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Sample records for address regulatory issues

  1. 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…

  2. Addressing Transgender Issues in Schools

    ERIC Educational Resources Information Center

    Cavanagh, Marian

    2016-01-01

    As mainstream media focus more attention on transgender issues, and as anti-discrimination laws evolve, a shift is taking place on campuses. Many schools now include gender identity and expression in their inclusivity work and seek to establish policies and procedures to support transgender students and their families. It's not an easy task. In…

  3. Addressing Transition Issues in Languages Education.

    ERIC Educational Resources Information Center

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

    2003-01-01

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

  4. 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…

  5. 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…

  6. 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.

  7. 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…

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

    SciTech Connect

    Chen, S.Y.

    1997-04-01

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

  9. THE ROLE OF RISK ASSESSMENT IN ADDRESSING HAZARDOUS WASTE ISSUES

    EPA Science Inventory

    Risk assessment plays many important roles in addressing hazardous waste issues. In addition to providing a scientific framework and common health metric to evaluate risks. Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or "Superfund") risk assessm...

  10. Addressing Physical and Emotional Issues in Children's Literature

    ERIC Educational Resources Information Center

    Johnson, Jonathon

    2010-01-01

    The purpose of this paper is to examine how physical and mental disabilities are addressed in children's literature. Many authors are able to integrate the issues into their work in a way that enhances the story and benefits the reader. As young readers learn about the issues and struggles faced by children with mental and physical disabilities,…

  11. Summary Report Panel 2: Regulatory Issues.

    PubMed

    Johnson, Craig; Dolman, Sarah

    2016-01-01

    The Effects of Noise on Aquatic Life 2013 Conference convened four panels to discuss specific topics related to the effects of anthropogenic noise on aquatic ecosystems. The second of these four panels, the Regulatory Issues Panel, brought together several different perspectives: representatives of agencies responsible for regulating activities that introduce anthropogenic noise into aquatic ecosystems: representatives of the regulated industries, agencies, and consultancies that advise regulators and regulated industries; and nongovernmental organizations and other stakeholders with an interest in anthropogenic noise. The goal of the panel was to help develop a more productive relationship between these groups.

  12. 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

  13. Inhalation exposure technology, dosimetry, and regulatory issues.

    PubMed

    Dorato, M A; Wolff, R K

    1991-01-01

    Inhalation toxicology technology has provided the scientific community with important advances in studies of inhaled toxicants. These advances include new and more efficient exposure systems (e.g., flow-past nose-only exposure systems), and improved approaches to inhalation chamber environmental control (e.g., temperature, humidity, air quality). Practical problems and approaches to testing and operating inhalation exposure systems and the advantages and disadvantages of the major inhalation exposure types (e.g., whole-body, nose-only) are discussed. Important aspects of study design, such as high level particulate exposures resulting in large lung burdens (e.g., greater than or equal to 2 mg/g of lung), slowed pulmonary clearance rates, and nonspecific toxicity are considered, along with practical issues of comparative dosimetry. Regulatory guidelines have continued to present challenges in designing and conducting acute, subchronic, and chronic inhalation studies. The important regulatory issue of performing acute inhalation toxicity studies at high aerosol concentrations and "respirable" particle size distribution is discussed. PMID:1813983

  14. Family Connections: Addressing Behavior Issues--Practical Tips for Parents

    ERIC Educational Resources Information Center

    LaCaze, Donna; Kirylo, James D.

    2012-01-01

    When parents get together, the subject of appropriately addressing the behavior of their children often comes to the forefront of conversations. Parents share various challenges they face with their children, including issues associated with listening, eating vegetables, doing chores, and a host of other discipline-related situations. The plethora…

  15. Effective Organizational Structures and Processes: Addressing Issues of Change

    ERIC Educational Resources Information Center

    Andrade, Maureen Snow

    2016-01-01

    This chapter describes organizational structures and processes at the institutional and project levels for the development and support of distance learning initiatives. It addresses environmental and stakeholder issues and explores principles and strategies of effective leadership for change creation and management.

  16. Addressing Consent Issues in Donation After Circulatory Determination of Death.

    PubMed

    Overby, Kim J; Weinstein, Michael S; Fiester, Autumn

    2015-01-01

    Given the widening gap between the number of individuals on transplant waiting lists and the availability of donated organs, as well as the recent plateau in donations based on neurological criteria (i.e., brain death), there has been a growing interest in expanding donation after circulatory determination of death. While the prevalence of this form of organ donation continues to increase, many thorny ethical issues remain, often creating moral distress in both clinicians and families. In this article, we address one of these issues, namely, the challenges surrounding patient and surrogate informed consent for donation after circulatory determination of death. First we discuss several general concerns regarding consent related to this form of organ donation, and then we address additional issues that are unique to three different patient categories: adult patients with medical decision-making capacity or potential capacity, adult patients who lack capacity, and pediatric patients. PMID:26225503

  17. Addressing Consent Issues in Donation After Circulatory Determination of Death.

    PubMed

    Overby, Kim J; Weinstein, Michael S; Fiester, Autumn

    2015-01-01

    Given the widening gap between the number of individuals on transplant waiting lists and the availability of donated organs, as well as the recent plateau in donations based on neurological criteria (i.e., brain death), there has been a growing interest in expanding donation after circulatory determination of death. While the prevalence of this form of organ donation continues to increase, many thorny ethical issues remain, often creating moral distress in both clinicians and families. In this article, we address one of these issues, namely, the challenges surrounding patient and surrogate informed consent for donation after circulatory determination of death. First we discuss several general concerns regarding consent related to this form of organ donation, and then we address additional issues that are unique to three different patient categories: adult patients with medical decision-making capacity or potential capacity, adult patients who lack capacity, and pediatric patients.

  18. Digital upgrade issues and the evolving regulatory environment

    SciTech Connect

    Meininger, R. D.

    2006-07-01

    This paper deals with the qualification of an Instrumentation and Control (I and C) upgrade for Electromagnetic Compatibility (EMC) in the plant, focusing on the interpretation of the NRC Regulatory Guide 1.180 Revision 1, 'Guidelines for Evaluating Electromagnetic and Radio-Frequency Interference in Safety-Related Instrumentation and Control Systems.' Options presented by Reg. Guide 1.180 are discussed along with alternative EMC Guidelines being used by nuclear power plants. Problems commonly encountered during the EMC qualification process are discussed and suggestions presented on how to deal with these common problems. Also included is a discussion of an emerging issue of how to address the issue of EMC of replacement discrete modules or printer circuit (PC) boards in a system that was either previously qualified or never qualified for EMC. (authors)

  19. Extending the ARS Experimental Watersheds to Address Regional Issues

    NASA Astrophysics Data System (ADS)

    Marks, D.; Goodrich, D. C.; Winstral, A.; Bosch, D. D.; Pool, D.

    2001-12-01

    The USDA-Agricultural Research Service's (ARS) Watershed Research Program maintains and operates a diverse, geog raphically distributed, nested, multi-scale, national ex perimental watershed network. This network, much of which has been operational for more than 40 years (several more than 60 years), constitutes one the best networks of its kind in the world. The watershed network and its instrumentation was primarily established to assess the hydrologic impacts of watershed conservation and management practices. It has evolved, through development of long-term hydrologic data, as a network of high quality outdoor laboratories for addressing emerging science issues facing hydrologists and resource managers. While the value of the experimental watershed for investigating precipitation, climatic, and hydrologic processes is unquestioned, extending the results from these investigations to other sites and larger areas is more difficult. ARS experimental watersheds are a few hundred km2 or smaller making it challenging to address regional scale issues. To address this the ARS watershed program is, with a suite of partners from universities and other federal agencies, enlarging its research focus to extend beyond the boundaries of the experimental watershed. In this poster we present several examples of this effort, with suggestions on how, using the experimental watershed and its core, a larger scale hydrologic observatory could be developed and maintained.

  20. Introduction: the need to address older women's mental health issues.

    PubMed

    Malatesta, Victor J

    2007-01-01

    Women are the primary consumers of mental health services. Ironically, research addressing their unique needs lags behind that of men's issues. The aging process introduces an important variable that accentuates the relative lack of information and specific treatment guidelines for older women who are confronted by mental health problems. This volume offers a comprehensive overview for the health professional who is seeking a greater depth of understanding with respect to the study of mental health problems in general, and how these issues pertain specifically to women and the aging process. A second goal of this project is to provide the practicing therapist and counselor with a research update and a broad clinical perspective offered by seasoned clinicians. Using current psychiatric diagnosis as a framework, the contributions address the range of mental health problems, including dementia and cognitive impairment, schizophrenia, alcohol abuse, mood and anxiety disorders, traumatic and dissociative conditions, sexual and eating disorders, and personality disorders. It is hoped that this book will inform, inspire and encourage students and health professionals in their work with middle aged and older women who are facing mental health challenges. PMID:17588876

  1. 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.

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

    PubMed

    Califf, Robert M; Sugarman, Jeremy

    2015-10-01

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

  3. Western Wind Strategy: Addressing Critical Issues for Wind Deployment

    SciTech Connect

    Douglas Larson; Thomas Carr

    2012-03-30

    The goal of the Western Wind Strategy project was to help remove critical barriers to wind development in the Western Interconnection. The four stated objectives of this project were to: (1) identify the barriers, particularly barriers to the operational integration of renewables and barriers identified by load-serving entities (LSEs) that will be buying wind generation, (2) communicate the barriers to state officials, (3) create a collaborative process to address those barriers with the Western states, utilities and the renewable industry, and (4) provide a role model for other regions. The project has been on the forefront of identifying and informing state policy makers and utility regulators of critical issues related to wind energy and the integration of variable generation. The project has been a critical component in the efforts of states to push forward important reforms and innovations that will enable states to meet their renewable energy goals and lower the cost to consumers of integrating variable generation.

  4. Regulatory issues for personalized pluripotent cells.

    PubMed

    Condic, Maureen L; Rao, Mahendra

    2008-11-01

    The development of personalized pluripotent stem cells for research and for possible therapies holds out great hope for patients. However, such cells will face significant technical and regulatory challenges before they can be used as therapeutic reagents. Here we consider two possible sources of personalized pluripotent stem cells: embryonic stem cells derived from nuclear transfer (NT-ESCs) and induced pluripotent stem cells (iPSCs) derived from direct reprogramming of adult somatic cells. Both sources of personalized pluripotent stem cells face unique regulatory hurdles that are in some ways significantly higher than those facing stem cells derived from embryos produced by fertilization (ESCs). However, the outstanding long-term potential of iPSCs and their relative freedom from the ethical concerns raised by both ESCs and NT-ESCs makes direct reprogramming an exceptionally promising approach to advancing research and providing therapies in the field of regenerative medicine.

  5. Legal and regulatory issues affecting compressed air energy storage

    SciTech Connect

    Hendrickson, P.L.

    1981-07-01

    Several regulatory and legal issues that can potentially affect implementation of a compressed air energy storage (CAES) system are discussed. This technology involves the compression of air using base load electric power for storage in an underground storage medium. The air is subsequently released and allowed to pass through a turbine to generate electricity during periods of peak demand. The storage media considered most feasible are a mined hard rock cavern, a solution-mined cavern in a salt deposit, and a porous geologic formation (normally an aquifer) of suitable structure. The issues are discussed in four categories: regulatory issues common to most CAES facilities regardless of storage medium, regulatory issues applicable to particular CAES reservoir media, issues related to possible liability from CAES operations, and issues related to acquisition of appropriate property rights for CAES implementation. The focus is on selected federal regulation. Lesser attention is given to state and local regulation. (WHK)

  6. Legal and regulatory issues affecting aquifer thermal energy storage

    SciTech Connect

    Hendrickson, P.L.

    1981-10-01

    This document updates and expands the report with a similar title issued in October 1980. This document examines a number of legal and regulatory issues that potentially can affect implementation of the aquifer thermal energy storage (ATES) concept. This concept involves the storage of thermal energy in an underground aquifer until a later date when it can be effectively utilized. Either heat energy or chill can be stored. Potential end uses of the energy include district space heating and cooling, industrial process applications, and use in agriculture or aquaculture. Issues are examined in four categories: regulatory requirements, property rights, potential liability, and issues related to heat or chill delivery.

  7. Addressing security issues related to virtual institute distributed activities

    NASA Astrophysics Data System (ADS)

    Stytz, Martin R.; Banks, Sheila B.

    2008-03-01

    One issue confounding the development and experimentation of distributed modeling and simulation environments is the inability of the project team to identify and collaborate with resources, both human and technical, from outside the United States. This limitation is especially significant within the human behavior representation area where areas such as cultural effects research and joint command team behavior modeling require the participation of various cultural and national representatives. To address this limitation, as well as other human behavior representation research issues, NATO Research and Technology Organization initiated a project to develop a NATO virtual institute that enables more effective and more collaborative research into human behavior representation. However, in building and operating a virtual institute one of the chief concerns must be the cyber security of the institute. Because the institute "exists" in cyberspace, all of its activities are susceptible to cyberattacks, subterfuge, denial of service and all of the vulnerabilities that networked computers must face. In our opinion, for the concept of virtual institutes to be successful and useful, their operations and services must be protected from the threats in the cyber environment. A key to developing the required protection is the development and promulgation of standards for cyber security. In this paper, we discuss the types of cyber standards that are required, how new internet technologies can be exploited and can benefit the promulgation, development, maintenance, and robustness of the standards. This paper is organized as follows. Section One introduces the concept of the virtual institutes, the expected benefits, and the motivation for our research and for research in this area. Section Two presents background material and a discussion of topics related to VIs, uman behavior and cultural modeling, and network-centric warfare. Section Three contains a discussion of the

  8. Distributed photovoltaic systems - Addressing the utility interface issues

    NASA Astrophysics Data System (ADS)

    Firstman, S. I.; Vachtsevanos, G. J.

    This paper reviews work conducted in the United States on the impact of dispersed photovoltaic sources upon utility operations. The photovoltaic (PV) arrays are roof-mounted on residential houses and connected, via appropriate power conditioning equipment, to the utility grid. The presence of such small (4-6 Kw) dispersed generators on the distribution network raises questions of a technical, economic and institutional nature. After a brief identification of utility interface issues, the paper addresses such technical concerns as protection of equipment and personnel safety, power quality and utility operational stability. A combination of experimental and analytical approaches has been adopted to arrive at solutions to these problems. Problem areas, under various PV system penetration scenarios, are identified and conceptual designs of protection and control equipment and operating policies are developed so that system reliability is maintained while minimizing capital costs. It is hoped that the resolution of balance-of-system and grid interface questions will ascertain the economic viability of photovoltaic systems and assist in their widespread utilization in the future.

  9. Air toxics regulatory issues facing urban settings.

    PubMed Central

    Olden, K; Guthrie, J

    1996-01-01

    Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics, metals, and pesticides. The National Institute of Environmental Health Sciences (NIEHS), through its affiliation with the National Toxicology Program, has generated toxicity and carcinogenicity data on more than 100 of these air toxics. The NIEHS extramural and intramural research portfolios support a variety of projects that develop and validate biomarkers for use in environmental health science and risk assessment. Biomarkers have a tremendous potential in the areas of regulating air toxics and protecting public health. Risk assessors need data provided by biomarkers of exposure, biomarkers of dose/pharmacokinetics, biomarkers of susceptibility or individual variability, and biomarkers of effects. The greatest benefit would be realized if biomarkers could be employed in four areas of primary and secondary prevention. The first is the use of biomarkers to enhance extrapolation of animal data to human exposure situations in establishing risk standards. The second is the use of biomarkers that assess noncancer, as well as cancer, end points. Important health end points include pulmonary dysfunction, immunotoxicity, and neurotoxicity. Third, biomarkers that serve as early waming signs to detect intermediate effects would enhance our ability to design timely and cost-effective intervention strategies. Finally, biomarkers used to evaluate the effectiveness of intervention strategies, both in clinical and regulatory settings, would enable us to ensure that programs designed to protect public health do, in fact, achieve the desired outcome. PMID:8933026

  10. US domestic and international regulatory issues

    NASA Technical Reports Server (NTRS)

    Levin, Lon C.; Nash, Dennis C.

    1993-01-01

    The U.S. domestic and international regulatory and policy milestones since 1982, when NASA filed its petition with the Federal Communications Commission (FCC) to establish the U.S. domestic Mobile Satellite Service (MSS), are described. In 1985, the FCC proposed to establish MSS services and allocate spectrum for such service. In 1986, the FCC allocated L-band spectrum for MSS. In 1987, at the Mobile World Administrative Radio Conference (MOB WARC-87), despite U.S., Canadian, and Mexican efforts, the WARC did not adopt a multi-service, generic MSS allocation. In 1989, the FCC licensed the first MSS system. After two decisions by the U.S. Court of Appeals, the FCC's licensing actions remain intact. The FCC also has permitted Comsat to provide international aeronautical and land MSS via the Inmarsat system. Inmarsat, however, may not serve the domestic U.S. market. In 1991, the FCC accepted applications for MSS systems, most of which were non-geostationary proposals, for operation in the Radiodetermination Satellite Service (RDSS) bands, and the VHF and UHF bands. In 1992, the FCC proposed rules for non-geostationary MSS systems and applied a negotiated rulemaking procedure to each. Also in 1992, the U.S. position for flexibility in existing MSS bands and for additional worldwide MSS allocations was adopted in large part at the 1992 World Administrative Radio Conference (WARC-92).

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  12. Legislative and regulatory issues related to reusable launch systems

    NASA Astrophysics Data System (ADS)

    Peinemann, Manfred K. A.

    1996-03-01

    The development of reusable launch systems with private investment funds for primarily commercial launch services raises a number of novel legal and regulatory issues. The issues discussed include requirements for a whole new spectrum of safety and environmental issues; new certification rules, procedures and oversight organizations; liability and jurisdiction definitions, taxation treatments; government commitments and/or participation in commercial enterprises; and international legal and business issues. The satisfactory solution to all of these issues is a necessary condition for the development and operation of reusable launch vehicles to be a viable commercial enterprise.

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

    PubMed

    Rothenberg, Joan R

    2010-01-01

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

  14. Trade, development, and regulatory issues in food.

    PubMed

    Ramaswamy, Sunder; Viswanathan, Brinda

    2007-03-01

    Trade in food and animal products has increased several-fold in the past decade, and simultaneously regulations governing the movement of such products across national boundaries have also increased. The present study reviews harmonization in food trade regulation by focusing on nutritional aspects to understand its role in enhancing world trade on the one hand and consumer interest and welfare on the other. Harmonization to a large extent brings in more regulation from the developed world acting through their governments, consumer organizations, and multinational companies; it does not seem to address, in general, the concerns of the large segments of the poor population for whom agriculture and food trade are the main sources of livelihood. There is a lack of quantifiable estimates of the loss in well-being of the disadvantaged. However, there is substantial research focused on the potential harm to developed nations as a result of nonadherence to the rules. Clearly, lack of adequate infrastructure, resource constraints, and weak institutions not only result in poor food safety regulation within developing countries but also remain barriers to realizing the greater potential benefits from increased trade. Harmonization of standards would have some losers and some winners, but to make it more inclusive, scientific knowledge alone may not be adequate; social and cultural aspects also need to be considered, since food systems differ among regions, with varying preferences, local resource availability, and levels of economic development. Improvement in governance in many countries not only would ensure better participation in international rule-making and the negotiation process for fairer trade but also would result in effective domestic legislation to ensure safer health for citizens, resulting in higher overall well-being. PMID:17521124

  15. Abandoning pipelines working group regulatory issues

    SciTech Connect

    1997-03-01

    The history of hydrocarbon development in Louisiana and off its coast is one of the interdependence of technological innovation, entrepreneurial risk-taking, resource management, judicial decisions, legislation, marketing, employee good will, infrastructure and support services, coupled with favorable geologic structures that made early exploration and development relatively easy. Mariners sailing off the coast of Louisiana and Texas in the 1600`s recorded one of the earliest known natural oil seeps. They shrugged it off as unimportant, as there was no market for the substance they witnessed. The seepage, however, provided a tiny clue to the vast storehouse of hydrocarbons trapped in the earth`s crust extending from the uplands, through Louisiana`s swamps and marshes, and into the subaqueous habitats of the Gulf of Mexico-the world`s ninth largest body of water. In all cases, each move into a new geographic province required considerable change in operation philosophy and in the science supporting the exploration and development activity. As technology changed, or was developed to meet the industry`s needs, new frontiers were explored. However, with time-as is the case with any nonrenewable resource-fields and wells lost their productive life. They had to be abandoned. In fact, the Minerals Management Service suggests that within the next 10 years the offshore industry will remove 150 platforms per year, or nearly half of the current number of production units. The industry will be asked to dispose of nearly one unit every 2.4 days. If this is the case, abandonment issues are going to continue to surface.

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

    PubMed

    McIntosh, Megan; Hauschild, Benjamin; Miller, Veronica

    2016-01-01

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

  17. Addressing Teachers' Feelings of Lack of Control over Policy Issues

    ERIC Educational Resources Information Center

    Judson, Eugene

    2014-01-01

    This study reports on how an American Education System course, traditionally taught with broad objectives, was contextualized for science teachers. Using pre-assessment data, specific policy issues were targeted with the objective of increasing teachers' feelings of influence over issues. The approach used was adapted from exposure therapy, a…

  18. Imaginative Thinking: Addressing Social Justice Issues through MovieMaker

    ERIC Educational Resources Information Center

    Boske, Christa A.

    2009-01-01

    Purpose: The purpose of this paper is to examine the experiences of aspiring school leaders who utilized artmaking in this case, photography, poetry, music, collage, and short films through Microsoft MovieMaker as a means for addressing injustices within surrounding school communities. The paper aims to explore how aspiring school leaders…

  19. Teaching Writing in a Digital Age: Addressing Issues of Access

    ERIC Educational Resources Information Center

    Cottrill, Brittany B.

    2010-01-01

    The way people write and communicate has changed both inside and outside the university, and because of this writing instructors are professionally responsible for addressing these changes in the classroom. Technologies have affected writing for thousands of years. From the invention of the printing press to the Internet, challenges to writing…

  20. Teacher Education's Responsibility to Address Diversity Issues: Enhancing Institutional Capacity.

    ERIC Educational Resources Information Center

    Melnick, Susan L.; Zeichner, Kenneth M.

    1998-01-01

    Preservice teachers must be prepared to address substantial student diversity and to educate all students to higher levels of understanding and competence. Many teacher educators are not competent to prepare new teachers in this area. Several approaches to handling institutional aspects of teacher education for diversity are discussed, noting…

  1. Addressing the human factors issues associated with control room modifications

    SciTech Connect

    O`Hara, J.; Stubler, W.; Kramer, J.

    1998-03-01

    Advanced human-system interface (HSI) technology is being integrated into existing nuclear plants as part of plant modifications and upgrades. The result of this trend is that hybrid HSIs are created, i.e., HSIs containing a mixture of conventional (analog) and advanced (digital) technology. The purpose of the present research is to define the potential effects of hybrid HSIs on personnel performance and plant safety and to develop human factors guidance for safety reviews of them where necessary. In support of this objective, human factors issues associated with hybrid HSIs were identified. The issues were evaluated for their potential significance to plant safety, i.e., their human performance concerns have the potential to compromise plant safety. The issues were then prioritized and a subset was selected for design review guidance development.

  2. Creating Art Environments That Address Social Justice Issues

    ERIC Educational Resources Information Center

    Tremblay, Gail

    2013-01-01

    In this article, I examine strategies for teaching students to make socially conscious art using a variety of media that emphasizes installation work. I present issues of social justice in the contemporary art world and include concerns of censorship that artists sometimes confront. I offer examples of team taught coordinated studies programs…

  3. Beyond Culturalism: Addressing Issues of Indigenous Disadvantage through Schooling

    ERIC Educational Resources Information Center

    Keddie, Amanda; Gowlett, Christina; Mills, Martin; Monk, Sue; Renshaw, Peter

    2013-01-01

    This paper draws from a study that explored issues of student equity, marginality and diversity in two secondary schools in regional Queensland (Australia). The paper foregrounds interview data gathered from administration, teaching and ancillary staff at one of the schools, "Crimson" High School. The school has a high Indigenous student…

  4. The Courage To Care: Addressing Sexual Minority Issues on Campus.

    ERIC Educational Resources Information Center

    Ottenritter, Nan

    1998-01-01

    Sexual minority students face issues similar to those of ethnic and racial minority students. This article provides a framework for assessing the community college's inclusion of sexual minority students: lesbians, gays, bisexual, and transgender (LGBT) individuals. The first section of the article assesses community colleges in terms of sexual…

  5. Teaching for Diversity: Addressing Diversity Issues in Responsive ESL Instruction

    ERIC Educational Resources Information Center

    Fu, Jing

    2013-01-01

    Student diversity has become a typical phenomenon in American public schools. The impact of increasing diversity on literacy instruction is unchallenged. Teachers reinforce this message by often citing ESL student diversity as a barrier for literacy teaching. In order to better understand the complexity of diversity issues, I explored two ESL…

  6. Plan for addressing issues relating to oil shale plant siting

    SciTech Connect

    Noridin, J. S.; Donovan, R.; Trudell, L.; Dean, J.; Blevins, A.; Harrington, L. W.; James, R.; Berdan, G.

    1987-09-01

    The Western Research Institute plan for addressing oil shale plant siting methodology calls for identifying the available resources such as oil shale, water, topography and transportation, and human resources. Restrictions on development are addressed: land ownership, land use, water rights, environment, socioeconomics, culture, health and safety, and other institutional restrictions. Descriptions of the technologies for development of oil shale resources are included. The impacts of oil shale development on the environment, socioeconomic structure, water availability, and other conditions are discussed. Finally, the Western Research Institute plan proposes to integrate these topics to develop a flow chart for oil shale plant siting. Western Research Institute has (1) identified relative topics for shale oil plant siting, (2) surveyed both published and unpublished information, and (3) identified data gaps and research needs. 910 refs., 3 figs., 30 tabs.

  7. Regulatory issues and assumptions associated with barriers in the vadose zone surrounding buried waste

    SciTech Connect

    Siskind, B.; Heiser, J.

    1993-02-01

    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. The barrier material should be compatible with soil and waste conditions specific to the site and have as low an effective diffusivity as is reasonably achievable to minimize or inhibit transport of moisture and contaminants. This report addresses the regulatory issues associated with the use of non-traditional organic polymer barriers as well as the use of soil-bentonite or cement-bentonite mixtures for such barriers, considering barriers constructed from these latter materials to be a regulatory baseline. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of such barriers to the EPA as a method for achieving site or performanceimprovement. 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.

  8. A mental model proposed to address sustainability and terrorism issues.

    PubMed

    Schwing, Richard

    2002-06-01

    I have assembled traditional ways to think about human needs and power along with empirical data to support a mental model of human values. The hierarchy of needs from the world of psychology and the hierarchy of power from the world of diplomacy provide a structure for the model. The empirical data collected from several nations over the last three decades support the structure. Furthermore, an examination of specific trends in this data for specific values indicates that it is not impossible to achieve a sustainable world driven by sustainable values. A world that will be defined by its successful movement toward the "triple bottom line," a term articulated by John Elkington, is a world in which economic prosperity, environmental protection, and social equity are aligned. To say that the model allows one to address terrorism is based on the assumption that the lack of social equity or the perception of that lack determines the likelihood of terrorism.

  9. Regulatory and tax issues for worksite wellness programs.

    PubMed

    Chapman, Larry S

    2007-01-01

    Worksite wellness programs continue to grow and find expression in employer organizations of all types. As these programs mature and are offered to larger and larger numbers of employees in more worksites increased opportunity exists for regulatory problems. Applicable legislation and major federal regulatory issues affecting worksite wellness programs are explored and categorized. Final rules regarding Title I non-discrimination provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are described and implications for employers are identified. Due to the increasing importance of incentive rewards in programming, the tax implications of various types of program expenditures are also described. Finally, suggestions for legislative amendments and regulatory changes that would enhance wellness program effects are described. PMID:17515012

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

    SciTech Connect

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

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

  11. Newborn falls in-hospital: time to address the issue.

    PubMed

    Paul, Siba Prosad; Goodman, Alexander; Remorino, Rowena; Bolger, Sarah

    2011-04-01

    Newborn falls in-hospital are considered rare and mostly accidental. Few studies are available explaining such accidents. The number of cases may be under reported by parents because of the inevitable sense of guilt they experience. Although deaths have been rarely reported, such accidents may be associated with serious outcomes. An urgent assessment by both the midwifery and paediatric teams should be undertaken following the reporting of such accidents. This paper explains what is meant by newborn falls, presents some relevant literature and uses a case study involving a newborn in hospital to form the basis of a discussion. Importantly it is felt that there is a need to raise awareness of the potential of these accidents amongst health professionals. We hope this paper goes some way towards highlighting some key issues and, moreover, increases awareness of newborn falls in hospital. PMID:21560948

  12. "Cairo must address the equity issue." Interview: Sandra Postel.

    PubMed

    1994-01-01

    Sandra Postel, of the Worldwatch Institute, believes that inequalities in consumption and income foster environmental degradation. The richest 20% are getting richer and consuming excessively. The bottom 20%, comprising about 1 billion people, are getting poorer and are degrading their environment in order to survive. Per capita availability of resources is continually being reduced. If there is a desire to improve the quality of life for the poorest segment of the world population, then the richest must forfeit something. Environmental taxation could reduce excessive consumption in general; this strategy would be the most efficient and useful. Taxes would be placed on pollution and resources in danger of depletion; income taxes could be reduced to balance the impact of increased taxes on the economy. Wealthy countries must make a renewed commitment to poverty alleviation and to realistic sustainable development. Aid budgets should no longer reflect military priorities or strategic objectives. Trade is clearly related to the environment and poverty, and these connections must be made publicly known. National and international trade policies must deal with poverty issues and not contribute to further environmental destruction. Eliminating debt problems is another problem in need of change. The World Bank and structural adjustment policies have not proved to be environmentally sound and have not benefitted the poor. Evaluation of programs is needed, and lending policies should reflect the growing awareness of the problems of the poor and environmental consequences. Consumption of energy, wood, paper, and water are all higher among industrialized wealthy countries. Technology needs to be applied to maximize resource use, and policies must reflect this commitment. Israel has set a good example with water consumption reduction through advanced technology. PMID:12345839

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

    ERIC Educational Resources Information Center

    Heilman, John G.; Johnson, Gerald W.

    1991-01-01

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

  14. Developing integrated methods to address complex resource and environmental issues

    USGS Publications Warehouse

    Smith, Kathleen S.; Phillips, Jeffrey D.; McCafferty, Anne E.; Clark, Roger N.

    2016-02-08

    IntroductionThis circular provides an overview of selected activities that were conducted within the U.S. Geological Survey (USGS) Integrated Methods Development Project, an interdisciplinary project designed to develop new tools and conduct innovative research requiring integration of geologic, geophysical, geochemical, and remote-sensing expertise. The project was supported by the USGS Mineral Resources Program, and its products and acquired capabilities have broad applications to missions throughout the USGS and beyond.In addressing challenges associated with understanding the location, quantity, and quality of mineral resources, and in investigating the potential environmental consequences of resource development, a number of field and laboratory capabilities and interpretative methodologies evolved from the project that have applications to traditional resource studies as well as to studies related to ecosystem health, human health, disaster and hazard assessment, and planetary science. New or improved tools and research findings developed within the project have been applied to other projects and activities. Specifically, geophysical equipment and techniques have been applied to a variety of traditional and nontraditional mineral- and energy-resource studies, military applications, environmental investigations, and applied research activities that involve climate change, mapping techniques, and monitoring capabilities. Diverse applied geochemistry activities provide a process-level understanding of the mobility, chemical speciation, and bioavailability of elements, particularly metals and metalloids, in a variety of environmental settings. Imaging spectroscopy capabilities maintained and developed within the project have been applied to traditional resource studies as well as to studies related to ecosystem health, human health, disaster assessment, and planetary science. Brief descriptions of capabilities and laboratory facilities and summaries of some

  15. Developing integrated methods to address complex resource and environmental issues

    USGS Publications Warehouse

    Smith, Kathleen S.; Phillips, Jeffrey D.; McCafferty, Anne E.; Clark, Roger N.

    2016-02-08

    IntroductionThis circular provides an overview of selected activities that were conducted within the U.S. Geological Survey (USGS) Integrated Methods Development Project, an interdisciplinary project designed to develop new tools and conduct innovative research requiring integration of geologic, geophysical, geochemical, and remote-sensing expertise. The project was supported by the USGS Mineral Resources Program, and its products and acquired capabilities have broad applications to missions throughout the USGS and beyond.In addressing challenges associated with understanding the location, quantity, and quality of mineral resources, and in investigating the potential environmental consequences of resource development, a number of field and laboratory capabilities and interpretative methodologies evolved from the project that have applications to traditional resource studies as well as to studies related to ecosystem health, human health, disaster and hazard assessment, and planetary science. New or improved tools and research findings developed within the project have been applied to other projects and activities. Specifically, geophysical equipment and techniques have been applied to a variety of traditional and nontraditional mineral- and energy-resource studies, military applications, environmental investigations, and applied research activities that involve climate change, mapping techniques, and monitoring capabilities. Diverse applied geochemistry activities provide a process-level understanding of the mobility, chemical speciation, and bioavailability of elements, particularly metals and metalloids, in a variety of environmental settings. Imaging spectroscopy capabilities maintained and developed within the project have been applied to traditional resource studies as well as to studies related to ecosystem health, human health, disaster assessment, and planetary science. Brief descriptions of capabilities and laboratory facilities and summaries of some

  16. Issue-Specific Barriers to Addressing Environmental Issues in the Classroom: An Exploratory Study

    ERIC Educational Resources Information Center

    Kim, Chankook; Fortner, Rosanne W.

    2006-01-01

    To explore issue-specific barriers to teaching environmental issues, the authors investigated secondary science teachers' perceived current and preferred teaching levels for 23 environmental issues and perceived barriers to teaching the selected issues. Subjects in this graduate project were 41 secondary science teachers self-selected to answer a…

  17. Utilizing Internet-based Community Collaboration Tools and Geobrowsers to Address Issues of Water Resource Sustainability

    NASA Astrophysics Data System (ADS)

    D'Agnese, F. A.

    2007-12-01

    More frequently society is demanding that earth- and environmental-resource issues be evaluated and addressed by interdisciplinary investigators from the scientific, engineering, planning, and regulatory communities. Often these investigators are required to interact with a larger community of public stakeholders. Also, these investigators, by necessity, develop databases and models derived from disparate data sets that are often large, complex, and vary dramatically in scale and quality. The tools to facilitate the interactions of these communities of individuals have only recently garnered the appropriate sophistication to enable real-time data viewing, encoding, browsing, and modeling. At the same time, the advent of second-generation internet, or Web 2.0, technologies found in web-based communities and hosted services (such as social-networking, wikis, weblogs, social bookmarking, podcasts, and RSS web feeds) have fused with the more traditional two- and three-dimensional geographic information systems. This "mash-up" of web-based and stand-alone tools and services creates a highly interactive user environment that is favorable to real-time collaboration, community discussion, and broad public dissemination in a wide-area distributed network. These tools and services are being utilized to facilitate the investigations and conversations of scientists and other stakeholders addressing water resource sustainability issues in the desert southwestern United States. The data and models derived from these investigations are visualized using industry standard tools like ArcGIS, Google Earth, and Google Maps to enable ease-of-use by both the technical and the public stakeholder communities.

  18. ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH

    Cancer.gov

    ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH, designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices.

  19. RFID in healthcare environment: electromagnetic compatibility regulatory issues.

    PubMed

    Censi, Federica; Calcagnini, Giovanni; Mattei, Eugenio; Triventi, Michele; Bartolini, Pietro

    2010-01-01

    Several wireless technology applications (RFID, WiFi, GSM, GPRS) have been developed to improve patient care, reaching a significant success and diffusion in healthcare. Given the potential development of such a technology, care must be paid on the potential risks deriving from the use of wireless device in healthcare, among which one of the most important is the electromagnetic interference with medical devices. The analysis of the regulatory issues concerning the electromagnetic compatibility of medical devices is essential to evaluate if and how the application of the current standards allows an effective control of the possible risks associated to the electromagnetic interference on medical devices. PMID:21096973

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

    PubMed

    Park, Douglas L; Troxell, Terry C

    2002-01-01

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

  1. 75 FR 44781 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ... COMMISSION SECURITIES AND EXCHANGE COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues...''). ACTION: Notice of Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting...

  2. 76 FR 6120 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... COMMISSION SECURITIES AND EXCHANGE COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues...''). ACTION: Notice of Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues will hold a public meeting...

  3. Duration of immunity (DOI)--The regulatory issues.

    PubMed

    Gaskell, Rosalind M; Dawson, Susan; Radford, Alan D

    2006-10-01

    This paper discusses the efficacy of cat and dog vaccines, with respect to duration of immunity and regulatory issues. The European Union (EU) regulatory requirements are described: briefly, efficacy claims, which include duration of immunity, have to be specific for the product and supported by controlled laboratory and field trials. As a result, the duration of immunity shown has typically been a minimum, because of the cost and welfare implications of keeping animals for long periods of time in isolation. In contrast, in the US, duration of immunity has not traditionally been required for each individual product, only for rabies vaccines and some other vaccines for which no other products are available. The consequence of this is that in the US, various scientific authorities have produced guidelines appropriate for individual diseases. Undoubtedly this will continue, although the regulatory authorities also appear to be moving towards a position where lack of information may be indicated on the product label, and studies are required to support extended duration of immunity claims. The advantages and disadvantages of laboratory challenge studies versus field trials are discussed, and the use of alternatives such as surrogate markers of protection. The approaches used for small animal vaccines are compared to those used, for example, in human medicine. The main issue for small animals is that unlike in some other species, the aim generally is to maximise protection in the individual, rather than induce protection at the population level. The drawbacks of the present EU system are summarised, and the ways in which the situation is currently being approached and improved are presented.

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

    PubMed

    Sanders, M E; Huis in't Veld, J

    1999-01-01

    Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

  10. The New ASERVIC Competencies for Addressing Spiritual and Religious Issues in Counseling

    ERIC Educational Resources Information Center

    Cashwell, Craig S.; Watts, Richard E.

    2010-01-01

    In 2009, leaders in the Association for Spiritual, Ethical and Religious Values in Counseling (ASERVIC) developed new competencies for addressing spiritual and religious issues in counseling. This article briefly addresses the need for new ASERVIC competencies, provides an overview of the process whereby the new competencies emerged, and concludes…

  11. Sarah's Story: Using Ritual Therapy to Address Psychospiritual Issues in Treating Survivors of Childhood Sexual Abuse.

    ERIC Educational Resources Information Center

    Parker, Radha J.; Horton, H. Shelton, Jr.; Watson, Terri

    1997-01-01

    Describes an individual's healing from the trauma of childhood sexual abuse through counseling, spiritual growth, and the use of therapeutic ritual. Explores relationships between the psychospiritual issues associated with childhood sexual abuse and commonly designated treatment goals. Claims that addressing psychospiritual issues is crucial in…

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

    PubMed

    Dane, Aaron; Wetherington, Jeffrey D

    2014-01-01

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

  13. Regulatory policy issues and the Clean Air Act: Issues and papers from the state implementation workshops

    SciTech Connect

    Rose, K.; Burns, R.E.

    1993-07-01

    The National Regulatory Research Institute (NRRI), with funding from the US Environmental Protection Agency (EPA) and the US Department of Energy (DOE), conducted four regional workshops` on state public utility commission implementation of the Clean Air Act Amendments of 1990 (CAAA). The workshops had four objectives: (1) to discuss key issues and concerns on CAAA implementation, (2) to encourage a discussion among states on issues of common interests, (3) to attempt to reach consensus, where possible, on key issues, and (4) to provide the workshop participants with information and materials to assist in developing state rules, orders, and procedures. From the federal perspective, a primary goal was to ensure that workshop participants return to their states with a comprehensive background and understanding of how state commission actions may affect implementation of the CAAA and to be able to provide guidance to their jurisdictional utilities. It was hoped that this would reduce some of the uncertainty utilities face and assist in the development of an efficient allowance market. This report is divided into two main sections. In Section II, eleven principal issues are identified and discussed. These issues were chosen because they were either the most frequently discussed or they were related to the questions asked in response to the speakers` presentations. This section does not cover all the issues relevant to state implementation nor all the issues discussed at the workshops; rather, Section II is intended to provide an overview of the,planning, ratemaking, and multistate issues. Part III is a series of workshop papers presented by some of the speakers. Individual papers have been cataloged separately.

  14. 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.

  15. The dilemma of low-level risks: the below-regulatory-concern issue

    SciTech Connect

    Congel, F.J.; Willis, C.A. )

    1991-01-01

    The US Nuclear Regulatory Commission (NRC), in an effort to concentrate its limited resources on significant safety issues, formulated the below-regulatory-concern (BRC) policy as a logical framework for exempting low-risk issues from regulatory control. Public and political opposition has been strong. The background, the issues, and the policy questions are discussed in this paper. There is a major difference between actual risk, as determined by analysis and experience, and the public perception of risk. Regulatory action must be determined in part by public perception. This creates a dilemma in allocating resources on significant issues. The problems with the BRC policy exemplify this problem.

  16. An overview of stem cell research and regulatory issues.

    PubMed

    Cogle, Christopher R; Guthrie, Steven M; Sanders, Ronald C; Allen, William L; Scott, Edward W; Petersen, Bryon E

    2003-08-01

    Stem cells are noted for their ability to self-renew and differentiate into a variety of cell types. Some stem cells, described as totipotent cells, have tremendous capacity to self-renew and differentiate. Embryonic stem cells have pluripotent capacity, able to form tissues of all 3 germ layers but unable to form an entire live being. Research with embryonic stem cells has enabled investigators to make substantial gains in developmental biology, therapeutic tissue engineering, and reproductive cloning. However, with these remarkable opportunities many ethical challenges arise, which are largely based on concerns for safety, efficacy, resource allocation, and methods of harvesting stem cells. Discussing the moral and legal status of the human embryo is critical to the debate on stem cell ethics. Religious perspectives and political events leading to regulation of stem cell research are presented and discussed, with special attention directed toward the use of embryonic stem cells for therapeutic and reproductive cloning. Adult stem cells were previously thought to have a restricted capacity to differentiate; however, several reports have described their plasticity potential. Furthermore, there have been close ties between the behavior of stem cells and cancer cells. True eradication of cancer will require a deeper understanding of stem cell biology. This article was written to inform medical scientists and practicing clinicians across the spectrum of medical education about the research and regulatory issues affecting the future of stem cell therapy.

  17. Safety and Regulatory Issues of the Thorium Fuel Cycle

    SciTech Connect

    Ade, Brian; Worrall, Andrew; Powers, Jeffrey; Bowman, Steve; Flanagan, George; Gehin, Jess

    2014-02-01

    Thorium has been widely considered an alternative to uranium fuel because of its relatively large natural abundance and its ability to breed fissile fuel (233U) from natural thorium (232Th). Possible scenarios for using thorium in the nuclear fuel cycle include use in different nuclear reactor types (light water, high temperature gas cooled, fast spectrum sodium, molten salt, etc.), advanced accelerator-driven systems, or even fission-fusion hybrid systems. The most likely near-term application of thorium in the United States is in currently operating light water reactors (LWRs). This use is primarily based on concepts that mix thorium with uranium (UO2 + ThO2), add fertile thorium (ThO2) fuel pins to LWR fuel assemblies, or use mixed plutonium and thorium (PuO2 + ThO2) fuel assemblies. The addition of thorium to currently operating LWRs would result in a number of different phenomenological impacts on the nuclear fuel. Thorium and its irradiation products have nuclear characteristics that are different from those of uranium. In addition, ThO2, alone or mixed with UO2 fuel, leads to different chemical and physical properties of the fuel. These aspects are key to reactor safety-related issues. The primary objectives of this report are to summarize historical, current, and proposed uses of thorium in nuclear reactors; provide some important properties of thorium fuel; perform qualitative and quantitative evaluations of both in-reactor and out-of-reactor safety issues and requirements specific to a thorium-based fuel cycle for current LWR reactor designs; and identify key knowledge gaps and technical issues that need to be addressed for the licensing of thorium LWR fuel in the United States.

  18. Addressing the shortage of health professionals in rural China: issues and progress

    PubMed Central

    Hou, Jianlin; Ke, Yang

    2015-01-01

    Maldistribution of health professionals between urban and rural areas has been a serious problem in China. Urban hospitals attract most of the health professionals with serious shortages in rural areas. To address this issue, a number of policies have been implemented by the government, such as free medical education in exchange for obligatory rural service. PMID:25905487

  19. From Professional Development to Classroom Instruction: Addressing Issues Related to Science Inquiry Discourse

    ERIC Educational Resources Information Center

    Oliveira, Alandeom W.

    2009-01-01

    In this rejoinder, I first provide a more detailed account of the discourse-focused professional development activities facilitated as part of the SMIT'N program, specifically addressing issues raised by van Zee with regard to the institute's overall format, goals and development strategies. Next, I resort to Peter Medawar's metaphorical view of…

  20. Beyond the Dialectics and Polemics: Canadian Catholic Schools Addressing LGBT Youth Issues

    ERIC Educational Resources Information Center

    Liboro, Renato M.; Travers, Robb; St. John, Alex

    2015-01-01

    In 2012, Canadian media coverage on Bill 13--an Ontario legislative proposal to require all publicly funded schools to support Gay-Straight Alliances as a means of addressing issues concerning bullied lesbian, gay, bisexual, and transgender (LGBT) students--instigated a divisive exchange among representatives of the Ontario Catholic school sector.…

  1. Recommendations and Strategies for Addressing Comprehensive Health Issues on Two-Year College Campuses.

    ERIC Educational Resources Information Center

    Winter, Gene M.; And Others

    The Two-Year College Development Center invited representatives from two-year colleges throughout New York to attend a two-day meeting to address comprehensive health issues, particularly pertaining to the transmission and prevention of Acquired Immune Deficiency Syndrome (AIDS), as well as other infectious and chronic diseases. The attending…

  2. 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...

  3. Regulatory issues associated with closure of the Hanford AX Tank Farm ancillary equipment

    SciTech Connect

    Becker, D.L.

    1998-09-02

    Liquid mixed, high-level radioactive waste has been stored in underground single-shell tanks at the US Department of Energy`s (DOE`s) Hanford Site. After retrieval of the waste from the single-shell tanks, the DOE will proceed with closure of the tank farm. The 241-AX Tank Farm includes four one-million gallon single-shell tanks in addition to sluice lines, transfer lines, ventilation headers, risers, pits, cribs, catch tanks, buildings, well and associated buried piping. This equipment is classified as ancillary equipment. This document addresses the requirements for regulatory close of the ancillary equipment in the Hanford Site 241-AX Tank Farm. The options identified for physical closure of the ancillary equipment include disposal in place, disposal in place after treatment, excavation and disposal on site in an empty single-shell tank, and excavation and disposal outside the AX Tank Farm. The document addresses the background of the Hanford Site and ancillary equipment in the AX Tank Farm, regulations for decontamination and decommissioning of radioactively contaminated equipment, requirements for the cleanup and disposal of radioactive wastes, cleanup and disposal requirements governing hazardous and mixed waste, and regulatory requirements and issues associated with each of the four physical closure options. This investigation was conducted by the Sandia National Laboratories, Albuquerque, New Mexico, during Fiscal Year 1998 for the Hanford Tanks Initiative Project.

  4. Web-Based Geospatial Tools to Address Hazard Mitigation, Natural Resource Management, and Other Societal Issues

    USGS Publications Warehouse

    Hearn,, Paul P.

    2009-01-01

    Federal, State, and local government agencies in the United States face a broad range of issues on a daily basis. Among these are natural hazard mitigation, homeland security, emergency response, economic and community development, water supply, and health and safety services. The U.S. Geological Survey (USGS) helps decision makers address these issues by providing natural hazard assessments, information on energy, mineral, water and biological resources, maps, and other geospatial information. Increasingly, decision makers at all levels are challenged not by the lack of information, but by the absence of effective tools to synthesize the large volume of data available, and to utilize the data to frame policy options in a straightforward and understandable manner. While geographic information system (GIS) technology has been widely applied to this end, systems with the necessary analytical power have been usable only by trained operators. The USGS is addressing the need for more accessible, manageable data tools by developing a suite of Web-based geospatial applications that will incorporate USGS and cooperating partner data into the decision making process for a variety of critical issues. Examples of Web-based geospatial tools being used to address societal issues follow.

  5. 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.

  6. Cell therapeutic options in liver diseases: cell types, medical devices and regulatory issues.

    PubMed

    Nussler, Andreas K; Zeilinger, Katrin; Schyschka, Lilianna; Ehnert, Sabrina; Gerlach, Jörg C; Yan, Xueying; Lee, Serene M L; Ilowski, Maren; Thasler, Wolfgang E; Weiss, Thomas S

    2011-05-01

    Although significant progress has been made in the field of orthotopic liver transplantation, cell-based therapies seem to be a promising alternative to whole-organ transplantation. The reasons are manifold but organ shortage is the main cause for this approach. However, many problems such as the question which cell type should be used or which application site is best for transplantation have been raised. In addition, some clinicians have had success by cultivating liver cells in bioreactors for temporary life support. Besides answering the question which cell type, which injection site or even which culture form should be used for liver support recent international harmonization of legal requirements is needed to be addressed by clinicians, scientists and companies dealing with cellular therapies. We here briefly summarize the possible cell types used to partially or temporarily correct liver diseases, the most recent development of bioreactor technology and important regulatory issues.

  7. Addressing Key Science and Technology Issues for IFE Chambers, Target Fabrication and Target Injection

    SciTech Connect

    Meier, W R; Goodin, D T; Nobile, A; Besenbruch, G; Haynes, D; Hoffer, J; Latkowski, J; Maxwell, J; Najmabadi, F; Nikroo, A; Peterson, P; Petzoldt, R; Rickman, W; Sethian, J; Steckle, W; Stephens, E; Tillack, M; Ying, A; Yoda, M

    2002-09-25

    Significant progress has been made in addressing critical issues for high repetition rate chambers, target fabrication and injection for inertial fusion energy (IFE) for both heavy ion and laser drivers. Research is being conducted in a coordinated manner by national laboratories, universities and industry. This paper provides an overview of U.S. research activities and discusses how interface considerations (such as beam propagation and target survival during injection) impact design choices.

  8. Multiple views to address diversity issues: an initial dialog to advance the chiropractic profession

    PubMed Central

    Johnson, Claire; Killinger, Lisa Zaynab; Christensen, Mark G.; Hyland, John K.; Mrozek, John P.; Zuker, R. Fred; Kizhakkeveettil, Anupama; Perle, Stephen M.; Oyelowo, Tolu

    2012-01-01

    The purpose of this article is to provide expert viewpoints on the topic of diversity in the chiropractic profession, including cultural competency, diversity in the profession, educational and clinical practice strategies for addressing diversity, and workforce issues. Over the next decades, changing demographics in North America will alter how the chiropractic profession functions on many levels. As the population increases in diversity, we will need to prepare our workforce to meet the needs of future patients and society. PMID:23966884

  9. The role of Violence Against Women Act in addressing intimate partner violence: a public health issue.

    PubMed

    Modi, Monica N; Palmer, Sheallah; Armstrong, Alicia

    2014-03-01

    Intimate partner violence (IPV) is defined as violence committed by a current or former boyfriend or girlfriend, spouse or ex-spouse. Each year, 1.3 to 5.3 million women in the United States experience IPV. The large number of individuals affected, the enormous healthcare costs, and the need for a multidisciplinary approach make IPV an important healthcare issue. The Violence Against Women Act (VAWA) addresses domestic violence, dating violence, sexual assault, and stalking. It emphasizes development of coordinated community care among law enforcement, prosecutors, victim services, and attorneys. VAWA was not reauthorized in 2012 because it lacked bipartisan support. VAWA 2013 contains much needed new provisions for Native Americans; lesbian, gay, bisexual, transgender, gay, and queer (LGBTQ) individuals; and victims of human trafficking but does not address the large amount of intimate partner violence in America's immigrant population. There are important remaining issues regarding intimate partner violence that need to be addressed by future legislation. This review examines the role of legislation and addresses proposals for helping victims of IPV. PMID:24299159

  10. The Role of Violence Against Women Act in Addressing Intimate Partner Violence: A Public Health Issue

    PubMed Central

    Modi, Monica N.; Palmer, Sheallah

    2014-01-01

    Abstract Intimate partner violence (IPV) is defined as violence committed by a current or former boyfriend or girlfriend, spouse or ex-spouse. Each year, 1.3 to 5.3 million women in the United States experience IPV. The large number of individuals affected, the enormous healthcare costs, and the need for a multidisciplinary approach make IPV an important healthcare issue. The Violence Against Women Act (VAWA) addresses domestic violence, dating violence, sexual assault, and stalking. It emphasizes development of coordinated community care among law enforcement, prosecutors, victim services, and attorneys. VAWA was not reauthorized in 2012 because it lacked bipartisan support. VAWA 2013 contains much needed new provisions for Native Americans; lesbian, gay, bisexual, transgender, gay, and queer (LGBTQ) individuals; and victims of human trafficking but does not address the large amount of intimate partner violence in America's immigrant population. There are important remaining issues regarding intimate partner violence that need to be addressed by future legislation. This review examines the role of legislation and addresses proposals for helping victims of IPV. PMID:24299159

  11. 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

    ... is to clarify the NRC staff guidance to address issues of gas accumulation in safety related systems... guidance documents. Disposition: On November 12, 2009 (74 FR 58323), the NRC staff issued proposed DC/COL... COMMISSION Final Interim Staff Guidance: Review of Evaluation To Address Gas Accumulation Issues in...

  12. Science Teachers' Use of Mass Media to Address Socio-Scientific and Sustainability Issues

    NASA Astrophysics Data System (ADS)

    Klosterman, Michelle L.; Sadler, Troy D.; Brown, Julie

    2012-01-01

    The currency, relevancy and changing nature of science makes it a natural topic of focus for mass media outlets. Science teachers and students can capitalize on this wealth of scientific information to explore socio-scientific and sustainability issues; however, without a lens on how those media are created and how representations of science are constructed through media, the use of mass media in the science classroom may be risky. Limited research has explored how science teachers naturally use mass media to explore scientific issues in the classroom or how mass media is used to address potential overlaps between socio-scientific-issue based instruction and education for sustainability. This naturalistic study investigated the reported and actual classroom uses of mass media by secondary science teachers' to explore socio-scientific and sustainability issues as well as the extent to which their instructional approaches did or did not overlap with frameworks for SSI-based instruction, education for sustainability, and media literacy education. The results of this study suggest that secondary science teachers use mass media to explore socio-scientific and sustainability issues, but their use of frameworks aligned with SSI-based, education for sustainability, and media literacy education was limited. This paper provides suggestions for how we, as science educators and researchers, can advance a teaching and learning agenda for encouraging instruction that more fully utilizes the potential of mass media to explore socio-scientific issues in line with perspectives from education for sustainability.

  13. Steam generators regulatory practices and issues in Spain

    SciTech Connect

    Mendoza, C.; Castelao, C.; Ruiz-Colino, J.; Figueras, J.M.

    1997-02-01

    This paper presents the actual status of Spanish Steam Generator tubes, actions developed by PWR plant owners and submitted to CSN, and regulatory activities related to tube degradation mechanisms analysis; NDT tube inspection techniques; tube, tubesheet and TSPs integrity studies; tube plugging/repair criteria; preventive and corrective measures including whole SGs replacement; tube leak measurement methods and other operational aspects.

  14. SOFTWARE TOOLS THAT ADDRESS HAZARDOUS MATERIAL ISSUES DURING NUCLEAR FACILITY D and D

    SciTech Connect

    M. COURNOYER; R. GRUNDEMANN

    2001-03-01

    The 49-year-old Chemistry and Metallurgy Research (CMR) Facility is where analytical chemistry and metallurgical studies on samples of plutonium and nuclear materials are conduct in support of the Department of Energy's nuclear weapons program. The CMR Facility is expected to be decontaminated and decommissioned (D and D) over the next ten to twenty years. Over the decades, several hazardous material issues have developed that need to be address. Unstable chemicals must be properly reassigned or disposed of from the workspace during D and D operation. Materials that have critical effects that are primarily chronic in nature, carcinogens, reproductive toxin, and materials that exhibit high chronic toxicity, have unique decontamination requirements, including the decontrolling of areas where these chemicals were used. Certain types of equipment and materials that contain mercury, asbestos, lead, and polychlorinated biphenyls have special provisions that must be addressed. Utilization of commercially available software programs for addressing hazardous material issues during D and D operations such as legacy chemicals and documentation are presented. These user-friendly programs eliminate part of the tediousness associated with the complex requirements of legacy hazardous materials. A key element of this approach is having a program that inventories and tracks all hazardous materials. Without an inventory of chemicals stored in a particular location, many important questions pertinent to D and D operations can be difficult to answer. On the other hand, a well-managed inventory system can address unstable and highly toxic chemicals and hazardous material records concerns before they become an issue. Tapping into the institutional database provides a way to take advantage of the combined expertise of the institution in managing a cost effective D and D program as well as adding a quality assurance element to the program. Using laboratory requirements as a logic flow

  15. Legal & regulatory issues affecting participation in distributed resource markets

    SciTech Connect

    Nimmons, J.T.

    1996-12-31

    This paper describes recent research co-sponsored by the National Renewable Energy Laboratory and four investor-owned utilities. Its purpose was to investigate how legal and regulatory factors will shape strategic decisions on the roles of utilities and others in the development of distributed resources. The work was performed during 1995 and early 1996 by John Nimmons & Associates, with support from Thomas J. Starts, Energy & Environmental Economics, and Awad & Singer.

  16. 75 FR 34704 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-18

    ... COMMISSION COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory... (``CFTC'') (each, an ``Agency,'' and collectively, ``Agencies''). ACTION: Notice of Meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. ] SUMMARY: The Joint CFTC-SEC Advisory...

  17. 75 FR 28667 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... COMMISSION COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory... (``CFTC'') (each, an ``Agency,'' and collectively, ``Agencies''). ACTION: Notice of meeting of Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues. SUMMARY: The Joint CFTC-SEC Advisory...

  18. 76 FR 10072 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... COMMISSION Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station Electric Distribution System Voltages; Reopening of Public Comment Period AGENCY: Nuclear Regulatory... January 18, 2011, in the Federal Register (76 FR 2924), which announced, in part, that the public...

  19. Legal, regulatory & institutional issues facing distributed resources development

    SciTech Connect

    1996-10-01

    This report describes legal, regulatory, and institutional considerations likely to shape the development and deployment of distributed resources. It is based on research co-sponsored by the National Renewable Energy Laboratory (NREL) and four investor-owned utilities (Central & South West Services, Cinergy Corp., Florida Power Corporation, and San Diego Gas & Electric Company). The research was performed between August 1995 and March 1996 by a team of four consulting firms experienced in energy and utility law, regulation, and economics. It is the survey phase of a project known as the Distributed Resources Institutional Analysis Project.

  20. Nanosilver and global public health: international regulatory issues.

    PubMed

    Faunce, Thomas; Watal, Aparna

    2010-06-01

    Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings, in dressings as a treatment for external wounds, burns and ulcers. Nanosilver is also an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. In addition, nanosilver is widely used for its antibacterial properties in food processing and packaging, as well as in consumer products used for domestic cleaning and clothing. This article argues that medical devices, therapeutic products, and domestic food and goods containing nanosilver, although offering therapeutic benefits, must be subject to precautionary regulation owing to associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. The article first examines the use of nanosilver in a variety of contemporary medical and domestic products, the utilization of which may assist in resolving global public health problems, such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the USA, EU, UK and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver.

  1. Nanosilver and global public health: international regulatory issues.

    PubMed

    Faunce, Thomas; Watal, Aparna

    2010-06-01

    Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings, in dressings as a treatment for external wounds, burns and ulcers. Nanosilver is also an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. In addition, nanosilver is widely used for its antibacterial properties in food processing and packaging, as well as in consumer products used for domestic cleaning and clothing. This article argues that medical devices, therapeutic products, and domestic food and goods containing nanosilver, although offering therapeutic benefits, must be subject to precautionary regulation owing to associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. The article first examines the use of nanosilver in a variety of contemporary medical and domestic products, the utilization of which may assist in resolving global public health problems, such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the USA, EU, UK and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver. PMID:20528456

  2. ONA Implementation Impact. ONA Technical and Regulatory Issues.

    ERIC Educational Resources Information Center

    Eckhart, B. J.

    This paper discusses technical considerations surrounding open network architecture (ONA), specifically: (1) the technical characteristics of the Public Networks (Local Exchange Carriers LATA Networks); (2) the impact of ONA success on the Public Network and some concerns that will have to be addressed in the early implementation stages; and (3)…

  3. QA/QC issues to aid regulatory acceptance of microarray gene expression data.

    PubMed

    Fuscoe, James C; Tong, Weida; Shi, Leming

    2007-06-01

    The U.S. Food and Drug Administration is responsible for (1) promoting and protecting public health by assuring the safety and effectiveness of medicines and medical devices and (2) advancing public health by helping to speed innovations that make medicines and foods safer, more effective, and more affordable. The genomics revolution has dramatically increased our knowledge of basic biology but this has not resulted in the expected acceleration of new medical product development. The Agency's Critical Path to New Medical Products stresses that new tools are needed to address this pipeline problem. Microarray technology is one of these promising tools although questions have risen about the reproducibility of measurements. The Microarray Quality Control (MAQC) Project was initiated by FDA scientists to address this issue. This large project, which evaluated reference RNA samples on seven microarray platforms, found good intralaboratory repeatability and interlaboratory reproducibility. In addition, there was high cross-platform consistency. All data are available free of cost and the reference RNA samples are available for proficiency testing. Thus, current microarray technology appears to provide both reliability and consistency for regulatory submissions. PMID:17567852

  4. Commentary: what role should physician organizations play in addressing social justice issues?

    PubMed

    Bright, Cedric M

    2012-06-01

    A study by Peek and colleagues in this issue reveals that although racial and ethnic health disparities are recognized as a major national challenge, few physician organizations with both the influence and ability to change practice standards and address disparities appear to be effectively directing their resources to mitigate health disparities. In this commentary, the author examines the history of U.S. health disparities through the lens of social justice. He argues that today, physician organizations have the opportunity to change the paradigm of medicine from being a reactive industry to becoming a proactive industry through collaborations such as the Commission to End Health Disparities, which brings together more than 60 organizations, and the National Medical Association's "We Stand With You" program to improve health and combat disparities. Physician organizations can also address health disparities through advocacy for fair reimbursement policies, funding for pipeline programs to increase the diversity of the workforce, diversity in clinical trials, and other issues. Health disparities present to us in organized medicine a challenge that is cleverly disguised as an immovable object but that is truly a great opportunity for innovation, improvement, and growth. Physician organizations have a unique opportunity to provide avenues of innovation and accomplishment.

  5. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

    PubMed

    Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

    2015-06-01

    Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings.

  6. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems

    PubMed Central

    Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

    2015-01-01

    Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. PMID:25733677

  7. Clinical data and regulatory issues of biosimilar products.

    PubMed

    Stevenson, James G

    2015-12-01

    Biologics are a fast-growing segment of pharmaceutical development. Many are effective in the treatment of illnesses such as cancers, rheumatoid arthritis, and multiple sclerosis. Biologics encompass a range of compounds, including recombinant hormones, growth factors, monoclonal antibodies, recombinant vaccines, and blood products. Many of these drugs are facing patent expiration, and pharmaceutical research is focusing on the development of generic substitutes, or "biosimilars." Because biologics generally exhibit high molecular complexity, the process of development and approval of biosimilars is complicated. Unlike standard small molecule generics where an identical drug copy is expected, variations in biosimilars may be inherent because the sponsor does not have knowledge of the originator's processes. Because of this intricacy, regulatory requirements are needed to ensure biosimilarity, comparability, and interchangeability with respect to efficacy and safety. Clinician awareness of the similarities and differences between original biopharmaceuticals and biosimilars, as well as their impact on efficacy and safety, is imperative. PMID:26788808

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

    SciTech Connect

    Miller, M.; Cox, S.

    2014-05-01

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

  9. The corporate impact of addressing social issues: a financial case study of a project in Peru.

    PubMed

    Dabbs, Alan; Bateson, Matthew

    2002-05-01

    Large, multinational resource development projects can affect many aspects, including social, economic and ecological realities, in the regions where they operate. Social and environmental issues that are usually ignored in such projects are increasingly affecting the financial future of multinational corporations in negative ways. In this article, we advance the argument that corporations can successfully manage these issues and that if they choose to view these management efforts as an investment rather than an expense, they may well acquire a competitive advantage over companies that do not. We describe as a case study the Camisea natural gas and condensates development project in Peru, operated by Shell Prospecting and Development Peru (SPDP). Camisea is one of the first projects anywhere in the world to conduct a detailed analysis of key industry-related social issues and the processes, required investment and financial impact of managing them. The Camisea example supports the argument that addressing social and environmental concerns makes financial sense. In present value terms, the benefit of managing these concerns was expected to surpass the cost investment by approximately US$50 million. PMID:12125747

  10. Optimization of Compound Plate Preparation to Address Precipitation Issue in Mammalian A549 Cytotoxicity Assay.

    PubMed

    Raghavendra Achar, Vijayashree Gauribidanur; Barde, Shubhada Pramod; Mallya, Meenakshy Venkatesh; Awasthy, Disha; Narayan, Chandan

    2016-06-01

    This study illustrates the optimization of low-volume dispensing on a liquid handling system (LHS) to overcome the precipitation of compounds in the mammalian cytotoxicity assay with low dimethyl sulfoxide (DMSO) tolerance. All compounds at AstraZeneca Bangalore are tested in the mammalian cytotoxicity assay. In order to maintain the DMSO levels, serially diluted plates were prepared in DMSO/water. It was observed that some of the compounds precipitated. The IC50 data for such compounds were therefore erratic. To circumvent the problem of compound precipitation, the LHS was optimized to dispense low volumes (<1 µL). The plates were serially diluted using neat DMSO. Since the dilution was done using neat DMSO, there were no issues with precipitation. The serially diluted sample (0.5 µL) from the plate was stamped onto the assay plate to give the desired DMSO concentration. No significant differences in IC50 data were observed for 1 µL dispenses made from DMSO/water and 0.5 µL dispenses from neat DMSO for the samples with no precipitation issues. These data therefore gave us the confidence to switch over to 0.5 µL dispenses for the cytotoxicity assay to address the precipitation issue. However, precipitation of samples in the assay buffer is beyond the scope of this discussion.

  11. The corporate impact of addressing social issues: a financial case study of a project in Peru.

    PubMed

    Dabbs, Alan; Bateson, Matthew

    2002-05-01

    Large, multinational resource development projects can affect many aspects, including social, economic and ecological realities, in the regions where they operate. Social and environmental issues that are usually ignored in such projects are increasingly affecting the financial future of multinational corporations in negative ways. In this article, we advance the argument that corporations can successfully manage these issues and that if they choose to view these management efforts as an investment rather than an expense, they may well acquire a competitive advantage over companies that do not. We describe as a case study the Camisea natural gas and condensates development project in Peru, operated by Shell Prospecting and Development Peru (SPDP). Camisea is one of the first projects anywhere in the world to conduct a detailed analysis of key industry-related social issues and the processes, required investment and financial impact of managing them. The Camisea example supports the argument that addressing social and environmental concerns makes financial sense. In present value terms, the benefit of managing these concerns was expected to surpass the cost investment by approximately US$50 million.

  12. Large system change challenges: addressing complex critical issues in linked physical and social domains

    NASA Astrophysics Data System (ADS)

    Waddell, Steve; Cornell, Sarah; Hsueh, Joe; Ozer, Ceren; McLachlan, Milla; Birney, Anna

    2015-04-01

    Most action to address contemporary complex challenges, including the urgent issues of global sustainability, occurs piecemeal and without meaningful guidance from leading complex change knowledge and methods. The potential benefit of using such knowledge is greater efficacy of effort and investment. However, this knowledge and its associated tools and methods are under-utilized because understanding about them is low, fragmented between diverse knowledge traditions, and often requires shifts in mindsets and skills from expert-led to participant-based action. We have been engaged in diverse action-oriented research efforts in Large System Change for sustainability. For us, "large" systems can be characterized as large-scale systems - up to global - with many components, of many kinds (physical, biological, institutional, cultural/conceptual), operating at multiple levels, driven by multiple forces, and presenting major challenges for people involved. We see change of such systems as complex challenges, in contrast with simple or complicated problems, or chaotic situations. In other words, issues and sub-systems have unclear boundaries, interact with each other, and are often contradictory; dynamics are non-linear; issues are not "controllable", and "solutions" are "emergent" and often paradoxical. Since choices are opportunity-, power- and value-driven, these social, institutional and cultural factors need to be made explicit in any actionable theory of change. Our emerging network is sharing and building a knowledge base of experience, heuristics, and theories of change from multiple disciplines and practice domains. We will present our views on focal issues for the development of the field of large system change, which include processes of goal-setting and alignment; leverage of systemic transitions and transformation; and the role of choice in influencing critical change processes, when only some sub-systems or levels of the system behave in purposeful ways

  13. Afterschool: A Strategy for Addressing and Preventing Middle School Bullying. MetLife Foundation Afterschool Alert. Issue Brief No. 51

    ERIC Educational Resources Information Center

    Afterschool Alliance, 2011

    2011-01-01

    The Afterschool Alliance, in partnership with MetLife Foundation, is proud to present the second in a series of four issue briefs examining critical issues facing middle school youth and the vital role afterschool programs play in addressing these issues. This brief focuses on bullying awareness and prevention. Bullying is a dangerous behavior…

  14. Regulatory issues in cell-based therapy for clinical purposes.

    PubMed

    Casaroli-Marano, Ricardo P; Tabera, Jaime; Vilarrodona, Anna; Trias, Esteve

    2014-01-01

    Rapid development in the fields of cellular and molecular biology, biotechnology, and bioengineering medicine has brought new, highly innovative treatments and medicinal products, some of which contain viable cells and tissues associated with scaffolds and devices. These new cell-based therapy approaches in regenerative medicine have great potential for use in the treatment of a number of diseases that at present cannot be managed effectively. Given the unique challenges associated with the development of human cell-based medicinal products, great care is required in the development of procedures, practices, and regulation. In cell therapy, appropriate methodologies in the areas of production, reproducibility, maintenance, and delivery are essential for accurate definition and reliable assurance of the suitability and quality of the final products. Recently, the official European Community agencies (EMA) and the relevant authority in the USA (FDA) have made significant efforts to establish regulatory guidance for use in the application of the cell-based therapies for human patients. The guidelines surrounding cell-based therapy take into account the current legislation, but focus less on the heterogeneity and requirements of individual human cell-based products, including specific combination products and applications. When considering guidelines and regulation, a risk assessment approach is an effective method of identifying priority areas for the development of human cell-based medicinal products. Additionally, effective design and thorough validation of the manufacturing process in line with existing Good Manufacturing Practices (GMPs) and quality control regimes and a program that ensures the traceability and biovigilance of the final products are also all essential elements to consider. PMID:24732772

  15. Levothyroxine: therapeutic use and regulatory issues related to bioequivalence.

    PubMed

    Wartofsky, Leonard

    2002-06-01

    Levothyroxine is the overwhelming choice of clinicians for the treatment of hypothyroidism and for the suppression of goitre and thyroid nodules in selected cases. The monitoring of serum levels of thyroid stimulating hormone is necessary for appropriate dosage adjustment of levothyroxine. Levothyroxine has a narrow therapeutic index: both underdosage (subclinical hypothyroidism) and excessive dosage (subclinical hyperthyroidism) are associated with adverse symptoms and pathophysiological effects and are to be avoided. The consequent necessity for careful titration of doses has had an impact on the issue of switchability, or bioequivalence, of the various marketed levothyroxine products. In this article, the basis for concern about currently accepted standards of the FDA for pharmacological bioequivalence are examined in the context of levothyroxine. The history and status of the recent request by the FDA for a new drug application for all levothyroxine products, and its impact on the market leader Synthroid, is also discussed.

  16. Ethical issues raised in addressing the needs of people with serious mental disorders in complex emergencies.

    PubMed

    Wissow, Lawrence S; Rutkow, Lainie; Kass, Nancy E; Rabins, Peter V; Vernick, Jon S; Hodge, James G

    2012-03-01

    Recent manmade and natural disasters highlight weaknesses in the public health systems designed to protect populations from harm and minimize disruption of the social and built environments. Emergency planning and response efforts have, as a result, focused largely on ensuring populations' physical well-being during and after a disaster. Many public health authorities, including the World Health Organization, have recognized the importance of addressing both mental and physical health concerns in emergency plans. Individuals with mental disorders represent a notable proportion of the overall population, and anticipating their needs is critical to comprehensive emergency planning and response efforts. Because people with serious mental disorders historically have been stigmatized, and many individuals with mental disorders may be unable to care for themselves, ethical guidance may be of assistance to those engaged in emergency planning and response. This article considers several broad categories of ethical issues that arise during emergencies for people with serious mental disorders and offers recommendations for ways in which emergency planners and other stakeholders can begin to address these ethical challenges.

  17. Can Go address the multicore issues of today and the manycore problems of tomorrow?

    NASA Astrophysics Data System (ADS)

    Binet, Sébastien

    2012-06-01

    Current High Energy and Nuclear Physics (HENP) libraries and frameworks were written before multicore systems became widely deployed and used. From this environment, a 'single-thread' processing model naturally emerged but the implicit assumptions it encouraged are greatly impairing our abilities to scale in a multicore/manycore world. While parallel programming - still in an intensive phase of R&D despite the 30+ years of literature on the subject - is an obvious topic to consider, other issues (build scalability, code clarity, code deployment and ease of coding) are worth investigating when preparing for the manycore era. Moreover, if one wants to use another language than C++, a language better prepared and tailored for expressing concurrency, one also needs to ensure a good and easy reuse of already field-proven libraries. We present the work resulting from such investigations applied to the Go programming language. We first introduce the concurrent programming facilities Go is providing and how its module system addresses the build scalability and dependency hell issues. We then describe the process of leveraging the many (wo)man-years put into scientific Fortran/C/C++ libraries and making them available to the Go ecosystem. The ROOT data analysis framework, the C-BLAS library and the Herwig-6 MonteCarlo generator will be taken as examples. Finally, performances of the tools involved in a small analysis written in Go and using ROOT I/O library will be presented.

  18. Progress in Addressing DNFSB Recommendation 2002-1 Issues: Improving Accident Analysis Software Applications

    SciTech Connect

    VINCENT, ANDREW

    2005-04-25

    Defense Nuclear Facilities Safety Board (DNFSB) Recommendation 2002-1 (''Quality Assurance for Safety-Related Software'') identified a number of quality assurance issues on the use of software in Department of Energy (DOE) facilities for analyzing hazards, and designing and operating controls to prevent or mitigate potential accidents. Over the last year, DOE has begun several processes and programs as part of the Implementation Plan commitments, and in particular, has made significant progress in addressing several sets of issues particularly important in the application of software for performing hazard and accident analysis. The work discussed here demonstrates that through these actions, Software Quality Assurance (SQA) guidance and software tools are available that can be used to improve resulting safety analysis. Specifically, five of the primary actions corresponding to the commitments made in the Implementation Plan to Recommendation 2002-1 are identified and discussed in this paper. Included are the web-based DOE SQA Knowledge Portal and the Central Registry, guidance and gap analysis reports, electronic bulletin board and discussion forum, and a DOE safety software guide. These SQA products can benefit DOE safety contractors in the development of hazard and accident analysis by precluding inappropriate software applications and utilizing best practices when incorporating software results to safety basis documentation. The improvement actions discussed here mark a beginning to establishing stronger, standard-compliant programs, practices, and processes in SQA among safety software users, managers, and reviewers throughout the DOE Complex. Additional effort is needed, however, particularly in: (1) processes to add new software applications to the DOE Safety Software Toolbox; (2) improving the effectiveness of software issue communication; and (3) promoting a safety software quality assurance culture.

  19. Regulatory framework in assisted reproductive technologies, relevance and main issues.

    PubMed

    Merlet, Françoise

    2009-01-01

    Assisted reproductive technologies (ART) have changed life for the past 25 years and many ethical and social issues have emerged following this new method of conception. In order to protect individuals against scientific and ethical abuses without inhibiting scientific progress, a specific legal framework is necessary. The first French law on Bioethics was voted after an extensive debate in 1994 then reviewed in 2004. This review previously scheduled every five years is currently being discussed. Legal provisions applying to ART are part of a large framework including the protection of the patients' rights and biomedical research. The key principles consist of respect for human life and ban on commercial practices of human body parts, eugenic practices and any kind of cloning. These key principles apply to ART. Donation is anonymous and free. Created in 2004, the Agence de la biomédecine is a government agency and one of the main tools of the French regulations. The missions focus on improving the quality and the safety of the management of ART. Evaluation of activities is available to all from the annual report. The agency represents the French competent authority for medical and scientific aspects of ART. Substantial differences in European legislations exist from the open-up "laissez faire" to the most restrictive one. As a consequence a large reproductive tourism has developed particularly for egg donation or surrogacy. The medical and ethical conditions of management of patients and donors represent the main critical points. In order to avoid ethical abuses, homogenization regarding the key principles is necessary in Europe. It is an opportunity to reassert that human body parts should not be a source of financial gain. PMID:20067901

  20. Legal and regulatory issues affecting the aquifer thermal energy storage concept

    SciTech Connect

    Hendrickson, P.L.

    1980-10-01

    A number of legal and regulatory issus that potentially can affect implementation of the Aquifer Thermal Energy Storage (ATES) concept are examined. This concept involves the storage of thermal energy in an underground aquifer until a later date when it can be effectively utilized. Either heat energy or chill can be stored. Potential end uses of the energy include district space heating and cooling, industrial process applications, and use in agriculture or aquaculture. Issues are examined in four categories: regulatory requirements, property rights, potential liability, and issues related to heat or chill delivery.

  1. Addressing Issues of Broadening Participation Highlighted in the Report on the Future of Undergraduate Geoscience Education

    NASA Astrophysics Data System (ADS)

    McDaris, J. R.; Manduca, C. A.; Macdonald, H.; Iverson, E. A. R.

    2015-12-01

    The final report for the Summit on the Future of Geoscience Education lays out a consensus on issues that must be tackled by the geoscience community collectively if there are to be enough qualified people to fill the large number of expected geoscience job vacancies over the coming decade. Focus areas cited in the report include: Strengthening the connections between two-year colleges and four-year institutions Sharing and making use of successful recruitment and retention practices for students from underrepresented groups Making students aware of high-quality job prospects in the geosciences as well as its societal relevance The InTeGrate STEP Center for the Geosciences, the Supporting and Advancing Geoscience Education at Two-Year Colleges (SAGE 2YC) program, and the Building Strong Geoscience Departments (BSGD) project together have developed a suite of web resources to help faculty and program leaders begin to address these and other issues. These resources address practices that support the whole student, both in the classroom and as a part of the co-curriculum as well as information on geoscience careers, guidance for developing coherent degree programs, practical advice for mentoring and advising, and many others. In addition to developing web resources, InTeGrate has also undertaken an effort to profile successful program practices at a variety of institutions. An analysis of these data shows several common themes (e.g. proactive marketing, community building, research experiences) that align well with the existing literature on what works to support student success. But there are also indications of different approaches and emphases between Minority Serving Institutions (MSIs) and Primarily White Institutions (PWIs) as well as between different kinds of MSIs. Highlighting the different strategies in use can point both MSIs and PWIs to possible alternate solutions to the challenges their students face. InTeGrate - http

  2. The National Academy of Sciences offers a new framework for addressing global warming issues.

    PubMed

    Barnard, R C; Morgan, D L

    2000-02-01

    The recent landmark report by the National Academy of Sciences reviewed the science on which the Kyoto Protocol was based. NAS concluded that the policy choices and the mandatory reductions in greenhouse gases by the developed nations were based on incomplete science with significant uncertainties. In view of these uncertainties the NAS report developed a comprehensive strategic 10-year research program to address the basic issue of whether human activity that results in environmental changes is responsible for climate changes. The report provides a new framework for consideration of global warming issues. The UN International Panel on Climate Change (the UN science advisor) in its 1997 report to the Kyoto parties pointed out the confusing difference between scientific usage of the term "climate change" that distinguishes human from natural causes of change and the official usage that combines natural and human causes of changes in climate. The conclusion of the UN panel on human causes is equivocal. The 1999 report of the U.S. Global Science Research Committee also reached an equivocal conclusion on human causes and announced a 10-year research program to be developed in consultation with NAS. The precautionary measures provided in the 1992 UN Framework Convention differ from the ill-defined "precautionary principle" based on fear of uncertainty, and are consistent with the objectives of the NAS proposed research program. These developments together with the third report of the UN Intergovernmental Science Panel on developments in climate science due in 2001 merit consideration by the convention of the parties under the Kyoto Protocol. PMID:10715229

  3. The National Academy of Sciences offers a new framework for addressing global warming issues.

    PubMed

    Barnard, R C; Morgan, D L

    2000-02-01

    The recent landmark report by the National Academy of Sciences reviewed the science on which the Kyoto Protocol was based. NAS concluded that the policy choices and the mandatory reductions in greenhouse gases by the developed nations were based on incomplete science with significant uncertainties. In view of these uncertainties the NAS report developed a comprehensive strategic 10-year research program to address the basic issue of whether human activity that results in environmental changes is responsible for climate changes. The report provides a new framework for consideration of global warming issues. The UN International Panel on Climate Change (the UN science advisor) in its 1997 report to the Kyoto parties pointed out the confusing difference between scientific usage of the term "climate change" that distinguishes human from natural causes of change and the official usage that combines natural and human causes of changes in climate. The conclusion of the UN panel on human causes is equivocal. The 1999 report of the U.S. Global Science Research Committee also reached an equivocal conclusion on human causes and announced a 10-year research program to be developed in consultation with NAS. The precautionary measures provided in the 1992 UN Framework Convention differ from the ill-defined "precautionary principle" based on fear of uncertainty, and are consistent with the objectives of the NAS proposed research program. These developments together with the third report of the UN Intergovernmental Science Panel on developments in climate science due in 2001 merit consideration by the convention of the parties under the Kyoto Protocol.

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

    ERIC Educational Resources Information Center

    Norwich, Brahm

    2014-01-01

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

  5. Addressing issues associated with evaluating prediction models for survival endpoints based on the concordance statistic.

    PubMed

    Wang, Ming; Long, Qi

    2016-09-01

    Prediction models for disease risk and prognosis play an important role in biomedical research, and evaluating their predictive accuracy in the presence of censored data is of substantial interest. The standard concordance (c) statistic has been extended to provide a summary measure of predictive accuracy for survival models. Motivated by a prostate cancer study, we address several issues associated with evaluating survival prediction models based on c-statistic with a focus on estimators using the technique of inverse probability of censoring weighting (IPCW). Compared to the existing work, we provide complete results on the asymptotic properties of the IPCW estimators under the assumption of coarsening at random (CAR), and propose a sensitivity analysis under the mechanism of noncoarsening at random (NCAR). In addition, we extend the IPCW approach as well as the sensitivity analysis to high-dimensional settings. The predictive accuracy of prediction models for cancer recurrence after prostatectomy is assessed by applying the proposed approaches. We find that the estimated predictive accuracy for the models in consideration is sensitive to NCAR assumption, and thus identify the best predictive model. Finally, we further evaluate the performance of the proposed methods in both settings of low-dimensional and high-dimensional data under CAR and NCAR through simulations.

  6. Approaches and incentives to implement integrated pest management that addresses regional and environmental issues.

    PubMed

    Brewer, Michael J; Goodell, Peter B

    2012-01-01

    Agricultural, environmental, and social and policy interests have influenced integrated pest management (IPM) from its inception. The first 50 years of IPM paid special attention to field-based management and market-driven decision making. Concurrently, IPM strategies became available that were best applied both within and beyond the bounds of individual fields and that also provided environmental benefits. This generated an incentives dilemma for farmers: selecting IPM activities for individual fields on the basis of market-based economics versus selecting IPM activities best applied regionally that have longer-term benefits, including environmental benefits, that accrue to the broader community as well as the farmer. Over the past several decades, public-supported incentives, such as financial incentives available to farmers from conservation programs for farms, have begun to be employed to encourage use of conservation techniques, including strategies with IPM relevance. Combining private investments with public support may effectively address the incentives dilemma when advanced IPM strategies are used regionally and provide public goods such as those benefiting resource conservation. This review focuses on adaptation of IPM to these broader issues, on transitions of IPM from primarily individual field-based decision making to coordinated community decision making, and on the form of partnerships needed to gain long-lasting regional and environmental benefits.

  7. A modular approach to addressing model design, scale, and parameter estimation issues in distributed hydrological modelling

    USGS Publications Warehouse

    Leavesley, G.H.; Markstrom, S.L.; Restrepo, P.J.; Viger, R.J.

    2002-01-01

    A modular approach to model design and construction provides a flexible framework in which to focus the multidisciplinary research and operational efforts needed to facilitate the development, selection, and application of the most robust distributed modelling methods. A variety of modular approaches have been developed, but with little consideration for compatibility among systems and concepts. Several systems are proprietary, limiting any user interaction. The US Geological Survey modular modelling system (MMS) is a modular modelling framework that uses an open source software approach to enable all members of the scientific community to address collaboratively the many complex issues associated with the design, development, and application of distributed hydrological and environmental models. Implementation of a common modular concept is not a trivial task. However, it brings the resources of a larger community to bear on the problems of distributed modelling, provides a framework in which to compare alternative modelling approaches objectively, and provides a means of sharing the latest modelling advances. The concepts and components of the MMS are described and an example application of the MMS, in a decision-support system context, is presented to demonstrate current system capabilities. Copyright ?? 2002 John Wiley and Sons, Ltd.

  8. From Silence to Safety and Beyond: Historical Trends in Addressing Lesbian, Gay, Bisexual, Transgender Issues in K-12 Schools

    ERIC Educational Resources Information Center

    Griffin, Pat; Ouellett, Mathew

    2003-01-01

    The purpose of this article is to provide an historical overview of changing perspectives in education practice and literature on addressing lesbian, gay, bisexual, transgender (LGBT) issues in public K-12 schools. This article describes how the presentation and analysis of lesbian, gay, bisexual, and transgender issues in the past 80 years have…

  9. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 1 2013-07-01 2013-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  10. Secondary Education Systemic Issues: Addressing Possible Contributors to a Leak in the Science Education Pipeline and Potential Solutions

    ERIC Educational Resources Information Center

    Young, Hollie

    2005-01-01

    To maintain the legacy of cutting edge scientific innovation in the United States our country must address the many pressing issues facing science education today. One of the most important issues relating to science education is the under-representation of African Americans and Hispanics in the science, technology, and engineering workforce.…

  11. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 1 2010-07-01 2010-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  12. 32 CFR Appendix C to Part 22 - Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 1 2011-07-01 2011-07-01 false Administrative Requirements and Issues To Be Addressed in Award Terms and Conditions C Appendix C to Part 22 National Defense Department of Defense... AND ADMINISTRATION Pt. 22, App. C Appendix C to Part 22—Administrative Requirements and Issues To...

  13. Earthquake Seismic Risk Reduction in Ohio: ODNR's Efforts to Address Issues with Natural and Induced Seismicity

    NASA Astrophysics Data System (ADS)

    Besana-Ostman, G. M.

    2013-05-01

    With the increasing concerns regarding both natural and induced seismicity in Ohio, ODNR (Ohio Department of Natural Resources) initial efforts on seismic risk reduction paved way to various changes and improvement to tackle several major issues. For natural earthquakes, regional seismicity indicates a NE-SW structure in the northern portion of the area associated with a number of moderate historical earthquakes but no active trace identified. On the other hand, earthquakes of 1986 and 2011 are most probably incidents of induced seismicity that trigger more public uproar against disposal of regulated waste waters through injections. ODNR, in efforts to adapt with increasing need to regulate all operations related to both the Utica and Marcellus shale play within the state, had recently strengthen itself both through additional human resources and improved infrastructure. Tougher regulations and additional field tests were required that took effect immediately when a M4 earthquake was associated with the operations of an injection well. Public meetings were undertaken focused on educating many local inhabitants related to oil and gas operations, hydraulic fracturing, injection wells, and seismicity. Trainings for new and existing staff were regularly done especially for field inspection, data management and technology advancements. Considering the existing seismic stations that are few and distant related to sites of the injection wells, additional seismic stations were installed to gather baseline data and monitor for earthquakes within the injection area(s). Furthermore, to assess if the sites of the injection wells are safe from active structures, initial geomorphic and structural analyses indicated possible active faults in the northern portion of state oriented NE-SW. With the above-mentioned recent changes, ODNR had made a significant leap not only in the improvement of its principal regulatory role in the state for oil and gas operations but also in its

  14. Regulatory issues.

    PubMed

    Molinuevo, José L; Blesa, Rafael

    2003-01-01

    Any medical decision generates consequences for the patient and for society. Medical practice should, therefore, be performed under the guidance of the following ethical principles: beneficence, nonmaleficence, autonomy, justice, integrity, dignity, and vulnerability. The overarching objective of clinical research is to develop knowledge to improve health, and the subjects who participate are the means to securing such knowledge. Clinical research, as part of medical practice, should be ruled by the same ethical principles.

  15. Rewarding altruism: addressing the issue of payments for volunteers in public health initiatives.

    PubMed

    South, Jane; Purcell, Martin E; Branney, Peter; Gamsu, Mark; White, Judy

    2014-03-01

    Lay involvement in public health programmes occurs through formalised lay health worker (LHW) and other volunteer roles. Whether such participation should be supported, or indeed rewarded, by payment is a critical question. With reference to policy in England, UK, this paper argues how framing citizen involvement in health only as time freely given does not account for the complexities of practice, nor intrinsic motivations. The paper reports results on payment drawn from a study of approaches to support lay people in public health roles, conducted in England, 2007-9. The first phase of the study comprised a scoping review of 224 publications, three public hearings and a register of projects. Findings revealed the diversity of approaches to payment, but also the contested nature of the topic. The second phase investigated programme support matters in five case studies of public health projects, which were selected primarily to reflect role types. All five projects involved volunteers, with two utilising forms of payment to support engagement. Interviews were conducted with a sample of project staff, LHWs (paid and unpaid), external partners and service users. Drawing on both lay and professional perspectives, the paper explores how payment relates to social context as well as various motivations for giving, receiving or declining financial support. The findings show that personal costs are not always absorbed, and that there is a potential conflict between financial support, whether sessional payment or expenses, and welfare benefits. In identifying some of the advantages and disadvantages of payment, the paper highlights the complexity of an issue often addressed only superficially. It concludes that, in order to support citizen involvement, fairness and value should be considered alongside pragmatic matters of programme management; however policy conflicts need to be resolved to ensure that employment and welfare rights are maintained.

  16. Rewarding altruism: addressing the issue of payments for volunteers in public health initiatives.

    PubMed

    South, Jane; Purcell, Martin E; Branney, Peter; Gamsu, Mark; White, Judy

    2014-03-01

    Lay involvement in public health programmes occurs through formalised lay health worker (LHW) and other volunteer roles. Whether such participation should be supported, or indeed rewarded, by payment is a critical question. With reference to policy in England, UK, this paper argues how framing citizen involvement in health only as time freely given does not account for the complexities of practice, nor intrinsic motivations. The paper reports results on payment drawn from a study of approaches to support lay people in public health roles, conducted in England, 2007-9. The first phase of the study comprised a scoping review of 224 publications, three public hearings and a register of projects. Findings revealed the diversity of approaches to payment, but also the contested nature of the topic. The second phase investigated programme support matters in five case studies of public health projects, which were selected primarily to reflect role types. All five projects involved volunteers, with two utilising forms of payment to support engagement. Interviews were conducted with a sample of project staff, LHWs (paid and unpaid), external partners and service users. Drawing on both lay and professional perspectives, the paper explores how payment relates to social context as well as various motivations for giving, receiving or declining financial support. The findings show that personal costs are not always absorbed, and that there is a potential conflict between financial support, whether sessional payment or expenses, and welfare benefits. In identifying some of the advantages and disadvantages of payment, the paper highlights the complexity of an issue often addressed only superficially. It concludes that, in order to support citizen involvement, fairness and value should be considered alongside pragmatic matters of programme management; however policy conflicts need to be resolved to ensure that employment and welfare rights are maintained. PMID:24581065

  17. 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.

  18. 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

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

    PubMed

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

    2016-01-01

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

  20. Exploring factors influencing farmers' willingness to pay (WTP) for a planned adaptation programme to address climatic issues in agricultural sectors.

    PubMed

    Ahmed, Adeel; Masud, Muhammad Mehedi; Al-Amin, Abul Quasem; Yahaya, Siti Rohani Binti; Rahman, Mahfuzur; Akhtar, Rulia

    2015-06-01

    This study empirically estimates farmers' willingness to pay (WTP) for a planned adaptation programme for addressing climate issues in Pakistan's agricultural sectors. The contingent valuation method (CVM) was employed to determine a monetary valuation of farmers' preferences for a planned adaptation programme by ascertaining the value attached to address climatic issues. The survey was conducted by distributing structured questionnaires among Pakistani farmers. The study found that 67 % of respondents were willing to pay for a planned adaptation programme. However, several socioeconomic and motivational factors exert greater influence on their willingness to pay (WTP). This paper specifies the steps needed for all institutional bodies to better address issues in climate change. The outcomes of this paper will support attempts by policy makers to design an efficient adaptation framework for mitigating and adapting to the adverse impacts of climate change. PMID:25613801

  1. Exploring factors influencing farmers' willingness to pay (WTP) for a planned adaptation programme to address climatic issues in agricultural sectors.

    PubMed

    Ahmed, Adeel; Masud, Muhammad Mehedi; Al-Amin, Abul Quasem; Yahaya, Siti Rohani Binti; Rahman, Mahfuzur; Akhtar, Rulia

    2015-06-01

    This study empirically estimates farmers' willingness to pay (WTP) for a planned adaptation programme for addressing climate issues in Pakistan's agricultural sectors. The contingent valuation method (CVM) was employed to determine a monetary valuation of farmers' preferences for a planned adaptation programme by ascertaining the value attached to address climatic issues. The survey was conducted by distributing structured questionnaires among Pakistani farmers. The study found that 67 % of respondents were willing to pay for a planned adaptation programme. However, several socioeconomic and motivational factors exert greater influence on their willingness to pay (WTP). This paper specifies the steps needed for all institutional bodies to better address issues in climate change. The outcomes of this paper will support attempts by policy makers to design an efficient adaptation framework for mitigating and adapting to the adverse impacts of climate change.

  2. Pursuing Justice for Refugee Students: Addressing Issues of Cultural (Mis)Recognition

    ERIC Educational Resources Information Center

    Keddie, Amanda

    2012-01-01

    In this paper Nancy Fraser's conceptual tools are drawn on to theorise issues of justice in a culturally diverse primary school in Australia where approximately 30% of the student population are immigrant/refugees. The paper examines justice issues of cultural recognition in relation to refugee student identity, behaviour and assessment. Drawing…

  3. A Consideration to Two Main Ethical Issues in Educational Research, and How May These Be Addressed

    ERIC Educational Resources Information Center

    Abed, Mohaned Ghazi

    2015-01-01

    This paper has firstly discussed the topic of Ethical Issues in Education, and has accordingly highlighted the fact that ethics are not something to deem at the commencement of a research project or fieldwork, but rather throughout the entire research process. Furthermore, two of the most important ethical issues have been given…

  4. Energy resources law: Update on environmental and health and safety regulatory issues

    SciTech Connect

    Kline, T.R.; Porter, J.M.; Hannapel, J.S.; Panzik, S.

    1993-12-31

    This article provides an update on several environmental and health and safety issues that impact the development, management, and use of energy resources. Specifically, regulatory developments involving waste management activities under the Resource Conservation and Recovery Act (RCRA), including threshold issues such as the definition of waste under RCRA (i.e., the mixture and derived-from rules), are included in this article. In addition, new regulations on used oil recycling management standards and land disposal restriction for hazardous debris also are summarized. An update on the regulatory developments under the Clean Air Act Amendments, such as nonattainment, mobile sources, hazardous air pollutants, acid rain, operating permits, and enforcement is provided. This article also includes a summary of developments in occupational health and safety, such as Occupational Health and Safety Administration (OSHA) enforcement initiatives; new regulations on bloodborne pathogens and progress safety management; recent court decisions on preemption of state standards, air contaminants rulemaking, and disclosure of self-audits; and legislative reforms. The regulatory developments discussed in this article illustrate how the development, management, and use of energy resources are impacted, as compliance with expanding regulatory controls continues to represent an increasing percentage of facilities` operating budgets and as civil and criminal enforcement efforts are accelerated. 102 refs.

  5. Health-related biotechnology in Africa: managing the legislative and regulatory issues.

    PubMed

    Andanda, A P

    2007-01-01

    The challenges that most African countries face in an attempt to join the ongoing quest for the development and transfer of the products derived from health biotechnology are threefold: High research costs, inadequate regulatory capacity and unfavourable intellectual property arrangements. It is argued in this paper that these challenges are representative of the legislative and regulatory issues that require proper management in order to enable African countries to focus on the key research areas that are related to the burden of diseases that are prevalent in the region and to harness the products of such research for the benefit of the region. This paper discusses the challenges involved in managing the legislative and regulatory issues in health biotechnology and proposes specific ideas on the way forward for Africa. The methodology used is a review of the manner in which three African countries, Cameroon, Kenya and Nigeria, have encountered and dealt with such regulatory challenges. The review is carried out from policy and legal analysis perspectives.

  6. Generating a taxonomy of regulatory responses to emerging issues in biomedicine.

    PubMed

    Lipworth, Wendy

    2005-01-01

    In the biomedical field, calls for the generation of new regulations or for the amendment of existing regulations often follow the emergence of apparently new research practices (such as embryonic stem cell research), clinical practices (such as facial transplantation) and entities (such as Avian Influenza/'Bird Flu'). Calls for regulatory responses also arise as a result of controversies which bring to light longstanding practices, such as the call for increased regulation of human tissue collections that followed the discovery of unauthorised post-mortem organ retention. Whilst it seems obvious that new regulations should only be generated if existing regulations are inadequate (a practice referred to in this paper as 'regulatory syncretism'), this does not always occur in practice. This paper examines the conceptual steps involved in generating regulatory responses to emerging phenomena. Two decision points are identified. First, a stance is taken as to whether the emerging phenomenon raises unique ethical or legal issues (exceptionalism versus non-exceptionalism). Second, the decision is made as to whether new regulation should be generated only for truly unique phenomena (syncretism versus asyncretism). It is argued here that it is important to make a careful assessment of novelty, followed by a reflective and deliberative choice of regulatory syncretism or asyncretism, since each type of regulatory response has advantages which need to be harnessed and disadvantages which need to be managed--something that can only occur if regulators are attentive to the choices they are making.

  7. The Constellation-EdF nuclear joint venture: regulatory issues and subsequent resolutions

    SciTech Connect

    Pfaff, Ryan; Lubow, Howard; Malko, J. Robert

    2010-03-15

    Corporate restructurings of electric utilities in the U.S. have become a significant and controversial issue due to the differing perspectives of electric utility executives and regulatory commissioners relating to corporate restructuring associated with mergers, diversification, and functional separation of generation, transmission, and distribution. The Maryland Public Service Commission assessed a joint venture between Constellation Energy Group and Electricite de France that reflects these tradeoffs. (author)

  8. Allergy to methyldibromoglutaronitrile/phenoxyethanol (Euxyl k 400): regulatory issues, epidemiology, clinical characteristics, and management.

    PubMed

    Aakhus, Angela E; Warshaw, Erin M

    2011-05-01

    Methyldibromoglutaronitrile/phenoxyethanol (Euxyl K 400) is a preservative found in both personal care products and industrial sources. Although Euxyl K 400 initially appeared to have low sensitizing potential, increased prevalence of contact allergy to Euxyl K 400 led to regulatory intervention. This review summarizes the history, epidemiology, and management of contact allergy to Euxyl K 400. Issues related to patch-test preparations are also discussed.

  9. Core Issues that Must be Addressed in Order to Improve Vocational Education and Training in Indonesia. An Institutional Analysis

    ERIC Educational Resources Information Center

    Cully, John H.

    2007-01-01

    Indonesia, like many other countries has to come to terms with the challenges of a rapidly advancing economic globalization. In order to address the major issues involved the government must take some very essential steps that are practical, attainable and sustainable. With global economies evolving from a traditional resource structure to that of…

  10. Teaching for Change: Addressing Issues of Difference in the College Classroom. Reprint Series No. 25. Harvard Educational Review.

    ERIC Educational Resources Information Center

    Geismar, Kathryn, Ed.; Nicoleau, Guitele, Ed.

    Contributors to this collection of essays describe how they address issues of race, gender, and class in their college courses as they attempt to ensure that their curricula and class discussions represent the perspectives of all students. Essays include: (1) "Introduction" (Kathryn Giesmar and Guitele Nicoleau); (2) "Dialogue across Differences:…

  11. Encouraging Pre-Service Teachers to Address Issues of Sexual Orientation in Their Classrooms: Walking the Walk & Talking the Talk

    ERIC Educational Resources Information Center

    Hansen, Laurie E.

    2015-01-01

    The purpose of this article is to describe ways that teacher educators can encourage future teachers to address lesbian, gay, bisexual, or transgender (LGBT) issues in their own classrooms. The Gay, Lesbian, Straight Education Network's ThinkB4YouSpeak Educator's Guide served as the framework for the activities that the author has implemented in…

  12. ISSUES THAT MUST BE ADDRESSED FOR RISK ASSESSMENT OF MIXED EXPOSURES: THE EPA EXPERIENCE WITH AIR QUALITY

    EPA Science Inventory

    Issues that Must be Addressed for Risk Assessment of Mixed Exposures: The EPA Experience with Air Quality

    Daniel L. Costa, Sc.D.

    Abstract
    Humans are routinely exposed to a complex mixture of air pollutants in both their outdoor and indoor environments. The wide...

  13. Addressing Air, Land & Water Nitrogen Issues under Changing Climate Trends & Variability

    EPA Science Inventory

    The climate of western U.S. dairy producing states is anticipated to change significantly over the next 50 to 75 years. A multimedia modeling system based upon the “nitrogen cascade” concept has been configured to address three aspects of sustainability (environmenta...

  14. Teaching Water: Connecting across Disciplines and into Daily Life to Address Complex Societal Issues

    ERIC Educational Resources Information Center

    Eisen, Arri; Hall, Anne; Lee, Tong Soon; Zupko, Jack

    2009-01-01

    A central problem in higher education is how to best develop in students interdisciplinary thinking and application skills necessary to work and engage effectively in the twenty-first century. Traditional university structures make addressing this problem especially challenging. Using as a model courses with diverse perspectives on water taught by…

  15. 2016 State of the State Addresses: Governors' Top Education Issues. Education Trends

    ERIC Educational Resources Information Center

    Auck, Alyssa; Railey, Hunter

    2016-01-01

    Each year, governors take the stage to highlight accomplishments and outline policy priorities for their states. In an effort to provide up-to-date information on education policy trends, Education Commission of the States tracks all education policy proposals and accomplishments featured by governors in these State of the State addresses. At the…

  16. Afterschool in Action: How Innovative Afterschool Programs Address Critical Issues Facing Middle School Youth

    ERIC Educational Resources Information Center

    Afterschool Alliance, 2012

    2012-01-01

    Over the last four years, the Afterschool Alliance and MetLife Foundation have worked together to identify exemplary, and often lesser-known afterschool programs across the nation. For the past two years, efforts have focused on finding innovative afterschool programs serving middle school students. This focus was developed to address the need for…

  17. Use of Social Software to Address Literacy and Identity Issues in Second Language Learning

    ERIC Educational Resources Information Center

    Hutchinson, Jill

    2009-01-01

    The emerging trend of social software technology can address many different second language (L2) learner needs through authentic social interaction and a variety of scaffolding processes. Social software connects education with real-life learning and interests, and engages and motivates students. It can facilitate learning environments that are…

  18. Standards, Assessment, and Readiness: Addressing Postsecondary Transition Issues across State Lines

    ERIC Educational Resources Information Center

    Michelau, Demarée K.

    2015-01-01

    This brief describes major challenges ahead for states, institutions, and most importantly, students as the standards and assessments from the Common Core Standards (CCSS) are implemented. It also offers recommendations to create a network structure that would assist K-12 and higher education leaders in addressing those challenges. To begin the…

  19. Governors' Top Education Issues: 2015 State of the State Addresses. ECS Education Trends

    ERIC Educational Resources Information Center

    Aragon, Stephanie; Rowland, Julie

    2015-01-01

    Education Commission of the States (ECS) strives to keep its constituency apprised of education policy trends across the states. To provide a comprehensive overview of educational priorities outlined by governors, ECS summarized the education proposals and accomplishments detailed in every 2015 State of the State address delivered to date. Each…

  20. Addressing Agricultural Issues in Health Care Education: An Occupational Therapy Curriculum Program Description

    ERIC Educational Resources Information Center

    Smallfield, Stacy; Anderson, Angela J.

    2008-01-01

    Context: Medical and allied health professionals who work in agricultural states frequently address the needs of clients who live and work in rural and frontier environments. The primary occupations of those living in rural areas include farming, ranching, or other agriculture-related work. Farming is consistently ranked as one of the most…

  1. Bridging the Gap: Essential Issues to Address in Recurring Writing Center Appointments with Chinese ELL Students

    ERIC Educational Resources Information Center

    Nan, Frances

    2012-01-01

    As the population of international--and particularly Chinese--students grows in US academic institutions, it is critical that writing center tutors be able to address these students' needs. However, whereas writing tutors at the author's institution are often taught to be indirect and focus on higher order concerns, such strategies are not always…

  2. Open Lives, Safe Schools: Addressing Gay and Lesbian Issues in Education.

    ERIC Educational Resources Information Center

    Walling, Donovan R., Ed.

    In all but a handful of states, it is legal to discriminate against individuals on the basis of sexual orientation. Ways in which homophobia and anti-gay sentiments affect education in the United States are addressed in this collection of essays. They are written for educators and others concerned about schooling, from kindergarten through…

  3. 32 CFR 37.1010 - What substantive issues should my award document address?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... and negotiate a TIA individually to meet the specific requirements of the particular project, so the... document must address: (a) Project scope. The scope is an overall vision statement for the project, including a discussion of the project's purpose, objectives, and detailed military and commercial goals....

  4. 32 CFR 37.1010 - What substantive issues should my award document address?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... and negotiate a TIA individually to meet the specific requirements of the particular project, so the... document must address: (a) Project scope. The scope is an overall vision statement for the project, including a discussion of the project's purpose, objectives, and detailed military and commercial goals....

  5. 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.

  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. PMID:26627049

  7. Clothing the Emperor: Addressing the Issue of English Language Proficiency in Australian Universities

    ERIC Educational Resources Information Center

    Dunworth, Katie

    2010-01-01

    The English language proficiency levels of students in Australian higher education who have English as an additional language (EAL) has become an increasingly prominent issue, particularly as it relates to international students. In 2009 this resulted in the publication of a set of good practice principles for the sector. This paper argues that…

  8. Progression in Ethical Reasoning When Addressing Socio-Scientific Issues in Biotechnology

    ERIC Educational Resources Information Center

    Berne, Birgitta

    2014-01-01

    This article reports on the outcomes of an intervention in a Swedish school in which the author, a teacher-researcher, sought to develop students' (14-15 years old) ethical reasoning in science through the use of peer discussions about socio-scientific issues. Prior to the student discussions various prompts were used to highlight different…

  9. Where We Live: A Curriculum Guide. ABE Materials that Address Housing Issues.

    ERIC Educational Resources Information Center

    Ellowitch, Azi

    This curriculum was developed to give adult basic education (ABE) teachers starting points for developing their own units around housing-related issues. The texts have been chosen thematically, rather than by skill level. The materials are designed for group work--oral reading and discussion. Readings focus on housing repairs, court procedures,…

  10. Extending Transition to Address Guardianship Alternatives: An Issue Concerning Students Who Have Intellectual Disability

    ERIC Educational Resources Information Center

    Millar, Dorothy Squatrito

    2014-01-01

    As students who have intellectual disability reach or have reached the age of majority, concerns regarding their competence to make informed decisions are often raised, as is the issue of adult guardianship. Guardianship refers to when a judge appoints an adult to be the guardian of another adult (ward) who has been determined to be unable to care…

  11. Teach to Reach: Addressing Lesbian, Gay, Bisexual, and Transgender Youth Issues in the Classroom

    ERIC Educational Resources Information Center

    Hall, Horace R.

    2006-01-01

    This article explores the delicate and complex issues immediate to the lives of lesbian, gay, bisexual, and transgender (LGBT) youth. The author places the discussion within the context of learning environments and presents ways in which pre-service and in-service teachers can help create safe and equitable spaces for all learners. Presented are…

  12. Skirting the Issue: Teachers' Experiences "Addressing Sexuality in Middle School Language Arts"

    ERIC Educational Resources Information Center

    Puchner, Laurel; Klein, Nicole Aydt

    2012-01-01

    The goal of this study was to examine perceptions, attitudes, and reported practices of a group of middle level Language Arts teachers concerning sexuality-related issues. Through interviews with 15 teachers, the study found that sexuality was in one sense pervasive, as it came up frequently in the teachers' practice. Yet at the same time the…

  13. The Role of Sexual Trauma in the Treatment of Chemically Dependent Women: Addressing the Relapse Issue.

    ERIC Educational Resources Information Center

    Wadsworth, Rick; And Others

    1995-01-01

    Explores issues surrounding sexual trauma and chemical dependency. Aims to provide direction for relapse prevention with a relapse-prone population and explores application of traditional milieu substance-abuse treatment for sexual-trauma survivors. Makes recommendations for working with sexual-trauma survivors who are also substance abusers. (RJM)

  14. Science Teachers' Use of Mass Media to Address Socio-Scientific and Sustainability Issues

    ERIC Educational Resources Information Center

    Klosterman, Michelle L.; Sadler, Troy D.; Brown, Julie

    2012-01-01

    The currency, relevancy and changing nature of science makes it a natural topic of focus for mass media outlets. Science teachers and students can capitalize on this wealth of scientific information to explore socio-scientific and sustainability issues; however, without a lens on how those media are created and how representations of science are…

  15. The Use of Cohorts: A Powerful Way for Addressing Issues of Diversity in Preparation Programs.

    ERIC Educational Resources Information Center

    Barnett, Bruce G.; Caffarella, Rosemary S.

    Educational administration preparation programs increasingly are using cohorts, particularly as a way to teach diversity issues. Cohorts are groups of students who go through a 1- to 2-year study program together. The special characteristics of adult learning, the need for acknowledgement and use of experience, the different learning techniques,…

  16. Addressing lesbian, gay, bisexual, and transgender issues from the inside: one federal agency's approach.

    PubMed Central

    Craft, E M; Mulvey, K P

    2001-01-01

    The mission of the Substance Abuse and Mental Health Services Administration (SAMHSA) is to protect and serve underserved and vulnerable populations. Congress established SAMHSA under Public Law 102-321 on October 1, 1992, to strengthen the nation's health care capacity to provide prevention, diagnosis, and treatment services for substance abuse and mental illnesses. SAMHSA works in partnership with states, communities, and private organizations to address the needs of people with substance abuse and mental illnesses as well as the community risk factors that contribute to these illnesses. As part of its efforts to address the unique needs of special populations, SAMHSA has reached out to the lesbian, gay, bisexual, and transgender (LGBT) community. SAMHSA and its centers (Center for Substance Abuse Treatment, Center for Substance Abuse Prevention, and Center for Mental Health Services) have made a concerted effort, through both policy and programs, to develop services responsive to this community. PMID:11392928

  17. Evaluating programs that address ideological issues: ethical and practical considerations for practitioners and evaluators.

    PubMed

    Lieberman, Lisa D; Fagen, Michael C; Neiger, Brad L

    2014-03-01

    There are important practical and ethical considerations for organizations in conducting their own, or commissioning external, evaluations and for both practitioners and evaluators, when assessing programs built on strongly held ideological or philosophical approaches. Assessing whether programs "work" has strong political, financial, and/or moral implications, particularly when expending public dollars, and may challenge objectivity about a particular program or approach. Using a case study of the evaluation of a school-based abstinence-until-marriage program, this article discusses the challenges, lessons learned, and ethical responsibilities regarding decisions about evaluation, specifically associated with ideologically driven programs. Organizations should consider various stakeholders and views associated with their program to help identify potential pitfalls in evaluation. Once identified, the program or agency needs to carefully consider its answers to two key questions: Do they want the answer and are they willing to modify the program? Having decided to evaluate, the choice of evaluator is critical to assuring that ethical principles are maintained and potential skepticism or criticism of findings can be addressed appropriately. The relationship between program and evaluator, including agreements about ownership and eventual publication and/or promotion of data, should be addressed at the outset. Programs and organizations should consider, at the outset, their ethical responsibility when findings are not expected or desired. Ultimately, agencies, organizations, and programs have an ethical responsibility to use their data to provide health promotion programs, whether ideologically founded or not, that appropriately and effectively address the problems they seek to solve. PMID:24532788

  18. Instream sand and gravel mining: Environmental issues and regulatory process in the United States

    USGS Publications Warehouse

    Meador, M.R.; Layher, A.O.

    1998-01-01

    Sand and gravel are widely used throughout the U.S. construction industry, but their extraction can significantly affect the physical, chemical, and biological characteristics of mined streams. Fisheries biologists often find themselves involved in the complex environmental and regulatory issues related to instream sand and gravel mining. This paper provides an overview of information presented in a symposium held at the 1997 midyear meeting of the Southern Division of the American Fisheries Society in San Antonio, Texas, to discuss environmental issues and regulatory procedures related to instream mining. Conclusions from the symposium suggest that complex physicochemical and biotic responses to disturbance such as channel incision and alteration of riparian vegetation ultimately determine the effects of instream mining. An understanding of geomorphic processes can provide insight into the effects of mining operations on stream function, and multidisciplinary empirical studies are needed to determine the relative effects of mining versus other natural and human-induced stream alterations. Mining regulations often result in a confusing regulatory process complicated, for example, by the role of the U.S. Army Corps of Engineers, which has undergone numerous changes and remains unclear. Dialogue among scientists, miners, and regulators can provide an important first step toward developing a plan that integrates biology and politics to protect aquatic resources.

  19. Progression in Ethical Reasoning When Addressing Socio-scientific Issues in Biotechnology

    NASA Astrophysics Data System (ADS)

    Berne, Birgitta

    2014-11-01

    This article reports on the outcomes of an intervention in a Swedish school in which the author, a teacher-researcher, sought to develop students' (14-15 years old) ethical reasoning in science through the use of peer discussions about socio-scientific issues. Prior to the student discussions various prompts were used to highlight different aspects of the issues. In addition, students were given time to search for further information themselves. Analysis of students' written arguments, from the beginning of the intervention and afterwards, suggests that many students seem to be moving away from their use of everyday language towards using scientific concepts in their arguments. In addition, they moved from considering cloning and 'designer babies' solely in terms of the present to considering them in terms of the future. Furthermore, the students started to approach the issues in additional ways using not only consequentialism but also the approaches of virtue ethics, and rights and duties. Students' progression in ethical reasoning could be related to the characteristics of the interactions in peer discussions as students who critically and constructively argued with each other's ideas, and challenged each other's claims, made progress in more aspects of ethical reasoning than students merely using cumulative talk. As such, the work provides valuable indications for the importance of introducing peer discussions and debates about SSIs in connection to biotechnology into the teaching of science in schools.

  20. Approaches of the German food industry for addressing the issue of food losses.

    PubMed

    Richter, Beate; Bokelmann, Wolfgang

    2016-02-01

    In the food industry the subject of food losses is of great importance due to economic balance and an efficient application of resources as well as the development of an efficient food chain system. This paper presents the explorative results of a quantitative survey of leading companies of the German food industry to evaluate the relevance and handling of this issue. The investigation reveals that the topic food losses have a high significance in the food industry which will probably increase in future. A sample breakdown by branches indicates that the issue has the highest relevance for companies in the confectionery industry. These companies as well as those in the meat and fish industry want to consider the subject prospectively more powerful in their companies. Across the food industry, there is no communication to consumers of the efforts concerning food losses. And companies in the confectionery industry and in the fruit and vegetable industry rather want to engage more powerful in this topic if consumers' interest increases. But in order to minimize food losses at all stages along the supply chain, communication and collaboration at all stages is essential, especially the communication to consumers. Thus, it has to be verified whether a suitable communication can lead to advantages in competition and become an important issue for companies to differentiate from competitors.

  1. Approaches of the German food industry for addressing the issue of food losses.

    PubMed

    Richter, Beate; Bokelmann, Wolfgang

    2016-02-01

    In the food industry the subject of food losses is of great importance due to economic balance and an efficient application of resources as well as the development of an efficient food chain system. This paper presents the explorative results of a quantitative survey of leading companies of the German food industry to evaluate the relevance and handling of this issue. The investigation reveals that the topic food losses have a high significance in the food industry which will probably increase in future. A sample breakdown by branches indicates that the issue has the highest relevance for companies in the confectionery industry. These companies as well as those in the meat and fish industry want to consider the subject prospectively more powerful in their companies. Across the food industry, there is no communication to consumers of the efforts concerning food losses. And companies in the confectionery industry and in the fruit and vegetable industry rather want to engage more powerful in this topic if consumers' interest increases. But in order to minimize food losses at all stages along the supply chain, communication and collaboration at all stages is essential, especially the communication to consumers. Thus, it has to be verified whether a suitable communication can lead to advantages in competition and become an important issue for companies to differentiate from competitors. PMID:26691601

  2. Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues.

    PubMed

    Rao, M

    2008-01-01

    Embryonic stem cells unlike most adult stem cell populations can replicate indefinitely while preserving genetic, epigenetic, mitochondrial and functional profiles. ESCs are therefore an excellent candidate cell type for providing a bank of cells for allogenic therapy and for introducing targeted genetic modifications for therapeutic intervention. This ability of prolonged self-renewal of stem cells and the unique advantages that this offers for gene therapy, discovery efforts, cell replacement, personalized medicine and other more direct applications requires the resolution of several important manufacturing, gene targeting and regulatory issues. In this review, we assess some of the advance made in developing scalable culture systems, improvement in vector design and gene insertion technology and the changing regulatory landscape.

  3. Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges.

    PubMed

    Wen, Hong; Jung, Huijeong; Li, Xuhong

    2015-11-01

    Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with poor water solubility or low permeability, techniques such as amorphous solid dispersion, liposomes, and complexations have been used to improve their oral bioavailability. Modified release (MR) formulations have been widely used to improve patient compliance, as well as to reduce side effects, especially for those drugs with short half-lives or narrow therapeutic windows. More than ten drugs using sterile long-acting release (LAR) formulations with clear clinical benefit have been successfully marketed. Furthermore, drug delivery systems have been used in delaying drug clearance processes. Additionally, modifying the in vivo drug distribution using targeted delivery systems has significantly improved oncology treatments. All the drug delivery approaches have their advantages and limitations. For both brand and generic drugs, the achievement of consistent quality and therapeutic performance using drug delivery systems can also pose serious challenges in developing a drug for the market, which requires close collaboration among industry, academia, and regulatory agencies. With the advent of personalized medicines, there will be great opportunities and challenges in utilizing drug delivery systems to provide better products and services for patients.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

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

    2016-04-01

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

  7. Regulatory policy issues and the Clean Air Act: An interim report on the state implementation workshops

    SciTech Connect

    Rose, K.; Burns, R.E.

    1992-08-01

    The National Regulatory Research Institute (NRRI), with funding from the U.S. Environmental Protection Agency (EPA) and U.S. Department of Energy (DOE), conducted two workshops on state public utility commission implementation of the Clean Air Act Amendments of 1990 (CAAA). The first workshop was held in Charlotte, North Carolina for southern and eastern states in April 1992 and the second was held in St. Louis, Missouri for Midwestern states in May. The workshops had four objectives: (1) discuss key issues and concerns on CAAA implementation, (2) encourage a discussion among states on issues of common interest, (3) attempt to reach consensus, where possible, on some key issues, and (4) provide the workshop participants with information and materials to assist in developing rules, orders, and procedures in their state. Of primary interest from the federal perspective was for workshop participants to return to their states with additional background and understanding of how state commission actions may affect implementation of the CAAA and enable them to provide guidance to their jurisdictional utilities. It was hoped this would reduce some of the uncertainty utilities face and assist in the development of an efficient allowance market. The basic format of the workshops was that invited speakers made presentations on specific issues. {open_quotes}Primary participants{close_quotes} from each state and other workshop attendees then discussed the issues raised by the speakers and other related concerns. The primary participants were state commissioners, commission staff, representatives from state consumer advocate organizations, EPA, DOE, and the Federal Energy Regulatory Commission (FERC). Other attendees were utility representatives, consultants, and other interested parties. All participants were given a workbook with excerpts from an NRRI report on CAAA implementation and papers or outlines from speakers.

  8. 18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  9. 18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  10. 18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  11. 18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  12. 18 CFR 2.1a - Public suggestions, comments, proposals on substantial prospective regulatory issues and problems.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Public suggestions, comments, proposals on substantial prospective regulatory issues and problems. 2.1a Section 2.1a Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY...

  13. Religiosity/spirituality of German doctors in private practice and likelihood of addressing R/S issues with patients.

    PubMed

    Voltmer, Edgar; Bussing, Arndt; Koenig, Harold G; Al Zaben, Faten

    2014-12-01

    This study examined the self-assessed religiosity and spirituality (R/S) of a representative sample of German physicians in private practice (n = 414) and how this related to their addressing R/S issues with patients. The majority of physicians (49.3 %)reported a Protestant denomination, with the remainder indicating mainly either Catholic(12.5 %) or none (31.9 %). A significant proportion perceived themselves as either religious(42.8 %) or spiritual (29.0 %). Women were more likely to rate themselves R/S than did men. Women (compared to men) were also somewhat more likely to attend religious services (7.4 vs. 2.1 % at least once a week) and participate in private religious activities(14.9 vs. 13.7 % at least daily), although these differences were not statistically significant.The majority of physicians (67.2 %) never/seldom addressed R/S issues with a typical patient. Physicians with higher self-perceived R/S and more frequent public and private religious activity were much more likely to address R/S issues with patients. Implications for patient care and future research are discussed.

  14. Introduction: what are the issues in addressing the allergenic potential of genetically modified foods?

    PubMed

    Metcalfe, Dean D

    2003-06-01

    There is growing concern among the general public and the scientific community regarding the potential toxicity of genetically modified organisms (GMOs). The use of biotechnology to enhance pest resistance or nutritional value has raised a number of fundamental questions including the consequences of insertion of reporter genes, the spread of resistance genes to surrounding plants, and the use of suicide genes to prohibit reuse of seed from engineered plants. Of particular interest is the ability of proteins from GMOs to elicit potentially harmful immunologic responses, including allergic hypersensitivity. The lack of information of the potential toxicity of these products suggests a need to identify the critical issues and research needs regarding these materials and to develop testing strategies to examine the allergenicity of these compounds.

  15. Introduction: what are the issues in addressing the allergenic potential of genetically modified foods?

    PubMed Central

    Metcalfe, Dean D

    2003-01-01

    There is growing concern among the general public and the scientific community regarding the potential toxicity of genetically modified organisms (GMOs). The use of biotechnology to enhance pest resistance or nutritional value has raised a number of fundamental questions including the consequences of insertion of reporter genes, the spread of resistance genes to surrounding plants, and the use of suicide genes to prohibit reuse of seed from engineered plants. Of particular interest is the ability of proteins from GMOs to elicit potentially harmful immunologic responses, including allergic hypersensitivity. The lack of information of the potential toxicity of these products suggests a need to identify the critical issues and research needs regarding these materials and to develop testing strategies to examine the allergenicity of these compounds. PMID:12826482

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

    NASA Astrophysics Data System (ADS)

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

    2011-06-01

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

  17. Regulatory and ethical issues in the conduct of clinical research involving children.

    PubMed

    Hirtz, Deborah G; Fitzsimmons, Lorraine G

    2002-12-01

    Children are a uniquely vulnerable population, yet there is an overwhelming need to test safety and efficacy of therapies and preventions in the pediatric population. Results from studies in adults do not provide sufficient or accurate information. Recently, the need for research involving children has been recognized and action has been taken at the federal level to address both the need for pediatric research and the protection of the welfare and rights of children as research subjects. Other ethical and legal issues such as privacy and confidentiality of information are being addressed as well.

  18. California renewable energy policy and implementation issues: An overview of recent regulatory and legislative action

    SciTech Connect

    Wiser, R.; Pickle, S.; Goldman, C.

    1996-09-01

    This paper has three primary goals: (1) to provide a brief account of recent events in California renewables policy; (2) to outline the California State Legislature`s ultimate decision on renewable energy policy; and (3) to aid other states in their efforts with renewables policy by summarizing some of the key implementation issues and political conflicts that may occur when crafting some of the potential threats and opportunities that electricity restructuring presents to the development of renewable energy. We then outline the renewables policy debate in California since the California Public Utility Commission`s ``Blue Book``, including both regulatory and legislative developments. We also provide some insight into the minimum renewables purchase requirement (MRPR) versus surcharge-based renewables policy debate in California. Finally, we identify and discuss key renewables policy implementation issues that have driven the dialogue and recent decisions in California`s renewables policy.

  19. A public-policy practicum to address current issues in human, animal, and ecosystem health.

    PubMed

    Herrmann, John A; Johnson, Yvette J; Troutt, H Fred; Prudhomme, Thomas

    2009-01-01

    There are recognized needs for cross-training health professionals in human, animal, and ecosystem health and for public health policy to be informed by experts from medical, science, and social science disciplines. Faculty members of the Community Health and Preventive Medicine Section at the University of Illinois at Urbana-Champaign, College of Veterinary Medicine, and the Institute of Government and Public Affairs, University of Illinois at Urbana-Champaign, have offered a public-policy course designed to meet those needs. The course was designed as a practicum to teach students the policy-making process through the development of policy proposals and to instruct students on how to effectively present accurate scientific, demographic, and statistical information to policy makers and to the public. All students substantially met the learning objectives of the course. This course represents another model that can be implemented to help students learn about complex, multifactorial issues that affect the health of humans, animals, and ecosystems, while promoting participation in public health policy development.

  20. Evaluation of Geese Theatre's Re-Connect program: addressing resettlement issues in prison.

    PubMed

    Harkins, Leigh; Pritchard, Cecilia; Haskayne, Donna; Watson, Andy; Beech, Anthony R

    2011-06-01

    This study examined the impact of Geese Theatre's Re-Connect program on a sample of offenders who attended it. This program used theatre performance, experiential exercises, skills practice role-plays, and metaphors such as the masks to invite a group of offenders to consider and explore issues connected with their release and reconnecting with a life outside prison. Pre- and postprogram psychometric tests, behavior ratings, and interviews were completed to assess the effectiveness of the program. Significant changes were observed from pre- to posttreatment in terms of self-efficacy, motivation to change, and improved confidence in skills (i.e., social and friendship, occupational, family and intimacy, dealing with authority, alternatives to aggression or offending, and self-management and self-control skills). Improved behavior and engagement within the program was observed over the 3 days of the program. Interviews also revealed the positive impact the program had on the participants. This provides evidence supporting the short-term effectiveness of the Re-Connect program.

  1. Addressing the amorphous content issue in quantitative phase analysis : the certification of NIST SRM 676a.

    SciTech Connect

    Cline, J. P.; Von Dreele, R. B.; Winburn, R.; Stephens, P. W.; Filliben, J. J.

    2011-07-01

    A non-diffracting surface layer exists at any boundary of a crystal and can comprise a mass fraction of several percent in a finely divided solid. This has led to the long-standing issue of amorphous content in standards for quantitative phase analysis (QPA). NIST standard reference material (SRM) 676a is a corundum ({alpha}-Al{sub 2}O{sub 3}) powder, certified with respect to phase purity for use as an internal standard in powder diffraction QPA. The amorphous content of SRM 676a is determined by comparing diffraction data from mixtures with samples of silicon powders that were engineered to vary their specific surface area. Under the (supported) assumption that the thickness of an amorphous surface layer on Si was invariant, this provided a method to control the crystalline/amorphous ratio of the silicon components of 50/50 weight mixtures of SRM 676a with silicon. Powder diffraction experiments utilizing neutron time-of-flight and 25 keV and 67 keV X-ray energies quantified the crystalline phase fractions from a series of specimens. Results from Rietveld analyses, which included a model for extinction effects in the silicon, of these data were extrapolated to the limit of zero amorphous content of the Si powder. The certified phase purity of SRM 676a is 99.02% {+-} 1.11% (95% confidence interval). This novel certification method permits quantification of amorphous content for any sample of interest, by spiking with SRM 676a.

  2. Addressing oral health disparities, inequity in access and workforce issues in a developing country.

    PubMed

    Singh, Abhinav; Purohit, Bharathi M

    2013-10-01

    The health sector challenges in India like those in other low and middle income countries are formidable. India has almost one-third of the world's dental schools. However, provisions of oral health-care services are few in rural parts of India where the majority of the Indian population resides. Disparities exist between the oral health status in urban and rural areas. The present unequal system of mainly private practice directed towards a minority of the population and based on reparative services needs to be modified. National oral health policy needs to be implemented as a priority, with an emphasis on strengthening dental care services under public health facilities. A fast-changing demographic profile and its implications needs to be considered while planning for the future oral health-care workforce. Current oral health status in developing countries, including India, is a result of government public health policies, not lack of dentists. The aim of the article is to discuss pertinent issues relating to oral health disparities, equity in health-care access, dental workforce planning and quality concerns pertaining to the present-day dental education and practices in India, which have implications for other developing countries. PMID:24074015

  3. Methods to address poultry robustness and welfare issues through breeding and associated ethical considerations.

    PubMed

    Muir, William M; Cheng, Heng-Wei; Croney, Candace

    2014-01-01

    As consumers and society in general become more aware of ethical and moral dilemmas associated with intensive rearing systems, pressure is put on the animal and poultry industries to adopt alternative forms of housing. This presents challenges especially regarding managing competitive social interactions between animals. However, selective breeding programs are rapidly advancing, enhanced by both genomics and new quantitative genetic theory that offer potential solutions by improving adaptation of the bird to existing and proposed production environments. The outcomes of adaptation could lead to improvement of animal welfare by increasing fitness of the animal for the given environments, which might lead to increased contentment and decreased distress of birds in those systems. Genomic selection, based on dense genetic markers, will allow for more rapid improvement of traits that are expensive or difficult to measure, or have a low heritability, such as pecking, cannibalism, robustness, mortality, leg score, bone strength, disease resistance, and thus has the potential to address many poultry welfare concerns. Recently selection programs to include social effects, known as associative or indirect genetic effects (IGEs), have received much attention. Group, kin, multi-level, and multi-trait selection including IGEs have all been shown to be highly effective in reducing mortality while increasing productivity of poultry layers and reduce or eliminate the need for beak trimming. Multi-level selection was shown to increases robustness as indicated by the greater ability of birds to cope with stressors. Kin selection has been shown to be easy to implement and improve both productivity and animal well-being. Management practices and rearing conditions employed for domestic animal production will continue to change based on ethical and scientific results. However, the animal breeding tools necessary to provide an animal that is best adapted to these changing conditions

  4. Methods to address poultry robustness and welfare issues through breeding and associated ethical considerations

    PubMed Central

    Muir, William M.; Cheng, Heng-Wei; Croney, Candace

    2014-01-01

    As consumers and society in general become more aware of ethical and moral dilemmas associated with intensive rearing systems, pressure is put on the animal and poultry industries to adopt alternative forms of housing. This presents challenges especially regarding managing competitive social interactions between animals. However, selective breeding programs are rapidly advancing, enhanced by both genomics and new quantitative genetic theory that offer potential solutions by improving adaptation of the bird to existing and proposed production environments. The outcomes of adaptation could lead to improvement of animal welfare by increasing fitness of the animal for the given environments, which might lead to increased contentment and decreased distress of birds in those systems. Genomic selection, based on dense genetic markers, will allow for more rapid improvement of traits that are expensive or difficult to measure, or have a low heritability, such as pecking, cannibalism, robustness, mortality, leg score, bone strength, disease resistance, and thus has the potential to address many poultry welfare concerns. Recently selection programs to include social effects, known as associative or indirect genetic effects (IGEs), have received much attention. Group, kin, multi-level, and multi-trait selection including IGEs have all been shown to be highly effective in reducing mortality while increasing productivity of poultry layers and reduce or eliminate the need for beak trimming. Multi-level selection was shown to increases robustness as indicated by the greater ability of birds to cope with stressors. Kin selection has been shown to be easy to implement and improve both productivity and animal well-being. Management practices and rearing conditions employed for domestic animal production will continue to change based on ethical and scientific results. However, the animal breeding tools necessary to provide an animal that is best adapted to these changing conditions

  5. Methods to address poultry robustness and welfare issues through breeding and associated ethical considerations.

    PubMed

    Muir, William M; Cheng, Heng-Wei; Croney, Candace

    2014-01-01

    As consumers and society in general become more aware of ethical and moral dilemmas associated with intensive rearing systems, pressure is put on the animal and poultry industries to adopt alternative forms of housing. This presents challenges especially regarding managing competitive social interactions between animals. However, selective breeding programs are rapidly advancing, enhanced by both genomics and new quantitative genetic theory that offer potential solutions by improving adaptation of the bird to existing and proposed production environments. The outcomes of adaptation could lead to improvement of animal welfare by increasing fitness of the animal for the given environments, which might lead to increased contentment and decreased distress of birds in those systems. Genomic selection, based on dense genetic markers, will allow for more rapid improvement of traits that are expensive or difficult to measure, or have a low heritability, such as pecking, cannibalism, robustness, mortality, leg score, bone strength, disease resistance, and thus has the potential to address many poultry welfare concerns. Recently selection programs to include social effects, known as associative or indirect genetic effects (IGEs), have received much attention. Group, kin, multi-level, and multi-trait selection including IGEs have all been shown to be highly effective in reducing mortality while increasing productivity of poultry layers and reduce or eliminate the need for beak trimming. Multi-level selection was shown to increases robustness as indicated by the greater ability of birds to cope with stressors. Kin selection has been shown to be easy to implement and improve both productivity and animal well-being. Management practices and rearing conditions employed for domestic animal production will continue to change based on ethical and scientific results. However, the animal breeding tools necessary to provide an animal that is best adapted to these changing conditions

  6. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

    PubMed

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

    2014-01-01

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

  7. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

    PubMed

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

    2014-01-01

    The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24). PMID:25529890

  8. Using Next Generation Science Standards (NGSS) Practices to Address Scientific Misunderstandings Around Complex Environmental Issues

    NASA Astrophysics Data System (ADS)

    Turrin, M.; Kenna, T. C.

    2014-12-01

    The new NGSS provide an important opportunity for scientists to develop curriculum that links the practice of science to research-based data in order to improve understanding in areas of science that are both complex and confusing. Our curriculum focuses in particular on the fate and transport of anthropogenic radionuclides. Radioactivity, both naturally occurring and anthropogenic, is highly debated and largely misunderstood, and for large sections of the population is a source of scientific misunderstanding. Developed as part of the international GEOTRACES project which focuses on identifying ocean processes and quantifying fluxes that control the distributions of selected trace elements and isotopes in the ocean, and on establishing the sensitivity of these distributions to changing environmental conditions, the curriculum topic fits nicely into the applied focus of NGSS with both environmental and topical relevance. Our curriculum design focuses on small group discussion driven by questions, yet unlike more traditional curriculum pieces these are not questions posed to the students, rather they are questions posed by the students to facilitate their deeper understanding. Our curriculum design challenges the traditional question/answer memorization approach to instruction as we strive to develop an educational approach that supports the practice of science as well as the NGSS Cross Cutting Concepts and the Science & Engineering Practices. Our goal is for students to develop a methodology they can employ when faced with a complex scientific issue. Through background readings and team discussions they identify what type of information is important for them to know and where to find a reliable source for that information. Framing their discovery around key questions such as "What type of radioactive decay are we dealing with?", "What is the potential half-life of the isotope?", and "What are the pathways of transport of radioactivity?" allows students to evaluate a

  9. End of Life and Life After Death - Issues to be Addressed.

    PubMed

    Sridhar, Poojar; Renuka, Pramod Kallur Parameshwar; Bonanthaya, Ravikiran

    2012-09-01

    Being an Oncologist, I have seen many patients suffering from cancer. It pains a lot looking at them fighting the battle of life, though knowing that they would lose miserably and surrender meekly as majority of the patients report to the hospital at an advanced stage of disease and only palliative care may be the option. There is an urgent need to create - Cancer Awareness in the villages and also about the end of life care in all terminally ill patients. 20 patients in the terminal phase were questioned regarding end of life care. The common questions they asked are, why has God punished me like this? Why me on earth? Should I die so early? Why should I leave my near and dear ones and go far away, from the point of no return? Do I ever see them again? With deep sorrow and sigh, they suffer till the last breath, having the feeling of insecurity as what would happen to their dear ones. In the terminal phase, the patients wishes must be respected and their needs must be fulfilled. The health care professionals should plan an appropriate care for each patient. Most of them feel that the best place to be in end of life is the home. Research has shown that Hospice care may improve the quality of life of a patient who is dying and of the patient's family. Communication about end of life care and decision making during the final moments of a person's life are very important. The patients suffering are mainly due to the physical, psychological, social and spiritual issues. Death of a terminally ill patient should never be a sudden loss. All healthcare professionals, Social workers and Non-Governmental Organisations must install the life after death of the person, who has struggled for every breath and assure that he/she shall rest in peace and shall smile seeing their near and dear ones living with dignity and pride in the society. Ultimately, the patient must have dignity in dying.

  10. The triad of success in personalised medicine: pharmacogenomics, biotechnology and regulatory issues from a Central European perspective.

    PubMed

    Mesko, Bertalan; Zahuczky, Gabor; Nagy, Laszlo

    2012-09-15

    The population of the world has recently passed the 7 billion milestone and as the cost of human genome sequencing is rapidly declining, sequence data of billions of people should be accessible much sooner than anyone would have predicted 10 years ago. This will form the basis of personalised medicine. However it is still not clear, even in principle, whether these data, combined with data of the expression of one's genome in various cells and tissues relevant to different diseases, could be used effectively in clinical medicine and healthcare, or in predicting responses to different therapies. Therefore this is an important issue which needs to be addressed before more resources are wasted on less than informative studies and surveys simply because technologies exist. As a typical example, we have selected and summarise here key studies from the biomedical literature that focus on gene expression profiling of the response to biologic therapies in peripheral blood and biopsy samples in autoimmune diseases such as rheumatoid arthritis, spondylarthropathy, inflammatory bowel diseases and psoriasis. We also present the state of the biotechnology market from a European perspective, discuss how spin-offs leverage the power of genomic technologies and describe how they might contribute to personalised medicine. As ethical, legal and social issues are essential in the area of genomics, we analysed these aspects and present here the European situation with a special focus on Hungary. We propose that the synergy of these three issues: pharmacogenomics, biotechnology and regulatory issues should be considered a triad necessary to succeed in personalised medicine.

  11. Ethical and regulatory issues with conducting sexuality research with LGBT adolescents: a call to action for a scientifically informed approach.

    PubMed

    Mustanski, Brian

    2011-08-01

    Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants' appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area. PMID:21528402

  12. Ethical and regulatory issues with conducting sexuality research with LGBT adolescents: a call to action for a scientifically informed approach.

    PubMed

    Mustanski, Brian

    2011-08-01

    Lesbian, gay, bisexual, and transgender (LGBT) adolescents experience disparities in mental and sexual health. There is also a lack of research on this population relative to other adolescents, which limits our ability to effectively address these health disparities. Researchers may unfortunately avoid conducting research with this population because of anticipated or actual experiences with difficulties in obtaining IRB approval. A case example is provided to illustrate the ethical and regulatory issues related to research with LGBT adolescents. Relevant U.S. federal and local regulations related to research on sexual and mental health with adolescents is then reviewed. Data are presented demonstrating that requiring parental consent for LGBT youth under age 18 would likely alter study result. Data are also presented on participants' appraisals of the risks and discomforts associated with research participation. The provision of such empirical data on the risks of research participation is consistent with the goal of moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based. Finally, recommendations are provided on how to approach these issues in IRB applications and investigators are called to help to build a corpus of scholarship that can advance empirical knowledge in this area.

  13. Secondary Education Systemic Issues: Addressing Possible Contributors to a Leak in the Science Education Pipeline and Potential Solutions

    NASA Astrophysics Data System (ADS)

    Young, Hollie

    2005-06-01

    To maintain the legacy of cutting edge scientific innovation in the United States our country must address the many pressing issues facing science education today. One of the most important issues relating to science education is the under-representation of African Americans and Hispanics in the science, technology, and engineering workforce. Foreshadowing such under-representation in the workforce are the disproportionately low rates of African American and Hispanic students attaining college degrees in science and related fields. Evidence suggests disparate systemic factors in secondary science education are contributing to disproportionately low numbers of African American and Hispanic students in the science education pipeline. The present paper embarks on a critical analysis of the issue by elucidating some of the systemic factors within secondary education that contribute to the leak in the science education pipeline. In addition, this review offers a synthesis and explication of some of the policies and programs being implemented to address disparate systemic factors in secondary schools. Finally, recommendations are offered regarding potential mechanisms by which disparities may be alleviated.

  14. 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.

  15. BWR internal cracking issues

    SciTech Connect

    Carpenter, C.E. Jr.; Lund, A.L.

    1999-07-01

    The regulatory issues associated with cracking of boiling water reactor (BWR) internals is being addressed by the Nuclear Regulatory Commission (NRC) staff and is the subject of a voluntary industry initiative. The lessons learned from this effort will be applied to pressurized water reactor (PWR) internals cracking issues.

  16. Work group III: Methodologic issues in research on the food and physical activity environments: addressing data complexity.

    PubMed

    Oakes, J Michael; Mâsse, Louise C; Messer, Lynne C

    2009-04-01

    Progress in transdisciplinary research addressing the health effects of the food and physical activity environments appears hampered by several methodologic obstacles, including: (1) the absence of clear, testable conceptual models; (2) slow adoption of practicable, rigorous research designs; (3) improper use of analytic techniques; and (4) concerns about ubiquitous measurement error. The consequence of such obstacles is that data collected as part of the typical study are more complex than need be. We offer diagnoses and recommendations from an NIH-sponsored meeting that addressed core issues in food- and physical activity-environment research. Recommendations include improved conceptual models and more elaborate theories, experimental thinking and increased attention to causal effect estimation, adoption of cross-validation techniques, use of existing measurement-error models, and increased support for methodologic research.

  17. Legal issues to address when managing clinical information across Europe: the ECIT case study (www.ECIT.info).

    PubMed

    Lawford Davies, James; Jenkins, Julian

    2005-01-01

    This paper identifies issues which will need to be addressed in pursuing the aims and objectives of the European Classification of Infertility Taskforce (ECIT), namely: to establish classification codes for infertility management; to improve the consistency of infertility information collection by specialist centres, particularly but not exclusively by computerised systems; to use these codes to enable the transfer of infertility information from specialist centres to national infertility data registries; to develop a Grid linking the data held in European infertility data registries; to use Grid processing to mine the data in the European infertility data registries to optimise patient management improving the effectiveness of treatment and reducing the risk.

  18. Langley's DEVELOP Team Applies NASA's Earth Observations to Address Environmental Issues Across the Country and Around the Globe

    NASA Technical Reports Server (NTRS)

    Childs, Lauren M.; Miller, Joseph E.

    2011-01-01

    The DEVELOP National Program was established over a decade ago to provide students with experience in the practical application of NASA Earth science research results. As part of NASA's Applied Sciences Program, DEVELOP focuses on bridging the gap between NASA technology and the public through projects that innovatively use NASA Earth science resources to address environmental issues. Cultivating a diverse and dynamic group of students and young professionals, the program conducts applied science research projects during three terms each year (spring, summer, and fall) that focus on topics ranging from water resource management to natural disasters.

  19. 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.

  20. Comprehensive Lifecycle Planning and Management System For Addressing Water Issues Associated With Shale Gas Development In New York, Pennsylvania, And West Virginia

    SciTech Connect

    Arthur, J. Daniel

    2012-07-01

    The objective of this project is to develop a modeling system to allow operators and regulators to plan all aspects of water management activities associated with shale gas development in the target project area of New York, Pennsylvania, and West Virginia (target area ), including water supply, transport, storage, use, recycling, and disposal and which can be used for planning, managing, forecasting, permit tracking, and compliance monitoring. The proposed project is a breakthrough approach to represent the entire shale gas water lifecycle in one comprehensive system with the capability to analyze impacts and options for operational efficiency and regulatory tracking and compliance, and to plan for future water use and disposition. It will address all of the major water-related issues of concern associated with shale gas development in the target area, including water withdrawal, transport, storage, use, treatment, recycling, and disposal. It will analyze the costs, water use, and wastes associated with the available options, and incorporate constraints presented by permit requirements, agreements, local and state regulations, equipment and material availability, etc. By using the system to examine the water lifecycle from withdrawals through disposal, users will be able to perform scenario analysis to answer "what if" questions for various situations. The system will include regulatory requirements of the appropriate state and regional agencies and facilitate reporting and permit applications and tracking. These features will allow operators to plan for more cost effective resource production. Regulators will be able to analyze impacts of development over an entire area. Regulators can then make informed decisions about the protections and practices that should be required as development proceeds. This modeling system will have myriad benefits for industry, government, and the public. For industry, it will allow planning all water management operations for a

  1. Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR & GEN IV

    SciTech Connect

    William J. O’Donnell; Donald S. Griffin

    2007-05-07

    The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

  2. A Cost-Efficient LDPC Decoder for DVB-S2 with the Solution to Address Conflict Issue

    NASA Astrophysics Data System (ADS)

    Ying, Yan; Bao, Dan; Yu, Zhiyi; Zeng, Xiaoyang; Chen, Yun

    In this paper, a cost-efficient LDPC decoder for DVB-S2 is presented. Based on the Normalized Min-Sum algorithm and the turbo-decoding message-passing (TDMP) algorithm, a dual line-scan scheduling is proposed to enable hardware reusing. Furthermore, we present the solution to the address conflict issue caused by the characteristic of the parity-check matrix defined by DVB-S2 LDPC codes. Based on SMIC 0.13µm standard CMOS process, the LDPC decoder has an area of 12.51mm2. The required operating frequency to meet the throughput requirement of 135Mbps with maximum iteration number of 30 is 105MHz. Compared with the latest published DVB-S2 LDPC decoder, the proposed decoder reduces area cost by 34%.

  3. Patient and healthcare perspectives on the importance and efficacy of addressing spiritual issues within an interdisciplinary bone marrow transplant clinic: a qualitative study

    PubMed Central

    Sinclair, Shane; McConnell, Shelagh; Raffin Bouchal, Shelley; Ager, Naree; Booker, Reanne; Enns, Bert; Fung, Tak

    2015-01-01

    Objectives The purpose of this study was to use a qualitative approach to better understand the importance and efficacy of addressing spiritual issues within an interdisciplinary bone marrow transplant clinic from the perspectives of patients and healthcare providers. Setting Participants were recruited from the bone marrow transplant clinic of a large urban outpatient cancer care centre in western Canada. Participants: Focus groups were conducted with patients (n=7) and healthcare providers (n=9) to explore the importance of addressing spiritual issues across the treatment trajectory and to identify factors associated with effectively addressing these needs. Results Data were analysed using the qualitative approach of latent content analysis. Addressing spiritual issues was understood by patients and healthcare providers, as a core, yet under addressed, component of comprehensive care. Both sets of participants felt that addressing basic spiritual issues was the responsibility of all members of the interdisciplinary team, while recognising the need for specialised and embedded support from a spiritual care professional. While healthcare providers felt that the impact of the illness and treatment had a negative effect on patients’ spiritual well-being, patients felt the opposite. Skills, challenges, key time points and clinical indicators associated with addressing spiritual issues were identified. Conclusions Despite a number of conceptual and clinical challenges associated with addressing spiritual issues patients and their healthcare providers emphasised the importance of an integrated approach whereby basic spiritual issues are addressed by members of the interdisciplinary team and by an embedded spiritual care professional, who in addition also provides specialised support. The identification of clinical issues associated with addressing spiritual needs provides healthcare providers with clinical guidance on how to better integrate this aspect of care into

  4. Practical guidelines addressing ethical issues pertaining to the curation of human locus-specific variation databases (LSDBs).

    PubMed

    Povey, Sue; Al Aqeel, Aida I; Cambon-Thomsen, Anne; Dalgleish, Raymond; den Dunnen, Johan T; Firth, Helen V; Greenblatt, Marc S; Barash, Carol Isaacson; Parker, Michael; Patrinos, George P; Savige, Judith; Sobrido, Maria-Jesus; Winship, Ingrid; Cotton, Richard G H

    2010-11-01

    More than 1,000 Web-based locus-specific variation databases (LSDBs) are listed on the Website of the Human Genetic Variation Society (HGVS). These individual efforts, which often relate phenotype to genotype, are a valuable source of information for clinicians, patients, and their families, as well as for basic research. The initiators of the Human Variome Project recently recognized that having access to some of the immense resources of unpublished information already present in diagnostic laboratories would provide critical data to help manage genetic disorders. However, there are significant ethical issues involved in sharing these data worldwide. An international working group presents second-generation guidelines addressing ethical issues relating to the curation of human LSDBs that provide information via a Web-based interface. It is intended that these should help current and future curators and may also inform the future decisions of ethics committees and legislators. These guidelines have been reviewed by the Ethics Committee of the Human Genome Organization (HUGO).

  5. Addressing the Federal-State-Local Interface Issues During a Catastrophic Event Such as an Anthrax Attack

    SciTech Connect

    Stein, Steven L.; Lesperance, Ann M.; Upton, Jaki F.

    2010-02-01

    On October 9, 2008, federal, state and local policy makers, emergency managers, and medical and public health officials convened in Seattle, Washington, for a workshop on Addressing the Federal-State-Local Interface Issues During a Catastrophic Event Such as an Anthrax Attack. The day-long symposium was aimed at generating a dialogue about recovery and restoration through a discussion of the associated challenges that impact entire communities, including people, infrastructure, and critical systems. The Principal Federal Official (PFO) provided an overview of the role of the PFO in a catastrophic event. A high-level summary of an anthrax scenario was presented. The remainder of the day was focused on interactive discussions among federal, state and local emergency management experts in the areas of: • Decision-making, prioritization, and command and control • Public health/medical services • Community resiliency and continuity of government. Key topics and issues that resulted from discussions included: • Local representation in the Joint Field Office (JFO) • JFO transition to the Long-Term Recovery Office • Process for prioritization of needs • Process for regional coordination • Prioritization - process and federal/military intervention • Allocation of limited resources • Re-entry decision and consistency • Importance of maintaining a healthy hospital system • Need for a process to establish a consensus on when it is safe to re-enter. This needs to be across all jurisdictions including the military. • Insurance coverage for both private businesses and individuals • Interaction between the government and industry. The symposium was sponsored by the Interagency Biological Restoration Demonstration, a collaborative regional program jointly funded by the U.S. Department of Homeland Security and the U.S. Department of Defense. To aid the program’s efforts and inform the development of blueprint for recovery from a biological incident

  6. Controversies concerning thymus-derived regulatory T cells: fundamental issues and a new perspective

    PubMed Central

    Ono, Masahiro; Tanaka, Reiko J

    2016-01-01

    Thymus-derived regulatory T cells (Tregs) are considered to be a distinct T-cell lineage that is genetically programmed and specialised for immunosuppression. This perspective is based on the key evidence that CD25+ Tregs emigrate to neonatal spleen a few days later than other T cells and that thymectomy of 3-day-old mice depletes Tregs only, causing autoimmune diseases. Although widely believed, the evidence has never been reproduced as originally reported, and some studies indicate that Tregs exist in neonates. Thus we examine the consequences of the controversial evidence, revisit the fundamental issues of Tregs and thereby reveal the overlooked relationship of T-cell activation and Foxp3-mediated control of the T-cell system. Here we provide a new model of Tregs and Foxp3, a feedback control perspective, which views Tregs as a component of the system that controls T-cell activation, rather than as a distinct genetically programmed lineage. This perspective provides new insights into the roles of self-reactivity, T cell–antigen-presenting cell interaction and T-cell activation in Foxp3-mediated immune regulation. PMID:26215792

  7. Controversies concerning thymus-derived regulatory T cells: fundamental issues and a new perspective.

    PubMed

    Ono, Masahiro; Tanaka, Reiko J

    2016-01-01

    Thymus-derived regulatory T cells (Tregs) are considered to be a distinct T-cell lineage that is genetically programmed and specialised for immunosuppression. This perspective is based on the key evidence that CD25(+) Tregs emigrate to neonatal spleen a few days later than other T cells and that thymectomy of 3-day-old mice depletes Tregs only, causing autoimmune diseases. Although widely believed, the evidence has never been reproduced as originally reported, and some studies indicate that Tregs exist in neonates. Thus we examine the consequences of the controversial evidence, revisit the fundamental issues of Tregs and thereby reveal the overlooked relationship of T-cell activation and Foxp3-mediated control of the T-cell system. Here we provide a new model of Tregs and Foxp3, a feedback control perspective, which views Tregs as a component of the system that controls T-cell activation, rather than as a distinct genetically programmed lineage. This perspective provides new insights into the roles of self-reactivity, T cell-antigen-presenting cell interaction and T-cell activation in Foxp3-mediated immune regulation.

  8. Brand names of Portuguese medication: understanding the importance of their linguistic structure and regulatory issues.

    PubMed

    Pires, Carla; Vigário, Marina; Cavaco, Afonso

    2015-08-01

    Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

  9. 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.

  10. Interactive efforts to address DSM and IRP issues: Findings from the first year of a two-year study

    SciTech Connect

    Schweitzer, M.; English, M.; Altman, J.; Yourstone, E.

    1993-04-01

    This report presents findings from the first year of a two-year study of interactive efforts involving utilities and non-utility parties (NUPS) working together to prepare plans, develop Demand-Side Management (DSM) programs, or otherwise promote integrated planning and the use of cost-effective DSM measures. Of the ten cases covered in the current study, seven involved the collaborative approach to NUP involvement, which generally is marked by intensive utility-NUP interactions designed to reach consensus on a broad range of important issues; in collaboratives, outside consultants often are provided to enhance the technical capabilities of the NUPS. Another of the cases in this study involved a ``cooperative arrangement,`` whereby a utility and a NLT worked together in a focused short-term effort to develop a single DSM program. The intense interaction involved in this approach makes it very similar to a collaborative, except that both the scope and the duration of the effort were much more limited than in a normal collaborative. The ninth case concerned a task force run by state regulatory staff that was charged with the limited job of studying various cost-effectiveness tests available for assessing prospective DSM measures. All of these approaches (collaborative, cooperative arrangement, and task force) are types of interactive effort, as that term is used in this report. The final case concerned NUPs` attempts to encourage greater utility use of DSM in Florida but, to date, no interactive effort has been initiated there. Three main features of interactive efforts are described in this report: (1) the participants involved; (2) the context in which the efforts took place; and (3) key characteristics of the interactive process. This report also examines the outcomes achieved by the interactive efforts. These outcomes can be divided into two general categories: Product-related and participant-related.

  11. Interactive efforts to address DSM and IRP issues: Findings from the first year of a two-year study

    SciTech Connect

    Schweitzer, M. ); English, M.; Altman, J. . Energy, Environment and Resources Center); Yourstone, E. )

    1993-04-01

    This report presents findings from the first year of a two-year study of interactive efforts involving utilities and non-utility parties (NUPS) working together to prepare plans, develop Demand-Side Management (DSM) programs, or otherwise promote integrated planning and the use of cost-effective DSM measures. Of the ten cases covered in the current study, seven involved the collaborative approach to NUP involvement, which generally is marked by intensive utility-NUP interactions designed to reach consensus on a broad range of important issues; in collaboratives, outside consultants often are provided to enhance the technical capabilities of the NUPS. Another of the cases in this study involved a cooperative arrangement,'' whereby a utility and a NLT worked together in a focused short-term effort to develop a single DSM program. The intense interaction involved in this approach makes it very similar to a collaborative, except that both the scope and the duration of the effort were much more limited than in a normal collaborative. The ninth case concerned a task force run by state regulatory staff that was charged with the limited job of studying various cost-effectiveness tests available for assessing prospective DSM measures. All of these approaches (collaborative, cooperative arrangement, and task force) are types of interactive effort, as that term is used in this report. The final case concerned NUPs' attempts to encourage greater utility use of DSM in Florida but, to date, no interactive effort has been initiated there. Three main features of interactive efforts are described in this report: (1) the participants involved; (2) the context in which the efforts took place; and (3) key characteristics of the interactive process. This report also examines the outcomes achieved by the interactive efforts. These outcomes can be divided into two general categories: Product-related and participant-related.

  12. What Is the Purpose of the Theses Addressing the Issue of Program Evaluation in Turkey? (The Case of Curriculum and Instruction: 1997-2015)

    ERIC Educational Resources Information Center

    Alkin-Sahin, Senar; Tunca, Nihal

    2016-01-01

    In the current study, the aim is to investigate the theses addressing the issue of program evaluation in the field of Curriculum and Instruction (C&I) in 1997-2015. The study employed the survey model. The universe of the study consists of totally 87 theses addressing the issue of program evaluation in the field of C&I in 1997-2015. As the…

  13. Issues in mass spectrometry between bench chemists and regulatory laboratory managers: summary of the roundtable on mass spectrometry held at the 123rd AOAC International Annual Meeting.

    PubMed

    Heller, David N; Lehotay, Steven J; Martos, Perry A; Hammack, Walter; Fernández-Alba, Amadeo R

    2010-01-01

    At the 123rd AOAC International Annual Meeting in Philadelphia, PA, 45 residue chemists gathered for a roundtable discussion of mass spectrometry (MS) used for regulatory chemical residues analysis. The session was conceived to address current technical and communication issues about MS between "bench chemists and their bosses". The topics covered a range of practical, routine, and recurring issues on capabilities and limitations of MS techniques, and suggestions on how chemists may better communicate their MS results with customers. The customers in this sense include laboratory managers, quality assurance officers, laboratory clients, regulatory officials, policy-makers, lawyers, and others who have interest in the data. The stated goals devised by the roundtable panelists were to provide independent advice, describe limitations, give practical tips, help set realistic expectations, and answer questions from the attendees. The panelists divided the topics into three main themes: practical aspects in routine analysis using MS, choice of MS technique depending on the purpose for analysis, and qualitative identification and confirmation concepts. This report was written to summarize and expand upon the discussion, frame the current issues, and provide advice on handling common situations in MS analysis and reporting of results. Topics included LODs, data quality objectives, quantification and reporting results, matrix effects, calibration, terminology, differences in performance across MS platforms, proficiency testing, qualitative analysis, and laboratory accreditation. Conclusions are presented as a set of questions for structuring a dialog between bench chemists and laboratory managers. PMID:21140676

  14. Fort Collins Science Center Ecosystem Dynamics branch--interdisciplinary research for addressing complex natural resource issues across landscapes and time

    USGS Publications Warehouse

    Bowen, Zachary H.; Melcher, Cynthia P.; Wilson, Juliette T.

    2013-01-01

    The Ecosystem Dynamics Branch of the Fort Collins Science Center offers an interdisciplinary team of talented and creative scientists with expertise in biology, botany, ecology, geology, biogeochemistry, physical sciences, geographic information systems, and remote-sensing, for tackling complex questions about natural resources. As demand for natural resources increases, the issues facing natural resource managers, planners, policy makers, industry, and private landowners are increasing in spatial and temporal scope, often involving entire regions, multiple jurisdictions, and long timeframes. Needs for addressing these issues include (1) a better understanding of biotic and abiotic ecosystem components and their complex interactions; (2) the ability to easily monitor, assess, and visualize the spatially complex movements of animals, plants, water, and elements across highly variable landscapes; and (3) the techniques for accurately predicting both immediate and long-term responses of system components to natural and human-caused change. The overall objectives of our research are to provide the knowledge, tools, and techniques needed by the U.S. Department of the Interior, state agencies, and other stakeholders in their endeavors to meet the demand for natural resources while conserving biodiversity and ecosystem services. Ecosystem Dynamics scientists use field and laboratory research, data assimilation, and ecological modeling to understand ecosystem patterns, trends, and mechanistic processes. This information is used to predict the outcomes of changes imposed on species, habitats, landscapes, and climate across spatiotemporal scales. The products we develop include conceptual models to illustrate system structure and processes; regional baseline and integrated assessments; predictive spatial and mathematical models; literature syntheses; and frameworks or protocols for improved ecosystem monitoring, adaptive management, and program evaluation. The descriptions

  15. Impact of learning nutrition on medical students: their eating habits, knowledge and confidence in addressing dietary issues of patients.

    PubMed

    Shaikh, Shama; Dwivedi, Shraddha; Khan, Maroof A

    2011-12-01

    Nutrition is an important component in the treatment of acute and chronic diseases and is a cornerstone in strategies for disease prevention and health promotion. Despite the acknowledged importance of nutrition, there is evidence to indicate that the nutrition training of medical students is inadequate in both quality and quantity. The study aimed to know the dietary/eating habits of medical students, assess their knowledge on nutrition and to assess their confidence in addressing the dietary issues of patients. It was a cross-sectional study conducted on final year medical students, interns and postgraduate students of Moti Lal Nehru Government Medical College, Allahabad. The sampling was purposive and a total of 218 participated in the study voluntarily. Overall 55% of the students were less knowledgeable and only 45% of them were more knowledgeable. Most (62%) postgraduates were more knowledgeable (p < 0.001). Majority of them (89.9%) were having healthy eating habits. There was no association between their healthy habits and more knowledge (p > 0.340). Only 45.4% of them were confident in assessing the diet of patients and 44% of them were confident in recommending change of diet in patients. However this study shows no association between increase in the level of knowledge and confidence levels of the students (p > 0.339 and p > 0.109) suggesting that we need to incorporate innovative teaching methods to increase their confidence. Most students (79%) said that the medical curriculum was either just enough or not enough in preparing them to deal with the dietary issues of patients and 55% of them were of the opinion that the faculty should be trained in nutrition. The study results intend to stimulate active consideration of proper role of nutrition learning in medical education.

  16. The Blood and Marrow Transplant Clinical Trials Network: An Effective Infrastructure for Addressing Important Issues in Hematopoietic Cell Transplantation.

    PubMed

    2016-10-01

    Hematopoietic cell transplantation (HCT) is a rapidly evolving field with active preclinical and clinical development of new strategies for patient assessment, graft selection and manipulation, and pre- and post-transplantation drug and cell therapy. New strategies require evaluation in definitive clinical trials; however, HCT trials face unique challenges, including the relatively small number of transplantations performed at any single center, the diverse indications for HCT requiring dissimilar approaches, the complex nature of the intervention itself, the risk of multiple complications in the immediate post-transplantation period, and the risk of important, though infrequent, late effects. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) was established by the US National Heart Lung and Blood Institute and the National Cancer Institute to meet these challenges. In its 15 years as a network, the BMT CTN has proven to be a successful infrastructure for planning, implementing, and completing such trials and for providing definitive answers to questions leading to improvements in the understanding and practice of HCT. It has opened 37 trials, about one-half phase 2 and one-half phase 3, enrolled more than 8000 patients, and published 57 papers addressing important issues in the treatment of patients with life-threatening malignant and nonmalignant blood disorders. This review describes the network's accomplishments, key components of its success, lessons learned over the past 15 years, and challenges for the future.

  17. Innovative patient-centered skills training addressing challenging issues in cancer communications: Using patient's stories that teach.

    PubMed

    Bishop, Thomas W; Gorniewicz, James; Floyd, Michael; Tudiver, Fred; Odom, Amy; Zoppi, Kathy

    2016-05-01

    This workshop demonstrated the utility of a patient-centered web-based/digital Breaking Bad News communication training module designed to educate learners of various levels and disciplines. This training module is designed for independent, self-directed learning as well as group instruction. These interactive educational interventions are based upon video-recorded patient stories. Curriculum development was the result of an interdisciplinary, collaborative effort involving faculty from the East Tennessee State University (ETSU) Graduate Storytelling Program and the departments of Family and Internal Medicine at the James H. Quillen College of Medicine. The specific goals of the BBN training module are to assist learners in: (1) understanding a five-step patient-centered model that is based upon needs, preferences, and expectations of patients with cancer and (2) individualizing communication that is consistent with patient preferences in discussing emotions, informational detail, prognosis and timeline, and whether or not to discuss end-of-life issues. The pedagogical approach to the training module is to cycle through Emotional Engagement, Data, Modeled Practices, Adaptation Opportunities, and Feedback. The communication skills addressed are rooted in concepts found within the Reaching Common Ground communication training. A randomized control study investigating the effectiveness of the Breaking Bad News module found that medical students as well as resident physicians improved their communication skills as measured by an Objective Structured Clinical Examination. Four other similarly designed modules were also created: Living Through Treatment, Transitions: From Curable to Treatable/From Treatable to End-of-Life, Spirituality, and Family.

  18. Addressing Social Issues in the Classroom and Beyond: The Pedagogical Efforts of Pioneers in the Field. Research in Curriculum and Instruction

    ERIC Educational Resources Information Center

    Totten, Samuel, Ed.; Pedersen, Jon, Ed.

    2007-01-01

    Addressing Social Issues in the Classroom and Beyond: The Pedagogical Efforts of Pioneers in the Field is comprised of essays that delineate the genesis and evolution of the thought and work of pioneers in the field of social issues and education. The authors (many of whom, themselves, are noted professors of education and who have done…

  19. Addressing Cultural Issues in an Organizational Context. Edited Conference Proceedings of the Teachers College Winter Roundtable (New York, New York, 1992).

    ERIC Educational Resources Information Center

    Johnson, Samuel D., Jr., Ed.; Carter, Robert T., Ed.

    Papers from this year's conference reflect the Roundtable's theme of addressing cultural issues in an organizational context. Topics cover a wide range of institutional and organizational issues in corporate, educational, and treatment settings. Papers include: (1) "The New Corporate Language for Race Relations" (keynote) (Clayton P. Alderfer);…

  20. 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...

  1. 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...

  2. Overview of US AID-World Bank-NASA Collaboration to Address Water Management Issues in the MENA Region

    NASA Technical Reports Server (NTRS)

    Habib, Shahid

    2012-01-01

    The World Bank, USAID and NASA have recently established a joint project to study multiple issues pertaining to water related applications in the Middle East North Africa (MENA) region. The main concentration of the project is on utilization of remote sensing data and hydrological models to address crop irrigation and mapping, flood mapping and forecasting, evapotranspiration and drought problems prevalent in this large geographic area. Additional emphases are placed on understanding the climate impact on these areas as well. Per IPCC 2007 report, by the end of this century MENA region is projected to experience an increase of 3 C to 5 C rise in mean temperatures and a 20% decline in precipitation. This poses a serious problem for this geographic zone especially when majority of the hydrological consumption is for the agriculture sector and the remaining amount is for domestic consumption. The remote sensing data from space is one of the best ways to study such complex issues and further feed into the decision support systems. NASA's fleet of Earth Observing satellites offer a great vantage point from space to look at the globe and provide vital signs necessary to maintain healthy and sustainable ecosystem. These observations generate multiple products such as soil moisture, global precipitation, aerosols, cloud cover, normalized difference vegetation index, land cover/use, ocean altimetry, ocean salinity, sea surface winds, sea surface temperature, ozone and atmospheric gases, ice and snow measurements, and many more. All of the data products, models and research results are distributed-via the Internet freely through out the world. This project will utilize several NASA models such as global Land Data Assimilation System (LDAS) to generate hydrological states and fluxes in near real time. These LDAS products will then be further compared with other NASA satellite observations (MODIS, VIIRS, TRMM, etc.) and other discrete models to compare and optimize

  3. Innovative patient-centered skills training addressing challenging issues in cancer communications: Using patient's stories that teach.

    PubMed

    Bishop, Thomas W; Gorniewicz, James; Floyd, Michael; Tudiver, Fred; Odom, Amy; Zoppi, Kathy

    2016-05-01

    This workshop demonstrated the utility of a patient-centered web-based/digital Breaking Bad News communication training module designed to educate learners of various levels and disciplines. This training module is designed for independent, self-directed learning as well as group instruction. These interactive educational interventions are based upon video-recorded patient stories. Curriculum development was the result of an interdisciplinary, collaborative effort involving faculty from the East Tennessee State University (ETSU) Graduate Storytelling Program and the departments of Family and Internal Medicine at the James H. Quillen College of Medicine. The specific goals of the BBN training module are to assist learners in: (1) understanding a five-step patient-centered model that is based upon needs, preferences, and expectations of patients with cancer and (2) individualizing communication that is consistent with patient preferences in discussing emotions, informational detail, prognosis and timeline, and whether or not to discuss end-of-life issues. The pedagogical approach to the training module is to cycle through Emotional Engagement, Data, Modeled Practices, Adaptation Opportunities, and Feedback. The communication skills addressed are rooted in concepts found within the Reaching Common Ground communication training. A randomized control study investigating the effectiveness of the Breaking Bad News module found that medical students as well as resident physicians improved their communication skills as measured by an Objective Structured Clinical Examination. Four other similarly designed modules were also created: Living Through Treatment, Transitions: From Curable to Treatable/From Treatable to End-of-Life, Spirituality, and Family. PMID:27497456

  4. Regulatory development of the interim and revised regulations for radioactivity in drinking water--past and present issues and problems.

    PubMed

    Lappenbusch, W L; Cothern, C R

    1985-05-01

    Developing the Revised Regulations for Radioactivity in Drinking Water under the Safe Drinking Water Act requires information from all related areas and disciplines. As one step in the regulatory process, the background and history of that process as it applies to radioactivity in drinking water is described. The issues involved in developing the revised regulations are as follows: monitoring and sources of exposure, dose evaluation, health effects, engineering, economics and general policy development. PMID:3988521

  5. Overview of regulatory/policy/economic issues related to carbon dioxide.

    PubMed

    Leaf, Dennis; Verolme, Hans J H; Hunt, William F

    2003-06-01

    This is an overview of Session 2c dealing with the regulatory, policy and economic issues related to carbon dioxide and its impact on global climate change. The information is taken from the two papers presented in this session (the U.S. Perspective by Dennis Leaf and the European Perspective by Hans J.H. Verolme) and from the panel discussion that took place at the end of the session. The overview focuses primarily on the policy responses of both the United States (US) and the United Kingdom (UK) to changes in global atmospheric pollution. To a lesser extent, the progress of policy responses to these changes is discussed. The United Nations Framework Convention on Climate Change (UNFCCC) has been signed and ratified by over 180 countries. The UNFCCC contained no binding targets or timetables for emissions reductions. The Kyoto Protocol [United Nations. Kyoto Protocol to the United Nations Framework Convention on Climate Change. UNEP.IUC/99/10. Chatlelaine, Switzerland: United Nations Environment Programme's Information Unit for Conventions, for the Climate Change Secretariat, 1997] to the UNFCCC did contain targets and timetables for reductions of greenhouse gases on the part of developed countries. The US has signed but not ratified the Kyoto Protocol. The US has experienced some movement to reduce greenhouse gas emissions on the part of various levels of government, as well as the private sector. The UK's commitment to reducing green house gases is laid down in the UK Climate Change Programme 2000. The UK is a member of the European Union (EU). In this context, an example of EU-wide progress, the voluntary agreement with car manufacturers to reduce CO(2) emissions in new vehicles, will be discussed. In addition, there will be some discussion on the UK CO(2) trading scheme that created the first market in the world in April 2001. Overall, the policy process is constantly informed by scientific research. In the case of climate change, much of this work is carried

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

    PubMed

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

    2015-06-01

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

  7. 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.

  8. What Educators in Catholic Schools Might Expect when Addressing Gay and Lesbian Issues: A Study of Needs and Barriers

    ERIC Educational Resources Information Center

    Maher, Michael J.; Sever, Linda M.

    2007-01-01

    Previous research indicated that Catholic high schools in the United States were not addressing the topic of homosexuality in any significant and systematic way prior to the mid-1990s, though practitioners in Catholic high schools have begun to address the topic in recent years. This study, in sampling seven Catholic schools in the greater Chicago…

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

    PubMed

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

    2007-01-01

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

  10. Regulatory and ethical issues on the utilization of FFPE tissues in research.

    PubMed

    With, Catherine M; Evers, David L; Mason, Jeffrey T

    2011-01-01

    Formalin-fixed, paraffin-embedded (FFPE) archival tissues and their associated diagnostic records represent an invaluable source of information on diseases where the patient outcomes are already known. Older archives contain many unique FFPE tissue specimens that would be impossible to replicate today due to changes in medical practice and technology. Unfortunately, there is no single regulatory or bioethical standard that covers research with FFPE tissue specimens. This makes it difficult for researchers to prepare protocols involving FFPE tissues and equally difficult for Institutional Review Boards to evaluate them. In this review, focused on US regulatory policy, the application of the Common Rule and the Privacy Rule of the Health Insurance Portability and Accountability Act to research involving FFPE tissue specimens will be discussed. It will be shown that the difficulty in applying regulatory and ethical standards to FFPE tissues results not from the tissues themselves, but from the personally identifiable health information associated with the tissue specimens.

  11. 76 FR 40282 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ..., ``Requirements for Expanded Definition of Byproduct Material'' (72 FR 55864; October 1, 2007), (hereinafter... Material'' (72 FR 55864; October 1, 2007). The RIS describes regulatory approaches to implement NRC's.... See NARM Rule (72 FR 55864; October 1, 2007). Additionally, NRC established a definition for the...

  12. Scientific Issues Relevant to Setting Regulatory Criteria to Identify Endocrine-Disrupting Substances in the European Union

    PubMed Central

    Slama, Rémy; Bourguignon, Jean-Pierre; Demeneix, Barbara; Ivell, Richard; Panzica, Giancarlo; Kortenkamp, Andreas; Zoeller, R. Thomas

    2016-01-01

    , Kortenkamp A, Zoeller RT. 2016. Scientific issues relevant to setting regulatory criteria to identify endocrine disrupting substances in the European Union. Environ Health Perspect 124:1497–1503; http://dx.doi.org/10.1289/EHP217 PMID:27108591

  13. Regulatory and institutional issues impending cleanup at US Department of Energy sites: Perspectives gained from an office of environmental restoration workshop

    SciTech Connect

    Fallon, W E; Gephart, J M; Gephart, R E; Quinn, R D; Stevenson, L A

    1991-05-01

    The US Department of Energy's (DOE) nuclear weapons and energy operations are conducted across a nation-wide industrial complex engaged in a variety of manufacturing, processing, testing, and research and development activities. The overall mission of DOE Office of Environmental Restoration and Waste Management (EM) is to protect workers, the public, and the environment from waste materials generated by past, current, and future DOE activities and to bring the DOE complex into compliance with all applicable laws, regulations, and agreements related to health, safety, and the environment. EM addresses this broad mandate through related and interdependent programs that include corrective actions, waste operations, environmental restoration, and technology development. The EM Office of Environmental Restoration (EM-40) recognizes the importance of implementing a complex-wide process to identify and resolve those issues that may impede progress towards site cleanup. As a first step in this process, FM-40 sponsored an exercise to identify and characterize major regulatory and institutional issues and to formulate integrated action steps towards their resolution. This report is the first product of that exercise. It is intended that the exercise described here will mark the beginning of an ongoing process of issue identification, tracking, and resolution that will benefit cleanup activities across the DOE complex.

  14. Top 10 Ways To Improve Public Schools. Innovative Solutions To Help Address the Issues and Challenges Facing Most Public School Districts.

    ERIC Educational Resources Information Center

    Texas State Comptroller of Public Accounts, Austin.

    This report offers the top 10 challenges identified by public schools and the ways that the Texas School Performance Review (TSPR) suggests that these issues be addressed. The TSPR ensures that scarce education resources are spent in the classroom. For a TSPR review, the TSPR team is invited in for months of detailed study, during which it asks…

  15. Inclusion in Urban Educational Environments: Addressing Issues of Diversity, Equity, and Social Justice. Issues in the Research, Theory, Policy, and Practice of Urban Education

    ERIC Educational Resources Information Center

    Armstrong, Denise E.; McMahon, Brenda J.

    2006-01-01

    This book is motivated by the authors' experiences in working with students and their families in urban communities. They are particularly concerned about the urgent imperative to address the endemic educational and societal challenges that pervade the lives of urban students, particularly those who live in poverty, are of minority and immigrant…

  16. Autoregressive models for gene regulatory network inference: sparsity, stability and causality issues.

    PubMed

    Michailidis, George; d'Alché-Buc, Florence

    2013-12-01

    Reconstructing gene regulatory networks from high-throughput measurements represents a key problem in functional genomics. It also represents a canonical learning problem and thus has attracted a lot of attention in both the informatics and the statistical learning literature. Numerous approaches have been proposed, ranging from simple clustering to rather involved dynamic Bayesian network modeling, as well as hybrid ones that combine a number of modeling steps, such as employing ordinary differential equations coupled with genome annotation. These approaches are tailored to the type of data being employed. Available data sources include static steady state data and time course data obtained either for wild type phenotypes or from perturbation experiments. This review focuses on the class of autoregressive models using time course data for inferring gene regulatory networks. The central themes of sparsity, stability and causality are discussed as well as the ability to integrate prior knowledge for successful use of these models for the learning task at hand. PMID:24176667

  17. Nuclear Regulatory Commission activities to prepare for reviewing license applications and issuing licenses

    SciTech Connect

    Uleck, R.B.; DeFino, C.V.

    1991-12-31

    The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) assigned States the responsibility to provide for disposal of commercial low-level radioactive waste (LLRW) by 1993. The LLRWPAA also required the US Nuclear Regulatory Commission (NRC) to establish procedures and develop the technical review capability to process license applications for new LLRW disposal facilities. Under the LLRWPAA, NRC is required, to the extent practicable, to complete its review of an LLRW disposal facility license application within 15 months of its submittal by a State. This provision of the LLRWPAA helps ensure that NRC, in addition to protecting public health and safety and the environment, facilitates States` achievement of LLRWPAA milestones for new facility development. A timely NRC review is needed for States to accomplish their objective of having new disposal facilities in operation on the dates prescribed in the LLRWPAA. To help assure NRC and States` compliance with the provisions of the LLRWPAA, NRC has developed a licensing review strategy that includes: (1) the further development of regulatory guidance, (2) enhancement of licensing review capability, and (3) prelicensing regulatory consultation with potential applicants.

  18. A Task-Based Needs Analysis for Australian Aboriginal Students: Going beyond the Target Situation to Address Cultural Issues

    ERIC Educational Resources Information Center

    Oliver, Rhonda; Grote, Ellen; Rochecouste, Judith; Exell, Michael

    2013-01-01

    While needs analyses underpin the design of second language analytic syllabi, the methodologies undertaken are rarely examined. This paper explores the value of multiple data sources and collection methods for developing a needs analysis model to enable vocational education and training teachers to address the needs of Australian Aboriginal…

  19. Addressing Three Common Issues in Research on Youth Activities: An Integrative Approach for Operationalizing and Analyzing Involvement

    ERIC Educational Resources Information Center

    Busseri, Michael A.; Rose-Krasnor, Linda

    2010-01-01

    Youth activity involvement has been operationalized and analyzed using a wide range of approaches. Researchers face the challenges of distinguishing between the effects of involvement versus noninvolvement and intensity of involvement in a particular activity, accounting simultaneously for cumulative effects of involvement, and addressing multiple…

  20. The American Competitiveness Initiative: Addressing the STEM Teacher Shortage and Improving Student Academic Readiness. BHEF Issue Brief

    ERIC Educational Resources Information Center

    Business-Higher Education Forum (NJ1), 2006

    2006-01-01

    America's leaders are increasingly concerned about U.S. competitiveness in a rapidly globalizing world. In response, during the 2006 State of the Union Address, President Bush introduced the American Competitiveness Initiative (ACI) to promote policy that bolsters student achievement in the areas of science, technology, engineering, and…

  1. Insights into the Interactions between Educational Messages: Looking across Multiple Organizations Addressing Water Issues in Maricopa County, Arizona

    ERIC Educational Resources Information Center

    Cutts, Bethany; Saltz, Charlene; Elser, Monica

    2008-01-01

    The public receives environmental information from a variety of sources. Evaluation of a single program or one organization's effort is incomplete. Through surveys and interviews, we evaluate the cumulative impact of outreach by 20 water-related organizations in Maricopa County, Arizona. Household water conservation is a topic addressed by 18…

  2. Women Reaching Women: Change in Action--Using Action Learning to Help Address Seemingly Intractable and Large Scale Social Issues

    ERIC Educational Resources Information Center

    Langley, Dawn; Watts, Richard

    2010-01-01

    In 2008, 28 women from the Women's Institute volunteered to join us in a project exploring the issue of world poverty and gender inequality, specifically highlighting the disproportionate effects of climate change on women. Collectively we were asking a big question about how we as individuals, based in England, make a difference on a global…

  3. Beyond Boston: Applying Theory to Understand and Address Sustainability Issues in Focused Deterrence Initiatives for Violence Reduction

    ERIC Educational Resources Information Center

    Tillyer, Marie Skubak; Engel, Robin S.; Lovins, Brian

    2012-01-01

    Focused deterrence initiatives, including the most famous, Boston's Operation Ceasefire, have been associated with significant reductions in violence in several U.S. cities. Despite early successes, some cities have experienced long-term sustainability issues. Recent work in Cincinnati, Ohio, has focused on institutionalizing focused deterrence in…

  4. Assessment of the National Wind Coordinating Collaborative: Addressing Environmental and Siting Issues Associated with Wind Energy Development

    SciTech Connect

    Van Cleve, Frances B.; States, Jennifer C.

    2010-11-09

    The National Wind Coordinating Collaborative (NWCC) is a consensus-based stakeholder group comprised of representatives from the utility, wind industry, environmental, consumer, regulatory, power marketer, agricultural, tribal, economic development, and state and federal government sectors. The purpose of the NWCC is to support the development of an environmentally, economically, and politically sustainable commercial market for wind power (NWCC 2010). The NWCC has been funded by the U.S. Department of Energy (DOE) since its inception in 1994. In order to evaluate the impact of the work of the NWCC and how this work aligns with DOE’s strategic priorities, DOE tasked Pacific Northwest National Laboratory (PNNL) to conduct a series of informal interviews with a small sample of those involved with NWCC.

  5. A survey of physical dosimetry to date and in the near future: Part 1. Review of standards and regulatory issues.

    PubMed

    Cassata, James R

    2002-02-01

    This article summarizes the status of the relevant standards and current regulatory issues for use of physical dosimetry devices for the occupational worker in the United States. Included is a summary of relevant standards from the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American National Standards Institute (ANSI), the United States Nuclear Regulatory Commission NUREG-Series, the National Voluntary Laboratory Accreditation Program (NVLAP), the Department of Energy Laboratory Accreditation Program (DOELAP), and the U.S. Military Specifications and Standards (MIL-STD). Proposed changes to ANSI N13.11-1993, "American National Standard for Dosimetry-Personnel Dosimetry Performance Criteria for Testing," are listed. The strategic changes that the United States Nuclear Regulatory Commission (NRC) is making in rulemaking activities related to dosimetry and standards are given. The status of Measurement Program Description (MPD) C.18, "Implementation of Electronic Dosimetry for Primary Dosimetry," from the Council on Ionizing Radiation Measurements and Standards (CIRMS) is given. PMID:11873507

  6. Is It More Important to Address the Issue of Patient Mobility or to Guarantee Universal Health Coverage in Europe?

    PubMed Central

    Legido-Quigley, Helena

    2016-01-01

    This paper discusses whether European institutions should devote so much attention and funding to cross-border healthcare or they should instead prioritise guaranteeing universal health coverage (UHC), “addressing inequalities” and tackling the effects of austerity measures. The paper argues through providing the evidence in both areas of research, that the priority at European level from a public health and social justice perspective should be to guarantee UHC for all the population living in Europe and prioritise protective action for those who are most in need. PMID:26673649

  7. The Internet and Some International Regulatory Issues Relating to Content: A Pilot Comparative Study.

    ERIC Educational Resources Information Center

    Australian Broadcasting Authority.

    In December 1996 UNESCO commissioned the Australian Broadcasting Authority to conduct a pilot study which considered a range of online issues; this report outlines the findings of the pilot study, based on data collected between February and May 1997 and updated in July 1997. The objective is to identify the main types of Internet content which…

  8. Real-time earthquake alert system for the greater San Francisco Bay Area: a prototype design to address operational issues

    SciTech Connect

    Harben, P.E.; Jarpe, S.; Hunter, S.

    1996-05-29

    This paper describes a prototype for this EAS (real time) in the Bay area. Approach is pragmatic, attempting to establish a prototype system at a low cost and quickly. A real-time warning system can protect the public and mitigate earthquake damage. The proposed system is a distributed network of real-time strong-motion monitoring stations that telemetered data in real time to a central analysis facility which could transmit earthquake parameter information to an area before elastic wave energy arrived. Upgrades and issues that should be resolved before an operational EAS can be established, are listed.

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

    SciTech Connect

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

    1996-07-01

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

  10. An approach to addressing ethical issues in a community-based risk assessment for HIV: a case from Chennai, India.

    PubMed

    Sivaram, Sudha; Srikrishnan, Aylur Kailasom; Murgavel, Kailapuri G; Mayer, Kenneth H; Anand, S; Celentano, David D; Solomon, Suniti

    2005-06-01

    Community-based assessment of HIV prevalence and behavioural risk factors is the basis for deciding priorities of prevention and care programmes. Here, upholding the human rights of participants in assessment is of utmost importance. The objective of the paper was to describe the process of implementation of an epidemiological survey to assess HIV-related behavioural and biological factors in Chennai city in South India and to suggest an ethical framework for conducting similar assessment activities in developing-country settings. A survey was conducted with participation from residents (n=1,659) of low-income urban communities (slums) as part of a community-based HIV/STD-prevention trial. Administration of the survey was preceded by extensive community contact and household visits to inform community members about the trial and assessment activities. Formative research further strengthened rapport with community, highlighted community concerns, and identified HIV-related risk behaviours that informed questionnaire design. The process of obtaining informed consent began before assessment activities and provided an opportunity for individuals to discuss participation with their families and friends. Privacy during assessment, comprehensive follow-up care for those who tested positive for HIV/STDs, such as nutritional and prevention counselling, referral services for opportunistic infections, and antenatal-care options for pregnant women increased trust and credibility of the project. The sustained availability of trial staff to facilitate access to resources to address non-HIV/STD-related felt-needs further strengthened participation of the community members. These resources included liaison services with local government to obtain public services, such as water and electricity and resources, to address concerns, such as alcohol abuse and domestic violence. Based on this experience, an ethical framework is suggested for conducting HIV epidemiological risk assessment

  11. International and domestic regulator issues facing the Canadian MSAT system

    NASA Technical Reports Server (NTRS)

    Bahman, Azarbar; Langlois, Jacques R.; Frank, Christopher J.

    1988-01-01

    International and domestic regulatory issues which affect the implementation of a mobile satellite system (MSAT) over North America are addressed. WARC-MOB-87, MSAT frequency co-ordination, frequency sharing and key Canadian domestic issues are discussed.

  12. Addressing System Integration Issues Required for the Developmente of Distributed Wind-Hydrogen Energy Systems: Final Report

    SciTech Connect

    Mann, M.D; Salehfar, H.; Harrison, K.W.; Dale, N.; Biaku, C.; Peters, A.J.; Hernandez-Pacheco: E.

    2008-04-01

    Wind generated electricity is a variable resource. Hydrogen can be generated as an energy storage media, but is costly. Advancements in power electronics and system integration are needed to make a viable system. Therefore, the long-term goal of the efforts at the University of North Dakota is to merge wind energy, hydrogen production, and fuel cells to bring emission-free and reliable power to commercial viability. The primary goals include 1) expand system models as a tool to investigate integration and control issues, 2) examine long-term effects of wind-electrolysis performance from a systematic perspective, and 3) collaborate with NREL and industrial partners to design, integrate, and quantify system improvements by implementing a single power electronics package to interface wild AC to PEM stack DC requirements. This report summarizes the accomplishments made during this project.

  13. Fostering youth leadership to address workplace and community environmental health issues: a university-school-community partnership.

    PubMed

    Delp, Linda; Brown, Marianne; Domenzain, Alejandra

    2005-07-01

    Many communities of color are disproportionately exposed to workplace and community environmental hazards. This article presents the results of a pilot project designed by a university-school-community partnership to develop youth leadership to confront these exposures. Using a popular empowerment education approach, students applied peer education, research, and organizing skills learned in the classroom to community-based internships in a service-learning model. Evaluation results from pretests and posttests, focus groups, and in-depth interviews demonstrated that students shared what they learned about young workers' rights and environmental justice with family and friends. They developed a critical analysis of environmental inequities, created a citywide youth coalition that advocates around legal, educational, and environmental issues affecting youth, and implemented campaigns to enforce child labor laws and to prevent school construction on contaminated land. This multifaceted model can serve as an important foundation to develop youth leaders to influence environmental policies in a variety of communities.

  14. Understanding the support needs of patients accessing test results online. PHRs offer great promise, but support issues must be addressed to ensure appropriate access.

    PubMed

    Wiljer, David; Urowitz, Sara; Apatu, Emma; Leonard, Kevin; Quartey, Naa Kwarley; Catton, Pamela

    2010-01-01

    Personal health records (PHR) offer great promise in transforming the patient experience, but a number of support issues must be addressed to ensure that patients have appropriate access to their health information. Two hundred and fifty breast cancer patients registered to use a portal providing access to personal health information over a six-week period. All support calls were directed to a research triage centre and redirected either to technical, clinical or psychosocial support. Log files were coded and analyzed. Two hundred and thirty-nine support contacts were logged by 122 participants. The majority was referred to technical support; the remaining contacts were directed to clinical support. Seven categories of technical support were identified: registration problems, site access, login issues, password reset, activation key issues, result access and other difficulties. In accessing their test results, patients required support in a number of technical domains, but educational and psychosocial support were not heavily utilized.

  15. Aspartame, low-calorie sweeteners and disease: regulatory safety and epidemiological issues.

    PubMed

    Marinovich, Marina; Galli, Corrado L; Bosetti, Cristina; Gallus, Silvano; La Vecchia, Carlo

    2013-10-01

    Aspartame is a synthetic sweetener that has been used safely in food for more than 30 years. Its safety has been evaluated by various regulatory agencies in accordance with procedures internationally recognized, and decisions have been revised and updated regularly. The present review summarizes the most relevant conclusions of epidemiological studies concerning the use of low-calorie sweeteners (mainly aspartame), published between January 1990 and November 2012. In the Nurses' Health study and the Health Professionals Followup study some excess risk of Hodgkin lymphoma and multiple myeloma was found in men but not in women; no association was found with leukemia. In the NIH-AARP Diet and Health Study, there was no association between aspartame and haematopoietic neoplasms. US case-control studies of brain and haematopoietic neoplasms also showed no association. The NIH-AARP Diet and Health Study and case-control studies from California showed no association with pancreatic cancer, and a case-control study from Denmark found no relation with breast cancer risk. Italian case-control studies conducted in 1991-2008 reported no consistent association for cancers of the upper aerodigestive tract, digestive tract, breast, endometrium, ovary, prostate, and kidney. Low calorie sweeteners were not consistently related to vascular events and preterm deliveries.

  16. Translating PrEP effectiveness into public health impact: key considerations for decision-makers on cost-effectiveness, price, regulatory issues, distributive justice and advocacy for access

    PubMed Central

    Hankins, Catherine; Macklin, Ruth; Warren, Mitchell

    2015-01-01

    Introduction The extraordinary feat of proving the effectiveness of oral pre-exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision-makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation. Discussion In considering the role that PrEP can play in combination prevention programmes, decision-makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost-effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost-effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low- and middle-income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision-making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward. Conclusions The time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit

  17. Regulatory and logistical issues influencing access to antineoplastic and supportive care medications for children with cancer in developing countries.

    PubMed

    Wiernikowski, John T; MacLeod, Stuart

    2014-08-01

    Globally there are numerous impediments, both logistical, regulatory and more recently global drug shortages, hindering pediatric access to therapeutic drugs of all types. Efforts to reduce barriers are ongoing and are especially important in low and middle income countries and for children requiring treatment of conditions such as those encountered in pediatric oncology characterized by the risk of life threatening treatment failures. Progress has been made through the efforts of the World Health Organization and regulators in the US and Europe to encourage the development of therapeutic agents for use in pediatrics and measures taken have fostered the availability of stronger pediatric data to guide therapeutic decisions. Nonetheless, pharmaceuticals remain a global commodity, subject to regulation by the World Trade Organization and this has often had detrimental effects in low and middle income countries. This article emphasizes the need for closer international collaboration to address the barriers currently impeding access to antineoplastic and supportive care medicines for children.

  18. Addressing Work-Related Issues in Medical Rehabilitation: Revision of an Online Information Tool for Healthcare Professionals

    PubMed Central

    Wolf, Hans-Dieter; Gerlich, Christian; Vogel, Heiner; Neuderth, Silke

    2016-01-01

    Background. Medical rehabilitation increasingly considers occupational issues as determinants of health and work ability. Information on work-related rehabilitation concepts should therefore be made available to healthcare professionals. Objective. To revise a website providing healthcare professionals in medical rehabilitation facilities with information on work-related concepts in terms of updating existing information and including new topics, based on recommendations from implementation research. Method. The modification process included a questionnaire survey of medical rehabilitation centers (n = 28); two workshops with experts from rehabilitation centers, health payers, and research institutions (n = 14); the selection of new topics and revision of existing text modules based on expert consensus; and an update of good practice descriptions of work-related measures. Results. Health payers' requirements, workplace descriptions, and practical implementation aids were added as new topics. The database of good practice examples was extended to 63 descriptions. Information on introductory concepts was rewritten and supplemented by current data. Diagnostic tools were updated by including additional assessments. Conclusions. Recommendations from implementation research such as assessing user needs and including expert knowledge may serve as a useful starting point for the dissemination of information on work-related medical rehabilitation into practice. Web-based information tools such as the website presented here can be quickly adapted to current evidence and changes in medicolegal regulations.

  19. The causality between smoking and lung cancer among groups and individuals: addressing issues in tobacco litigation in South Korea.

    PubMed

    Khang, Young-Ho

    2015-01-01

    This article discusses issues on the causality between smoking and lung cancer, which have been raised during the tobacco litigation in South Korea. It should be recognized that the explanatory ability of risk factor(s) for inter-individual variations in disease occurrence is different from the causal contribution of the risk factor(s) to disease occurrence. The affected subjects of the tobacco litigation in South Korea are lung cancer patients with a history of cigarette smoking. Thus, the attributable fraction of the exposed rather than the population attributable fraction should be used in the tobacco litigation regarding the causal contribution of smoking to lung cancer. Scientific evidence for the causal relationship between smoking and lung cancer is based on studies of individuals and groups, studies in animals and humans, studies that are observational or experimental, studies in laboratories and communities, and studies in both underdeveloped and developed countries. The scientific evidence collected is applicable to both groups and individuals. The probability of causation, which is calculated based on the attributable fraction for the association between smoking and lung cancer, could be utilized as evidence to prove causality in individuals.

  20. Addressing Work-Related Issues in Medical Rehabilitation: Revision of an Online Information Tool for Healthcare Professionals

    PubMed Central

    Wolf, Hans-Dieter; Gerlich, Christian; Vogel, Heiner; Neuderth, Silke

    2016-01-01

    Background. Medical rehabilitation increasingly considers occupational issues as determinants of health and work ability. Information on work-related rehabilitation concepts should therefore be made available to healthcare professionals. Objective. To revise a website providing healthcare professionals in medical rehabilitation facilities with information on work-related concepts in terms of updating existing information and including new topics, based on recommendations from implementation research. Method. The modification process included a questionnaire survey of medical rehabilitation centers (n = 28); two workshops with experts from rehabilitation centers, health payers, and research institutions (n = 14); the selection of new topics and revision of existing text modules based on expert consensus; and an update of good practice descriptions of work-related measures. Results. Health payers' requirements, workplace descriptions, and practical implementation aids were added as new topics. The database of good practice examples was extended to 63 descriptions. Information on introductory concepts was rewritten and supplemented by current data. Diagnostic tools were updated by including additional assessments. Conclusions. Recommendations from implementation research such as assessing user needs and including expert knowledge may serve as a useful starting point for the dissemination of information on work-related medical rehabilitation into practice. Web-based information tools such as the website presented here can be quickly adapted to current evidence and changes in medicolegal regulations. PMID:27610246

  1. The causality between smoking and lung cancer among groups and individuals: addressing issues in tobacco litigation in South Korea

    PubMed Central

    Khang, Young-Ho

    2015-01-01

    This article discusses issues on the causality between smoking and lung cancer, which have been raised during the tobacco litigation in South Korea. It should be recognized that the explanatory ability of risk factor(s) for inter-individual variations in disease occurrence is different from the causal contribution of the risk factor(s) to disease occurrence. The affected subjects of the tobacco litigation in South Korea are lung cancer patients with a history of cigarette smoking. Thus, the attributable fraction of the exposed rather than the population attributable fraction should be used in the tobacco litigation regarding the causal contribution of smoking to lung cancer. Scientific evidence for the causal relationship between smoking and lung cancer is based on studies of individuals and groups, studies in animals and humans, studies that are observational or experimental, studies in laboratories and communities, and studies in both underdeveloped and developed countries. The scientific evidence collected is applicable to both groups and individuals. The probability of causation, which is calculated based on the attributable fraction for the association between smoking and lung cancer, could be utilized as evidence to prove causality in individuals. PMID:26137845

  2. Addressing the Amorphous Content Issue in Quantitative Phase Analysis: The Certification of NIST Standard Reference Material 676a

    SciTech Connect

    J Cline; R Von Dreele; R Winburn; P Stephens; J Filliben

    2011-12-31

    A non-diffracting surface layer exists at any boundary of a crystal and can comprise a mass fraction of several percent in a finely divided solid. This has led to the long-standing issue of amorphous content in standards for quantitative phase analysis (QPA). NIST standard reference material (SRM) 676a is a corundum ({alpha}-Al{sub 2}O{sub 3}) powder, certified with respect to phase purity for use as an internal standard in powder diffraction QPA. The amorphous content of SRM 676a is determined by comparing diffraction data from mixtures with samples of silicon powders that were engineered to vary their specific surface area. Under the (supported) assumption that the thickness of an amorphous surface layer on Si was invariant, this provided a method to control the crystalline/amorphous ratio of the silicon components of 50/50 weight mixtures of SRM 676a with silicon. Powder diffraction experiments utilizing neutron time-of-flight and 25 keV and 67 keV X-ray energies quantified the crystalline phase fractions from a series of specimens. Results from Rietveld analyses, which included a model for extinction effects in the silicon, of these data were extrapolated to the limit of zero amorphous content of the Si powder. The certified phase purity of SRM 676a is 99.02% {+-} 1.11% (95% confidence interval). This novel certification method permits quantification of amorphous content for any sample of interest, by spiking with SRM 676a.

  3. Addressing Work-Related Issues in Medical Rehabilitation: Revision of an Online Information Tool for Healthcare Professionals.

    PubMed

    Lukasczik, Matthias; Wolf, Hans-Dieter; Gerlich, Christian; Küffner, Roland; Vogel, Heiner; Neuderth, Silke

    2016-01-01

    Background. Medical rehabilitation increasingly considers occupational issues as determinants of health and work ability. Information on work-related rehabilitation concepts should therefore be made available to healthcare professionals. Objective. To revise a website providing healthcare professionals in medical rehabilitation facilities with information on work-related concepts in terms of updating existing information and including new topics, based on recommendations from implementation research. Method. The modification process included a questionnaire survey of medical rehabilitation centers (n = 28); two workshops with experts from rehabilitation centers, health payers, and research institutions (n = 14); the selection of new topics and revision of existing text modules based on expert consensus; and an update of good practice descriptions of work-related measures. Results. Health payers' requirements, workplace descriptions, and practical implementation aids were added as new topics. The database of good practice examples was extended to 63 descriptions. Information on introductory concepts was rewritten and supplemented by current data. Diagnostic tools were updated by including additional assessments. Conclusions. Recommendations from implementation research such as assessing user needs and including expert knowledge may serve as a useful starting point for the dissemination of information on work-related medical rehabilitation into practice. Web-based information tools such as the website presented here can be quickly adapted to current evidence and changes in medicolegal regulations. PMID:27610246

  4. Successful Drug Development Despite Adverse Preclinical Findings Part 1: Processes to Address Issues and Most Important Findings

    PubMed Central

    Kuroda, Junji; Plassmann, Stephanie; Prentice, David E.

    2010-01-01

    Unexpected adverse preclinical findings (APFs) are not infrequently encountered during drug development. Such APFs can be functional disturbances such as QT prolongation, morphological toxicity or carcinogenicity. The latter is of particular concern in conjunction with equivocal genotoxicity results. The toxicologic pathologist plays an important role in recognizing these effects, in helping to characterize them, to evaluate their risk for man, and in proposing measures to mitigate the risk particularly in early clinical trials. A careful scientific evaluation is crucial while termination of the development of a potentially useful drug must be avoided. This first part of the review discusses processes to address unexpected APFs and provides an overview over typical APFs in particular classes of drugs. If the mode of action (MoA) by which a drug candidate produces an APF is known, this supports evaluation of its relevance for humans. Tailor-made mechanistic studies, when needed, must be planned carefully to test one or several hypotheses regarding the potential MoA and to provide further data for risk evaluation. Safety considerations are based on exposure at no-observed-adverse-effect levels (NOAEL) of the most sensitive and relevant animal species and guide dose escalation in clinical trials. The availability of early markers of toxicity for monitoring of humans adds further safety to clinical studies. Risk evaluation is concluded by a weight of evidence analysis (WoE) with an array of parameters including drug use, medical need and alternatives on the market. In the second part of this review relevant examples of APFs will be discussed in more detail. PMID:22272031

  5. [Health issues and regulatory aspects of the use of ultrasound in physiotherapy].

    PubMed

    Giliberti, Claudia; Pozzi, Roberta; Calicchia, Paola; Polichetti, Alessandro

    2015-01-01

    The use of ultrasounds in medicine requires, like all physical agents potentially harmful to human health, an accurate assessment of the risks to the health of patients. The nature and extent of these risks depend on exposure levels which in turn are differentiated according to the specific diagnostic or therapeutic applications. Intermediate exposure levels are associated to physiotherapic applications. To analyze specific issues relating to the effectiveness and safety of physiotherapic treatments, a review of the scientific literature and technical standards was carried out. At present, the actual effectiveness of ultrasound physiotherapy is still far from being clearly assessed: further clinical and experimental studies are needed in order to optimize therapies, determining the benefits and risks of treatments and deepening the understanding of the action mechanisms of the physical agent, even on the basis of a better characterization of those physical quantities mostly significant for biological effects. The examination of technical standards defining the security requirements of the equipment allowed the identification of some critical issues; on these bases some proposals are suggested for the improvement of quality and safety of treatments.

  6. Regulatory Analysis for the resolution of Generic Issue 142: Leakage through electrical isolators in instrumentation circuits

    SciTech Connect

    Rourk, C.J.

    1993-09-01

    Generic Issue (GI) 142 deals with staff concerns about the design of isolation devices used to ensure separation between Class 1E and non-Class 1E electrical control and instrumentation circuits. This issue was initiated in June 1987. Staff reviews of the implementation of the Safety Parameter Display System (SPDS) requirement indicated that some isolation devices used to provide an interface between the non-Class 1E SPDS and the Class 1E safety systems would allow signal leakage if electrically challenged. It was unknown if the amount of leakage posed a hazard to safe operation of the Class 1E system. A review of failure records does not reveal any incidents of system damage caused by isolation device challenge. Furthermore, a review of existing PRA data indicates that the safety significance of ID challenge is low, at the expected challenge event frequency. However, based upon the potential design variations in future control systems resulting from application of computer technology, additional design and qualification test requirements for future plants are recommended.

  7. Regulatory Issues and Challenges in Developing Seismic Source Characterizations for New Nuclear Power Plant Applications in the US

    NASA Astrophysics Data System (ADS)

    Fuller, C. W.; Unruh, J.; Lindvall, S.; Lettis, W.

    2009-05-01

    further complicated by: (1) a given applicant's uncertainty in how to revise the EPRI-SOG model, which was developed using a process similar to that dictated by SSHAC for a level 3 or 4 study, without conducting a resource-intensive SSHAC level 3 or higher study for their respective application; and (2) a lack of guidance from the NRC on acceptable methods of demonstrating that new data, interpretations, and opinions are adequately represented within the EPRI-SOG model. Partly because of these issues, initiative was taken by the nuclear industry, NRC and DOE to develop a new base PSHA model for the central and eastern US. However, this new SSC model will not be completed for several years and does not resolve many of the fundamental regulatory and philosophical issues that have been raised during the current round of applications. To ensure regulatory stability and to provide accurate estimates of hazard for nuclear power plants, a dialog must be started between regulators and industry to resolve these issues. Two key issues that must be discussed are: (1) should new data and new interpretations or opinions of old data be treated differently in updated SSCs, and if so, how?; and (2) how can new data or interpretations developed by a small subset of the technical community be weighed against and potentially combined with a SSC model that was originally developed to capture the "center, body and range" of the technical community?

  8. Subsurface Contaminant Focus Area: Monitored Natural Attenuation (MNA)--Programmatic, Technical, and Regulatory Issues

    SciTech Connect

    Krupka, Kenneth M.; Martin, Wayne J.

    2001-07-23

    Natural attenuation processes are commonly used for remediation of contaminated sites. A variety of natural processes occur without human intervention at all sites to varying rates and degrees of effectiveness to attenuate (decrease) the mass, toxicity, mobility, volume, or concentration of organic and inorganic contaminants in soil, groundwater, and surface water systems. The objective of this review is to identify potential technical investments to be incorporated in the Subsurface Contaminant Focus Area Strategic Plan for monitored natural attenuation. When implemented, the technical investments will help evaluate and implement monitored natural attenuation as a remediation option at DOE sites. The outcome of this review is a set of conclusions and general recommendations regarding research needs, programmatic guidance, and stakeholder issues pertaining to monitored natural attenuation for the DOE complex.

  9. [International comparison and regulatory issues of the molecular targeted therapy development].

    PubMed

    Iwasaku, Masahiro; Kawakami, Koji

    2015-08-01

    In July 2013 from the Ministry of Health, Labour and Welfare of Japan notified "Approval application for in vitro companion diagnostics and corresponding therapeutic products" (manager notification). They recommended concurrent development of molecular targeted therapies and companion diagnostics. However, there are specific difficulties; cooperation between diagnostic company and pharmaceutical company, indeterminacy of profitability outlook etc. Moreover, it is also a problem how to supervise and to secure the quality and safety of the examination. In the future, multiplex diagnostic examination, which detect multiple molecular targets abnormalities at once, is developed commercially. In this paper, we outline the issues as well as international comparison in the current state of the approval and application system. PMID:26281697

  10. Real-time earthquake alert system for the greater San Francisco Bay Area: a prototype design to address operational issues

    SciTech Connect

    Harben, P.E.; Jarpe, S.; Hunter, S.

    1996-12-10

    The purpose of the earthquake alert system (EAS) is to outrun the seismic energy released in a large earthquake using a geographically distributed network of strong motion sensors that telemeter data to a rapid CPU-processing station, which then issues an area-wide warning to a region before strong motion will occur. The warning times involved are short, from 0 to 30 seconds or so; consequently, most responses must be automated. The San Francisco Bay Area is particularly well suited for an EAS because (1) large earthquakes have relatively shallow hypocenters (10- to 20-kilometer depth), giving favorable ray-path geometries for larger warning times than deeper from earthquakes, and (2) the active faults are few in number and well characterized, which means far fewer geographically distributed strong motion sensors are (about 50 in this region). An EAS prototype is being implemented in the San Francisco Bay Area. The system consists of four distinct subsystems: (1) a distributed strong motion seismic network, (2) a central processing station, (3) a warning communications system and (4) user receiver and response systems. We have designed a simple, reliable, and inexpensive strong motion monitoring station that consists of a three-component Analog Devices ADXLO5 accelerometer sensing unit, a vertical component weak motion sensor for system testing, a 16-bit digitizer with multiplexing, and communication output ports for RS232 modem or radio telemetry. The unit is battery-powered and will be sited in fire stations. The prototype central computer analysis system consists of a PC dam-acquisition platform that pipes the incoming strong motion data via Ethernet to Unix-based workstations for dam processing. Simple real-time algorithms, particularly for magnitude estimation, are implemented to give estimates of the time since the earthquake`s onset its hypocenter location, its magnitude, and the reliability of the estimate. These parameters are calculated and transmitted

  11. Addressing healthcare.

    PubMed

    Daly, Rich

    2013-02-11

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

  12. Mission impossible? Regulatory and enforcement issues to ensure safety of dietary supplements.

    PubMed

    Petroczi, A; Taylor, G; Naughton, D P

    2011-02-01

    Dietary supplements are widely used across all ages and user groups and constitute a considerable business sector in most developed countries. Hazards relating to concentration, composition, individual contaminants and supplement interactions present an increasing public health concern. The aim of this paper is to review the literature for reported supplement contaminations (occurs in ca 25% of supplements, with anabolic steroids being the most common) and complement these findings with notifications logged in the EU's Rapid Alert System for Food and Feed (RASFF) through imports or market surveillance, typically logged for poor quality control issues. Notifications in the RASFF have steadily increased by sixfold for supplements in the past 7 years with the USA and China being the major transgressors. Finland and Italy lead in detections, mainly notifying unpermitted substances and contaminants in sexual-enhancing or weight-loss supplements. This paper highlights the paucity of enforcement. Regulating supplements as a foodstuff and not a medicine, coupled with the fact that a significant proportion of the supplement market is distributed via the Internet (hence absent from routine border control and surveillance), make ensuring and enforcing safety a very challenging task. The need for better quality control, compliance and public awareness is evident.

  13. Biomonitoring in occupational health: Scientific, socio-ethical, and regulatory issues

    SciTech Connect

    Viau, Claude . E-mail: claude.viau@umontreal.ca

    2005-09-01

    Biomonitoring is one of the best available tools for the prevention of deleterious effects resulting from occupational exposure to chemicals. The availability of analytical techniques having low detection limits allows for the measurement of numerous biomarkers. Complemented with quality control programs, our ability to collect validated information on exposure to toxicants improves. This is important as exposure doses tend to decrease in workplaces. Concurrently, there is an increasing preoccupation towards skin exposure, which cannot currently be reliably assessed through external measurements. Furthermore, as lower exposure doses are encountered, background concentrations of some biomarkers become a serious limitation to their use. This prompts researchers to seek for minor, more specific metabolites, that may however be produced through metabolic pathways that are prone to larger inter-individual variations. Assessment of exposure to complex mixtures of chemicals is another major challenge. There is a growing interest towards ethical issues in biomonitoring. The understanding of the advantages and of the limits of this preventive approach may be very different among occupational health professionals, but more importantly, between health professionals and those they are seeking to protect, i.e., the workers themselves. Many organizations have proposed guideline values for biomarker concentrations, but these seldom find their way in the various countries' bylaws. One underlying reason might be the greater complexity of the scientific aspects of biomarkers, whose understanding is required to set limit values, compared to the process of setting airborne limit concentrations. But the fact that the latter does not consider all aspects of biological complexity does not make it more reliable.

  14. Addressing mental health disparities through clinical competence not just cultural competence: the need for assessment of sociocultural issues in the delivery of evidence-based psychosocial rehabilitation services.

    PubMed

    Yamada, Ann-Marie; Brekke, John S

    2008-12-01

    Recognition of ethnic/racial disparities in mental health services has not directly resulted in the development of culturally responsive psychosocial interventions. There remains a fundamental need for assessment of sociocultural issues that have been linked with the expectations, needs, and goals of culturally diverse consumers with severe and persistent mental illness. The authors posit that embedding the assessment of sociocultural issues into psychosocial rehabilitation practice is one step in designing culturally relevant empirically supported practices. It becomes a foundation on which practitioners can examine the relevance of their interventions to the diversity encountered in everyday practice. This paper provides an overview of the need for culturally and clinically relevant assessment practices and asserts that by improving the assessment of sociocultural issues the clinical competence of service providers is enhanced. The authors offer a conceptual framework for linking clinical assessment of sociocultural issues to consumer outcomes and introduce an assessment tool adapted to facilitate the process in psychosocial rehabilitation settings. Emphasizing competent clinical assessment skills will ultimately offer a strategy to address disparities in treatment outcomes for understudied populations of culturally diverse consumers with severe and persistent mental illness.

  15. Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid.

    PubMed

    Fitzpatrick, Kelley C

    2004-06-01

    The Canadian Food and Drugs Act and Regulations, through its definitions of food and drug, currently restricts health-related claims for foods, food ingredients, and natural health products (NHPs). Over the past few decades, scientific research has led to a large body of information that demonstrates the benefits for health of many food and NHP ingredients. Health Canada recognized the constraints of the current regulatory environment and started to develop regulations related to the allowance of health claims for functional foods and NHPs, including those foods and NHPs that would contain conjugated linoleic acid isomers. Health Canada has 3 initiatives under way in the area of health claims for foods: 1) to adopt the generic health claims of the United States within a Canadian context, 2) to develop scientific standards of evidence and a guidance document for supporting the validity of product-specific claims, and 3) to develop an overall regulatory framework for functional foods. In 2000, Health Canada announced approval for the use of 5 generic diet-related health claims: sodium and hypertension, calcium and osteoporosis, saturated and trans fat and cholesterol and coronary artery disease, fruits and vegetables and cancer, and sugar alcohols and dental caries. Under a separate initiative, Natural Health Products Regulations were published in the Canada Gazette Part II on June 18, 2003. The NHP Regulations came into force on January 1, 2004, with a transition period ranging from 2 y (for site licensing) to 6 y (for product licensing, for products already issued a drug identification number). PMID:15159260

  16. 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.

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

    PubMed

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

    2010-03-01

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

  18. Regulatory analysis for the resolution of Generic Issue 143: Availability of chilled water system and room cooling

    SciTech Connect

    Leung, V.T.

    1993-12-01

    This report presents the regulatory analysis for Generic Issue (GI-143), {open_quotes}Availability of Chilled Water System and Room Cooling.{close_quotes} The heating, ventilating, and air conditioning (HVAC) systems and related auxiliaries are required to provide control of environmental conditions in areas in light water reactor (LWR) plants that contain safety-related equipment. In some plants, the HVAC and chilled water systems serve to maintain a suitable environment for both safety and non-safety-related areas. Although some plants have an independent chilled water system for the safety-related areas, the heat removal capability often depends on the operability of other supporting systems such as the service water system or the component cooling water system. The operability of safety-related components depends upon operation of the HVAC and chilled water systems to remove heat from areas containing the equipment. If cooling to dissipate the heat generated is unavailable, the ability of the safety-related equipment to operate as intended cannot be assured. Typical components or areas in the nuclear power plant that could be affected by the failure of cooling from HVAC or chilled water systems include the (1) emergency switchgear and battery rooms, (2) emergency diesel generator room, (3) pump rooms for residual heat removal, reactor core isolation cooling, high-pressure core spray, and low-pressure core spray, and (4) control room. The unavailability of such safety-related equipment or areas could cause the core damage frequency (CDF) to increase significantly.

  19. 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.

  20. 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.

  1. Enhancing capacities of riparian professionals to address and resolve transboundary issues in international river basins: experiences from the Lower Mekong River Basin

    NASA Astrophysics Data System (ADS)

    Douven, W.; Mul, M. L.; Álvarez, B. F.; Son, L. H.; Bakker, N.; Radosevich, G.; van der Zaag, P.

    2012-03-01

    This paper analyses the design and impact of capacity building programmes aimed at enhancing capacities of riparian professionals to address and resolve transboundary issues in international river basins. Case study is a programme developed by the Mekong River Commission (MRC). A post training evaluation was applied to assess its impact in terms of individual capacity enhancement and change (use and application of knowledge, factors hampering application, and change in function and opportunities within their organisation). The design of the Capacity Building Programme of the MRC Flood Management and Mitigation Programme showed a well balanced range of subjects (such as IWRM, models and decision support systems and international water law) which are required for such an integrated topic. The post training evaluation, 6 months after the last training workshop, showed the increase in familiarity of the topics for all 37 respondents, with highest increase for the respondents with few years of working experience and from training and educational institutions. The relevance of the subjects taught is shown by the fact that 95% of the respondents indicated they saw the relevance of the subjects and 78% had already used some knowledge acquired in their job. The respondents also indicated that they did not have sufficient opportunities to apply all knowledge acquired. The phased implementation and training of lecturers during the training workshops, had a good impact, directly through increasing involvement in facilitation and delivery of the capacity building programme and through the use of the knowledge gained in short courses and development of curricula at their training institute. For these types of capacity building programmes, a few recommendations can be made. The selection of participants is crucial for the application of the learned knowledge in their work. The integrative nature of transboundary water issues calls for a capacity building programme addressing a

  2. 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.

  3. Multiaxial Creep-Fatigue and Creep-Ratcheting Failures of Grade 91 and Haynes 230 Alloys Toward Addressing Design Issues of Gen IV Nuclear Power Plants

    SciTech Connect

    Hassan, Tasnim; Lissenden, Cliff; Carroll, Laura

    2015-04-01

    The proposed research will develop systematic sets of uniaxial and multiaxial experimental data at a very high temperature (850-950°C) for Alloy 617. The loading histories to be prescribed in the experiments will induce creep-fatigue and creep-ratcheting failure mechanisms. These experimental responses will be scrutinized in order to quantify the influences of temperature and creep on fatigue and ratcheting failures. A unified constitutive model (UCM) will be developed and validated against these experimental responses. The improved UCM will be incorporated into the widely used finite element commercial software packages ANSYS. The modified ANSYS will be validated so that it can be used for evaluating the very high temperature ASME-NH design-by-analysis methodology for Alloy 617 and thereby addressing the ASME-NH design code issues.

  4. Canada's Compassionate Care Benefit: Is it an adequate public health response to addressing the issue of caregiver burden in end-of-life care?

    PubMed Central

    2011-01-01

    Background An increasingly significant public health issue in Canada, and elsewhere throughout the developed world, pertains to the provision of adequate palliative/end-of-life (P/EOL) care. Informal caregivers who take on the responsibility of providing P/EOL care often experience negative physical, mental, emotional, social and economic consequences. In this article, we specifically examine how Canada's Compassionate Care Benefit (CCB) - a contributory benefits social program aimed at informal P/EOL caregivers - operates as a public health response in sustaining informal caregivers providing P/EOL care, and whether or not it adequately addresses known aspects of caregiver burden that are addressed within the population health promotion (PHP) model. Methods As part of a national evaluation of Canada's Compassionate Care Benefit, 57 telephone interviews were conducted with Canadian informal P/EOL caregivers in 5 different provinces, pertaining to the strengths and weaknesses of the CCB and the general caregiving experience. Interview data was coded with Nvivo software and emerging themes were identified by the research team, with such findings published elsewhere. The purpose of the present analysis was identified after comparing the findings to the literature specific to caregiver burden and public health, after which data was analyzed using the PHP model as a guiding framework. Results Informal caregivers spoke to several of the determinants of health outlined in the PHP model that are implicated in their burden experience: gender, income and social status, working conditions, health and social services, social support network, and personal health practises and coping strategies. They recognized the need for improving the CCB to better address these determinants. Conclusions This study, from the perspective of family caregivers, demonstrates that the CCB is not living up to its full potential in sustaining informal P/EOL caregivers. Effort is required to

  5. Mediation: Sanity in the regulatory process

    SciTech Connect

    Cohen, D.S.

    1993-01-15

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

  6. How agro-ecological research helps to address food security issues under new IPM and pesticide reduction policies for global crop production systems.

    PubMed

    E Birch, A Nicholas; Begg, Graham S; Squire, Geoffrey R

    2011-06-01

    Drivers behind food security and crop protection issues are discussed in relation to food losses caused by pests. Pests globally consume food estimated to feed an additional one billion people. Key drivers include rapid human population increase, climate change, loss of beneficial on-farm biodiversity, reduction in per capita cropped land, water shortages, and EU pesticide withdrawals under policies relating to 91/414 EEC. IPM (Integrated Pest Management) will be compulsory for all EU agriculture by 2014 and is also being widely adopted globally. IPM offers a 'toolbox' of complementary crop- and region-specific crop protection solutions to address these rising pressures. IPM aims for more sustainable solutions by using complementary technologies. The applied research challenge now is to reduce selection pressure on single solution strategies, by creating additive/synergistic interactions between IPM components. IPM is compatible with organic, conventional, and GM cropping systems and is flexible, allowing regional fine-tuning. It reduces pests below economic thresholds utilizing key 'ecological services', particularly biocontrol. A recent global review demonstrates that IPM can reduce pesticide use and increase yields of most of the major crops studied. Landscape scale 'ecological engineering', together with genetic improvement of new crop varieties, will enhance the durability of pest-resistant cultivars (conventional and GM). IPM will also promote compatibility with semiochemicals, biopesticides, precision pest monitoring tools, and rapid diagnostics. These combined strategies are urgently needed and are best achieved via multi-disciplinary research, including complex spatio-temporal modelling at farm and landscape scales. Integrative and synergistic use of existing and new IPM technologies will help meet future food production needs more sustainably in developed and developing countries, in an era of reduced pesticide availability. Current IPM research gaps are

  7. Toward improving hurricane forecasts using the JPL Tropical Cyclone Information System (TCIS): A framework to address the issues of Big Data

    NASA Astrophysics Data System (ADS)

    Hristova-Veleva, S. M.; Boothe, M.; Gopalakrishnan, S.; Haddad, Z. S.; Knosp, B.; Lambrigtsen, B.; Li, P.; montgomery, M. T.; Niamsuwan, N.; Tallapragada, V. S.; Tanelli, S.; Turk, J.; Vukicevic, T.

    2013-12-01

    Accurate forecasting of extreme weather requires the use of both regional models as well as global General Circulation Models (GCMs). The regional models have higher resolution and more accurate physics - two critical components needed for properly representing the key convective processes. GCMs, on the other hand, have better depiction of the large-scale environment and, thus, are necessary for properly capturing the important scale interactions. But how to evaluate the models, understand their shortcomings and improve them? Satellite observations can provide invaluable information. And this is where the issues of Big Data come: satellite observations are very complex and have large variety while model forecast are very voluminous. We are developing a system - TCIS - that addresses the issues of model evaluation and process understanding with the goal of improving the accuracy of hurricane forecasts. This NASA/ESTO/AIST-funded project aims at bringing satellite/airborne observations and model forecasts into a common system and developing on-line tools for joint analysis. To properly evaluate the models we go beyond the comparison of the geophysical fields. We input the model fields into instrument simulators (NEOS3, CRTM, etc.) and compute synthetic observations for a more direct comparison to the observed parameters. In this presentation we will start by describing the scientific questions. We will then outline our current framework to provide fusion of models and observations. Next, we will illustrate how the system can be used to evaluate several models (HWRF, GFS, ECMWF) by applying a couple of our analysis tools to several hurricanes observed during the 2013 season. Finally, we will outline our future plans. Our goal is to go beyond the image comparison and point-by-point statistics, by focusing instead on understanding multi-parameter correlations and providing robust statistics. By developing on-line analysis tools, our framework will allow for consistent

  8. Regulatory and Technical Issues Concerning the Detection and Treatment of NDMA-Contaminated Groundwater at NASA WSTF

    NASA Technical Reports Server (NTRS)

    Wiebe, D. T.; Zigmond, M. J.; Tufts, C. A.

    2002-01-01

    The National Aeronautics and Space Administration (NASA) White Sands Test Facility (WSTF) was established in 1963 primarily to provide rocket engine testing services for several NASA programs. The groundwater underlying the site has been contaminated as a result of historical operations. Groundwater contaminants include several volatile organic compounds (VOCs) and two semi-volatile compounds: N-nitrosodimethylamine (NDMA) and N-nitrodimethylamine (DMN). This paper discusses some of the technical, analytical, regulatory, and health risk issues associated with the contaminant plume. The plume has moved approximately 2.5 miles downgradient of the facility industrial boundary, with evidence of continued migration. As a result, NASA has proposed a pump and treat system using air strippers and ultraviolet (UV) oxidation to stabilize future movement of the contaminant plume. The system has been designed to treat 1,076 gallons (4,073 liters) per minute, with provisions for future expansion. The UV oxidation process was selected to treat NDMA-contaminated groundwater based on successes at other NDMA-contaminated sites. Bench- and pilot-scale testing of WSTF groundwater confirmed the ability of UV oxidation to destroy NDMA and generated sufficient data to design the proposed full-scale treatment system. NDMA is acutely toxic and is a probable human carcinogen. EPA-recommended health risk criteria for the residential consumption of NDMA/DMN-contaminated groundwater was used to determine that a 1.0 x 10(exp -6) excess cancer risk corresponds to 1.7 parts per trillion (ppt). EPA analytical methods are unable to detect NDMA and DMN in the low ppt range. EPA's current Appendix IX analytical method used to screen for NDMA, Method 8270, can detect NDMA only at levels that are orders of magnitude greater than the recommended health risk level. Additionally, EPA Method 607, the most sensitive EPA approved method, has a detection limit of 150 ppt. This corresponds to an excess cancer

  9. Proceedings of the tenth annual DOE low-level waste management conference: Session 1: Institutional and regulatory issues

    SciTech Connect

    Not Available

    1988-12-01

    This document contains eleven papers on various aspects of low-level radioactive waste regulation. Topics include: EPA environmental standards; international exemption principles; the concept of below regulatory concern; envirocare activities in Utah; mixed waste; FUSRAP and the Superfund; and a review of various incentive programs. Individual papers are processed separately for the data base. (TEM)

  10. 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

  11. 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

  12. Convocation address.

    PubMed

    Ghatowar, P S

    1993-07-01

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

  13. 12 CFR 562.2 - Regulatory reports.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  14. Challenging the One-Way Paradigm for More Effective Science Communication: A Critical Review of Two Public Campaigns Addressing Contentious Environmental Issues

    ERIC Educational Resources Information Center

    McEntee, Marie; Mortimer, Claire

    2013-01-01

    This article examines two large-scale public communication campaigns to explore the appropriateness and effectiveness of using one-way communication in contentious environmental issues. The findings show while one-way communication can be successfully employed in contentious issues, it is not appropriate for all contexts and may contribute to…

  15. Pharmacogenetics: ethical issues and policy options.

    PubMed

    Buchanan, Allen; Califano, Andrea; Kahn, Jeffrey; McPherson, Elizabeth; Robertson, John; Brody, Baruch

    2002-03-01

    Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) clinicians' changing responsibilities in the era of pharmacogenetic medicine. We analyze each of these categories of ethical issues and provide policy approaches for addressing them.

  16. Recommended Changes to the No Child Left Behind Act to Address Workforce Issues. Submitted to the House Subcommittee on Higher Education, Lifelong Learning, and Competitiveness of the Committee on Education and Labor

    ERIC Educational Resources Information Center

    Harris, Linda; Tsoi-A-Fatt, Rhonda

    2007-01-01

    This paper presents Center for Law and Social Policy's (CLASP's) recommendations on how No Child Left Behind (NCLB) could better address the workforce challenges faced by this country. CLASP is a nonprofit organization engaged in research, analysis, technical assistance, and advocacy on a range of issues affecting low-income families. The…

  17. Religious Congregations' Collaborations: With Whom Do They Work and What Resources Do They Share in Addressing HIV and Other Health Issues?

    ERIC Educational Resources Information Center

    Werber, Laura; Derose, Kathryn Pitkin; Dominguez, Blanca X.; Mata, Michael A.

    2012-01-01

    This study explores how religious congregations interact with other community organizations to address health and, in particular, HIV-related needs within their membership and/or local communities. Case study data from a diverse sample of 14 urban congregations (6 Black, 4 Latino, 2 White, and 2 mixed race-ethnicity) indicate that they engaged in…

  18. The Design and Evaluation of a Teaching-Learning Sequence Addressing the Solubility Concept with Turkish Secondary School Students. Special Issue

    ERIC Educational Resources Information Center

    Kabapinar, Filiz; Leach, John; Scott, Phil

    2004-01-01

    This paper reports upon a study addressing teaching and learning about solubility to Turkish first-year secondary school students (age 14-15). The principal aim of the research was to investigate the impact on students' understanding of solubility, of introducing a simple particle model of matter. A teaching intervention to fit within the existing…

  19. Addressing Racism

    ERIC Educational Resources Information Center

    Journal for Research in Mathematics Education, 2013

    2013-01-01

    This dialogue, extracted from a conversation among some members of the Equity Special Issue Editorial Panel, concerns racism in mathematics education. It raises issues about the use of various terms; about fields of research outside of mathematics education; and about the kinds of racialization processes that occur for students, teachers, and…

  20. Results of a multi-year study aimed at the resolution of regulatory issues related to the storage and transportation of high-burnup spent fuel

    SciTech Connect

    Rashid, Joseph; Machiels, Albert

    2007-07-01

    Available in abstract form only. Full text of publication follows: Finding timely resolutions of current regulatory issues related to spent fuel storage and transportation is one of the most important priorities for both industry and regulators. Spent fuel pools at many US power plants have either reached or are rapidly approaching full capacity, a condition made worse by the longer cooling time required for high burnup (>45 GWd/MTU) spent fuel compared to lower burnup fuel for which most spent fuel pools were designed to accommodate. Consequently, the need for the transfer of spent fuel to dry storage, with eventual transportation to off-site interim storage facilities or to a permanent repository, has brought with it the need to cope with a number of regulatory issues that require significant lead time to resolve. In anticipation of this need, EPRI has, over the past several years, implemented a number of research programs, which include: (a) assessing the criticality risks during transportation; (b) evaluating the option of moderator exclusion; (c) participating in data gathering for implementation of full burnup credit; (d) evaluating the potential for fuel reconfiguration during transportation accidents; and (e) assessing the impact of fuel reconfiguration on spent fuel reactivity levels. The criteria by which the results of this program may be evaluated are the regulations contained in 10 CFR Parts 71 and 72 as well as in Standard Review Plans and Interim Staff Guidance (ISG) documents such as ISG-11, ISG-8 and ISG-19. Of these research programs, the fuel reconfiguration issue is the most complex because it requires long lead-time to develop the necessary material behavior models and analysis methods. To this end, the paper describes the results of EPRI's multi-year research program, with emphasis on the various phenomena that govern cladding thermo-mechanical behavior from the onset of placing spent fuel in dry storage casks to the consequences of

  1. Project 10 Handbook: Addressing Lesbian and Gay Issues in Our Schools. A Resource Directory for Teachers, Guidance Counselors, Parents and School-Based Adolescent Care Providers. Third Edition.

    ERIC Educational Resources Information Center

    Friends of Project 10, Inc.

    This handbook was developed by Project 10, an on-campus counseling program within the Los Angeles (California) Unified School District. The handbook covers many of the issues and problems that arise for homosexual high school students. Introductory material includes a history of the informal beginnings of Project 10. The first chapter describes…

  2. Looking beyond first-world problems: an emerging global workplace is encouraging more biomedical engineers to address the health issues of the developing world.

    PubMed

    Tucker, Lindsay

    2014-01-01

    Each year, the developed world is flooded with complex new medical technologies, from robotic prosthetics to remote-controlled aspirin implants. Meanwhile, only about 10% of health research funds are spent addressing the pressing problems of developing nations, although these countries make up 93% of the worldwide burden of disease. In short, while a small fraction of the world pops brand-name pharmaceuticals, the majority suffers from poor sanitation, contaminated drinking water, preventable disease, and child mortality.

  3. Addressing Concerns.

    ERIC Educational Resources Information Center

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

    2002-01-01

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

  4. 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.

  5. Academic Institutions and One Health: Building Capacity for Transdisciplinary Research Approaches to Address Complex Health Issues at the Animal-Human-Ecosystem Interface.

    PubMed

    Allen-Scott, Lisa K; Buntain, Bonnie; Hatfield, Jennifer M; Meisser, Andrea; Thomas, Christopher James

    2015-07-01

    To improve health at the human, animal, and ecosystem interface, defined as One Health, training of researchers must transcend individual disciplines to develop a new process of collaboration. The transdisciplinary research approach integrates frameworks and methodologies beyond academic disciplines and includes involvement of and input from policy makers and members of the community. The authors argue that there should be a significant shift in academic institutions' research capacity to achieve the added value of a transdisciplinary approach for addressing One Health problems. This Perspective is a call to action for academic institutions to provide the foundations for this salient shift. The authors begin by describing the transdisciplinary approach, propose methods for building transdisciplinary research capacity, and highlight three value propositions that support the case. Examples are provided to illustrate how the transdisciplinary approach to research adds value through improved sustainability of impact, increased cost-effectiveness, and enhanced abilities to mitigate potentially harmful unintended consequences. The authors conclude with three key recommendations for academic institutions: (1) a focus on creating enabling environments for One Health and transdisciplinary research, (2) the development of novel funding structures for transdisciplinary research, and (3) training of "transmitters" using real-world-oriented educational programs that break down research silos through collaboration across disciplines.

  6. Religious congregations' collaborations: with whom do they work and what resources do they share in addressing HIV and other health issues?

    PubMed

    Werber, Laura; Derose, Kathryn Pitkin; Domínguez, Blanca X; Mata, Michael A

    2012-12-01

    This study explores how religious congregations interact with other community organizations to address health and, in particular, HIV-related needs within their membership and/or local communities. Case study data from a diverse sample of 14 urban congregations (6 Black, 4 Latino, 2 White, and 2 mixed race-ethnicity) indicate that they engaged in three types of relationships to conduct HIV and other health-related activities: (a) resources flowed to congregations from external entities, (b) resources flowed from congregations to external entities, and (c) congregations interacted with external entities. These types of relationships were present in roughly equal proportions; thus, congregations were not primarily the recipients of resources from other organizations in these interactions. Financial, material, and human capital resources were shared across these three relationship types, and the most common organization types that congregations were involved with for health efforts were prevention and social service organizations, health care providers, and other congregations. In addition, congregations tended to have more collaborative relationships with other faith-based organizations (FBOs) and tended to engage with non-FBOs more to either receive or provide resources. Results suggest that congregations contribute to community health by not only sponsoring health activities for their own members but also by providing specific support or resources to enhance the programming of other community organizations and collaborating with external organizations to sponsor congregation-based and community-based health activities.

  7. Academic Institutions and One Health: Building Capacity for Transdisciplinary Research Approaches to Address Complex Health Issues at the Animal–Human–Ecosystem Interface

    PubMed Central

    Allen-Scott, Lisa K.; Buntain, Bonnie; Hatfield, Jennifer M.; Meisser, Andrea

    2015-01-01

    To improve health at the human, animal, and ecosystem interface, defined as One Health, training of researchers must transcend individual disciplines to develop a new process of collaboration. The transdisciplinary research approach integrates frameworks and methodologies beyond academic disciplines and includes involvement of and input from policy makers and members of the community. The authors argue that there should be a significant shift in academic institutions’ research capacity to achieve the added value of a transdisciplinary approach for addressing One Health problems. This Perspective is a call to action for academic institutions to provide the foundations for this salient shift. The authors begin by describing the transdisciplinary approach, propose methods for building transdisciplinary research capacity, and highlight three value propositions that support the case. Examples are provided to illustrate how the transdisciplinary approach to research adds value through improved sustainability of impact, increased cost-effectiveness, and enhanced abilities to mitigate potentially harmful unintended consequences. The authors conclude with three key recommendations for academic institutions: (1) a focus on creating enabling environments for One Health and transdisciplinary research, (2) the development of novel funding structures for transdisciplinary research, and (3) training of “transmitters” using real-world-oriented educational programs that break down research silos through collaboration across disciplines. PMID:25650827

  8. Advanced alarm systems: Display and processing issues

    SciTech Connect

    O`Hara, J.M.; Wachtel, J.; Perensky, J.

    1995-05-01

    This paper describes a research program sponsored by the US Nuclear Regulatory Commission to address the human factors engineering (HFE) deficiencies associated with nuclear power plant alarm systems. The overall objective of the study is to develop HFE review guidance for alarm systems. In support of this objective, human performance issues needing additional research were identified. Among the important issues were alarm processing strategies and alarm display techniques. This paper will discuss these issues and briefly describe our current research plan to address them.

  9. Chemical Issues Addressing the Construction of the Distal Ni[Cysteine-Glycine-Cysteine]2- Site of Acetyl CoA Synthase: Why Not Copper?

    PubMed Central

    Green, Kayla. N.; Brothers, Scott M.; Lee, Boram; Darensbourg, Marcetta. Y.; Rockcliffe, David. A.

    2009-01-01

    The discovery of the Ni(Cysteine-Glycine-Cysteine)2-, Ni(CGC)2-, in the A-cluster active site of Acetyl CoA Synthase has prompted the synthesis of many small molecule models which employ M(N2S2) complexes as metalloligands. In vitro studies have shown that nickel incorporates into the N2S2 binding pocket even when copper is in the enzyme growth medium, while copper is preferentially taken up in the proximal site, displacing the catalytically active nickel. (Darnault, C.; Volbeda, A.; Kim, E.J.; Legrand, P.; Vernede, X.; Lindahl, P.A.; Fontecilla-Camps, J.C. Nat. Struct. Biol. 2003, 10, 271-279.) The work herein has been designed to address the chemical viability of copper(II) within the tripeptide N2S2 ligand set. To this end, a series of CuN2S2 2- complexes, the resin-bound, O-Cu(CGC)2- (A) and free Cu(CGC)2- (B) complexes, as well as Cu(ema)2- (C) and Cu(emi)2- (D) dianions, have been characterized by UV-vis, EPR, and ESI-MS spectroscopies, cyclic voltammetry (CV), and, where appropriate, x-ray diffraction studies, and compared to the NiII congeners. EPR spectroscopic results have indicated that, in frozen DMF solution, the copper complexes are distorted square planar structures with nitrogen and sulfur donors. This is consistent with X-ray diffraction measurements which also show copper(II) in a distorted square planar environment that is bereft of CuN2S2 2- intermolecular interactions. DFT calculations resulted in optimized structures that are consistent with crystallographic data and indicated HOMO-SOMO gaps of 5.01 eV and 4.68 eV for C and D as respectively. Optimized structures of Ni(ema)2- and Ni(emi)2- share the same basic characteristics as for the copper(II) congeners. Electrochemical characterization of C and D resulted in a reversible CuIII/II couple at -1.20 V and - 1.40 V, respectively. Reactivity studies with Rh(CO)2+ show similar donor capabilities for complexes A-D. Analysis of A shows that transmetallation does not occur. From competitive metal

  10. Addressing Global Change Issues Using Atmospheric Chemistry Observations from Space: Providing Measurements for the Recovery of the Ozone Layer, Climate, and Pollution

    NASA Astrophysics Data System (ADS)

    Fishman, J.

    2008-05-01

    As we enter the second decade of the 21st century, there is a trilogy of major issues around which satellite observations of trace gases and aerosols can be classified. The first large-scale problem focuses on the recovery of the stratospheric ozone layer, where satellites have a multi-decadal heritage of making important contributions to understanding the chemistry and dynamics of stratospheric ozone. The second aspect of this trilogy is the long-term build up of tropospheric trace gases and aerosols that affect climate, where relevant measurements include methane and the precursors to tropospheric ozone formation, nitrogen dioxide and carbon monoxide. Satellite observations during the past decade have provided new insight into both trends and interannual variability of key tropospheric trace gases. However, the last and the most challenging aspect of this trilogy deals with the capability to use space observations to observe and hopefully help mitigate the detrimental aspects of air pollution that result in widespread harm to human health and other biological systems. The recently released "Decadal Survey" by the U.S. National Research Council (NRC) concurs with this philosophy and strongly encourages the use of satellite measurements for societal benefits. The NRC emphasized that if Earth scientists are to foster applications and extend the societal benefits of their work, they must also understand that satellite measurements need to be transformed into useful information that is understandable and meets the needs of being a tool for those who make decisions regarding air quality and policy-makers as well as for scientists, the traditional users of such measurements. Specifically, with respect to future atmospheric chemistry missions, the NRC (2007) recommended that a mission dedicated to the measurement of tropospheric trace gases from a geostationary satellite should be launched in the 2013-2016 timeframe (GEO-CAPE, Geostationary Coastal and Air Pollution

  11. Inaugural address

    NASA Astrophysics Data System (ADS)

    Joshi, P. S.

    2014-03-01

    From jets to cosmos to cosmic censorship P S Joshi Tata Institute of Fundamental Research, Homi Bhabha Road, Colaba, Mumbai 400005, India E-mail: psj@tifr.res.in 1. Introduction At the outset, I should like to acknowledge that part of the title above, which tries to capture the main flavour of this meeting, and has been borrowed from one of the plenary talks at the conference. When we set out to make the programme for the conference, we thought of beginning with observations on the Universe, but then we certainly wanted to go further and address deeper questions, which were at the very foundations of our inquiry, and understanding on the nature and structure of the Universe. I believe, we succeeded to a good extent, and it is all here for you in the form of these Conference Proceedings, which have been aptly titled as 'Vishwa Mimansa', which could be possibly translated as 'Analysis of the Universe'! It is my great pleasure and privilege to welcome you all to the ICGC-2011 meeting at Goa. The International Conference on Gravitation and Cosmology (ICGC) series of meetings are being organized by the Indian Association for General Relativity and Gravitation (IAGRG), and the first such meeting was planned and conducted in Goa in 1987, with subsequent meetings taking place at a duration of about four years at various locations in India. So, it was thought appropriate to return to Goa to celebrate the 25 years of the ICGC meetings. The recollections from that first meeting have been recorded elsewhere here in these Proceedings. The research and teaching on gravitation and cosmology was initiated quite early in India, by V V Narlikar at the Banares Hindu University, and by N R Sen in Kolkata in the 1930s. In course of time, this activity grew and gained momentum, and in early 1969, at the felicitation held for the 60 years of V V Narlikar at a conference in Ahmedabad, P C Vaidya proposed the formation of the IAGRG society, with V V Narlikar being the first President. This

  12. Regulatory aspects on nanomedicines.

    PubMed

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

    2015-12-18

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

  13. Convocation address.

    PubMed

    Gore, M S

    1997-07-01

    In India, data from the decennial censuses have been the catalyst that has led researchers to identify social policy needs and craft programs to lower overall mortality rates, infant mortality rates, and fertility rates. A new demographic phenomenon that is being exposed by the data is the increase in life expectancy that will see large numbers of individuals surviving 15-20 years beyond age 60. This increased life expectancy will lead to an increased old age dependency ratio and will require reexamination of the issue of resources to meet the needs of the elderly. These needs are social and psychological as well as physical. Research is needed to predict the initial consequences of population aging within different states. International comparisons within the Asian region will also foster identification of effective policies. Research is also needed to identify whether longevity is tied to higher educational and socioeconomic status in order to improve life expectancy among low-income groups. Another aspect that requires consideration is that most elderly women will likely survive their husbands. This means that they will be available to care for their husbands but will have to depend upon their children to care for them. The possible demographic diversity in the experience of aging among various states and classes and between the genders may be of special interest to researchers. PMID:12293130

  14. 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

  15. Recycling of radioactively contaminated materials: Public policy issues

    SciTech Connect

    Hocking, E.K.

    1994-07-01

    Recycling radioactively contaminated materials requires varying degrees of interaction among Federal regulatory agencies such as the Nuclear Regulatory Commission (NRC) and the Environmental Protection Agency (EPA), State governments and regulators, the public, and the Department of Energy. The actions of any of these parties can elicit reactions from the other parties and will raise issues that must be addressed in order to achieve a coherent policy on recycling. The paper discusses potential actions and reactions of Federal regulatory agencies (defined as NRC and EPA), the States, and the Department and the policy issues they raise.

  16. Space Station Engineering Design Issues

    NASA Technical Reports Server (NTRS)

    Mcruer, Duane T.; Boehm, Barry W.; Debra, Daniel B.; Green, C. Cordell; Henry, Richard C.; Maycock, Paul D.; Mcelroy, John H.; Pierce, Chester M.; Stafford, Thomas P.; Young, Laurence R.

    1989-01-01

    Space Station Freedom topics addressed include: general design issues; issues related to utilization and operations; issues related to systems requirements and design; and management issues relevant to design.

  17. 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

  18. Addressing Cyberbullying as a Media Literacy Issue

    ERIC Educational Resources Information Center

    Bhat, Christine Suniti; Chang, Shih-Hua; Linscott, Jamie A.

    2010-01-01

    Background: The Asian region accounts for the highest number of internet and mobile cell phones consumers among the regions of the world. As the use of information and communications technology becomes more and more widespread, the misuse of such technology becomes a concern. Cyberbullying, or bullying using information and communications…

  19. Team Packs: Addressing Human Sexuality Issues.

    ERIC Educational Resources Information Center

    Florida Univ., Gainesville. Inst. for Child Health Policy.

    This kit provides materials that teach about Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), sexually transmitted diseases (STDs), and pregnancy using group instructional methodology to actively engage students in the learning process. Using cooperative learning materials and videotape recordings, the program stresses…

  20. Addressing hypertext design and conversion issues

    NASA Technical Reports Server (NTRS)

    Glusko, Robert J.

    1990-01-01

    Hypertext is a network of information units connected by relational links. A hypertext system is a configuration of hardware and software that presents a hypertext to users and allows them to manage and access the information that it contains. Hypertext is also a user interface concept that closely supports the ways that people use printed information. Hypertext concepts encourage modularity and the elimination of redundancy in data bases because information can be stored only once but viewed in any appropriate context. Hypertext is such a hot idea because it is an enabling technology in that workstations and personal computers finally provide enough local processing power for hypertext user interfaces.

  1. Scientific Issues Addressed by the Kepler Mission

    NASA Technical Reports Server (NTRS)

    Bourcki, W. J.; Koch, D. G.; Lissauer, J. J.; Jenkins, J. M.; DeVincenzi, Donald L. (Technical Monitor)

    1998-01-01

    The Kepler Mission uses a wide field-of-view telescope to photometrically monitor 100,000 main-sequence stars for evidence of planetary transits. Because of the large number of stars monitored and because the mission is designed with a precision (0.002%) sufficient to readily recognize Earth-size planets transiting solar-like stars, several hundred Earth-size planets should be found. Based on the the Dopper velocity observations that find 2% of the main-sequence stars have Jupiter-size planets in short-period orbits, the Kepler mission is also expected to detect about 2000 giant planets. Several questions about the association of planet types and stellar characteristics can be investigated. For example; Are small planets found when Jupiter-mass planets are also present in inner orbits? What is the frequency of small planets compared to Jupiter-mass planets? What is the frequency and distribution of planets intermediate in size and mass to that of Earth and Jupiter? What correlations exist between planet size, distribution, and frequency with the characteristics of the stars they orbit? A comparison between model predictions and observation should be a useful step in evolving better models of planetary system formation and help put the formation of our Solar System in perspective.

  2. Addressing endotoxin issues in bioengineered heparin.

    PubMed

    Suwan, Jiraporn; Torelli, Amanda; Onishi, Akihiro; Dordick, Jonathan S; Linhardt, Robert J

    2012-01-01

    Heparin is a widely used clinical anticoagulant that is prepared from pig intestine. A contamination of heparin in 2008 has led to a reexamination of animal-derived pharmaceuticals. A bioengineered heparin prepared by bacterial fermentation and chemical and enzymatic processing is currently under development. This study examines the challenges of reducing or removing endotoxins associated with this process that are necessary to proceed with preclinical in vivo evaluation of bioengineered heparin. The current process is assessed for endotoxin levels, and strategies are examined for endotoxin removal from polysaccharides and enzymes involved in this process. PMID:23586950

  3. The importance for the MDG4 and MDG5 of addressing reproductive health issues during the second decade of life: review and analysis from times series data of 51 African countries.

    PubMed

    Defo, Barthelemy Kuate

    2011-06-01

    Addressing adolescent sexual and reproductive health issues are central to efforts for reducing childhood and maternal mortality embedded in MDG4 and MDG5. This paper reviews these issues in Africa and uses statistical methods for measuring changes to analyze recent and comparable time series data from 51 African countries. The contribution of adolescent fertility to total fertility and mortality remains quite high. Delayed marriage is occurring concomitantly with postponement of sexual debut among unmarried adolescents. Six African countries are likely to achieve the MGD4 and five are likely to reach the target for the MDG5; the majority of sub-Saharan African countries will fall short of achieving these goals, not even by 2100 for many at current rates of change in progress indicators. Implementing ground-breaking nationally owned mortality-reduction schemes covering preconceptional and interconceptional periods and well-functioning comprehensive health-care system secured by sustained commitments and financial investments in health and social services are urgently needed, in order to repeal trends of further undoing successes achieved so far or slowing recent progress, thus hastening the pace of child and maternal mortality decline. PMID:22590890

  4. 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

  5. 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.

  6. Overview and discussion of the key regulatory issues in implementing the electric utility provisions of the Clean Air Act Amendments of 1990

    SciTech Connect

    Rose, K.; Burns, R.E.

    1991-06-01

    Title 4 of the Clean Air Act Amendments of 1990 (CAAA) created a new regulatory instrument that electric power producers (utilities and others) will be required to possess and expand in order to emit sulfur dioxide (SO{sub 2}) into the atmosphere. The emission allowance system created by the CAAA will be grafted onto an already complex system of state and federal electric utility regulation. How public utility commissions (PUCs) and the Federal Energy Regulatory Commission (FERC) regulate these allowances will greatly affect the decisions that electric utilities under their jurisdiction make to comply with the CAAA and, therefore, the cost of compliance to ratepayers. 2 figs., 9 tabs.

  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. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  9. 10 CFR 218.34 - Addresses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  10. Addressing adolescent pregnancy with legislation.

    PubMed

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

    2014-01-01

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

  11. Addressing adolescent pregnancy with legislation.

    PubMed

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

    2014-01-01

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

  12. 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.

  13. 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.

  14. 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

  15. Addressing Environmental Health Inequalities.

    PubMed

    Gouveia, Nelson

    2016-01-01

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

  16. Environment International, Special Issue, "Future Directions in Air Quality Research Ecological, Atmospheric, Regulatory/Policy/Economic, and Educational Issues", Volume 29, #2-3. June 2003. ISSN 0160 4120

    SciTech Connect

    Alcock, Ruth E; Heck, Walter W; Chappelka, Arthur H; Hunt, William F; Innes, John L; and Unsworth, Michael

    2003-06-01

    The Air Resources Consortium sponsored a Conference entitled "Future Directions in Air Quality Research". The Conference was held on February 12-15, 2001 at the Sheraton Imperial Hotel and Conference Center in the Research Triangle Park, NC. This was an international conference that had wide interest in both the scientific and regulatory communities at both State and Federal levels in the U.S. and in the international community. Attendance over the four days of the Conference was over 200 with excellent international participation. The primary purpose of the Conference was to highlight future directions in air quality research based on our current knowledge and ongoing research. Three atmospheric contaminates (ozone, carbon dioxide and species of nitrogen) as the primary focus for the Conference, since they would likely be of continuing concern to the international community over the next several decades. Speakers focused on ways that research could support regulatory, policy and environmental needs of federal, state and local government as well as the concerns of both industrial and environmental groups. Economic impacts were considered when covering policy implications. The program was developed around ecological effects, atmospheric processes and their relationships. Conference speakers were asked to develop their papers for inclusion in a Conference Proceedings. The proceedings were published in the Journal "Environment International" as Volume 29, Numbers 2-3, in June of 2003. Copies of the Proceedings have been sent to DOE.

  17. [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.

  18. Regulatory oversight in the United States of vascularized composite allografts.

    PubMed

    Glazier, Alexandra K

    2016-06-01

    Vascularized composite allograft (VCA) transplantation is a medically acceptable treatment for the reconstruction of major tissue loss. The advent of VCA transplantation has spurred regulatory and policy development in the United States to address the multiple clinical, ethical and legal issues that must be considered for the practice of VCA donation and transplantation to develop within the existing framework of public trust and transparency vital to the success of donation and transplantation. PMID:26284312

  19. Regulatory instrument review: Aging management of LWR cables, containment and basemat, reactor coolant pumps, and motor-operated valves

    SciTech Connect

    Werry, E.V.; Somasundaram, S.

    1995-09-01

    The results of Stage 2 of the Regulatory Instrument Review are presented in this volume. Selected regulatory instruments, such as the Code of Federal Regulations (CFR), US Nuclear Regulatory Commission (NRC), Regulatory Guides, and ASME Codes, were investigated to determine the extent to which these regulations apply aging management to selected safety-related components in nuclear power plants. The Regulatory Instrument Review was funded by the NRC under the Nuclear Plant Aging Research (NPAR) program. Stage 2 of the review focused on four safety-related structures and components; namely, cables, containment and basemat, reactor coolant pumps, and motor-operated valves. The review suggests that the primary-emphasis of the regulatory instruments was on the design, construction, start-up, and operation of a nuclear power plant, and that aging issues were primarily addressed after an aging-related problem was recognized. This Stage 2 review confirms the results of the prior review; (see Regulatory Instrument Review: Management of Aging of LWR Major Safety-Related Components NUREG/CR-5490. The observations indicate that the regulations generally address management of age-related degradation indirectly. Specific age-related degradation phenomena frequently are dealt with in bulletins and notices or through generic issues, letters, etc. The major recommendation of this report, therefore, is that the regulatory instruments should more directly and explicitly address the aging phenomenon and the management of the age-related degradation process.

  20. Regulatory aspects of clinical xenotransplantation.

    PubMed

    Schuurman, Henk-Jan

    2015-11-01

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

  1. Tempo and mode of regulatory evolution in Drosophila.

    PubMed

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

    2014-05-01

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

  2. Tempo and mode of regulatory evolution in Drosophila

    PubMed Central

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

    2014-01-01

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

  3. Issues in Peer Review.

    ERIC Educational Resources Information Center

    Sawamura, Mark H.

    2001-01-01

    Based on concerns raised at a workshop at the Southern California College of Optometry, addresses critical issues in the process of peer review of faculty teaching and possible alternatives to these issues as applied to an optometric institution. (EV)

  4. 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.

  5. Public participation in environmental issues

    SciTech Connect

    Pilot, J.

    1998-12-31

    The need for public participation in environmental issues has grown in the past five years. The Responsible Care{reg_sign} Program, developed by the chemical industry, as well as government requirements for citizens` input into regulatory review have initiated public committees for environmental management issues. This paper will discuss three programs that have been implemented in Ontario to assist in public participation in environmental issues covering the following: 1. Great Waste Management Debate held in co-operation with Government, Boards of Trade, Industry, and Youth; 2. Public Liaison committee for Ontario`s Resource Recovery -- Waste to Energy Facility operating in the Region of Peel, the role they have played in its operation with the community; and 3. Brampton Environmental Community Advisory Panel, initiated by the Brampton Chemical Association`s need under Responsible Care for a public program to address concern related to company`s environmental issues in the community. As Chair of all three Committees, the paper will cover the benefits of the committees for public input and review of environmental issues related to environmental management.

  6. Regulatory analysis for the resolution of Generic Safety Issue 105: Interfacing system loss-of-coolant accident in light-water reactors

    SciTech Connect

    Not Available

    1993-07-01

    An interfacing systems loss of coolant accident (ISLOCA) involves failure or improper operation of pressure isolation valves (PIVs) that compose the boundary between the reactor coolant system and low-pressure rated systems. Some ISLOCAs can bypass containment and result in direct release of fission products to the environment. A cost/benefit evaluation, using three PWR analyses, calculated the benefit of two potential modifications to the plants. Alternative 1 is improved plant operations to optimize the operator`s performance and reduce human error probabilities. Alternative 2 adds pressure sensing devices, cabling, and instrumentation between two PIVs to provide operators with continuous monitoring of the first PIV. These two alternatives were evaluated for the base case plants (Case 1) and for each plant, assuming the plants had a particular auxiliary building design in which severe flooding would be a problem if an ISLOCA occurred. The auxiliary building design (Case 2) was selected from a survey that revealed a number of designs with features that provided less than optimal resistance to ECCS equipment loss caused by a ISLOCA-induced environment. The results were judged not to provide sufficient basis for generic requirements. It was concluded that the most viable course of action to resolve Generic Issue 105 is licensee participation in individual plant examinations (IPEs).

  7. Steam generator issues in the United States

    SciTech Connect

    Strosnider, J.R.

    1997-02-01

    Alloy 600 steam generator tubes in the US have exhibited degradation mechanisms similar to those observed in other countries. Effective programs have been implemented to address several degradation mechanisms including: wastage; mechanical wear; pitting; and fatigue. These degradation mechanisms are fairly well understood as indicated by the ability to effectively mitigate/manage them. Stress corrosion cracking (SCC) is the dominant degradation mechanism in the US. SCC poses significant inspection and management challenges to the industry and the regulators. The paper also addresses issues of research into SCC, inspection programs, plugging, repair strategies, water chemistry, and regulatory control. Emerging issues in the US include: parent tube cracking at sleeve joints; detection and repair of circumferential cracks; free span cracking; inspection and cracking of dented regions; and severe accident analysis.

  8. Social Security and Undergraduates with Disabilities: An Analysis of the National Postsecondary Student Aid Survey. Addressing Trends in Development in Secondary Education and Transition. Information Brief. Vol. 3, Issue 4.

    ERIC Educational Resources Information Center

    Berry, Hugh; Conway, Megan A.; Change, Kelly B.T.

    2004-01-01

    The purpose of this brief is to describe the characteristics of undergraduate students receiving Social Security Disability Insurance (SSDI) and Social Security Administration (SSI) benefits as they relate to issues of participation in postsecondary education and employment. This brief describes results from the National Postsecondary Student Aid…

  9. A review of public policy issues in promoting the development and commercialization of pharmacogenomic applications: challenges and implications.

    PubMed

    Garrison, Louis P; Carlson, Rick J; Carlson, Josh J; Kuszler, Patricia C; Meckley, Lisa M; Veenstra, David L

    2008-01-01

    This article reviews the regulatory, social, policy, and other issues that will shape the development of pharmacogenomics applications. We identify and analyze 19 key public policy issues, ranging from the economic incentives for linked diagnostic-drug development, to the regulation of tests and drugs, and to privacy and informed consent. Challenging technical, business, and policy-related issues might either hinder progress in the field of pharmacogenomics or potentially accelerate it, depending on how they are addressed and resolved. How well the numerous important stakeholders - both private and public - address these issues will be critical for pharmacogenomics to deliver on its promise.

  10. Hazardous waste: 1998 Regulatory and judicial developments

    SciTech Connect

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

    1998-12-31

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

  11. 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 ...

  12. Is It More Important to Address the Issue of Patient Mobility or to Guarantee Universal Health Coverage in Europe?: Comment on "Regional Incentives and Patient Cross-Border Mobility: Evidence From the Italian Experience".

    PubMed

    Legido-Quigley, Helena

    2015-09-02

    This paper discusses whether European institutions should devote so much attention and funding to cross-border healthcare or they should instead prioritise guaranteeing universal health coverage (UHC), "addressing inequalities" and tackling the effects of austerity measures. The paper argues through providing the evidence in both areas of research, that the priority at European level from a public health and social justice perspective should be to guarantee UHC for all the population living in Europe and prioritise protective action for those who are most in need.

  13. Is It More Important to Address the Issue of Patient Mobility or to Guarantee Universal Health Coverage in Europe?: Comment on "Regional Incentives and Patient Cross-Border Mobility: Evidence From the Italian Experience".

    PubMed

    Legido-Quigley, Helena

    2016-01-01

    This paper discusses whether European institutions should devote so much attention and funding to cross-border healthcare or they should instead prioritise guaranteeing universal health coverage (UHC), "addressing inequalities" and tackling the effects of austerity measures. The paper argues through providing the evidence in both areas of research, that the priority at European level from a public health and social justice perspective should be to guarantee UHC for all the population living in Europe and prioritise protective action for those who are most in need. PMID:26673649

  14. Addressing psychiatric comorbidity.

    PubMed

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

    1991-01-01

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

  15. Variable addressability imaging systems

    NASA Astrophysics Data System (ADS)

    Kubala, Kenneth Scott

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

  16. Mediating equity in shared water between community and industry: The effects of an after school program that addresses adolescents' knowledge, attitudes, and perceptions of water science and environmental issues

    NASA Astrophysics Data System (ADS)

    Patton, Mary Chandler

    This critical ethnography deconstructs how one participant researcher came to understand young adults' changing knowledge about water science and environmental issues in an after school program in Colombia. The program intended to empower self-identified young community leaders by teaching participants to engage community members in discourse related to how environmental factors impact one's level of health and quality of life. The data presented in this study illustrate how student participants responded to long-term teacher engagement and to particular curricular components that included hands-on science teaching and social justice coaching. I assessed how student interest in and knowledge of local water ecology and sanitation infrastructure changed throughout the program. Students' responses to the use of technology and digital media were also included in the analysis. The data demonstrates a dramatic change in student's attitudes and perceptions related to their environment and how they feel about their ability to make positive changes in their community.

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

    PubMed

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

    2015-02-01

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

  18. PROFILE: Chemical Warfare Materiel: Unique Regulatory Issues.

    PubMed

    Etnier; King; Watson

    2000-04-01

    / The US Army manages an extensive program of environmental restoration that is carried out primarily under authority of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which establishes response authority for cleanup of inactive waste sites. The Resource Conservation and Recovery Act (RCRA) regulates the management and cleanup of hazardous materials at active hazardous waste facilities. Based on the definitions found in these acts, and corresponding promulgated regulations, environmental media contaminated with chemical warfare materiel (CWM) can be regulated as CERCLA "pollutants or contaminants" but do not appear to be regulated either as CERCLA hazardous substances or RCRA hazardous wastes.In those states that have not included CWM as hazardous materials in their RCRA programs, the RCRA requirements for management of hazardous waste would not strictly apply to any of the CWM. The Army has historically implemented procedures requiring that chemical warfare agents be managed as RCRA hazardous waste regardless of the concentration, physical form, or configuration of the agent. Such application of strict hazardous waste requirements to management of potentially nonhazardous CWM can result in remedial costs well out of proportion to potential human health and environmental benefits. Recent development of chronic toxicity values for the CWM has opened the door for development of cleanup and waste management standards for waste streams or media containing small residual amounts of CWM. Implementation of this health-based approach to management of CWM remediation wastes may, in part, help to reduce potentially unnecessary hazardous waste management costs for the nonhazardous CWM.

  19. Regulatory views on current criticality safety issues

    SciTech Connect

    Conde, J.M.; Recio, M.

    1996-12-31

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

  20. PROFILE: Chemical Warfare Materiel: Unique Regulatory Issues.

    PubMed

    Etnier; King; Watson

    2000-04-01

    / The US Army manages an extensive program of environmental restoration that is carried out primarily under authority of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which establishes response authority for cleanup of inactive waste sites. The Resource Conservation and Recovery Act (RCRA) regulates the management and cleanup of hazardous materials at active hazardous waste facilities. Based on the definitions found in these acts, and corresponding promulgated regulations, environmental media contaminated with chemical warfare materiel (CWM) can be regulated as CERCLA "pollutants or contaminants" but do not appear to be regulated either as CERCLA hazardous substances or RCRA hazardous wastes.In those states that have not included CWM as hazardous materials in their RCRA programs, the RCRA requirements for management of hazardous waste would not strictly apply to any of the CWM. The Army has historically implemented procedures requiring that chemical warfare agents be managed as RCRA hazardous waste regardless of the concentration, physical form, or configuration of the agent. Such application of strict hazardous waste requirements to management of potentially nonhazardous CWM can result in remedial costs well out of proportion to potential human health and environmental benefits. Recent development of chronic toxicity values for the CWM has opened the door for development of cleanup and waste management standards for waste streams or media containing small residual amounts of CWM. Implementation of this health-based approach to management of CWM remediation wastes may, in part, help to reduce potentially unnecessary hazardous waste management costs for the nonhazardous CWM. PMID:10667941

  1. Regulatory decisions. Emphasis on safety issues.

    PubMed

    Strandberg, K; Wiholm, B E

    1986-01-01

    Effective post-marketing surveillance of drugs calls for an approach tuned to the individual problem. In Sweden, the combined use of spontaneous adverse drug reaction (ADR) reporting data and different registers has yielded much valuable information on safety problems with different drugs. However, the raw data must be interpreted with care and often be supplemented by in-depth studies. The advantage with registers is that they comprise the whole or a random sample of the population and that the reporting routines are fairly simple. Since much of the information is collected primarily for other purposes (like health care planning or budgeting) the cost of the information is low. The potential of spontaneous ADR reporting for detecting new rare ADRs is exemplified by the zimeldine case. Limitations of the system besides low and selective reporting are that the physicians must suspect the clinical manifestation to be drug-induced and that patient compliance is unknown. The greatest disadvantage with the patient- and disease-oriented registers is the frequent inaccuracy of the diagnoses and the delay in the appearance of the data. Improved education and more resources for updating the registers are required. The ICD-code should be adapted to the needs of drug monitoring. Since the registers contain sensitive information about individual patients, the confidentiality of the data must be secured. As a logical complement to these sources of information, systems for case control studies, to be adopted ad hoc when problems arise, should be instituted. Moreover, for certain kinds of long term drug reactions, record-linkage systems are probably the only means to disclose risks (e.g. of cancer) after long term drug exposure. In this respect, the computerisation of Swedish pharmacies offers unique possibilities for the retrieval of prescription data on individual patients. PMID:2950292

  2. Contemporary Native American Address.

    ERIC Educational Resources Information Center

    Maestas, John R., Ed.

    A compilation of 58 representative speeches from the American Indian Community, this book is divided into 2 parts; Part I deals with issues of contemporary concern and Part II illustrates speech types and styles. All speeches are classified by issue as follows: sovereignty (2 speeches, 1 on the rise and fall of Indian sovereignty); trust…

  3. Addressivity in cogenerative dialogues

    NASA Astrophysics Data System (ADS)

    Hsu, Pei-Ling

    2014-03-01

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

  4. 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.

  5. [Regulatory science forum--its background and goal].

    PubMed

    Uchiyama, M

    1993-01-01

    Regulatory science is, broadly speaking, the effort to insure that the products of our advanced technological civilization are developed in harmony with human needs. More specifically, regulatory science can be described as the science of evaluating the safety, efficacy and quality of these products. An unbiased assessment of these aspects is necessary for proper regulation of food, drugs, the environment, agricultural chemicals as well as the countless new materials available to the public every year. Evaluation does not interfere with product development; indeed, it often hastens the appearance of beneficial products in the public sector. Evaluation criteria should be established through consensus between industry, academia, and government and only after a thorough scientific discussion grounded in the basic principle of protecting the welfare of society's citizens. Even more important than broad-ranging knowledge is the need to develop new evaluation strategies and methodologies. Numerous problems confronting the world today can surely benefit from the evaluative techniques of regulatory science. Since research in the academic sphere often fails to address many of these issues, I want to reiterate the need for our National Institute to play a more prominent role in coordinating regulatory policy and pursuing these issues based on my firm belief that such activity is indispensable for human survival.

  6. The U.S. Nuclear Regulatory Commission's Strategy for Revising the RIA Acceptance Criteria

    SciTech Connect

    Clifford, Paul M.

    2007-07-01

    The U.S. Nuclear Regulatory Commission (NRC) has issued interim criteria and guidance for the reactivity-initiated accident (RIA) within the latest revision to NUREG-0800, 'Standard Review Plan' (SRP), Section 4.2, 'Fuel System Design', Appendix B (Revision 03, March 2007). The purpose of this paper is as follows: 1. present a change in regulatory staff position regarding the requirements of 10 CFR 50, Appendix A, General Design Criteria 28 (GDC28) and changes in regulatory guidance provided in Regulatory Guide (RG) 1.77, RG 1.195, RG 1.183, and previous versions of NUREG-0800 SRP; 2. describe the implementation strategy and schedule for both new reactors and the existing fleet; and 3. encourage licensees and nuclear fuel vendors to (1) develop improved core physics analytical methods to allow a more deliberate transition to the new fuel cladding failure criteria and (2) develop the technical basis to address the new core coolability criteria. (authors)

  7. The regulatory sciences for stem cell-based medicinal products.

    PubMed

    Yuan, Bao-Zhu; Wang, Junzhi

    2014-06-01

    Over the past few years, several new achievements have been made from stem cell studies, many of which have moved up from preclinical stages to early, or from early to middle or late, stages thanks to relatively safe profile and preliminary evidence of effectiveness. Moreover, some stem cell-based products have been approved for marketing by different national regulatory authorities. However, many critical issues associated mainly with incomplete understanding of stem cell biology and the relevant risk factors, and lack of effective regulations still exist and need to be urgently addressed, especially in countries where establishment of appropriate regulatory system just commenced. More relevantly, the stem cell regulatory sciences need to be established or improved to more effectively evaluate quality, safety and efficacy of stem cell products, and for building up the appropriate regulatory framework. In this review, we summarize some new achievements in stem cell studies, especially the preclinical and clinical studies, the existing regulations, and the associated challenges, and we then propose some considerations for improving stem cell regulatory sciences with a goal of promoting the steadfast growth of the well-regulated stem cell therapies abreast of evolvement of stem cell sciences and technologies.

  8. An empirical study of tissue banking in Australia: navigating regulatory and ethical challenges.

    PubMed

    Clark, Georgina; Lipworth, Wendy; Les, Bokey; Little, J M; Kerridge, Ian H

    2006-08-01

    Collections of tumour samples can be an invaluable resource for medical research. There are, however, numerous ethical and legal challenges associated with tumour banking. While there has been extensive discussion of these issues in the legal and ethical literature, there are few available empirical data in relation to the activities of tumour banks in Australia, their practices around ethically charged issues, and their success in implementing complex regulatory guidelines. The aim of this study was to gain more information about the activities of tumour banks in New South Wales, Australia, with a particular focus on their management of, and attitudes towards, ethical and regulatory issues. A survey of 27 tumour collection and research facilities was conducted using a 55-item questionnaire. There is significant heterogeneity of research methodologies as well as of methods for gaining consent and ensuring donor privacy, and there is general concern among the research community about ethical and regulatory issues related to tumour banking. Heterogeneity of practice and uncertainty about ethical and regulatory requirements is problematic in its potential to hinder research and its potential to generate the space for unethical practice, whether intentional or unintentional. There is a pressing need to address these issues so that tumour banks can be used in the most ethical and efficient way possible.

  9. 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…

  10. Space Station Software Issues

    NASA Technical Reports Server (NTRS)

    Voigt, S. (Editor); Beskenis, S. (Editor)

    1985-01-01

    Issues in the development of software for the Space Station are discussed. Software acquisition and management, software development environment, standards, information system support for software developers, and a future software advisory board are addressed.

  11. MODELING OF GENE REGULATORY PROCESSES BY POPULATION MEDIATED SIGNALING. NEW APPLICATIONS OF POPULATION BALANCES

    PubMed Central

    Shu, Che-Chi; Chatterjee, Anushree; Hu, Wei-Shou

    2011-01-01

    Population balance modeling is considered for cell populations in gene regulatory processes in which one or more intracellular variables undergo stochastic dynamics as determined by Ito stochastic differential equations. This paper addresses formulation and computational issues with sample applications to the spread of drug resistance among bacterial cells. It is shown that predictions from population balances can display qualitative differences from those made with single cell models which are usually encountered in the literature. Such differences are deemed to be important. PMID:22581980

  12. Natural gas 1995: Issues and trends

    SciTech Connect

    1995-11-01

    Natural Gas 1995: Issues and Trends addresses current issues affecting the natural gas industry and markets. Highlights of recent trends include: Natural gas wellhead prices generally declined throughout 1994 and for 1995 averages 22% below the year-earlier level; Seasonal patterns of natural gas production and wellhead prices have been significantly reduced during the past three year; Natural gas production rose 15% from 1985 through 1994, reaching 18.8 trillion cubic feet; Increasing amounts of natural gas have been imported; Since 1985, lower costs of producing and transporting natural gas have benefitted consumers; Consumers may see additional benefits as States examine regulatory changes aimed at increasing efficiency; and, The electric industry is being restructured in a fashion similar to the recent restructuring of the natural gas industry.

  13. Nuclear Regulatory Commission Issuances, Volume 42, No. 2

    SciTech Connect

    1995-08-01

    This report include the issuances received during the specificed period (August 1995) from the NRC, the Atomic Safety and Licensing Boards, the Administrative Law Judges, and the Decisions on Petitions for Rule Making. In these issuances, the following areas were addressed: (1) Emergency planning at the University of Missouri, (2) Transfer of operating license at Plant Vogtle, (3) Discriminatory action against a whistle-blower at Millstone Units 1 & 2, (4) Regulatory issues related to embittlement and cracking at Oyster Creek, and (5) Age-related deterioration of reactor internals components at Pilgrim.

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. Holographic content addressable storage

    NASA Astrophysics Data System (ADS)

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

    2015-03-01

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

  20. Addressing Poverty Issues in Christian Schools: Teachers' Perspectives

    ERIC Educational Resources Information Center

    Bankston, Catherine

    2015-01-01

    The purpose of Christian education is to incorporate Biblical values in the curriculum, and one essential message in the Bible is to reach out and liberate the poor. Through interviews, writing protocols, a focus group meeting, and document analysis, this narrative study focuses on the question of how do Christian educators create pedagogical…

  1. A Strategic Model to Address Issues of Student Achievement

    ERIC Educational Resources Information Center

    Fontana, Leonard; Johnson, Elease; Green, Peggy; Macia, Jose; Wright, Ted; Daniel, Yanick; Distefano Diaz, Mary F.; Obenauf, Steve

    2006-01-01

    This article describes an interactive and collaborative strategic planning process by a community college in which student retention and success became a focus of a re-accreditation endeavor. The underlying assumption of this strategic planning effort was that engaging all groups that have a stake in student retention at the beginning of the…

  2. Jupiter's Polar Magnetosphere: Outstanding Issues to be Addressed By Juno

    NASA Astrophysics Data System (ADS)

    Kurth, W. S.; Connerney, J. E. P.; McComas, D. J.; Mauk, B.; Gladstone, R.; Adriani, A.; Bagenal, F.; Bolton, S. J.

    2014-12-01

    Juno is on course to enter polar orbit at Jupiter on July 4, 2016. After a small number of preliminary orbits during which the orbital period is reduced, approximately 30 science orbits will be executed to explore the interior of Jupiter, hence, its origin. A second primary objective of the mission, and the subject of this talk, is to carry out the first exploration of Jupiter's polar magnetosphere. All previous missions to Jupiter, including Ulysses, remained at low Jovian latitudes at close range, hence, our knowledge of Jupiter's polar magnetosphere is a composite of remote sensing (such as radio emissions in the hectometric and decametric bands as well as IR and UV images); application of observations of Earth's auroral and polar cap particles, fields, and auroral emissions; and modeling. While these likely inform our expectations of what Juno will actually measure qualitatively, Juno will provide the first in depth exploration of auroral processes at another planet, other than a small number of very brief encounters of Saturn's kilometric radio source region by Cassini. With a reasonably complete suite of in situ magnetospheric measurements coupled with remote sensing, Juno will enable us to compare Jupiter's polar magnetosphere with those expectations. Certainly, understanding the nature of auroral currents and mechanisms for particle acceleration are high on the list of priorities for these studies. In addition, it is expected that Juno will greatly improve our understanding of the mapping of auroral processes from high latitudes and low altitudes to the middle and outer magnetosphere.

  3. Ethical Issues in Addressing Inequity in/through ESL Research

    ERIC Educational Resources Information Center

    Lee, Ena

    2011-01-01

    This article outlines a researcher's struggles with conducting "ethical" research when her case study reveals racializations faced by a minority teacher in a Canadian ESL program. How might becoming privy to research participants' experiences of inequity in ESL education complicate the notion of research ethics when "doing the right thing" runs…

  4. Obama address touches on research, energy, and environmental issues

    NASA Astrophysics Data System (ADS)

    Showstack, Randy

    2012-02-01

    President Barack Obama's State of the Union message, delivered on 24 January, touched on the need for basic research, energy production, support for clean energy, and environmental protection, but it included just one passing reference to climate change. In addition, the speech made no note of the Administration's recent denial of a controversial application for the Keystone XL pipeline to transport crude oil from Canada to the United States and made just an elliptical reference regarding the bankrupt Solyndra Corporation, which the administration had touted as a clean energy company. Innovation "demands basic research," Obama said, adding that Congress should not "gut these investments in our budget." Noting that one promise for innovation is American-made energy, Obama said he is directing the administration to "open more than 75% of our potential offshore oil and gas resources."

  5. Advances in Pediatric Asthma in 2010: Addressing the Major Issues

    PubMed Central

    Szefler, Stanley J.

    2010-01-01

    Last year’s Advances in Pediatric Asthma concluded with the following statement “If we can close these [remaining] gaps through better communication, improvements in the health care system and new insights into treatment, we will move closer to better methods to intervene early in the course of the disease and induce clinical remission as quickly as possible in most children”. This year’s summary will focus on recent advances in pediatric asthma that take steps moving forward as reported in Journal of Allergy and Clinical Immunology publications in 2010. Some of those recent reports show us how to improve asthma management through steps to better understand the natural history of asthma, individualize asthma care, reduce asthma exacerbations, manage inner city asthma, and some potential new ways to use available medications to improve asthma control. It is clear that we have made many significant gains in managing asthma in children but we have a ways to go to prevent asthma exacerbations, alter the natural history of the disease, and to reduce health disparities in asthma care. Perhaps new directions in personalized medicine and improved health care access and communication will help maintain steady progress in alleviating the burden of this disease in children, especially young children. PMID:21211645

  6. Something to "Speak" about: Addressing Sensitive Issues through Literature

    ERIC Educational Resources Information Center

    Jackett, Mark

    2007-01-01

    "Speak," by Laurie Halse Anderson, is one of the most powerful young adult novels to come along in the past decade. It has won numerous awards, including the "School Library Journal" award for "Best Book of the Year," and was a National Book Award Finalist. Despite this acclaim, many English teachers are uncomfortable teaching "Speak" in their…

  7. A Model for Addressing Spiritual Issues in Counseling.

    ERIC Educational Resources Information Center

    Russo, Thomas J.

    1984-01-01

    Discusses the hesitancy of counselors and psychotherapists to approach the spiritual concerns of clients. Proposes a counseling and psychotherapy training model that contains discrete yet continuous levels of learning. The holistic epistemology of Gregory Bateson is used to derive guiding theoretical principles for the training model. (Author/JAC)

  8. Developing Social Marketing Capacity to Address Health Issues

    ERIC Educational Resources Information Center

    Whitelaw, S.; Smart, E.; Kopela, J.; Gibson, T.; King, V.

    2011-01-01

    Purpose: Social marketing is increasingly being seen as a potentially effective means of pursuing health education practice generally and within various specific areas such as mental health and wellbeing and more broadly in tackling health inequalities. This paper aims to report and reflect on the authors' experiences of undertaking a health…

  9. New smart materials to address issues of structural health monitoring.

    SciTech Connect

    Chaplya, Pavel Mikhail

    2004-12-01

    Nuclear weapons and their storage facilities may benefit from in-situ structural health monitoring systems. Appending health-monitoring functionality to conventional materials and structures has been only marginally successful. The purpose of this project was to evaluate feasibility of a new smart material that includes self-sensing health monitoring functions similar to that of a nervous system of a living organism. Reviews of current efforts in the fields of heath-monitoring, nanotechnology, micro-electromechanical systems (MEMS), and wireless sensor networks were conducted. Limitations of the current nanotechnology methods were identified and new approaches were proposed to accelerate the development of self-sensing materials. Wireless networks of MEMS sensors have been researched as possible prototypes of self-sensing materials. Sensor networks were also examined as enabling technologies for dense data collection techniques to be used for validation of numerical methods and material parameter identification. Each grain of the envisioned material contains sensors that are connected in a dendritic manner similar to networks of neurons in a nervous system. Each sensor/neuron can communicate with the neighboring grains. Both the state of the sensor (on/off) and the quality of communication signal (speed/amplitude) should indicate not only a presence of a structural defect but the nature of the defect as well. For example, a failed sensor may represent a through-grain crack, while a lost or degraded communication link may represent an inter-granular crack. A technology to create such material does not exist. While recent progress in the fields of MEMS and nanotechnology allows to envision these new smart materials, it is unrealistic to expect creation of self-sensing materials in the near future. The current state of MEMS, nanotechnology, communication, sensor networks, and data processing technologies indicates that it will take more than ten years for the technologies to mature enough to make self-sensing materials a reality. Nevertheless, recent advances in the field of nanotechnology demonstrate that nanotubes, nanorods, and nanoparticles of carbon, boron and other materials have remarkable mechanical and electrical properties. This would provide. for a plethora of potential applications including self-sensing materials. Record strength-to-weight ratios, ballistic conductivity, and sensing capabilities (i.e., piezo- resistance and piezoelectricity) have been reported for carbon nanotubes. The first transistors, sensors, and actuators have been made from the carbon nanotubes and other nanomaterials. However, nanomaterials are notoriously difficult to manipulate into useful geometries. Nano-manufacturing processes often produce bundles or random networks of nanostructured materials. Samples of the material are then manipulated with advanced microscopy tools to measure properties or to create a single device. This is a laborious and time consuming process. An often overlooked property of the manufactured nanotube bundles is their similarity to the dendritic structure of neural networks with a great quantity of interconnects that may serve as initiation sites for artificial neurons in a self-sensing material nervous system. To accelerate the development of self-sensing materials, future research should concentrate on naturally occurring dendritic nano-structures. While self-sensing materials with subgrain size sensors (scale of micrometers) remain in the realm of basic research, meso-scale (millimeters to centimeters) sensors and their networks are in the state of mature research and have begun to find their way into commercial applications. Macro-scale (centimeters to decimeters) sensors and their networks are commercially available from various sources. The majority of applications that employ sensor networks are driven by the needs of the Department of Defense. Widespread adaptation of sensor networks has been limited by, on one hand, the sensor's high cost of design, development, and deployment, and on the other hand, a lack of reliable long-term power sources. Solutions to both of these drawbacks require significant investments driven by real-life applications. Possible applications for sensor networks at Sandia National Laboratories include dense data collection techniques for validation of numerical methods and material parameter identification. For example, an array of distributed wireless macro-scale sensors can record the structural response of soils and reinforced concrete during explosive loading. Another example is an array of surface mounted micro-sensors that can record the modal response of nuclear weapon components. The collected data would be used to validate existing numerical codes and to identify new physical mechanisms to improve Sandia's computational models.

  10. Assessing Rural Coalitions That Address Safety and Health Issues

    ERIC Educational Resources Information Center

    Burgus, Shari; Schwab, Charles; Shelley, Mack

    2012-01-01

    Community coalitions can help national organizations meet their objectives. Farm Safety 4 Just Kids depends on coalitions of local people to deliver farm safety and health educational programs to children and their families. These coalitions are called chapters. An evaluation was developed to identify individual coalition's strengths and…

  11. Creating Safety To Address Controversial Issues: Strategies for the Classroom.

    ERIC Educational Resources Information Center

    Valerio, Nina L.

    2001-01-01

    Presents seven elements of a safe classroom in controversy-driven courses, where students can exchange ideas rather than emotions as they learn and discuss. The elements are: collegiality, empowerment, role modeling, preparation, shared purpose, reflection, and commitment. Explains how teachers can create and nurture safe classrooms, describing…

  12. Addressing Issues of Peer Rejection in Child-Centered Classrooms.

    ERIC Educational Resources Information Center

    Matthews, Mona W.

    1996-01-01

    Notes that children ignored or rebuffed by their peers may be denied access to learning opportunities involving peer interaction. Describes how the sociometric dynamics in one classroom affected three children. Suggests implementations to minimize negative impact of peer rejection including identifying sociometric patterns, and then utilizing…

  13. Addressing Issues of Workplace Harassment: Counseling the Targets.

    ERIC Educational Resources Information Center

    Lewis, Jacqueline; Coursol, Diane; Wahl, Kay Herting

    2002-01-01

    Workplace harassment includes dysfunctional personal interactions characterized by bullying behaviors, personal attacks, and attempts to denigrate others. Targets of workplace harassment may experience stress, depression, low self-esteem, loss of sleep, and even posttraumatic stress disorder. Strategies that counselors can use to work effectively…

  14. Addressing criminality in childhood: is responsivity the central issue?

    PubMed

    Nee, Claire; Ellis, Tom; Morris, Paul; Wilson, Amy

    2013-11-01

    The responsivity principle is the third element of the now well-established risk-need-responsivity (RNR) model of offender rehabilitation. Accruing evidence suggests it is often sacrificed in intervention programs. We aim to demonstrate the central importance of this principle when designing offender interventions by describing the results of a successful, highly responsive intervention for very young children (aged 7 upward) who have offended. A small slice of the offending population as a whole, child offenders are nevertheless tomorrow's serious, violent, and prolific lawbreakers, yet little is understood about what reduces their risk. Recent developments on responsivity are reviewed, before presenting the evaluation indicating significant and sustained drops in risk of recidivism. In-program factors such as the nature and dosage of interventions are examined, alongside outcome data. The article discusses how RNR and other models might apply to this particularly young and underresearched age group. PMID:23070956

  15. SLIIDEA: Positive Approaches for Addressing Behavioral Issues. inForum

    ERIC Educational Resources Information Center

    Misra, Sunil

    2006-01-01

    When Congress passed the Individuals with Disabilities Education Act (IDEA) in 1997, it authorized an evaluation to track progress at the state and local levels on the legislative goals of IDEA. The U.S. Department of Education's Office of Special Education Programs (OSEP) commissioned a national longitudinal study, the Study of State and Local…

  16. Addressing Machining Issues for the Intermetallic Compound 60-NITINOL

    NASA Technical Reports Server (NTRS)

    Stanford, Malcolm K.; Wozniak, Walter A.; McCue, Terry R.

    2012-01-01

    60-NITINOL (60 wt.% Ni - 40 wt.% Ti) is being studied as a material for advanced aerospace components. Frequent wire breakage during electrical-discharge machining of this material was investigated. The studied material was fabricated from hot isostatically pressed 60-NITINOL powder obtained through a commercial source. Bulk chemical analysis of the material showed that the composition was nominal but had relatively high levels of certain impurities, including Al and O. It was later determined that Al2O3 particles had contaminated the material during the hot isostatic pressing procedure and that these particles were the most likely cause of the wire breakage. The results of this investigation highlight the importance of material cleanliness to its further implementation.

  17. Addressing Issues of Power, Justice, and Privilege in Literacy Instruction

    ERIC Educational Resources Information Center

    Tate, Stacie L.

    2014-01-01

    Tate applauds Rogers's use of teacher research to illustrate how literacy coaches and teachers can approach an accelerative literacy framework with a critical literacy lens. Citing her own work, as well as the work of other critical literacy educators, Tate reminds readers that teacher research is a careful plan that encompasses the power of…

  18. 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

  19. Changing concepts: the presidential address.

    PubMed

    Weed, J C

    1974-09-01

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

  20. Issue Brief on Diversity

    ERIC Educational Resources Information Center

    Division on Developmental Disabilities, Council for Exceptional Children (NJ1), 2013

    2013-01-01

    During the past year, the Diversity Committee of the Division of Developmental Disabilities (DDD) Board worked with the Board and the Issues Committee Chair to develop an issue brief addressing diversity, its impact on the membership and the wider community that is served by the work of DDD, resulting in recommendations that will influence policy…

  1. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    PubMed Central

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

  2. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues.

    PubMed

    Russo, Ethan B

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration "Botanical Guidance." The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain.

  3. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues.

    PubMed

    Russo, Ethan B

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration "Botanical Guidance." The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

  4. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    PubMed Central

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain.

  5. 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.

  6. Federal Trade Commission Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

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

  7. 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...

  8. 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...

  9. Legal issues for blood banks.

    PubMed

    Bierig, J R

    1994-04-01

    This article first examines the standard of care applied by courts in litigation brought against blood banks by persons who contracted the acquired immunodeficiency syndrome (AIDS) from a transfusion. It describes cases that have held as a matter of law that a blood bank was not negligent if it followed the screening procedures recommended by the government and the medical profession at the time of the transfusion. The article also sets forth cases that have allowed the issue of alleged negligence by the blood bank to be decided by a jury--even if the blood bank complied with governing regulatory and professional guidelines. It analyzes the reasoning applied in each line of cases. It then discusses judicial approaches to applications of the statute of limitations in transfusion-transmitted AIDS cases. The second part of the article addresses AIDS-related confidentiality issues for blood banks. Specifically, it examines (a) record-keeping procedures that blood banks should consider and (b) approaches to informing donors that their identities may not be kept confidential. It provides general guidelines for blood banks on how to minimize exposure to liability for breach of confidentiality.

  10. Opening Address of Chairman Michael Pertschuk.

    ERIC Educational Resources Information Center

    Pertschuk, Michael

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

  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. 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…

  13. Importance of Addressing Sexuality in Certified Rehabilitation Counselor Practice

    ERIC Educational Resources Information Center

    Kazukauskas, Kelly A.; Lam, Chow S.

    2009-01-01

    This study investigated Certified Rehabilitation Counselors' (CRCs) beliefs about the importance of addressing sexuality issues during rehabilitation. A modified version of the Family Life Sex Education Goals Questionnaire (FLSEGQ) was completed by 199 CRCs to determine which issues CRCs believe are most important to address. Six sexuality-related…

  14. 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.

  15. Bax: Addressed to kill.

    PubMed

    Renault, Thibaud T; Manon, Stéphen

    2011-09-01

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

  16. 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

  17. Environmental Protection Agency Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ...:// Not in FR www.epa.gov/lawsregs/search/regagenda.html Semiannual Regulatory Flexibility Agenda www....html issue ] Monthly Action Initiation List http://www.regulations.gov/fdmspublic/component/ Not in FR... Rulemaking Gateway www.epa.gov/rulemaking/ Not in FR B. What Are EPA's Regulatory Goals, and What...

  18. 77 FR 10351 - Regulatory Review Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... plan and requested comments on the plan. 76 FR 59066 (September 23, 2011). FHFA received no comments... XII Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION: Notice of final regulatory review plan. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of the final...

  19. 75 FR 79925 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... FR Cite Board Issued Final Rule on 02/22/10 75 FR 7658 Regulatory Flexibility Analysis Required: Yes... FR 37526 Regulatory Flexibility Analysis Required: Yes Agency Contact: Amy Henderson, Senior Attorney... similar to the proposed rule. Timetable: Action Date FR Cite Board Requested Comment 08/26/09 74 FR...

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

    PubMed

    Araki, Motoko; Ishii, Tetsuya

    2014-11-24

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

  1. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    PubMed

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  2. 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

  3. Regulatory RNAs

    PubMed Central

    Vazquez-Anderson, Jorge; Contreras, Lydia M

    2013-01-01

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

  4. 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.

  5. Federal Clean Water Act legislative and regulatory developments impacting the oil and gas industry

    SciTech Connect

    Lesniak, K.Z.

    1995-12-31

    Although the 103rd Congress made substantial progress towards passage of Clean Water Act amendments and reauthorization legislation and other environmental bills, including Safe Drinking Water Act reauthorization, 1994 resulted in no substantial new environmental legislation. Regulatory developments proceeded slowly as well, the most significant water regulatory issues on the federal level potentially impacting oil and gas operations being the anticipated issuance of a multi-sector storm water general permit and continuing EPA study of effluent limitations for coastal oil and gas extraction. The several Oil Pollution Act regulatory developments over the last year, including vessel financial responsibility, oil spill response planning, and revisions to the National Contingency Plan are not addressed in this paper.

  6. The Democratic Imperative to Address Sexual Equality Rights in Schools

    ERIC Educational Resources Information Center

    Gereluk, Dianne

    2013-01-01

    Issues of sexual orientation elicit ethical debates in schools and society. In jurisdictions where a legal right has not yet been established, one argument commonly rests on whether schools ought to address issues of same-sex relationships and marriage on the basis of civil equality, or whether such controversial issues ought to remain in the…

  7. Regulatory pathways for vaccines for developing countries.

    PubMed

    Milstien, Julie; Belgharbi, Lahouari

    2004-02-01

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

  8. 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

  9. Collective efficacy and the regulatory framing of health messages: influences on concern for body image.

    PubMed

    Johnson-Young, Elizabeth A; Magee, Robert G

    2014-01-01

    A collective efficacy scale is presented and used in 2 experiments that tested the effects of collective efficacy and regulatory framing on concern for body image. In Study 1 (N = 73), participants viewed online video messages from a health campaign that varied in their regulatory frame (promotion vs. prevention), after which they expressed the likelihood that they would discuss it with someone else. In Study 2, participants (N = 307) viewed either a regulatory-framed message or no message, after which they expressed their concern for the issue and their behavioral intentions. Study 2 also introduced moderating variables and addressed potential alternate explanations. Overall, participants who were higher in collective efficacy indicated greater concern for the issue of body image and expressed a greater likelihood to discuss the issue. The messages' regulatory frame also moderated the effect of collective efficacy. Collective efficacy was a stronger predictor in the prevention condition than in the promotion condition, presumably because the promotion frame was more effective in increasing participants' concern and intentions regardless of their sense of collective efficacy. PMID:24377398

  10. Ensuring accountability through health professional regulatory bodies: the case of conflict of interest.

    PubMed

    Zelisko, Debra; Baumann, Andrea; Gamble, Brenda; Laporte, Audrey; Deber, Raisa B

    2014-09-01

    How do self-regulated health professions' regulatory bodies address financial conflict of interest (coi) and ensure accountability to the public? using document analysis, we examined how four ontario regulatory colleges (physicians, nurses, physiotherapists, audiologists/speech-language pathologists) defined coi and the education, guidance and enforcement they provided for coi-related issues. These colleges are upholding the mandates to define, identify and address financial coi by providing regulations or standards and guidelines to their membership; they differed in the amount of educational materials provided to their registrants and in the possible coi scenarios they presented. Although there were few disciplinary hearings pertaining to financial coi, findings for the hearings that did occur were documented and posted on the college public registers (the listing of all registered college members along with all relevant practice information), informing the public of any limitations or restrictions placed on a member as a result of the hearing. PMID:25305394

  11. Ensuring Accountability through Health Professional Regulatory Bodies: The Case of Conflict of Interest

    PubMed Central

    Zelisko, Debra; Baumann, Andrea; Gamble, Brenda; Laporte, Audrey; Deber, Raisa B.

    2014-01-01

    How do self-regulated health professions' regulatory bodies address financial conflict of interest (COI) and ensure accountability to the public? Using document analysis, we examined how four Ontario regulatory colleges (physicians, nurses, physiotherapists, audiologists/speech-language pathologists) defined COI and the education, guidance and enforcement they provided for COI-related issues. These colleges are upholding the mandates to define, identify and address financial COI by providing regulations or standards and guidelines to their membership; they differed in the amount of educational materials provided to their registrants and in the possible COI scenarios they presented. Although there were few disciplinary hearings pertaining to financial COI, findings for the hearings that did occur were documented and posted on the college public registers (the listing of all registered college members along with all relevant practice information), informing the public of any limitations or restrictions placed on a member as a result of the hearing. PMID:25305394

  12. Gender: addressing a critical focus.

    PubMed

    Thornton, L; Wegner, M N

    1995-01-01

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

  13. Research opportunities for medications to treat alcohol dependence: addressing stakeholders' needs.

    PubMed

    Litten, Raye Z; Falk, Daniel; Ryan, Megan; Fertig, Joanne

    2014-01-01

    During the past decade, significant advances have been made in the development of medications to treat alcohol dependence. Four medications have been approved by the U.S. Food and Drug Administration for treating alcohol dependence-naltrexone, injectable naltrexone, acamprosate, and disulfiram-and several others show promise. The fact remains, however, that because of the heterogeneity of alcohol dependence, these medications will not work for all people, in all circumstances. Moreover, clinicians are not routinely prescribing these medications for alcohol treatment. This commentary poses a number of issues that must be addressed in order to advance the alcohol research field and to make medications a mainstream treatment for problematic drinking. These issues are framed from the perspective of the various stakeholders involved, including clinicians, patients, regulatory agencies, the pharmaceutical industry, and third-party payers. Addressing these issues will not only help to improve treatment but, as further described, will also open up many new research opportunities for alcohol investigators in the coming decade.

  14. Multicultural Issues.

    ERIC Educational Resources Information Center

    Reid, Charrles; Kampfe, Charlene

    This chapter examines issues related to working with diverse populations with addictions. A brief history of multiculturalism and multicultural counseling is presented. Issues particular to the treatment of people with addictions are examined, as well as prevention and assessment issues. Substance abuse issues among people in the gay male and…

  15. Critical Issues Facing School Principals

    ERIC Educational Resources Information Center

    Styron, Ronald A., Jr.; Styron, Jennifer L.

    2011-01-01

    The purpose of this study was to further extend research initially conducted in 2003 pertaining to the critical issues K-12 principals address on a daily basis. The study involved surveying school principals within the state of Mississippi to discover the critical issues they identified, the significance level of these issues, and the rationale…

  16. Technical and regulatory challenges for digital instrumentation and control and control room systems in nuclear plants

    SciTech Connect

    Torok, R.; Naser, J.; Harris, T.; Keithline, K.

    2006-07-01

    There are several unsettled technical and licensing issues in the areas of instrumentation and control (I and C), human factors, and updated control room designs that need coordinated, proactive industry attention. Some of these issues are already causing protracted regulatory reviews for existing plants, and left untreated, may cause substantial delays and increased costs for new plant combined construction and operating license approvals. Both industry and the NRC will have roles in resolving the key issues and addressing them in future design efforts and regulatory reviews. Where action is needed, the industry will want to minimize costs and risks by defining industry consensus solutions with corresponding technical bases. NEI has formed a working group to coordinate industry efforts and communications with NRC staff. The working group will also help determine priorities and coordinate both new and existing plant resources. EPRI will provide technical input and guidance for the working group. In order to be able to conduct reviews in a timely fashion, the NRC will likely need to enhance and expand staff resources as existing plants are upgraded and new plant reviews become more active. The industry initiative began with a workshop sponsored by EPRI and NEI on March 28-29, 2006, which led to the creation of the NEI working group. The working group has now identified and prioritized important generic issues, established resolution paths and schedules, and identified the roles of various stakeholders including utility companies, EPRI, NEI, vendors and the NRC. Through the course of this initiative I and C issues for both existing and new plants are being addressed. This paper describes the key I and C related technical and regulatory issues and their implications for new and operating plants, and provides a status report on the efforts to resolve them. (authors)

  17. Summation from a regulatory perspective

    SciTech Connect

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

    1986-11-01

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

  18. 75 FR 34183 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Market Volatility) To Permit FINRA To Halt Trading by FINRA Members Otherwise Than on an Exchange Where a Primary Listing Market Has Issued a Trading Pause Due to Extraordinary Market Conditions June 10, 2010....

  19. Employment. Feature Issue.

    ERIC Educational Resources Information Center

    Wallace, Teri, Ed.; And Others

    1993-01-01

    This theme issue addresses current trends and new developments in ensuring that individuals with disabilities have meaningful employment opportunities, especially in the context of recent federal legislation. Stressed throughout is the importance of collaboration among professionals, individuals with disabilities, and family members in achieving…

  20. ADDRESSING ENVIRONMENTAL ENGINEERING CHALLENGES WITH COMPUTATIONAL FLUID DYNAMICS

    EPA Science Inventory

    In the field of environmental engineering, modeling tools are playing an ever larger role in addressing air quality issues, including source pollutant emissions, atmospheric dispersion and human exposure risks. More detailed modeling of environmental flows requires tools for c...

  1. Global regulatory standards for the approval of biosimilars.

    PubMed

    Mounho, Barbara; Phillips, Audrey; Holcombe, Kay; Grampp, Gustavo; Lubiniecki, Tony; Mollerup, Inger; Jones, Carolyn

    2010-01-01

    On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act, which contains the Biologics Price Competition and Innovation Act. Biosimilars have an important role in the United States health care system, and this new law creates an abbreviated approval pathway for biosimilar products in the U.S. A biosimilar is a biologic product demonstrated to be highly similar to an approved innovator biologic product ("reference product"). While the law provides general information on the standards to demonstrate biosimilarity, Congress has authorized the FDA to define the scientific standards and content of biosimilar applications. There is an increasing global interest in the development of biosimilar products, and several regulatory authorities around the world, as well as the World Health Organization (WHO), have established regulatory guidelines for the approval of biosimilars. The scientific standards and requirements in the biosimilar guidelines of the WHO and other health authorities, including the European Union, Canada, Japan, and South Africa, are reviewed in this paper. The similarities as well as the differences among the policies adopted by these regulatory authorities may provide the FDA valuable information as the agency develops its standards and approaches for the approval of biosimilars in the U.S. At the same time, while establishing such approaches, the FDA has the opportunity to demonstrate leadership in addressing significant safety and other issues related to multi-source biologics and biosimilars that remain a global challenge. PMID:24479248

  2. Current issues with research support

    SciTech Connect

    Russell, W.T.

    1996-03-01

    It would be difficult to condense current issues in nuclear reactor regulation to just a few minutes. So, let me start off by saying that I have not tried to give a comprehensive listing of issues that are currently facing the reactor program, but rather to select those that I thought were relevant as they relate to research activities. Use of probabilistic risk assessment in regulatory decisions; materials aging issues concerning steam generators and reactor vessels; high burnup fuels; accident management; and digital instrumentation and control, are just a sampling of the important issues that I want to talk about.

  3. 2015 ASHG Awards and Addresses

    PubMed Central

    2016-01-01

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

  4. 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…

  5. Special Issue of Teaching Ideas.

    ERIC Educational Resources Information Center

    Health Education (Washington D.C.), 1986

    1986-01-01

    This special issue contains teaching strategies and suggestions for health-related activities at all educational levels. A few of the topics addressed by the 21 articles are heart disease, testicular cancer, hospital stress, family life, and sexual responsibility. (MT)

  6. Contractual Issues for Faculty Practice.

    ERIC Educational Resources Information Center

    Williams, M. Dee; Gregg, Andrea C.

    2001-01-01

    Discusses contractual issues surrounding nursing faculty's clinical practice, such as competent participants, offer, consideration, and acceptance. Addresses evaluation of faculty practice contracts and alternatives for problem resolution. (Contains 24 references.) (SK)

  7. Generic medicines: issues and relevance for global health.

    PubMed

    Rana, Proteesh; Roy, Vandana

    2015-12-01

    Generic medicine is a pharmaceutical product which is bioequivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use. Generic medicines are a cornerstone for providing affordable medicines to patients. The major generic markets in the world include United States of America followed by European Union, Canada, Japan, and Australia. The major suppliers of generic medicines China and India are showing tremendous growth in the generic medicine sector. There are many legal and regulatory issues along with quality concerns associated with the use of the generic products. Lately, bilateral international agreements called free trade agreements, delaying tactics by originator companies like strategic patenting and litigations on generic manufacturers, have been a major setback for the generic medicine industry. These issues need to be addressed to optimize the use of generic medicines. The sustainability of generic medicine sector is crucial for improving access to essential medicines for the worldwide. PMID:26405851

  8. Addressing Stereotypes by Moving along the Continuum of Cultural Proficiency

    ERIC Educational Resources Information Center

    Ward, Cheryl James

    2013-01-01

    Programs to help middle school students deal with racism and hate have been in place for some years, yet almost monthly we hear of students committing suicide or killing other students due to issues of isolation or harassment. Within the confines of a safe classroom, doctoral students in Educational Leadership addressed issues of stereotypes and…

  9. Regulatory guidance on soil cover systems

    SciTech Connect

    Kane, J.D.

    1991-12-31

    The US Nuclear Regulatory Commission (NRC) in September 1991, completed revisions to 14 sections of the Standard Review Plan (SRP) for the Review of a License Application for a Low-Level Radioactive Waste Disposal Facility. The major purposes of the SRP are to ensure the quality and uniformity of the NRC staff`s safety reviews, and to present a well-defined base from which to evaluate the acceptability of information and data provided in the Safety Analysis Report (SAR) portion of the license application. SRP 3.2, entitled, Design Considerations for Normal and Abnormal/Accident Conditions, was one of the sections that was revised by the NRC staff. This revision was completed to provide additional regulatory guidance on the important considerations that need to be addressed for the proper design and construction of soil cover systems that are to be placed over the LLW. The cover system over the waste is acknowledged to be one of the most important engineered barriers for the long-term stable performance of the disposal facility. The guidance in revised SRP 3.2 summarizes the previous efforts and recommendations of the US Army Corps of Engineers (COE), and a peer review panel on the placement of soil cover systems. NRC published these efforts in NUREG/CR-5432. The discussions in this paper highlight selected recommendations on soil cover issues that the NRC staff considers important for ensuring the safe, long-term performance of the soil cover systems. The development phases to be discussed include: (1) cover design; (2) cover material selection; (3) laboratory and field testing; (4) field placement control and acceptance; and (5) penetrations through the constructed covers.

  10. Genetic Issues in Mental Retardation, 1996-1997.

    ERIC Educational Resources Information Center

    Genetic Issues in Mental Retardation, 1996

    1996-01-01

    This document consists of the first six issues of a newsletter, which discusses current knowledge about and concerns related to genetics and mental retardation. The second issue addresses the problem of genetic discrimination. The third issue considers genetic testing, screening, and counseling. The fourth issue addresses genetic privacy issues.…

  11. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

    PubMed

    Welink, Jan; Fluhler, Eric; Hughes, Nicola; Arnold, Mark; Garofolo, Fabio; Bustard, Mark; Coppola, Laura; Dhodda, Raj; Evans, Christopher; Gleason, Carol; Haidar, Sam; Hayes, Roger; Heinig, Katja; Katori, Noriko; Blaye, Olivier Le; Li, Wenkui; Liu, Guowen; Lima Santos, Gustavo Mendes; Meng, Min; Nicholson, Bob; Savoie, Natasha; Skelly, Michael; Sojo, Luis; Tampal, Nilufer; de Merbel, Nico van; Verhaeghe, Tom; Vinter, Stephen; Wickremsinhe, Enaksha; Whale, Emma; Wilson, Amanda; Witte, Bärbel; Woolf, Eric

    2015-01-01

    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 to provide 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 1 covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (hybrid LBA/LCMS and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will also be published in volume 7 of Bioanalysis, issues 23 and 24, respectively.

  12. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

    PubMed

    Amaravadi, Lakshmi; Song, An; Myler, Heather; Thway, Theingi; Kirshner, Susan; Devanarayan, Viswanath; Ni, Yan G; Garofolo, Fabio; Birnboeck, Herbert; Richards, Susan; Gupta, Shalini; Luo, Linlin; Kingsley, Clare; Salazar-Fontana, Laura; Fraser, Stephanie; Gorovits, Boris; Allinson, John; Barger, Troy; Chilewski, Shannon; Fjording, Marianne Scheel; Haidar, Sam; Islam, Rafiqul; Jaitner, Birgit; Kamerud, John; Katori, Noriko; Krinos-Fiorotti, Corinna; Lanham, David; Ma, Mark; McNally, Jim; Morimoto, Alyssa; Mytych, Daniel; Nogueira da Costa, Andre; Papadimitriou, Apollon; Pillutla, Renuka; Ray, Soma; Safavi, Afshin; Savoie, Natasha; Schaefer, Martin; Shih, Judy; Smeraglia, John; Skelly, Michael F; Spond, Jeffrey; Staack, Roland F; Stouffer, Bruce; Tampal, Nilufer; Torri, Albert; Welink, Jan; Yang, Tong-Yuan; Zoghbi, Jad

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was 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 and LBA approaches, including the focus on biomarkers and immunogenicity. This 2015 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. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 3 discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Part 1 (small molecule bioanalysis using LCMS) and Part 2 (hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in volume 7, issues 22 and 23 of Bioanalysis, respectively.

  13. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

    PubMed

    Welink, Jan; Fluhler, Eric; Hughes, Nicola; Arnold, Mark; Garofolo, Fabio; Bustard, Mark; Coppola, Laura; Dhodda, Raj; Evans, Christopher; Gleason, Carol; Haidar, Sam; Hayes, Roger; Heinig, Katja; Katori, Noriko; Blaye, Olivier Le; Li, Wenkui; Liu, Guowen; Lima Santos, Gustavo Mendes; Meng, Min; Nicholson, Bob; Savoie, Natasha; Skelly, Michael; Sojo, Luis; Tampal, Nilufer; de Merbel, Nico van; Verhaeghe, Tom; Vinter, Stephen; Wickremsinhe, Enaksha; Whale, Emma; Wilson, Amanda; Witte, Bärbel; Woolf, Eric

    2015-01-01

    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 to provide 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 1 covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (hybrid LBA/LCMS and regulatory agencies' inputs) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will also be published in volume 7 of Bioanalysis, issues 23 and 24, respectively. PMID:26573485

  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. Addressing medical errors in hand surgery.

    PubMed

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

    2014-09-01

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

  16. 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

  17. Gender Issues.

    ERIC Educational Resources Information Center

    Ilfeld, Ellen M., Ed.; Hanssen, Elizabeth, Ed.

    1997-01-01

    This issue of "Coordinators' Notebook" focuses on gender issues in early childhood. The first article, "Both Halves of the Sky: Gender Socialization in the Early Years," focuses on the arguments that have led to an international call for increased participation of girls in education, an introduction to studies which map young children's…

  18. Issues Curriculum.

    ERIC Educational Resources Information Center

    Sando, Joe S.

    A program for teaching techniques of critical thinking on issues concerning American Indians was developed for students at Albuquerque Indian School. It was designed to include not only the students but also their families with learning activities that required consultation in search of answers or understanding. The first issue presented sought to…

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

    PubMed

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

    2015-10-01

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

  20. Global and robust stability analysis of genetic regulatory networks with time-varying delays and parameter uncertainties.

    PubMed

    Fang-Xiang Wu

    2011-08-01

    The study of stability is essential for designing or controlling genetic regulatory networks. This paper addresses global and robust stability of genetic regulatory networks with time delays and parameter uncertainties. Most existing results on this issue are based on the linear matrix inequalities (LMIs) approach, which results in checking the existence of a feasible solution to high dimensional LMIs. Based on M-matrix theory, we will present several novel global stability conditions for genetic regulatory networks with time-varying and time-invariant delays. All of these stability conditions are given in terms of M-matrices, for which there are many and very easy ways to be verified. Then, we extend these results to genetic regulatory networks with time delays and parameter uncertainties. To illustrate the effectiveness of our theoretical results, several genetic regulatory networks are analyzed. Compared with existing results in the literature, we also show that our results are less conservative than existing ones with these illustrative genetic regulatory networks.

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

    PubMed

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

    2015-10-01

    The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. PMID:26188116

  2. Best Practices in Hiring: Addressing Unconscious Bias

    NASA Astrophysics Data System (ADS)

    Simpson, Caroline E.

    2012-01-01

    Research has shown that implementing certain hiring practices will increase diversity in the workplace while enhancing academic quality. All of these practices rely on addressing the issue of 'unconscious bias.' A brief overview of unconscious bias--what it is, how it works, and simple measures to counter it--will be presented. Successful strategies, actions, and recommendations for implementing best recruiting and hiring practices, which have been proven to enhance academic excellence by ensuring a deep and diverse applicant pool, will also be presented.

  3. Addressing the underperformance of faculty and staff.

    PubMed

    Kenner, Carole; Pressler, Jana L

    2006-01-01

    Many new nursing leaders assuming work as deans, assistant deans, or interim deans have limited education, experience, or background to prepare them for the job. To assist new deans and those aspiring to be deans, the authors of this department, both deans, offer survival tips based on their personal experiences and insights. They address common issues, challenges, and opportunities that face academic executive teams, such as negotiating an executive contract, obtaining faculty lines, building effective work teams, managing difficult employees, and creating nimble organizational structure to respond to changing consumer, healthcare delivery, and community needs. The authors welcome counterpoint discussions with readers. PMID:17108781

  4. Drugs. Social Issues Resources Series.

    ERIC Educational Resources Information Center

    Goldstein, Eleanor C.; And Others

    The Social Issues Resources Series (SIRS) is a set of loose leaf units each of which is addressed to a different social issue. Each unit consists of articles which have been reproduced from newspapers, magazines, journals and government publications representing the prevailing spectrum of opinion, emphasis and complexity. Sixty articles are…

  5. Concrete Masonry Designs: Educational Issue.

    ERIC Educational Resources Information Center

    Hertzberg, Randi, Ed.

    2001-01-01

    This special journal issue addresses concrete masonry in educational facilities construction. The issue's feature articles are: (1) "It Takes a Village To Construct a Massachusetts Middle School," describing a middle school constructed almost entirely of concrete masonry and modeled after a typical small New England village; (2) "Lessons Learned,"…

  6. 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).

  7. 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

  8. 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.

  9. Issues management made easier

    SciTech Connect

    Brownson, L.

    1993-10-01

    Increases in ES&H compliance issues within the past few years have necessitated a formal process by which DOE facilities address these issues. In May 1991, ANL-W implemented the ANL-W Issues Management System (IMS) to facilitate the management of compliance issues and scheduling of corrective action plans with limited resources. The central focus of this process is a computer database, Integrated Resource Management System (IRMS), which allows quick retrieval of compliance information, organization of compliance issues based on a risk-based prioritization methodology, and tracking of corrective action plans. Without the IRMS, the ANL-W Issues Management System would have been difficult to administer and manage. ANL-W has used the IRMS for both audit preparation and audit response, most noticeably the preparation and subsequent response to the 1991 Tiger Team audit. The IRMS was used to track ANL-W Self-Assessment corrective action plans, provide instant information to Tiger Team members regarding Self-Assessment findings, produce prioritized lists of Tiger Team concerns for developing corrective action plans, and track Tiger Team corrective action plans. Status reports to senior, laboratory management regarding the Tiger Team corrective action plan are produced based on information provided by the IRMS. This paper discusses the criteria used for selecting the IRMS, implementation of the Issues Management System using the IRMS, lessons learned, and the future evolution of the IRMS.

  10. 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

  11. Contractual issues for faculty practice.

    PubMed

    Gregg, A C; Williams, M D

    2001-01-01

    Contracts are a common foundation for faculty practice relationships between a college of nursing and other agencies. Although the legal format of a contract is relatively standardized, the process of contracting entails decisions and issues that increase its complexity. Little is available in the faculty practice literature that addresses contracts and contractual issues as a comprehensive whole. This article contains discussions of nursing faculty practice contractual issues such as the elements of a contract as a framework, including competent parties, offer, consideration, and acceptance. Evaluation of contract performance is addressed and alternatives for decision making and problem resolutions are suggested throughout. J Prof Nurs 17:173-179, 2001. PMID:11464338

  12. Global Regulatory Pathways in the Alphaproteobacteria

    SciTech Connect

    2007-04-27

    A major goal for microbiologists in the twenty-first century is to develop an understanding of the microbial cell in all its complexity. In addition to understanding the function of individual gene products we need to focus on how the cell regulates gene expression at a global level to respond to different environmental parameters. Development of genomic technologies such as complete genome sequencing, proteomics, and global comparisons of mRNA expression patterns allows us to begin to address this issue. This proposal focuses on a number of phylogenetically related bacteria that are involved in environmentally important processes such as carbon sequestration and bioremediation. Genome sequencing projects of a number of these bacteria have revealed the presence of a small family of regulatory genes found thus far only in the alpha-proteobacteria. These genes encode proteins that are related to the global regulatory protein RosR in Rhizobium etli, which is involved in determining nodulation competitiveness in this bacterium. Our goal is to examine the function of the proteins encoded by this gene family in several of the bacteria containing homologs to RosR. We will construct gene disruption mutations in a number of these bacteria and characterize the resulting mutant strains using two-dimensional gel electrophoresis and genetic and biochemical techniques. We will thus determine if the other proteins also function as global regulators of gene expression. Using proteomics methods we will identify the specific proteins whose expression varies depending on the presence or absence of the RosR homolog. Over fifty loci regulated by RosR have been identified in R. etli using transposon mutagenesis; this will serve as out benchmark to which we will compare the other regulons. We expect to identify genes regulated by RosR homologs in several bacterial species, including, but not limited to Rhodopseudomonas palustris and Sphingomonas aromaticivorans. In this way we will

  13. Family Issues

    MedlinePlus

    ... not mean that everyone gets along all the time. Conflicts are a part of family life. Many things can lead to conflict, such as illness, disability, addiction, job loss, school problems, and marital issues. Listening to ...

  14. Contemporary issues in transfusion medicine informatics

    PubMed Central

    Sharma, Gaurav; Parwani, Anil V.; Raval, Jay S.; Triulzi, Darrell J.; Benjamin, Richard J.; Pantanowitz, Liron

    2011-01-01

    The Transfusion Medicine Service (TMS) covers diverse clinical and laboratory-based services that must be delivered with accuracy, efficiency and reliability. TMS oversight is shared by multiple regulatory agencies that cover product manufacturing and validation standards geared toward patient safety. These demands present significant informatics challenges. Over the past few decades, TMS information systems have improved to better handle blood product manufacturing, inventory, delivery, tracking and documentation. Audit trails and access to electronic databases have greatly facilitated product traceability and biovigilance efforts. Modern blood bank computing has enabled novel applications such as the electronic crossmatch, kiosk-based blood product delivery systems, and self-administered computerized blood donor interview and eligibility determination. With increasing use of barcoding technology, there has been a marked improvement in patient and specimen identification. Moreover, the emergence of national and international labeling standards such as ISBT 128 have facilitated the availability, movement and tracking of blood products across national and international boundaries. TMS has only recently begun to leverage the electronic medical record to address quality issues in transfusion practice and promote standardized documentation within institutions. With improved technology, future growth is expected in blood bank automation and product labeling with applications such as radio frequency identification devices. This article reviews several of these key informatics issues relevant to the contemporary practice of TMS. PMID:21383927

  15. Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

    SciTech Connect

    Sheehan, M.A.

    1997-04-01

    This compilation is the annual cumulation of bibliographic data and abstracts for the formal regulatory and technical reports issued by the U.S. Nuclear Regulatory Commission (NRC) Staff and its contractors.

  16. Fitness for duty in the nuclear power industry: A review of technical issues

    SciTech Connect

    Moore, C.; Barnes, V.; Hauth, J.; Wilson, R.; Fawcett-Long, J.; Toquam, J.; Baker, K.; Wieringa, D.; Olson, J.; Christensen, J.

    1989-05-01

    This report presents information gathered and analyzed in support of the US Nuclear Regulatory Commission's (NRC's) efforts to develop a rule that will ensure that workers with unescorted access to protected areas of nuclear power plants are fit for duty. This report supplements information previously published in NUREG/CR-5227, Fitness for Duty in the Nuclear Power Industry: A Review of Technical Issues (Barnes et al., 1988). The primary potential fitness-for-duty concern addressed in both of these reports is impairment caused by substance abuse, although other fitness concerns are discussed. This report addresses issues pertaining to workers' use and misuse of alcohol, prescription drugs, and over-the-counter drugs as fitness-for-duty concerns; responds to several questions raised by NRC Commissioners; discusses subversion of the chemical testing process and methods of preventing such subversion; and examines concerns about the urinalysis cutoff levels used when testing for marijuana metabolites, amphetamines, and phencyclidine (PCP).

  17. Post 9-11 Security Issues for Non-Power Reactor Facilities

    SciTech Connect

    Zaffuts, P. J.

    2003-02-25

    This paper addresses the legal and practical issues arising out of the design and implementation of a security-enhancement program for non power reactor nuclear facilities. The security enhancements discussed are derived from the commercial nuclear power industry's approach to security. The nuclear power industry's long and successful experience with protecting highly sensitive assets provides a wealth of information and lessons that should be examined by other industries contemplating security improvements, including, but not limited to facilities using or disposing of nuclear materials. This paper describes the nuclear industry's approach to security, the advantages and disadvantages of its constituent elements, and the legal issues that facilities will need to address when adopting some or all of these elements in the absence of statutory or regulatory requirements to do so.

  18. 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...

  19. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  20. 21 CFR 810.11 - Regulatory hearing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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