Science.gov

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 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

  3. 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....

  4. 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....

  5. 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 Notification of current addresses. Each assignee and each beneficiary of an 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, 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....

  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. 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

  11. 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.

  12. 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.

  13. 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.…

  14. 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

  15. Biosimilars: current scientific and regulatory considerations.

    PubMed

    Chugh, Preeta Kaur; Roy, Vandana

    2014-02-01

    The widespread use of biologics has paved way for newer options in therapeutics for once incurable illnesses. Their large and complex protein structure, post-translational modifications, elaborate manufacturing/production process and risk for immunogenicity adds to the uniqueness of a biologic product. Patent expiration of innovator biologics has led to the development of biosimilars; biologics similar /comparable to the reference product in terms of quality, safety and efficacy. We discuss the clinical safety and regulatory requirements for biosimilars in various countries across the world. Future holds promise for biosimilars to provide affordable, efficacious and safe treatment to a vast majority of patients with significant cost savings to the nation. PMID:23952143

  16. 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...

  17. 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...

  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, 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...

  20. 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...

  1. Regulatory factors of induced pluripotency: current status

    PubMed Central

    Ning, Bo; Qian, Chen

    2014-01-01

    Somatic cells can be reprogrammed to induced pluripotent stem cells (iPSCs) through enforced expression of four transcription factors [Oct4, Sox2, Klf4, and c-Myc (OSKM)]; however, the reprogramming efficiency is extremely low. This finding raises fundamental questions about the regulators that influence the change in epigenetic stability and endowment of dedifferentiation potential during reprogramming. Identification of such regulators is critical to removing the roadblocks impeding the efficient generation of safe iPSCs and their successful translation into clinical therapies. In this review, we summarize the current progress that has been made in understanding cellular reprogramming, with an emphasis on the molecular mechanisms of epigenetic regulators in induced pluripotency.

  2. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Current Addresses and Geographic Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS...

  4. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Current Addresses and Geographic Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS...

  5. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Current Addresses and Geographic Jurisdictions A Appendix A to Chapter XIV Foreign Relations FOREIGN SERVICE LABOR RELATIONS BOARD; FEDERAL LABOR... IMPASSE DISPUTES PANEL Ch. XIV, App. A Appendix A to Chapter XIV—Current Addresses and...

  6. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 2 2013-04-01 2009-04-01 true Current Addresses and Geographic Jurisdictions A Appendix A to Chapter XIV Foreign Relations FOREIGN SERVICE LABOR RELATIONS BOARD; FEDERAL LABOR RELATIONS... DISPUTES PANEL Ch. XIV, App. A Appendix A to Chapter XIV—Current Addresses and Geographic Jurisdictions...

  7. 5 CFR Appendix A to 5 Cfr Chapter... - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Current Addresses and Geographic Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS...

  8. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 2 2012-04-01 2009-04-01 true Current Addresses and Geographic Jurisdictions A Appendix A to Chapter XIV Foreign Relations FOREIGN SERVICE LABOR RELATIONS BOARD; FEDERAL LABOR RELATIONS... DISPUTES PANEL Ch. XIV, App. A Appendix A to Chapter XIV—Current Addresses and Geographic Jurisdictions...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... A Appendix A to 5 CFR Chapter XIV—Current Addresses and Geographic Jurisdictions (a) The Office... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Current Addresses and Geographic Jurisdictions A Appendix A to 5 CFR Chapter XIV Administrative Personnel FEDERAL LABOR RELATIONS...

  10. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Current Addresses and Geographic Jurisdictions A Appendix A to Chapter XIV Foreign Relations FOREIGN SERVICE LABOR RELATIONS BOARD; FEDERAL LABOR RELATIONS... DISPUTES PANEL Ch. XIV, App. A Appendix A to Chapter XIV—Current Addresses and Geographic Jurisdictions...

  11. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Current Addresses and Geographic Jurisdictions A Appendix A to Chapter XIV Foreign Relations FOREIGN SERVICE LABOR RELATIONS BOARD; FEDERAL LABOR RELATIONS... DISPUTES PANEL Ch. XIV, App. A Appendix A to Chapter XIV—Current Addresses and Geographic Jurisdictions...

  12. 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

  13. 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

  14. 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.

  15. 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

  16. 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

  17. ARS, university and regulatory partnerships needed to address the challenge and complete eradication

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Although most of the U.S. Cotton Belt has achieved functional eradication of the boll weevil, certain areas of Texas as well as Northern Mexico still experience economic loss to this pest. Currently under active eradication, most of these areas are considered subtropical, where boll weevils can per...

  18. 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

  19. 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

  20. 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.

  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. REVIEW OF VARIOUS APPROACHES TO ADDRESS HIGH CURRENTS IN SRF ELECTRON LINACS.

    SciTech Connect

    BEN-ZVI, I.

    2005-07-10

    The combination of high-brightness electron sources and high-current SRF Energy Recovery Linacs (ERL) leads to a new emerging technology: High-power, high-brightness electron beams. This technology enables extremely high average power Free-Electron Lasers, a new generation of extreme brightness light sources, electron coolers of high-energy hadron storage rings, polarized electron-hadron colliders of very high luminosity, compact Thomson scattering X-ray sources, terahertz radiation generators and much more. What is typical for many of these applications is the need for very high current, defined here as over 100 mA average current, and high brightness, which is charge dependant, but needs to be in the range of between sub micron up to perhaps 50 microns, usually the lower--the better. Suffice it to say that while there are a number of projects aiming at this level of performance, none is anywhere near it. This work will review the problems associated with the achievement of such performance and the various approaches taken in a number of laboratories around the world to address the issues.

  3. 17 CFR 3.30 - Current address for purpose of delivery of communications from the Commission or the National...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Current address for purpose of delivery of communications from the Commission or the National Futures Association. 3.30 Section 3.30 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Registration § 3.30 Current address for purpose of delivery...

  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. Current status and regulatory perspective of chimeric antigen receptor-modified T cell therapeutics.

    PubMed

    Kim, Mi-Gyeong; Kim, Dongyoon; Suh, Soo-Kyung; Park, Zewon; Choi, Min Joung; Oh, Yu-Kyoung

    2016-04-01

    Chimeric antigen receptor-modified T cells (CAR-T) have emerged as a new modality for cancer immunotherapy due to their potent efficacy against terminal cancers. CAR-Ts are reported to exert higher efficacy than monoclonal antibodies and antibody-drug conjugates, and act via mechanisms distinct from T cell receptor-engineered T cells. These cells are constructed by transducing genes encoding fusion proteins of cancer antigen-recognizing single-chain Fv linked to intracellular signaling domains of T cell receptors. CAR-Ts are classified as first-, second- and third-generation, depending on the intracellular signaling domain number of T cell receptors. This review covers the current status of CAR-T research, including basic proof-of-concept investigations at the cell and animal levels. Currently ongoing clinical trials of CAR-T worldwide are additionally discussed. Owing to the lack of existing approved products, several unresolved concerns remain with regard to safety, efficacy and manufacturing of CAR-T, as well as quality control issues. In particular, the cytokine release syndrome is the major side-effect impeding the successful development of CAR-T in clinical trials. Here, we have addressed the challenges and regulatory perspectives of CAR-T therapy. PMID:26895243

  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. 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.

  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. PMID:24218789

  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. 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,…

  13. 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...

  14. 17 CFR 3.30 - Current address for purpose of delivery of communications from the Commission or the National...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... delivery of communications from the Commission or the National Futures Association. 3.30 Section 3.30 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Registration § 3.30 Current address for purpose of delivery of communications from the Commission or the National...

  15. Addressing Prediabetes in Childhood Obesity Treatment Programs: Support from Research and Current Practice

    PubMed Central

    Grow, H. Mollie; Fernandez, Cristina; Lukasiewicz, Gloria J.; Rhodes, Erinn T.; Shaffer, Laura A.; Sweeney, Brooke; Woolford, Susan J.; Estrada, Elizabeth

    2014-01-01

    Abstract Background: Type 2 diabetes mellitus (T2DM) and prediabetes have increased in prevalence among overweight and obese children, with significant implications for long-term health. There is little published evidence on the best approaches to care of prediabetes among overweight youth or the current practices used across pediatric weight management programs. Methods: This article reviews the literature and summarizes current practices for screening, diagnosis, and treatment of prediabetes at childhood obesity treatment centers. Findings regarding current practice were based on responses to an online survey from 28 pediatric weight management programs at 25 children's hospitals in 2012. Based on the literature reviewed, and empiric data, consensus support statements on prediabetes care and T2DM prevention were developed among representatives of these 25 children's hospitals' obesity clinics. Results: The evidence reviewed demonstrates that current T2DM and prediabetes diagnostic parameters are derived from adult-based studies with little understanding of clinical outcomes among youth. Very limited evidence exists on preventing progression of prediabetes. Some evidence suggests that a significant proportion of obese youth with prediabetes will revert to normoglycemia without pharmacological management. Evidence supports lifestyle modification for children with prediabetes, but further study of specific lifestyle changes and pharmacological treatments is needed. Conclusion: Evidence to guide management of prediabetes in children is limited. Current practice patterns of pediatric weight management programs show areas of variability in practice, reflecting the limited evidence base. More research is needed to guide clinical care for overweight youth with prediabetes. PMID:25055134

  16. 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.

  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. Do currently available blood glucose monitors meet regulatory standards? 1-day public meeting in Arlington, Virginia.

    PubMed

    Klonoff, David C; Reyes, Juliet S

    2013-07-01

    Blood glucose monitors (BGMs) are approved by regulatory agencies based on their performance during strict testing conducted by their manufacturers. However, after approval, there is uncertainty whether BGMs maintain the accuracy levels that were achieved in the initial data. The availability of inaccurate BGM systems pose a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles have concluded that BGMs in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. To address this growing concern, Diabetes Technology Society organized and conducted a 1-day public meeting on May 21, 2013, in Arlington, VA, presided by its president, David Klonoff, M.D., FACP, Fellow AIMBE, to determine whether BGMs on the market meet regulatory standards. The meeting consisted of four sessions in which Food and Drug Administration diabetes experts as well as leading academic clinicians and clinical chemists participated: (1) How is BGM performance determined? (2) Do approved BGMs perform according to International Organization for Standardization standards? (3) How do approved BGMs perform when used by patients and health care professionals? (4) What could be the consequence of poor BGM performance? PMID:23911191

  19. Do Currently Available Blood Glucose Monitors Meet Regulatory Standards? 1-Day Public Meeting in Arlington, Virginia

    PubMed Central

    Klonoff, David C.; Reyes, Juliet S.

    2013-01-01

    Blood glucose monitors (BGMs) are approved by regulatory agencies based on their performance during strict testing conducted by their manufacturers. However, after approval, there is uncertainty whether BGMs maintain the accuracy levels that were achieved in the initial data. The availability of inaccurate BGM systems pose a public health problem because their readings serve as a basis for treatment decisions that can be incorrect. Several articles have concluded that BGMs in the marketplace may not consistently provide accurate results in accordance with the regulatory standards that led to approval. To address this growing concern, Diabetes Technology Society organized and conducted a 1-day public meeting on May 21, 2013, in Arlington, VA, presided by its president, David Klonoff, M.D., FACP, Fellow AIMBE, to determine whether BGMs on the market meet regulatory standards. The meeting consisted of four sessions in which Food and Drug Administration diabetes experts as well as leading academic clinicians and clinical chemists participated: (1) How is BGM performance determined? (2) Do approved BGMs perform according to International Organization for Standardization standards? (3) How do approved BGMs perform when used by patients and health care professionals? (4) What could be the consequence of poor BGM performance? PMID:23911191

  20. 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. PMID:26024722

  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. 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...

  3. 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...

  4. 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. PMID:26248374

  5. 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

  6. 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. PMID:21996052

  7. Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies.

    PubMed

    Gauvin, David V; Zimmermann, Zachary J; Baird, Theodore J

    2015-10-01

    Current regulatory policies of both the US Food and Drug Administration and Drug Enforcement Administration do not delineate automatic exceptions for biologics with respect to preclinical assessments for abuse liability of all new entities. As defined in current guidance documents and drug control policies, an exception may be given upon thorough review of available data, therapeutic target and in consultation with the Controlled Substances Staff within the Center for Drug Evaluation and Research of the FDA, but a blanket exception for all biological entities is not currently available. We review the abuse liability testing of four known biologics with definitive positive abuse liability signals in the three core abuse liability assays, self-administration, drug discrimination, and dependence potential described in the FDA draft guidance document. Interestingly, while all four examplars have positive abuse liability signals in all three assays, two of these biologics are controlled under the Comprehensive Drug Abuse and Control Act (CSA, 1970) and the other two are not currently controlled. Admittedly, these four biologics are small molecule entities. However, there is no reference to "molecular size" in the legally-binding statutory definition of biologics under the FD&C act or in the Controlled Substances Act. Neither of these drug control policy mandates have a bifurcated control status in which to make exceptions based solely on molecular size. With the current pharmaceutical focus on new technologies, such as "Trojan Horses", targeting the active transport of large molecule entities directly into the CNS, an argument to automatically exempt new molecular entities solely on molecular size is untenable. We argue that for the safety and health of general public the current regulatory control status be maintained until definitive criteria for exceptions can be identified and amended to both the FD&CA and CSA, if warranted. PMID:26107292

  8. Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals.

    PubMed

    Brownawell, Amy M; Caers, Wim; Gibson, Glenn R; Kendall, Cyril W C; Lewis, Kara D; Ringel, Yehuda; Slavin, Joanne L

    2012-05-01

    First defined in the mid-1990s, prebiotics, which alter the composition and activity of gastrointestinal (GI) microbiota to improve health and well-being, have generated scientific and consumer interest and regulatory debate. The Life Sciences Research Organization, Inc. (LSRO) held a workshop, Prebiotics and the Health Benefits of Fiber: Future Research and Goals, in February 2011 to assess the current state of the science and the international regulatory environment for prebiotics, identify research gaps, and create a strategy for future research. A developing body of evidence supports a role for prebiotics in reducing the risk and severity of GI infection and inflammation, including diarrhea, inflammatory bowel disease, and ulcerative colitis as well as bowel function disorders, including irritable bowel syndrome. Prebiotics also increase the bioavailability and uptake of minerals and data suggest that they reduce the risk of obesity by promoting satiety and weight loss. Additional research is needed to define the relationship between the consumption of different prebiotics and improvement of human health. New information derived from the characterization of the composition and function of different prebiotics as well as the interactions among and between gut microbiota and the human host would improve our understanding of the effects of prebiotics on health and disease and could assist in surmounting regulatory issues related to prebiotic use. PMID:22457389

  9. Addressing the Sexual and Reproductive Health Needs of Young People in Ethiopia: An Analysis of the Current Situation.

    PubMed

    Muntean, Nigina; Kereta, Worknesh; Mitchell, Kirstin R

    2015-09-01

    Young people in Ethiopia face a number of risks to their sexual and reproductive health, including adolescent pregnancy, sexual violence, and unmet need for family planning. This study explores the extent to which current service provision addresses the SRH needs of young Ethiopians . Methods included a comprehensive review of the academic and policy literature on young people's SRH and service provision in Ethiopia; and 14 semi-structured Key Informant Interviews. Factors affecting utilization of sexual and reproductive services by young people include: limited SRH knowledge, lack of open discussion of sexual matters, low status of women, cultural and logistical barriers, competing priorities among community health professionals, limited resources for health facilities, and negative attitudes of providers towards unmarried youth. While the antenatal needs of young married women are somewhat addressed, gaps exist in terms of services for unmarried youth, young men, rural youth and vulnerable groups. The national policy platform has created an enabling environment for addressing youth SRH needs but challenges to implementing these policies still persist. The way forward requires a focus on reducing barriers to utilization of services, and attention to underserved groups. It also requires resource mobilization, strong leadership and effective coordination between stakeholders and donors. PMID:26897917

  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. Characterization of volume-activated chloride currents in regulatory volume decrease of human cholangiocyte.

    PubMed

    Chen, Biyi; Jefferson, Douglas M; Cho, Won Kyoo

    2010-05-01

    Volume-activated chloride channel (VACC) plays vital roles in many physiological functions. In bile duct epithelium, VACC actively participates in biliary secretion and cell volume regulation, and it mediates regulatory volume decrease (RVD). Recently, we have shown that mouse cholangiocytes have an intact RVD via VACC and K(+) conductance. However, such cell volume regulation was not studied in the normal human cholangiocyte. Volume measurement by Coulter counter and whole-cell patch clamp technique were used to characterize the RVD and VACC in human cholangiocyte cell line (HBDC). When exposed to hypotonic solution, HBDC exhibited an intact RVD, which was inhibited by 1,2-Bis(2-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid tetrakis(acetoxymethyl ester) (BAPTA-AM), NPPB (5-nitro-2'- (3-phenylpropylamino)-benzoate), DIDS (4,4'-diisothiocyanatostilbene-2-disulfonic acid), and tamoxifen, but was not affected by the removal of extracellular calcium. During RVD, HBDC exhibited large, outwardly rectifying currents and time-dependent inactivation at positive potential. The amplitude of the outward current was approximately 3 times of that of the inward current, and this volume-activated current returned to the baseline when switched to isotonic solution. The amplitude and reversal potential of the volume-activated current was dependent on Cl(-) concentration, and the VACC was significantly inhibited by replacing chloride with gluconate, glutamate, sucrose, and acetate in the hypotonic solution. In addition, classical VACC inhibitors, such as NPPB or tamoxifen, inhibited the VACC. These inhibitory effects were reversible with washing out the inhibitors from the bath solution. The present study is the first to characterize and show that HBDC has an intact RVD, mediated by VACC, which has similar electrophysiological characteristics as that in mouse cholangiocytes. PMID:20411247

  12. 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. PMID:23453314

  13. Clinical pharmacokinetics: current requirements and future perspectives from a regulatory point of view.

    PubMed

    Shah, R R

    1993-11-01

    1. There is an increasing appreciation of the relevance of pharmacokinetics of drugs during evaluation of their safety for human clinical use. Regulatory requirements for clinical pharmacokinetic data have progressively evolved to emphasize and address these safety implications. 2. Historically the dose schedules usually recommended have been too high, often with serious consequences. Therefore, the need to establish reliable dose response (both therapeutic and toxic) relationships must be an important objective. 3. Concurrent developments in our understanding of the pharmacological effects (therapeutic or toxic) of metabolites, the interethnic and interindividual differences in drug responses and the toxicological aspects of drug chirality now provide compelling reasons for the roles of bioactivation, pharmacogenetics and stereochemical factors to be addressed in pharmacokinetic studies during the clinical development of drugs. 4. Apart from the traditional pharmacokinetic studies following single and multiple doses in healthy volunteers, patients and special subgroups, reliable dose-response curves for therapeutic and toxic effects must be established in well-designed controlled studies using a wide range of doses. Often, doses lower than those recommended have a much improved risk/benefit ratio. 5. Secondary pharmacology of the drug and its active metabolites must be defined for assessment of safety (adverse reactions and pharmacokinetic and pharmacodynamic drug-drug interactions) in high dose/concentration situations. 6. The enzyme systems responsible for the metabolism of a drug must be identified followed by rational investigations of drug-drug and drug-disease interactions both from the efficacy and safety viewpoints. Factors responsible for alterations in the functional expression of this enzyme system must be identified and the safety and efficacy implications of these findings at interethnic, inter- and intraindividual levels must be fully explored during

  14. 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

  15. 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)

  16. 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.

  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. 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

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

    PubMed

    Heinemann, Lutz; Khatami, Hootan; McKinnon, Ross; Home, Philip

    2015-07-01

    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. 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

  3. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework

    PubMed Central

    Manolis, Efthymios; Pons, Gérard

    2009-01-01

    The new paediatric European Union (EU) regulation and the consequent demand for paediatric studies on one hand and the ethical need for minimizing the burden of studies in children on the other hand necessitate optimal techniques in the assessment of safety/efficacy and use of drugs in children. Modelling and simulation (M&S) is one way to circumvent some difficulties in developing medicinal products in children. M&S allows the quantitative use of sparse sampling, characterization and prediction of pharmacokinetics/ pharmacodynamics (PK/PD), extrapolation from adults to children, interpolation between paediatric age subsets, optimal use of scientific literature and in vitro/preclinical data. Together, industry, academia and regulators recognize the usefulness of modelling and simulation in this setting. However, even if M&S is an emerging science, its integration in the EU regulatory decision making is for the time being deficient and M&S expertise is concentrated in big pharmaceutical companies and academic institutions. The European Medicines Agency, acknowledging all the above conditions, organized and hosted a Workshop on Modelling in Paediatric Medicines. The article presents the personal views of the authors on the issues presented and discussed in the workshop. We attempt to identify the regulatory framework for the use of M&S in paediatric medicinal development and to make proposals for model-based paediatric medicinal development. The objective is to open the discussion between industry, academia, paediatricians and regulators on the optimal use of M&S in paediatric medicinal development. PMID:19843052

  4. 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).

  5. Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States.

    PubMed

    Wu, Kuei-Meng; Ghantous, Hanan; Birnkrant, Debra B

    2008-08-01

    Toxicological studies constitute an essential part of the effort in developing an herbal medicine into a drug product. The US food and drug administration (FDA) published a guidance to assist academic and industry sponsors in the development of this unique group of drug products, and has recently approved an new drug application (NDA) based on green tea extract (Veregen) for topical treatment of genital and perianal warts. In this article, current regulatory views on issues related to requirements and recommendations on various types of nonclinical toxicity studies in support of clinical trials and filing an NDA for a herbal medicine, including pharm/tox aspects of green tea extract (Veregen) NDA, are discussed. Topics include nonclinical pharmacology/toxicology perspectives on herbal nomenclature and its identification, previous human experience and initial clinical trial proposal, regulatory aspects of acute toxicity studies, chronic toxicity studies, mutagenicity studies, reproductive toxicity studies, and carcinogenicity studies on botanicals. Certain regulatory review-related issues are also presented. It is anticipated that through a proactive two-way communication between the Agency and the sponsor, toxicological development of botanical drug product can be significantly facilitated. PMID:18614266

  6. 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

  7. Current status of IL-10 and regulatory T-cells in cancer

    PubMed Central

    Dennis, Kristen L.; Blatner, Nichole R.; Gounari, Fotini; Khazaie, Khashayarsha

    2014-01-01

    Purpose of review Tumor growth elicits antigen-specific cytotoxic as well as immune suppressive responses. Interleukin-10 (IL-10) is a key immune-suppressive cytokine produced by regulatory T-cells (Tregs) and by helper T-cells (TH). Here we review pleiotropic functions of IL-10 that impact the immune pathology of cancer. Recent findings The role of IL-10 in cancer has become less certain with knowledge of its immune stimulatory functions. IL-10 is needed for T-helper cell functions, T-cell immune surveillance, and suppression of cancer-associated inflammation. By promoting tumor specific immune surveillance and hindering pathogenic inflammation IL-10 is emerging as a key cytokine in the battle of the host against cancer. Summary IL-10 functions at the cross roads of immune stimulation and immune suppression in cancer. Immunological mechanisms of action of IL-10 can be ultimately exploited to develop novel and effective cancer therapies. PMID:24076584

  8. 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.

  9. 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

  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

    2008-05-16

    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

  11. 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

  12. 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. PMID:21771557

  13. 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

  14. International regulatory requirements for Leptospira vaccine potency testing. Roundtable: current requirements and opportunity for harmonization.

    PubMed

    Draayer, Hans A; Bruckner, Lukas; Peña-Moctezuma, Alejandro de la; Srinivas, Geetha

    2013-09-01

    Progress continues to be made in the ongoing efforts to replace, reduce, or refine the use of laboratory animals for Leptospira vaccine potency testing in certain markets/regions. Leptospira-containing vaccines, as with many veterinary vaccines, are manufactured and distributed both on a regional basis by local manufacturers and internationally by large multinational firms. Three general scenarios exist for the international testing and distribution of veterinary vaccines including: 1) the importing country recognizes the country of origin's testing and batch release data with no additional testing; 2) the importing country requires the manufacturer to conduct a specific potency assay based on the current importing market's regulations for the importing country or 3) the importing country requires retesting of the product in country prior to distribution. Scenarios 2 and 3 both have the potential to significantly increase the usage of laboratory animals for what may be considered redundant testing. Specific requirements for the importation of Leptospira vaccines in the United States, Europe, and Mexico were presented as well as efforts to reduce the use of laboratory animal testing through the availability of internationally recognized tests. PMID:23890730

  15. Opening addresses.

    PubMed

    Chukudebelu, W O; Lucas, A O; Ransome-kuti, O; Akinla, O; Obayi, G U

    1988-01-01

    The theme of the 3rd International Conference of the Society of Gynecology and Obstetrics of Nigeria (SOGON) held October 26, 1986 in Enugu was maternal morbidity and mortality in Africa. The opening addresses emphasize the high maternal mortality rate in Africa and SOGON's dedication to promoting women's health and welfare. In order to reduce maternal mortality, the scope of this problem must be made evident by gathering accurate mortality rates through maternity care monitoring and auditing. Governments, health professionals, educators, behavioral scientists, and communication specialists have a responsibility to improve maternal health services in this country. By making the population aware of this problem through education, measures can be taken to reduce the presently high maternal mortality rates. Nigerian women are physically unprepared for childbirth; therefore, balanced diets and disease prevention should be promoted. Since about 40% of deliveries are unmanaged, training for traditional birth attendants should be provided. Furthermore, family planning programs should discourage teenage pregnancies, encourage birth spacing and small families, and promote the use of family planning techniques among men. The problem of child bearing and rearing accompanied by hard work should also be investigated. For practices to change so that maternal mortality rates can be reduced, attitudes must be changed such that the current rates are viewed as unacceptable. PMID:12179275

  16. 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.

  17. 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

  18. Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin

    PubMed Central

    Wildi, Karin; Gimenez, Maria Rubini; Twerenbold, Raphael; Reichlin, Tobias; Jaeger, Cedric; Heinzelmann, Amely; Arnold, Christiane; Nelles, Berit; Druey, Sophie; Haaf, Philip; Hillinger, Petra; Schaerli, Nicolas; Kreutzinger, Philipp; Tanglay, Yunus; Herrmann, Thomas; Moreno Weidmann, Zoraida; Krivoshei, Lian; Freese, Michael; Stelzig, Claudia; Puelacher, Christian; Rentsch, Katharina; Osswald, Stefan

    2015-01-01

    Background— Misdiagnosis of acute myocardial infarction (AMI) may significantly harm patients and may result from inappropriate clinical decision values (CDVs) for cardiac troponin (cTn) owing to limitations in the current regulatory process. Methods and Results— In an international, prospective, multicenter study, we quantified the incidence of inconsistencies in the diagnosis of AMI using fully characterized and clinically available high-sensitivity (hs) cTn assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not biologically equivalent and might therefore contribute to inconsistencies in the diagnosis of AMI. Findings were validated by use of sex-specific CDVs and parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent diagnoses when the approved uniform CDV was used. When sex-specific CDVs were used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses. Using biologically equivalent CDV reduced inconsistencies to 10% (P<0.001). These findings were confirmed with parallel measurements of other hs-cTn assays. The incidence of inconsistencies was only 7.0% for assays with CDVs that were nearly biologically equivalent. Patients with inconsistent AMI had long-term mortality comparable to that of patients with consistent diagnoses (P=NS) and a trend toward higher long-term mortality than patients diagnosed with unstable angina (P=0.05). Conclusions— Currently approved CDVs are not biologically equivalent and contribute to major inconsistencies in the diagnosis of AMI. One of 5 AMI patients will receive a diagnosis other than AMI if managed with the alternative hs-cTn assay. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00470587. PMID:25948541

  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. 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

  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. 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

  3. 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

  4. Presidential address.

    PubMed

    Vohra, U

    1993-07-01

    The Secretary of India's Ministry of Health and Family Welfare serves as Chair of the Executive Council of the International Institute for Population Sciences in Bombay. She addressed its 35th convocation in 1993. Global population stands at 5.43 billion and increases by about 90 million people each year. 84 million of these new people are born in developing countries. India contributes 17 million new people annually. The annual population growth rate in India is about 2%. Its population size will probably surpass 1 billion by the 2000. High population growth rates are a leading obstacle to socioeconomic development in developing countries. Governments of many developing countries recognize this problem and have expanded their family planning programs to stabilize population growth. Asian countries that have done so and have completed the fertility transition include China, Japan, Singapore, South Korea, and Thailand. Burma, Malaysia, North Korea, Sri Lanka, and Vietnam have not yet completed the transition. Afghanistan, Bangladesh, Iran, Nepal, and Pakistan are half-way through the transition. High population growth rates put pressure on land by fragmenting finite land resources, increasing the number of landless laborers and unemployment, and by causing considerable rural-urban migration. All these factors bring about social stress and burden civic services. India has reduced its total fertility rate from 5.2 to 3.9 between 1971 and 1991. Some Indian states have already achieved replacement fertility. Considerable disparity in socioeconomic development exists among states and districts. For example, the states of Bihar, Madhya Pradesh, Rajasthan, and Uttar Pradesh have female literacy rates lower than 27%, while that for Kerala is 87%. Overall, infant mortality has fallen from 110 to 80 between 1981 and 1990. In Uttar Pradesh, it has fallen from 150 to 98, while it is at 17 in Kerala. India needs innovative approaches to increase contraceptive prevalence rates

  5. Convocation address.

    PubMed

    Alexander, P C

    1994-07-01

    Total world population is growing at the annual rate of 2%. While this rate of growth represents a decline from the annual growth rate of 2.5% during the early 1960s, world population still continues to grow rapidly in absolute terms as a result of the already enormous population base. Experts predict world population to grow to 12-14 billion before it stabilizes. Most of this growth will be due to high fertility amid declining mortality in developing countries; 80% of world population by the year 2000 will be in developing countries. India, for example, had a population of 358 million people in 1950. That population, however, should grow to more than one billion by the year 2000. The author, governor of Maharashtra, congratulates all who have successfully completed courses at the International Institute for Population Sciences during the year and voices his expectation that graduates will use their newfound knowledge and expertise in research and teaching as well as in developing meaningful and effective population policies in their respective countries. He also describes some of India's current population-related problems and future prospects. India has thus far kept its rate of food production above the rate of population growth. Even so, the average caloric intake in India needs to be increased by at least 50% in order for the population to maintain adequate health standards. The current scarcity of additional arable land, the need to halt further deforestation, and the ongoing absolute growth in population, however, suggest that India will be unable to raise the level of caloric intake for its people. India may even become dependent upon other countries to provide food for its population. PMID:12346131

  6. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2004-09-01

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

  8. 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)

  9. 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. PMID:26260323

  10. 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...

  11. 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. PMID:25796433

  12. 75 FR 41241 - Draft Regulatory Guide; Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-15

    ... COMMISSION Draft Regulatory Guide; Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Issuance, availability of Draft Regulatory Guide (DG)-1234. ADDRESSES: You may submit comments by any one... and licenses. The draft regulatory guide, entitled, ``Water Sources for Long-Term...

  13. 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.

  14. 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

  15. 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.

  16. 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...

  17. 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...

  18. Legislative and regulatory modernization for therapeutic products.

    PubMed

    Maher, Maurica

    2010-01-01

    This presentation is intended to show how the work coming from scientists, physicians, and other healthcare professionals is incorporated into the regulatory assessment of therapeutic products in Canada. One of the primary objectives within the regulatory environment is to provide information back to healthcare professionals and patients in order to help them make informed decisions. The current regulatory system for health products in Canada and why it needs modernization is addressed; a "lifecycle approach" to the regulation of health products is presented; the Food and Consumer Safety Action Plan and Bill C-51, a bill to amend the Food and Drugs Act is reviewed; and the challenges and opportunities for Canada and its fellow regulators are examined. PMID:21041867

  19. 78 FR 1636 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ...This Regulatory Agenda is a semiannual summary of all current and projected rulemakings, existing regulations, and completed actions of the Small Business Administration (SBA). For this fall edition of the SBA's Regulatory Agenda, a Regulatory Plan that contains a list of the Agency's most important and significant regulatory actions and a Statement of Regulatory Priorities is also included.......

  20. Awards and Addresses Summary

    PubMed Central

    2008-01-01

    Each year at the annual ASHG meeting, addresses are given in honor of the society and a number of award winners. A summary of each of these addresses is given below. On the next pages, we have printed the Presidential Address and the addresses for the William Allan Award. The other addresses, accompanied by pictures of the speakers, can be found at www.ashg.org.

  1. An address geocoding solution for Chinese cities

    NASA Astrophysics Data System (ADS)

    Zhang, Xuehu; Ma, Haoming; Li, Qi

    2006-10-01

    We introduce the challenges of address geocoding for Chinese cities and present a potential solution along with a prototype system that deal with these challenges by combining and extending current geocoding solutions developed for United States and Japan. The proposed solution starts by separating city addresses into "standard" addresses which meet a predefined address model and non-standard ones. The standard addresses are stored in a structured relational database in their normalized forms, while a selected portion of the non-standard addresses are stored as aliases to the standard addresses. An in-memory address index is then constructed from the address database and serves as the basis for real-time address matching. Test results were obtained from two trials conducted in the city Beijing. On average 80% matching rate were achieved. Possible improvements to the current design are also discussed.

  2. 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

  3. 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.

  4. Magnetic content addressable memories

    NASA Astrophysics Data System (ADS)

    Jiang, Zhenye

    Content Addressable Memories are designed with comparison circuits built into every bit cell. This parallel structure can increase the speed of searching from O(n) (as with Random Access Memories) to O(1), where n is the number of entries being searched. The high cost in hardware limits the application of CAM within situations where higher searching speed is extremely desired. Spintronics technology can build non-volatile Magnetic RAM with only one device for one bit cell. There are various technologies involved, like Magnetic Tunnel Junctions, off-easy-axis programming method, Synthetic Anti-Ferromagnetic tri-layers, Domain Wall displacement, Spin Transfer Torque tri-layers and etc. With them, particularly the Tunnel Magneto-Resistance variation in MTJ due to difference in magnetization polarity of the two magnets, Magnetic CAM can be developed with reduced hardware cost. And this is demonstrated by the discussion in this dissertation. Six MCAM designs are discussed. In the first design, comparand (C), local information (S) and their complements are stored into 4 MTJs connected in XOR gate pattern. The other five designs have one or two stacks for both information storage and comparison, and full TMR ratio can be taken advantage of. Two challenges for the five are specifically programming C without changing S and selectively programming a cell out of an array. The solutions to specific programming are: by confining the programming field for C in a ring structure design; by using field programming and spin polarized current programming respectively for C and S in the SAF+DW and SAF+STT tri-layer design; by making use of the difference in thresholds between direct mode and toggle mode switching in the SAF+SAF design. The problem of selective programming is addressed by off-easy-axis method and by including SAF tri-layers. Cell with STT tri-layers for both C and S can completely avoid the problems of specific and selective programming, but subject to the limit of

  5. Regulatory reform proposals and the public health.

    PubMed Central

    Buffler, P A; Kyle, A D

    1996-01-01

    The U.S. Congress is considering legislation that would change policy for environmental health in important ways. Current approaches have been criticized for addressing the wrong set of priorities and consuming too many resources. The legislation requires additional analyses and sets new decision criteria to be applied to federal agency actions taken to protect the environment and public health. Close review of the legislation suggests that though it is intended to address identified problems, it is unlikely to lead to an improved basis for public policy and is likely to paralyze the regulatory process. Reform proposals that reduce rather than increase fragmentation of decision-making and that address problems comprehensively rather than selectively are needed. PMID:8732938

  6. 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.

  7. Canadian drug regulatory framework.

    PubMed

    Kelly, L; Lazzaro, M; Petersen, C

    2007-03-01

    The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues. PMID:17469674

  8. 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 ...

  9. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.

    PubMed

    Hochhaus, Guenther; Davis-Cutting, Craig; Oliver, Martin; Lee, Sau L; Lyapustina, Svetlana

    2015-09-01

    This article summarizes discussions at the March 2014 conference organized by the University of Florida (UF) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), entitled "Orlando Inhalation Conference: Approaches in International Regulation." The special focus of the conference was on global scientific and regulatory issues associated with the testing and demonstration of equivalence for the registration of orally inhaled drug products (OIDPs) in the United States, Europe, Brazil, China, and India. The scope included all types of OIDPs throughout their lifecycle, e.g., innovator/brand-name products, generics, modifications due to lifecycle management, device changes, etc. Details were presented for the U.S. "weight of evidence approach" for registration of generic products (which includes demonstration of in vitro and in vivo equivalence, as well as quantitative and qualitative sameness, and device similarity). The European "stepwise" approach was elucidated, and the thinking of regulatory agencies in the major emerging markets was clarified. The conference also highlighted a number of areas that would benefit from further research and discussion, especially around patient/device interface and human factor studies, statistical methods and criteria for demonstrating equivalence, the relative roles of in vivo and in vitro tests, and appropriate designs and metrics for in vivo studies of inhaled drugs. PMID:26033698

  10. 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.)

  11. 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.

  12. REGULATORY AIR QUALITY MODELS

    EPA Science Inventory

    Appendix W to 40CFR Part 51 (Guideline on Air Quality Models) specifies the models to be used for purposes of permitting, PSD, and SIPs. Through a formal regulatory process this modeling guidance is periodically updated to reflect current science. In the most recent action, thr...

  13. 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.

  14. 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…

  15. States Address Achievement Gaps.

    ERIC Educational Resources Information Center

    Christie, Kathy

    2002-01-01

    Summarizes 2 state initiatives to address the achievement gap: North Carolina's report by the Advisory Commission on Raising Achievement and Closing Gaps, containing an 11-point strategy, and Kentucky's legislation putting in place 10 specific processes. The North Carolina report is available at www.dpi.state.nc.us.closingthegap; Kentucky's…

  16. Address of the President

    ERIC Educational Resources Information Center

    Ness, Frederic W.

    1976-01-01

    The president of the Association of American Colleges addresses at the 62nd annual meeting the theme of the conference: "Looking to the Future--Liberal Education in a Radically Changing Society." Contributions to be made by AAC are examined. (LBH)

  17. 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…

  18. Space sciences - Keynote address

    NASA Technical Reports Server (NTRS)

    Alexander, Joseph K.

    1990-01-01

    The present status and projected future developments of the NASA Space Science and Applications Program are addressed. Emphasis is given to biochemistry experiments that are planned for the Space Station. Projects for the late 1990s which will study the sun, the earth's magnetosphere, and the geosphere are briefly discussed.

  19. Adequacy of human reliability data for addressing risk reduction issues at commercial nuclear power plants

    SciTech Connect

    Ryan, T.G.; O'Brien, J.N.; Spettell, C.M.

    1985-01-01

    This paper describes the results of an assessment of how well currently available Probabilistic Risk Assessment (PRA) data address a representative set of human risk issues of current concern to the US Nuclear Regulatory Commission (NRC). A three-step process was used to make that assessment. First, all Human Reliability Analysis (HRA) data included in 19 PRAs were identified, collected, and stored on a computer. Second, a list of human risk ''working level issues'' of concern to NRC was compiled. Finally, the HRA/PRA data which were collected from 19 PRAs were compared to the data needs to assess the extent to which currently available PRA data are useful in addressing human risk issues of concern to NRC. Less than 1% of the data needs were determined to be addressed by currently available PRA data. Findings indicate that PRA data could be far more useful in addressing human risk issues with modification of the development process and documentation structure of PRAs. In addition, information from non-PRA sources could be integrated with PRA data to address many other issues. 7 refs., 13 tabs.

  20. 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. PMID:25237840

  1. 21 CFR 1321.01 - DEA mailing addresses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 9 2013-04-01 2013-04-01 false DEA mailing addresses. 1321.01 Section 1321.01 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE DEA MAILING ADDRESSES § 1321.01... substances certification request. DEA Regulatory Section 1301.71(d)—Security system compliance review...

  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, 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...

  4. 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...

  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, 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...

  7. 48 CFR 401.170 - Electronic access to regulatory information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... regulatory information. 401.170 Section 401.170 Federal Acquisition Regulations System DEPARTMENT OF... access to regulatory information. The USDA Departmental Administration Procurement Homepage provides... guidance in electronic form. The Internet address for the Procurement Homepage is URL...

  8. Excerpts from keynote address

    SciTech Connect

    Creel, G.C.

    1995-06-01

    Excerpts from the keynote principally address emissions issues in the fossil power industry as related to heat rate improvements. Stack emissions of both sulfur and nitrogen oxides are discussed, and a number of examples are given: (1) PEPCO`s Potomac River Station, and (2) Morgantown station`s NOX reduction efforts. Circulating water emissions are also briefly discussed, as are O & M costs of emission controls.

  9. 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.

  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. 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.

  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. 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

  14. 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... analysis is required, and the status of regulations previously reported. ADDRESSES: Acting Assistant... the new accessibility standards. Other amendments include updates to organizational information,...

  15. 78 FR 1634 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Date FR Cite NPRM 02/00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W... analysis is required, and the status of regulations previously reported. ADDRESSES: Director, for Internal... accessibility standards. Other amendments include updates to organizational information, use of the...

  16. 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.

  17. 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

  18. Addressing Consumer Questions.

    Technology Transfer Automated Retrieval System (TEKTRAN)

    It seems people either have very strong thoughts and opinions on food or they could care less as long as food is available to feed them and their families. With the current economy, many individuals are examining food choices more closely to ensure the greatest nutrition for their families at the l...

  19. 78 FR 1624 - Fall 2012 Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ..., ``Regulatory Planning and Review'' (58 FR 51735, Oct. 4, 1993), as supplemented by Executive Order (EO) 13563, ``Improving Regulation and Regulatory Review'' (76 FR 3821, Jan. 21, 2011); 12898, ``Federal Actions to Address Environmental Justice in Minority Populations and Low-income Populations'' (59 FR 7629, Feb....

  20. 75 FR 79929 - 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 75 FR 70044 - Withdrawal of Regulatory Guide 1.39

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory... of RG 1.28 and RG 1.33 adequately address the related Quality Assurance Program with the latest ANSI... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING CODE 7590-01-P...

  9. Uterus transplantation: ethical and regulatory challenges.

    PubMed

    Arora, Kavita Shah; Blake, Valarie

    2014-06-01

    Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved--the patient, the donor and the potential child--as well as discuss the regulatory implications as research on uterus transplantations moves forward. PMID:23760727

  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. 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.

  13. 2014 ASHG Awards and Addresses

    PubMed Central

    2015-01-01

    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 addresses 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.

  14. 2013 ASHG Awards and Addresses

    PubMed Central

    2014-01-01

    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 addresses 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.

  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. Addressing Gender Differences in Young Adolescents.

    ERIC Educational Resources Information Center

    Butler, Deborah A.; Manning, M. Lee

    The current interest in identifying gender differences in young adolescents suggests a need to focus on how gender differences affect teaching and learning situations and on how middle level school educators can address these differences. This book explains what gender differences are, how gender differences affect learning, how both girls and…

  17. 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

  18. 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

  19. 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). PMID:26230287

  20. 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

  1. 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

  2. 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

  3. 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…

  4. 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…

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

    PubMed

    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

  6. 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. PMID:11922095

  7. 78 FR 44331 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ...This Regulatory Agenda is a semiannual summary of all current and projected rulemakings and completed actions of the Small Business Administration (SBA). SBA expects that this summary information will enable the public to be more aware of, and effectively participate in, SBA's regulatory activity. SBA invites the public to submit comments on any aspect of this...

  8. 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 ...

  9. Computational architecture of the yeast regulatory network

    NASA Astrophysics Data System (ADS)

    Maslov, Sergei; Sneppen, Kim

    2005-12-01

    The topology of regulatory networks contains clues to their overall design principles and evolutionary history. We find that while in- and out-degrees of a given protein in the regulatory network are not correlated with each other, there exists a strong negative correlation between the out-degree of a regulatory protein and in-degrees of its targets. Such correlation positions large regulatory modules on the periphery of the network and makes them rather well separated from each other. We also address the question of relative importance of different classes of proteins quantified by the lethality of null-mutants lacking one of them as well as by the level of their evolutionary conservation. It was found that in the yeast regulatory network highly connected proteins are in fact less important than their low-connected counterparts.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. The Regulatory Status of Genome-edited Crops.

    PubMed

    Wolt, Jeffrey D; Wang, Kan; Yang, Bing

    2016-02-01

    Genome editing with engineered nucleases (GEEN) represents a highly specific and efficient tool for crop improvement with the potential to rapidly generate useful novel phenotypes/traits. Genome editing techniques initiate specifically targeted double strand breaks facilitating DNA-repair pathways that lead to base additions or deletions by non-homologous end joining as well as targeted gene replacements or transgene insertions involving homology-directed repair mechanisms. Many of these techniques and the ancillary processes they employ generate phenotypic variation that is indistinguishable from that obtained through natural means or conventional mutagenesis; and therefore, they do not readily fit current definitions of genetically engineered or genetically modified used within most regulatory regimes. Addressing ambiguities regarding the regulatory status of genome editing techniques is critical to their application for development of economically useful crop traits. Continued regulatory focus on the process used, rather than the nature of the novel phenotype developed, results in confusion on the part of regulators, product developers, and the public alike and creates uncertainty as of the use of genome engineering tools for crop improvement. PMID:26251102

  16. 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. PMID:21537142

  17. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Regulatory Review Presidential Documents Other Presidential Documents Memorandum of January 30, 2009 Regulatory Review Memorandum for the Heads of Executive Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at the Office of Management...

  18. Regulatory affairs administration as regulatory policy determinant

    SciTech Connect

    Forcier, J.R.

    1984-05-10

    It is the thesis of this article that the processing of a utility company's regulation-related work, the supporting tasks and the manner in which they are completed, can and does have a significant impact on the final results or work product of the regulatory affairs function, including even, potentially, the action of the regulatory agency. The article is therefore full of practical pointers on how the interface with the regulatory authority can best be organized, managed, and carried through to the attainment of optimum results for the utility. 2 references.

  19. 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...

  20. 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...

  1. 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...

  2. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  3. 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...

  4. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  5. 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…

  6. Communities Address Barriers to Connectivity.

    ERIC Educational Resources Information Center

    Byers, Anne

    1996-01-01

    Rural areas lag behind urban areas in access to information technologies. Public institutions play a critical role in extending the benefits of information technologies to those who would not otherwise have access. The most successful rural telecommunications plans address barriers to use, such as unawareness of the benefits, technophobia, the…

  7. Keynote Address: Rev. Mark Massa

    ERIC Educational Resources Information Center

    Massa, Mark S.

    2011-01-01

    Rev. Mark S. Massa, S.J., is the dean and professor of Church history at the School of Theology and Ministry at Boston College. He was invited to give a keynote to begin the third Catholic Higher Education Collaborative Conference (CHEC), cosponsored by Boston College and Fordham University. Fr. Massa's address posed critical questions about…

  8. State of the Lab Address

    ScienceCinema

    King, Alex

    2013-03-01

    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.

  9. 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.

  10. The role and activities of the ISCT Regulatory Affairs Committee.

    PubMed

    Kelley, L

    2003-01-01

    The following article is written as part of a series of reviews addressing regulatory issues relevant to the field of cellular therapy. The first in the series describes the activities and mission of the Legal and Regulatory Affairs Committee of ISCT. PMID:12944232

  11. 14 CFR 61.60 - Change of address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Change of address. 61.60 Section 61.60 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN... office box number, then the holder's current residential address....

  12. Pronouns of Address in Western Ukrainian: Between Tradition and Modernity

    ERIC Educational Resources Information Center

    Weissenbock, Maria

    2006-01-01

    This article examines the current usage of terms of address in the Western Ukrainian variety of the Ukrainian language. It investigates the use of pronominal ("ty"--intimate form; ["Vy"--polite, distant form) and nominal forms of address (such as first name, father's name, surname, title, "pan/pani" (Mr/Mrs), "tovarys" (Comrade) etc.) in Western…

  13. Implications of Globalization for Training in Counseling Psychology: Presidential Address

    ERIC Educational Resources Information Center

    Nutt, Roberta L.

    2007-01-01

    This article presents the presidential address delivered by Roberta L. Nutt during the 114th annual meeting of the American Psychological Association last August 12, 2006. In her address, Nutt talks about that despite of the contributions of the many counseling psychologists who have advanced the current knowledge and training in the field of…

  14. 27 CFR 478.52 - Change of address.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Change of address. 478.52....52 Change of address. (a) Licensees may during the term of their current license remove their... for denial in accordance with § 478.71. (Approved by the Office of Management and Budget under...

  15. 27 CFR 478.52 - Change of address.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Change of address. 478.52....52 Change of address. (a) Licensees may during the term of their current license remove their... for denial in accordance with § 478.71. (Approved by the Office of Management and Budget under...

  16. 27 CFR 478.52 - Change of address.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Change of address. 478.52....52 Change of address. (a) Licensees may during the term of their current license remove their... for denial in accordance with § 478.71. (Approved by the Office of Management and Budget under...

  17. Building technology services that address student needs.

    PubMed

    Le Ber, Jeanne M; Lombardo, Nancy T; Wimmer, Erin

    2015-01-01

    A 16-question technology use survey was conducted to assess incoming health sciences students' knowledge of and interest in current technologies, and to identify student device and tool preferences. Survey questions were developed by colleagues at a peer institution and then edited to match this library's student population. Two years of student responses have been compiled, compared, and reviewed as a means for informing library decisions related to technology and resource purchases. Instruction and event programming have been revised to meet student preferences. Based on the number of students using Apple products, librarians are addressing the need to become more proficient with this platform. PMID:25611437

  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. 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)

  20. 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.

  1. 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.

  2. 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

  3. Identifying and addressing vaccine hesitancy.

    PubMed

    Kestenbaum, Lori A; Feemster, Kristen A

    2015-04-01

    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

  4. New treatments addressing the pathophysiology of hereditary angioedema

    PubMed Central

    Davis, Alvin E

    2008-01-01

    Hereditary angioedema is a serious medical condition caused by a deficiency of C1-inhibitor. The condition is the result of a defect in the gene controlling the synthesis of C1-inhibitor, which regulates the activity of a number of plasma cascade systems. Although the prevalence of hereditary angioedema is low – between 1:10,000 to 1:50,000 – the condition can result in considerable pain, debilitation, reduced quality of life, and even death in those afflicted. Hereditary angioedema presents clinically as cutaneous swelling of the extremities, face, genitals, and trunk, or painful swelling of the gastrointestinal mucosa. Angioedema of the upper airways is extremely serious and has resulted in death by asphyxiation. Subnormal levels of C1-inhibitor are associated with the inappropriate activation of a number of pathways – including, in particular, the complement and contact systems, and to some extent, the fibrinolysis and coagulation systems. Current findings indicate bradykinin, a product of contact system activation, as the primary mediator of angioedema in patients with C1-inhibitor deficiency. However, other systems may play a role in bradykinin's rapid and excessive generation by depleting available levels of C1-inhibitor. There are currently no effective therapies in the United States to treat acute attacks of hereditary angioedema, and currently available agents used to treat hereditary angioedema prophylactically are suboptimal. Five new agents are, however, in Phase III development. Three of these agents replace C1-inhibitor, directly addressing the underlying cause of hereditary angioedema and re-establishing regulatory control of all pathways and proteases involved in its pathogenesis. These agents include a nano-filtered C1-inhibitor replacement therapy, a pasteurized C1-inhibitor, and a recombinant C1-inhibitor isolated from the milk of transgenic rabbits. All C1-inhibitors are being investigated for acute angioedema attacks; the nano-filtered C1

  5. New treatments addressing the pathophysiology of hereditary angioedema.

    PubMed

    Davis, Alvin E

    2008-01-01

    Hereditary angioedema is a serious medical condition caused by a deficiency of C1-inhibitor. The condition is the result of a defect in the gene controlling the synthesis of C1-inhibitor, which regulates the activity of a number of plasma cascade systems. Although the prevalence of hereditary angioedema is low - between 1:10,000 to 1:50,000 - the condition can result in considerable pain, debilitation, reduced quality of life, and even death in those afflicted. Hereditary angioedema presents clinically as cutaneous swelling of the extremities, face, genitals, and trunk, or painful swelling of the gastrointestinal mucosa. Angioedema of the upper airways is extremely serious and has resulted in death by asphyxiation.Subnormal levels of C1-inhibitor are associated with the inappropriate activation of a number of pathways - including, in particular, the complement and contact systems, and to some extent, the fibrinolysis and coagulation systems.Current findings indicate bradykinin, a product of contact system activation, as the primary mediator of angioedema in patients with C1-inhibitor deficiency. However, other systems may play a role in bradykinin's rapid and excessive generation by depleting available levels of C1-inhibitor.There are currently no effective therapies in the United States to treat acute attacks of hereditary angioedema, and currently available agents used to treat hereditary angioedema prophylactically are suboptimal. Five new agents are, however, in Phase III development. Three of these agents replace C1-inhibitor, directly addressing the underlying cause of hereditary angioedema and re-establishing regulatory control of all pathways and proteases involved in its pathogenesis. These agents include a nano-filtered C1-inhibitor replacement therapy, a pasteurized C1-inhibitor, and a recombinant C1-inhibitor isolated from the milk of transgenic rabbits. All C1-inhibitors are being investigated for acute angioedema attacks; the nano-filtered C1

  6. 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.

  7. 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.

  8. 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.

  9. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false United States Nuclear Regulatory Commission Regional Offices D Appendix D to Part 20 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices Address Telephone (24 hour) E-Mail...

  10. 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.

  11. 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. PMID:27088919

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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…

  17. Addressing Consumer Questions and Concerns

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Food can be a touchy subject. It seems people either have very strong thoughts and opinions on food or they could care less as long as food is available to feed them and their families. With the current economic environment, many individuals are examining the food choices more closely to ensure t...

  18. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ...) 2010, less the amounts appropriated from the Nuclear Waste Fund, amounts appropriated for Waste... 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...

  19. NRC regulatory agenda

    SciTech Connect

    Not Available

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  20. NRC regulatory agenda

    SciTech Connect

    Not Available

    1992-05-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  1. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  2. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  3. NRC regulatory agenda

    SciTech Connect

    Not Available

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  4. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-07-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  5. Plant Regulatory Organizations

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The chapter on Plant Regulatory Organizations is part of a book titled Pest Management and Phytosanitary Trade Barriers authored by Neil Heather (Australia) and Guy Hallman. It covers the role of plant regulatory organizations from the international to state level in protecting plant health. At on...

  6. 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

  7. 78 FR 69728 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... on April 27, 2012. FINRA received 71 comment letters in response to the Regulatory Notice. A list of... listed in Exhibit 2b. Ten of the 71 comment letters received addressed the general expansion of the time.../sro.shtml ); or Send an email to rule-comments@sec.gov . Please include File Number...

  8. 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

  9. Creating a Comprehensive, Efficient, and Sustainable Nuclear Regulatory Structure: A Process Report from the U.S. Department of Energy's Material Protection, Control and Accounting Program

    SciTech Connect

    Wright, Troy L.; O'Brien, Patricia E.; Hazel, Michael J.; Tuttle, John D.; Cunningham, Mitchel E.; Schlegel, Steven C.

    2010-08-11

    With the congressionally mandated January 1, 2013 deadline for the U.S. Department of Energy’s (DOE) Nuclear Material Protection, Control and Accounting (MPC&A) program to complete its transition of MPC&A responsibility to the Russian Federation, National Nuclear Security Administration (NNSA) management directed its MPC&A program managers and team leaders to demonstrate that work in ongoing programs would lead to successful and timely achievement of these milestones. In the spirit of planning for successful project completion, the NNSA review of the Russian regulatory development process confirmed the critical importance of an effective regulatory system to a sustainable nuclear protection regime and called for an analysis of the existing Russian regulatory structure and the identification of a plan to ensure a complete MPC&A regulatory foundation. This paper describes the systematic process used by DOE’s MPC&A Regulatory Development Project (RDP) to develop an effective and sustainable MPC&A regulatory structure in the Russian Federation. This nuclear regulatory system will address all non-military Category I and II nuclear materials at State Corporation for Atomic Energy “Rosatom,” the Federal Service for Ecological, Technological, and Nuclear Oversight (Rostechnadzor), the Federal Agency for Marine and River Transport (FAMRT, within the Ministry of Transportation), and the Ministry of Industry and Trade (Minpromtorg). The approach to ensuring a complete and comprehensive nuclear regulatory structure includes five sequential steps. The approach was adopted from DOE’s project management guidelines and was adapted to the regulatory development task by the RDP. The five steps in the Regulatory Development Process are: 1) Define MPC&A Structural Elements; 2) Analyze the existing regulatory documents using the identified Structural Elements; 3) Validate the analysis with Russian colleagues and define the list of documents to be developed; 4) Prioritize and

  10. 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

  11. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ...The Department of Justice is publishing its spring 2013 regulatory agenda pursuant to Executive Order 12866, ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. sections 601 to 612...

  12. 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

  13. The ensembl regulatory build.

    PubMed

    Zerbino, Daniel R; Wilder, Steven P; Johnson, Nathan; Juettemann, Thomas; Flicek, Paul R

    2015-01-01

    Most genomic variants associated with phenotypic traits or disease do not fall within gene coding regions, but in regulatory regions, rendering their interpretation difficult. We collected public data on epigenetic marks and transcription factor binding in human cell types and used it to construct an intuitive summary of regulatory regions in the human genome. We verified it against independent assays for sensitivity. The Ensembl Regulatory Build will be progressively enriched when more data is made available. It is freely available on the Ensembl browser, from the Ensembl Regulation MySQL database server and in a dedicated track hub. PMID:25887522

  14. Bacteriophage therapy: a regulatory perspective.

    PubMed

    Pelfrene, Eric; Willebrand, Elsa; Cavaleiro Sanches, Ana; Sebris, Zigmars; Cavaleri, Marco

    2016-08-01

    Despite the recognized problem of antibiotic multidrug resistance, very few antibacterial agents with new mechanisms of action are under development. Bacteriophage therapy could offer one alternative strategy to mitigate this challenge. Although widely used throughout the 20th century in Eastern Europe and the former Soviet Union, this potential therapy has not yet been investigated according to rigorous scientific standards. This paper reports on a multistakeholder meeting held at the EMA, which outlined the existing regulatory framework to which such therapy should adhere and reviewed the current obstacles and shortcomings in scientific development for bacteriophage therapy. PMID:27068400

  15. Combined hepatocellular cholangiocarcinoma: Controversies to be addressed

    PubMed Central

    Wang, An-Qiang; Zheng, Yong-Chang; Du, Juan; Zhu, Cheng-Pei; Huang, Han-Chun; Wang, Shan-Shan; Wu, Liang-Cai; Wan, Xue-Shuai; Zhang, Hao-Hai; Miao, Ruo-Yu; Sang, Xin-Ting; Zhao, Hai-Tao

    2016-01-01

    Combined hepatocellular cholangiocarcinoma (CHC) accounts for 0.4%-14.2% of primary liver cancer cases and possesses pathological features of both hepatocellular carcinoma and cholangiocarcinoma. Since this disease was first described and classified in 1949, the classification of CHC has continuously evolved. The latest definition and classification of CHC by the World Health Organization is based on the speculation that CHC arises from hepatic progenitor cells. However, there is no evidence demonstrating the common origin of different components of CHC. Furthermore, the definition of CHC subtypes is still ambiguous and the identification of CHC subtype when a single tumor contains many components has remained unresolved. In addition, there is no summary on the newly recognized histopathology features or the contribution of CHC components to prognosis and outcome of this disease. Here we provide a review of the current literature to address these questions. PMID:27182157

  16. 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

  17. 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. PMID:25213376

  18. 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.

  19. 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. PMID:24493763

  20. 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.

  1. 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

  2. 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. PMID:26408947

  3. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  4. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1989-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  5. NRC regulatory agenda

    SciTech Connect

    Not Available

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition.

  6. 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.

  7. 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

  8. 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.

  9. Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.

    PubMed

    Hayakawa, Takao; Aoi, Takashi; Bravery, Christopher; Hoogendoorn, Karin; Knezevic, Ivana; Koga, Junichi; Maeda, Daisuke; Matsuyama, Akifumi; McBlane, James; Morio, Tomohiro; Petricciani, John; Rao, Mahendra; Ridgway, Anthony; Sato, Daisaku; Sato, Yoji; Stacey, Glyn; Sakamoto, Norihisa; Trouvin, Jean-Hugues; Umezawa, Akihiro; Yamato, Masayuki; Yano, Kazuo; Yokote, Hiroyuki; Yoshimatsu, Kentaro; Zorzi-Morre, Pierrette

    2015-09-01

    The regulation of human cell therapy products is a key factor in their development and use to treat human diseases. In that regard, there is a recognized need for a global effort to develop a set of common principles that may serve to facilitate a convergence of regulatory approaches to ensure the smooth and efficient evaluation of products. This conference, with experts from regulatory agencies, industry, and academia, contributed to the process of developing such a document. Elements that could form a minimum consensus package of requirements for evaluating human cell therapy products were the overall focus of the conference. The important regulatory considerations that are unique to human cell therapy products were highlighted. Sessions addressed specific points that are different from those of traditional biological/biotechnological protein products. Panel discussions complemented the presentations. The conference concluded that most of the current regulatory framework is appropriate for cell therapy, but there are some areas where the application of the requirements for traditional biologicals is inappropriate. In addition, it was agreed that there is a need for international consensus on core regulatory elements, and that one of the major international organizations should take the lead in formulating such a consensus document. PMID:26315651

  10. 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

  11. 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.

  12. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, 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, 1988), 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 {prime}978 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. A primer for clinical researchers in the emergency department: part I: ethical and regulatory background.

    PubMed

    Davidson, Andrew; Babl, Franz E

    2010-10-01

    Research is an important part of emergency medicine and provides the scientific underpinning for optimal patient care. Although increasing numbers of emergency physicians participate in research activities, formal research training is currently neither part of emergency physician training in Australia nor easily available for clinicians interested in clinical research. In a two-part series, which is targeted at part-time clinical researchers in the ED, we set out and explain the key elements for conducting high-quality and ethical research. In Part I, we describe important underlying ethical principles for research in humans and explain key regulatory processes and documents pertaining to good clinical research practice in Australia. The ethics of research in children as a particularly vulnerable group will also be addressed. Part II will address important elements of research science and conduct. PMID:20726870

  18. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... amounts appropriated from the Nuclear Waste Fund, amounts appropriated for Waste Incidental to... 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...

  19. 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.

  20. 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.

  1. 32 CFR 516.7 - Mailing addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 3 2011-07-01 2009-07-01 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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…

  9. 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...

  10. 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...

  11. 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

  12. 76 FR 2369 - Priorities for Addressing Risks to the Reliability of the Bulk-Power System; Notice of Technical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Energy Regulatory Commission Priorities for Addressing Risks to the Reliability of the Bulk- Power System... related to reliability of the Bulk-Power System, including priorities for addressing risks to reliability.... The conference will be Webcast. Anyone with Internet access who desires to listen to this event can...

  13. Telecommunications Policy Research Conference 1987. Program [and] Keynote Address by Morris Tanenbaum.

    ERIC Educational Resources Information Center

    Telecommunications Policy Research Conference, Inc., Washington, DC.

    Panelists, discussants, and speakers at the 20 sessions of this three-day conference on telecommunications policy research are listed under the appropriate sessions in this conference program, as well luncheon and dinner speakers. Topics addressed by the various sessions include: federal regulatory policies and technical change in…

  14. 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.

  15. 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…

  16. 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…

  17. 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…

  18. 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.

  19. 78 FR 46656 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Proposed Plan for the Allocation of Regulatory Responsibilities Between the Financial Industry Regulatory..., Topaz Exchange, LLC (``Topaz'') and the Financial Industry Regulatory Authority, Inc. (``FINRA... Exchange Act Release No. 12352 (April 20, 1976), 41 FR 18808 (May 7, 1976). To address...

  20. 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

  1. 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.

  2. Toxicogenomics in Regulatory Ecotoxicology

    EPA Science Inventory

    The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions, and as with any new technology, there is a wide range of opinion. The purpose of this feature article is to consider roles of toxicogenomic...

  3. 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.

  4. 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).

  5. REFINE WETLAND REGULATORY PROGRAM

    EPA Science Inventory

    The Tribes will work toward refining a regulatory program by taking a draft wetland conservation code with permitting incorporated to TEB for review. Progress will then proceed in developing a permit tracking system that will track both Tribal and fee land sites within reservati...

  6. NRC regulatory agenda

    SciTech Connect

    Not Available

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  7. NRC regulatory agenda

    SciTech Connect

    Not Available

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  8. NRC Regulatory Agenda

    SciTech Connect

    Not Available

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter.

  9. 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. PMID:18495751

  10. 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.

  11. 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.

  12. 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

  13. 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. PMID:26530796

  14. 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

  15. 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

  16. 78 FR 27113 - Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... drug research, with a focus on the following: 1. Identification of current regulatory science...; Regulatory Science Initiatives Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS... of the regulatory science initiatives for generic drugs and an opportunity for public input...

  17. 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

  18. 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.

  19. 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.

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

    PubMed Central

    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/. PMID:26578589

  1. 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/. PMID:26578589

  2. Computational strategies to address chromatin structure problems.

    PubMed

    Perišić, Ognjen; Schlick, Tamar

    2016-01-01

    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. PMID:27345617

  3. 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.

  4. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Official address. 0.2 Section 0.2 Commercial 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...

  5. 40 CFR 374.6 - Addresses.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 29 2012-07-01 2012-07-01 false Addresses. 374.6 Section 374.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS PRIOR NOTICE OF CITIZEN SUITS § 374.6 Addresses. Administrator, U.S. Environmental Protection Agency, 1200...

  6. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Official address. 0.2 Section 0.2 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2... 20580, unless otherwise specifically directed. The Commission's Web site address is www.ftc.gov....

  7. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Official address. 0.2 Section 0.2 Commercial Practices FEDERAL TRADE COMMISSION ORGANIZATION, PROCEDURES AND RULES OF PRACTICE ORGANIZATION § 0.2... 20580, unless otherwise specifically directed. The Commission's Web site address is www.ftc.gov....

  8. 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…

  9. 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)

  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... FUELS AND FUEL ADDITIVES Detergent Gasoline § 80.174 Addresses. (a) The detergent additive sample required under § 80.161(b)(2) shall be sent to: Manager, Fuels and Technical Analysis Group,...

  11. 7 CFR 1730.3 - RUS addresses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false RUS addresses. 1730.3 Section 1730.3 Agriculture Regulations of the Department of Agriculture (Continued) RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC SYSTEM OPERATIONS AND MAINTENANCE General § 1730.3 RUS addresses. (a) Persons wishing to obtain forms referred to in this part...

  12. 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…

  13. 40 CFR 374.6 - Addresses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 28 2014-07-01 2014-07-01 false Addresses. 374.6 Section 374.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS PRIOR NOTICE OF CITIZEN SUITS § 374.6 Addresses. Administrator, U.S. Environmental Protection Agency, 1200...

  14. 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 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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.

  20. Approaches for Resolving Dynamic IP Addressing.

    ERIC Educational Resources Information Center

    Foo, Schubert; Hui, Siu Cheung; Yip, See Wai; He, Yulan

    1997-01-01

    A problem with dynamic Internet protocol (IP) addressing arises when the Internet connection is through an Internet provider since the IP address is allocated only at connection time. This article examines a number of online and offline methods for resolving the problem. Suggests dynamic domain name system (DNS) and directory service look-up are…

  1. Tradition and Change in Swedish Address Forms.

    ERIC Educational Resources Information Center

    Mitchell, Stephen A.

    In most European languages, choice of address form classifies the relation between speakers. The first theoretical framework for analyzing address form usage was established by Brown and Gilman (1960) in their investigation of the semantics of pronoun use in a wide variety of Indo-European languages, which concluded that Europeans use the informal…

  2. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 6 2014-01-01 2014-01-01 false Address. 504.5 Section 504.5 Agriculture Regulations... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to.... University St., Peoria, Illinois 61604; (309) 685-4011....

  3. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 6 2012-01-01 2012-01-01 false Address. 504.5 Section 504.5 Agriculture Regulations... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to.... University St., Peoria, Illinois 61604; (309) 685-4011....

  4. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Address. 504.5 Section 504.5 Agriculture Regulations... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to.... University St., Peoria, Illinois 61604; (309) 685-4011....

  5. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 6 2011-01-01 2011-01-01 false Address. 504.5 Section 504.5 Agriculture Regulations... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to.... University St., Peoria, Illinois 61604; (309) 685-4011....

  6. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 6 2013-01-01 2013-01-01 false Address. 504.5 Section 504.5 Agriculture Regulations... USER FEES § 504.5 Address. Deposits of and requests for microbial patent cultures should be directed to.... University St., Peoria, Illinois 61604; (309) 685-4011....

  7. 25 CFR 2.14 - Record address.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Record address. 2.14 Section 2.14 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR PROCEDURES AND PRACTICE APPEALS FROM ADMINISTRATIVE ACTIONS § 2.14 Record address. (a) Every interested party who files a document in connection with an...

  8. 25 CFR 2.14 - Record address.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Record address. 2.14 Section 2.14 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR PROCEDURES AND PRACTICE APPEALS FROM ADMINISTRATIVE ACTIONS § 2.14 Record address. (a) Every interested party who files a document in connection with an...

  9. 75 FR 58007 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... new rule language, arbitrators would be authorized to make mid-case referrals based on what they learn... Regulatory Activities; Arbitrator Referral During or at Conclusion of Case.'' Second, the current rule would...''), would be amended and moved to new subparagraph (e). In its place, FINRA would insert new rule...

  10. 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.

  11. Regulatory Impact Analysis: a new tool for better regulation at ANVISA.

    PubMed

    Alves, Flávia Neves Rocha; Peci, Alketa

    2011-08-01

    Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main definitions related to the regulatory field as well as some international case experiences are presented. PMID:21779641

  12. A Multi-Systemic School-Based Approach for Addressing Childhood Aggression

    ERIC Educational Resources Information Center

    Runions, Kevin

    2008-01-01

    School-based approaches to addressing aggression in the early grades have focused on explicit curriculum addressing social and emotional processes. The current study reviews research on the distinct modes of aggression, the status of current research on social and emotional processing relevant to problems of aggression amongst young children, as…

  13. 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.

  14. 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.

  15. 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.

  16. Natural regulatory T cells in autoimmunity

    PubMed Central

    Lourenço, Elaine V.; La Cava, Antonio

    2010-01-01

    The suppressive/immunomodulatory function of CD4+CD25+Foxp+ regulatory T (Treg) cells is crucial for the maintenance of immune homeostasis, which helps to prevent autoimmunity and reduce the inflammation induced by pathogens and environmental insults. This review summarizes the current knowledge on the types and mechanisms of action of Treg cells and their role in the immune tolerance to self antigens, with a particular focus on naturally occurring Treg cells. PMID:21091291

  17. 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.

  18. 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.

  19. Securities and Exchange Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... [Securities and Exchange Commission Semiannual Regulatory Agenda ] Part XXIII Securities and Exchange Commission Semiannual Regulatory Agenda ] SECURITIES AND EXCHANGE COMMISSION (SEC) SECURITIES AND EXCHANGE COMMISSION 17 CFR Ch. II Regulatory Flexibility Agenda AGENCY: Securities and Exchange Commission. ACTION: Semiannual regulatory...

  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. 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).

  2. Current regulatory policies regarding pediatric indications and exclusivity.

    PubMed

    Rodriguez, William J; Roberts, Rosemary; Murphy, Dianne

    2003-01-01

    Pediatric studies have resulted in changes in the dose of many medications given to children and an increased awareness of safety issues. An additional 6 months of pediatric exclusivity legislated under the Food and Drug Administration (FDA) Modernization Act of 1997 for pediatric studies undertaken in response to written requests from the FDA have stimulated the conduct of a large number of studies. PMID:14685077

  3. [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. PMID:23834089

  4. 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…

  5. Spanish regulatory approach for Biobanking

    PubMed Central

    Arias-Diaz, Javier; Martín-Arribas, María C; García del Pozo, Javier; Alonso, Carlos

    2013-01-01

    The Spanish regulatory framework for storage of samples for research responds to most issues raised by both researchers and society regarding biobanking. The Spanish regulation currently foresees three possible ways in which these samples are to be handled: (a) gathering for use in a specific project, (b) storage in a collection, and (c) storage in a Biobank. Samples incorporated into a ‘collection' can only be used by the investigator who requested them and cannot be transferred to third parties or used in research projects outside the particular research line foreseen in the original consent. On the other hand, the legal entity ‘Biobank' refers not only to a set of physical facilities but to the management of the samples stored under that label, and particularly to the requirements for their cession. An approach based on putting most of the regulatory weight on the biobank side has been chosen in order to guaranty the rights of the donors as well as to ease the task of the researchers. A Biobank requires both to be authorized and to be registered in a public Registry. The requirements are quite stringent, allowing for the consent to be given as ‘broad' in scope without implying being ‘blank.' In this regard, for Biobanks to justify the taking on of some of the donors' rights, a key requirement is to have an external ethics committee supervising the adequacy of samples cession and use, notwithstanding the need for a previous bioethical supervision of the target protocol. PMID:23188043

  6. 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....

  7. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... BIOLOGICAL PRODUCTS: GENERAL General Provisions § 600.2 Mailing addresses. (a) Licensed biological products... applications (BLAs) and their amendments and supplements, adverse experience reports, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be...

  8. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... BIOLOGICAL PRODUCTS: GENERAL General Provisions § 600.2 Mailing addresses. (a) Licensed biological products... applications (BLAs) and their amendments and supplements, adverse experience reports, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be...

  9. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... BIOLOGICAL PRODUCTS: GENERAL General Provisions § 600.2 Mailing addresses. (a) Licensed biological products... applications (BLAs) and their amendments and supplements, adverse experience reports, biological product deviation reports, fatality reports, and other correspondence. Biological products samples must not be...

  10. 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 ...

  11. 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....

  12. 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....

  13. 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....

  14. 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.

  15. 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

  16. 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.

  17. 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. PMID:26069647

  18. Regulatory beneficiaries and informal agency policymaking.

    PubMed

    Mendelson, Nina A

    2007-03-01

    Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise low-level employees and supply valuable information to regulated entities regarding how an agency will implement a program. Thus far, however, the debate has largely ignored the distinct and substantial interests of regulatory beneficiaries--those who expect to benefit from government regulation of others. Regulatory beneficiaries include, among others, pharmaceutical consumers, environmental users, and workers seeking safe workplaces. When agencies make policy informally, regulatory beneficiaries suffer distinctive losses to their ability to participate in the agency's decision and to invoke judicial review. This Article argues that considering the interests of regulatory beneficiaries strengthens the case for procedural reform. The Article then assesses some possible solutions. PMID:17410678

  19. The core to regulatory reform

    SciTech Connect

    Partridge, J.W. Jr.

    1993-06-15

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

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. Japanese pharmaceutical and regulatory environment.

    PubMed

    Nagata, Ryoichi; Rafizadeh-Kabe, Jean-David

    2002-12-01

    Drastic regulatory changes in Japan since 1997 have had a considerable impact on the way new medicines are developed. The regulatory authority itself has been transformed. Clinical trials are now performed according to international guidelines. Clinical data generated in one area are acceptable in the rest of the world in some cases through a bridging process that is viewed as only temporary. The future of drug development lies in multinational clinical trials and simultaneous submission to the major regulatory authorities. PMID:22034129

  6. Waterborne cryptosporidiosis: current status.

    PubMed

    Smith, H V; Rose, J B

    1998-01-01

    In the past ten years Cryptosporidium oocysts have been shown to be common contaminants of water, causing at least 19 waterborne outbreaks of cryptosporidiosis which have affected more than 427 000 individuals. Recommended methods for oocyst isolation and enumeration are time-consuming and inefficient and experts state that the absence of Cryptosporidium oocysts in drinking water can never be guaranteed. In the UK alone, a National Research Programme costing pound3 million has been undertaken. Here, Huw Smith and Joan Rose review the current status of knowledge and identify approaches taken by UK and USA Government regulatory bodies in order to reduce the likelihood of waterborne transmission. PMID:17040684

  7. Roles of regulatory T cells in cancer immunity.

    PubMed

    Takeuchi, Yoshiko; Nishikawa, Hiroyoshi

    2016-08-01

    CD4(+) regulatory T cells (Tregs) expressing the transcription factor FoxP3 are highly immune suppressive and play central roles in the maintenance of self-tolerance and immune homeostasis, yet in malignant tumors they promote tumor progression by suppressing effective antitumor immunity. Indeed, higher infiltration by Tregs is observed in tumor tissues, and their depletion augments antitumor immune responses in animal models. Additionally, increased numbers of Tregs and, in particular, decreased ratios of CD8(+) T cells to Tregs among tumor-infiltrating lymphocytes are correlated with poor prognosis in various types of human cancers. The recent success of cancer immunotherapy represented by immune checkpoint blockade has provided a new insight in cancer treatment, yet more than half of the treated patients did not experience clinical benefits. Identifying biomarkers that predict clinical responses and developing novel immunotherapies are therefore urgently required. Cancer patients whose tumors contain a large number of neoantigens stemming from gene mutations, which have not been previously recognized by the immune system, provoke strong antitumor T-cell responses associated with clinical responses following immune checkpoint blockade, depending on the resistance to Treg-mediated suppression. Thus, integration of a strategy restricting Treg-mediated immune suppression may expand the therapeutic spectrum of cancer immunotherapy towards patients with a lower number of neoantigens. In this review, we address the current understanding of Treg-mediated immune suppressive mechanisms in cancer, the involvement of Tregs in cancer immunotherapy, and strategies for effective and tolerable Treg-targeted therapy. PMID:27160722

  8. 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.

  9. 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.

  10. 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.

  11. 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. PMID:20495689

  12. 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

  13. 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.

  14. Initiative Addresses Subsurface Energy and Environment Problems

    NASA Astrophysics Data System (ADS)

    Bodvarsson, Gudmundur S.; Majer, Ernest L.; Wang, Joseph S. Y.; Colwell, Frederick; Redden, George

    2006-01-01

    Members of the geoscience community are cooperating in conceptualizing fundamental, crosscutting research to address major obstacles to solving energy and environmental problems related to the subsurface, through the SECUREarth initiative, which began in 2004. Addressing problems, such as reliable nuclear waste storage and safe carbon dioxide (CO2) sequestration, are critical to maintaining an economical and safe energy supply and clean environment. A recent workshop in Golden, Colo., helped to further the development of the SECUREarth (Scientific Energy/Environmental Crosscutting Underground Research for Urgent Solutions to Secure the Earth's Future) initiative by identifying the key scientific challenges in the geosciences, as well as to target possible approaches for overcoming roadblocks.

  15. Frequency addressable beams for land mobile communications

    NASA Technical Reports Server (NTRS)

    Thompson, J. D.; Dubellay, G. G.

    1988-01-01

    Satellites used for mobile communications need to serve large numbers of small, low cost terminals. The most important parameters affecting the capacity of such systems are the satellite equivalent isotropically radiated power (EIRP) and gain to noise temperature ratio (G/T) and available bandwidth. Satellites using frequency addressed beams provide high EIRP and G/T with high-gain antenna beams that also permit frequency reuse over the composite coverage area. Frequency addressing is easy to implement and compatible with low-cost terminals and offers higher capacity than alternative approaches.

  16. Cheaper Adjoints by Reversing Address Computations

    DOE PAGESBeta

    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.

  17. Emerging regulatory paradigms in glutathione metabolism.

    PubMed

    Liu, Yilin; Hyde, Annastasia S; Simpson, Melanie A; Barycki, Joseph J

    2014-01-01

    One of the hallmarks of cancer is the ability to generate and withstand unusual levels of oxidative stress. In part, this property of tumor cells is conferred by elevation of the cellular redox buffer glutathione. Though enzymes of the glutathione synthesis and salvage pathways have been characterized for several decades, we still lack a comprehensive understanding of their independent and coordinate regulatory mechanisms. Recent studies have further revealed that overall central metabolic pathways are frequently altered in various tumor types, resulting in significant increases in biosynthetic capacity and feeding into glutathione synthesis. In this review, we will discuss the enzymes and pathways affecting glutathione flux in cancer and summarize current models for regulating cellular glutathione through both de novo synthesis and efficient salvage. In addition, we examine the integration of glutathione metabolism with other altered fates of intermediary metabolites and highlight remaining questions about molecular details of the accepted regulatory modes. PMID:24974179

  18. Regulatory mechanisms link phenotypic plasticity to evolvability.

    PubMed

    van Gestel, Jordi; Weissing, Franz J

    2016-01-01

    Organisms have a remarkable capacity to respond to environmental change. They can either respond directly, by means of phenotypic plasticity, or they can slowly adapt through evolution. Yet, how phenotypic plasticity links to evolutionary adaptability is largely unknown. Current studies of plasticity tend to adopt a phenomenological reaction norm (RN) approach, which neglects the mechanisms underlying plasticity. Focusing on a concrete question - the optimal timing of bacterial sporulation - we here also consider a mechanistic approach, the evolution of a gene regulatory network (GRN) underlying plasticity. Using individual-based simulations, we compare the RN and GRN approach and find a number of striking differences. Most importantly, the GRN model results in a much higher diversity of responsive strategies than the RN model. We show that each of the evolved strategies is pre-adapted to a unique set of unseen environmental conditions. The regulatory mechanisms that control plasticity therefore critically link phenotypic plasticity to the adaptive potential of biological populations. PMID:27087393

  19. Emerging regulatory paradigms in glutathione metabolism

    PubMed Central

    Liu, Yilin; Hyde, Annastasia S.; Simpson, Melanie A.; Barycki, Joseph J.

    2015-01-01

    One of the hallmarks of cancer is the ability to generate and withstand unusual levels of oxidative stress. In part, this property of tumor cells is conferred by elevation of the cellular redox buffer glutathione. Though enzymes of the glutathione synthesis and salvage pathways have been characterized for several decades, we still lack a comprehensive understanding of their independent and coordinate regulatory mechanisms. Recent studies have further revealed that overall central metabolic pathways are frequently altered in various tumor types, resulting in significant increases in biosynthetic capacity, and feeding into glutathione synthesis. In this review, we will discuss the enzymes and pathways affecting glutathione flux in cancer, and summarize current models for regulating cellular glutathione through both de novo synthesis and efficient salvage. In addition, we examine the integration of glutathione metabolism with other altered fates of intermediary metabolites, and highlight remaining questions about molecular details of the accepted regulatory modes. PMID:24974179

  20. 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

  1. Regulatory approach on environmental risk assessment. Risk management recommendations, reasonable and prudent alternatives.

    PubMed

    Meisel, Maria Leonor; do Céu Costa, Maria; Pena, Angelina

    2009-11-01

    Current knowledge shows that residues of human medicinal products at trace quantities are widespread in aquatic systems. The sewage treatment plants are pointed out as the major source discharge of these compounds on the environment. In this context, it has been worldwide recognised that the environmental impact of medicinal products have to be evaluated, according to recent EU legislation and regulatory guidance. The strategy of the global risk assessment includes primarily a pre-screening based on the estimation of exposure concentrations of drugs in the wastewater. The present paper addresses the decision-maker frontier of the ecologically relevant endpoints. Risk management recommendation and reasonable and prudent alternatives are discussed to minimise the possible environmental impact. PMID:19590955

  2. 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. PMID:26232717

  3. Metabolic Constraint-Based Refinement of Transcriptional Regulatory Networks

    PubMed Central

    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

  4. 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

  5. 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

  6. 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…

  7. 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…

  8. 50 CFR 228.8 - Mailing address.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 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. 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…

  10. 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…

  11. 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:...

  12. 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…

  13. 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)...

  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. 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...

  16. Naming and Address in Afghan Society.

    ERIC Educational Resources Information Center

    Miran, M. Alam

    Forms of address in Afghan society reflect the relationships between the speakers as well as the society's structure. In Afghan Persian, or Dari, first, second, and last names have different semantic dimensions. Boys' first names usually consist of two parts or morphemes, of which one may be part of the father's name. Girls' names usually consist…

  17. 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…

  18. 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…

  19. 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…

  20. 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…

  1. EMAIL -- E-mail address searching

    NASA Astrophysics Data System (ADS)

    Bly, M. J.; Mellor, G. R.

    One of the most common activities on networked computers is the sending and receiving of personal electronic mail (email). Starlink nodes are connected to the worldwide Internet network. This document describes how to find email addresses to communicate with other astronomers and astronomy groups in the UK and the rest of the world.

  2. 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)

  3. 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…

  4. 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…

  5. 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 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND... Administrator, Region VII, U.S. Environmental Protection Agency, 726 Minnesota Avenue, Kansas City, KS...

  6. 40 CFR 374.6 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 27 2010-07-01 2010-07-01 false Addresses. 374.6 Section 374.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND... Administrator, Region VII, U.S. Environmental Protection Agency, 726 Minnesota Avenue, Kansas City, KS...

  7. 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…

  8. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Section 301.2 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS GENERAL...., and be addressed as follows: Copyright Royalty Board, Library of Congress, James Madison Memorial... Royalty Board, Library of Congress, James Madison Memorial Building, 101 Independence Avenue,...

  9. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Section 301.2 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS GENERAL...., and be addressed as follows: Copyright Royalty Board, Library of Congress, James Madison Memorial... Royalty Board, Library of Congress, James Madison Memorial Building, 101 Independence Avenue,...

  10. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Section 301.2 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS GENERAL...., and be addressed as follows: Copyright Royalty Board, Library of Congress, James Madison Memorial... Royalty Board, Library of Congress, James Madison Memorial Building, 101 Independence Avenue,...

  11. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Section 301.2 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS GENERAL...., and be addressed as follows: Copyright Royalty Board, Library of Congress, James Madison Memorial... Royalty Board, Library of Congress, James Madison Memorial Building, 101 Independence Avenue,...

  12. The Conversational Frame in Public Address.

    ERIC Educational Resources Information Center

    Branham, Robert James; Pearce, W. Barnett

    1996-01-01

    Explores the diverse forms and motives of the conversational frame in public address. Argues that, by framing their remarks and transactions with their listeners as conversational, orators may attempt to reconstruct or seem to reconstruct speaker-audience relationships and to position themselves and their audiences within networks of reciprocal…

  13. 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…

  14. Chemical Address Tags of Fluorescent Bioimaging Probes

    PubMed Central

    Shedden, Kerby; Rosania, Gus R.

    2010-01-01

    Chemical address tags can be defined as specific structural features shared by a set of bioimaging probes having a predictable influence on cell-associated visual signals obtained from these probes. Here, using a large image dataset acquired with a high content screening instrument, machine vision and cheminformatics analysis have been applied to reveal chemical address tags. With a combinatorial library of fluorescent molecules, fluorescence signal intensity, spectral, and spatial features characterizing each one of the probes' visual signals were extracted from images acquired with the three different excitation and emission channels of the imaging instrument. With multivariate regression, the additive contribution from each one of the different building blocks of the bioimaging probes towards each measured, cell-associated image-based feature was calculated. In this manner, variations in the chemical features of the molecules were associated with the resulting staining patterns, facilitating quantitative, objective analysis of chemical address tags. Hierarchical clustering and paired image-cheminformatics analysis revealed key structure-property relationships amongst many building blocks of the fluorescent molecules. The results point to different chemical modifications of the bioimaging probes that can exert similar (or different) effects on the probes' visual signals. Inspection of the clustered structures suggests intramolecular charge migration or partial charge distribution as potential mechanistic determinants of chemical address tag behavior. PMID:20104576

  15. Comprehensive Planning To Address Homelessness. City Initiatives.

    ERIC Educational Resources Information Center

    Zawisza, Kris

    This packet contains documents that provide information about the planning and implementation of a comprehensive plan to address homelessness in cities throughout the U.S. Information on the following components of a comprehensive strategy are included: (1) "Task Forces"; (2) "Assessment Studies"; (3) "Emergency Services"; (4) "Transitional…

  16. 40 CFR 80.174 - Addresses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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:...

  17. 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, Climate Change Division, 1310 L St, NW., Washington, DC 20005....

  18. 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, Climate Change Division, 1310 L St, NW., Washington, DC 20005....

  19. 37 CFR 251.1 - Official addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Copyright Arbitration Royalty Panels (CARPs) must be addressed as follows: (a) If hand delivered by a... Friday between 8:30 a.m. and 5 p.m. (b) If hand delivered by a commercial courier (excluding Federal...) located at Second and D Street, NE., Washington, DC. The CCAS will accept items from couriers with...

  20. 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.

  1. Building Developmental Gene Regulatory Networks

    PubMed Central

    Li, Enhu; Davidson, Eric H.

    2009-01-01

    Animal development is an elaborate process programmed by genomic regulatory instructions. Regulatory genes encode transcription factors and signal molecules, and their expression is under the control of cis-regulatory modules that define the logic of transcriptional responses to the inputs of other regulatory genes. The functional linkages amongst regulatory genes constitute the gene regulatory networks (GRNs) that govern cell specification and patterning in development. Constructing such networks requires identification of the regulatory genes involved and characterization of their temporal and spatial expression patterns. Interactions (activation/repression) among transcription factors or signals can be investigated by large-scale perturbation analysis, in which the function of each gene is specifically blocked. Resultant expression changes are then integrated to identify direct linkages, and to reveal the structure of the GRN. Predicted GRN linkages can be tested and verified by cis-regulatory analysis. The explanatory power of the GRN was shown in the lineage specification of sea urchin endomesoderm. Acquiring such networks is essential for a systematic and mechanistic understanding of the developmental process. PMID:19530131

  2. 75 FR 79759 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... use throughout the rulemaking process. Timetable: Action Date FR Cite Notice: Public Meeting Framework... heating equipment. This is the second review for water heaters. Completed: Reason Date FR Cite Final... ``Regulatory Planning and Review,'' 58 FR 51735, and the Regulatory Flexibility Act, 5 U.S.C. 601 et...

  3. 76 FR 3825 - Regulatory Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ..., Washington, January 18, 2011 [FR Doc. 2011-1386 Filed 1-20-11; 8:45 am] Billing code 3110-01-P ... Documents#0;#0; ] Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive... accessible to the public, information concerning their regulatory compliance and enforcement activities,...

  4. Citizen participation on regulatory boards.

    PubMed

    Chesney, J D

    1984-01-01

    This article examines the relationship between regulatory board function and citizen participation. The research indicates that public members generally prefer advisory boards, while provider members prefer quasi-judicial bodies. Implications of these findings for structuring citizen participation in the regulatory process are examined. PMID:6736596

  5. 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...

  6. 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…

  7. 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...

  8. Addressing disease surveillance needs for marine recreational bathers.

    PubMed

    Turbow, David

    2009-03-01

    Contamination of the nearshore marine environment contributes to a high burden of illness among recreational bathers. Disease surveillance activities carried out by local, state, and territorial agencies in the United States are at present voluntary and passive. Several gaps in the existing regulatory framework for beach management and public health protection are highlighted in this paper. The need for disease surveillance of marine bathers is established. A demonstration is made of how surveillance activities can be used to guide risk management and gauge the effectiveness of current water contact standards. Recommendations are offered for agencies to improve surveillance and protect public health. A foundation is presented on which to develop a model marine health code. PMID:18957774

  9. Emerging Infections Program Efforts to Address Health Equity

    PubMed Central

    Vugia, Duc J.; Bennett, Nancy M.; Moore, Matthew R.

    2015-01-01

    The Emerging Infections Program (EIP), a collaboration between (currently) 10 state health departments, their academic center partners, and the Centers for Disease Control and Prevention, was established in 1995. The EIP performs active, population-based surveillance for important infectious diseases, addresses new problems as they arise, emphasizes projects that lead to prevention, and develops and evaluates public health practices. The EIP has increasingly addressed the health equity challenges posed by Healthy People 2020. These challenges include objectives to increase the proportion of Healthy People–specified conditions for which national data are available by race/ethnicity and socioeconomic status as a step toward first recognizing and subsequently eliminating health inequities. EIP has made substantial progress in moving from an initial focus on monitoring social determinants exclusively through collecting and analyzing data by race/ethnicity to identifying and piloting ways to conduct population-based surveillance by using area-based socioeconomic status measures. PMID:26291875

  10. Understanding genetic regulatory networks

    NASA Astrophysics Data System (ADS)

    Kauffman, Stuart

    2003-04-01

    Random Boolean networks (RBM) were introduced about 35 years ago as first crude models of genetic regulatory networks. RBNs are comprised of N on-off genes, connected by a randomly assigned regulatory wiring diagram where each gene has K inputs, and each gene is controlled by a randomly assigned Boolean function. This procedure samples at random from the ensemble of all possible NK Boolean networks. The central ideas are to study the typical, or generic properties of this ensemble, and see 1) whether characteristic differences appear as K and biases in Boolean functions are introducted, and 2) whether a subclass of this ensemble has properties matching real cells. Such networks behave in an ordered or a chaotic regime, with a phase transition, "the edge of chaos" between the two regimes. Networks with continuous variables exhibit the same two regimes. Substantial evidence suggests that real cells are in the ordered regime. A key concept is that of an attractor. This is a reentrant trajectory of states of the network, called a state cycle. The central biological interpretation is that cell types are attractors. A number of properties differentiate the ordered and chaotic regimes. These include the size and number of attractors, the existence in the ordered regime of a percolating "sea" of genes frozen in the on or off state, with a remainder of isolated twinkling islands of genes, a power law distribution of avalanches of gene activity changes following perturbation to a single gene in the ordered regime versus a similar power law distribution plus a spike of enormous avalanches of gene changes in the chaotic regime, and the existence of branching pathway of "differentiation" between attractors induced by perturbations in the ordered regime. Noise is serious issue, since noise disrupts attractors. But numerical evidence suggests that attractors can be made very stable to noise, and meanwhile, metaplasias may be a biological manifestation of noise. As we learn more

  11. Department of Justice Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] Part XI Department of Justice Semiannual Regulatory Agenda ] DEPARTMENT OF JUSTICE (DOJ) DEPARTMENT OF JUSTICE 8 CFR Ch. V 21 CFR Ch. I 27 CFR Ch. II 28 CFR Ch. I, V Regulatory Agenda AGENCY: Department of Justice. ACTION: Semiannual regulatory agenda....

  12. 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.

  13. 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

  14. 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.

  15. 77 FR 11383 - Change of Address and Electronic Submission of FOIA Requests

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... INVESTMENT BOARD 5 CFR Parts 1630, 1631, and 1632 Change of Address and Electronic Submission of FOIA... address and to permit Freedom of Information Act (FOIA) requests via electronic mail and facsimile. DATES... Submission of Freedom of Information Act Requests Section 1631.6(a) currently permits submission of...

  16. 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…

  17. 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.

  18. 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

  19. 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. PMID:24758452

  20. 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.

  1. 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.

  2. 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

  3. Global-Address Space Networking (GASNet) Library

    SciTech Connect

    Welcome, Michael L.; Bell, Christian S.

    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 space 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.

  4. 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

  5. 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).

  6. 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.

  7. 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

  8. 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

  9. 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.

  10. 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

  11. Software programs that address site-specific inventory characteristics issues.

    SciTech Connect

    Dare, J. H.; Cournoyer, M. E.

    2001-01-01

    The proper characterization of Hazardous, Mixed Low-Level, and Mixed Transuranic waste enhances productivity and safety. Hazardous material criteria that need to be considered include physical and health hazards inherent to the waste stream. Other factors that may influence characterization include: particulate diameter, complexing or chelating agent properties, lead, and mercury content, pressurized containers, and P-listed wastes. To meet these requirements are only a simple matter of generating a database with the proper fields. Manufactures and institutional databases bank huge sources of information, such as, work control documents, substance identification, container types, components of mixtures, physical property data, and regulatory data. In this report, utilization of commercially available software programs to take advantage of these resources in addressing waste characterization issues are presented. The application of user-friendly programs eliminates part of the tediousness associated with the complex requirements of certifying to general waste acceptance criteria with minimal impact on programmatic work. In other words, tapping into manufacturer and institutional database provides a way to take advantage of the combined expertise of these resources in managing a cost effective waste certification program as well as adding a quality assurance element to the program.

  12. Self-regulatory deficits in fibromyalgia and temporomandibular disorders.

    PubMed

    Solberg Nes, Lise; Carlson, Charles R; Crofford, Leslie J; de Leeuw, Reny; Segerstrom, Suzanne C

    2010-10-01

    Chronic pain conditions such as fibromyalgia (FM) and temporomandibular disorders (TMDs) are accompanied by complex interactions of cognitive, emotional, and physiological disturbances. Such conditions are complicated and draining to live with, and successful adaptation may depend on ability to self-regulate. Self-regulation involves capacity to exercise control and guide or alter reactions and behavior, abilities essential for human adjustment. Research indicates that self-regulatory strength is a limited source that can be depleted or fatigued, however, and the current study aimed to show that patients with FM and TMD are vulnerable to self-regulatory fatigue as a consequence of their condition. Patients (N=50) and pain-free matched controls (N=50) were exposed to an experimental self-regulation task followed by a persistence task. Patients displayed significantly less capacity to persist on the subsequent task compared with controls. In fact, patients exposed to low self-regulatory effort displayed similar low persistence to patients and controls exposed to high self-regulatory effort, indicating that patients with chronic pain conditions may be suffering from chronic self-regulatory fatigue. Baseline heart rate variability, blood glucose, and cortisol predicted persistence, more so for controls than for patients, and more so in the low vs. high self-regulation condition. Impact of chronic pain conditions on self-regulatory effort was mediated by pain, but not by any other factors. The current study suggests that patients with chronic pain conditions likely suffer from chronic self-regulatory fatigue, and underlines the importance of taking self-regulatory capacity into account when aiming to understand and treat these complex conditions. PMID:20561749

  13. Regulatory evaluation and acceptance issues for phytotechnology projects.

    PubMed

    Flechas, Felix W; Latady, Marisa

    2003-01-01

    The use of plant based systems in hazardous waste management or site clean up is growing at a rapid rate. Major hurdles to implementation will be encountered by proponents if essential regulatory policies and regulations are not understood or addressed early in the project development. Understanding the regulatory requirements or issues as they relate to innovative clean up approaches such as phytotechnologies are critical to the successful implementation and long-term monitoring of these technologies. This chapter will address the issues that regulators may have in applying phytotechnologies to site conditions or contaminants, designing phytoremediation projects, monitoring or maintaining the systems for the long-term, establishing performance criteria, and demonstrating achievement of performance goals. PMID:12674403

  14. Regulatory Immunotherapy in Bone Marrow Transplantation

    PubMed Central

    Morales-Tirado, Vanessa; Luszczek, Wioleta; van der Merwe, Marié; Pillai, Asha

    2011-01-01

    Every year individuals receive hematopoietic stem cell transplantation (HSCT) to eradicate malignant and nonmalignant disease. The immunobiology of allotransplantation is an area of ongoing discovery, from the recipient's conditioning treatment prior to the transplant to the donor cell populations responsible for engraftment, graft-versus-host disease, and graft-versus-tumor effect. In this review, we focus on donor-type immunoregulatory T cells, namely, natural killer T cells (NKT) and regulatory T cells (Treg), and their current and potential roles in tolerance induction after allogeneic HSCT. PMID:22262950

  15. 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

  16. 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. PMID:21846200

  17. 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. PMID:25271928

  18. Comparative Analysis of Prostate Cancer Gene Regulatory Networks via Hub Type Variation

    PubMed Central

    Khosravi, Pegah; Gazestani, Vahid H.; Akbarzadeh, Mohammad; Mirkhalaf, Samira; Sadeghi, Mehdi; Goliaei, Bahram

    2015-01-01

    Background Prostate cancer is one of the most widespread cancers in men and is fundamentally a genetic disease. Identifying regulators in cancer using novel systems biology approaches will potentially lead to new insight into this disease. It was sought to address this by inferring gene regulatory networks (GRNs). Moreover, dynamical analysis of GRNs can explain how regulators change among different conditions, such as cancer subtypes. Methods In our approach, independent gene regulatory networks from each prostate state were reconstructed using one of the current state-of-art reverse engineering approaches. Next, crucial genes involved in this cancer were highlighted by analyzing each network individually and also in comparison with each other. Results In this paper, a novel network-based approach was introduced to find critical transcription factors involved in prostate cancer. The results led to detection of 38 essential transcription factors based on hub type variation. Additionally, experimental evidence was found for 29 of them as well as 9 new transcription factors. Conclusion The results showed that dynamical analysis of biological networks may provide useful information to gain better understanding of the cell. PMID:25926947

  19. Regulatory considerations for determining postmarketing study commitments.

    PubMed

    Meyer, R J

    2007-08-01

    Postmarketing Study Commitments (PMCs) are, most commonly, agreements made by pharmaceutical companies at the time of an FDA approval to perform a study or studies to elucidate further characteristics of the drug under consideration. The role of PMCs in drug regulation has come under considerable scrutiny in recent years, particularly as discussions of drug safety have intensified. Although these agreed-upon PMCs are described in FDA regulations, such PMCs are not sought by FDA with every approval, and completion of the agreed-upon studies is not a requirement for the drug's sponsor (there are required PMCs under certain regulatory provisions and these are discussed below). Requests by FDA at the time of regulatory approval for studies under PMCs have been a common practice for many years. When made, PMCs are described in the approval letters and are therefore publicly available. Concerns over whether PMCs were being duly performed, reported, and reviewed by FDA were addressed in the FDA Modernization Act of 1997, which required more detailed reporting by manufactures on their progress in meeting the PMCs and required FDA to report certain information publicly. PMID:17538552

  20. Regulatory T cells: regulators of life.

    PubMed

    Schumacher, Anne; Zenclussen, Ana Claudia

    2014-08-01

    Pregnancy still represents one of the most fascinating paradoxical phenomena in science. Immediately after conception, the maternal immune system is challenged by the presence of foreign paternal antigens in the semen. This triggers mechanisms of recognition and tolerance that all together allow the embryo to implant and later the fetus to develop. Tolerance mechanisms to maintain pregnancy are of special interest as they defy the classical immunology rules. Several cell types, soluble factors, and immune regulatory molecules have been proposed to contribute to fetal tolerance. Within these, regulatory T cells (Treg) are one of the most studied immune cell populations lately. They are reportedly involved in fetal acceptance. Here, we summarize several aspects of Treg biology in normal and pathologic pregnancies focusing on Treg frequencies, subtypes, antigen specificity, and activity as well as on factors influencing Treg generation, recruitment, and function. This review also highlights the contribution of fetal Treg in tolerance induction and addresses the role of Treg in autoimmune diseases and infections during gestation. Finally, the potential of Treg as a predictive marker for the success of assisted reproductive techniques and for therapeutic interventions is discussed. PMID:24661545

  1. 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.

  2. Photosensitive biosensor array system using optical addressing without an addressing circuit on array biochips

    NASA Astrophysics Data System (ADS)

    Ahn, Chang-Geun; Ah, Chil Seong; Kim, Tae-Youb; Park, Chan Woo; Yang, Jong-Heon; Kim, Ansoon; Sung, Gun Yong

    2010-09-01

    This paper introduces a photosensitive biosensor array system with a simple photodiode array that detects photocurrent changes caused by reactions between probe and target molecules. Using optical addressing, the addressing circuit on the array chip is removed for low-cost application, and real cell addressing is achieved using an externally located computer-controllable light-emitting diode array module. The fabricated biosensor array chip shows a good dynamic range of 1-100 ng/mL under prostate-specific antigen detection, with an on-chip resolution of roughly 1 ng/mL.

  3. Addressing value in surgical oncology: Why and how.

    PubMed

    Abbott, Daniel E

    2016-09-01

    Value, or outcome per cost, is increasingly emphasized in the current health care climate. With more sophisticated and expensive therapies available, treating a population with growing longevity, sustainability of current trends in health care spending is a significant challenge. And all too often, our devices and therapies are implemented without understanding the value that they offer; policy solutions for these issues are lagging. Certainly, cancer patients, in particular, are at the center of these value conundrums. A majority of patients with malignancy are elderly, with accumulated co-morbidities, and are disproportionately costly. To address these contemporary issues, we must first identify opportunities to maximize value through improved outcomes and/or decreased costs. Doing so in the setting of evolving delivery and payment models will provide providers, health systems and insurers an opportunity to flourish with demonstration of high quality, low cost care. J. Surg. Oncol. 2016;114:263-267. © 2016 Wiley Periodicals, Inc. PMID:27040903

  4. 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

  5. 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

  6. 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.

  7. 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

  8. Addressing the challenges of emerging infectious disease.

    PubMed

    Pinner, R W

    1996-01-01

    Through the recent examples of diphtheria in the former Soviet Union, plague in India, and trends in pneumonia mortality in the United States, the author, in this article, illustrates issues in emerging infectious diseases. The Centers for Disease Control's plan, Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States, is summarized. Initial efforts to implement this plan are described, with particular focus on the development of Emerging Infections Programs, which are conducting epidemiologic and laboratory projects on several infectious diseases, including invasive bacterial diseases, unexplained deaths, foodborne diseases, and ehrlichiosis in four population-based sites in the United States. PMID:8571983

  9. Versions to Address Business Process Flexibility Issue

    NASA Astrophysics Data System (ADS)

    Chaâbane, Mohamed Amine; Andonoff, Eric; Bouaziz, Rafik; Bouzguenda, Lotfi

    This paper contributes to address an important issue in business process management: the Business Process (BP) flexibility issue. First, it defends that versions are an interesting solution to deal with both a priori (when designing BPs) and a posteriori (when executing BPs) flexibility. It also explains why previous contributions about versions of BPs are incomplete, and need to be revisited. Then, the paper presents a meta-model for BP versions, which combines five perspectives -the functional, process, informational, organizational and operation perspectives- for BP modelling, and which allows a comprehensive description of versionalized BPs.

  10. Homotypic Regulatory Clusters in Drosophila

    PubMed Central

    Lifanov, Alexander P.; Makeev, Vsevolod J.; Nazina, Anna G.; Papatsenko, Dmitri A.

    2003-01-01

    Cis-regulatory modules (CRMs) are transcription regulatory DNA segments (∼1 Kb range) that control the expression of developmental genes in higher eukaryotes. We analyzed clustering of known binding motifs for transcription factors (TFs) in over 60 known CRMs from 20 Drosophila developmental genes, and we present evidence that each type of recognition motif forms significant clusters within the regulatory regions regulated by the corresponding TF. We demonstrate how a search with a single binding motif can be applied to explore gene regulatory networks and to discover coregulated genes in the genome. We also discuss the potential of the clustering method in interpreting the differential response of genes to various levels of transcriptional regulators. PMID:12670999

  11. 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.

  12. 78 FR 46644 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ..., Financial Industry Regulatory Authority, Inc., NYSE Arca, Inc., The NASDAQ Stock Market LLC, NASDAQ OMX BX... to Rule 17d- 2 of the Act,\\2\\ by Financial Industry Regulatory Authority, Inc. (``FINRA'') and Topaz... Securities Exchange Act Release No. 12352 (April 20, 1976), 41 FR 18808 (May 7, 1976). To address...

  13. 77 FR 73711 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-11

    ..., Incorporated, C2 Options Exchange, Incorporated, the International Securities Exchange, LLC, Financial Industry... International Securities Exchange, LLC (``ISE''), Financial Industry Regulatory Authority, Inc. (``FINRA.... 12352 (April 20, 1976), 41 FR 18808 (May 7, 1976). To address regulatory duplication in these and...

  14. 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.

  15. 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

  16. Economic analysis requirements in support of orbital debris regulatory policy

    NASA Astrophysics Data System (ADS)

    Greenberg, Joel S.

    1996-10-01

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

  17. Facing regulatory challenges of on-line hemodiafiltration.

    PubMed

    Kümmerle, Wolfgang

    2011-01-01

    On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. PMID:22188690

  18. 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. PMID:24733351

  19. 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.

  20. 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.