Sample records for address regulatory issues

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

    ERIC Educational Resources Information Center

    American Chemical Society, Washington, DC.

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

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

    USDA-ARS?s Scientific Manuscript database

    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 ...

  3. Key anticipated regulatory issues for clinical use of human induced pluripotent stem cells.

    PubMed

    Knoepfler, Paul S

    2012-09-01

    The production of human induced pluripotent stem cells (hiPSCs) has greatly expanded the realm of possible stem cell-based regenerative medicine therapies and has particularly exciting potential for autologous therapies. However, future therapies based on hiPSCs will first have to address not only similar regulatory issues as those facing human embryonic stem cells with the US FDA and international regulatory agencies, but also hiPSCs have raised unique concerns as well. While the first possible clinical use of hiPSCs remains down the road, as a field it would be wise for us to anticipate potential roadblocks and begin formulating solutions. In this article, I discuss the potential regulatory issues facing hiPSCs and propose some potential changes in the direction of the field in response.

  4. 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…

  5. 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.

  6. 75 FR 44781 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... 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 on August 11, 2010, from 9 a.m...

  7. 75 FR 66362 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-28

    ...; File No. 265-26] Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Commodity... 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 on November 5, 2010, from 9 a.m...

  8. Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

    PubMed

    Pires, Carla; Vigário, Marina; Cavaco, Afonso

    2015-01-01

    Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

  9. Ten Years of Addressing Children’s Health through Regulatory Policy at the U.S. Environmental Protection Agency

    PubMed Central

    Payne-Sturges, Devon; Kemp, Debra

    2008-01-01

    Background Executive Order (EO) 13045, Protection of Children From Environmental Health Risks and Safety Risks, directs each federal agency to ensure that its policies, programs, activities, and standards address disproportionate environmental health and safety risks to children. Objectives We reviewed regulatory actions published by U.S. Environmental Protection Agency (EPA) in the Federal Register from April 1998 through December 2006 to evaluate applicability of EO 13045 to U.S. EPA actions and consideration of children’s health issues in U.S. EPA rulemakings. Discussion Although virtually all actions discussed EO 13045, fewer than two regulations per year, on average, were subject to the EO requirement to evaluate children’s environmental health risks. Nonetheless, U.S. EPA considered children’s environmental health in all actions addressing health or safety risks that may disproportionately affect children. Conclusion The EO does not apply to a broad enough set of regulatory actions to ensure protection of children’s health and safety risks, largely because of the small number of rules that are economically significant. However, given the large number of regulations that consider children’s health issues despite not being subject to the EO, other statutory requirements and agency policies reach a larger set of regulations to ensure protection of children’s environmental health. PMID:19079726

  10. 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.

  11. 77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555... State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington...

  12. 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.

  13. How health technology assessment agencies address the issue of unpublished data.

    PubMed

    Kreis, Julia; Panteli, Dimitra; Busse, Reinhard

    2014-01-01

    Reporting bias potentially threatens the validity of results in health technology assessment (HTA) reports. Our study aimed to explore policies and practices of HTA agencies regarding strategies to include previously unpublished data in their assessments, focusing on requests to industry for unpublished data. We included international HTA agencies with publicly available methods papers as well as HTA reports. From the methods papers and recent reports we extracted information on requests to industry and on searches in trial registries, regulatory authority Web sites and for conference abstracts. Eighteen HTA agencies and seventy-three reports were included. Agencies' methods papers showed variability regarding requests to industry (requests are routinely carried out in seven cases, not mentioned in six, at the discretion of HTA authors in three, and based on manufacturer applications in two), which were reflected in the reports investigated. As reporting of requests was limited, it often remained unclear whether unpublished data had been received. Searches in trial registries, at regulatory authorities or for conference abstracts are described as a routine or optional part of the search strategy in the methods papers of 9, 11, and 8 included agencies, respectively. A total of 52 percent, 39 percent, and 16 percent of reports described searches in trial registries, at regulatory agencies, and hand searching of conference proceedings. International HTA agencies currently differ considerably in their efforts to address the issue of unpublished data. Requests to industry may constitute one strategy to access and include unpublished data, while agencies can learn from each other concerning successful practice.

  14. 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…

  15. Advances in Behavioral Laboratory Methods that Inform Tobacco Regulatory Science: A TCORS Working Group Special Issue

    PubMed Central

    Wright, M. Jerry; Valentine, Gerald

    2017-01-01

    Objective The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) created unprecented enabling conditions for establishing national regulatory policy that reduces the burden of public health and societal problems associated with tobacco product use. The Center for Tobacco Products (CTP), created by the FDA to implement the TCA, developed a first-of-its-kind FDA/National Institutes of Health (NIH) collaborative program to fund Tobacco Centers of Regulatory Science (TCORS). Methods To assist the TCORS with addressing research priorites, working groups (WGs) comprised of FDA-CTP liasions and TCORS investigators were formed. Under the direction of the Center for Evaluation and Coordination of Trainin and Research (CECTR), the TCORS WGs seek to develop tangible work products in their respective areas of focus. Results The focus of the behavioral pharmacology WG evolved from publishing a narrow paper on behavioral methods in electronic cigarette research to a collection of papers on advances in behavioral laboratory methods that may inform tobacco regulatory science. Conclusion This Special Issue contains articles that address all of the CTP research priorities and demonstrates how advances in behavioral laboratory methods made by TCORS investigators can inform FDA efforst to regulate tobacco products. PMID:29152546

  16. Regulatory issues in accreditation of toxicology laboratories.

    PubMed

    Bissell, Michael G

    2012-09-01

    Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

  17. 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.

  18. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

    PubMed

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

    2016-12-01

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

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Miller, M.; Cox, S.

    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,more » and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.« less

  20. 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,…

  1. Addressing Measurement Issues Related to Bullying Involvement

    ERIC Educational Resources Information Center

    Casper, Deborah M.; Meter, Diana J.; Card, Noel A.

    2015-01-01

    In this article, we address measurement issues related to select aspects of bullying involvement with the goal of moving psychometrically sound measurement practices toward applied bullying research. We first provide a nontechnical introduction to psychometric considerations in measuring bullying involvement, highlighting the importance of…

  2. Biomedical applications of tissue engineering technology: regulatory issues.

    PubMed

    Hellman, K B

    1995-01-01

    for Veterinary Medicine (CVM) has developed a Draft Report considering recent developments in tissue engineering and scientific and regulatory issues in the product application areas. The Working Group has identified generic safety and effectiveness issues for consideration by the research and development community in its development of products. The FDA centers are using multiple approaches at their disposal in the evaluation of tissue engineered products including research, data and information monitoring, regulatory guidance, training and education, and cooperation with public and private groups.

  3. Prescription Drug Abuse: Epidemiology, Regulatory Issues, Chronic Pain Management with Narcotic Analgesics

    PubMed Central

    Manubay, Jeanne M.; Muchow, Carrie; Sullivan, Maria A.

    2012-01-01

    Synopsis The epidemic of prescription drug abuse has reached a critical level, which has received national attention. Physicians must learn strategies to effectively treat chronic pain, and help reduce the rates of prescription drug abuse. This chapter will provide insight into the epidemiology of prescription drug abuse, explain regulatory issues, and provide guidelines for the assessment and management of pain, particularly with chronic opioid therapy. The use of informed consent forms, treatment agreements, risk documentation tools, and regular monitoring of the 4 “A's” helps to educate patients, as well as guide management based on treatment goals. By using universal precautions, and being aware of aberrant behaviors, physicians may feel more confident in identifying and addressing problematic behaviors. PMID:21356422

  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. Addressing Career Issues Online: Perceptions of Counselor Education Professionals

    ERIC Educational Resources Information Center

    Lewis, Jacqueline; Coursol, Diane

    2007-01-01

    The Internet is the latest arena in which counseling services are available for a variety of issues. This study surveyed counselor education professionals about their perceptions regarding the use of online counseling to address various mental health issues including career counseling. It also examined their perceptions about 3 formats of online…

  6. Animal Health Ireland: providing national leadership and coordination of non-regulatory animal health issues in Ireland.

    PubMed

    More, S J; Doherty, M L; Downey, L; McKenzie, K; Devitt, C; O'Flaherty, J

    2011-12-01

    Livestock production plays an important role in the Irish economy. Regulatory animal health issues are the responsibility of government, but until recently there has been no national coordination of non-regulatory animal health issues. This gap has recently been filled with the establishment of Animal Health Ireland (AHI), a not-for-profit, partnership-based organisation providing national leadership and coordination of non-regulatory animal health issues in Ireland. Animal Health Ireland provides benefits to livestock producers and processors by providing the knowledge, education and coordination required to establish effective control strategies, both on-farm and nationally. This paper presents a brief overview of the context for AHI, and of its establishment and initial activities. Non-regulatory animal health issues have been prioritised. A series of work programmes (each focusing on a high-priority issue) have been established. Partnership is critical to success, both for AHI as an organisation and for effective farm-level transfer of knowledge. This model for national leadership and coordination of non-regulatory animal health issues may be of relevance elsewhere.

  7. 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

  8. 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 Commission...

  9. 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 Commission...

  10. 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 Commission...

  11. 10 CFR Appendix A to Part 73 - U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  12. 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 Commission...

  13. Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues.

    PubMed

    Kramer, Gregory M; Luxton, David D

    2016-04-01

    The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations.

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

    PubMed

    Benda, Norbert; Brandt, Andreas

    2018-01-01

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

  15. Nanomedicines: addressing the scientific and regulatory gap.

    PubMed

    Tinkle, Sally; McNeil, Scott E; Mühlebach, Stefan; Bawa, Raj; Borchard, Gerrit; Barenholz, Yechezkel Chezy; Tamarkin, Lawrence; Desai, Neil

    2014-04-01

    Nanomedicine is the application of nanotechnology to the discipline of medicine: the use of nanoscale materials for the diagnosis, monitoring, control, prevention, and treatment of disease. Nanomedicine holds tremendous promise to revolutionize medicine across disciplines and specialties, but this promise has yet to be fully realized. Beyond the typical complications associated with drug development, the fundamentally different and novel physical and chemical properties of some nanomaterials compared to materials on a larger scale (i.e., their bulk counterparts) can create a unique set of opportunities as well as safety concerns, which have only begun to be explored. As the research community continues to investigate nanomedicines, their efficacy, and the associated safety issues, it is critical to work to close the scientific and regulatory gaps to assure that nanomedicine drives the next generation of biomedical innovation. © 2014 New York Academy of Sciences.

  16. Measuring students' attitudes toward college education's role in addressing social issues.

    PubMed

    Weber, James E; Weber, Paula S; Craven, Barney L

    2008-06-01

    As service-learning projects have spread throughout academia, efforts to assess the service-learning experience have assumed a greater importance. The BERSI scale (Business Education's Role in addressing Social Issues) was developed as a measure of business students' attitudes toward social issues being addressed as part of a business education. As such, it was intended to be useful in assessing attitudinal outcomes of service learning. In order for the BERSI to be useful for nonbusiness students, the scale would need to be reconceptualized and revalidated. This study modified the BERSI items with a focus on college students in general rather than business students, making the resulting scale, College Education's Role in addressing Social Issues (CERSI), potentially helpful to service-learning researchers in a broader setting. The CERSI scale was then validated using standard techniques and normative data were reported.

  17. Addressing chronic operational issues at the W. M. Keck Observatory

    NASA Astrophysics Data System (ADS)

    Nordin, Tom; Matsuda, Richard

    2016-07-01

    The W. M. Keck Observatory (WMKO) has a good track record at addressing large critical faults which impact observing. Our performance tracking and correcting chronic minor faults has been mixed, yet this class of problems has a significant negative impact on scientific productivity and staff effectiveness. We have taken steps to address this shortcoming. This paper outlines the creation of a program to identify, categorize and rank these chronic operational issues, track them over time, and develop management options for their resolution. The success of the program at identifying these chronic operational issues and the advantages of dedicating observatory resources to this endeavor are presented.

  18. Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

    PubMed

    Risso-Gill, Isabelle; Legido-Quigley, H; Panteli, D; Mckee, M

    2014-08-01

    This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  19. 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.

  20. 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.

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

    PubMed

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

    2018-02-01

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

  2. 77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

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

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Peterson, Mark J.; Cada, Glenn F.; Sale, Michael J.

    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 implementingmore » 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

  4. 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.

  5. 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…

  6. Rationales for regulatory activity

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Perhac, R.M.

    1997-02-01

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

  7. Common Carrier Access to Cable Communications: Regulatory and Economic Issues.

    ERIC Educational Resources Information Center

    Kestenbaum, Lionel

    The implications of cable television (CATV) common carrier access and economic and regulatory issues associated with it are examined in this paper. The first section provides a discussion of the feasibility and legal basis of common carrier access; the next section contrasts common carrier access with existing over-the-air television broadcasting…

  8. 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...

  9. Addressing Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) Issues in Teacher Education: Teacher Candidates' Perceptions

    ERIC Educational Resources Information Center

    Kitchen, Julian; Bellini, Christine

    2012-01-01

    Homophobic harassment and bullying are persistent issues in Canadian schools despite recent initiatives to improve school climate. Among the reasons is that educators feel reluctant or ill-prepared to address these issues. The purpose of this paper is to examine how teacher education can help make schools safer by addressing LGBTQ issues and…

  10. Study of the regulatory issues affecting truck freight movement in the Midwest : [tech transfer summary].

    DOT National Transportation Integrated Search

    2014-12-01

    This initial study identified the need for and interest in a peer-to-peer event focused on identifying regulatory trends and issues, as : well as the potential for Iowa and other states to find and prioritize : possible regulatory changes to improve ...

  11. Study of the regulatory issues affecting truck freight movement in the Midwest.

    DOT National Transportation Integrated Search

    2014-12-01

    This project investigated regulatory issues that may affect or limit freight movement in Iowa and other Midwest states: Illinois, Kansas, : Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin. Current state regulations for the following are re...

  12. 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

  13. 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.

  14. 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 GENERAL...

  15. 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 GENERAL...

  16. 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 GENERAL...

  17. 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 GENERAL...

  18. Ethical and regulatory issues arising from proteomic research and technology.

    PubMed

    Reymond, Marc A; Steinert, Ralf; Eder, Frank; Lippert, Hans

    2003-08-01

    Over the last two decades, medical research has begun to make extensive use of products of human origin in therapeutics, oncology, and most recently, in genetic diseases. This has raised many ethical issues involving patient rights, including issues of consent. Besides informed consent, researchers should address several topics when designing studies using human tissues. Reward for the patient should be kept minimal. Sample transfer should be organized along non-profit lines, at least in Europe. Sampling procedures should be at no risk for human volunteers, and at minimal risk for patients. Biosafety aspects should be addressed, in particular when international collaborations are intended or when collaboration is existing between academia and industry. Regulations on importation and exportation of human tissues should be observed. Data acquisition and storage should be addressed in accordance with national data protection regulations, in particular when using computerized databases. If follow-up information is to be taken, the authorization for such information should be requested. The right for patient's information (or for no information) on the research results should also be addressed. The issues of validation and patenting should be also solved, usually by informing the patient that he/she will have no commercial rights on potential research results. The patient should be told if the samples are transferred to another research laboratory or private company. Samples and related data should be destroyed on request at any time point during the course of the study. If possible, traceability of the donor should be ensured.

  19. Empowering people to change occupational behaviours to address critical global issues.

    PubMed

    Ikiugu, Moses N; Westerfield, Madeline A; Lien, Jamie M; Theisen, Emily R; Cerny, Shana L; Nissen, Ranelle M

    2015-06-01

    The greatest threat to human well-being in this century is climate change and related global issues. We examined the effectiveness of the Modified Instrumentalism in Occupational Therapy model as a framework for facilitating occupational behaviour change to address climate change and related issues. Eleven individuals participated in this mixed-methods single-subject-design study. Data were gathered using the Modified Assessment and Intervention Instrument for Instrumentalism in Occupational Therapy and Daily Occupational Inventories. Quantitative data were analyzed using two- and three-standard deviation band methods. Qualitative data were analyzed using heuristic phenomenological procedures. Occupational performance changed for five participants. Participants' feelings shifted from frustration and helplessness to empowerment and a desire for action. They felt empowered to find occupation-based solutions to the global issues. Occupation-based interventions that increase personal awareness of the connection between occupational performance and global issues could empower people to be agents for action to ameliorate the issues.

  20. 23 CFR 636.501 - What issues may be addressed in discussions?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false What issues may be addressed in discussions? 636.501 Section 636.501 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND...-take, and may apply to price, schedule, technical requirements, type of contract, or other terms of a...

  1. 23 CFR 636.501 - What issues may be addressed in discussions?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 23 Highways 1 2013-04-01 2013-04-01 false What issues may be addressed in discussions? 636.501 Section 636.501 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND...-take, and may apply to price, schedule, technical requirements, type of contract, or other terms of a...

  2. 23 CFR 636.501 - What issues may be addressed in discussions?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false What issues may be addressed in discussions? 636.501 Section 636.501 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND...-take, and may apply to price, schedule, technical requirements, type of contract, or other terms of a...

  3. 23 CFR 636.501 - What issues may be addressed in discussions?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false What issues may be addressed in discussions? 636.501 Section 636.501 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND...-take, and may apply to price, schedule, technical requirements, type of contract, or other terms of a...

  4. 23 CFR 636.501 - What issues may be addressed in discussions?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 23 Highways 1 2014-04-01 2014-04-01 false What issues may be addressed in discussions? 636.501 Section 636.501 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND...-take, and may apply to price, schedule, technical requirements, type of contract, or other terms of a...

  5. Addressing Issues of Religious Difference through Values Education: An Islam Instance

    ERIC Educational Resources Information Center

    Lovat, Terence; Clement, Neville; Dally, Kerry; Toomey, Ron

    2010-01-01

    The article's main focus is on exploring ways in which modern forms of values education are being utilized to address major issues of social dissonance, with special focus on dissonance related to religious difference between students of Islamic and non-Islamic backgrounds. The article begins by appraising philosophical and neuroscientific…

  6. Addressing Dynamic Issues of Program Model Checking

    NASA Technical Reports Server (NTRS)

    Lerda, Flavio; Visser, Willem

    2001-01-01

    Model checking real programs has recently become an active research area. Programs however exhibit two characteristics that make model checking difficult: the complexity of their state and the dynamic nature of many programs. Here we address both these issues within the context of the Java PathFinder (JPF) model checker. Firstly, we will show how the state of a Java program can be encoded efficiently and how this encoding can be exploited to improve model checking. Next we show how to use symmetry reductions to alleviate some of the problems introduced by the dynamic nature of Java programs. Lastly, we show how distributed model checking of a dynamic program can be achieved, and furthermore, how dynamic partitions of the state space can improve model checking. We support all our findings with results from applying these techniques within the JPF model checker.

  7. Addressing Personal Issues in Supervision: Impact of Counselors' Experience Level on Various Aspects of the Supervisory Relationship.

    ERIC Educational Resources Information Center

    Sumerel, Marie B.; Borders, L. Dianne

    1996-01-01

    In this study, entry-level and advanced counselors (N=40) rated videotaped supervision sessions in which either the counselor's personal issues or skills deficits were addressed. The study's goal was to determine the impact that addressing counselors' personal issues in supervision has on relationship, quality of the session, postsession mood, and…

  8. 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. Published by Elsevier Inc.

  9. 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.

  10. 2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

    PubMed

    Garofolo, Fabio; Rocci, Mario L; Dumont, Isabelle; Martinez, Suzanne; Lowes, Steve; Woolf, Eric; van Amsterdam, Peter; Bansal, Surendra; Barra, Ariadna Cristina Gomes; Bauer, Ronald; Booth, Brian P; Carrasco-Triguero, Montserrat; DeSilva, Binodh; Dunn, John; Gallicano, Keith; Gouty, Dominique; Ho, Stacy; Hucker, Richard; Jemal, Mohammed; Katori, Noriko; Le Blaye, Olivier; Lee, Jean; Li, Wenkui; Michael, Steve; Nehls, Corey; Nicholson, Robert; Ormsby, Eric; Tang, Daniel; Viswanathan, C T; Weiner, Russell; Young, Graeme

    2011-09-01

    The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.

  11. 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...

  12. 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.

  13. 49 CFR 192.933 - What actions must be taken to address integrity issues?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Transmission Pipeline Integrity Management § 192.933 What actions must be taken to address integrity issues? (a... any indication of metal loss, cracking or a stress riser. (iii) An indication or anomaly that in the...

  14. 49 CFR 192.933 - What actions must be taken to address integrity issues?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Transmission Pipeline Integrity Management § 192.933 What actions must be taken to address integrity issues? (a... any indication of metal loss, cracking or a stress riser. (iii) An indication or anomaly that in the...

  15. 49 CFR 192.933 - What actions must be taken to address integrity issues?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Transmission Pipeline Integrity Management § 192.933 What actions must be taken to address integrity issues? (a... any indication of metal loss, cracking or a stress riser. (iii) An indication or anomaly that in the...

  16. Addressing Individual Difficulties in Reading: Issues Relating to Reading Recovery and Pause, Prompt, Praise

    ERIC Educational Resources Information Center

    Wearmouth, Janice

    2004-01-01

    Recently the DfES has issued guidance on ways to address the needs of students who experience difficulties in literacy through Wave Three provision in the National Literacy Strategy (DfES, 2002). This guidance raises the issue of what kind of programmes might be initiated in mainstream schools that will improve what is available generally for…

  17. 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.…

  18. Regional Seminars to Address Current Nuclear Export Control Issues

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Killinger, Mark H.

    2002-07-01

    The control of nuclear-related exports, a critical component of the nonproliferation regime, is facing several opportunities and challenges. As countries sign and ratify the International Atomic Energy Agency's (IAEA) safeguards Additional Protocol (AP), they will begin to report far more export information, including exports of a list of items similar to the Nuclear Supplier Group's Trigger List that existed when the AP was developed in the mid-1990s. This positive development contrasts with challenges such as globalization, transshipments, and tracking of end-uses. Pacific Northwest National Laboratory is proposing that the US Department of Energy (DOE) develop regional seminars that address thesemore » types of issues related to export/import controls. The DOE seminars would be designed to supplement regional seminars sponsored by the IAEA and member states on topics related to the Additional Protocol (referred to as "IAEA seminars"). The topic of nuclear export/import controls is not thoroughly addressed in the IAEA seminars. The proposed DOE seminars would therefore have two objectives: familiarizing countries with the export/import provisions of the Additional Protocol, and addressing challenges such as those noted above. The seminars would be directed particularly at countries that have not ratified the AP, and at regions where export-related problems are particularly prevalent. The intent is to encourage governments to implement more effective nuclear export control systems that meet the challenges of the 21st century.« less

  19. 49 CFR 192.933 - What actions must be taken to address integrity issues?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS Gas Transmission Pipeline Integrity Management § 192.933 What actions must be taken to address integrity issues? (a...

  20. Regulatory issues for computerized electrocardiographic devices.

    PubMed

    Muni, Neal I; Ho, Charles; Mallis, Elias

    2004-01-01

    Computerized electrocardiogram (ECG) devices are regulated in the U.S. by the FDA Center for Devices and Radiological Health (CDRH). This article aims to highlight the salient points of the FDA regulatory review process, including the important distinction between a "tool" claim and a "clinical" claim in the intended use of a computerized ECG device. Specifically, a tool claim relates to the ability of the device to accurately measure a certain ECG parameter, such as T-wave alternans (TWA), while a clinical claim imputes a particular health hazard associated with the identified parameter, such as increased risk of ventricular tachyarrhythmia or sudden death. Given that both types of claims are equally important and receive the same regulatory scrutiny, the manufacturer of a new ECG diagnostic device should consider the distinction and regulatory pathways for approval between the two types of claims discussed in this paper.

  1. Addressing Issues for Land Change Science

    NASA Astrophysics Data System (ADS)

    Braimoh, Ademola; Huang, He Qing

    2009-09-01

    Workshop on Vulnerability and Resilience of Land Systems in Asia; Beijing, China, 15-17 June 2009; There is a growing international community of scholars who work within the interdisciplinary field of land change science, a scientific domain that seeks to understand the dynamics of the land system as a coupled human-environment system. A coupled human-environment system is one in which the social and biophysical subsystems are intertwined so that the system's condition and responses to external forcing are based on the synergy of the two subsystems. Research on land system vulnerability, defined as a function of exposure and sensitivity to natural and anthropogenic perturbations, such as climate variability and sudden changes in macroeconomic conditions and the ability to cope with the impacts of those perturbations, is a fundamental component of land change science. To address issues related to land system vulnerability, the Global Land Project (GLP; http://www.glp-beijing.org.cn/index.php and http://www.glp.hokudai.ac.jp) brought together an interdisciplinary group of researchers with backgrounds ranging from environmental to social sciences. Participants came from both developed and developing countries. The workshop sought to (1) improve knowledge of the causal processes that affect a system's vulnerability and capacity to cope with different perturbations and (2) identify factors that hinder the integration of vulnerability assessment into policies and decision making.

  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. 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. Copyright © 2012 Elsevier B.V. All rights reserved.

  4. International Conference on Harmonisation; guidance on the M4 Common Technical Document--Quality: Questions and Answers/Location Issues; availability. Notice.

    PubMed

    2004-06-09

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance provides further clarification for preparing the quality components of an application file in the common technical document (CTD) format. The guidance addresses the relationship between linked sections for certain parameters (such as polymorphism and particle size), and it addresses location issues (by indicating the section in which to place requested information). The guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.

  5. 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…

  6. The Learning Community: A Program to Address Issues of Academic Achievement and Retention.

    ERIC Educational Resources Information Center

    Hummel, Mary; Steele, Claude

    1996-01-01

    Describes the 21st Century Program at the University of Michigan, a program to address issues of academic achievement and student retention in higher education. The conceptual basis for this program comes from C. Steele's work that finds that there are disruptive pressures tied to racial stereotypes that in turn diminish academic performance. (SLD)

  7. 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

  8. 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

  9. 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.

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

    NASA Astrophysics Data System (ADS)

    Greenberg, Joel S.

    1996-10-01

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

  11. NIH Research Addresses Aging Issues and Disparities in Oral Health | NIH MedlinePlus the Magazine

    MedlinePlus

    ... JavaScript on. Feature: Oral Health and Aging NIH Research Addresses Aging Issues and Disparities in Oral Health ... NIH Why is it important to have a research focus on older adults? One reason is that ...

  12. 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.

  13. A Leadership Imperative: Addressing Legal Issues.

    ERIC Educational Resources Information Center

    Woolley, Rosemary; And Others

    Focusing on the Student Right to Know and Campus Security Act (SRKCSA) of 1990, the First Amendment, and judicial issues related to disciplinary counseling, this document discusses legal issues for student development personnel not engaged in instruction and therefore falling outside of traditional academic rulings. The first section describes the…

  14. Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

    PubMed

    Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

    2014-12-01

    Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

  15. Addressing agricultural issues in health care education: an occupational therapy curriculum program description.

    PubMed

    Smallfield, Stacy; Anderson, Angela J

    2008-01-01

    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 high-risk occupations for work-related injuries and accidents; therefore, it is critical that health education programs include content to prepare future medical and health professionals to work with this population. This paper describes the rural issues component of the occupational therapy curriculum at The University of South Dakota. This rural issues module is designed to provide occupational therapists with training about the physical, temporal, and sociocultural aspects of production agriculture and the impact these have on the health and well-being of the agricultural population. It also addresses the occupational therapy implications for farmers and ranchers who have disabilities. Student assessments of the course content have been above average. Training in agricultural health enables our occupational therapy students to be well prepared for work in the rural and frontier areas of South Dakota and other rural locations.

  16. Steam generator issues in the United States

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 themore » 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.« less

  17. Regulatory Issues Associated with Preharvest Food Safety: United States Perspective.

    PubMed

    Micallef, Shirley A; Buchanan, Robert L

    2017-07-01

    The preharvest and preslaughter steps of food production constitute a first stage at which food can become contaminated with foodborne and toxigenic pathogens. Contamination at this early stage of food production can lead to amplification as food travels through the production and supply chain, accentuating the crucial need to address hazards and establish science-based metrics that are feasible to implement. This article discusses the preharvest food safety regulatory landscape in the United States, with a specific emphasis on fresh produce crops. Best practices, certification, audit schemes and challenges due to market channels, economies of scales, and grower behavior are considered in relation to the Food Safety Modernization Act. An outlook on the needs to facilitate implementation of the new law, develop educational programs for growers and stakeholders, and continue to better align food safety with environmental goals are presented.

  18. Waste-to-energy: What are the issues?

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Merritt, J.A.

    1995-09-01

    It is very difficult to have been associated with the Waste-to-Energy ({open_quotes}WTE{close_quotes}) Industry during the past twelve months without feeling a profound sense of being under attack and more than a little shell shocked. That is not to say that scrutiny and regulation haven`t been an important factor for WTE from its inception, only that it seems that certain difficult issues have been thrust to the fore through the recent actions of the courts and regulatory agencies. While ash management and flow control hit center stage with a flourish in a one-two punch last Spring with the Supreme Court inmore » the City of Chicago and Carbone decisions, significant compliance issues still remain with respect to implementing the Clean Air Act Amendments of 1990 ({open_quotes}CAAA{close_quotes}). In my state, the long term plans for waste management have WTE facilities responsible for turning 50% of the total waste stream into electricity, with other recycling accounting for all but 4% of the rest. With similar reliance upon WTE facilities elsewhere, it is critical that cost effective ways of managing these issues be found. Beyond these primarily regulatory and legal issues, there are also numerous challenges in the marketplace with increased reliance on recycling and the normal ebb and flow of the business cycle. Finally, there are always issues, including those already mentioned, which are best addressed in the political arena. Working together as an industry and regulated community will be essential if we are to make progress in addressing many of our challenges.« less

  19. Identifying the mathematics middle year students use as they address a community issue

    NASA Astrophysics Data System (ADS)

    Marshman, Margaret

    2017-03-01

    Middle year students often do not see the mathematics in the real world whereas the Australian Curriculum: Mathematics aims for students to be "confident and creative users and communicators of mathematics" (Australian Curriculum Assessment and Reporting Authority [ACARA] 2012). Using authentic and real mathematics tasks can address this situation. This paper is an account of how, working within a Knowledge Producing Schools' framework, a group of middle year students addressed a real community issue, the problem of the lack of a teenage safe space using mathematics and technology. Data were collected for this case study via journal observations and reflections, semi-structured interviews, samples of the students' work and videos of students working. The data were analysed by identifying the mathematics the students used determining the function and location of the space and focused on problem negotiation, formulation and solving through the statistical investigation cycle. The paper will identify the mathematics and statistics these students used as they addressed a real problem in their local community.

  20. Regulatory Compliance in Multi-Tier Supplier Networks

    NASA Technical Reports Server (NTRS)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

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

  1. Regulatory issues in international maritime transport

    DOT National Transportation Integrated Search

    2001-08-11

    This report focuses on regulations governing international liner and bulk shipping. The report discusses the web of regulatory measures that surround these two segments of the shipping industry, and which have a considerable impact on its performance...

  2. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kisner, Roger A; Wilgen, John B; Ewing, Paul D

    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 tomore » 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.« less

  3. Regulatory guidance for lightning protection in nuclear power plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kisner, R. A.; Wilgen, J. B.; Ewing, P. D.

    2006-07-01

    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 andmore » 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. (authors)« less

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

    EPA Pesticide Factsheets

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

  5. US FDA perspective on regulatory issues affecting circulatory assist devices.

    PubMed

    Sapirstein, Wolf; Chen, Eric; Swain, Julie; Zuckerman, Bram

    2006-11-01

    There has been a rapid development in mechanical circulatory support systems in the decade since the US FDA first approved a mechanical device to provide the circulatory support lacking from a failing heart. Devices are presently approved for marketing by the FDA to replace a failing ventricle, the Ventricular Assist Device or the entire heart, Total Artificial Heart. Contemporaneous with, and permitted by, improvement in technology and design, devices have evolved from units located extracorporeally to paracorporeal systems and totally implanted devices. Clinical studies have demonstrated a parallel improvement in the homeostatic adequacy of the circulatory support provided. Thus, while the circulatory support was initially tolerated for short periods to permit recovery of cardiac function, this technology eventually provided effective circulatory support for increasing periods that permitted the FDA to approve devices for bridging patients in end-stage cardiac failure awaiting transplant and eventually a device for destination therapy where patients in end-stage heart failure are not cardiac transplant candidates. The approved devices have relied on displacement pumps that mimic the pulsatility of the physiological system. Accelerated development of more compact devices that rely on alternative pump mechanisms have challenged both the FDA and device manufacturers to assure that the regulatory requirements for safety and effectiveness are met for use of mechanical circulatory support systems in expanded target populations. An FDA regulatory perspective is reviewed of what can be a potentially critical healthcare issue.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 informingmore » 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.« less

  7. 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…

  8. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns.

    PubMed

    Calleja-Castillo, Juan M; Gonzalez-Calderon, Gina

    2018-01-01

    Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use.

  9. WhatsApp in Stroke Systems: Current Use and Regulatory Concerns

    PubMed Central

    Calleja-Castillo, Juan M.; Gonzalez-Calderon, Gina

    2018-01-01

    Smartphone use is extremely common. Applications such as WhatsApp have billions of users and physicians are no exception. Stroke Medicine is a field where instant communication among fairly large groups is essential. In developing countries, economic limitations preclude the possibility of acquiring proper communication platforms. Thus, WhatsApp has been used as an organizational tool, for sharing clinical data, and for real time guidance of clinical care decisions. It has evolved into a cheap, accessible tool for telemedicine. Nevertheless, regulatory and privacy issues must be addressed. Some countries have implemented legislation to address this issue, while others lag behind. In this article, we present an overview on the different roles WhatsApp has acquired as a clinical tool in stroke systems and the potential privacy concerns of its use. PMID:29904369

  10. Ethical and regulatory issues surrounding African traditional medicine in the context of HIV/AIDS.

    PubMed

    Nyika, Aceme

    2007-04-01

    It has been estimated that more than 80% of people in Africa use traditional medicine (TM). With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code, African TM seems to be exempt from such scrutiny. Although recently there have been calls for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues. In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: (i) the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; (ii) the importance of research on TM in order to improve and demystify its therapeutic qualities; (iii) the need to tailor-make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers' associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients' welfare.

  11. 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.

  12. 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…

  13. Possible Role of Green Chemistry in Addressing Environmenal Plastic Debris: Scientific, Economic and Policy Issues

    NASA Astrophysics Data System (ADS)

    Bayha, K. M.

    2016-02-01

    Plastics have revolutionized modern life, replacing other raw materials in a vast array of products, due to their ease in molding and shaping, as well as superior recalcitrance to wearing and aging. However, this functional benefit makes plastic one of the most problematic pollutants, since they accumulate as environmental debris for decades and possibly for centuries. Rightfully so, programs addressing plastic debris typically involve efforts to reduce consumption, reuse plastic products and recycle them when usefulness is complete. However, some of these options can be problematic for certain applications, as well as in countries that lack efficient municipal solid waste or recycling facilities. The principles of Green Chemistry were developed to help scientists design chemical products that reduce or eliminate the use or generation of hazardous substances. These principles have also been applied to developing sustainable or greener polymers for use in consumer plastics. For instance, the EPA's Green Chemistry Program awards the Presidential Green Chemistry Challenge Awards each year, with a large percentage of awards having gone to developments in greener polymers. Many of these advancements involve the development of sustainable bio-based, more degradable or more recyclable polymers that deliver significant environmental benefits. This presentation is meant to address what role the development of truly greener polymers might have in addressing environmental plastic debris in parallel with efforts to reduce, reuse and recycle. The intention is to evaluate the issues posed by traditional polymer types, address the ultimate goals of alternative polymer development and evaluate research on current alternative polymer technologies, in order to objectively assess their usefulness in addressing environmental plastic debris accumulation. In addition, the scientific, policy and market issues that may be impeding accurate development, evaluation and implementation of

  14. 77 FR 70517 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68262; File No. SR-CBOE-2012-108] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule Change To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error Accounts November 19...

  15. 77 FR 70511 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68265; File No. SR-CBOE-2012-109] Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Proposed Rule Change Related to CBSX To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error...

  16. 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.…

  17. Addressing the Crisis in Curriculum Studies: Curriculum Integration That Bridges Issues of Identity and Knowledge

    ERIC Educational Resources Information Center

    Garcia-Huidobro, Juan Cristobal

    2018-01-01

    Many people from non-dominant backgrounds or believers from various religions want their children to acquire the best modern knowledge and to remain open to their home cultures and beliefs. However, this double aspiration poses complex challenges, and most scholars have either stressed the importance of addressing identity (and diversity) issues,…

  18. 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.

  19. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).

    PubMed

    Richards, Susan; Amaravadi, Lakshmi; Pillutla, Renuka; Birnboeck, Herbert; Torri, Albert; Cowan, Kyra J; Papadimitriou, Apollon; Garofolo, Fabio; Satterwhite, Christina; Piccoli, Steven; Wu, Bonnie; Krinos-Fiorotti, Corinna; Allinson, John; Berisha, Flora; Cocea, Laurent; Croft, Stephanie; Fraser, Stephanie; Galliccia, Fabrizio; Gorovits, Boris; Gupta, Swati; Gupta, Vinita; Haidar, Sam; Hottenstein, Charles; Ishii-Watabe, Akiko; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Litwin, Virginia; Lima Santos, Gustavo Mendes; Nelson, Robert; Ni, Yan; Pedras-Vasconcelos, João; Qiu, Yongchang; Rhyne, Paul; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Scheibner, Kara; Schick, Eginhard; Siguenza, Patricia Y; Smeraglia, John; Staack, Roland F; Subramanyam, Meena; Sumner, Giane; Thway, Theingi; Uhlinger, David; Ullmann, Martin; Vitaliti, Alessandra; Welink, Jan; Whiting, Chan C; Xue, Li; Zeng, Rong

    2016-12-01

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

  20. 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.

  1. Cannabis regulatory science: risk-benefit considerations for mental disorders.

    PubMed

    Borodovsky, Jacob T; Budney, Alan J

    2018-05-29

    The evolving legal cannabis landscape in the US continues to present novel regulatory challenges that necessitate the development of a Cannabis Regulatory Science. Two specific issues of concern within Cannabis Regulatory Science are (1) the impact that cannabis use has on the incidence, prevalence, and severity of mental disorders, and (2) how cannabis laws and regulations modify this impact. This paper first provides several conceptual points that are useful for evaluating the relationship between cannabis use and mental disorders. Second, it selectively reviews and comments on data relevant to the relationship between cannabis use and depression, several forms of anxiety, post-traumatic stress disorder, schizophrenia, and bipolar disorder. Next, regulatory and public health parallels between the nascent cannabis industry and the pharmaceutical, tobacco, and alcohol industries are discussed. The focus is on specific types of industry practices that may harm those with or at risk for mental disorders. Recommendations are then offered for legal cannabis regulations that could mitigate this harm. Last, future research goals are discussed for building the field of Cannabis Regulatory Science and addressing the potential negative impact of cannabis on those with mental disorders.

  2. Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 2. Results

    NASA Astrophysics Data System (ADS)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

    The risk-cost-benefit analysis developed in the companion paper (J. Massmann and R. A. Freeze, this issue) is here applied to (1) an assessment of the relative worth of containment-construction activities, site-exploration activities, and monitoring activities as components of a design strategy for the owner/operator of a waste management facility; (2) an assessment of alternative policy options available to a regulatory agency; and (3) a case history. Sensitivity analyses designed to address the first issue show that the allocation of resources by the owner/operator is sensitive to the stochastic parameters used to describe the hydraulic conductivity field at a site. For the cases analyzed, the installation of a dense monitoring network is of less value to the owner/operator than a more conservative containment design. Sensitivity analyses designed to address the second issue suggest that from a regulatory perspective, design standards should be more effective than performance standards in reducing risk, and design specifications on the containment structure should be more effective than those on the monitoring network. Performance bonds posted before construction have a greater potential to influence design than prospective penalties to be imposed at the time of failure. Siting on low-conductivity deposits is a more effective method of risk reduction than any form of regulatory influence. Results of the case history indicate that the methodology can be successfully applied at field sites.

  3. 18 CFR 376.203 - Mailing address of Commission during emergency conditions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REVISED GENERAL RULES ORGANIZATION, MISSION... § 376.203 Mailing address of Commission during emergency conditions. The Chairman may direct that during... Commission shall be addressed to the Federal Energy Regulatory Commission, Official Mail and Messenger...

  4. 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 Be...

  5. Barriers to midwives and nurses addressing mental health issues with women during the perinatal period: The Mind Mothers study.

    PubMed

    Higgins, Agnes; Downes, Carmel; Monahan, Mark; Gill, Ailish; Lamb, Stephen A; Carroll, Margaret

    2018-01-03

    To explore barriers to midwives and nurses addressing mental health issues with women during the perinatal period. Perinatal mental health is considered an important public health issue with health policy internationally identifying the importance of psychological support for women in the perinatal period. Midwives and primary care nurses are ideally positioned to detect mental distress early, but evidence suggests that they are reluctant to discuss mental health issues with women during pregnancy or in the postnatal period. The research used a descriptive design. A total of 809 midwives and nurses completed an anonymous, online or hard copy survey. Designed by the research team, the survey listed 26 potential barriers to the provision of perinatal mental health care. Participants identified organisational factors as presenting the greatest barriers. Organisational barriers included lack of perinatal mental health services, absence of care pathways, heavy workload, lack of time, lack of privacy and not seeing women regularly enough to build a relationship. Over 50% of participants identified practitioner-related barriers, such as lack of knowledge on perinatal mental health and cultural issues; lack of skill, in particular, skills to respond to a disclosure of a mental health issue; and fears of causing women offence and distress. Findings also indicated that the context of care and education influenced the degree to which participants perceived certain items as barriers. Midwives and primary care nurses encounter many organisational- and practitioner-related barriers that negatively impact on their ability to incorporate mental health care into their practice. Midwifery and nursing services need to develop strategies to address system- and practitioner-related barriers, including the development of services and care pathways, and the provision of culturally sensitive education on perinatal mental health in order to support practitioners to address issues with

  6. 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

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

    PubMed

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

    2012-12-01

    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.

  8. Emerging and recurrent issues in drug development.

    PubMed

    Anello, C

    This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodology. Recurrent issues include: renewed interest in statistical methods for handling subgroups in the design and analysis of clinical trials; renewed interest in alternatives to the 'intention-to-treat' analysis in the presence of non-compliance in randomized clinical trials; renewed interest in methodology to address the multiplicities resulting from a variety of sources inherent in the drug development process, and renewed interest in methods to assure data integrity. These emerging and recurrent issues provide a continuing challenge to the international community of statisticians involved in drug development. Moreover, the involvement of statisticians with different perspectives continues to enrich the field and contributes to improvement in the public health.

  9. A Regulatory Framework for Nanotechnology

    DTIC Science & Technology

    informed by a map of the regulatory landscape of nanotechnology and a review of the regulatory frameworks for the aviation and biotechnology industries...aviation and biotechnology and maps the regulatory landscape in the United States by examining stakeholders, regulatory entities, and applicable legislation...state of nanotechnology if the limitations of technical expertise are addressed. This expertise can be provided by advisory committees of technical

  10. Practical Issues in Delivery of Clinician-to-Patient Telemental Health in an Academic Medical Center.

    PubMed

    Abrams, Jessica; Sossong, Sarah; Schwamm, Lee H; Barsanti, Lauren; Carter, Michael; Kling, Naomi; Kotarski, Meghan; Leddy, Jaclyn; Meller, Benjamin; Simoni, Marcy; Sullivan, Michael; Wozniak, Janet

    In the age of online communication, psychiatric care can now be provided via videoconferencing technologies. While virtual visits as a part of telepsychiatry and telemental health provide a highly efficient and beneficial modality of care, the implementation of virtual visits requires attention to quality and safety issues. As practitioners continue to utilize this technology, issues of clinician licensing, treatment outcomes of virtual visits versus in-person visits, and cost offset require ongoing study. This review provides an overview of the topics of technology, legal and regulatory issues, clinical issues, and cost savings as they relate to practicing psychiatry and psychology via virtual visits in an academic medical center. We review the telepsychiatry/telemental health effectiveness literature from 2013 to the present. Our literature searches used the following terms: telemental health effective, telepsychiatry effective, telepsychiatry efficacy, and telemental health efficacy. These searches produced 58 articles, reduced to 16 when including only articles that address effectiveness of clinician-to-patient services. The technological, legal, and regulatory issues vary from state to state and over time. The emerging research addressing diverse populations and disorders provides strong evidence for the effectiveness of telepsychiatry. Cost savings are difficult to precisely determine and depend on the scope of the cost and benefit measured. Establishing a telepsychiatry program requires a comprehensive approach with up-to-date legal and technological considerations.

  11. 77 FR 70496 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Proposed Rule Change...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-26

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-68260; File No. SR-C2-2012-038] Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Proposed Rule Change To Address Authority To Cancel Orders When a Technical or Systems Issue Occurs and To Describe the Operation of Routing Service Error Accounts November 19, 2012....

  12. Communication Regulatory Science: Mapping a New Field.

    PubMed

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

    2017-12-13

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

  13. Strategies and recommendations for addressing forest health issues in the Blue Mountains of Oregon and Washington.

    Treesearch

    J.A. Tanaka; G.L. Starr; T.M. Quigley

    1995-01-01

    The Blue Mountains Natural Resources Institute held three types of meetings to obtain public and scientific input into the development of strategies and recommendations for addressing forest health issues in the Blue Mountains of Oregon and Washington. Seven strategies are proposed: (1) plan and implement management activities on a landscape level; (2) enhance training...

  14. 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…

  15. Addressing Authorship Issues Prospectively: A Heuristic Approach.

    PubMed

    Roberts, Laura Weiss

    2017-02-01

    Collaborative writing in academic medicine gives rise to more richly informed scholarship, and yet challenging ethical issues surrounding authorship are commonly encountered. International guidelines on authorship help clarify whether individuals who have contributed to a completed scholarly work have been correctly included as authors, but these guidelines do not facilitate intentional and proactive authorship planning or decisions regarding authorship order.In this Commentary, the author presents a heuristic approach to help collaborators clarify, anticipate, and resolve practical and ethically important authorship issues as they engage in the process of developing manuscripts. As this approach illustrates, assignment of authorship should balance work effort and professional responsibility, reflecting the effort and intellectual contribution and the public accountability of the individuals who participate in the work. Using a heuristic approach for managing authorship issues prospectively can foster an ethical, collaborative writing process in which individuals are properly recognized for their contributions.

  16. Feasibility of a mindfulness-based intervention to address youth issues in Vietnam.

    PubMed

    Le, Thao N; Trieu, Don T

    2016-06-01

    Youth problems including risky sex, drug use, violence and mental health issues are on the rise in Vietnam. Mindfulness is proposed as one way to address unskillful responses to stress that give rise to these behavioral and psychosocial issues in Vietnam. This study explores the feasibility of a mindfulness program for adolescents and young adults in a central city in Vietnam. The mindfulness-based intervention was comprised 1-h daily session over 3 weeks that was conducted at two different sites, one with handicapped adolescents/young adults at the Vocational School for Handicapped and the other with at-risk youth at a semi-private high school. Forty-two Vietnamese youth participants and five Vietnamese teachers/facilitators who were trained in the mindfulness program provided personal reflections of their experiences. Analyses of the qualitative data suggest that mindfulness was enthusiastically received and accepted by both youth and teachers. There is strong indication that mindfulness is promising as a prevention strategy to help with stress and to build important life skills among Vietnamese youth. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).

    PubMed

    Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun Julia; Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Arienzo, Celia; Danan-Leon, Lieza; Donato, Lorella Di; Garofolo, Fabio; Haidar, Sam; Ishii-Watabe, Akiko; Jiang, Hao; Kadavil, John; Kassim, Sean; Kurki, Pekka; Blaye, Olivier Le; Liu, Kai; Mathews, Rod; Lima Santos, Gustavo Mendes; Niwa, Makoto; Pedras-Vasconcelos, João; Qian, Mark; Rago, Brian; Saad, Ola; Saito, Yoshiro; Savoie, Natasha; Su, Dian; Szapacs, Matthew; Tampal, Nilufer; Vinter, Stephen; Wang, Jian; Welink, Jan; Whale, Emma; Wilson, Amanda; Xue, Y-J

    2017-12-01

    The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for biotherapeutics, biomarkers and immunogenicity assays using hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (LCMS for small molecules, peptides and small molecule biomarkers) and Part 3 (LBA: immunogenicity, biomarkers and pharmacokinetic assays) are published in Volume 9 of Bioanalysis, issues 22 and 24 (2017), respectively.

  18. Computer Science and Engineering Students Addressing Critical Issues Regarding Gender Differences in Computing: A Case Study

    ERIC Educational Resources Information Center

    Tsagala, Evrikleia; Kordaki, Maria

    2008-01-01

    This study focuses on how Computer Science and Engineering Students (CSESs) of both genders address certain critical issues for gender differences in the field of Computer Science and Engineering (CSE). This case study is based on research conducted on a sample of 99 Greek CSESs, 43 of which were women. More specifically, these students were asked…

  19. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... party may challenge the regulatory status granted an MAS licensee. System License Requirements ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.1309 Section 101.1309... SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission will...

  20. Monitoring ethical, legal, and social issues in developing population genetic databases.

    PubMed

    Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

    2003-01-01

    To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

  1. Cross-Cutting issues in Regulatory Supervision of Spent Fuel Radioactive Waste and Radioactively Contaminated Land in North-West Russia

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sneve, M. K.; Smith, G. M.

    2006-07-01

    The Norwegian Government is promoting improvements in radiation protection and nuclear safety in North-West Russia. Among priority areas there is the improvement of spent nuclear fuel and radioactive waste management, as well as remediation operations at the Shore Technical Bases operated by Federal Enterprise SevRAO at Andreeva Bay and Gremikha on the Kola Peninsula. The extreme radiological conditions at these sites present novel difficulties for regulatory supervision of operations. The situation at these sites is such that the existing regulations are applicable, and actions to remedy the situation are not permitted under the current regulatory regime. An improved regulatory process,more » including development of special norms and rules, is required to take account of this unusual situation. The Norwegian strategy includes not only support to industrial projects, but also support to Russian Federation regulatory bodies, to ensure that work is carried out in compliance with Russian Federation law, taking account of international recommendations and other national good practice as relevant in the RF. Accordingly, the Norwegian Radiation Protection Authority has set up a programme of cooperation with the Federal Medical-Biological Agency (FMBA), which is the primary radiation protection authority in the RF. The work is carried out with technical input from the Russian Institute of Biophysics and with inputs from western technical support organisations. The overall objective of the work is to promote effective and efficient regulatory supervision of SevRAO activities at Andreeva Bay and Gremikha within the scope of responsibilities of FMBA. This paper describes the results of an initial threat assessment which allows consideration of the cross-cutting issues associated with developing an overall effective site management plan which deals with short- and long-term issues, and protection of workers as well as of the public and the environment, while achieving a

  2. 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...

  3. 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

  4. 75 FR 3760 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0018] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory...) is issuing for public comment a draft guide in the agency's ``Regulatory Guide'' series. This series...

  5. Safety and Regulatory Issues of the Thorium Fuel Cycle

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Ade, Brian; Worrall, Andrew; Powers, Jeffrey

    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),more » 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.« less

  6. Importance of a midterm time horizon for addressing ethical issues integral to nanobiotechnology.

    PubMed

    Khushf, George

    2007-01-01

    There is a consensus emerging on the importance of upstream ethical engagement in nanobiotechnology. Such a preventive ethic would anticipate downstream concerns that might arise and mitigate them as part of the research and development process. However, there is an unappreciated tension between the time horizon of upstream ethics and that assumed by most bioethical research. Current standards of high-quality research on ethical issues biases the research in favor of near-term, science-based, results-oriented work. A near-term focus would miss many of the important ethical issues integral to nanobiotechnology and undermine the goals integral to upstream ethical engagement. However, if we move to a far-term time horizon, the ethical debates tend to get too speculative and are no longer disciplined by existing research trajectories. This paper addresses the link between the midterm time horizon necessary for upstream ethics and the form, content, and style of ethical reflection. New paradigm cases, standards, and criteria will be needed for high-quality upstream ethics work in the area of nanobiotechnology.

  7. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  8. 75 FR 45166 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0265] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft guide in the...

  9. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

    PubMed

    Yang, Eric; Welink, Jan; Cape, Stephanie; Woolf, Eric; Sydor, Jens; James, Christopher; Goykhman, Dina; Arnold, Mark; Addock, Neil; Bauer, Ronald; Buonarati, Michael; Ciccimaro, Eugene; Dodda, Raj; Evans, Christopher; Garofolo, Fabio; Hughes, Nicola; Islam, Rafiq; Nehls, Corey; Wilson, Amanda; Briscoe, Chad; Bustard, Mark; Coppola, Laura; Croft, Stephanie; Drexler, Dieter; Ferrari, Luca; Fraier, Daniela; Jenkins, Rand; Kadavil, John; King, Lloyd; Li, Wenkui; Lima Santos, Gustavo Mendes; Musuku, Adrien; Ramanathan, Ragu; Saito, Yoshiro; Savoie, Natasha; Summerfield, Scott; Sun, Rachel; Tampal, Nilufer; Vinter, Steve; Wakelin-Smith, Jason; Yue, Qin

    2016-10-07

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

  10. Unique agricultural safety and health issues of migrant and immigrant children.

    PubMed

    McLaurin, Jennie A; Liebman, Amy K

    2012-01-01

    Immigrant and migrant youth who live and work in agricultural settings experience unique agricultural safety and health issues. Mobility, poverty, cultural differences, immigration status, language, education, housing, food security, regulatory standards and enforcement, and access to childcare and health care influence exposure risk and the well-being of this population. Approximately 10% of the migrant agricultural labor force is composed of unaccompanied minors, whose safety and health is further compounded by lack of social supports and additional stresses associated with economic independence. This paper examines the current demographic and health data, regulatory protections, and programs and practices addressing safety and health in this sector of youth in agriculture. Gaps in knowledge and practice are identified, with emphasis on data collection and regulatory limitations. Best practices in programs addressing the special needs of this population are highlighted. Recommendations identify seven priority areas for impact to promote transformative change in the agricultural health and safety concerns of unaccompanied minors and children of immigrant, migrant and seasonal farmworkers. This framework may be used to examine similar needs in other identified subpopulations of children as they merit attention, whether now or in the future.

  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

    ... of the comments. A document comparing the version of the ISG that went out for public comment and the final version of the ISG can be found under ADAMS Accession No. ML111170302. ADDRESSES: Publicly... its issued staff guidance in the agency external web page ( http://www.nrc.gov/reading-rm/doc...

  12. 76 FR 6085 - Draft Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ...-2011-0014] RIN 3150-AI49 Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice Availability of Draft Regulatory Guide. SUMMARY: The U.S. Nuclear Regulatory Commission (Commission or NRC) is issuing for public comment Draft Regulatory Guide, DG-5019, ``Reporting and...

  13. 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. Copyright © 2014 Longwoods Publishing.

  14. 25 CFR 1000.176 - What issues must the bureau and the Tribe/Consortium address at negotiation meetings?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 2 2010-04-01 2010-04-01 false What issues must the bureau and the Tribe/Consortium address at negotiation meetings? 1000.176 Section 1000.176 Indians OFFICE OF THE ASSISTANT SECRETARY, INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ANNUAL FUNDING AGREEMENTS UNDER THE TRIBAL SELF-GOVERNMENT ACT AMENDMENTS TO THE INDIAN SELF-DETERMINATION...

  15. 75 FR 36715 - Final Regulatory Guide: Issuance, Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision..., Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory...

  16. Regulatory Scientific Advice on Non-Inferiority Drug Trials

    PubMed Central

    Knol, Mirjam J.; Klungel, Olaf H.; Gispen-De Wied, Christine C.; de Boer, Antonius; Hoes, Arno W.; Leufkens, Hubert G.; Mantel-Teeuwisse, Aukje K.

    2013-01-01

    The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provide some general statements on how a non-inferiority trial should be conducted. Moreover, in a scientific advice procedure, regulators give companies the opportunity to discuss critical trial issues prior to the start of the trial. The aim of this study was to identify potential issues that may benefit from more explicit guidance by regulators. To achieve this, we collected and analyzed questions about non-inferiority trials posed by applicants for scientific advice in Europe in 2008 and 2009, as well as the responses given by the European Medicines Agency (EMA). In our analysis we included 156 final letters of advice from 2008 and 2009, addressed to 94 different applicants (manufacturers). Our analysis yielded two major findings: (1) applicants frequently asked questions ‘whether’ and ‘how’ to conduct a non-inferiority trial, 26% and 74%, respectively, and (2) the EMA regulators seem mainly concerned about the choice of the non-inferiority margin in non-inferiority trials (36% of total regulatory answers). In 40% of the answers, the EMA recommended using a stricter margin, and in 10% of the answers regarding non-inferiority margins, the EMA questioned the justification of the proposed non-inferiority margin. We conclude that there are still difficulties in selecting the appropriate methodology for non-inferiority trials. Straightforward and harmonized guidance regarding non-inferiority trials is required, for example on whether it is necessary to conduct such a trial and how the non-inferiority margin is determined. It is unlikely that regulatory guidelines can cover all therapeutic areas; therefore, in some cases regulatory scientific advice may be used as an opportunity for tailored advice. PMID:24040346

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 trackingmore » 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

  18. Women's Issues Are Economic Issues.

    ERIC Educational Resources Information Center

    Schroeder, Patricia

    1983-01-01

    Faulty laws, unfair practices, and years of tradition in the workplace keep women from economic equality. The Economic Equity Act proposed by Congress will address inequalities in tax and retirement matters, the need for better dependent care, nondiscrimination in insurance, regulatory reform, and child support enforcement. (IS)

  19. A needs assessment on addressing environmental health issues within reproductive health service provision: Considerations for continuing education and support.

    PubMed

    Williamson, Linzi; Sangster, Sarah; Bayly, Melanie; Gibson, Kirstian; Lawson, Karen; Clark, Megan

    2017-12-01

    This needs assessment was initially undertaken to explore the beliefs and knowledge of nurses and physicians about the impact of environmental toxicants on maternal and infant health, as well as to describe current practice and needs related to addressing environmental health issues (EHI). One hundred and thirty-five nurses (n = 99) and physicians (n = 36) working in Saskatchewan completed an online survey. Survey questions were designed to determine how physicians and nurses think about and incorporate environmental health issues into their practice and means of increasing their capacity to do so. Although participants considered it important to address EHIs with patients, in actual practice they do so with only moderate frequency. Participants reported low levels of knowledge about EHIs' impact on health, and low levels of confidence discussing them with patients. Participants requested additional information on EHIs, especially in the form of online resources. The results suggests that while nurses and physicians consider EHIs important to address with patients, more education, support, and resources would increase their capacity to do so effectively. Based on the findings, considerations and recommendations for continuing education in this area have been provided.

  20. 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…

  1. 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…

  2. Federal control of Indian Lands v. State control of Gaming - Cabazon Bingo and the Indian Gaming regulatory act.

    PubMed

    Strate, L D; Mayo, A M

    1990-03-01

    In September, 1988, the 100th Congress passed the Indian Gaming Regulatory Act, concluding five years of debate over the Indian Gaming issue - brought to a head by a Supreme Court decision in February, 1987, that barred states from regulating Indian Gaming. That case (State of California v. Cabazon Band of Mission Indians) forced the legislature to take a serious look at issues of gaming on Indian lands. The result was the creation of a three-tiered system whereby tribes will control ceremonial games, the federal government will control bingo, and the states and tribes will negotiate agreements to cover casino games, parimutuel racing, and jai alai, if such games are legal in that particular state. In light of the case of the Cabazon Indians and the passage of the Indian Gaming Regulatory Act, this paper will address the following competing issues: tribal sovereignty, state interests, federal interests, and states like Nevada, which have a regulated gaming industry.

  3. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

    PubMed

    Gupta, Shalini; Richards, Susan; Amaravadi, Lakshmi; Piccoli, Steven; Desilva, Binodh; Pillutla, Renuka; Stevenson, Lauren; Mehta, Devangi; Carrasco-Triguero, Montserrat; Neely, Robert; Partridge, Michael; Staack, Roland F; Zhao, Xuemei; Gorovits, Boris; Kolaitis, Gerry; Sumner, Giane; Stubenrauch, Kay-Gunnar; Zou, Linglong; Amur, Shashi; Beaver, Chris; Berger, Isabella; Berisha, Flora; Birnboeck, Herbert; Bower, Joe; Cho, Seongeun Julia; Cludts, Isabelle; Cocea, Laurent; Donato, Lorella Di; Fischer, Saloumeh; Fraser, Stephanie; Garofolo, Fabio; Haidar, Sam; Haulenbeek, Jonathan; Hottenstein, Charles; Hu, Jenny; Ishii-Watabe, Akiko; Islam, Rafiq; Jani, Darshana; Kadavil, John; Kamerud, John; Kramer, Daniel; Kurki, Pekka; MacMannis, Stephen; McNally, Jim; Mullan, Ashley; Papadimitriou, Apollon; Pedras-Vasconcelos, João; Ray, Soma; Safavi, Afshin; Saito, Yoshiro; Savoie, Natasha; Fjording, Marianne Scheel; Scheibner, Kara; Smeraglia, John; Song, An; Stouffer, Bruce; Tampal, Nilufer; der Strate, Barry van; Verch, Thorsten; Welink, Jan; Xu, Yuanxin; Yang, Tong-Yuan; Yengi, Lilian; Zeng, Jianing; Zhang, Yan; Zhang, Yanhua; Zoog, Stephen

    2017-12-01

    The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.

  4. 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 for...

  5. 10 CFR 590.104 - Address for filing documents.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  6. Cleaning by clustering: methodology for addressing data quality issues in biomedical metadata.

    PubMed

    Hu, Wei; Zaveri, Amrapali; Qiu, Honglei; Dumontier, Michel

    2017-09-18

    The ability to efficiently search and filter datasets depends on access to high quality metadata. While most biomedical repositories require data submitters to provide a minimal set of metadata, some such as the Gene Expression Omnibus (GEO) allows users to specify additional metadata in the form of textual key-value pairs (e.g. sex: female). However, since there is no structured vocabulary to guide the submitter regarding the metadata terms to use, consequently, the 44,000,000+ key-value pairs in GEO suffer from numerous quality issues including redundancy, heterogeneity, inconsistency, and incompleteness. Such issues hinder the ability of scientists to hone in on datasets that meet their requirements and point to a need for accurate, structured and complete description of the data. In this study, we propose a clustering-based approach to address data quality issues in biomedical, specifically gene expression, metadata. First, we present three different kinds of similarity measures to compare metadata keys. Second, we design a scalable agglomerative clustering algorithm to cluster similar keys together. Our agglomerative cluster algorithm identified metadata keys that were similar, based on (i) name, (ii) core concept and (iii) value similarities, to each other and grouped them together. We evaluated our method using a manually created gold standard in which 359 keys were grouped into 27 clusters based on six types of characteristics: (i) age, (ii) cell line, (iii) disease, (iv) strain, (v) tissue and (vi) treatment. As a result, the algorithm generated 18 clusters containing 355 keys (four clusters with only one key were excluded). In the 18 clusters, there were keys that were identified correctly to be related to that cluster, but there were 13 keys which were not related to that cluster. We compared our approach with four other published methods. Our approach significantly outperformed them for most metadata keys and achieved the best average F-Score (0

  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 will...

  8. 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.

  9. 78 FR 23507 - Notice of Regulatory Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    .... 2013-N-06] Notice of Regulatory Review AGENCY: Federal Housing Finance Agency. ACTION: Request for comment. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of a regulatory review that will be conducted in accordance with the process set forth in the regulatory review plan published...

  10. Hardware-in-the-loop environment facility to address pilot-vehicle-interface issues of a fighter aircraft

    NASA Astrophysics Data System (ADS)

    Pandurangareddy, Meenige

    2002-07-01

    The evolution of Pilot-Vehicle-Interface (PVI) of a fighter aircraft is a complex task. The PVI design involves both static and dynamic issues. Static issues involve the study of reach of controls and switches, ejection path clearance, readability of indicators and display symbols, etc. Dynamic issues involve the study of the effect of aircraft motion on display symbols, pilot emergency handling, situation awareness, weapon aiming, etc. This paper describes a method of addressing the above issues by building a facility with cockpit, which is ergonomically similar to the fighter cockpit. The cockpit is also fitted with actual displays, controls and switches. The cockpit is interfaced with various simulation models of aircraft and outside-window-image generators. The architecture of the facility is designed to represent the latencies of the aircraft and facilitates replacement of simulation models with actual units. A parameter injection facility could be used to induce faults in a comprehensive manner. Pilots could use the facility right from familiarising themselves with procedures to start the engine, take-off, navigate, aim the weapons, handling of emergencies and landing. This approach is being followed and further being enhanced on Cockpit-Environment-Facility (CEF) at Aeronautical Development Agency (ADA), Bangalore, India.

  11. Are Some Technologies Beyond Regulatory Regimes?

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Jones, Wendell B.; Kusnezov, Dimitri

    Regulatory frameworks are a common tool in governance to incent and coerce behaviors supporting national or strategic stability. This includes domestic regulations and international agreements. Though regulation is always a challenge, the domain of fast evolving threats, like cyber, are proving much more difficult to control. Many discussions are underway searching for approaches that can provide national security in these domains. We use game theoretic learning models to explore the question of strategic stability with respect to the democratization of certain technologies (such as cyber). We suggest that such many-player games could inherently be chaotic with no corresponding (Nash) equilibria.more » In the absence of such equilibria, traditional approaches, as measures to achieve levels of overall security, may not be suitable approaches to support strategic stability in these domains. Altogether new paradigms may be needed for these issues. At the very least, regulatory regimes that fail to address the basic nature of the technology domains should not be pursued as a default solution, regardless of success in other domains. In addition, the very chaotic nature of these domains may hold the promise of novel approaches to regulation.« less

  12. Global Acceptance of Biosimilars: Importance of Regulatory Consistency, Education, and Trust.

    PubMed

    Cazap, Eduardo; Jacobs, Ira; McBride, Ali; Popovian, Robert; Sikora, Karol

    2018-05-16

    Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics. Biosimilar approval pathways in many major regulatory regions worldwide are, to a broad degree, scientifically aligned. However, owing to regional differences in health care priorities, policies, and resources, some important regulatory inconsistencies are evident. Acceptance of biosimilars by health care systems, health care professionals, and patients will be a key factor in the uptake of these therapies, and such regulatory variations could contribute to confusion and diminished confidence regarding the quality, efficacy, and reliability of these agents. Furthermore, the need for manufacturers to account for regulatory inconsistencies introduces inefficiencies and delays into biosimilar development programs. These issues should be addressed if biosimilars are to attain their maximal global potential. This review summarizes the evolution of the global biosimilar landscape and provides examples of inconsistencies between regulatory requirements in different regions. In addition, we review ongoing efforts to improve regulatory alignment and highlight the importance of education as a crucial factor in generating trust in, and acceptance of, biosimilars on a worldwide scale. Biosimilars of monoclonal antibody anticancer therapies are beginning to emerge, and more are likely to become available for clinical use in the near future. The extent to which biosimilars

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

    PubMed

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

    2007-01-01

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

  14. 75 FR 79049 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ..., Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2010-31731 Filed...

  15. 2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).

    PubMed

    Welink, Jan; Yang, Eric; Hughes, Nicola; Rago, Brian; Woolf, Eric; Sydor, Jens; Coppola, Laura; Ackermann, Brad; Li, Wenkui; Alley, Stephen C; Arnold, Mark; Berger, Isabella; Briscoe, Chad; Buonarati, Michael; Bustard, Mark; Cancilla, Mark; Cho, Seongeun Julia; Duggan, Jeff; Fraier, Daniela; Garofolo, Fabio; Green, Rachel; Haidar, Sam; Hittle, Lucinda; Ishii-Watabe, Akiko; Islam, Rafiq; Jenkins, Rand; Jones, Barry; Kadavil, John; Kassim, Sean; Kavetska, Olga; Blaye, Olivier Le; Lee, Anita; Liu, Hanlan; Mehl, John; Lima Santos, Gustavo Mendes; Musuku, Adrien; Ramanathan, Ragu; Saito, Yoshiro; Savoie, Natasha; Summerfield, Scott; Surapaneni, Sekhar; Szapacs, Matthew; Tampal, Nilufer; Verhaeghe, Tom; Vinter, Stephen; Whale, Emma

    2017-11-01

    The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for Small Molecules, Peptides and Small Molecule Biomarkers using LCMS. Part 2 (Biotherapeutics, Biomarkers and Immunogenicity Assays using Hybrid LBA/LCMS and Regulatory Agencies' Inputs) and Part 3 (LBA: Immunogenicity, Biomarkers and PK Assays) are published in volume 9 of Bioanalysis, issues 23 and 24 (2017), respectively.

  16. 76 FR 26333 - National Federal Regulatory Enforcement Fairness Hearing Region III Regulatory Fairness Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... National Ombudsman is issuing this notice to announce the location, date and time of the National Federal... Visual and Performing Arts Center--Smith Theatre, Howard Community College, 10901 Little Patuxent Parkway... regulatory enforcement issues affecting their members. Free parking is available at the college. Anyone...

  17. Statistical issues in the design, conduct and analysis of two large safety studies.

    PubMed

    Gaffney, Michael

    2016-10-01

    The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

  18. Dilemmas with Dilemmas...Exploring the Suitability of Dilemma Stories as a Way of Addressing Ethical Issues in Science Education.

    ERIC Educational Resources Information Center

    Settelmaier, Elisabeth

    Traditionally, many science educators have taught science without addressing ethical questions. However, the inclusion of moral discourse in science teaching may help educators to bring to the fore problematic issues in relation to science, and it may offer an opportunity for students to practice their future engagement in the public discourse…

  19. Steam generators regulatory practices and issues in Spain

    DOE Office of Scientific and Technical Information (OSTI.GOV)

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

    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.

  20. 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

  1. Methodological issues associated with clinical trials in epilepsy.

    PubMed

    Ferlazzo, Edoardo; Sueri, Chiara; Gasparini, Sara; Russo, Emilio; Cianci, Vittoria; Ascoli, Michele; De Sarro, Giovambattista; Aguglia, Umberto

    2017-10-01

    despite methodological advances in epilepsy clinical trials, the proportion of patients reaching seizure-freedom has not substantially changed over the years. We review the main methodological limitations of current trials, the possible strategies to overcome these limits, and the issues that need to be addressed in next future. Area covered: references were identified by PubMed search until March 2017 and unpublished literature was searched on ClinicalTrials.gov. Add-on trials mainly involve refractory epilepsy subjects, reducing overall response to the investigational drug. The inclusion of subjects with earlier disease from less developed countries has partially allowed overcoming this limitation, but has introduced more random variability of results. Monotherapy trials rise methodological, economical, and ethical concerns with different regulatory requirements in European Union and in the United States of America. Newer trial designs, such as futility trials or 'time-to-event' design, have been implemented. Moreover, both add-on and monotherapy trials results might be affected by patient's ability to recognize and record seizures, and by randomness of seizures occurrence over time. Possible strategies to achieve more reliable outcomes are detailed. Expert commentary: clinical trial methodology needs to be optimized to better address regulatory agencies requirements and to encounter both patients' and clinicians' needs.

  2. 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…

  3. Optimizing Wartime Materiel Delivery: An Overview of DoD containerization. Volume 2. Framework for Action to Address DoD Containerization Issues

    DOT National Transportation Integrated Search

    1988-10-01

    This second volume of the study entitled, Optimizing Wartime Materiel Delivery: An Overview of DOD Containerization Efforts, -outlines a framework for action to address containerization issues identified in Volume I. The objectives of the study inclu...

  4. 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…

  5. 2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

    PubMed

    Stevenson, Lauren; Garofolo, Fabio; DeSilva, Binodh; Dumont, Isabelle; Martinez, Suzanne; Rocci, Mario; Amaravadi, Lakshmi; Brudny-Kloeppel, Margarete; Musuku, Adrien; Booth, Brian; Dicaire, Catherine; Wright, Laura; Mayrand-Provencher, Laurence; Losauro, Mike; Gouty, Dominique; Arnold, Mark; Bansal, Surendra; Dudal, Sherri; Dufield, Dawn; Duggan, Jeff; Evans, Christopher; Fluhler, Eric; Fraser, Stephanie; Gorovits, Boris; Haidar, Sam; Hayes, Roger; Ho, Stacy; Houghton, Richard; Islam, Rafiqul; Jenkins, Rand; Katori, Noriko; Kaur, Surinder; Kelley, Marian; Knutsson, Magnus; Lee, Jean; Liu, Hanlan; Lowes, Steve; Ma, Mark; Mikulskis, Alvydas; Myler, Heather; Nicholson, Bob; Olah, Timothy; Ormsby, Eric; Patel, Shefali; Pucci, Vincenzo; Ray, Chad; Schultz, Gary; Shih, Judy; Shoup, Ronald; Simon, Craig; Song, An; Neto, João Tavares; Theobald, Valerie; Thway, Theingi; Wakelin-Smith, Jason; Wang, Jian; Wang, Laixin; Welink, Jan; Whale, Emma; Woolf, Eric; Xu, Raymond

    2013-12-01

    The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis.

  6. Select Biosolids Regulatory Processes

    EPA Pesticide Factsheets

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

  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. 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

    Hankins, Catherine; Macklin, Ruth; Warren, Mitchell

    2015-01-01

    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. 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. 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 from it and if current regulatory and

  9. 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. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  10. Infections are a global issue: infection addresses global issues.

    PubMed

    Grobusch, M P; Calleri, G; Bogner, J R

    2012-12-01

    Infections are of unifying global concern, despite regional differences in disease epidemiology, clinical appearance and the instruments to tackle them. The primary aim of Infection is "to be a forum for the presentation and discussion of clinically relevant information on infectious diseases… from all over the world". To that end, and as a reflection of the global burden of infectious diseases, we intend to increase the number of high-quality contributions from authors addressing the aetiology, pathogenesis, diagnosis and treatment of infectious diseases from outside Europe and the affluent North (Chang et al. Infection 40:359-365, 2012; Misra et al. Infection 40:125-130, 2012). The Editorial Board of Infection envisages the journal as an interface between where infectious diseases meet and mix between "North and South"--i.e., the field of travel medicine--frequently functioning as a sentinel for altered/novel disease activities that are encountered as imported conditions. With the change in generation on the Editorial Board, Infection aims to expand the areas of tropical medicine, travel medicine and global health with its own section editors (GC and MPG). Contributions from outside Europe are actively encouraged.

  11. 75 FR 20868 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ...: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.68.2... Water-Cooled Nuclear Power Plants.'' FOR FURTHER INFORMATION CONTACT: Mark P. Orr, Regulatory Guide... Shutdown Capability for Water-Cooled Nuclear Power Plants,'' was issued with a temporary identification as...

  12. Four essays on offshore wind power potential, development, regulatory framework, and integration

    NASA Astrophysics Data System (ADS)

    Dhanju, Amardeep

    Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware

  13. 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

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Barbose, Galen; Wiser, Ryan; Phadke, Amol

    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,more » 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.« less

  15. 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.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Barbose, Galen; Miller, John; Sigrin, Ben

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

  17. Teaching undergraduate nursing students about environmental health: addressing public health issues through simulation.

    PubMed

    Stanley, Mary Jo; Rojas, Deb

    2014-01-01

    Schools of nursing are challenged to find clinical placements in public health settings. Use of simulation can address situations unique to public health, with attention to specific concerns, such as environmental health. Environmental health is an integral part of public health nursing and is a standard of professional practice. Current simulations focus on acute care situations, offering limited scenarios with a public health perspective and excluding environmental health. This study's simulation scenario was created to enhance nursing students' understanding of public health concepts within an environmental health context. Outcomes from the simulation include the need for integration of environmental issues in public health teaching. Students stated that this scenario provided a broader understanding of the environmental influences that can affect the client's and family's health. This scenario fills a void in simulation content, while providing an interactive teaching and learning strategy to help students to apply knowledge to practice. Copyright 2014, SLACK Incorporated.

  18. Legal and regulatory responses to innovative treatment.

    PubMed

    Chan, Tracey Evans

    2013-01-01

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

  19. Fitness for duty in the nuclear power industry: A review of technical issues

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Moore, C.; Barnes, V.; Hauth, J.

    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,more » 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).« less

  20. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...

  1. 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

  2. 75 FR 43207 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing.... Jervey, Acting Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear...

  3. Complexities in understanding and addressing the serious public health issues related to the nonmedical use of prescription drugs

    PubMed Central

    Arria, Amelia M.; Compton, Wilson M.

    2016-01-01

    The nonmedical use of prescription drugs (NMUPD) is not only a serious public health problem, but also a complex one. The articles presented in this special issue underscore that complexity by describing multiple classes of prescription drugs (e.g., opioid analgesics, benzodiazepines, stimulants, anxiolytics, and sedatives) and examining multiple aspects of their patterns of use. Collectively, the articles examine epidemiologic use patterns in the United States, risk factors, clinical characteristics of individuals in treatment for dependence, and consequences. The key to addressing NMUPD is to construct a solid understanding of the issues through scientific research, and to translate the scientific evidence into action. The articles in this issue build upon a large body of literature that has accumulated during the last two decades. Dramatic increases in overdoses from prescription opioids and the transition to heroin use among nonmedical users of prescription opioids has captured the attention of community leaders across the nation. Yet, less well known is the co-occurrence of multiple substances among those using prescription drug nonmedically. This represents a common theme across these articles which document that nonmedical users were observed to have a history of using alcohol, marijuana, tobacco, and other psychoactive substances. In addition, the articles dispel certain ideas that appear to have gained traction in the popular discourse that have little scientific evidence behind them. First, the notion that prescription drug problems arise in cases of drug naïve individuals who are first exposed through a physician’s prescription for pain medication is widespread, but is not rooted in scientific evidence. Second, despite the popular notion that nonmedical use of stimulants confers an “academic edge”, nonmedical users have lower grade point averages (GPAs) than non-users. NMUPD was also shown to be associated with sexual aggression victimization and

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Moe, Wayne L.

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

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Moe, Wayne Leland

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

  6. 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.

  7. Courts Continue to Address the Wealth Disparity Issue.

    ERIC Educational Resources Information Center

    La Morte, Michael W.

    1989-01-01

    A review of case law on the constitutionality of state school finance provisions on equal protection and equal adequacy grounds is provided. Protracted rounds of litigation over the years in several states and a rash of recent suits reveal that this issue remains lively and contentious. (TJH)

  8. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    PubMed

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  9. 77 FR 8072 - Semiannual Regulatory Flexibility Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... six months. ADDRESSES: Comments should be addressed to Jennifer J. Johnson, Secretary of the Board... Regulatory and Deregulatory Actions, which is coordinated by the Office of Management and Budget under... pledged; and certain other elements including a strategic analysis of the company's plans for maintaining...

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

    PubMed Central

    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 GH

    2010-01-01

    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). Hum Mutat 31:–6, 2010. © 2010 Wiley-Liss, Inc. PMID:20683926

  11. 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…

  12. 76 FR 14107 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing a revision... Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2011-5967 Filed 3-14-11...

  13. Health insurance exchanges under the Patient Protection and Affordable Care Act: regulatory and design challenges.

    PubMed

    Hoffmann, Stephanie M

    2012-12-01

    Under the Patient Protection and Affordable Care Act, all states are required to establish health insurance exchanges, marketplaces where individuals and small businesses can purchase health care coverage. In establishing these exchanges, states must address a range of regulatory and design issues to ensure that their exchanges are sustainable and meet the needs of their populations. The issues include the degree of federal involvement in the management of the exchanges, the overall structure and governance of the exchanges, the requirements for insurance plans to be offered on the exchanges, and the design of the exchanges themselves. Each of these issues will play a crucial role in determining the quality of coverage offered to consumers and how effectively they can access that coverage. Copyright © 2012 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  14. Propelling novel vaccines directed against tuberculosis through the regulatory process.

    PubMed

    Brennan, M J; Collins, F M; Morris, S L

    1999-01-01

    The development of novel vaccines for use in the prevention and immunotherapy of tuberculosis is an area of intense interest for scientific researchers, public health agencies and pharmaceutical manufacturers. Development of effective anti-tuberculosis vaccines for use in specific target populations will require close cooperation among several different international organizations including agencies responsible for evaluating the safety and effectiveness of new biologics for human use. In this review, the major issues that are addressed by regulatory agencies to ensure that vaccines are pure, potent, safe, and effective are discussed. It is hoped that the comments provided here will help accelerate the development of new effective vaccines for the prevention and treatment of tuberculosis.

  15. 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.

  16. NCI, NHLBI, FDA, AACC, and CMS Collaborate in Advancing Proteomics Regulatory Science | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    Despite great strides in proteomics and the growing number of articles citing the discovery of potential biomarkers, the actual rate of introduction of Food and Drug Administration (FDA) approved protein analytes has been relatively unchanged over the past 10 years. One of reasons for the lack of new protein-based biomarkers approved has been a lack of information and understanding by the proteomics research community to the regulatory process used by the FDA. To address this issue, Dr.

  17. 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…

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    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.

  19. Therapeutic gene editing: delivery and regulatory perspectives.

    PubMed

    Shim, Gayong; Kim, Dongyoon; Park, Gyu Thae; Jin, Hyerim; Suh, Soo-Kyung; Oh, Yu-Kyoung

    2017-06-01

    Gene-editing technology is an emerging therapeutic modality for manipulating the eukaryotic genome by using target-sequence-specific engineered nucleases. Because of the exceptional advantages that gene-editing technology offers in facilitating the accurate correction of sequences in a genome, gene editing-based therapy is being aggressively developed as a next-generation therapeutic approach to treat a wide range of diseases. However, strategies for precise engineering and delivery of gene-editing nucleases, including zinc finger nucleases, transcription activator-like effector nuclease, and CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats-associated nuclease Cas9), present major obstacles to the development of gene-editing therapies, as with other gene-targeting therapeutics. Currently, viral and non-viral vectors are being studied for the delivery of these nucleases into cells in the form of DNA, mRNA, or proteins. Clinical trials are already ongoing, and in vivo studies are actively investigating the applicability of CRISPR/Cas9 techniques. However, the concept of correcting the genome poses major concerns from a regulatory perspective, especially in terms of safety. This review addresses current research trends and delivery strategies for gene editing-based therapeutics in non-clinical and clinical settings and considers the associated regulatory issues.

  20. Therapeutic gene editing: delivery and regulatory perspectives

    PubMed Central

    Shim, Gayong; Kim, Dongyoon; Park, Gyu Thae; Jin, Hyerim; Suh, Soo-Kyung; Oh, Yu-Kyoung

    2017-01-01

    Gene-editing technology is an emerging therapeutic modality for manipulating the eukaryotic genome by using target-sequence-specific engineered nucleases. Because of the exceptional advantages that gene-editing technology offers in facilitating the accurate correction of sequences in a genome, gene editing-based therapy is being aggressively developed as a next-generation therapeutic approach to treat a wide range of diseases. However, strategies for precise engineering and delivery of gene-editing nucleases, including zinc finger nucleases, transcription activator-like effector nuclease, and CRISPR/Cas9 (clustered regularly interspaced short palindromic repeats-associated nuclease Cas9), present major obstacles to the development of gene-editing therapies, as with other gene-targeting therapeutics. Currently, viral and non-viral vectors are being studied for the delivery of these nucleases into cells in the form of DNA, mRNA, or proteins. Clinical trials are already ongoing, and in vivo studies are actively investigating the applicability of CRISPR/Cas9 techniques. However, the concept of correcting the genome poses major concerns from a regulatory perspective, especially in terms of safety. This review addresses current research trends and delivery strategies for gene editing-based therapeutics in non-clinical and clinical settings and considers the associated regulatory issues. PMID:28392568

  1. Addressing the ethical, legal, and social issues raised by voting by persons with dementia.

    PubMed

    Karlawish, Jason H; Bonnie, Richard J; Appelbaum, Paul S; Lyketsos, Constantine; James, Bryan; Knopman, David; Patusky, Christopher; Kane, Rosalie A; Karlan, Pamela S

    2004-09-15

    This article addresses an emerging policy problem in the United States participation in the electoral process by citizens with dementia. At present, health care professionals, family caregivers, and long-term care staff lack adequate guidance to decide whether individuals with dementia should be precluded from or assisted in casting a ballot. Voting by persons with dementia raises a series of important questions about the autonomy of individuals with dementia, the integrity of the electoral process, and the prevention of fraud. Three subsidiary issues warrant special attention: development of a method to assess capacity to vote; identification of appropriate kinds of assistance to enable persons with cognitive impairment to vote; and formulation of uniform and workable policies for voting in long-term care settings. In some instances, extrapolation from existing policies and research permits reasonable recommendations to guide policy and practice. However, in other instances, additional research is necessary.

  2. Summary of SMIRT20 Preconference Topical Workshop – Identifying Structural Issues in Advanced Reactors

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    William Richins; Stephen Novascone; Cheryl O'Brien

    Summary of SMIRT20 Preconference Topical Workshop – Identifying Structural Issues in Advanced Reactors William Richins1, Stephen Novascone1, and Cheryl O’Brien1 1Idaho National Laboratory, US Dept. of Energy, Idaho Falls, Idaho, USA, e-mail: William.Richins@inl.gov The Idaho National Laboratory (INL, USA) and IASMiRT sponsored an international forum Nov 5-6, 2008 in Porvoo, Finland for nuclear industry, academic, and regulatory representatives to identify structural issues in current and future advanced reactor design, especially for extreme conditions and external threats. The purpose of this Topical Workshop was to articulate research, engineering, and regulatory Code development needs. The topics addressed by the Workshop were selectedmore » to address critical industry needs specific to advanced reactor structures that have long lead times and can be the subject of future SMiRT technical sessions. The topics were; 1) structural/materials needs for extreme conditions and external threats in contemporary (Gen. III) and future (Gen. IV and NGNP) advanced reactors and 2) calibrating simulation software and methods that address topic 1 The workshop discussions and research needs identified are presented. The Workshop successfully produced interactive discussion on the two topics resulting in a list of research and technology needs. It is recommended that IASMiRT communicate the results of the discussion to industry and researchers to encourage new ideas and projects. In addition, opportunities exist to retrieve research reports and information that currently exists, and encourage more international cooperation and collaboration. It is recommended that IASMiRT continue with an off-year workshop series on select topics.« less

  3. Current regulatory issues in cell and tissue therapy.

    PubMed

    Burger, S R

    2003-01-01

    Cell-based therapies have grown dramatically in power and scope in recent years. Once limited to blood and BM transplantation, these therapies now encompass tissue repair and regeneration, metabolic support, gene replacement, and immune effector functions, with established and investigational clinical applications in disorders affecting nearly every tissue and organ system. The complexity and novel applications of human cells, tissues, and cellular and tissue-based products (HCT/Ps), however, present potential risks for adverse events. The US Food and Drug Administration, responding to these concerns, has established a tiered, risk-based regulatory structure, in which more rigorous controls and safeguards are required for products thought to pose increased risk. The proposed good tissue practices (GTP) rule and existing good manufacturing practices (GMP) requirements form the principal elements of this regulatory framework. The proposed GTPs are intended to prevent HCT/P contamination with infectious disease agents, and to ensure that these cells and tissues maintain their integrity and function. GMPs focus on production of safe, pure, and potent products, and entail a higher level of process control and product characterization. All HCT/Ps will be required to comply with GTPs. HCT/Ps considered to present greater risks of adverse events, however, will be subject to both GTPs and GMPs, and must obtain premarket approval using the Investigational New Drug (IND) mechanism established for biologics. Although these requirements will present significant challenges for clinician- investigators and laboratories producing HCT/Ps, the regulations fundamentally support good clinical care by increasing safety and control, and enable good science by improving the quality and reliability of data.

  4. Addressing health care market reform through an insurance exchange: essential policy components, the public plan option, and other issues to consider.

    PubMed

    Fronstin, Paul; Ross, Murray N

    2009-06-01

    HEALTH INSURANCE EXCHANGE: This Issue Brief examines issues related to managed competition and the use of a health insurance exchange for the purpose of addressing cost, quality, and access to health care services. It discusses issues that must be addressed when designing an exchange in order to reform the health insurance market and also examines state efforts at health reform that use an exchange. RISK VS. PRICE COMPETITION: The basic component of managed competition is the creation an organized marketplace that brings together health insurers and consumers (either as individuals or through their employers). The sponsor of the exchange would set "rules of engagement" for participating insurers and offer consumers a menu of choices among different plans. Ultimately, the goal of a health insurance exchange is to shift the market from competition based on risk to competition based on price and quality. ADVERSE SELECTION AND AFFORDABILITY: Among the issues that need to be addressed if an exchange that uses managed competition has a realistic chance of reducing costs, improving quality, and expanding coverage: Everyone needs to be in the risk pool, with individuals required to purchase insurance or face significant financial consequences; effective risk adjustment is essential to eliminate risk selection as an insurance business model--forcing competition on costs and quality; the insurance benefit must be specific and clear--without standards governing cost sharing, covered services, and network coverage there is no way to assess whether a requirement to purchase or issue coverage has been met; and subsidies would be necessary for low-income individuals to purchase insurance. THE PUBLIC PLAN OPTION: The public plan option is shaping up to be one of the most contentious issues in the health reform debate. Proponents also believe of a public plan is necessary to drive private insurers toward true competition. Opponents view it as a step toward government-run health

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MULKEY, C.H.

    1999-07-06

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

  6. An audit of local government planning tools for their potential use in addressing community food and nutrition issues.

    PubMed

    Good, Elizabeth; Hammond, Melinda; Martin, Caroline; Burns, Catherine; Groos, Anita

    2010-04-01

    This project aimed to identify how local government planning tools could be used to influence physical and policy environments to support healthy eating behaviours in communities. An audit of Queensland's legislative and non-legislative local government planning tools was conducted by a public health nutritionist to assess their potential use in addressing strategies to achieve positive nutrition outcomes. Ten strategies were identified and covered the following themes: improving access to healthy foods and drinks; increasing access to breastfeeding facilities; decreasing fast food outlet density; and unhealthy food advertising. The audit found that all of the 10 strategies to achieve positive nutrition outcomes could be considered through three or more of the planning tools. Based on the findings of this audit, local government planning tools provide opportunities to address food and nutrition issues and contribute toward creating physical and policy environments that support healthy eating behaviours.

  7. 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…

  8. Do Supplemental Remedial Reading Programs Address the Motivational Issues of Struggling Readers? An Analysis of Five Popular Programs.

    PubMed

    Quirk, Matthew P; Schwanenflugel, Paula J

    2004-04-01

    Five popular, but distinctly different, remedial reading programs were reviewed regarding the potential to motivate children to read. It is argued that current remedial reading program designs and research on program effectiveness ignore the impact that motivation has on struggling readers. In addition, we develop a theory of reading motivation specific to struggling readers that highlights motivational constructs we feel are important to the improvement of reading skill for this population of students. The three aspects of reading motivation most relevant to the instruction of remedial readers include: (a) improving reading self-efficacy; (b) making internal and controllable outcome attributions for successes and failures associated with reading; and (c) establishing personally relevant value in becoming a better reader. We conclude that, while most programs address some motivational issues and other issues not at all, most programs could make minor modifications that would greatly enhance their motivational impact.

  9. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    PubMed

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 plantmore » 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.« less

  11. Computational architecture of the yeast regulatory network

    NASA Astrophysics Data System (ADS)

    Maslov, Sergei; Sneppen, Kim

    2005-12-01

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

  12. Functional Evolution of a cis-Regulatory Module

    PubMed Central

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

    2005-01-01

    Lack of knowledge about how regulatory regions evolve in relation to their structure–function may limit the utility of comparative sequence analysis in deciphering cis-regulatory sequences. To address this we applied reverse genetics to carry out a functional genetic complementation analysis of a eukaryotic cis-regulatory module—the even-skipped stripe 2 enhancer—from four Drosophila species. The evolution of this enhancer is non-clock-like, with important functional differences between closely related species and functional convergence between distantly related species. Functional divergence is attributable to differences in activation levels rather than spatiotemporal control of gene expression. Our findings have implications for understanding enhancer structure–function, mechanisms of speciation and computational identification of regulatory modules. PMID:15757364

  13. Addressing the Economic Security Issues Facing Same-Sex Couples.

    ERIC Educational Resources Information Center

    Dolan, Elizabeth M.; Stum, Marlene S.; Rupured, Michael

    1999-01-01

    Provides educators and researchers with an awareness of the financial security issues faced by same-sex couples and offers suggestions for incorporating the discussion of these ideas into existing curricula and research. (Author/JOW)

  14. Uncovering MicroRNA and Transcription Factor Mediated Regulatory Networks in Glioblastoma

    PubMed Central

    Sun, Jingchun; Gong, Xue; Purow, Benjamin; Zhao, Zhongming

    2012-01-01

    Glioblastoma multiforme (GBM) is the most common and lethal brain tumor in humans. Recent studies revealed that patterns of microRNA (miRNA) expression in GBM tissue samples are different from those in normal brain tissues, suggesting that a number of miRNAs play critical roles in the pathogenesis of GBM. However, little is yet known about which miRNAs play central roles in the pathology of GBM and their regulatory mechanisms of action. To address this issue, in this study, we systematically explored the main regulation format (feed-forward loops, FFLs) consisting of miRNAs, transcription factors (TFs) and their impacting GBM-related genes, and developed a computational approach to construct a miRNA-TF regulatory network. First, we compiled GBM-related miRNAs, GBM-related genes, and known human TFs. We then identified 1,128 3-node FFLs and 805 4-node FFLs with statistical significance. By merging these FFLs together, we constructed a comprehensive GBM-specific miRNA-TF mediated regulatory network. Then, from the network, we extracted a composite GBM-specific regulatory network. To illustrate the GBM-specific regulatory network is promising for identification of critical miRNA components, we specifically examined a Notch signaling pathway subnetwork. Our follow up topological and functional analyses of the subnetwork revealed that six miRNAs (miR-124, miR-137, miR-219-5p, miR-34a, miR-9, and miR-92b) might play important roles in GBM, including some results that are supported by previous studies. In this study, we have developed a computational framework to construct a miRNA-TF regulatory network and generated the first miRNA-TF regulatory network for GBM, providing a valuable resource for further understanding the complex regulatory mechanisms in GBM. The observation of critical miRNAs in the Notch signaling pathway, with partial verification from previous studies, demonstrates that our network-based approach is promising for the identification of new and important

  15. Big data, little security: Addressing security issues in your platform

    NASA Astrophysics Data System (ADS)

    Macklin, Thomas; Mathews, Joseph

    2017-05-01

    This paper describes some patterns for information security problems that consistently emerge among traditional enterprise networks and applications, both with respect to cyber threats and data sensitivity. We draw upon cases from qualitative studies and interviews of system developers, network operators, and certifiers of military applications. Specifically, the problems discussed involve sensitivity of data aggregates, training efficacy, and security decision support in the human machine interface. While proven techniques can address many enterprise security challenges, we provide additional recommendations on how to further improve overall security posture, and suggest additional research thrusts to address areas where known gaps remain.

  16. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2016-01-01

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

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

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

    2013-07-01

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

  19. Regulatory issues relating to therapies for periodontal regeneration.

    PubMed

    Singleton, D G; Torres-Cabassa, A

    1997-03-01

    The Food and Drug Administration (FDA) has regulated medical devices since May 1976, when the Medical Device Amendments were enacted. The clinical trial requirements for the marketing of periodontal regeneration devices have been dependent, in part, on the degree of their similarity to devices marketed prior to the legislative enactment date in terms of materials, indication statements, and labeling claims. Nonresorbable barriers were allowed to be marketed based on their equivalence to devices marketed prior to the enactment date based on biocompatability and clinical trial data under the premarket notification requirements section of the law. Bone filling materials such as hydroxyapatite were first marketed based on the finding of equivalence to predicate devices. Newer technologies such as bioabsorbable barriers have also been reviewed under the premarket notification provisions of the law, but manufacturers have been required to provide more extensive safety and effectiveness data to establish equivalence to pre-Amendments devices. Data to answer questions related to the potential toxicity of breakdown products, period of absorption, and ultimate clinical effectiveness needed to be answered prior to marketing. New devices that incorporate technologies that are not substantially equivalent to predicate devices must proceed through the premarket approval route to marketing. For new devices considered a potential significant risk to the patient population, clinical trials are conducted via the investigational device exemption (IDE) requirements that specify the means by which trials will proceed in order to protect the rights of patients. New devices of organic origin, such as bone morphogenic protein, have followed the premarket approval route with IDE requirements instituted as a condition for their path to the marketplace. Issues associated with immediate and long-term contact including potential toxicity, tumorigenicity, and sensitization need to be addressed

  20. Bulimia: Issues a University Counseling Center Needs To Address.

    ERIC Educational Resources Information Center

    Whitner, Phillip A.; Shetterly, Arminta

    The eating disorder known as bulimia is a relatively new and baffling phenomenon. This paper raises questions that college and university counseling center professionals need to address regarding this phenomenon. The first section focuses on defining the term "bulimia" and its evolution. The second section identifies numerous symptoms that need to…

  1. 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…

  2. Regulatory T Cell and Forkhead Box Protein 3 as Modulators of Immune Homeostasis

    PubMed Central

    Pereira, Leonn Mendes Soares; Gomes, Samara Tatielle Monteiro; Ishak, Ricardo; Vallinoto, Antonio Carlos Rosário

    2017-01-01

    The transcription factor forkhead box protein 3 (FOXP3) is an essential molecular marker of regulatory T cell (Treg) development in different microenvironments. Tregs are cells specialized in the suppression of inadequate immune responses and the maintenance of homeostatic tolerance. Studies have addressed and elucidated the role played by FOXP3 and Treg in countless autoimmune and infectious diseases as well as in more specific cases, such as cancer. Within this context, the present article reviews aspects of the immunoregulatory profile of FOXP3 and Treg in the management of immune homeostasis, including issues relating to pathology as well as immune tolerance. PMID:28603524

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

    PubMed

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

    2016-10-01

    Endocrine disruptors (EDs) are defined by the World Health Organization (WHO) as exogenous compounds or mixtures that alter function(s) of the endocrine system and consequently cause adverse effects in an intact organism, or its progeny, or (sub)populations. European regulations on pesticides, biocides, cosmetics, and industrial chemicals require the European Commission to establish scientific criteria to define EDs. We address the scientific relevance of four options for the identification of EDs proposed by the European Commission. Option 1, which does not define EDs and leads to using interim criteria unrelated to the WHO definition of EDs, is not relevant. Options 2 and 3 rely on the WHO definition of EDs, which is widely accepted by the scientific community, with option 3 introducing additional categories based on the strength of evidence (suspected EDs and endocrine-active substances). Option 4 adds potency to the WHO definition, as a decision criterion. We argue that potency is dependent on the adverse effect considered and is scientifically ambiguous, and note that potency is not used as a criterion to define other particularly hazardous substances such as carcinogens and reproductive toxicants. The use of potency requires a context that goes beyond hazard identification and corresponds to risk characterization, in which potency (or, more relevantly, the dose-response function) is combined with exposure levels. There is scientific agreement regarding the adequacy of the WHO definition of EDs. The potency concept is not relevant to the identification of particularly serious hazards such as EDs. As is common practice for carcinogens, mutagens, and reproductive toxicants, a multi-level classification of ED based on the WHO definition, and not considering potency, would be relevant (corresponding to option 3 proposed by the European Commission). Slama R, Bourguignon JP, Demeneix B, Ivell R, Panzica G, Kortenkamp A, Zoeller RT. 2016. Scientific issues relevant

  4. 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

  5. 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…

  6. Legal Considerations of Internet Use--Issues To Be Addressed.

    ERIC Educational Resources Information Center

    Thomas, Daphyne Saunders; Forcht, Karen A.; Counts, Peter

    1998-01-01

    Explores issues related to legal considerations of the widespread use of the Internet worldwide. Topics considered include: e-mail; data theft and piracy; search and seizure; electronic banking; offensive behavior; liability; copyright infringement; laws regulating the Internet; and the Telecommunications Act. (PEN)

  7. 76 FR 14108 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ..., Revision 1, ``Control of Preheat Temperature for Welding of Low-Alloy Steel.'' FOR FURTHER INFORMATION... for Welding of Low-Alloy Steel,'' was issued with a temporary identification as Draft Regulatory Guide... implementing regulatory requirements related to the control of welding for low-alloy steel components during...

  8. Adolescent Social Issues: Using Media to Address Crucial Concerns.

    ERIC Educational Resources Information Center

    Sokoloff, Michele

    1987-01-01

    This article describes media resources available to help adolescents deal with a variety of social concerns, including substance abuse, dropouts, Acquired Immune Deficiency Syndrome (AIDS), suicide, and pregnancy. A list of 56 companies that provide resources dealing with social issues is also provided. (LRW)

  9. 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.

  10. Cleaning up our Federal energy regulatory mess

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kennedy, R.T.

    1978-08-01

    The new Department of Energy is making much effort to cut back on overlaps of regulations in regard to energy. Several governmental agencies were absorbed into DOE, but many of the previous agencies' policies are still on the books. The Energy Reorganization Act of 1977 did not eliminate the problem of regulatory overlap and confusion, the author says. Also, our future national energy policy will have to rest on this very complex of laws and regulations, he says. The author, being a former deputy administrator of the FEA, uses the nuclear industry to discuss ''the confusion.'' He concludes that eachmore » of us ''has a responsibility to clean up the energy regulation situation. Broad national policy issues must be addressed by Congress and the President. The States must focus hard on ways to simplify and strengthen their processes; and Federal agencies must look to ways to improve their interface with the states and to reduce duplication both with the states and with each other. All regulatory agencies must, mindful of their role in the process, police themselves, and keep a close eye on how that process is working. Finally, each government official and citizen must do his part to bring problems and solutions to the attention of the appropriate officials. For you are the watchdogs in this process, the keystone upon which our system rests.'' (MCW)« less

  11. 76 FR 42074 - Consideration of Rulemaking To Address Prompt Remediation of Residual Radioactivity During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-18

    ... Address Prompt Remediation of Residual Radioactivity During Operations AGENCY: Nuclear Regulatory... States, and other stakeholders on a potential rulemaking to address prompt remediation of residual... DPR does not have a mandatory requirement for licensees to conduct radiological remediation during...

  12. 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

  13. Address tracing for parallel machines

    NASA Technical Reports Server (NTRS)

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

    1991-01-01

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

  14. 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…

  15. 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).

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Grabaskas, David; Bucknor, Matthew; Jerden, James

    2016-02-01

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

  17. Fitness for duty in the nuclear industry: Update of the technical issues 1996

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Durbin, N.; Grant, T.

    The purpose of this report is to provide an update of information on the technical issues surrounding the creation, implementation, and maintenance of fitness-for-duty (FFD) policies and programs. It has been prepared as a resource for Nuclear Regulatory Commission (NRC) and nuclear power plant personnel who deal with FFD programs. It contains a general overview and update on the technical issues that the NRC considered prior to the publication of its original FFD rule and the revisions to that rule (presented in earlier NUREG/CRs). It also includes chapters that address issues about which there is growing concern and/or about whichmore » there have been substantial changes since NUREG/CR-5784 was published. Although this report is intended to support the NRC`s rule making on fitness for duty, the conclusions of the authors of this report are their own and do not necessarily represent the opinions of the NRC.« less

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-04-06

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

  20. Challenges and Opportunities for Tribal Waters: Addressing Disparities in Safe Public Drinking Water on the Crow Reservation in Montana, USA.

    PubMed

    Doyle, John T; Kindness, Larry; Realbird, James; Eggers, Margaret J; Camper, Anne K

    2018-03-21

    Disparities in access to safe public drinking water are increasingly being recognized as contributing to health disparities and environmental injustice for vulnerable communities in the United States. As the Co-Directors of the Apsaálooke Water and Wastewater Authority (AWWWA) for the Crow Tribe, with our academic partners, we present here the multiple and complex challenges we have addressed in improving and maintaining tribal water and wastewater infrastructure, including the identification of diverse funding sources for infrastructure construction, the need for many kinds of specialized expertise and long-term stability of project personnel, ratepayer difficulty in paying for services, an ongoing legacy of inadequate infrastructure planning, and lack of water quality research capacity. As a tribal entity, the AWWWA faces additional challenges, including the complex jurisdictional issues affecting all phases of our work, lack of authority to create water districts, and additional legal and regulatory gaps-especially with regards to environmental protection. Despite these obstacles, the AWWWA and Crow Tribe have successfully upgraded much of the local water and wastewater infrastructure. We find that ensuring safe public drinking water for tribal and other disadvantaged U.S. communities will require comprehensive, community-engaged approaches across a broad range of stakeholders to successfully address these complex legal, regulatory, policy, community capacity, and financial challenges.

  1. Challenges and Opportunities for Tribal Waters: Addressing Disparities in Safe Public Drinking Water on the Crow Reservation in Montana, USA

    PubMed Central

    Doyle, John T.; Kindness, Larry; Realbird, James; Camper, Anne K.

    2018-01-01

    Disparities in access to safe public drinking water are increasingly being recognized as contributing to health disparities and environmental injustice for vulnerable communities in the United States. As the Co-Directors of the Apsaálooke Water and Wastewater Authority (AWWWA) for the Crow Tribe, with our academic partners, we present here the multiple and complex challenges we have addressed in improving and maintaining tribal water and wastewater infrastructure, including the identification of diverse funding sources for infrastructure construction, the need for many kinds of specialized expertise and long-term stability of project personnel, ratepayer difficulty in paying for services, an ongoing legacy of inadequate infrastructure planning, and lack of water quality research capacity. As a tribal entity, the AWWWA faces additional challenges, including the complex jurisdictional issues affecting all phases of our work, lack of authority to create water districts, and additional legal and regulatory gaps—especially with regards to environmental protection. Despite these obstacles, the AWWWA and Crow Tribe have successfully upgraded much of the local water and wastewater infrastructure. We find that ensuring safe public drinking water for tribal and other disadvantaged U.S. communities will require comprehensive, community-engaged approaches across a broad range of stakeholders to successfully address these complex legal, regulatory, policy, community capacity, and financial challenges. PMID:29561815

  2. Environmental Regulatory Update Table, May/June 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

    1992-07-01

    This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

  3. Environmental Regulatory Update Table, May/June 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.

    1992-07-01

    This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

  4. Ethical issues in newer assisted reproductive technologies: A view from Nigeria.

    PubMed

    Fadare, J O; Adeniyi, A A

    2015-12-01

    Infertility is a prevalent condition in many developing countries with significant physical and psychosocial implications. The aim of this study is to discuss briefly the ethics of newer assisted reproductive technology (ART) with special emphasis on the peculiarities in Nigeria. MEDLINE and Google Scholar were searched for English-language articles from January 1990 to July 2014 using the search terms "ethics of ART AND Nigeria," "ethical issues in in vitro fertilization AND Nigeria." Using the above search phrases, a total of 43 articles were retrieved out of which only 5 dealt specifically with the subject matter. The core ethical issues found in the reviewed literature are listed in [Table 1]. Inequitable access to ART due to its high cost, lack of regulatory body, safety of the procedure, and fate of the embryos were the main themes identified from the papers. Surrogacy, sex selection, and gamete donation were additional relevant ethical issues. There is an urgent need for stakeholders in developing countries to formulate cultural and context-specific guidelines to help address some of these ethical dilemmas.

  5. Regulatory Aspects Of Implementing Electrokinetic Remediation

    EPA Science Inventory

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

  6. Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

    PubMed

    Roberts, Jeffrey N; Gruber, Marion F

    2015-02-18

    Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy. In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products. Published by Elsevier Ltd.

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

    PubMed

    Hall, Joseph L; McGraw, Deven

    2014-02-01

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

  8. Flight training efforts would benefit from more flexible aviation regulatory structures.

    PubMed

    Bent, J

    1996-10-01

    Training and regulatory issues related to modern flight deck systems are reviewed. Philosophical differences in regulatory bodies in the United States and Europe are highlighted. Methods of changing regulations in Europe and the United States are discussed.

  9. 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.…

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    None, None

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

  11. 78 FR 61999 - Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop As announced in the Notices issued on September 3, 2013 and September 18, 2013, the Federal Energy Regulatory Commission (FERC or Commission...

  12. A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

    ERIC Educational Resources Information Center

    Cole, Jack E.; And Others

    Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

  13. Argumentation in elementary science education: addressing methodological issues and conceptual understanding

    NASA Astrophysics Data System (ADS)

    Kaya, Ebru

    2017-11-01

    In this review essay I respond to issues raised in Mijung Kim and Wolff-Michael Roth's paper titled "Dialogical argumentation in elementary science classrooms", which presents a study dealing with dialogical argumentation in early elementary school classrooms. Since there is very limited research on lower primary school students' argumentation in school science, their paper makes a contribution to research on children's argumentation skills. In this response, I focus on two main issues to extend the discussion in Kim and Roth's paper: (a) methodological issues including conducting a quantitative study on children's argumentation levels and focusing on children's written argumentation in addition to their dialogical argumentation, and (b) investigating children's conceptual understanding along with their argumentation levels. Kim and Roth emphasize the difficulty in determining the level of children's argumentation through the Toulmin's Argument Pattern and lack of high level arguments by children due to their difficulties in writing texts. Regarding these methodological issues, I suggest designing quantitative research on coding children's argument levels because such research could potentially provide important findings on children's argumentation. Furthermore, I discuss alternative written products including posters, figures, or pictures generated by children in order to trace children's arguments, and finally articulating argumentation and conceptual understanding of children.

  14. 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.

  15. Ethical Issues in Addressing Social Media Posts About Suicidal Intentions During an Online Study Among Youth: Case Study.

    PubMed

    Young, Sean D; Garett, Renee

    2018-05-03

    Due to the popularity of social media, researchers are increasingly conducting studies that monitor and analyze people's health-related social media conversations. Because social media users can post about any topic at any time, no known best ethical practices exist as to whether and how to monitor participants' posts for safety-related issues that might be unrelated to the study, such as expressions of suicidal intentions. This is a case study during a social media-based study on sleep and activity among freshman undergraduate students, where we by chance noticed that a student was using social media to express suicidal intentions. Although we connected the student to student psychological services in order to receive treatment, we encountered a number of barriers that initially prevented this from occurring, such as institutional review board and regulatory practices related to lack of experience with these newer types of studies. We discuss the implications of this experience for future research. ©Sean D Young, Renee Garett. Originally published in JMIR Mental Health (http://mental.jmir.org), 03.05.2018.

  16. 76 FR 34815 - Wyoming Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...We are issuing a final decision on an amendment to the Wyoming regulatory program (the ``Wyoming program'') under the Surface Mining Control and Reclamation Act of 1977 (``SMCRA'' or ``the Act''). Our decision approves in part, disapproves in part and defers in part the amendment. Wyoming proposed to amend Chapters 1, 2, 4, 5, and Appendix A of the Land Quality Division (LQD) Coal Rules and Regulations to address required program amendments and other deficiencies identified by OSMRE, and to improve and clarify rules relating to requirements for vegetation measurements and performance standards. Specifically, the proposed changes clarify baseline vegetation requirements and revegetation reclamation plan requirements, clarify revegetation success standards and codify normal husbandry practices, reorganize and clarify species diversity and shrub density requirements, and revise and add definitions supporting those proposed changes. Wyoming also proposed changes to its rules in Chapters 2, 4, and 5 regarding cultural and historic resources, prime farmland, siltation structures and impoundments, and operator information. Wyoming revised its program to be consistent with the corresponding Federal regulations and SMCRA, clarify ambiguities, and improve operational efficiency.

  17. Legislative and regulatory modernization for therapeutic products.

    PubMed

    Maher, Maurica

    2010-01-01

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

  18. Issues and concerns in nanotech product development and its commercialization.

    PubMed

    Kaur, Indu Pal; Kakkar, Vandita; Deol, Parneet Kaur; Yadav, Monika; Singh, Mandeep; Sharma, Ikksheta

    2014-11-10

    The revolutionary and ubiquitous nature of nanotechnology has fetched it a considerable attention in the past few decades. Even though its enablement and application to various sectors including pharmaceutical drug development is increasing with the enormous government aided funding for nanotechnology-based products, however the parallel commercialization of these systems has not picked up a similar impetus. The technology however does address the unmet needs of pharmaceutical industry, including the reformulation of drugs to improve their solubility, bioavailability or toxicity profiles as observed from the wide array of high-quality research publications appearing in various scientific journals and magazines. Based on our decade-long experience in the field of nanotech-based drug delivery systems and extensive literature survey, we perceive that the major hiccups to the marketing of these nanotechnology products can be categorized as 1) inadequate regulatory framework; 2) lack of support and acceptance by the public, practicing physician, and industry; 3) developmental considerations like scalability, reproducibility, characterization, quality control, and suitable translation; 4) toxicological issues and safety profiles; 5) lack of available multidisciplinary platforms; and, 6) poor intellectual property protection. The present review dwells on these issues elaborating the trends followed by the industry, regulatory role of the USFDA and their implication, and the challenges set forth for a successful translation of these products from the lab and different clinical phases to the market. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. Generation of intervention strategy for a genetic regulatory network represented by a family of Markov Chains.

    PubMed

    Berlow, Noah; Pal, Ranadip

    2011-01-01

    Genetic Regulatory Networks (GRNs) are frequently modeled as Markov Chains providing the transition probabilities of moving from one state of the network to another. The inverse problem of inference of the Markov Chain from noisy and limited experimental data is an ill posed problem and often generates multiple model possibilities instead of a unique one. In this article, we address the issue of intervention in a genetic regulatory network represented by a family of Markov Chains. The purpose of intervention is to alter the steady state probability distribution of the GRN as the steady states are considered to be representative of the phenotypes. We consider robust stationary control policies with best expected behavior. The extreme computational complexity involved in search of robust stationary control policies is mitigated by using a sequential approach to control policy generation and utilizing computationally efficient techniques for updating the stationary probability distribution of a Markov chain following a rank one perturbation.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

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

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

  1. Analysis of federal and state policies and environmental issues for bioethanol production facilities.

    PubMed

    McGee, Chandra; Chan Hilton, Amy B

    2011-03-01

    The purpose of this work was to investigate incentives and barriers to fuel ethanol production from biomass in the U.S. during the past decade (2000-2010). In particular, we examine the results of policies and economic conditions during this period by way of cellulosic ethanol activity in four selected states with the potential to produce different types of feedstocks (i.e., sugar, starch, and cellulosic crops) for ethanol production (Florida, California, Hawaii, and Iowa). Two of the four states, Iowa and California, currently have commercial ethanol production facilities in operation using corn feedstocks. While several companies have proposed commercial scale facilities in Florida and Hawaii, none are operating to date. Federal and state policies and incentives, potential for feedstock production and conversion to ethanol and associated potential environmental impacts, and environmental regulatory conditions among the states were investigated. Additionally, an analysis of proposed and operational ethanol production facilities provided evidence that a combination of these policies and incentives along with the ability to address environmental issues and regulatory environment and positive economic conditions all impact ethanol production. The 2000-2010 decade saw the rise of the promise of cellulosic ethanol. Federal and state policies were enacted to increase ethanol production. Since the initial push for development, expansion of cellulosic ethanol production has not happened as quickly as predicted. Government and private funding supported the development of ethanol production facilities, which peaked and then declined by the end of the decade. Although there are technical issues that remain to be solved to more efficiently convert cellulosic material to ethanol while reducing environmental impacts, the largest barriers to increasing ethanol production appear to be related to government policies, economics, and logistical issues. The numerous federal and state

  2. Patient safety issues in office-based surgery and anaesthesia in Switzerland: a qualitative study.

    PubMed

    McLennan, Stuart; Schwappach, David; Harder, Yves; Staender, Sven; Elger, Bernice

    2017-08-01

    To identify the spectrum of patient safety issues in office-based surgery and anaesthesia in Switzerland. Purposive sample of 23 experts in surgery and anaesthesia and quality and regulation in Switzerland. Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between March 2016 and September 2016. Interviews were transcribed and analysed using conventional content analysis. Issues were categorised under the headings "structure", "process", and "outcome". Experts identified two key overarching patient safety and regulatory issues in relation to office-based surgery and anaesthesia in Switzerland. First, experts repeatedly raised the current lack of data and transparency of the setting. It is unknown how many surgeons are operating in offices, how many and what types of operations are being done, and what the outcomes are. Secondly, experts also noted the limited oversight and regulation of the setting. While some standards exists, most experts felt that more minimal safety standards are needed regarding the requirements that must be met to do office-based surgery and what can and cannot be done in the office-based setting are needed, but they advocated a self-regulatory approach. There is a lack of empirical data regarding the quantity and quality office-based surgery and anaesthesia in Switzerland. Further research is needed to address these research gaps and inform health policy in relation to patient safety in office-based surgery and anaesthesia in Switzerland. Copyright © 2017. Published by Elsevier GmbH.

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 andmore » 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.« less

  4. A survey of pharmacists' perceptions of the adequacy of their training for addressing mental health–related medication issues

    PubMed Central

    2017-01-01

    Introduction: The purpose of this study was to conduct a survey of North Carolina pharmacists' perceptions of their pharmacy training in mental health–related medication issues and how this influenced their perceived ability to address these issues in the provision of pharmaceutical care to their patients. Methods: A survey consisting of 17 questions was developed and emailed to licensed pharmacists in North Carolina. Surveys that were returned were analyzed to see if conclusions could be made regarding the pharmacists' perceptions about their mental health–related medication training and its influence on their practice. Results: A total of 848 pharmacists completed the survey (response rate of 7.9%). Of the survey participants, 489 (58.2%) reported that pharmacy school training adequately prepared them to provide basic pharmaceutical care to patients taking mental health–related medications. However, 350 (41.4%) reported feeling less comfortable providing medication counseling for mental health–related medications compared to cardiac medications. Discussion: Despite the volume of prescriptions that mental health–related medications represent in day-to-day practice, a significant portion of licensed pharmacists responding to our survey indicate that the emphasis on mental health in their training may have been inadequate.

  5. Who owns Australia's water--elements of an effective regulatory model.

    PubMed

    McKay, J

    2003-01-01

    This paper identifies and describes a number of global trends in regulatory theory and legal scholarship. It points out the huge level of complexity demanded by globalisation and the unfortunate complication of this is that there is legal indeterminacy. The legal indeterminacy springs from the desire to amend and alter existing models. That has been the thrust of the Council of Australian Governments changes to adapt and add huge amounts of complexity to a flawed system. This paper argues that an effective water regulatory model requires a fundamental re-examination of the concept of water ownership and a capturing by the State of the right to allocate rainfall. This foundation is effective and the way forward to deal with the key issues in this transition phase. The second key element to an effective regulatory model is the concept of performance-based assessment. This requires information and schemes to be set up to work out ways to monitor and evaluate the performance of the utility on selected criteria. For Australia at present there is a dire lack of agreed criteria on these key issues and these have the potential to pull apart the whole process. The key issues are indigenous rights, governance issues, public participation, alteration of pre-existing rights and incorporation of environmental requirements.

  6. 48 CFR 401.170 - Electronic access to regulatory information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... access to regulatory information. The USDA Departmental Administration Procurement Homepage provides... guidance in electronic form. The Internet address for the Procurement Homepage is URL http://www.usda.gov...

  7. 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.

  8. Regulatory and Non-regulatory Responses to Hydraulic Fracturing in Local Communities

    NASA Astrophysics Data System (ADS)

    Phartiyal, P.

    2015-12-01

    The practice of extracting oil and gas from tight rock formations using advances in technology, such as hydraulic fracturing and directional drilling, has expanded exponentially in states and localities across the country. As the scientific data collection and analysis catches up on the many potential impacts of this unconventional oil and gas development, communities are turning to their local officials to make decisions on whether and how fracking should proceed. While most regulatory authority on the issue rests with the state agencies, local officials have experimented with a wide range of regulatory, non-regulatory, and fiscal tools to manage the impacts of fracking. These impacts can occur on the local air, water, seismicity, soil, roads, schools, and affect residents, on-site workers, emergency and social services. Local officials' approaches are often influenced by their prior experience with minerals extraction in their localities. The speaker will present examples of the kinds of information sources, tools and approaches communities across the country are using, from noise barriers to setback requirements to information sharing in order to be able to balance the promise and perils of oil and gas development in their jurisdictions.

  9. Stakeholders' views on ethical issues in the practice of in-vitro fertilisation and embryo transfer in Nigeria.

    PubMed

    Ajayi, R A; Dibosa-Osadolor, O J

    2011-09-01

    The provision of IVF for the specialized treatment of infertility has grown very rapidly in Nigeria in recent times, especially within the private sector. The objective of this study was to document the views of key stakeholders regarding salient ethical issues relating to the practice of in-vitro fertilisation (IVF) in Nigeria. A think-tank session was convened with participants drawn from different backgrounds and disciplines to deliberate on ethical issues in IVF. Ten key issues were discussed at this inaugural session. It was unanimously agreed that there are no right or wrong answers when considering the ethics and morality of IVF as these are principally dependent on choice and circumstances. However within the legal and socio-cultural dictates of the Nigerian society, right and wrong may be clearly determined on some issues. With the expansion of the IVF industry and technology in Nigeria, the need to address related ethical issues have become paramount. The forum recommended that it is important that regulatory guidelines are put in place to regulate the practice of IVF in Nigeria and to protect patients' rights and safety.

  10. Analysis of Regulatory Guidance for Health Monitoring

    NASA Technical Reports Server (NTRS)

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

    2000-01-01

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

  11. Regulatory alerts for dietary supplements in Canada and the United States, 2005-13.

    PubMed

    Abe, Andrew M; Hein, Darren J; Gregory, Philip J

    2015-06-01

    Dietary supplement regulatory alerts published by the Food and Drug Administration (FDA) and Health Canada were evaluated and characterized. FDA MedWatch and Health Canada websites were reviewed to identify regulatory alerts regarding dietary supplements from January 1, 2005, through December 31, 2013. Alerts were analyzed to identify product characteristics that may be predictive of product quality issues and potential patient harm. A total of 1560 dietary supplement-related regulatory alerts were identified. Of those, 1287 (83%) were identified through Health Canada, and 273 (18%) were identified through FDA MedWatch. The country of origin of dietary supplements associated with regulatory alerts was not provided in most regulatory alerts; however, when their origin was provided, the United States was the most common. Dietary supplements intended for sexual enhancement were the subject of 33% of all regulatory alerts identified. Products purchased online were the most likely to be associated with a regulatory alert. Dietary supplements intended for sexual enhancement, weight loss, and bodybuilding or athletic performance appeared to pose the greatest risk for patient harm due to product contamination with a pharmaceutical such as a phosphodiesterase-5 inhibitor or sibutramine. Analysis of Canadian and U.S. regulatory alerts concerning dietary supplements revealed that more than 80% of the composite alerts were issued by Health Canada. The most common intended uses of supplements for which alerts were issued were sexual enhancement, weight loss, and bodybuilding or athletic performance. The most common reason for alerts was the presence of a pharmaceutical contaminant. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  12. The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.

    PubMed

    Elahi, Merina; Eshera, Noha; Bambata, Nkosazana; Barr, Helen; Lyn-Cook, Beverly; Beitz, Julie; Rios, Maria; Taylor, Deborah R; Lightfoote, Marilyn; Hanafi, Nada; DeJager, Lowri; Wiesenfeld, Paddy; Scott, Pamela E; Fadiran, Emmanuel O; Henderson, Marsha B

    2016-03-01

    The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

  13. The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

    PubMed Central

    Elahi, Merina; Eshera, Noha; Bambata, Nkosazana; Barr, Helen; Lyn-Cook, Beverly; Beitz, Julie; Rios, Maria; Taylor, Deborah R.; Lightfoote, Marilyn; Hanafi, Nada; DeJager, Lowri; Wiesenfeld, Paddy; Scott, Pamela E.; Henderson, Marsha B.

    2016-01-01

    Abstract The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products. PMID:26871618

  14. 47 CFR 63.10 - Regulatory classification of U.S. international carriers.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 3 2010-10-01 2010-10-01 false Regulatory classification of U.S. international... and Supplements § 63.10 Regulatory classification of U.S. international carriers. (a) Unless otherwise... issue it raises as to the proper classification of the U.S. carrier. (c) Any carrier classified as...

  15. 47 CFR 63.10 - Regulatory classification of U.S. international carriers.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 3 2011-10-01 2011-10-01 false Regulatory classification of U.S. international... and Supplements § 63.10 Regulatory classification of U.S. international carriers. (a) Unless otherwise... issue it raises as to the proper classification of the U.S. carrier. (c) Any carrier classified as...

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

    PubMed Central

    Pomeranz, Jennifer L

    2015-01-01

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

  17. Addressing HIV/AIDS Education: A Look at Teacher Preparedness in Ghana

    ERIC Educational Resources Information Center

    Weiler, Jim Martin; Martin-Weiler, Cassandra J.

    2012-01-01

    Our research shows that social science university trained Ghanaian student/teachers do have the knowledge, confidence, and willingness to address HIV/AIDS issues in their teaching, yet they do not. The reason, we argue, is that teachers have little incentive to address contentious issues in the classroom. Questionnaires were administered to 382…

  18. Policy issues in space analogues

    NASA Astrophysics Data System (ADS)

    Auger, Robin N.; Facktor, Debra D.

    Space mission planning is increasingly focusing on destinations beyond Earth orbit. Advancements in technology will inevitably be required to enable long-duration human spaceflight missions, and breakthroughs in the policy arena will also be needed to achieve success in such missions. By exploring how policy issues have been addressed in analogous extreme environments, policymakers can develop a framework for addressing these issues as they apply to long-term human spaceflight. Policy issues that need to be addressed include: crew selection, training, organization, and activities, medical testing, illness, injury, and death; communication; legal accountability and liability; mission safety and risk management; and environmental contamination. This paper outlines the approach of a study underway by The George Washington University and ANSER to examine how these policy issues have been addressed in several analogues and how the experiences of these analogues can help formulate policies for long-duration human spaceflight missions. Analogues being studied include Antarctic bases, submarine voyages, undersea stations, Biosphere 2, and the U.S. Skylab and Russian Mir space stations.

  19. 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…

  20. Department of the Treasury Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

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

  1. It Comes With the Job: Work Organizational, Job Design, and Self-Regulatory Barriers to Improving the Health Status of Train Drivers.

    PubMed

    Naweed, Anjum; Chapman, Janine; Allan, Matthew; Trigg, Joshua

    2017-03-01

    This study aimed to examine the impacts of key barriers to improving the occupational health status of Australian train drivers. From May to June, 2015, five semi-structured qualitative focus groups were conducted with 29 train drivers from South Australian, Victorian, and New South Wales-based rail organizations in Australia. Occupational health was impeded by multiple barriers regarding sleep (patterns/fatigue), diet (planning/context), mental health (occupational stress), rostering (low autonomy), sedentary time, low fitness motivation, and family/social life conflicts. Work organizational barriers included communication issues, low organizational support, and existing social norms. Job design barriers included rostering, fatigue, stimulant reliance, and family/social life imbalances. Self-regulatory barriers included dietary and exercise patterns habits and patterns. Occupational health interventions for Australian train drivers must address work organizational, job design, and self-regulatory barriers to healthier lifestyle behaviors.

  2. Dynamic Covalent Chemistry of Carbon Dioxide: Opportunities to Address Environmental Issues.

    PubMed

    Septavaux, Jean; Germain, Geoffroy; Leclaire, Julien

    2017-07-18

    Extraction and purification of basic chemicals from complex mixtures has been a persistent issue throughout the development of the chemical sciences. The chemical industry and academic research have grown over the centuries by following a deconstruction-reconstruction approach, reminiscent of the metabolism process. Chemists have designed and optimized extraction, purification, and transformation processes of molecules from natural deposits (fossil fuels, biomass, ores), in order to reassemble them into complex adducts. These highly selective and cost-effective techniques arose from developments in physical chemistry but also in supramolecular chemistry, long before the term was even coined. Thanks to the extremely diverse toolbox currently available to the scientific community, artificial molecular systems of increasing complexity can be built and integrated into high-technology products. If humanity has proven through the ages how gifted it can be at this deconstruction-reconstruction game, which has transformed the natural world to a human-shaped one, it has been confronted for more than a century by a new challenge: the deconstruction and reconstruction from a new type of deposit, the waste resulting from the mass production of disposable manufactured goods. In this Account, we will explore the potential contribution of controlled molecular and supramolecular self-assembly phenomena to the challenge of selective and efficient capture of valuable target molecules from mixtures found in postconsumer waste. While it may appear paradoxical to add more molecular ingredients to an already compositionally complex system in order to address a purification issue, we will compare the selectivity, yield, and cost of such an atypical procedure with traditional physical techniques. In the context of carbon dioxide capture or release, we will specifically focus on the coupling between this reversible covalent fixation of the gas by amines and an additional chemical

  3. 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…

  4. Regulatory Focus Affects Physician Risk Tolerance

    PubMed Central

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

    2014-01-01

    Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention – regulatory focus theory suggests such a factor. This study tested whether regulatory focus affects risk tolerance among primary care physicians. Twenty-seven primary care physicians were assigned to promotion-focused or prevention-focused manipulations and compared on the Risk Taking Attitudes in Medical Decision Making scale using a randomization test. Results provide evidence that physicians assigned to the promotion-focus manipulation adopted an attitude of greater risk tolerance than the physicians assigned to the prevention-focused manipulation (P=0.01). The Cohen’s d statistic was conventionally large at 0.92. Results imply that situational regulatory focus in primary care physicians affects risk tolerance and may thereby be a nonclinical source of practice variation. Results also provide marginal evidence that chronic regulatory focus is associated with risk tolerance (P=0.05), but the mechanism remains unclear. Research and intervention targeting physician risk tolerance may benefit by considering situational regulatory focus as an explanatory factor. PMID:25431799

  5. Report Outlines Promising Opportunities for Addressing Climate Change

    Science.gov Websites

    Report Outlines Promising Opportunities for Addressing Climate Change For more information contact , have issued a major report that finds the United States can make impressive strides toward addressing climate change through smart policies and technologies. The report, "Scenarios for a Clean Energy

  6. 10 CFR 13.6 - Prerequisities for issuing a complaint.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Prerequisities for issuing a complaint. 13.6 Section 13.6 Energy NUCLEAR REGULATORY COMMISSION PROGRAM FRAUD CIVIL REMEDIES § 13.6 Prerequisities for issuing a complaint. (a) The reviewing official may issue a complaint under § 13.7 only if— (1) The Department of...

  7. RSAT 2015: Regulatory Sequence Analysis Tools

    PubMed Central

    Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A.; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M.; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

    2015-01-01

    RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. PMID:25904632

  8. A Novel Addressing Scheme for PMIPv6 Based Global IP-WSNs

    PubMed Central

    Islam, Md. Motaharul; Huh, Eui-Nam

    2011-01-01

    IP based Wireless Sensor Networks (IP-WSNs) are being used in healthcare, home automation, industrial control and agricultural monitoring. In most of these applications global addressing of individual IP-WSN nodes and layer-three routing for mobility enabled IP-WSN with special attention to reliability, energy efficiency and end to end delay minimization are a few of the major issues to be addressed. Most of the routing protocols in WSN are based on layer-two approaches. For reliability and end to end communication enhancement the necessity of layer-three routing for IP-WSNs is generating significant attention among the research community, but due to the hurdle of maintaining routing state and other communication overhead, it was not possible to introduce a layer-three routing protocol for IP-WSNs. To address this issue we propose in this paper a global addressing scheme and layer-three based hierarchical routing protocol. The proposed addressing and routing approach focuses on all the above mentioned issues. Simulation results show that the proposed addressing and routing approach significantly enhances the reliability, energy efficiency and end to end delay minimization. We also present architecture, message formats and different routing scenarios in this paper. PMID:22164084

  9. A novel addressing scheme for PMIPv6 based global IP-WSNs.

    PubMed

    Islam, Md Motaharul; Huh, Eui-Nam

    2011-01-01

    IP based Wireless Sensor Networks (IP-WSNs) are being used in healthcare, home automation, industrial control and agricultural monitoring. In most of these applications global addressing of individual IP-WSN nodes and layer-three routing for mobility enabled IP-WSN with special attention to reliability, energy efficiency and end to end delay minimization are a few of the major issues to be addressed. Most of the routing protocols in WSN are based on layer-two approaches. For reliability and end to end communication enhancement the necessity of layer-three routing for IP-WSNs is generating significant attention among the research community, but due to the hurdle of maintaining routing state and other communication overhead, it was not possible to introduce a layer-three routing protocol for IP-WSNs. To address this issue we propose in this paper a global addressing scheme and layer-three based hierarchical routing protocol. The proposed addressing and routing approach focuses on all the above mentioned issues. Simulation results show that the proposed addressing and routing approach significantly enhances the reliability, energy efficiency and end to end delay minimization. We also present architecture, message formats and different routing scenarios in this paper.

  10. Insights Into Collaborative Networks Of Nonprofit, Private, And Public Organizations That Address Complex Health Issues.

    PubMed

    Hogg, Rachel A; Varda, Danielle

    2016-11-01

    Community networks that include nonprofit, public, and private organizations have formed around many health issues, such as chronic disease management and healthy living and eating. Despite the increases in the numbers of and funding for cross-sector networks, and the growing literature about them, there are limited data and methods that can be used to assess their effectiveness and analyze their designs. We addressed this gap in knowledge by analyzing the characteristics of 260 cross-sector community health networks that collectively consisted of 7,816 organizations during the period 2008-15. We found that nonprofit organizations were more prevalent than private firms or government agencies in these networks. Traditional types of partners in community health networks such as hospitals, community health centers, and public health agencies were the most trusted and valued by other members of their networks. However, nontraditional partners, such as employer or business groups and colleges or universities, reported contributing relatively high numbers of resources to their networks. Further evidence is needed to inform collaborative management processes and policies as a mechanism for building what the Robert Wood Johnson Foundation describes as a culture of health. Project HOPE—The People-to-People Health Foundation, Inc.

  11. Regulatory and ethical issues with dietary supplements.

    PubMed

    Harris, I M

    2000-11-01

    Dietary supplements are commonly used, and many are effective or hold promise for treating various conditions. However, they do not require Food and Drug Administration (FDA) approval. Impurities and adulterants have been found in the products, mostly due to the lack of requirements for good manufacturing practices. In addition, as no standardization is required, the active ingredient may be absent or highly variable among manufacturers. The FDA published its 10-year plan for dietary supplements that addresses safety, labeling, boundaries, enforcement, research, and outreach. This endeavor, if put into place, will be instrumental in providing consumers with more confidence in the safety, composition, and labeling of dietary supplements.

  12. Regulatory guidance on soil cover systems

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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 bymore » 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.« less

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

    PubMed

    Ogbogu, Ubaka; Burningham, Sarah; Ollenberger, Adam; Calder, Kathryn; Du, Li; El Emam, Khaled; Hyde-Lay, Robyn; Isasi, Rosario; Joly, Yann; Kerr, Ian; Malin, Bradley; McDonald, Michael; Penney, Steven; Piat, Gayle; Roy, Denis-Claude; Sugarman, Jeremy; Vercauteren, Suzanne; Verhenneman, Griet; West, Lori; Caulfield, Timothy

    2014-02-03

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

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

    PubMed Central

    2014-01-01

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

  15. Regulatory and technical reports (abstract index journal): Annual compilation for 1996, Volume 21, No. 4

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    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. 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...

  17. Revealing cell cycle control by combining model-based detection of periodic expression with novel cis-regulatory descriptors

    PubMed Central

    Andersson, Claes R; Hvidsten, Torgeir R; Isaksson, Anders; Gustafsson, Mats G; Komorowski, Jan

    2007-01-01

    Background We address the issue of explaining the presence or absence of phase-specific transcription in budding yeast cultures under different conditions. To this end we use a model-based detector of gene expression periodicity to divide genes into classes depending on their behavior in experiments using different synchronization methods. While computational inference of gene regulatory circuits typically relies on expression similarity (clustering) in order to find classes of potentially co-regulated genes, this method instead takes advantage of known time profile signatures related to the studied process. Results We explain the regulatory mechanisms of the inferred periodic classes with cis-regulatory descriptors that combine upstream sequence motifs with experimentally determined binding of transcription factors. By systematic statistical analysis we show that periodic classes are best explained by combinations of descriptors rather than single descriptors, and that different combinations correspond to periodic expression in different classes. We also find evidence for additive regulation in that the combinations of cis-regulatory descriptors associated with genes periodically expressed in fewer conditions are frequently subsets of combinations associated with genes periodically expression in more conditions. Finally, we demonstrate that our approach retrieves combinations that are more specific towards known cell-cycle related regulators than the frequently used clustering approach. Conclusion The results illustrate how a model-based approach to expression analysis may be particularly well suited to detect biologically relevant mechanisms. Our new approach makes it possible to provide more refined hypotheses about regulatory mechanisms of the cell cycle and it can easily be adjusted to reveal regulation of other, non-periodic, cellular processes. PMID:17939860

  18. Unmanned Aircraft Systems (UAS): Addressing the Regulatory Issues for National Airspace System (NAS) Integration

    DTIC Science & Technology

    2009-04-01

    terms of IFR operations or passenger enplanements. The configuration of each Class B airspace area is individually tailored and consists of a surface...are serviced by a radar approach control, and that have a certain number of IFR operations or passenger enplanements. Although the configuration of...ft MSL Figure 3 depicts DoD UASs operating in their respective NAS classifications: Global Hawk Predator B Transponder See & Avoid DME IFR

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

    PubMed

    Lusser, Maria; Davies, Howard V

    2013-06-25

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

  20. 75 FR 22868 - Withdrawal of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... Characterization of Seismic Sources and Determination of Safe Shutdown Earthquake Ground Motion.'' FOR FURTHER.... Nuclear Regulatory Commission (NRC) is withdrawing RG 1.165, ``Identification and Characterization of... alter the licensing basis of any currently operating reactor or any of the currently issued early site...

  1. Guidelines for Performing Regulatory Impact Analysis (1983/1991)

    EPA Pesticide Factsheets

    These 1983 guidelines as modified in 1991 provide guidance for preparing EPA Regulatory Impact Analyses including benefit-cost analyses. These guidelines have been superseded by the Guidelines for Preparing Economic Analyses issued in 2000 (see EE-0568).

  2. Regulatory Promotion of Emergent CCS Technology

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensivemore » regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.« less

  3. 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.

  4. Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.

    Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report thatmore » investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach

  5. 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. Copyright © 2012 by Annual Reviews. All rights reserved.

  6. 17 CFR 1.63 - Service on self-regulatory organization governing boards or committees by persons with...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... EXCHANGE ACT Miscellaneous § 1.63 Service on self-regulatory organization governing boards or committees by... organization means a “self-regulatory organization” as defined in § 1.3(ee), and includes a “clearing... self-regulatory organization to issue disciplinary charges, to conduct disciplinary proceedings, to...

  7. 17 CFR 1.63 - Service on self-regulatory organization governing boards or committees by persons with...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... EXCHANGE ACT Miscellaneous § 1.63 Service on self-regulatory organization governing boards or committees by... organization means a “self-regulatory organization” as defined in § 1.3(ee), and includes a “clearing... self-regulatory organization to issue disciplinary charges, to conduct disciplinary proceedings, to...

  8. 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 ...

  9. Science in the regulatory setting: a challenging but incompatible mix?

    PubMed

    Yetley, Elizabeth A

    2007-01-01

    Regulatory decisions informed by sound science have an important role in many regulatory applications involving drugs and foods, including applications related to dietary supplements. However, science is only one of many factors that must be taken into account in the regulatory decision-making process. In many cases, the scientific input to a regulatory decision must compete with other factors (e.g. economics, legal requirements, stakeholder interests) for impact on the resultant policy decision. Therefore, timely and effective articulation of the available science to support a regulatory decision can significantly affect the relative weight given to science. However, the incorporation of science into the regulatory process for dietary supplements is often fraught with challenges. The available scientific evidence has rarely been designed for the purpose of addressing regulatory questions and is often preliminary and of widely varying scientific quality. To add to the confusion, the same scientific evidence may result in what appears to be different regulatory decisions because the context in which the science is used differs. The underlying assumption is that scientists who have a basic understanding of the interface between science and policy decisions can more effectively provide scientific input into these decisions.

  10. Handbook on Teaching Social Issues. NCSS Bulletin 93.

    ERIC Educational Resources Information Center

    Evans, Ronald W., Ed.; Saxe, David Warren, Ed.

    This handbook explores the issues-centered curriculum for social studies teaching and how student performance reflects an intellectual capacity to address public issues. The book is divided into 11 parts with essays to address specific aspects of the approach. The foreword, written by Shirley Engle, establishes a context for issues-based…

  11. Addressing Diversity: A Call for Action.

    ERIC Educational Resources Information Center

    Henderson, Ingeborg

    1991-01-01

    Suggests a series of steps that individuals in the foreign language profession can take to effectively address the issue of demographic changes in the U.S. college student populations and keeping foreign language learning a feasible discipline in the future. (26 references) (GLR)

  12. Current status of herbal product: Regulatory overview

    PubMed Central

    Sharma, Sanjay

    2015-01-01

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

  13. Current status of herbal product: Regulatory overview.

    PubMed

    Sharma, Sanjay

    2015-01-01

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

  14. Modeling stochasticity and robustness in gene regulatory networks.

    PubMed

    Garg, Abhishek; Mohanram, Kartik; Di Cara, Alessandro; De Micheli, Giovanni; Xenarios, Ioannis

    2009-06-15

    Understanding gene regulation in biological processes and modeling the robustness of underlying regulatory networks is an important problem that is currently being addressed by computational systems biologists. Lately, there has been a renewed interest in Boolean modeling techniques for gene regulatory networks (GRNs). However, due to their deterministic nature, it is often difficult to identify whether these modeling approaches are robust to the addition of stochastic noise that is widespread in gene regulatory processes. Stochasticity in Boolean models of GRNs has been addressed relatively sparingly in the past, mainly by flipping the expression of genes between different expression levels with a predefined probability. This stochasticity in nodes (SIN) model leads to over representation of noise in GRNs and hence non-correspondence with biological observations. In this article, we introduce the stochasticity in functions (SIF) model for simulating stochasticity in Boolean models of GRNs. By providing biological motivation behind the use of the SIF model and applying it to the T-helper and T-cell activation networks, we show that the SIF model provides more biologically robust results than the existing SIN model of stochasticity in GRNs. Algorithms are made available under our Boolean modeling toolbox, GenYsis. The software binaries can be downloaded from http://si2.epfl.ch/ approximately garg/genysis.html.

  15. Inflammation, Self-Regulation, and Health: An Immunologic Model of Self-Regulatory Failure.

    PubMed

    Shields, Grant S; Moons, Wesley G; Slavich, George M

    2017-07-01

    Self-regulation is a fundamental human process that refers to multiple complex methods by which individuals pursue goals in the face of distractions. Whereas superior self-regulation predicts better academic achievement, relationship quality, financial and career success, and lifespan health, poor self-regulation increases a person's risk for negative outcomes in each of these domains and can ultimately presage early mortality. Given its centrality to understanding the human condition, a large body of research has examined cognitive, emotional, and behavioral aspects of self-regulation. In contrast, relatively little attention has been paid to specific biologic processes that may underlie self-regulation. We address this latter issue in the present review by examining the growing body of research showing that components of the immune system involved in inflammation can alter neural, cognitive, and motivational processes that lead to impaired self-regulation and poor health. Based on these findings, we propose an integrated, multilevel model that describes how inflammation may cause widespread biobehavioral alterations that promote self-regulatory failure. This immunologic model of self-regulatory failure has implications for understanding how biological and behavioral factors interact to influence self-regulation. The model also suggests new ways of reducing disease risk and enhancing human potential by targeting inflammatory processes that affect self-regulation.

  16. 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)

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

    ERIC Educational Resources Information Center

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

    2017-01-01

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

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

    ERIC Educational Resources Information Center

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

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

  19. 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…

  20. The Regulatory Framework for Privacy and Security

    NASA Astrophysics Data System (ADS)

    Hiller, Janine S.

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

  1. RSAT 2015: Regulatory Sequence Analysis Tools.

    PubMed

    Medina-Rivera, Alejandra; Defrance, Matthieu; Sand, Olivier; Herrmann, Carl; Castro-Mondragon, Jaime A; Delerce, Jeremy; Jaeger, Sébastien; Blanchet, Christophe; Vincens, Pierre; Caron, Christophe; Staines, Daniel M; Contreras-Moreira, Bruno; Artufel, Marie; Charbonnier-Khamvongsa, Lucie; Hernandez, Céline; Thieffry, Denis; Thomas-Chollier, Morgane; van Helden, Jacques

    2015-07-01

    RSAT (Regulatory Sequence Analysis Tools) is a modular software suite for the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, appropriate to genome-wide data sets like ChIP-seq, (ii) transcription factor binding motif analysis (quality assessment, comparisons and clustering), (iii) comparative genomics and (iv) analysis of regulatory variations. Nine new programs have been added to the 43 described in the 2011 NAR Web Software Issue, including a tool to extract sequences from a list of coordinates (fetch-sequences from UCSC), novel programs dedicated to the analysis of regulatory variants from GWAS or population genomics (retrieve-variation-seq and variation-scan), a program to cluster motifs and visualize the similarities as trees (matrix-clustering). To deal with the drastic increase of sequenced genomes, RSAT public sites have been reorganized into taxon-specific servers. The suite is well-documented with tutorials and published protocols. The software suite is available through Web sites, SOAP/WSDL Web services, virtual machines and stand-alone programs at http://www.rsat.eu/. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

  2. 77 FR 25872 - Oklahoma Regulatory Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). None of the revisions that Oklahoma proposed to... regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma...

  3. Facing regulatory challenges of on-line hemodiafiltration.

    PubMed

    Kümmerle, Wolfgang

    2011-01-01

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

  4. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    NASA Technical Reports Server (NTRS)

    Scroggins, Sharon

    2008-01-01

    NASA's Agency-wide.resource for identifying and managing risks associated with changing environmental regulations Goals of the RRAC PC: 1) Proactively. detect, analyze and communicate environmental regulatory risks to NASA Programs and facilities; 2) Communicate with regulators and participate in the mitigation of such risks; and 3) Provide centralized support on emerging regulations to NASA HQ Environmental Management Division. When significant regulatory changes are identified, timely communication is essential. Communication of changing requirements to the regulatory stakeholders - NASA Programs and Facilities. Communication of potential issues to management and, when appropriate, back to the regulating agency.

  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. © 2016, The International Biometric Society.

  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. Fire and worker health and safety: an introduction to the special issue.

    PubMed

    Campbell, Richard; Levenstein, Charles

    2015-02-01

    One century ago, the landmark fire at the Triangle Shirtwaist Factory in New York City claimed the lives of 146 garment workers and helped spur the adoption of fire safety measures and laws targeting dangerous working conditions. Since that time, continuing advances have been made to address the threat of fire-in workplace fire safety practices and regulations, in training and safety requirements for firefighters and first responders, and in hazard communication laws that enhance disaster planning and response. Recent high profile events, including the West, Texas fertilizer plant explosion, derailments of fuel cargo trains, and garment factory fires in Bangladesh, have brought renewed attention to fire as a workplace health and safety issue and to the unevenness of safety standards and regulatory enforcement, in the United States as well as internationally. In this article, we provide an overview of fire as a workplace health and safety hazard and an introduction to the essays included in this special issue of New Solutions on fire and work. © 2015 SAGE Publications.

  8. Toward a Regulatory Framework for the Waterpipe.

    PubMed

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

    2016-10-01

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

  9. Toward a Regulatory Framework for the Waterpipe

    PubMed Central

    Salloum, Ramzi G.; Asfar, Taghrid

    2016-01-01

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

  10. MicroRNA-mediated regulatory circuits: outlook and perspectives

    NASA Astrophysics Data System (ADS)

    Cora', Davide; Re, Angela; Caselle, Michele; Bussolino, Federico

    2017-08-01

    MicroRNAs have been found to be necessary for regulating genes implicated in almost all signaling pathways, and consequently their dysfunction influences many diseases, including cancer. Understanding of the complexity of the microRNA-mediated regulatory network has grown in terms of size, connectivity and dynamics with the development of computational and, more recently, experimental high-throughput approaches for microRNA target identification. Newly developed studies on recurrent microRNA-mediated circuits in regulatory networks, also known as network motifs, have substantially contributed to addressing this complexity, and therefore to helping understand the ways by which microRNAs achieve their regulatory role. This review provides a summarizing view of the state-of-the-art, and perspectives of research efforts on microRNA-mediated regulatory motifs. In this review, we discuss the topological properties characterizing different types of circuits, and the regulatory features theoretically enabled by such properties, with a special emphasis on examples of circuits typifying their biological significance in experimentally validated contexts. Finally, we will consider possible future developments, in particular regarding microRNA-mediated circuits involving long non-coding RNAs and epigenetic regulators.

  11. 47 CFR 1.1155 - Schedule of regulatory fees and filing locations for cable television services.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Schedule of regulatory fees and filing locations for cable television services. 1.1155 Section 1.1155 Telecommunication FEDERAL COMMUNICATIONS... Schedule of regulatory fees and filing locations for cable television services. Fee amount Address 1. Cable...

  12. A Case Study on Science Teacher Leadership to Address Diversity and Equity through Professional Development

    ERIC Educational Resources Information Center

    Doraiswamy, Nithya

    2015-01-01

    This qualitative case study focused on the multifaceted issue of exploring science teacher leaders understanding and addressing of issues of diversity and equity with peers through professional development. The purpose of the study was to highlight the opportunities and barriers to the addressing of issues of diversity and equity through the work…

  13. An electronic regulatory document management system for a clinical trial network.

    PubMed

    Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

    2010-01-01

    A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  14. 78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management... issuing a document entitled: ``White Paper on a Conceptual Example of a Proposed Risk Management... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

  15. The Regulatory Challenges of Decommissioning Nuclear Power Plants in Korea - 13101

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lee, Jungjoon; Ahn, Sangmyeon; Choi, Kyungwoo

    As of 2012, 23 units of nuclear power plants are in operation, but there is no experience of permanent shutdown and decommissioning of nuclear power plant in Korea. It is realized that, since late 1990's, improvement of the regulatory framework for decommissioning has been emphasized constantly from the point of view of International Atomic Energy Agency (IAEA)'s safety standards. And it is known that now IAEA prepare the safety requirement on decommissioning of facilities, its title is the Safe Decommissioning of Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission tomore » Korea in 2011, it was recommended that the regulatory framework for decommissioning should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became also important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we identify the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is to be established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. After dealing with it, it is expected that the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  16. Global Regulatory Pathways in the Alphaproteobacteria

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    none

    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 andmore » 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

  17. Impact of illness and its treatment on workplace costs: regulatory and measurement issues.

    PubMed

    Greenberg, P E; Birnbaum, H G; Kessler, R C; Morgan, M; Stang, P

    2001-01-01

    In an attempt to document a broader spectrum of the benefits of their pharmaceutical products, drug companies increasingly seek to include productivity claims in their promotional campaigns. We describe the existing regulatory framework of the Food and Drug Administration (FDA) for considering productivity claims, distinguishing between the traditional "substantial evidence" standard and the "competent and reliable scientific evidence" standard. But the notion of competent and reliable scientific evidence may itself be problematic, even when it is the appropriate regulatory standard, because there exists no consistent measurement approach across diseases, workplaces, jobs, and worker capabilities that is widely accepted in this emerging area of health outcomes research. We examine the various measurement approaches that have been used to quantify the impact of illness and its treatment on workplace productivity, and we describe some of the shortcomings associated with each alternative. This discussion highlights the possible difficulties faced by the FDA in reviewing productivity-based promotional claims. Finally, we suggest possible strategies for furthering this field of investigation.

  18. Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

    PubMed

    Breyer, Didier; Herman, Philippe; Brandenburger, Annick; Gheysen, Godelieve; Remaut, Erik; Soumillion, Patrice; Van Doorsselaere, Jan; Custers, René; Pauwels, Katia; Sneyers, Myriam; Reheul, Dirk

    2009-01-01

    In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques. In this paper, we describe regulatory and safety issues associated with the use of oligonucleotide-mediated mutagenesis to develop novel organisms. We present scientific arguments for not having organisms developed through this technique fall within the scope of the EU regulation on GMOs. We conclude that any political decision on this issue should be taken on the basis of a broad reflection at EU level, while avoiding discrepancies at international level.

  19. 77 FR 2556 - Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...

  20. Giants That Occasionally Roar: Broadcast Regulatory Policy in the United States.

    ERIC Educational Resources Information Center

    Busby, Linda J.

    In this document, broadcast regulatory issues since 1940 are outlined and discussed in relation to social forces. The 1940s saw open warfare between the Federal Communications Commission (FCC) and broadcasters, as a result of the FCC expanding its powers. In 1946, the FCC issued its "Public Service Responsibility of Broadcast Licensees,"…

  1. The complex legal and ethical issues related to generic medications. Viral hepatitis: a case study.

    PubMed

    Danta, M; Ghinea, N

    2017-04-01

    The economic impact of medications is significant, with many countries unable to afford the essential medicines listed by the WHO. Generic medications are one strategy to address this issue. Generic medications are similar to but not the same as originator medications. They have a significant cost advantage because they do not require the background research and development studies to support registration. Consequently, they are gaining increased market share in both the developed and developing world. Many new medications are now licensed to generic manufacturers in the developing world. As a result, it is possible for patients to bypass regulatory and cost barriers by importing medications directly from generic producers. Importation of the novel hepatitis C direct-acting antiviral therapy into Australia before it was registered in the country is an illustrative case study. This review will characterise generic medications and some of the legal and ethical issues around their utilisation, focusing on the relevant players, including pharma, government, patients and doctors.

  2. 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, Pedro 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.

  3. 78 FR 55339 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ...The Federal Deposit Insurance Corporation (FDIC) is adopting an interim final rule that revises its risk-based and leverage capital requirements for FDIC-supervised institutions. This interim final rule is substantially identical to a joint final rule issued by the Office of the Comptroller of the Currency (OCC) and the Board of Governors of the Federal Reserve System (Federal Reserve) (together, with the FDIC, the agencies). The interim final rule consolidates three separate notices of proposed rulemaking that the agencies jointly published in the Federal Register on August 30, 2012, with selected changes. The interim final rule implements a revised definition of regulatory capital, a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for FDIC-supervised institutions subject to the advanced approaches risk-based capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator. The interim final rule incorporates these new requirements into the FDIC's prompt corrective action (PCA) framework. In addition, the interim final rule establishes limits on FDIC-supervised institutions' capital distributions and certain discretionary bonus payments if the FDIC-supervised institution does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk-based capital requirements. The interim final rule amends the methodologies for determining risk-weighted assets for all FDIC-supervised institutions. The interim final rule also adopts changes to the FDIC's regulatory capital requirements that meet the requirements of section 171 and section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The interim final rule also codifies the FDIC's regulatory capital rules, which have previously resided in various appendices to their respective regulations, into a harmonized integrated regulatory framework. In

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

    PubMed

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

    2016-08-25

    Regulatory interactions are an important part of the drug development and licensing process. A survey on the use of biopharmaceutical tools for regulatory purposes has been carried out within the industry community of the EU project OrBiTo within Innovative Medicines Initiative (IMI). The aim was to capture current practice and experience in using in vitro and in silico biopharmaceutics tools at various stages of development, what barriers exist or are perceived, and to understand the current gaps in regulatory biopharmaceutics. The survey indicated that biorelevant dissolution testing and physiologically based modelling and simulation are widely applied throughout development to address a number of biopharmaceutics issues. However, data from these in vitro and in silico predictive biopharmaceutics tools are submitted to regulatory authorities far less often than they are used for internal risk assessment and decision making. This may prevent regulators from becoming familiar with these tools and how they are applied in industry, and limits the opportunities for biopharmaceutics scientists working in industry to understand the acceptability of these tools in the regulatory environment. It is anticipated that the advanced biopharmaceutics tools and understanding delivered in the next years by OrBiTo and other initiatives in the area of predictive tools will also be of value in the regulatory setting, and provide a basis for more informed and confident biopharmaceutics risk assessment and regulatory decision making. To enable the regulatory potential of predictive biopharmaceutics tools to be realized, further scientific dialogue is needed between industry, regulators and scientists in academia, and more examples need to be published to demonstrate the applicability of these tools. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. 76 FR 40777 - Interim Enforcement Policy for Certain Fire Protection Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... Certain Fire Protection Issues AGENCY: Nuclear Regulatory Commission. ACTION: Policy statement; revision... Enforcement Policy on enforcement discretion for certain fire protection issues to extend the enforcement... policy affects licensees that are transitioning to use the National Fire Protection Association Standard...

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

    DOE Office of Scientific and Technical Information (OSTI.GOV)

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

    1997-02-01

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

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

    PubMed

    Johnston, John D; Feldschreiber, Peter

    2014-03-01

    The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed. © 2013 The British Pharmacological Society.

  8. Policing Matters: Addressing the Controversial Issue of Policing Through Education for Reconciliation

    NASA Astrophysics Data System (ADS)

    Cusack, Mella

    2009-05-01

    Policing is widely held to constitute a contentious issue in classrooms on both sides of the border on the island of Ireland, despite the fact that the ongoing peace process has led to a normalising of cross-border policing relationships. The Education for Reconciliation Project works with teachers and members of the two police services to produce teaching/learning modules on law and policing for use in Citizenship Education classrooms. This paper examines the commonly-held teacher perception of policing as a controversial issue and the reasons why these perceptions exist. It takes into consideration the opinion that it is time for schools to begin work on policing, and investigates the implications for practice.

  9. Addressing uncertainty in vulnerability assessments [Chapter 5

    Treesearch

    Linda Joyce; Molly Cross; Evan Girvatz

    2011-01-01

    This chapter addresses issues and approaches for dealing with uncertainty specifically within the context of conducting climate change vulnerability assessments (i.e., uncertainties related to identifying and modeling the sensitivities, levels of exposure, and adaptive capacity of the assessment targets).

  10. Do Faith Communities Have a Role in Addressing Childhood Obesity?

    PubMed

    Opalinski, Andra; Dyess, Susan; Grooper, Sareen

    2015-01-01

    Pediatric obesity is a multifaceted phenomenon. A partnership with faith-based communities to address the issue has been suggested. The purpose of this study was to describe the cultural beliefs of faith community leaders regarding childhood obesity and to examine attitudes about their role in addressing the issue. A qualitative descriptive design informed by ethnographic methods and triangulation of multiple data sources was utilized to assess the cultural beliefs of faith community leaders. A purposive sample of 13 leaders (nine females, four males) from seven multicultural and multigenerational local faith communities participated in the study. No more than three participants from any one faith community were enrolled in the study. Twenty-first century lifestyle challenges, accountability of behaviors (a dichotomy that fluctuated between individual responsibility to community and/or social responsibility), and the need for intentionality emerged as themes from the data. Faith community leaders envisioned a role for faith communities in addressing childhood obesity. Findings support the ongoing development of population based health promotion programs through faith community engagement. The findings provide a foundation for nurses partnering with faith communities on health promotion programs targeting childhood obesity to address family health issues in a holistic way. © 2015 Wiley Periodicals, Inc.

  11. 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…

  12. Electronic cigarettes: patterns of use, health effects, use in smoking cessation and regulatory issues.

    PubMed

    Rahman, Muhammad Aziz; Hann, Nicholas; Wilson, Andrew; Worrall-Carter, Linda

    2014-01-01

    Electronic cigarettes (e-cigarettes) are battery-powered devices that vaporize a liquid solution to deliver a dose of inhaled nicotine to the user. There is ongoing debate regarding their regulation. This comprehensive narrative review aimed to discuss key issues including usage patterns, health effects, efficacy in smoking cessation and regulatory concerns with a view to informing future regulation and research agendas. PubMed, Scopus and Web of Science databases were searched using the terms (electronic cigarettes OR e-cigarettes) for articles in English, relevant to humans and published during January 2009-January 2014. The literature search revealed 37 relevant articles. Findings suggest that e-cigarettes are mostly used by middle-aged current smokers, particularly males, to help them for quitting or for recreation. E-cigarettes contain very low levels of multiple toxic substances such as formaldehyde and acrolein, but these levels are many times lower than those found in cigarettes. They were found to have effectiveness in aiding smoking cessation to a limited degree. Debate continues regarding regulating their use for cessation versus heavy restrictions to control recreational use on the basis that it perpetuates nicotine addiction. The cytotoxicity and long term health effects of e-cigarettes are unknown. Nevertheless the e-cigarette market continues to expand, largely driven by middle-aged smokers who claim to be using e-cigarettes in an attempt to reduce or quit smoking. E-cigarettes may have some potential as smoking cessation aids and, in the researchers' view, should therefore be subject to further research and regulation similar to other nicotine replacement therapies.

  13. Issues in International Rehabilitation.

    ERIC Educational Resources Information Center

    Nathanson, Jeanne H., Ed.

    1991-01-01

    Eight articles address issues and programs in international rehabilitation. The issue is introduced by a message from the Assistant Secretary of the United States Department of Education for the Office of Special Education and Rehabilitation Services, Robert R. Davila. Next, "A History of International Rehabilitation" (Nora Ellen Groce)…

  14. Catalyzing Cross-Disciplinary Research and Education Within and Beyond the Environmental and Geosciences to Address Emerging, Societally-Relevant Issues

    NASA Astrophysics Data System (ADS)

    Cak, A. D.; Vigdor, L. J.; Vorosmarty, C. J.; Giebel, B. M.; Santistevan, C.; Chasteau, C.

    2017-12-01

    Tackling emergent, societally-relevant problems in the environmental sciences is hardly confined to a single research discipline, but rather requires collaborations that bridge diverse domains and perspectives. While new technologies (e.g., Skype) can in theory unite otherwise geographically distributed participation in collaborative research, physical distance nevertheless raises the bar on intellectual dialogue. Such barriers may reveal perceptions of or real differences across disciplines, reflecting particular traditions in their histories and academic cultures. Individual disciplines are self-defined by their scientific, epistemologic, methodologic, or philosophical traditions (e.g., difficulties in understanding processes occurring at different scales, insufficient research funding for interdisciplinary work), or cultural and discursive hurdles (e.g., navigating a new field's jargon). Coupled with these challenges is a considerable deficiency in educating the next generation of scientists to help them develop a sufficient comfort level with thinking critically across multiple disciplinary domains and conceptual frameworks. To address these issues, the City University of New York (CUNY), the largest public urban university in the U.S., made a significant investment in advancing cross-disciplinary research and education, culminating in the opening of the CUNY Advanced Science Research Center (ASRC) in New York City (NYC) in late 2014. We report here on our experiences incubating new collaborative efforts to address environmental science-related research as it is interwoven with the ASRC's five research initiatives (Environmental Sciences, Neuroscience, Structural Biology, Photonics, and Nanoscience). We describe the ASRC's overall structure and function as both a stand-alone interdisciplinary center and one that collaborates more broadly with CUNY's network of twenty-four campuses distributed across NYC's five boroughs. We identify challenges we have faced so

  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. Copyright © 2013 Elsevier

  16. Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions.

    PubMed

    Tralau, Tewes; Oelgeschläger, Michael; Gürtler, Rainer; Heinemeyer, Gerhard; Herzler, Matthias; Höfer, Thomas; Itter, Heike; Kuhl, Thomas; Lange, Nikola; Lorenz, Nicole; Müller-Graf, Christine; Pabel, Ulrike; Pirow, Ralph; Ritz, Vera; Schafft, Helmut; Schneider, Heiko; Schulz, Thomas; Schumacher, David; Zellmer, Sebastian; Fleur-Böl, Gaby; Greiner, Matthias; Lahrssen-Wiederholt, Monika; Lampen, Alfonso; Luch, Andreas; Schönfelder, Gilbert; Solecki, Roland; Wittkowski, Reiner; Hensel, Andreas

    2015-06-01

    The advent of new testing systems and "omics"-technologies has left regulatory toxicology facing one of the biggest challenges for decades. That is the question whether and how these methods can be used for regulatory purposes. The new methods undoubtedly enable regulators to address important open questions of toxicology such as species-specific toxicity, mixture toxicity, low-dose effects, endocrine effects or nanotoxicology, while promising faster and more efficient toxicity testing with the use of less animals. Consequently, the respective assays, methods and testing strategies are subject of several research programs worldwide. On the other hand, the practical application of such tests for regulatory purposes is a matter of ongoing debate. This document summarizes key aspects of this debate in the light of the European "regulatory status quo", while elucidating new perspectives for regulatory toxicity testing.

  17. "Letting myself go forward past wrongs": How regulatory modes affect self-forgiveness

    PubMed Central

    Giannini, Anna Maria; Higgins, E. Tory; Kruglanski, Arie W.

    2018-01-01

    The present research addresses the question of whether regulatory-mode orientations affect self-forgiveness. We expected that people with a strong locomotion orientation would be more inclined to self-forgiveness because of their tendencies toward movement and change, which focus them on the future, whereas people with a strong assessment orientation would refrain from self-forgiveness due to their evaluative tendencies which focus them on the past. These hypotheses were supported by the results in four studies that tested the relation between regulatory modes and self-forgiveness by measuring (Studies 1, 3 and 4) and manipulating (Study 2) regulatory-mode-orientations. Finally, in Study 4 we examined more closely our hypothesis that the relation between self-forgiveness and regulatory modes is mediated by past and future temporal foci. The implications of the results for regulatory mode theory are also discussed. PMID:29529065

  18. "Letting myself go forward past wrongs": How regulatory modes affect self-forgiveness.

    PubMed

    Pierro, Antonio; Pica, Gennaro; Giannini, Anna Maria; Higgins, E Tory; Kruglanski, Arie W

    2018-01-01

    The present research addresses the question of whether regulatory-mode orientations affect self-forgiveness. We expected that people with a strong locomotion orientation would be more inclined to self-forgiveness because of their tendencies toward movement and change, which focus them on the future, whereas people with a strong assessment orientation would refrain from self-forgiveness due to their evaluative tendencies which focus them on the past. These hypotheses were supported by the results in four studies that tested the relation between regulatory modes and self-forgiveness by measuring (Studies 1, 3 and 4) and manipulating (Study 2) regulatory-mode-orientations. Finally, in Study 4 we examined more closely our hypothesis that the relation between self-forgiveness and regulatory modes is mediated by past and future temporal foci. The implications of the results for regulatory mode theory are also discussed.

  19. Ethical issues in exercise psychology.

    PubMed

    Pauline, Jeffrey S; Pauline, Gina A; Johnson, Scott R; Gamble, Kelly M

    2006-01-01

    Exercise psychology encompasses the disciplines of psychiatry, clinical and counseling psychology, health promotion, and the movement sciences. This emerging field involves diverse mental health issues, theories, and general information related to physical activity and exercise. Numerous research investigations across the past 20 years have shown both physical and psychological benefits from physical activity and exercise. Exercise psychology offers many opportunities for growth while positively influencing the mental and physical health of individuals, communities, and society. However, the exercise psychology literature has not addressed ethical issues or dilemmas faced by mental health professionals providing exercise psychology services. This initial discussion of ethical issues in exercise psychology is an important step in continuing to move the field forward. Specifically, this article will address the emergence of exercise psychology and current health behaviors and offer an overview of ethics and ethical issues, education/training and professional competency, cultural and ethnic diversity, multiple-role relationships and conflicts of interest, dependency issues, confidentiality and recording keeping, and advertisement and self-promotion.

  20. The Spiritual Dimension of Education--Addressing Issues of Identity and Belonging

    ERIC Educational Resources Information Center

    de Souza, Marian

    2016-01-01

    In a shrinking world where events across the globe become relevant for the lives of masses of people regardless of the distances that divide them, some serious issues have arisen which have particular significance for education policies and practice. Too many children are growing up against a backdrop of polarised views and attitudes which is a…

  1. "Must-know" legal issues for healthcare CFOS.

    PubMed

    Peregrine, Michael W; Schwartz, James R

    2002-03-01

    Healthcare financial managers are finding that regulatory agencies' customary focus on Medicare and tax-exemption concerns is shifting to other issues directly related to financial management. Regulatory agencies, such as the Securities and Exchange Commission, are scrutinizing not-for-profit and charitable trust law matters. Because of this renewed attention to existing regulations, healthcare financial managers need to increase their diligence in ensuring their organizations' compliance with those laws governing areas for which they traditionally have been accountable, including auditor relationships, restricted gifts, consulting arrangements, investment management, and financial reporting.

  2. Public health issues.

    PubMed

    Ward, R D

    1992-04-01

    In a recent MSMS survey, MSMS members ranked public health as one the top five issues of major concern to Michigan physicians. Tobacco use, chronic illness, and HIV-infected health care workers comprise some of the major public health issues facing physicians and patients in Michigan. Following is a brief examination of each of these issues. Also included is a brief discussion of medical doctors as public health directors. Should all public health directors be medical doctors? This question is addressed in this cover story.

  3. Re-evaluation of Non-regulatory Asbestos Group Minerals for Regulatory Agencies

    NASA Astrophysics Data System (ADS)

    Dogan, M.; Dogan, A.

    2013-05-01

    There are established rules and regulations for some asbestos group minerals - amphibole group minerals of actinolite, amosite, anthophyllite, crocidolite, tremolite; and serpentine group minerals of chrysotile- called "regulatory". There are also "non-regulatory" naturally occurring asbestos (NOA) group minerals as constituent of rocks and soil, including richterite, winchite, fluoro-edenite, balangeroite, carlosturanite, gageite, arfvedsonite, and magnesio-arfvedsonite. Strong evidences for carcinogenicity of these NOA minerals in later cohorts of cancer patients demonstrated the risks associated with these minerals. In addition, although the chrysotile asbestos regulated by some organizations such as WHO, World Trade Organization, United Nations, US EPA, International Labour Organization, and EU Countries; however, controversies still continue surrounding the use of chrysotile. Determinations of polymineralic fibrous veins, mixed particles, amphibole cleavage fragments, and genetic predisposition are also important issues (i.e. Dogan et al., 2006).Therefore, accurate characterizations of chemical composition, morphology, structure, and defects are necessary in order to find out mechanism(s) of carcinogenicity of all asbestos group minerals. Calculation methods of chemical composition are still under debate because of assumption of no vacancies at any sites and intergrowth of minerals. Substitution(s) may cause deviations from the ideal chemical formula and wide variations in chemical compositions. Detail morphological and chemical quantification of individual asbestos group minerals in micro- and nano-scale may help to evaluate its true carcinogenetic mechanism(s), and consequently prevention and possibly treatment of related diseases. we propose that nonregulatory asbestos minerals and the chrysotile should be re-evaluated. The amount of fibers inhaled, in terms of weight percent and number, need also be re-evaluated by mineralogists. Finally, Regulatory

  4. Aboriginal Self-Government in Canada: Current Trends and Issues. Purich's Aboriginal Issues Series.

    ERIC Educational Resources Information Center

    Hylton, John H., Ed.

    This book contains 13 chapters analyzing important practical issues that must be addressed as Aboriginal self-government becomes fully operational in Canada. These issues are related to social problems and policies, criminal justice, community services, education, employment and job training, finance, the land base of government, women's rights…

  5. 14 CFR 47.45 - Change of address.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.45 Change of address. Within 30 days after any change... will issue, without charge, a revised Certificate of Aircraft Registration, AC Form 8050-3, reflecting...

  6. 14 CFR 47.45 - Change of address.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.45 Change of address. Within 30 days after any change... will issue, without charge, a revised Certificate of Aircraft Registration, AC Form 8050-3, reflecting...

  7. 14 CFR 47.45 - Change of address.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.45 Change of address. Within 30 days after any change... will issue, without charge, a revised Certificate of Aircraft Registration, AC Form 8050-3, reflecting...

  8. 14 CFR 47.45 - Change of address.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRCRAFT REGISTRATION Certificates of Aircraft Registration § 47.45 Change of address. Within 30 days after any change... will issue, without charge, a revised Certificate of Aircraft Registration, AC Form 8050-3, reflecting...

  9. Issues for the Traveling Team Physician.

    PubMed

    Kaeding, Christopher C; Borchers, James

    2016-07-01

    This article outlines the value of having the team physician traveling with athletes to away venues for competitions or training sessions. At present, this travel presents several issues for the team physician who crosses state lines for taking care of the athletes. In this article, these issues and their possible remedies are discussed. A concern for the travelling team physician is practicing medicine while caring for the team in a state where the physician is not licensed. Another issue can be the transportation of controlled substances in the course of providing optimal care for the team athletes. These two issues are regulatory and legislative issues at both the state and federal levels. On the practical side of being a team physician, the issues of emergency action plans, supplies, and when to transport injured or ill patients are also reviewed. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  10. Understanding and Addressing Racial Disparities in Health Care

    PubMed Central

    Williams, David R.; Rucker, Toni D.

    2000-01-01

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

  11. 32 CFR 37.1010 - What substantive issues should my award document address?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... document must address: (a) Project scope. The scope is an overall vision statement for the project... must set forth the minimum required Federal Government rights in intellectual property generated under... tangible property. Your property provisions for for-profit and nonprofit participants must be in accordance...

  12. Comparing Distributions of Environmental Outcomes for Regulatory Environmental Justice Analysis

    PubMed Central

    Maguire, Kelly; Sheriff, Glenn

    2011-01-01

    Economists have long been interested in measuring distributional impacts of policy interventions. As environmental justice (EJ) emerged as an ethical issue in the 1970s, the academic literature has provided statistical analyses of the incidence and causes of various environmental outcomes as they relate to race, income, and other demographic variables. In the context of regulatory impacts, however, there is a lack of consensus regarding what information is relevant for EJ analysis, and how best to present it. This paper helps frame the discussion by suggesting a set of questions fundamental to regulatory EJ analysis, reviewing past approaches to quantifying distributional equity, and discussing the potential for adapting existing tools to the regulatory context. PMID:21655146

  13. Ethics and animal issues in US medical education.

    PubMed

    Wiebers, D O; Barron, R A; Leaning, J; Ascione, F R

    1994-11-01

    Increasing public and regulatory agency concern about a variety of animal protection issues that affect the field of medicine have made these issues increasingly relevant to medical school curricula. The purpose of this study was to assess the availability and forms of medical school training relating to ethical, conceptual, and societal concerns in the use of animals within the field of medicine and the perceived need for such training. Questionnaire surveys were mailed to the Deans of the 125 accredited US medical schools, and completed by Deans or their designees within the same medical institution. Questionnaire recipients were informed that results would be compiled in a fashion that did not identify specific individuals or institutions. Survey responses were obtained from 84 medical institutions (67% response). Sixty respondents (71%) indicated that their medical school offered or sponsored some type of activity related to ethical and conceptual concerns in the use of animals in medical research and training. Most schools (43) offered informal discussions/seminars relating to these issues, but nine schools offered full formal courses with up to 15 lectures on these topics. Programme content and perceived need for additional instruction varied greatly amongst respondents. The results suggest a wide diversity amongst US medical schools in the availability and perceived importance of medical school training relating to ethical and conceptual concerns in the uses of animals in medicine. It is proposed that instruction in these areas be pursued with more concerted efforts to address the growing body of knowledge about non-human beings and the ethical implications of such knowledge.

  14. Sexual Harassment as an Ethical Issue in Academic Life. Issues in Academic Ethics.

    ERIC Educational Resources Information Center

    Francis, Leslie Pickering

    This book provides a full examination of sexual harassment as an ethical issue in education. It considers issues raised by the definition, understanding, and regulation of campus sexual harassment and addresses the arguments that regulation may conflict with academic freedom and choice in relationships. Part 1 contains these chapters: (1) "Sexual…

  15. The Distance Education Evolution: Issues and Case Studies

    ERIC Educational Resources Information Center

    Monolescu, Dominique; Schifter, Catherine; Greenwood, Linda

    2004-01-01

    "The Distance Education Evolution: Case Studies" addresses issues regarding the development and design of online courses, and the implementation and evaluation of an online learning program. Several chapters include design strategies for online courses that range from the specific to the universal. Many authors address pedagogical issues from both…

  16. Addressing psychosocial issues in cancer survivorship: past, present and future.

    PubMed

    Walsh, Katherine

    2016-12-01

    With a burgeoning population of cancer survivors, organizations in the USA and around the world are considering how to address the many long-term and late psychosocial effects of cancer and cancer treatment. This article reviews the changing landscape of survivorship care over the past 50 years, from the time when there were relatively few survivors to the future, when the number of cancer survivors in the USA alone is expected to reach close to 20 million. Institute of Medicine Reports, intra-organizational summits and accrediting standards that have influenced the development of survivorship care plans and programs and the roles of the Internet and smartphone applications along with oncology specialist and primary care providers are discussed.

  17. 77 FR 40668 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-10

    ...-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Proposed Rule Change To Amend Rule G-34, on CUSIP Numbers, New Issue, and Market Information Requirements July 3, 2012. Pursuant.... 78s(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance...

  18. Addressing Barriers to the Development and Adoption of Rapid Diagnostic Tests in Global Health.

    PubMed

    Miller, Eric; Sikes, Hadley D

    Immunochromatographic rapid diagnostic tests (RDTs) have demonstrated significant potential for use as point-of-care diagnostic tests in resource-limited settings. Most notably, RDTs for malaria have reached an unparalleled level of technological maturity and market penetration, and are now considered an important complement to standard microscopic methods of malaria diagnosis. However, the technical development of RDTs for other infectious diseases, and their uptake within the global health community as a core diagnostic modality, has been hindered by a number of extant challenges. These range from technical and biological issues, such as the need for better affinity agents and biomarkers of disease, to social, infrastructural, regulatory and economic barriers, which have all served to slow their adoption and diminish their impact. In order for the immunochromatographic RDT format to be successfully adapted to other disease targets, to see widespread distribution, and to improve clinical outcomes for patients on a global scale, these challenges must be identified and addressed, and the global health community must be engaged in championing the broader use of RDTs.

  19. Addressing Barriers to the Development and Adoption of Rapid Diagnostic Tests in Global Health

    PubMed Central

    Miller, Eric; Sikes, Hadley D.

    2015-01-01

    Immunochromatographic rapid diagnostic tests (RDTs) have demonstrated significant potential for use as point-of-care diagnostic tests in resource-limited settings. Most notably, RDTs for malaria have reached an unparalleled level of technological maturity and market penetration, and are now considered an important complement to standard microscopic methods of malaria diagnosis. However, the technical development of RDTs for other infectious diseases, and their uptake within the global health community as a core diagnostic modality, has been hindered by a number of extant challenges. These range from technical and biological issues, such as the need for better affinity agents and biomarkers of disease, to social, infrastructural, regulatory and economic barriers, which have all served to slow their adoption and diminish their impact. In order for the immunochromatographic RDT format to be successfully adapted to other disease targets, to see widespread distribution, and to improve clinical outcomes for patients on a global scale, these challenges must be identified and addressed, and the global health community must be engaged in championing the broader use of RDTs. PMID:26594252

  20. Copyright, the Internet, and Other Legal Issues.

    ERIC Educational Resources Information Center

    Gasaway, Laura N.

    1998-01-01

    Copyright and other intellectual property issues have dominated discussions of legal issues surrounding the Internet. There are other issues of considerable importance that also attract attention. Five legal issues affecting the Internet are addressed: copyright, online service-provider liability, database protection, obscenity, and privacy. Cited…

  1. Transmission Pricing Issues for Electricity Generation From Renewable Resources

    EIA Publications

    1999-01-01

    This article discusses how the resolution of transmission pricing issues which have arisen under the Federal Energy Regulatory Commission's (FERC) open access environment may affect the prospects for renewable-based electricity.

  2. Path forward: emerging issues and challenges.

    PubMed

    Gillen, Matt; Gittleman, Janie L

    2010-06-01

    The NIOSH Construction Program worked with industry stakeholders to develop a National Occupational Safety and Health Construction Agenda to target future research and activities. The Program and its partners are also cognizant that new developments can emerge over time and that research can play an important role in helping to understand and address these emerging issues. Examples of emerging issues relevant to construction safety and health are described. These include: (a) climate change and energy considerations; (b) green construction developments and opportunities; (c) new materials; (d) changes in industry structure and practice; (e) workforce developments and disparities; (f) injury underreporting and cost and risk shifting; and (g) increased interest in addressing root causes. Responding to emerging issues while maintaining a focus on fundamental longstanding issues represents an ongoing challenge for researchers and industry organizations. Additional research to understand the diffusion and adoption of research by the industry is also needed. Research accomplished to date provides a strong foundation for addressing future industry needs and trends. (c) 2010 Elsevier Ltd. All rights reserved.

  3. The Corporate Library and Issues Management.

    ERIC Educational Resources Information Center

    Lancaster, F. W.; Loescher, Jane

    1994-01-01

    Discussion of corporate library services and the role of the librarian focuses on the recognition and tracking of issues of potential significance to the corporation, or issues management. Topics addressed include environmental scanning of relevant literature, and the use of databases to track issues. (16 references) (LRW)

  4. 30 CFR 773.21 - Initial review and finding requirements for improvidently issued permits.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.21 Initial review and finding requirements for improvidently issued permits. (a) If we, the regulatory authority... paragraph (c) of this section, you may challenge the preliminary finding by providing us with evidence as to...

  5. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kroger, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  6. Securities and Exchange Commission Rule 151A and Annuities: Issues and Legislation

    DTIC Science & Technology

    2010-07-01

    brokers are required to be members of the Financial Industry Regulatory Authority (FINRA), a non -governmental self-regulatory organization for the...Issues and Legislation Baird Webel Specialist in Financial Economics Rena S. Miller Analyst in Financial Economics July 1, 2010 Congressional...4173) and the Restoring American Financial Stability Act (S. 3217)....................................................................... 12

  7. Using the Environmental Intelligence Framework to Address Arctic Issues: A Case Study of Alaskan Fisheries and Ocean Acidification

    NASA Astrophysics Data System (ADS)

    Mathis, J. T.; Osborne, E.; Bamzai, A. S.; Starkweather, S.

    2017-12-01

    Profound environmental change in the Arctic region is driving an urgent need for faster and more efficient knowledge creation and delivery for residents of the Arctic as well as stakeholders around the globe. The overarching issues at play include environmental stewardship, community health and cultural survival. To effectively address these issues, the Interagency Arctic Research Policy Committee (IAPRC) recently established the Environmental Intelligence Collaboration Team (EICT) that integrates observing capabilities, modelling efforts and data management. Since its inception, the EICT has been working to create pathways to environmental knowledge that sustains end-to-end integration of research across the linked steps of data integration, environmental observing, predictive modelling, assessing responsiveness to stakeholder needs and ultimately providing decision support. The EICT is currently focusing on the carbon-climate aspect of environmental knowledge and identifing specific decision-making needs to meet policy goals for topics such as carbon emissions from permafrost thaw, increasing wildfire frequency and ocean acidification. As a case study, we applied the Environmental Intelligence framework to understanding the effects of ocean acidification in southern Alaska where there are critical commercial and subsistence fisheries. The results of this work revealed that there is currently a 5-month window of optimal growing conditions at a hatchery facility for many juvenile shellfish although that window is expected to close by 2040. The outcome of this work relates directly to fisheries management decisions and identifies the need for continued Environmental Intelligence collection to monitor and mitigate ocean acidification in the Alaskan region.

  8. 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…

  9. "That's Not Fair!"--Using RET to Address the Issue of Fairness in Classroom Guidance.

    ERIC Educational Resources Information Center

    Kelly, Forrest R., Jr.

    1996-01-01

    If school counselors give a typical Rational Emotive Therapy disputative response to the issue of fairness, students are not helped to develop a more reasonable and rational view on this issue. Describes discussion led by counselor emphasizing choice, acceptance, and the irrationality of the belief that the world is unfair. (LSR)

  10. Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.

    PubMed

    Dickert, Neal W; Brown, Jeremy; Cairns, Charles B; Eaves-Leanos, Aaliyah; Goldkind, Sara F; Kim, Scott Y H; Nichol, Graham; O'Conor, Katie J; Scott, Jane D; Sinert, Richard; Wendler, David; Wright, David W; Silbergleit, Robert

    2016-04-01

    Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report-the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research-we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  11. 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…

  12. Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

    PubMed

    Schechtman, Leonard M

    2002-01-01

    Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also

  13. (PURPA grants to state utility regulatory commissions and electric utilities). Final report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lambert, E.S.

    The Utah Commission considered fully in hearings each of the eleven regulatory and ratemaking standards. In addition, the Commission held hearings concerning the lifeline rates provision of PURPA and the cogeneration and small power production provision. The Utah Commission has taken action with respect to each of these standards. In its Order concerning cases numbered 80-999-09 and 81-999-01, 02, 03, 04, and 05, issued May 14, 1982, and appended to this report, the Utah Commission adopted each of the ratemaking standards. Its actions concerning adoption of the regulatory standards have been the subject of hearings and orders issued during themore » period of time prior to the issuance of the May 14, 1982 Order. After full hearing on the subject, the Utah Commission declined to adopt lifeline rates. In an Order issued April 9, 1981, the Commission implemented the FERC regulations issued pursuant to PURPA Sections 201 and 210. Contained in that Order were interim rates based upon the avoided costs of the electric utilities under this Commission's jurisdiction that are subject to PURPA.« less

  14. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... October 15, 2013. The Nuclear Energy Institute (NEI) submitted a letter on September 17, 2013 (Agencywide... NUCLEAR REGULATORY COMMISSION [NRC-2013-0212: NRC-2013-0211] Environmental Issues Associated With... AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; re-opening of comment period...

  15. Inclusion of ethical issues in dementia guidelines: a thematic text analysis.

    PubMed

    Knüppel, Hannes; Mertz, Marcel; Schmidhuber, Martina; Neitzke, Gerald; Strech, Daniel

    2013-08-01

    Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care. To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained. Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines. Please see later in the article for the Editors

  16. Regulation of stem cell-based therapies in Canada: current issues and concerns.

    PubMed

    von Tigerstrom, Barbara; Nguyen, Thu Minh; Knoppers, Bartha Maria

    2012-09-01

    Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

  17. The importance of defining technical issues in interagency environmental negotiations

    USGS Publications Warehouse

    Lamb, B.L.; Burkardt, N.; Taylor, J.G.

    2001-01-01

    The role of technical clarity in successful multiparty negotiations was studied. Investigations involved in-depth interviews with the principal participants in six consultations conducted under the U.S. Federal Energy Regulatory Commission’s hydroelectric power project licensing procedures. Technical clarity was especially important in these cases because they concerned science-based questions. The principal issues in the six cases were fish passage, instream flow for fish habitat, and entrainment of fish in hydropower turbines. It was concluded that technical clarity was one of the most critical elements in resolving these conflicts. In the least successful negotiations, parties failed to address the basic values of the dispute before plunging into technical studies. The results of those studies usually highlighted the potential for negative outcomes and increased polarization between the participants. In the most successful negotiations, the various parties shared an understanding of each of their basic values. These shared understandings led to technical studies that cast the negotiation in a positive light and illuminated possible solutions.

  18. 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…

  19. The European Regulatory Environment of RNA-Based Vaccines.

    PubMed

    Hinz, Thomas; Kallen, Kajo; Britten, Cedrik M; Flamion, Bruno; Granzer, Ulrich; Hoos, Axel; Huber, Christoph; Khleif, Samir; Kreiter, Sebastian; Rammensee, Hans-Georg; Sahin, Ugur; Singh-Jasuja, Harpreet; Türeci, Özlem; Kalinke, Ulrich

    2017-01-01

    A variety of different mRNA-based drugs are currently in development. This became possible, since major breakthroughs in RNA research during the last decades allowed impressive improvements of translation, stability and delivery of mRNA. This article focuses on antigen-encoding RNA-based vaccines that are either directed against tumors or pathogens. mRNA-encoded vaccines are developed both for preventive or therapeutic purposes. Most mRNA-based vaccines are directly administered to patients. Alternatively, primary autologous cells from cancer patients are modified ex vivo by the use of mRNA and then are adoptively transferred to patients. In the EU no regulatory guidelines presently exist that specifically address mRNA-based vaccines. The existing regulatory framework, however, clearly defines that mRNA-based vaccines in most cases have to be centrally approved. Interestingly, depending on whether RNA-based vaccines are directed against tumors or infectious disease, they are formally considered gene therapy products or not, respectively. Besides an overview on the current clinical use of mRNA vaccines in various therapeutic areas a detailed discussion of the current regulatory situation is provided and regulatory perspectives are discussed.

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

    PubMed

    Lee, David; Chen, Alice; Nair, Ramesh

    2008-01-01

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

  1. The regulatory framework for safe decommissioning of nuclear power plants in Korea

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sangmyeon Ahn; Jungjoon Lee; Chanwoo Jeong

    We are having 23 units of nuclear power plants in operation and 5 units of nuclear power plants under construction in Korea as of September 2012. However, we don't have any experience on shutdown permanently and decommissioning of nuclear power plants. There are only two research reactors being decommissioned since 1997. It is realized that improvement of the regulatory framework for decommissioning of nuclear facilities has been emphasized constantly from the point of view of IAEA's safety standards. It is also known that IAEA will prepare the safety requirement on decommissioning of facilities; its title is the Safe Decommissioning ofmore » Facilities, General Safety Requirement Part 6. According to the result of IAEA's Integrated Regulatory Review Service (IRRS) mission to Korea in 2011, it was recommended that the regulatory framework should require decommissioning plans for nuclear installations to be constructed and operated and these plans should be updated periodically. In addition, after the Fukushima nuclear disaster in Japan in March of 2011, preparedness for early decommissioning caused by an unexpected severe accident became important issues and concerns. In this respect, it is acknowledged that the regulatory framework for decommissioning of nuclear facilities in Korea need to be improved. First of all, we focus on identifying the current status and relevant issues of regulatory framework for decommissioning of nuclear power plants compared to the IAEA's safety standards in order to achieve our goal. And then the plan is established for improvement of regulatory framework for decommissioning of nuclear power plants in Korea. It is expected that if the things will go forward as planned, the revised regulatory framework for decommissioning could enhance the safety regime on the decommissioning of nuclear power plants in Korea in light of international standards. (authors)« less

  2. Physicians’ perspectives on cancer survivors’ work integration issues

    PubMed Central

    Morrison, Tricia; Thomas, Roanne; Guitard, Paulette

    2015-01-01

    Abstract Objective To explore physicians’ perspectives on supporting cancer survivors’ work integration (WI) issues. Design Using vignette methodology, 10 physicians were individually interviewed. Interviews were audiorecorded, transcribed, and subsequently analyzed. Setting Ontario. Participants A total of 10 physicians participated: 5 oncologists and 5 FPs. Methods An inductive interpretive description approach was used to identify themes across the entire data set. Main findings Physicians primarily focused on patients’ medical needs and did not spontaneously address WI issues with them. Instead, it was their patients who raised WI issues, most often owing to insurance requirements. Physicians readily completed insurance forms to aid patients’ well-being, but they did not believe their guidance was empirically sound based upon their limited WI training; rather, they recognized other health professionals, such as occupational therapists, as being better equipped to address cancer survivors’ WI issues. Despite this recognition, referrals for WI support were not routinely facilitated owing to a lack of resources or knowledge. Conclusion Owing to a lack of training and time, as well as the belief that WI issues are not part of their mandate of care, physicians perceive themselves as ill-equipped to address cancer survivors’ WI issues. These findings underscore the need for enhanced awareness of cancer survivors’ WI issues and the need for accessible support services offered by duly trained health care professionals, such as occupational therapists, ideally working in a multidisciplinary team to holistically address cancer survivors’ unique needs. PMID:25756147

  3. Regulatory ozone modeling: status, directions, and research needs.

    PubMed Central

    Georgopoulos, P G

    1995-01-01

    The Clean Air Act Amendments (CAAA) of 1990 have established selected comprehensive, three-dimensional, Photochemical Air Quality Simulation Models (PAQSMs) as the required regulatory tools for analyzing the urban and regional problem of high ambient ozone levels across the United States. These models are currently applied to study and establish strategies for meeting the National Ambient Air Quality Standard (NAAQS) for ozone in nonattainment areas; State Implementation Plans (SIPs) resulting from these efforts must be submitted to the U.S. Environmental Protection Agency (U.S. EPA) in November 1994. The following presentation provides an overview and discussion of the regulatory ozone modeling process and its implications. First, the PAQSM-based ozone attainment demonstration process is summarized in the framework of the 1994 SIPs. Then, following a brief overview of the representation of physical and chemical processes in PAQSMs, the essential attributes of standard modeling systems currently in regulatory use are presented in a nonmathematical, self-contained format, intended to provide a basic understanding of both model capabilities and limitations. The types of air quality, emission, and meteorological data needed for applying and evaluating PAQSMs are discussed, as well as the sources, availability, and limitations of existing databases. The issue of evaluating a model's performance in order to accept it as a tool for policy making is discussed, and various methodologies for implementing this objective are summarized. Selected interim results from diagnostic analyses, which are performed as a component of the regulatory ozone modeling process for the Philadelphia-New Jersey region, are also presented to provide some specific examples related to the general issues discussed in this work. Finally, research needs related to a) the evaluation and refinement of regulatory ozone modeling, b) the characterization of uncertainty in photochemical modeling, and c

  4. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ..., Revision 2, ``An Acceptable Model and Related Statistical Methods for the Analysis of Fuel Densification.... Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing guide in the... nuclear power reactors. To meet these objectives, the guide describes statistical methods related to...

  5. 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.

  6. Addressing overuse of health services in health systems: a critical interpretive synthesis.

    PubMed

    Ellen, Moriah E; Wilson, Michael G; Vélez, Marcela; Shach, Ruth; Lavis, John N; Grimshaw, Jeremy M; Moat, Kaelan A

    2018-06-15

    Health systems are increasingly focusing on the issue of 'overuse' of health services and how to address it. We developed a framework focused on (1) the rationale and context for health systems prioritising addressing overuse, (2) elements of a comprehensive process and approach to reduce overuse and (3) implementation considerations for addressing overuse. We conducted a critical interpretive synthesis informed by a stakeholder-engagement process. The synthesis identified relevant empirical and non-empirical articles about system-level overuse. Two reviewers independently screened records, assessed for inclusion and conceptually mapped included articles. From these, we selected a purposive sample, created structured summaries of key findings and thematically synthesised the results. Our search identified 3545 references, from which we included 251. Most articles (76%; n = 192) were published within 5 years of conducting the review and addressed processes for addressing overuse (63%; n = 158) or political and health system context (60%; n = 151). Besides negative outcomes at the patient, system and global level, there were various contextual factors to addressing service overuse that seem to be key issue drivers. Processes for addressing overuse can be grouped into three elements comprising a comprehensive approach, including (1) approaches to identify overused health services, (2) stakeholder- or patient-led approaches and (3) government-led initiatives. Key implementation considerations include the need to develop 'buy in' from stakeholders and citizens. Health systems want to ensure the use of high-value services to keep citizens healthy and avoid harm. Our synthesis can be used by policy-makers, stakeholders and researchers to understand how the issue has been prioritised, what approaches have been used to address it and implementation considerations. PROSPERO CRD42014013204 .

  7. The expanding universe of regulatory T cell subsets in cancer.

    PubMed

    Gajewski, Thomas F

    2007-08-01

    Evidence has indicated that failed antitumor immunity is dominated by immunosuppressive mechanisms within the tumor microenvironment. In this issue of Immunity, Peng et al. (2007) add to this list by describing tumor-infiltrating gammadelta T cells that have regulatory function.

  8. Healthcare M&A: critical issues in today's fast-paced market.

    PubMed

    Ralph, Ron

    2015-09-01

    In an accelerating market for healthcare mergers and acquisitions, parties to a potential deal should consider the following factors when assessing risk and reward: Economic, business, and cultural forces. Funding issues and financing structures. Potential complications during due diligence. The critical importance of effective postmerger integration. The numerous regulatory, tax, and accounting issues that can affect an acquisition.

  9. 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...

  10. Security and health research databases: the stakeholders and questions to be addressed.

    PubMed

    Stewart, Sara

    2006-01-01

    Health research database security issues abound. Issues include subject confidentiality, data ownership, data integrity and data accessibility. There are also various stakeholders in database security. Each of these stakeholders has a different set of concerns and responsibilities when dealing with security issues. There is an obvious need for training in security issues, so that these issues may be addressed and health research will move on without added obstacles based on misunderstanding security methods and technologies.

  11. 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…

  12. Revisiting the Issues: The Uniform Adoption Act.

    ERIC Educational Resources Information Center

    Hollinger, Joan Heifetz

    1995-01-01

    Discusses how a complex regulatory system, along with a lack of consensus about the functions served by adoption, produces uncertainty on many basic issues, including distinguishing lawful adoption versus illegal "baby-selling." The author recommends passage of more uniform state adoption laws, describes the 1994 Uniform Adoption Act,…

  13. Regulatory Aspects of Smart Water Networks in the U.S.

    EPA Science Inventory

    The presentation addresses regulatory aspects of smart water networks in the U.S. It will be presented at the Smart Water Networks Forum (SWAN) annual conference in London, England from April 29-30, 2015. The conference will bring together key voices in the smart water space f...

  14. Abandoning pipelines working group regulatory issues

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    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 themore » 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.« less

  15. 77 FR 59427 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-27

    ...-Regulatory Organizations; Municipal Securities Rulemaking Board; Order Granting Approval of a Proposed Rule Change To Amend Rule G-34 on CUSIP Numbers, New Issue, and Market Information Requirements September 21... consisting of amendments to Rule G-34 on CUSIP numbers, new issue, and market information requirements. The...

  16. Anticipated Ethics and Regulatory Challenges in PCORnet: The National Patient-Centered Clinical Research Network.

    PubMed

    Ali, Joseph; Califf, Robert; Sugarman, Jeremy

    2016-01-01

    PCORnet, the National Patient-Centered Clinical Research Network, seeks to establish a robust national health data network for patient-centered comparative effectiveness research. This article reports the results of a PCORnet survey designed to identify the ethics and regulatory challenges anticipated in network implementation. A 12-item online survey was developed by leadership of the PCORnet Ethics and Regulatory Task Force; responses were collected from the 29 PCORnet networks. The most pressing ethics issues identified related to informed consent, patient engagement, privacy and confidentiality, and data sharing. High priority regulatory issues included IRB coordination, privacy and confidentiality, informed consent, and data sharing. Over 150 IRBs and five different approaches to managing multisite IRB review were identified within PCORnet. Further empirical and scholarly work, as well as practical and policy guidance, is essential if important initiatives that rely on comparative effectiveness research are to move forward.

  17. MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Phillips, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  18. 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)…

  19. 75 FR 62534 - Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference October 1, 2010. The Federal...-referenced proceeding to explore issues associated with reliability monitoring, enforcement and compliance...

  20. 76 FR 47089 - Regulatory Review Schedule; Cancellation of Consultation Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Cancellation of Consultation Meetings AGENCY: National Indian Gaming Commission. ACTION: Notice. SUMMARY: On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and...

  1. Identifying veterinary students' capacity for moral behavior concerning animal ethics issues.

    PubMed

    Verrinder, Joy M; Phillips, Clive J C

    2014-01-01

    Veterinarians face unique animal ethics challenges as practitioners and policy advisors to government and industry. Changing societal attitudes, cultural diversity, and the often conflicting needs and interests of patients and clients contribute to moral distress. Yet little has been done to identify veterinarians' capacity to address these animal ethics issues. In this study, first-year and final-year veterinary students in an Australian university were surveyed to explore moral sensitivity, moral motivation, and moral character and their relationship with moral reasoning. The majority of students were concerned about animal ethics issues and had experienced moral distress in relation to the treatment of animals. Most believed that veterinarians should address the wider social issues of animal protection and that veterinary medicine should require a commitment to animals' interests over owners'/caregivers' interests. There was less agreement that the veterinary profession was sufficiently involved in addressing animal ethics issues. The principal motivators for studying veterinary medicine were, in declining importance, enjoyment in working with animals, helping sick and injured animals, and improving the way animals are treated. However, most students had taken little or no action to address animal ethics issues. These results suggest that both first- and fifth-year veterinary students are sensitive to animal ethics issues and are motivated to prioritize the interests of animals but have little experience in taking action to address these issues. Further research is needed to determine ways to identify and assess these moral behavior components in veterinary education to develop veterinarians' capacity to address animal ethics issues.

  2. Skin sensitisation--moving forward with non-animal testing strategies for regulatory purposes in the EU.

    PubMed

    Basketter, David; Alépée, Nathalie; Casati, Silvia; Crozier, Jonathan; Eigler, Dorothea; Griem, Peter; Hubesch, Bruno; de Knecht, Joop; Landsiedel, Robert; Louekari, Kimmo; Manou, Irene; Maxwell, Gavin; Mehling, Annette; Netzeva, Tatiana; Petry, Thomas; Rossi, Laura H

    2013-12-01

    In a previous EPAA-Cefic LRI workshop in 2011, issues surrounding the use and interpretation of results from the local lymph node assay were addressed. At the beginning of 2013 a second joint workshop focused greater attention on the opportunities to make use of non-animal test data, not least since a number of in vitro assays have progressed to an advanced position in terms of their formal validation. It is already recognised that information produced from non-animal assays can be used in regulatory decision-making, notably in terms of classifying a substance as a skin sensitiser. The evolution into a full replacement for hazard identification, where the decision is not to classify, requires the generation of confidence in the in vitro alternative, e.g. via formal validation, the existence of peer reviewed publications and the knowledge that the assay(s) are founded on key elements of the Adverse Outcome Pathway for skin sensitisation. It is foreseen that the validated in vitro assays and relevant QSAR models can be organised into formal testing strategies to be applied for regulatory purposes by the industry. To facilitate progress, the European Partnership for Alternative Approaches to animal testing (EPAA) provided the platform for cross-industry and regulatory dialogue, enabling an essential and open debate on the acceptability of an in vitro based integrated strategy. Based on these considerations, a follow up activity was agreed upon to explore an example of an Integrated Testing Strategy for skin sensitisation hazard identification purposes in the context of REACH submissions. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. 77 FR 33253 - Regulatory Guide 8.24, Revision 2, Health Physics Surveys During Enriched Uranium-235 Processing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0115] Regulatory Guide 8.24, Revision 2, Health Physics..., ``Health Physics Surveys During Enriched Uranium-235 Processing and Fuel Fabrication'' was issued with a... specifically with the following aspects of an acceptable occupational health physics program that are closely...

  4. Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

    PubMed

    Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

    2014-01-01

    International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

  5. Ethical issues in perinatal mental health research.

    PubMed

    Brandon, Anna R; Shivakumar, Geetha; Lee, Simon Craddock; Inrig, Stephen J; Sadler, John Z

    2009-11-01

    To review the background of current ethical standards for the conduct of perinatal mental health research and describe the ethical challenges in this research domain. Current literature reflects a growing sentiment in the scientific community that having no information regarding the impact of psychiatric treatment on the mother and developing fetus/infant poses dangers that may exceed the risks involved in research. However, without sufficient consensus across the scientific community, both regulatory bodies and perinatal researchers find themselves without a framework for decision making that satisfactorily limits the risks and facilitates the benefits of participation of pregnant and lactating women in clinical research. Psychiatric research in perinatal mental health is critically important as it enables clinicians and patients to participate in informed decision-making concerning treatment for psychiatric disorders. Specific areas of concern include fetal safety, maternal risk, the therapeutic misconception, commercial interests, forensic/legal issues, the informed consent process, and study design. Developing guidelines that address ethical challenges and include the views and concerns of multiple stakeholders could improve the access of perinatal women to the benefits of participation in mental health research in addition to providing evidence-based mental healthcare for this subpopulation.

  6. Computer Technology and Social Issues.

    ERIC Educational Resources Information Center

    Garson, G. David

    Computing involves social issues and political choices. Issues such as privacy, computer crime, gender inequity, disemployment, and electronic democracy versus "Big Brother" are addressed in the context of efforts to develop a national public policy for information technology. A broad range of research and case studies are examined in an…

  7. Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

    PubMed

    McBlane, James W; Phul, Parvinder; Sharpe, Michaela

    2018-06-25

    This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical. After establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined. This includes understanding biodistribution, persistence and toxicity, including potential for malignant transformation. These elements need to be considered in the context of the intended clinical development. This article describes regulatory mechanisms available to developers to support product development that aim to resolve scientific issues prior to marketing authorization application, to enable patients to have faster access to the product than would otherwise be the case. Developers are encouraged to be aware of both the scientific issues and regulatory mechanisms to ensure patients can be supplied with these products.

  8. Regulatory landscape for cell therapy--EU view.

    PubMed

    McBlane, James W

    2015-09-01

    This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. For clinical trials, this can lead to different decisions in different countries for the same trial. A regulation is soon to come into force that will address this and introduce a more efficient clinical trial application process. However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators. Copyright © 2015.

  9. Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis

    PubMed Central

    Knüppel, Hannes; Schmidhuber, Martina; Neitzke, Gerald

    2013-01-01

    Background Clinical practice guidelines (CPGs) aim to improve professionalism in health care. However, current CPG development manuals fail to address how to include ethical issues in a systematic and transparent manner. The objective of this study was to assess the representation of ethical issues in general CPGs on dementia care. Methods and Findings To identify national CPGs on dementia care, five databases of guidelines were searched and national psychiatric associations were contacted in August 2011 and in June 2013. A framework for the assessment of the identified CPGs' ethical content was developed on the basis of a prior systematic review of ethical issues in dementia care. Thematic text analysis and a 4-point rating score were employed to assess how ethical issues were addressed in the identified CPGs. Twelve national CPGs were included. Thirty-one ethical issues in dementia care were identified by the prior systematic review. The proportion of these 31 ethical issues that were explicitly addressed by each CPG ranged from 22% to 77%, with a median of 49.5%. National guidelines differed substantially with respect to (a) which ethical issues were represented, (b) whether ethical recommendations were included, (c) whether justifications or citations were provided to support recommendations, and (d) to what extent the ethical issues were explained. Conclusions Ethical issues were inconsistently addressed in national dementia guidelines, with some guidelines including most and some including few ethical issues. Guidelines should address ethical issues and how to deal with them to help the medical profession understand how to approach care of patients with dementia, and for patients, their relatives, and the general public, all of whom might seek information and advice in national guidelines. There is a need for further research to specify how detailed ethical issues and their respective recommendations can and should be addressed in dementia guidelines. Please

  10. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    PubMed Central

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations. PMID:28101455

  11. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development.

    PubMed

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-12-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

  12. From coverage to care: addressing the issue of churn.

    PubMed

    Milligan, Charles

    2015-02-01

    In any given year, a significant number of individuals will move between Medicaid and qualified health plans (QHP). Known as "churn," this movement could disrupt continuity of health care services, even when no gap in insurance coverage exists. The number of people who churn in any given year is significant, and they often are significant utilizers of health care services. They could experience disruption in care in several ways: (1) changing carrier; (2) changing provider because of network differences; (3) a disruption in ongoing services, even when the benefit is covered in both programs (e.g., surgery that has been authorized but not yet performed; ongoing prescription medications for chronic illness; or some but not all therapy or counseling sessions have been completed); and (4) the loss of coverage for a service that is not a covered benefit in the new program. Many strategies are available to states to reduce the disruption caused by churn. The specific option, intervention, and set of policies in a given state will depend on its context. Policy makers would benefit from an examination and discussion of these issues. Copyright © 2015 by Duke University Press.

  13. 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,…

  14. Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.

    PubMed

    Sferrazza, Gianluca; Siviero, Paolo D; Nicotera, Giuseppe; Turella, Paola; Serafino, Annalucia; Blandizzi, Corrado; Pierimarchi, Pasquale

    2017-09-01

    Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.

  15. ITS National Architecture -- Rural Issues Workshop

    DOT National Transportation Integrated Search

    1995-06-15

    THE PURPOSE OF THE WORKSHOP IS TO BRING TOGETHER A DIVERSITY OF PEOPLE INTERESTED IN HOW THE NATIONAL ITS ARCHITECTURE IS ADDRESSING ISSUES THAT IMPACT IMPLEMENTATION OF ITS IN RURAL AREAS (AND TO WHAT DEGREE IT ADDRESSES THEM). : THE TWO-DAY AGEN...

  16. A Restorationist Views the Modernist/Post Modernist Debate. (Presidential Address).

    ERIC Educational Resources Information Center

    Flinders, Neil J.

    The nation's schools and society in general face serious problems that are largely rooted in moral and spiritual issues. Modern philosophy has led to a secular culture in which the existence of a divine God has been rejected, and man has become his own God, his own standard of measurement. These issues are addressed from the point of view of a…

  17. Participatory workplace wellness programs: reward, penalty, and regulatory conflict.

    PubMed

    Pomeranz, Jennifer L

    2015-06-01

    POLICY POINTS: Workplace wellness programs that provide incentives for completing a health risk assessment are a form of participatory programs. There are legal and ethical concerns when employers assess penalties for not completing a health risk assessment, raising questions about the voluntariness of such a program. The Departments of Treasury, Labor, and Health and Human Services' 2013 regulations for participatory programs and employers' current practices conflict with the Equal Employment Opportunity Commission's prevailing interpretation of the Americans with Disabilities Act of 1990. In keeping with the Patient Protection and Affordable Care Act, Congress revised the law related to workplace wellness programs. In June 2013, the Departments of Treasury, Labor, and Health and Human Services passed the final regulations, updating their 2006 regulatory framework. Participatory programs that reward the completion of a health risk assessment are now the most common type of wellness program in the United States. However, legal and ethical concerns emerge when employers utilize incentives that raise questions about the voluntariness of such programs. At issue is that under the Americans with Disabilities Act (ADA) of 1990, employers cannot require health-related inquiries and exams. To analyze the current interpretation of the ADA, I conducted research on both LexisNexis and federal agency websites. The resulting article evaluates the differences in the language of Congress's enabling legislation and the federal departments' regulations and how they may conflict with the ADA. It also reviews the federal government's authority to address both the legal conflict and ethical concerns related to nonvoluntary participatory programs. Employers' practices and the federal departments' regulations conflict with the current interpretation of the ADA by permitting employers to penalize employees who do not complete a health risk assessment. The departments' regulations may be

  18. 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.

  19. 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 Central

    Yamada, Ann-Marie; Brekke, John S

    2008-01-01

    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. PMID:18778881

  20. Teaching Social Issues in the English Classroom.

    ERIC Educational Resources Information Center

    Totten, Samuel, Ed.

    1986-01-01

    Focusing on the rationales and materials for teaching social issues in the English classroom, this thematic issue contains the following articles: "Introduction: Reflections of Society in Literature" (M. B. Fleming); "Addressing Social and/or Controversial Issues in the English Classroom" (S. Totten); "The Growing Threat to Quality Education: How…

  1. A Case Study on Science Teacher Leadership to Address Diversity and Equity Through Professional Development

    NASA Astrophysics Data System (ADS)

    Doraiswamy, Nithya

    This qualitative case study focused on the multifaceted issue of exploring science teacher leaders understanding and addressing of issues of diversity and equity with peers through professional development. The purpose of the study was to highlight the opportunities and barriers to the addressing of issues of diversity and equity through the work of a community of teachers leaders in science professional development. To frame this study, the researcher drew from the interdisciplinary field of multicultural education, transformative learning, and teacher leadership. In drawing out the connections from these vast bodies of literature, the study speaks to the need of both, creating teacher leaders in science education who are capable of meeting the twin demands of excellence and equity, and also attending to the challenges in the professional learning continuums of teachers leaders and their peers towards addressing issues of diversity and equity in science education.

  2. Plant maintenance and advanced reactors issue, 2004

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Agnihotri, Newal

    2004-09-15

    The focus of the September-October issue is on plant maintenance and advanced reactors. Major articles/reports in this issue include: Optimism about the future of nuclear power, by Ruth G. Shaw, Duke Power Company; Licensed in three countries, by GE Energy; Enhancing public acceptance, by Westinghouse Electric Company; Standardized MOV program, by Ted Neckowicz, Exelon; Inservice testing, by Steven Unikewicz, U.S. Nuclear Regulatory Commission; Asian network for education, Fatimah Mohd Amin, Malaysian Institute for Nuclear Technology Research; and, Cooling water intake optimization, by Jeffrey M. Jones and Bert Mayer, P.E., Framatome ANP.

  3. Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges

    PubMed Central

    Knowles, Lori; Luth, Westerly; Bubela, Tania

    2017-01-01

    Abstract Personalized medicine (PM) aims to harness a wave of ‘omics’ discoveries to facilitate research and discovery of targeted diagnostics and therapies and increase the efficiency of healthcare systems by predicting and treating individual predispositions to diseases or conditions. Despite significant investment, limited progress has been made bringing PM to market. We describe the major perceived regulatory, intellectual property, and reimbursement challenges to the development, translation, adoption, and implementation of PM products into clinical care. We conducted a scoping review to identify (i) primary challenges for the development and implementation of PM identified in the academic literature; (ii) solutions proposed in the academic literature to address these challenges; and (iii) gaps that exist in that literature. We identified regulatory barriers to PM development and recommendations in 344 academic papers. Regulatory uncertainty was a cross-cutting theme that appeared in conjunction with other themes including: reimbursement; clinical trial regulation; regulation of co-development; unclear evidentiary requirements; insufficient incentives for research and development; incompatible information systems; and different regulation of different diagnostics. To fully realize the benefits of PM for healthcare systems and patients, regulatory, intellectual property, and reimbursement challenges need to be addressed in lock step with scientific advances. PMID:29868182

  4. A prior-based integrative framework for functional transcriptional regulatory network inference

    PubMed Central

    Siahpirani, Alireza F.

    2017-01-01

    Abstract Transcriptional regulatory networks specify regulatory proteins controlling the context-specific expression levels of genes. Inference of genome-wide regulatory networks is central to understanding gene regulation, but remains an open challenge. Expression-based network inference is among the most popular methods to infer regulatory networks, however, networks inferred from such methods have low overlap with experimentally derived (e.g. ChIP-chip and transcription factor (TF) knockouts) networks. Currently we have a limited understanding of this discrepancy. To address this gap, we first develop a regulatory network inference algorithm, based on probabilistic graphical models, to integrate expression with auxiliary datasets supporting a regulatory edge. Second, we comprehensively analyze our and other state-of-the-art methods on different expression perturbation datasets. Networks inferred by integrating sequence-specific motifs with expression have substantially greater agreement with experimentally derived networks, while remaining more predictive of expression than motif-based networks. Our analysis suggests natural genetic variation as the most informative perturbation for network inference, and, identifies core TFs whose targets are predictable from expression. Multiple reasons make the identification of targets of other TFs difficult, including network architecture and insufficient variation of TF mRNA level. Finally, we demonstrate the utility of our inference algorithm to infer stress-specific regulatory networks and for regulator prioritization. PMID:27794550

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Address Loss of Large Areas of the Plant Due to Explosions and Fires AGENCY: Nuclear Regulatory Commission... Standard Review Plan (SRP), Section 19.4 ``Strategies and Guidance to Address Loss of Large Areas of the... review of the subject of loss-of-large areas of the plant due to explosions and fires. DATES: Submit...

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2008-08-01

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

  8. Measuring Up: Assessment Issues for Teachers, Counselors, and Administrators.

    ERIC Educational Resources Information Center

    Wall, Janet E., Ed.; Walz, Garry R., Ed.

    This book attempts to promote improved understanding of assessment concepts by addressing the broad expanse of issues facing educators as they go about their duties and fulfill their responsibilities in schools and classrooms. The chapters in the book address some of the "hot button" issues related to testing and assessment in our nation's…

  9. Education Issues. GAO Transition Series.

    ERIC Educational Resources Information Center

    Comptroller General of the U.S., Washington, DC.

    This summary report is one of a series addressing major policy, management, or program issues facing Congress and the administration. The issues identified in this report indicate the need to: reduce the cost and preserve the integrity of higher education student loan and grant programs; enhance the federal role in monitoring lenders, agencies,…

  10. Foreword: Biomonitoring Equivalents special issue.

    PubMed

    Meek, M E; Sonawane, B; Becker, R A

    2008-08-01

    The challenge of interpreting results of biomonitoring for environmental chemicals in humans is highlighted in this Foreword to the Biomonitoring Equivalents (BEs) special issue of Regulatory Toxicology and Pharmacology. There is a pressing need to develop risk-based tools in order to empower scientists and health professionals to interpret and communicate the significance of human biomonitoring data. The BE approach, which integrates dosimetry and risk assessment methods, represents an important advancement on the path toward achieving this objective. The articles in this issue, developed as a result of an expert panel meeting, present guidelines for derivation of BEs, guidelines for communication using BEs and several case studies illustrating application of the BE approach for specific substances.

  11. 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. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    PubMed Central

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

    2017-01-01

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

  13. Why issues emerge

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Coates, J.F.; Jarrett, J.; Decker, C.

    1989-10-01

    For those analysts and managers responsible for anticipating issues that may become important to their organizations, the origin of such issues is an important question. This study looks at how, and why, an issue may emerge from a situation, or an event. The full development of an issue, and its resolution may take from five to 30 years or more. The earlier it can be anticipated, the more opportunity for its stakeholders to develop positions and options for addressing it. Three approaches to examining the origins of issues are employed; the invention of ten models as metaphors for the formationmore » and growth of issues; the test of these models against 12 well-known, and fully developed issues; and the analysis of three case studies of issue development. This analysis assesses the readiness at different times for cultural, institutional and situational factors to allow or promote a situation to transition into an issue. Six of the ten conceptual models prove to be more powerful metaphors of issue development than the others. Analysis of the case studies shows that a readiness assessment of an unfolding situation may yield clues to a new issue. A readiness checklist is provided. 6 figs., 4 tabs.« less

  14. Regulatory Myeloid Cells in Transplantation

    PubMed Central

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

    2013-01-01

    Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages (Mreg), regulatory dendritic cells (DCreg) and myeloid-derived suppressor cells (MDSC) to regulate alloimmunity, their potential as cellular therapeutic agents and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity following RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and usher in a new era of immune modulation exploiting cells of myeloid origin. PMID:24092382

  15. How Partners are Producing Science and Addressing Issues of Scale for Springs Management in the Desert Southwest

    NASA Astrophysics Data System (ADS)

    Johnson, G.; Springer, A. E.; Misztal, L.; Grabau, M.

    2017-12-01

    decisions that address resource protection at the regional level and in climate change adaptation planning for natural resources. This work highlights the need to increase collaboration and coproduction of information tailored for management issues at different spatial and temporal scales.

  16. 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…

  17. The Public-Private Divide in Ethiopian Higher Education: Issues and Policy Implications

    ERIC Educational Resources Information Center

    Nega, Mulu

    2017-01-01

    This article explores the current issues on the public-private divide in the Ethiopian higher education landscape and their policy implications. It critically examines issues related to legal and regulatory frameworks in order to understand the public-private divide in the Ethiopian higher education context. The article is based on two premises.…

  18. Interventions to address the stigma associated with leprosy: a perspective on the issues.

    PubMed

    Cross, Hugh

    2006-08-01

    This paper presents a perspective on stigma as an effect of leprosy. It identifies some of the strengths and weaknesses of current approaches to stigma reduction in leprosy and presents a rationale for considering alternative strategies. It is suggested that models used to explain health behavior in developed societies are inappropriate for explaining leprosy stigma or for developing strategies to address it. The author recommends due consideration of the alternative logic that characterizes cultural belief systems in countries where leprosy is a challenge. Criticism of the common practice of information dissemination as a strategy to address leprosy stigma is defended and the merits and limitations of an integrated health service in India is discussed. The author defends the suggestion that the principal objective of stigma interventions should be "normalization". An example of a Nepalese project based on empowerment theory is given to demonstrate how the transformation of identity from outcast to positive change agent, can effect "normalization".

  19. New technologies in radiation therapy: ensuring patient safety, radiation safety and regulatory issues in radiation oncology.

    PubMed

    Amols, Howard I

    2008-11-01

    New technologies such as intensity modulated and image guided radiation therapy, computer controlled linear accelerators, record and verify systems, electronic charts, and digital imaging have revolutionized radiation therapy over the past 10-15 y. Quality assurance (QA) as historically practiced and as recommended in reports such as American Association of Physicists in Medicine Task Groups 40 and 53 needs to be updated to address the increasing complexity and computerization of radiotherapy equipment, and the increased quantity of data defining a treatment plan and treatment delivery. While new technology has reduced the probability of many types of medical events, seeing new types of errors caused by improper use of new technology, communication failures between computers, corrupted or erroneous computer data files, and "software bugs" are now being seen. The increased use of computed tomography, magnetic resonance, and positron emission tomography imaging has become routine for many types of radiotherapy treatment planning, and QA for imaging modalities is beyond the expertise of most radiotherapy physicists. Errors in radiotherapy rarely result solely from hardware failures. More commonly they are a combination of computer and human errors. The increased use of radiosurgery, hypofractionation, more complex intensity modulated treatment plans, image guided radiation therapy, and increasing financial pressures to treat more patients in less time will continue to fuel this reliance on high technology and complex computer software. Clinical practitioners and regulatory agencies are beginning to realize that QA for new technologies is a major challenge and poses dangers different in nature than what are historically familiar.

  20. 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.

  1. 33 CFR 320.2 - Authorities to issue permits.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ....2 Section 320.2 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE GENERAL REGULATORY POLICIES § 320.2 Authorities to issue permits. (a) Section 9 of the... causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of...

  2. 33 CFR 320.2 - Authorities to issue permits.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....2 Section 320.2 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE GENERAL REGULATORY POLICIES § 320.2 Authorities to issue permits. (a) Section 9 of the... causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of...

  3. 33 CFR 320.2 - Authorities to issue permits.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....2 Section 320.2 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE GENERAL REGULATORY POLICIES § 320.2 Authorities to issue permits. (a) Section 9 of the... causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of...

  4. 33 CFR 320.2 - Authorities to issue permits.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ....2 Section 320.2 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE GENERAL REGULATORY POLICIES § 320.2 Authorities to issue permits. (a) Section 9 of the... causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of...

  5. 33 CFR 320.2 - Authorities to issue permits.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....2 Section 320.2 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE GENERAL REGULATORY POLICIES § 320.2 Authorities to issue permits. (a) Section 9 of the... causeways was transferred to the Secretary of Transportation under the Department of Transportation Act of...

  6. 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

  7. Massively parallel cis-regulatory analysis in the mammalian central nervous system

    PubMed Central

    Shen, Susan Q.; Myers, Connie A.; Hughes, Andrew E.O.; Byrne, Leah C.; Flannery, John G.; Corbo, Joseph C.

    2016-01-01

    Cis-regulatory elements (CREs, e.g., promoters and enhancers) regulate gene expression, and variants within CREs can modulate disease risk. Next-generation sequencing has enabled the rapid generation of genomic data that predict the locations of CREs, but a bottleneck lies in functionally interpreting these data. To address this issue, massively parallel reporter assays (MPRAs) have emerged, in which barcoded reporter libraries are introduced into cells, and the resulting barcoded transcripts are quantified by next-generation sequencing. Thus far, MPRAs have been largely restricted to assaying short CREs in a limited repertoire of cultured cell types. Here, we present two advances that extend the biological relevance and applicability of MPRAs. First, we adapt exome capture technology to instead capture candidate CREs, thereby tiling across the targeted regions and markedly increasing the length of CREs that can be readily assayed. Second, we package the library into adeno-associated virus (AAV), thereby allowing delivery to target organs in vivo. As a proof of concept, we introduce a capture library of about 46,000 constructs, corresponding to roughly 3500 DNase I hypersensitive (DHS) sites, into the mouse retina by ex vivo plasmid electroporation and into the mouse cerebral cortex by in vivo AAV injection. We demonstrate tissue-specific cis-regulatory activity of DHSs and provide examples of high-resolution truncation mutation analysis for multiplex parsing of CREs. Our approach should enable massively parallel functional analysis of a wide range of CREs in any organ or species that can be infected by AAV, such as nonhuman primates and human stem cell–derived organoids. PMID:26576614

  8. Genetic testing: medico-legal issues.

    PubMed

    Bird, Sara

    2014-07-01

    The availability and frequency of genetic testing is increasing. Genetic testing poses some unique ethical and legal issues for medical practitioners because of the potential to identify genetic variants that carry implications for the risk of disease in the future for the patient and their relatives. The regulatory framework within which genetic testing is provided in Australia is also changing. This article examines some medico-legal issues associated with genetic testing that general practitioners (GPs) are likely encounter in their practices. There is inevitable involvement of the GP in the long term care of a patient (and possibly their family) following genetic testing, regardless of whether or not the GP has ordered the testing. Cases are presented to illustrate some of the medico-legal issues that may arise from direct-to-consumer genetic testing, information disclosure to genetic relatives and requests for parentage testing.

  9. Development of Regulatory Documents for Creation (Upgrade) of Physical Protection Systems under the Russian/American MPC&A Program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Izmaylov, Alexandr V.; Babkin, Vladimir; Kurov, Valeriy

    2009-10-07

    The development of new or the upgrade of existing physical protection systems (PPS) for nuclear facilities involves a multi-step and multidimensional process. The process consists of conceptual design, design, and commissioning stages. The activities associated with each of these stages are governed by Russian government and agency regulations. To ensure a uniform approach to development or upgrading of PPS at Russian nuclear facilities, the development of a range of regulatory and methodological documents is necessary. Some issues of PPS development are covered by the regulatory documents developed by Rosatom, as well as other Russian agencies with nuclear facilities under theirmore » control. This regulatory development has been accomplished as part of the U.S.-Russian MPC&A cooperation or independently by the Russian Federation. While regulatory coverage is extensive, there are a number of issues such as vulnerability analysis, effectiveness assessment, upgrading PPS, and protection of information systems for PPS that require additional regulations be developed. This paper reports on the status of regulatory coverage for PPS development or upgrade, and outlines a new approach to regulatory document development. It describes the evolutionary process of regulatory development through experience gained in the design, development and implementation of PPS as well as experience gained through the cooperative efforts of Russian and U.S. experts involved the development of MPC&A regulations.« less

  10. Engagement studios: students and communities working to address the determinants of health.

    PubMed

    Bainbridge, Lesley; Grossman, Susan; Dharamsi, Shafik; Porter, Jill; Wood, Victoria

    2014-01-01

    This article presents an innovative model for interprofessional community-oriented learning. The Engagement Studios model involves a partnership between community organizations and students as equal partners in conversations and activities aimed at addressing issues of common concern as they relate to the social determinants of health. Interprofessional teams of students from health and non-health disciplines work with community partners to identify priority community issues and explore potential solutions. The student teams work with a particular community organization, combining their unique disciplinary perspectives to develop a project proposal, which addresses the community issues that have been jointly identified. Approved proposals receive a small budget to implement the project. In this paper we present the Engagement Studios model and share lessons learned from a pilot of this educational initiative.

  11. Addressing Environmental Health Inequalities.

    PubMed

    Gouveia, Nelson

    2016-08-27

    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.

  12. Following the giant's paces-governance issues and bioethical reflections in China.

    PubMed

    Wang, Zhaochen; Zhang, Di; Ng, Vincent H; Lie, Reidar; Zhai, Xiaomei

    2014-10-31

    China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus on bioethics developments in western countries, but also should pay attention to the situation in China. Under this era of rapid advancement in genomics, reassessing the conventionally accepted bioethical principles is strongly needed. In this paper, we will analyze the case of BGI in the context of the Chinese regulatory system in order to identify methods to regulate genetic research more effectively and to strengthen BGI's role in international collaborative research projects. Three main issues concerning sample collection and samples/data management are addressed. Firstly, an ambiguous definition of research, which does not specifically include biosamples/data, when applied to genetic research, may cause confusion and leave loopholes in governance. Secondly, the current regulations do not provide sufficient guidelines on the details of what information to present to prospective subjects, and how to combine informed consent with strategies of re-consent, withdrawal and feedback from research. Finally, the existing regulations do not adequately address issues of genetic privacy and data protection. Bioethical issues related to genetic research in China may be partially due to the nature of genetic research and partially stems from the strategy of simply adopting general international guidelines into the Chinese context without detailed considerations of the local needs. However, there are no perfect readymade ethical solutions for

  13. Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".

    PubMed

    O'Reilly, Erin K; Blair Holbein, M E; Berglund, Jelena P; Parrish, Amanda B; Roth, Mary-Tara; Burnett, Bruce K

    2013-12-01

    This study highlights Warning Letter (WL) findings issued to sponsor-investigators (S-Is) by the Food and Drug Administration (FDA). The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. A review of FDA WLs issued over a five-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

  14. 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…

  15. Developing a Fitness to Teach Policy to Address Retention Issues in Teacher Education

    ERIC Educational Resources Information Center

    Desjean-Perrotta, Blanche

    2006-01-01

    Teaching, to a large degree, depends on more than just technical skills. The demands of classroom teaching require interpersonal skills and dispositions that are often ignored when determining a preservice teacher's fitness to teach. This article provides an example of how one university addresses the challenge of evaluating students' skills and…

  16. RSAT 2018: regulatory sequence analysis tools 20th anniversary.

    PubMed

    Nguyen, Nga Thi Thuy; Contreras-Moreira, Bruno; Castro-Mondragon, Jaime A; Santana-Garcia, Walter; Ossio, Raul; Robles-Espinoza, Carla Daniela; Bahin, Mathieu; Collombet, Samuel; Vincens, Pierre; Thieffry, Denis; van Helden, Jacques; Medina-Rivera, Alejandra; Thomas-Chollier, Morgane

    2018-05-02

    RSAT (Regulatory Sequence Analysis Tools) is a suite of modular tools for the detection and the analysis of cis-regulatory elements in genome sequences. Its main applications are (i) motif discovery, including from genome-wide datasets like ChIP-seq/ATAC-seq, (ii) motif scanning, (iii) motif analysis (quality assessment, comparisons and clustering), (iv) analysis of regulatory variations, (v) comparative genomics. Six public servers jointly support 10 000 genomes from all kingdoms. Six novel or refactored programs have been added since the 2015 NAR Web Software Issue, including updated programs to analyse regulatory variants (retrieve-variation-seq, variation-scan, convert-variations), along with tools to extract sequences from a list of coordinates (retrieve-seq-bed), to select motifs from motif collections (retrieve-matrix), and to extract orthologs based on Ensembl Compara (get-orthologs-compara). Three use cases illustrate the integration of new and refactored tools to the suite. This Anniversary update gives a 20-year perspective on the software suite. RSAT is well-documented and available through Web sites, SOAP/WSDL (Simple Object Access Protocol/Web Services Description Language) web services, virtual machines and stand-alone programs at http://www.rsat.eu/.

  17. Counseling Issues for Adult Women in Career Transition

    ERIC Educational Resources Information Center

    Ronzio, Cynthia R.

    2012-01-01

    This article addresses current psychosocial issues facing women in career transition and the implications of those issues for career counselors. Specifically, psychosocial developmental trajectories, the roles of family and relationships, the importance of underlying physical and mental health issues, and sociocultural and contextual stressors are…

  18. Medicare Part D: Pharmacists and formularies--whose job is it to address copays?

    PubMed

    Khan, Shamima

    2014-09-01

    To explore pharmacists' perceived responsibility to assist Part D patients in the community in managing their out-of-pocket (OOP) costs as well as pharmacists' overall experience with Medicare Part D. Cross-sectional analysis. Maine, New Jersey, New York, Massachusetts, Maryland, and Pennsylvania. 272 pharmacists. 37-question online survey. Perceived responsibility to assist Part D patients in managing their OOP costs and pharmacists' overall experience with Medicare Part D. Of the 4,888 online surveys, 1,108 were assumed to have reached the intended recipients, of which 272 responded (adjusted response rate 25.0%). Fifty-seven percent, 43.3%, and 41.9% of pharmacists reported that it was not their responsibility to address Part D patients' copayment/cost issue, prior authorization issues, or dispense preferred formulary medications, respectively. However, 43.2% reported that their most time-consuming task in reference to Part D were addressing formulary and copayment issues. In reference to overall experience with Part D, 42.9% reported that the impact on pharmacy's workflow was negative or very negative. A significant difference was observed between pharmacists' practice settings, the state in which they practiced, and reporting of negative impact of Part D on workflow (χ² = 4.9, P = 0.028; χ² = 6.16, P = 0.013, respectively). Most community pharmacists reported that it was not their responsibility to address patients' OOP costs issues, though a majority reported that the most time-consuming task in reference to Part D was addressing formulary and copayment issues. Almost half of the pharmacists also reported that the impact of Part D on workflow was negative.

  19. Public Education Policy Issues in Montana.

    ERIC Educational Resources Information Center

    Hitz, Randy, Ed.; Chambers, Keith, Ed.

    This document contains articles that address six major issues affecting Montana public education. The issues were selected by an advisory group comprised of representatives from professional education organizations, state agencies, the legislature, and business. Each of the articles, written by members of the advisory group, contains an executive…

  20. Intertextuality for Handling Complex Environmental Issues

    ERIC Educational Resources Information Center

    Byhring, Anne Kristine; Knain, Erik

    2016-01-01

    Nowhere is the need for handling complexity more pertinent than in addressing environmental issues. Our study explores students' situated constructs of complexity in unfolding discourses on socio-scientific issues. Students' dialogues in two group-work episodes are analysed in detail, with tools from Systemic Functional Linguistics. We identify…