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Sample records for address current regulatory

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

    PubMed

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

    2015-06-01

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

  2. Current Regulations and Regulatory Actions

    EPA Pesticide Factsheets

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

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

    SciTech Connect

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

    2003-03-01

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

  4. 5 CFR 870.910 - Notification of current addresses.

    Code of Federal Regulations, 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....

  5. Current european regulatory perspectives on insulin analogues

    PubMed Central

    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

  6. Current status of herbal product: Regulatory overview.

    PubMed

    Sharma, Sanjay

    2015-01-01

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

  7. 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

  8. 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.

  9. 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.

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. Elliptical polarization effects in a chromatically addressed Faraday current sensor

    NASA Astrophysics Data System (ADS)

    Li, G. D.; Aspey, R. A.; Kong, M. G.; Gibson, J. R.; Jones, G. R.

    1999-01-01

    Optical polarization processes in a parallel-sided glass element used in a Faraday rotation current sensor have been considered. In such sensors the path length necessary to produce sufficient rotation of the plane of polarization is produced by a multiplicity of reflections within the glass element. It is shown that such reflections induce ellipticity of polarization and that this affects the current-sensing performance of the sensor. Two reflection cases, corresponding to total internal reflections at a glass-air interface and reflections by aluminium-coated surfaces, are considered. The latter are shown to produce higher optical attenuation but a lower degree of elliptical polarization. The implications of the induced elliptical polarization in relation to chromatically modulated polychromatic light are considered. It is shown that the resolution of the Faraday sensing is improved by minimizing the ellipticity of the polarization with the aluminium-coated reflections. However a greater dynamic range and signal strength may be achievable with the total internal reflection element.

  16. 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...

  17. 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...

  18. 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

  19. 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

    2016-04-06

    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.

  20. TUESDAY: EPA Administrator to Address National Association of Regulatory Utility Commissioners

    EPA Pesticide Factsheets

    WASHINGTON- On Tuesday, U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy will deliver remarks at the National Association of Regulatory Utility Commissioners' Winter Committee Meetings in Washington, DC. Administrator McCarthy

  1. Transfer of a large gene regulatory apparatus to a new developmental address in echinoid evolution.

    PubMed

    Gao, Feng; Davidson, Eric H

    2008-04-22

    Of the five echinoderm classes, only the modern sea urchins (euechinoids) generate a precociously specified embryonic micromere lineage that ingresses before gastrulation and then secretes the biomineral embryonic skeleton. The gene regulatory network (GRN) underlying the specification and differentiation of this lineage is now known. Many of the same differentiation genes as are used in the biomineralization of the embryo skeleton are also used to make the similar biomineral of the spines and test plates of the adult body. Here, we determine the components of the regulatory state upstream of these differentiation genes that are shared between embryonic and adult skeletogenesis. An abrupt "break point" in the micromere GRN is thus revealed, on one side of which most of the regulatory genes are used in both, and on the other side of which the regulatory apparatus is entirely micromere-specific. This reveals the specific linkages of the micromere GRN forged in the evolutionary process by which the skeletogenic gene batteries were caused to be activated in the embryonic micromere lineage. We also show, by comparison with adult skeletogenesis in the sea star, a distant echinoderm outgroup, that the regulatory apparatus responsible for driving the skeletogenic differentiation gene batteries is an ancient pleisiomorphic aspect of the echinoderm-specific regulatory heritage.

  2. 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.

  3. Water Systems Project 1: Current Systems and Regulatory Support

    EPA Science Inventory

    Water Systems Project 1 objectives: 1) Supply research results to support federal regulations and guidance; 2) provide strategies to regions, states, and communities for improved regulatory compliance, and 3) provide rapid and effective emergency response where appropriate (e.g. ...

  4. Evolving PBPK applications in regulatory risk assessment: current situation and future goals

    EPA Science Inventory

    The presentation includes current applications of PBPK modeling in regulatory risk assessment and discussions on conflicts between assuring consistency with experimental data in current situation and the desire for animal-free model development.

  5. 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

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

    PubMed

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

    2016-06-08

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

  7. Research on Current Water Systems and Regulatory Support

    EPA Science Inventory

    This project will supply research results to support federal regulations and guidance. It will also provide strategies to regions, states, and communities for improved regulatory compliance and rapid and effective emergency response where appropriate (e.g. harmful algal bloom out...

  8. 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...

  9. 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.

  10. 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

  11. 77 FR 66850 - Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) is announcing the following...

  12. Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

    PubMed

    Tohkin, Masahiro

    2017-01-01

     I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

  13. On the Path to SunShot. Utility Regulatory and Business Model Reforms for Addressing the Financial Impacts of Distributed Solar on Utilities

    SciTech Connect

    Barbose, Galen; Miller, John; Sigrin, Ben; Reiter, Emerson; Cory, Karlynn; McLaren, Joyce; Seel, Joachim; Mills, Andrew; Darghouth, Naim; Satchwell, Andrew

    2016-05-01

    Net-energy metering (NEM) has helped drive the rapid growth of distributed PV (DPV) but has raised concerns about electricity cost shifts, utility financial losses, and inefficient resource allocation. These concerns have motivated real and proposed reforms to utility regulatory and business models. This report explores the challenges and opportunities associated with such reforms in the context of the U.S. Department of Energy's SunShot Initiative. Most of the reforms to date address NEM concerns by reducing the benefits provided to DPV customers and thus constraining DPV deployment. Eliminating NEM nationwide, by compensating exports of PV electricity at wholesale rather than retail rates, could cut cumulative DPV deployment by 20% in 2050 compared with a continuation of current policies. This would slow the PV cost reductions that arise from larger scale and market certainty. It could also thwart achievement of the SunShot deployment goals even if the initiative's cost targets are achieved. This undesirable prospect is stimulating the development of alternative reform strategies that address concerns about distributed PV compensation without inordinately harming PV economics and growth. These alternatives fall into the categories of facilitating higher-value DPV deployment, broadening customer access to solar, and aligning utility profits and earnings with DPV. Specific strategies include utility ownership and financing of DPV, community solar, distribution network operators, services-driven utilities, performance-based incentives, enhanced utility system planning, pricing structures that incentivize high-value DPV configurations, and decoupling and other ratemaking reforms that reduce regulatory lag. These approaches represent near- and long-term solutions for preserving the legacy of the SunShot Initiative.

  14. 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.

  15. Addressing drought conditions under current and future climates in the Jordan River region

    NASA Astrophysics Data System (ADS)

    Törnros, T.; Menzel, L.

    2014-01-01

    The Standardized Precipitation-Evaporation Index (SPEI) was applied in order to address the drought conditions under current and future climates in the Jordan River region located in the southeastern Mediterranean area. In the first step, the SPEI was derived from spatially interpolated monthly precipitation and temperature data at multiple timescales: accumulated precipitation and monthly mean temperature were considered over a number of timescales - for example 1, 3, and 6 months. To investigate the performance of the drought index, correlation analyses were conducted with simulated soil moisture and the Normalized Difference Vegetation Index (NDVI) obtained from remote sensing. A comparison with the Standardized Precipitation Index (SPI), i.e., a drought index that does not incorporate temperature, was also conducted. The results show that the 6-month SPEI has the highest correlation with simulated soil moisture and best explains the interannual variation of the monthly NDVI. Hence, a timescale of 6 months is the most appropriate when addressing vegetation growth in the semi-arid region. In the second step, the 6-month SPEI was derived from three climate projections based on the Intergovernmental Panel on Climate Change emission scenario A1B. When comparing the period 2031-2060 with 1961-1990, it is shown that the percentage of time with moderate, severe and extreme drought conditions is projected to increase strongly. To address the impact of drought on the agricultural sector, the irrigation water demand during certain drought years was thereafter simulated with a hydrological model on a spatial resolution of 1 km. A large increase in the demand for irrigation water was simulated, showing that the agricultural sector is expected to become even more vulnerable to drought in the future.

  16. 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

  17. On the Path to SunShot - Utility Regulatory Business Model Reforms forAddressing the Financial Impacts of Distributed Solar on Utilities

    SciTech Connect

    None, None

    2016-05-01

    Net-energy metering (NEM) with volumetric retail electricity pricing has enabled rapid proliferation of distributed photovoltaics (DPV) in the United States. However, this transformation is raising concerns about the potential for higher electricity rates and cost-shifting to non-solar customers, reduced utility shareholder profitability, reduced utility earnings opportunities, and inefficient resource allocation. Although DPV deployment in most utility territories remains too low to produce significant impacts, these concerns have motivated real and proposed reforms to utility regulatory and business models, with profound implications for future DPV deployment. This report explores the challenges and opportunities associated with such reforms in the context of the U.S. Department of Energy’s SunShot Initiative. As such, the report focuses on a subset of a broader range of reforms underway in the electric utility sector. Drawing on original analysis and existing literature, we analyze the significance of DPV’s financial impacts on utilities and non-solar ratepayers under current NEM rules and rate designs, the projected effects of proposed NEM and rate reforms on DPV deployment, and alternative reforms that could address utility and ratepayer concerns while supporting continued DPV growth. We categorize reforms into one or more of four conceptual strategies. Understanding how specific reforms map onto these general strategies can help decision makers identify and prioritize options for addressing specific DPV concerns that balance stakeholder interests.

  18. Model-based probe state estimation and crack inverse methods addressing eddy current probe variability

    NASA Astrophysics Data System (ADS)

    Aldrin, John C.; Oneida, Erin K.; Shell, Eric B.; Sabbagh, Harold A.; Sabbagh, Elias; Murphy, R. Kim; Mazdiyasni, Siamack; Lindgren, Eric A.; Mooers, Ryan D.

    2017-02-01

    A model-based calibration process is introduced that estimates the state of the eddy current probe. First, a carefully designed surrogate model was built using VIC-3D® simulations covering the critical range of probe rotation angles, tilt in two directions, and probe offset (liftoff) for both transverse and longitudinal flaw orientations. Some approximations and numerical compromises in the model were made to represent tilt in two directions and reduce simulation time; however, this surrogate model was found to represent the key trends in the eddy current response for each of the four probe properties in experimental verification studies well. Next, this model was incorporated into an iterative inversion scheme during the calibration process, to estimate the probe state while also addressing the amplitude/phase fit and centering the calibration notch indication. Results are presented showing several examples of the blind estimation of tilt and rotation angle for known experimental cases with reasonable agreement. Once the probe state is estimated, the final step is to transform the base crack inversion surrogate model and apply it for crack characterization. Using this process, results are presented demonstrating improved crack inversion performance for extreme probe states.

  19. 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.

  20. 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.

  1. [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

    PubMed

    Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

    2016-05-01

    Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

  2. 22 CFR Appendix A to Chapter Xiv - Current Addresses and Geographic Jurisdictions

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) The Office address of the Board is as follows: 1900 E Street, NW., Room 7469, Washington, DC 20424...—254-7362; Commercial—(202) 254-7362 (b) The Office address of the General Counsel is as follows: 1900... (c) The Office address of the Chief Administrative Law Judge is as follows: 1111 20th Street,...

  3. Addressing current and future challenges for the NHS: the role of good leadership.

    PubMed

    Elton, Lotte

    2016-10-03

    Purpose This paper aims to describe and analyse some of the ways in which good leadership can enable those working within the National Health Service (NHS) to weather the changes and difficulties likely to arise in the coming years, and takes the format of an essay written by the prize-winner of the Faculty of Medical Leadership and Management's Student Prize. The Faculty of Medical Leadership and Management ran its inaugural Student Prize in 2015-2016, which aimed at medical students with an interest in medical leadership. In running the Prize, the Faculty hoped to foster an enthusiasm for and understanding of the importance of leadership in medicine. Design/methodology/approach The Faculty asked entrants to discuss the role of good leadership in addressing the current and future challenges faced by the NHS, making reference to the Leadership and Management Standards for Medical Professionals published by the Faculty in 2015. These standards were intended to help guide current and future leaders and were grouped into three categories, namely, self, team and corporate responsibility. Findings This paper highlights the political nature of health care in the UK and the increasing impetus on medical professionals to navigate debates on austerity measures and health-care costs, particularly given the projected deficit in NHS funding. It stresses the importance of building organisational cultures prizing transparency to prevent future breaches in standards of care and the value of patient-centred approaches in improving satisfaction for both patients and staff. Identification of opportunities for collaboration and partnership is emphasised as crucial to assuage the burden that lack of appropriate social care places on clinical services. Originality/value This paper offers a novel perspective - that of a medical student - on the complex issues faced by the NHS over the coming years and utilises a well-regarded set of standards in conceptualising the role that health

  4. The current unmet need in type 2 diabetes mellitus: addressing glycemia and cardiovascular disease.

    PubMed

    Levy, Philip

    2009-05-01

    The treatment of type 2 diabetes mellitus (T2DM) requires a multifaceted approach of both lifestyle modification (diet, exercise, weight control, smoking cessation) and pharmacological therapy. In addition to agents that improve hyperglycemia, patients often require treatments to address the additional cardiovascular (CV) risk factors of hypertension and dyslipidemia. Although the benefits of early, aggressive glycemic control are clearly established, treatment remains suboptimal. Many patients fail to achieve long-term glycemic control, with rates of patients with T2DM achieving target goals for hypertension and dyslipidemia also unsatisfactory. Several factors contribute to the failure to meet treatment goals. These include poor adherence by patients to lifestyle and pharmacological treatment, lack of understanding by patients of the long-term benefits of treatment, patient concerns about adverse effects leading to poor compliance, and failure of health care providers to initiate or intensify medications appropriately (termed clinical inertia). This article reviews the current state of T2DM treatment and the management of CV risk factors associated with T2DM, and identifies unmet treatment needs.

  5. 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.

  6. 21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Regulatory authorities not listed as currently equivalent. 26.10 Section 26.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL...

  7. 21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory authorities not listed as currently equivalent. 26.10 Section 26.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND...

  8. 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

  9. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., DC 20424-0001; telephone: (202) 218-7740; fax: (202) 482-6657. (b) The Office address, telephone number, and fax number of the General Counsel are: Suite 200, 1400 K Street, NW., Washington, DC 20424... the Chief Administrative Law Judge are: Suite 300, 1400 K Street, NW., Washington, DC 20424;...

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

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., DC 20424-0001; telephone: (202) 218-7740; fax: (202) 482-6657. (b) The Office address, telephone number, and fax number of the General Counsel are: Suite 200, 1400 K Street, NW., Washington, DC 20424... the Chief Administrative Law Judge are: Suite 300, 1400 K Street, NW., Washington, DC 20424;...

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

    PubMed

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

    2016-10-01

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

  14. 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... Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Registration § 3.30..., commodity pool operator, commodity trading advisor, floor trader that is a non-natural person, or...

  15. 17 CFR 3.30 - Current address for purpose of delivery of communications from the Commission or the National...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 17 Commodity and Securities Exchanges 1 2012-04-01 2012-04-01 false Current address for purpose of... Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION REGISTRATION Registration § 3.30..., introducing broker, commodity pool operator, commodity trading advisor, or leverage transaction merchant...

  16. 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?

  17. Current progress in public health models addressing the critical organ shortage.

    PubMed

    Shanmugarajah, Kumaran; Villani, Vincenzo; Madariaga, Maria Lucia L; Shalhoub, Joseph; Michel, Sebastian G

    2014-12-01

    Since its inauguration in 1954, the field of modern transplantation has made great strides in surgical technique, the prevention of acute and chronic rejection, the minimization of immunosuppression-related side-effects and transplant tolerance. As such, organ transplantation is used worldwide as a curative, life-saving treatment for people with end-stage organ failure. However, the successes of organ transplantation have resulted in the number of patients on transplant waiting lists far exceeding the number of organs available, with growing numbers of patients dying while awaiting transplants. In order to address this critical organ shortage, a number of legislative changes have been implemented worldwide to increase the number of individuals registering as organ donors. These have included presumed consent donation, incentivized organ donation, commercial organ transplantation and mandated choice models. This article will address these public health policies in turn. The implementation of these strategies and the evidence for their efficacy will be evaluated. Based on this, we have identified that well-supported transplant coordinators approaching next-of-kin, incentives and public health campaigns are key factors that increase organ donation. Finally we propose a modified mandated choice model that may be an alternative option to maximize the number of available organs for transplantation.

  18. 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.

  19. 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.

  20. 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...

  1. 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...

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

    PubMed Central

    Arciniegas, David B.

    2011-01-01

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

  3. Current and future therapies for addressing the effects of inflammation on HDL cholesterol metabolism.

    PubMed

    Iqbal, Fatima; Baker, Wendy S; Khan, Madiha I; Thukuntla, Shwetha; McKinney, Kevin H; Abate, Nicola; Tuvdendorj, Demidmaa

    2017-03-22

    Cardiovascular disease (CVD) is a major cause of morbidity and mortality worldwide. Inflammatory processes arising from metabolic abnormalities are known to precipitate the development of CVD. Several metabolic and inflammatory markers have been proposed for predicting the progression of CVD, including high density lipoprotein cholesterol (HDL-C). For ~50 years, HDL-C has been considered as the atheroprotective 'good' cholesterol because of its strong inverse association with the progression of CVD. Thus, interventions to increase the concentration of HDL-C have been successfully tested in animals; however, clinical trials were unable to confirm the cardiovascular benefits of pharmaceutical interventions aimed at increasing HDL-C levels. Based on these data, the significance of HDL-C in the prevention of CVD has been called into question. Fundamental in vitro and animal studies suggest that HDL-C functionality, rather than HDL-C concentration, is important for the CVD-preventive qualities of HDL-C. Our current review of the literature positively demonstrates the negative impact of systemic and tissue (i.e. adipose tissue) inflammation in the healthy metabolism and function of HDL-C. Our survey indicates that HDL-C may be a good marker of adipose tissue health, independently of its atheroprotective associations. We summarize the current findings on the use of anti-inflammatory drugs to either prevent HDL-C clearance or improve the function and production of HDL-C particles. It is evident that the therapeutic agents currently available may not provide the optimal strategy for altering HDL-C metabolism and function, and thus, further research is required to supplement this mechanistic approach for preventing the progression of CVD.

  4. 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.

  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. 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.

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

    PubMed

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

    2007-01-01

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

  8. 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.

  9. NRC regulatory initiatives

    SciTech Connect

    Johnson, T.C.

    1989-11-01

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

  10. 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.

  11. Current status and regulatory aspects of pesticides considered to be persistent organic pollutants (POPs) in Taiwan.

    PubMed

    Tsai, Wen-Tien

    2010-10-01

    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.

  12. Drug interaction studies on new drug applications: current situations and regulatory views in Japan.

    PubMed

    Nagai, Naomi

    2010-01-01

    Drug interaction studies on new drug applications (NDAs) for new molecular entities (NMEs) approved in Japan between 1997 and 2008 are examined in the Pharmaceuticals and Medical Devices Agency (PMDA). The situations of drug interaction studies in NDAs have changed over the past 12 years, especially in metabolizing enzyme and transporter-based drug interactions. Materials and approaches to study drug-metabolizing enzyme-based drug interactions have improved, and become more rational based on mechanistic theory and new technologies. On the basis of incremental evidence of transporter roles in human pharmacokinetics, transporter-based drug interactions have been increasingly studied during drug development and submitted in recent NDAs. Some recently approved NMEs include transporter-based drug interaction information in their package inserts (PIs). The regulatory document "Methods of Drug Interaction Studies," in addition to recent advances in science and technology, has also contributed to plan and evaluation of drug interaction studies in recent new drug development. This review summarizes current situations and further discussion points on drug interaction studies in NDAs in Japan.

  13. Current industrial practices and regulatory requirements to assess analyte and reagent stability using ligand-binding assays.

    PubMed

    Wang, Jin; Nowatzke, William; Ma, Mark

    2015-01-01

    Specific guidelines on bioanalytical method validation for drug development support are recommended by regulatory agencies. Regarding stability assessment, US FDA states that 'Stability procedures should evaluate the stability of the analytes during sample collection and handling, after long-term (frozen at the intended storage temperature) and short-term (bench-top, room temperature) storage, and after going through freeze and thaw cycles and the analytical process'. Additional regulatory considerations are discussed including topics such as analyte and reagent stability. This article reviews the regulatory requirements as issued by the USA (FDA), Europe (EMA) and Japan (MHLW), for stability studies where bioanalytical methods are used to support drug development programs and summarizes the current industry standard for conducting stability studies when utilizing ligand-binding assays.

  14. 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.

  15. Comparative overview of current international strategies and guidelines for genetic toxicology testing for regulatory purposes.

    PubMed

    Cimino, Michael C

    2006-06-01

    National and international regulatory agencies historically have used genotoxicity information as part of a weight-of-evidence approach to evaluate potential human carcinogenicity. Additionally, some agencies consider heritable mutation a regulatory endpoint. Furthermore, genotoxicity has the potential to contribute to other adverse health conditions. This article provides a comparative overview of the testing strategies used by regulatory agencies throughout the world. Despite minor variations in details, the genotoxicity test schemes for most regulatory entities generally comprise three tests: a bacterial gene mutation assay, an in vitro mammalian cell assay for gene mutation and/or chromosome aberrations, and often an in vivo assay for chromosomal effects. In some cases, fewer than these three tests are required. In other cases, when exposure data, structure-activity considerations, or other factors warrant, even chemicals negative in the three baseline tests may be subject to additional testing. If genotoxicity is identified by the baseline screening tests, assessment of the ability of the chemical to interact with DNA in the gonad may be required. This may apply regardless of whether or not a cancer bioassay has been triggered. Mutagens positive in second stage gonadal assay(s) may be tested in third stage in vivo rodent tests to provide data for a quantitative risk assessment. In all testing, theutilization of internationally-recognized protocols, where they exist, is advisable, although not in all instances required. When testing for regulatory purposes, it is advisable to verify the testing program with the specific regulatory body or bodies responsible forregulatory oversight before beginning testing.

  16. Quality and safety of genetic testing in Australia and New Zealand: a review of the current regulatory framework

    PubMed Central

    Goold, Imogen L; Pearn, Amy; Bettiol, Silvana; Ballantyne, Angela

    2006-01-01

    This paper provides an overview of the regulation of quality assurance for genetic testing in Australia and New Zealand and outlines the steps currently being taken to critically appraise and improve the regulatory framework in each country. It aims to contextualize this framework within the broader context of quality and patient safety concerns; and to draw together the concerns and recommendations of the various organizations that have been working to improve quality assurance in this area. PMID:17092338

  17. Effects of pulsed potential on address electrode in a surface-discharge alternating-current plasma display panel

    NASA Astrophysics Data System (ADS)

    Ahn, Jeong Chull; Shintani, Youichi; Tachibana, Kunihide; Sakai, Tetsuo; Kosugi, Naoki

    2003-06-01

    The influence of pulsed potential application onto the address electrode of an ac-type plasma display panel was investigated from the observation of front and side views of Xe atom densities in the metastable (1s5) and excited (2p) states in a unit discharge cell by using microscopic laser absorption spectroscopy and optical emission spectroscopy. It was seen that a predischarge occurs between the address electrode and one of the sustain electrode worked as a preceding anode, which is a similar effect found previously by applying a higher sustain voltage. The predischarge partially erases the surface charge accumulated in the preceding pulse, but it induces a faster main sustain discharge, bowing towards the address electrode, and enhances the production efficiency of Xe(1s5) atoms, if the applied potential is within an optimal range.

  18. 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

    ... application for registration (Form 7-R or Form 8-R) or as submitted on the biographical supplement (Form 8-R... relating to a biographical supplement submitted for or on behalf of a principal to the futures commission... Association of any change of the address an the application for registration, biographical supplement,...

  19. 17 CFR 3.30 - Current address for purpose of delivery of communications from the Commission or the National...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... application for registration (Form 7-R or Form 8-R) or as submitted on the biographical supplement (Form 8-R... relating to a biographical supplement submitted for or on behalf of a principal to the futures commission... application for registration, biographical supplement, or other address filed with the National...

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

    SciTech Connect

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

    2015-06-01

    In this report, we will present a descriptive and organizational framework for incremental and fundamental changes to regulatory and utility business models in the context of clean energy public policy goals. We will also discuss the regulated utility's role in providing value-added services that relate to distributed energy resources, identify the "openness" of customer information and utility networks necessary to facilitate change, and discuss the relative risks, and the shifting of risks, for utilities and customers.

  1. 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

  2. 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.

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

    PubMed

    Nakayama, Yoshikazu; Aruga, Atsushi

    2015-03-18

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

  4. 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

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

    PubMed Central

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

    2016-01-01

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

  6. 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).

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

    PubMed Central

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

    2009-01-01

    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 (ICl,swell) in the regulatory volume decrease (RVD) and (ii) the regulatory role of tyrosine phosphorylation in ICl,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 Ca2+ 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 ICl,swell blocker 4-(2-butyl-6,7-dichloro-2-cyclopentyl-indan-1-on-5-yl)oxobutyric acid (DCPIB) at 20 μm. Exposure to a hyposmotic solution activated ICl,swell, which was also largely inhibited by 20 μm DCPIB. ICl,swell in rabbit articular chondrocytes had a relative taurine permeability (Ptau/PCl) of 0.21. Activation of ICl,swell was significantly reduced by the protein tyrosine kinase (PTK) inhibitor genistein (30 μm) but was only weakly affected by its inactive analogue daidzein (30 μm). Intracellular application of protein tyrosine phosphatase (PTP) inhibitor sodium orthovanadate (250 and 500 μm) 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 μm) and was also largely suppressed by exposure to hyperosmotic solution, thus indicating a close similarity to ICl,swell. Pretreatment of chondrocytes with genistein significantly prevented the activation of the Cl− current by sodium orthovanadate, suggesting that the basal activity of endogenous PTK is required for

  8. [Biobanks and use of samples of human origin for surgical research. Current regulatory framework].

    PubMed

    Martín Arribas, María Concepción; Arias Díaz, Javier

    2011-04-01

    In recent years, there has been a growing interest in the development of biological samples and biobanks that make it easier for investigators to have access to quality samples and their associated clinical and epidemiological data. Thus, biobanks have become indispensible technological platforms for the development of both basic and clinical research. The properties of the biological sample as a support medium of personal and family information require that they are treated in accordance with new ethical standards. For this reason, the Law on Biomedical Research, provides a new regulatory framework in the process of obtaining samples and their storage for research purposes, where the consent of the source subject, data protection, the favourable opinion of a Research Ethics Committee, the prior taking out of an insurance policy against possible adverse effects, and the quality and safety requirements in the handling and management of these materials are key elements.

  9. Monitoring the frequency and function of regulatory T cells and summary of the approaches currently used to inhibit regulatory T cells in cancer patients.

    PubMed

    Camisaschi, Chiara; Tazzari, Marcella; Rivoltini, Licia; Castelli, Chiara

    2014-01-01

    Regulatory T cells (Treg) are a subset of T lymphocytes that in humans represent less than the 10 % of circulating CD4(+) T cells. Treg are specialized in the inhibition of the immune responses and play a crucial role in the maintenance of immunological tolerance. Several lines of evidence clearly documented the role of Treg in restraining antitumor immune responses. For this reason, antitumor immunotherapy approaches have been recently associated with drug treatments aimed at depleting Treg or blocking their functions. A summary of the currently used in vivo approaches to limit Treg expansion in cancer patients is here provided.A comprehensive phenotypic and functional monitoring of Treg is crucial for the precise assessment of the effects that these different drug treatments exert on Treg. In this chapter, we will provide guidelines for an accurate ex vivo identification of human Treg. Due to the phenotypic and functional heterogeneity, intrinsic plasticity, and the lack of a unique marker exclusively expressed by human Treg, the clear-cut identification of this T cell subset requires the expert usage of multiparametric flow cytometry analysis (FACS). In this view, a combination of phenotypic and functional assessment of Treg is mandatory. In this chapter, we will describe the most reliable methods to identify and monitor the modulation of human Treg in patients undergoing immunological or drug-based treatments. Protocols to measure ex vivo the suppressive functions of Treg are also provided.

  10. Addressing current medical needs in invasive fungal infection prevention and treatment with new antifungal agents, strategies and formulations.

    PubMed

    Pitman, Stuart K; Drew, Richard H; Perfect, John R

    2011-09-01

    Introduction: Morbidity and mortality associated with invasive fungal infections (IFIs) remains unacceptably high. Such diseases represent a substantial burden to the healthcare system. New options are needed to address antifungal resistance in existing and emerging pathogens and improve treatment outcomes while minimizing drug-related toxicities and interactions. Awareness of new and potential future options is of great value for those healthcare professionals who care for patients with IFIs. Areas covered: A search of PubMed, infectious diseases conference abstracts and reference lists from relevant publications was conducted and relevant information abstracted. This review describes the limitations of existing systemic antifungal therapies (e.g., resistance, drug-drug interactions, drug-related toxicities) and summarizes data regarding several emerging antifungal compounds including (but not limited to) new triazoles (e.g. isavuconazole, ravuconazole), echinocandins (e.g., aminocandin) and nikkomycin Z. Agents in clinical trials such as (but not limited to) new triazoles (e.g., isavuconazole, ravuconazole), echinocandins (e.g., aminocandin) and nikkomycin are included. New formulations of existing drugs including reformulations of miconazole, posaconazole and amphotericin B are also reviewed. Finally, new or novel administration strategies for existing drugs such as combination antifungal therapy, antifungal dose escalation, adjunctive use of iron chelators and preemptive therapy are discussed. Expert opinion: All present antifungal agents have some deficiencies in antifungal spectra, toxicity, pharmacokinetics and/or drug-drug interactions, making them less than ideal for some fungal infections. Therefore, there remains an urgent need to find safe, effective, rapidly fungicidal, broad-spectrum antifungal agents with excellent pharmacodynamics to effectively eliminate the fungus from the body with short antifungal courses.

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

    SciTech Connect

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

    2008-05-16

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

  12. 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.

  13. Addressing the current bottlenecks of metabolomics: Isotopic Ratio Outlier Analysis™, an isotopic-labeling technique for accurate biochemical profiling.

    PubMed

    de Jong, Felice A; Beecher, Chris

    2012-09-01

    Metabolomics or biochemical profiling is a fast emerging science; however, there are still many associated bottlenecks to overcome before measurements will be considered robust. Advances in MS resolution and sensitivity, ultra pressure LC-MS, ESI, and isotopic approaches such as flux analysis and stable-isotope dilution, have made it easier to quantitate biochemicals. The digitization of mass spectrometers has simplified informatic aspects. However, issues of analytical variability, ion suppression and metabolite identification still plague metabolomics investigators. These hurdles need to be overcome for accurate metabolite quantitation not only for in vitro systems, but for complex matrices such as biofluids and tissues, before it is possible to routinely identify biomarkers that are associated with the early prediction and diagnosis of diseases. In this report, we describe a novel isotopic-labeling method that uses the creation of distinct biochemical signatures to eliminate current bottlenecks and enable accurate metabolic profiling.

  14. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern.

    PubMed

    Shah, Rashmi

    2002-12-01

    The development of safe and effective new drug treatments for schizophrenia poses a challenging task. This class of drugs is known to be associated with a wide range of serious and troublesome safety problems that include neurological, cardiac, endocrine, and metabolic side effects. Many of these drugs have a narrow therapeutic index and generate metabolites that often have their own unique pharmacological profile different from the parent compound. These features make it imperative that the optimal dose schedules for neuroleptic drugs are carefully characterized. Many of these drugs are metabolized by cytochrome P450 enzymes, which show genetic polymorphism and a bi modal distribution within the population, A significant subset of the population cannot eliminate these drugs as effectively as the majority. This brings an added dimension of complexity in characterizing the dose and individualizing therapy. Many neuroleptic agents are proarrhythmic with an adverse effect on cardiac repolarization. They are prone to prolonging the QT interval and inducing torsade de pointes. Given the potentially fatal outcome of this ventricular tachyarrhythmia, drug development programs need to ensure that the proarrhythmic potential of any new neuroleptic agent is thoroughly explored and its proarrhythmic risk characterized. The clinical use of many of these drugs is further troubled by their high potential for drug-drug interactions. These too need to be adequately investigated during development The approval and the labeling of a new neuroleptic agent require a careful regulatory assessment of its risk/benefit ratio in comparison with the available alternatives. Their safe and effective use in routine clinical practice depends on careful attention to prescribing information, especially the contraindications, precautions, and patient-monitoring requirements.

  15. 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

  16. Monoclonal antibodies for use in man: current regulatory situation in the Federal Republic of Germany.

    PubMed

    Haase, M

    1990-01-01

    The article addresses the requirement to be met for approval of monoclonal antibodies with special emphasis on products coupled with radionuclides and on principles for the conduct of clinical trials. According to the German Drug Law monoclonal antibodies are considered as being sera. Therefore, the Paul-Ehrlich-Institut, Federal Office for Sera and Vaccines, is responsible for marketing authorizations. Sera and vaccines need a special manufacturing licence which is given by the competent authority of the Federal State. Batches of monoclonal antibodies can only be marketed if they have been released by the Paul-Ehrlich-Institut; in connexion with batch control the importance of reference preparations is stressed. The standard requirements for the data to be submitted with the applications for marketing authorizations are in accordance with the EEC Council Directives and Notes for Guidance. For the testing of radioactive monoclonal antibodies in clinical trials, compliance with both the Drug Law and The German Radiation Protection Ordinance must be ensured. In addition to the authorizations required for non-labelled monoclonal antibody products, the use of radioactive substances in diagnosis and therapy requires an authorization by the competent Federal State authority. The main purpose of the planning and performance of clinical trials with new monoclonal antibody in diagnosis and therapy must be the comparison with established diagnostic tools and/or established medicinal products of known effect.

  17. 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.

  18. 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

  19. Current topics on software use in medicinal chemistry: intellectual property, taxes, and regulatory issues.

    PubMed

    Duardo-Sánchez, Aliuska; Patlewicz, Grace; López-Díaz, Antonio

    2008-01-01

    In recent times, there has been an increased use of software and computational models in Medicinal Chemistry, both for the prediction of effects such as drug-target interactions, as well as for the development of (Quantitative) Structure-Activity Relationships ((Q)SAR). Whilst the ultimate goal of Medicinal Chemistry research is for the discovery of new drug candidates, a secondary yet important outcome that results is in the creation of new computational tools. The adoption of computational tools by medicinal chemists is sadly, and all too often accompanied, by a lack of understanding of the legal aspects related to software and model use, that is, the copyright protection of new medicinal chemistry software and software-mediated discovered products. This article aims to provide a reference to the various legal avenues that are available for the protection of software, and the acceptance and legal treatment of scientific results and techniques derived from such software. An overview of relevant international tax issues is also presented. We have considered cases of patents protecting software, models, and/or new compounds discovered using methods such as molecular modeling or QSAR. This paper has been written and compiled by the authors as a review of current topics and trends on the legal issues in certain fields of Medicinal Chemistry and as such is not intended to be exhaustive.

  20. 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.

  1. 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

  2. A global regulatory science agenda for vaccines.

    PubMed

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

    2013-04-18

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

  3. 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

  4. 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

  5. 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

  6. 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.

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

    PubMed

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

    2015-08-26

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

  8. 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

  9. Convocation address.

    PubMed

    Kakodkar, A

    1999-07-01

    This convocation addressed by Dr. Anil Kakodkar focuses on the challenges faced by graduating students. In his speech, he emphasized the high level of excellence achieved by the industrial sector; however, he noted that there has been a loss of initiative in maximizing value addition, which was worsened by an increasing population pressure. In facing a stiff competition in the external and domestic markets, it is imperative to maximize value addition within the country in a competitive manner and capture the highest possible market share. To achieve this, high-quality human resources are central. Likewise, family planning programs should become more effective and direct available resources toward national advantage. To boost the domestic market, he suggests the need to search for strengths to achieve leadership position in those areas. First, an insight into the relationship between the lifestyles and the needs of our people and the natural resource endowment must be gained. Second, remodeling of the education system must be undertaken to prepare the people for adding the necessary innovative content in our value addition activities. Lastly, Dr. Kakodkar emphasizes the significance of developing a strong bond between parents and children to provide a sound foundation and allow the education system to grow upon it.

  10. 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

  11. 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

  12. 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.

  13. 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.

  14. Regulatory RNAs in Planarians.

    PubMed

    Pawlicka, Kamila; Perrigue, Patrick M; Barciszewski, Jan

    2016-01-01

    The full scope of regulatory RNA evolution and function in epigenetic processes is still not well understood. The development of planarian flatworms to be used as a simple model organism for research has shown a great potential to address gaps in the knowledge in this field of study. The genomes of planarians encode a wide array of regulatory RNAs that function in gene regulation. Here, we review planarians as a suitable model organism for the identification and function of regulatory RNAs.

  15. Select Biosolids Regulatory Processes

    EPA Pesticide Factsheets

    Historical Regulatory Development and activities EPA has undertaken to respond to statutory obligations, respond to the National Academy of Sciences, understand pollutants that may occur in sewage sludge, and address dioxins in sewage sludge.

  16. An analysis of pharmaceutical experience with decades of rat carcinogenicity testing: support for a proposal to modify current regulatory guidelines.

    PubMed

    Sistare, Frank D; Morton, Daniel; Alden, Carl; Christensen, Joel; Keller, Douglas; Jonghe, Sandra De; Storer, Richard D; Reddy, M Vijayaraj; Kraynak, Andrew; Trela, Bruce; Bienvenu, Jean-Guy; Bjurström, Sivert; Bosmans, Vanessa; Brewster, David; Colman, Karyn; Dominick, Mark; Evans, John; Hailey, James R; Kinter, Lewis; Liu, Matt; Mahrt, Charles; Marien, Dirk; Myer, James; Perry, Richard; Potenta, Daniel; Roth, Arthur; Sherratt, Philip; Singer, Thomas; Slim, Rabih; Soper, Keith; Fransson-Steen, Ronny; Stoltz, James; Turner, Oliver; Turnquist, Susan; van Heerden, Marjolein; Woicke, Jochen; DeGeorge, Joseph J

    2011-06-01

    Data collected from 182 marketed and nonmarketed pharmaceuticals demonstrate that there is little value gained in conducting a rat two-year carcinogenicity study for compounds that lack: (1) histopathologic risk factors for rat neoplasia in chronic toxicology studies, (2) evidence of hormonal perturbation, and (3) positive genetic toxicology results. Using a single positive result among these three criteria as a test for outcome in the two-year study, fifty-two of sixty-six rat tumorigens were correctly identified, yielding 79% test sensitivity. When all three criteria were negative, sixty-two of seventy-six pharmaceuticals (82%) were correctly predicted to be rat noncarcinogens. The fourteen rat false negatives had two-year study findings of questionable human relevance. Applying these criteria to eighty-six additional chemicals identified by the International Agency for Research on Cancer as likely human carcinogens and to drugs withdrawn from the market for carcinogenicity concerns confirmed their sensitivity for predicting rat carcinogenicity outcome. These analyses support a proposal to refine regulatory criteria for conducting a two-year rat study to be based on assessment of histopathologic findings from a rat six-month study, evidence of hormonal perturbation, genetic toxicology results, and the findings of a six-month transgenic mouse carcinogenicity study. This proposed decision paradigm has the potential to eliminate over 40% of rat two-year testing on new pharmaceuticals without compromise to patient safety.

  17. 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...

  18. 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

  19. 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.

  20. 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.

  1. Single-Session Transcranial Direct Current Stimulation Temporarily Improves Symptoms, Mood, and Self-Regulatory Control in Bulimia Nervosa: A Randomised Controlled Trial

    PubMed Central

    Kekic, Maria; McClelland, Jessica; Bartholdy, Savani; Boysen, Elena; Musiat, Peter; Dalton, Bethan; Tiza, Meyzi; David, Anthony S.; Campbell, Iain C.; Schmidt, Ulrike

    2017-01-01

    Background Evidence suggests that pathological eating behaviours in bulimia nervosa (BN) are underpinned by alterations in reward processing and self-regulatory control, and by functional changes in neurocircuitry encompassing the dorsolateral prefrontal cortex (DLPFC). Manipulation of this region with transcranial direct current stimulation (tDCS) may therefore alleviate symptoms of the disorder. Objective This double-blind sham-controlled proof-of-principle trial investigated the effects of bilateral tDCS over the DLPFC in adults with BN. Methods Thirty-nine participants (two males) received three sessions of tDCS in a randomised and counterbalanced order: anode right/cathode left (AR/CL), anode left/cathode right (AL/CR), and sham. A battery of psychological/neurocognitive measures was completed before and after each session and the frequency of bulimic behaviours during the following 24-hours was recorded. Results AR/CL tDCS reduced eating disorder cognitions (indexed by the Mizes Eating Disorder Cognitions Questionnaire-Revised) when compared to AL/CR and sham tDCS. Both active conditions suppressed the self-reported urge to binge-eat and increased self-regulatory control during a temporal discounting task. Compared to sham stimulation, mood (assessed with the Profile of Mood States) improved after AR/CL but not AL/CR tDCS. Lastly, the three tDCS sessions had comparable effects on the wanting/liking of food and on bulimic behaviours during the 24 hours post-stimulation. Conclusions These data suggest that single-session tDCS transiently improves symptoms of BN. They also help to elucidate possible mechanisms of action and highlight the importance of selecting the optimal electrode montage. Multi-session trials are needed to determine whether tDCS has potential for development as a treatment for adult BN. PMID:28121991

  2. 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...

  3. Assessing the regulatory picture

    SciTech Connect

    Not Available

    1994-02-01

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

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

    PubMed

    Trevisan, Lauren

    2011-01-01

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

  5. 78 FR 35072 - Proposed Revision to Strategies and Guidance to Address Loss of Large Areas of the Plant Due to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Explosions and Fires AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section... and Guidance to Address Loss of Large Areas of the Plant due to Explosions and Fires.'' The current... due to explosions and fires. DATES: Submit comments by July 11, 2013. Comments received after...

  6. 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.

  7. 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.

  8. 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

  9. 78 FR 44355 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... flexibility agenda. In addition, this document includes an agenda of regulatory actions the Commission expects... requirements of the Regulatory Flexibility Act and Executive Order 12866. DATES: The Commission welcomes... Secretary by July 31, 2013. ADDRESSES: Comments on the regulatory flexibility agenda should be...

  10. 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.

  11. Creating a Comprehensive, Efficient, and Sustainable Nuclear Regulatory Structure

    SciTech Connect

    O'Brien, Patricia; Wright, Troy L.; Tuttle, John D.; Hazel, Michael J.; Schlegel, Steven C.; Miller, Daniel R.

    2009-03-30

    Abstract. 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, 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 the U.S. DOE 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 schedule the development of

  12. Research strategies for addressing uncertainties

    USGS Publications Warehouse

    Busch, David E.; Brekke, Levi D.; Averyt, Kristen; Jardine, Angela; Welling, Leigh; Garfin, Gregg; Jardine, Angela; Merideth, Robert; Black, Mary; LeRoy, Sarah

    2013-01-01

    Research Strategies for Addressing Uncertainties builds on descriptions of research needs presented elsewhere in the book; describes current research efforts and the challenges and opportunities to reduce the uncertainties of climate change; explores ways to improve the understanding of changes in climate and hydrology; and emphasizes the use of research to inform decision making.

  13. 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 ...

  14. 78 FR 1568 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... type of document, a citation to any rulemaking or other action taken since publication of the most... current regulations in the Code of Federal Regulations. A citation of legal authority. The name, address... Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jacquelyn Butler, Office of...

  15. 77 FR 7940 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... of document, a citation to any rulemaking or other action taken since publication of the most recent... current regulations in the Code of Federal Regulations. A citation of legal authority. The name, address.... Completed: Reason Date FR Cite Final Action 06/13/11 76 FR 34386 Regulatory Flexibility Analysis...

  16. 78 FR 44243 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... type of document, a citation to any rulemaking or other action taken since publication of the most... current regulations in the Code of Federal Regulations. A citation of legal authority. The name, address... End. Final Rule 01/00/14 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Nathan...

  17. 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.)

  18. 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.

  19. Allergic contact dermatitis: epidemiology, molecular mechanisms, in vitro methods and regulatory aspects. Current knowledge assembled at an international workshop at BfR, Germany.

    PubMed

    Peiser, M; Tralau, T; Heidler, J; Api, A M; Arts, J H E; Basketter, D A; English, J; Diepgen, T L; Fuhlbrigge, R C; Gaspari, A A; Johansen, J D; Karlberg, A T; Kimber, I; Lepoittevin, J P; Liebsch, M; Maibach, H I; Martin, S F; Merk, H F; Platzek, T; Rustemeyer, T; Schnuch, A; Vandebriel, R J; White, I R; Luch, A

    2012-03-01

    Contact allergies are complex diseases, and one of the important challenges for public health and immunology. The German 'Federal Institute for Risk Assessment' hosted an 'International Workshop on Contact Dermatitis'. The scope of the workshop was to discuss new discoveries and developments in the field of contact dermatitis. This included the epidemiology and molecular biology of contact allergy, as well as the development of new in vitro methods. Furthermore, it considered regulatory aspects aiming to reduce exposure to contact sensitisers. An estimated 15-20% of the general population suffers from contact allergy. Workplace exposure, age, sex, use of consumer products and genetic predispositions were identified as the most important risk factors. Research highlights included: advances in understanding of immune responses to contact sensitisers, the importance of autoxidation or enzyme-mediated oxidation for the activation of chemicals, the mechanisms through which hapten-protein conjugates are formed and the development of novel in vitro strategies for the identification of skin-sensitising chemicals. Dendritic cell cultures and structure-activity relationships are being developed to identify potential contact allergens. However, the local lymph node assay (LLNA) presently remains the validated method of choice for hazard identification and characterisation. At the workshop the use of the LLNA for regulatory purposes and for quantitative risk assessment was also discussed.

  20. 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.

  1. Genetically engineered crops for biofuel production: regulatory perspectives.

    PubMed

    Lee, David; Chen, Alice; Nair, Ramesh

    2008-01-01

    There are numerous challenges in realizing the potential of biofuels that many policy makers have envisioned. The technical challenges in making the production of biofuels economical and on a scale to replace a significant fraction of transportation fuel have been well described, along with the potential environmental concerns. The use of biotechnology can potentially address many of these technical challenges and environmental concerns, but brings significant regulatory hurdles that have not been discussed extensively in the scientific community. This review will give an overview of the approaches being developed to produce transgenic biofuel feedstocks, particularly cellulosic ethanol, and the regulatory process in the United States that oversees the development and commercialization of new transgenic plants. We hope to illustrate that the level of regulation for transgenic organisms is not proportional to their potential risk to human health or the environment, and that revisions to the regulatory system in the U.S. currently under consideration are necessary to streamline the process.

  2. Addressing Ozone Layer Depletion

    EPA Pesticide Factsheets

    Access information on EPA's efforts to address ozone layer depletion through regulations, collaborations with stakeholders, international treaties, partnerships with the private sector, and enforcement actions under Title VI of the Clean Air Act.

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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…

  9. Invitational Addresses, 1965.

    ERIC Educational Resources Information Center

    Gates, Arthur I.; And Others

    The full texts of invitational addresses given at the 1965 International Reading Association (IRA) Convention in Detroit, Michigan, by six recipients of IRA citation awards are presented. Gates suggests steps IRA should take to revive and redirect reading research. McCallister discusses the implications of the changing and expanding vocabulary of…

  10. 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…

  11. 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…

  12. 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...

  13. 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...

  14. Content Addressable Memory Project

    DTIC Science & Technology

    1990-11-01

    The Content Addressable M1-emory Project consists of the development of several experimental software systems on an AMT Distributed Array Processor...searching (database) compiler algorithms memory management other systems software) Linear C is an unlovely hybrid language which imports the CAM...memory from AMT’s operating system for the DAP; how- ever, other than this limitation, the memory management routines work exactly as their C counterparts

  15. Addressing inequities in healthy eating.

    PubMed

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

    2015-09-01

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

  16. 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.

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

    PubMed

    Patsner, Bruce

    2009-01-01

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

  18. 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

  19. Bioreactors addressing diabetes mellitus.

    PubMed

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

    2014-11-01

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

  20. 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.

  1. Addressing Environmental Health Inequalities

    PubMed Central

    Gouveia, Nelson

    2016-01-01

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

  2. Regulatory Forum.

    PubMed

    Peden, W Michael

    2016-12-01

    Revision of the International Council for Harmonization (ICH) S1 guidance for rat carcinogenicity studies to be more selective of compounds requiring a 2-year rat carcinogenicity study has been proposed following extensive evaluation of rat carcinogenicity and chronic toxicity studies by industry and drug regulatory authorities. To inform the ICH S1 expert working group in their potential revision of ICH S1, a prospective evaluation study was initiated in 2013, in which sponsors would assess the pharmacologic and toxicologic findings present in the chronic toxicity studies and predict a positive or negative carcinogenicity outcome using a weight of evidence argument (a carcinogenicity assessment document [CAD]). The Scientific and Regulatory Policy Committee was asked by the Society of Toxicology Pathology (STP) executive committee to track these changes with ICH S1 and inform the STP membership of status changes. This commentary is intended to provide a brief summary of recent changes to the CAD guidance and highlight the importance of STP membership participation in the process of CAD submissions.

  3. 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.

  4. 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...

  5. 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

  6. 76 FR 58846 - Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in Safety.... Nuclear Regulatory Commission (NRC) staff is issuing its Final Interim Staff Guidance (ISG)...

  7. 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

  8. 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.

  9. Cognitive regulatory control therapies.

    PubMed

    Bowins, Brad

    2013-01-01

    Cognitive regulatory control processes play an essential but typically unappreciated role in maintaining mental health. The purpose of the current paper is to identify this role and demonstrate how cognitive-behavioral and related techniques can compensate for impairments. Impaired cognitive regulation contributes to the overly intense emotional states present in anxiety disorders, depression, and personality disorders; progression of adaptive hypomania to mania; expression of psychosis in the conscious and awake state; dominance of immature defense mechanisms in borderline and other personality disorders. A wide variety of standard (monitoring, reappraisal, response inhibition, relaxation training) and more novel (suppression therapy, willful detachment, cost-benefit analysis, normalization, mature defense mechanism training) cognitive-behavioral and related techniques can be applied to compensate for cognitive regulatory control impairments, and their success probably aligns with this capacity.

  10. 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.

  11. [Keynote address: Climate change

    SciTech Connect

    Forrister, D.

    1994-12-31

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

  12. Addressing the United States Debt and Deficit

    DTIC Science & Technology

    2010-03-01

    effectively with the American debt and deficit, by first describing the background of our current government approach to the economy , then examining the...to address the problem of deficit financing and the associated debt in a positive manner and thereby strengthen the economy of the United States...current government approach to the economy , then examining the current projections for United States’ spending from 2009 through 2019 and examining what

  13. Disposal of Large Reactor Components - Rulemaking to Address Funding of Disposal Costs

    SciTech Connect

    Greeves, J.T.; Lieberman, J.; Magette, T.E.

    2008-07-01

    The paper will explore the current challenges of financing the disposal costs for disposing of large reactor components such as reactor pressure vessel heads and steam generators and the resulting delays in disposal caused by the current regulatory requirements. The paper also will discuss a recent rulemaking petition submitted by EnergySolutions to the US Nuclear Regulatory Commission designed to improve the regulatory process by providing a process to permit funds from decommissioning trust funds to be used to fund disposal of large reactor components. If granted, the disposal of these large components could be expedited where reactor licensees have sufficient decommissioning trust funds available. Perspectives on the rulemaking will be addressed. In conclusion: NRC should provide serious consideration to this Petition. There is support in the industry for granting this Petition. As of the date this paper was submitted, there have been no negative comments. Granting this Petition is prudent and consistent with the underlying purpose of 10 C.F.R. 50.82(a)(8) and 10 CFR 20.1406. It provides flexibility without any adverse impact on the public health and safety. It should facilitate the decommissioning process by providing a regulatory framework to allow removing MRCs from sites, resulting in (1) the source term at the site being reduced, (2) the site workers being exposed to less radiation, (3) eliminating an unnecessary regulatory burden as the costs associated with maintaining the MRCs on-site and providing protection to the workers as a result of those components can be avoided, (4) the overall cost to decommission the site being reduced, and (5) more funds being made available to decommission the reactor at the time the reactor ceases operation. Finally, the framework would provide the demonstration by a site-specific decommissioning cost estimate and the associated funding program that adequate funds are available to dispose of these components as well as

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

    PubMed

    Curet Bobey, Marianne

    2015-02-28

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

  15. The regulatory gap in chronic disease prevention: a historical perspective.

    PubMed

    Walls, Helen L; Walls, Kelvin L; Loff, Bebe

    2012-02-01

    Experience shows that regulatory intervention can lead to substantial improvement in population health. The history of regulatory intervention in public health suggests that 'tipping points' necessary to catalyse regulatory change may be identified. We examine three areas in which governments have legislated to protect public health: sanitation, building standards, and vehicle emissions. We apply the lessons to regulatory reform addressing obesity and the chronic disease it causes.

  16. 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...

  17. Summation from a regulatory perspective

    PubMed Central

    Ohanian, Edward V.; Cotruvo, Joseph A.

    1986-01-01

    There is an urgent need to discuss the Office of Drinking Water's standard-setting or rulemaking process since most of the researchers whose papers are presented here directly or indirectly play a crucial role in this complex undertaking. Therefore, this paper will address the research data required to support policymaking and regulatory decisions pertaining to health effects of disinfectants and disinfection by-products. PMID:3816731

  18. 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.

  19. 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.

  20. The Reach Address Database (RAD)

    EPA Pesticide Factsheets

    The Reach Address Database (RAD) stores reach address information for each Water Program feature that has been linked to the underlying surface water features (streams, lakes, etc) in the National Hydrology Database (NHD) Plus dataset.

  1. Regulatory considerations for biosimilars.

    PubMed

    Nellore, Ranjani

    2010-01-01

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

  2. The Regulatory Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] #7; #7; The Regulatory Plan #7; #7; ] OPEN GOVERNMENT AND EVIDENCE-BASED REGULATION There is a close connection, even an inextricable relationship, between open government and evidence- based regulation. If regulatory choices are based on careful analysis of...

  3. Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

    SciTech Connect

    Grabaskas, David; Bucknor, Matthew; Jerden, James; Brunett, Acacia J.

    2016-02-01

    The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides during a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.

  4. Glycoconjugate Vaccines: The Regulatory Framework.

    PubMed

    Jones, Christopher

    2015-01-01

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

  5. 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 ...

  6. 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).

  7. Current Research and Opportunities to Address Environmental Asbestos Exposures

    EPA Science Inventory

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

  8. 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…

  9. Chemical Education in India: Addressing Current Challenges and Optimizing Opportunities

    ERIC Educational Resources Information Center

    Krishnan, Mangala Sunder; Brakaspathy, R.; Arunan, E.

    2016-01-01

    This article gives a brief introduction to the structure of higher education programs in chemical and general sciences in India. The lack of high-quality chemical education in India in the past is traced back to the economic and social developments of the past. Remedial measures undertaken recently to improve the overall quality of chemical…

  10. Current Issues Concerning Clinical Optometric Education. Keynote Address.

    ERIC Educational Resources Information Center

    Imperato, Pascal James

    1996-01-01

    Clinical optometric education is in flux. It must meet the challenges of advances in bioscience, newer diagnostic and therapeutic modalities, a changing health care environment, and interdisciplinary learning for problem solving; engender social responsibility; promote good provider-patient relations; stress primary care; and emphasize prevention.…

  11. 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

  12. CONTENT-ADDRESSABLE MEMORY SYSTEMS,

    DTIC Science & Technology

    The utility of content -addressable memories (CAM’s) within a general purpose computing system is investigated. Word cells within CAM may be...addressed by the character of all or a part of cell contents . Multimembered sets of word cells may be addressed simultaneously. The distributed logical...package is developed which allows simulation of CAM commands within job programs run on the IBM 7090 and derives tallies of execution times corresponding to a particular realization of a CAM system . (Author)

  13. Contextual analysis of machine-printed addresses

    NASA Astrophysics Data System (ADS)

    Cullen, Peter B.; Ho, Tin K.; Hull, Jonathan J.; Prussak, Michal; Srihari, Sargur N.

    1992-08-01

    The assignment of a nine digit ZIP Code (ZIP + 4 Code) to the digital image of a machine printed address block is a problem of central importance in automated mail sorting. This problem is especially difficult since most addresses do not contain ZIP + 4 Codes and often the information that must be read to match an address to one of the 28 million entries in the ZIP + 4 file is either erroneous, incomplete, or missing altogether. This paper discusses a system for interpreting a machine printed address and assigning a ZIP + 4 Code that uses a constraint satisfaction approach. Words in an address block are first segmented and parsed to assign probable semantic categories. Word images are then recognized by a combination of digit, character, and word recognition algorithms. The control structure uses a constraint satisfaction problem solving approach to match the recognition results to an entry in the ZIP + 4 file. It is shown how this technique can both determine correct responses as well as compensate for incomplete or erroneous information. Experimental results demonstrate the success of this system. In a recent test on over 1000 machine printed address blocks, the ZIP + 4 encode rate was over 73 percent. This compares to the success rate of current postal OCRs which is about 45 percent. Additionally, the word recognition algorithm recognizes over 92 percent of the input images (over 98 percent in the top 10 choices.

  14. 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

  15. 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.

  16. Anti-regulatory T cells.

    PubMed

    Andersen, Mads Hald

    2017-04-01

    Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells-termed anti-regulatory T cells (anti-Tregs)-that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells, including indoleamine 2,3-dioxygenase (IDO), tryptophan 2,6-dioxygenase (TDO), programmed death-ligand 1 (PD-L1), and forkhead box P3 (Foxp3). These proteins are highly expressed in professional antigen-presenting cells under various physiological conditions, such as inflammation and stress. Therefore, self-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles in immune homeostasis and their potential future clinical applications.

  17. 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.

  18. Regulatory Considerations for Biosimilars

    PubMed Central

    Nellore, Ranjani

    2010-01-01

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

  19. Strengthening the Canadian alcohol advertising regulatory system.

    PubMed

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

    2012-05-24

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

  20. Address block localization based on graph theory

    NASA Astrophysics Data System (ADS)

    Gaceb, Djamel; Eglin, Véronique; Lebourgeois, Frank; Emptoz, Hubert

    2008-01-01

    An efficient mail sorting system is mainly based on an accurate optical recognition of the addresses on the envelopes. However, the localizing of the address block (ABL) should be done before the OCR recognition process. The location step is very crucial as it has a great impact on the global performance of the system. Currently, a good localizing step leads to a better recognition rate. The limit of current methods is mainly caused by modular linear architectures used for ABL: their performances greatly depend on each independent module performance. We are presenting in this paper a new approach for ABL based on a pyramidal data organization and on a hierarchical graph coloring for classification process. This new approach presents the advantage to guarantee a good coherence between different modules and reduces both the computation time and the rejection rate. The proposed method gives a very satisfying rate of 98% of good locations on a set of 750 envelope images.

  1. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES 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...

  2. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES 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...

  3. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES 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...

  4. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES 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...

  5. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES 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...

  6. 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...

  7. Address tracing for parallel machines

    NASA Technical Reports Server (NTRS)

    Stunkel, Craig B.; Janssens, Bob; Fuchs, W. Kent

    1991-01-01

    Recently implemented parallel system address-tracing methods based on several metrics are surveyed. The issues specific to collection of traces for both shared and distributed memory parallel computers are highlighted. Five general categories of address-trace collection methods are examined: hardware-captured, interrupt-based, simulation-based, altered microcode-based, and instrumented program-based traces. The problems unique to shared memory and distributed memory multiprocessors are examined separately.

  8. 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.

  9. Is Maxwell's Displacement Current a Current?

    ERIC Educational Resources Information Center

    French, A. P.

    2000-01-01

    Discusses in detail the claim that certain well-known physics experiments demonstrate the magnetic field produced by Maxwell's displacement current. Addresses the question of whether the displacement current acts as a source of magnetic field in the same way as a current in a wire would. (Contains 12 references.) (WRM)

  10. Every Other Day. Keynote Address.

    ERIC Educational Resources Information Center

    Tiller, Tom

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

  11. Agenda to address climate change

    SciTech Connect

    1998-10-01

    This document looks at addressing climate change in the 21st century. Topics covered are: Responding to climate change; exploring new avenues in energy efficiency; energy efficiency and alternative energy; residential sector; commercial sector; industrial sector; transportation sector; communities; renewable energy; understanding forests to mitigate and adapt to climate change; the Forest Carbon budget; mitigation and adaptation.

  12. Addressing Phonological Questions with Ultrasound

    ERIC Educational Resources Information Center

    Davidson, Lisa

    2005-01-01

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

  13. 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…

  14. State of the Lab Address

    ScienceCinema

    King, Alex

    2016-07-12

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

  15. Regulatory Risk Management of Advanced Nuclear Power Plants

    SciTech Connect

    George, Glenn R.

    2002-07-01

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

  16. Regulatory Information By Sector

    EPA Pesticide Factsheets

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  17. Presidential address. Fatti Maschii Parole Femine.

    PubMed

    Murphy, G P

    1984-03-15

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

  18. 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.

  19. Terms of Address in the Chinese Business Enterprise

    ERIC Educational Resources Information Center

    Huang, Xiaoyan; Sultan, Robert

    2014-01-01

    This study examines terms of address currently used by employees of Chinese business enterprises. The authors find that a speaker's address selections are related significantly to the gender of the speaker, the location of the enterprise in Eastern or Western China, and the ownership type of the enterprise; that is, whether the enterprise is…

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

    ERIC Educational Resources Information Center

    Center for Mental Health in Schools at UCLA, 2006

    2006-01-01

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

  1. The 2006 ACTER Presidential Address: The Premier Educational Delivery System

    ERIC Educational Resources Information Center

    Elliot, Jack

    2007-01-01

    In this address, ACTER President Jack Elliot states that Career and Technical Education (CTE) is the premier educational delivery system in the world. It addresses all learning styles by employing pedagogical strategies that embrace all of the multiple intelligence areas and incorporate the current knowledge in brain-based research. He discusses…

  2. Atomic clusters with addressable complexity

    NASA Astrophysics Data System (ADS)

    Wales, David J.

    2017-02-01

    A general formulation for constructing addressable atomic clusters is introduced, based on one or more reference structures. By modifying the well depths in a given interatomic potential in favour of nearest-neighbour interactions that are defined in the reference(s), the potential energy landscape can be biased to make a particular permutational isomer the global minimum. The magnitude of the bias changes the resulting potential energy landscape systematically, providing a framework to produce clusters that should self-organise efficiently into the target structure. These features are illustrated for small systems, where all the relevant local minima and transition states can be identified, and for the low-energy regions of the landscape for larger clusters. For a 55-particle cluster, it is possible to design a target structure from a transition state of the original potential and to retain this structure in a doubly addressable landscape. Disconnectivity graphs based on local minima that have no direct connections to a lower minimum provide a helpful way to visualise the larger databases. These minima correspond to the termini of monotonic sequences, which always proceed downhill in terms of potential energy, and we identify them as a class of biminimum. Multiple copies of the target cluster are treated by adding a repulsive term between particles with the same address to maintain distinguishable targets upon aggregation. By tuning the magnitude of this term, it is possible to create assemblies of the target cluster corresponding to a variety of structures, including rings and chains.

  3. 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.

  4. Optical addressing technique for a CMOS RAM

    NASA Technical Reports Server (NTRS)

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

    1988-01-01

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

  5. 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

  6. 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

  7. 78 FR 44279 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... Regulatory Flexibility Act, 5 U.S.C. sections 601 to 612 (1988). FOR FURTHER INFORMATION CONTACT: Robert... mandated for the regulatory flexibility agendas required by the Regulatory Flexibility Act (5 U.S.C. 602... regulatory flexibility agenda, in accordance with the Regulatory Flexibility Act, because they are likely...

  8. 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.

  9. 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.

  10. Current limitations and recommendations to improve testing ...

    EPA Pesticide Factsheets

    In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across organizations, but all basically evaluate whether a chemical possesses endocrine activity and whether this activity can result in adverse outcomes either to humans or the environment. Current test systems include in silico, in vitro and in vivo techniques focused on detecting potential endocrine activity, and in vivo tests that collect apical data to detect possible adverse effects. These test systems are currently designed to robustly assess endocrine activity and/or adverse effects in the estrogen, androgen, and thyroid hormonal pathways; however, there are some limitations of current test systems for evaluating endocrine hazard and risk. These limitations include a lack of certainty regarding: 1)adequately sensitive species and life-stages, 2) mechanistic endpoints that are diagnostic for endocrine pathways of concern, and 3) the linkage between mechanistic responses and apical, adverse outcomes. Furthermore, some existing test methods are resource intensive in regard to time, cost, and use of animals. However, based on recent experiences, there are opportunities to improve approaches to, and guidance for existing test methods, and to reduce uncertainty. For example, in vitro high throughput

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Safety and regulatory requirements and challenge for CNS drug development.

    PubMed

    Gad, Shayne C

    2014-01-01

    As our recognition and understanding of diseases and disorders of the central nervous system (CNS) become more insightful, and society's concerns for the safety, efficacy, and use of such drugs become more acute, the regulatory requirements and expectations around assessing potential safety of the drug have continued to become more complex. Currently, these concerns and requirements are addressed in a time phased manner, attempting to match the advance of spending rate on assessing safety issues in alignment with advancing the moiety through development of the therapeutics. This article seeks to communicate all the critical but frequently overlooked aspects of current and pending regulatory requirements including the lesser known parts associated with impurities, active metabolites, and distribution of active components to (and subsequent clearance from) the population brain. While there are some exciting developments in treating CNS diseases with stem cells and some protein based therapies (Aboody et al., 2011), drugs meant to favorably effect, prevent, or cure a disease process within the central nervous system (CNS) are primarily small molecule and must meet a number of regulatory and scientifically mandated criteria to establish that their safety in clinical use is acceptable. This is initially done in in vivo animals or in in vitro preparations. The starting place for such nonclinical safety assessment requires some fundamental assumptions about the potential therapeutic (Ball et al., 2007; Gad, 2009; ICH S6, 2004; ICH M3 (R2), 2008). The first assumption is that the primary intended route of therapeutic administration is oral, as is indeed the case for the vast majority of both current and for most potential new drugs. Most aspects of nonclinical safety assessment do not depend on route, and we will consider the situations where the use of other routes influences requirements for nonclinical safety assessment, and why. A second general case assumption in the

  17. Regulatory myeloid cells in transplantation.

    PubMed

    Rosborough, Brian R; Raïch-Regué, Dàlia; Turnquist, Heth R; Thomson, Angus W

    2014-02-27

    Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages, regulatory dendritic cells, and myeloid-derived suppressor cells to regulate alloimmunity, their potential as cellular therapeutic agents, and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity after RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and to promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and to usher in a new era of immune modulation exploiting cells of myeloid origin.

  18. 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

  19. Content-addressable holographic databases

    NASA Astrophysics Data System (ADS)

    Grawert, Felix; Kobras, Sebastian; Burr, Geoffrey W.; Coufal, Hans J.; Hanssen, Holger; Riedel, Marc; Jefferson, C. Michael; Jurich, Mark C.

    2000-11-01

    Holographic data storage allows the simultaneous search of an entire database by performing multiple optical correlations between stored data pages and a search argument. We have recently developed fuzzy encoding techniques for this fast parallel search and demonstrated a holographic data storage system that searches digital data records with high fidelity. This content-addressable retrieval is based on the ability to take the two-dimensional inner product between the search page and each stored data page. We show that this ability is lost when the correlator is defocussed to avoid material oversaturation, but can be regained by the combination of a random phase mask and beam confinement through total internal reflection. Finally, we propose an architecture in which spatially multiplexed holograms are distributed along the path of the search beam, allowing parallel search of large databases.

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 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.

  7. Regulatory T cell memory

    PubMed Central

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  8. 3 CFR - Regulatory Compliance

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... protecting the air we breathe and the water we drink. Consistent regulatory enforcement also levels the... can lead the Government to hold itself more accountable, encouraging agencies to identify and...

  9. 3 CFR - Regulatory Review

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... in general—should be revisited. I therefore direct the Director of OMB, in consultation with... delay; clarify the role of the behavioral sciences in formulating regulatory policy; and identify...

  10. A review of research examining the regulatory role of lymphocytes in normal wound healing.

    PubMed

    Keen, D

    2008-05-01

    Lymphocytes play a distinct, regulatory role in normal wound healing through the secretion of lymphokines. This paper evaluates the current research on the regulatory role of lymphocytes and their secretions in normal wound healing.

  11. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug... Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical...

  12. Legal and regulatory responses to innovative treatment.

    PubMed

    Chan, Tracey Evans

    2013-01-01

    Developments in medical technology, healthcare delivery, and commercial interests in medicine have increased both the potential for conflicts of interest on the part of physicians, and doubts over the sufficiency of patient autonomy as a justification for administering innovative therapy. The legal and regulatory treatment of innovative therapy is therefore an important question, on which there is a current lack of consensus on a number of issues. This paper discusses recent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment: the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight.

  13. 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.

  14. 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.

  15. 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.

  16. A region addresses patient safety.

    PubMed

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

    2002-06-01

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

  17. 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.

  18. 78 FR 1604 - Department Regulatory Agenda; Semiannual Summary

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ...The Regulatory Agenda is a semiannual summary of all current and projected rulemakings, reviews of existing regulations, and completed actions of the Department. The Agenda provides the public with information about the Department of Transportation's regulatory activity. It is expected that this information will enable the public to be more aware of and allow it to more effectively participate......

  19. 77 FR 7980 - Department Regulatory Agenda; Semiannual Summary

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ...The Regulatory Agenda is a semiannual summary of all current and projected rulemakings, reviews of existing regulations, and completed actions of the Department. The Agenda provides the public with information about the Department of Transportation's regulatory activity. It is expected that this information will enable the public to be more aware of and allow it to more effectively participate......

  20. 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.

  1. 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.

  2. 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

  3. Perspectives in regulatory science: translational and clinical pharmacology.

    PubMed

    Grillo, Joseph A; Huang, Shiew Mei

    This paper focuses on the role of clinical and translational pharmacology in the drug development and the regulatory process. Contemporary regulatory issues faced by FDA's Office of Clinical Pharmacology (OCP) in fulfilling its mission to advance the science of drug response and translate patient diversity into optimal drug therapy are discussed. Specifically current focus of the following key aspects of the drug development and regulatory science processes are discussed: the OCP vision and mission, two key OCP initiatives (i.e. guidance modernization, labeling and health communications), and translational and clinical pharmacology related regulatory science issues in (i.e. uncertainty, breakthrough therapies, individualization).

  4. 75 FR 61530 - Issuance of Regulatory Guides

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Issuance of Regulatory Guides AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY:...

  5. 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.

  6. 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.

  7. 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.

  8. Current limitations and recommendations to improve testing for the environmental assessment of endocrine active substances

    EPA Science Inventory

    In this paper existing regulatory frameworks and test systems for assessing potential endocrine-active chemicals are described, and associated challenges discussed, along with proposed approaches to address these challenges. Regulatory frameworks vary somewhat across organizatio...

  9. 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.

  10. T Regulatory Cells and Transplantation Tolerance

    PubMed Central

    Gorantla, Vijay S.; Schneeberger, Stefan; Brandacher, Gerald; Sucher, Robert; Zhang, Dong; Lee, Andrew; Zheng, Xin Xiao

    2010-01-01

    Despite the development of successful immunosuppression protocols and tremendous improvement in short-term graft survival rates, the problem of chronic graft loss remains the bane of clinical transplantation. The induction and maintenance of transplantation tolerance is the “Holy grail” of transplantation. The recent identification and characterization of regulatory T cells (T regs) has opened up exciting opportunities for tolerance induction, immunotherapy and immunomodulation in transplantation. This review focuses on current understanding of regulatory T cells and their role in transplantation tolerance. PMID:20541385

  11. 75 FR 15423 - U.S. Nuclear Regulatory Commission Technical Evaluation Report for the Phase 1 Decommissioning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    .... Nuclear Regulatory Commission Technical Evaluation Report for the Phase 1 Decommissioning Plan for the... Regulatory Commission (NRC) Technical Evaluation Report (TER) for the Phase 1 Decommissioning Plan for the... Center (DOE/ EIS-0226). ADDRESSES: Copies of the U.S. Nuclear Regulatory Commission Technical...

  12. The Dessau workshop on bioaccumulation: state of the art, challenges and regulatory implications.

    PubMed

    Treu, Gabriele; Drost, Wiebke; Jöhncke, Ulrich; Rauert, Caren; Schlechtriem, Christian

    2015-01-01

    Bioaccumulation plays a vital role in understanding the fate of a substance in the environment and is key to the regulation of chemicals in several jurisdictions. The current assessment approaches commonly use the octanol-water partition coefficient (log KOW) as an indicator for bioaccumulation and the bioconcentration factor (BCF) as a standard criterion to identify bioaccumulative substances show limitations. The log KOW does not take into account active transport phenomena or special structural properties (e.g., amphiphilic substances or dissociating substances) and therefore additional screening criteria are required. Regulatory BCF studies are so far restricted to fish and uptake through the gills. Studies on (terrestrial) air-breathing organisms are missing. Though there are alternative tests such as the dietary exposure bioaccumulation fish test described in the recently revised OECD test guideline 305, it still remains unclear how to deal with results of alternative tests in regulatory decision-making processes. A substantial number of bioaccumulation fish tests are required in regulation. The development of improved test systems following the 3R principles, namely to replace, reduce and refine animal testing, is thus required. All these aspects stress the importance to further develop the assessment of bioaccumulation. The Dessau Workshop on Bioaccumulation which was held from June 26th to 27th 2014, in Dessau, Germany, provided a comprehensive overview of the state of the art of bioaccumulation assessment, provided insights into the problems and challenges addressed by the regulatory authorities and described new research concepts and their regulatory implications. The event was organised by UBA (Dessau, Germany) and Fraunhofer IME (Schmallenberg, Germany). About 50 participants from industry, regulatory bodies and academia listened to 14 lectures on selected topics and joined the plenary discussions.

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

    SciTech Connect

    MULKEY, C.H.

    1999-07-06

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

  14. A regulatory model for clinical laboratories: an empirical evaluation.

    PubMed

    Peddecord, K M

    1989-04-01

    Clinical laboratories in the United States are subject to various regulatory and accreditation programs, which mandate a broad range of requirements regarding personnel, quality-control systems, and analytical proficiency standards. Reported here, for a cross-section of U.S. laboratories, is the degree of compliance with these regulatory requirements, some other laboratory characteristics, and their relation to analytical proficiency. The results suggest that those laboratory characteristics that predict highest proficiency-test performance differ for each laboratory specialty. Regression models are presented that explain from 12% to 35% of the variation in analytical performance and suggest that factors outside of those specified in the regulatory model and other characteristics measured in this research are important. Indeed, the current regulatory approach may not ensure highest performance. Also discussed are the current status, limitations, and prospects for change of the clinical laboratory regulatory system.

  15. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  16. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  17. 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.

  18. 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...

  19. 75 FR 54349 - Animal Models-Essential Elements To Address Efficacy Under the Animal Rule; Notice of Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... HUMAN SERVICES Food and Drug Administration Animal Models--Essential Elements To Address Efficacy Under... concerns of industry, other government agencies, and interested parties on the regulatory and scientific challenges as addressed in the draft document entitled ``Guidance for ] Industry: Animal...

  20. 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.

  1. 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...

  2. 78 FR 52810 - Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of Filing and Immediate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... addresses industry topics that establish the appropriate regulatory and procedural knowledge base necessary...., CBOE Rule 3.6A.08(b); NASD Notice to Members 01- 51 (August 2001), available at http://www.finra.org... address industry topics and establish the appropriate regulatory and procedural knowledge base relevant...

  3. The Role of Nutrition-Related Initiatives in Addressing Community Health Needs Assessments

    ERIC Educational Resources Information Center

    George, Daniel R.; Rovniak, Liza S.; Dillon, Judy; Snyder, Gail

    2017-01-01

    Academic Health Centers and nonprofit hospitals are exploring strategies to meet Affordable Care Act mandates requiring tax-exempt institutions to address community health needs, which commonly include major chronic illnesses. We explore the implications of this regulatory landscape, describing methods that nonprofit health care institutions are…

  4. 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…

  5. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  6. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

  7. 16 CFR 0.2 - Official address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Official address. The principal office of the Commission is at Washington, DC. All communications to the Commission should be addressed to the Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington,...

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

    PubMed

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

    2011-01-01

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

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 37 CFR 41.10 - Correspondence addresses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Correspondence addresses. 41... Correspondence addresses. Except as the Board may otherwise direct, (a) Appeals. Correspondence in an application... correspondence in an application or a patent involved in an appeal to the Board for which an address is...

  15. 37 CFR 41.10 - Correspondence addresses.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Correspondence addresses. 41... Correspondence addresses. Except as the Board may otherwise direct, (a) Appeals. Correspondence in an application... correspondence in an application or a patent involved in an appeal to the Board for which an address is...

  16. 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...

  17. 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...

  18. Multiregional medical device development: regulatory perspective.

    PubMed

    Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    There are difficulties in conducting worldwide medical device development simultaneously because each country and/or region has their own medical device regulations. However, to aid globalization of the medical device market, and to quickly provide innovative medical devices to patients, attempts have been made to encourage harmonization and convergence of medical device regulations. 'Harmonization by doing' is a bilateral effort from the United States and Japan to develop global clinical trials and address regulatory barriers that may be impediments to timely device approval. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. Since 2012, the GHTF has been replaced by the International Medical Device Regulators Forum.

  19. 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.

  20. 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.

  1. 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.

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

    PubMed

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

    2010-04-01

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

  3. High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

    PubMed

    Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

    2007-01-01

    Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

  4. Functional footprinting of regulatory DNA

    PubMed Central

    Vierstra, Jeff; Reik, Andreas; Chang, Kai-Hsin; Stehling-Sun, Sandra; Zhou, Yuan-Yue; Hinkley, Sarah J.; Paschon, David E.; Zhang, L.; Psatha, Nikoletta; Bendana, Yuri R.; O'Neill, Colleen M.; Song, Alex H.; Mich, Andrea; Liu, Pei-Qi; Lee, Gary; Bauer, Daniel E.; Holmes, Michael C.; Orkin, Stuart H.; Papayannopoulou, Thalia; Stamatoyannopoulos, George; Rebar, Edward J.; Gregory, Philip D.; Urnov, Fyodor D.; Stamatoyannopoulos, John A.

    2017-01-01

    Regulatory regions harbor multiple transcription factor recognition sites; however, the contribution of individual sites to regulatory function remains challenging to define. We describe a facile approach that exploits the error-prone nature of genome editing-induced double-strand break repair to map functional elements within regulatory DNA at nucleotide resolution. We demonstrate the approach on a human erythroid enhancer, revealing single TF recognition sites that gate the majority of downstream regulatory function. PMID:26322838

  5. 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.

  6. 77 FR 1777 - 60-Day Notice of Proposed Information Collection: DS-261, Electronic Choice of Address and Agent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ...). Form Number: DS-261. Respondents: Immigrant beneficiaries requesting change of address or designation... an approved and current immigrant visa petition to provide the Department with his current...

  7. 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.

  8. 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…

  9. NIH Research Addresses Aging Issues and Disparities in Oral Health

    MedlinePlus

    ... please turn JavaScript on. Feature: Oral Health and Aging NIH Research Addresses Aging Issues and Disparities in Oral Health Past Issues / ... What types of research is NIDCR conducting on aging and oral health? We’re currently funding basic ...

  10. 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…

  11. 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.

  12. 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…

  13. Effective Language Education Practices and Native Language Survival. Keynote Address.

    ERIC Educational Resources Information Center

    Littlebear, Dick

    The importance of Native languages to Native Americans and the effort needed to maintain them are discussed in this keynote address at the ninth Native American Language Issues Institute. It is noted that the current cultural transition has demeaned Native languages and cultures and that strategies must be devised by Native Americans to counter…

  14. 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.

  15. Reconstructing prokaryotic transcriptional regulatory networks: lessons from actinobacteria

    PubMed Central

    Venancio, Thiago M; Aravind, L

    2009-01-01

    Reconstruction of transcriptional regulatory networks of uncharacterized bacteria is a main challenge for the post-genomic era. Recent studies, including one in BMC Systems Biology, address this problem in the relatively underexplored actinobacteria clade, which includes major pathogenic and economically relevant taxa. PMID:19435474

  16. Hydraulic Fracturing Fluid Analysis for Regulatory Parameters - A Progress Report

    EPA Pesticide Factsheets

    This presentation is a progress report on the analysis of Hydraulic Fracturing Fluids for regulatory compounds outlined in the various US EPA methodologies. Fracturing fluids vary significantly in consistency and viscosity prior to fracturing. Due to the nature of the fluids the analytical challenges will have to be addressed. This presentation also outlines the sampling issues associated with the collection of dissolved gas samples.

  17. 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.

  18. 78 FR 52814 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... addresses industry topics that establish the appropriate regulatory and procedural knowledge base necessary...); NASD Notice to Members 01- 51 (August 2001), available at http://www.finra.org/web/groups/industry/@ip... establish the appropriate regulatory and procedural knowledge base relevant to proprietary trading....

  19. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    SciTech Connect

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

    2006-01-01

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

  20. 75 FR 61531 - Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... E. Norris, Component Integrity Branch, Division of Engineering, Office of Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice. SUMMARY:...

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

    PubMed

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

    2015-01-01

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

  2. 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).

  3. 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

  4. Taking Steps To Address the Digital Divide.

    ERIC Educational Resources Information Center

    Sorensen, Barbara

    2001-01-01

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

  5. 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.

  6. 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.

  7. 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.

  8. 75 FR 10671 - Changes to and Consolidation of DEA Mailing Addresses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-09

    ...DEA is amending Title 21 of the Code of Federal Regulations (CFR) to update and consolidate existing mailing addresses. Mailing addresses are being removed from the individual sections in which they currently appear and are being consolidated into one table in a new part 1321. DEA is making this change to the CFR to ensure registrants have the most current and accurate information, reduce......

  9. 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.

  10. 49 CFR 1102.1 - How addressed.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false How addressed. 1102.1 Section 1102.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE COMMUNICATIONS § 1102.1 How addressed. All communications...

  11. 49 CFR 1102.1 - How addressed.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 8 2013-10-01 2013-10-01 false How addressed. 1102.1 Section 1102.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE COMMUNICATIONS § 1102.1 How addressed. All communications...

  12. 49 CFR 1102.1 - How addressed.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 8 2014-10-01 2014-10-01 false How addressed. 1102.1 Section 1102.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE COMMUNICATIONS § 1102.1 How addressed. All communications...

  13. 49 CFR 1102.1 - How addressed.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 8 2012-10-01 2012-10-01 false How addressed. 1102.1 Section 1102.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE COMMUNICATIONS § 1102.1 How addressed. All communications...

  14. 49 CFR 1102.1 - How addressed.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 8 2011-10-01 2011-10-01 false How addressed. 1102.1 Section 1102.1 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE COMMUNICATIONS § 1102.1 How addressed. All communications...

  15. 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)

  16. 49 CFR 369.6 - Address.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS REPORTS OF MOTOR CARRIERS § 369.6 Address. The following address must be used by motor carriers when submitting a report, requesting an exemption from filing...

  17. 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....

  18. 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…

  19. 37 CFR 41.10 - Correspondence addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Correspondence addresses. 41....10 Correspondence addresses. Except as the Board may otherwise direct, (a) Appeals. Correspondence in... all other correspondence in an application or a patent involved in an appeal to the Board for which...

  20. 37 CFR 41.10 - Correspondence addresses.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Correspondence addresses. 41....10 Correspondence addresses. Except as the Board may otherwise direct, (a) Appeals. Correspondence in... all other correspondence in an application or a patent involved in an appeal to the Board for which...

  1. 37 CFR 41.10 - Correspondence addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Correspondence addresses. 41....10 Correspondence addresses. Except as the Board may otherwise direct, (a) Appeals. Correspondence in... all other correspondence in an application or a patent involved in an appeal to the Board for which...

  2. 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…

  3. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false Address searches. 674.44 Section 674.44 Education..., DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If mail... litigation; (2) The account is assigned to the United States; or (3) The account is written off under §...

  4. 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..., DEPARTMENT OF EDUCATION FEDERAL PERKINS LOAN PROGRAM Due Diligence § 674.44 Address searches. (a) If mail... litigation; (2) The account is assigned to the United States; or (3) The account is written off under §...

  5. 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…

  6. 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.

  7. Automated measurement of printer effective addressability

    NASA Astrophysics Data System (ADS)

    Cooper, Brian E.; Eid, Ahmed H.; Rippetoe, Edward E.

    2014-01-01

    When evaluating printer resolution, addressability is a key consideration. Addressability defines the maximum number of spots or samples within a given distance, independent of the size of the spots when printed. Effective addressability is the addressability demonstrated by the final, printed output. It is the minimum displacement possible between the centers of printed objects. In this paper, we present a measurement procedure for effective addressability that offers an automated way to experimentally determine the addressability of the printed output. It requires printing, scanning, and measuring a test target. The effective addressability test target contains two types of elements, repeated to fill the page: fiducial lines and line segments. The fiducial lines serve as a relative reference for the incremental displacements of the individual line segments, providing a way to tolerate larger-scale physical distortions in the printer. An ordinary reflection scanner captures the printed test target. By rotating the page on the scanner, it is possible to measure effective addressability well beyond the scanner's sampling resolution. The measurement algorithm computes the distribution of incremental displacements, forming either a unimodal or bimodal histogram. In the latter case, the mean of the second (non-zero) peak indicates the effective addressability. In the former case, the printer successfully rendered the target's resolution, requiring another iteration of the procedure after increasing the resolution of the test target. The algorithm automatically estimates whether the histogram is unimodal or bimodal and computes parameters describing the quality of the measured histogram. Several experiments have refined the test target and measurement procedure, including two round-robin evaluations by the ISO WG4 committee. Results include an analysis of approximately 150 printed samples. The effective addressability attribute and measurement procedure are included in

  8. Meeting Regulatory Needs.

    PubMed

    Weber, Michael Fred

    2017-02-01

    The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

  9. Clinical research: regulatory issues.

    PubMed

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  10. Firewall for Dynamic IP Address in Mobile IPv6

    NASA Astrophysics Data System (ADS)

    Qiu, Ying; Bao, Feng; Zhou, Jianying

    Mobile communication is becoming the mainstream with the rapid growth of mobile devices penetrating our daily life. More and more mobile devices such as mobile phones, personal digital assistants, notebooks etc, are capable of Internet access. Mobile devices frequently change their communication IP addresses in mobile IPv6 network following its current attached domain. This raises a big challenge for building firewall for mobile devices. The conventional firewalls are primarily based on IPv4 networks where the security criteria are specified only to the fixed IP addresses or subnets, which apparently do not apply to mobile IPv6. In this paper we propose three solutions for mobile IPv6 firewall. Our approaches make the firewall adaptive to dynamic IP addresses in mobile IPv6 network. They have different expense and weight corresponding to different degree of universality. The paper focuses the study more from practical aspect.

  11. Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

    PubMed

    Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

    2017-02-09

    Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

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

    PubMed

    Uchida, Eriko; Igarashi, Yuka; Sato, Yoji

    2014-01-01

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

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

    PubMed

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

    2013-01-01

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

  14. [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.

  15. 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…

  16. 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.

  17. 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

  18. 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.

  19. Perchlorate Regulatory Determination Fact Sheets

    EPA Pesticide Factsheets

    Fact sheets have been developed for the perchlorate regulatory determination corresponding to the following stages published in the Federal Register: Final, Supplemental request for comments, and Preliminary.

  20. Regulatory issues for deep borehole plutonium disposition

    SciTech Connect

    Halsey, W.G.

    1995-03-01

    As a result of recent changes throughout the world, a substantial inventory of excess separated plutonium is expected to result from dismantlement of US nuclear weapons. The safe and secure management and eventual disposition of this plutonium, and of a similar inventory in Russia, is a high priority. A variety of options (both interim and permanent) are under consideration to manage this material. The permanent solutions can be categorized into two broad groups: direct disposal and utilization. The deep borehole disposition concept involves placing excess plutonium deep into old stable rock formations with little free water present. Issues of concern include the regulatory, statutory and policy status of such a facility, the availability of sites with desirable characteristics and the technologies required for drilling deep holes, characterizing them, emplacing excess plutonium and sealing the holes. This white paper discusses the regulatory issues. Regulatory issues concerning construction, operation and decommissioning of the surface facility do not appear to be controversial, with existing regulations providing adequate coverage. It is in the areas of siting, licensing and long term environmental protection that current regulations may be inappropriate. This is because many current regulations are by intent or by default specific to waste forms, facilities or missions significantly different from deep borehole disposition of excess weapons usable fissile material. It is expected that custom regulations can be evolved in the context of this mission.

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

    PubMed

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

    2014-08-01

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

  2. The 2016 AANS Presidential Address: Leading the way.

    PubMed

    Batjer, H Hunt; Ban, Vin Shen

    2016-12-01

    This AANS presidential address focuses on enduring values of the neurosurgical profession that transcend the current political climate. The address was delivered by Dr. Batjer during a US presidential election year, but the authors have intentionally avoided discussing the current chaos of the American health care system in the knowledge that many pressing issues will change depending on the outcome of the 2016 elections. Instead, they have chosen to focus on clarifying what neurosurgeons, and the American Association of Neurological Surgeons, in particular, stand for; identifying important challenges to these fundamental principles and values; and proposing specific actions to address these challenges. The authors cite "de-professionalism" and commoditization of medicine as foremost among the threats that confront medicine and surgery today and suggest concrete action that can be taken to reverse these trends as well as steps that can be taken to address other significant challenges. They emphasize the importance of embracing exceptionalism and never compromising the standards that have characterized the profession of neurosurgery since its inception.

  3. Naturally occurring regulatory T cells: markers, mechanisms, and manipulation.

    PubMed

    Schmetterer, Klaus G; Neunkirchner, Alina; Pickl, Winfried F

    2012-06-01

    Naturally occurring CD4(+)CD25(high) forkhead box protein 3 (FOXP3)(+) regulatory T cells (nTregs) are key mediators of immunity, which orchestrate and maintain tolerance to self and foreign antigens. In the recent 1.5 decades, a multitude of studies have aimed to define the phenotype and function of nTregs and to assess their therapeutic potential for modulating immune mediated disorders such as autoimmunity, allergy, and episodes of transplant rejection. In this review, we summarize the current knowledge on the biology of nTregs. We address the exact definition of nTregs by specific markers and combinations thereof, which is a prerequisite for the state-of-the-art isolation of defined nTreg populations. Furthermore, we discuss the mechanism by which nTregs mediate immunosuppression and how this knowledge might translate into novel therapeutic modalities. With first clinical studies of nTreg-based therapies being finished, questions concerning the reliable sources of nTregs are becoming more and more eminent. Consequently, approaches allowing conversion of CD4(+) T cells into nTregs by coculture with antigen-presenting cells, cytokines, and/or pharmacological agents are discussed. In addition, genetic engineering approaches for the generation of antigen-specific nTregs are described.

  4. Implications of Developmental Gene Regulatory Networks Inside and Outside Developmental Biology.

    PubMed

    Peter, Isabelle S; Davidson, Eric H

    2016-01-01

    The insight that the genomic control of developmental process is encoded in the form of gene regulatory networks has profound impacts on many areas of modern bioscience. Most importantly, it affects developmental biology itself, as it means that a causal understanding of development requires knowledge of the architecture of regulatory network interactions. Furthermore, it follows that functional changes in developmental gene regulatory networks have to be considered as a primary mechanism for evolutionary process. We here discuss some of the recent advances in gene regulatory network biology and how they have affected our current understanding of development, evolution, and regulatory genomics.

  5. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  6. 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.

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

    NASA Astrophysics Data System (ADS)

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

    2009-09-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2010-11-01

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

  9. Regulatory and reimbursement issues regarding endoscopic bariatric procedures.

    PubMed

    Schwaitzberg, Steven D

    2011-04-01

    Although innovation marches forward and places new therapeutic options at our doorsteps, the regulatory and payer environment must be considered if any of these new opportunities will be available in the clinical mainstream. Endolumenal treatment of bariatric disease will face many of the same challenges as those the endolumenal treatment of gastroesophageal reflux has faced over the last decade. In an era of shrinking health care dollars, the challenge of reimbursement will be significant. Strategies for the implementation of endolumenal therapies for the treatment of obesity must include a data-driven approach that addresses not only regulatory but also financial concerns to be successful.

  10. Targeting regulatory T cells.

    PubMed

    Ménétrier-Caux, Christine; Curiel, Tyler; Faget, Julien; Manuel, Manuarii; Caux, Christophe; Zou, Weiping

    2012-03-01

    Cancers express tumor-associated antigens that should elicit immune response to antagonize the tumor growth, but spontaneous immune rejection of established cancer is rare, suggesting an immunosuppressive environment hindering host antitumor immunity. Among the specific and active tumor-mediated mechanisms, CD4(+)CD25(high) T regulatory cells (Treg) are important mediators of active immune evasion in cancer. In this review, we will discuss Treg subpopulations and the mechanisms of their suppressive functions. Treg depletion improves endogenous antitumor immunity and the efficacy of active immunotherapy in animal models for cancer, suggesting that inhibiting Treg function could also improve the limited successes of human cancer immunotherapy. We will also discuss specific strategies for devising effective cancer immunotherapy targeting Treg.

  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).

  12. Regulatory T cells.

    PubMed

    Thompson, Claire; Powrie, Fiona

    2004-08-01

    Regulatory T (TR) cells are a subset of T cells that function to control immune responses. Different populations of TR cells have been described, including thymically derived CD4(+)CD25+ TR cells and Tr1 cells induced in the periphery through exposure to antigen. A transcription factor, Foxp3, has been identified that is essential for CD4(+)CD25+ TR cell development and function. There is now evidence that transforming growth factor-beta might play a role in this pathway. CD4(+)CD25+ TR cells proliferate extensively in vivo in an antigen-specific manner, and can respond to both self and foreign peptides. By suppressing excessive immune responses, TR cells play a key role in the maintenance of self-tolerance, thus preventing autoimmune disease, as well as inhibiting harmful inflammatory diseases such as asthma and inflammatory bowel disease.

  13. 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.

  14. A WiFi Public Address System for Disaster Management

    PubMed Central

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

    2006-01-01

    The WiFi Bullhorn is designed to assist emergency workers in the event of a disaster situation by offering a rapidly configurable wireless public address system for disaster sites. The current configuration plays either pre recorded or custom recorded messages and utilizes 802.11b networks for communication. Units can be position anywhere wireless coverage exists to help manage crowds or to recall first responders from dangerous areas. PMID:17238466

  15. A WiFi public address system for disaster management.

    PubMed

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

    2006-01-01

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

  16. Regulatory mechanisms link phenotypic plasticity to evolvability.

    PubMed

    van Gestel, Jordi; Weissing, Franz J

    2016-04-18

    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.

  17. 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 ...

  18. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  19. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  20. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  1. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  2. 7 CFR 504.5 - Address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  3. 76 FR 27020 - Representative and Address Provisions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF COMMERCE United States Patent and Trademark Office Representative and Address Provisions ACTION: Proposed collection; comment request. SUMMARY: The United States Patent and Trademark Office (USPTO), as part of...

  4. Optical Addressing And Clocking Of RAM's

    NASA Technical Reports Server (NTRS)

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

    1989-01-01

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

  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. IA channels: diverse regulatory mechanisms.

    PubMed

    Carrasquillo, Yarimar; Nerbonne, Jeanne M

    2014-04-01

    In many peripheral and central neurons, A-type K(+) currents, IA, have been identified and shown to be key determinants in shaping action potential waveforms and repetitive firing properties, as well as in the regulation of synaptic transmission and synaptic plasticity. The functional properties and physiological roles of native neuronal IA, however, have been shown to be quite diverse in different types of neurons. Accumulating evidence suggests that this functional diversity is generated by multiple mechanisms, including the expression and subcellular distributions of IA channels encoded by different voltage-gated K(+) (Kv) channel pore-forming (α) subunits, interactions of Kv α subunits with cytosolic and/or transmembrane accessory subunits and regulatory proteins and post-translational modifications of channel subunits. Several recent reports further suggest that local protein translation in the dendrites of neurons and interactions between IA channels with other types of voltage-gated ion channels further expands the functional diversity of native neuronal IA channels. Here, we review the diverse molecular mechanisms that have been shown or proposed to underlie the functional diversity of native neuronal IA channels.

  7. Issues in Peer Review of the Scientific Basis for Regulatory Decisions.

    ERIC Educational Resources Information Center

    American Chemical Society, Washington, DC.

    This document is intended to provide a discussion of the issues that need to be addressed in the development of peer review guidelines, the options for addressing the issues, and a range of views about such options. The document focuses on peer review with regard to regulatory decisions and contains major sections which deal with: (1) what should…

  8. 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…

  9. 75 FR 79763 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ...The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semi-annual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public...

  10. Microbial regulatory and metabolic networks.

    PubMed

    Cho, Byung-Kwan; Charusanti, Pep; Herrgård, Markus J; Palsson, Bernhard O

    2007-08-01

    Reconstruction of transcriptional regulatory and metabolic networks is the foundation of large-scale microbial systems and synthetic biology. An enormous amount of information including the annotated genomic sequences and the genomic locations of DNA-binding regulatory proteins can be used to define metabolic and regulatory networks in cells. In particular, advances in experimental methods to map regulatory networks in microbial cells have allowed reliable data-driven reconstruction of these networks. Recent work on metabolic engineering and experimental evolution of microbes highlights the key role of global regulatory networks in controlling specific metabolic processes and the need to consider the integrated function of multiple types of networks for both scientific and engineering purposes.

  11. 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.

  12. Computational identification of transcriptional regulatory elements in DNA sequence

    PubMed Central

    GuhaThakurta, Debraj

    2006-01-01

    Identification and annotation of all the functional elements in the genome, including genes and the regulatory sequences, is a fundamental challenge in genomics and computational biology. Since regulatory elements are frequently short and variable, their identification and discovery using computational algorithms is difficult. However, significant advances have been made in the computational methods for modeling and detection of DNA regulatory elements. The availability of complete genome sequence from multiple organisms, as well as mRNA profiling and high-throughput experimental methods for mapping protein-binding sites in DNA, have contributed to the development of methods that utilize these auxiliary data to inform the detection of transcriptional regulatory elements. Progress is also being made in the identification of cis-regulatory modules and higher order structures of the regulatory sequences, which is essential to the understanding of transcription regulation in the metazoan genomes. This article reviews the computational approaches for modeling and identification of genomic regulatory elements, with an emphasis on the recent developments, and current challenges. PMID:16855295

  13. Impact of regulatory science on global public health.

    PubMed

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

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

  14. Computational inference of gene regulatory networks: Approaches, limitations and opportunities.

    PubMed

    Banf, Michael; Rhee, Seung Y

    2017-01-01

    Gene regulatory networks lie at the core of cell function control. In E. coli and S. cerevisiae, the study of gene regulatory networks has led to the discovery of regulatory mechanisms responsible for the control of cell growth, differentiation and responses to environmental stimuli. In plants, computational rendering of gene regulatory networks is gaining momentum, thanks to the recent availability of high-quality genomes and transcriptomes and development of computational network inference approaches. Here, we review current techniques, challenges and trends in gene regulatory network inference and highlight challenges and opportunities for plant science. We provide plant-specific application examples to guide researchers in selecting methodologies that suit their particular research questions. Given the interdisciplinary nature of gene regulatory network inference, we tried to cater to both biologists and computer scientists to help them engage in a dialogue about concepts and caveats in network inference. Specifically, we discuss problems and opportunities in heterogeneous data integration for eukaryotic organisms and common caveats to be considered during network model evaluation. This article is part of a Special Issue entitled: Plant Gene Regulatory Mechanisms and Networks, edited by Dr. Erich Grotewold and Dr. Nathan Springer.

  15. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  16. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  17. 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.

  18. 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.

  19. 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

  20. Colloid-facilitated radionuclide transport: a regulatory perspective

    NASA Astrophysics Data System (ADS)

    Dam, W. L.; Pickett, D. A.; Codell, R. B.; Nicholson, T. J.

    2001-12-01

    What hydrogeologic-geochemical-microbial conditions and processes affect migration of radionuclides sorbed onto microparticles or native colloid-sized radionuclide particles? The U.S. Nuclear Regulatory Commission (NRC) is responsible for protecting public health, safety, and the environment at numerous nuclear facilities including a potential high-level nuclear waste disposal site. To fulfill these obligations, NRC needs to understand the mechanisms controlling radionuclide release and transport and their importance to performance. The current focus of NRC staff reviews and technical interactions dealing with colloid-facilitated transport relates to the potential nuclear-waste repository at Yucca Mountain, Nevada. NRC staff performed bounding calculations to quantify radionuclide releases available for ground-water transport to potential receptors from a Yucca Mountain repository. Preliminary analyses suggest insignificant doses of plutonium and americium colloids could be derived from spent nuclear fuel. Using surface complexation models, NRC staff found that colloids can potentially lower actinide retardation factors by up to several orders of magnitude. Performance assessment calculations, in which colloidal transport of plutonium and americium was simulated by assuming no sorption or matrix diffusion, indicated no effect of colloids on human dose within the 10,000 year compliance period due largely to long waste-package lifetimes. NRC staff have identified information gaps and developed technical agreements with the U.S. Department of Energy (DOE) to ensure sufficient information will be presented in any potential future Yucca Mountain license application. DOE has agreed to identify which radionuclides could be transported via colloids, incorporate uncertainties in colloid formation, release and transport parameters, and conceptual models, and address the applicability of field data using synthetic microspheres as colloid analogs. NRC is currently

  1. Fungal regulatory evolution: cis and trans in the balance

    PubMed Central

    Thompson, Dawn Anne; Regev, Aviv

    2009-01-01

    Regulatory divergence is likely a major driving force in evolution. Comparative genomics is being increasingly used to infer the evolution of gene regulation. Ascomycota fungi are uniquely suited among eukaryotes for regulatory evolution studies, due to broad phylogenetic scope, many sequenced genomes, and tractability of genomic analysis. Here we review recent advances in the identification of the contribution of cis and trans factors to expression divergence. Whereas current strategies have led to the discovery of surprising signatures and mechanisms, we still understand very little about the adaptive role of regulatory evolution. Empirical studies including experimental evolution, comparative functional genomics and hybrid and engineered strains are showing early promise toward deciphering the contribution of regulatory divergence to adaptation. PMID:19914250

  2. Regulatory Functions of Natural Killer Cells in Multiple Sclerosis

    PubMed Central

    Gross, Catharina C.; Schulte-Mecklenbeck, Andreas; Wiendl, Heinz; Marcenaro, Emanuela; Kerlero de Rosbo, Nicole; Uccelli, Antonio; Laroni, Alice

    2016-01-01

    There is increasing evidence that natural killer (NK) cells exhibit regulatory features. Among them, CD56bright NK cells have been suggested to play a major role in controlling T cell responses and maintaining homeostasis. Dysfunction in NK cell-mediated regulatory features has been recently described in untreated multiple sclerosis (MS), suggesting a contribution to MS pathogenesis. Moreover, biological disease-modifying treatments effective in MS apparently enhance the frequencies and/or regulatory function of NK cells, further pointing toward an immunoprotective role of NK cells in MS. Here, we summarize the current knowledge on the regulatory functions of NK cells, based on their interactions with other cells belonging to the innate compartment, as well as with adaptive effector cells. We review the more recent data reporting disruption of NK cell/T cell interactions in MS and discuss how disease-modifying treatments for MS affect NK cells. PMID:28066417

  3. 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.

  4. 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).

  5. Internationalization of regulatory requirements.

    PubMed

    Juillet, Y

    2003-02-01

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

  6. 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.

  7. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

    Song, An; Lee, Anita; Garofolo, Fabio; Kaur, Surinder; Duggan, Jeff; Evans, Christopher; Palandra, Joe; Donato, Lorella Di; Xu, Keyang; Bauer, Ronald; Bustard, Mark; Chen, Linzhi; Cocea, Laurent; Croft, Stephanie; Galliccia, Fabrizio; Haidar, Sam; Hughes, Nicola; Ishii-Watabe, Akiko; Islam, Rafiqul; Jones, Barry; Kadavil, John; Krantz, Carsten; Lima Santos, Gustavo Mendes; Olah, Timothy; Pedras-Vasconcelos, João; Staelens, Ludovicus; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Spitz, Susan; Tampal, Nilufer; Thomas, Eric; Vinter, Stephen; Wakelin-Smith, Jason; Welink, Jan; Zeng, Jianing; Zhou, Shaolian

    2016-12-01

    The 2016 10th Workshop on Recent Issues in Bioanalysis (10(th) WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and Immunogenicity. As usual, it is specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecules involving LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This White Paper is published in 3 parts due to length. This part (Part 2) discusses the recommendations for Hybrid LBA/LCMS and regulatory inputs from major global health authorities. Parts 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) have been published in the Bioanalysis journal, issues 22 and 23, respectively.

  8. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method...

  9. 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.

  10. Shared address collectives using counter mechanisms

    DOEpatents

    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.

  11. Cheaper Adjoints by Reversing Address Computations

    DOE PAGES

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

    2008-01-01

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

  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.

  13. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development.

    PubMed

    Bertram, Timothy A; Johnson, Peter C; Tawil, Bill J; Van Dyke, Mark; Hellman, Kiki B

    2015-10-01

    TERMIS-AM Industry Committee (TERMIS-AM/IC), in collaboration with the TERMIS-Europe (EU)/IC, conducted a symposium involving the European Medicines Agency and the U.S. Food and Drug Administration (FDA) toward building an understanding of the rational basis for regulatory decision-making and providing a framework for decisions made during the evaluation of safety and efficacy of TE/RM technologies. This symposium was held in August 2012 during the TERMIS-WC in Vienna, Austria. Emerging from this international initiative by the European Union and the United States, representatives from the respective agencies demonstrated that there are ongoing interagency efforts for developing common national practices toward harmonization of regulatory requirements for the TE/RM products. To extend a broad-based understanding of the role of science in regulatory decision-making, TERMIS-AM/IC, in cooperation with the FDA, organized a symposium at the 2014 TERMIS-AM Annual Meeting, which was held in Washington, DC. This event provided insights from leaders in the FDA and TERMIS on the current status of regulatory approaches for the approved TE/RM products, the use of science in making regulatory decisions, and TE/RM technologies that are in the development pipeline to address unmet medical needs. A far-ranging discussion with FDA representatives, industrialists, physicians, regenerative medicine biologists, and tissue engineers considered the gaps in today's scientific and regulatory understanding of TE/RM technologies. The identified gaps represent significant opportunities to advance TE/RM technologies toward commercialization.

  14. Regulatory T cells and COPD.

    PubMed

    Dancer, Rachel; Sansom, David M

    2013-12-01

    While the innate immune system has long been implicated in the pathogenesis of COPD, a role for the acquired immune system is less well studied. The increasing recognition that COPD shares features with autoimmune disease has led to interest in a potential role for regulatory T cells, which are intimately involved in the control of autoimmunity. The suggestion that regulatory T cell numbers are increased in patients with COPD may indicate their dysfunction or resistance to suppression by target cells. Investigation of regulatory T cells may therefore be of importance in understanding the inflammation and tissue damage that occurs in patients with COPD who cease smoking.

  15. 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…

  16. 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 showcase…

  17. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Mailing addresses. 600.2 Section 600.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401...

  18. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Mailing addresses. 600.2 Section 600.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401...

  19. 21 CFR 600.2 - Mailing addresses.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Mailing addresses. 600.2 Section 600.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS... (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401...

  20. Transition through Teamwork: Professionals Address Student Access

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  1. 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…

  2. 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…

  3. Native Women at Risk: Addressing Cancer Prevention.

    ERIC Educational Resources Information Center

    Thiemann, Kay M. B.

    1994-01-01

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

  4. 50 CFR 18.78 - Mailing address.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 50 Wildlife and Fisheries 9 2014-10-01 2014-10-01 false Mailing address. 18.78 Section 18.78 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE, DEPARTMENT OF THE INTERIOR (CONTINUED... PLANTS (CONTINUED) MARINE MAMMALS Notice and Hearing on Section 103 Regulations § 18.78 Mailing...

  5. 34 CFR 674.44 - Address searches.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 mail... litigation; (2) The account is assigned to the United States; or (3) The account is written off under §...

  6. 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)

  7. Addressing Psychosocial Factors with Library Mentoring

    ERIC Educational Resources Information Center

    Farrell, Bridget; Alabi, Jaena; Whaley, Pambanisha; Jenda, Claudine

    2017-01-01

    The majority of articles on mentoring in the library and information science field address career development by emphasizing the orientation process for new librarians and building the requisite skills for a specific job. Few articles deal with the psychological and social challenges that many early-career and minority librarians face, which can…

  8. 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…

  9. 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…

  10. 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…

  11. 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…

  12. 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…

  13. 40 CFR 98.9 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... submitted to the following address: (a) For U.S. mail. Director, Climate Change Division, 1200 Pennsylvania Ave., NW., Mail Code: 6207J, Washington, DC 20460. (b) For package deliveries. Director, Climate Change Division, 1310 L St, NW., Washington, DC 20005....

  14. 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....

  15. 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:...

  16. 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:...

  17. 78 FR 35149 - Addresses of Regional Offices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR... Addresses of Regional Offices AGENCY: Fish and Wildlife Service, Interior. ACTION: Final rule. SUMMARY: We... offices in our regulations at title 50 of the Code of Federal Regulations. We are also making...

  18. EPA Addresses Environmental Justice in Houston

    EPA Pesticide Factsheets

    DALLAS - (Oct. 8, 2015) Today, the U.S. Environmental Protection Agency (EPA) announced Texas Environmental Justice Advocacy Services (t.e.j.a.s.) was selected as a grant recipient to address environmental justice (EJ) issues in the Manchester area

  19. 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…

  20. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...: Copyright Royalty Board, P.O. Box 70977, Southwest Station, Washington, DC 20024-0977. (b) If hand delivered... Building, 101 Independence Avenue, SE., Washington, DC 20559-6000. (c) If hand delivered by a commercial...., Washington, DC, Monday through Friday, between 8:30 a.m. and 4 p.m., and be addressed as follows:...

  1. 37 CFR 301.2 - Official addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...: Copyright Royalty Board, P.O. Box 70977, Southwest Station, Washington, DC 20024-0977. (b) If hand delivered... Building, 101 Independence Avenue, SE., Washington, DC 20559-6000. (c) If hand delivered by a commercial...., Washington, DC, Monday through Friday, between 8:30 a.m. and 4 p.m., and be addressed as follows:...

  2. 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…

  3. 40 CFR 80.174 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  4. 40 CFR 80.174 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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:...

  5. Addressing Deaf Culture in the Classroom.

    ERIC Educational Resources Information Center

    Pagliaro, Claudia

    2001-01-01

    The importance of recognizing the culture of deaf people is often overlooked when addressing issues of student diversity in the schools. Including the culture of deaf students can add vitality and energy to the educational environment, providing an alternative and unique perspective. This paper describes deafness, explains deaf culture, and…

  6. 50 CFR 228.8 - Mailing address.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    DOEpatents

    Gala, Alan; Ohmacht, Martin

    2014-09-02

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

  8. Personal genetics: regulatory framework in Europe from a service provider's perspective.

    PubMed

    Grimaldi, Keith A; Look, Markus P; Scioli, G Antonio; Clavero, Juan Coll; Marinos, Stathis; Tagaris, Tassos

    2011-04-01

    The purpose of this article is to give an overview and discuss the relevant regulations in place, or under consideration, regarding healthcare-related personal genetics services in Europe - this is a rapidly evolving field and in most European Union (EU) countries the regulatory framework is not yet clear. The review will be framed from the perspective of potential service providers (companies, health services and practitioners, including medical, nutritional, complementary, etc), the growing number of which will need to be aware of potential regulatory hurdles existing now and that may arise in the future. The main conclusion from the survey is that strict regulations regarding practitioner-delivered personal genetic-testing services are unlikely to be enforced over the next 5 years in most EU countries, with the exception of Germany. There is broad-based, but by no means universal, support for a strong voluntary code of practice as an alternative to government regulations to protect consumers and to enable all stakeholders to recognise serious and reputable service providers. On the other hand, there are influential bodies calling for strict regulation. As genotyping costs rapidly fall, it is likely that it will become routine and a major challenge that does not seem to be addressed by current debate on regulations is the emergence of companies offering/selling personal genetic services based on a customer's pre-existing genetic results and therefore no actual laboratory testing involved.

  9. 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.

  10. 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.

  11. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    PubMed Central

    Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

    2016-01-01

    Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

  12. Self-Assembly of Structures with Addressable Complexity.

    PubMed

    Jacobs, William M; Frenkel, Daan

    2016-03-02

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

  13. Current standardisation for nanotechnology

    NASA Astrophysics Data System (ADS)

    Bard, Delphine; Mark, David; Möhlmann, Carsten

    2009-05-01

    Standardisation and standards provide an important mechanism to support both innovation and the application of regulations. There is currently no specific regulation for any nanomaterials. Health, safety and environmental protection aspects associated with nanomaterials are however in principle covered to different levels by current EU regulatory framework. There are a number of national, European and international organisations developing standards associated with the development, description and use of nanomaterials as well as the protection of human health and the environment from the production and use of chemicals and consumer products, including nanomaterials. These organisations have also established specific committees on nanotechnology. This paper outlines the different relevant regulations and standards. This paper will mainly be focused on a European health and safety perspective.

  14. 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

  15. State/Federal Regulatory Considerations

    EPA Pesticide Factsheets

    This page contains presentations from the Brown to Green: Make the Connection to Renewable Energy workshop held in Santa Fe, New Mexico, during December 10-11, 2008, regarding State/Federal Regulatory Considerations.

  16. 77 FR 7972 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... Identifier No. 396 National Standards to 1105-AB34 Prevent, Detect, and Respond to Prison Rape (Reg Plan Seq... Prevent, Detect, and Respond to Prison Rape Regulatory Plan: This entry is Seq. No. 85 in part II of...

  17. A cis-Regulatory Signature for Chordate Anterior Neuroectodermal Genes

    PubMed Central

    Christiaen, Lionel; Joly, Jean-Stéphane

    2010-01-01

    One of the striking findings of comparative developmental genetics was that expression patterns of core transcription factors are extraordinarily conserved in bilaterians. However, it remains unclear whether cis-regulatory elements of their target genes also exhibit common signatures associated with conserved embryonic fields. To address this question, we focused on genes that are active in the anterior neuroectoderm and non-neural ectoderm of the ascidian Ciona intestinalis. Following the dissection of a prototypic anterior placodal enhancer, we searched all genomic conserved non-coding elements for duplicated motifs around genes showing anterior neuroectodermal expression. Strikingly, we identified an over-represented pentamer motif corresponding to the binding site of the homeodomain protein OTX, which plays a pivotal role in the anterior development of all bilaterian species. Using an in vivo reporter gene assay, we observed that 10 of 23 candidate cis-regulatory elements containing duplicated OTX motifs are active in the anterior neuroectoderm, thus showing that this cis-regulatory signature is predictive of neuroectodermal enhancers. These results show that a common cis-regulatory signature corresponding to K50-Paired homeodomain transcription factors is found in non-coding sequences flanking anterior neuroectodermal genes in chordate embryos. Thus, field-specific selector genes impose architectural constraints in the form of combinations of short tags on their target enhancers. This could account for the strong evolutionary conservation of the regulatory elements controlling field-specific selector genes responsible for body plan formation. PMID:20419150

  18. On the Concept of Cis-regulatory Information: From Sequence Motifs to Logic Functions

    NASA Astrophysics Data System (ADS)

    Tarpine, Ryan; Istrail, Sorin

    The regulatory genome is about the “system level organization of the core genomic regulatory apparatus, and how this is the locus of causality underlying the twin phenomena of animal development and animal evolution” (E.H. Davidson. The Regulatory Genome: Gene Regulatory Networks in Development and Evolution, Academic Press, 2006). Information processing in the regulatory genome is done through regulatory states, defined as sets of transcription factors (sequence-specific DNA binding proteins which determine gene expression) that are expressed and active at the same time. The core information processing machinery consists of modular DNA sequence elements, called cis-modules, that interact with transcription factors. The cis-modules “read” the information contained in the regulatory state of the cell through transcription factor binding, “process” it, and directly or indirectly communicate with the basal transcription apparatus to determine gene expression. This endowment of each gene with the information-receiving capacity through their cis-regulatory modules is essential for the response to every possible regulatory state to which it might be exposed during all phases of the life cycle and in all cell types. We present here a set of challenges addressed by our CYRENE research project aimed at studying the cis-regulatory code of the regulatory genome. The CYRENE Project is devoted to (1) the construction of a database, the cis-Lexicon, containing comprehensive information across species about experimentally validated cis-regulatory modules; and (2) the software development of a next-generation genome browser, the cis-Browser, specialized for the regulatory genome. The presentation is anchored on three main computational challenges: the Gene Naming Problem, the Consensus Sequence Bottleneck Problem, and the Logic Function Inference Problem.

  19. Electronic Commerce Removing Regulatory Impediments

    DTIC Science & Technology

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

  20. 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.

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

    PubMed

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

    2013-02-01

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

  2. Image Coding Based on Address Vector Quantization.

    NASA Astrophysics Data System (ADS)

    Feng, Yushu

    Image coding is finding increased application in teleconferencing, archiving, and remote sensing. This thesis investigates the potential of Vector Quantization (VQ), a relatively new source coding technique, for compression of monochromatic and color images. Extensions of the Vector Quantization technique to the Address Vector Quantization method have been investigated. In Vector Quantization, the image data to be encoded are first processed to yield a set of vectors. A codeword from the codebook which best matches the input image vector is then selected. Compression is achieved by replacing the image vector with the index of the code-word which produced the best match, the index is sent to the channel. Reconstruction of the image is done by using a table lookup technique, where the label is simply used as an address for a table containing the representative vectors. A code-book of representative vectors (codewords) is generated using an iterative clustering algorithm such as K-means, or the generalized Lloyd algorithm. A review of different Vector Quantization techniques are given in chapter 1. Chapter 2 gives an overview of codebook design methods including the Kohonen neural network to design codebook. During the encoding process, the correlation of the address is considered and Address Vector Quantization is developed for color image and monochrome image coding. Address VQ which includes static and dynamic processes is introduced in chapter 3. In order to overcome the problems in Hierarchical VQ, Multi-layer Address Vector Quantization is proposed in chapter 4. This approach gives the same performance as that of the normal VQ scheme but the bit rate is about 1/2 to 1/3 as that of the normal VQ method. In chapter 5, a Dynamic Finite State VQ based on a probability transition matrix to select the best subcodebook to encode the image is developed. In chapter 6, a new adaptive vector quantization scheme, suitable for color video coding, called "A Self -Organizing

  3. 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.

  4. The Development and Evaluation of a Measure Assessing School Nurses' Perceived Barriers to Addressing Pediatric Obesity

    ERIC Educational Resources Information Center

    Wu, Yelena P.; Steele, Ric G.

    2011-01-01

    School nurses represent an important resource for addressing pediatric obesity and weight-related health. However, school nurses perceive numerous barriers that prevent them from addressing the weight-related health of students. The current study developed and tested a new, comprehensive measure of nurses' perceptions of 10 types of barriers to…

  5. Factors influencing physicians’ choice of workplace: systematic review of drivers of attrition and policy interventions to address them

    PubMed Central

    El Koussa, Maria; Atun, Rifat; Bowser, Diana; Kruk, Margaret E

    2016-01-01

    Objectives The movement of skilled physicians from the public to the private sector is a key constraint to achieving universal health coverage and is currently affecting health systems worldwide. This systematic review aims to assess factors influencing physicians’ choice of workplace, and policy interventions for retaining physicians in the public sector. Methods Five literature databases were searched. Studies were included in the review if they focused on at least one of the following criteria: (i) incentives or motivators for retaining physicians in the public sector, (ii) pull factors that encouraged physicians to move to the private sector, (iii) push factors that forced physicians to leave the public sector, (iv) policy interventions or case studies that addressed physician retention in the public sector, and (v) qualitative reviews of policy interventions that were implemented in different health system settings. Results Nineteen articles met the inclusion criteria. Six major themes that affected physicians’ choice of workplace were identified including: financial incentives, career development, infrastructure and staffing, professional work environment, workload and autonomy. The majority of the studies suggested that the use of financial incentives was a motivator in retaining physicians in the public sector. The review also identified policy interventions including: regulatory controls, incentives and management reforms. Regulatory controls and incentives were the two most frequently reported policy interventions. Conclusion While factors affecting physicians’ choice of workplace are country specific, financial incentives and professional development are core factors. Other factors are highly influenced by context, and thus, it would be useful for future cross–country research to use standardized data collection tools, allowing comparison of contextual factors as well as the examination of how context affects physician retention in the public

  6. Optically addressed asymmetric Fabry-Perot modulator

    NASA Technical Reports Server (NTRS)

    Larsson, A.; Maserjian, J.

    1991-01-01

    A low power, high contrast optically addressed modulator, operating with normal incidence, has been fabricated. Optically controlled reflection modulation is achieved through optically induced absorption modulation in a periodically delta-doped InGaAs/GaAs multiple quantum well structure inserted in an integrated asymmetric Fabry-Perot resonator. A contrast ratio over 60:1 was measured using a spectrally matched low power InGaAs/GaAs quantum well laser to generate the write (control) signal. The insertion loss for the normally off modulator is 4.6 dB at the highest write signal power (30 mW) used. The device lends itself to the fabrication of arrays for optically addressed spatial light modulation.

  7. Addressing Medical Errors in Hand Surgery

    PubMed Central

    Johnson, Shepard P.; Adkinson, Joshua M.; Chung, Kevin C.

    2014-01-01

    Influential think-tank such as the Institute of Medicine has raised awareness about the implications of medical errors. In response, organizations, medical societies, and institutions have initiated programs to decrease the incidence and effects of these errors. Surgeons deal with the direct implications of adverse events involving patients. In addition to managing the physical consequences, they are confronted with ethical and social issues when caring for a harmed patient. Although there is considerable effort to implement system-wide changes, there is little guidance for hand surgeons on how to address medical errors. Admitting an error is difficult, but a transparent environment where patients are notified of errors and offered consolation and compensation is essential to maintain trust. Further, equipping hand surgeons with a guide for addressing medical errors will promote compassionate patient interaction, help identify system failures, provide learning points for safety improvement, and demonstrate a commitment to ethically responsible medical care. PMID:25154576

  8. Matrix-addressable electrochromic display cell

    NASA Astrophysics Data System (ADS)

    Beni, G.; Schiavone, L. M.

    1981-04-01

    We report an electrochromic display cell with intrinsic matrix addressability. The cell, based on a sputtered iridium oxide film (SIROF) and a tantalum-oxide hysteretic counterelectrode, has electrochromic parameters (i.e., response times, operating voltages, and contrast) similar to those of other SIROF display devices, but in addition, has short-circuit memory and voltage threshold. Memory and threshold are sufficiently large to allow, in principle, multiplexing of electrochromic display panels of large-screen TV pixel size.

  9. 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.

  10. Aboriginal health promotion through addressing employment discrimination.

    PubMed

    Ferdinand, Angeline S; Paradies, Yin; Perry, Ryan; Kelaher, Margaret

    2014-01-01

    The Localities Embracing and Accepting Diversity (LEAD) program aimed to improve the mental health of Aboriginal Victorians by addressing racial discrimination and facilitating social and economic participation. As part of LEAD, Whittlesea Council adopted the Aboriginal Employment Pathways Strategy (AEPS) to increase Aboriginal employment and retention within the organisation. The Aboriginal Cultural Awareness Training Program was developed to build internal cultural competency and skills in recruiting and retaining Aboriginal staff. Analysis of surveys conducted before (pre; n=124) and after (post; n=107) the training program indicated a significant increase in participant understanding across all program objectives and in support of organisational policies to improve Aboriginal recruitment and retention. Participants ended the training with concrete ideas about intended changes, as well as how these changes could be supported by their supervisors and the wider organisation. Significant resources have since been allocated to implementing the AEPS over 5 years. In line with principles underpinning the National Aboriginal and Torres Strait Islander Health Plan 2013-23, particularly the focus on addressing racism as a determinant of health, this paper explores the AEPS and training program as promising approaches to health promotion through addressing barriers to Aboriginal employment. Possible implications for other large organisations are also considered.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Addressing gaps in the contraceptive method mix: methods in development.

    PubMed

    Nanda, Kavita; Callahan, Rebecca; Dorflinger, Laneta

    2015-11-01

    Despite the availability of a variety of contraceptive methods, millions of women still have an unmet need for contraceptive choices. Short-acting methods are plagued by issues with adherence, leading to imperfect or inconsistent use and subsequent unintended pregnancy. Long-acting contraceptive methods such as intrauterine devices and contraceptive implants, while providing highly effective and safe contraception, do not meet the needs of all women, often due to cost, access or acceptability issues. Several new methods are in various stages of development and are designed to address the shortcomings of current methods. Providers should be aware of these future options and how they might better meet women's needs.

  16. “Pressured to prescribe” The impact of economic and regulatory factors on South-Eastern ED physicians when managing the drug seeking patient

    PubMed Central

    Kelly, Sharon; Johnson, Giffe T.; Harbison, Raymond D.

    2016-01-01

    Objective: The purpose of this study was to elicit the opinions of Emergency Department (ED) physicians, currently practicing in the United States, regarding the impact of economic and regulatory factors on their management of patients exhibiting “drug seeking” behavior. Methods: A descriptive, cross-sectional study, utilizing a convenience sample of ED physicians located in Florida and Georgia was conducted for a period of 2 months. The inclusion criteria specified that any ED physician, currently practicing within the United States, could participate. Results: Of the ED physicians surveyed (n = 141), 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism and 98% related patient satisfaction scores as being too highly emphasized by reimbursement entities as a means of evaluating their patient management. Rising patient volumes and changes in the healthcare climate were cited by ED physicians as impacting their management of patients exhibiting “drug seeking” behavior. Conclusions: The ED physician faces unique challenges in changing healthcare and economic climates. Requirements to address pain as the “fifth vital sign,” patient satisfaction based reimbursement metrics and an economically driven rise in ED patient volume, may have inadvertently created an environment conducive to exploitation by prescription opioid abusers. There is an identified need for the development of continuing medical education and standardized regulatory and legislative protocols to assist ED physicians in the appropriate management of patients exhibiting “drug seeking” behavior. PMID:27162437

  17. 75 FR 79811 - Department Regulatory Agenda; Semiannual Summary

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... keep those requirements operationally current, we only include the general category of the regulations... attention to the Department's review plan in Appendix D. Regulatory Flexibility Act The Department is... to conduct such reviews. This includes the use of plain language techniques in new rules...

  18. Perspectives on an alternative career path in regulatory science

    PubMed Central

    Fields, F. Owen

    2013-01-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed. PMID:23846346

  19. Perspectives on an alternative career path in regulatory science.

    PubMed

    Fields, F Owen

    2013-07-01

    Perspectives are provided on an alternative career path in regulatory science for those currently involved in basic biology research. This path is compared and contrasted with basic research, and factors to be examined if one is considering such a path are discussed.

  20. Determinants of Effective Information Transfer in International Regulatory Standards Adoption

    ERIC Educational Resources Information Center

    Popescu, Denisa

    2010-01-01

    The role of international regulatory standards within the current global environment has become of the most importance. The age of the global system and free market capitalism carried us into the unprecedented age of regulations, and standard setting. Regulations are now becoming the emerging mode of global governance. This study focuses on…

  1. Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines

    PubMed Central

    Johnston, John D; Feldschreiber, Peter

    2014-01-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. PMID:23738917

  2. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory... method validation data. (c) FDA will publish in the Federal Register the complete regulatory method for... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food...

  3. Regulatory and Permitting Issues

    SciTech Connect

    Larry Myer

    2005-12-01

    As part of the West Coast Regional Carbon Sequestration Partnership (WESTCARB), Terralog Technologies USA, Inc., reviewed current state and federal regulations related to carbon dioxide capture and storage within geologic formations and enhanced carbon uptake in terrestrial ecosystems. We have evaluated and summarized the current and possible future permitting requirements for the six states that comprise the West Coast Regional Partnership. Four options exist for CO{sub 2} injection into appropriate geologic formations, including storage in: (1) oil and gas reservoirs, (2) saline formations, (3) unmineable coal beds, and (4) salt caverns. Terrestrial CO{sub 2} sequestration involves improved carbon conservation management (e.g. reduction of deforestation), carbon substitution (e.g., substitution for fossil fuel-based products, energy conservation through urban forestry, biomass for energy generation), and improved carbon storage management (e.g., expanding the storage of carbon in forest ecosystems). The primary terrestrial options for the West Coast Region include: (1) reforestation of under-producing lands (including streamside forest restoration), (2) improved forest management, (3) forest protection and conservation, and (4) fuel treatments for the reduction of risk of uncharacteristically severe fires (potentially with associated biomass energy generation). The permits and/or contracts required for any land-use changes/disturbances and biomass energy generation that may occur as part of WESTCARB's activities have been summarized for each state.

  4. Addressable nanoelectrode membrane arrays: fabrication and steady-state behavior.

    PubMed

    Zoski, Cynthia G; Yang, Nianjun; He, Peixin; Berdondini, Luca; Koudelka-Hep, Milena

    2007-02-15

    An addressable nanoelectrode membrane array (ANEMA) based on a Au-filled track-etched polycarbonate membrane was fabricated. The Au-filled membrane was secured to a lithographically fabricated addressable ultramicroelectrode (UME) array patterned with 25 regularly spaced (100 microm center to center spacing), 10 microm diameter recessed Pt UMEs to create 25 microregions of 10 microm diameter nanoelectrode ensembles (NEEs) on the membrane. The steady-state voltammetric behavior of 1.0 mM Ru(NH(3))(6)Cl(3) and 1.0 mM ferrocene methanol in 0.1 M KCl on each of the micro NEEs resulted in sigmoidal-shaped voltammograms which were reproducible across the ANEMA. This reproducibility of the steady-state current was attributed to the overlapping hemispherical diffusion layers at the Au-filled nanopores of each 10 microm diameter NEE of a ANEMA. The track-etched polycarbonate membranes were filled using a gold electroless deposition procedure into the 30 nm diameter pores in the membrane. Electrical connection between the Au-filled template array and the lithographic UME platform array was achieved by potentiostatic electrodeposition of Cu from an acidic copper solution into each of the 25 recessed Pt UMEs on the UME array platform. A multiplexer unit capable of addressing 64 individual micro NEEs on an ANEMA is described. ANEMAs have advantages of high reproducibility, facile fabrication, multitime reuse of lithographically fabricated UME arrays, and purely steady-state behavior.

  5. HVDC control developments - addressing system requirements

    SciTech Connect

    Hauth, R.L.; Patel, H.S.; Piwko, R.J.

    1984-01-01

    This article describes typical high voltage direct current (HVDC) control systems and some of the new developments in the control area. HVDC control systems are showing their flexible characteristics as demonstrated, for example, by the new modulation, torsional damping, and alternating current voltage and reactive power controllers. Extensive studies are conducted to design and integrate such controllers into HVDC systems and to assure against any detrimental interactions within the total control system. 8 figures.

  6. 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.

  7. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  8. 76 FR 14107 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    .... Boyce, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice...

  9. 75 FR 1658 - Withdrawal of Regulatory Guide 7.5

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-12

    .... Valentin, Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Withdrawal of Regulatory Guide 7.5 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal...

  10. Genomic analysis reveals major determinants of cis-regulatory variation in Capsella grandiflora

    PubMed Central

    Steige, Kim A.; Laenen, Benjamin; Reimegård, Johan; Slotte, Tanja

    2017-01-01

    Understanding the causes of cis-regulatory variation is a long-standing aim in evolutionary biology. Although cis-regulatory variation has long been considered important for adaptation, we still have a limited understanding of the selective importance and genomic determinants of standing cis-regulatory variation. To address these questions, we studied the prevalence, genomic determinants, and selective forces shaping cis-regulatory variation in the outcrossing plant Capsella grandiflora. We first identified a set of 1,010 genes with common cis-regulatory variation using analyses of allele-specific expression (ASE). Population genomic analyses of whole-genome sequences from 32 individuals showed that genes with common cis-regulatory variation (i) are under weaker purifying selection and (ii) undergo less frequent positive selection than other genes. We further identified genomic determinants of cis-regulatory variation. Gene body methylation (gbM) was a major factor constraining cis-regulatory variation, whereas presence of nearby transposable elements (TEs) and tissue specificity of expression increased the odds of ASE. Our results suggest that most common cis-regulatory variation in C. grandiflora is under weak purifying selection, and that gene-specific functional constraints are more important for the maintenance of cis-regulatory variation than genome-scale variation in the intensity of selection. Our results agree with previous findings that suggest TE silencing affects nearby gene expression, and provide evidence for a link between gbM and cis-regulatory constraint, possibly reflecting greater dosage sensitivity of body-methylated genes. Given the extensive conservation of gbM in flowering plants, this suggests that gbM could be an important predictor of cis-regulatory variation in a wide range of plant species. PMID:28096395

  11. Genomic analysis reveals major determinants of cis-regulatory variation in Capsella grandiflora.

    PubMed

    Steige, Kim A; Laenen, Benjamin; Reimegård, Johan; Scofield, Douglas G; Slotte, Tanja

    2017-01-31

    Understanding the causes of cis-regulatory variation is a long-standing aim in evolutionary biology. Although cis-regulatory variation has long been considered important for adaptation, we still have a limited understanding of the selective importance and genomic determinants of standing cis-regulatory variation. To address these questions, we studied the prevalence, genomic determinants, and selective forces shaping cis-regulatory variation in the outcrossing plant Capsella grandiflora We first identified a set of 1,010 genes with common cis-regulatory variation using analyses of allele-specific expression (ASE). Population genomic analyses of whole-genome sequences from 32 individuals showed that genes with common cis-regulatory variation (i) are under weaker purifying selection and (ii) undergo less frequent positive selection than other genes. We further identified genomic determinants of cis-regulatory variation. Gene body methylation (gbM) was a major factor constraining cis-regulatory variation, whereas presence of nearby transposable elements (TEs) and tissue specificity of expression increased the odds of ASE. Our results suggest that most common cis-regulatory variation in C. grandiflora is under weak purifying selection, and that gene-specific functional constraints are more important for the maintenance of cis-regulatory variation than genome-scale variation in the intensity of selection. Our results agree with previous findings that suggest TE silencing affects nearby gene expression, and provide evidence for a link between gbM and cis-regulatory constraint, possibly reflecting greater dosage sensitivity of body-methylated genes. Given the extensive conservation of gbM in flowering plants, this suggests that gbM could be an important predictor of cis-regulatory variation in a wide range of plant species.

  12. What explains regulatory failure? Analysing the architecture of health care regulation in two Indian states.

    PubMed

    Sheikh, Kabir; Saligram, Prasanna S; Hort, Krishna

    2015-02-01

    Regulating health care is a pre-eminent policy challenge in many low- and middle-income countries (LMIC), particularly those with a strong private health sector. Yet, the regulatory approaches instituted in these countries have often been reported to be ineffective-India being exemplary. There is limited empirical research on the architecture and processes of health care regulation in LMIC that would explain these regulatory failures. We undertook a research study in two Indian states, with the aims of (1) mapping the organizations engaged with, and the written policies focused on health care regulation, (2) identifying gaps in the design and implementation of policies for health care regulation and (3) investigating underlying reasons for the identified gaps. We adopted a stepped research approach and applied a framework of basic regulatory functions for health care, to assess prevailing gaps in policy design and implementation. Qualitative research methods were employed including in-depth interviews with 32 representatives of regulatory organizations and document review. Several gaps in policy design were observed across both states, with a number of basic regulatory functions not underwritten in law, nor assigned to a regulatory organization to enact. In some instances the contents of regulatory policies had been weakened or diluted, rendering them less effective. Implementation gaps were also extensively reported in both states. Regulatory gaps were underpinned by human resource constraints, ambivalence in the roles of regulatory organizations, ineffective co-ordination between regulatory groups and extensive contestation of regulatory policies by private stakeholders. The findings are instructive that prevailing arrangements for health care regulation are ill equipped to enact several basic functions, and further that the performance of regulatory organizations is subject to pressures and distortions similar to those characterizing the wider health system

  13. Addressing tomorrow's DMO technical challenges today

    NASA Astrophysics Data System (ADS)

    Milligan, James R.

    2009-05-01

    Distributed Mission Operations (DMO) is essentially a type of networked training that pulls in participants from all the armed services and, increasingly, allies to permit them to "game" and rehearse highly complex campaigns, using a mix of local, distant, and virtual players. The United States Air Force Research Laboratory (AFRL) is pursuing Science and Technology (S&T) solutions to address technical challenges associated with distributed communications and information management as DMO continues to progressively scale up the number, diversity, and geographic dispersal of participants in training and rehearsal exercises.

  14. 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

  15. Addressing the underperformance of faculty and staff.

    PubMed

    Kenner, Carole; Pressler, Jana L

    2006-01-01

    Many new nursing leaders assuming work as deans, assistant deans, or interim deans have limited education, experience, or background to prepare them for the job. To assist new deans and those aspiring to be deans, the authors of this department, both deans, offer survival tips based on their personal experiences and insights. They address common issues, challenges, and opportunities that face academic executive teams, such as negotiating an executive contract, obtaining faculty lines, building effective work teams, managing difficult employees, and creating nimble organizational structure to respond to changing consumer, healthcare delivery, and community needs. The authors welcome counterpoint discussions with readers.

  16. 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.

  17. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-10

    ... Federal Energy Regulatory Commission Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the... the Nuclear Regulatory Commission (NRC) will hold a joint meeting on Tuesday, March 16, 2010 at...

  18. A review of the characteristics of nanoparticles in the urban atmosphere and the prospects for developing regulatory controls

    NASA Astrophysics Data System (ADS)

    Kumar, Prashant; Robins, Alan; Vardoulakis, Sotiris; Britter, Rex

    2010-12-01

    The likely health and environmental implications associated with atmospheric nanoparticles have prompted considerable recent research activity. Knowledge of the characteristics of these particles has improved considerably due to an ever growing interest in the scientific community, though not yet sufficient to enable regulatory decision making on a particle number basis. This review synthesizes the existing knowledge of nanoparticles in the urban atmosphere, highlights recent advances in our understanding and discusses research priorities and emerging aspects of the subject. The article begins by describing the characteristics of the particles and in doing so treats their formation, chemical composition and number concentrations, as well as the role of removal mechanisms of various kinds. This is followed by an overview of emerging classes of nanoparticles (i.e. manufactured and bio-fuel derived), together with a brief discussion of other sources. The subsequent section provides a comprehensive review of the working principles, capabilities and limitations of the main classes of advanced instrumentation that are currently deployed to measure number and size distributions of nanoparticles in the atmosphere. A further section focuses on the dispersion modelling of nanoparticles and associated challenges. Recent toxicological and epidemiological studies are reviewed so as to highlight both current trends and the research needs relating to exposure to particles and the associated health implications. The review then addresses regulatory concerns by providing an historical perspective of recent developments together with the associated challenges involved in the control of airborne nanoparticle concentrations. The article concludes with a critical discussion of the topic areas covered.

  19. Addressing Fission Product Validation in MCNP Burnup Credit Criticality Calculations

    SciTech Connect

    Mueller, Don; Bowen, Douglas G; Marshall, William BJ J

    2015-01-01

    The US Nuclear Regulatory Commission (NRC) Division of Spent Fuel Storage and Transportation issued Interim Staff Guidance (ISG) 8, Revision 3 in September 2012. This ISG provides guidance for NRC staff members’ review of burnup credit (BUC) analyses supporting transport and dry storage of pressurized water reactor spent nuclear fuel (SNF) in casks. The ISG includes guidance for addressing validation of criticality (keff) calculations crediting the presence of a limited set of fission products and minor actinides (FP&MAs). Based on previous work documented in NRC Regulatory Guide (NUREG) Contractor Report (CR)-7109, the ISG recommends that NRC staff members accept the use of either 1.5 or 3% of the FP&MA worth—in addition to bias and bias uncertainty resulting from validation of keff calculations for the major actinides in SNF—to conservatively account for the bias and bias uncertainty associated with the specified unvalidated FP&MAs. The ISG recommends (1) use of 1.5% of the FP&MA worth if a modern version of SCALE and its nuclear data are used and (2) 3% of the FP&MA worth for well qualified, industry standard code systems other than SCALE with the Evaluated Nuclear Data Files, Part B (ENDF/B),-V, ENDF/B-VI, or ENDF/B-VII cross sections libraries. The work presented in this paper provides a basis for extending the use of the 1.5% of the FP&MA worth bias to BUC criticality calculations performed using the Monte Carlo N-Particle (MCNP) code. The extended use of the 1.5% FP&MA worth bias is shown to be acceptable by comparison of FP&MA worths calculated using SCALE and MCNP with ENDF/B-V, -VI, and -VII–based nuclear data. The comparison supports use of the 1.5% FP&MA worth bias when the MCNP code is used for criticality calculations, provided that the cask design is similar to the hypothetical generic BUC-32 cask model and that the credited FP&MA worth is no more than 0.1 Δkeff (ISG-8, Rev. 3, Recommendation 4).

  20. Multi-port, optically addressed RAM

    NASA Technical Reports Server (NTRS)

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

    1989-01-01

    A random access memory addressing system utilizing optical links between memory and the read/write logic circuits comprises addressing circuits including a plurality of light signal sources, a plurality of optical gates including optical detectors associated with the memory cells, and a holographic optical element adapted to reflect and direct the light signals to the desired memory cell locations. More particularly, it is a multi-port, binary computer memory for interfacing with a plurality of computers. There are a plurality of storage cells for containing bits of binary information, the storage cells being disposed at the intersections of a plurality of row conductors and a plurality of column conductors. There is interfacing logic for receiving information from the computers directing access to ones of the storage cells. There are first light sources associated with the interfacing logic for transmitting a first light beam with the access information modulated thereon. First light detectors are associated with the storage cells for receiving the first light beam, for generating an electrical signal containing the access information, and for conducting the electrical signal to the one of the storage cells to which it is directed. There are holographic optical elements for reflecting the first light beam from the first light sources to the first light detectors.