeks after cART initiation. RESULTS......: Soluble RANKL changed significantly over time (overall p = 0.02) with 25% decrease (95% CI: -42 to -5) at week 24 compared to baseline and stabilized at a lower level thereafter. We found no correlation between CD4+ T cell count increment and changes in sRANKL or between percentage change in BMD...... and changes in sRANKL. CONCLUSION: In this study there was no indication that the accelerated bone loss after cART initiation was mediated by early changes in sRANKL due to CD4+ T cell recovery. Future studies should focus on the initial weeks after initiation of cART. TRIAL REGISTRATION: Clinical...

  18. How maya women respond to changing technology : The effect of helping behavior on initiating reproduction.

    Science.gov (United States)

    Kramer, K L; McMillan, G P

    1998-06-01

    In the mid 1970s labor-saving technology was introduced into a Maya subsistence agricultural community that markedly increased the efficiency with which maize could be ground and water collected. This increased efficiency introduces a possible savings in the time that women allocate to work, which can be reapportioned to child care, food production, domestic work, or leisure. An earlier study suggested that this labor-saving technology had a positive effect in decreasing the age at which these Maya women begin their reproductive careers. Although there is a statistical association between the age at which women bear their first child and the introduction of modern technology, this association does not demonstrate that the decline in age at first birth is causally related to the presence of technology. This paper pursues two objectives to evaluate this potential causal relationship in greater detail. First, a theory relating technological change to the initiation of a reproductive career is briefly developed in order to make qualitative predictions about behavioral changes as a response to changing technology. Second, these predictions are then tested against time allocation data recently collected in this same Maya community.We suggest that both of the conditions necessary to initiate reproduction-fecundity and access to mates-fundamentally depend on the amount of help that a girl provides to her family. Further, the help that a girl provides can be affected by technological changes. Analyses show that when modern technology is available, unmarried young women do not change the time allocated to domestic tasks and child care, and allocate more time to low-energy leisure activities. This lack of perceived benefit to working more and a potential concomitant shift towards a positive energy balance may in part explain why Maya women leave home and initiate reproduction at a younger age after labor-saving technology is introduced.

  19. Regulatory inspection of nuclear power plants in NEA member countries

    International Nuclear Information System (INIS)

    Gronow, W.S.; Ilani, O.

    1977-01-01

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

  20. 77 FR 74715 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-12-17

    .... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The... Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the... significant aspects of such statements. A. Self-Regulatory Organization's Statement of the Purpose of, and...

  1. 77 FR 34420 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-06-11

    ... statements. A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the... respect to marking Strategy Trades would be uniformly applied to members. B. Self-Regulatory Organization... the Act. C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received...

  2. Teachers’ perceptions of their own initiative: Collective initiative vs. personal initiative

    Directory of Open Access Journals (Sweden)

    Džinović Vladimir

    2013-01-01

    Full Text Available Current trends in education demand from teachers to exhibit proactive behaviour and assume responsibility for the implementation of changes in school practice. In that sense, it is important to study how teachers perceive their own initiative and to gain insight into the activities where such initiative is demonstrated. This study has been conceived as a mixed-methods research. The qualitative study implied forming four focus groups with subject teachers and class teachers (N=38, while the quantitative study entailed surveying 1441 teachers in forty primary schools in Serbia using the questionnaire constructed based on qualitative data. Data from focus groups were processed by qualitative thematic analysis, while the questionnaire data were processed by principal component analysis and univariate analysis of variance. The findings of the study have shown that teachers mostly demonstrate initiative through co­operative activities that include planning of joint teaching as well as conducting joint projects within school and with the local community actors. Teachers are least ready to demonstrate personal initiative and the initiative aimed at accomplishing considerable changes in school work. The concluding part includes the recommendations for encouraging teachers’ personal initiative and building organizational culture that would support such initiative. [Projekat Ministarstva nauke Republike Srbije, br. br. 47008: Unapređivanje kvaliteta i dostupnosti obrazovanja u procesima modernizacije Srbije i br. 179034: Od podsticanja inicijative, saradnje i stvaralaštva u obrazovanju do novih uloga i identiteta u društvu

  3. Safety culture as a matter of regulatory control and regulatory effectiveness

    International Nuclear Information System (INIS)

    Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.

    2002-01-01

    More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)

  4. 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.

  5. Health care administrators' perspectives on the role of absorptive capacity for strategic change initiatives: a qualitative study.

    Science.gov (United States)

    Kash, Bita A; Spaulding, Aaron; Gamm, Larry; Johnson, Christopher E

    2013-01-01

    The dimensions of absorptive capacity (ACAP) are defined, and the importance of ACAP is established in the management literature, but the concept has not been applied to health care organizations attempting to implement multiple strategic initiatives. The aim of this study was to test the utility of ACAP by analyzing health care administrators' experiences with multiple strategic initiatives within two health systems. Results are drawn from administrators' assessments of multiple initiatives within two health systems using in-depth personal interviews with a total of 61 health care administrators. Data analysis was performed following deductive qualitative analysis guidelines. Interview transcripts were coded based on the four dimensions of ACAP: acquiring, assimilating, internalizing/transforming, and exploiting knowledge. Furthermore, we link results related to utilization of management resources, including number of key personnel involved and time consumption, to dimensions of ACAP. Participants' description of multiple strategic change initiatives confirmed the importance of the four ACAP dimensions. ACAP can be a useful framework to assess organizational capacity with respect to the organization's ability to concurrently implement multiple strategic initiatives. This capacity specifically revolves around human capital requirements from upper management based on the initiatives' location or stage within the ACAP framework. Strategic change initiatives in health care can be usefully viewed from an ACAP perspective. There is a tendency for those strategic initiatives ranking higher in priority and time consumption to reflect more advanced dimensions of ACAP (assimilate and transform), whereas few initiatives were identified in the ACAP "exploit" dimension. This may suggest that health care leaders tend to no longer identify as strategic initiatives those innovations that have moved to the exploitation stage or that less attention is given to the exploitation

  6. Changes of microRNA profile and microRNA-mRNA regulatory network in bones of ovariectomized mice.

    Science.gov (United States)

    An, Jee Hyun; Ohn, Jung Hun; Song, Jung Ah; Yang, Jae-Yeon; Park, Hyojung; Choi, Hyung Jin; Kim, Sang Wan; Kim, Seong Yeon; Park, Woog-Yang; Shin, Chan Soo

    2014-03-01

    Growing evidence shows the possibility of a role of microRNAs (miRNA) in regulating bone mass. We investigated the change of miRNAs and mRNA expression profiles in bone tissue in an ovariectomized mice model and evaluated the regulatory mechanism of bone mass mediated by miRNAs in an estrogen-deficiency state. Eight-week-old female C3H/HeJ mice underwent ovariectomy (OVX) or sham operation (Sham-op), and their femur and tibia were harvested to extract total bone RNAs after 4 weeks for microarray analysis. Eight miRNAs (miR-127, -133a, -133a*, -133b, -136, -206, -378, -378*) were identified to be upregulated after OVX, whereas one miRNA (miR-204) was downregulated. Concomitant analysis of mRNA microarray revealed that 658 genes were differentially expressed between OVX and Sham-op mice. Target prediction of differentially expressed miRNAs identified potential targets, and integrative analysis using the mRNA microarray results showed that PPARγ and CREB pathways are activated in skeletal tissues after ovariectomy. Among the potential candidates of miRNA, we further studied the role of miR-127 in vitro, which exhibited the greatest changes after OVX. We also studied the effects of miR-136, which has not been studied in the context of bone mass regulation. Transfection of miR-127 inhibitor has enhanced osteoblastic differentiation in UAMS-32 cells as measured by alkaline phosphatase activities and mRNA expression of osteoblast-specific genes, whereas miR-136 precursor has inhibited osteoblastic differentiation. Furthermore, transfection of both miR-127 and miR-136 inhibitors enhanced the osteocyte-like morphological changes and survival in MLO-Y4 cells, whereas precursors of miR-127 and -136 have aggravated dexamethasone-induced cell death. Both of the precursors enhanced osteoclastic differentiation in bone marrow macrophages, indicating that both miR-127 and -136 are negatively regulating bone mass. Taken together, these results suggest a novel insight into the

  7. Dual Nature of Translational Control by Regulatory BC RNAs ▿

    Science.gov (United States)

    Eom, Taesun; Berardi, Valerio; Zhong, Jun; Risuleo, Gianfranco; Tiedge, Henri

    2011-01-01

    In higher eukaryotes, increasing evidence suggests, gene expression is to a large degree controlled by RNA. Regulatory RNAs have been implicated in the management of neuronal function and plasticity in mammalian brains. However, much of the molecular-mechanistic framework that enables neuronal regulatory RNAs to control gene expression remains poorly understood. Here, we establish molecular mechanisms that underlie the regulatory capacity of neuronal BC RNAs in the translational control of gene expression. We report that regulatory BC RNAs employ a two-pronged approach in translational control. One of two distinct repression mechanisms is mediated by C-loop motifs in BC RNA 3′ stem-loop domains. These C-loops bind to eIF4B and prevent the factor's interaction with 18S rRNA of the small ribosomal subunit. In the second mechanism, the central A-rich domains of BC RNAs target eIF4A, specifically inhibiting its RNA helicase activity. Thus, BC RNAs repress translation initiation in a bimodal mechanistic approach. As BC RNA functionality has evolved independently in rodent and primate lineages, our data suggest that BC RNA translational control was necessitated and implemented during mammalian phylogenetic development of complex neural systems. PMID:21930783

  8. Department of the Treasury Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ..., money laundering, and other financial crime. The proposed changes are intended to address regulatory... for the use of prepaid access as a means for furthering money laundering, terrorist financing, and...) exempting certain categories of prepaid access products and services posing lower risks of money laundering...

  9. The EU commission and national governments as partners: EC regulatory expansion in telecommunications 1979-2000

    OpenAIRE

    Mark Thatcher

    2001-01-01

    Explicitly or implicitly, general models of European integration claim that EC regulatory expansion involves a struggle for power between Commission and national governments. The Commission is seen as a policy entrepreneur, taking the initiative to drive forward integration (Sandholtz and Zysman 1989). It seeks regulatory expansion due to constraints on its expenditure (Majone 1996, ch4). Neo-functionalists emphasise the Commission's ability to expand its role against the wishes of government...

  10. 75 FR 18556 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

    Science.gov (United States)

    2010-04-12

    ... have been prepared by the self-regulatory organization. Amex filed the proposal pursuant to Section 19.... Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change The... , at the Exchange's principal office and at the Commission's Public Reference Room. II. Self-Regulatory...

  11. 76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-19

    ... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

  12. Understanding Changes in Modeled Land Surface Characteristics Prior to Lightning-Initiated Holdover Fire Breakout

    Science.gov (United States)

    Schultz, Christopher J.; Case, Jonathan L.; Hain, Christopher R.; White, Kristopher; Wachter, J. Brent; Nauslar, Nicholas; MacNamara, Brittany

    2018-01-01

    Lightning initiated wildfires are only 16% of the total number of wildfires within the United States, but account for 56% of the acreage burned. One of the challenges with lightning-initiated wildfires is their ability to "holdover" which means smolder for up to 2+ weeks before breaking out into a full fledged fire. This work helps characterize the percentage of holdover events due to lightning, and helps quantify changes in the land surface characteristics to help understand trends in soil moisture and vegetation stress that potentially contribute to the fire breaking out into a full wildfire.

  13. Harmonisation within atmospheric dispersion modelling for regulatory purposes. Proceedings. Vol. 1

    International Nuclear Information System (INIS)

    Suppan, P.

    2004-01-01

    Dispersion modelling has proved to be a very effective tool to assess the environmental impact of human activities to be a very effective tool to assess the environmental impact of human activities on air quality already at the early planning stage. Environmental assessments during planning are required by the EU directive 85/337/EEC. Only models can give detailed information on the distribution of pollutants with high spatial and temporal resolution, while they allow the decision-maker to devise a range of scenarios, in which the various processes determining the environmental impact can be easily simulated and changed. In June 1991, the Joint Research Centre of the European Commission started an initiative on the sharing of information and possible harmonisation of new approaches to atmospheric disperion modelling and model evaluation. This initiative has fostered a series of conferences that have be concerned with improvement of ''modelling culture'' in Europe. The 9th International Conference on Harmonisation within Atmospheric dispersion Modelling for Regulatory Purposes in Garmisch-Partenkirchen, in Germany/Bavaria, 1-4 June, 2004, will continue the efforts of the previous conferences. The conference has a role as a forum where users and decision-makers can bring their requirements to the attention of scientists. It is also a natural forum for discussing environmental issues related to the European Union enlargement process. The scope of this conference is covered by the following topics: 1. Validation and inter-comparison of models: Model evaluation methodology - 2. Experiences with implementation of EU directives: regulatory modelling - 3. Short distance dispersion modelling - 4. Urban scale and street canyon modelling: Meteorology and air quality - 5. Mesoscale meteorology and air quality modelling - 6. Environmental impact assessment: Air pollution management and decision support systems. (orig.)

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

    International Nuclear Information System (INIS)

    2002-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

  15. Alberta Energy and Utilities Board, regulatory highlights for 1998

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-08-01

    This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta`s energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB`s position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board`s efforts in the area of timely stakeholder consultation was highlighted. tabs., figs.

  16. The Contribution of Serine 194 Phosphorylation to Steroidogenic Acute Regulatory Protein Function

    OpenAIRE

    Sasaki, Goro; Zubair, Mohamad; Ishii, Tomohiro; Mitsui, Toshikatsu; Hasegawa, Tomonobu; Auchus, Richard J.

    2014-01-01

    The steroidogenic acute regulatory protein (StAR) facilitates the delivery of cholesterol to the inner mitochondrial membrane, where the cholesterol side-chain cleavage enzyme catalyzes the initial step of steroid hormone biosynthesis. StAR was initially identified in adrenocortical cells as a phosphoprotein, the expression and phosphorylation of which were stimulated by corticotropin. A number of in vitro studies have implicated cAMP-dependent phosphorylation at serine 194 (S194, S195 in hum...

  17. Regulatory Risk Reduction for Advanced Reactor Technologies – FY2016 Status and Work Plan Summary

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-08-01

    Millions of public and private sector dollars have been invested over recent decades to realize greater efficiency, reliability, and the inherent and passive safety offered by advanced nuclear reactor technologies. However, a major challenge in experiencing those benefits resides in the existing U.S. regulatory framework. This framework governs all commercial nuclear plant construction, operations, and safety issues and is highly large light water reactor (LWR) technology centric. The framework must be modernized to effectively deal with non-LWR advanced designs if those designs are to become part of the U.S energy supply. The U.S. Department of Energy’s (DOE) Advanced Reactor Technologies (ART) Regulatory Risk Reduction (RRR) initiative, managed by the Regulatory Affairs Department at the Idaho National Laboratory (INL), is establishing a capability that can systematically retire extraneous licensing risks associated with regulatory framework incompatibilities. This capability proposes to rely heavily on the perspectives of the affected regulated community (i.e., commercial advanced reactor designers/vendors and prospective owner/operators) yet remain tuned to assuring public safety and acceptability by regulators responsible for license issuance. The extent to which broad industry perspectives are being incorporated into the proposed framework makes this initiative unique and of potential benefit to all future domestic non-LWR applicants

  18. Sustainability Initiatives Driving Supply Chain: Climate Governance on Beef Production System

    Directory of Open Access Journals (Sweden)

    Ieda Kanashiro Makiya

    2015-04-01

    Full Text Available Two conceptual frameworks have been analytically dominant in researching innovation dynamics in sustainability transition processes, namely technological innovation systems (TIS and the multi-level perspective (MLP. The innovation systems has been principally concerned with emerging new technologies and their potential contribution to future sustainability, whereas MLP has been more strongly oriented toward reconstructing historical processes of sectorial change. In this perspective, this study aims to analyses how global climate change and environmental pressures impact on the governance of supply chain and the ripple effects on natural resource-intensive economies. Some initiatives are taken to address regulatory issues and reconcile decision-making tools on quality assurance program on value chains. This includes a multi-level perspective (MLP as Carbon Disclosure Project (CDP and technological innovation systems (TIS as Geographic Information System (GIS used as a tracking system for monitoring sustainable practices. The paper discuss the drivers of sustainable beef production system, mainly in Legal Amazon, Brazil, and requirements from a largest retailer aligned to Brazilian public policies. This study presents three distinct strategies: (1 government and public policies to control deforestation related to beef cattle production system, (2 economic approach related to transnational supermarket chain and sustainability initiatives, (3 collective action for decision-making by multiple drivers

  19. A Discussion of Change Theory, System Theory, and State Designed Standards and Accountability Initiatives.

    Science.gov (United States)

    McNeal, Larry; Christy, W. Keith

    This brief paper is a presentation that preceeded another case of considering the ongoing dialogue on the advantages and disadvantages of centralized and decentralized school-improvement processes. It attempts to raise a number of questions about the relationship between state-designed standards and accountability initiatives and change and…

  20. Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

    International Nuclear Information System (INIS)

    Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2011-01-01

    Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

  1. Nuclear regulatory communication with the public: 10 years of progress

    International Nuclear Information System (INIS)

    Gauvain, J.; Jorle, A.; Chanial, L.

    2008-01-01

    The NEA has an acknowledged role to assist its member countries in maintaining and developing, through international co-operation, the scientific, technological and legal bases required for a safe, environmentally friendly and economical use of nuclear energy. In this context, the NEA Committee on Nuclear Regulatory Activities (CNRA) provides a forum for senior representatives from nuclear regulatory bodies to exchange information and experience on nuclear regulatory policies and practices in NEA member countries and to review developments which could affect regulatory requirements. Public confidence in government and in risk management structures is important to all developed countries with an open society. The use of nuclear power in a democracy is built upon a certain trust in the political system and the national authorities. To foster and maintain such trust in a period of greater public scrutiny of nuclear activities, a number of nuclear regulatory organisations (NROs) initiated various processes to pro-actively inform the public about their supervision and control of nuclear activities, or when appropriate to involve the public in decision making. In 1998 the question was raised within the CNRA of whether public trust in the regulator might be very different from one country to another, and an activity was started among member countries to exchange experience and best practices and to learn lessons about NRO communication with their publics. Three workshops were organised by the NEA, and a Working Group on Public Communication of Nuclear Regulatory Organisations was set up in 2001. The activities and findings are summarised below. (author)

  2. 77 FR 45401 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of a...

    Science.gov (United States)

    2012-07-31

    ... change. All such Regulatory Bulletins will contain information regarding changes to the risk settings in...-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule... Applicable to the Market Maker Risk Limitation Mechanism Will Be Between One and 100 Executions per Second...

  3. Red blood cell aggregation changes are depended on its initial value: Effect of long-term drug treatment and short-term cell incubation with drug.

    Science.gov (United States)

    Muravyov, A V; Tikhomirova, I A; Maimistova, A A; Bulaeva, S V; Mikhailov, P V; Kislov, N V

    2011-01-01

    This study was designed to investigate whether the red cell aggregation depends on its initial level under drug therapy or cell incubation with bioactive chemical compounds. Sixty six subjects were enrolled onto this study, and sub-divided into two groups: the first group of patients (n = 36) with cerebral atherosclerosis received pentoxifylline therapy (400 mg, thrice daily) for 4 weeks. The patients of the second group were initially treated with Epoetin beta 10,000 units subcutaneously thrice a week, for 4 weeks. The second group - adult anemic patients (n = 30) with the confirmed diagnosis of solid cancer (Hb treatment the red cell aggregation increased (p treatment with pentoxifylline reduced it markedly (p treatment 75% the anemic patients with initially high RBCA had an aggregation lowering. The drop of aggregation was about 34% (p treatment. The initially low red cell aggregation after incubation with epoetin-beta was markedly increased by 122% (p drugs depend markedly on the initial, pre-treatment aggregation status of the patients. These results demonstrate that the different red blood cell aggregation responses to the biological stimuli depend strongly on the initial, pre-treatment status of the subject and the most probably it is connected with the crosstalk between the adenylyl cyclase signaling pathway and Ca2+ regulatory mechanism.

  4. A gene regulatory network armature for T-lymphocyte specification

    Energy Technology Data Exchange (ETDEWEB)

    Fung, Elizabeth-sharon [Los Alamos National Laboratory

    2008-01-01

    Choice of a T-lymphoid fate by hematopoietic progenitor cells depends on sustained Notch-Delta signaling combined with tightly-regulated activities of multiple transcription factors. To dissect the regulatory network connections that mediate this process, we have used high-resolution analysis of regulatory gene expression trajectories from the beginning to the end of specification; tests of the short-term Notchdependence of these gene expression changes; and perturbation analyses of the effects of overexpression of two essential transcription factors, namely PU.l and GATA-3. Quantitative expression measurements of >50 transcription factor and marker genes have been used to derive the principal components of regulatory change through which T-cell precursors progress from primitive multipotency to T-lineage commitment. Distinct parts of the path reveal separate contributions of Notch signaling, GATA-3 activity, and downregulation of PU.l. Using BioTapestry, the results have been assembled into a draft gene regulatory network for the specification of T-cell precursors and the choice of T as opposed to myeloid dendritic or mast-cell fates. This network also accommodates effects of E proteins and mutual repression circuits of Gfil against Egr-2 and of TCF-l against PU.l as proposed elsewhere, but requires additional functions that remain unidentified. Distinctive features of this network structure include the intense dose-dependence of GATA-3 effects; the gene-specific modulation of PU.l activity based on Notch activity; the lack of direct opposition between PU.l and GATA-3; and the need for a distinct, late-acting repressive function or functions to extinguish stem and progenitor-derived regulatory gene expression.

  5. Transcriptome analysis revealed the possible regulatory pathways initiating female geese broodiness within the hypothalamic-pituitary-gonadal axis.

    Directory of Open Access Journals (Sweden)

    Hehe Liu

    Full Text Available Geese have the strongest tendency toward broodiness among all poultry. The mechanisms initiating broodiness within the goose hypothalamic-pituitary-gonadal axis (HPGA are still unclear. Here, we reported the transcriptome differences between laying and initial nesting within the HPGA tissues of geese. We constructed a unigene database based on HPGA tissues and identified 128,148 unigenes, 100% of which have been annotated. By using Digital Gene Expression (DGE sequencing, we screened 19, 110, 289, and 211 differentially expressed genes (DEGs in the hypothalamus, pituitary gland, stroma ovarii, and follicles, respectively, between laying and nesting geese. Expression changes of hypocretin (HCRT and pro-opiomelanocortin (POMC in the hypothalamus of nesting geese may cause appetite reduction, which is possibly the first step and a prerequisite to initiate broodiness. In addition to prolactin (PRL, follicle-stimulating hormone (FSH and luteinizing hormone (LH, genes including oxytocin-neurophysin (OXT, chordin-like protein 1 (CHRDL1 and growth hormone (GH, expressed in the pituitary gland, are new candidate molecules that may be involved in broodiness in geese. Heme oxygenase 1 (HMOX1 in the pituitary gland, the proto-oncogene c-Fos (FOS, heat shock protein 90-alpha (HSP90AA, and cyclin-dependent kinase 1 (CDK1 in the ovary that may consolidate and transduce signals regulating the HPGA during broodiness in geese.

  6. Transcriptome analysis revealed the possible regulatory pathways initiating female geese broodiness within the hypothalamic-pituitary-gonadal axis

    Science.gov (United States)

    Wang, Jiwen; Li, Liang; Han, Chunchun; He, Hua; Xu, Hengyong

    2018-01-01

    Geese have the strongest tendency toward broodiness among all poultry. The mechanisms initiating broodiness within the goose hypothalamic-pituitary-gonadal axis (HPGA) are still unclear. Here, we reported the transcriptome differences between laying and initial nesting within the HPGA tissues of geese. We constructed a unigene database based on HPGA tissues and identified 128,148 unigenes, 100% of which have been annotated. By using Digital Gene Expression (DGE) sequencing, we screened 19, 110, 289, and 211 differentially expressed genes (DEGs) in the hypothalamus, pituitary gland, stroma ovarii, and follicles, respectively, between laying and nesting geese. Expression changes of hypocretin (HCRT) and pro-opiomelanocortin (POMC) in the hypothalamus of nesting geese may cause appetite reduction, which is possibly the first step and a prerequisite to initiate broodiness. In addition to prolactin (PRL), follicle-stimulating hormone (FSH) and luteinizing hormone (LH), genes including oxytocin-neurophysin (OXT), chordin-like protein 1 (CHRDL1) and growth hormone (GH), expressed in the pituitary gland, are new candidate molecules that may be involved in broodiness in geese. Heme oxygenase 1 (HMOX1) in the pituitary gland, the proto-oncogene c-Fos (FOS), heat shock protein 90-alpha (HSP90AA), and cyclin-dependent kinase 1 (CDK1) in the ovary that may consolidate and transduce signals regulating the HPGA during broodiness in geese. PMID:29408859

  7. Mutual information and the fidelity of response of gene regulatory models

    International Nuclear Information System (INIS)

    Tabbaa, Omar P; Jayaprakash, C

    2014-01-01

    We investigate cellular response to extracellular signals by using information theory techniques motivated by recent experiments. We present results for the steady state of the following gene regulatory models found in both prokaryotic and eukaryotic cells: a linear transcription-translation model and a positive or negative auto-regulatory model. We calculate both the information capacity and the mutual information exactly for simple models and approximately for the full model. We find that (1) small changes in mutual information can lead to potentially important changes in cellular response and (2) there are diminishing returns in the fidelity of response as the mutual information increases. We calculate the information capacity using Gillespie simulations of a model for the TNF-α-NF-κ B network and find good agreement with the measured value for an experimental realization of this network. Our results provide a quantitative understanding of the differences in cellular response when comparing experimentally measured mutual information values of different gene regulatory models. Our calculations demonstrate that Gillespie simulations can be used to compute the mutual information of more complex gene regulatory models, providing a potentially useful tool in synthetic biology. (paper)

  8. Basis for revision 2 of the U.S. Nuclear Regulatory Commission's Regulatory Guide 1.99

    International Nuclear Information System (INIS)

    Randall, P.N.

    1986-01-01

    Regulatory Guide 1.99. ''Radiation Damage to Reactor Vessel Materials,'' is being updated to reflect recent studies of the physical basis for neutron radiation damage and efforts to correlate damage to chemical composition and fluence. Revision 2 of the Guide contains several significant changes. Welds and base metal are treated separately. Nickel content is added as a variable and phosphorus removed. The exponent in the fluence factor is reduced, especially at high fluences. And, guidance is given for calculating attenuation of damage through the vessel wall. This paper describes the basis for these changes in the Guide

  9. Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

    Science.gov (United States)

    2011-01-01

    Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA) and abscisic acid (ABA) are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up-regulated by both GA and seed

  10. Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

    Directory of Open Access Journals (Sweden)

    Lin Li

    2011-06-01

    Full Text Available Abstract Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA and abscisic acid (ABA are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up

  11. A reappraisal of transport aircraft needs 1985 - 2000: Perceptions of airline management in a changing economic, regulatory, and technological environment

    Science.gov (United States)

    Spencer, F. A.

    1982-01-01

    Views of the executives of 24 major, national, regional, and commuter airlines concerning the effect of recent regulatory, economic, and technological changes on the roles they see for their airlines, and consequent changes in their plans for acquiring aircraft for the 1985 to 2000 period were surveyed. Differing perceptions on the economic justification for new-technology jets in the context of the carriers' present and projected financial conditions are outlined. After examining the cases for new or intermediate size jets, the study discusses turboprop powered transports, including the carriers' potential interest in an advanced technology, high-speed turboprop or prop-fan. Finally, the implications of foreign competition are examined in terms of each carrier's evaluation of the quality and financial offerings, as well as possible 'Buy American' policy predisposition.

  12. Legislative and regulatory framework of radioactive waste management in Romania

    International Nuclear Information System (INIS)

    Cutoiu, D.

    2000-01-01

    The paper intent is to present an update on the Romanian legislative and regulatory framework in the area of radioactive waste management. Based on the experiences gained by the National Commission for Nuclear Activities Control in the past years, the recent legislative initiatives related to the coherent radwaste management policy at the national level are presented. (author)

  13. Regulatory approaches in the United States of America for safe management and disposal of long-lived radionuclides

    International Nuclear Information System (INIS)

    Greeves, J.T.; Bell, M.J.; Nelson, R.A.

    1998-01-01

    Regulation of the safe management and disposal of commercial, man-made, long-lived radioactive wastes in the United States is the responsibility of the US Nuclear Regulatory Commission (NRC). In some instances, state regulatory authorities have entered into agreements with the NRC to exercise regulatory authority over management and disposal of low-level radioactive wastes and uranium mill tailings within their borders. The legal and regulatory framework employed to achieve safe management and disposal of long-lived radioactive wastes in the US regulatory system is quite detailed, and in many cases the requirements are considerably prescriptive. The NRC has undertaken an initiative to move in the direction of adopting risk-informed, performance-based and risk-informed, less-prescriptive regulations. The current status and future direction of the legal and regulatory framework for management and disposal of commercial long-lived radioactive waste in the US is described. (author)

  14. Nickel decreases cellular iron level and converts cytosolic aconitase to iron-regulatory protein 1 in A549 cells

    International Nuclear Information System (INIS)

    Chen Haobin; Davidson, Todd; Singleton, Steven; Garrick, Michael D.; Costa, Max

    2005-01-01

    Nickel (Ni) compounds are well-established carcinogens and are known to initiate a hypoxic response in cells via the stabilization and transactivation of hypoxia-inducible factor-1 alpha (HIF-1α). This change may be the consequence of nickel's interference with the function of several Fe(II)-dependent enzymes. In this study, the effects of soluble nickel exposure on cellular iron homeostasis were investigated. Nickel treatment decreased both mitochondrial and cytosolic aconitase (c-aconitase) activity in A549 cells. Cytosolic aconitase was converted to iron-regulatory protein 1, a form critical for the regulation of cellular iron homeostasis. The increased activity of iron-regulatory protein 1 after nickel exposure stabilized and increased transferrin receptor (Tfr) mRNA and antagonized the iron-induced ferritin light chain protein synthesis. The decrease of aconitase activity after nickel treatment reflected neither direct interference with aconitase function nor obstruction of [4Fe-4S] cluster reconstitution by nickel. Exposure of A549 cells to soluble nickel decreased total cellular iron by about 40%, a decrease that likely caused the observed decrease in aconitase activity and the increase of iron-regulatory protein 1 activity. Iron treatment reversed the effect of nickel on cytosolic aconitase and iron-regulatory protein 1. To assess the mechanism for the observed effects, human embryonic kidney (HEK) cells over expressing divalent metal transporter-1 (DMT1) were compared to A549 cells expressing only endogenous transporters for inhibition of iron uptake by nickel. The inhibition data suggest that nickel can enter via DMT1 and compete with iron for entry into the cell. This disturbance of cellular iron homeostasis by nickel may have a great impact on the ability of the cell to regulate a variety of cell functions, as well as create a state of hypoxia in cells under normal oxygen tension. These effects may be very important in how nickel exerts phenotypic

  15. An Analysis of Regulatory Strategies for Recycling and Re-Use of Metals in Australia

    Directory of Open Access Journals (Sweden)

    Wayne Gumley

    2014-04-01

    Full Text Available This article considers regulatory strategies that promote more efficient use of material inputs within the Australian economy, with particular focus on recycling and recovery of metals, drawing upon the concept of a “circular economy”. It briefly reviews the nature of regulation and trends in regulatory strategies within changing policy contexts, and then examines the regulatory framework applicable to the various phases in the life cycle of metals, ranging from extraction of minerals to processing and assimilation of metals into finished products, through to eventual disposal of products as waste. Discussion focuses upon the regulatory strategies applied in each phase and the changing roles of government and business operators within global distribution networks. It is concluded that the prevailing political agenda favoring deregulation and reduced taxation may be a major barrier to development of new styles of regulation and more effective use of taxation powers that is needed to support a more circular economy in metals. The implication for future research is the need to substantiate the outcomes of reflexive regulatory strategies with well-designed empirical studies.

  16. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  17. Direct and indirect land use changes issues in European sustainability initiatives: State-of-the-art, open issues and future developments

    International Nuclear Information System (INIS)

    Van Stappen, Florence; Brose, Isabelle; Schenkel, Yves

    2011-01-01

    Facing climate change and growing energy prices, the use of bioenergy is continuously increasing in order to diminish greenhouse gas emissions, secure energy supply and create employment in rural areas. Because the production of biomass or biofuels, wherever it takes place, comes along with externalities, positive or negative, the need for biomass and bioenergy sustainability criteria is more than ever felt. Research on sustainability criteria and certification systems has started through several national and international initiatives. Considering the benefits of an increased use of bioenergy but also the urge for limiting potential negative environmental and socio-economic impacts, the aim of these initiatives was to make the first move regarding bioenergy sustainability, while waiting for the European legislation to regulate this crucial issue. Land use changes, whether direct or indirect, are one of the most important consequences of bioenergy production. While direct land use changes are more easily assessed locally, indirect land use changes exceed the company level and need to be considered at a global scale. Methodologies for dealing with direct and indirect land use changes are proposed among others in the European, Dutch, British and German sustainability initiatives. This paper aims at presenting and comparing those four European initiatives, with a focus on their propositions for direct and indirect land use changes assessment. Key issues are discussed and recommendations are made for steps to overcome identified difficulties in accurately assessing the effects of indirect land use change due to bioenergy production.

  18. Confirming competence of operators - A regulatory approach to fuel cycle facilities

    International Nuclear Information System (INIS)

    Vesely, M.; Sigetich, J.

    2013-01-01

    For the past 40 years the Canadian Nuclear Safety Commission (CNSC), formerly the Atomic Energy Control Board, has certified workers in nuclear facilities. The requirement for certified personnel has ensured that workers assigned to positions that have a direct impact on the safe operation of the facility are fully qualified to perform their duties. This certification regime is defined in the regulatory framework under which the CNSC operates. Traditionally, this certification regime has been applied to Reactor Operators, Shift Supervisors and Health Physicists in Nuclear Power Plants and research reactors as well as to Exposure Device Operators who use nuclear substances for the purposes of industrial radiography. Stemming from progress made in implementing risk-informed regulatory oversight activities as well as a formal suggestion from the International Atomic Energy Agency - International Regulatory Review Service (IRRS) conducted on the CNSC in 2009, a regulatory approach to confirming the competence of Operators at Fuel Cycle Facilities has been initiated by CNSC staff. In the first stage of the implementation of this new regulatory approach, the CNSC had Cameco Corporation implement a formal internal qualification programme for the UF6 Operators at its Port Hope Conversion Facility (PHCF) in Port Hope, Ontario. In the future, following a review of the results of the qualification programme at the PHCF, the CNSC staff will evaluate the need for the application of a similar regulatory approach to confirm the competence of the Operators at other Fuel Cycle Facilities in Canada. (authors)

  19. 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

  20. 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...

  1. Regulatory Impacts on Sustainable Drinking Water Supply: A Comparative Study on Dutch Water Companies

    NARCIS (Netherlands)

    Dalhuisen, J.M.; Nijkamp, P.

    2006-01-01

    Regulatory changes have exerted deep impacts on public service provision. This paper aims to disentangle recent differences in the external production circumstances of Dutch regional water companies in order to identify the crucial regulatory factors influencing the supply of water to various users

  2. Regulatory Impacts on Sustainable Drinking Water Supply: A Comparative Study on Dutch Water Companies

    NARCIS (Netherlands)

    Dalhuisen, J.M.; Nijkamp, P.

    2007-01-01

    Regulatory changes have exerted deep impacts on public service provision. This paper aims to disentangle recent differences in the external production circumstances of Dutch regional water companies in order to identify the crucial regulatory factors influencing the supply of water to various users

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

    International Nuclear Information System (INIS)

    Cory, A.R.

    2004-01-01

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

  4. Role of the Regulatory Body in Implementing Defence in Depth in Nuclear Installations - Regulatory Oversight in Egypt

    Energy Technology Data Exchange (ETDEWEB)

    El-Sheikh, B. M., E-mail: badawymel@yahoo.com [Egyptian Nuclear and Radiological Regulatory Authority Cairo (Egypt)

    2014-10-15

    The fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times in an acceptably safe manner including the safe conduct of decommissioning activities. Defence in depth is recognized as one of the fundamental safety principles that underlie the safety of nuclear power plants. Defence in depth is implemented to provide a graded protection against a wide variety of transients, incidents and accidents, including equipment failures and human errors within nuclear power plants and events initiated outside plants. The Regulator Body plays an important role in implementing defence in depth in nuclear installations in the context of a clear allocation of responsibilities with an operating organization. This role starting with setting safety objectives and by its own independent review and technical assessment of the safety justifications provided by the operating organization in addition to safety culture investigating within relevant organizations. This paper briefly reviews this role in normal operation and post accidents, and its effects on overall nuclear safety in nuclear installations with reference to Egyptian regulatory oversight. (author)

  5. Role of cooperation activities for capacity building of Romanian Regulatory Authority (CNCAN)

    International Nuclear Information System (INIS)

    Biro, L.; Ciurea-Ercau, C.

    2010-01-01

    With a slow but active nuclear development program of sector since 1980, Romanian regulatory authority had to permanently adapt to the changes in national and international environment in order ensure continuously increase of capacity building and effectiveness, commensurate with the growing nuclear sector. Limited human resources available at the national level put the Romanian Regulatory Authority in the position of building the Technical Support Organization as part of its on organization. International cooperation played an important role in capacity building of Romanian regulatory body and providing necessary assistance in performing regulatory activities or support in development of regulatory framework. Fellowships and technical visits, workshops and training courses provided through IAEA TC at national or regional level, technical assistance provided by European Commission (EC) through PHARE Projects, all provided valuable contribution in assuring training of regulatory staff and development of proper regulatory framework in Romania. Therefore, Romanian Regulatory Authority is putting a strong accent on strengthening and promoting international cooperation through IAEA Technical Cooperation Programme, Molls between regulatory bodies, as one of the key elements in supporting capacity building of regulatory authorities in countries having small or embarking on nuclear power program. Building networks between training centers and research facilities and establishments of regional training centers represent one of the future viable options in preserving knowledge in nuclear field. (author)

  6. "Letting myself go forward past wrongs": How regulatory modes affect self-forgiveness.

    Science.gov (United States)

    Pierro, Antonio; Pica, Gennaro; Giannini, Anna Maria; Higgins, E Tory; Kruglanski, Arie W

    2018-01-01

    The present research addresses the question of whether regulatory-mode orientations affect self-forgiveness. We expected that people with a strong locomotion orientation would be more inclined to self-forgiveness because of their tendencies toward movement and change, which focus them on the future, whereas people with a strong assessment orientation would refrain from self-forgiveness due to their evaluative tendencies which focus them on the past. These hypotheses were supported by the results in four studies that tested the relation between regulatory modes and self-forgiveness by measuring (Studies 1, 3 and 4) and manipulating (Study 2) regulatory-mode-orientations. Finally, in Study 4 we examined more closely our hypothesis that the relation between self-forgiveness and regulatory modes is mediated by past and future temporal foci. The implications of the results for regulatory mode theory are also discussed.

  7. Aging has small effects on initial ischemic acute kidney injury development despite changing intrarenal immunologic micromilieu in mice.

    Science.gov (United States)

    Jang, Hye Ryoun; Park, Ji Hyeon; Kwon, Ghee Young; Park, Jae Berm; Lee, Jung Eun; Kim, Dae Joong; Kim, Yoon-Goo; Kim, Sung Joo; Oh, Ha Young; Huh, Wooseong

    2016-02-15

    Inflammatory process mediated by innate and adaptive immune systems is a major pathogenic mechanism of renal ischemia-reperfusion injury (IRI). There are concerns that organ recipients may be at increased risk of developing IRI after receiving kidneys from elder donors. To reveal the effects of aging on the development of renal IRI, we compared the immunologic micromilieu of normal and postischemic kidneys from mice of three different ages (9 wk, 6 mo, and 12 mo). There was a higher number of total T cells, especially effector memory CD4/CD8 T cells, and regulatory T cells in the normal kidneys of old mice. On day 2 after IRI, the proportion of necrotic tubules and renal functional changes were comparable between groups although old mice had a higher proportion of damaged tubule compared with young mice. More T cells, but less B cells, trafficked into the postischemic kidneys of old mice. The infiltration of NK T cells was similar across the groups. Macrophages and neutrophils were comparable between groups in both normal kidneys and postischemic kidneys. The intrarenal expressions of TNF-α and VEGF were decreased in normal and postischemic kidneys of aged mice. These mixed effects of aging on lymphocytes and cytokines/chemokines were not different between the two groups of old mice. Our study demonstrates that aging alters the intrarenal micromilieu but has small effects on the development of initial renal injury after IRI. Further study investigating aging-dependent differences in the repair process of renal IRI may be required. Copyright © 2016 the American Physiological Society.

  8. QT interval correction for drug-induced changes in body temperature during integrated cardiovascular safety assessment in regulatory toxicology studies in dogs: A case study.

    Science.gov (United States)

    El Amrani, Abdel-Ilah; El Amrani-Callens, Francine; Loriot, Stéphane; Singh, Pramila; Forster, Roy

    2016-01-01

    Cardiovascular safety assessment requires accurate evaluation of QT interval, which depends on the length of the cardiac cycle and also on core body temperature (BT). Increases in QT interval duration have been shown to be associated with decreases in BT in dogs. An example of altered QT interval duration associated with changes in body temperature observed during a 4-week regulatory toxicology study in dogs is presented. Four groups of Beagle dogs received the vehicle or test item once on Day 1, followed by a 4-week observation period. Electrocardiogram (ECG) parameters were continuously recorded on Days 1 and 26 by jacketed external telemetry (JET). Core body temperature (BT) was measured with a conventional rectal thermometer at appropriate time-points during the Day 1 recording period. Decreased BT was observed approximately 2h after treatment on Day 1, along with increased QT interval duration corrected according to the Van de Water formula (QTcV), but the effect was no longer observed after correction for changes in BT [QTcVcT=QTcV-14(37.5-BT)] according to the Van der Linde formula. No significant changes in QTcV were reported at the end of the observation period, on Day 26. The present study demonstrates that core body (rectal) temperature can easily be monitored at appropriate time-points during JET recording in regulatory toxicology studies in dogs, in order to correct QT interval duration values for treatment-related changes in BT. The successful application of the Van der Linde formula to correct QTc prolongation for changes in BT was demonstrated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  9. 77 FR 27255 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To...

    Science.gov (United States)

    2012-05-09

    ... Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Reduce the Current Level of Risk Mutualization Among Clearing Participants and To Modify the Initial Margin Risk Model So That It Is Easier for... modifications to its risk model for clearing credit default swaps (``CDS'') contracts. For the first...

  10. An improved and homogeneous altimeter sea level record from the ESA Climate Change Initiative

    DEFF Research Database (Denmark)

    Legeais, Jean-Francois; Ablain, Michael; Zawadzki, Lionel

    2018-01-01

    , the sea level ECV has been measured from space by different altimetry missions that have provided global and regional observations of sea level variations. As part of the Climate Change Initiative (CCI) program of the European Space Agency (ESA) (established in 2010), the Sea Level project (SL_cci) aimed...... to provide an accurate and homogeneous long-term satellite-based sea level record. At the end of the first phase of the project (2010-2013), an initial version (v1.1) of the sea level ECV was made available to users (Ablain et al., 2015). During the second phase of the project (2014-2017), improved altimeter...

  11. An overview of the UK regulatory expectation for design basis accident analysis

    International Nuclear Information System (INIS)

    Trimble, Andy

    2013-01-01

    The UK Health and Safety Executive published its most recent regulatory expectations in the 2006 version of it's safety assessment principles (SAPs). This built on experience regulating the full range of facilities for which it is responsible. Thus the principles underpinning all regulatory safety case assessment are the same but the implementation differs depending on the application. This paper will describe the published design basis accident analysis (DBAA) logic in context with other technical aspects of the regulatory expectation for safety cases. It will further illustrate the DBAA methodology with practical examples from actual experience on reprocessing plant gained over the last 15 years or so. Among the examples will be the relevance of conventional safety fault initiators to nuclear safety assessment. It will further demonstrate the derivation of facility limits and conditions necessary for nuclear safety. (authors)

  12. Nuclear energy's future: lifting the regulatory cloud

    International Nuclear Information System (INIS)

    Walske, C.

    1983-01-01

    Nuclear energy provides 13% of US and 10% of world electricity, with an exemplary safety record and less insult to the environment than any other power source. Walske argues that nuclear power is 15% cheaper than coal despite the high capital and regulatory costs, but regulatory delays in the construction and licensing periods have increased 70% to 10 to 14 years, more than twice the lead time in France and Japan. The long lead time exaggerates the difficulty in forecasting demand, and allows interruptions for fundamental design changes after construction has begun. Walske outlines new legislation for site pre-approval, plant standardization, combined construction and operating licenses, and hybrid procedures for public hearings that would make regulation less uncertain

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

    International Nuclear Information System (INIS)

    2009-01-01

    that indicate areas in which improvements are necessary or desirable to continue improving effectiveness of regulatory controls,' he said. 'These are made to an organization that seeks to improve its performance. Many of them are related to areas in which CNSC has already or is in the process of implementing a programme for change.' Mr. Tomihiro Taniguchi, IAEA Deputy Director General and Head of the Department for Nuclear Safety and Security, added: 'Through the IRRS missions, both a host country and the reviewers share their experiences and lessons learned for regulatory improvements. Canada, as a mature nuclear country has also significantly contributed to this goal.' Among the particular strengths of CNSC, its policy, its regulatory framework and its regulatory activities identified by the IRRS team were: - The Canadian legislative and regulatory framework is very comprehensive, and the legal regime is effectively applied through an appropriate range of instruments; - CNSC has done commendable work over the last years in establishing and implementing a strong management system that seeks continuous improvement within the organization; - The consistent harmonized plan that considers the results of all recent audits and assessments brings together all improvement initiatives under one plan and optimizes the use of resources to deliver further improvements in key areas; - The recommendations made by the Talisman International LLC report on the NRU and reviewed by the IRRS team have been adequately addressed by the CNSC. The IRRS team also made recommendations and suggestions that may significantly enhance the overall performance of the regulatory system. Examples include: - CNSC should initiate a periodic strategic planning programme to define both short- and long-term research activities needed to support pending and potential regulatory decisions. Sufficient resources should be allocated to support the results of the programme; - CNSC should continue developing a

  14. Fumigant emission reductions with TIF warrant regulatory changes

    Directory of Open Access Journals (Sweden)

    Husein Ajwa

    2013-07-01

    Full Text Available With methyl bromide's phase-out, most growers have turned to alternative fumigants, particularly 1,3-dichloropropene (1,3-D and chloropicrin. These alternatives are tightly regulated because they are classified as toxic air contaminants and volatile organic compounds; the latter combine with other substances to produce ground-level ozone (smog. Two ambient air monitoring studies were conducted to evaluate the potential of totally impermeable film (TIF to reduce emissions from shank applications of chloropicrin and 1,3-D. In 2009, a study demonstrated that TIF reduced chloropicrin and 1,3-D peak emissions by 45% and 38%, respectively, but TIF did not reduce total emissions when it was cut after 6 days. In 2011, increasing the tarp period from 5 to 10 days decreased chloropicrin and 1,3-D peak emissions by 88% and 78%, and their total emissions by 64% and 43%, respectively. Concurrent dynamic flux chamber results corroborated the ambient air monitoring data. These studies provide regulatory agencies with mitigation measures that should allow continued fumigant use at efficacious application rates.

  15. Industrial initiatives in the wind industry

    International Nuclear Information System (INIS)

    Edworthy, J.

    1992-01-01

    Industrial initiatives are methods of lobbying and marketing to increase the activity, revenues, profits, and commercial viability of an industry. They may be undertaken by industry individuals or firms, industry groups, government agencies, or combinations of all these. In Canada, one example of an industrial initiative is the Canadian Wind Energy Association. Other initiatives relevant to the wind power industry include Technology Inflow Programs sponsored by External Affairs Canada, used for visiting foreign firms with the view to licensing foreign technology, and Industrial Research Assistance Programs to develop or adapt new technologies in partnership with government. The Conservation/Renewable Energy Council, Small Power Producers of Alberta, and Independent Power Producers Society of Ontario are also active in supporting wind energy initiatives. In other countries, notable initiatives for wind energy include the Danish wind turbine warranty guarantee program. The Western Wind Industry Network of Canada conducts regional lobbying. It is suggested that in Canada, more such networks are needed, as well as joint ventures with utilities and governments, and more work with the regulatory agencies, to promote wind energy

  16. Attenuating initial beliefs: Increasing the acceptance of anthropogenic climate change information by reflecting on values

    NARCIS (Netherlands)

    van Prooijen, A.M.; Sparks, P.

    2014-01-01

    Anthropogenic climate change information tends to be interpreted against the backdrop of initial environmental beliefs, which can lead to some people being resistant toward the information. In this article (N = 88), we examined whether self-affirmation via reflection on personally important values

  17. Towards a predictive theory for genetic regulatory networks

    Science.gov (United States)

    Tkacik, Gasper

    When cells respond to changes in the environment by regulating the expression levels of their genes, we often draw parallels between these biological processes and engineered information processing systems. One can go beyond this qualitative analogy, however, by analyzing information transmission in biochemical ``hardware'' using Shannon's information theory. Here, gene regulation is viewed as a transmission channel operating under restrictive constraints set by the resource costs and intracellular noise. We present a series of results demonstrating that a theory of information transmission in genetic regulatory circuits feasibly yields non-trivial, testable predictions. These predictions concern strategies by which individual gene regulatory elements, e.g., promoters or enhancers, read out their signals; as well as strategies by which small networks of genes, independently or in spatially coupled settings, respond to their inputs. These predictions can be quantitatively compared to the known regulatory networks and their function, and can elucidate how reproducible biological processes, such as embryonic development, can be orchestrated by networks built out of noisy components. Preliminary successes in the gap gene network of the fruit fly Drosophila indicate that a full ab initio theoretical prediction of a regulatory network is possible, a feat that has not yet been achieved for any real regulatory network. We end by describing open challenges on the path towards such a prediction.

  18. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

    Science.gov (United States)

    Johnson, F Reed; Zhou, Mo

    Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  19. 78 FR 79028 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of...

    Science.gov (United States)

    2013-12-27

    ... finding or (ii) as to which the self-regulatory organization consents, the Commission will: (A) By order... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71156; File No. SR-NSCC-2013-13] Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change...

  20. Did our current initial treatment practice change after EAU/ESPU vesicoureteral reflux risk grouping?

    Science.gov (United States)

    Tokat, Eda; Gurocak, Serhat; Ure, Iyimser; Acar, Cenk; Sınık, Zafer; Tan, Mustafa Ozgur

    2018-06-02

    The "European Association of Urology (EAU) Guidelines on Vesicoureteral Reflux (VUR) in Children (September 2012)" established risk classification by analyzing and defining risk factors for each patient. In this study we aimed to investigate how our initial treatment procedures were affected by EAU/ESPU guideline vesicoureteral reflux risk grouping and to compare the early clinical results of treatments performed before and after the risk classification in our patients with VUR. 334 renal units with regular clinical follow-up who were treated owing to VUR (vesicoureteral reflux) between years 2009 and 2017 were retrospectively reviewed. Preoperative clinical parameters such as grade and laterality of reflux, presence of renal scar, initial and follow-up treatments, findings of medical treatment and surgical procedures were analyzed. The initial medical and surgical methods were compared by categorizing patients according to risk groups before and after 2013. Mean age and follow-up duration were 71.4(6-216) months and 47(4-141) months, respectively. Among the preoperative parameters, only high EAU risk group (p = 0.01) and treating lower urinary tract symptoms (p age, sex, and presence of renal scar at DMSA were not affecting the success of treatment significantly. While no significant difference in medical and surgical treatment rates is observed after risk grouping system in low risk group, the percentages of patients who are treated with surgical methods initially were significantly decreased in moderate and high risk groups (p = 0.002 and p = 0.012, respectively). We determined that VUR risk grouping did not change clinical success significantly in all risk groups. Despite the fact that EAU/ESPU VUR risk classification changed our current practice in terms of initial treatment method, this different approach did not seem to affect early clinical success positively. There is still an absolute need for studies with larger sample size and long

  1. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Science.gov (United States)

    2010-03-10

    ... the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold...

  2. Regulatory aspects of emergency planning

    International Nuclear Information System (INIS)

    Jamgochian, M.T.

    1986-01-01

    The paper discusses the advances that have been made in the USA in the field of emergency planning over the past several years and considers regulatory changes that may be on the horizon. The paper examines the importance of severe accident source terms and their relationship to emergency preparedness, recent research results of work on source terms, and the experience gained from evaluation of licensee performance during annual emergency preparedness exercises. (author)

  3. Innovative approach to training radiation safety regulatory professionals

    International Nuclear Information System (INIS)

    Gilley, Debbie Bray

    2008-01-01

    Full text: The supply of human resources required to adequately manage a radiation safety regulatory program has diminished in the last five years. Competing professional opportunities and a reduction in the number of health physics secondary schools have made it necessary to look at alternative methods of training. There are limited educational programs in the US that prepare our professionals for careers in the Radiation Regulatory Programs. The state of Florida's radiation control program embraced a new methodology using a combination of didactic and work experience using qualification journals, subject matter experts, and formalized training to develop a qualified pool of employees to perform the regulatory functions and emergency response requirements of a state radiation control program. This program uses a task-based approach to identify training needs and draws upon current staff to develop and implement the training. This has led to a task-oriented staff capable of responding to basic regulatory and emergency response activities within one year of employment. Florida's program lends itself to other states or countries with limited resources that have experienced staff attrition due to retirement or competing employment opportunities. Information on establishing a 'task-based' pool of employees that can perform basic regulatory functions and emergency response after one year of employment will be described. Initial task analysis of core functions and methodology is used to determine the appropriate training methodology for these functions. Instructions will be provided on the methodology used to 'mentor' new employees and then incorporate the new employees into the established core functions and be a useful employee at the completion of the first year of employment. New training philosophy and regime may be useful in assisting in the development of programs in countries and states with limited resources for training radiation protection personnel. (author)

  4. A linguistic representation of the regulation of transcription initiation. I. An ordered array of complex symbols with distinctive features.

    Science.gov (United States)

    Collado-Vides, J

    1993-01-01

    The inadequacy of context-free grammars in the description of regulatory information contained in DNA gave the formal justification for a linguistic approach to the study of gene regulation. Based on that result, we have initiated a linguistic formalization of the regulatory arrays of 107 sigma 70 E. coli promoters. The complete sequences of promoter (Pr), operator (Op) and activator binding sites (I) have previously been identified as the smallest elements, or categories, for a combinatorial analysis of the range of transcription initiation of sigma 70 promoters. These categories are conceptually equivalent to phonemes of natural language. Several features associated with these categories are required in a complete description of regulatory arrays of promoters. We have to select the best way to describe the properties that are pertinent for the description of such regulatory regions. In this paper we define distinctive features of regulatory regions based on the following criteria: identification of subclasses of substitutable elements, simplicity, selection of the most directly related information, and distinction of one array among the whole set of promoters. Alternative ways to represent distances in between regulatory sites are discussed, permitting, together with a principle of precedence, the identification of an ordered set of complex symbols as a unique representation for a promoter and its associated regulatory sites. In the accompanying paper additional distinctive features of promoters and regulatory sites are identified.

  5. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.

    2000-01-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants

  6. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants.

  7. 78 FR 62809 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing of Proposed Rule Change...

    Science.gov (United States)

    2013-10-22

    ... not be added, since the initial strikes go as low as possible ($1). Or, assume that the McDonald's... proposed rule change from interested persons. \\1\\ 15 U.S.C. 78s(b)(1). \\2\\ 17 CFR 240.19b-4. [[Page 62810

  8. Regional changes over time in initial virologic response rates to combination antiretroviral therapy across Europe

    DEFF Research Database (Denmark)

    Bannister, Wendy P; Kirk, Ole; Gatell, Jose M

    2006-01-01

    BACKGROUND: Changes in virologic response to initial combination antiretroviral therapy (cART) over calendar time may indicate improvements in cART or emergence of primary resistance. Regional variations may identify differences in available antiretroviral drugs or patient management. METHODS: Vi...... rates Udgivelsesdato: 2006/6...

  9. Defining Tobacco Regulatory Science Competencies.

    Science.gov (United States)

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

    2017-02-01

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

  10. Nuclear energy research initiative, an overview of the cooperative program for the risk-informed assessment of regulatory and design requirements for future nuclear power plants

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2000-01-01

    EPRI sstudies have shown that nuclear plant capital costs will have to decrease by about 35% to 40% to be competitive with fossil-generated electricity in the Unite States. Also, the ''first concrete'' to fuel load construction schedule will have to be decreased to less than 40 months. Therefore, the U. S. Department of Energy (DOE) initiate the Nuclear Energy Research Initiative (NERI) and ABB CENP proposed a cooperative program with Sandia National Laboratory (SNL) and Duke Engineering and Services (DE and S) to begin an innovative research effort to drastically cut the cost of new nuclear power plant construction for the U. S. de-regulated market place. This program was approved by the DOE through three separate but coordinated ''cooperative agreements.'' They are the ''Risk-Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants'' (Risk-Informed NPP), the ''Smart Nuclear Power Plant Program'' (Smart-NPP), and ''Design, Procure, Construct, Install and Test'' (DPCIT) Program. DOE funded the three cooperative agreements at a level of $2.6 million for the first year of the program. Funding for the complete program is durrently at a level $6.9 million, however, ABB CENP and all partners anticipate that the scope of the NERI program will be increased as a result of the overall importance of NERI to the U. S. Government. The Risk-Informed NPP program, which is aimed at revising costly regularory and design requirements without reducing overall plant safety, has two basic tasks: ''development of Risk-Informed Methods'' and ''strengthening the Reliability Database.'' The overall objective of the first task is to develop a scientific, risk-informed approach for identifying and simplifying deterministic industry standards, regulatory requirements, and safety systems that do not significantly contribute to nuclear power plant reliability and safety. The second basic task is to develop a means for strengthening the reliability database

  11. 75 FR 63878 - Self-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate...

    Science.gov (United States)

    2010-10-18

    ...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...

  12. Regulatory environment of transitioning to risk-informed regulations in U.S.A

    International Nuclear Information System (INIS)

    Choi, C. H.; Kim, C. H.

    1999-01-01

    With the publication of the PRA Policy Statement and recent regulatory guides, the U.S.NRC makes a continuous approach towards risk-informed regulations with the goal of establishing an overall framework for risk-informed decisions in all regulatory activities as well as plant specific licensing issues. Faced with the changing environment of deregulation of the electricity generation market, the licensee's effort to reduce design margins to enhance flexibility and to relieve unnecessary regulatory burdens have been focused on the control and reduction of plant operating costs. The risk-informed approach provides a structured, systematic, and defensible method that can be applied not only to rulemaking, but also to licensing, inspection, enforcement, and performance assessment, as well as provides basis for prioritization in the establishment of programs and the allocation of resources. This report describes the current regulatory environment of transitioning to risk-informed regulations with an emphasis on its background, concepts, regulatory guides, proposed options for modifying the 10CFR50, and risk-informed applications in U.S.A. Review of the risk informed applications utilizing the information provided by the PRAs and their insights in the U.S.NRC and nuclear industry will provide the insights of predicting the expected regulation changes in Korea. Also it could provide the applicable methods or guides for the implementation of the risk-informed applications in plant design and operations. (author)

  13. Dose response relationship in anti-stress gene regulatory networks.

    Science.gov (United States)

    Zhang, Qiang; Andersen, Melvin E

    2007-03-02

    To maintain a stable intracellular environment, cells utilize complex and specialized defense systems against a variety of external perturbations, such as electrophilic stress, heat shock, and hypoxia, etc. Irrespective of the type of stress, many adaptive mechanisms contributing to cellular homeostasis appear to operate through gene regulatory networks that are organized into negative feedback loops. In general, the degree of deviation of the controlled variables, such as electrophiles, misfolded proteins, and O2, is first detected by specialized sensor molecules, then the signal is transduced to specific transcription factors. Transcription factors can regulate the expression of a suite of anti-stress genes, many of which encode enzymes functioning to counteract the perturbed variables. The objective of this study was to explore, using control theory and computational approaches, the theoretical basis that underlies the steady-state dose response relationship between cellular stressors and intracellular biochemical species (controlled variables, transcription factors, and gene products) in these gene regulatory networks. Our work indicated that the shape of dose response curves (linear, superlinear, or sublinear) depends on changes in the specific values of local response coefficients (gains) distributed in the feedback loop. Multimerization of anti-stress enzymes and transcription factors into homodimers, homotrimers, or even higher-order multimers, play a significant role in maintaining robust homeostasis. Moreover, our simulation noted that dose response curves for the controlled variables can transition sequentially through four distinct phases as stressor level increases: initial superlinear with lesser control, superlinear more highly controlled, linear uncontrolled, and sublinear catastrophic. Each phase relies on specific gain-changing events that come into play as stressor level increases. The low-dose region is intrinsically nonlinear, and depending on

  14. Dose response relationship in anti-stress gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Qiang Zhang

    2007-03-01

    Full Text Available To maintain a stable intracellular environment, cells utilize complex and specialized defense systems against a variety of external perturbations, such as electrophilic stress, heat shock, and hypoxia, etc. Irrespective of the type of stress, many adaptive mechanisms contributing to cellular homeostasis appear to operate through gene regulatory networks that are organized into negative feedback loops. In general, the degree of deviation of the controlled variables, such as electrophiles, misfolded proteins, and O2, is first detected by specialized sensor molecules, then the signal is transduced to specific transcription factors. Transcription factors can regulate the expression of a suite of anti-stress genes, many of which encode enzymes functioning to counteract the perturbed variables. The objective of this study was to explore, using control theory and computational approaches, the theoretical basis that underlies the steady-state dose response relationship between cellular stressors and intracellular biochemical species (controlled variables, transcription factors, and gene products in these gene regulatory networks. Our work indicated that the shape of dose response curves (linear, superlinear, or sublinear depends on changes in the specific values of local response coefficients (gains distributed in the feedback loop. Multimerization of anti-stress enzymes and transcription factors into homodimers, homotrimers, or even higher-order multimers, play a significant role in maintaining robust homeostasis. Moreover, our simulation noted that dose response curves for the controlled variables can transition sequentially through four distinct phases as stressor level increases: initial superlinear with lesser control, superlinear more highly controlled, linear uncontrolled, and sublinear catastrophic. Each phase relies on specific gain-changing events that come into play as stressor level increases. The low-dose region is intrinsically nonlinear

  15. FORECAST: Regulatory effects cost analysis software manual -- Version 4.1. Revision 1

    International Nuclear Information System (INIS)

    Lopez, B.; Sciacca, F.W.

    1996-07-01

    The FORECAST program was developed to facilitate the preparation of the value-impact portion of NRC regulatory analyses. This PC program integrates the major cost and benefit considerations that may result from a proposed regulatory change. FORECAST automates much of the calculations typically needed in a regulatory analysis and thus reduces the time and labor required to perform these analyses. More importantly, its integrated and consistent treatment of the different value-impact considerations should help assure comprehensiveness, uniformity, and accuracy in the preparation of NRC regulatory analyses. The Current FORECAST Version 4.1 has been upgraded from the previous version and now includes an uncertainty package, an automatic cost escalation package, and other improvements. In addition, it now explicitly addresses public health impacts, occupational health impacts, onsite property damage, and government costs. Thus, FORECAST Version 4.1 can treat all attributes normally quantified in a regulatory analysis

  16. Development of transient initiating event frequencies for use in probabilistic risk assessments

    International Nuclear Information System (INIS)

    Mackowiak, D.P.; Gentillon, C.D.; Smith, K.L.

    1985-05-01

    Transient initiating event frequencies are an essential input to the analysis process of a nuclear power plant probabilistic risk assessment. These frequencies describe events causing or requiring scrams. This report documents an effort to validate and update from other sources a computer-based data file developed by the Electric Power Research Institute (EPRI) describing such events at 52 United States commercial nuclear power plants. Operating information from the United States Nuclear Regulatory Commission on 24 additional plants from their date of commercial operation has been combined with the EPRI data, and the entire data base has been updated to add 1980 through 1983 events for all 76 plants. The validity of the EPRI data and data analysis methodology and the adequacy of the EPRI transient categories are examined. New transient initiating event frequencies are derived from the expanded data base using the EPRI transient categories and data display methods. Upper bounds for these frequencies are also provided. Additional analyses explore changes in the dominant transients, changes in transient outage times and their impact on plant operation, and the effects of power level and scheduled scrams on transient event frequencies. A more rigorous data analysis methodology is developed to encourage further refinement of the transient initiating event frequencies derived herein. Updating the transient event data base resulted in approx.2400 events being added to EPRI's approx.3000-event data file. The resulting frequency estimates were in most cases lower than those reported by EPRI, but no significant order-of-magnitude changes were noted. The average number of transients per year for the combined data base is 8.5 for pressurized water reactors and 7.4 for boiling water reactors

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

    Science.gov (United States)

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

    2013-01-01

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

  18. Regulatory volume decrease in Leishmania mexicana: effect of anti-microtubule drugs

    Directory of Open Access Journals (Sweden)

    Francehuli Dagger

    2013-02-01

    Full Text Available The trypanosomatid cytoskeleton is responsible for the parasite's shape and it is modulated throughout the different stages of the parasite's life cycle. When parasites are exposed to media with reduced osmolarity, they initially swell, but subsequently undergo compensatory shrinking referred to as regulatory volume decrease (RVD. We studied the effects of anti-microtubule (Mt drugs on the proliferation of Leishmania mexicana promastigotes and their capacity to undergo RVD. All of the drugs tested exerted antiproliferative effects of varying magnitudes [ansamitocin P3 (AP3> trifluoperazine > taxol > rhizoxin > chlorpromazine]. No direct relationship was found between antiproliferative drug treatment and RVD. Similarly, Mt stability was not affected by drug treatment. Ansamitocin P3, which is effective at nanomolar concentrations, blocked amastigote-promastigote differentiation and was the only drug that impeded RVD, as measured by light dispersion. AP3 induced 2 kinetoplasts (Kt 1 nucleus cells that had numerous flagella-associated Kts throughout the cell. These results suggest that the dramatic morphological changes induced by AP3 alter the spatial organisation and directionality of the Mts that are necessary for the parasite's hypotonic stress-induced shape change, as well as its recovery.

  19. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

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

  20. Information data systems for a global change technology initiative architecture trade study

    Science.gov (United States)

    Murray, Nicholas D.

    1991-01-01

    The Global Change Technology Initiative (GCTI) was established to develop technology which will enable use of satellite systems of Earth observations on a global scale, enable use of the observations to predictively model Earth's changes, and provide scientists, government, business, and industry with quick access to the resulting information. At LaRC, a GCTI Architecture Trade Study was undertaken to develop and evaluate the architectural implications to meet the requirements of the global change studies and the eventual implementation of a global change system. The output of the trade study are recommended technologies for the GCTI. That portion of the study concerned with the information data system is documented. The information data system for an earth global change modeling system can be very extensive and beyond affordability in terms of today's costs. Therefore, an incremental approach to gaining a system is most likely. An options approach to levels of capability versus needed technologies was developed. The primary drivers of the requirements for the information data system evaluation were the needed science products, the science measurements, the spacecraft orbits, the instruments configurations, and the spacecraft configurations and their attendant architectures. The science products requirements were not studied here; however, some consideration of the product needs were included in the evaluation results. The information data system technology items were identified from the viewpoint of the desirable overall information system characteristics.