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Sample records for address current regulatory

  1. Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

    PubMed

    Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

    2015-06-01

    High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development. PMID:25963556

  2. Regulatory approaches to obesity prevention: A systematic overview of current laws addressing diet-related risk factors in the European Union and the United States.

    PubMed

    Sisnowski, Jana; Handsley, Elizabeth; Street, Jackie M

    2015-06-01

    High prevalence of overweight and obesity remains a significant international public health problem. Law has been identified as a tool for obesity prevention and selected high-profile measures have been reported. However, the nature and extent of enacted legislation internationally are unclear. This research provides an overview of regulatory approaches enacted in the United States, the European Union, and EU Member States since 2004. To this end, relevant databases of primary and secondary legislation were systematically searched to identify and explore laws addressing dietary risk factors for obesity. Across jurisdictions, current regulatory approaches to obesity prevention are limited in reach and scope. Target groups are rarely the general population, but instead sub-populations in government-supported settings. Consumer information provision is preferred over taxation and marketing restrictions other than the regulation of health and nutrition claims. In the EU in particular, product reformulation with industry consent has also emerged as a popular small-scale measure. While consistent and widespread use of law is lacking, governments have employed a range of regulatory measures in the name of obesity prevention, indicating that there is, in principle, political will. Results from this study may serve as a starting point for future research and policy development.

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

    SciTech Connect

    Peterson, Mark J.; Cada, Glenn F.; Sale, Michael J.; Eddlemon, Gerald K.

    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

  4. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Notification of current addresses. 870....910 Notification of current addresses. Each assignee must keep the office where the assignment is filed informed of his/her current address....

  5. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Notification of current addresses. 870....910 Notification of current addresses. Each assignee must keep the office where the assignment is filed informed of his/her current address....

  6. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Notification of current addresses. 870....910 Notification of current addresses. Each assignee must keep the office where the assignment is filed informed of his/her current address....

  7. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Notification of current addresses. 870....910 Notification of current addresses. Each assignee must keep the office where the assignment is filed informed of his/her current address....

  8. Current european regulatory perspectives on insulin analogues.

    PubMed

    Enzmann, Harald G; Weise, Martina

    2011-01-01

    Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions. PMID:21736748

  9. Protecting the confidentiality of interim data: addressing current challenges.

    PubMed

    Fleming, Thomas R

    2015-02-01

    There is compelling evidence supporting the importance of maintaining confidentiality of interim data in clinical trials designed to reliably address the benefit-to-risk profile of interventions. While this is widely recognized, creative approaches are needed to achieve this in challenging settings where interim data are released for regulatory review and action, even though the trial would be continued to address its primary hypothesis. An illustration is the recently emerging setting of cardiovascular safety trials in type 2 diabetes mellitus. At the first stage of such trials, if large relative increases in cardiovascular major morbidity/mortality can be ruled out, data can be released solely for the purpose of allowing regulatory decision making about marketing approval. The trial is then continued in the post-marketing setting to address the primary hypothesis regarding whether smaller relative increases can be ruled out. Active rather than passive approaches are needed to protect the integrity of cardiovascular safety trials. Given the importance to trial integrity of maintaining confidentiality of interim data such as the estimated relative effect on cardiovascular risk, a Data Access Plan should be in place in these trials to ensure such data are not revealed to study participants and their caregivers, investigators involved in trial conduct, the sponsor's management team, and the public, until trial completion. A Performance Standards Document also should be developed to pre-specify targeted and minimally acceptable levels for recruitment rate, best real-world achievable adherence, avoidance of cross-ins, and retention rate. This document should specify creative approaches for achieving these targets, oversight procedures during trial conduct to monitor performance levels, and actions to be taken if emerging data indicate minimally acceptable levels are not being reached. In settings where meaningful breaches in confidentiality have occurred, such

  10. Protecting the confidentiality of interim data: addressing current challenges.

    PubMed

    Fleming, Thomas R

    2015-02-01

    There is compelling evidence supporting the importance of maintaining confidentiality of interim data in clinical trials designed to reliably address the benefit-to-risk profile of interventions. While this is widely recognized, creative approaches are needed to achieve this in challenging settings where interim data are released for regulatory review and action, even though the trial would be continued to address its primary hypothesis. An illustration is the recently emerging setting of cardiovascular safety trials in type 2 diabetes mellitus. At the first stage of such trials, if large relative increases in cardiovascular major morbidity/mortality can be ruled out, data can be released solely for the purpose of allowing regulatory decision making about marketing approval. The trial is then continued in the post-marketing setting to address the primary hypothesis regarding whether smaller relative increases can be ruled out. Active rather than passive approaches are needed to protect the integrity of cardiovascular safety trials. Given the importance to trial integrity of maintaining confidentiality of interim data such as the estimated relative effect on cardiovascular risk, a Data Access Plan should be in place in these trials to ensure such data are not revealed to study participants and their caregivers, investigators involved in trial conduct, the sponsor's management team, and the public, until trial completion. A Performance Standards Document also should be developed to pre-specify targeted and minimally acceptable levels for recruitment rate, best real-world achievable adherence, avoidance of cross-ins, and retention rate. This document should specify creative approaches for achieving these targets, oversight procedures during trial conduct to monitor performance levels, and actions to be taken if emerging data indicate minimally acceptable levels are not being reached. In settings where meaningful breaches in confidentiality have occurred, such

  11. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Notification of current addresses. 870.910 Section 870.910 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) FEDERAL EMPLOYEES' GROUP LIFE INSURANCE PROGRAM Assignments of Life Insurance §...

  12. Current status of herbal product: Regulatory overview

    PubMed Central

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

  13. Current status of herbal product: Regulatory overview.

    PubMed

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment.

  14. Strategic Science to Address Current and Future Space Weather Needs

    NASA Astrophysics Data System (ADS)

    Mannucci, A. J.; Schwadron, N.; Antiochos, S. K.; Bhattacharjee, A.; Bisi, M. M.; Gopalswamy, N.; Kamalabadi, F.; Pulkkinen, A. A.; Tobiska, W. K.; Weimer, D. R.; Withers, P.

    2014-12-01

    NASA's Living With a Star (LWS) program has contributed a wealth of scientific knowledge that is relevant to space weather and user needs. A targeted approach to science questions has resulted in leveraging new scientific knowledge to improve not only our understanding of the Heliophysics domain, but also to develop predictive capabilities in key areas of LWS science. This fascinating interplay between science and applications promises to benefit both domains. Scientists providing feedback to the LWS program are now discussing an evolution of the targeted approach that explicitly considers how new science improves, or enables, predictive capability directly. Long-term program goals are termed "Strategic Science Areas" (SSAs) that address predictive capabilities in six specific areas: geomagnetically induced currents, satellite drag, solar energetic particles, ionospheric total electron content, radio frequency scintillation induced by the ionosphere, and the radiation environment. SSAs are organized around user needs and the impacts of space weather on society. Scientists involved in the LWS program identify targeted areas of research that reference (or bear upon) societal needs. Such targeted science leads to new discoveries and is one of the valid forms of exploration. In this talk we describe the benefits of targeted science, and how addressing societal impacts in an appropriate way maintains the strong science focus of LWS, while also leading to its broader impacts.

  15. Is Current Hydrogeologic Research Addressing Long-TermPredictions?

    SciTech Connect

    Tsang, Chin-Fu

    2004-09-10

    Hydrogeology is a field closely related to the needs of society. Many problems of current national and local interest require predictions of hydrogeological system behavior, and, in a number of important cases, the period of prediction is tens to hundreds of thousands of years. It is argued that the demand for such long-term hydrogeological predictions casts a new light on the future needs of hydrogeological research. Key scientific issues are no longer concerned only with simple processes or narrowly focused modeling or testing methods, but also with assessment of prediction uncertainties and confidence, couplings among multiple physico-chemical processes occurring simultaneously at a site, and the interplay between site characterization and predictive modeling. These considerations also have significant implications for hydrogeological education. With this view, it is asserted that hydrogeological directions and education need to be reexamined and possibly refocused to address specific needs for long-term predictions.

  16. How State Regulatory Agencies Address Privatization: The Case of Wastewater Treatment.

    ERIC Educational Resources Information Center

    Heilman, John G.; Johnson, Gerald W.

    1991-01-01

    How state agencies have addressed privatization in a service setting (municipal wastewater treatment) is discussed. The implications for evaluations of many types of programs, particularly those of local service programs regulated by the states, are explored. Data from a national survey of state environmental regulatory agencies are highlighted.…

  17. In search of the silver bullet: regulatory models to address childhood obesity.

    PubMed

    Rothenberg, Joan R

    2010-01-01

    The concern over obesity today has evolved beyond an issue of personal vanity to a serious national health issue affecting millions of Americans. Obesity in children is especially alarming. Overweight children and adolescents are at risk for health problems throughout their lives. While under-nutrition or diet insufficiencies were once major obstacles in the development of healthy infants and children, the epidemic of childhood obesity marks the start of the 21st century with equally menacing health consequences. Childhood obesity creates an increased burden of disease on our economy with increased indirect economic costs of time lost from work for parents and time lost from school for the child. Data raise the possibility that the current generation of children could suffer greater illness or experience a shorter lifespan than that of their parents. Some experts believe that government mandated restrictions on dietary choices would alleviate the obesity problem, while others find such actions to be an unwarranted government intrusion. Still, as concerns about obesity continue to grow, especially regarding children, some say government intervention of some type is necessary to solve the problem. This paper examines the history and factors involved in the childhood obesity epidemic, explores regulatory options for its resolution, and provides an overview of obesity as a serious challenge to public health, and the health of children in particular. The federal agencies who share the responsibility for regulating food in the United States and their efforts to address the obesity problem are discussed as a background to various state and federal regulatory models influencing dietary choices. The effectiveness of proposed regulations and alternatives to government intervention suggest that the resolution of the childhood obesity issue requires a coordinated, multilevel approach. PMID:24475539

  18. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory...

  19. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory...

  20. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory...

  1. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory...

  2. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses A Appendix A to Part 73 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PHYSICAL PROTECTION OF PLANTS AND MATERIALS Pt. 73, App. A Appendix A to Part 73—U.S. Nuclear Regulatory...

  3. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Current Addresses and Geographic Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY.... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The...

  4. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market

    PubMed Central

    Geris, L.; Guyot, Y.; Schrooten, J.; Papantoniou, I.

    2016-01-01

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design. PMID:27051516

  5. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

    PubMed

    Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

    2016-04-01

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design.

  6. In silico regenerative medicine: how computational tools allow regulatory and financial challenges to be addressed in a volatile market.

    PubMed

    Geris, L; Guyot, Y; Schrooten, J; Papantoniou, I

    2016-04-01

    The cell therapy market is a highly volatile one, due to the use of disruptive technologies, the current economic situation and the small size of the market. In such a market, companies as well as academic research institutes are in need of tools to advance their understanding and, at the same time, reduce their R&D costs, increase product quality and productivity, and reduce the time to market. An additional difficulty is the regulatory path that needs to be followed, which is challenging in the case of cell-based therapeutic products and should rely on the implementation of quality by design (QbD) principles. In silico modelling is a tool that allows the above-mentioned challenges to be addressed in the field of regenerative medicine. This review discusses such in silico models and focuses more specifically on the bioprocess. Three (clusters of) examples related to this subject are discussed. The first example comes from the pharmaceutical engineering field where QbD principles and their implementation through the use of in silico models are both a regulatory and economic necessity. The second example is related to the production of red blood cells. The described in silico model is mainly used to investigate the manufacturing process of the cell-therapeutic product, and pays special attention to the economic viability of the process. Finally, we describe the set-up of a model capturing essential events in the development of a tissue-engineered combination product in the context of bone tissue engineering. For each of the examples, a short introduction to some economic aspects is given, followed by a description of the in silico tool or tools that have been developed to allow the implementation of QbD principles and optimal design. PMID:27051516

  7. Nanomaterials in Food - Current and Future Applications and Regulatory Aspects

    NASA Astrophysics Data System (ADS)

    Aschberger, K.; Gottardo, S.; Amenta, V.; Arena, M.; Botelho Moniz, F.; Bouwmeester, H.; Brandhoff, P.; Mech, A.; Quiros Pesudo, L.; Rauscher, H.; Schoonjans, R.; Vittoria Vettori, M.; Peters, R.

    2015-05-01

    Nanotechnology can contribute to the development of innovative applications in the agriculture, food and feed sector by e.g. enabling improved delivery of nutrients or increased efficacy of agrichemicals. It is expected that applications will increase in the near future and may therefore become a relevant source of human exposure to nanomaterials (NM). To gain more up-to date information, RIKILT and the Joint Research Centre (JRC) were commissioned by the European Food Safety Authority (EFSA) to prepare an inventory of currently used and reasonably foreseen applications of NM in agriculture and food/feed production and carried out a review of regulatory aspects concerning NM in both EU and non-EU countries. An analysis of the information records in the inventory shows that nano-encapsulates, silver and titanium dioxide are the most frequent type of NM listed and that food additives and food contact materials are the most frequent types of application. A comparison between marketed applications and those in development indicates a trend from inorganic materials (e.g. silver) towards organic materials (nano-encapsulates, nanocomposites). Applications in novel food, feed additives, biocides and pesticides are currently mostly at a developmental stage. The review of EU and non-EU legislation shows that currently a few EU legal acts incorporate a definition of a nanomaterial and specific provisions for NM, whereas in many non-EU countries a broader approach is applied, which mainly builds on guidance for industry.

  8. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY.... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... land and water areas west of the continents of North and South America (except coastal islands) to...

  9. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY.... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... land and water areas west of the continents of North and South America (except coastal islands) to...

  10. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY.... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... land and water areas west of the continents of North and South America (except coastal islands) to...

  11. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS AUTHORITY.... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... land and water areas west of the continents of North and South America (except coastal islands) to...

  12. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals.

    PubMed

    Dugas, Tammy R; Lomnicki, Slawomir; Cormier, Stephania A; Dellinger, Barry; Reams, Margaret

    2016-06-08

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm) and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant.

  13. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals

    PubMed Central

    Dugas, Tammy R.; Lomnicki, Slawomir; Cormier, Stephania A.; Dellinger, Barry; Reams, Margaret

    2016-01-01

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm) and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant. PMID:27338429

  14. Addressing Emerging Risks: Scientific and Regulatory Challenges Associated with Environmentally Persistent Free Radicals.

    PubMed

    Dugas, Tammy R; Lomnicki, Slawomir; Cormier, Stephania A; Dellinger, Barry; Reams, Margaret

    2016-01-01

    Airborne fine and ultrafine particulate matter (PM) are often generated through widely-used thermal processes such as the combustion of fuels or the thermal decomposition of waste. Residents near Superfund sites are exposed to PM through the inhalation of windblown dust, ingestion of soil and sediments, and inhalation of emissions from the on-site thermal treatment of contaminated soils. Epidemiological evidence supports a link between exposure to airborne PM and an increased risk of cardiovascular and pulmonary diseases. It is well-known that during combustion processes, incomplete combustion can lead to the production of organic pollutants that can adsorb to the surface of PM. Recent studies have demonstrated that their interaction with metal centers can lead to the generation of a surface stabilized metal-radical complex capable of redox cycling to produce ROS. Moreover, these free radicals can persist in the environment, hence their designation as Environmentally Persistent Free Radicals (EPFR). EPFR has been demonstrated in both ambient air PM2.5 (diameter < 2.5 µm) and in PM from a variety of combustion sources. Thus, low-temperature, thermal treatment of soils can potentially increase the concentration of EPFR in areas in and around Superfund sites. In this review, we will outline the evidence to date supporting EPFR formation and its environmental significance. Furthermore, we will address the lack of methodologies for specifically addressing its risk assessment and challenges associated with regulating this new, emerging contaminant. PMID:27338429

  15. In Vivo Demonstration of Addressable Microstimulators Powered by Rectification of Epidermically Applied Currents for Miniaturized Neuroprostheses.

    PubMed

    Becerra-Fajardo, Laura; Ivorra, Antoni

    2015-01-01

    Electrical stimulation is used in order to restore nerve mediated functions in patients with neurological disorders, but its applicability is constrained by the invasiveness of the systems required to perform it. As an alternative to implantable systems consisting of central stimulation units wired to the stimulation electrodes, networks of wireless microstimulators have been devised for fine movement restoration. Miniaturization of these microstimulators is currently hampered by the available methods for powering them. Previously, we have proposed and demonstrated a heterodox electrical stimulation method based on electronic rectification of high frequency current bursts. These bursts can be delivered through textile electrodes on the skin. This approach has the potential to result in an unprecedented level of miniaturization as no bulky parts such as coils or batteries are included in the implant. We envision microstimulators designs based on application-specific integrated circuits (ASICs) that will be flexible, thread-like (diameters < 0.5 mm) and not only with controlled stimulation capabilities but also with sensing capabilities for artificial proprioception. We in vivo demonstrate that neuroprostheses composed of addressable microstimulators based on this electrical stimulation method are feasible and can perform controlled charge-balanced electrical stimulation of muscles. We developed miniature external circuit prototypes connected to two bipolar probes that were percutaneously implanted in agonist and antagonist muscles of the hindlimb of an anesthetized rabbit. The electronic implant architecture was able to decode commands that were amplitude modulated on the high frequency (1 MHz) auxiliary current bursts. The devices were capable of independently stimulating the target tissues, accomplishing controlled dorsiflexion and plantarflexion joint movements. In addition, we numerically show that the high frequency current bursts comply with safety standards

  16. In Vivo Demonstration of Addressable Microstimulators Powered by Rectification of Epidermically Applied Currents for Miniaturized Neuroprostheses

    PubMed Central

    2015-01-01

    Electrical stimulation is used in order to restore nerve mediated functions in patients with neurological disorders, but its applicability is constrained by the invasiveness of the systems required to perform it. As an alternative to implantable systems consisting of central stimulation units wired to the stimulation electrodes, networks of wireless microstimulators have been devised for fine movement restoration. Miniaturization of these microstimulators is currently hampered by the available methods for powering them. Previously, we have proposed and demonstrated a heterodox electrical stimulation method based on electronic rectification of high frequency current bursts. These bursts can be delivered through textile electrodes on the skin. This approach has the potential to result in an unprecedented level of miniaturization as no bulky parts such as coils or batteries are included in the implant. We envision microstimulators designs based on application-specific integrated circuits (ASICs) that will be flexible, thread-like (diameters < 0.5 mm) and not only with controlled stimulation capabilities but also with sensing capabilities for artificial proprioception. We in vivo demonstrate that neuroprostheses composed of addressable microstimulators based on this electrical stimulation method are feasible and can perform controlled charge-balanced electrical stimulation of muscles. We developed miniature external circuit prototypes connected to two bipolar probes that were percutaneously implanted in agonist and antagonist muscles of the hindlimb of an anesthetized rabbit. The electronic implant architecture was able to decode commands that were amplitude modulated on the high frequency (1 MHz) auxiliary current bursts. The devices were capable of independently stimulating the target tissues, accomplishing controlled dorsiflexion and plantarflexion joint movements. In addition, we numerically show that the high frequency current bursts comply with safety standards

  17. Current and future applications of PRA in regulatory activities

    SciTech Connect

    Speis, T.P.; Murphy, J.A.; Cunningham, M.A.

    1995-04-01

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

  18. Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies.

    PubMed

    Dane, Aaron; Wetherington, Jeffrey D

    2014-01-01

    At present, there are situations in antibiotic drug development where the low number of enrollable patients with key problem pathogens makes it impossible to conduct fully powered non-inferiority trials in the traditional way. Recent regulatory changes have begun to address this situation. In parallel, statistical issues regarding the application of alternative techniques, balancing the unmet need with the level of certainty in the approval process, and the use of additional sources of data are critical areas to increase development feasibility. Although such approaches increase uncertainty compared with a traditional development program, this will be necessary to allow new agents to be made available. Identification of these risks and explicit discussion around requirements in these areas should help clarify the situation, and hence, the feasibility of developing drugs to treat the most concerning pathogens before the unmet need becomes even more acute than at present.

  19. Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems.

    PubMed

    Sapsford, Kim E; Lauritsen, Kristina; Tyner, Katherine M

    2012-12-01

    The US FDA is the US agency responsible for regulating intelligent drug-delivery systems (IDDS). IDDS can be classified as a device, drug, biologic or combination product. In this perspective, the current regulatory framework for IDDS and future perspectives on how the field is expected to evolve from a regulatory standpoint is discussed.

  20. Towards addressable wireless microstimulators based on electronic rectification of epidermically applied currents.

    PubMed

    Becerra-Fajardo, L; Ivorra, A

    2014-01-01

    Electrical stimulation has been explored to restore the capabilities of the nervous system in paralysis patients. This area of research and of clinical practice, known as Functional Electrical Stimulation, would greatly benefit from further miniaturization of implantable stimulators. To that end, we recently proposed and demonstrated an innovative electrical stimulation method in which implanted microstimulators operate as rectifiers of bursts of innocuous high frequency current supplied by skin electrodes, thus generating low frequency currents capable of stimulating excitable tissues. A diode could suffice in some applications but, in order to broaden the method's clinical applicability, we envision rectifiers with advanced capabilities such as current control and addressability. We plan flexible thread-like implants (diameters < 300 μm) containing ASICs. As an intermediate stage, we are developing macroscopic implants (diameters ~ 2 mm) made of off-the-shelf components. Here we present a circuit which responds to commands modulated within the high frequency bursts and which is able to deliver charge-balanced currents. We show that a number of these circuits can perform independent stimulation of segments of an anesthetized earthworm following commands from a computer. PMID:25570862

  1. The role of business in addressing the long-term implications of the current food crisis.

    PubMed

    Yach, Derek

    2008-01-01

    Before the onset of the current food crisis, the evidence of a severely neglected nutrition crisis was starting to receive attention. Increased food prices are having severe impacts on the nutritional status of populations. Our current food system has evolved over decades in a largely unplanned manner and without consideration for the complexity and implications of linkages between health, nutrition, agricultural, economic, trade and security issues. The underlying causes for the nutrition crisis include the above, as well as decades of neglect with regard to nutrition, and agricultural science (especially in emerging markets); a failure of governance with respect to the major players involved in nutrition, a weak response by government donors and Foundations to invest in basic nutrition (in contrast to growing support for humanitarian aspects of food aid), and a reluctance to develop private-public partnerships. The emergence of new business models that tackle social problems while remaining profitable offers promise that the long term nutrition needs of people can be met. Businesses can have greater impact acting collectively than individually. Food, retail, food service, chemical and pharmaceutical companies have expertise, distribution systems and customers insights, if well harnessed, could leapfrog progress in addressing the food and nutrition crises. While business can do lots more, its combined impact will be minimal if a range of essential government actions and policies are not addressed. Governments need to create innovative and complementary opportunities that include incentives for businesses including: setting clear nutritional guidelines for fortification and for ready-to eat products; offering agreements to endorse approved products and support their distribution to clinics and schools; eliminating duties on imported vitamins and other micronutrients; and providing tax and other incentives for industry to invest with donors in essential nutrition

  2. The role of business in addressing the long-term implications of the current food crisis

    PubMed Central

    Yach, Derek

    2008-01-01

    Before the onset of the current food crisis, the evidence of a severely neglected nutrition crisis was starting to receive attention. Increased food prices are having severe impacts on the nutritional status of populations. Our current food system has evolved over decades in a largely unplanned manner and without consideration for the complexity and implications of linkages between health, nutrition, agricultural, economic, trade and security issues. The underlying causes for the nutrition crisis include the above, as well as decades of neglect with regard to nutrition, and agricultural science (especially in emerging markets); a failure of governance with respect to the major players involved in nutrition, a weak response by government donors and Foundations to invest in basic nutrition (in contrast to growing support for humanitarian aspects of food aid), and a reluctance to develop private-public partnerships. The emergence of new business models that tackle social problems while remaining profitable offers promise that the long term nutrition needs of people can be met. Businesses can have greater impact acting collectively than individually. Food, retail, food service, chemical and pharmaceutical companies have expertise, distribution systems and customers insights, if well harnessed, could leapfrog progress in addressing the food and nutrition crises. While business can do lots more, its combined impact will be minimal if a range of essential government actions and policies are not addressed. Governments need to create innovative and complementary opportunities that include incentives for businesses including: setting clear nutritional guidelines for fortification and for ready-to eat products; offering agreements to endorse approved products and support their distribution to clinics and schools; eliminating duties on imported vitamins and other micronutrients; and providing tax and other incentives for industry to invest with donors in essential nutrition

  3. The role of business in addressing the long-term implications of the current food crisis.

    PubMed

    Yach, Derek

    2008-01-01

    Before the onset of the current food crisis, the evidence of a severely neglected nutrition crisis was starting to receive attention. Increased food prices are having severe impacts on the nutritional status of populations. Our current food system has evolved over decades in a largely unplanned manner and without consideration for the complexity and implications of linkages between health, nutrition, agricultural, economic, trade and security issues. The underlying causes for the nutrition crisis include the above, as well as decades of neglect with regard to nutrition, and agricultural science (especially in emerging markets); a failure of governance with respect to the major players involved in nutrition, a weak response by government donors and Foundations to invest in basic nutrition (in contrast to growing support for humanitarian aspects of food aid), and a reluctance to develop private-public partnerships. The emergence of new business models that tackle social problems while remaining profitable offers promise that the long term nutrition needs of people can be met. Businesses can have greater impact acting collectively than individually. Food, retail, food service, chemical and pharmaceutical companies have expertise, distribution systems and customers insights, if well harnessed, could leapfrog progress in addressing the food and nutrition crises. While business can do lots more, its combined impact will be minimal if a range of essential government actions and policies are not addressed. Governments need to create innovative and complementary opportunities that include incentives for businesses including: setting clear nutritional guidelines for fortification and for ready-to eat products; offering agreements to endorse approved products and support their distribution to clinics and schools; eliminating duties on imported vitamins and other micronutrients; and providing tax and other incentives for industry to invest with donors in essential nutrition

  4. Left ventricular partitioning in systolic heart failure subjects: addressing a mechanistic void with current therapies.

    PubMed

    Schäfer, Ulrich

    2016-05-17

    ICD patients with narrow QRS, CRT non-responders, and functional MR patients all have one mechanistic failure mode that is left untreated - the scar left behind following an MI. ICDs, CRTs, and MitraClip implantation are all well-proven therapies, but the Parachute device may address the mechanistic void that remains after each of these therapies has been used and may further improve patients' outcomes. A pooled analysis of 134 subjects was conducted using the first three clinical trials which included subjects with symptomatic ischaemic HF with LV wall motion abnormalities secondary to MI, and an LV ejection fraction less than 40%. The two-year cumulative mortality rate was 12.9%, with 8.7% in the first year and an increment of 4.2% in the second, which is a 53% reduction as compared to the first year. There is a significant proportion of patients with ischaemic heart failure being excluded from cardiac rhythm management (CRT, etc.), leaving a large treatment gap until mechanical support devices (LVAD) or heart transplantation in progressive heart failure are indicated. Along with other heart failure devices, Parachute may be a useful treatment modality, addressing a mechanistic void in the treatment of this disease. Current data support improvements in haemodynamics, functional capacity, six-minute walk distance, quality of life and a promising decline in mortality two years after Parachute implantation. PMID:27174122

  5. Is current biochar soil study addressing global soil constraints for sustainable agriculture?

    NASA Astrophysics Data System (ADS)

    Pan, Genxing; Zhang, Dengxiao; Yan, Ming; Niu, Yaru; Liu, Xiaoyu; van Zwieten, Lukas; Chen, De; Bian, Rongjun; Cheng, Kun; Li, Lianqing; Joseph, Stephen; Zheng, Jinwei; Zhang, Xuhui; Zheng, Jufeng; Crowley, David; Filley, Timothy

    2016-04-01

    Global soil degradation has been increasingly threatened sustainability of world agriculture. Use of biochar from bio-wastes has been proposed as a global option for its great potential in tackling soil degradation and mitigating climate change in agriculture. For last 10 years, there have been greatly increasing interests in application of charred biomass, more recently termed biochar, as a soil amendment for addressing soil constraints for sustainable agriculture. Biochar soil studies could deliver reliable information for appropriate application of biochar to soils where for sustainable agriculture has been challenged. Here we review the literature of 798 publications reporting biochar soil studies by August, 2015 to address potential gaps in understanding of biochar's role in agriculture. We have found some substantial biases and gaps inherent in the current biochar studies. 1) The majority of published studies were from developed regions where the soils are less constrained and were much more frequent in laboratory and glasshouse pot experiments than field studies under realistic agriculture. 2) The published biochar soil studies have used more often small kiln or lab prepared biochar than commercial scale biochars, more often wood and municipal waste derived biochars than crop straw biochars. Overall, the lack of long-term well designed field studies using biochar produced in commercial processes may have limited our current understanding of biochar's potential to enhance global crop production and climate change mitigation. We have also recommended a global alliance between longer-term research experiments and biochar production facilities to foster the uptake of this important technology at a global scale. Keywords: biochar, soil study, literature review, research gap, global perspective, quantitative assessment, sustainable agriculture

  6. Pursuing Energy Efficiency as a Hedge against Carbon Regulatory Risks: Current Resource Planning Practices in the West

    SciTech Connect

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-08-01

    Uncertainty surrounding the nature and timing of future carbon regulations poses a fundamental and far-reaching financial risk for electric utilities and their ratepayers. Long-term resource planning provides a potential framework within which utilities can assess carbon regulatory risk and evaluate options for mitigating exposure to this risk through investments in energy efficiency and other low-carbon resources. In this paper, we examine current resource planning practices related to managing carbon regulatory risk, based on a comparative analysis of the most-recent long-term resource plans filed by fifteen major utilities in the Western U.S. First, we compare the assumptions and methods used by utilities to assess carbon regulatory risk and to evaluate energy efficiency as a risk mitigation option. Although most utilities have made important strides in beginning to address carbon regulatory risk within their resource plan, we also identify a number of opportunities for improvement and offer recommendations for resource planners and state regulators to consider. We also summarize the composition and carbon intensity of the preferred resource portfolios selected by the fifteen Western utilities, highlighting the contribution of energy efficiency and its impact on the carbon intensity of utilities' proposed resource strategies. Energy efficiency and renewables are the dominant low-carbon resources included in utilities' preferred portfolios. Across the fifteen utilities, energy efficiency constitutes anywhere from 6percent to almost 50percent of the preferred portfolio energy resources, and represents 22percent of all incremental resources in aggregate.

  7. Pursuing Energy Efficiency as a Hedge against Carbon Regulatory Risks: Current Resource Planning Practices in the West

    SciTech Connect

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-07-11

    Uncertainty surrounding the nature and timing of future carbon regulations poses a fundamental and far-reaching financial risk for electric utilities and their ratepayers. Long-term resource planning provides a potential framework within which utilities can assess carbon regulatory risk and evaluate options for mitigating exposure to this risk through investments in energy efficiency and other low-carbon resources. In this paper, we examine current resource planning practices related to managing carbon regulatory risk, based on a comparative analysis of the most-recent long-term resource plans filed by fifteen major utilities in the Western U.S. First, we compare the assumptions and methods used by utilities to assess carbon regulatory risk and to evaluate energy efficiency as a risk mitigation option. Although most utilities have made important strides in beginning to address carbon regulatory risk within their resource plan, we also identify a number of opportunities for improvement and offer recommendations for resource planners and state regulators to consider. We also summarize the composition and carbon intensity of the preferred resource portfolios selected by the fifteen Western utilities, highlighting the contribution of energy efficiency and its impact on the carbon intensity of utilities' proposed resource strategies. Energy efficiency and renewables are the dominant low-carbon resources included in utilities' preferred portfolios. Across the fifteen utilities, energy efficiency constitutes anywhere from 6percent to almost 50percent of the preferred portfolio energy resources, and represents 22percent of all incremental resources in aggregate.

  8. Jabs and barbs: ways to address misleading vaccination and immunisation information using currently available strategies.

    PubMed

    Wardle, Jon; Stewart, Cameron; Parker, Malcolm

    2013-09-01

    Misleading vaccination information undermines confidence in vaccination and may lead to reductions in the effectiveness of vaccination programs. A number of regulatory techniques can be employed to challenge the spread of false information, including health care complaints, therapeutic goods laws, consumer protection laws and professional discipline. This article examines three case studies involving the publication of anti-vaccination information by non-professionally aligned organisations, by non-registered health professionals, and by registered health professionals under the National Law. The article examines the effectiveness of different regulatory responses and makes suggestions for future strategies to deal with the publication of demonstrably false information regarding vaccination. PMID:24218789

  9. Jabs and barbs: ways to address misleading vaccination and immunisation information using currently available strategies.

    PubMed

    Wardle, Jon; Stewart, Cameron; Parker, Malcolm

    2013-09-01

    Misleading vaccination information undermines confidence in vaccination and may lead to reductions in the effectiveness of vaccination programs. A number of regulatory techniques can be employed to challenge the spread of false information, including health care complaints, therapeutic goods laws, consumer protection laws and professional discipline. This article examines three case studies involving the publication of anti-vaccination information by non-professionally aligned organisations, by non-registered health professionals, and by registered health professionals under the National Law. The article examines the effectiveness of different regulatory responses and makes suggestions for future strategies to deal with the publication of demonstrably false information regarding vaccination.

  10. The GÉANT network: addressing current and future needs of the HEP community

    NASA Astrophysics Data System (ADS)

    Capone, Vincenzo; Usman, Mian

    2015-12-01

    The GÉANT infrastructure is the backbone that serves the scientific communities in Europe for their data movement needs and their access to international research and education networks. Using the extensive fibre footprint and infrastructure in Europe the GÉANT network delivers a portfolio of services aimed to best fit the specific needs of the users, including Authentication and Authorization Infrastructure, end-to-end performance monitoring, advanced network services (dynamic circuits, L2-L3VPN, MD-VPN). This talk will outline the factors that help the GÉANT network to respond to the needs of the High Energy Physics community, both in Europe and worldwide. The Pan-European network provides the connectivity between 40 European national research and education networks. In addition, GÉANT also connects the European NRENs to the R&E networks in other world region and has reach to over 110 NREN worldwide, making GÉANT the best connected Research and Education network, with its multiple intercontinental links to different continents e.g. North and South America, Africa and Asia-Pacific. The High Energy Physics computational needs have always had (and will keep having) a leading role among the scientific user groups of the GÉANT network: the LHCONE overlay network has been built, in collaboration with the other big world REN, specifically to address the peculiar needs of the LHC data movement. Recently, as a result of a series of coordinated efforts, the LHCONE network has been expanded to the Asia-Pacific area, and is going to include some of the main regional R&E network in the area. The LHC community is not the only one that is actively using a distributed computing model (hence the need for a high-performance network); new communities are arising, as BELLE II. GÉANT is deeply involved also with the BELLE II Experiment, to provide full support to their distributed computing model, along with a perfSONAR-based network monitoring system. GÉANT has also

  11. Data Integrity-A Study of Current Regulatory Thinking and Action.

    PubMed

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  12. The Importance of Exposure in Addressing Current and Emerging Air Quality Issues

    EPA Science Inventory

    The air quality issues that we face today and will face in the future are becoming increasingly more complex and require an improved understanding of human exposure to be effectively addressed. The objectives of this paper are (1) to discuss how concepts of human exposure and ex...

  13. A Problem-Solving Approach to Addressing Current Global Challenges in Education

    ERIC Educational Resources Information Center

    Chapman, Judith D.; Aspin, David N.

    2013-01-01

    This paper begins with an analysis of global problems shaping education, particularly as they impact upon learning and life chances. In addressing these problems a range of philosophical positions and controversies are considered, including: traditional romantic and institutional views of schooling; and more recent maximalist, neo-liberal,…

  14. Regulatory assessment of chemical mixtures: Requirements, current approaches and future perspectives.

    PubMed

    Kienzler, Aude; Bopp, Stephanie K; van der Linden, Sander; Berggren, Elisabet; Worth, Andrew

    2016-10-01

    This paper reviews regulatory requirements and recent case studies to illustrate how the risk assessment (RA) of chemical mixtures is conducted, considering both the effects on human health and on the environment. A broad range of chemicals, regulations and RA methodologies are covered, in order to identify mixtures of concern, gaps in the regulatory framework, data needs, and further work to be carried out. Also the current and potential future use of novel tools (Adverse Outcome Pathways, in silico tools, toxicokinetic modelling, etc.) in the RA of combined effects were reviewed. The assumptions made in the RA, predictive model specifications and the choice of toxic reference values can greatly influence the assessment outcome, and should therefore be specifically justified. Novel tools could support mixture RA mainly by providing a better understanding of the underlying mechanisms of combined effects. Nevertheless, their use is currently limited because of a lack of guidance, data, and expertise. More guidance is needed to facilitate their application. As far as the authors are aware, no prospective RA concerning chemicals related to various regulatory sectors has been performed to date, even though numerous chemicals are registered under several regulatory frameworks. PMID:27211294

  15. Regulatory assessment of chemical mixtures: Requirements, current approaches and future perspectives.

    PubMed

    Kienzler, Aude; Bopp, Stephanie K; van der Linden, Sander; Berggren, Elisabet; Worth, Andrew

    2016-10-01

    This paper reviews regulatory requirements and recent case studies to illustrate how the risk assessment (RA) of chemical mixtures is conducted, considering both the effects on human health and on the environment. A broad range of chemicals, regulations and RA methodologies are covered, in order to identify mixtures of concern, gaps in the regulatory framework, data needs, and further work to be carried out. Also the current and potential future use of novel tools (Adverse Outcome Pathways, in silico tools, toxicokinetic modelling, etc.) in the RA of combined effects were reviewed. The assumptions made in the RA, predictive model specifications and the choice of toxic reference values can greatly influence the assessment outcome, and should therefore be specifically justified. Novel tools could support mixture RA mainly by providing a better understanding of the underlying mechanisms of combined effects. Nevertheless, their use is currently limited because of a lack of guidance, data, and expertise. More guidance is needed to facilitate their application. As far as the authors are aware, no prospective RA concerning chemicals related to various regulatory sectors has been performed to date, even though numerous chemicals are registered under several regulatory frameworks.

  16. 78 FR 45910 - Proposed Information Collection; Comment Request; Current Population Survey (CPS) Email Address...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE Census Bureau Proposed Information Collection; Comment Request; Current Population Survey (CPS) Email... Population Survey (CPS) has been collecting data on household employment for decades. Through the years,...

  17. Current California legislative and regulatory activity impacting geothermal hydrothermal commercialization: a monitoring report. Report No. 1017

    SciTech Connect

    Not Available

    1980-01-20

    Four key geothermal-impacting bills presently before the California legislature are described. Two deal with state financial backing for geothermal projects. The third relates to the use of the state's share of the BLM geothermal revenues and the fourth to the protection of sensitive hot springs. The current regulatory activities of the California Energy Commission, the California Division of Oil and Gas, and the counties are discussed. (MHR)

  18. Multiscale Modeling in Computational Biomechanics: Determining Computational Priorities and Addressing Current Challenges

    SciTech Connect

    Tawhai, Merryn; Bischoff, Jeff; Einstein, Daniel R.; Erdemir, Ahmet; Guess, Trent; Reinbolt, Jeff

    2009-05-01

    Abstract In this article, we describe some current multiscale modeling issues in computational biomechanics from the perspective of the musculoskeletal and respiratory systems and mechanotransduction. First, we outline the necessity of multiscale simulations in these biological systems. Then we summarize challenges inherent to multiscale biomechanics modeling, regardless of the subdiscipline, followed by computational challenges that are system-specific. We discuss some of the current tools that have been utilized to aid research in multiscale mechanics simulations, and the priorities to further the field of multiscale biomechanics computation.

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

    PubMed

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

    2015-08-01

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

  20. Addressing neuropsychiatric disturbances during rehabilitation after traumatic brain injury: current and future methods

    PubMed Central

    Arciniegas, David B.

    2011-01-01

    Cognitive, emotional, behavioral, and sensorimotor disturbances are the principal clinical manifestations of traumatic brain injury (TBI) throughout the early postinjury period. These post-traumatic neuropsychiatric disturbances present substantial challenges to patients, their families, and clinicians providing their rehabilitative care, the optimal approaches to which remain incompletely developed. In this article, a neuropsychiairically informed, neurobiologically anchored approach to understanding and meeting challenges is described. The foundation for thai approach is laid, with a review of clinical case definitions of TBI and clarification of their intended referents. The differential diagnosis of event-related neuropsychiatric disturbances is considered next, after which the clinical and neurobiological heterogeneity within the diagnostic category of TBI are discussed. The clinical manifestations of biomechanical force-induced brain dysfunction are described as a state of post-traumatic encephalopathy (PTE) comprising several phenomenologically distinct stages, PTE is then used as a framework for understanding and clinically evaluating the neuropsychiatric sequelae of TBI encountered commonly during the early post-injury rehabilitation period, and for considering the types and timings of neurorehabilitative interventions. Finally, directions for future research that may address productively the challenges to TBI rehabilitation presented by neuropsychiatric disturbances are considered. PMID:22034400

  1. Developing and Using Benchmarks for Eddy Current Simulation Codes Validation to Address Industrial Issues

    NASA Astrophysics Data System (ADS)

    Mayos, M.; Buvat, F.; Costan, V.; Moreau, O.; Gilles-Pascaud, C.; Reboud, C.; Foucher, F.

    2011-06-01

    To achieve performance demonstration, which is a legal requirement for the qualification of NDE processes applied on French nuclear power plants, the use of modeling tools is a valuable support, provided that the employed models have been previously validated. To achieve this, in particular for eddy current modeling, a validation methodology based on the use of specific benchmarks close to the actual industrial issue has to be defined. Nonetheless, considering the high variability in code origin and complexity, the feedback from experience on actual cases has shown that it was critical to define simpler generic and public benchmarks in order to perform a preliminary selection. A specific Working Group has been launched in the frame of COFREND, the French Association for NDE, resulting in the definition of several benchmark problems. This action is now ready for mutualization with similar international approaches.

  2. A practical validation approach for virus titer testing of avian infectious bursal disease live vaccine according to current regulatory guidelines.

    PubMed

    Weber Sušanj, Mirta; Košiček, Miljenko; Krnić, Ela Kosor; Ballarin-Perharić, Alenka; Terzić, Svjetlana

    2012-01-01

    The method for virus titer determination of avian infectious bursal disease (IBD) live vaccine, developed long before regulatory validation guidelines is a cell culture based biological assay intended for use in vaccine release testing. The aim of our study was to perform a validation, based on fit-for-purpose principle, of an old 50% tissue culture infectious dose (TCID(50)) method according to Guidelines of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This paper addresses challenges and discusses some key aspects that should be considered when validating biological methods. A different statistical approach and non-parametric statistics was introduced in validation protocol in order to derive useful information from experimental data. This approach is applicable for a wide range of methods. In conclusion, the previous virus titration method had showed to be precise, accurate, linear, robust and in accordance with current regulatory standards, which indicates that there is no need for additional re-development or upgrades of the method for its suitability for intended use.

  3. MEETING IN TUCSON: MODEL EVALUATION SCIENCE TO MEET TODAY'S QUALITY ASSURANCE REQUIREMENTS FOR REGULATORY USE: ADDRESSING UNCERTAINTY, SENSITIVITY, AND PARAMETERIZATION

    EPA Science Inventory

    The EPA/ORD National Exposure Research Lab's (NERL) UA/SA/PE research program addresses both tactical and strategic needs in direct support of ORD's client base. The design represents an integrated approach in achieving the highest levels of quality assurance in environmental dec...

  4. MODEL EVALUATION SCIENCE TO MEET TODAY'S QUALITY ASSURANCE REQUIREMENTS FOR REGULATORY USE: ADDRESSING UNCERTAINTY, SENSITIVITY, AND PARAMETERIZATION

    EPA Science Inventory

    The EPA/ORD National Exposure Research Lab's (NERL) UA/SA/PE research program addresses both tactical and strategic needs in direct support of ORD's client base. The design represents an integrated approach in achieving the highest levels of quality assurance in environmental de...

  5. Potential of old-generation antibiotics to address current need for new antibiotics.

    PubMed

    Falagas, Matthew E; Grammatikos, Alexandros P; Michalopoulos, Argyris

    2008-10-01

    Despite the constantly increasing need for new antimicrobial agents, antibiotic drug discovery and development seem to have greatly decelerated in recent years. Presented with the significant problem of advancing antimicrobial resistance, the global scientific community has attempted to find alternative solutions; one of the most promising ones is the evaluation and use of old antibiotic compounds. Due to the low-level use of many of the old antibiotic compounds, these have remained active against a large number of currently prevalent bacterial isolates. Thus, clinicians are beginning to re-evaluate their use in various patient populations and infections, despite the fact that they were previously thought to be less effective and/or more toxic than newer agents. A number of old antibiotic compounds, such as polymyxins, fosfomycin, fusidic acid, cotrimoxazole, aminoglycosides and chloramphenicol, are re-emerging as valuable alternatives for the treatment of difficult-to-treat infections. The availability of novel genetic and molecular modification methods provides hope that the toxicity and efficacy drawbacks presented by some of these agents can be surpassed in the future. PMID:18847400

  6. Potential of old-generation antibiotics to address current need for new antibiotics.

    PubMed

    Falagas, Matthew E; Grammatikos, Alexandros P; Michalopoulos, Argyris

    2008-10-01

    Despite the constantly increasing need for new antimicrobial agents, antibiotic drug discovery and development seem to have greatly decelerated in recent years. Presented with the significant problem of advancing antimicrobial resistance, the global scientific community has attempted to find alternative solutions; one of the most promising ones is the evaluation and use of old antibiotic compounds. Due to the low-level use of many of the old antibiotic compounds, these have remained active against a large number of currently prevalent bacterial isolates. Thus, clinicians are beginning to re-evaluate their use in various patient populations and infections, despite the fact that they were previously thought to be less effective and/or more toxic than newer agents. A number of old antibiotic compounds, such as polymyxins, fosfomycin, fusidic acid, cotrimoxazole, aminoglycosides and chloramphenicol, are re-emerging as valuable alternatives for the treatment of difficult-to-treat infections. The availability of novel genetic and molecular modification methods provides hope that the toxicity and efficacy drawbacks presented by some of these agents can be surpassed in the future.

  7. Addressing Therapeutic Options for Ebola Virus Infection in Current and Future Outbreaks

    PubMed Central

    Hober, Didier; Blondiaux, Joel

    2015-01-01

    Ebola virus can cause severe hemorrhagic disease with high fatality rates. Currently, no specific therapeutic agent or vaccine has been approved for treatment and prevention of Ebola virus infection of humans. Although the number of Ebola cases has fallen in the last few weeks, multiple outbreaks of Ebola virus infection and the likelihood of future exposure highlight the need for development and rapid evaluation of pre- and postexposure treatments. Here, we briefly review the existing and future options for anti-Ebola therapy, based on the data coming from rare clinical reports, studies on animals, and results from in vitro models. We also project the mechanistic hypotheses of several potential drugs against Ebola virus, including small-molecule-based drugs, which are under development and being tested in animal models or in vitro using various cell types. Our paper discusses strategies toward identifying and testing anti-Ebola virus properties of known and medically approved drugs, especially those that can limit the pathological inflammatory response in Ebola patients and thereby provide protection from mortality. We underline the importance of developing combinational therapy for better treatment outcomes for Ebola patients. PMID:26248374

  8. Addressing Therapeutic Options for Ebola Virus Infection in Current and Future Outbreaks.

    PubMed

    Haque, Azizul; Hober, Didier; Blondiaux, Joel

    2015-10-01

    Ebola virus can cause severe hemorrhagic disease with high fatality rates. Currently, no specific therapeutic agent or vaccine has been approved for treatment and prevention of Ebola virus infection of humans. Although the number of Ebola cases has fallen in the last few weeks, multiple outbreaks of Ebola virus infection and the likelihood of future exposure highlight the need for development and rapid evaluation of pre- and postexposure treatments. Here, we briefly review the existing and future options for anti-Ebola therapy, based on the data coming from rare clinical reports, studies on animals, and results from in vitro models. We also project the mechanistic hypotheses of several potential drugs against Ebola virus, including small-molecule-based drugs, which are under development and being tested in animal models or in vitro using various cell types. Our paper discusses strategies toward identifying and testing anti-Ebola virus properties of known and medically approved drugs, especially those that can limit the pathological inflammatory response in Ebola patients and thereby provide protection from mortality. We underline the importance of developing combinational therapy for better treatment outcomes for Ebola patients.

  9. Molecular paleoecology: using gene regulatory analysis to address the origins of complex life cycles in the late Precambrian.

    PubMed

    Dunn, Ewan F; Moy, Vanessa N; Angerer, Lynne M; Angerer, Robert C; Morris, Robert L; Peterson, Kevin J

    2007-01-01

    Molecular paleoecology is the application of molecular data to test hypotheses made by paleoecological scenarios. Here, we use gene regulatory analysis to test between two competing paleoecological scenarios put forth to explain the evolution of complex life cycles. The first posits that early bilaterians were holobenthic, and the evolution of macrophagous grazing drove the exploitation of the pelagos by metazoan eggs and embryos, and eventually larvae. The alternative hypothesis predicts that early bilaterians were holopelagic, and new adult stages were added on when these holopelagic forms began to feed on the benthos. The former hypothesis predicts that the larvae of protostomes and deuterostomes are not homologous, with the implication that larval-specific structures, including the apical organ, are the products of convergent evolution, whereas the latter hypothesis predicts homology of larvae, specifically homology of the apical organ. We show that in the sea urchin, Strongylocentrotus purpuratus, the transcription factors NK2.1 and HNF6 are necessary for the correct spatial expression profiles of five different cilia genes. All of these genes are expressed exclusively in the apical plate after the mesenchyme-blastula stage in cells that also express NK2.1 and HNF6. In addition, abrogation of SpNK2.1 results in embryos that lack the apical tuft. However, in the red abalone, Haliotis rufescens, NK2.1 and HNF6 are not expressed in any cells that also express these same five cilia genes. Nonetheless, like the sea urchin, the gastropod expresses both NK2.1 and FoxA around the stomodeum and foregut, and FoxA around the proctodeum. As we detected no similarity in the development of the apical tuft between the sea urchin and the abalone, these molecular data are consistent with the hypothesis that the evolution of mobile, macrophagous metazoans drove the evolution of complex life cycles multiple times independently in the late Precambrian.

  10. Comprehensive analysis of current approaches to inhibit regulatory T cells in cancer

    PubMed Central

    Pere, Helene; Tanchot, Corinne; Bayry, Jagadeesh; Terme, Magali; Taieb, Julien; Badoual, Cecile; Adotevi, Olivier; Merillon, Nathalie; Marcheteau, Elie; Quillien, Ve´ronique; Banissi, Claire; Carpentier, Alain; Sandoval, Federico; Nizard, Mevyn; Quintin-Colonna, Françoise; Kroemer, Guido; Fridman, Wolf H.; Zitvogel, Laurence; Oudard, Ste´phane; Tartour, Eric

    2012-01-01

    CD4+CD25+Foxp3+ regulatory T cells (Treg) have emerged as a dominant T cell population inhibiting anti-tumor effector T cells. Initial strategies used for Treg-depletion (cyclophosphamide, anti-CD25 mAb…) also targeted activated T cells, as they share many phenotypic markers. Current, ameliorated approaches to inhibit Treg aim to either block their function or their migration to lymph nodes and the tumor microenvironment. Various drugs originally developed for other therapeutic indications (anti-angiogenic molecules, tyrosine kinase inhibitors,etc) have recently been discovered to inhibit Treg. These approaches are expected to be rapidly translated to clinical applications for therapeutic use in combination with immunomodulators. PMID:22737608

  11. Addressing the unequal geographic distribution of specialist doctors in indonesia: the role of the private sector and effectiveness of current regulations.

    PubMed

    Meliala, Andreasta; Hort, Krishna; Trisnantoro, Laksono

    2013-04-01

    As in many countries, the geographic distribution of the health workforce in Indonesia is unequal, with a concentration in urban and more developed areas, and a scarcity in rural and remote areas. There is less information on the distribution of specialist doctors, yet inequalities in their distribution could compromise efforts to achieve universal coverage by 2014. This paper uses data from 2007 and 2008 to describe the geographic distribution of specialist doctors in Indonesia, and to examine two key factors that influence the distribution and are targets of current policies: sources of income for specialist doctors, and specialist doctor engagement in private practice. The data demonstrates large differences in the ratio of specialist doctors to population among the provinces of Indonesia, with higher ratios on the provinces of the islands of Java, and much lower ratios on the more remote provinces in eastern Indonesia. Between 65% and 80% of specialist doctors' income derives from private practice in non-state hospitals or private clinics. Despite regulations limiting practice locations to three, most specialists studied in a provincial capital city were working in more than three locations, with some working in up to 7 locations, and spending only a few hours per week in their government hospital practice. Our study demonstrates that the current regulatory policies and financial incentives have not been effective in addressing the maldistribution of specialist doctors in a context of a growing private sector and predominance of doctors' income from private sources. A broader and more integrated policy approach, including more innovative service delivery strategies for rural and remote areas, is recommended.

  12. Current Status and Regulatory Aspects of Pesticides Considered to be Persistent Organic Pollutants (POPs) in Taiwan

    PubMed Central

    Tsai, Wen-Tien

    2010-01-01

    Organochlorine pesticides (OCPs) are capable of persisting in the environment, transporting between phase media and accumulating to high levels, implying that they could pose a risk of causing adverse effects to human health and the environment. Consequently, most OCPs are designated as persistent organic pollutants (POPs) and even as endocrine disrupting chemicals (EDCs). The objective of this paper was to review the current status of pesticide POPs in Taiwan, including aldrin, chlordane, chlordecone, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, α/β-hexachlorocyclohexanes, lindane, mirex, pentachloro-benzene, and toxaphene. The information about their environmental properties, banned use, carcinogenic toxicity and environmental levels, can be connected with the regulatory infrastructure, which has been established by the joint-venture of the central competent authorities (i.e., Environmental Protection Administration, Department of Health, Council of Agriculture, and Council of Labor Affairs). The significant progress to be reported is that the residual levels of these pesticide-POPs, ranging from trace amounts to a few ppb, have declined notably in recent years. PMID:21139852

  13. NRC regulatory initiatives

    SciTech Connect

    Johnson, T.C.

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  14. Current California legislative and regulatory activity impacting geothermal hydrothermal commercialization: monitoring report No. 2. Report No. 1020

    SciTech Connect

    Not Available

    1980-04-20

    The progress of four bills relating to geothermal energy is reported. The current regulatory activities of the California Energy Commission, the Lake County Planning Commission/Lake County Air Pollution Control District, the Governor's Office of Planning and Research, the State Lands' Commission, and the California Public Utilities Commission are reviewed. (MHR)

  15. How Does the Capability Approach Address Current Issues in Special Educational Needs, Disability and Inclusive Education Field?

    ERIC Educational Resources Information Center

    Norwich, Brahm

    2014-01-01

    This paper aims to examine what the capability approach has to offer to the field of special needs and inclusive education. Several key questions are addressed: can the capability approach replace the language of needs and rights; whether the capability approach can address key issues in the field of disabilities and difficulties in education and…

  16. Addressing Concerns.

    ERIC Educational Resources Information Center

    Cronin, Greg; Helmig, Mary; Kaplan, Bill; Kosch, Sharon

    2002-01-01

    Four camp directors discuss how the September 11 tragedy and current world events will affect their camps. They describe how they are addressing safety concerns, working with parents, cooperating with outside agencies, hiring and screening international staff, and revising emergency plans. Camps must continue to offer community and support to…

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

    NASA Astrophysics Data System (ADS)

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

    1985-02-01

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

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

    SciTech Connect

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

    1985-02-01

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

  19. An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins

    PubMed Central

    Khatami, Hootan; McKinnon, Ross; Home, Philip

    2015-01-01

    Abstract Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As of August 2014, general biosimilar and insulin-specific guidelines are available in 34 countries and two countries/regulatory domains, respectively. Many guidelines are clearly related to, or partly derived from, the general and insulin-specific European Medicines Agency (EMA) guidelines. Areas covered by these guidelines are fairly consistent, covering preclinical, pharmacokinetic (PK), and pharmacodynamic (PD) studies in humans and clinical areas; however, there are differences in emphasis. The EMA insulin-specific guidelines include detailed criteria on PK/PD studies, as do most other general biosimilar guidelines and, to a lesser extent, clinical studies. The U.S. Food and Drug Administration has general biosimilar guidelines, emphasizing consideration of the whole package of in vitro, biological, and human studies, rather than concentrating on any one aspect. In countries such as Mexico, guidelines are broad, leaving wide discretion to the regulatory authority. In conclusion, from a global perspective, this area of drug regulation is heterogeneous and evolving, and the authors call for an initiative aimed at harmonizing the requirements for biosimilar insulins. PMID:25789689

  20. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. PMID:26344953

  1. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

    PubMed Central

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-01-01

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region. PMID:26344953

  2. Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan.

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-03-18

    Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trials have been conducted to date, no DNA vaccines or recombinant viral-vectored vaccines expressing heterologous antigens for human use have yet been licensed in the U.S., Europe or Japan. In this research, we describe the current regulatory context for gene-based prophylactic vaccines against infectious disease in the U.S., Europe, and Japan. We identify the important considerations, in particular, on the preclinical assessments that would allow these vaccines to proceed to clinical trials, and the differences on the regulatory pathway for the marketing authorization in each region.

  3. Clinical Potential of Regulatory T Cell Therapy in Liver Diseases: An Overview and Current Perspectives

    PubMed Central

    Jeffery, Hannah C.; Braitch, Manjit Kaur; Brown, Solomon; Oo, Ye Htun

    2016-01-01

    The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg). The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis, or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients. Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment, and good manufacturing practice facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases (AILD), chronic rejection, and posttransplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases, and solid organ transplantations. There have not been any new therapies for the AILD for more than three decades; thus, the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior, and microenvironment of Treg before applying the cells to the patients.

  4. Clinical Potential of Regulatory T Cell Therapy in Liver Diseases: An Overview and Current Perspectives

    PubMed Central

    Jeffery, Hannah C.; Braitch, Manjit Kaur; Brown, Solomon; Oo, Ye Htun

    2016-01-01

    The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg). The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis, or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients. Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment, and good manufacturing practice facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases (AILD), chronic rejection, and posttransplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases, and solid organ transplantations. There have not been any new therapies for the AILD for more than three decades; thus, the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior, and microenvironment of Treg before applying the cells to the patients. PMID:27656181

  5. Clinical Potential of Regulatory T Cell Therapy in Liver Diseases: An Overview and Current Perspectives.

    PubMed

    Jeffery, Hannah C; Braitch, Manjit Kaur; Brown, Solomon; Oo, Ye Htun

    2016-01-01

    The increasing demand for liver transplantation and the decline in donor organs has highlighted the need for alternative novel therapies to prevent chronic active hepatitis, which eventually leads to liver cirrhosis and liver cancer. Liver histology of chronic hepatitis is composed of both effector and regulatory lymphocytes. The human liver contains different subsets of effector lymphocytes that are kept in check by a subpopulation of T cells known as Regulatory T cells (Treg). The balance of effector and regulatory lymphocytes generally determines the outcome of hepatic inflammation: resolution, fulminant hepatitis, or chronic active hepatitis. Thus, maintaining and adjusting this balance is crucial in immunological manipulation of liver diseases. One of the options to restore this balance is to enrich Treg in the liver disease patients. Advances in the knowledge of Treg biology and development of clinical grade isolation reagents, cell sorting equipment, and good manufacturing practice facilities have paved the way to apply Treg cells as a potential therapy to restore peripheral self-tolerance in autoimmune liver diseases (AILD), chronic rejection, and posttransplantation. Past and on-going studies have applied Treg in type-1 diabetes mellitus, systemic lupus erythematosus, graft versus host diseases, and solid organ transplantations. There have not been any new therapies for the AILD for more than three decades; thus, the clinical potential for the application of autologous Treg cell therapy to treat autoimmune liver disease is an attractive and novel option. However, it is fundamental to understand the deep immunology, genetic profiles, biology, homing behavior, and microenvironment of Treg before applying the cells to the patients. PMID:27656181

  6. Discovery and verification of functional single nucleotide polymorphisms in regulatory genomic regions: Current and developing technologies

    PubMed Central

    Chorley, Brian N.; Wang, Xuting; Campbell, Michelle R.; Pittman, Gary S.; Noureddine, Maher A.; Bell, Douglas A.

    2008-01-01

    The most common form of genetic variation, single nucleotide polymorphisms or SNPs, can affect the way an individual responds to the environment and modify disease risk. Although most of the millions of SNPs have little or no effect on gene regulation and protein activity, there are many circumstances where base changes can have deleterious effects. Non-synonymous SNPs that result in amino acid changes in proteins have been studied because of their obvious impact on protein activity. It is well known that SNPs within regulatory regions of the genome can result in disregulation of gene transcription. However, the impact of SNPs located in putative regulatory regions, or rSNPs, is harder to predict for two primary reasons. First, the mechanistic roles of non-coding genomic sequence remain poorly defined. Second, experimental validation of the functional consequences of rSNPs is often slow and laborious. In this review, we summarize traditional and novel methodologies for candidate rSNPs selection, in particular in silico techniques that aid in candidate rSNP selection. Additionally we will discuss molecular biological techniques that assess the impact of rSNPs on binding of regulatory machinery, as well as functional consequences on transcription. Standard techniques such as EMSA and luciferase reporter constructs are still widely used to assess effects of rSNPs on binding and gene transcription; however, these protocols are often bottlenecks in the discovery process. Therefore, we highlight novel and developing high-throughput protocols that promise to aid in shortening the process of rSNP validation. Given the large amount of genomic information generated from a multitude of re-sequencing and genome-wide SNP array efforts, future focus should be to develop validation techniques that will allow greater understanding of the impact these polymorphisms have on human health and disease. PMID:18565787

  7. A Framework for Organizing Current and Future Electric Utility Regulatory and Business Models

    SciTech Connect

    Satchwell, Andrew; Cappers, Peter; Schwartz, Lisa C.; Fadrhonc, Emily Martin

    2015-06-01

    Many regulators, utilities, customer groups, and other stakeholders are reevaluating existing regulatory models and the roles and financial implications for electric utilities in the context of today’s environment of increasing distributed energy resource (DER) penetrations, forecasts of significant T&D investment, and relatively flat or negative utility sales growth. When this is coupled with predictions about fewer grid-connected customers (i.e., customer defection), there is growing concern about the potential for serious negative impacts on the regulated utility business model. Among states engaged in these issues, the range of topics under consideration is broad. Most of these states are considering whether approaches that have been applied historically to mitigate the impacts of previous “disruptions” to the regulated utility business model (e.g., energy efficiency) as well as to align utility financial interests with increased adoption of such “disruptive technologies” (e.g., shareholder incentive mechanisms, lost revenue mechanisms) are appropriate and effective in the present context. A handful of states are presently considering more fundamental changes to regulatory models and the role of regulated utilities in the ownership, management, and operation of electric delivery systems (e.g., New York “Reforming the Energy Vision” proceeding).

  8. Regulatory role of tyrosine phosphorylation in the swelling-activated chloride current in isolated rabbit articular chondrocytes.

    PubMed

    Okumura, Noriaki; Imai, Shinji; Toyoda, Futoshi; Isoya, Eiji; Kumagai, Kousuke; Matsuura, Hiroshi; Matsusue, Yoshitaka

    2009-08-01

    Articular chondrocytes are exposed in vivo to the continually changing osmotic environment and thus require volume regulatory mechanisms. The present study was designed to investigate (i) the functional role of the swelling-activated Cl(-) current (I(Cl,swell)) in the regulatory volume decrease (RVD) and (ii) the regulatory role of tyrosine phosphorylation in I(Cl,swell), in isolated rabbit articular chondrocytes. Whole-cell membrane currents were recorded from chondrocytes in isosmotic, hyposmotic and hyperosmotic external solutions under conditions where Na(+), K(+) and Ca(2+) currents were minimized. The cell surface area was also measured using microscope images from a separate set of chondrocytes and was used as an index of cell volume. The isolated chondrocytes exhibited a RVD during sustained exposure to hyposmotic solution, which was mostly inhibited by the I(Cl,swell) blocker 4-(2-butyl-6,7-dichloro-2-cyclopentyl-indan-1-on-5-yl)oxobutyric acid (DCPIB) at 20 microM. Exposure to a hyposmotic solution activated I(Cl,swell), which was also largely inhibited by 20 microM DCPIB. I(Cl,swell) in rabbit articular chondrocytes had a relative taurine permeability (P(tau)/P(Cl)) of 0.21. Activation of I(Cl,swell) was significantly reduced by the protein tyrosine kinase (PTK) inhibitor genistein (30 microM) but was only weakly affected by its inactive analogue daidzein (30 microM). Intracellular application of protein tyrosine phosphatase (PTP) inhibitor sodium orthovanadate (250 and 500 microM) resulted in a gradual activation of a Cl(-) current even in isosmotic solutions. This Cl(-) current was almost completely inhibited by 4,4-diisothiocyanatostilbene-2,2-disulfonate (DIDS, 500 microM) and was also largely suppressed by exposure to hyperosmotic solution, thus indicating a close similarity to I(Cl,swell). Pretreatment of chondrocytes with genistein significantly prevented the activation of the Cl(-) current by sodium orthovanadate, suggesting that the basal

  9. Individually addressable multi-chamber electroporation platform with dielectrophoresis and alternating-current-electro-osmosis assisted cell positioning

    PubMed Central

    Park, Sinwook; Bassat, Dana Ben; Yossifon, Gilad

    2014-01-01

    A multi-functional microfluidic platform was fabricated to demonstrate the feasibility of on-chip electroporation integrated with dielectrophoresis (DEP) and alternating-current-electro-osmosis (ACEO) assisted cell/particle manipulation. A spatial gradient of electroporation parameters was generated within a microchamber array and validated using normal human dermal fibroblast (NHDF) cells and red fluorescent protein-expressing human umbilical vein endothelial cells (RFP-HUVECs) with various fluorescent indicators. The edge of the bottom electrode, coinciding with the microchamber entrance, may act as an on-demand gate, functioning under either positive or negative DEP. In addition, at sufficiently low activation frequencies, ACEO vortices can complement the DEP to contribute to a rapid trapping/alignment of particles. As such, results clearly indicate that the microfluidic platform has the potential to achieve high-throughput screening for electroporation with spatial control and uniformity, assisted by DEP and ACEO manipulation/trapping of particles/cells into individual microchambers. PMID:24803966

  10. Managing Carbon Regulatory Risk in Utility Resource Planning: Current Practices in the Western United States

    SciTech Connect

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-07-11

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. As such, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by fifteen electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without Federal climate regulation in the U.S., the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of U.S. electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations.

  11. Managing Carbon Regulatory Risk in Utility Resource Planning:Current Practices in the Western United States

    SciTech Connect

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-05-16

    Concerns about global climate change have substantially increased the likelihood that future policy will seek to minimize carbon dioxide emissions. Assuch, even today, electric utilities are making resource planning and investment decisions that consider the possible implications of these future carbon regulations. In this article, we examine the manner in which utilities assess the financial risks associated with future carbon regulations within their long-term resource plans. We base our analysis on a review of the most recent resource plans filed by fifteen electric utilities in the Western United States. Virtually all of these utilities made some effort to quantitatively evaluate the potential cost of future carbon regulations when analyzing alternate supply- and demand-side resource options for meeting customer load. Even without Federal climate regulation in the U.S., the prospect of that regulation is already having an impact on utility decision-making and resource choices. That said, the methods and assumptions used by utilities to analyze carbon regulatory risk, and the impact of that analysis on their choice of a particular resource strategy, vary considerably, revealing a number of opportunities for analytic improvement. Though our review focuses on a subset of U.S. electric utilities, this work holds implications for all electric utilities and energy policymakers who are seeking to minimize the compliance costs associated with future carbon regulations

  12. Examining the differences in current regulatory processes for sunscreens and proposed safety assessment paradigm.

    PubMed

    Sargent, Edward V; Travers, Jeffrey B

    2016-08-01

    Skin cancers including malignant melanoma which are due to UV radiation constitute a serious public health problem. Recent studies have confirmed the importance of UVA radiation in the pathogenesis of skin cancer, as well as the protective effects of broad-spectrum sunscreen use. Barriers for effective protection of the US public include the lack of effective UV filters, especially in the UVA spectrum. The major reason for the paucity of UVA-effective filters in the US is due primarily to the FDA's reluctance to approve agents which have already been on the market in Europe and elsewhere in the world for more than a decade. The underlying reasons for these discrepancies in new sunscreen approval success between the US and abroad are complex, and include factors such as that the FDA considers UV filters as drugs, whereas they are regulated as cosmetics elsewhere. FDA has not as yet developed a consistent approach for the approval of new UV filters. We provide a paradigm for both non-clinical testing and human safety testing which includes parameters for a human maximum use test (MUsT) that is based upon both ethical and scientific concepts. These suggestions could form the basis of future regulatory guidelines for rational testing thus allowing us to reach the consensus goal of more efficient and timely approval of much-needed UV filters to provide protection for the US public. PMID:27016397

  13. Exploring Ivorian perspectives on the effectiveness of the current Ivorian science curriculum in addressing issues related to HIV/AIDS

    NASA Astrophysics Data System (ADS)

    Ado, Gustave Firmin

    School-based HIV/AIDS science education has the potential to impact students when integrated into the science curriculum. However, this mixed method study shows that school-based HIV/AIDS science education is often not infused into career subjects such as science education but integrated into civics education and taught by teachers who lack the skills, knowledge, and the training in the delivery of effective school HIV/AIDS education. Since science is where biological events take place, it is suggested that HIV/AIDS science merits being taught in the science education classroom. This study took place in nine public middle schools within two school districts in Abidjan, Ivory Coast, one major urban city in the southern region. The study utilized triangulation of multiple data sources---both qualitative and quantitative. To substantiate the claims made in this study, a range of qualitative methods such as field notes and individual interviews with 39 teachers, 63 sixth grade students, 8 school administrators, and 20 community elders were used. For the quantitative portion 140 teachers and 3510 sixth grade students were surveyed. The findings from the study prioritize science education that includes HIV/AIDS science education for all, with emphasis on HIV/AIDS prevention in Ivory Coast. The factors that influence the implementation of HIV/AIDS curricula within the Ivorian sixth grade classrooms are discussed. Interview and survey data from students, teachers, school administrators, and community elders indicate that in the Ivorian school setting, "gerontocratic" cultural influences, religious beliefs, personal cultural beliefs, and time spent toward the discourse on HIV/AIDS have led to HIV/AIDS education that is often insufficient to change either misconceptions about HIV/AIDS or risky practices. It was also found that approaches to teaching HIV/AIDS does not connect with youth cultures. By reframing and integrating current HIV/AIDS curricula into the science

  14. Training in clinical forensic medicine in the UK--perceptions of current regulatory standards.

    PubMed

    Stark, Margaret M; Norfolk, Guy A

    2011-08-01

    As clinical forensic medicine (CFM) is not currently recognised as a speciality in the UK there are no nationally agreed mandatory standards for training forensic physicians in either general forensic (GFM) or sexual offence medicine (SOM). The General Medical Council (GMC), the medical regulator in the UK, has issued clear standards for training in all specialities recommending that "trainees must be supported to acquire the necessary skills and experience through induction, effective educational supervision, an appropriate workload and time to learn". In order to evaluate the current situation in the field of clinical forensic medicine, doctors who have recently (within the last two years) started working in the field "trainees" (n = 38), and trainers (n = 61) with responsibility for clinical and educational supervision of new trainees, were surveyed by questionnaire to gather their perceptions of how the relevant GMC standards are being met in initial on-the-job training. Telephone interviews were performed with eleven doctors working as clinical or medical directors to determine their views. It is clear that currently the quality of training in CFM is sub-standard and inconsistent and that the published standards, as to the minimum requirement for training that must be met by post-graduate medical and training providers at all levels, are not being met. The Faculty of Forensic and Legal Medicine (FFLM) needs to set explicit minimum standards which will comply with the regulator and work to pilot credentialing for forensic physicians. A number of recommendations are made for urgent FFLM development.

  15. Use of Biosensors as Alternatives to Current Regulatory Methods for Marine Biotoxins

    PubMed Central

    Vilariño, Natalia; Fonfría, Eva S.; Louzao, M. Carmen; Botana, Luis M.

    2009-01-01

    Marine toxins are currently monitored by means of a bioassay that requires the use of many mice, which poses a technical and ethical problem in many countries. With the exception of domoic acid, there is a legal requirement for the presence of other toxins (yessotoxin, saxitoxin and analogs, okadaic acid and analogs, pectenotoxins and azaspiracids) in seafood to be controlled by bioassay, but other toxins, such as palytoxin, cyclic imines, ciguatera and tetrodotoxin are potentially present in European food and there are no legal requirements or technical approaches available to identify their presence. The need for alternative methods to the bioassay is clearly important, and biosensors have become in recent years a feasible alternative to animal sacrifice. This review will discuss the advantages and disadvantages of using biosensors as alternatives to animal assays for marine toxins, with particular focus on surface plasmon resonance (SPR) technology. PMID:22291571

  16. Regulatory aspects of oncology drug safety evaluation: past practice, current issues, and the challenge of new drugs.

    PubMed

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M Stacey; McGuinn, W David; Verbois, S Leigh

    2010-03-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements. PMID:20045015

  17. Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

    SciTech Connect

    Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

    2010-03-01

    The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

  18. Inaugural address

    NASA Astrophysics Data System (ADS)

    Joshi, P. S.

    2014-03-01

    was how IAGRG was born, and currently the association has about 350 members, both from within India and abroad. The full inaugural address is available in the PDF

  19. Welcome Address

    NASA Astrophysics Data System (ADS)

    Kiku, H.

    2014-12-01

    Ladies and Gentlemen, It is an honor for me to present my welcome address in the 3rd International Workshop on "State of the Art in Nuclear Cluster Physics"(SOTANCP3), as the president of Kanto Gakuin University. Particularly to those from abroad more than 17 countries, I am very grateful for your participation after long long trips from your home to Yokohama. On the behalf of the Kanto Gakuin University, we certainly welcome your visit to our university and stay in Yokohama. First I would like to introduce Kanto Gakuin University briefly. Kanto Gakuin University, which is called KGU, traces its roots back to the Yokohama Baptist Seminary founded in 1884 in Yamate, Yokohama. The seminary's founder was Albert Arnold Bennett, alumnus of Brown University, who came to Japan from the United States to establish a theological seminary for cultivating and training Japanese missionaries. Now KGU is a major member of the Kanto Gakuin School Corporation, which is composed of two kindergartens, two primary schools, two junior high schools, two senior high schools as well as KGU. In this university, we have eight faculties with graduate school including Humanities, Economics, Law, Sciences and Engineering, Architecture and Environmental Design, Human and Environmental Studies, Nursing, and Law School. Over eleven thousands students are currently learning in our university. By the way, my major is the geotechnical engineering, and I belong to the faculty of Sciences and Engineering in my university. Prof. T. Yamada, here, is my colleague in the same faculty. I know that the nuclear physics is one of the most active academic fields in the world. In fact, about half of the participants, namely, more than 50 scientists, come from abroad in this conference. Moreover, I know that the nuclear physics is related to not only the other fundamental physics such as the elementary particle physics and astrophysics but also chemistry, medical sciences, medical cares, and radiation metrology

  20. A global regulatory science agenda for vaccines.

    PubMed

    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

  1. Innovative Legal Approaches to Address Obesity

    PubMed Central

    Pomeranz, Jennifer L; Teret, Stephen P; Sugarman, Stephen D; Rutkow, Lainie; Brownell, Kelly D

    2009-01-01

    Context: The law is a powerful public health tool with considerable potential to address the obesity issue. Scientific advances, gaps in the current regulatory environment, and new ways of conceptualizing rights and responsibilities offer a foundation for legal innovation. Methods: This article connects developments in public health and nutrition with legal advances to define promising avenues for preventing obesity through the application of the law. Findings: Two sets of approaches are defined: (1) direct application of the law to factors known to contribute to obesity and (2) original and innovative legal solutions that address the weak regulatory stance of government and the ineffectiveness of existing policies used to control obesity. Specific legal strategies are discussed for limiting children's food marketing, confronting the potential addictive properties of food, compelling industry speech, increasing government speech, regulating conduct, using tort litigation, applying nuisance law as a litigation strategy, and considering performance-based regulation as an alternative to typical regulatory actions. Finally, preemption is an overriding issue and can play both a facilitative and a hindering role in obesity policy. Conclusions: Legal solutions are immediately available to the government to address obesity and should be considered at the federal, state, and local levels. New and innovative legal solutions represent opportunities to take the law in creative directions and to link legal, nutrition, and public health communities in constructive ways. PMID:19298420

  2. Addressing healthcare.

    PubMed

    Daly, Rich

    2013-02-11

    Though President Barack Obama has rarely made healthcare references in his State of the Union addresses, health policy experts are hoping he changes that strategy this year. "The question is: Will he say anything? You would hope that he would, given that that was the major issue he started his presidency with," says Dr. James Weinstein, left, of the Dartmouth-Hitchcock health system. PMID:23487896

  3. Implementation workshop of WHO guidelines on evaluation of malaria vaccines: Current regulatory concepts and issues related to vaccine quality, Pretoria, South Africa 07 Nov 2014.

    PubMed

    Ho, Mei Mei; Baca-Estrada, Maria; Conrad, Christoph; Karikari-Boateng, Eric; Kang, Hye-Na

    2015-08-26

    The current World Health Organization (WHO) guidelines on the quality, safety and efficacy of recombinant malaria vaccines targeting the pre-erythrocytic and blood stages of Plasmodium falciparum were adopted by the WHO Expert Committee on Biological Standardization in 2012 to provide guidance on the quality, nonclinical and clinical aspects of recombinant malaria vaccines. A WHO workshop was organised to facilitate implementation into African (national/regional) regulatory practices, of the regulatory evaluation principles outlined in the guidelines regarding quality aspects. The workshop was used also to share knowledge and experience on regulatory topics of chemistry, manufacturing and control with a focus on vaccines through presentations and an interactive discussion using a case study approach. The basic principles and concepts of vaccine quality including consistency of production, quality control and manufacturing process were presented and discussed in the meeting. By reviewing and practicing a case study, better understanding on the relationship between consistency of production and batch release tests of an adjuvanted pre-erythrocytic recombinant malaria vaccine was reached. The case study exercise was considered very useful to understand regulatory evaluation principles of vaccines and a suggestion was made to WHO to provide such practices also through its Global Learning Opportunities for Vaccine Quality programme.

  4. The Platte River - High Plains Aquifer (PR-HPA) Long Term Agroecosystem Research (LTAR) Network - Data and Technological Resources to Address Current and Emerging Issues in Agroecosystems.

    NASA Astrophysics Data System (ADS)

    Okalebo, J. A.; Wienhold, B.; Suyker, A.; Erickson, G.; Hayes, M. J.; Awada, T.

    2015-12-01

    The Platte River - High Plains Aquifer (PR-HPA) is one of 18 established Long Term Agroecosystem Research (LTAR) networks across the US. PR-HPA is a partnership between the Institute of Agriculture and Natural Resources at the University of Nebraska-Lincoln (UNL), the USDA-ARS Agroecosystem Management Research Unit (AMRU) in Lincoln, and the USDA-ARS Environmental Management Research Unit (EMRU) in Clay Center, NE. The PR-HPA network encompasses 27,750 ha of research sites with data going back to the early 1900s. A partial list of on-going research projects include those encompassing long-term manuring and continuous corn (Est. 1912), dryland tillage plots (Est. 1970), soil nutrients and tillage (Est. 1983), biofuel feedstock studies (Est. 2001), and carbon sequestration study (Est. 2000). Affiliated partners include the National Drought Mitigation Center (NDMC) that develops measures to improve preparedness and adaptation to climate variability and drought; the High Plains Regional Climate Center (HPRCC) that coordinates data acquisition from over 170 automated weather stations and around 50 automated soil moisture network across NE and beyond; the AMERIFLUX and NEBFLUX networks that coordinate the water vapor and carbon dioxide flux measurements across NE with emphasis on rainfed and irrigated crop lands; the ARS Greenhouse gas Reduction through Agricultural Carbon Enhancement network (GRACEnet) and the Resilient Economic Agricultural Practices (REAP) project; and the Center for Advanced Land Management Information Technologies (CALMIT) that assists with the use of geospatial technologies for agriculture and natural resource applications. Current emphases are on addressing present-day and emerging issues related to profitability and sustainability of agroecosystems. The poster will highlight some of the ongoing and planned efforts in research pertaining to climate variability and change, water sustainability, and ecological and agronomic challenges associated

  5. Opening Address

    NASA Astrophysics Data System (ADS)

    Yamada, T.

    2014-12-01

    Ladies and Gentlemen, it is my great honor and pleasure to present an opening address of the 3rd International Workshop on "State of the Art in Nuclear Cluster Physics"(SOTANCP3). On the behalf of the organizing committee, I certainly welcome all your visits to KGU Kannai Media Center belonging to Kanto Gakuin University, and stay in Yokohama. In particular, to whom come from abroad more than 17 countries, I would appreciate your participations after long long trips from your homeland to Yokohama. The first international workshop on "State of the Art in Nuclear Cluster Physics", called SOTANCP, was held in Strasbourg, France, in 2008, and the second one was held in Brussels, Belgium, in 2010. Then the third workshop is now held in Yokohama. In this period, we had the traditional 10th cluster conference in Debrecen, Hungary, in 2012. Thus we have the traditional cluster conference and SOTANCP, one after another, every two years. This obviously shows our field of nuclear cluster physics is very active and flourishing. It is for the first time in about 10 years to hold the international workshop on nuclear cluster physics in Japan, because the last cluster conference held in Japan was in Nara in 2003, about 10 years ago. The president in Nara conference was Prof. K. Ikeda, and the chairpersons were Prof. H. Horiuchi and Prof. I. Tanihata. I think, quite a lot of persons in this room had participated at the Nara conference. Since then, about ten years passed. So, this workshop has profound significance for our Japanese colleagues. The subjects of this workshop are to discuss "the state of the art in nuclear cluster physics" and also discuss the prospect of this field. In a couple of years, we saw significant progresses of this field both in theory and in experiment, which have brought better and new understandings on the clustering aspects in stable and unstable nuclei. I think, the concept of clustering has been more important than ever. This is true also in the

  6. Convocation address.

    PubMed

    Ghatowar, P S

    1993-07-01

    The Union Deputy Minister of Health and Family Welfare in India addressed the 35th convocation of the International Institute for Population Sciences in Bombay in 1993. Officials in developing countries have been concerned about population growth for more than 30 years and have instituted policies to reduce population growth. In the 1960s, population growth in developing countries was around 2.5%, but today it is about 2%. Despite this decline, the world will have 1 billion more individuals by the year 2001. 95% of these new people will be born in developing countries. India's population size is so great that India does not have the time to wait for development to reduce population growth. Population needs to be viewed as an integrated part of overall development, since it is linked to poverty, illiteracy, environmental damage, gender issues, and reproductive health. Despite a large population size, India has made some important advancements in health and family planning. For example, India has reduced population growth (to 2.14% annually between 1981-1991), infant mortality, and its birth rate. It has increased the contraceptive use rate and life expectancy. Its southern states have been more successful at achieving demographic goals than have the northern states. India needs to implement efforts to improve living conditions, to change attitudes and perceptions about small families and contraception, and to promote family planning acceptance earlier among young couples. Improvement of living conditions is especially important in India, since almost 33% of the people live in poverty. India needs to invest in nutrition, health, and education. The mass media and nongovernmental organizations need to create population awareness and demand for family planning services. Improvement in women's status accelerates fertility decline, as has happened in Kerala State. The government needs to facilitate generation of jobs. Community participation is needed for India to achieve

  7. The Public Utilities Regulatory Policy Act (PURPA) and US Geothermal Industry: Current controversies and trends in federal and state implementation

    SciTech Connect

    Not Available

    1988-09-01

    This report is an analysis of the issues confronting US energy policymakers and the US geothermal industry as the result of the implementation and interpretation of the 1978 Public Utility Regulatory Policies Act, commonly known as PURPA. It seeks to answer four sets of questions about PURPA: (1) What has the existence of PURPA meant to the US geothermal industry. (2) How has the interpretation of PURPA evolved over the past decade. (3) What particular portions of PURPA rule making have been most crucial to the growth and development of the geothermal industry. (4) What aspects of PURPA have been most troubling to utilities purchasing or developing geothermal energy.

  8. Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

    PubMed

    Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

    2014-03-01

    For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.

  9. Variable addressability imaging systems

    NASA Astrophysics Data System (ADS)

    Kubala, Kenneth Scott

    The use of variable addressability for creating an optimum human-machine interface is investigated. Current wide field optical systems present more information to the human visual system than it has the capacity to perceive. The axial resolution, and/or the field of view can be increased by minimizing the difference between what the eye can perceive and what the system presents. The variable addressability function was developed through the use of a human factors experiment that characterized the position of the eye during the simulated use of a binocular system. Applying the variable addressability function to a conventional optical design required the development of a new metric for evaluating the expected performance of the variable addressability system. The new metric couples psycho-visual data and traditional optical data in order to specify the required performance of the variable addressability system. A non-linear mapping of the pixels is required in order to have the system work most efficiently with the human visual system, while also compensating for eye motion. The non-linear mapping function, which is the backbone of the variable addressability technique, can be created using optical distortion. The lens and system design is demonstrated in two different spectral bands. One of the designs was fabricated, tested, and assembled into a prototype. Through a second human factors study aimed at measuring performance, the variable addressability prototype was directly compared to a uniform addressability prototype, quantifying the difference in performance for the two prototypes. The human factors results showed that the variable addressability prototype provided better resolution 13% of the time throughout the experiment, but was 15% slower in use than the uniform addressability prototype.

  10. Designing a New Radioactive Liquid Waste Treatment Facility for Los Alamos National Laboratory to Update Treatment Technologies and Meet Current Regulatory Requirements

    SciTech Connect

    Lucas, M.E.; Evans, K.M.

    2008-07-01

    This paper discusses the new Radioactive Liquid Waste Treatment Facility (RLWTF) being designed for Los Alamos National Laboratory (LANL) and also provides information regarding the updates to the facility resulting from improvements in technologies and changes in regulations and codes that have occurred since the existing facility was built. It explains how the new facility will be a suitable replacement for the existing facility and how the new facility will allow LANL to continue its current mission as well as have the capability to treat any new waste stream resulting from a future expansion of the laboratory. Specific topics relating to the improvements in technology that are discussed include replacing existing settling technologies with improved chemical precipitation technologies using hydrochloric acid, sodium hydroxide, magnesium chloride, and ferric chloride. Also discussed are improved filtration technologies and dewatering technologies. Topics discussed regarding regulatory and code requirements include the current state and federal regulatory criteria and the new seismic criteria requirements that the design conforms to. (authors)

  11. Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A.

    PubMed

    Wu, Kuei-Meng; Dou, Jinhui; Ghantous, Hanan; Chen, Shaw; Bigger, Anita; Birnkrant, Debra

    2010-02-01

    Genotoxicity testing is an important part of preclinical safety assessment of new drugs and is required prior to Phase I/II clinical trials. It is designed to detect genetic damage such as gene mutations and chromosomal aberration, which may be reflected in tumorigenic or heritable mutation potential of the drug. Botanical new drugs in the U.S. are entitled to a waiver for preclinical pharmacology/toxicology studies, including genotoxicity testing, in support of an initial clinical trial under IND, contingent on previous human experience. Recently, ethical concerns have been raised over conducting Phase I/II clinical trials of new drugs with positive genotoxicity findings in healthy volunteers. Although the relevance of this issue to patients, as opposed to healthy volunteers, depends on the drug's indication, duration of treatment, and specific findings related to the assays, the regulatory view is to avoid exposing patients to genotoxic compounds unnecessarily in clinical trials. This philosophy may impact on herbal supplement marketing and botanical drug development, in that genotoxicity data are often lacking while consumers are exposed to the herbal supplement, or healthy volunteers are tested in an initial Phase I/II clinical trial on the botanical drug. This paper presents results of a survey conducted on genotoxicity data in botanical INDs submitted to the Agency and discusses the significance of this information. The information presented indicates that the sponsors of botanical INDs have increasingly recognized the importance of genotoxicity information and may have prioritized its acquisition in their strategic drug development programs.

  12. Regulatory aspects on nanomedicines.

    PubMed

    Sainz, Vanessa; Conniot, João; Matos, Ana I; Peres, Carina; Zupancic, Eva; Moura, Liane; Silva, Liana C; Florindo, Helena F; Gaspar, Rogério S

    2015-12-18

    Nanomedicines have been in the forefront of pharmaceutical research in the last decades, creating new challenges for research community, industry, and regulators. There is a strong demand for the fast development of scientific and technological tools to address unmet medical needs, thus improving human health care and life quality. Tremendous advances in the biomaterials and nanotechnology fields have prompted their use as promising tools to overcome important drawbacks, mostly associated to the non-specific effects of conventional therapeutic approaches. However, the wide range of application of nanomedicines demands a profound knowledge and characterization of these complex products. Their properties need to be extensively understood to avoid unpredicted effects on patients, such as potential immune reactivity. Research policy and alliances have been bringing together scientists, regulators, industry, and, more frequently in recent years, patient representatives and patient advocacy institutions. In order to successfully enhance the development of new technologies, improved strategies for research-based corporate organizations, more integrated research tools dealing with appropriate translational requirements aiming at clinical development, and proactive regulatory policies are essential in the near future. This review focuses on the most important aspects currently recognized as key factors for the regulation of nanomedicines, discussing the efforts under development by industry and regulatory agencies to promote their translation into the market. Regulatory Science aspects driving a faster and safer development of nanomedicines will be a central issue for the next years.

  13. Comparison of the volatile emission profiles of ground almond and pistachio mummies: part 1 – addressing a gap in knowledge of current attractants of navel orangeworm

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Over the years various tissues of almond and pistachios have been evaluated for their ability to attract the navel orangeworm moth, a major insect pest to almond and pistachio orchards in California. Almond meal, which typically consists of ground almond kernels, is the current monitoring tool for n...

  14. Genomics in the land of regulatory science.

    PubMed

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.

  15. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    PubMed Central

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  16. Model for Electron-Beam-Induced Current Analysis of mc-Si Addressing Defect Contrast Behavior in Heavily Contaminated PV Material: Preprint

    SciTech Connect

    Guthrey, H.; Gorman, B.; Al-Jassim, M.

    2012-06-01

    Much work has been done to correlate electron-beam-induced current (EBIC) contrast behavior of extended defects with the character and degree of impurity decoration. However, existing models fail to account for recently observed contrast behavior of defects in heavily contaminated mc-Si PV cells. We have observed large increases in defect contrast with decreasing temperature for all electrically active defects, regardless of their initial contrast signatures at ambient temperature. This negates the usefulness of the existing models in identifying defect character and levels of impurity decoration based on the temperature dependence of the contrast behavior. By considering the interactions of transition metal impurities with the silicon lattice and extended defects, we attempt to provide an explanation for these observations. Our findings will enhance the ability of the PV community to understand and mitigate the effects of these types of defects as the adoption of increasingly lower purity feedstocks for mc-Si PV production continues.

  17. Analysis of Regulatory Guidance for Health Monitoring

    NASA Technical Reports Server (NTRS)

    Munns, Thomas E.; Beard, Richard E.; Culp, Aubrey M.; Murphy, Dennis A.; Kent, Renee M.; Cooper, Eric G. (Technical Monitor)

    2000-01-01

    The purpose of this study was to assess the connection between current FAA regulations and the incorporation of Health Management (HM) systems into commercial aircraft. To address the overall objectives ARINC: (1) investigated FAA regulatory guidance, (2) investigated airline maintenance practices, (3) systematically identified regulations and practices that would be affected or could act as barriers to the introduction of HM technology, and (4) assessed regulatory and operational tradeoffs that should be considered for implementation. The assessment procedure was validated on a postulated structural HM capability for the B757 horizontal stabilizer.

  18. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 3 2010-01-01 2010-01-01 false Addresses. 218.34 Section 218.34 Energy DEPARTMENT OF ENERGY OIL STANDBY MANDATORY INTERNATIONAL OIL ALLOCATION Procedures § 218.34 Addresses. All..., Economic Regulatory Administration, Department of Energy, 2000 M Street, NW., Washington, DC 20461, and...

  19. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 3 2011-01-01 2011-01-01 false Addresses. 218.34 Section 218.34 Energy DEPARTMENT OF ENERGY OIL STANDBY MANDATORY INTERNATIONAL OIL ALLOCATION Procedures § 218.34 Addresses. All correspondence, petitions, and any information required by this part shall be submitted to: Administrator, Economic Regulatory Administration, Department...

  20. Toxicogenomics and the Regulatory Framework

    EPA Science Inventory

    Toxicogenomics presents regulatory agencies with the opportunity to revolutionize their analyses by enabling the collection of information on a broader range of responses than currently considered in traditional regulatory decision making. Analyses of genomic responses are expec...

  1. Assessing the regulatory picture

    SciTech Connect

    Not Available

    1994-02-01

    This article addresses the safety of the nation's drinking water supply and discusses compliance of the Clean Water Act. Right now, the shape of the regulatory future is uncertain. The results of the D-DBP regulatory negotiation are imminent. Congress is ready to begin debating reauthorization of the Safe Drinking Water Act, and utilities are trying to comply with the regulations while trying not to price water out of the reach of some of their customers.

  2. Human health and the environment can't wait for reform: current opportunities for the federal government and states to address chemical risks under the Toxic Substances Control Act.

    PubMed

    Trevisan, Lauren

    2011-01-01

    Expressing its concern about growing rates of cancer and other diseases, coupled with the lack of data about the effect of the thousands of chemicals used in U.S. society, in 1976 Congress enacted the Toxic Substances Control Act (TSCA). Congress intended for TSCA to shed new light on chemical risks and provide the U.S. Environmental Protection Agency (EPA) with a set of tools to address those risks and protect human health and the environment. In the years since TSCA's passage, the procedural hurdles and the difficult-to-meet legal standards built into the statute, along with a court decision rejecting EPA's use of its authority to ban dangerous chemicals, have impeded EPA's ability to regulate chemical use and manufacture. This Comment argues that both the EPA and state governments have the authority to act now to address the risks posed by dangerous chemicals. By utilizing certain sections of the statute in new and aggressive ways, EPA can effectively address chemical risks. Further, this Comment argues that TSCA's preemption provision affords states leeway to continue to regulate the use of chemicals within their borders. Though reform of TSCA is necessary, EPA and states can effectively protect against chemical risks in the near-term by using the full extent of their authority under the current law.

  3. Addressing adolescent pregnancy with legislation.

    PubMed

    Montgomery, Tiffany M; Folken, Lori; Seitz, Melody A

    2014-01-01

    Adolescent pregnancy is a concern among many women's health practitioners. While it is practical and appropriate to work to prevent adolescent pregnancy by educating adolescents in health care clinics, schools and adolescent-friendly community-based organizations, suggesting and supporting legislative efforts to reduce adolescent pregnancy can help address the issue on an even larger scale. This article aims to help nurses better understand current legislation that addresses adolescent pregnancy, and to encourage support of future adolescent pregnancy prevention legislation. PMID:25145716

  4. Addressing adolescent pregnancy with legislation.

    PubMed

    Montgomery, Tiffany M; Folken, Lori; Seitz, Melody A

    2014-01-01

    Adolescent pregnancy is a concern among many women's health practitioners. While it is practical and appropriate to work to prevent adolescent pregnancy by educating adolescents in health care clinics, schools and adolescent-friendly community-based organizations, suggesting and supporting legislative efforts to reduce adolescent pregnancy can help address the issue on an even larger scale. This article aims to help nurses better understand current legislation that addresses adolescent pregnancy, and to encourage support of future adolescent pregnancy prevention legislation.

  5. Regulatory guidance document

    SciTech Connect

    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.

  6. Addressing Risks to Advance Mental Health Research

    PubMed Central

    Iltis, Ana S.; Misra, Sahana; Dunn, Laura B.; Brown, Gregory K.; Campbell, Amy; Earll, Sarah A.; Glowinski, Anne; Hadley, Whitney B.; Pies, Ronald; DuBois, James M.

    2015-01-01

    Objective Risk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards (IRBs) may reject study designs that appear too risky. This can discourage needed research, particularly in higher risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research. This article provides mental health researchers with practical approaches to: 1) identify and define various intrinsic research risks; 2) communicate these risks to others (e.g., potential participants, regulatory bodies, society); 3) manage these risks during the course of a study; and 4) justify the risks. Methods As part of a National Institute of Mental Health (NIMH)-funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. IRB review was not required because there were no human subjects. The NIMH played no role in developing or reviewing the manuscript. Results Challenges, current data, practical strategies, and topics for future research are addressed for each of four key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks. Conclusions Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain IRB approval. PMID:24173618

  7. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

    PubMed

    Abraham, John; Davis, Courtney

    2005-09-01

    By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

  8. Regulatory sequence analysis tools.

    PubMed

    van Helden, Jacques

    2003-07-01

    The web resource Regulatory Sequence Analysis Tools (RSAT) (http://rsat.ulb.ac.be/rsat) offers a collection of software tools dedicated to the prediction of regulatory sites in non-coding DNA sequences. These tools include sequence retrieval, pattern discovery, pattern matching, genome-scale pattern matching, feature-map drawing, random sequence generation and other utilities. Alternative formats are supported for the representation of regulatory motifs (strings or position-specific scoring matrices) and several algorithms are proposed for pattern discovery. RSAT currently holds >100 fully sequenced genomes and these data are regularly updated from GenBank.

  9. Rationales for regulatory activity

    SciTech Connect

    Perhac, R.M.

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  10. Regulatory activities to address the needs of older patients.

    PubMed

    Cerreta, F; Temple, R; Asahina, Y; Connaire, C

    2015-02-01

    At the Drug Information Association (DIA) 49th annual meeting, for the first time regulators (Dr Francesca Cerreta, Dr Robert Temple and Dr Yasuko Asahina) from the three International Conference on Harmonization (ICH) co-sponsor regions came together in a forum to discuss their perspective on how the aging population impacts on drug development and on the design of clinical trials. In 2010, the ICH E7 Guideline (Studies in support of Special Populations: Geriatrics) was revised with the addition of a Questions and Answers document to take into account the rapidly changing world demographics. Regulators from the three ICH regions (Europe, USA and Japan) discuss here how they foresee the application of this guideline, and the impact that this might have on new drug development and clinical trial design. This article aims to summarize the discussions at the session for the benefit of a wider audience.

  11. Issues in mass spectrometry between bench chemists and regulatory laboratory managers

    Technology Transfer Automated Retrieval System (TEKTRAN)

    At the 123rd AOAC Annual Meeting in Philadelphia, 45 residue chemists gathered for a roundtable discussion of mass spectrometry (MS) for regulatory purposes involving chemical residues analysis. The session was conceived to address current technical and communication issues about MS between “bench ...

  12. Regulatory cross-cutting topics for fuel cycle facilities.

    SciTech Connect

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

    2013-10-01

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

  13. Addressivity in cogenerative dialogues

    NASA Astrophysics Data System (ADS)

    Hsu, Pei-Ling

    2014-03-01

    Ashraf Shady's paper provides a first-hand reflection on how a foreign teacher used cogens as culturally adaptive pedagogy to address cultural misalignments with students. In this paper, Shady drew on several cogen sessions to showcase his journey of using different forms of cogens with his students. To improve the quality of cogens, one strategy he used was to adjust the number of participants in cogens. As a result, some cogens worked and others did not. During the course of reading his paper, I was impressed by his creative and flexible use of cogens and at the same time was intrigued by the question of why some cogens work and not others. In searching for an answer, I found that Mikhail Bakhtin's dialogism, especially the concept of addressivity, provides a comprehensive framework to address this question. In this commentary, I reanalyze the cogen episodes described in Shady's paper in the light of dialogism. My analysis suggests that addressivity plays an important role in mediating the success of cogens. Cogens with high addressivity function as internally persuasive discourse that allows diverse consciousnesses to coexist and so likely affords productive dialogues. The implications of addressivity in teaching and learning are further discussed.

  14. FORECAST: Regulatory effects cost analysis software manual -- Version 4.1. Revision 1

    SciTech Connect

    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.

  15. Addressing psychiatric comorbidity.

    PubMed

    Woody, G E; McLellan, A T; O'Brien, C P; Luborsky, L

    1991-01-01

    Research studies indicate that addressing psychiatric comorbidity can improve treatment for selected groups of substance-abusing patients. However, the chances for implementing the necessary techniques on a large scale are compromised by the absence of professional input and guidance within programs. This is especially true in public programs, which treat some of the most disadvantaged, disturbed, and socially destructive individuals in the entire mental health system. One starting point for upgrading the level of knowledge and training of staff members who work in this large treatment system could be to develop a better and more authoritative information dissemination network. Such a system exists in medicine; physicians are expected to read appropriate journals and to guide their treatment decisions using the data contained in the journals. Standards of practice and methods for modifying current practice are within the tradition of reading new facts, studying old ones, and comparing treatment outcome under different conditions with what is actually being done. No such general system of information-gathering or -sharing exists, particularly in public treatment programs. One of the most flagrant examples of this "educational shortfall" can be found among those methadone programs that adamantly insist on prescribing no more than 30 to 35 mg/day for all patients, in spite of the overwhelming evidence that these dose levels generally are inadequate. In some cases, program directors are unaware of studies that have shown the relationship between dose and outcome. In other cases, they are aware of the studies but do not modify their practices accordingly. This example of inadequate dosing is offered as an example of one situation that could be improved by adherence to a system of authoritative and systematic information dissemination. Many issues in substance abuse treatment do not lend themselves to information dissemination as readily as that of methadone dosing

  16. Regulatory Compliance in Multi-Tier Supplier Networks

    NASA Technical Reports Server (NTRS)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  17. Evaluation of comparative performance of orally inhaled drug products in view of the classical bioequivalence paradigms: an analysis of the current scientific and regulatory dilemmas of inhaler evaluation.

    PubMed

    Horhota, Stephen T

    2014-12-01

    Since the early 1960s, there has been a continuous evolution in scientific understanding regarding bioequivalence (BE) of oral dosage forms, intermittently punctuated by some breakthrough research findings and conceptual advances. The accumulated knowledge from this body of research has been translated into a sophisticated risk management framework of regulations and guidelines supported by an extensive set of tools and decision rules. This has permitted us to arrive at a state that now allows, in the majority of cases, not only the unrestricted substitution of a generic product for the innovator version, but also unquestioned substitution between different generic manufacturers. This framework has been successfully extended or adapted to go beyond oral dosage forms to include, for example, topical semisolid applications and nasal sprays. In the case of orally inhaled locally acting drug products (OIP), a similar level of success has yet to be realized. For OIP's, the risk management toolbox is incompletely outfitted due to missing science, knowledge, and experience in some key areas. This article presents a gap analysis of the situation highlighting unresolved residual risks. Assessment of the residual risks by US and EU medicines authorities has interestingly led to different regulatory positions with respect to BE for this class of drug products in these two regions. A parallel comparison with the history for BE of oral dosage forms shows that resolution for inhaled products will come eventually with the final outcome and timeframe, depending as much on science as it does on economics and the degree to which legislators intervene.

  18. Addressing Social Issues.

    ERIC Educational Resources Information Center

    Schoebel, Susan

    1991-01-01

    Maintains that advertising can help people become more aware of social responsibilities. Describes a successful nationwide newspaper advertising competition for college students in which ads address social issues such as literacy, drugs, teen suicide, and teen pregnancy. Notes how the ads have helped grassroots programs throughout the United…

  19. Addressing Sexual Harassment

    ERIC Educational Resources Information Center

    Young, Ellie L.; Ashbaker, Betty Y.

    2008-01-01

    This article discusses ways on how to address the problem of sexual harassment in schools. Sexual harassment--simply defined as any unwanted and unwelcome sexual behavior--is a sensitive topic. Merely providing students, parents, and staff members with information about the school's sexual harassment policy is insufficient; schools must take…

  20. Addressing poor nutrition to promote heart health: Moving upstream

    PubMed Central

    Raine, Kim D

    2010-01-01

    Current dietary recommendations for cardiovascular disease prevention suggest dietary patterns that promote achieving healthy weight, emphasize vegetables, legumes, fruit, whole grains, fish and nuts, substituting mono-unsaturated fats for saturated fats and restricting dietary sodium to less than 2300 mg/day. However, trends in nutrient intake and food consumption patterns suggest that the need for improvement in the dietary patterns of Canadians is clear. Influencing eating behaviour requires more than addressing nutrition knowledge and perceptions of healthy eating – it requires tackling the context within which individuals make choices. A comprehensive approach to improving nutrition includes traditional downstream strategies such as counselling to improve knowledge and skills; midstream strategies such as using the media to change social norms; and upstream strategies such as creating supportive environments through public policy including regulatory measures. While the evidence base for more upstream strategies continues to grow, key examples of comprehensive approaches to population change provide a call to action. PMID:20847988

  1. Addressing poor nutrition to promote heart health: moving upstream.

    PubMed

    Raine, Kim D

    2010-01-01

    Current dietary recommendations for cardiovascular disease prevention suggest dietary patterns that promote achieving healthy weight, emphasize vegetables, legumes, fruit, whole grains, fish and nuts, substituting mono-unsaturated fats for saturated fats and restricting dietary sodium to less than 2300 mg/day. However, trends in nutrient intake and food consumption patterns suggest that the need for improvement in the dietary patterns of Canadians is clear. Influencing eating behaviour requires more than addressing nutrition knowledge and perceptions of healthy eating - it requires tackling the context within which individuals make choices. A comprehensive approach to improving nutrition includes traditional downstream strategies such as counselling to improve knowledge and skills; midstream strategies such as using the media to change social norms; and upstream strategies such as creating supportive environments through public policy including regulatory measures. While the evidence base for more upstream strategies continues to grow, key examples of comprehensive approaches to population change provide a call to action.

  2. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Address for filing documents. 590.104 Section 590.104 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS General Provisions § 590.104 Address...

  3. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Address for filing documents. 590.104 Section 590.104 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS General Provisions § 590.104 Address...

  4. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Address for filing documents. 590.104 Section 590.104 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS General Provisions § 590.104 Address...

  5. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Address for filing documents. 590.104 Section 590.104 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS General Provisions § 590.104 Address...

  6. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Address for filing documents. 590.104 Section 590.104 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS General Provisions § 590.104 Address...

  7. Holographic content addressable storage

    NASA Astrophysics Data System (ADS)

    Chao, Tien-Hsin; Lu, Thomas; Reyes, George

    2015-03-01

    We have developed a Holographic Content Addressable Storage (HCAS) architecture. The HCAS systems consists of a DMD (Digital Micromirror Array) as the input Spatial Light Modulator (SLM), a CMOS (Complementary Metal-oxide Semiconductor) sensor as the output photodetector and a photorefractive crystal as the recording media. The HCAS system is capable of performing optical correlation of an input image/feature against massive reference data set stored in the holographic memory. Detailed system analysis will be reported in this paper.

  8. Problems associated with direct-to-consumer advertising (DTCA) of restricted, implantable medical devices: should the current regulatory approach be changed?

    PubMed

    Patsner, Bruce

    2009-01-01

    Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade. Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products, but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs. Even when FDA has sponsored public hearings to address the issue of DTCA of all medical products, as it did in 2005, review of the content of the speakers' presentations reveals that almost all of the subject matter, nearly all of the data, and the majority of comments concerned DTCA of drugs. Not a single law review article has ever been devoted exclusively to the subject of advertising and promotion of medical devices to consumers--until now. PMID:19998571

  9. Addressing inequities in healthy eating.

    PubMed

    Friel, Sharon; Hattersley, Libby; Ford, Laura; O'Rourke, Kerryn

    2015-09-01

    What, when, where and how much people eat is influenced by a complex mix of factors at societal, community and individual levels. These influences operate both directly through the food system and indirectly through political, economic, social and cultural pathways that cause social stratification and influence the quality of conditions in which people live their lives. These factors are the social determinants of inequities in healthy eating. This paper provides an overview of the current evidence base for addressing these determinants and for the promotion of equity in healthy eating. PMID:26420812

  10. Addressing the workforce pipeline challenge

    SciTech Connect

    Leonard Bond; Kevin Kostelnik; Richard Holman

    2006-11-01

    A secure and affordable energy supply is essential for achieving U.S. national security, in continuing U.S. prosperity and in laying the foundations to enable future economic growth. To meet this goal the next generation energy workforce in the U.S., in particular those needed to support instrumentation, controls and advanced operations and maintenance, is a critical element. The workforce is aging and a new workforce pipeline, to support both current generation and new build has yet to be established. The paper reviews the challenges and some actions being taken to address this need.

  11. Regulatory tone and mucosal immunity in asthma

    PubMed Central

    Chapman, Timothy J; Georas, Steve N

    2014-01-01

    The lung is constantly exposed to a variety of inhaled foreign antigens, many of which are harmless to the body. Therefore, the mucosal immune system must not only have the capacity to distinguish self from non-self, but also harmless versus dangerous non-self. To address this, mucosal immune cells establish an anti-inflammatory steady state in the lung that must be overcome by inflammatory signals in order to mount an effector immune response. In the case of inhaled allergens, the false detection of dangerous non-self results in inappropriate immune activation and eventual allergic asthma. Both basic and clinical studies suggest that the balance between tolerogenic and inflammatory immune responses is a key feature in the outcome of health or disease. This Review is focused on what we term ‘regulatory tone’: the immunosuppressive environment in the lung that must be overcome to induce inflammatory responses. We will summarize the current literature on this topic, with a particular focus on the role of regulatory T cells in preventing allergic disease of the lung. We propose that inter-individual differences in regulatory tone have the potential to not only establish the threshold for immune activation in the lung, but also shape the quality of resulting effector responses following tolerance breakdown. PMID:24975833

  12. Bioreactors Addressing Diabetes Mellitus

    PubMed Central

    Minteer, Danielle M.; Gerlach, Jorg C.

    2014-01-01

    The concept of bioreactors in biochemical engineering is a well-established process; however, the idea of applying bioreactor technology to biomedical and tissue engineering issues is relatively novel and has been rapidly accepted as a culture model. Tissue engineers have developed and adapted various types of bioreactors in which to culture many different cell types and therapies addressing several diseases, including diabetes mellitus types 1 and 2. With a rising world of bioreactor development and an ever increasing diagnosis rate of diabetes, this review aims to highlight bioreactor history and emerging bioreactor technologies used for diabetes-related cell culture and therapies. PMID:25160666

  13. Bioreactors addressing diabetes mellitus.

    PubMed

    Minteer, Danielle M; Gerlach, Jorg C; Marra, Kacey G

    2014-11-01

    The concept of bioreactors in biochemical engineering is a well-established process; however, the idea of applying bioreactor technology to biomedical and tissue engineering issues is relatively novel and has been rapidly accepted as a culture model. Tissue engineers have developed and adapted various types of bioreactors in which to culture many different cell types and therapies addressing several diseases, including diabetes mellitus types 1 and 2. With a rising world of bioreactor development and an ever increasing diagnosis rate of diabetes, this review aims to highlight bioreactor history and emerging bioreactor technologies used for diabetes-related cell culture and therapies.

  14. Content addressable memory project

    NASA Technical Reports Server (NTRS)

    Hall, J. Storrs; Levy, Saul; Smith, Donald E.; Miyake, Keith M.

    1992-01-01

    A parameterized version of the tree processor was designed and tested (by simulation). The leaf processor design is 90 percent complete. We expect to complete and test a combination of tree and leaf cell designs in the next period. Work is proceeding on algorithms for the computer aided manufacturing (CAM), and once the design is complete we will begin simulating algorithms for large problems. The following topics are covered: (1) the practical implementation of content addressable memory; (2) design of a LEAF cell for the Rutgers CAM architecture; (3) a circuit design tool user's manual; and (4) design and analysis of efficient hierarchical interconnection networks.

  15. Addressing Environmental Health Inequalities

    PubMed Central

    Gouveia, Nelson

    2016-01-01

    Environmental health inequalities refer to health hazards disproportionately or unfairly distributed among the most vulnerable social groups, which are generally the most discriminated, poor populations and minorities affected by environmental risks. Although it has been known for a long time that health and disease are socially determined, only recently has this idea been incorporated into the conceptual and practical framework for the formulation of policies and strategies regarding health. In this Special Issue of the International Journal of Environmental Research and Public Health (IJERPH), “Addressing Environmental Health Inequalities—Proceedings from the ISEE Conference 2015”, we incorporate nine papers that were presented at the 27th Conference of the International Society for Environmental Epidemiology (ISEE), held in Sao Paulo, Brazil, in 2015. This small collection of articles provides a brief overview of the different aspects of this topic. Addressing environmental health inequalities is important for the transformation of our reality and for changing the actual development model towards more just, democratic, and sustainable societies driven by another form of relationship between nature, economy, science, and politics. PMID:27618906

  16. Addressing Environmental Health Inequalities.

    PubMed

    Gouveia, Nelson

    2016-01-01

    Environmental health inequalities refer to health hazards disproportionately or unfairly distributed among the most vulnerable social groups, which are generally the most discriminated, poor populations and minorities affected by environmental risks. Although it has been known for a long time that health and disease are socially determined, only recently has this idea been incorporated into the conceptual and practical framework for the formulation of policies and strategies regarding health. In this Special Issue of the International Journal of Environmental Research and Public Health (IJERPH), "Addressing Environmental Health Inequalities-Proceedings from the ISEE Conference 2015", we incorporate nine papers that were presented at the 27th Conference of the International Society for Environmental Epidemiology (ISEE), held in Sao Paulo, Brazil, in 2015. This small collection of articles provides a brief overview of the different aspects of this topic. Addressing environmental health inequalities is important for the transformation of our reality and for changing the actual development model towards more just, democratic, and sustainable societies driven by another form of relationship between nature, economy, science, and politics. PMID:27618906

  17. Federal Trade Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... and Review'' of September 30, 1993, 58 FR 51735 (Oct. 4, 1993). This edition of the Unified Agenda of..., ``Federalism,'' of August 4, 1999, 64 FR 43255 (Aug. 10, 1999), which does not apply to independent regulatory...'s Telemarketing Sales Rule (TSR or Rule) to address the sale of debt relief services (74 FR...

  18. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  19. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission...

  20. Content addressable memory project

    NASA Technical Reports Server (NTRS)

    Hall, Josh; Levy, Saul; Smith, D.; Wei, S.; Miyake, K.; Murdocca, M.

    1991-01-01

    The progress on the Rutgers CAM (Content Addressable Memory) Project is described. The overall design of the system is completed at the architectural level and described. The machine is composed of two kinds of cells: (1) the CAM cells which include both memory and processor, and support local processing within each cell; and (2) the tree cells, which have smaller instruction set, and provide global processing over the CAM cells. A parameterized design of the basic CAM cell is completed. Progress was made on the final specification of the CPS. The machine architecture was driven by the design of algorithms whose requirements are reflected in the resulted instruction set(s). A few of these algorithms are described.

  1. Bax: Addressed to kill.

    PubMed

    Renault, Thibaud T; Manon, Stéphen

    2011-09-01

    The pro-apoptototic protein Bax (Bcl-2 Associated protein X) plays a central role in the mitochondria-dependent apoptotic pathway. In healthy mammalian cells, Bax is essentially cytosolic and inactive. Following a death signal, the protein is translocated to the outer mitochondrial membrane, where it promotes a permeabilization that favors the release of different apoptogenic factors, such as cytochrome c. The regulation of Bax translocation is associated to conformational changes that are under the control of different factors. The evidences showing the involvement of different Bax domains in its mitochondrial localization are presented. The interactions between Bax and its different partners are described in relation to their ability to promote (or prevent) Bax conformational changes leading to mitochondrial addressing and to the acquisition of the capacity to permeabilize the outer mitochondrial membrane. PMID:21641962

  2. Healthcare regulatory concepts in Brazil.

    PubMed

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

  3. [Keynote address: Climate change

    SciTech Connect

    Forrister, D.

    1994-12-31

    Broadly speaking, the climate issue is moving from talk to action both in the United States and internationally. While few nations have adopted strict controls or stiff new taxes, a number of them are developing action plans that are making clear their intention to ramp up activity between now and the year 2000... and beyond. There are sensible, economically efficient strategies to be undertaken in the near term that offer the possibility, in many countries, to avoid more draconian measures. These strategies are by-and-large the same measures that the National Academy of Sciences recommended in a 1991 report called, Policy Implications of Greenhouse Warming. The author thinks the Academy`s most important policy contribution was how it recommended the nations act in the face of uncertain science and high risks--that cost effective measures are adopted as cheap insurance... just as nations insure against other high risk, low certainty possibilities, like catastrophic health insurance, auto insurance, and fire insurance. This insurance theme is still right. First, the author addresses how the international climate change negotiations are beginning to produce insurance measures. Next, the author will discuss some of the key issues to watch in those negotiations that relate to longer-term insurance. And finally, the author will report on progress in the United States on the climate insurance plan--The President`s Climate Action Plan.

  4. Addressing Passive Smoking in Children

    PubMed Central

    Hutchinson, Sasha G.; Kuijlaars, Jennifer S.; Mesters, Ilse; Muris, Jean W. M.; van Schayck, Constant P.; Dompeling, Edward; Feron, Frans J. M.

    2014-01-01

    Background A significant number of parents are unaware or unconvinced of the health consequences of passive smoking (PS) in children. Physicians could increase parental awareness by giving personal advice. Aim To evaluate the current practices of three Dutch health professions (paediatricians, youth health care physicians, and family physicians) regarding parental counselling for passive smoking (PS) in children. Methods All physicians (n = 720) representing the three health professions in Limburg, the Netherlands, received an invitation to complete a self-administered electronic questionnaire including questions on their: sex, work experience, personal smoking habits, counselling practices and education regarding PS in children. Results The response rate was 34%. One tenth (11%) of the responding physicians always addressed PS in children, 32% often, 54% occasionally and 4% reported to never attend to it. The three health professions appeared comparable regarding their frequency of parental counselling for PS in children. Addressing PS was more likely when children had respiratory problems. Lack of time was the most frequently mentioned barrier, being very and somewhat applicable for respectively 14% and 43% of the physicians. One fourth of the responders had received postgraduate education about PS. Additionally, 49% of the responders who did not have any education about PS were interested in receiving it. Conclusions Physicians working in the paediatric field in Limburg, the Netherlands, could more frequently address PS in children with parents. Lack of time appeared to be the most mentioned barrier and physicians were more likely to counsel parents for PS in children with respiratory complaints/diseases. Finally, a need for more education on parental counselling for PS was expressed. PMID:24809443

  5. Regulatory Anatomy

    PubMed Central

    2015-01-01

    This article proposes the term “safety logics” to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. PMID:26139952

  6. Regulatory RNAs

    PubMed Central

    Vazquez-Anderson, Jorge; Contreras, Lydia M

    2013-01-01

    RNAs have many important functional properties, including that they are independently controllable and highly tunable. As a result of these advantageous properties, their use in a myriad of sophisticated devices has been widely explored. Yet, the exploitation of RNAs for synthetic applications is highly dependent on the ability to characterize the many new molecules that continue to be discovered by large-scale sequencing and high-throughput screening techniques. In this review, we present an exhaustive survey of the most recent synthetic bacterial riboswitches and small RNAs while emphasizing their virtues in gene expression management. We also explore the use of these RNA components as building blocks in the RNA synthetic biology toolbox and discuss examples of synthetic RNA components used to rewire bacterial regulatory circuitry. We anticipate that this field will expand its catalog of smart devices by mimicking and manipulating natural RNA mechanisms and functions. PMID:24356572

  7. Regulatory Physiology

    NASA Technical Reports Server (NTRS)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  8. Regulatory pathways for vaccines for developing countries.

    PubMed

    Milstien, Julie; Belgharbi, Lahouari

    2004-02-01

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

  9. Regulatory pathways for vaccines for developing countries.

    PubMed Central

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

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

  10. Fundamental concepts, current regulatory design and interpretation

    EPA Science Inventory

    Developmental toxicology became a formalized field about 50 years ago. Over this time, it has evolved from a largely observational science to one that is highly mechanistic in nature. Our increasing knowledge of mechanism of action, coupled with techniques that facilitate the gen...

  11. Regulatory views on current criticality safety issues

    SciTech Connect

    Conde, J.M.; Recio, M.

    1996-12-31

    The nuclear facilities in Spain of interest from the stand-point of criticality are a fuel fabrication facility, handling only fresh fuel; seven pressurized water reactor (PWR) plants with different nuclear steam supply system designs; two boiling water reactor (BWR) plants; and an ongoing program of dual-purpose casks (storage and transport) for spent fuel. Given the spent-fuel storage space problems with the original rack designs, a plan was developed and started in 1990 to incorporate high-density racks (borated steel or Boral) in the spent-fuel storage of all plants, giving credit for fuel burnup. Following this plan, five PWR units have licensed burnup-credited criticality safety analyses using a two-zone approach (fresh and spent fuel) for the spent-fuel pool. The two BWR plants have also licensed a criticality safety analysis with credit for the reactivity reduction provided by the gadolinia rods. The only spent-fuel cask yet licensed has followed the expected fresh fuel assumption for the criticality safety evaluation. However, it can be expected that the industry will submit burnup-credit safety analyses for the future casks designs.

  12. Innovative medicines: new regulatory procedures for the third millennium.

    PubMed

    Rasi, Guido; Bonini, Sergio

    2015-01-01

    Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.

  13. Current issues and actions

    SciTech Connect

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the progress that has been made toward achieving full regulatory compliance at the Hanford Site. Ongoing compliance self-assessments, implementation of the Tri-Party Agreement, and public meetings continue to identify environmental compliance issues. These issues are discussed openly with the regulatory agencies and with the public to ensure that all environmental compliance issues are addressed.

  14. Harmonization of regulatory guidelines on efficacy of ectoparasiticides for companion animals: status and missing points.

    PubMed

    Curet Bobey, Marianne

    2015-02-28

    Ectoparasites of major clinical significance in companion animals include fleas, ticks, lice, mange, mite, mosquitoes and sandflies, as well as biting flies. Obtaining a marketing authorization (or licence) for an ectoparasiticide relies on the assessment by regulatory agencies of a comprehensive data package to confirm the quality, safety and efficacy of the product when used in the target animal species for the proposed claims. Such approval is done under a highly regulated system. However, the global regulatory framework for pet ectoparasiticides is complex, since these products may be classified either as pesticides or as pharmaceuticals depending on the country or even within a given country, based on the presentation or mode of action. Within each jurisdiction, regulatory guidelines provide standards relating to study designs, relevant parasite species, efficacy calculation and acceptable thresholds, and define the corresponding acceptable label claims. Despite some similarities, there is no formal international harmonization for development requirements. In some areas, gaps and/or inconsistencies are more marked than others. Published recommendations from scientific expert groups (e.g. W.A.A.V.P. guidelines) are therefore a useful tool for regulatory bodies, researchers, developers and animal health companies. These expert recommendations reflect the current position of the scientific community and potentially address aspects not covered satisfactorily by regulatory texts while taking into account the latest advancements in experimental methodologies. Since the changes to official regulatory texts generally occur at a slower pace than the scientific state-of-the-art, and because of the lack of a harmonized approach, both scientific and regulatory guidance documents are necessary. The main objective of this review is to explore the complexity of the international regulatory framework for pet ectoparasiticides and to highlight some areas that are

  15. Harmonization of regulatory guidelines on efficacy of ectoparasiticides for companion animals: status and missing points.

    PubMed

    Curet Bobey, Marianne

    2015-02-28

    Ectoparasites of major clinical significance in companion animals include fleas, ticks, lice, mange, mite, mosquitoes and sandflies, as well as biting flies. Obtaining a marketing authorization (or licence) for an ectoparasiticide relies on the assessment by regulatory agencies of a comprehensive data package to confirm the quality, safety and efficacy of the product when used in the target animal species for the proposed claims. Such approval is done under a highly regulated system. However, the global regulatory framework for pet ectoparasiticides is complex, since these products may be classified either as pesticides or as pharmaceuticals depending on the country or even within a given country, based on the presentation or mode of action. Within each jurisdiction, regulatory guidelines provide standards relating to study designs, relevant parasite species, efficacy calculation and acceptable thresholds, and define the corresponding acceptable label claims. Despite some similarities, there is no formal international harmonization for development requirements. In some areas, gaps and/or inconsistencies are more marked than others. Published recommendations from scientific expert groups (e.g. W.A.A.V.P. guidelines) are therefore a useful tool for regulatory bodies, researchers, developers and animal health companies. These expert recommendations reflect the current position of the scientific community and potentially address aspects not covered satisfactorily by regulatory texts while taking into account the latest advancements in experimental methodologies. Since the changes to official regulatory texts generally occur at a slower pace than the scientific state-of-the-art, and because of the lack of a harmonized approach, both scientific and regulatory guidance documents are necessary. The main objective of this review is to explore the complexity of the international regulatory framework for pet ectoparasiticides and to highlight some areas that are

  16. Summation from a regulatory perspective

    SciTech Connect

    Ohanian, E.V.; Cotruvo, J.A.

    1986-11-01

    There is an urgent need to discuss the Office of Drinking Water's standard-setting or rule making process since most of the researchers whose papers are presented here directly or indirectly play a crucial role in this complex undertaking. Therefore, this paper will address the research data required to support policy making and regulatory decisions pertaining to health effects of disinfectants and disinfection by-products.

  17. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    PubMed

    Gonçalves, Joana P; Aires, Ricardo S; Francisco, Alexandre P; Madeira, Sara C

    2012-01-01

    Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules) under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1) apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2) ignore local patterns, abundant in most interesting cases of transcriptional activity; (3) neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4) limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots). Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in functionally enriched

  18. Addressing neurological disorders with neuromodulation.

    PubMed

    Oluigbo, Chima O; Rezai, Ali R

    2011-07-01

    Neurological disorders are becoming increasingly common in developed countries as a result of the aging population. In spite of medications, these disorders can result in progressive loss of function as well as chronic physical, cognitive, and emotional disability that ultimately places enormous emotional and economic on the patient, caretakers, and the society in general. Neuromodulation is emerging as a therapeutic option in these patients. Neuromodulation is a field, which involves implantable devices that allow for the reversible adjustable application of electrical, chemical, or biological agents to the central or peripheral nervous system with the objective of altering its functioning with the objective of achieving a therapeutic or clinically beneficial effect. It is a rapidly evolving field that brings together many different specialties in the fields of medicine, materials science, computer science and technology, biomedical, and neural engineering as well as the surgical or interventional specialties. It has multiple current and emerging indications, and an enormous potential for growth. The main challenges before it are in the need for effective collaboration between engineers, basic scientists, and clinicians to develop innovations that address specific problems resulting in new devices and clinical applications. PMID:21193369

  19. Addressing neurological disorders with neuromodulation.

    PubMed

    Oluigbo, Chima O; Rezai, Ali R

    2011-07-01

    Neurological disorders are becoming increasingly common in developed countries as a result of the aging population. In spite of medications, these disorders can result in progressive loss of function as well as chronic physical, cognitive, and emotional disability that ultimately places enormous emotional and economic on the patient, caretakers, and the society in general. Neuromodulation is emerging as a therapeutic option in these patients. Neuromodulation is a field, which involves implantable devices that allow for the reversible adjustable application of electrical, chemical, or biological agents to the central or peripheral nervous system with the objective of altering its functioning with the objective of achieving a therapeutic or clinically beneficial effect. It is a rapidly evolving field that brings together many different specialties in the fields of medicine, materials science, computer science and technology, biomedical, and neural engineering as well as the surgical or interventional specialties. It has multiple current and emerging indications, and an enormous potential for growth. The main challenges before it are in the need for effective collaboration between engineers, basic scientists, and clinicians to develop innovations that address specific problems resulting in new devices and clinical applications.

  20. Bilingual Cognitive Development: Addressing Three Gaps in Current Research.

    ERIC Educational Resources Information Center

    Diaz, Rafael M.

    1985-01-01

    Results question the validity of Cummins's threshold hypothesis and suggest that degree of bilingualism is related to variability in cognitive measures only before a certain threshold of proficiency in the second language is attained. A cause-effect model in which degree of bilingualism appears as the causal factor affecting children's cognitive…

  1. Swimming Against the Current: Zebrafish Help Address Educational Challenges.

    PubMed

    Pickart, Michael A; Liang, Jennifer; Hutson, Lara; Pierret, Christopher

    2016-08-01

    Zebrafish can be important tools for learning and authentic student research. The broad zebrafish community is rich with examples to improve education for learners of all ages and geographical locales. This special collection of articles is presented with the hope of encouraging readers to reflect on the educational outcomes reported here and to consider new ways zebrafish may engage others to learn and grow.

  2. Sun Protection: Current Management Strategies Addressing UV Exposure.

    PubMed

    Cohen, Leslie E; Grant, Robert T

    2016-07-01

    The use of sunscreen is essential for protection against photoaging and skin cancer. There is no global consensus on rating systems for sunscreens but it is essential to understand what makes a product broad-spectrum. In addition, physicians should have a general understanding that high-quality successful sunscreens should not only provide broad-spectrum ultraviolet A/B protection but should also be formulated so that they are easy to apply, are water resistant, and are photostable in order to increase user compliance.

  3. Current Research and Opportunities to Address Environmental Asbestos Exposures

    PubMed Central

    Larson, Theodore C.; Pfau, Jean C.; Gavett, Stephen H.; Shukla, Arti; Miller, Aubrey; Hines, Ronald

    2015-01-01

    Summary Asbestos-related diseases continue to result in approximately 120,000 deaths every year in the United States and worldwide. Although extensive research has been conducted on health effects of occupational exposures to asbestos, many issues related to environmental asbestos exposures remain unresolved. For example, environmental asbestos exposures associated with a former mine in Libby, Montana, have resulted in high rates of nonoccupational asbestos-related disease. Additionally, other areas with naturally occurring asbestos deposits near communities in the United States and overseas are undergoing investigations to assess exposures and potential health risks. Some of the latest public health, epidemiological, and basic research findings were presented at a workshop on asbestos at the 2014 annual meeting of the Society of Toxicology in Phoenix, Arizona. The following focus areas were discussed: a) mechanisms resulting in fibrosis and/or tumor development; b) relative toxicity of different forms of asbestos and other hazardous elongated mineral particles (EMPs); c) proper dose metrics (e.g., mass, fiber number, or surface area of fibers) when interpreting asbestos toxicity; d) asbestos exposure to susceptible populations; and e) using toxicological findings for risk assessment and remediation efforts. The workshop also featured asbestos research supported by the National Institute of Environmental Health Sciences, the Agency for Toxic Substances and Disease Registry, and the U.S. Environmental Protection Agency. Better protection of individuals from asbestos-related health effects will require stimulation of new multidisciplinary research to further our understanding of what constitutes hazardous exposures and risk factors associated with toxicity of asbestos and other hazardous EMPs (e.g., nanomaterials). PMID:26230287

  4. Current Research and Opportunities to Address Environmental Asbestos Exposures

    EPA Science Inventory

    Asbestos-related diseases continue to result in approximately 120,000 deaths every year in the United States and worldwide.Although extensive research has been conducted on health effects of occupational exposures to asbestos, many issues related to environmental asbestos exposur...

  5. Current Research and Opportunities to Address Environmental Asbestos Exposures.

    PubMed

    Carlin, Danielle J; Larson, Theodore C; Pfau, Jean C; Gavett, Stephen H; Shukla, Arti; Miller, Aubrey; Hines, Ronald

    2015-08-01

    Asbestos-related diseases continue to result in approximately 120,000 deaths every year in the United States and worldwide. Although extensive research has been conducted on health effects of occupational exposures to asbestos, many issues related to environmental asbestos exposures remain unresolved. For example, environmental asbestos exposures associated with a former mine in Libby, Montana, have resulted in high rates of nonoccupational asbestos-related disease. Additionally, other areas with naturally occurring asbestos deposits near communities in the United States and overseas are undergoing investigations to assess exposures and potential health risks. Some of the latest public health, epidemiological, and basic research findings were presented at a workshop on asbestos at the 2014 annual meeting of the Society of Toxicology in Phoenix, Arizona. The following focus areas were discussed: a) mechanisms resulting in fibrosis and/or tumor development; b) relative toxicity of different forms of asbestos and other hazardous elongated mineral particles (EMPs); c) proper dose metrics (e.g., mass, fiber number, or surface area of fibers) when interpreting asbestos toxicity; d) asbestos exposure to susceptible populations; and e) using toxicological findings for risk assessment and remediation efforts. The workshop also featured asbestos research supported by the National Institute of Environmental Health Sciences, the Agency for Toxic Substances and Disease Registry, and the U.S. Environmental Protection Agency. Better protection of individuals from asbestos-related health effects will require stimulation of new multidisciplinary research to further our understanding of what constitutes hazardous exposures and risk factors associated with toxicity of asbestos and other hazardous EMPs (e.g., nanomaterials).

  6. Interventions to address maternal and childhood undernutrition: current evidence.

    PubMed

    Bhutta, Zulfiqar A; Das, Jai K

    2014-01-01

    The global burden of undernutrition remains high with little evidence of change in many countries. We reviewed the evidence of the potential nutritional interventions and estimated their effect on nutrition-related outcomes of women and children. Among the maternal interventions, daily iron supplementation results in a 69% reduction in incidence of anemia, 20% in incidence of low birthweight (LBW) and improves mean birthweight. MMN supplementation during pregnancy has been shown to significantly decrease the number of LBW infants by 14% and small for gestational age (SGA) by 13%. Balanced protein-energy supplementation reduces the incidence of SGA by 32% and risk of stillbirths by 38%. Antimalarials when given to pregnant women increase the mean birthweight significantly and were associated with a 43% reduction in LBW and severe antenatal anemia by 38%. Among the neonatal and child interventions, educational/counseling interventions increased exclusive breastfeeding by 43% at 4-6 weeks and 137% at 6 months. Vitamin A supplementation (VAS) reduces all-cause mortality by 24% and results in a 14% reduction in the risk of infant mortality at 6 months. Intermittent iron supplementation in children reduces the risk of anemia by 49% and iron deficiency by 76%, and significantly improves hemoglobin and ferritin concentration. Preventive zinc supplementation in populations at risk of zinc deficiency decreases morbidity from childhood diarrhea and acute lower respiratory infections, and increases linear growth and weight gain among infants and young children. Among the supportive interventions, hand washing with soap significantly reduces diarrhea morbidity by 48%, though it depends on access to water. The effect of water treatment on diarrhea morbidity also appears similarly large with a 17% reduction. Recent research has established linkages of preconception interventions with improved maternal, perinatal and neonatal health outcomes, and it has been suggested that several proven interventions recommended during pregnancy may be even more effective if implemented before conception. These proven interventions, if scaled up have the potential to reduce the global burden of undernutrition substantially. PMID:24504207

  7. Sun Protection: Current Management Strategies Addressing UV Exposure.

    PubMed

    Cohen, Leslie E; Grant, Robert T

    2016-07-01

    The use of sunscreen is essential for protection against photoaging and skin cancer. There is no global consensus on rating systems for sunscreens but it is essential to understand what makes a product broad-spectrum. In addition, physicians should have a general understanding that high-quality successful sunscreens should not only provide broad-spectrum ultraviolet A/B protection but should also be formulated so that they are easy to apply, are water resistant, and are photostable in order to increase user compliance. PMID:27363775

  8. Interventions to address maternal and childhood undernutrition: current evidence.

    PubMed

    Bhutta, Zulfiqar A; Das, Jai K

    2014-01-01

    The global burden of undernutrition remains high with little evidence of change in many countries. We reviewed the evidence of the potential nutritional interventions and estimated their effect on nutrition-related outcomes of women and children. Among the maternal interventions, daily iron supplementation results in a 69% reduction in incidence of anemia, 20% in incidence of low birthweight (LBW) and improves mean birthweight. MMN supplementation during pregnancy has been shown to significantly decrease the number of LBW infants by 14% and small for gestational age (SGA) by 13%. Balanced protein-energy supplementation reduces the incidence of SGA by 32% and risk of stillbirths by 38%. Antimalarials when given to pregnant women increase the mean birthweight significantly and were associated with a 43% reduction in LBW and severe antenatal anemia by 38%. Among the neonatal and child interventions, educational/counseling interventions increased exclusive breastfeeding by 43% at 4-6 weeks and 137% at 6 months. Vitamin A supplementation (VAS) reduces all-cause mortality by 24% and results in a 14% reduction in the risk of infant mortality at 6 months. Intermittent iron supplementation in children reduces the risk of anemia by 49% and iron deficiency by 76%, and significantly improves hemoglobin and ferritin concentration. Preventive zinc supplementation in populations at risk of zinc deficiency decreases morbidity from childhood diarrhea and acute lower respiratory infections, and increases linear growth and weight gain among infants and young children. Among the supportive interventions, hand washing with soap significantly reduces diarrhea morbidity by 48%, though it depends on access to water. The effect of water treatment on diarrhea morbidity also appears similarly large with a 17% reduction. Recent research has established linkages of preconception interventions with improved maternal, perinatal and neonatal health outcomes, and it has been suggested that several proven interventions recommended during pregnancy may be even more effective if implemented before conception. These proven interventions, if scaled up have the potential to reduce the global burden of undernutrition substantially.

  9. Keeping Current. Library Media Specialists: Addressing the Student Health Epidemic

    ERIC Educational Resources Information Center

    Buddy, Juanita

    2005-01-01

    Health and educational leaders are sounding the alarm about the unhealthy condition of many students in America's K-12 schools. Each day, new scientific studies confirm that "The majority of American youth are sedentary and do not eat well. Sixteen percent of school-aged children and adolescents--or nine million--are overweight, a figure that has…

  10. Swimming Against the Current: Zebrafish Help Address Educational Challenges.

    PubMed

    Pickart, Michael A; Liang, Jennifer; Hutson, Lara; Pierret, Christopher

    2016-08-01

    Zebrafish can be important tools for learning and authentic student research. The broad zebrafish community is rich with examples to improve education for learners of all ages and geographical locales. This special collection of articles is presented with the hope of encouraging readers to reflect on the educational outcomes reported here and to consider new ways zebrafish may engage others to learn and grow. PMID:27333079

  11. U.S. perspective on mycotoxin regulatory issues.

    PubMed

    Park, Douglas L; Troxell, Terry C

    2002-01-01

    Control programs set up by the Food and Drug Administration (FDA) for aflatoxin, an unavoidable natural contaminant produced by specific molds that invade a number of feedstuffs and basic foods, provide an example of forces that affect risk assessment and management strategies by a regulatory agency. More recently, on an international scale, efforts to establish international food standards for fumonisin, deoxynivalenol, ochratoxin A, zearalenone, and patulin, as well as for aflatoxin, demonstrate the complexity of developing regulations and/or standards designed to protect consumer health and ensure fair trade practices on a global scale. Current FDA regulations for aflatoxins address public health concerns for potential contamination in basic foods, residues in milk, and animal feeds for numerous commodities and applications. Regulatory limits, sampling and analytical procedures, decontamination and/or diversion to less risk uses for contaminated product are components of mycotoxin control programs. Current efforts by FDA to establish regulatory controls for deoxynivalenol, fumonisin, and patulin add further insight on the role that safety and risk assessment procedures play in the development of action levels and advisories for mycotoxins.

  12. 2015 ASHG Awards and Addresses

    PubMed Central

    2016-01-01

    Each year at the annual meeting of The American Society of Human Genetics (ASHG), addresses are given in honor of The Society and a number of award winners. A summary of each of these is given below. On the following pages, we have printed the presidential address and the addresses for the William Allan Award, the Curt Stern Award, and the Victor A. McKusick Leadership Award. Webcasts of these addresses, as well as those of many other presentations, can be found at http://www.ashg.org.

  13. Mediation: Sanity in the regulatory process

    SciTech Connect

    Cohen, D.S.

    1993-01-15

    The regulatory process is in need of change. The adversarial model used by most regulatory agencies is an inefficient, expensive, and conflict-producing procedure. Ill-adapted to resolving issues of great public policy concern, regulation calls out for non-adversarial alternative processes to address the resolution of public policy disputes between the players in the regulatory process. The adversarial model of regulation mimics traditional courtroom procedures. It is designed to determine issues of fact, not issues of public policy with legal maneuvering used to shroud the development of facts. Conflict maintenance and not conflict resolution has become the hallmark of the adversarial process in the regulatory arena. Unlike the courtroom process which provides a certain finality to conflicts, the adversarial process in the regulatory process is perpetual.

  14. OVERVIEW OF VOLUNTARY STEWARDSHIP EFFORTS TO ADDRESS PHARMACEUTICAL DISPOSAL

    EPA Science Inventory

    This presentation will provide an overview of current federal regulatory guidance for pharmaceutical disposal, currently funded pilot programs for take-back pilot studies, and state programs. The EPA Office of Water's role is to protect our Nation's watersheds and drinking water ...

  15. Glycoconjugate Vaccines: The Regulatory Framework.

    PubMed

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  16. Toxicogenomics in regulatory ecotoxicology

    USGS Publications Warehouse

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  17. Regulatory Streamlining and Improvement

    SciTech Connect

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and Development: This area

  18. Regulatory physiology discipline science plan

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

  19. Exploring the ethical and regulatory issues in pragmatic clinical trials.

    PubMed

    Califf, Robert M; Sugarman, Jeremy

    2015-10-01

    The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care.

  20. Exploring the ethical and regulatory issues in pragmatic clinical trials.

    PubMed

    Califf, Robert M; Sugarman, Jeremy

    2015-10-01

    The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care. PMID:26374676

  1. Regulatory Considerations for Biosimilars

    PubMed Central

    Nellore, Ranjani

    2010-01-01

    Currently there is considerable interest in the legislative debate around generic biological drugs or “biosimilars” in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved “similar” biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products. PMID:21829775

  2. Strengthening the Canadian alcohol advertising regulatory system.

    PubMed

    Heung, Carly M; Rempel, Benjamin; Krank, Marvin

    2012-05-24

    Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups.

  3. Strengthening the Canadian alcohol advertising regulatory system.

    PubMed

    Heung, Carly M; Rempel, Benjamin; Krank, Marvin

    2012-01-01

    Research evidence points to harmful effects from alcohol advertising among children and youth. In particular, exposure to alcohol advertising has been associated with adolescents drinking both earlier and heavier. Although current federal and provincial guidelines have addressed advertising practices to prevent underage drinking, practice has not been supported by existing policy. While protective measures such as social marketing campaigns have the potential for counteracting the effects from alcohol advertising, the effectiveness of such measures can be easily drowned out with increasing advertising activities from the alcohol industry, especially without effective regulation. Research reviewed by the European Focus on Alcohol Safe Environment (FASE) Project has identified a set of key elements that are necessary to make alcohol advertising policy measures effective at protecting children and youth from the harmful effects of alcohol marketing. Using these key elements as an evaluation framework, there are critical components in the Canadian alcohol advertising regulatory system that clearly require strengthening. To protect impressionable children and youth against the harmful effects of alcohol advertising, 13 recommendations to strengthen current alcohol advertising regulations in Canada are provided for Canadian policy-makers, advertising standard agencies, and public health groups. PMID:23618638

  4. Applications of toxicogenomics to nonclinical drug development: regulatory science considerations.

    PubMed

    Sistare, Frank D; Degeorge, Joseph J

    2008-01-01

    Scientists in the pharmaceutical industry have ready access to samples from animal toxicology studies carefully designed to test the safety characteristics of a steady pipeline of agents advancing toward clinical testing. Applications of toxicogenomics to the evaluation of compounds could best be realized if this promising technology could be implemented in these studies fully anchored in the traditional study end points currently used to characterize phenotypic outcome and to support the safe conduct of clinical testing. Regulatory authorities worldwide have declared their support for toxicogenomics and related technological tools to positively impact drug development, and guidance has been published. However, applications of exploratory "omics" technologies to compounds undergoing safety testing remain inhibited due to two core data submission responsibility implications and ambiguities: (1) constraints arising from continual literature surveillance and data reanalysis burdens, under the shadow of looming subsequent reporting requirements to regulatory authorities as gene expression end points loosely linked to safety gain attention in the published literature, and (2) ambiguities in interpretation of validation stature remain between exploratory, probable valid, and known valid safety biomarkers. A proposal is offered to address these regulatory implementation barriers to open access for exploring this technology in prospective drug development animal toxicology studies.

  5. Regulatory Aspects Of Implementing Electrokinetic Remediation

    EPA Science Inventory

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

  6. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Any request for a regulatory hearing shall be submitted in writing to the agency employee identified..., modify, or vacate the order, and addressing an appropriate cease distribution and notification strategy... that might be required by a recall order, including an appropriate recall strategy, if FDA later...

  7. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.11 Regulatory hearing. (a... a recall of the device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later...

  8. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.11 Regulatory hearing. (a... a recall of the device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later...

  9. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical Device Recall Procedures § 810.11 Regulatory hearing. (a... a recall of the device that was the subject of the order. The hearing may also address the actions that might be required by a recall order, including an appropriate recall strategy, if FDA later...

  10. Addressing problems of employee performance.

    PubMed

    McConnell, Charles R

    2011-01-01

    Employee performance problems are essentially of 2 kinds: those that are motivational in origin and those resulting from skill deficiencies. Both kinds of problems are the province of the department manager. Performance problems differ from problems of conduct in that traditional disciplinary processes ordinarily do not apply. Rather, performance problems are addressed through educational and remedial processes. The manager has a basic responsibility in ensuring that everything reasonable is done to help each employee succeed. There are a number of steps the manager can take to address employee performance problems.

  11. 30 CFR 902.10 - State regulatory program approval.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... date, the Alaska Department of Natural Resources shall be deemed the regulatory authority in Alaska for... approved program are available at the following addresses: (a) Department of Natural Resources, Division of... 30 Mineral Resources 3 2012-07-01 2012-07-01 false State regulatory program approval....

  12. Addressing Phonological Questions with Ultrasound

    ERIC Educational Resources Information Center

    Davidson, Lisa

    2005-01-01

    Ultrasound can be used to address unresolved questions in phonological theory. To date, some studies have shown that results from ultrasound imaging can shed light on how differences in phonological elements are implemented. Phenomena that have been investigated include transitional schwa, vowel coalescence, and transparent vowels. A study of…

  13. Every Other Day. Keynote Address.

    ERIC Educational Resources Information Center

    Tiller, Tom

    Schools need to be reoriented and restructured so that what is taught and learned, and the way in which it is taught and learned, are better integrated with young people's real-world experiences. Many indicators suggest that the meaningful aspects of school have been lost in the encounter with modern times. The title of this address--"Every Other…

  14. State of the Lab Address

    SciTech Connect

    King, Alex

    2010-01-01

    In his third-annual State of the Lab address, Ames Laboratory Director Alex King called the past year one of "quiet but strong progress" and called for Ames Laboratory to continue to build on its strengths while responding to changing expectations for energy research.

  15. State of the Lab Address

    ScienceCinema

    King, Alex

    2016-07-12

    In his third-annual State of the Lab address, Ames Laboratory Director Alex King called the past year one of "quiet but strong progress" and called for Ames Laboratory to continue to build on its strengths while responding to changing expectations for energy research.

  16. Presidential address. Fatti Maschii Parole Femine.

    PubMed

    Murphy, G P

    1984-03-15

    The current role of the Society of Surgical Oncology has demonstrated leadership in the field of surgical oncology in both word and deed, as exemplified by the motto of the State of Maryland, adopted from the 1632 family seal of Lord Baltimore, "Fatti Maschii Parole Femine." The current emphasis on the need for clinical research on human cancers, and the education of surgeons in all aspects of various cancers is well founded in the writings and the addresses of Dr. James Ewing, the Society's founder. Our goals as a society for the next decade have been precisely defined and, as in all important national programs, made current and interfaced with corresponding priorities of the American Cancer Society and the National Cancer Institute. The Society, in three project areas, is: (1) assessing current progress in surgical oncology, as well as future manpower needs; (2) studying on a comprehensive basis the surgical practices in cancer patient management; and (3) surveying academic centers concerning the nature of current education and training of academic surgeons in clinical research. The Training Committee currently reviews and recognizes 2-year postresidency multidisciplinary training at several institutions, and the James Ewing Foundation has expanded its fiscal support of educational activities. This annual meeting marks an historic first signified by the conjoint sessions being held with other international surgical oncology societies.

  17. Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

    SciTech Connect

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

    To help reduce the uncertainty associated with application of digital instrumentation and controls (I&C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I&C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I&C Regulation, Communication issues, Human Factors and the Digital I&C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I&C systems.

  18. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. PMID:25830179

  19. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation.

  20. [Regulatory B cells in human autoimmune diseases].

    PubMed

    Miyagaki, Tomomitsu

    2015-01-01

    B cells have been generally considered to be positive regulators of immune responses because of their ability to produce antigen-specific antibodies and to activate T cells through antigen presentation. Impairment of B cell development and function may cause autoimmune diseases. Recently, specific B cell subsets that can negatively regulate immune responses have been described in mouse models of a wide variety of autoimmune diseases. The concept of those B cells, termed regulatory B cells, is now recognized as important in the murine immune system. Among several regulatory B cell subsets, IL-10-producing regulatory B cells are the most widely investigated. On the basis of discoveries from studies of such mice, human regulatory B cells that produce IL-10 in most cases are becoming an active area of research. There have been emerging data suggesting the importance of human regulatory B cells in various diseases. Revealing the immune regulation mechanisms of human regulatory B cells in human autoimmune diseases could lead to the development of novel B cell targeted therapies. This review highlights the current knowledge on regulatory B cells, mainly IL-10-producing regulatory B cells, in clinical research using human samples. PMID:26725860

  1. Addressing Barriers to Learning. Volume 11, Number 2. Spring 2006

    ERIC Educational Resources Information Center

    Center for Mental Health in Schools at UCLA, 2006

    2006-01-01

    This issue of the quarterly newsletter of the Center for Mental Health in Schools includes the following features and regular segments: (1) Concerns = Opportunities: Addressing Student Disengagement, Acting Out, and Dropouts by Moving in New Directions; (2) Info Sheet: Costs of Not Addressing Barriers to Learning; and (3) Current Status of Mental…

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

    SciTech Connect

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

    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)

  3. Environmental regulatory update table

    SciTech Connect

    Brown, K.J.; Langston, M.E.; Tucker, C.S.; Reed, R.M.

    1987-06-01

    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. Optical addressing technique for a CMOS RAM

    NASA Technical Reports Server (NTRS)

    Wu, W. H.; Bergman, L. A.; Allen, R. A.; Johnston, A. R.

    1988-01-01

    Progress on optically addressing a CMOS RAM for a feasibility demonstration of free space optical interconnection is reported in this paper. The optical RAM chip has been fabricated and functional testing is in progress. Initial results seem promising. New design and SPICE simulation of optical gate cell (OGC) circuits have been carried out to correct the slow fall time of the 'weak pull down' OGC, which has been characterized experimentally. Methods of reducing the response times of the photodiodes and the associated circuits are discussed. Even with the current photodiode, it appears that an OGC can be designed with a performance that is compatible with a CMOS circuit such as the RAM.

  5. Current titles

    SciTech Connect

    1995-07-01

    This booklet is published for those interested in current research being conducted at the National Center for Electron Microscopy. The NCEM is a DOE-designated national user facility and is available at no charge to qualified researchers. Access is controlled by an external steering committee. Interested researchers may contact Gretchen Hermes at (510) 486-5006 or address below for a User`s Guide. Copies of available papers can be ordered from: Theda Crawford National Center for Electron Microscopy, Lawrence Berkeley Laboratory, One Cyclotron Rd., MS72, Berkeley, California, USA 94720.

  6. The Regulatory Framework for Privacy and Security

    NASA Astrophysics Data System (ADS)

    Hiller, Janine S.

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

  7. Regulatory cells and transplantation tolerance.

    PubMed

    Cobbold, Stephen P; Waldmann, Herman

    2013-06-01

    Transplantation tolerance is a continuing therapeutic goal, and it is now clear that a subpopulation of T cells with regulatory activity (Treg) that express the transcription factor foxp3 are crucial to this aspiration. Although reprogramming of the immune system to donor-specific transplantation tolerance can be readily achieved in adult mouse models, it has yet to be successfully translated in human clinical practice. This requires that we understand the fundamental mechanisms by which donor antigen-specific Treg are induced and function to maintain tolerance, so that we can target therapies to enhance rather than impede these regulatory processes. Our current understanding is that Treg act via numerous molecular mechanisms, and critical underlying components such as mTOR inhibition, are only now emerging. PMID:23732858

  8. Identifying and Addressing Vaccine Hesitancy

    PubMed Central

    Kestenbaum, Lori A.; Feemster, Kristen A.

    2015-01-01

    In the 20th century, the introduction of multiple vaccines significantly reduced childhood morbidity, mortality, and disease outbreaks. Despite, and perhaps because of, their public health impact, an increasing number of parents and patients are choosing to delay or refuse vaccines. These individuals are described as vaccine hesitant. This phenomenon has developed due to the confluence of multiple social, cultural, political and personal factors. As immunization programs continue to expand, understanding and addressing vaccine hesitancy will be crucial to their successful implementation. This review explores the history of vaccine hesitancy, its causes, and suggested approaches for reducing hesitancy and strengthening vaccine acceptance. PMID:25875982

  9. Nanoscale content-addressable memory

    NASA Technical Reports Server (NTRS)

    Davis, Bryan (Inventor); Principe, Jose C. (Inventor); Fortes, Jose (Inventor)

    2009-01-01

    A combined content addressable memory device and memory interface is provided. The combined device and interface includes one or more one molecular wire crossbar memories having spaced-apart key nanowires, spaced-apart value nanowires adjacent to the key nanowires, and configurable switches between the key nanowires and the value nanowires. The combination further includes a key microwire-nanowire grid (key MNG) electrically connected to the spaced-apart key nanowires, and a value microwire-nanowire grid (value MNG) electrically connected to the spaced-apart value nanowires. A key or value MNGs selects multiple nanowires for a given key or value.

  10. T follicular regulatory cells.

    PubMed

    Sage, Peter T; Sharpe, Arlene H

    2016-05-01

    Pathogen exposure elicits production of high-affinity antibodies stimulated by T follicular helper (Tfh) cells in the germinal center reaction. Tfh cells provide both costimulation and stimulatory cytokines to B cells to facilitate affinity maturation, class switch recombination, and plasma cell differentiation within the germinal center. Under normal circumstances, the germinal center reaction results in antibodies that precisely target foreign pathogens while limiting autoimmunity and excessive inflammation. In order to have this degree of control, the immune system ensures Tfh-mediated B-cell help is regulated locally in the germinal center. The recently identified T follicular regulatory (Tfr) cell subset can migrate to the germinal center and inhibit Tfh-mediated B-cell activation and antibody production. Although many aspects of Tfr cell biology are still unclear, recent data have begun to delineate the specialized roles of Tfr cells in controlling the germinal center reaction. Here we discuss the current understanding of Tfr-cell differentiation and function and how this knowledge is providing new insights into the dynamic regulation of germinal centers, and suggesting more efficacious vaccine strategies and ways to treat antibody-mediated diseases.

  11. Recent NRC research activities addressing valve and pump issues

    SciTech Connect

    Morrison, D.L.

    1996-12-01

    The mission of the U.S. Nuclear Regulatory Commission (NRC) is to ensure the safe design, construction, and operation of commercial nuclear power plants and other facilities in the U.S.A. One of the main roles that the Office of Nuclear Regulatory Research (RES) plays in achieving the NRC mission is to plan, recommend, and implement research programs that address safety and technical issues deemed important by the NRC. The results of the research activities provide the bases for developing NRC positions or decisions on these issues. Also, RES performs confirmatory research for developing the basis to evaluate industry responses and positions on various regulatory requirements. This presentation summarizes some recent RES supported research activities that have addressed safety and technical issues related to valves and pumps. These activities include the efforts on determining valve and motor-operator responses under dynamic loads and pressure locking events, evaluation of monitoring equipment, and methods for detecting and trending aging of check valves and pumps. The role that RES is expected to play in future years to fulfill the NRC mission is also discussed.

  12. IP address management : augmenting Sandia's capabilities through open source tools.

    SciTech Connect

    Nayar, R. Daniel

    2005-08-01

    Internet Protocol (IP) address management is an increasingly growing concern at Sandia National Laboratories (SNL) and the networking community as a whole. The current state of the available IP addresses indicates that they are nearly exhausted. Currently SNL doesn't have the justification to obtain more IP address space from Internet Assigned Numbers Authority (IANA). There must exist a local entity to manage and allocate IP assignments efficiently. Ongoing efforts at Sandia have been in the form of a multifunctional database application notably known as Network Information System (NWIS). NWIS is a database responsible for a multitude of network administrative services including IP address management. This study will explore the feasibility of augmenting NWIS's IP management capabilities utilizing open source tools. Modifications of existing capabilities to better allocate available IP address space are studied.

  13. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... agenda on April 26, 2010 (75 FR 21960). For this edition of the NRC's regulatory agenda, the most... publication of the last NRC semiannual agenda on April 26, 2010 (75 FR 21960). Within each group, the rules... regulations to improve the control over the distribution of source material to exempt persons and to...

  14. Environmental Programs: Status of Work and Current Priorities for FY13

    SciTech Connect

    Jones, Patricia

    2012-08-17

    Presentation outline is: Mission/overview, Regulatory framework, Current status of cleanup, Shift in priorities to address highest risk, Removal of above-ground waste, Continued focus on protecting water resources, and Priorities for fiscal year 2013. LANL's Environmental Mission is to: (1) Repack and ship legacy transuranic waste containers; (2) Investigate and remediate Cold War (legacy) hazardous and radioactive waste areas; (3) Demolish unused buildings; (4) Disposition solid waste from Laboratory operations; and (5) Lifecycle cost nearly $3 billion.

  15. Participatory Workplace Wellness Programs: Reward, Penalty, and Regulatory Conflict

    PubMed Central

    Pomeranz, Jennifer L

    2015-01-01

    Context In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. Methods To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments’ regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Findings Employers’ practices and the federal departments’ regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments’ regulations may be interpreted as conflicting with Congress's legislation, which mentions penalties only for health-contingent wellness programs. Furthermore, the regulatory protections for employees applicable to health-contingent wellness programs do not apply to participatory programs. Conclusions Either Congress or the federal agencies should address the conflict among employers’ practices, the wellness regulations, and the ADA and also consider additional protections for employees. Employers can avoid ethical and legal complications by offering voluntary programs with

  16. Addressing viral resistance through vaccines

    PubMed Central

    Laughlin, Catherine; Schleif, Amanda; Heilman, Carole A

    2015-01-01

    Antimicrobial resistance is a serious healthcare concern affecting millions of people around the world. Antiviral resistance has been viewed as a lesser threat than antibiotic resistance, but it is important to consider approaches to address this growing issue. While vaccination is a logical strategy, and has been shown to be successful many times over, next generation viral vaccines with a specific goal of curbing antiviral resistance will need to clear several hurdles including vaccine design, evaluation and implementation. This article suggests that a new model of vaccination may need to be considered: rather than focusing on public health, this model would primarily target sectors of the population who are at high risk for complications from certain infections. PMID:26604979

  17. Changing concepts: the presidential address.

    PubMed

    Weed, J C

    1974-09-01

    A discussion of conceptual change in areas related to fertility and medicine is presented in an address by the president of the American Fertility Society. Advances in technological research and medicine, particularly in steroids and reporductive physiology, have been the most readily acceptable changes. Cesarean section and surgical sterilization have also become increasingly accepted. Newer developments such as sperm banks, artificial insemination, and ovum transfer have created profound ethical, moral, and medical issued in human engineering research and evolutionary theory. The legalization of abortion has brought moral, ethical, and legal problems for many members of the medical profession. It is urged that the Society promote education of the people in reproductive function, sexual activity, and parental obligation while being acutely aware of the problems in influencing or altering human reproduction.

  18. Addressing Failures in Exascale Computing

    SciTech Connect

    Snir, Marc; Wisniewski, Robert; Abraham, Jacob; Adve, Sarita; Bagchi, Saurabh; Balaji, Pavan; Belak, J.; Bose, Pradip; Cappello, Franck; Carlson, Bill; Chien, Andrew; Coteus, Paul; DeBardeleben, Nathan; Diniz, Pedro; Engelmann, Christian; Erez, Mattan; Fazzari, Saverio; Geist, Al; Gupta, Rinku; Johnson, Fred; Krishnamoorthy, Sriram; Leyffer, Sven; Liberty, Dean; Mitra, Subhasish; Munson, Todd; Schreiber, Rob; Stearley, Jon; Van Hensbergen, Eric

    2014-01-01

    We present here a report produced by a workshop on Addressing failures in exascale computing' held in Park City, Utah, 4-11 August 2012. The charter of this workshop was to establish a common taxonomy about resilience across all the levels in a computing system, discuss existing knowledge on resilience across the various hardware and software layers of an exascale system, and build on those results, examining potential solutions from both a hardware and software perspective and focusing on a combined approach. The workshop brought together participants with expertise in applications, system software, and hardware; they came from industry, government, and academia, and their interests ranged from theory to implementation. The combination allowed broad and comprehensive discussions and led to this document, which summarizes and builds on those discussions.

  19. Addressing failures in exascale computing

    SciTech Connect

    Snir, Marc; Wisniewski, Robert W.; Abraham, Jacob A.; Adve, Sarita; Bagchi, Saurabh; Balaji, Pavan; Belak, Jim; Bose, Pradip; Cappello, Franck; Carlson, William; Chien, Andrew A.; Coteus, Paul; Debardeleben, Nathan A.; Diniz, Pedro; Engelmann, Christian; Erez, Mattan; Saverio, Fazzari; Geist, Al; Gupta, Rinku; Johnson, Fred; Krishnamoorthy, Sriram; Leyffer, Sven; Liberty, Dean; Mitra, Subhasish; Munson, Todd; Schreiber, Robert; Stearly, Jon; Van Hensbergen, Eric

    2014-05-01

    We present here a report produced by a workshop on “Addressing Failures in Exascale Computing” held in Park City, Utah, August 4–11, 2012. The charter of this workshop was to establish a common taxonomy about resilience across all the levels in a computing system; discuss existing knowledge on resilience across the various hardware and software layers of an exascale system; and build on those results, examining potential solutions from both a hardware and software perspective and focusing on a combined approach. The workshop brought together participants with expertise in applications, system software, and hardware; they came from industry, government, and academia; and their interests ranged from theory to implementation. The combination allowed broad and comprehensive discussions and led to this document, which summarizes and builds on those discussions.

  20. Light addressable photoelectrochemical cyanide sensor

    SciTech Connect

    Licht, S.; Myung, N.; Sun, Y.

    1996-03-15

    A sensor is demonstrated that is capable of spatial discrimination of cyanide with use of only a single stationary sensing element. Different spatial regions of the sensing element are light activated to reveal the solution cyanide concentration only at the point of illumination. In this light addressable photoelectrochemical (LAP) sensor the sensing element consists of an n-CdSe electrode immersed in solution, with the open-circuit potential determined under illumination. In alkaline ferro-ferri-cyanide solution, the open-circuit photopotential is highly responsive to cyanide, with a linear response of (120 mV) log [KCN]. LAP detection with a spatial resolution of {+-}1 mm for cyanide detection is demonstrated. The response is almost linear for 0.001-0.100 m cyanide with a resolution of 5 mV. 38 refs., 7 figs., 1 tab.

  1. Addressing the Special Education Crisis

    ERIC Educational Resources Information Center

    Amprey, Walter G.

    2005-01-01

    In the author's past work as a superintendent, and in his current capacity as an educational consultant, he has seen hundreds of dollars (per special education student) wasted in unnecessary costs and lost funding opportunities resulting from out-of-date, ineffective management systems. In addition to the fiscal implications, this imposes…

  2. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

    PubMed

    Sneve, M K; Kiselev, M; Shandala, N K

    2014-05-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  3. Radio-ecological characterization and radiological assessment in support of regulatory supervision of legacy sites in northwest Russia.

    PubMed

    Sneve, M K; Kiselev, M; Shandala, N K

    2014-05-01

    The Norwegian Radiation Protection Authority has been implementing a regulatory cooperation program in the Russian Federation for over 10 years, as part of the Norwegian government's Plan of Action for enhancing nuclear and radiation safety in northwest Russia. The overall long-term objective has been the enhancement of safety culture and includes a special focus on regulatory supervision of nuclear legacy sites. The initial project outputs included appropriate regulatory threat assessments, to determine the hazardous situations and activities which are most in need of enhanced regulatory supervision. In turn, this has led to the development of new and updated norms and standards, and related regulatory procedures, necessary to address the often abnormal conditions at legacy sites. This paper presents the experience gained within the above program with regard to radio-ecological characterization of Sites of Temporary Storage for spent nuclear fuel and radioactive waste at Andreeva Bay and Gremikha in the Kola Peninsula in northwest Russia. Such characterization is necessary to support assessments of the current radiological situation and to support prospective assessments of its evolution. Both types of assessments contribute to regulatory supervision of the sites. Accordingly, they include assessments to support development of regulatory standards and guidance concerning: control of radiation exposures to workers during remediation operations; emergency preparedness and response; planned radionuclide releases to the environment; development of site restoration plans, and waste treatment and disposal. Examples of characterization work are presented which relate to terrestrial and marine environments at Andreeva Bay. The use of this data in assessments is illustrated by means of the visualization and assessment tool (DATAMAP) developed as part of the regulatory cooperation program, specifically to help control radiation exposure in operations and to support

  4. Regulatory impact analysis of environmental standards for uranium mill tailings at active sites. Final report

    SciTech Connect

    Not Available

    1983-03-01

    The Environmental Protection Agency was directed by Congress, under PL 95-604, the Uranium Mill Tailings Radiation Control Act of 1978, to set standards of general application that provide protection from the hazards associated with uranium mill tailings. Title I of the Act pertains to tailings at inactive sites for which the Agency has developed standards as part of a separate rulemaking. Title II of the Act requires standards covering the processing and disposal of byproduct materials at mills which are currently licensed by the appropriate regulatory authorities. This Regulatory Impact Analysis (RIA) addresses the standards developed under Title II. There are two major parts of the standards for active mills: standards for control of releases from tailings during processing operations and prior to final disposal, and standards for protection of the public after the disposal of tailings. This report presents a detailed analysis of standards for disposal only, since the analysis required for the operations standards is very limited.

  5. A region addresses patient safety.

    PubMed

    Feinstein, Karen Wolk; Grunden, Naida; Harrison, Edward I

    2002-06-01

    The Pittsburgh Regional Healthcare Initiative (PRHI) is a coalition of 35 hospitals, 4 major insurers, more than 30 major and small-business health care purchasers, dozens of corporate and civic leaders, organized labor, and partnerships with state and federal government all working together to deliver perfect patient care throughout Southwestern Pennsylvania. PRHI believes that in pursuing perfection, many of the challenges facing today's health care delivery system (eg, waste and error in the delivery of care, rising costs, frustration and shortage among clinicians and workers, financial distress, overcapacity, and lack of access to care) will be addressed. PRHI has identified patient safety (nosocomial infections and medication errors) and 5 clinical areas (obstetrics, orthopedic surgery, cardiac surgery, depression, and diabetes) as ideal starting points. In each of these areas of work, PRHI partners have assembled multifacility/multidisciplinary groups charged with defining perfection, establishing region-wide reporting systems, and devising and implementing recommended improvement strategies and interventions. Many design and conceptual elements of the PRHI strategy are adapted from the Toyota Production System and its Pittsburgh derivative, the Alcoa Business System. PRHI is in the proof-of-concept phase of development. PMID:12032502

  6. Gender: addressing a critical focus.

    PubMed

    Thornton, L; Wegner, M N

    1995-01-01

    The definition of gender was addressed at the Fourth World Conference on Women (Beijing, China). After extensive debate, the definition developed by the UN Population Fund in 1995 was adopted: "a set of qualities and behaviors expected from a female or male by society." The sustainability of family planning (FP) programs depends on acknowledgment of the role gender plays in contraceptive decision-making and use. For example, programs must consider the fact that women in many cultures do not make FP decisions without the consent of their spouse. AVSC is examining providers' gender-based ideas about clients and the effects of these views on the quality of reproductive health services. Questions such as how service providers can encourage joint responsibility for contraception without requiring spousal consent or how they can make men feel comfortable about using a male method in a society where FP is considered a woman's issue are being discussed. Also relevant is how service providers can discuss sexual matters openly with female clients in cultures that do not allow women to enjoy their sexuality. Another concern is the potential for physical violence to a client as a result of the provision of FP services. PMID:12294397

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

    PubMed Central

    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

  8. Understanding and Addressing Racial Disparities in Health Care

    PubMed Central

    Williams, David R.; Rucker, Toni D.

    2000-01-01

    Racial disparities in medical care should be understood within the context of racial inequities in societal institutions. Systematic discrimination is not the aberrant behavior of a few but is often supported by institutional policies and unconscious bias based on negative stereotypes. Effectively addressing disparities in the quality of care requires improved data systems, increased regulatory vigilance, and new initiatives to appropriately train medical professionals and recruit more providers from disadvantaged minority backgrounds. Identifying and implementing effective strategies to eliminate racial inequities in health status and medical care should be made a national priority. PMID:11481746

  9. Current activities handbook: formerly utilized sites remedial action program

    SciTech Connect

    1981-02-27

    This volume is one of a series produced under contract with the DOE, by Politech Corporation to develop a legislative and regulatory data base to assist the FUSRAP management in addressing the institutional and socioeconomic issues involved in carrying out the Formerly Utilized Sites Remedial Action Program. This Information Handbook series contains information about all relevant government agencies at the Federal and state levels, the pertinent programs they administer, each affected state legislature, and current Federal and state legislative and regulatory initiatives. This volume is a compilation of information about the activities each of the thirteen state legislatures potentially affected by the Formerly Utilized Sites Remedial Action Program. It contains a description of the state legislative procedural rules and a schedule of each legislative session; a summary of pending relevant legislation; the name and telephone number of legislative and state agency contacts; and the full text of all bills identified.

  10. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... been learned since that time. Far more is now known about regulation—not only about when it is... interests of future generations; identify methods of ensuring that regulatory review does not produce...

  11. Regulatory aspects of clinical xenotransplantation.

    PubMed

    Schuurman, Henk-Jan

    2015-11-01

    Xenotransplantation attracted interest from regulatory authorities, particularly after the demonstration of pig-to-human transmission of porcine endogenous retrovirus (1996). This added to the risk of a product, resulting in a Guidance of the US Food and Drug Administration (2003). This addresses the full flow chart in product manufacturing, starting with the designated pathogen-free status of the source animal; and special aspects regarding the recipient like informed consent and monitoring for infectious pathogens. Also archiving of records from the donor and recipient, as well as storage of samples is described. The European Medicines Agency issued a Guideline on xenogeneic cell therapy products (2009). Cell-based medicinal products are subject to specific regulations and directives, which apply also to xenogeneic products: the xenotransplant guidances/guidelines are an addition to these regulations. Noteworthy, acellular products like heart valves and decellularized cornea are not considered a cell therapy product, but rather a medical device with its own regulation. WHO issued relevant documents, especially about safety, and the International Xenotransplantation Association published consensus documents, a.o., addressing preclinical efficacy requirements before entering clinical trials. This manuscript presents an overview of the regulatory framework, with special focus on cell therapy products necause these are expected to reach the market first (i.e., pancreatic islets, hepatocytes and cellularized cornea); major illustrations are from the European situation. Albeit being complex, the regulation of xenotransplant products does not form a block in product development, but rather supports the introduction of efficacious and safe products to meet the medical need.

  12. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    SciTech Connect

    2000-08-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. 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-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or 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 further by focusing on the design of new plants.

  13. Applying evolutionary biology to address global challenges

    PubMed Central

    Carroll, Scott P.; Jørgensen, Peter Søgaard; Kinnison, Michael T.; Bergstrom, Carl T.; Denison, R. Ford; Gluckman, Peter; Smith, Thomas B.; Strauss, Sharon Y.; Tabashnik, Bruce E.

    2014-01-01

    Two categories of evolutionary challenges result from escalating human impacts on the planet. The first arises from cancers, pathogens and pests that evolve too quickly, and the second from the inability of many valued species to adapt quickly enough. Applied evolutionary biology provides a suite of strategies to address these global challenges that threaten human health, food security, and biodiversity. This review highlights both progress and gaps in genetic, developmental and environmental manipulations across the life sciences that either target the rate and direction of evolution, or reduce the mismatch between organisms and human-altered environments. Increased development and application of these underused tools will be vital in meeting current and future targets for sustainable development. PMID:25213376

  14. Applying evolutionary biology to address global challenges.

    PubMed

    Carroll, Scott P; Jørgensen, Peter Søgaard; Kinnison, Michael T; Bergstrom, Carl T; Denison, R Ford; Gluckman, Peter; Smith, Thomas B; Strauss, Sharon Y; Tabashnik, Bruce E

    2014-10-17

    Two categories of evolutionary challenges result from escalating human impacts on the planet. The first arises from cancers, pathogens, and pests that evolve too quickly and the second, from the inability of many valued species to adapt quickly enough. Applied evolutionary biology provides a suite of strategies to address these global challenges that threaten human health, food security, and biodiversity. This Review highlights both progress and gaps in genetic, developmental, and environmental manipulations across the life sciences that either target the rate and direction of evolution or reduce the mismatch between organisms and human-altered environments. Increased development and application of these underused tools will be vital in meeting current and future targets for sustainable development.

  15. Extreme space weather studies: Addressing societal needs

    NASA Astrophysics Data System (ADS)

    Ngwira, C. M.

    2014-12-01

    Extreme space weather events can adversely impact the operations of critical modern-day technological infrastructure such as high-voltage electric power transmission grids. Understanding of coupled magnetosphere-ionosphere dynamics under extreme solar wind driving conditions is still a major challenge mainly because of a lack of data during such time intervals. This presentation will highlight some of the past and on-going investigations on extreme space weather events, and how these investigations are used to address societal needs. Particularly, I will describe how first principles physics-based 3-D global MHD models are playing a major role in advancing our knowledge on extreme geomagnetically induced currents. These MHD models represent a very important component of attempts to understand the response of the magnetosphere-ionosphere system to varying solar wind conditions.

  16. Unified agenda of federal regulatory and deregulatory actions--HHS. Semiannual regulatory agenda.

    PubMed

    1998-11-01

    The President's Executive Order 12866 and the Regulatory Flexibility Act of 1980 require the semiannual publication of an agenda which summarizes all current, projected, and recently completed rulemakings of the Department. The agenda informs the public about regulatory actions that are under development within the components of the Department, and it provides all concerned with the opportunity to participate in this work at an early stage. The last such agenda was published on April 27, 1998.

  17. For telehealth to succeed, privacy and security risks must be identified and addressed.

    PubMed

    Hall, Joseph L; McGraw, Deven

    2014-02-01

    The success of telehealth could be undermined if serious privacy and security risks are not addressed. For example, sensors that are located in a patient's home or that interface with the patient's body to detect safety issues or medical emergencies may inadvertently transmit sensitive information about household activities. Similarly, routine data transmissions from an app or medical device, such as an insulin pump, may be shared with third-party advertisers. Without adequate security and privacy protections for underlying telehealth data and systems, providers and patients will lack trust in the use of telehealth solutions. Although some federal and state guidelines for telehealth security and privacy have been established, many gaps remain. No federal agency currently has authority to enact privacy and security requirements to cover the telehealth ecosystem. This article examines privacy risks and security threats to telehealth applications and summarizes the extent to which technical controls and federal law adequately address these risks. We argue for a comprehensive federal regulatory framework for telehealth, developed and enforced by a single federal entity, the Federal Trade Commission, to bolster trust and fully realize the benefits of telehealth.

  18. Air modeling: Air dispersion models; regulatory applications and technological advances

    SciTech Connect

    Miller, M.; Liles, R.

    1995-09-01

    Air dispersion models are a useful and practical tool for both industry and regulatory agencies. They serve as tools for engineering, permitting, and regulations development. Their cost effectiveness and ease of implementation compared to ambient monitoring is perhaps their most-appealing trait. Based on the current momentum within the U.S. EPA to develop better models and contain regulatory burdens on industry, it is likely that air dispersion modeling will be a major player in future air regulatory initiatives.

  19. Regulatory focus affects physician risk tolerance.

    PubMed

    Veazie, Peter J; McIntosh, Scott; Chapman, Benjamin P; Dolan, James G

    2014-01-01

    Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention-regulatory focus theory suggests such a factor. This study tested whether regulatory focus affects risk tolerance among primary care physicians. Twenty-seven primary care physicians were assigned to promotion-focused or prevention-focused manipulations and compared on the Risk Taking Attitudes in Medical Decision Making scale using a randomization test. Results provide evidence that physicians assigned to the promotion-focus manipulation adopted an attitude of greater risk tolerance than the physicians assigned to the prevention-focused manipulation (p = 0.01). The Cohen's d statistic was conventionally large at 0.92. Results imply that situational regulatory focus in primary care physicians affects risk tolerance and may thereby be a nonclinical source of practice variation. Results also provide marginal evidence that chronic regulatory focus is associated with risk tolerance (p = 0.05), but the mechanism remains unclear. Research and intervention targeting physician risk tolerance may benefit by considering situational regulatory focus as an explanatory factor.

  20. 77 FR 13258 - Biotechnology Regulatory Services; Changes Regarding the Solicitation of Public Comment for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... Animal and Plant Health Inspection Service Biotechnology Regulatory Services; Changes Regarding the.... FOR FURTHER INFORMATION CONTACT: Dr. T. Clint Nesbitt, Chief of Staff, Biotechnology Regulatory...://www.aphis.usda.gov/biotechnology/pet_proc_imp.shtml . Current Comment Process for Petitions...

  1. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    SciTech Connect

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  2. WELCOME ADDRESS: Welcome Address for the 60th Yamada Conference

    NASA Astrophysics Data System (ADS)

    Fukuyama, Hidetoshi

    2006-12-01

    Ladies and Gentlemen On behalf of Yamada Science Foundation, I would like to extend our hearty welcome to all of you who are participating in the 60th Yamada Conference and International Symposium on Research in High Magnetic Fields particularly to those who have come a long way to Japan from various places all over the world. Yamada Science Foundation was founded in 1977 at Osaka, Japan. It develops its activities by giving support to the outstanding research projects in the basic natural sciences, especially in the interdisciplinary domains that bridge between well established research fields such as physics, chemistry, and biology. The Foundation also provides travel funds for scientists to visit or to go out of Japan in order to carry out international collaborative projects. It also holds conferences and workshops. Among these activities, one of the most important is the organization of Yamada Conferences, which are usually held two or three times a year on various topics which seem to be pioneering current research activities in natural sciences. Upon organizing Yamada Conferences, The Board of Directors of The Foundation put emphasis on the three symbolic English letter `I's. The first I stands for International, the second I means Interdisciplinary, and the third, perhaps the most important I symbolizes Innovative. As for this conference, I think it is in some sense interdisciplinary, because it deals with on one hand, the smallest scale of matter, the elementary particles while, on the other hand deals with the largest scale of matter, the universe, which are linked together. I also think many innovative ideas are presented in this conference. In this context, I believe this Conference is well suited to the scope of our Foundation. Another important aspect of holding Yamada Conference is to provide the forum of `Friendship' among the participants. We encourage all of you, particularly young scientists, to get acquainted with each other not only through hot

  3. 78 FR 11735 - Semiannual Regulatory Agenda; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... FURTHER INFORMATION CONTACT: Mariana A. Pardo, Director, Government Contracting and Business Development... From the Federal Register Online via the Government Publishing Office ] Vol. 78 Tuesday, No. 33... 8, 2013 (78 FR 1636). The regulatory agenda is a semiannual summary of all current and...

  4. Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps?

    PubMed

    Flanagan, Talia; Van Peer, Achiel; Lindahl, Anders

    2016-08-25

    Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory purposes has been carried out within the industry community of the EU project OrBiTo within Innovative Medicines Initiative (IMI). The aim was to capture current practice and experience in using in vitro and in silico biopharmaceutics tools at various stages of development, what barriers exist or are perceived, and to understand the current gaps in regulatory biopharmaceutics. The survey indicated that biorelevant dissolution testing and physiologically based modelling and simulation are widely applied throughout development to address a number of biopharmaceutics issues. However, data from these in vitro and in silico predictive biopharmaceutics tools are submitted to regulatory authorities far less often than they are used for internal risk assessment and decision making. This may prevent regulators from becoming familiar with these tools and how they are applied in industry, and limits the opportunities for biopharmaceutics scientists working in industry to understand the acceptability of these tools in the regulatory environment. It is anticipated that the advanced biopharmaceutics tools and understanding delivered in the next years by OrBiTo and other initiatives in the area of predictive tools will also be of value in the regulatory setting, and provide a basis for more informed and confident biopharmaceutics risk assessment and regulatory decision making. To enable the regulatory potential of predictive biopharmaceutics tools to be realized, further scientific dialogue is needed between industry, regulators and scientists in academia, and more examples need to be published to demonstrate the applicability of these tools. PMID:27283487

  5. Addressing the vaccine confidence gap.

    PubMed

    Larson, Heidi J; Cooper, Louis Z; Eskola, Juhani; Katz, Samuel L; Ratzan, Scott

    2011-08-01

    Vaccines--often lauded as one of the greatest public health interventions--are losing public confidence. Some vaccine experts have referred to this decline in confidence as a crisis. We discuss some of the characteristics of the changing global environment that are contributing to increased public questioning of vaccines, and outline some of the specific determinants of public trust. Public decision making related to vaccine acceptance is neither driven by scientific nor economic evidence alone, but is also driven by a mix of psychological, sociocultural, and political factors, all of which need to be understood and taken into account by policy and other decision makers. Public trust in vaccines is highly variable and building trust depends on understanding perceptions of vaccines and vaccine risks, historical experiences, religious or political affiliations, and socioeconomic status. Although provision of accurate, scientifically based evidence on the risk-benefit ratios of vaccines is crucial, it is not enough to redress the gap between current levels of public confidence in vaccines and levels of trust needed to ensure adequate and sustained vaccine coverage. We call for more research not just on individual determinants of public trust, but on what mix of factors are most likely to sustain public trust. The vaccine community demands rigorous evidence on vaccine efficacy and safety and technical and operational feasibility when introducing a new vaccine, but has been negligent in demanding equally rigorous research to understand the psychological, social, and political factors that affect public trust in vaccines. PMID:21664679

  6. Addressing the vaccine confidence gap.

    PubMed

    Larson, Heidi J; Cooper, Louis Z; Eskola, Juhani; Katz, Samuel L; Ratzan, Scott

    2011-08-01

    Vaccines--often lauded as one of the greatest public health interventions--are losing public confidence. Some vaccine experts have referred to this decline in confidence as a crisis. We discuss some of the characteristics of the changing global environment that are contributing to increased public questioning of vaccines, and outline some of the specific determinants of public trust. Public decision making related to vaccine acceptance is neither driven by scientific nor economic evidence alone, but is also driven by a mix of psychological, sociocultural, and political factors, all of which need to be understood and taken into account by policy and other decision makers. Public trust in vaccines is highly variable and building trust depends on understanding perceptions of vaccines and vaccine risks, historical experiences, religious or political affiliations, and socioeconomic status. Although provision of accurate, scientifically based evidence on the risk-benefit ratios of vaccines is crucial, it is not enough to redress the gap between current levels of public confidence in vaccines and levels of trust needed to ensure adequate and sustained vaccine coverage. We call for more research not just on individual determinants of public trust, but on what mix of factors are most likely to sustain public trust. The vaccine community demands rigorous evidence on vaccine efficacy and safety and technical and operational feasibility when introducing a new vaccine, but has been negligent in demanding equally rigorous research to understand the psychological, social, and political factors that affect public trust in vaccines.

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

    SciTech Connect

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

    2008-06-01

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

  8. 78 FR 44199 - Semiannual Regulatory Agenda, Spring 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... on current general, industry, and scientific knowledge and experience. Timetable: Action Date FR Cite...: Action Date FR Cite NPRM 12/00/13 Final Action 09/00/14 Regulatory Flexibility Analysis Required: Yes... organic crop production. Timetable: ] Action Date FR Cite NPRM 11/00/13 Regulatory Flexibility...

  9. Current waste-management practices and operations at Oak Ridge National Laboratory, 1982

    SciTech Connect

    Eisenhower, B.M.; Oakes, T.W.; Coobs, J.H.; Weeter, D.W.

    1982-09-01

    The need for efficient management of industrial chemical wastes, especially those considered hazardous or radioactive, is receiving increased attention in the United States. During the past five years, several federal laws have addressed the establishment of stronger programs for the control of hazardous and residual wastes. At a facility such as Oak Ridge National Laboratory (ORNL), an efficient waste management program is an absolute necessity to ensure protection of human health and compliance with regulatory requirements addressing the treatment and disposal of hazardous, nonhazardous, and radioactive wastes. This report highlights the major regulatory requirements under which the Laboratory must operate and their impact on ORNL facilities. Individual waste streams, estimates of quantities of waste, and current waste management operations are discussed.

  10. Two regional regulatory meetings on distributed resources. Final technical report

    SciTech Connect

    2001-02-01

    An overview and discussion of Eastern Regional and Western Regional State Utility Regulators Workshops on Distributed Resources (DR) is given. The purpose of the workshops was for state regulators to learn about DR and the regulatory issues surrounding their greater use. The following issues were addressed: introduction to DR technologies and their potential benefits, interconnection and market barriers, regulatory incentives, rate design issues, and environmental issues.

  11. International regulatory landscape and integration of corrective genome editing into in vitro fertilization.

    PubMed

    Araki, Motoko; Ishii, Tetsuya

    2014-11-24

    Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.

  12. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... December 7, 2009 (74 FR 64572). ADDRESSES: Comments on any rule in the agenda may be sent to the Secretary... occurred on rules since publication of the last NRC semiannual agenda on December 7, 2009 (74 FR 64572... regulations to improve the control over the distribution of source material to exempt persons and to...

  13. TRUPACT-II, a regulatory perspective

    SciTech Connect

    Gregory, P.C.; Spooner, O.R.

    1995-12-31

    The Transuranic Package Transporter II (TRUPACT-II) is a US Nuclear Regulatory Commission (NRC) certified Type B packaging for the shipment of contact-handled transuranic (CH-TRU) material by the US Department of Energy (DOE). The NRC approved the TRUPACT-II design as meeting the requirements of Title 10, Code of Federal Regulations, Part 71 (10 CFR 71) and issued Certificate of Compliance (CofC) Number 9218 to the DOE. There are currently 15 certified TRUPACT-IIs. Additional TRUPACT-IIs will be required to make more than 15,000 shipments of CH-TRU waste to the Waste Isolation Pilot Plant (WIPP) site near Carlsbad, New Mexico. The TRUPACT-II may also be used for the DOE inter-site and intra-site shipments of CH-TRU waste. The Land Withdrawal Act (Public Law 102-579), enacted by the US Congress, October 30, 1992, and an agreement between the DOE and the State of New Mexico, signed August 4, 1987, both stipulate that only NRC approved packaging may be used for shipments of TRU waste to the WIPP. Early in the TRUPACT-II development phase it was decided that the transportation system (tractor, trailer, and TRUPACT-II) should be highway legal on all routes without the need for oversize and/or overweight permits. In large measure, public acceptance of the DOE`s efforts to safely transport CH-TRU waste depends on the public`s perception that the TRUPACT-II is in compliance with all applicable regulations, standards, and quality assurance requirements. This paper addresses some of the numerous regulations applicable to Type B packaging, and it describes how the TRUPACT-II complies with these regulations.

  14. Techniques for analyzing the impacts of certain electric-utility ratemaking and regulatory-policy concepts. Regulatory laws and policies. [State by state

    SciTech Connect

    1980-08-01

    This report is a legal study prepared to provide a review of the substantive and procedural laws of each regulatory jurisdiction that may affect implementation of the PURPA standards, and to summarize the current state of consideration and implementation of policies and rate designs similar or identical to the PURPA standards by state regulatory agencies and nonregulated utilities. This report is divided into three sections. The first section, the Introduction, summarizes the standards promulgated by PURPA and the results of the legal study. The second section, State Regulatory Law and Procedure, summarizes for each state or other ratemaking jurisdiction: (1) general constitutional and statutory provisions affecting utility rates and conditions of service; (2) specific laws or decisions affecting policy or rate design issues covered by PURPA standards; and (3) statutes and decisions governing administrative procedures, including judicial review. A chart showing actions taken on the policy and rate design issues addressed by PURPA is also included for each jurisdiction, and citations to relevant authorities are presented for each standard. State statutes or decisions that specifically define a state standard similar or identical to a PURPA standard, or that refer to one of the three PURPA objectives, are noted. The third section, Nonregulated Electric Utilities, summarizes information available on nonregulated utilities, i.e., publicly or cooperatively owned utilities which are specifically exempted from state regulation by state law.

  15. The waste isolation pilot plant regulatory compliance program

    SciTech Connect

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

    1996-06-01

    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

  16. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Economic Regulatory Administration, Department of Energy, 2000 M Street, NW., Washington, DC 20461, and to the Director, Office of Hearings and Appeals, Department of Energy, 2000 M Street, NW., Washington,...

  17. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Economic Regulatory Administration, Department of Energy, 2000 M Street, NW., Washington, DC 20461, and to the Director, Office of Hearings and Appeals, Department of Energy, 2000 M Street, NW., Washington,...

  18. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Economic Regulatory Administration, Department of Energy, 2000 M Street, NW., Washington, DC 20461, and to the Director, Office of Hearings and Appeals, Department of Energy, 2000 M Street, NW., Washington,...

  19. Viral complement regulatory proteins.

    PubMed

    Rosengard, A M; Ahearn, J M

    1999-05-01

    The inactivation of complement provides cells and tissues critical protection from complement-mediated attack and decreases the associated recruitment of other inflammatory mediators. In an attempt to evade the host immune response, viruses have evolved two mechanisms to acquire complement regulatory proteins. They can directly seize the host cell complement regulators onto their outer envelope and/or they can produce their own proteins which are either secreted into the neighboring intercellular space or expressed as membrane-bound proteins on the infected host cell. The following review will concentrate on the viral homologues of the mammalian complement regulatory proteins, specifically those containing complement control protein (CCP) repeats. PMID:10408371

  20. Wetlands: The changing regulatory landscape

    SciTech Connect

    Glick, R.M. )

    1993-05-01

    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]buildable[close 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.

  1. CCCC Chair's Address: Representing Ourselves, 2008

    ERIC Educational Resources Information Center

    Glenn, Cheryl

    2008-01-01

    This article presents the text of the author's address at the fifty-ninth annual convention of the Conference on College Composition and Communication (CCCC) in March 2008. In her address, the author picks up strands of previous Chairs' addresses and weaves them through the fabric of her remarks. What she hopes will give sheen to the fabric is her…

  2. 32 CFR 516.7 - Mailing addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Mailing addresses. 516.7 Section 516.7 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY AID OF CIVIL AUTHORITIES AND PUBLIC RELATIONS LITIGATION General § 516.7 Mailing addresses. Mailing addresses for organizations referenced...

  3. 47 CFR 13.10 - Licensee address.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Licensee address. 13.10 Section 13.10 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMERCIAL RADIO OPERATORS General § 13.10 Licensee address. In accordance with § 1.923 of this chapter all applications must specify an address where...

  4. 75 FR 49813 - Change of Address

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... COMMISSION 11 CFR Parts 9405, 9407, 9409, 9410, 9420, and 9428 Change of Address AGENCY: United States... Assistance Commission (EAC) is amending its regulations to reflect a change of address for its headquarters. This technical amendment is a nomenclature change that updates and corrects the address for...

  5. 77 FR 48429 - Commission Address Change

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... HEALTH REVIEW COMMISSION 29 CFR Parts 2700, 2701, 2702, 2704, 2705, 2706 Commission Address Change AGENCY... to inform the public of the address change. DATES: This final rule will take effect on August 27... because the amendments are of a minor and administrative nature dealing with only a change in address....

  6. 47 CFR 97.23 - Mailing address.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Mailing address. 97.23 Section 97.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO... name and mailing address. The mailing address must be in an area where the amateur service is...

  7. 47 CFR 97.23 - Mailing address.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Mailing address. 97.23 Section 97.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO... name and mailing address. The mailing address must be in an area where the amateur service is...

  8. 47 CFR 97.23 - Mailing address.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Mailing address. 97.23 Section 97.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO... name and mailing address. The mailing address must be in an area where the amateur service is...

  9. 47 CFR 97.23 - Mailing address.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Mailing address. 97.23 Section 97.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO... name and mailing address. The mailing address must be in an area where the amateur service is...

  10. 47 CFR 97.23 - Mailing address.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Mailing address. 97.23 Section 97.23 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AMATEUR RADIO... name and mailing address. The mailing address must be in an area where the amateur service is...

  11. EPAct Transportation Regulatory Activities

    SciTech Connect

    2011-11-21

    The U.S. Department of Energy's (DOE) Vehicle Technologies Program manages several transportation regulatory activities established by the Energy Policy Act of 1992 (EPAct), as amended by the Energy Conservation Reauthorization Act of 1998, EPAct 2005, and the Energy Independence and Security Act of 2007 (EISA).

  12. The regulatory horizon

    NASA Technical Reports Server (NTRS)

    Cook, ED

    1987-01-01

    The author briefly discusses the FAA's position as it relates to cockpit resource management. For example, if Cockpit Resource Management (CRM) is a positive concept, why isn't everyone required to implement it? The regulatory practice of the FAA is discussed and questions and answers are presented.

  13. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    SciTech Connect

    MULKEY, C.H.

    1999-07-06

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.

  14. General and regulatory proteolysis in Bacillus subtilis.

    PubMed

    Molière, Noël; Turgay, Kürşad

    2013-01-01

    The soil-dwelling bacterium Bacillus subtilis is widely used as a model organism to study the Gram-positive branch of Bacteria. A variety of different developmental pathways, such as endospore formation, genetic competence, motility, swarming and biofilm formation, have been studied in this organism. These processes are intricately connected and regulated by networks containing e.g. alternative sigma factors, two-component systems and other regulators. Importantly, in some of these regulatory networks the activity of important regulatory factors is controlled by proteases. Furthermore, together with chaperones, the same proteases constitute the cellular protein quality control (PQC) network, which plays a crucial role in protein homeostasis and stress tolerance of this organism. In this review, we will present the current knowledge on regulatory and general proteolysis in B. subtilis and discuss its involvement in developmental pathways and cellular stress management.

  15. Regulatory considerations for companion diagnostic devices.

    PubMed

    Lee, Eunice Y; Shen, Hsin-Chieh Jennifer

    2015-01-01

    The emergence of companion diagnostic devices has been spurred by drug discovery and development efforts towards targeted therapies, particularly in oncology. Companion diagnostics and their corresponding therapeutics are often codeveloped, or developed in parallel, to ensure the safe and effective use of the products. The regulatory framework for companion diagnostics has gradually evolved as a result of the essential role of diagnostic tests to identify the intended population for a corresponding treatment. Here, we describe the current regulatory model for companion diagnostics in the US and outline key strategies for a successful codevelopment program from the device perspective. We also discuss how technological advances and changes in clinical management may challenge the regulatory model in the future. PMID:25605456

  16. 77 FR 11383 - Change of Address and Electronic Submission of FOIA Requests

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... address and to permit Freedom of Information Act (FOIA) requests via electronic mail and facsimile. DATES... requests by electronic mail and facsimile. Regulatory Flexibility Act I certify that this regulation will... letter and the envelope. (2) By electronic mail at FOIAREQUEST@tsp.gov . The subject must include...

  17. 10 CFR 110.53 - United States address, records, and inspections.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false United States address, records, and inspections. 110.53 Section 110.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND... producing a clear and legible copy after storage for the period specified by Commission regulations....

  18. 10 CFR 110.53 - United States address, records, and inspections.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false United States address, records, and inspections. 110.53 Section 110.53 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND... microform is capable of producing a clear and legible copy after storage for the period specified...

  19. RSAT: regulatory sequence analysis tools.

    PubMed

    Thomas-Chollier, Morgane; Sand, Olivier; Turatsinze, Jean-Valéry; Janky, Rekin's; Defrance, Matthieu; Vervisch, Eric; Brohée, Sylvain; van Helden, Jacques

    2008-07-01

    The regulatory sequence analysis tools (RSAT, http://rsat.ulb.ac.be/rsat/) is a software suite that integrates a wide collection of modular tools for the detection of cis-regulatory elements in genome sequences. The suite includes programs for sequence retrieval, pattern discovery, phylogenetic footprint detection, pattern matching, genome scanning and feature map drawing. Random controls can be performed with random gene selections or by generating random sequences according to a variety of background models (Bernoulli, Markov). Beyond the original word-based pattern-discovery tools (oligo-analysis and dyad-analysis), we recently added a battery of tools for matrix-based detection of cis-acting elements, with some original features (adaptive background models, Markov-chain estimation of P-values) that do not exist in other matrix-based scanning tools. The web server offers an intuitive interface, where each program can be accessed either separately or connected to the other tools. In addition, the tools are now available as web services, enabling their integration in programmatic workflows. Genomes are regularly updated from various genome repositories (NCBI and EnsEMBL) and 682 organisms are currently supported. Since 1998, the tools have been used by several hundreds of researchers from all over the world. Several predictions made with RSAT were validated experimentally and published.

  20. Regulatory Promotion of Emergent CCS Technology

    SciTech Connect

    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.

  1. Integrated Communications, Navigation and Surveillance Technologies Keynote Address

    NASA Technical Reports Server (NTRS)

    Lebacqz, J. Victor

    2004-01-01

    Slides for the Keynote Address present graphics to enhance the discussion of NASA's vision, the National Space Exploration Initiative, current Mars exploration, and aeronautics exploration. The presentation also focuses on development of an Air Transportation System and transformation from present systems.

  2. Addressing Educational Accountability and Political Legitimacy with Citizen Responsibility

    ERIC Educational Resources Information Center

    Stitzlein, Sarah M.

    2015-01-01

    In this essay, Sarah Stitzlein addresses a key current crisis in public education: accountability. Rather than centrally being about poor performance of teachers or inefficiency of schools, as we most often hear in media outlets and in education reform speeches, Stitzlein argues the crisis is at heart one about citizen responsibility and political…

  3. Can Innovation Save Gifted Education? 2010 NAGC Presidential Address

    ERIC Educational Resources Information Center

    Robinson, Ann

    2012-01-01

    Connecting innovation with gifted education is a necessity not only in the current political climate but also because it is a field with deeply held beliefs about the importance of problem solving, creativity, imagination, and invention--all critical components of innovation. In this address, the author focuses on three key ideas. First, she…

  4. Bullying in Schools: Addressing Desires, Not Only Behaviours

    ERIC Educational Resources Information Center

    Rigby, Ken

    2012-01-01

    Currently the main approach in responding to bullying in schools is to focus on undesired behaviours and to apply sanctions. This approach is often ineffective as well as failing to address the needs of children as persons as distinct from the behaviour they produce. A proposed alternative approach is to inquire into the motivation of children who…

  5. State Laws and Policies to Address Bullying in Schools

    ERIC Educational Resources Information Center

    Limber, Susan P.; Small, Mark A.

    2003-01-01

    This article focuses on the recent flurry of legislation in states to address bullying among school children. The primary purpose is to describe, compare, and contrast current state laws about bullying. Specifically, a description is provided of legislators' definitions of bullying and legislative findings about the nature and seriousness of…

  6. A European framework to address psychosocial hazards.

    PubMed

    Leka, Stavroula; Kortum, Evelyn

    2008-01-01

    Over the past decades, emphasis has been placed on the changing nature of work and new forms of risk that could negatively affect employee health and safety. These are mainly associated with new types of occupational hazards that have been termed psychosocial. Issues such as work-related stress, bullying and harassment are now receiving attention on a global basis and efforts have been made to address them at the workplace level. However, it has been acknowledged that despite developments of policy in this area, there still appear to be a broad science-policy gap and an even broader one between policy and practice. The WHO Network of Collaborating Centers in Occupational Health has, since the late 1990s, been supporting a dedicated program of work on psychosocial factors and work-related stress. Part of the Network's work is currently focusing on the translation of existing knowledge into practice in the area of psychosocial risk management. This program has identified that the optimum way forward lies in the development of a European framework for psychosocial risk management. This framework will serve as the basis for coordination of research activities and preventive action with an emphasis on evidence based interventions and best practice on an international basis. PMID:18408344

  7. Generation and Characterization of Mouse Regulatory Macrophages.

    PubMed

    Carretero-Iglesia, Laura; Hill, Marcelo; Cuturi, Maria Cristina

    2016-01-01

    In the last years, cell therapy has become a promising approach to therapeutically manipulate immune responses in autoimmunity, cancer, and transplantation. Several types of lymphoid and myeloid cells origin have been generated in vitro and tested in animal models. Their efficacy to decrease pharmacological treatment has successfully been established. Macrophages play an important role in physiological and pathological processes. They represent an interesting cell population due to their high plasticity in vivo and in vitro. Here, we describe a protocol to differentiate murine regulatory macrophages in vitro from bone marrow precursors. We also describe several methods to assess macrophage classical functions, as their bacterial killing capacity and antigen endocytosis and degradation. Importantly, regulatory macrophages also display suppressive characteristics, which are addressed by the study of their hypostimulatory T lymphocyte capacity and polyclonal T lymphocyte activation suppression.

  8. A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry.

    PubMed

    García-Talavera, M; Matarranz, J L M; Salas, R; Ramos, L

    2011-01-01

    Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. PMID:20952107

  9. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 2. Evaluation of seismic designs: a review of seismic design requirements for Nuclear Power Plant Piping

    SciTech Connect

    Not Available

    1985-04-01

    This document reports the position and recommendations of the NRC Piping Review Committee, Task Group on Seismic Design. The Task Group considered overlapping conservation in the various steps of seismic design, the effects of using two levels of earthquake as a design criterion, and current industry practices. Issues such as damping values, spectra modification, multiple response spectra methods, nozzle and support design, design margins, inelastic piping response, and the use of snubbers are addressed. Effects of current regulatory requirements for piping design are evaluated, and recommendations for immediate licensing action, changes in existing requirements, and research programs are presented. Additional background information and suggestions given by consultants are also presented.

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

    PubMed

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

    2010-04-01

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

  11. Human cytomegalovirus and transplantation: drug development and regulatory issues.

    PubMed

    McIntosh, Megan; Hauschild, Benjamin; Miller, Veronica

    2016-01-01

    Cytomegalovirus (CMV) infection is highly prevalent worldwide and can cause serious disease among immunocompromised individuals, including persons with HIV and transplant recipients on immunosuppressive therapies. It can also result in congenital cytomegalovirus when women are infected during pregnancy. Treatment and prevention of CMV in solid organ and haematopoietic stem cell transplant recipients is accomplished in one of three ways: (1) prophylactic therapy to prevent CMV viraemia; (2) pre-emptive therapy for those with low levels of replicating virus; and (3) treatment for established disease. Despite the high prevalence of CMV, there are few available approved drug therapies, and those that are available are hampered by toxicity and less-than-optimal efficacy. New therapies are being developed and tested; however, inconsistency in standardisation of virus levels and questions about potential endpoints in clinical trials present regulatory hurdles that must be addressed. This review covers the current state of CMV therapy, drugs currently under investigation, and clinical trial issues and questions that are in need of resolution. PMID:27482453

  12. Nuclear Regulatory Commission information digest

    SciTech Connect

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  13. Regulatory analysis of Regulatory Guide 1. 35 (Revision 3, Draft 2): In-service inspection of ungrouted tendons in prestressed concrete containments

    SciTech Connect

    Naus, D.J.

    1987-02-01

    The objectives of this study were to review all the changes in the latest version (Rev. 3, Draft 2) of Regulatory Guide 1.35 and to provide a regulatory analysis for all positions in the guide to determine if it is cost-effective to backfit the guide to the containments of existing plants. To meet these objectives, three tasks were undertaken. The first task outlined containment design criteria, traced the evolution of prestressed concrete containment configurations and prestressing systems, reviewed the history of the development of the guide, and summarized the applicability of the particular versions of the regulatory guide to the 43 nuclear plants that utilize a prestressed concrete containment. Under the second task a comparative regulatory analysis of Rev. 3 (Draft 2) of the guide was developed in which major decision factors affected by the proposed change were identified, and differential risk and cost factors were addressed in relation to the current version of the guide which is in effect (Rev. 2). Finally, under the third task a backfit analysis was conducted in accordance with the requirements of the ''Backfitting'' Rule, Section 50.109 for each of the revised or added positions contained in Rev. 3 (Draft 2). Application of the revision to operating plants will provide consistency in review and a uniform standard for assessing the in-service condition of the ungrouted tendons in prestressed concrete containments. It is concluded that the revisions will have a positive impact on safety and thus lower public risk. Backfitting of the revised guide is possible for most plants licensed since 1974.

  14. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of the special supervisory, regulatory, and economic policy needs served by such reports. Regulatory... reflects the underlying economic substance of the transaction at issue. Regulatory reporting...

  15. 78 FR 44329 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ....nasa.gov/open . Timetable: Action Date FR Cite NPRM 10/00/13 Regulatory Flexibility Analysis Required... Administration (NASA). ACTION: Semiannual regulatory agenda. SUMMARY: NASA's regulatory agenda describes those regulations being considered for development or amendment by NASA, the need and legal basis for the...

  16. 75 FR 79759 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... Action 04/16/10 75 FR 2012 Regulatory Flexibility Analysis Required: Yes Agency Contact: Mohammed Khan... ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et seq... use throughout the rulemaking process. Timetable: Action Date FR Cite Notice: Public Meeting...

  17. ORegAnno 3.0: a community-driven resource for curated regulatory annotation.

    PubMed

    Lesurf, Robert; Cotto, Kelsy C; Wang, Grace; Griffith, Malachi; Kasaian, Katayoon; Jones, Steven J M; Montgomery, Stephen B; Griffith, Obi L

    2016-01-01

    The Open Regulatory Annotation database (ORegAnno) is a resource for curated regulatory annotation. It contains information about regulatory regions, transcription factor binding sites, RNA binding sites, regulatory variants, haplotypes, and other regulatory elements. ORegAnno differentiates itself from other regulatory resources by facilitating crowd-sourced interpretation and annotation of regulatory observations from the literature and highly curated resources. It contains a comprehensive annotation scheme that aims to describe both the elements and outcomes of regulatory events. Moreover, ORegAnno assembles these disparate data sources and annotations into a single, high quality catalogue of curated regulatory information. The current release is an update of the database previously featured in the NAR Database Issue, and now contains 1 948 307 records, across 18 species, with a combined coverage of 334 215 080 bp. Complete records, annotation, and other associated data are available for browsing and download at http://www.oreganno.org/.

  18. Establishing regulatory priorities

    SciTech Connect

    Pontius, F.W.

    1995-12-01

    Statutory deadlines for setting regulations under the 1986 Safe Drinking Water Act (SDWA) have not been met. Faced with limited resources, the US Environmental Protection Agency (USEPA) has historically set regulatory priorities based on perceived need, politics, and legal deadlines. This has resulted in a fragmented regulatory program and confusion on the part of the regulated community and on the part of other stakeholders. Even though the agency has been subject to court-imposed deadlines for most new regulations, resource limitations have caused these deadlines to be missed, resulting in new court-imposed deadlines. In 1994, the agency began considering a new approach for determining how many regulations can be developed and in what order. A draft strategic plan was prepared in December 1994. Based on discussion of this plan, USEPA requested the US District Court for Oregon to extend certain regulatory deadlines so that new priorities could be set for the highest-risk substances. An extension was granted until Aug. 1, 1995, and was subsequently extended to Dec. 15, 1995.

  19. Novel Duplicate Address Detection with Hash Function

    PubMed Central

    Song, GuangJia; Ji, ZhenZhou

    2016-01-01

    Duplicate address detection (DAD) is an important component of the address resolution protocol (ARP) and the neighbor discovery protocol (NDP). DAD determines whether an IP address is in conflict with other nodes. In traditional DAD, the target address to be detected is broadcast through the network, which provides convenience for malicious nodes to attack. A malicious node can send a spoofing reply to prevent the address configuration of a normal node, and thus, a denial-of-service attack is launched. This study proposes a hash method to hide the target address in DAD, which prevents an attack node from launching destination attacks. If the address of a normal node is identical to the detection address, then its hash value should be the same as the “Hash_64” field in the neighboring solicitation message. Consequently, DAD can be successfully completed. This process is called DAD-h. Simulation results indicate that address configuration using DAD-h has a considerably higher success rate when under attack compared with traditional DAD. Comparative analysis shows that DAD-h does not require third-party devices and considerable computing resources; it also provides a lightweight security resolution. PMID:26991901

  20. Novel Duplicate Address Detection with Hash Function.

    PubMed

    Song, GuangJia; Ji, ZhenZhou

    2016-01-01

    Duplicate address detection (DAD) is an important component of the address resolution protocol (ARP) and the neighbor discovery protocol (NDP). DAD determines whether an IP address is in conflict with other nodes. In traditional DAD, the target address to be detected is broadcast through the network, which provides convenience for malicious nodes to attack. A malicious node can send a spoofing reply to prevent the address configuration of a normal node, and thus, a denial-of-service attack is launched. This study proposes a hash method to hide the target address in DAD, which prevents an attack node from launching destination attacks. If the address of a normal node is identical to the detection address, then its hash value should be the same as the "Hash_64" field in the neighboring solicitation message. Consequently, DAD can be successfully completed. This process is called DAD-h. Simulation results indicate that address configuration using DAD-h has a considerably higher success rate when under attack compared with traditional DAD. Comparative analysis shows that DAD-h does not require third-party devices and considerable computing resources; it also provides a lightweight security resolution.

  1. Novel Duplicate Address Detection with Hash Function.

    PubMed

    Song, GuangJia; Ji, ZhenZhou

    2016-01-01

    Duplicate address detection (DAD) is an important component of the address resolution protocol (ARP) and the neighbor discovery protocol (NDP). DAD determines whether an IP address is in conflict with other nodes. In traditional DAD, the target address to be detected is broadcast through the network, which provides convenience for malicious nodes to attack. A malicious node can send a spoofing reply to prevent the address configuration of a normal node, and thus, a denial-of-service attack is launched. This study proposes a hash method to hide the target address in DAD, which prevents an attack node from launching destination attacks. If the address of a normal node is identical to the detection address, then its hash value should be the same as the "Hash_64" field in the neighboring solicitation message. Consequently, DAD can be successfully completed. This process is called DAD-h. Simulation results indicate that address configuration using DAD-h has a considerably higher success rate when under attack compared with traditional DAD. Comparative analysis shows that DAD-h does not require third-party devices and considerable computing resources; it also provides a lightweight security resolution. PMID:26991901

  2. Unified agenda of federal regulatory and deregulatory actions--HHS. Semiannual regulatory agenda.

    PubMed

    1998-04-27

    The President's Executive Order 12866 and the Regulatory Flexibility Act of 1980 require the semiannual publication of an agenda which summarizes all current, projected, and recently completed rulemakings of the Department. The agenda enables the public to know about and to participate in the Department's regulations development work. The last such agenda was published on October 29, 1997.

  3. Reading the Tea Leaves: How Utilities in the West Are Managing Carbon Regulatory Risk in their Resource Plans

    SciTech Connect

    Barbose, Galen; Wiser, Ryan; Phadke, Amol; Goldman, Charles

    2008-02-01

    The long economic lifetime and development lead-time of many electric infrastructure investments requires that utility resource planning consider potential costs and risks over a lengthy time horizon. One long-term -- and potentially far-reaching -- risk currently facing the electricity industry is the uncertain cost of future carbon dioxide (CO2) regulations. Recognizing the importance of this issue, many utilities (sometimes spurred by state regulatory requirements) are beginning to actively assess carbon regulatory risk within their resource planning processes, and to evaluate options for mitigating that risk. However, given the relatively recent emergence of this issue and the rapidly changing political landscape, methods and assumptions used to analyze carbon regulatory risk, and the impact of this analysis on the selection of a preferred resource portfolio, vary considerably across utilities. In this study, we examine the treatment of carbon regulatory risk in utility resource planning, through a comparison of the most-recent resource plans filed by fifteen investor-owned and publicly-owned utilities in the Western U.S. Together, these utilities account for approximately 60percent of retail electricity sales in the West, and cover nine of eleven Western states. This report has two related elements. First, we compare and assess utilities' approaches to addressing key analytical issues that arise when considering the risk of future carbon regulations. Second, we summarize the composition and carbon intensity of the preferred resource portfolios selected by these fifteen utilities and compare them to potential CO2 emission benchmark levels.

  4. Acid rain compliance: The need for regulatory guidance

    SciTech Connect

    Solomon, B.D.

    1993-07-01

    This article presents a broad view of the need for regulatory guidance when confronting the problem of acid rain. The two major topics addressed are (1) Why is guidance needed and (2) What kind of guidance is needed. Discussion of rate and accounting treatment of allowances, acid rain compliance planning, and allowance trading and energy efficiency are included.

  5. Taking Steps To Address the Digital Divide.

    ERIC Educational Resources Information Center

    Sorensen, Barbara

    2001-01-01

    Following hearings concerning inadequate telephone access on American Indian lands, the Federal Communications Commission (FCC) committed to promoting a government-to-government relationship with federally recognized tribes and consulting with them prior to implementing regulatory actions, and created financial assistance programs for telephone…

  6. Computational strategies to address chromatin structure problems

    NASA Astrophysics Data System (ADS)

    Perišić, Ognjen; Schlick, Tamar

    2016-06-01

    While the genetic information is contained in double helical DNA, gene expression is a complex multilevel process that involves various functional units, from nucleosomes to fully formed chromatin fibers accompanied by a host of various chromatin binding enzymes. The chromatin fiber is a polymer composed of histone protein complexes upon which DNA wraps, like yarn upon many spools. The nature of chromatin structure has been an open question since the beginning of modern molecular biology. Many experiments have shown that the chromatin fiber is a highly dynamic entity with pronounced structural diversity that includes properties of idealized zig-zag and solenoid models, as well as other motifs. This diversity can produce a high packing ratio and thus inhibit access to a majority of the wound DNA. Despite much research, chromatin’s dynamic structure has not yet been fully described. Long stretches of chromatin fibers exhibit puzzling dynamic behavior that requires interpretation in the light of gene expression patterns in various tissue and organisms. The properties of chromatin fiber can be investigated with experimental techniques, like in vitro biochemistry, in vivo imagining, and high-throughput chromosome capture technology. Those techniques provide useful insights into the fiber’s structure and dynamics, but they are limited in resolution and scope, especially regarding compact fibers and chromosomes in the cellular milieu. Complementary but specialized modeling techniques are needed to handle large floppy polymers such as the chromatin fiber. In this review, we discuss current approaches in the chromatin structure field with an emphasis on modeling, such as molecular dynamics and coarse-grained computational approaches. Combinations of these computational techniques complement experiments and address many relevant biological problems, as we will illustrate with special focus on epigenetic modulation of chromatin structure.

  7. Public health approach to address maternal mortality.

    PubMed

    Rai, Sanjay K; Anand, K; Misra, Puneet; Kant, Shashi; Upadhyay, Ravi Prakash

    2012-01-01

    Reducing maternal mortality is one of the major challenges to health systems worldwide, more so in developing countries that account for nearly 99% of these maternal deaths. Lack of a standard method for reporting of maternal death poses a major hurdle in making global comparisons. Currently much of the focus is on documenting the "number" of maternal deaths and delineating the "medical causes" behind these deaths. There is a need to acknowledge the social correlates of maternal deaths as well. Investigating and in-depth understanding of each maternal death can provide indications on practical ways of addressing the problem. Death of a mother has serious implications for the child as well as other family members and to prevent the same, a comprehensive approach is required. This could include providing essential maternal care, early management of complications and good quality intrapartum care through the involvement of skilled birth attendants. Ensuring the availability, affordability, and accessibility of quality maternal health services, including emergency obstetric care (EmOC) would prove pivotal in reducing the maternal deaths. To increase perceived seriousness of the community regarding maternal health, a well-structured awareness campaign is needed with importance be given to avoid adolescent pregnancy as well. Initiatives like Janani Surakhsha Yojna (JSY) that have the potential to improve maternal health needs to be strengthened. Quality assessments should form an essential part of all services that are directed toward improving maternal health. Further, emphasis needs to be given on research by involving multiple allied partners, with the aim to develop a prioritized, coordinated, and innovative research agenda for women's health. PMID:23229211

  8. Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties.

    PubMed

    Marx-Stoelting, P; Niemann, L; Ritz, V; Ulbrich, B; Gall, A; Hirsch-Ernst, K I; Pfeil, R; Solecki, R

    2014-12-01

    Recent EU legislation has introduced endocrine disrupting properties as a hazard-based "cut-off" criterion for the approval of active substances as pesticides and biocides. Currently, no specific science-based approach for the assessment of substances with endocrine disrupting properties has been agreed upon, although this new legislation provides interim criteria based on classification and labelling. Different proposals for decision making on potential endocrine disrupting properties in human health risk assessment have been developed by the German Federal Institute for Risk Assessment (BfR) and other regulatory bodies. All these frameworks, although differing with regard to hazard characterisation, include a toxicological assessment of adversity of the effects, the evaluation of underlying modes/mechanisms of action in animals and considerations concerning the relevance of effects to humans. Three options for regulatory decision making were tested upon 39 pesticides for their applicability and to analyze their potential impact on the regulatory status of active substances that are currently approved for use in Europe: Option 1, based purely on hazard identification (adversity, mode of action, and the plausibility that both are related); Option 2, based on hazard identification and additional elements of hazard characterisation (severity and potency); Option 3, based on the interim criteria laid down in the recent EU pesticides legislation. Additionally, the data analysed in this study were used to address the questions, which parts of the endocrine system were affected, which studies were the most sensitive and whether no observed adverse effect levels were observed for substance with ED properties. The results of this exercise represent preliminary categorisations and must not be used as a basis for definitive regulatory decisions. They demonstrate that a combination of criteria for hazard identification with additional criteria of hazard characterisation

  9. Functional evolution of a cis-regulatory module.

    PubMed

    Ludwig, Michael Z; Palsson, Arnar; Alekseeva, Elena; Bergman, Casey M; Nathan, Janaki; Kreitman, Martin

    2005-04-01

    Lack of knowledge about how regulatory regions evolve in relation to their structure-function may limit the utility of comparative sequence analysis in deciphering cis-regulatory sequences. To address this we applied reverse genetics to carry out a functional genetic complementation analysis of a eukaryotic cis-regulatory module-the even-skipped stripe 2 enhancer-from four Drosophila species. The evolution of this enhancer is non-clock-like, with important functional differences between closely related species and functional convergence between distantly related species. Functional divergence is attributable to differences in activation levels rather than spatiotemporal control of gene expression. Our findings have implications for understanding enhancer structure-function, mechanisms of speciation and computational identification of regulatory modules.

  10. Issues related to regulatory control of naturally occurring radioactive materials

    SciTech Connect

    Chen, S.Y.

    1997-04-01

    Nearly 80% of human radiation exposure is from naturally occurring radioactive materials (NORM). While exposure from man-made sources of radiation has been well regulated, no consistent regulatory controls exist for NORM. Because elevated radiation levels have resulted from NORM enhancement activities such as occur in the petroleum, fertilizer, mining, and processing industries, some form of regulatory control is in order. In the US, regulation of NORM by federal agencies such as the Nuclear Regulatory Commission or the Environmental Protection Agency is not anticipated in the near future because there are no authorizing federal statutes. Important issues for addressing the control of NORM include source characterization and generation, radiation protection concerns, waste management and disposition, and the regulatory framework.

  11. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    SciTech Connect

    Kisner, Roger A; Wilgen, John B; Ewing, Paul D; Korsah, Kofi; Antonescu, Christina E

    2006-01-01

    Abstract - Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.

  12. Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

    PubMed

    Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

    2015-01-01

    At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

  13. Public Address Systems. Specifications - Installation - Operation.

    ERIC Educational Resources Information Center

    Palmer, Fred M.

    Provisions for public address in new construction of campus buildings (specifications, installations, and operation of public address systems), are discussed in non-technical terms. Consideration is given to microphones, amplifiers, loudspeakers and the placement and operation of various different combinations. (FS)

  14. Addressing Standards and Assessments on the IEP.

    ERIC Educational Resources Information Center

    Thompson, Sandra J.; Thurlow, Martha L.; Esler, Amy; Whetstone, Patti J.

    2001-01-01

    A study that examined state Individualized Education Program (IEP) forms found that out of the 41 with IEP forms, only 5 specifically addressed educational standards on their forms. Thirty-one states addressed the general curriculum on their IEP forms and 30 states listed three or more options for assessment participation. (Contains nine…

  15. History Forum Addresses Creation/Evolution Controversy.

    ERIC Educational Resources Information Center

    Schweinsberg, John

    1997-01-01

    A series of programs entitled Creationism and Evolution: The History of a Controversy was presented at the University of Alabama in Huntsville. The controversy was addressed from an historical and sociological, rather than a scientific perspective. Speakers addressed the evolution of scientific creationism, ancient texts versus sedimentary rocks…

  16. 16 CFR 1000.4 - Commission address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Commission address. 1000.4 Section 1000.4 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION ORGANIZATION AND FUNCTIONS § 1000.4 Commission address. The principal Offices of the Commission are at 4330 East West...

  17. 40 CFR 374.6 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 28 2011-07-01 2011-07-01 false Addresses. 374.6 Section 374.6... COMMUNITY RIGHT-TO-KNOW PROGRAMS PRIOR NOTICE OF CITIZEN SUITS § 374.6 Addresses. Administrator, U.S.... Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, IL 60604. Regional Administrator, Region...

  18. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 3 2011-07-01 2011-07-01 false Address searches. 674.44 Section 674.44 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If...

  19. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 3 2012-07-01 2012-07-01 false Address searches. 674.44 Section 674.44 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If...

  20. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 3 2014-07-01 2014-07-01 false Address searches. 674.44 Section 674.44 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If...

  1. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 3 2013-07-01 2013-07-01 false Address searches. 674.44 Section 674.44 Education Regulations of the Offices of the Department of Education (Continued) OFFICE OF POSTSECONDARY EDUCATION, DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If...

  2. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2 Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  3. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2 Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  4. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2 Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  5. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2 Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  6. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2 Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  7. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Address searches. 674.44 Section 674.44 Education..., DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If mail... institutional offices; (2) Reviews of telephone directories or inquiries of information operators in the...

  8. Forms of Address in Chilean Spanish

    ERIC Educational Resources Information Center

    Bishop, Kelley; Michnowicz, Jim

    2010-01-01

    The present investigation examines possible social and linguistic factors that influence forms of address used in Chilean Spanish with various interlocutors. A characteristic of the Spanish of Chile is the use of a variety of forms of address for the second person singular, "tu", "vos", and "usted", with corresponding verb conjugations (Lipski…

  9. 37 CFR 251.1 - Official addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ARBITRATION ROYALTY PANEL RULES AND PROCEDURES COPYRIGHT ARBITRATION ROYALTY PANEL RULES OF PROCEDURE... Copyright Arbitration Royalty Panels (CARPs) must be addressed as follows: (a) If hand delivered by a... through the U.S. Postal Service, use the following address: Copyright Arbitration Royalty Panel, P.O....

  10. Image compression using address-vector quantization

    NASA Astrophysics Data System (ADS)

    Nasrabadi, Nasser M.; Feng, Yushu

    1990-12-01

    A novel vector quantization scheme, the address-vector quantizer (A-VQ), is proposed which exploits the interblock correlation by encoding a group of blocks together using an address-codebook (AC). The AC is a set of address-codevectors (ACVs), each representing a combination of addresses or indices. Each element of the ACV is an address of an entry in the LBG-codebook, representing a vector-quantized block. The AC consists of an active (addressable) region and an inactive (nonaddressable) region. During encoding the ACVs in the AC are reordered adaptively to bring the most probable ACVs into the active region. When encoding an ACV, the active region is checked, and if such an address combination exists, its index is transmitted to the receiver. Otherwise, the address of each block is transmitted individually. The SNR of the images encoded by the A-VQ method is the same as that of a memoryless vector quantizer, but the bit rate is by a factor of approximately two.

  11. 76 FR 31884 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... http://www.regulations.gov , or e-mail electronic comments to hq-regulatory-review@mail.nasa.gov... requested on or before July 5, 2011. ADDRESSES: Submit comments to http://www.regulations.gov , or e-mail comments to hq-regulatory-review@mail.nasa.gov . FOR FURTHER INFORMATION CONTACT: Nanette Jennings,...

  12. Worker hazard communications: The regulatory framework

    SciTech Connect

    West, A.S. )

    1991-01-01

    Material Safety Data Sheets (MSDS) are a key element in the communication of chemical hazards in the workplace. Their use has grown far faster than earlier anticipated. This paper describes aspects of the regulatory requirements in the US, in Canada, and in Europe. Some concern is expressed that the length and complexity of some of the data sheets currently being published may be deleterious to the original intent.

  13. Tempo and mode of regulatory evolution in Drosophila.

    PubMed

    Coolon, Joseph D; McManus, C Joel; Stevenson, Kraig R; Graveley, Brenton R; Wittkopp, Patricia J

    2014-05-01

    Genetic changes affecting gene expression contribute to phenotypic divergence; thus, understanding how regulatory networks controlling gene expression change over time is critical for understanding evolution. Prior studies of expression differences within and between species have identified properties of regulatory divergence, but technical and biological differences among these studies make it difficult to assess the generality of these properties or to understand how regulatory changes accumulate with divergence time. Here, we address these issues by comparing gene expression among strains and species of Drosophila with a range of divergence times and use F1 hybrids to examine inheritance patterns and disentangle cis- and trans-regulatory changes. We find that the fixation of compensatory changes has caused the regulation of gene expression to diverge more rapidly than gene expression itself. Specifically, we observed that the proportion of genes with evidence of cis-regulatory divergence has increased more rapidly with divergence time than the proportion of genes with evidence of expression differences. Surprisingly, the amount of expression divergence explained by cis-regulatory changes did not increase steadily with divergence time, as was previously proposed. Rather, one species (Drosophila sechellia) showed an excess of cis-regulatory divergence that we argue most likely resulted from positive selection in this lineage. Taken together, this work reveals not only the rate at which gene expression evolves, but also the molecular and evolutionary mechanisms responsible for this evolution.

  14. Tempo and mode of regulatory evolution in Drosophila

    PubMed Central

    Coolon, Joseph D.; McManus, C. Joel; Stevenson, Kraig R.; Graveley, Brenton R.; Wittkopp, Patricia J.

    2014-01-01

    Genetic changes affecting gene expression contribute to phenotypic divergence; thus, understanding how regulatory networks controlling gene expression change over time is critical for understanding evolution. Prior studies of expression differences within and between species have identified properties of regulatory divergence, but technical and biological differences among these studies make it difficult to assess the generality of these properties or to understand how regulatory changes accumulate with divergence time. Here, we address these issues by comparing gene expression among strains and species of Drosophila with a range of divergence times and use F1 hybrids to examine inheritance patterns and disentangle cis- and trans-regulatory changes. We find that the fixation of compensatory changes has caused the regulation of gene expression to diverge more rapidly than gene expression itself. Specifically, we observed that the proportion of genes with evidence of cis-regulatory divergence has increased more rapidly with divergence time than the proportion of genes with evidence of expression differences. Surprisingly, the amount of expression divergence explained by cis-regulatory changes did not increase steadily with divergence time, as was previously proposed. Rather, one species (Drosophila sechellia) showed an excess of cis-regulatory divergence that we argue most likely resulted from positive selection in this lineage. Taken together, this work reveals not only the rate at which gene expression evolves, but also the molecular and evolutionary mechanisms responsible for this evolution. PMID:24567308

  15. Current directions in screening-level ecological risk assessments

    SciTech Connect

    Carlsen, T M; Efroymson, R A

    2000-12-11

    Ecological risk assessment (ERA) is a tool used by many regulatory agencies to evaluate the impact to ecological receptors from changes in environmental conditions. Widespread use of ERAs began with the United States Environmental Protection Agency's Superfund program to assess the ecological impact from hazardous chemicals released to the environment. Many state hazardous chemical regulatory agencies have adopted the use of ERAs, and several state regulatory agencies are evaluating the use of ERAs to assess ecological impacts from releases of petroleum and gas-related products. Typical ERAs are toxicologically-based, use conservative assumptions with respect to ecological receptor exposure duration and frequency, often require complex modeling of transport and exposure and are very labor intensive. In an effort to streamline the ERA process, efforts are currently underway to develop default soil screening levels, to identify ecological screening criteria for excluding sites from formal risk assessment, and to create risk-based corrective action worksheets. This should help reduce the time spent on ERAs, at least for some sites. Work is also underway to incorporate bioavailability and spatial considerations into ERAs. By evaluating the spatial nature of contaminant releases with respect to the spatial context of the ecosystem under consideration, more realistic ERAs with respect to the actual impact to ecological receptors at the population, community or ecosystem scale should be possible. In addition, by considering the spatial context, it should be possible to develop mitigation and monitoring efforts to more appropriately address such sites within the context of an ecological framework.

  16. Current sensor

    DOEpatents

    Yakymyshyn, Christopher Paul; Brubaker, Michael Allen; Yakymyshyn, Pamela Jane

    2007-01-16

    A current sensor is described that uses a plurality of magnetic field sensors positioned around a current carrying conductor. The sensor can be hinged to allow clamping to a conductor. The current sensor provides high measurement accuracy for both DC and AC currents, and is substantially immune to the effects of temperature, conductor position, nearby current carrying conductors and aging.

  17. Codes and standards and other guidance cited in regulatory documents

    SciTech Connect

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  18. Identification of altered cis-regulatory elements in human disease.

    PubMed

    Mathelier, Anthony; Shi, Wenqiang; Wasserman, Wyeth W

    2015-02-01

    It has long been appreciated that variations in regulatory regions of genes can impact gene expression. With the advent of whole-genome sequencing (WGS), it has become possible to begin cataloging these noncoding variants. Evidence continues to accumulate linking clinical cases with cis-regulatory element disruption in a wide range of diseases. Identifying variants is becoming routine, but assessing their impact on regulation remains challenging. Bioinformatics approaches that identify variations functionally altering transcription factor (TF) binding are increasingly important for meeting this challenge. We present the current state of computational tools and resources for identifying the genomic regulatory components (cis-regulatory regions and TF binding sites, TFBSs) controlling gene transcriptional regulation. We review how such approaches can be used to interpret the potential disease causality of point mutations and small insertions or deletions. We hope this will motivate further the development of methods enabling the identification of etiological cis-regulatory variations.

  19. 76 FR 65255 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule... herein, the current corporate structure, governance and self-regulatory independence and separation...

  20. Hazardous waste: 1998 Regulatory and judicial developments

    SciTech Connect

    Henry, M.E.; Wright, W.G. Jr.

    1998-12-31

    Every year, owners and operators of facilities generating, transporting, treating, storing, or disposing of hazardous waste, or persons held liable for past hazardous waste management practice through EPA`s Superfund program, are affected by changes in the application and interpretation of hazardous waste regulation. This paper will summarize the significant 1997 hazardous waste regulatory developments, including changes and additions to land disposal restrictions and treatment standards, hazardous waste determination procedures, used oil management practices. This paper will also summarize key judicial decisions addressing expanded definitions of solid and hazardous waste, activities constituting disposal, and circumstances constituting imminent and substantial endangerment. Finally, this paper will summarize new EPA Superfund guidance documents and judicial decisions addressing issues of liability and defenses to liability under Superfund.

  1. Wind vs. Biofuels: Addressing Climate, Health and Energy

    SciTech Connect

    Professor Mark Jacobson

    2007-01-29

    The favored approach today for addressing global warming is to promote a variety of options: biofuels, wind, solar thermal, solar photovoltaic, geothermal, hydroelectric, and nuclear energy and to improve efficiency. However, by far, most emphasis has been on biofuels. It is shown here, though, that current-technology biofuels cannot address global warming and may slightly increase death and illness due to ozone-related air pollution. Future biofuels may theoretically slow global warming, but only temporarily and with the cost of increased air pollution mortality. In both cases, the land required renders biofuels an impractical solution. Recent measurements and statistical analyses of U.S. and world wind power carried out at Stanford University suggest that wind combined with other options can substantially address global warming, air pollution mortality, and energy needs simultaneously.

  2. Wind versus Biofuels for Addressing Climate, Health, and Energy

    SciTech Connect

    Jacobson, Mark Z.

    2007-01-29

    The favored approach today for addressing global warming is to promote a variety of options: biofuels, wind, solar thermal, solar photovoltaic, geothermal, hydroelectric, and nuclear energy and to improve efficiency. However, by far, most emphasis has been on biofuels. It is shown here, though, that current-technology biofuels cannot address global warming and may slightly increase death and illness due to ozone-related air pollution. Future biofuels may theoretically slow global warming, but only temporarily and with the cost of increased air pollution mortality. In both cases, the land required renders biofuels an impractical solution. Recent measurements and statistical analyses of U.S. and world wind power carried out at Stanford University suggest that wind combined with other options can substantially address global warming, air pollution mortality, and energy needs simultaneously.

  3. [Current views of activating and regulatory mechanisms of blood coagulation].

    PubMed

    Osaki, Tsukasa; Ichinose, Akitada

    2014-07-01

    Coagulation factors play essential roles in not only hemostasis but also thrombosis. The coagulation reaction consists of a stepwise sequence of proteolytic reactions of the coagulation factors, and is generally divided into two pathways, a tissue factor(TF)-dependent "extrinsic pathway" and a contact factor-dependent "intrinsic pathway". The extrinsic pathway is responsible for the initiation of the clotting reaction, while the intrinsic pathway most likely amplifies it. Elevated levels of various coagulation factors such as TF, factor VIII and prothrombin have been linked to an increased thrombotic risk. To prevent thrombus formation, endothelial cells express several receptors and activators for anticoagulant factors such as antithrombin, TF-pathway inhibitor, protein C and protein S. Defects in this anticoagulant system also increase the risk of thrombosis.

  4. [Environmental health: the evolution of Colombia's current regulatory framework].

    PubMed

    García-Ubaque, Cesar A; García-Ubaque, Juan C; Vaca-Bohórquez, Martha L

    2013-01-01

    This essay presents an analysis of the evolution of environmental health management in Colombia, covering the period from the introduction of the Colombian Healthcare Code (1979) to laws 99 and 100 in 1993 and the introduction of Environmental Health Policy in Bogotá DC (2011). It proposes a conceptual model for environmental health management at three levels: proximal (physical, chemical and biological setting), intermediate (natural and cultural environment) and distal (economic, political and social structures). Relevant aspects of environmental health policy in Bogotá are analysed based on the proposed model.

  5. Current Regulation of Private Police: Regulatory Agency Experience and Views.

    ERIC Educational Resources Information Center

    Kakalik, James S.; Wildhorn, Sorrel

    This report is the third in a series of five describing a 16-month study of the nature and extent of the private police industry in the United States, its problems, present regulation, and the laws impinging on it. Licensing and regulation of the industry in every state and several cities are described in this volume. Extensive tables present the…

  6. [A current and global review of sweeteners. Regulatory aspects].

    PubMed

    García-Almeida, J M; Casado Fdez, Gracia M; García Alemán, J

    2013-07-01

    In this chapter we review the role and potential benefits of non-caloric sweeteners, as part of the diet. After appearing and interest in the beneficial effects attributed to them, face different situations and conditions (obesity, diabetes...), more and more numerous studies, show their ineffective use. In conclusion, further research and results are needed to provide convincing evidence of their long-term effectiveness and the absence of negative effects from their use. The interest of the chapter lies in examining the distinctive aspects of sweeteners compared with sugar, measured as the standard of comparison. We will focus then on the other substances that are commonly used to sweeten foods instead of sugar.

  7. Regulatory Challenges for Cartilage Repair Technologies.

    PubMed

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

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

  8. Regulatory issues and assumptions associated with polymers for subsurface barriers surrounding buried waste

    SciTech Connect

    Heiser, J.; Siskind, B.

    1993-11-01

    One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. Subsurface barriers will improve remediation performance by removing pathways for contaminant transport due to groundwater movement, meteorological water infiltration, vapor- and gas-phase transport, transpiration, etc. Subsurface barriers may be used to {open_quotes}direct{close_quotes} contaminant movement to collection sumps/lysimeters in cases of unexpected remediation failures or transport mechanisms, to contain leakage from underground storage tanks, and to restrict in-situ soil cleanup operation and chemicals. Brookhaven National Laboratory is currently investigating advanced polymer materials for subsurface barriers. This report addresses the regulatory aspects of using of non-traditional polymer materials as well as soil-bentonite or cement-bentonite mixtures for such barriers. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of subsurface barriers to the Environmental Protection Agency (EPA) as a method for achieving waste site performance improvement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used. Since many of EPA`s concerns regarding subsurface barriers focus on the chemicals used during installation of these barriers the authors discuss the results of a search of the Federal Register and the Code of Federal Regulations for references in Titles 29 and 40 pertaining to key chemicals likely to be utilized in installing non-traditional barrier materials. The use of polymeric materials in the construction industry has been accomplished with full compliance with the applicable health, safety, and environmental regulations.

  9. An address geocoding method for improving rural spatial information infrastructure

    NASA Astrophysics Data System (ADS)

    Pan, Yuchun; Chen, Baisong; Lu, Zhou; Li, Shuhua; Zhang, Jingbo; Zhou, YanBing

    2010-11-01

    The transition of rural and agricultural management from divisional to integrated mode has highlighted the importance of data integration and sharing. Current data are mostly collected by specific department to satisfy their own needs and lake of considering on wider potential uses. This led to great difference in data format, semantic, and precision even in same area, which is a significant barrier for constructing an integrated rural spatial information system to support integrated management and decision-making. Considering the rural cadastral management system and postal zones, the paper designs a rural address geocoding method based on rural cadastral parcel. It puts forward a geocoding standard which consists of absolute position code, relative position code and extended code. It designs a rural geocoding database model, and addresses collection and update model. Then, based on the rural address geocoding model, it proposed a data model for rural agricultural resources management. The results show that the address coding based on postal code is stable and easy to memorize, two-dimensional coding based on the direction and distance is easy to be located and memorized, while extended code can enhance the extensibility and flexibility of address geocoding.

  10. An address geocoding method for improving rural spatial information infrastructure

    NASA Astrophysics Data System (ADS)

    Pan, Yuchun; Chen, Baisong; Lu, Zhou; Li, Shuhua; Zhang, Jingbo; Zhou, Yanbing

    2009-09-01

    The transition of rural and agricultural management from divisional to integrated mode has highlighted the importance of data integration and sharing. Current data are mostly collected by specific department to satisfy their own needs and lake of considering on wider potential uses. This led to great difference in data format, semantic, and precision even in same area, which is a significant barrier for constructing an integrated rural spatial information system to support integrated management and decision-making. Considering the rural cadastral management system and postal zones, the paper designs a rural address geocoding method based on rural cadastral parcel. It puts forward a geocoding standard which consists of absolute position code, relative position code and extended code. It designs a rural geocoding database model, and addresses collection and update model. Then, based on the rural address geocoding model, it proposed a data model for rural agricultural resources management. The results show that the address coding based on postal code is stable and easy to memorize, two-dimensional coding based on the direction and distance is easy to be located and memorized, while extended code can enhance the extensibility and flexibility of address geocoding.

  11. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to the Curator, ARS Patent Culture Collection, Northern Regional Research Center, USDA-ARS, 1815...

  12. 40 CFR 98.9 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... submitted to the following address: (a) For U.S. mail. Director, Climate Change Division, 1200 Pennsylvania Ave., NW., Mail Code: 6207J, Washington, DC 20460. (b) For package deliveries. Director,...

  13. 40 CFR 98.9 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... submitted to the following address: (a) For U.S. mail. Director, Climate Change Division, 1200 Pennsylvania Ave., NW., Mail Code: 6207J, Washington, DC 20460. (b) For package deliveries. Director,...

  14. Addressing Your Child's Weight at the Doctor

    MedlinePlus

    ... a Healthy Heart Healthy Kids Our Kids Programs Childhood Obesity What is childhood obesity? Overweight in Children BMI in Children Is Childhood Obesity an Issue in Your Home? Addressing your Child's ...

  15. Addressing Transition Issues in Languages Education.

    ERIC Educational Resources Information Center

    Steigler-Peters, Susi; Moran, Wendy; Piccioli, Maria Teresa; Chesterton, Paul

    2003-01-01

    Focuses on what has been learned from the implementation and evaluation of the Australian Language and Continuity Initiative (LCI) in relation to addressing transition issues in language education. (Author/VWL)

  16. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to the Curator, ARS Patent Culture Collection, Northern Regional Research Center, USDA-ARS, 1815...

  17. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to the Curator, ARS Patent Culture Collection, Northern Regional Research Center, USDA-ARS, 1815...

  18. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain... assigned RUS General Field Representative (GFR) or such other office as designated by RUS....

  19. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain... assigned RUS General Field Representative (GFR) or such other office as designated by RUS....

  20. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain... assigned RUS General Field Representative (GFR) or such other office as designated by RUS....

  1. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain... assigned RUS General Field Representative (GFR) or such other office as designated by RUS....

  2. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain... assigned RUS General Field Representative (GFR) or such other office as designated by RUS....

  3. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to the Curator, ARS Patent Culture Collection, Northern Regional Research Center, USDA-ARS, 1815...

  4. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to the Curator, ARS Patent Culture Collection, Northern Regional Research Center, USDA-ARS, 1815...

  5. Toward a Regulatory Framework for the Waterpipe.

    PubMed

    Salloum, Ramzi G; Asfar, Taghrid; Maziak, Wasim

    2016-10-01

    Waterpipe smoking has been dramatically increasing among youth worldwide and in the United States. Despite its general association with misperceptions of reduced harm, evidence suggests this is a harmful and dependence-inducing tobacco use method that represents a threat to public health. Waterpipe products continue to be generally unregulated, which likely has contributed to their spread. The Family Smoking Prevention and Tobacco Control Act of 2009 granted the US Food and Drug Administration (FDA) the authority to regulate waterpipe products, and the FDA finalized a rule extending its authority over waterpipe products in May 2016. This critical step in addressing the alarming increase in waterpipe smoking in the United States has created urgency for research to provide the evidence needed for effective regulatory initiatives for waterpipe products. We aim to stimulate such research by providing a framework that addresses the scope of waterpipe products and their unique context and use patterns. The proposed framework identifies regulatory targets for waterpipe product components (i.e., tobacco, charcoal, and device), the waterpipe café setting, and its marketing environment dominated by Internet promotion. PMID:27552262

  6. Oliver Wendell Holmes: The Professor and Autocrat Addresses Medical Matters

    PubMed Central

    Bergey, Gregory Kent

    1977-01-01

    Oliver Wendell Holmes, the physician, poet and novelist, was a frequent and at times outspoken commentator on the practice of medicine. His speeches and writings reveal Holmes's remarkable wit and facility in addressing such topics as medical education, drug prescription and medicine in society. Although delivered in the previous century his comments often seem to retain remarkable relevance in the current medical forum. PMID:345633

  7. Battery Cell Voltage Sensing and Balancing Using Addressable Transformers

    NASA Technical Reports Server (NTRS)

    Davies, Francis

    2009-01-01

    A document discusses the use of saturating transformers in a matrix arrangement to address individual cells in a high voltage battery. This arrangement is able to monitor and charge individual cells while limiting the complexity of circuitry in the battery. The arrangement has inherent galvanic isolation, low cell leakage currents, and allows a single bad cell in a battery of several hundred cells to be easily spotted.

  8. A WiFi public address system for disaster management.

    PubMed

    Andrade, Nicholas; Palmer, Douglas A; Lenert, Leslie A

    2006-01-01

    The WiFi Bullhorn is designed to assist emergency workers in the event of a disaster situation by offering a rapidly configurable wireless of public address system for disaster sites. The current configuration plays either pre recorded or custom recorded messages and utilizes 802.11b networks for communication. Units can be position anywhere wireless coverage exists to help manage crowds or to recall first responders from dangerous areas.

  9. Optical Addressing And Clocking Of RAM's

    NASA Technical Reports Server (NTRS)

    Johnston, Alan R.; Nixon, Robert H.; Bergman, Larry A.; Esener, Sadik

    1989-01-01

    Proposed random-access-memory (RAM) addressing system, in which memory linked optically to read/write logic circuits, greatly increases computer operating speed. System - comprises addressing circuits including numerous lasers as signal sources, numerous optical gates including optical detectors associated with memory cells, and holographic element to direct light signals to desired memory-cell locations - applied to high-capacity digital systems, supercomputers, and complex microcircuits.

  10. (Q)SAR modeling and safety assessment in regulatory review.

    PubMed

    Kruhlak, N L; Benz, R D; Zhou, H; Colatsky, T J

    2012-03-01

    The ability to predict clinical safety based on chemical structures is becoming an increasingly important part of regulatory decision making. (Quantitative) structure-activity relationship ((Q)SAR) models are currently used to evaluate late-arising safety concerns and possible nonclinical effects of a drug and its related compounds when adequate safety data are absent or equivocal. Regulatory use will likely increase with the standardization of analytical approaches, more complete and reliable data collection methods, and a better understanding of toxicity mechanisms.

  11. International Conference on Population Aging. Keynote address.

    PubMed

    Tabone, V

    1992-11-01

    This is the keynote address of H.E.Dr. Vincent Tabone, President of Malta, at the International Conference on Aging, which was held in San Diego in September 1992. He states that the conference celebrates the tenth anniversary of the Vienna International Plan of Action, and provides an opportunity to evaluate progress and plan future direction. Dr. Tabone, as Minister of Foreign Affairs, first introduced the question of aging at the UN General Assembly over twenty years ago; the United Nations Secretariat established its first program in the field of aging in 1970. At the World Assembly on Aging in 1982, all members adopted the International Plan of Action, which defined guidelines for policies and programs in support of the aging populations. As a direct result of this, and in support of the needs of developing countries, the UN signed an agreement with the government of Malta that established the International Institute on Aging as an autonomous body under the auspices of the UN; it is the major expression of the Vienna Plan of Action. Concern for aging populations has developed enough maturity and momentum to oversee its own progress. Although current events may relegate the social and economic implications of the aged to the sphere of rhetoric, they demand thinking in terms of generations and transcend all political boundaries. This conference will evaluate progress toward deflecting a situation where the elderly constitute an increasing proportion of the population, without adequate and appropriate provision for their livelihood, and could have direct bearing on encouraging and ensuring the continuity of the family's vital and traditional role in preserving the dignity, status, and well-being of its aging members. A nation which begrudges its dues to the elderly, the successful products of society and triumphs of life, denies its past. This conference is a reaffirmation of commitment to the United Nations Principles for Older Persons, an omen of the review of

  12. International Conference on Population Aging. Keynote address.

    PubMed

    Tabone, V

    1992-11-01

    This is the keynote address of H.E.Dr. Vincent Tabone, President of Malta, at the International Conference on Aging, which was held in San Diego in September 1992. He states that the conference celebrates the tenth anniversary of the Vienna International Plan of Action, and provides an opportunity to evaluate progress and plan future direction. Dr. Tabone, as Minister of Foreign Affairs, first introduced the question of aging at the UN General Assembly over twenty years ago; the United Nations Secretariat established its first program in the field of aging in 1970. At the World Assembly on Aging in 1982, all members adopted the International Plan of Action, which defined guidelines for policies and programs in support of the aging populations. As a direct result of this, and in support of the needs of developing countries, the UN signed an agreement with the government of Malta that established the International Institute on Aging as an autonomous body under the auspices of the UN; it is the major expression of the Vienna Plan of Action. Concern for aging populations has developed enough maturity and momentum to oversee its own progress. Although current events may relegate the social and economic implications of the aged to the sphere of rhetoric, they demand thinking in terms of generations and transcend all political boundaries. This conference will evaluate progress toward deflecting a situation where the elderly constitute an increasing proportion of the population, without adequate and appropriate provision for their livelihood, and could have direct bearing on encouraging and ensuring the continuity of the family's vital and traditional role in preserving the dignity, status, and well-being of its aging members. A nation which begrudges its dues to the elderly, the successful products of society and triumphs of life, denies its past. This conference is a reaffirmation of commitment to the United Nations Principles for Older Persons, an omen of the review of

  13. [Collaborative study on regulatory science for facilitating clinical development of gene therapy products for genetic diseases].

    PubMed

    Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

    2014-01-01

    Gene therapy products are expected as innovative medicinal products for intractable diseases such as life-threatening genetic diseases and cancer. Recently, clinical developments by pharmaceutical companies are accelerated in Europe and the United States, and the first gene therapy product in advanced countries was approved for marketing authorization by the European Commission in 2012. On the other hand, more than 40 clinical studies for gene therapy have been completed or ongoing in Japan, most of them are conducted as clinical researches by academic institutes, and few clinical trials have been conducted for approval of gene therapy products. In order to promote the development of gene therapy products, revision of the current guideline and/or preparation of concept paper to address the evaluation of the quality and safety of gene therapy products are necessary and desired to clearly show what data should be submitted before First-in-Human clinical trials of novel gene therapy products. We started collaborative study with academia and regulatory agency to promote regulatory science toward clinical development of gene therapy products for genetic diseases based on lentivirus and adeno-associated virus vectors; National Center for Child Health and Development (NCCHD), Nippon Medical School and PMDA have been joined in the task force. At first, we are preparing pre-draft of the revision of the current gene therapy guidelines in this project.

  14. 46 CFR 67.113 - Managing owner designation; address; requirement to report change of address.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 2 2011-10-01 2011-10-01 false Managing owner designation; address; requirement to... Required for Vessel Documentation § 67.113 Managing owner designation; address; requirement to report change of address. The owner of each vessel must designate a managing owner on the Application...

  15. 46 CFR 67.113 - Managing owner designation; address; requirement to report change of address.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Managing owner designation; address; requirement to... Required for Vessel Documentation § 67.113 Managing owner designation; address; requirement to report change of address. The owner of each vessel must designate a managing owner on the Application...

  16. 46 CFR 67.113 - Managing owner designation; address; requirement to report change of address.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 2 2014-10-01 2014-10-01 false Managing owner designation; address; requirement to... Required for Vessel Documentation § 67.113 Managing owner designation; address; requirement to report change of address. The owner of each vessel must designate a managing owner on the Application...

  17. 46 CFR 67.113 - Managing owner designation; address; requirement to report change of address.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 2 2013-10-01 2013-10-01 false Managing owner designation; address; requirement to... Required for Vessel Documentation § 67.113 Managing owner designation; address; requirement to report change of address. The owner of each vessel must designate a managing owner on the Application...

  18. 46 CFR 67.113 - Managing owner designation; address; requirement to report change of address.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 2 2012-10-01 2012-10-01 false Managing owner designation; address; requirement to... Required for Vessel Documentation § 67.113 Managing owner designation; address; requirement to report change of address. The owner of each vessel must designate a managing owner on the Application...

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

    SciTech Connect

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

    1997-02-01

    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.

  20. Regulatory aspects of vascular dementia in the United States.

    PubMed

    Oliva, Armando; Mani, Ranjit; Katz, Russell

    2003-01-01

    There is significant interest in the development of new drugs to treat vascular dementia. However, before US approval of new drugs for this entity is possible, certain issues with regulatory implications need to be addressed. Is vascular dementia a distinct clinical syndrome with valid diagnostic criteria? Can this entity be distinguished from Alzheimer's disease (AD) and other causes of dementia? What design features are important for clinical trials in this disorder? The US Food and Drug Administration (FDA) convened a special meeting of the Peripheral and Central Nervous System Advisory Committee in an attempt to answer these questions. The conclusions from this meeting indicate that vascular dementia (VaD) is a pathologically heterogeneous disorder but appears to be reasonably distinguishable from AD dementia. The NINDS-AIREN diagnostic criteria are suitable as entry criteria for vascular dementia trials. Trials should be similar in duration to AD dementia trials and should employ a dual outcome strategy (cognitive + global/functional measures). For drugs that are believed to have a disease-modifying effect, clinical trials should study specific vascular dementia subtypes and would need to employ substantially different designs from those used currently. The term "vascular dementia" may not be entirely appropriate to describe this population. PMID:16191257

  1. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance

    PubMed Central

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2010-01-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus. PMID:20495689

  2. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance.

    PubMed

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2008-08-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus.

  3. Human neurobehavioral toxicology testing: Current perspectives

    SciTech Connect

    Anger, W.K.

    1989-03-01

    Standardized tests or test batteries for neurotoxic effects are needed for premarket testing of chemicals (and related regulatory needs) and for the development of a neurotoxicity data base. Three widely known human test batteries based on past research findings and developed to screen for a broad range of neurotoxic effects are currently in use. One was developed by Finland's Institute of Occupational Health, one was recently recommended by the World Health Organization, and one was recently developed as a computer-implemented battery by US researchers. Each of these batteries assesses many frequently occurring neurotoxic effects, but each is limited by the lack of tests for some motor and sensory functions and affective responses that often occur following chemical exposures. Problems with field or worksite assessments using these test batteries involve age, education, socioeconomic, and job differences between exposed and comparison groups, and the lack of normative data on these batteries. To address some of these problems, the human neurobehavioral test batteries are currently undergoing reliability or validity assessments on a national and international scale. This will provide an assessment of their utility and accelerate development of a data base of neurotoxic effects of chemicals.

  4. Current and future North American compost markets

    SciTech Connect

    Alexander, R.

    1995-09-01

    As composting grows in popularity and research continues, the science of composting is becoming better understood. The successful marketing and distribution of composted products, however, is less than an exact science. In order to develop a successful compost marketing program, it is important to understand current and potential compost markets, their specific applications for compost products, their product quality requirements, and their current level of acceptance for specific products. It is also important to understand that specific barriers to market development exist, as do specific challenges. When preparing to approach specific compost markets, we must first consider the characteristics of our particular compost product. The specific chemical, physical, and biological characteristics of a product will affect our ability to market it within specific markets. Producing a product of consistent quality or possessing consistent characteristics will also influence its acceptability within specific markets. The ability to meet other end user requirements, such as providing technical assistance and service, are also factor not often considered. It is necessary to educate end users regarding proper compost use, as well as to address stigmas that may be attached to the product. False marketing barriers, based on regulatory issues, must be removed and market related research and planning must be approached with the same seriousness as design and operational considerations.

  5. Advanced Eddy current NDE steam generator tubing.

    SciTech Connect

    Bakhtiari, S.

    1999-03-29

    As part of a multifaceted project on steam generator integrity funded by the U.S. Nuclear Regulatory Commission, Argonne National Laboratory is carrying out research on the reliability of nondestructive evaluation (NDE). A particular area of interest is the impact of advanced eddy current (EC) NDE technology. This paper presents an overview of work that supports this effort in the areas of numerical electromagnetic (EM) modeling, data analysis, signal processing, and visualization of EC inspection results. Finite-element modeling has been utilized to study conventional and emerging EC probe designs. This research is aimed at determining probe responses to flaw morphologies of current interest. Application of signal processing and automated data analysis algorithms has also been addressed. Efforts have focused on assessment of frequency and spatial domain filters and implementation of more effective data analysis and display methods. Data analysis studies have dealt with implementation of linear and nonlinear multivariate models to relate EC inspection parameters to steam generator tubing defect size and structural integrity. Various signal enhancement and visualization schemes are also being evaluated and will serve as integral parts of computer-aided data analysis algorithms. Results from this research will ultimately be substantiated through testing on laboratory-grown and in-service-degraded tubes.

  6. Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

    PubMed

    Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

    2014-08-01

    The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have

  7. Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

    PubMed

    Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

    2014-08-01

    The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have

  8. Asymptotic stability of delayed stochastic genetic regulatory networks with impulses

    NASA Astrophysics Data System (ADS)

    Sakthivel, R.; Raja, R.; Anthoni, S. Marshal

    2010-11-01

    In this paper, the asymptotic stability analysis problem is considered for a class of delayed stochastic genetic regulatory networks with impulses. Based on the Lyapunov stability technique and stochastic analysis theory, stability criteria are proposed in terms of linear matrix inequalities (LMI). It is shown that the addressed stochastic genetic regulatory networks are globally asymptotically stable if four LMIs are feasible, where the feasibility of LMIs can be readily checked by Matlab LMI toolbox. Finally, a numerical example is given to demonstrate the usefulness of the proposed result.

  9. Metabolic constraint-based refinement of transcriptional regulatory networks.

    PubMed

    Chandrasekaran, Sriram; Price, Nathan D

    2013-01-01

    There is a strong need for computational frameworks that integrate different biological processes and data-types to unravel cellular regulation. Current efforts to reconstruct transcriptional regulatory networks (TRNs) focus primarily on proximal data such as gene co-expression and transcription factor (TF) binding. While such approaches enable rapid reconstruction of TRNs, the overwhelming combinatorics of possible networks limits identification of mechanistic regulatory interactions. Utilizing growth phenotypes and systems-level constraints to inform regulatory network reconstruction is an unmet challenge. We present our approach Gene Expression and Metabolism Integrated for Network Inference (GEMINI) that links a compendium of candidate regulatory interactions with the metabolic network to predict their systems-level effect on growth phenotypes. We then compare predictions with experimental phenotype data to select phenotype-consistent regulatory interactions. GEMINI makes use of the observation that only a small fraction of regulatory network states are compatible with a viable metabolic network, and outputs a regulatory network that is simultaneously consistent with the input genome-scale metabolic network model, gene expression data, and TF knockout phenotypes. GEMINI preferentially recalls gold-standard interactions (p-value = 10(-172)), significantly better than using gene expression alone. We applied GEMINI to create an integrated metabolic-regulatory network model for Saccharomyces cerevisiae involving 25,000 regulatory interactions controlling 1597 metabolic reactions. The model quantitatively predicts TF knockout phenotypes in new conditions (p-value = 10(-14)) and revealed potential condition-specific regulatory mechanisms. Our results suggest that a metabolic constraint-based approach can be successfully used to help reconstruct TRNs from high-throughput data, and highlights the potential of using a biochemically-detailed mechanistic framework to

  10. Metabolic constraint-based refinement of transcriptional regulatory networks.

    PubMed

    Chandrasekaran, Sriram; Price, Nathan D

    2013-01-01

    There is a strong need for computational frameworks that integrate different biological processes and data-types to unravel cellular regulation. Current efforts to reconstruct transcriptional regulatory networks (TRNs) focus primarily on proximal data such as gene co-expression and transcription factor (TF) binding. While such approaches enable rapid reconstruction of TRNs, the overwhelming combinatorics of possible networks limits identification of mechanistic regulatory interactions. Utilizing growth phenotypes and systems-level constraints to inform regulatory network reconstruction is an unmet challenge. We present our approach Gene Expression and Metabolism Integrated for Network Inference (GEMINI) that links a compendium of candidate regulatory interactions with the metabolic network to predict their systems-level effect on growth phenotypes. We then compare predictions with experimental phenotype data to select phenotype-consistent regulatory interactions. GEMINI makes use of the observation that only a small fraction of regulatory network states are compatible with a viable metabolic network, and outputs a regulatory network that is simultaneously consistent with the input genome-scale metabolic network model, gene expression data, and TF knockout phenotypes. GEMINI preferentially recalls gold-standard interactions (p-value = 10(-172)), significantly better than using gene expression alone. We applied GEMINI to create an integrated metabolic-regulatory network model for Saccharomyces cerevisiae involving 25,000 regulatory interactions controlling 1597 metabolic reactions. The model quantitatively predicts TF knockout phenotypes in new conditions (p-value = 10(-14)) and revealed potential condition-specific regulatory mechanisms. Our results suggest that a metabolic constraint-based approach can be successfully used to help reconstruct TRNs from high-throughput data, and highlights the potential of using a biochemically-detailed mechanistic framework to

  11. Evolving Robust Gene Regulatory Networks

    PubMed Central

    Noman, Nasimul; Monjo, Taku; Moscato, Pablo; Iba, Hitoshi

    2015-01-01

    Design and implementation of robust network modules is essential for construction of complex biological systems through hierarchical assembly of ‘parts’ and ‘devices’. The robustness of gene regulatory networks (GRNs) is ascribed chiefly to the underlying topology. The automatic designing capability of GRN topology that can exhibit robust behavior can dramatically change the current practice in synthetic biology. A recent study shows that Darwinian evolution can gradually develop higher topological robustness. Subsequently, this work presents an evolutionary algorithm that simulates natural evolution in silico, for identifying network topologies that are robust to perturbations. We present a Monte Carlo based method for quantifying topological robustness and designed a fitness approximation approach for efficient calculation of topological robustness which is computationally very intensive. The proposed framework was verified using two classic GRN behaviors: oscillation and bistability, although the framework is generalized for evolving other types of responses. The algorithm identified robust GRN architectures which were verified using different analysis and comparison. Analysis of the results also shed light on the relationship among robustness, cooperativity and complexity. This study also shows that nature has already evolved very robust architectures for its crucial systems; hence simulation of this natural process can be very valuable for designing robust biological systems. PMID:25616055

  12. Bringing plant-based veterinary vaccines to market: Managing regulatory and commercial hurdles.

    PubMed

    MacDonald, Jacqueline; Doshi, Ketan; Dussault, Marike; Hall, J Christopher; Holbrook, Larry; Jones, Ginny; Kaldis, Angelo; Klima, Cassidy L; Macdonald, Phil; McAllister, Tim; McLean, Michael D; Potter, Andrew; Richman, Alex; Shearer, Heather; Yarosh, Oksana; Yoo, Han Sang; Topp, Edward; Menassa, Rima

    2015-12-01

    The production of recombinant vaccines in plants may help to reduce the burden of veterinary diseases, which cause major economic losses and in some cases can affect human health. While there is abundant research in this area, a knowledge gap exists between the ability to create and evaluate plant-based products in the laboratory, and the ability to take these products on a path to commercialization. The current report, arising from a workshop sponsored by an Organisation for Economic Co-operation and Development (OECD) Co-operative Research Programme, addresses this gap by providing guidance in planning for the commercialization of plant-made vaccines for animal use. It includes relevant information on developing business plans, assessing market opportunities, manufacturing scale-up, financing, protecting and using intellectual property, and regulatory approval with a focus on Canadian regulations.

  13. Using Patient Avatars to Promote Health Data Sharing Applications: Perspectives and Regulatory Challenges.

    PubMed

    Dahi, Alan; Forgó, Nikolaus; Jensen, Sarah; Stauch, Marc

    2016-04-01

    The potential of ICT to address problems in modern healthcare is considerable, and an ICT-driven revolution in healthcare appears imminent. Such developments maybe viewed largely in positive terms. Thus they should result in enhanced treatment and care options, empowering patients--including by permitting greater self-management of illness outside hospital, while offering economic benefits and costs savings over traditional healthcare provision. However, the new possibilities also present manifold risks, such as of data breaches, encroachments on subject autonomy, as well as of other harms. This article considers some of the key regulatory challenges against the background of the progress of the current EU Commission-sponsored 'MyHealthAvatar' project.

  14. Using Patient Avatars to Promote Health Data Sharing Applications: Perspectives and Regulatory Challenges.

    PubMed

    Dahi, Alan; Forgó, Nikolaus; Jensen, Sarah; Stauch, Marc

    2016-04-01

    The potential of ICT to address problems in modern healthcare is considerable, and an ICT-driven revolution in healthcare appears imminent. Such developments maybe viewed largely in positive terms. Thus they should result in enhanced treatment and care options, empowering patients--including by permitting greater self-management of illness outside hospital, while offering economic benefits and costs savings over traditional healthcare provision. However, the new possibilities also present manifold risks, such as of data breaches, encroachments on subject autonomy, as well as of other harms. This article considers some of the key regulatory challenges against the background of the progress of the current EU Commission-sponsored 'MyHealthAvatar' project. PMID:27228685

  15. Policy recommendations for addressing privacy challenges associated with cell-based research and interventions

    PubMed Central

    2014-01-01

    Background The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what is done with their genetic data, amplify the privacy concerns. Discussion To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. Summary This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that

  16. 77 FR 7972 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... agenda pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735, and the... Identifier No. 396 National Standards to 1105-AB34 Prevent, Detect, and Respond to Prison Rape (Reg Plan Seq... Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is Seq. No. 85 in part II of...

  17. 78 FR 1634 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Administration (NASA). ACTION: Semiannual regulatory agenda. SUMMARY: NASA's regulatory agenda describes those regulations being considered for development or amendment by NASA, the need and legal basis for the actions... Controls and Management Systems, Office of Management Systems Division, NASA Headquarters, Washington,...

  18. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... and stability to receive opioid addiction treatment medication. Timetable: Action Date FR Cite NPRM 06/19/09 74 FR 29153 NPRM Comment Period End 08/18/09 Final Action 12/06/12 77 FR 72752 Regulatory... FR Cite NPRM 03/00/13 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Charles...

  19. Regulatory Foci and Organizational Commitment

    ERIC Educational Resources Information Center

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  20. Cheaper Adjoints by Reversing Address Computations

    DOE PAGES

    Hascoët, L.; Utke, J.; Naumann, U.

    2008-01-01

    The reverse mode of automatic differentiation is widely used in science and engineering. A severe bottleneck for the performance of the reverse mode, however, is the necessity to recover certain intermediate values of the program in reverse order. Among these values are computed addresses, which traditionally are recovered through forward recomputation and storage in memory. We propose an alternative approach for recovery that uses inverse computation based on dependency information. Address storage constitutes a significant portion of the overall storage requirements. An example illustrates substantial gains that the proposed approach yields, and we show use cases in practical applications.

  1. Shared address collectives using counter mechanisms

    SciTech Connect

    Blocksome, Michael; Dozsa, Gabor; Gooding, Thomas M; Heidelberger, Philip; Kumar, Sameer; Mamidala, Amith R; Miller, Douglas

    2014-02-18

    A shared address space on a compute node stores data received from a network and data to transmit to the network. The shared address space includes an application buffer that can be directly operated upon by a plurality of processes, for instance, running on different cores on the compute node. A shared counter is used for one or more of signaling arrival of the data across the plurality of processes running on the compute node, signaling completion of an operation performed by one or more of the plurality of processes, obtaining reservation slots by one or more of the plurality of processes, or combinations thereof.

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

    PubMed Central

    2012-01-01

    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 professional standards in this

  3. 40 CFR 80.174 - Addresses.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... FUELS AND FUEL ADDITIVES Detergent Gasoline § 80.174 Addresses. (a) The detergent additive sample..., 2565 Plymouth Road, Ann Arbor, Michigan 48105. (b) Other detergent registration and certification data, and certain other information which may be specified in this subpart, shall be sent to:...

  4. Transition through Teamwork: Professionals Address Student Access

    ERIC Educational Resources Information Center

    Bube, Sue Ann; Carrothers, Carol; Johnson, Cinda

    2016-01-01

    Prior to 2013, there was no collaboration around the transition services for deaf and hard of hearing students in Washington State. Washington had numerous agencies providing excellent support, but those agencies were not working together. It was not until January 29, 2013, when pepnet 2 hosted the Building State Capacity to Address Critical…

  5. Address Systems in "The Plum Plum Pickers"

    ERIC Educational Resources Information Center

    Geuder, Patricia A.

    1975-01-01

    The address systems in Raymond Barrio's "The Plum Plum Pickers" imply sociolinguistic differences between the Chicano and the Anglo characters. The kinds of sociolinguistic situations, the number of dyadic patterns, and the quantity of the dyadic patterns strongly suggest the differences. (Author)

  6. Preservice Educators' Confidence in Addressing Sexuality Education

    ERIC Educational Resources Information Center

    Wyatt, Tammy Jordan

    2009-01-01

    This study examined 328 preservice educators' level of confidence in addressing four sexuality education domains and 21 sexuality education topics. Significant differences in confidence levels across the four domains were found for gender, academic major, sexuality education philosophy, and sexuality education knowledge. Preservice educators…

  7. 50 CFR 228.8 - Mailing address.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 50 Wildlife and Fisheries 11 2013-10-01 2013-10-01 false Mailing address. 228.8 Section 228.8 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION... the Presiding Officer, c/o Assistant Administrator, National Marine Fisheries Service, 1315...

  8. 50 CFR 228.8 - Mailing address.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 50 Wildlife and Fisheries 9 2011-10-01 2011-10-01 false Mailing address. 228.8 Section 228.8 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION... the Presiding Officer, c/o Assistant Administrator, National Marine Fisheries Service, 1315...

  9. Autocheck: Addressing the Problem of Rural Transportation.

    ERIC Educational Resources Information Center

    Payne, Guy A.

    This paper describes a project implemented by a social worker from the Glynn County School District in rural Georgia to address transportation problems experienced by students and their families. The project aims to assist families who are unable to keep appointments or attend other important events due to unreliable transportation. A county needs…

  10. 40 CFR 80.174 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 16 2011-07-01 2011-07-01 false Addresses. 80.174 Section 80.174 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGULATION OF... Services Division, U.S. Environmental Protection Agency, National Vehicle and Fuel Emissions...

  11. Addressing Student Debt in the Classroom

    ERIC Educational Resources Information Center

    Perkins, David; Johnston, Tim; Lytle, Rick

    2016-01-01

    Student debt is a national concern. The authors address debt in the classroom to enhance students' understanding of the consequences of debt and the need for caution when financing their education. However, student feedback indicates this understanding has a delayed effect on borrowing behavior and underscores the importance of making difficult…

  12. Opening Address of Chairman Michael Pertschuk.

    ERIC Educational Resources Information Center

    Pertschuk, Michael

    Presented to a symposium sponsored by the Federal Trade Commission (FTC) to consider some of the issues involved in the continuing growth of a few large companies in the field of communication, this address cites statements of concern, made by the Supreme Court and by some periodicals, that excessive concentrations of power threaten First…

  13. How Sociology Texts Address Gun Control

    ERIC Educational Resources Information Center

    Tonso, William R.

    2004-01-01

    William R. Tonso has chosen an issue that he knows something about to examine how sociology textbooks address controversy. Appealing for gun control is fashionable, but it is at odds with a fondness that ordinary Americans have for their firearms--one that is supported by a growing body of research on deterrence to crime. There are two sides to…

  14. Registering Names and Addresses for Information Technology.

    ERIC Educational Resources Information Center

    Knapp, Arthur A.

    The identification of administrative authorities and the development of associated procedures for registering and accessing names and addresses of communications data systems are considered in this paper. It is noted that, for data communications systems using standards based on the Open Systems Interconnection (OSI) Reference Model specified by…

  15. Addressing Issues Related to Technology and Engineering

    ERIC Educational Resources Information Center

    Technology Teacher, 2008

    2008-01-01

    This article presents an interview with Michael Hacker and David Burghardt, codirectors of Hoftra University's Center for Technological Literacy. Hacker and Burghardt address issues related to technology and engineering. They argue that teachers need to be aware of the problems kids are facing, and how to present these problems in an engaging…

  16. Latitude and Longitude. AIR Presidential Address.

    ERIC Educational Resources Information Center

    Chaffee, Ellen Earle

    This speech addresses the problem of higher education's response to the forces of change and argues for a reinventing of higher education rather than repeatedly amending core teaching and research activities to fit new social and economic situations. Three higher education organizational dynamics (recruitment, budgeting, and handling outside…

  17. Federal Offices That Address Women's Issues.

    ERIC Educational Resources Information Center

    Weber, Patricia A.; And Others

    This directory contains a listing of federal offices that address women's issues. Among the departments and agencies included are: the executive branch and the executive agencies departments of agriculture, commerce, defense (Air Force, Army, Coast Guard, Marine Corps, National Guard and Navy), education, health and human services, housing and…

  18. Problem Solvers: Solutions--The Inaugural Address

    ERIC Educational Resources Information Center

    Dause, Emily

    2014-01-01

    Fourth graders in Miss Dause's and Mrs. Hicks's mathematics classes at South Mountain Elementary School in Dillsburg, Pennsylvania, worked with the data from the Inauagural Address problem that was previously published published in the February 2013 issue of "Teaching Children Mathematics". This activity allowed students to…

  19. State of the District Address, 1982.

    ERIC Educational Resources Information Center

    Koltai, Leslie

    This address by the Chancellor of the Los Angeles Community College District (LACCD) discusses recent and long-term changes in the district's programs, educational quality, and financial standing, and suggests means for future improvements. First, the paper highlights the district's achievements in improving transfer education and developing new…

  20. 40 CFR 65.14 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false Addresses. 65.14 Section 65.14 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONSOLIDATED... Department of Health and Environment, Bureau of Air Quality and Radiation Control, Forbes Field,...

  1. Addressing South Africa's Engineering Skills Gaps

    ERIC Educational Resources Information Center

    Hall, Jonathan; Sandelands, Eric

    2009-01-01

    Purpose: This paper aims to provide a case study of how engineering skills gaps are being addressed by Murray & Roberts in South Africa. Design/methodology/approach: The paper focuses on skills challenges in South Africa from a reflective practitioner perspective, exploring a case example from an industry leader. Findings: The paper explores how…

  2. 76 FR 80903 - Mandatory Declassification Review Addresses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... of the Secretary Mandatory Declassification Review Addresses AGENCY: Department of Defense. ACTION... Declassification Review requests may be sent. This notice benefits the public in advising them where to send such requests for declassification review. FOR FURTHER INFORMATION CONTACT: Mr. Robert Storer, (571)...

  3. Native Women at Risk: Addressing Cancer Prevention.

    ERIC Educational Resources Information Center

    Thiemann, Kay M. B.

    1994-01-01

    Discusses outcomes of a conference that brought together representatives from Indian tribes, state health departments, the Indian Health Service, the Mayo Clinic, and the American Cancer Society, to address the high rate of cervical cancer among American Indian women. Describes barriers to health care and plans to promote cancer screening among…

  4. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Mailing addresses. 600.2 Section 600.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... Health, 21 Wilson Dr., rm. 107, Bethesda, MD 20892-6780. (d) Vaccine Adverse Event Reporting...

  5. Rational Rhymes for Addressing Common Childhood Issues

    ERIC Educational Resources Information Center

    Warren, Jeffrey M.

    2011-01-01

    Music-based interventions are valuable tools counselors can use when working with children. Specific types of music-based interventions, such as songs or rhymes, can be especially pertinent in addressing the thoughts, feelings, and behaviors of children. Rational-emotive behavior therapy (REBT) provides a therapeutic framework that encourages…

  6. Violence Goes to School. Keynote Address.

    ERIC Educational Resources Information Center

    Levin, Jack

    1998-01-01

    Increased juvenile violence in schools has led to suggested solutions that are politically expedient but fail to address what makes violence so appealing. Instead of school uniforms, conflict resolution programs, or media rating systems, a grass roots approach of alternative programs, parental involvement, and youth support systems could repair…

  7. Mapping virtual addresses to different physical addresses for value disambiguation for thread memory access requests

    DOEpatents

    Gala, Alan; Ohmacht, Martin

    2014-09-02

    A multiprocessor system includes nodes. Each node includes a data path that includes a core, a TLB, and a first level cache implementing disambiguation. The system also includes at least one second level cache and a main memory. For thread memory access requests, the core uses an address associated with an instruction format of the core. The first level cache uses an address format related to the size of the main memory plus an offset corresponding to hardware thread meta data. The second level cache uses a physical main memory address plus software thread meta data to store the memory access request. The second level cache accesses the main memory using the physical address with neither the offset nor the thread meta data after resolving speculation. In short, this system includes mapping of a virtual address to a different physical addresses for value disambiguation for different threads.

  8. Internationalization of regulatory requirements.

    PubMed

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  9. Regulatory and Permitting Information Desktop (RAPID) Toolkit (Poster)

    SciTech Connect

    Young, K. R.; Levine, A.

    2014-09-01

    The Regulatory and Permitting Information Desktop (RAPID) Toolkit combines the former Geothermal Regulatory Roadmap, National Environmental Policy Act (NEPA) Database, and other resources into a Web-based tool that gives the regulatory and utility-scale geothermal developer communities rapid and easy access to permitting information. RAPID currently comprises five tools - Permitting Atlas, Regulatory Roadmap, Resource Library, NEPA Database, and Best Practices. A beta release of an additional tool, the Permitting Wizard, is scheduled for late 2014. Because of the huge amount of information involved, RAPID was developed in a wiki platform to allow industry and regulatory agencies to maintain the content in the future so that it continues to provide relevant and accurate information to users. In 2014, the content was expanded to include regulatory requirements for utility-scale solar and bulk transmission development projects. Going forward, development of the RAPID Toolkit will focus on expanding the capabilities of current tools, developing additional tools, including additional technologies, and continuing to increase stakeholder involvement.

  10. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    SciTech Connect

    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.

  11. Self-Assembly of Structures with Addressable Complexity.

    PubMed

    Jacobs, William M; Frenkel, Daan

    2016-03-01

    The self-assembly of structures with "addressable complexity", where every component is distinct and is programmed to occupy a specific location within a target structure, is a promising route to engineering materials with precisely defined morphologies. Because systems with many components are inherently complicated, one might assume that the chances of successful self-assembly are extraordinarily small. Yet recent advances suggest otherwise: addressable structures with hundreds of distinct building blocks have been designed and assembled with nanometer precision. Despite this remarkable success, it is often challenging to optimize a self-assembly reaction to ensure that the intended structure is kinetically accessible. In this Perspective, we focus on the prediction of kinetic pathways for self-assembly and implications for the design of robust experimental protocols. The development of general principles to predict these pathways will enable the engineering of complex materials using a much wider range of building blocks than is currently possible. PMID:26862684

  12. Scientific and Regulatory Policy Committee (SRPC) Review: Interpretation and Use of Cell Proliferation Data in Cancer Risk Assessment.

    PubMed

    Wood, Charles E; Hukkanen, Renee R; Sura, Radhakrishna; Jacobson-Kram, David; Nolte, Thomas; Odin, Marielle; Cohen, Samuel M

    2015-08-01

    Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardization of proliferation assays will become an increasingly important part of cancer risk assessment. To help address this development, we also discuss the potential role for proliferation data as a component of alternative carcinogenicity testing models. This information should improve consistency of cell proliferation methods and increase efficiency of targeted testing strategies. PMID:25903269

  13. Functional Annotation of Putative Regulatory Elements at Cancer Susceptibility Loci

    PubMed Central

    Rosse, Stephanie A; Auer, Paul L; Carlson, Christopher S

    2014-01-01

    Most cancer-associated genetic variants identified from genome-wide association studies (GWAS) do not obviously change protein structure, leading to the hypothesis that the associations are attributable to regulatory polymorphisms. Translating genetic associations into mechanistic insights can be facilitated by knowledge of the causal regulatory variant (or variants) responsible for the statistical signal. Experimental validation of candidate functional variants is onerous, making bioinformatic approaches necessary to prioritize candidates for laboratory analysis. Thus, a systematic approach for recognizing functional (and, therefore, likely causal) variants in noncoding regions is an important step toward interpreting cancer risk loci. This review provides a detailed introduction to current regulatory variant annotations, followed by an overview of how to leverage these resources to prioritize candidate functional polymorphisms in regulatory regions. PMID:25288875

  14. NGNP Project Regulatory Gap Analysis for Modular HTGRs

    SciTech Connect

    Wayne Moe

    2011-09-01

    The Next Generation Nuclear Plant (NGNP) Project Regulatory Gap Analysis (RGA) for High Temperature Gas-Cooled Reactors (HTGR) was conducted to evaluate existing regulatory requirements and guidance against the design characteristics specific to a generic modular HTGR. This final report presents results and identifies regulatory gaps concerning current Nuclear Regulatory Commission (NRC) licensing requirements that apply to the modular HTGR design concept. This report contains appendices that highlight important HTGR licensing issues that were found during the RGA study. The information contained in this report will be used to further efforts in reconciling HTGR-related gaps in the NRC licensing structure, which has to date largely focused on light water reactor technology.

  15. Regulatory requirements affecting disposal of asbestos-containing waste

    SciTech Connect

    1995-11-01

    Many U.S. Department of Energy (DOE) facilities are undergoing decontamination and decommissioning (D&D) activities. The performance of these activities may generate asbestos-containing waste because asbestos was formerly used in many building materials, including floor tile, sealants, plastics, cement pipe, cement sheets, insulating boards, and insulating cements. The regulatory requirements governing the disposal of these wastes depend on: (1) the percentage of asbestos in the waste and whether the waste is friable (easily crumbled or pulverized); (2) other physical and chemical characteristics of the waste; and (3) the State in which the waste is generated. This Information Brief provides an overview of the environment regulatory requirements affecting disposal of asbestos-containing waste. It does not address regulatory requirements applicable to worker protection promulgated under the Occupational Safety and Health Act (OSHAct), the Mining Safety and Health Act (MSHA), or the Toxic Substances Control Act (TSCA).

  16. Small Regulatory RNA and Legionella pneumophila

    PubMed Central

    Faucher, Sébastien P.; Shuman, Howard A.

    2011-01-01

    Legionella pneumophila is a gram-negative bacterial species that is ubiquitous in almost any aqueous environment. It is the agent of Legionnaires’ disease, an acute and often under-reported form of pneumonia. In mammals, L. pneumophila replicates inside macrophages within a modified vacuole. Many protein regulators have been identified that control virulence-related properties, including RpoS, LetA/LetS, and PmrA/PmrB. In the past few years, the importance of regulation of virulence factors by small regulatory RNA (sRNAs) has been increasingly appreciated. This is also the case in L. pneumophila where three sRNAs (RsmY, RsmZ, and 6S RNA) were recently shown to be important determinants of virulence regulation and 79 actively transcribed sRNAs were identified. In this review we describe current knowledge about sRNAs and their regulatory properties and how this relates to the known regulatory systems of L. pneumophila. We also provide a model for sRNA-mediated control of gene expression that serves as a framework for understanding the regulation of virulence-related properties of L. pneumophila. PMID:21833335

  17. Accelerating adaptation of natural resource management to address climate change.

    PubMed

    Cross, Molly S; McCarthy, Patrick D; Garfin, Gregg; Gori, David; Enquist, Carolyn A F

    2013-02-01

    Natural resource managers are seeking tools to help them address current and future effects of climate change. We present a model for collaborative planning aimed at identifying ways to adapt management actions to address the effects of climate change in landscapes that cross public and private jurisdictional boundaries. The Southwest Climate Change Initiative (SWCCI) piloted the Adaptation for Conservation Targets (ACT) planning approach at workshops in 4 southwestern U.S. landscapes. This planning approach successfully increased participants' self-reported capacity to address climate change by providing them with a better understanding of potential effects and guiding the identification of solutions. The workshops fostered cross-jurisdictional and multidisciplinary dialogue on climate change through active participation of scientists and managers in assessing climate change effects, discussing the implications of those effects for determining management goals and activities, and cultivating opportunities for regional coordination on adaptation of management plans. Facilitated application of the ACT framework advanced group discussions beyond assessing effects to devising options to mitigate the effects of climate change on specific species, ecological functions, and ecosystems. Participants addressed uncertainty about future conditions by considering more than one climate-change scenario. They outlined opportunities and identified next steps for implementing several actions, and local partnerships have begun implementing actions and conducting additional planning. Continued investment in adaptation of management plans and actions to address the effects of climate change in the southwestern United States and extension of the approaches used in this project to additional landscapes are needed if biological diversity and ecosystem services are to be maintained in a rapidly changing world.

  18. Addressing concerns related to geologic hazards at the site of the proposed Transuranic Waste Facility , TA-63, Los Alamos National Laboratory: focus on the current Los Alamos Seismic Network earthquake catalog, proximity of identified seismic events to the proposed facility , and evaluation of prev

    SciTech Connect

    Roberts, Peter M.; Schultz-Fellenz, Emily S.; Kelley, Richard E.

    2012-04-02

    . Understanding the subtle differences between Tshirege Member cooling units and the nature of the contacts between cooling units is critical to identifying the presence or absence of faults associated with the Pajarito fault system on the Pajarito Plateau. The Los Alamos Seismic Network (LASN) continuously monitors local earthquake activity in the Los Alamos area in support of LANL's Seismic Hazards program. Seismic monitoring of LANL facilities is a requirement of DOE Order 420.1B (Facility Safety). LASN currently consists of nine permanent seismic instrument field stations that telemeter real-time sensitive ground motion data to a central recording facility. Four of these stations are located on LANL property, with three of those within 2.5 miles of TA-63. The other five stations are in remote locations in the Jemez Mountains, Valles Caldera, St Peters Dome, and the Caja del Rio plateau across the Rio Grande from the Los Alamos area. Local earthquakes are defined as those with locations within roughly 100 miles of Los Alamos. Plate 1 shows the current LASN station locations and all local earthquakes recorded from 1973 through 2011. During this time period, LASN has detected and recorded over 850 local earthquakes in north-central New Mexico. Over 650 of these were located within about 50 miles of Los Alamos, and roughly 60 were within 10 miles. The apparent higher density of earthquakes close to Los Alamos, relative to the rest of north-central New Mexico, is due largely to the fact that LASN is a sensitive local seismic network, recording many very small nearby events (magnitude less than 1.0) that are undetectable at greater distances.

  19. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

    Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

  20. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

    Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively. PMID:26627049

  1. Functional cis-regulatory genomics for systems biology

    PubMed Central

    Nam, Jongmin; Dong, Ping; Tarpine, Ryan; Istrail, Sorin; Davidson, Eric H.

    2010-01-01

    Gene expression is controlled by interactions between trans-regulatory factors and cis-regulatory DNA sequences, and these interactions constitute the essential functional linkages of gene regulatory networks (GRNs). Validation of GRN models requires experimental cis-regulatory tests of predicted linkages to authenticate their identities and proposed functions. However, cis-regulatory analysis is, at present, at a severe bottleneck in genomic system biology because of the demanding experimental methodologies currently in use for discovering cis-regulatory modules (CRMs), in the genome, and for measuring their activities. Here we demonstrate a high-throughput approach to both discovery and quantitative characterization of CRMs. The unique aspect is use of DNA sequence tags to “barcode” CRM expression constructs, which can then be mixed, injected together into sea urchin eggs, and subsequently deconvolved. This method has increased the rate of cis-regulatory analysis by >100-fold compared with conventional one-by-one reporter assays. The utility of the DNA-tag reporters was demonstrated by the rapid discovery of 81 active CRMs from 37 previously unexplored sea urchin genes. We then obtained simultaneous high-resolution temporal characterization of the regulatory activities of more than 80 CRMs. On average 2–3 CRMs were discovered per gene. Comparison of endogenous gene expression profiles with those of the CRMs recovered from each gene showed that, for most cases, at least one CRM is active in each phase of endogenous expression, suggesting that CRM recovery was comprehensive. This approach will qualitatively alter the practice of GRN construction as well as validation, and will impact many additional areas of regulatory system biology. PMID:20142491

  2. Improving student learning by addressing misconceptions

    NASA Astrophysics Data System (ADS)

    Engelmann, Carol A.; Huntoon, Jacqueline E.

    2011-12-01

    Students—and often those who teach them—come to class with preconceptions and misconceptions that hinder their learning. For instance, many K-12 students and teachers believe groundwater exists in the ground in actual rivers or lakes, but in fact, groundwater is found in permeable rock layers called aquifers. Such misconceptions need to be addressed before students can learn scientific concepts correctly. While other science disciplines have been addressing preconceptions and misconceptions for many years, the geoscience community has only recently begun to concentrate on the impact these have on students' learning. Valuable research is being done that illuminates how geologic thinking evolves from the "novice" to "expert" level. The expert is defined as an individual with deep understanding of Earth science concepts. As research progresses, geoscientists are realizing that correcting preconceptions and misconceptions can move teachers and students closer to the "expert" level [Libarkin, 2005].

  3. Addressing medical errors in hand surgery.

    PubMed

    Johnson, Shepard P; Adkinson, Joshua M; Chung, Kevin C

    2014-09-01

    Influential think tanks such as the Institute of Medicine have raised awareness about the implications of medical errors. In response, organizations, medical societies, and hospitals have initiated programs to decrease the incidence and prevent adverse effects of these errors. Surgeons deal with the direct implications of adverse events involving patients. In addition to managing the physical consequences, they are confronted with ethical and social issues when caring for a harmed patient. Although there is considerable effort to implement system-wide changes, there is little guidance for hand surgeons on how to address medical errors. Admitting an error by a physician is difficult, but a transparent environment where patients are notified of errors and offered consolation and compensation is essential to maintain physician-patient trust. Furthermore, equipping hand surgeons with a guide for addressing medical errors will help identify system failures, provide learning points for safety improvement, decrease litigation against physicians, and demonstrate a commitment to ethical and compassionate medical care.

  4. The Development and Evaluation of a Measure Assessing School Nurses' Perceived Barriers to Addressing Pediatric Obesity

    ERIC Educational Resources Information Center

    Wu, Yelena P.; Steele, Ric G.

    2011-01-01

    School nurses represent an important resource for addressing pediatric obesity and weight-related health. However, school nurses perceive numerous barriers that prevent them from addressing the weight-related health of students. The current study developed and tested a new, comprehensive measure of nurses' perceptions of 10 types of barriers to…

  5. Increasing hope by addressing clients' outcome expectations.

    PubMed

    Swift, Joshua K; Derthick, Annie O

    2013-09-01

    Addressing clients' outcome expectations is an important clinical process that can lead to a strong therapeutic alliance, more positive treatment outcomes, and decreased rates of premature termination from psychotherapy. Five interventions designed to foster appropriate outcome expectations are discussed, including presenting a convincing treatment rationale, increasing clients' faith in their therapists, expressing faith in clients, providing outcome education, and comparing progress with expectations. Clinical examples and research support are provided for each. PMID:24000836

  6. Addressing spiritual leadership: an organizational model.

    PubMed

    Burkhart, Lisa; Solari-Twadell, P Ann; Haas, Sheila

    2008-01-01

    The Joint Commission requires health systems to address spiritual care. Research indicates that spirituality is associated with better physical, psychological, and social health and that culturally diverse populations and individuals at end-of-life often request spiritual care. The authors report the results of a consensus conference of 21 executives representing 10 large faith-based health systems who discussed the input, process, and outcomes of a corporate model for spiritual leadership. Specific initiatives are highlighted.

  7. Addressing psychosocial aspects of atopic dermatitis.

    PubMed

    Kelsay, Kimberly; Klinnert, Mary; Bender, Bruce

    2010-08-01

    Moderate to severe atopic dermatitis (AD) negatively affects patients and their families. Pruritus, scratching, and sleep problems are common complaints linked to disturbed quality of life. Treatment is complex, and nonadherence rates are high. This article reviews the effect of AD on patients and their families and intervention strategies that have some success in improving quality of life. A treatment model for addressing the psychosocial effect of moderate to severe AD within a multidisciplinary setting is suggested herein. PMID:20670820

  8. Global-Address Space Networking (GASNet) Library

    2011-04-06

    GASNet (Global-Address Space Networking) is a language-independent, low-level networking layer that provides network-independent, high-performance communication primitives tailored for implementing parallel global address space SPMD languages such as UPC and Titanium. The interface is primarily intended as a compilation target and for use by runtime library writers (as opposed to end users), and the primary goals are high performance, interface portability, and expressiveness. GASNet is designed specifically to support high-performance, portable implementations of global address spacemore » languages on modern high-end communication networks. The interface provides the flexibility and extensibility required to express a wide variety of communication patterns without sacrificing performance by imposing large computational overheads in the interface. The design of the GASNet interface is partitioned into two layers to maximize porting ease without sacrificing performance: the lower level is a narrow but very general interface called the GASNet core API - the design is basedheavily on Active Messages, and is implemented directly on top of each individual network architecture. The upper level is a wider and more expressive interface called GASNet extended API, which provides high-level operations such as remote memory access and various collective operations. This release implements GASNet over MPI, the Quadrics "elan" API, the Myrinet "GM" API and the "LAPI" interface to the IBM SP switch. A template is provided for adding support for additional network interfaces.« less

  9. Aboriginal health promotion through addressing employment discrimination.

    PubMed

    Ferdinand, Angeline S; Paradies, Yin; Perry, Ryan; Kelaher, Margaret

    2014-01-01

    The Localities Embracing and Accepting Diversity (LEAD) program aimed to improve the mental health of Aboriginal Victorians by addressing racial discrimination and facilitating social and economic participation. As part of LEAD, Whittlesea Council adopted the Aboriginal Employment Pathways Strategy (AEPS) to increase Aboriginal employment and retention within the organisation. The Aboriginal Cultural Awareness Training Program was developed to build internal cultural competency and skills in recruiting and retaining Aboriginal staff. Analysis of surveys conducted before (pre; n=124) and after (post; n=107) the training program indicated a significant increase in participant understanding across all program objectives and in support of organisational policies to improve Aboriginal recruitment and retention. Participants ended the training with concrete ideas about intended changes, as well as how these changes could be supported by their supervisors and the wider organisation. Significant resources have since been allocated to implementing the AEPS over 5 years. In line with principles underpinning the National Aboriginal and Torres Strait Islander Health Plan 2013-23, particularly the focus on addressing racism as a determinant of health, this paper explores the AEPS and training program as promising approaches to health promotion through addressing barriers to Aboriginal employment. Possible implications for other large organisations are also considered. PMID:25155236

  10. Aboriginal health promotion through addressing employment discrimination.

    PubMed

    Ferdinand, Angeline S; Paradies, Yin; Perry, Ryan; Kelaher, Margaret

    2014-01-01

    The Localities Embracing and Accepting Diversity (LEAD) program aimed to improve the mental health of Aboriginal Victorians by addressing racial discrimination and facilitating social and economic participation. As part of LEAD, Whittlesea Council adopted the Aboriginal Employment Pathways Strategy (AEPS) to increase Aboriginal employment and retention within the organisation. The Aboriginal Cultural Awareness Training Program was developed to build internal cultural competency and skills in recruiting and retaining Aboriginal staff. Analysis of surveys conducted before (pre; n=124) and after (post; n=107) the training program indicated a significant increase in participant understanding across all program objectives and in support of organisational policies to improve Aboriginal recruitment and retention. Participants ended the training with concrete ideas about intended changes, as well as how these changes could be supported by their supervisors and the wider organisation. Significant resources have since been allocated to implementing the AEPS over 5 years. In line with principles underpinning the National Aboriginal and Torres Strait Islander Health Plan 2013-23, particularly the focus on addressing racism as a determinant of health, this paper explores the AEPS and training program as promising approaches to health promotion through addressing barriers to Aboriginal employment. Possible implications for other large organisations are also considered.

  11. Addressable parallel cavity-based quantum memory

    NASA Astrophysics Data System (ADS)

    Vetlugin, Anton N.; Sokolov, Ivan V.

    2014-09-01

    We elaborate theoretically a model of addressable parallel cavity-based quantum memory for light able to store multiple transverse spatial modes of the input light signal of finite duration and, at the same time, a time sequence of the signals by side illumination. Having in mind possible applications for, e.g., quantum repeaters, we reveal the addressability of our memory, that is, its handiness for the read-out on demand of a given transverse quantized signal mode and of a given signal from the time sequence. The addressability is achieved by making use of different spatial configurations of pump wave during the write-in and the readout. We also demonstrate that for the signal durations of the order of few cavity decay times, better efficiency is achieved when one excites the cavity with zero light-matter coupling and finally performs fast excitation transfer from the intracavity field to the collective spin. On the other hand, the light-matter coupling control in time, based on dynamical impedance matching, allows to store and retrieve time restricted signals of the on-demand smooth time shape.

  12. Matching Alternative Addresses: a Semantic Web Approach

    NASA Astrophysics Data System (ADS)

    Ariannamazi, S.; Karimipour, F.; Hakimpour, F.

    2015-12-01

    Rapid development of crowd-sourcing or volunteered geographic information (VGI) provides opportunities for authoritatives that deal with geospatial information. Heterogeneity of multiple data sources and inconsistency of data types is a key characteristics of VGI datasets. The expansion of cities resulted in the growing number of POIs in the OpenStreetMap, a well-known VGI source, which causes the datasets to outdate in short periods of time. These changes made to spatial and aspatial attributes of features such as names and addresses might cause confusion or ambiguity in the processes that require feature's literal information like addressing and geocoding. VGI sources neither will conform specific vocabularies nor will remain in a specific schema for a long period of time. As a result, the integration of VGI sources is crucial and inevitable in order to avoid duplication and the waste of resources. Information integration can be used to match features and qualify different annotation alternatives for disambiguation. This study enhances the search capabilities of geospatial tools with applications able to understand user terminology to pursuit an efficient way for finding desired results. Semantic web is a capable tool for developing technologies that deal with lexical and numerical calculations and estimations. There are a vast amount of literal-spatial data representing the capability of linguistic information in knowledge modeling, but these resources need to be harmonized based on Semantic Web standards. The process of making addresses homogenous generates a helpful tool based on spatial data integration and lexical annotation matching and disambiguating.

  13. Addressing language barriers to healthcare in India.

    PubMed

    Narayan, Lalit

    2013-01-01

    In spite of a growing recognition of the importance of doctor-patient communication, the issue of language barriers to healthcare has received very little attention in India. The Indian population speaks over 22 major languages with English used as the lingua franca for biomedicine. Large-scale internal migration has meant that health workers are encountering increasing instances of language discordance within clinical settings. Research done predominantly in the West has shown language discordance to significantly affect access to care, cause problems of comprehension and adherence, and decrease the satisfaction and quality of care. Addressing language barriers to healthcare in India requires a stronger political commitment to providing non-discriminatory health services, especially to vulnerable groups such as illiterate migrant workers. Research will have to address three broad areas: the ways in which language barriers affect health and healthcare, the efficacy of interventions to overcome language barriers, and the costs of language barriers and efforts to overcome them. There is a need to address such barriers in health worker education and clinical practice. Proven strategies such as hiring multilingual healthcare workers, providing language training to health providers, employing in situ translators or using telephone interpretation services will have to be evaluated for their appropriateness to the Indian context. Internet-based initiatives, the proliferation of mobile phones and recent advances in machine translation promise to contribute to the solution.

  14. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

    PubMed

    Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

    2015-10-01

    TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

  15. Optically Addressed Spatial Light Modulators for 3d Display

    NASA Astrophysics Data System (ADS)

    Collings, N.

    An optically addressed spatial light modulator (OASLM) records the image on a write beam and transfers it to a read beam. Some example application areas are: image transduction; optical correlation; adaptive optics; and optical neural networks. Current interest in OASLMs has been generated by the work of Qinetiq on 3D display. This work is based on Active tiling, where an image can be recorded in one part of the device and is memorised, whilst the remainder of the device is updated with images. This paper will explain this system and survey the technological alternatives for this application.

  16. Individual addressing in quantum computation through spatial refocusing

    NASA Astrophysics Data System (ADS)

    Shen, C.; Gong, Z.-X.; Duan, L.-M.

    2013-11-01

    Separate addressing of individual qubits is a challenging requirement for scalable quantum computation, and crosstalk between operations on neighboring qubits remains a significant source of error for current experimental implementations of multiqubit platforms. We propose a scheme based on spatial refocusing from interference of several coherent laser beams to significantly reduce the crosstalk error for any type of quantum gate. A general framework is developed for the spatial refocusing technique, in particular with practical Gaussian beams, and we show that the crosstalk-induced infidelity of quantum gates can be reduced by several orders of magnitude with a moderate cost of a few correction laser beams under typical experimental conditions.

  17. A novel electron gun with an independently addressable cathode array

    SciTech Connect

    Rudys, Joseph Matthew; Reed, Kim Warren; Pena, Gary Edward; Schneider, Larry X.

    2006-08-01

    The design of a novel electron gun with an array of independently addressable cathode elements is presented. Issues relating to operation in a 6.5 Tesla axial magnetic field are discussed. Simulations with the TriComp electromagnetic field code that were used to determine the space charge limited tube characteristic and to model focusing of the electron beam in the magnetic field are reviewed. Foil heating and stress calculations are discussed. The results of CYLTRAN simulations yielding the energy spectrum of the electron beam and the current transmitted through the foil window are presented.

  18. Regulatory oversight in the United States of vascularized composite allografts.

    PubMed

    Glazier, Alexandra K

    2016-06-01

    Vascularized composite allograft (VCA) transplantation is a medically acceptable treatment for the reconstruction of major tissue loss. The advent of VCA transplantation has spurred regulatory and policy development in the United States to address the multiple clinical, ethical and legal issues that must be considered for the practice of VCA donation and transplantation to develop within the existing framework of public trust and transparency vital to the success of donation and transplantation. PMID:26284312

  19. Regulatory and ethical issues for phase I in utero gene transfer studies.

    PubMed

    Strong, Carson

    2011-11-01

    Clinical gene transfer research has involved adult and child subjects, and it is expected that gene transfer in fetal subjects will occur in the future. Some genetic diseases have serious adverse effects on the fetus before birth, and there is hope that prenatal gene therapy could prevent such disease progression. Research in animal models of prenatal gene transfer is actively being pursued. The prospect of human phase I in utero gene transfer studies raises important regulatory and ethical issues. One issue not previously addressed arises in applying U.S. research regulations to such studies. Specifically, current regulations state that research involving greater than minimal risk to the fetus and no prospect of direct benefit to the fetus or pregnant woman is not permitted. Phase I studies will involve interventions such as needle insertions through the uterus, which carry risks to the fetus including spontaneous abortion and preterm birth. It is possible that these risks will be regarded as exceeding minimal. Also, some regard the probability of therapeutic benefit in phase I studies to be so low that these studies do not satisfy the regulatory requirement that they "hold out the prospect of direct benefit" to subjects. On the basis of these considerations, investigators and institutional review boards might reasonably conclude that some phase I in utero studies are not to be permitted. This paper identifies considerations that are relevant to such judgments and explores ethically acceptable ways in which phase I studies can be designed so that they are permitted by the regulations.

  20. Scientific foundation of regulating ionizing radiation: application of metrics for evaluation of regulatory science information.

    PubMed

    Moghissi, A Alan; Gerraa, Vikrham Kumar; McBride, Dennis K; Swetnam, Michael

    2014-11-01

    This paper starts by describing the historical evolution of assessment of biologic effects of ionizing radiation leading to the linear non-threshold (LNT) system currently used to regulate exposure to ionizing radiation. The paper describes briefly the concept of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived for BAS. It identifies three phases of regulatory science consisting of the initial phase, when the regulators had to develop regulations without having the needed scientific information; the exploratory phase, when relevant tools were developed; and the standard operating phase, when the tools were applied to regulations. Subsequently, an attempt is made to apply the BAS/MESC system to various stages of LNT. This paper then compares the exposure limits imposed by regulatory agencies and also compares them with naturally occurring radiation at several cities. Controversies about LNT are addressed, including judgments of the U.S. National Academies and their French counterpart. The paper concludes that, based on the BAS/MESC system, there is no disagreement between the two academies on the scientific foundation of LNT; instead, the disagreement is based on their judgment or speculation.

  1. Factors influencing physicians’ choice of workplace: systematic review of drivers of attrition and policy interventions to address them

    PubMed Central

    El Koussa, Maria; Atun, Rifat; Bowser, Diana; Kruk, Margaret E

    2016-01-01

    Objectives The movement of skilled physicians from the public to the private sector is a key constraint to achieving universal health coverage and is currently affecting health systems worldwide. This systematic review aims to assess factors influencing physicians’ choice of workplace, and policy interventions for retaining physicians in the public sector. Methods Five literature databases were searched. Studies were included in the review if they focused on at least one of the following criteria: (i) incentives or motivators for retaining physicians in the public sector, (ii) pull factors that encouraged physicians to move to the private sector, (iii) push factors that forced physicians to leave the public sector, (iv) policy interventions or case studies that addressed physician retention in the public sector, and (v) qualitative reviews of policy interventions that were implemented in different health system settings. Results Nineteen articles met the inclusion criteria. Six major themes that affected physicians’ choice of workplace were identified including: financial incentives, career development, infrastructure and staffing, professional work environment, workload and autonomy. The majority of the studies suggested that the use of financial incentives was a motivator in retaining physicians in the public sector. The review also identified policy interventions including: regulatory controls, incentives and management reforms. Regulatory controls and incentives were the two most frequently reported policy interventions. Conclusion While factors affecting physicians’ choice of workplace are country specific, financial incentives and professional development are core factors. Other factors are highly influenced by context, and thus, it would be useful for future cross–country research to use standardized data collection tools, allowing comparison of contextual factors as well as the examination of how context affects physician retention in the public

  2. Factors influencing physicians’ choice of workplace: systematic review of drivers of attrition and policy interventions to address them

    PubMed Central

    El Koussa, Maria; Atun, Rifat; Bowser, Diana; Kruk, Margaret E

    2016-01-01

    Objectives The movement of skilled physicians from the public to the private sector is a key constraint to achieving universal health coverage and is currently affecting health systems worldwide. This systematic review aims to assess factors influencing physicians’ choice of workplace, and policy interventions for retaining physicians in the public sector. Methods Five literature databases were searched. Studies were included in the review if they focused on at least one of the following criteria: (i) incentives or motivators for retaining physicians in the public sector, (ii) pull factors that encouraged physicians to move to the private sector, (iii) push factors that forced physicians to leave the public sector, (iv) policy interventions or case studies that addressed physician retention in the public sector, and (v) qualitative reviews of policy interventions that were implemented in different health system settings. Results Nineteen articles met the inclusion criteria. Six major themes that affected physicians’ choice of workplace were identified including: financial incentives, career development, infrastructure and staffing, professional work environment, workload and autonomy. The majority of the studies suggested that the use of financial incentives was a motivator in retaining physicians in the public sector. The review also identified policy interventions including: regulatory controls, incentives and management reforms. Regulatory controls and incentives were the two most frequently reported policy interventions. Conclusion While factors affecting physicians’ choice of workplace are country specific, financial incentives and professional development are core factors. Other factors are highly influenced by context, and thus, it would be useful for future cross–country research to use standardized data collection tools, allowing comparison of contextual factors as well as the examination of how context affects physician retention in the public

  3. Regulatory facility guide for Ohio

    SciTech Connect

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O.; Rymer, A.C.

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  4. Current limiters

    SciTech Connect

    Loescher, D.H.; Noren, K.

    1996-09-01

    The current that flows between the electrical test equipment and the nuclear explosive must be limited to safe levels during electrical tests conducted on nuclear explosives at the DOE Pantex facility. The safest way to limit the current is to use batteries that can provide only acceptably low current into a short circuit; unfortunately this is not always possible. When it is not possible, current limiters, along with other design features, are used to limit the current. Three types of current limiters, the fuse blower, the resistor limiter, and the MOSFET-pass-transistor limiters, are used extensively in Pantex test equipment. Detailed failure mode and effects analyses were conducted on these limiters. Two other types of limiters were also analyzed. It was found that there is no best type of limiter that should be used in all applications. The fuse blower has advantages when many circuits must be monitored, a low insertion voltage drop is important, and size and weight must be kept low. However, this limiter has many failure modes that can lead to the loss of over current protection. The resistor limiter is simple and inexpensive, but is normally usable only on circuits for which the nominal current is less than a few tens of milliamperes. The MOSFET limiter can be used on high current circuits, but it has a number of single point failure modes that can lead to a loss of protective action. Because bad component placement or poor wire routing can defeat any limiter, placement and routing must be designed carefully and documented thoroughly.

  5. The limits of regulatory toxicology

    SciTech Connect

    Carrington, Clark D.; Bolger, P. Michael

    2010-03-01

    The Acceptable Daily Intake (ADI) has been used by regulatory and public health organizations (e.g., the U.S. Food and Drug and Administration, and the World Health Organization) for chemicals for more than 50 years. The ADI concept was also initially employed at the U.S. Environmental Protection Agency at its inception in 1971, although with the adoption of newer terminology, it later became known as the Reference Dose (RfD). It is clear from the literature that both were first devised as instruments of regulatory policy. In the intervening years, it has become common to use language that implies that these standards are statements of scientific fact. Similarly, some of the discretionary or default values that are used to derive regulatory standards are represented as scientific assumptions when in fact they also represent regulatory policy. This confusion impedes both the best use of the available science and informed public participation in policy making. In addition, the misconception of the ADI or the RfD as statements of scientific fact may impede the consideration of alternative means to reduce exposure to chemicals that may be harmful, including regulatory measures that do not involve prescribing a regulatory concentration limit.

  6. The regulatory sciences for stem cell-based medicinal products.

    PubMed

    Yuan, Bao-Zhu; Wang, Junzhi

    2014-06-01

    Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

  7. A regulatory theory of cortical organization and its applications to robotics

    NASA Astrophysics Data System (ADS)

    Thangavelautham, Jekanthan

    2009-11-01

    Fundamental aspects of biologically-inspired regulatory mechanisms are considered in a robotics context, using artificial neural-network control systems. Regulatory mechanisms are used to control expression of genes, adaptation of form and behavior in organisms. Traditional neural network control architectures assume networks of neurons are fixed and are interconnected by wires. However, these architectures tend to be specified by a designer and are faced with several limitations that reduce scalability and tractability for tasks with larger search spaces. Traditional methods used to overcome these limitations with fixed network topologies are to provide more supervision by a designer. More supervision as shown does not guarantee improvement during training particularly when making incorrect assumptions for little known task domains. Biological organisms often do not require such external intervention (more supervision) and have self-organized through adaptation. Artificial neural tissues (ANT) addresses limitations with current neural-network architectures by modeling both wired interactions between neurons and wireless interactions through use of chemical diffusion fields. An evolutionary (Darwinian) selection process is used to 'breed' ANT controllers for a task at hand and the framework facilitates emergence of creative solutions since only a system goal function and a generic set of basis behaviours need be defined. Regulatory mechanisms are formed dynamically within ANT through superpositioning of chemical diffusion fields from multiple sources and are used to select neuronal groups. Regulation drives competition and cooperation among neuronal groups and results in areas of specialization forming within the tissue. These regulatory mechanisms are also shown to increase tractability without requiring more supervision using a new statistical theory developed to predict performance characteristics of fixed network topologies. Simulations also confirm the

  8. Addressing Extremes within the WCRP - GEWEX Framework

    NASA Astrophysics Data System (ADS)

    van Oevelen, P. J.; Stewart, R.; Detemmerman, V.

    2008-12-01

    For large international coordination programs such as the Global Energy and Water Cycle Experiment (GEWEX) as part of the World Climate Research Programme (WCRP) it is difficult to strike a good balance between enabling as much international involvement as is possible and desirable and the achievability of the objectives. WCRP has decided that "Extremes Research" is one of several areas where it would like to see its efforts strengthened and scientific research pushed forward. The foci that are being selected should be phrased such that they are practical and achievable within a time span of 1 to 3 years. Preferably these foci build upon the expertise from cross WCRP activities and are not restricted to single core project activities. In this presentation an overview will be given of the various activities within GEWEX that are related to extremes and which ones would be most ideal to be addressed as WCRP foci from a GEWEX perspective. The rationale and context of extreme research will be presented as well links to other national and international programs. "Extremes Research" as a topic is attractive since it has a high societal relevance and impact. However, numerous definitions of extremes exist and they are being used in widely varying contexts making it not always clear of what exactly is being addressed. This presentation will give an outlook on what can be expected research wise in the near future based upon the outcomes of the Extremes Workshop organised last June in Vancouver in the context of the Coordinated Energy and water cycle Observations Project (CEOP) as part of GEWEX. In particular it will be shown how these activities, which will only address certain types of extremes, can be linked to adaptation and mitigation efforts taking place in other organisations and by national and international bodies.

  9. Challenges in Diabetes Care: Can Digital Health Help Address Them?

    PubMed

    Iyengar, Varun; Wolf, Alexander; Brown, Adam; Close, Kelly

    2016-07-01

    In Brief There is great enthusiasm for the potential of digital health solutions in medicine and diabetes to address key care challenges: patient and provider burden, lack of data to inform therapeutic decision-making, poor access to care, and costs. However, the field is still in its nascent days; many patients and providers do not currently engage with digital health tools, and for those who do, the burden is still often high. Over time, digital health has excellent potential to collect data more seamlessly, make collected data more useful, and drive better outcomes at lower costs in less time. But there is still much to prove. This review offers key background information on the current state of digital health in diabetes, six of the most promising digital health technologies and services, and the challenges that remain. PMID:27621530

  10. On the Concept of Cis-regulatory Information: From Sequence Motifs to Logic Functions

    NASA Astrophysics Data System (ADS)

    Tarpine, Ryan; Istrail, Sorin

    The regulatory genome is about the “system level organization of the core genomic regulatory apparatus, and how this is the locus of causality underlying the twin phenomena of animal development and animal evolution” (E.H. Davidson. The Regulatory Genome: Gene Regulatory Networks in Development and Evolution, Academic Press, 2006). Information processing in the regulatory genome is done through regulatory states, defined as sets of transcription factors (sequence-specific DNA binding proteins which determine gene expression) that are expressed and active at the same time. The core information processing machinery consists of modular DNA sequence elements, called cis-modules, that interact with transcription factors. The cis-modules “read” the information contained in the regulatory state of the cell through transcription factor binding, “process” it, and directly or indirectly communicate with the basal transcription apparatus to determine gene expression. This endowment of each gene with the information-receiving capacity through their cis-regulatory modules is essential for the response to every possible regulatory state to which it might be exposed during all phases of the life cycle and in all cell types. We present here a set of challenges addressed by our CYRENE research project aimed at studying the cis-regulatory code of the regulatory genome. The CYRENE Project is devoted to (1) the construction of a database, the cis-Lexicon, containing comprehensive information across species about experimentally validated cis-regulatory modules; and (2) the software development of a next-generation genome browser, the cis-Browser, specialized for the regulatory genome. The presentation is anchored on three main computational challenges: the Gene Naming Problem, the Consensus Sequence Bottleneck Problem, and the Logic Function Inference Problem.

  11. Best Practices in Hiring: Addressing Unconscious Bias

    NASA Astrophysics Data System (ADS)

    Simpson, Caroline E.

    2012-01-01

    Research has shown that implementing certain hiring practices will increase diversity in the workplace while enhancing academic quality. All of these practices rely on addressing the issue of 'unconscious bias.' A brief overview of unconscious bias--what it is, how it works, and simple measures to counter it--will be presented. Successful strategies, actions, and recommendations for implementing best recruiting and hiring practices, which have been proven to enhance academic excellence by ensuring a deep and diverse applicant pool, will also be presented.

  12. A Task Force to Address Bullying.

    PubMed

    Keller, Ronald; Budin, Wendy C; Allie, Tammy

    2016-02-01

    Bullying in the workplace can create a dysfunctional environment that is associated with serious physical and psychological harm to the person being bullied. Nurses' experience with bullying has gained considerable attention in recent years, and warrants further discussion. Nurse leaders need to develop and implement effective bullying prevention initiatives that will foster the functioning of a professional and productive staff in a healthy work environment. The aim of this article is to review workplace bullying as experienced by nurses, and describe how nurses at a Magnet-designated academic medical center developed and implemented a bullying task force to address the problem.

  13. Addressing the water budget with SMOS

    NASA Astrophysics Data System (ADS)

    Kerr, Y. H.; AlBitar, A.; Tomer, S. K.; Merlin, O.; Pellarin, T.

    2012-12-01

    SMOS, a L Band radiometer using aperture synthesis to achieve a good spatial resolution, was successfully launched on November 2, 2009. It was developed and made under the leadership of the European Space Agency (ESA) as an Earth Explorer Opportunity mission. It is a joint program with the Centre National d'Etudes Spatiales (CNES) in France and the Centro para el Desarrollo Teccnologico Industrial (CDTI) in Spain. SMOS carries a single payload, an L band 2D interferometric,radiometer in the 1400-1427 MHz h protected band. This wavelength penetrates well through the vegetation and the atmosphere is almost transparent enabling to infer both soil moisture and vegetation water content. SMOS achieves an unprecedented spatial resolution of 50 km at L-band maximum (43 km on average) with multi angular-dual polarized (or fully polarized) brightness temperatures over the globe and with a revisit time smaller than 3 days. SMOS as been now acquiring data for almost 2 years. The data quality exceeds what was expected, showing very good sensitivity and stability. The data is however very much impaired by man made emission in the protected band, leading to degraded measurements in several areas including parts of Europe and of China. However, many different international teams are now addressing cal val activities in various parts of the world, with notably large field campaigns either on the long time scale or over specific targets to address the specific issues. In parallel different teams are now starting addressing data use in various fields including hydrology. It requires coupling with other models and or disaggregation to address soil moisture distribution over watersheds. Significant new results were obtained for floods and drought events, together with new potential applications in terms of precipitation monitoring This paper thus gives an overview of the science goals of the SMOS mission, a description of its main elements, and a taste of the first results including

  14. A Task Force to Address Bullying.

    PubMed

    Keller, Ronald; Budin, Wendy C; Allie, Tammy

    2016-02-01

    Bullying in the workplace can create a dysfunctional environment that is associated with serious physical and psychological harm to the person being bullied. Nurses' experience with bullying has gained considerable attention in recent years, and warrants further discussion. Nurse leaders need to develop and implement effective bullying prevention initiatives that will foster the functioning of a professional and productive staff in a healthy work environment. The aim of this article is to review workplace bullying as experienced by nurses, and describe how nurses at a Magnet-designated academic medical center developed and implemented a bullying task force to address the problem. PMID:26817556

  15. Addressing the underperformance of faculty and staff.

    PubMed

    Kenner, Carole; Pressler, Jana L

    2006-01-01

    Many new nursing leaders assuming work as deans, assistant deans, or interim deans have limited education, experience, or background to prepare them for the job. To assist new deans and those aspiring to be deans, the authors of this department, both deans, offer survival tips based on their personal experiences and insights. They address common issues, challenges, and opportunities that face academic executive teams, such as negotiating an executive contract, obtaining faculty lines, building effective work teams, managing difficult employees, and creating nimble organizational structure to respond to changing consumer, healthcare delivery, and community needs. The authors welcome counterpoint discussions with readers. PMID:17108781

  16. Multi-port, optically addressed RAM

    NASA Technical Reports Server (NTRS)

    Johnston, Alan R. (Inventor); Nixon, Robert H. (Inventor); Bergman, Larry A. (Inventor); Esener, Sadik (Inventor)

    1989-01-01

    A random access memory addressing system utilizing optical links between memory and the read/write logic circuits comprises addressing circuits including a plurality of light signal sources, a plurality of optical gates including optical detectors associated with the memory cells, and a holographic optical element adapted to reflect and direct the light signals to the desired memory cell locations. More particularly, it is a multi-port, binary computer memory for interfacing with a plurality of computers. There are a plurality of storage cells for containing bits of binary information, the storage cells being disposed at the intersections of a plurality of row conductors and a plurality of column conductors. There is interfacing logic for receiving information from the computers directing access to ones of the storage cells. There are first light sources associated with the interfacing logic for transmitting a first light beam with the access information modulated thereon. First light detectors are associated with the storage cells for receiving the first light beam, for generating an electrical signal containing the access information, and for conducting the electrical signal to the one of the storage cells to which it is directed. There are holographic optical elements for reflecting the first light beam from the first light sources to the first light detectors.

  17. Framework for Address Cooperative Extended Transactions

    1997-12-01

    The Framework for Addressing Cooperative Extended Transactions (FACET) is an object-oriented software framework for building models of complex, cooperative behaviors of agents. it can be used to implement simulation models of societal processes such as the complex interplay of participating individuals and organizations engaged in multiple concurrent transactions in pursuit of their various goals. These transactions can be patterned on, for example, clinical guidelines and procedures, business practices, government and corporate policies, etc. FACET canmore » also address other complex behaviors such as biological life cycles or manufacturing processes. FACET includes generic software objects representing the fundamental classes of agent -- Person and Organization - with mechanisms for resource management, including resolution of conflicting requests for participation and/or use of the agent's resources. The FACET infrastructure supports stochastic behavioral elements and coping mechanisms by which specified special conditions and events can cause an active cooperative process to be preempted, diverting the participants onto appropriate alternative behavioral pathways.« less

  18. Addressing Science Use Cases with HELIO

    NASA Astrophysics Data System (ADS)

    Bentley, R. D.; Aboudarham, J.; Csillaghy, A.; Jacquey, C.; Hapgood, M. A.; Messerotti, M.; Gallagher, P.; Bocchialini, K.; Hurlburt, N. E.; Roberts, D.; Sanchez Duarte, L.

    2009-12-01

    The Heliophysics Integrated Observatory (HELIO) is a new VO project funded under the EC's Seventh Framework Programme (FP7). It includes thirteen partners scattered over six countries and is led by University College London. HELIO is designed to support the heliophysics community and is based on a Service Oriented Architecture. The services developed by and integrated into HELIO can be used to address a wide range of science problems; they can be used individually or as part of a work-flow driven search engine that can use a propagation (or other) model to help locate obervations that describe interesting phenomena. We will describe and discuss how the components of HELIO could be used to address science use cases, particularly how a user can adapt the work flow to their own science interests. Networking is one of the three Activities of the HELIO Integrated Infrastructure Initiatives (I3) project. Within this activity we plan to involve the community in all aspects of the design and testing of the HELIO system, including determining which data and metadata should be included, how the quality and content of metadata can be included, etc. We are investigating ways of making HELIO "domain-aware" so that researchers who are specialists in one of the communities that constitute heliophysics can easily identify, access and use data they need from the other communities. We will discuss how the community can help us develop this capability.

  19. EVALUATING INTERNAL STAKEHOLDER PERSPECTIVES ON RISK-INFORMED REGULATORY PRACTICES FOR THE NUCLEAR REGULATORY COMMISSION

    SciTech Connect

    Peterson, L.K.; Wight, E.H.; Caruso, M.A.

    2003-02-27

    The U.S. Nuclear Regulatory Commission's (NRC) Office of Nuclear Reactor Regulation has begun a program to create a risk-informed environment within the reactor program. The first step of the process is to evaluate the existing environment and internal NRC stakeholder perceptions of risk-informed regulatory practices. This paper reports on the results of the first phase of this evaluation: assessing the current environment, including the level of acceptance of risk-informed approaches throughout the reactor program, the level of integration, areas of success, and areas of difficulty. The other two phases of the evaluation will identify barriers to the integration of risk into NRC activities and gather input on how to move to a risk-informed environment.

  20. Modeling genomic regulatory networks with big data.

    PubMed

    Bolouri, Hamid

    2014-05-01

    High-throughput sequencing, large-scale data generation projects, and web-based cloud computing are changing how computational biology is performed, who performs it, and what biological insights it can deliver. I review here the latest developments in available data, methods, and software, focusing on the modeling and analysis of the gene regulatory interactions in cells. Three key findings are: (i) although sophisticated computational resources are increasingly available to bench biologists, tailored ongoing education is necessary to avoid the erroneous use of these resources. (ii) Current models of the regulation of gene expression are far too simplistic and need updating. (iii) Integrative computational analysis of large-scale datasets is becoming a fundamental component of molecular biology. I discuss current and near-term opportunities and challenges related to these three points.